,,ii #aafth ,,congress #b;d ,session ,s4 #dgif ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,october #e1 #bjbj,mr4 ,braun introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to address the high costs of health care services1 prescription drugs1 and health insurance coverage in the ,united ,states1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,fair ,care ,act of #bjbj4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,title ,i--,medisave,subtitle ,a--,medisave ,accounts and ,contributions,sec4 #aja4 ,establishment of ,medisave accounts4,sec4 #ajb4 ,consolidation of ,h,s,as1 ,h,r,as1 ,f,s,as1 and ,m,s,as into ,medisave accounts4,sec4 #ajc4 ,health ,reimbursement ,arrangements and ,other ,account-,based ,group ,health ,plans4,sec4 #ajd4 ,cost-sharing reduction payments as eligible contributions4,sec4 #aje4 ,direct primary care4,subtitle ,b--,assistance to ,medisave ,accounts,sec4 #aaa4 ,support in implementation4,sec4 #aab4 ,new corporations required to use ,medisave4,sec4 #aac4 ,federal employee health benefits and ,medisave4,sec4 #aad4 ,grants to ,states for consumer assistance4,title ,,ii--,improving ,private ,health ,insurance,subtitle ,a--,maintaining ,protections for ,patients with ,preexisting ,conditions,sec4 #bja4 ,guaranteed availability of coverage2 prohibiting discrimination4,subtitle ,b--,expanding ,coverage ,options,sec4 #baa4 ,rules governing association health plans4,sec4 #bab4 ,clarification of treatment of single employer arrangements4,sec4 #bac4 ,enforcement provisions relating to association health plans4,sec4 #bad4 ,cooperation between ,federal and ,state authorities4,sec4 #bae4 ,effective date and transitional and other rules4,sec4 #baf4 ,short-term limited duration insurance4,subtitle ,c--,improving ,commercial ,health ,insurance,sec4 #bba4 ,invisible ,guaranteed ,coverage ,pool ,reinsurance ,program2 tax on exchange plans4,sec4 #bbb4 ,employer health insurance mandate repeal4,sec4 #bbc4 ,refundable credits for coverage under a qualified health plan for individuals offered employer-sponsored insurance4,sec4 #bbd4 ,inclusion in income of certain costs of employer-provided coverage under health plans4,sec4 #bbe4 ,change in permissible age variation in health insurance premium rates4,sec4 #bbf4 ,premium assistance adjustment to reflect age4,sec4 #bbg4 ,premium assistance4,sec4 #bbh4 ,adding copper plans to ,exchanges4,sec4 #bbi4 ,copper and bronze plans4,sec4 #bcj4 ,waivers for ,state innovation4,sec4 #bca4 ,enrollment periods4,sec4 #bcb4 ,state-operated ,exchanges flexibility for open enrollment periods4,sec4 #bcc4 ,promoting health plans that cover individuals in more than one ,state4,title ,,iii--,competition1 ,transparency and ,accountability,subtitle ,a--,provider and ,insurer ,competition,sec4 #cja4 ,hospital consolidation4,sec4 #cjb4 ,authority of ,federal ,trade ,commission over certain tax-exempt organizations4,sec4 #cjc4 ,restoring the application of antitrust laws to the business of health insurance4,sec4 #cjd4 ,leveling the playing field between payers and providers4,sec4 #cje4 ,increasing transparency by removing gag clauses on price and quality information4,sec4 #cjf4 ,banning anticompetitive terms in facility and insurance contracts that limit access to higher quality1 lower cost care4,sec4 #cjg4 ,repealing eligibility of certain ,a,c,os4,sec4 #cjh4 ,repeal of health care reform provisions limiting ,medicare exception to the prohibition on certain physician referrals for hospitals4,sec4 #cji4 ,alternative payment model for certain shoppable procedures4,subtitle ,b--,price ,transparency,sec4 #cba4 ,price transparency4,sec4 #cbb4 ,price transparency requirements4,sec4 #cbc4 ,designation of nongovernmental1 nonprofit transparency organizations to lower ,americans' health care costs4,sec4 #cbd4 ,protecting patients and improving the accuracy of provider directory information4,sec4 #cbe4 ,ensuring enrollee access to cost-sharing information4,sec4 #cbf4 ,access of individuals to protected health information4,sec4 #cbg4 ,timely bills for patients4,sec4 #cbh4 ,advisory group on reducing burden of hospital administrative requirements4,sec4 #cbi4 ,data reporting to improve the transparency regarding how #cdj;,b hospital covered entities provide care for patients4,sec4 #ccj4 ,requiring #cdj;,b drug discount program reports by ,,dsh hospital covered entities on low-income utilization rate of outpatient hospital services4,sec4 #cca4 ,employer benefits reports4,sec4 #ccb4 ,group health plan reporting requirements4,sec4 #ccc4 ,government ,accountability ,office study on profit- and revenue-sharing in health care4,subtitle ,c--,prescription ,drug ,competition and ,innovation,sec4 #cda4 ,expedited development and priority review for generic complex drug products4,sec4 #cdb4 ,preventing blocking of generic drugs4,sec4 #cdc4 ,ensuring timely access to generics4,sec4 #cdd4 ,preemption of ,state barriers to the substitution of biosimilar products4,sec4 #cde4 ,increasing pharmaceutical options to treat an unmet medical need4,sec4 #cdf4 ,provisional approval of new human drugs4,sec4 #cdg4 ,consolidating exclusivity periods for drugs treating rare diseases and conditions4,sec4 #cdh4 ,exclusivity period for brand name biological products4,sec4 #cdi4 ,protecting access to biological products4,sec4 #cej4 ,streamlining the transition of biological products4,sec4 #cea4 ,regulation of manufacturer-sponsored copay contributions4,sec4 #ceb4 ,antitrust exemption for private health insurer issuers to negotiate wholesale acquisition prices of prescription drugs purchased from drug manufacturers4,sec4 #cec4 ,biological product innovation4,sec4 #ced4 ,clarifying the meaning of new chemical entity4,sec4 #cee4 ,prompt approval of drugs related to safety information4,sec4 #cef4 ,conditions of use for biosimilar biological products4,sec4 #ceg4 ,education on biological products4,sec4 #ceh4 ,congressional review of the ,food and ,drug ,administration rulemaking4,sec4 #cei4 ,government ,accountability ,office study of rules4,subtitle ,d--,prescription ,drug and ,pharmacy ,benefit ,manager ,transparency,sec4 #cfa4 ,patent disclosure requirements4,sec4 #cfb4 ,biological product patent transparency4,sec4 #cfc4 ,orange ,book modernization4,sec4 #cfd4 ,modernizing the labeling of certain generic drugs4,sec4 #cfe4 ,requirements with respect to prescription drug benefits4,sec4 #cff4 ,,pbm transparency and elimination of ,,dir fees4,sec4 #cfg4 ,health plan oversight of pharmacy benefit manager services4,sec4 #cfh4 ,study by ,comptroller ,general of ,united ,states4,subtitle ,e--,medicare and ,medicaid ,prescription ,drug ,reforms,sec4 #cga4 ,medicare part ,b rebate by manufacturers for drugs or biologicals with prices increasing faster than inflation4,sec4 #cgb4 ,market based part ,b pricing index4,sec4 #cgc4 ,innovation model testing of ,medicare drug payments4,sec4 #cgd4 ,modification of maximum rebate amount under ,medicaid drug rebate program4,subtitle ,f--,medical ,malpractice ,reform,sec4 #cha4 ,definitions4,sec4 #chb4 ,encouraging speedy resolution of claims4,sec4 #chc4 ,compensating patient injury4,sec4 #chd4 ,maximizing patient recovery4,sec4 #che4 ,authorization of payment of future damages to claimants in health care lawsuits4,sec4 #chf4 ,product liability for health care providers4,sec4 #chg4 ,effect on other laws4,sec4 #chh4 ,limitation on expert witness testimony4,sec4 #chi4 ,expert witness qualifications4,sec4 #cij4 ,communications following unanticipated outcome4,sec4 #cia4 ,affidavit of merit4,sec4 #cib4 ,notice of intent to commence lawsuit4,sec4 #cic4 ,limitation on liability for volunteer health care professionals4,sec4 #cid4 ,rules of construction4,sec4 #cie4 ,effective date4,title ,,iv--,medicare and ,medicaid ,reforms,subtitle ,a--,medicaid ,reforms,sec4 #dja4 ,medicaid payment reform4,sec4 #djb4 ,income limitations for refundable credits for coverage under a qualified health plan4,sec4 #djc4 ,medicaid eligibility determinations4,sec4 #djd4 ,lowering safe harbor threshold with respect to ,state taxes on health care providers4,sec4 #dje4 ,providing for ,state approval and implementation of specified waivers under the ,medicaid program4,sec4 #djf4 ,deduction for qualified charity care4,subtitle ,b--,medicare ,reforms,sec4 #daa4 ,off-campus provider-based department ,medicare site neutral payment4,sec4 #dab4 ,eliminating ,,fehbp eligibility for annuitants4,sec4 #dac4 ,elimination of ,medicare eligibility for certain individuals4,sec4 #dad4 ,medicare part ,d tax deduction4,sec4 #dae4 ,repeal of net investment income tax4,sec4 #daf4 ,medicare coverage of bad debt4,subtitle ,c--,medicare ,choice and ,competition,sec4 #dba4 ,competitive bidding and premiums under unified ,medicare4,sec4 #dbb4 ,new unified eligibility and enrollment rules4,sec4 #dbc4 ,new benefit structure under unified ,medicare4,sec4 #dbd4 ,late enrollment penalty not to apply for months of any health coverage4,sec4 #dbe4 ,medigap reform4,sec4 #dbf4 ,,aco revision4,sec4 #dbg4 ,primary care options4,sec4 #dbh4 ,general provisions2 effective date4,subtitle ,d--,telehealth ,improvements and ,expansion,sec4 #dca4 ,expansion of coverage of telehealth services4,sec4 #dcb4 ,expanding the use of telehealth through the waiver of certain requirements4,sec4 #dcc4 ,expanding the use of telehealth for mental health services4,sec4 #dcd4 ,use of telehealth in emergency medical care4,sec4 #dce4 ,improvements to the process for adding telehealth services4,sec4 #dcf4 ,rural health clinics and ,federally qualified health centers4,sec4 #dcg4 ,native ,american health facilities4,sec4 #dch4 ,waiver of telehealth restrictions during national emergencies4,sec4 #dci4 ,use of telehealth in recertification for hospice care4,sec4 #ddj4 ,clarification for fraud and abuse laws regarding technologies provided to beneficiaries4,sec4 #dda4 ,study and report on increasing access to telehealth services in the home4,sec4 #ddb4 ,analysis of telehealth waivers in alternative payment models4,sec4 #ddc4 ,model to allow additional health professionals to furnish telehealth services4,sec4 #ddd4 ,testing of models to examine the use of telehealth under the ,medicare program4 ,i ,medisave ,a ,medisave ,accounts and ,contributions #aja4 ,establishment of ,medisave accounts 7a7 ,in general ,part ,,viii of subchapter ,f of chapter #a of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new section3 #ecj;,a4 ,medisave accounts 7a7 ,medisave account ,for purposes of this section-- 7#a7 ,in general ,the term ,medisave account means a trust created or organized in the ,united ,states as a ,medisave account exclusively for the purpose of paying the qualified medical expenses of the account beneficiary1 but only if the written governing instrument creating the trust meets the following requirements3 7,a7 ,except in the case of a rollover contribution described in subparagraph 7,a7 or 7,b7 of subsection 7e77#e71 no contribution will be accepted-- 7i7 unless it is in cash1 7ii7 to the extent such contribution1 when added to previous contributions to the trust for the calendar year1 exceeds the limitation amount specified in subsection 7b77#a71 or 7iii7 to the extent such contribution1 when added to the balance of the account1 exceeds the limitation amount specified in subsection 7b77#b74 7,b7 ,the trustee is a bank 7as defined in section #djh7n771 an insurance company 7as defined in section #haf71 or another person who demonstrates to the satisfaction of the ,secretary that the manner in which such person will administer the trust will be consistent with the requirements of this section4 7,c7 ,no part of the trust assets will be invested in life insurance contracts4 7,d7 ,the assets of the trust will not be commingled with other property except in a common trust fund or common investment fund4 7,e7 ,the interest of an individual in the balance in his account is nonforfeitable4 7#b7 ,qualified medical expenses 7,a7 ,in general ,the term qualified medical expenses means1 with respect to an account beneficiary1 amounts paid by such beneficiary for medical care1 but only to the extent such amounts are not compensated for by insurance or otherwise-- 7i7 for-- 7,i7 such individual1 7,,ii7 the spouse of such individual1 7,,iii7 any dependent 7as defined in section #aeb1 determined without regard to subsections 7b77#a71 7b77#b71 and 7d77#a77;,b7 thereof7 of such individual1 and 7,,iv7 any individual who bears a relationship to the account beneficiary that is described in subparagraph 7,c7 or 7,d7 of section #aeb7;d7 if the account beneficiary is or was a dependent of such individual for any taxable year ending before or with the taxable year in which the individual attained #ah years of age1 and 7ii7 if1 on the date such medical care was provided1 such individual1 spouse or dependent to whom such care was provided was covered under the qualified health insurance of the account beneficiary4 7,b7 ,modified definition of medical care ,for purposes of subparagraph 7,a71 the term medical care has the meaning given such term by section #bac7;d71 except that such term includes-- 7i7 a direct primary care service arrangement1 and 7ii7 predetermined level of access to care from an integrated health plan4 7#c7 ,account beneficiary ,the term account beneficiary means the individual on whose behalf the ,medisave account was established4 7#d7 ,certain rules to apply ,rules similar to the following rules shall apply for purposes of this section3 7,a7 ,section #bai7;d77#b7 7relating to no deduction for rollovers74 7,b7 ,section #bai7;f77#c7 7relating to time when contributions deemed made74 7,c7 ,except as provided in section #ajf7;d71 section #bai7;f77#e7 7relating to employer payments74 7,d7 ,section #djh7;g7 7relating to community property laws74 7,e7 ,section #djh7;h7 7relating to custodial accounts74 7b7 ,limitations 7#a7 ,annual limitation 7,a7 ,in general ,the limitation amount specified in this paragraph is-- 7i7 #e1jjj in the case of a qualified health plan with an actuarial value of less than #dj percent1 7ii7 #d1cjj in the case of a qualified health plan with an actuarial value that is #dj percent or more and less than #ge percent1 and 7iii7 #c1fjj in the case of a qualified health plan with an actuarial value that is #ge percent or more4 7,b7 ,actuarial value of qualified health plan ,for purposes of subparagraph 7,a71 the actuarial value of a qualified health plan is the percentage of the total average costs of covered benefits under the health plan4 7#b7 ,account accumulation limitation ,the limitation amount specified in this paragraph is #ej1jjj4 7#c7 ,indexing 7,a7 ,in general ,in the case of any taxable year beginning in a calendar year after #bjbj1 each dollar amount contained in paragraph 7#a77;,a7 shall be increased by the medical care cost adjustment of such amount for such calendar year4 7,b7 ,medical care cost adjustment ,for purposes of subparagraph 7,a71 the medical care cost adjustment for any calendar year is the percentage 7if any7 by which-- 7i7 the medical care component of the ,c-,,cpi-,u 7as defined in section #a7;f77#f77 for ,august of the preceding calendar year1 exceeds 7ii7 such component of the ,c-,,cpi-,u 7as so defined7 for ,august of #bjai4 7,c7 ,rounding 7i7 ,annual limitation ,if any increase in a dollar amount contained in paragraph 7#a77;,a7 determined under subparagraph 7,a7 is not a multiple of #ajj1 such increase shall be rounded to the nearest multiple of #ajj4 7ii7 ,account limitation ,if any increase in the dollar amount contained in paragraph 7#b7 determined under subparagraph 7,a7 is not a multiple of #a1jjj1 such increase shall be rounded to the nearest multiple of #a1jjj4 7#d7 ,coordination with other contributions ,the limitation which would 7but for this paragraph7 apply under paragraphs 7#a7 and 7#b7 to an individual for any taxable year shall be reduced 7but not below zero7 by the sum of-- 7,a7 the aggregate amount contributed to ,medisave accounts of such individual which is excludable from the taxpayer's gross income for such taxable year under section #ajf7;d71 and 7,b7 the aggregate amount contributed to ,medisave accounts of such individual for such taxable year under section #djh7;d77#i74 7#e7 ,deposit of advance premium tax credit ,an account beneficiary who is eligible for an advance payment of the premium tax credit under section #cf;,b may elect to have the ,secretary deposit the advance payment into the ,medisave account of the account beneficiary4 7c7 ,definitions and special rules ,for purposes of this section-- 7#a7 ,eligible individual 7,a7 ,in general ,the term eligible individual means1 with respect to any month-- 7i7 any individual who is covered under a qualified health plan as of the #ast day of such month2 and 7ii7 any individual whose household income is greater than #bej percent of the ,federal poverty level-- 7,i7 if such individual is covered under a qualified health plan with an actuarial value not more than #hj percent2 or 7,,ii7 if-- 7aa7 such individual is covered under a high deductible health plan as of the #ast day of such month2 and 7bb7 such individual is not1 while covered under a high deductible health plan1 covered under any health plan-- 7,,aa7 which is not a high deductible health plan2 and 7,,bb7 which provides coverage for any benefit which is covered under the high deductible health plan4 7,b7 ,certain coverage disregarded ,subparagraph 7,a7 shall be applied without regard to-- 7i7 coverage for any benefit provided by permitted insurance1 and 7ii7 coverage 7whether through insurance or otherwise7 for accidents1 disability1 dental care1 vision care1 or long-term care4 7,c7 ,special rule for individuals eligible for certain veterans benefits ,an individual shall not fail to be treated as an eligible individual for any period merely because the individual receives hospital care or medical services under any law administered by the ,secretary of ,veterans ,affairs for a service-connected disability 7within the meaning of section #aja7af7 of title #ch1 ,united ,states ,code74 7#b7 ,qualified health plan 7,a7 ,in general ,the term qualified health plan means a health plan that offers health insurance coverage4 ,such term includes entitlement to benefits under title ,,xviii or title ,,xix of the ,social ,security ,act4 7,b7 ,exclusion of certain plans ,such term does not include a health plan if substantially all of its coverage is disregarded under paragraph 7#a77;,b74 7,c7 ,health insurance coverage ,the term health insurance coverage means benefits consisting of medical care 7provided directly1 through insurance or reimbursement1 or otherwise and including items and services paid for as medical care7 under any hospital or medical service policy or certificate1 hospital or medical service plan contract1 or health maintenance organization contract offered by a health insurance issuer4 7,d7 ,health insurance issuer ,the term health insurance issuer means an insurance company1 insurance service1 or insurance organization 7including a health maintenance organization7 which is licensed to engage in the business of insurance in a ,state and which is subject to ,state law which regulates insurance 7within the meaning of section #ead7;b77#b7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aadd7;b77#b7774 7,e7 ,health maintenance organization ,the term health maintenance organization means-- 7i7 a ,federally qualified health maintenance organization 7as defined in section #acja7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;e7a7771 7ii7 an organization recognized under ,state law as a health maintenance organization1 or 7iii7 a similar organization regulated under ,state law for solvency in the same manner and to the same extent as such a health maintenance organization4 7#c7 ,permitted insurance ,the term permitted insurance means-- 7,a7 insurance if substantially all of the coverage provided under such insurance relates to-- 7i7 liabilities incurred under workers' compensation laws1 7ii7 tort liabilities1 7iii7 liabilities relating to ownership or use of property1 or 7iv7 such other similar liabilities as the ,secretary may specify by regulations1 7,b7 insurance for a specified disease or illness1 and 7,c7 insurance paying a fixed amount per day 7or other period7 of hospitalization4 7#d7 ,family coverage ,the term family coverage means any coverage other than self-only coverage4 7d7 ,tax treatment of accounts 7#a7 ,in general ,a ,medisave account is exempt from taxation under this subtitle unless such account has ceased to be a ,medisave account4 ,notwithstanding the preceding sentence1 any ,medisave account is subject to the taxes imposed by section #eaa 7relating to imposition of tax on unrelated business income of charitable1 etc4 organizations74 7#b7 ,account terminations ,rules similar to the rules of paragraphs 7#b7 and 7#d7 of section #djh7;e7 shall apply to ,medisave accounts1 and any amount treated as distributed under such rules shall be treated as not used to pay qualified medical expenses4 7e7 ,tax treatment of distributions 7#a7 ,amounts used for qualified medical expenses ,any amount paid or distributed out of a ,medisave account which is used exclusively to pay qualified medical expenses of any account beneficiary shall not be includible in gross income4 7#b7 ,inclusion of amounts not used for qualified medical expenses ,any amount paid or distributed out of a ,medisave account which is not used exclusively to pay the qualified medical expenses of the account beneficiary shall be included in the gross income of such beneficiary4 7#c7 ,excess contributions returned before due date of return 7,a7 ,in general ,if any excess contribution is contributed for a taxable year to any ,medisave account of an individual1 paragraph 7#b7 shall not apply to distributions from the ,medisave accounts of such individual 7to the extent such distributions do not exceed the aggregate excess contributions to all such accounts of such individual for such year7 if-- 7i7 such distribution is received by the individual on or before the last day prescribed by law 7including extensions of time7 for filing such individual's return for such taxable year1 and 7ii7 such distribution is accompanied by the amount of net income attributable to such excess contribution4 ,any net income described in clause 7ii7 shall be included in the gross income of the individual for the taxable year in which it is received4 7,b7 ,excess contribution ,for purposes of subparagraph 7,a71 the term excess contribution means any contribution 7other than a rollover contribution described in paragraph 7#e77 which exceeds the limitations specified in subsection 7b74 7#d7 ,additional tax on distributions not used for qualified medical expenses 7,a7 ,in general ,the tax imposed by this chapter on the account beneficiary for any taxable year in which there is a payment or distribution from a ,medisave account of such beneficiary which is includible in gross income under paragraph 7#b7 shall be increased by #bj percent of the amount which is so includible4 7,b7 ,exception for disability or death ,subparagraph 7,a7 shall not apply if the payment or distribution is made after the account beneficiary becomes disabled within the meaning of section #gb7m77#g7 or dies4 7#e7 ,rollover contribution 7,a7 ,in general ,an amount is described in this subparagraph as a rollover contribution if it meets the requirements of clauses 7i7 and 7ii74 7i7 ,in general ,paragraph 7#b7 shall not apply to any amount paid or distributed from a ,medisave account to the account beneficiary to the extent the amount received is paid into a ,medisave account for the benefit of such beneficiary not later than the #fjth day after the day on which the beneficiary receives the payment or distribution4 7ii7 ,limitation ,this paragraph shall not apply to any amount described in clause 7i7 received by an individual from a ,medisave account if1 at any time during the #a-year period ending on the day of such receipt1 such individual received any other amount described in clause 7i7 from a ,medisave account which was not includible in the individual's gross income because of the application of this paragraph4 7,b7 ,rollover from ,,fsa1 ,archer ,,msa1 and ,,hsa ,an amount is described in this subparagraph for a calendar year as a rollover contribution if the amount is the remaining balance in a flexible spending account1 ,archer ,,msa1 or health savings account that is contributed to the ,medisave account for a taxable year ending on or before one year after the date of the enactment of the ,fair ,care ,act of #bjbj4 7#f7 ,coordination with medical expense deduction ,for purposes of determining the amount of the deduction under section #bac1 any payment or distribution out of a ,medisave account for qualified medical expenses shall not be treated as an expense paid for medical care4 7#g7 ,transfer of account incident to divorce ,the transfer of an individual's interest in a ,medisave account to an individual's spouse or former spouse under a divorce or separation instrument described in clause 7i7 of section #aba7;d77#c77;,c7 shall not be considered a taxable transfer made by such individual notwithstanding any other provision of this subtitle1 and such interest shall1 after such transfer1 be treated as a ,medisave account with respect to which such spouse is the account beneficiary4 7#h7 ,treatment after death of account beneficiary 7,a7 ,treatment if designated beneficiary is spouse ,if the account beneficiary's surviving spouse acquires such beneficiary's interest in a ,medisave account by reason of being the designated beneficiary of such account at the death of the account beneficiary1 such ,medisave account shall be treated as if the spouse were the account beneficiary4 7,b7 ,other cases 7i7 ,in general ,if1 by reason of the death of the account beneficiary1 any person acquires the account beneficiary's interest in a ,medisave account in a case to which subparagraph 7,a7 does not apply-- 7,i7 such account shall cease to be a ,medisave account as of the date of death1 and 7,,ii7 an amount equal to the fair market value of the assets in such account on such date shall be includible if such person is not the estate of such beneficiary1 in such person's gross income for the taxable year which includes such date1 or if such person is the estate of such beneficiary1 in such beneficiary's gross income for the last taxable year of such beneficiary4 7ii7 ,special rules 7,i7 ,reduction of inclusion for predeath expenses ,the amount includible in gross income under clause 7i7 by any person 7other than the estate7 shall be reduced by the amount of qualified medical expenses which were incurred by the decedent before the date of the decedent's death and paid by such person within #a year after such date4 7,,ii7 ,deduction for estate taxes ,an appropriate deduction shall be allowed under section #fia7;c7 to any person 7other than the decedent or the decedent's spouse7 with respect to amounts included in gross income under clause 7i7 by such person4 7f7 ,reports ,the ,secretary may require-- 7#a7 the trustee of a ,medisave account to make such reports regarding such account to the ,secretary and to the account beneficiary with respect to contributions1 distributions1 the return of excess contributions1 and such other matters as the ,secretary determines appropriate1 and 7#b7 any person who provides an individual with a qualified health plan to make such reports to the ,secretary and to the account beneficiary with respect to such plan as the ,secretary determines appropriate4 ,the reports required by this subsection shall be filed at such time and in such manner and furnished to such individuals at such time and in such manner as may be required by the ,secretary4 7g7 ,regulations and guidance ,for purposes of this section1 the ,secretary shall prescribe such regulations or other guidance as the ,secretary determines necessary or appropriate to carry out this section1 including regulations or guidance on the methods acceptable to the ,secretary for determining qualified health plan actuarial value4 4 7b7 ,clerical amendments ,the table of sections for part ,,viii of subchapter ,f of chapter #a of such ,code is amended by adding at the end the following new item3 ,sec4 #ecj;,a4 ,medisave accounts4 4 7c7 ,effective date ,the amendments made by this section shall apply to taxable years beginning after one year after the date of the enactment of this ,act4 #ajb4 ,consolidation of ,h,s,as1 ,h,r,as1 ,f,s,as1 and ,m,s,as into ,medisave accounts 7a7 ,treatment of employer payments 7#a7 ,exclusion limited to self-funded major medical plan of employers ,section #aje7;b7 of the ,internal ,revenue ,code of #aihf is amended by striking paid1 and inserting paid under a self-funded major medical plan of the employer4 7#b7 ,exclusion not applicable to health reimbursement arrangements ,subsection 7h7 of such ,code is amended to read as follows3 7h7 ,exclusion not applicable to health reimbursement arrangements ,subsection 7b7 shall not apply to health reimbursement arrangements4 4 7#c7 ,repeal of exclusions from income for ,archer ,m,s,as1 ,f,s,as1 and ,h,s,as 7,a7 ,in general ,section #ajf of such ,code is amended-- 7i7 by striking subsections 7b71 7d71 and 7e71 and 7ii7 by redesignating subsections 7f7 and 7g7 as subsections 7d7 and 7e71 respectively4 7,b7 ,exclusion from income for ,medisave accounts ,section #ajf of such ,code1 as amended by subparagraph 7,a71 is amended by inserting after subsection 7a7 the following3 7b7 ,contributions to ,medisave accounts 7#a7 ,in general ,in the case of an employee who is an eligible individual 7as defined in section #ecj;,a7c77#a771 amounts contributed by such employee's employer to any ,medisave account 7as defined in section #ecj;,a7a77 of such employee shall be treated as employer-provided coverage for medical expenses under an accident or health plan to the extent such amounts do not exceed the limitations specified in clauses 7ii7 and 7iii7 of section #ecj;,a7a77#a77;,a7 7determined without regard to this subsection7 which is applicable to such employee for such taxable year unless such employee is receiving and advance payment of the premium tax credit under section1 then such amounts shall not be treated as employer-provided coverage for medical expense under an accident or health plan and are subject to taxation as personal income4 7#b7 ,no constructive receipt ,no amount shall be included in the gross income of any employee solely because the employee may choose between the contributions referred to in paragraph 7#a7 and employer contributions to another health plan of the employer4 7#c7 ,special rule for deduction of employer contributions ,any employer contribution to a ,medisave account1 if otherwise allowable as a deduction under this chapter1 shall be allowed only for the taxable year in which paid4 7#d7 ,employer ,medisave account contributions required to be shown on return ,every individual required to file a return under section #fjab for the taxable year shall include on such return the aggregate amount contributed by employers to the ,medisave accounts of such individual or such individual's spouse for such taxable year4 7#e7 ,medisave account contributions not part of ,,cobra coverage ,paragraph 7#a7 shall not apply for purposes of section #dihj;,b4 7#f7 ,cross reference ,for penalty on failure by employer to make comparable contributions to the ,medisave accounts of comparable employees1 see section #dihj;,g4 4 7#d7 ,distribution from certain retirement accounts for ,medisave account funding ,section #djh7;d77#i7 of such ,code is amended to read as follows3 7#i7 ,distribution for ,medisave account funding 7,a7 ,in general ,in the case of an individual who is an eligible individual 7as defined in section #ecj;,a7c77#a77 and who elects the application of this paragraph for a taxable year1 gross income of the individual for the taxable year does not include a qualified ,medisave account funding distribution to the extent such distribution is otherwise includible in gross income4 7,b7 ,qualified ,medisave account funding distribution ,for purposes of this paragraph1 the term qualified ,medisave account funding distribution means a distribution from an individual retirement plan 7other than a plan described in subsection 7k7 or 7p77 of the employee to the extent that-- 7i7 such distribution is contributed to the ,medisave account of the individual in a direct trustee-to-trustee transfer1 and 7ii7 such distribution-- 7,i7 when added to previous contributions to the ,medisave account for the calendar year does not exceed the limitation amount specified in section #ecj;,a7b77#a71 and 7,,ii7 when added to the balance of the ,medisave account1 exceeds the limitation amount specified in section #ecj;,a7b77#b74 7,c7 ,one-time transfer ,an individual may make an election under subparagraph 7,a7 only for one qualified ,medisave account funding distribution during the lifetime of the individual4 ,such an election1 once made1 shall be irrevocable4 7,d7 ,application of section #gb ,notwithstanding section #gb1 in determining the extent to which an amount is treated as otherwise includible in gross income for purposes of subparagraph 7,a71 the aggregate amount distributed from an individual retirement plan shall be treated as includible in gross income to the extent that such amount does not exceed the aggregate amount which would have been so includible if all amounts from all individual retirement plans were distributed4 ,proper adjustments shall be made in applying section #gb to other distributions in such taxable year and subsequent taxable years4 4 7#e7 ,failure of employer to make comparable contributions 7,a7 ,section #dihj;,g7a7 of such ,code is amended by striking health savings account and inserting ,medisave account4 7,b7 ,section #dihj;,g7c7 of such ,code is amended by striking ,archer ,m,s,as and health savings accounts and inserting ,medisave accounts4 7#f7 ,w-#b statements ,section #fjea7;a7 of such ,code is amended-- 7,a7 by striking paragraph 7#aa7 and redesignating paragraphs 7#ab7 through 7#ag7 as paragraphs 7#aa7 through 7#af71 respectively1 and 7,b7 by amending paragraph 7#aa71 as so redesignated1 to read as follows3 7#aa7 the amount contributed to any ,medisave account 7as defined in section #ecj;,a7 of such employee or such employee's spouse1 4 7b7 ,other conforming amendments 7#a7 ,archer ,m,s,as ,section #bbj7;a7 of such ,code is amended by adding at the end the following3 ,no amount is allowed as a deduction under the preceding sentence for any taxable year beginning after one year after the date of the enactment of the ,fair ,care ,act of #bjbj44 7#b7 ,health savings accounts ,section #bbc7;a7 of such ,code is amended by adding at the end the following3 ,no amount is allowed as a deduction under the preceding sentence for any taxable year beginning after one year after the date of the enactment of the ,fair ,care ,act of #bjbj44 7c7 ,rollover of ,,fsa1 ,archer ,,msa1 ,,hsa to ,medisave account ,notwithstanding any other provision of law1 if the remaining balance in a health flexible spending arrangement1 ,archer ,,msa1 or health savings account is transferred to a ,medisave account before the end of any taxable year ending on or before one year after the date of the enactment of the ,fair ,care ,act of #bjbj1 such transfer shall be treated as a rollover to the ,medisave account under section #ecj;,a7e77#e77;,b7 of the ,internal ,revenue ,code of #aihf and the distribution from the health flexible spending arrangement1 ,archer ,,msa1 or health savings account shall not be includible in gross income4 7d7 ,effective date ,the amendments made by this section shall apply to taxable years beginning after one year after the date of the enactment of this ,act4 #ajc4 ,health ,reimbursement ,arrangements and ,other ,account-,based ,group ,health ,plans ,the rule published by the ,internal ,revenue ,service1 the ,employee ,benefits ,security ,administration1 and the ,health and ,human ,services ,department relating to ,health ,reimbursement ,arrangements and ,other ,account-,based ,group ,health ,plans 7,june #bj1 #bjai7 shall have the force and effect of law4 ,health ,reimbursement ,arrangements as described in this rule are subject to all sections in this title4 #ajd4 ,cost-sharing reduction payments as eligible contributions 7a7 ,alternative waiver for ,state innovation ,section #accb of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjeb7 is amended by adding at the end the following new subsection3 7f7 ,alternative waiver for ,state innovation 7#a7 ,in general ,notwithstanding any preceding provision of this section1 a ,state may apply to the ,secretary for the waiver of any requirement of subsection 7a77#b7 with respect to health insurance coverage within that ,state for plan years beginning on or after ,january #a1 #bjbb1 if instead of complying with section #adjb the ,state provides for the distribution of funding received under paragraph 7#b7 to ,medisave accounts of qualifying individuals with respect to such ,state4 ,such application shall be filed at such time and in such manner as the ,secretary may require1 and shall include such information as the ,secretary may require 7including a #aj-year budget plan for such plan that is budget neutral for the ,federal ,government74 7#b7 ,pass-through funding ,with respect to a ,state waiver under paragraph 7#a71 under which1 due to the structure of such waiver1 individuals in the ,state would not qualify for cost-sharing reductions under section #adjb for which they would otherwise be eligible1 the ,secretary shall provide for an alternative means by which an amount is transferred to the ,state equal to the aggregate amount of such reductions that would have been paid on behalf of the participants in the ,exchanges established under this title-- 7,a7 had the ,state not received such waiver2 7,b7 had references to eligible insureds under section #adjb referred to qualifying insureds 7as defined in section #accb7;f772 7,c7 had1 after application of clause 7ii71 in the case of a qualifying insured enrolled in the bronze level of coverage-- 7i7 the percentages specified in subclauses 7,i71 7,,ii71 and 7,,iii7 of section #adjb7;c77#a77;,b7 were references to #hd percent1 #gg percent1 and #fc percent1 respectively2 and 7ii7 the references in subparagraphs 7,a71 7,b71 and 7,c7 of section #adjb7;c77#b7 to #id percent1 #hg percent1 and #gc percent1 respectively1 were references to #hd percent1 #gg percent1 and #fc percent1 respectively2 and 7,d7 had1 after application of clause 7ii71 in the case of a qualifying insured enrolled in the copper level of coverage-- 7i7 the percentages specified in subclauses 7,i71 7,,ii71 and 7,,iii7 of section #adjb7;c77#a77;,b7 were references to #gd percent1 #fg percent1 and #ec percent1 respectively2 and 7ii7 the references in subparagraphs 7,a71 7,b71 and 7,c7 of section #adjb7;c77#b7 to #id percent1 #hg percent1 and #gc percent1 respectively1 were references to #gd percent1 #fg percent1 and #ec percent1 respectively4 ,the amount transferred pursuant to the previous sentence shall be determined annually by the ,secretary1 taking into consideration the experience of other ,states with respect to participation in an ,exchange and reductions provided under such provisions to residents of the other ,states1 and shall be paid to the ,state for purposes of implementing such waiver4 7#c7 ,waiver consideration and transparency ,the provisions of paragraph 7#d7 of subsection 7a7 shall apply to an application for a waiver under paragraph 7#a7 in the same manner as such provisions apply with respect to an application for a waiver under subsection 7a77#a71 except that1 for purposes of this paragraph1 the provisions of subsection 7a77#d77;,b77ii7 shall not apply4 7#d7 ,determinations2 term of waiver ,the provisions of subsections 7d7 and 7e7 shall apply with respect to a determination with respect to an application under paragraph 7#a71 and with respect to the term of a waiver under such paragraph1 in the same manner as such provisions apply with respect to a determination with respect to an application under subsection 7a77#a71 and with respect to the term of a waiver under such subsection4 7#e7 ,definitions ,for purposes of this subsection3 7,a7 ,medisave account ,the term ,medisave account has the meaning given such term in section #ecj;,a7a7 of the ,internal ,revenue ,code of #aihf4 7,b7 ,qualifying insured ,the term qualifying insured means1 with respect to a ,state and a year1 an individual-- 7i7 who is enrolled in a ,medisave account2 7ii7 who is enrolled for such year in a silver1 bronze1 or copper level coverage offered through an ,exchange2 and 7iii7 whose household income is not more than #bej percent of the ,federal poverty line for a family of the size involved4 4 7b7 ,additional amendments ,section #adjb of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjga7 is amended by striking not less than #ajj percent but and exceeds #ajj percent but and more than #ajj percent but each place such phrases appear4 7c7 ,conforming amendments ,section #accb of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjeb71 as amended by subsection 7a71 is further amended in subsection 7a77#d7-- 7#a7 in subparagraph 7,a7 by striking the period and inserting 1 except in the case of a waiver described in subsection 7f742 and 7#b7 in subparagraph 7,b77ii7 by inserting after an application the following3 7except in the case of a waiver described in subsection 7f774 7d7 ,appropriation for cost-,sharing payments ,section #adjb of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjga7 is amended by adding at the end the following new subsection3 7g7 ,funding 7#a7 ,appropriations ,out of any funds in the ,treasury not otherwise appropriated1 there is appropriated such sums as may be necessary to1 subject to paragraph 7#b71 provide health benefits coverage through payment to issuers 7under this section or through advance payment by the ,secretary of the ,treasury under section #adab7;c77#c77 of the amounts computed under this section for each of plan years #bjbb through #bjbf4 7#b7 ,adjustments ,notwithstanding any other provision of law1 payments and other actions for adjustments to obligations incurred prior to ,december #ca1 #bjbb1 may be made through ,december #ca1 #bjbb4 7#c7 ,limitation ,amounts appropriated under paragraph 7#a7 for each of plan years #bjbb through #bjbf are subject to the requirements and limitations under sections #ejf and #ejg of division ,h of ,public ,law #aae-ca in the same manner and to the same extent as if such amounts for each such year were appropriated under such division4 4 #aje4 ,direct primary care 7a7 ,in general ,section #bbc7;c77#a7 of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new subparagraph3 7,d7 ,treatment of direct primary care service arrangements 7i7 ,in general ,a direct primary care service arrangement shall not be treated as a health plan for purposes of subparagraph 7,a77ii74 7ii7 ,direct primary care service arrangement ,for purposes of this paragraph-- 7,i7 ,in general ,the term direct primary care service arrangement means1 with respect to any individual1 an arrangement under which such individual is provided medical care 7as defined in section #bac7;d77 consisting solely of primary care services provided by primary care practitioners 7as defined in section #ahcc7x77#b77;,a7 of the ,social ,security ,act1 determined without regard to clause 7ii7 thereof71 if the sole compensation for such care is a fixed periodic fee4 7,,ii7 ,limitation ,with respect to any individual for any month1 such term shall not include any arrangement if the aggregate fees for all direct primary care service arrangements 7determined without regard to this subclause7 with respect to such individual for such month exceed #aej 7twice such dollar amount in the case of an individual with any direct primary care service arrangement 7as so determined7 that covers more than one individual74 7iii7 ,certain services specifically excluded from treatment as primary care services ,for purposes of this paragraph1 the term primary care services shall not include-- 7,i7 procedures that require the use of general anesthesia1 and 7,,ii7 laboratory services not typically administered in an ambulatory primary care setting4 ,the ,secretary1 after consultation with the ,secretary of ,health and ,human ,services1 shall issue regulations or other guidance regarding the application of this clause4 4 7b7 ,direct primary care service arrangement fees treated as medical expenses ,section #bbc7;d77#b77;,c7 is amended by striking or at the end of clause 7iii71 by striking the period at the end of clause 7iv7 and inserting 1 or1 and by adding at the end the following new clause3 7v7 any direct primary care service arrangement4 4 7c7 ,inflation adjustment ,section #bbc7;g77#a7 of such ,code is amended-- 7#a7 by inserting 1 7c77#a77;,d77ii77,,ii71 after 7b77#b71 each place such term appears1 and 7#b7 in subparagraph 7,b71 by inserting and 7iii7 after clause 7ii7 in clause 7i71 by striking and at the end of clause 7i71 by striking the period at the end of clause 7ii7 and inserting 1 and1 and by inserting after clause 7ii7 the following new clause3 7iii7 in the case of the dollar amount in subsection 7c77#a77;,d77ii77,,ii7 for taxable years beginning in calendar years after #bjbj1 calendar year #bjai4 4 7d7 ,reporting of direct primary care service arrangement fees on ,w-#b ,section #fjea7;a7 of such ,code is amended by striking and at the end of paragraph 7#af71 by striking the period at the end of paragraph 7#ag7 and inserting 1 and1 and by inserting after paragraph 7#ag7 the following new paragraph3 7#ah7 in the case of a direct primary care service arrangement 7as defined in section #bbc7;c77#a77;,d77ii77 which is provided in connection with employment1 the aggregate fees for such arrangement for such employee4 4 7e7 ,effective date ,the amendments made by this section shall apply to months beginning after ,december #ca1 #bjai1 in taxable years ending after such date4 ,b ,assistance to ,medisave ,accounts #aaa4 ,support in implementation 7a7 ,in general ,in the case of an individual who makes a contribution to a ,medisave account before the end of the #a-year period beginning on the date of the enactment of this ,act1 there shall be allowed as a credit against the tax imposed by subtitle ,a of the ,internal ,revenue ,code of #aihf for the taxable year in which the contribution is made an amount equal to the aggregate of #a for every #c contributed to the account 7other than a rollover contribution under section #ecj;,a7e77#e7 of such ,code7 for such taxable year4 7b7 ,limitation ,the aggregate amount allowed to an individual as a credit under subsection 7a7 for all taxable years shall not exceed #a1jjj4 7c7 ,portion of credit refundable ,for purposes of this section-- 7#a7 ,in general ,for purposes of the ,internal ,revenue ,code of #aihf1 in the case of an eligible individual-- 7,a7 ,increase in credit rate ,subsection 7a7 shall be applied by substituting #a for every #a contributed for #a for every #c contributed4 7,b7 ,credit refundable ,the credit allowed under this section shall be treated in the same manner as a credit allowed under subpart ,c of part ,,iv of subchapter ,a of chapter #a of such ,code4 7#b7 ,eligible individual 7,a7 ,in general ,the term eligible individual means1 with respect to any taxable year1 a taxpayer whose household income for the taxable year does not exceed #djj percent of an amount equal to the poverty line for a family of the size involved4 7,b7 ,married couples must file joint return ,if the taxpayer is married 7within the meaning of section #ggjc of such ,code7 at the close of the taxable year-- 7i7 the taxpayer shall be treated as an eligible individual only if the taxpayer and the taxpayer's spouse file a joint return for the taxable year1 and 7ii7 paragraph 7#a7 shall be applied separately to each spouse4 7#c7 ,family size1 household income1 modified adjusted gross income1 poverty line ,the terms family size1 household income1 modified adjusted gross income1 and poverty line have the meaning given such terms by section #cf;,b7d7 of such ,code4 7d7 ,denial of credit to dependents ,no credit shall be allowed under this section to any individual with respect to whom a deduction under section #aea is allowable to another taxpayer for a taxable year beginning in the calendar year in which such individual's taxable year begins4 #aab4 ,new corporations required to use ,medisave ,notwithstanding any other provision of law1 a corporation incorporated after ,december #ca1 #bjba1 may not receive tax benefits for offering employees health insurance4 ,the previous sentence shall not apply to ,medisave contributions offered by such a corporation4 #aac4 ,federal employee health benefits and ,medisave 7a7 ,in general ,section #acab7;d77#c77;,d7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjcb7;d77#c77;,d77 is amended-- 7#a7 in the subparagraph heading1 by striking ,members of ,congress and inserting ,president1 ,vice ,president1 ,members of ,congress1 and ,federal employees2 7#b7 in clause 7i71 in the matter preceding subclause 7,i7-- 7,a7 by striking ,members of ,congress and congressional staff and inserting the ,president1 ,vice ,president1 ,members of ,congress1 and ,federal employees2 and 7,b7 by striking a ,member of ,congress or congressional staff and inserting the ,president1 the ,vice ,president1 a ,member of ,congress1 or a ,federal employee2 and 7#c7 in clause 7ii71 by amending subclause 7,,ii7 to read as follows3 7,,ii7 ,federal employee ,the term ,federal employee means-- 7aa7 an employee1 as such term is defined in section #baje of title #e1 ,united ,states ,code2 and 7bb7 includes an individual to whom subsection 7c7 or 7f7 of such section #baje pertains 7whether or not such individual satisfies item 7aa774 4 7b7 ,conversion to ,medisave accounts ,each plan offered under chapter #hi of title #e1 ,united ,states ,code1 shall be converted into a ,medisave account deposit and funded at the level of the second-least expensive silver plan available through the ,exchange where the applicable individual resides4 #aad4 ,grants to ,states for consumer assistance 7a7 ,in general ,the ,administrator shall establish a grant program to provide assistance to eligible entities to carry out the activities described in subsection 7c7 for the #e-year period beginning on the date of the enactment of this section4 7b7 ,application ,an eligible entity shall submit an application to the ,administrator in such time and in such manner as the ,administrator may require1 providing that such application requires a demonstration of the existence of a relationship with1 or the ability to establish a relationship with1 an employer1 employee1 self-employed individual1 or consumer eligible to enroll in a ,medisave account4 7c7 ,use of funds ,an eligible entity receiving a grant under this section shall use such funds to-- 7#a7 distribute fair and impartial information to consumers about ,medisave accounts1 including the availability of such accounts and how such accounts may be utilized2 7#b7 conduct activities to raise public awareness of ,medisave accounts2 7#c7 facilitate enrollment in ,medisave accounts2 and 7#d7 refer individuals enrolled in a ,medisave account to the appropriate official1 organization1 or ,state agency for the purpose of addressing a complaint1 grievance1 or other question with respect to such ,medisave account4 7d7 ,amount ,the ,administrator may distribute up to #e1jjj1jjj annually for each year occurring during the period described in subsection 7a7 to be divided among grant recipients under this section4 7e7 ,report ,not later than one year after the date on which the last of the grant periods awarded under this section ends1 the ,administrator shall submit a report to the ,congress on the effectiveness of the grants provided under this section4 7f7 ,definitions ,in this section3 7#a7 ,administrator ,the term ,administrator means the ,administrator of the ,centers for ,medicare ,medicaid ,services4 7#b7 ,consumer ,the term consumer means an individual enrolled in1 or seeking to enroll in1 a ,medisave account4 7#c7 ,eligible entity ,the term eligible entity includes the following3 7,a7 ,a ,state4 7,b7 ,trade4 7,c7 ,industry4 7,d7 ,professional associations4 7,e7 ,commercial fishing industry organizations4 7,f7 ,ranching and farming organizations4 7,g7 ,community and consumer-focused nonprofit groups4 7,h7 ,chambers of ,commerce4 7,i7 ,unions4 7,j7 ,small business development centers 7as defined in section #ba of the ,small ,business ,act 7#ae ,u4,s4,c4 #fdh774 7,k7 ,other entities capable of carrying out the activities described under subsection 7b74 7#d7 ,medisave account ,the term ,medisave account has the meaning given such term in section #ecj;,a7a7 of the ,internal ,revenue ,code of #aihf 7as added by section #b7;a774 7#e7 ,state ,the term ,state means each of the several ,states1 the ,district of ,columbia1 each territory and possession of the ,united ,states1 and each federally recognized ,indian ,tribe4 ,,ii ,improving ,private ,health ,insurance ,a ,maintaining ,protections for ,patients with ,preexisting ,conditions #bja4 ,guaranteed availability of coverage2 prohibiting discrimination 7a7 ,in general ,subtitle ,c of title ,i of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7,public ,law #ajd-aia7 is amended by adding at the end the following3 #aif4 ,guaranteed availability of coverage 7a7 ,guaranteed issuance of coverage in the individual and group market ,subject to subsections 7b7 through 7d71 each health insurance issuer that offers health insurance coverage in the individual or group market in a ,state must accept every employer and individual in the ,state that applies for such coverage4 7b7 ,enrollment 7#a7 ,restriction ,a health insurance issuer described in subsection 7a7 may restrict enrollment in coverage described in such subsection to open or special enrollment periods4 7#b7 ,establishment ,a health insurance issuer described in subsection 7a7 shall1 in accordance with the regulations promulgated under paragraph 7#c71 establish special enrollment periods for qualifying events 7under section #fjc of the ,employee ,retirement ,income ,security ,act of #aigd74 7#c7 ,regulations ,the ,secretary shall promulgate regulations with respect to enrollment periods under paragraphs 7#a7 and 7#b74 7c7 ,special rules for network plans 7#a7 ,in general ,in the case of a health insurance issuer that offers health insurance coverage in the group and individual market through a network plan1 the issuer may-- 7,a7 limit the employers that may apply for such coverage to those with eligible individuals who live1 work1 or reside in the service area for such network plan2 and 7,b7 within the service area of such plan1 deny such coverage to such employers and individuals if the issuer has demonstrated1 if required1 to the applicable ,state authority that-- 7i7 it will not have the capacity to deliver services adequately to enrollees of any additional groups or any additional individuals because of its obligations to existing group contract holders and enrollees2 and 7ii7 it is applying this paragraph uniformly to all employers and individuals without regard to the claims experience of those individuals1 employers and their employees 7and their dependents71 or any health status-related factor relating to such individuals1 employees1 and dependents4 7#b7 #ahj-;day suspension upon denial of coverage ,an issuer1 upon denying health insurance coverage in any service area in accordance with paragraph 7#a77;,b71 may not offer coverage in the group or individual market within such service area for a period of #ahj days after the date such coverage is denied4 7d7 ,application of financial capacity limits 7#a7 ,in general ,a health insurance issuer may deny health insurance coverage in the group or individual market if the issuer has demonstrated1 if required1 to the applicable ,state authority that-- 7,a7 it does not have the financial reserves necessary to underwrite additional coverage2 and 7,b7 it is applying this paragraph uniformly to all employers and individuals in the group or individual market in the ,state consistent with applicable ,state law and without regard to the claims experience of those individuals1 employers and their employees 7and their dependents7 or any health status-related factor relating to such individuals1 employees1 and dependents4 7#b7 #ahj-;day suspension upon denial of coverage ,a health insurance issuer upon denying health insurance coverage in connection with group health plans in accordance with paragraph 7#a7 in a ,state may not offer coverage in connection with group health plans in the group or individual market in the ,state for a period of #ahj days after the date such coverage is denied or until the issuer has demonstrated to the applicable ,state authority1 if required under applicable ,state law1 that the issuer has sufficient financial reserves to underwrite additional coverage1 whichever is later4 ,an applicable ,state authority may provide for the application of this subsection on a service-area-specific basis4 7e7 ,definitions ,in this section and in sections #aig through #aii;,a3 7#a7 ,the term ,secretary means the ,secretary of ,health and ,human ,services4 7#b7 ,the terms genetic information1 genetic test1 group health plan1 group market1 health insurance coverage1 health insurance issuer1 group health insurance coverage1 individual health insurance coverage1 individual market1 and underwriting purpose have the meanings given such terms in section #bgia of the ,public ,health ,service ,act4 #aig4 ,fair health insurance premiums 7a7 ,prohibiting discriminatory premium rates 7#a7 ,in general ,with respect to the premium rate charged by a health insurance issuer for health insurance coverage offered in the individual or small group market-- 7,a7 such rate shall vary with respect to the particular plan or coverage involved only by-- 7i7 whether such plan or coverage covers an individual or family2 7ii7 rating area1 as established in accordance with paragraph 7#b72 7iii7 age1 except that such rate shall not vary by more than #e to #a for adults2 and 7iv7 tobacco use1 except that such rate shall not vary by more than #a4e to #a2 and 7,b7 such rate shall not vary with respect to the particular plan or coverage involved by any other factor not described in subparagraph 7,a74 7#b7 ,rating area 7,a7 ,in general ,each ,state shall establish #a or more rating areas within that ,state for purposes of applying the requirements of this title4 7,b7 ,secretarial review ,the ,secretary shall review the rating areas established by each ,state under subparagraph 7,a7 to ensure the adequacy of such areas for purposes of carrying out the requirements of this title4 ,if the ,secretary determines a ,state's rating areas are not adequate1 or that a ,state does not establish such areas1 the ,secretary may establish rating areas for that ,state4 7#c7 ,permissible age bands ,the ,secretary1 in consultation with the ,national ,association of ,insurance ,commissioners1 shall define the permissible age bands for rating purposes under paragraph 7#a77;,a77iii74 7#d7 ,application of variations based on age or tobacco use ,with respect to family coverage under a group health plan or health insurance coverage1 the rating variations permitted under clauses 7iii7 and 7iv7 of paragraph 7#a77;,a7 shall be applied based on the portion of the premium that is attributable to each family member covered under the plan or coverage4 #aih4 ,prohibiting discrimination against individual participants and beneficiaries based on health status 7a7 ,in general ,a group health plan and a health insurance issuer offering group or individual health insurance coverage may not establish rules for eligibility 7including continued eligibility7 of any individual to enroll under the terms of the plan or coverage based on any of the following health status-related factors in relation to the individual or a dependent of the individual3 7#a7 ,health status4 7#b7 ,medical condition 7including both physical and mental illnesses74 7#c7 ,claims experience4 7#d7 ,receipt of health care4 7#e7 ,medical history4 7#f7 ,genetic information4 7#g7 ,evidence of insurability 7including conditions arising out of acts of domestic violence74 7#h7 ,disability4 7#i7 ,any other health status-related factor determined appropriate by the ,secretary4 7b7 ,in premium contributions 7#a7 ,in general ,a group health plan1 and a health insurance issuer offering group or individual health insurance coverage1 may not require any individual 7as a condition of enrollment or continued enrollment under the plan7 to pay a premium or contribution which is greater than such premium or contribution for a similarly situated individual enrolled in the plan on the basis of any health status-related factor in relation to the individual or to an individual enrolled under the plan as a dependent of the individual4 7#b7 ,construction ,nothing in paragraph 7#a7 shall be construed-- 7,a7 to restrict the amount that an employer or individual may be charged for coverage under a group health plan except as provided in paragraph 7#c7 or individual health coverage1 as the case may be2 or 7,b7 to prevent a group health plan1 and a health insurance issuer offering group health insurance coverage1 from establishing premium discounts or rebates or modifying otherwise applicable copayments or deductibles in return for adherence to programs of health promotion and disease prevention4 7#c7 ,no group-based discrimination on basis of genetic information 7,a7 ,in general ,for purposes of this section1 a group health plan1 and health insurance issuer offering group health insurance coverage in connection with a group health plan1 may not adjust premium or contribution amounts for the group covered under such plan on the basis of genetic information4 7,b7 ,rule of construction ,nothing in subparagraph 7,a7 or in paragraphs 7#a7 and 7#b7 of subsection 7d7 shall be construed to limit the ability of a health insurance issuer offering group or individual health insurance coverage to increase the premium for an employer based on the manifestation of a disease or disorder of an individual who is enrolled in the plan4 ,in such case1 the manifestation of a disease or disorder in one individual cannot also be used as genetic information about other group members and to further increase the premium for the employer4 7c7 ,genetic testing 7#a7 ,limitation on requesting or requiring genetic testing ,a group health plan1 and a health insurance issuer offering health insurance coverage in connection with a group health plan1 shall not request or require an individual or a family member of such individual to undergo a genetic test4 7#b7 ,rule of construction ,paragraph 7#a7 shall not be construed to limit the authority of a health care professional who is providing health care services to an individual to request that such individual undergo a genetic test4 7#c7 ,rule of construction regarding payment 7,a7 ,in general ,nothing in paragraph 7#a7 shall be construed to preclude a group health plan1 or a health insurance issuer offering health insurance coverage in connection with a group health plan1 from obtaining and using the results of a genetic test in making a determination regarding payment 7as such term is defined for the purposes of applying the regulations promulgated by the ,secretary under part ,c of title ,,xi of the ,social ,security ,act and section #bfd of this ,act1 as may be revised from time to time7 consistent with subsection 7a74 7,b7 ,limitation ,for purposes of subparagraph 7,a71 a group health plan1 or a health insurance issuer offering health insurance coverage in connection with a group health plan1 may request only the minimum amount of information necessary to accomplish the intended purpose4 7#d7 ,research exception ,notwithstanding paragraph 7#a71 a group health plan1 or a health insurance issuer offering health insurance coverage in connection with a group health plan1 may request1 but not require1 that a participant or beneficiary undergo a genetic test if each of the following conditions is met3 7,a7 ,the request is made pursuant to research that complies with part #df of title #de1 ,code of ,federal ,regulations1 or equivalent ,federal regulations1 and any applicable ,state or local law or regulations for the protection of human subjects in research4 7,b7 ,the plan or issuer clearly indicates to each participant or beneficiary1 or in the case of a minor child1 to the legal guardian of such beneficiary1 to whom the request is made that-- 7i7 compliance with the request is voluntary2 and 7ii7 noncompliance will have no effect on enrollment status or premium or contribution amounts4 7,c7 ,no genetic information collected or acquired under this paragraph shall be used for underwriting purposes4 7,d7 ,the plan or issuer notifies the ,secretary in writing that the plan or issuer is conducting activities pursuant to the exception provided for under this paragraph1 including a description of the activities conducted4 7,e7 ,the plan or issuer complies with such other conditions as the ,secretary may by regulation require for activities conducted under this paragraph4 7d7 ,prohibition on collection of genetic information 7#a7 ,in general ,a group health plan1 and a health insurance issuer offering health insurance coverage in connection with a group health plan1 shall not request1 require1 or purchase genetic information for underwriting purposes4 7#b7 ,prohibition on collection of genetic information prior to enrollment ,a group health plan1 and a health insurance issuer offering health insurance coverage in connection with a group health plan1 shall not request1 require1 or purchase genetic information with respect to any individual prior to such individual's enrollment under the plan or coverage in connection with such enrollment4 7#c7 ,incidental collection ,if a group health plan1 or a health insurance issuer offering health insurance coverage in connection with a group health plan1 obtains genetic information incidental to the requesting1 requiring1 or purchasing of other information concerning any individual1 such request1 requirement1 or purchase shall not be considered a violation of paragraph 7#b7 if such request1 requirement1 or purchase is not in violation of paragraph 7#a74 7e7 ,genetic information of a fetus or embryo ,any reference in this part to genetic information concerning an individual or family member of an individual shall-- 7#a7 with respect to such an individual or family member of an individual who is a pregnant woman1 include genetic information of any fetus carried by such pregnant woman2 and 7#b7 with respect to an individual or family member utilizing an assisted reproductive technology1 include genetic information of any embryo legally held by the individual or family member4 7f7 ,programs of health promotion or disease prevention 7#a7 ,general provisions 7,a7 ,general rule ,for purposes of subsection 7b77#b77;,b71 a program of health promotion or disease prevention 7referred to in this subsection as a wellness program7 shall be a program offered by an employer that is designed to promote health or prevent disease that meets the applicable requirements of this subsection4 7,b7 ,no conditions based on health status factor ,if none of the conditions for obtaining a premium discount or rebate or other reward for participation in a wellness program is based on an individual satisfying a standard that is related to a health status factor1 such wellness program shall not violate this section if participation in the program is made available to all similarly situated individuals and the requirements of paragraph 7#b7 are complied with4 7,c7 ,conditions based on health status factor ,if any of the conditions for obtaining a premium discount or rebate or other reward for participation in a wellness program is based on an individual satisfying a standard that is related to a health status factor1 such wellness program shall not violate this section if the requirements of paragraph 7#c7 are complied with4 7#b7 ,wellness programs not subject to requirements ,if none of the conditions for obtaining a premium discount or rebate or other reward under a wellness program as described in paragraph 7#a77;,b7 are based on an individual satisfying a standard that is related to a health status factor 7or if such a wellness program does not provide such a reward71 the wellness program shall not violate this section if participation in the program is made available to all similarly situated individuals4 ,the following programs shall not have to comply with the requirements of paragraph 7#c7 if participation in the program is made available to all similarly situated individuals3 7,a7 ,a program that reimburses all or part of the cost for memberships in a fitness center4 7,b7 ,a diagnostic testing program that provides a reward for participation and does not base any part of the reward on outcomes4 7,c7 ,a program that encourages preventive care related to a health condition through the waiver of the copayment or deductible requirement under group health plan for the costs of certain items or services related to a health condition 7such as prenatal care or well-baby visits74 7,d7 ,a program that reimburses individuals for the costs of smoking cessation programs without regard to whether the individual quits smoking4 7,e7 ,a program that provides a reward to individuals for attending a periodic health education seminar4 7#c7 ,wellness programs subject to requirements ,if any of the conditions for obtaining a premium discount1 rebate1 or reward under a wellness program as described in paragraph 7#a77;,c7 is based on an individual satisfying a standard that is related to a health status factor1 the wellness program shall not violate this section if the following requirements are complied with3 7,a7 ,the reward for the wellness program1 together with the reward for other wellness programs with respect to the plan that requires satisfaction of a standard related to a health status factor1 shall not exceed #cj percent of the cost of employee-only coverage under the plan4 ,if1 in addition to employees or individuals1 any class of dependents 7such as spouses or spouses and dependent children7 may participate fully in the wellness program1 such reward shall not exceed #cj percent of the cost of the coverage in which an employee or individual and any dependents are enrolled4 ,for purposes of this paragraph1 the cost of coverage shall be determined based on the total amount of employer and employee contributions for the benefit package under which the employee is 7or the employee and any dependents are7 receiving coverage4 ,a reward may be in the form of a discount or rebate of a premium or contribution1 a waiver of all or part of a cost-sharing mechanism 7such as deductibles1 copayments1 or coinsurance71 the absence of a surcharge1 or the value of a benefit that would otherwise not be provided under the plan4 ,the ,secretaries of ,labor1 ,health and ,human ,services1 and the ,treasury may increase the reward available under this subparagraph to up to #ej percent of the cost of coverage if the ,secretaries determine that such an increase is appropriate4 7,b7 ,the wellness program shall be reasonably designed to promote health or prevent disease4 ,a program complies with the preceding sentence if the program has a reasonable chance of improving the health of1 or preventing disease in1 participating individuals and it is not overly burdensome1 is not a subterfuge for discriminating based on a health status factor1 and is not highly suspect in the method chosen to promote health or prevent disease4 7,c7 ,the plan shall give individuals eligible for the program the opportunity to qualify for the reward under the program at least once each year4 7,d7 ,the full reward under the wellness program shall be made available to all similarly situated individuals4 ,for such purpose1 among other things3 7i7 ,the reward is not available to all similarly situated individuals for a period unless the wellness program allows-- 7,i7 for a reasonable alternative standard 7or waiver of the otherwise applicable standard7 for obtaining the reward for any individual for whom1 for that period1 it is unreasonably difficult due to a medical condition to satisfy the otherwise applicable standard2 and 7,,ii7 for a reasonable alternative standard 7or waiver of the otherwise applicable standard7 for obtaining the reward for any individual for whom1 for that period1 it is medically inadvisable to attempt to satisfy the otherwise applicable standard4 7ii7 ,if reasonable under the circumstances1 the plan or issuer may seek verification1 such as a statement from an individual's physician1 that a health status factor makes it unreasonably difficult or medically inadvisable for the individual to satisfy or attempt to satisfy the otherwise applicable standard4 7,e7 ,the plan or issuer involved shall disclose in all plan materials describing the terms of the wellness program the availability of a reasonable alternative standard 7or the possibility of waiver of the otherwise applicable standard7 required under subparagraph 7,d74 ,if plan materials disclose that such a program is available1 without describing its terms1 the disclosure under this subparagraph shall not be required4 #aii4 ,prohibition of preexisting condition exclusions or other discrimination based on health status 7a7 ,in general ,a group health plan and a health insurance issuer offering group or individual health insurance coverage may not impose any preexisting condition exclusion with respect to such plan or coverage4 7b7 ,definitions ,for purposes of this section-- 7#a7 ,preexisting condition exclusion 7,a7 ,in general ,the term preexisting condition exclusion means1 with respect to coverage1 a limitation or exclusion of benefits relating to a condition based on the fact that the condition was present before the date of enrollment for such coverage1 whether or not any medical advice1 diagnosis1 care1 or treatment was recommended or received before such date4 7,b7 ,treatment of genetic information ,genetic information shall not be treated as a condition described in subsection 7a77#a7 in the absence of a diagnosis of the condition related to such information4 7#b7 ,enrollment date ,the term enrollment date means1 with respect to an individual covered under a group health plan or health insurance coverage1 the date of enrollment of the individual in the plan or coverage or1 if earlier1 the first day of the waiting period for such enrollment4 7#c7 ,late enrollee ,the term late enrollee means1 with respect to coverage under a group health plan1 a participant or beneficiary who enrolls under the plan other than during-- 7,a7 the first period in which the individual is eligible to enroll under the plan2 or 7,b7 a special enrollment period under subsection 7f74 7#d7 ,waiting period ,the term waiting period means1 with respect to a group health plan and an individual who is a potential participant or beneficiary in the plan1 the period that must pass with respect to the individual before the individual is eligible to be covered for benefits under the terms of the plan4 7c7 ,rules relating to crediting previous coverage 7#a7 ,creditable coverage defined ,for purposes of this title1 the term creditable coverage means1 with respect to an individual1 coverage of the individual under any of the following3 7,a7 ,a group health plan4 7,b7 ,health insurance coverage4 7,c7 ,part ,a or part ,b of title ,,xviii of the ,social ,security ,act4 7,d7 ,title ,,xix of the ,social ,security ,act1 other than coverage consisting solely of benefits under section #aibh4 7,e7 ,chapter #ee of title #aj1 ,united ,states ,code4 7,f7 ,a medical care program of the ,indian ,health ,service or of a tribal organization4 7,g7 ,a ,state health benefits risk pool4 7,h7 ,a health plan offered under chapter #hi of title #e1 ,united ,states ,code4 7,i7 ,a public health plan 7as defined in regulations74 7,j7 ,a health benefit plan under section #e7;e7 of the ,peace ,corps ,act 7#bb ,u4,s4,c4 #bejd7;e774 ,such term does not include coverage consisting solely of coverage of excepted benefits 7as defined in section #bgia7;c774 7#b7 ,not counting periods before significant breaks in coverage 7,a7 ,in general ,a period of creditable coverage shall not be counted1 with respect to enrollment of an individual under a group or individual health plan1 if1 after such period and before the enrollment date1 there was a #fc-;day period during all of which the individual was not covered under any creditable coverage4 7,b7 ,waiting period not treated as a break in coverage ,for purposes of subparagraph 7,a7 and subsection 7d77#d71 any period that an individual is in a waiting period for any coverage under a group or individual health plan 7or for group health insurance coverage7 or is in an affiliation period 7as defined in subsection 7g77#b77 shall not be taken into account in determining the continuous period under subparagraph 7,a74 7,c7 ,,taa-eligible individuals ,in the case of plan years beginning before ,january #a1 #bjad-- 7i7 ,,taa pre-certification period rule ,in the case of a ,,taa-eligible individual1 the period beginning on the date the individual has a ,,taa-related loss of coverage and ending on the date that is #g days after the date of the issuance by the ,secretary 7or by any person or entity designated by the ,secretary7 of a qualified health insurance costs credit eligibility certificate for such individual for purposes of section #gebg of the ,internal ,revenue ,code of #aihf shall not be taken into account in determining the continuous period under subparagraph 7,a74 7ii7 ,definitions ,the terms ,,taa-eligible individual and ,,taa-related loss of coverage have the meanings given such terms in section #bbje7;b77#d74 7#c7 ,method of crediting coverage 7,a7 ,standard method ,except as otherwise provided under subparagraph 7,b71 for purposes of applying subsection 7a77#c71 a group health plan1 and a health insurance issuer offering group or individual health insurance coverage1 shall count a period of creditable coverage without regard to the specific benefits covered during the period4 7,b7 ,election of alternative method ,a group health plan1 or a health insurance issuer offering group or individual health insurance1 may elect to apply subsection 7a77#c7 based on coverage of benefits within each of several classes or categories of benefits specified in regulations rather than as provided under subparagraph 7,a74 ,such election shall be made on a uniform basis for all participants and beneficiaries4 ,under such election a group or individual health plan or issuer shall count a period of creditable coverage with respect to any class or category of benefits if any level of benefits is covered within such class or category4 7,c7 ,plan notice ,in the case of an election with respect to a group health plan under subparagraph 7,b7 7whether or not health insurance coverage is provided in connection with such plan71 the plan shall-- 7i7 prominently state in any disclosure statements concerning the plan1 and state to each enrollee at the time of enrollment under the plan1 that the plan has made such election2 and 7ii7 include in such statements a description of the effect of this election4 7,d7 ,issuer notice ,in the case of an election under subparagraph 7,b7 with respect to health insurance coverage offered by an issuer in the individual or group market1 the issuer-- 7i7 shall prominently state in any disclosure statements concerning the coverage1 and to each employer at the time of the offer or sale of the coverage1 that the issuer has made such election2 and 7ii7 shall include in such statements a description of the effect of such election4 7#d7 ,establishment of period ,periods of creditable coverage with respect to an individual shall be established through presentation of certifications described in subsection 7e7 or in such other manner as may be specified in regulations4 7d7 ,exceptions 7#a7 ,exclusion not applicable to certain newborns ,subject to paragraph 7#d71 a group health plan1 and a health insurance issuer offering group or individual health insurance coverage1 may not impose any preexisting condition exclusion in the case of an individual who1 as of the last day of the #cj-;day period beginning with the date of birth1 is covered under creditable coverage4 7#b7 ,exclusion not applicable to certain adopted children ,subject to paragraph 7#d71 a group health plan1 and a health insurance issuer offering group or individual health insurance coverage1 may not impose any preexisting condition exclusion in the case of a child who is adopted or placed for adoption before attaining #ah years of age and who1 as of the last day of the #cj-;day period beginning on the date of the adoption or placement for adoption1 is covered under creditable coverage4 ,the previous sentence shall not apply to coverage before the date of such adoption or placement for adoption4 7#c7 ,exclusion not applicable to pregnancy ,a group health plan1 and health insurance issuer offering group or individual health insurance coverage1 may not impose any preexisting condition exclusion relating to pregnancy as a preexisting condition4 7#d7 ,loss if break in coverage ,paragraphs 7#a7 and 7#b7 shall no longer apply to an individual after the end of the first #fc-;day period during all of which the individual was not covered under any creditable coverage4 7e7 ,certifications and disclosure of coverage 7#a7 ,requirement for certification of period of creditable coverage 7,a7 ,in general ,a group health plan1 and a health insurance issuer offering group or individual health insurance coverage1 shall provide the certification described in subparagraph 7,b7-- 7i7 at the time an individual ceases to be covered under the plan or otherwise becomes covered under a ,,cobra continuation provision2 7ii7 in the case of an individual becoming covered under such a provision1 at the time the individual ceases to be covered under such provision2 and 7iii7 on the request on behalf of an individual made not later than #bd months after the date of cessation of the coverage described in clause 7i7 or 7ii71 whichever is later4 ,the certification under clause 7i7 may be provided1 to the extent practicable1 at a time consistent with notices required under any applicable ,,cobra continuation provision4 7,b7 ,certification ,the certification described in this subparagraph is a written certification of-- 7i7 the period of creditable coverage of the individual under such plan and the coverage 7if any7 under such ,,cobra continuation provision2 and 7ii7 the waiting period 7if any7 7and affiliation period1 if applicable7 imposed with respect to the individual for any coverage under such plan4 7,c7 ,issuer compliance ,to the extent that medical care under a group health plan consists of group health insurance coverage1 the plan is deemed to have satisfied the certification requirement under this paragraph if the health insurance issuer offering the coverage provides for such certification in accordance with this paragraph4 7#b7 ,disclosure of information on previous benefits ,in the case of an election described in subsection 7c77#c77;,b7 by a group health plan or health insurance issuer1 if the plan or issuer enrolls an individual for coverage under the plan and the individual provides a certification of coverage of the individual under paragraph 7#a7-- 7,a7 upon request of such plan or issuer1 the entity which issued the certification provided by the individual shall promptly disclose to such requesting plan or issuer information on coverage of classes and categories of health benefits available under such entity's plan or coverage2 and 7,b7 such entity may charge the requesting plan or issuer for the reasonable cost of disclosing such information4 7#c7 ,regulations ,the ,secretary shall establish rules to prevent an entity's failure to provide information under paragraph 7#a7 or 7#b7 with respect to previous coverage of an individual from adversely affecting any subsequent coverage of the individual under another group health plan or health insurance coverage4 7f7 ,special enrollment periods 7#a7 ,individuals losing other coverage ,a group health plan1 and a health insurance issuer offering group health insurance coverage in connection with a group health plan1 shall permit an employee who is eligible1 but not enrolled1 for coverage under the terms of the plan 7or a dependent of such an employee if the dependent is eligible1 but not enrolled1 for coverage under such terms7 to enroll for coverage under the terms of the plan if each of the following conditions is met3 7,a7 ,the employee or dependent was covered under a group health plan or had health insurance coverage at the time coverage was previously offered to the employee or dependent4 7,b7 ,the employee stated in writing at such time that coverage under a group health plan or health insurance coverage was the reason for declining enrollment1 but only if the plan sponsor or issuer 7if applicable7 required such a statement at such time and provided the employee with notice of such requirement 7and the consequences of such requirement7 at such time4 7,c7 ,the employee's or dependent's coverage described in subparagraph 7,a7-- 7i7 was under a ,,cobra continuation provision and the coverage under such provision was exhausted2 or 7ii7 was not under such a provision and either the coverage was terminated as a result of loss of eligibility for the coverage 7including as a result of legal separation1 divorce1 death1 termination of employment1 or reduction in the number of hours of employment7 or employer contributions toward such coverage were terminated4 7,d7 ,under the terms of the plan1 the employee requests such enrollment not later than #cj days after the date of exhaustion of coverage described in subparagraph 7,c77i7 or termination of coverage or employer contribution described in subparagraph 7,c77ii74 7#b7 ,for dependent beneficiaries 7,a7 ,in general ,if-- 7i7 a group health plan makes coverage available with respect to a dependent of an individual2 7ii7 the individual is a participant under the plan 7or has met any waiting period applicable to becoming a participant under the plan and is eligible to be enrolled under the plan but for a failure to enroll during a previous enrollment period72 and 7iii7 a person becomes such a dependent of the individual through marriage1 birth1 or adoption or placement for adoption1 the group health plan shall provide for a dependent special enrollment period described in subparagraph 7,b7 during which the person 7or1 if not otherwise enrolled1 the individual7 may be enrolled under the plan as a dependent of the individual1 and in the case of the birth or adoption of a child1 the spouse of the individual may be enrolled as a dependent of the individual if such spouse is otherwise eligible for coverage4 7,b7 ,dependent special enrollment period ,a dependent special enrollment period under this subparagraph shall be a period of not less than #cj days and shall begin on the later of-- 7i7 the date dependent coverage is made available2 or 7ii7 the date of the marriage1 birth1 or adoption or placement for adoption 7as the case may be7 described in subparagraph 7,a77iii74 7,c7 ,no waiting period ,if an individual seeks to enroll a dependent during the first #cj days of such a dependent special enrollment period1 the coverage of the dependent shall become effective-- 7i7 in the case of marriage1 not later than the first day of the first month beginning after the date the completed request for enrollment is received2 7ii7 in the case of a dependent's birth1 as of the date of such birth2 or 7iii7 in the case of a dependent's adoption or placement for adoption1 the date of such adoption or placement for adoption4 7#c7 ,special rules for application in case of ,medicaid and ,,chip 7,a7 ,in general ,a group health plan1 and a health insurance issuer offering group health insurance coverage in connection with a group health plan1 shall permit an employee who is eligible1 but not enrolled1 for coverage under the terms of the plan 7or a dependent of such an employee if the dependent is eligible1 but not enrolled1 for coverage under such terms7 to enroll for coverage under the terms of the plan if either of the following conditions is met3 7i7 ,termination of ,medicaid or ,,chip coverage ,the employee or dependent is covered under a ,medicaid plan under title ,,xix of the ,social ,security ,act or under a ,state child health plan under title ,,xxi of such ,act and coverage of the employee or dependent under such a plan is terminated as a result of loss of eligibility for such coverage and the employee requests coverage under the group health plan 7or health insurance coverage7 not later than #fj days after the date of termination of such coverage4 7ii7 ,eligibility for employment assistance under ,medicaid or ,,chip ,the employee or dependent becomes eligible for assistance1 with respect to coverage under the group health plan or health insurance coverage1 under such ,medicaid plan or ,state child health plan 7including under any waiver or demonstration project conducted under or in relation to such a plan71 if the employee requests coverage under the group health plan or health insurance coverage not later than #fj days after the date the employee or dependent is determined to be eligible for such assistance4 7,b7 ,coordination with ,medicaid and ,,chip 7i7 ,outreach to employees regarding availability of ,medicaid and ,,chip coverage 7,i7 ,in general ,each employer that maintains a group health plan in a ,state that provides medical assistance under a ,state ,medicaid plan under title ,,xix of the ,social ,security ,act1 or child health assistance under a ,state child health plan under title ,,xxi of such ,act1 in the form of premium assistance for the purchase of coverage under a group health plan1 shall provide to each employee a written notice informing the employee of potential opportunities then currently available in the ,state in which the employee resides for premium assistance under such plans for health coverage of the employee or the employee's dependents4 ,for purposes of compliance with this subclause1 the employer may use any ,state-specific model notice developed in accordance with section #gja7;f77#c77;,b77i77,,ii7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aaha7;f77#c77;,b77i77,,ii774 7,,ii7 ,option to provide concurrent with provision of plan materials to employee ,an employer may provide the model notice applicable to the ,state in which an employee resides concurrent with the furnishing of materials notifying the employee of health plan eligibility1 concurrent with materials provided to the employee in connection with an open season or election process conducted under the plan1 or concurrent with the furnishing of the summary plan description as provided in section #ajd7;b7 of the ,employee ,retirement ,income ,security ,act of #aigd4 7ii7 ,disclosure about group health plan benefits to ,states for medicaid and chip eligible individuals ,in the case of an enrollee in a group health plan who is covered under a ,medicaid plan of a ,state under title ,,xix of the ,social ,security ,act or under a ,state child health plan under title ,,xxi of such ,act1 the plan administrator of the group health plan shall disclose to the ,state1 upon request1 information about the benefits available under the group health plan in sufficient specificity1 as determined under regulations of the ,secretary of ,health and ,human ,services in consultation with the ,secretary that require use of the model coverage coordination disclosure form developed under section #caa7;b77#a77;,c7 of the ,children's ,health ,insurance ,reauthorization ,act of #bjji1 so as to permit the ,state to make a determination 7under paragraph 7#b77;,b71 7#c71 or 7#aj7 of section #baje7;c7 of the ,social ,security ,act or otherwise7 concerning the cost-effectiveness of the ,state providing medical or child health assistance through premium assistance for the purchase of coverage under such group health plan and in order for the ,state to provide supplemental benefits required under paragraph 7#aj77;,e7 of such section or other authority4 7g7 ,use of ,affiliation ,period by ,h,m,os as ,alternative to ,preexisting ,condition ,exclusion 7#a7 ,in general ,a health maintenance organization which offers health insurance coverage in connection with a group health plan and which does not impose any preexisting condition exclusion allowed under subsection 7a7 with respect to any particular coverage option may impose an affiliation period for such coverage option1 but only if-- 7,a7 such period is applied uniformly without regard to any health status-related factors2 and 7,b7 such period does not exceed #b months 7or #c months in the case of a late enrollee74 7#b7 ,affiliation period 7,a7 ,defined ,for purposes of this title1 the term affiliation period means a period which1 under the terms of the health insurance coverage offered by the health maintenance organization1 must expire before the health insurance coverage becomes effective4 ,the organization is not required to provide health care services or benefits during such period and no premium shall be charged to the participant or beneficiary for any coverage during the period4 7,b7 ,beginning ,such period shall begin on the enrollment date4 7,c7 ,runs concurrently with waiting periods ,an affiliation period under a plan shall run concurrently with any waiting period under the plan4 7#c7 ,alternative methods ,a health maintenance organization described in paragraph 7#a7 may use alternative methods1 from those described in such paragraph1 to address adverse selection as approved by the ,state insurance commissioner or official or officials designated by the ,state to enforce the requirements of this part for the ,state involved with respect to such issuer4 #aii;,a4 ,extension of dependent coverage 7a7 ,in general ,a group health plan and a health insurance issuer offering group or individual health insurance coverage that provides dependent coverage of children shall continue to make such coverage available for an adult child 7who is not married7 until the child turns #bf years of age4 ,nothing in this section shall require a health plan or a health insurance issuer described in the preceding sentence to make coverage available for a child of a child receiving dependent coverage4 7b7 ,regulations ,the ,secretary shall promulgate regulations to define the dependents to which coverage shall be made available under subsection 7a74 7c7 ,rule of construction ,nothing in this section shall be construed to modify the definition of dependent as used in the ,internal ,revenue ,code of #aihf with respect to the tax treatment of the cost of coverage4 #aii;,b4 ,annual limitation on cost-sharing 7a7 ,in general 7#a7 #bjad ,the cost-sharing incurred under a group health plan or group or individual health insurance coverage with respect to self-only coverage or coverage other than self-only coverage for a plan year beginning in #bjad shall not exceed the dollar amounts in effect under section #bbc7;c77#b77;,a77ii7 of the ,internal ,revenue ,code of #aihf for self-only and family coverage1 respectively1 for taxable years beginning in #bjad4 7#b7 #bjae and later ,in the case of any plan year beginning in a calendar year after #bjad1 the limitation under this paragraph shall-- 7,a7 in the case of self-only coverage1 be equal to the dollar amount under paragraph 7#a7 for self-only coverage for plan years beginning in #bjad1 increased by an amount equal to the product of that amount and the premium adjustment percentage under subsection 7c7 for the calendar year2 and 7,b7 in the case of other coverage1 twice the amount in effect under subparagraph 7,a74 ,if the amount of any increase under subparagraph 7,a7 is not a multiple of #ej1 such increase shall be rounded to the next lowest multiple of #ej4 7b7 ,cost-,sharing ,in this section3 7#a7 ,in general ,the term cost-sharing includes-- 7,a7 deductibles1 coinsurance1 copayments1 or similar charges2 and 7,b7 any other expenditure required of an insured individual which is a qualified medical expense 7within the meaning of section #bbc7;d77#b7 of the ,internal ,revenue ,code of #aihf7 with respect to essential health benefits covered under the plan4 7#b7 ,exceptions ,such term does not include premiums1 balance billing amounts for non-network providers1 or spending for non-covered services4 7c7 ,premium adjustment percentage ,for purposes of subsection 7a77#b77;,a71 the premium adjustment percentage for any calendar year is the percentage 7if any7 by which the average per capita premium for health insurance coverage in the ,united ,states for the preceding calendar year 7as estimated by the ,secretary no later than ,october #a of such preceding calendar year7 exceeds such average per capita premium for #bjac 7as determined by the ,secretary74 #aii;,c4 ,enforcement of certain health insurance requirements 7a7 ,state ,enforcement 7#a7 ,state authority ,each ,state may require that health insurance issuers that issue1 sell1 renew1 or offer health insurance coverage in the ,state in the individual or group market meet the requirements of this part with respect to such issuers4 7#b7 ,failure to implement provisions ,in the case of a determination by the ,secretary that a ,state has failed to substantially enforce a provision 7or provisions7 of sections #aif through #aii;,a with respect to health insurance issuers in the ,state1 the ,secretary shall enforce such provision 7or provisions7 under subsection 7b7 insofar as they relate to the issuance1 sale1 renewal1 and offering of health insurance coverage in connection with group health plans or individual health insurance coverage in such ,state4 7b7 ,secretarial ,enforcement ,authority 7#a7 ,limitation ,the provisions of this subsection shall apply to enforcement of a provision 7or provisions7 described in subsection 7a77#b7 only-- 7,a7 as provided under such subsection2 and 7,b7 with respect to individual health insurance coverage or group health plans that are non-,federal governmental plans4 7#b7 ,imposition of penalties ,in the cases described in paragraph 7#a7-- 7,a7 ,in general ,subject to the succeeding provisions of this subsection1 any non-,federal governmental plan that is a group health plan and any health insurance issuer that fails to meet a provision of this part applicable to such plan or issuer is subject to a civil money penalty under this subsection4 7,b7 ,liability for penalty ,in the case of a failure by-- 7i7 a health insurance issuer1 the issuer is liable for such penalty2 or 7ii7 a group health plan that is a non-,federal governmental plan which is-- 7,i7 sponsored by #b or more employers1 the plan is liable for such penalty2 or 7,,ii7 not so sponsored1 the employer is liable for such penalty4 7,c7 ,amount of penalty 7i7 ,in general ,the maximum amount of penalty imposed under this paragraph is #ajj for each day for each individual with respect to which such a failure occurs4 7ii7 ,considerations in imposition ,in determining the amount of any penalty to be assessed under this paragraph1 the ,secretary shall take into account the previous record of compliance of the entity being assessed with the applicable provisions of this part and the gravity of the violation4 7iii7 ,limitations 7,i7 ,penalty not to apply where failure not discovered exercising reasonable diligence ,no civil money penalty shall be imposed under this paragraph on any failure during any period for which it is established to the satisfaction of the ,secretary that none of the entities against whom the penalty would be imposed knew1 or exercising reasonable diligence would have known1 that such failure existed4 7,,ii7 ,penalty not to apply to failures corrected within #cj days ,no civil money penalty shall be imposed under this paragraph on any failure if such failure was due to reasonable cause and not to willful neglect1 and such failure is corrected during the #cj-;day period beginning on the first day any of the entities against whom the penalty would be imposed knew1 or exercising reasonable diligence would have known1 that such failure existed4 7,d7 ,administrative review 7i7 ,opportunity for hearing ,the entity assessed shall be afforded an opportunity for hearing by the ,secretary upon request made within #cj days after the date of the issuance of a notice of assessment4 ,in such hearing the decision shall be made on the record pursuant to section #eed of title #e1 ,united ,states ,code4 ,if no hearing is requested1 the assessment shall constitute a final and unappealable order4 7ii7 ,hearing procedure ,if a hearing is requested1 the initial agency decision shall be made by an administrative law judge1 and such decision shall become the final order unless the ,secretary modifies or vacates the decision4 ,notice of intent to modify or vacate the decision of the administrative law judge shall be issued to the parties within #cj days after the date of the decision of the judge4 ,a final order which takes effect under this paragraph shall be subject to review only as provided under subparagraph 7,e74 7,e7 ,judicial review 7i7 ,filing of action for review ,any entity against whom an order imposing a civil money penalty has been entered after an agency hearing under this paragraph may obtain review by the ,united ,states district court for any district in which such entity is located or the ,united ,states ,district ,court for the ,district of ,columbia by filing a notice of appeal in such court within #cj days from the date of such order1 and simultaneously sending a copy of such notice by registered mail to the ,secretary4 7ii7 ,certification of administrative record ,the ,secretary shall promptly certify and file in such court the record upon which the penalty was imposed4 7iii7 ,standard for review ,the findings of the ,secretary shall be set aside only if found to be unsupported by substantial evidence as provided by section #gjf7b77;,e7 of title #e1 ,united ,states ,code4 7iv7 ,appeal ,any final decision1 order1 or judgment of the district court concerning such review shall be subject to appeal as provided in chapter #hc of title #bh of such ,code4 7,f7 ,failure to pay assessment2 maintenance of action 7i7 ,failure to pay assessment ,if any entity fails to pay an assessment after it has become a final and unappealable order1 or after the court has entered final judgment in favor of the ,secretary1 the ,secretary shall refer the matter to the ,attorney ,general who shall recover the amount assessed by action in the appropriate ,united ,states district court4 7ii7 ,nonreviewability ,in such action the validity and appropriateness of the final order imposing the penalty shall not be subject to review4 7,g7 ,payment of penalties ,except as otherwise provided1 penalties collected under this paragraph shall be paid to the ,secretary 7or other officer7 imposing the penalty and shall be available without appropriation and until expended for the purpose of enforcing the provisions with respect to which the penalty was imposed4 7#c7 ,enforcement authority relating to genetic discrimination 7,a7 ,general rule ,in the cases described in paragraph 7#a71 notwithstanding the provisions of paragraph 7#b77;,c71 the succeeding subparagraphs of this paragraph shall apply with respect to an action under this subsection by the ,secretary with respect to any failure of a health insurance issuer in connection with a group health plan1 to meet the requirements of subsection 7a77#a77;,f71 7b77#c71 7c71 or 7d7 of section #aif or section #aig or #aif7;b77#a7 with respect to genetic information in connection with the plan4 7,b7 ,amount 7i7 ,in general ,the amount of the penalty imposed under this paragraph shall be #ajj for each day in the noncompliance period with respect to each participant or beneficiary to whom such failure relates4 7ii7 ,noncompliance period ,for purposes of this paragraph1 the term noncompliance period means1 with respect to any failure1 the period-- 7,i7 beginning on the date such failure first occurs2 and 7,,ii7 ending on the date the failure is corrected4 7,c7 ,minimum penalties where failure discovered ,notwithstanding clauses 7i7 and 7ii7 of subparagraph 7,d73 7i7 ,in general ,in the case of #a or more failures with respect to an individual-- 7,i7 which are not corrected before the date on which the plan receives a notice from the ,secretary of such violation2 and 7,,ii7 which occurred or continued during the period involved2 the amount of penalty imposed by subparagraph 7,a7 by reason of such failures with respect to such individual shall not be less than #b1ejj4 7ii7 ,higher minimum penalty where violations are more than de minimis ,to the extent violations for which any person is liable under this paragraph for any year are more than de minimis1 clause 7i7 shall be applied by substituting #ae1jjj for #b1ejj with respect to such person4 7,d7 ,limitations 7i7 ,penalty not to apply where failure not discovered exercising reasonable diligence ,no penalty shall be imposed by subparagraph 7,a7 on any failure during any period for which it is established to the satisfaction of the ,secretary that the person otherwise liable for such penalty did not know1 and exercising reasonable diligence would not have known1 that such failure existed4 7ii7 ,penalty not to apply to failures corrected within certain periods ,no penalty shall be imposed by subparagraph 7,a7 on any failure if-- 7,i7 such failure was due to reasonable cause and not to willful neglect2 and 7,,ii7 such failure is corrected during the #cj-;day period beginning on the first date the person otherwise liable for such penalty knew1 or exercising reasonable diligence would have known1 that such failure existed4 7iii7 ,overall limitation for unintentional failures ,in the case of failures which are due to reasonable cause and not to willful neglect1 the penalty imposed by subparagraph 7,a7 for failures shall not exceed the amount equal to the lesser of-- 7,i7 #aj percent of the aggregate amount paid or incurred by the employer 7or predecessor employer7 during the preceding taxable year for group health plans2 or 7,,ii7 #ejj1jjj4 7,e7 ,waiver by ,secretary ,in the case of a failure which is due to reasonable cause and not to willful neglect1 the ,secretary may waive part or all of the penalty imposed by subparagraph 7,a7 to the extent that the payment of such penalty would be excessive relative to the failure involved4 7c7 ,definitions ,for purposes of this section3 7#a7 ,governmental plan ,the term governmental plan has the meaning given such term under section #c7cb7 of the ,employee ,retirement ,income ,security ,act of #aigd and any ,federal governmental plan4 7#b7 ,federal governmental plan ,the term #8,federal governmental plan' means a governmental plan established or maintained for its employees by the ,government of the ,united ,states or by any agency or instrumentality of such ,government4 7#c7 ,non-,federal governmental plan ,the term non-,federal governmental plan means a governmental plan that is not a ,federal governmental plan4 4 7b7 ,conforming amendment ,the table of contents under section #a7;b7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7,public ,law #ajd-aia7 is amended by inserting after the item relating to section #aie the following3 ,sec4 #aif4 ,guaranteed availability of coverage4 ,sec4 #aig4 ,fair health insurance premiums4 ,sec4 #aih4 ,prohibiting discrimination against individual participants and beneficiaries based on health status4 ,sec4 #aii4 ,prohibition of preexisting condition exclusions or other discrimination based on health status4 ,sec4 #aii;,a4 ,extension of dependent coverage4 ,sec4 #aii;,b4 ,annual limitation on cost-sharing4 ,sec4 #aii;,c4 ,enforcement of certain health insurance requirements4 4 7c7 ,,erisa and ,,irc ,enforcement 7#a7 ,,erisa ,subpart ,b of part #g of title ,i of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aahe et seq47 is amended by adding at the end the following new section3 #gaf4 ,other market reforms ,sections #aif and #aig of the ,health ,insurance ,portability and ,accountability ,act of #aiif shall apply to health insurance issuers providing health insurance coverage in connection with group health plans1 and sections #aih through #aii;,b of such ,act shall apply to group health plans and health insurance issuers providing health insurance coverage in connection with group health plans1 as if included in this subpart1 and to the extent that any provision of this part conflicts with a provision of such section #aif or #aig with respect to health insurance issuers providing health insurance coverage in connection with group health plans or of such section #aih1 #aii1 #aii;,a1 or #aii;,b with respect to group health plans or health insurance issuers providing health insurance coverage in connection with group health plans1 the provisions of such sections #aif through #aii;,b shall apply4 4 7#b7 ,,irc ,subchapter ,b of chapter #ajj of subtitle ,k of title #bf of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new section3 #ihaf4 ,other market reforms ,sections #aif and #aig of the ,health ,insurance ,portability and ,accountability ,act of #aiif shall apply to health insurance issuers providing health insurance coverage in connection with group health plans1 and sections #aih through #aii;,b of such ,act shall apply to group health plans and health insurance issuers providing health insurance coverage in connection with group health plans1 as if included in this subchapter1 and to the extent that any provision of this chapter conflicts with a provision of such section #aif or #aig with respect to health insurance issuers providing health insurance coverage in connection with group health plans or of such section #aih1 #aii1 #aii;,a1 or #aii;,b with respect to group health plans or health insurance issuers providing health insurance coverage in connection with group health plans1 the provisions of such sections #aif through #aii;,b shall apply4 4 7d7 ,effective date ,the amendments made by this section shall take effect on the date on which the ,supreme ,court of the ,united ,states issues a decision striking down the ,patient ,protection and ,affordable ,care ,act 7,public ,law #aaa-adh7 in its entirety4 ,b ,expanding ,coverage ,options #baa4 ,rules governing association health plans 7a7 ,in ,general ,subtitle ,b of title ,i of the ,employee ,retirement ,income ,security ,act of #aigd is amended by adding after part #g the following new part3 #h ,,rules ,,governing ,,association ,,health ,,plans #hja4 ,association health plans 7a7 ,in ,general ,for purposes of this part1 the term association health plan means a group health plan whose sponsor is 7or is deemed under this part to be7 described in subsection 7b74 7b7 ,sponsorship ,the sponsor of a group health plan is described in this subsection if such sponsor-- 7#a7 is organized and maintained in good faith1 with a constitution and bylaws specifically stating its purpose and providing for periodic meetings on at least an annual basis1 as a bona fide trade association1 a bona fide industry association 7including a rural electric cooperative association or a rural telephone cooperative association71 a bona fide professional association1 or a bona fide chamber of commerce 7or similar bona fide business association1 including a corporation or similar organization that operates on a cooperative basis 7within the meaning of section #acha of the ,internal ,revenue ,code of #aihf771 for substantial purposes other than that of obtaining or providing medical care2 7#b7 is established as a permanent entity which receives the active support of its members and requires for membership payment on a periodic basis of dues or payments necessary to maintain eligibility for membership in the sponsor2 and 7#c7 does not condition membership1 such dues or payments1 or coverage under the plan on the basis of health status-related factors with respect to the employees of its members 7or affiliated members71 or the dependents of such employees1 and does not condition such dues or payments on the basis of group health plan participation4 ,any sponsor consisting of an association of entities which meet the requirements of paragraphs 7#a71 7#b71 and 7#c7 shall be deemed to be a sponsor described in this subsection4 #hjb4 ,certification of association health plans 7a7 ,in ,general ,the applicable authority shall prescribe by regulation a procedure under which1 subject to subsection 7b71 the applicable authority shall certify association health plans which apply for certification as meeting the requirements of this part4 7b7 ,standards ,under the procedure prescribed pursuant to subsection 7a71 in the case of an association health plan that provides at least one benefit option which does not consist of health insurance coverage1 the applicable authority shall certify such plan as meeting the requirements of this part only if the applicable authority is satisfied that the applicable requirements of this part are met 7or1 upon the date on which the plan is to commence operations1 will be met7 with respect to the plan4 7c7 ,requirements ,applicable to ,certified ,plans ,an association health plan with respect to which certification under this part is in effect shall meet the applicable requirements of this part1 effective on the date of certification 7or1 if later1 on the date on which the plan is to commence operations74 7d7 ,requirements for ,continued ,certification ,the applicable authority may provide by regulation for continued certification of association health plans under this part4 7e7 ,class ,certification for ,fully ,insured ,plans ,the applicable authority shall establish a class certification procedure for association health plans under which all benefits consist of health insurance coverage4 ,under such procedure1 the applicable authority shall provide for the granting of certification under this part to the plans in each class of such association health plans upon appropriate filing under such procedure in connection with plans in such class and payment of the prescribed fee under section #hjg7;a74 7f7 ,certification of ,self-,insured ,association ,health ,plans ,an association health plan which offers one or more benefit options which do not consist of health insurance coverage may be certified under this part only if such plan consists of any of the following3 7#a7 ,a plan which offered such coverage on the date of the enactment of this section4 7#b7 ,a plan under which the sponsor does not restrict membership to one or more trades and businesses or industries and whose eligible participating employers represent a broad cross-section of trades and businesses or industries4 7#c7 ,a plan whose eligible participating employers represent one or more trades or businesses1 or one or more industries1 consisting of any of the following3 agriculture2 equipment and automobile dealerships2 barbering and cosmetology2 certified public accounting practices2 child care2 construction2 dance1 theatrical and orchestra productions2 disinfecting and pest control2 financial services2 fishing2 food service establishments2 hospitals2 labor organizations2 logging2 manufacturing 7metals72 mining2 medical and dental practices2 medical laboratories2 professional consulting services2 sanitary services2 transportation 7local and freight72 warehousing2 wholesaling_/distributing2 or any other trade or business or industry which has been indicated as having average or above-average risk or health claims experience by reason of ,state rate filings1 denials of coverage1 proposed premium rate levels1 or other means demonstrated by such plan in accordance with regulations4 #hjc4 ,requirements relating to sponsors and boards of trustees 7a7 ,sponsor ,the requirements of this subsection are met with respect to an association health plan if the sponsor has met 7or is deemed under this part to have met7 the requirements of section #hja7;b7 for a continuous period of not less than #c years ending with the date of the application for certification under this part4 7b7 ,board of ,trustees ,the requirements of this subsection are met with respect to an association health plan if the following requirements are met3 7#a7 ,fiscal control ,the plan is operated1 pursuant to a trust agreement1 by a board of trustees which has complete fiscal control over the plan and which is responsible for all operations of the plan4 7#b7 ,rules of operation and financial controls ,the board of trustees has in effect rules of operation and financial controls1 based on a #c-year plan of operation1 adequate to carry out the terms of the plan and to meet all requirements of this title applicable to the plan4 7#c7 ,rules governing relationship to participating employers and to contractors 7,a7 ,board membership 7i7 ,in general ,except as provided in clauses 7ii7 and 7iii71 the members of the board of trustees are individuals selected from individuals who are the owners1 officers1 directors1 or employees of the participating employers or who are partners in the participating employers and actively participate in the business4 7ii7 ,limitation 7,i7 ,general rule ,except as provided in subclauses 7,,ii7 and 7,,iii71 no such member is an owner1 officer1 director1 or employee of1 or partner in1 a contract administrator or other service provider to the plan4 7,,ii7 ,limited exception for providers of services solely on behalf of the sponsor ,officers or employees of a sponsor which is a service provider 7other than a contract administrator7 to the plan may be members of the board if they constitute not more than #be percent of the membership of the board and they do not provide services to the plan other than on behalf of the sponsor4 7,,iii7 ,treatment of providers of medical care ,in the case of a sponsor which is an association whose membership consists primarily of providers of medical care1 subclause 7,i7 shall not apply in the case of any service provider described in subclause 7,i7 who is a provider of medical care under the plan4 7iii7 ,certain plans excluded ,clause 7i7 shall not apply to an association health plan which is in existence on the date of the enactment of this section4 7,b7 ,sole authority ,the board has sole authority under the plan to approve applications for participation in the plan and to contract with a service provider to administer the day-to-day affairs of the plan4 7c7 ,treatment of ,franchise ,networks ,in the case of a group health plan which is established and maintained by a franchiser for a franchise network consisting of its franchisees-- 7#a7 the requirements of subsection 7a7 and section #hja7;a7 shall be deemed met if such requirements would otherwise be met if the franchiser were deemed to be the sponsor referred to in section #hja7;b71 such network were deemed to be an association described in section #hja7;b71 and each franchisee were deemed to be a member 7of the association and the sponsor7 referred to in section #hja7;b72 and 7#b7 the requirements of section #hjd7;a77#a7 shall be deemed met4 ,the ,secretary may by regulation define for purposes of this subsection the terms franchiser1 franchise network1 and franchisee4 #hjd4 ,participation and coverage requirements 7a7 ,covered ,employers and ,individuals ,the requirements of this subsection are met with respect to an association health plan if1 under the terms of the plan-- 7#a7 each participating employer must be-- 7,a7 a member of the sponsor2 7,b7 the sponsor2 or 7,c7 an affiliated member of the sponsor with respect to which the requirements of subsection 7b7 are met1 except that1 in the case of a sponsor which is a professional association or other individual-based association1 if at least one of the officers1 directors1 or employees of an employer1 or at least one of the individuals who are partners in an employer and who actively participates in the business1 is a member or such an affiliated member of the sponsor1 participating employers may also include such employer2 and 7#b7 all individuals commencing coverage under the plan after certification under this part must be-- 7,a7 active or retired owners 7including self-employed individuals71 officers1 directors1 or employees of1 or partners in1 participating employers2 or 7,b7 the beneficiaries of individuals described in subparagraph 7,a74 7b7 ,coverage of ,previously ,uninsured ,employees ,in the case of an association health plan in existence on the date of the enactment of this section1 an affiliated member of the sponsor of the plan may be offered coverage under the plan as a participating employer only if-- 7#a7 the affiliated member was an affiliated member on the date of certification under this part2 or 7#b7 during the #ab-month period preceding the date of the offering of such coverage1 the affiliated member has not maintained or contributed to a group health plan with respect to any of its employees who would otherwise be eligible to participate in such association health plan4 7c7 ,individual ,market ,unaffected ,the requirements of this subsection are met with respect to an association health plan if1 under the terms of the plan1 no participating employer may provide health insurance coverage in the individual market for any employee not covered under the plan which is similar to the coverage contemporaneously provided to employees of the employer under the plan1 if such exclusion of the employee from coverage under the plan is based on a health status-related factor with respect to the employee and such employee would1 but for such exclusion on such basis1 be eligible for coverage under the plan4 7d7 ,prohibition of ,discrimination ,against ,employers and ,employees ,eligible ,to ,participate ,the requirements of this subsection are met with respect to an association health plan if-- 7#a7 under the terms of the plan1 all employers meeting the preceding requirements of this section are eligible to qualify as participating employers for all geographically available coverage options1 unless1 in the case of any such employer1 participation or contribution requirements of the type referred to in section #bgaa of the ,public ,health ,service ,act are not met2 7#b7 upon request1 any employer eligible to participate is furnished information regarding all coverage options available under the plan2 and 7#c7 the applicable requirements of sections #gja1 #gjb1 and #gjc are met with respect to the plan4 #hje4 ,other requirements relating to plan documents1 contribution rates1 and benefit options 7a7 ,in ,general ,the requirements of this section are met with respect to an association health plan if the following requirements are met3 7#a7 ,contents of governing instruments ,the instruments governing the plan include a written instrument1 meeting the requirements of an instrument required under section #djb7;a77#a71 which-- 7,a7 provides that the board of trustees serves as the named fiduciary required for plans under section #djb7;a77#a7 and serves in the capacity of a plan administrator 7referred to in section #c7af77;,a772 7,b7 provides that the sponsor of the plan is to serve as plan sponsor 7referred to in section #c7af77;,b772 and 7,c7 incorporates the requirements of section #hjf4 7#b7 ,contribution rates must be nondiscriminatory 7,a7 ,the contribution rates for any participating small employer do not vary on the basis of any health status-related factor in relation to employees of such employer or their beneficiaries and do not vary on the basis of the type of business or industry in which such employer is engaged4 7,b7 ,nothing in this title or any other provision of law shall be construed to preclude an association health plan1 or a health insurance issuer offering health insurance coverage in connection with an association health plan1 from-- 7i7 setting contribution rates based on the claims experience of the plan2 or 7ii7 varying contribution rates for small employers in a ,state to the extent that such rates could vary using the same methodology employed in such ,state for regulating premium rates in the small group market with respect to health insurance coverage offered in connection with bona fide associations 7within the meaning of section #bgia7;d77#c7 of the ,public ,health ,service ,act71 subject to the requirements of section #gjb7;b7 relating to contribution rates4 7#c7 ,floor for number of covered individuals with respect to certain plans ,if any benefit option under the plan does not consist of health insurance coverage1 the plan has as of the beginning of the plan year not fewer than #a1jjj participants and beneficiaries4 7#d7 ,marketing requirements 7,a7 ,in general ,if a benefit option which consists of health insurance coverage is offered under the plan1 ,state-licensed insurance agents shall be used to distribute to small employers coverage which does not consist of health insurance coverage in a manner comparable to the manner in which such agents are used to distribute health insurance coverage4 7,b7 ,state-licensed insurance agents ,for purposes of subparagraph 7,a71 the term ,state-licensed insurance agents means one or more agents who are licensed in a ,state and are subject to the laws of such ,state relating to licensure1 qualification1 testing1 examination1 and continuing education of persons authorized to offer1 sell1 or solicit health insurance coverage in such ,state4 7#e7 ,regulatory requirements ,such other requirements as the applicable authority determines are necessary to carry out the purposes of this part1 which shall be prescribed by the applicable authority by regulation4 7b7 ,ability of ,association ,health ,plans ,to ,design ,benefit ,options ,subject to section #ead7;d71 nothing in this part or any provision of ,state law 7as defined in section #ead7;c77#a77 shall be construed to preclude an association health plan1 or a health insurance issuer offering health insurance coverage in connection with an association health plan1 from exercising its sole discretion in selecting the specific items and services consisting of medical care to be included as benefits under such plan or coverage1 except 7subject to section #ead7 in the case of 7#a7 any law to the extent that it is not preempted under section #gca7;a77#a7 with respect to matters governed by section #gaa1 #gab1 or #gac1 or 7#b7 any law of the ,state with which filing and approval of a policy type offered by the plan was initially obtained to the extent that such law prohibits an exclusion of a specific disease from such coverage4 #hjf4 ,maintenance of reserves and provisions for solvency for plans providing health benefits in addition to health insurance coverage 7a7 ,in ,general ,the requirements of this section are met with respect to an association health plan if-- 7#a7 the benefits under the plan consist solely of health insurance coverage2 or 7#b7 if the plan provides any additional benefit options which do not consist of health insurance coverage1 the plan-- 7,a7 establishes and maintains reserves with respect to such additional benefit options1 in amounts recommended by the qualified actuary1 consisting of-- 7i7 a reserve sufficient for unearned contributions2 7ii7 a reserve sufficient for benefit liabilities which have been incurred1 which have not been satisfied1 and for which risk of loss has not yet been transferred1 and for expected administrative costs with respect to such benefit liabilities2 7iii7 a reserve sufficient for any other obligations of the plan2 and 7iv7 a reserve sufficient for a margin of error and other fluctuations1 taking into account the specific circumstances of the plan2 and 7,b7 establishes and maintains aggregate and specific excess_/stop loss insurance and solvency indemnification1 with respect to such additional benefit options for which risk of loss has not yet been transferred1 as follows3 7i7 ,the plan shall secure aggregate excess_/stop loss insurance for the plan with an attachment point which is not greater than #abe percent of expected gross annual claims4 ,the applicable authority may by regulation provide for upward adjustments in the amount of such percentage in specified circumstances in which the plan specifically provides for and maintains reserves in excess of the amounts required under subparagraph 7,a74 7ii7 ,the plan shall secure specific excess_/stop loss insurance for the plan with an attachment point which is at least equal to an amount recommended by the plan's qualified actuary4 ,the applicable authority may by regulation provide for adjustments in the amount of such insurance in specified circumstances in which the plan specifically provides for and maintains reserves in excess of the amounts required under subparagraph 7,a74 7iii7 ,the plan shall secure indemnification insurance for any claims which the plan is unable to satisfy by reason of a plan termination4 ,any person issuing to a plan insurance described in clause 7i71 7ii71 or 7iii7 of subparagraph 7,b7 shall notify the ,secretary of any failure of premium payment meriting cancellation of the policy prior to undertaking such a cancellation4 ,any regulations prescribed by the applicable authority pursuant to clause 7i7 or 7ii7 of subparagraph 7,b7 may allow for such adjustments in the required levels of excess_/stop loss insurance as the qualified actuary may recommend1 taking into account the specific circumstances of the plan4 7b7 ,minimum ,surplus in ,addition to ,claims ,reserves ,in the case of any association health plan described in subsection 7a77#b71 the requirements of this subsection are met if the plan establishes and maintains surplus in an amount at least equal to-- 7#a7 #ejj1jjj2 or 7#b7 such greater amount 7but not greater than #b1jjj1jjj7 as may be set forth in regulations prescribed by the applicable authority1 considering the level of aggregate and specific excess_/stop loss insurance provided with respect to such plan and other factors related to solvency risk1 such as the plan's projected levels of participation or claims1 the nature of the plan's liabilities1 and the types of assets available to assure that such liabilities are met4 7c7 ,additional ,requirements ,in the case of any association health plan described in subsection 7a77#b71 the applicable authority may provide such additional requirements relating to reserves1 excess_/stop loss insurance1 and indemnification insurance as the applicable authority considers appropriate4 ,such requirements may be provided by regulation with respect to any such plan or any class of such plans4 7d7 ,adjustments for ,excess_/,stop ,loss ,insurance ,the applicable authority may provide for adjustments to the levels of reserves otherwise required under subsections 7a7 and 7b7 with respect to any plan or class of plans to take into account excess_/stop loss insurance provided with respect to such plan or plans4 7e7 ,alternative ,means of ,compliance ,the applicable authority may permit an association health plan described in subsection 7a77#b7 to substitute1 for all or part of the requirements of this section 7except subsection 7a77#b77;,b77iii771 such security1 guarantee1 hold-harmless arrangement1 or other financial arrangement as the applicable authority determines to be adequate to enable the plan to fully meet all its financial obligations on a timely basis and is otherwise no less protective of the interests of participants and beneficiaries than the requirements for which it is substituted4 ,the applicable authority may take into account1 for purposes of this subsection1 evidence provided by the plan or sponsor which demonstrates an assumption of liability with respect to the plan4 ,such evidence may be in the form of a contract of indemnification1 lien1 bonding1 insurance1 letter of credit1 recourse under applicable terms of the plan in the form of assessments of participating employers1 security1 or other financial arrangement4 7f7 ,measures ,to ,ensure ,continued ,payment of ,benefits by ,certain ,plans in ,distress 7#a7 ,payments by certain plans to association health plan fund 7,a7 ,in general ,in the case of an association health plan described in subsection 7a77#b71 the requirements of this subsection are met if the plan makes payments into the ,association ,health ,plan ,fund under this subparagraph when they are due4 ,such payments shall consist of annual payments in the amount of #e1jjj1 and1 in addition to such annual payments1 such supplemental payments as the ,secretary may determine to be necessary under paragraph 7#b74 ,payments under this paragraph are payable to the ,fund at the time determined by the ,secretary4 ,initial payments are due in advance of certification under this part4 ,payments shall continue to accrue until a plan's assets are distributed pursuant to a termination procedure4 7,b7 ,penalties for failure to make payments ,if any payment is not made by a plan when it is due1 a late payment charge of not more than #ajj percent of the payment which was not timely paid shall be payable by the plan to the ,fund4 7,c7 ,continued duty of the secretary ,the ,secretary shall not cease to carry out the provisions of paragraph 7#b7 on account of the failure of a plan to pay any payment when due4 7#b7 ,payments by secretary to continue excess_/stop loss insurance coverage and indemnification insurance coverage for certain plans ,in any case in which the applicable authority determines that there is1 or that there is reason to believe that there will be3 7,a7 ,a failure to take necessary corrective actions under section #hji7;a7 with respect to an association health plan described in subsection 7a77#b72 or 7,b7 a termination of such a plan under section #hji7;b7 or #haj7;b77#h7 7and1 if the applicable authority is not the ,secretary1 certifies such determination to the ,secretary71 the ,secretary shall determine the amounts necessary to make payments to an insurer 7designated by the ,secretary7 to maintain in force excess_/stop loss insurance coverage or indemnification insurance coverage for such plan1 if the ,secretary determines that there is a reasonable expectation that1 without such payments1 claims would not be satisfied by reason of termination of such coverage4 ,the ,secretary shall1 to the extent provided in advance in appropriation ,acts1 pay such amounts so determined to the insurer designated by the ,secretary4 7#c7 ,association health plan fund 7,a7 ,in general ,there is established on the books of the ,treasury a fund to be known as the ,association ,health ,plan ,fund4 ,the ,fund shall be available for making payments pursuant to paragraph 7#b74 ,the ,fund shall be credited with payments received pursuant to paragraph 7#a77;,a71 penalties received pursuant to paragraph 7#a77;,b72 and earnings on investments of amounts of the ,fund under subparagraph 7,b74 7,b7 ,investment ,whenever the ,secretary determines that the moneys of the fund are in excess of current needs1 the ,secretary may request the investment of such amounts as the ,secretary determines advisable by the ,secretary of the ,treasury in obligations issued or guaranteed by the ,united ,states4 7g7 ,excess_/,stop ,loss ,insurance ,for purposes of this section-- 7#a7 ,aggregate excess_/stop loss insurance ,the term aggregate excess_/stop loss insurance means1 in connection with an association health plan1 a contract-- 7,a7 under which an insurer 7meeting such minimum standards as the applicable authority may prescribe by regulation7 provides for payment to the plan with respect to aggregate claims under the plan in excess of an amount or amounts specified in such contract2 7,b7 which is guaranteed renewable2 and 7,c7 which allows for payment of premiums by any third party on behalf of the insured plan4 7#b7 ,specific excess_/stop loss insurance ,the term specific excess_/stop loss insurance means1 in connection with an association health plan1 a contract-- 7,a7 under which an insurer 7meeting such minimum standards as the applicable authority may prescribe by regulation7 provides for payment to the plan with respect to claims under the plan in connection with a covered individual in excess of an amount or amounts specified in such contract in connection with such covered individual2 7,b7 which is guaranteed renewable2 and 7,c7 which allows for payment of premiums by any third party on behalf of the insured plan4 7h7 ,indemnification ,insurance ,for purposes of this section1 the term indemnification insurance means1 in connection with an association health plan1 a contract-- 7#a7 under which an insurer 7meeting such minimum standards as the applicable authority may prescribe by regulation7 provides for payment to the plan with respect to claims under the plan which the plan is unable to satisfy by reason of a termination pursuant to section #hji7;b7 7relating to mandatory termination72 7#b7 which is guaranteed renewable and noncancellable for any reason 7except as the applicable authority may prescribe by regulation72 and 7#c7 which allows for payment of premiums by any third party on behalf of the insured plan4 7i7 ,reserves ,for purposes of this section1 the term reserves means1 in connection with an association health plan1 plan assets which meet the fiduciary standards under part #d and such additional requirements regarding liquidity as the applicable authority may prescribe by regulation4 7j7 ,solvency ,standards ,working ,group 7#a7 ,in general ,within #ij days after the date of the enactment of this section1 the applicable authority shall establish a ,solvency ,standards ,working ,group4 ,in prescribing the initial regulations under this section1 the applicable authority shall take into account the recommendations of such ,working ,group4 7#b7 ,membership ,the ,working ,group shall consist of not more than #ae members appointed by the applicable authority4 ,the applicable authority shall include among persons invited to membership on the ,working ,group at least one of each of the following3 7,a7 ,a representative of the ,national ,association of ,insurance ,commissioners4 7,b7 ,a representative of the ,american ,academy of ,actuaries4 7,c7 ,a representative of the ,state governments1 or their interests4 7,d7 ,a representative of existing self-insured arrangements1 or their interests4 7,e7 ,a representative of associations of the type referred to in section #hja7;b77#a71 or their interests4 7,f7 ,a representative of multiemployer plans that are group health plans1 or their interests4 #hjg4 ,requirements for application and related requirements 7a7 ,filing ,fee ,under the procedure prescribed pursuant to section #hjb7;a71 an association health plan shall pay to the applicable authority at the time of filing an application for certification under this part a filing fee in the amount of #e1jjj1 which shall be available in the case of the ,secretary1 to the extent provided in appropriation ,acts1 for the sole purpose of administering the certification procedures applicable with respect to association health plans4 7b7 ,information ,to ,be ,included in ,application for ,certification ,an application for certification under this part meets the requirements of this section only if it includes1 in a manner and form which shall be prescribed by the applicable authority by regulation1 at least the following information3 7#a7 ,identifying information ,the names and addresses of-- 7,a7 the sponsor2 and 7,b7 the members of the board of trustees of the plan4 7#b7 ,states in which plan intends to do business ,the ,states in which participants and beneficiaries under the plan are to be located and the number of them expected to be located in each such ,state4 7#c7 ,bonding requirements ,evidence provided by the board of trustees that the bonding requirements of section #dab will be met as of the date of the application or 7if later7 commencement of operations4 7#d7 ,plan documents ,a copy of the documents governing the plan 7including any bylaws and trust agreements71 the summary plan description1 and other material describing the benefits that will be provided to participants and beneficiaries under the plan4 7#e7 ,agreements with service providers ,a copy of any agreements between the plan and contract administrators and other service providers4 7#f7 ,funding report ,in the case of association health plans providing benefits options in addition to health insurance coverage1 a report setting forth information with respect to such additional benefit options determined as of a date within the #abj-;day period ending with the date of the application1 including the following3 7,a7 ,reserves ,a statement1 certified by the board of trustees of the plan1 and a statement of actuarial opinion1 signed by a qualified actuary1 that all applicable requirements of section #hjf are or will be met in accordance with regulations which the applicable authority shall prescribe4 7,b7 ,adequacy of contribution rates ,a statement of actuarial opinion1 signed by a qualified actuary1 which sets forth a description of the extent to which contribution rates are adequate to provide for the payment of all obligations and the maintenance of required reserves under the plan for the #ab-month period beginning with such date within such #abj-;day period1 taking into account the expected coverage and experience of the plan4 ,if the contribution rates are not fully adequate1 the statement of actuarial opinion shall indicate the extent to which the rates are inadequate and the changes needed to ensure adequacy4 7,c7 ,current and projected value of assets and liabilities ,a statement of actuarial opinion signed by a qualified actuary1 which sets forth the current value of the assets and liabilities accumulated under the plan and a projection of the assets1 liabilities1 income1 and expenses of the plan for the #ab-month period referred to in subparagraph 7,b74 ,the income statement shall identify separately the plan's administrative expenses and claims4 7,d7 ,costs of coverage to be charged and other expenses ,a statement of the costs of coverage to be charged1 including an itemization of amounts for administration1 reserves1 and other expenses associated with the operation of the plan4 7,e7 ,other information ,any other information as may be determined by the applicable authority1 by regulation1 as necessary to carry out the purposes of this part4 7c7 ,filing ,notice of ,certification ,with ,states ,a certification granted under this part to an association health plan shall not be effective unless written notice of such certification is filed with the applicable ,state authority of each ,state in which at least #be percent of the participants and beneficiaries under the plan are located4 ,for purposes of this subsection1 an individual shall be considered to be located in the ,state in which a known address of such individual is located or in which such individual is employed4 7d7 ,notice of ,material ,changes ,in the case of any association health plan certified under this part1 descriptions of material changes in any information which was required to be submitted with the application for the certification under this part shall be filed in such form and manner as shall be prescribed by the applicable authority by regulation4 ,the applicable authority may require by regulation prior notice of material changes with respect to specified matters which might serve as the basis for suspension or revocation of the certification4 7e7 ,reporting ,requirements for ,certain ,association ,health ,plans ,an association health plan certified under this part which provides benefit options in addition to health insurance coverage for such plan year shall meet the requirements of section #ajc by filing an annual report under such section which shall include information described in subsection 7b77#f7 with respect to the plan year and1 notwithstanding section #ajd7;a77#a77;,a71 shall be filed with the applicable authority not later than #ij days after the close of the plan year 7or on such later date as may be prescribed by the applicable authority74 ,the applicable authority may require by regulation such interim reports as it considers appropriate4 7f7 ,engagement of ,qualified ,actuary ,the board of trustees of each association health plan which provides benefits options in addition to health insurance coverage and which is applying for certification under this part or is certified under this part shall engage1 on behalf of all participants and beneficiaries1 a qualified actuary who shall be responsible for the preparation of the materials comprising information necessary to be submitted by a qualified actuary under this part4 ,the qualified actuary shall utilize such assumptions and techniques as are necessary to enable such actuary to form an opinion as to whether the contents of the matters reported under this part-- 7#a7 are in the aggregate reasonably related to the experience of the plan and to reasonable expectations2 and 7#b7 represent such actuary's best estimate of anticipated experience under the plan4 ,the opinion by the qualified actuary shall be made with respect to1 and shall be made a part of1 the annual report4 #hjh4 ,notice requirements for voluntary termination ,except as provided in section #hji7;b71 an association health plan which is or has been certified under this part may terminate 7upon or at any time after cessation of accruals in benefit liabilities7 only if the board of trustees1 not less than #fj days before the proposed termination date-- 7#a7 provides to the participants and beneficiaries a written notice of intent to terminate stating that such termination is intended and the proposed termination date2 7#b7 develops a plan for winding up the affairs of the plan in connection with such termination in a manner which will result in timely payment of all benefits for which the plan is obligated2 and 7#c7 submits such plan in writing to the applicable authority4 ,actions required under this section shall be taken in such form and manner as may be prescribed by the applicable authority by regulation4 #hji4 ,corrective actions and mandatory termination 7a7 ,actions ,to ,avoid ,depletion of ,reserves ,an association health plan which is certified under this part and which provides benefits other than health insurance coverage shall continue to meet the requirements of section #hjf1 irrespective of whether such certification continues in effect4 ,the board of trustees of such plan shall determine quarterly whether the requirements of section #hjf are met4 ,in any case in which the board determines that there is reason to believe that there is or will be a failure to meet such requirements1 or the applicable authority makes such a determination and so notifies the board1 the board shall immediately notify the qualified actuary engaged by the plan1 and such actuary shall1 not later than the end of the next following month1 make such recommendations to the board for corrective action as the actuary determines necessary to ensure compliance with section #hjf4 ,not later than #cj days after receiving from the actuary recommendations for corrective actions1 the board shall notify the applicable authority 7in such form and manner as the applicable authority may prescribe by regulation7 of such recommendations of the actuary for corrective action1 together with a description of the actions 7if any7 that the board has taken or plans to take in response to such recommendations4 ,the board shall thereafter report to the applicable authority1 in such form and frequency as the applicable authority may specify to the board1 regarding corrective action taken by the board until the requirements of section #hjf are met4 7b7 ,mandatory ,termination ,in any case in which-- 7#a7 the applicable authority has been notified under subsection 7a7 7or by an issuer of excess_/stop loss insurance or indemnity insurance pursuant to section #hjf7;a77 of a failure of an association health plan which is or has been certified under this part and is described in section #hjf7;a77#b7 to meet the requirements of section #hjf and has not been notified by the board of trustees of the plan that corrective action has restored compliance with such requirements2 and 7#b7 the applicable authority determines that there is a reasonable expectation that the plan will continue to fail to meet the requirements of section #hjf1 the board of trustees of the plan shall1 at the direction of the applicable authority1 terminate the plan and1 in the course of the termination1 take such actions as the applicable authority may require1 including satisfying any claims referred to in section #hjf7;a77#b77;,b77iii7 and recovering for the plan any liability under subsection 7a77#b77;,b77iii7 or 7e7 of section #hjf1 as necessary to ensure that the affairs of the plan will be1 to the maximum extent possible1 wound up in a manner which will result in timely provision of all benefits for which the plan is obligated4 #haj4 ,trusteeship by the ,secretary of insolvent association health plans providing health benefits in addition to health insurance coverage 7a7 ,appointment of ,secretary as ,trustee for ,insolvent ,plans ,whenever the ,secretary determines that an association health plan which is or has been certified under this part and which is described in section #hjf7;a77#b7 will be unable to provide benefits when due or is otherwise in a financially hazardous condition1 as shall be defined by the ,secretary by regulation1 the ,secretary shall1 upon notice to the plan1 apply to the appropriate ,united ,states district court for appointment of the ,secretary as trustee to administer the plan for the duration of the insolvency4 ,the plan may appear as a party and other interested persons may intervene in the proceedings at the discretion of the court4 ,the court shall appoint such ,secretary trustee if the court determines that the trusteeship is necessary to protect the interests of the participants and beneficiaries or providers of medical care or to avoid any unreasonable deterioration of the financial condition of the plan4 ,the trusteeship of such ,secretary shall continue until the conditions described in the first sentence of this subsection are remedied or the plan is terminated4 7b7 ,powers as ,trustee ,the ,secretary1 upon appointment as trustee under subsection 7a71 shall have the power-- 7#a7 to do any act authorized by the plan1 this title1 or other applicable provisions of law to be done by the plan administrator or any trustee of the plan2 7#b7 to require the transfer of all 7or any part7 of the assets and records of the plan to the ,secretary as trustee2 7#c7 to invest any assets of the plan which the ,secretary holds in accordance with the provisions of the plan1 regulations prescribed by the ,secretary1 and applicable provisions of law2 7#d7 to require the sponsor1 the plan administrator1 any participating employer1 and any employee organization representing plan participants to furnish any information with respect to the plan which the ,secretary as trustee may reasonably need in order to administer the plan2 7#e7 to collect for the plan any amounts due the plan and to recover reasonable expenses of the trusteeship2 7#f7 to commence1 prosecute1 or defend on behalf of the plan any suit or proceeding involving the plan2 7#g7 to issue1 publish1 or file such notices1 statements1 and reports as may be required by the ,secretary by regulation or required by any order of the court2 7#h7 to terminate the plan 7or provide for its termination in accordance with section #hji7;b77 and liquidate the plan assets1 to restore the plan to the responsibility of the sponsor1 or to continue the trusteeship2 7#i7 to provide for the enrollment of plan participants and beneficiaries under appropriate coverage options2 and 7#aj7 to do such other acts as may be necessary to comply with this title or any order of the court and to protect the interests of plan participants and beneficiaries and providers of medical care4 7c7 ,notice of ,appointment ,as soon as practicable after the ,secretary's appointment as trustee1 the ,secretary shall give notice of such appointment to-- 7#a7 the sponsor and plan administrator2 7#b7 each participant2 7#c7 each participating employer2 and 7#d7 if applicable1 each employee organization which1 for purposes of collective bargaining1 represents plan participants4 7d7 ,additional ,duties ,except to the extent inconsistent with the provisions of this title1 or as may be otherwise ordered by the court1 the ,secretary1 upon appointment as trustee under this section1 shall be subject to the same duties as those of a trustee under section #gjd of title #aa1 ,united ,states ,code1 and shall have the duties of a fiduciary for purposes of this title4 7e7 ,other ,proceedings ,an application by the ,secretary under this subsection may be filed notwithstanding the pendency in the same or any other court of any bankruptcy1 mortgage foreclosure1 or equity receivership proceeding1 or any proceeding to reorganize1 conserve1 or liquidate such plan or its property1 or any proceeding to enforce a lien against property of the plan4 7f7 ,jurisdiction of ,court 7#a7 ,in general ,upon the filing of an application for the appointment as trustee or the issuance of a decree under this section1 the court to which the application is made shall have exclusive jurisdiction of the plan involved and its property wherever located with the powers1 to the extent consistent with the purposes of this section1 of a court of the ,united ,states having jurisdiction over cases under chapter #aa of title #aa1 ,united ,states ,code4 ,pending an adjudication under this section such court shall stay1 and upon appointment by it of the ,secretary as trustee1 such court shall continue the stay of1 any pending mortgage foreclosure1 equity receivership1 or other proceeding to reorganize1 conserve1 or liquidate the plan1 the sponsor1 or property of such plan or sponsor1 and any other suit against any receiver1 conservator1 or trustee of the plan1 the sponsor1 or property of the plan or sponsor4 ,pending such adjudication and upon the appointment by it of the ,secretary as trustee1 the court may stay any proceeding to enforce a lien against property of the plan or the sponsor or any other suit against the plan or the sponsor4 7#b7 ,venue ,an action under this section may be brought in the judicial district where the sponsor or the plan administrator resides or does business or where any asset of the plan is situated4 ,a district court in which such action is brought may issue process with respect to such action in any other judicial district4 7g7 ,personnel ,in accordance with regulations which shall be prescribed by the ,secretary1 the ,secretary shall appoint1 retain1 and compensate accountants1 actuaries1 and other professional service personnel as may be necessary in connection with the ,secretary's service as trustee under this section4 #haa4 ,state assessment authority 7a7 ,in ,general ,notwithstanding section #ead1 a ,state may impose by law a contribution tax on an association health plan described in section #hjf7;a77#b71 if the plan commenced operations in such ,state after the date of the enactment of this section4 7b7 ,contribution ,tax ,for purposes of this section1 the term contribution tax imposed by a ,state on an association health plan means any tax imposed by such ,state if-- 7#a7 such tax is computed by applying a rate to the amount of premiums or contributions1 with respect to individuals covered under the plan who are residents of such ,state1 which are received by the plan from participating employers located in such ,state or from such individuals2 7#b7 the rate of such tax does not exceed the rate of any tax imposed by such ,state on premiums or contributions received by insurers or health maintenance organizations for health insurance coverage offered in such ,state in connection with a group health plan2 7#c7 such tax is otherwise nondiscriminatory2 and 7#d7 the amount of any such tax assessed on the plan is reduced by the amount of any tax or assessment otherwise imposed by the ,state on premiums1 contributions1 or both received by insurers or health maintenance organizations for health insurance coverage1 aggregate excess_/stop loss insurance 7as defined in section #hjf7;g77#a771 specific excess_/stop loss insurance 7as defined in section #hjf7;g77#b771 other insurance related to the provision of medical care under the plan1 or any combination thereof provided by such insurers or health maintenance organizations in such ,state in connection with such plan4 #hab4 ,definitions and rules of construction 7a7 ,definitions ,for purposes of this part-- 7#a7 ,group health plan ,the term group health plan has the meaning provided in section #gcc7;a77#a7 7after applying subsection 7b7 of this section74 7#b7 ,medical care ,the term medical care has the meaning provided in section #gcc7;a77#b74 7#c7 ,health insurance coverage ,the term health insurance coverage has the meaning provided in section #gcc7;b77#a74 7#d7 ,health insurance issuer ,the term health insurance issuer has the meaning provided in section #gcc7;b77#b74 7#e7 ,applicable authority ,the term applicable authority means the ,secretary1 except that1 in connection with any exercise of the ,secretary's authority regarding which the ,secretary is required under section #ejf7;d7 to consult with a ,state1 such term means the ,secretary1 in consultation with such ,state4 7#f7 ,health status-related factor ,the term health status-related factor has the meaning provided in section #gcc7;d77#b74 7#g7 ,individual market 7,a7 ,in general ,the term individual market means the market for health insurance coverage offered to individuals other than in connection with a group health plan4 7,b7 ,treatment of very small groups 7i7 ,in general ,subject to clause 7ii71 such term includes coverage offered in connection with a group health plan that has fewer than #b participants as current employees or participants described in section #gcb7;d77#c7 on the first day of the plan year4 7ii7 ,state exception ,clause 7i7 shall not apply in the case of health insurance coverage offered in a ,state if such ,state regulates the coverage described in such clause in the same manner and to the same extent as coverage in the small group market 7as defined in section #bgia7;e77#e7 of the ,public ,health ,service ,act7 is regulated by such ,state4 7#h7 ,participating employer ,the term participating employer means1 in connection with an association health plan1 any employer1 if any individual who is an employee of such employer1 a partner in such employer1 or a self-employed individual who is such employer 7or any dependent1 as defined under the terms of the plan1 of such individual7 is or was covered under such plan in connection with the status of such individual as such an employee1 partner1 or self-employed individual in relation to the plan4 7#i7 ,applicable state authority ,the term applicable ,state authority means1 with respect to a health insurance issuer in a ,state1 the ,state insurance commissioner or official or officials designated by the ,state to enforce the requirements of title ,,xxvii of the ,public ,health ,service ,act for the ,state involved with respect to such issuer4 7#aj7 ,qualified actuary ,the term qualified actuary means an individual who is a member of the ,american ,academy of ,actuaries4 7#aa7 ,affiliated member ,the term affiliated member means1 in connection with a sponsor-- 7,a7 a person who is otherwise eligible to be a member of the sponsor but who elects an affiliated status with the sponsor1 7,b7 in the case of a sponsor with members which consist of associations1 a person who is a member of any such association and elects an affiliated status with the sponsor1 or 7,c7 in the case of an association health plan in existence on the date of the enactment of this section1 a person eligible to be a member of the sponsor or one of its member associations4 7#ab7 ,large employer ,the term large employer means1 in connection with a group health plan with respect to a plan year1 an employer who employed an average of at least #ea employees on business days during the preceding calendar year and who employs at least #b employees on the first day of the plan year4 7#ac7 ,small employer ,the term small employer means1 in connection with a group health plan with respect to a plan year1 an employer who is not a large employer4 7b7 ,rules of ,construction 7#a7 ,employers and employees ,for purposes of determining whether a plan1 fund1 or program is an employee welfare benefit plan which is an association health plan1 and for purposes of applying this title in connection with such plan1 fund1 or program so determined to be such an employee welfare benefit plan-- 7,a7 in the case of a partnership1 the term employer 7as defined in section #c7e77 includes the partnership in relation to the partners1 and the term employee 7as defined in section #c7f77 includes any partner in relation to the partnership2 and 7,b7 in the case of a self-employed individual1 the term employer 7as defined in section #c7e77 and the term employee 7as defined in section #c7f77 shall include such individual4 7#b7 ,plans1 funds1 and programs treated as employee welfare benefit plans ,in the case of any plan1 fund1 or program which was established or is maintained for the purpose of providing medical care 7through the purchase of insurance or otherwise7 for employees 7or their dependents7 covered thereunder and which demonstrates to the ,secretary that all requirements for certification under this part would be met with respect to such plan1 fund1 or program if such plan1 fund1 or program were a group health plan1 such plan1 fund1 or program shall be treated for purposes of this title as an employee welfare benefit plan on and after the date of such demonstration4 4 7b7 ,conforming ,amendments to ,preemption ,rules 7#a7 ,section #ead7;b77#f7 of such ,act 7#bi ,u4,s4,c4 #aadd7;b77#f77 is amended by adding at the end the following new subparagraph3 7,e7 ,the preceding subparagraphs of this paragraph do not apply with respect to any ,state law in the case of an association health plan which is certified under part #h4 4 7#b7 ,section #ead of such ,act 7#bi ,u4,s4,c4 #aadd7 is amended-- 7,a7 in subsection 7b77#d71 by striking ,subsection 7a7 and inserting ,subsections 7a7 and 7f72 7,b7 in subsection 7b77#e71 by striking subsection 7a7 in subparagraph 7,a7 and inserting subsection 7a7 of this section and subsections 7a77#b77;,b7 and 7b7 of section #hje1 and by striking subsection 7a7 in subparagraph 7,b7 and inserting subsection 7a7 of this section or subsection 7a77#b77;,b7 or 7b7 of section #hje2 and 7,c7 by adding at the end the following new subsection3 7f7 7#a7 ,except as provided in subsection 7b77#d71 the provisions of this title shall supersede any and all ,state laws insofar as they may now or hereafter preclude1 or have the effect of precluding1 a health insurance issuer from offering health insurance coverage in connection with an association health plan which is certified under part #h4 7#b7 ,except as provided in paragraphs 7#d7 and 7#e7 of subsection 7b7 of this section-- 7,a7 ,in any case in which health insurance coverage of any policy type is offered under an association health plan certified under part #h to a participating employer operating in such ,state1 the provisions of this title shall supersede any and all laws of such ,state insofar as they may preclude a health insurance issuer from offering health insurance coverage of the same policy type to other employers operating in the ,state which are eligible for coverage under such association health plan1 whether or not such other employers are participating employers in such plan4 7,b7 ,in any case in which health insurance coverage of any policy type is offered in a ,state under an association health plan certified under part #h and the filing1 with the applicable ,state authority 7as defined in section #hab7;a77#i771 of the policy form in connection with such policy type is approved by such ,state authority1 the provisions of this title shall supersede any and all laws of any other ,state in which health insurance coverage of such type is offered1 insofar as they may preclude1 upon the filing in the same form and manner of such policy form with the applicable ,state authority in such other ,state1 the approval of the filing in such other ,state4 7#c7 ,nothing in subsection 7b77#f77;,e7 or the preceding provisions of this subsection shall be construed1 with respect to health insurance issuers or health insurance coverage1 to supersede or impair the law of any ,state-- 7,a7 providing solvency standards or similar standards regarding the adequacy of insurer capital1 surplus1 reserves1 or contributions1 or 7,b7 relating to prompt payment of claims4 7#d7 ,for additional provisions relating to association health plans1 see subsections 7a77#b77;,b7 and 7b7 of section #hje4 7#e7 ,for purposes of this subsection1 the term association health plan has the meaning provided in section #hja7;a71 and the terms health insurance coverage1 participating employer1 and health insurance issuer have the meanings provided such terms in section #hab1 respectively4 4 7#c7 ,section #ead7;b77#f77;,a7 of such ,act 7#bi ,u4,s4,c4 #aadd7;b77#f77;,a77 is amended-- 7,a7 in clause 7i77,,ii71 by striking and at the end2 7,b7 in clause 7ii71 by inserting and which does not provide medical care 7within the meaning of section #gcc7;a77#b771 after arrangement11 and by striking title4 and inserting title1 and2 and 7,c7 by adding at the end the following new clause3 7iii7 subject to subparagraph 7,e71 in the case of any other employee welfare benefit plan which is a multiple employer welfare arrangement and which provides medical care 7within the meaning of section #gcc7;a77#b771 any law of any ,state which regulates insurance may apply4 4 7#d7 ,section #ead7;d7 of such ,act 7#bi ,u4,s4,c4 #aadd7;d77 is amended-- 7,a7 by striking ,nothing and inserting 7#a7 ,except as provided in paragraph 7#b71 nothing2 and 7,b7 by adding at the end the following new paragraph3 7#b7 ,nothing in any other provision of law enacted on or after the date of the enactment of this paragraph shall be construed to alter1 amend1 modify1 invalidate1 impair1 or supersede any provision of this title1 except by specific cross-reference to the affected section4 4 7c7 ,plan ,sponsor ,section #c7af77;,b7 of such ,act 7#bi ,u4,s4,c4 #ajb7af77;,b77 is amended by adding at the end the following new sentence3 ,such term also includes a person serving as the sponsor of an association health plan under part #h44 7d7 ,disclosure of ,solvency ,protections ,related to ,self-,insured and ,fully ,insured ,options ,under ,association ,health ,plans ,section #ajb7;b7 of such ,act 7#bi ,u4,s4,c4 #ajb7;b77 is amended by adding at the end the following3 ,an association health plan shall include in its summary plan description1 in connection with each benefit option1 a description of the form of solvency or guarantee fund protection secured pursuant to this ,act or applicable ,state law1 if any44 7e7 ,savings ,clause ,section #gca7;c7 of such ,act is amended by inserting or part #h after this part4 7f7 ,report to the ,congress ,regarding ,certification of ,self-,insured ,association ,health ,plans ,not later than ,january #a1 #bjbb1 the ,secretary of ,labor shall report to the ,committee on ,education and ,labor of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate the effect association health plans have had1 if any1 on reducing the number of uninsured individuals4 7g7 ,clerical ,amendment ,the table of contents in section #a of the ,employee ,retirement ,income ,security ,act of #aigd is amended by inserting after the item relating to section #gcd the following new items3 ,part #h4 ,rules ,governing ,association ,health ,plans #hja4 ,association health plans4 #hjb4 ,certification of association health plans4 #hjc4 ,requirements relating to sponsors and boards of trustees4 #hjd4 ,participation and coverage requirements4 #hje4 ,other requirements relating to plan documents1 contribution rates1 and benefit options4 #hjf4 ,maintenance of reserves and provisions for solvency for plans providing health benefits in addition to health insurance coverage4 #hjg4 ,requirements for application and related requirements4 #hjh4 ,notice requirements for voluntary termination4 #hji4 ,corrective actions and mandatory termination4 #haj4 ,trusteeship by the ,secretary of insolvent association health plans providing health benefits in addition to health insurance coverage4 #haa4 ,state assessment authority4 #hab4 ,definitions and rules of construction4 4 #bab4 ,clarification of treatment of single employer arrangements ,section #c7dj77;,b7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #ajjb7dj77;,b77 is amended-- 7#a7 in clause 7i71 by inserting after control group1 the following3 except that1 in any case in which the benefit referred to in subparagraph 7,a7 consists of medical care 7as defined in section #hab7;a77#b771 two or more trades or businesses1 whether or not incorporated1 shall be deemed a single employer for any plan year of such plan1 or any fiscal year of such other arrangement1 if such trades or businesses are within the same control group during such year or at any time during the preceding #a-year period12 7#b7 in clause 7iii71 by striking 7iii7 the determination and inserting the following3 7iii7 7,i7 in any case in which the benefit referred to in subparagraph 7,a7 consists of medical care 7as defined in section #hab7;a77#b771 the determination of whether a trade or business is under common control with another trade or business shall be determined under regulations of the ,secretary applying principles consistent and coextensive with the principles applied in determining whether employees of two or more trades or businesses are treated as employed by a single employer under section #djja7;b71 except that1 for purposes of this paragraph1 an interest of greater than #be percent may not be required as the minimum interest necessary for common control1 or 7,,ii7 in any other case1 the determination 2 7#c7 by redesignating clauses 7iv7 and 7v7 as clauses 7v7 and 7vi71 respectively2 and 7#d7 by inserting after clause 7iii7 the following new clause3 7iv7 in any case in which the benefit referred to in subparagraph 7,a7 consists of medical care 7as defined in section #hab7;a77#b771 in determining1 after the application of clause 7i71 whether benefits are provided to employees of two or more employers1 the arrangement shall be treated as having only one participating employer if1 after the application of clause 7i71 the number of individuals who are employees and former employees of any one participating employer and who are covered under the arrangement is greater than #ge percent of the aggregate number of all individuals who are employees or former employees of participating employers and who are covered under the arrangement1 4 #bac4 ,enforcement provisions relating to association health plans 7a7 ,criminal ,penalties for ,certain ,willful ,misrepresentations ,section #eja of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aaca7 is amended by adding at the end the following new subsection3 7c7 ,any person who willfully falsely represents1 to any employee1 any employee's beneficiary1 any employer1 the ,secretary1 or any ,state1 a plan or other arrangement established or maintained for the purpose of offering or providing any benefit described in section #c7a7 to employees or their beneficiaries as-- 7#a7 being an association health plan which has been certified under part #h2 7#b7 having been established or maintained under or pursuant to one or more collective bargaining agreements which are reached pursuant to collective bargaining described in section #h7;d7 of the ,national ,labor ,relations ,act 7#bi ,u4,s4,c4 #aeh7;d77 or paragraph ,fourth of section #b of the ,railway ,labor ,act 7#de ,u4,s4,c4 #aeb1 paragraph ,fourth7 or which are reached pursuant to labor-management negotiations under similar provisions of ,state public employee relations laws2 or 7#c7 being a plan or arrangement described in section #c7dj77;,a77i71 shall1 upon conviction1 be imprisoned not more than #e years1 be fined under title #ah1 ,united ,states ,code1 or both4 4 7b7 ,cease ,activities ,orders ,section #ejb of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aacb7 is amended by adding at the end the following new subsection3 7n7 ,association ,health ,plan ,cease and ,desist ,orders 7#a7 ,in general ,subject to paragraph 7#b71 upon application by the ,secretary showing the operation1 promotion1 or marketing of an association health plan 7or similar arrangement providing benefits consisting of medical care 7as defined in section #gcc7;a77#b777 that-- 7,a7 is not certified under part #h1 is subject under section #ead7;b77#f7 to the insurance laws of any ,state in which the plan or arrangement offers or provides benefits1 and is not licensed1 registered1 or otherwise approved under the insurance laws of such ,state2 or 7,b7 is an association health plan certified under part #h and is not operating in accordance with the requirements under part #h for such certification1 a district court of the ,united ,states shall enter an order requiring that the plan or arrangement cease activities4 7#b7 ,exception ,paragraph 7#a7 shall not apply in the case of an association health plan or other arrangement if the plan or arrangement shows that-- 7,a7 all benefits under it referred to in paragraph 7#a7 consist of health insurance coverage2 and 7,b7 with respect to each ,state in which the plan or arrangement offers or provides benefits1 the plan or arrangement is operating in accordance with applicable ,state laws that are not superseded under section #ead4 7#c7 ,additional equitable relief ,the court may grant such additional equitable relief1 including any relief available under this title1 as it deems necessary to protect the interests of the public and of persons having claims for benefits against the plan4 4 7c7 ,responsibility for ,claims ,procedure ,section #ejc of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aacc7 is amended by inserting 7a7 ,in general4-- before ,in accordance1 and by adding at the end the following new subsection3 7b7 ,association ,health ,plans ,the terms of each association health plan which is or has been certified under part #h shall require the board of trustees or the named fiduciary 7as applicable7 to ensure that the requirements of this section are met in connection with claims filed under the plan4 4 #bad4 ,cooperation between ,federal and ,state authorities ,section #ejf of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aacf7 is amended by adding at the end the following new subsection3 7d7 ,consultation ,with ,states ,with ,respect to ,association ,health ,plans 7#a7 ,agreements with states ,the ,secretary shall consult with the ,state recognized under paragraph 7#b7 with respect to an association health plan regarding the exercise of-- 7,a7 the ,secretary's authority under sections #ejb and #ejd to enforce the requirements for certification under part #h2 and 7,b7 the ,secretary's authority to certify association health plans under part #h in accordance with regulations of the ,secretary applicable to certification under part #h4 7#b7 ,recognition of primary domicile state ,in carrying out paragraph 7#a71 the ,secretary shall ensure that only one ,state will be recognized1 with respect to any particular association health plan1 as the ,state with which consultation is required4 ,in carrying out this paragraph-- 7,a7 in the case of a plan which provides health insurance coverage 7as defined in section #hab7;a77#c771 such ,state shall be the ,state with which filing and approval of a policy type offered by the plan was initially obtained1 and 7,b7 in any other case1 the ,secretary shall take into account the places of residence of the participants and beneficiaries under the plan and the ,state in which the trust is maintained4 4 #bae4 ,effective date and transitional and other rules 7a7 ,effective ,date ,the amendments made by this ,act shall take effect #a year after the date of the enactment of this ,act4 ,the ,secretary of ,labor shall first issue all regulations necessary to carry out the amendments made by this ,act within #a year after the date of the enactment of this ,act4 7b7 ,treatment of ,certain ,existing ,health ,benefits ,programs 7#a7 ,in general ,in any case in which1 as of the date of the enactment of this ,act1 an arrangement is maintained in a ,state for the purpose of providing benefits consisting of medical care for the employees and beneficiaries of its participating employers1 at least #bjj participating employers make contributions to such arrangement1 such arrangement has been in existence for at least #aj years1 and such arrangement is licensed under the laws of one or more ,states to provide such benefits to its participating employers1 upon the filing with the applicable authority 7as defined in section #hab7;a77#e7 of the ,employee ,retirement ,income ,security ,act of #aigd 7as amended by this ,act77 by the arrangement of an application for certification of the arrangement under part #h of subtitle ,b of title ,i of such ,act-- 7,a7 such arrangement shall be deemed to be a group health plan for purposes of title ,i of such ,act2 7,b7 the requirements of sections #hja7;a7 and #hjc7;a7 of the ,employee ,retirement ,income ,security ,act of #aigd shall be deemed met with respect to such arrangement2 7,c7 the requirements of section #hjc7;b7 of such ,act shall be deemed met1 if the arrangement is operated by a board of directors which-- 7i7 is elected by the participating employers1 with each employer having one vote2 and 7ii7 has complete fiscal control over the arrangement and which is responsible for all operations of the arrangement2 7,d7 the requirements of section #hjd7;a7 of such ,act shall be deemed met with respect to such arrangement2 and 7,e7 the arrangement may be certified by any applicable authority with respect to its operations in any ,state only if it operates in such ,state on the date of certification4 ,the provisions of this subsection shall cease to apply with respect to any such arrangement at such time after the date of the enactment of this ,act as the applicable requirements of this subsection are not met with respect to such arrangement4 7#b7 ,definitions ,for purposes of this subsection1 the terms group health plan1 medical care1 and participating employer shall have the meanings provided in section #hab of the ,employee ,retirement ,income ,security ,act of #aigd1 except that the reference in paragraph 7#g7 of such section to an association health plan shall be deemed a reference to an arrangement referred to in this subsection4 7c7 ,coordination with existing law ,nothing in this ,act shall require plans to become certified under section #hjb of the ,employee ,retirement ,income ,security ,act of #aigd1 as amended by this ,act1 or require plans that are not certified under such section to comply with the requirements under part #h of such ,act1 except to the extent provided in section #hji of such ,act4 #baf4 ,short-term limited duration insurance 7a7 ,definition ,section #bgia7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ia7;b77 is amended by adding at the end the following3 7#f7 ,short-term limited duration insurance ,the term short-term limited duration insurance means health insurance coverage provided pursuant to a contract with a health insurance issuer that has an expiration date specified in the contract 7not taking into account any extensions that may be elected by the policyholder with or without the issuer's consent7 that is less than #ab months after the original effective date of the contract4 4 7b7 ,guaranteed renewability ,section #bgjc of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#b7 is amended-- 7#a7 in subsection 7a71 by inserting or offers short-term limited duration insurance after group market2 and 7#b7 by adding at the end the following3 7f7 ,application to short-,term limited duration insurance 7#a7 ,in general ,in applying this section in the case of short-term limited duration insurance-- 7,a7 a reference to health insurance coverage with respect to such coverage offered in the individual market shall be deemed to include short-term limited duration insurance2 and 7,b7 a reference to health insurance issuer with respect to health insurance coverage offered in the individual market shall be deemed to include an issuer of short-term limited duration insurance4 7#b7 ,special rule for short-term limited duration insurance ,in the case of short-term limited duration insurance1 at the time of application for enrollment in such insurance coverage1 an issuer of such insurance may offer renewability of such coverage1 and an individual may decline renewability of such coverage in accordance with this section1 and the contract between such individual and the health insurance issuer shall specify whether the individual opted for renewability or no renewability4 4 7c7 ,applicability ,the amendments made by subsections 7a7 and 7b7 shall apply with respect to contracts for short-term limited duration insurance that take effect on or after ,january #a1 #bjba4 ,c ,improving ,commercial ,health ,insurance #bba4 ,invisible ,guaranteed ,coverage ,pool ,reinsurance ,program2 tax on exchange plans 7a7 ,establishment ,not later than ,january #a1 #bjba1 the ,secretary of ,health and ,human ,services shall establish the ,invisible ,guaranteed ,coverage ,pool ,reinsurance ,program 7in this section referred to as the ,,igcpr program74 7b7 ,state grants ,under the ,,igcpr program1 the ,secretary shall1 from amounts appropriated under subsection 7f7 for a fiscal year1 award grants to ,states for such fiscal year1 in amounts determined in accordance with the allocation methodology specified under subsection 7d74 ,such grants shall be used for the purpose of establishing or maintaining a qualifying ,invisible ,guaranteed ,coverage ,pool for the ,state4 7c7 ,federal default 7#a7 ,in general ,in the case of a ,state that does not1 by a date and in a manner specified by the ,secretary1 choose to be awarded a grant under subsection 7b7 for a fiscal year to operate a qualifying ,invisible ,guaranteed ,coverage ,pool for the ,state1 the ,secretary shall1 from amounts appropriated under subsection 7f7 for such fiscal year1 use the allocation determined for the ,state under subsection 7d7 for participation of such ,state in the ,federal default qualifying ,invisible ,guaranteed ,coverage ,pool described in paragraph 7#b74 7#b7 ,federal default qualifying ,invisible ,guaranteed ,coverage ,pool ,the ,federal default qualifying high risk pool is1 with respect to each ,state that chooses not to be awarded a grant under subsection 7b7 with respect to a fiscal year for which funds are appropriated under subsection 7f71 an ,invisible ,guaranteed ,coverage ,pool under which health insurance issuers participating in the ,exchange of such a ,state1 with respect to designated individuals who are enrolled in health insurance coverage and are expected to experience higher than average health costs as determined by the insurer1 cede risk to the pool1 without affecting the premium paid by the designated individuals or their terms of coverage4 ,with respect to such pool-- 7,a7 high-risk individuals designated for cession to the pool shall be designated by the ceding issuer2 7,b7 the premium amount the ceding issuer shall pay to the reinsurance pool shall be #ij percent of the premium paid to the issuer for the coverage2 7,c7 the ceding issuer shall retain the same risk under the ceded policies as under any other policy of the issuer with respect to the first #aj1jjj of benefits for each ceded policy involved and will not retain any risk under ceded policies after such first #aj1jjj of benefits2 and 7,d7 after a ceding issuer1 with respect to a ceded policy1 no longer retains risk under such policy pursuant to subparagraph 7,c71 the negotiated rate under such policy for items and services shall be payable at the reimbursement rate under the ,medicare program under title ,,xviii of the ,social ,security ,act for such items and services1 or in the case of items and services for which payment is available under the policy but not the ,medicare program1 at a rate determined by the ,secretary4 7d7 ,allocation methodology ,not later than ,june #cj1 #bjba1 the ,secretary shall specify an allocation methodology for determining the amount of funds appropriated under subsection 7f7 for a fiscal year to be allocated for each ,state for purposes of subsections 7b7 and 7c74 ,such methodology shall be based on the number of residents of each ,state and the general health status of such residents4 7e7 ,qualifying ,invisible ,guaranteed ,coverage ,pool ,for purposes of this section1 the term qualifying ,invisible ,guaranteed ,coverage ,pool means1 with respect to a ,state1 a method of designation under which health insurance issuers identify individuals who experience higher than average health costs as determined by the ,state and are enrolled in health insurance coverage offered in the individual market1 and cede the risk of spending more than #aj1jjj on health care services for a single individual to the pool without affecting the premium paid by the designated individuals or their terms of coverage4 ,with respect to such pool1 the ,state1 or an entity operating the pool on behalf of the ,state1 shall establish-- 7#a7 the premium amount the ceding issuer shall pay to the reinsurance pool2 7#b7 the applicable attachment points or coinsurance percentages if the ceding issuer retains any portion of the risk under ceded policies1 except that the provisions of subparagraphs 7,c7 and 7,d7 of subsection 7c77#b7 shall apply to such high risk pool in the same manner as such clauses apply to the ,federal default high risk pool2 and 7#c7 the mechanism by which high-risk individuals are designated for cession to the pool1 which may include a list of designated high-cost health conditions4 7f7 ,appropriations ,there is appropriated to the ,secretary of ,health and ,human ,services #bjj1jjj1jjj1jjj to carry out this section for the period of fiscal year #bjba through fiscal year #bjbi4 7g7 ,tax on health insurance plans sold on exchanges 7#a7 ,in general ,chapter #cd of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new subchapter3 ,c ,additional tax on health insurance plans sold by insurers offering plans on exchanges ,sec4 #ddja4 ,additional tax on health insurance plans sold by insurers offering plans on exchanges4 #ddja4 ,additional tax on health insurance plans sold by insurers offering plans on exchanges 7a7 ,imposition of tax ,there is imposed a tax of #d for each policy month of each health insurance policy sold by insurers offering plans through an ,exchange established under the ,patient ,protection and ,affordable ,care ,act4 7b7 ,liability ,the tax imposed by subsection 7a7 shall be paid by the plan sponsor4 4 7#b7 ,conforming amendment ,the table of subchapters for chapter #cd of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following item3 ,subchapter ,c--,additional tax on health insurance plans sold by insurers offering plans on exchanges 4 7#c7 ,effective date ,the amendments made by this subsection shall apply with respect to months beginning after the date of enactment of this ,act4 7h7 ,report ,the ,secretary of ,health and ,human ,services1 in collaboration with the ,comptroller ,general of the ,united ,states1 shall submit to ,congress1 not later than ,january #a1 #bjbf1 and again #e years thereafter1 a report on the status of reinsurance pool funding1 along with any recommendations with respect to future allocations or funding methods for such pool4 #bbb4 ,employer health insurance mandate repeal 7a7 ,in general ,chapter #dc of the ,internal ,revenue ,code of #aihf is amended by striking section #dihj;,h4 7b7 ,repeal of ,related ,reporting ,requirements ,subpart ,d of part ,,iii of subchapter ,a of chapter #fa of such ,code is amended by striking section #fjef4 7c7 ,conforming amendments 7#a7 ,section #fgbd7;d77#a77;,b7 of such ,code is amended by inserting or at the end of clause 7xxiii71 by striking or at the end of clause 7xxiv71 and by striking clause 7xxv74 7#b7 ,section #fgbd7;d77#b7 of such ,code is amended by inserting or at the end of subparagraph 7,,gg7 and by striking subparagraph 7,,hh74 7#c7 ,the table of sections for chapter #dc of such ,code is amended by striking the item relating to section #dihj;,h4 7#d7 ,the table of sections for subpart ,d of part ,,iii of subchapter ,a of chapter #fa of such ,code is amended by striking the item relating to section #fjef4 7#e7 ,section #aeac of the ,patient ,protection and ,affordable ,care ,act is amended by striking subsection 7c74 7d7 ,effective date 7#a7 ,in general ,except as otherwise provided in this subsection1 the amendments made by this section shall apply to months and other periods beginning after ,december #ca1 #bjba4 7#b7 ,repeal of study and report ,the amendment made by subsection 7c77#e7 shall take effect on the date of the enactment of this ,act4 #bbc4 ,refundable credits for coverage under a qualified health plan for individuals offered employer-sponsored insurance 7a7 ,in general ,section #cf;,b7c77#b7 of the ,internal ,revenue ,code of #aihf is amended-- 7#a7 in subparagraph 7,b77i71 by inserting or section #ejjj;,a7f77#a77;,b71 and 7#b7 by striking subparagraph 7,c74 7b7 ,effective date ,the amendments made by this section shall apply to taxable years beginning after the date of the enactment of this ,act4 #bbd4 ,inclusion in income of certain costs of employer-provided coverage under health plans 7a7 ,in general ,section #ajf of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new subsection3 7h7 ,limitation 7#a7 ,in general ,subsection 7a7 shall not apply to the extent that employer-provided coverage under health plans for an employee for a taxable year exceeds-- 7,a7 #aj1bjj for self-only coverage1 and 7,b7 #bg1ejj for all other coverage4 7#b7 ,in general ,in the case of any calendar year after #bjba1 the dollar amounts in paragraph 7#a7 shall each be increased by an amount equal to-- 7,a7 such dollar amount1 multiplied by-- 7,b7 the cost-of-living adjustment determined under section #a7;f77#c7 for such calendar year1 determined 7i7 by substituting calendar year #bjba for calendar year #bjaf in subparagraph 7,a77ii7 thereof1 and 7ii7 by substituting for the ,c-,,cpi-,u referred to in section #a7;f77#c77;,a7 the amount that such ,,cpi would have been if the annual percentage increase in ,,cpi with respect to each year after #bjba and before #bjca had been one percentage point greater4 7#c7 ,terms related to ,,cpi 7,a7 ,annual percentage increase ,for purposes of subparagraph 7,b77ii77,,ii71 the term annual percentage increase means the percentage 7if any7 by which ,c-,,cpi-,u for any year exceeds the ,c-,,cpi-,u for the prior year4 7,b7 ,other terms ,terms used in this paragraph which are also used in section #a7;f77#c7 shall have the same meanings as when used in such section4 4 7b7 ,effective date ,the amendments made by this section shall apply with respect to taxable years beginning after ,december #ca1 #bjba4 #bbe4 ,change in permissible age variation in health insurance premium rates ,section #bgja7;a77#a77;,a77iii7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg7a77#a77;,a77iii77 is amended by inserting after 7consistent with section #bgjg7;c77 the following3 or1 for plan years beginning on or after ,january #a1 #bjba1 as the ,secretary may implement through interim final regulation1 #e to #a for adults 7consistent with section #bgjg7;c774 #bbf4 ,premium assistance adjustment to reflect age 7a7 ,modification of applicable percentage ,section #cf;,b7b77#c77;,a7 of the ,internal ,revenue ,code of #aihf is amended to read as follows3 7,a7 ,applicable percentage 7i7 ,in general ,the applicable percentage for any taxable year shall be the percentage such that the applicable percentage for any taxpayer whose household income is within an income tier specified in the following table shall increase1 on a sliding scale in a linear manner1 from the initial percentage to the final percentage specified in such table for such income tier with respect to a taxpayer of the age involved3 ,in the case of household income 7expressed as a percent of the poverty line7 within the following income tier3,up to ,age #bi;,age #cj-ci;,age #dj-di;,age #ej-ei,over ,age #ei;,initial ,final ,initial ,final ,initial ,final ,initial ,final ,initial ,final ,up to #ajjjjjjjjjjjjajj-accbbbbbbbbbbacc-aejcd 4ccd4ccd4ccd4ccd4caej-bjjd4cf4gd4cf4gd4c f4gd4cf4gd4cf4gbjj-bejf4gf4gf4gg4ff4gh4e f4gh4ef4gh4ebej-cjjf4gf4gg4fg4fh4ci4hh4c i4hh4ci4hcjj-djjf4ggg4fhi4haji4haji4hajd jj-fjjgihajajaeajaeajae 7ii7 ,age determinations 7,i7 ,in general ,for purposes of clause 7i71 the age of the taxpayer taken into account under clause 7i7 with respect to any taxable year is the age attained by such taxpayer before the close of such taxable year4 7,,ii7 ,joint returns ,in the case of a joint return1 the age of the older spouse shall be taken into account under clause 7i74 7iii7 ,indexing ,in the case of any taxable year beginning after calendar year #bjba1 the initial and final percentages contained in clause 7i7 shall be adjusted to reflect-- 7,i7 the excess 7if any7 of the rate of premium growth for the period beginning with calendar year #bjac and ending with calendar year #bjba1 over the rate of income growth for such period1 and 7,,ii7 in addition to any adjustment under subclause 7,i71 the excess 7if any7 of the rate of premium growth for calendar year #bjba1 over the rate of growth in the consumer price index for calendar year #bjba4 7iv7 ,failsafe ,clause 7iii77,,ii7 shall apply only if the aggregate amount of premium tax credits under this section and cost-sharing reductions under section #adjb of the ,patient ,protection and ,affordable ,care ,act for the preceding calendar year exceeds an amount equal to #j4ejd percent of the gross domestic product for such calendar year4 4 7b7 ,expansion of eligibility ,section #cf;,b of the ,internal ,revenue ,code of #aihf is amended-- 7#a7 in subsection 7c77#a77;,a71 by striking #djj and inserting #fjj2 and 7#b7 in subsection 7f77#b77;,b77i71 by striking #djj each place such reference appears and inserting #fjj in each such place4 7c7 ,effective date ,the amendment made by this section shall apply to taxable years beginning after ,december #ca1 #bjba4 #bbg4 ,premium assistance ,notwithstanding any other provision of law1 the ,secretary of the ,treasury shall calculate the credit allowable under section #cf;,b of the ,internal ,revenue ,code of #aihf based on the taxpayer's prior year tax return and the ,secretary of ,health and ,human ,services shall provide for open enrollment periods that end on ,april #ae4 #bbh4 ,adding copper plans to ,exchanges 7a7 ,in general ,section #acjb of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjbb7 is amended-- 7#a7 in subsection 7a77#c71 by inserting copper1 after either the2 7#b7 in subsection 7c71 by adding at the end the following new paragraph3 7#e7 ,special rule for copper plans ,a health plan in the copper level of coverage 7as described in subsection 7d77#a77;,e77 shall be deemed to meet the requirements of this subsection4 2 7#c7 in subsection 7d7-- 7,a7 in paragraph 7#a71 by adding at the end the following new subparagraph3 7,e7 ,copper level ,a plan in the copper level shall provide a level of coverage that is designed to provide benefits that are actuarially equivalent to #ej percent of the full actuarial value of the benefits provided under the plan and will have out-of-pocket limits that are #cj percent higher than bronze plans4 2 and 7,b7 in paragraph 7#d7-- 7i7 by inserting copper1 after any reference to a2 and 7ii7 by inserting copper1 after providing a2 and 7#d7 in subsection 7e77#a71 by inserting copper1 after not providing a4 7b7 ,effective date ,the amendments made by this section shall apply with respect to plan years beginning on or after ,january #a1 #bjba4 #bbi4 ,copper and bronze plans ,notwithstanding any other provision of law1 refundable credits for coverage under a qualified health plan and cost-sharing reductions may be used to purchase bronze and copper plans4 #bcj4 ,waivers for ,state innovation 7a7 ,streamlining the ,state ,application ,process ,section #accb of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjeb7 is amended-- 7#a7 in subsection 7a77#a77;,c71 by striking the law and inserting a law or has in effect a certification2 and 7#b7 in subsection 7b77#b7-- 7,a7 in the paragraph heading1 by inserting or certify after law2 7,b7 in subparagraph 7,a7-- 7i7 by striking ,a law and inserting the following3 7i7 ,laws ,a law 2 and 7ii7 by adding at the end the following3 7ii7 ,certifications ,a certification described in this paragraph is a document1 signed by the ,governor of the ,state1 that certifies that such ,governor has the authority under existing ,federal and ,state law to take action under this section1 including implementation of the ,state plan under subsection 7a77#a77;,b74 2 and 7,c7 in subparagraph 7,b7-- 7i7 in the subparagraph heading1 by striking of opt out2 and 7ii7 by striking may repeal a law and all that follows through the period at the end and inserting the following3 8may terminate the authority provided under the waiver with respect to the ,state by-- 7i7 repealing a law described in subparagraph 7,a77i72 or 7ii7 terminating a certification described in subparagraph 7,a77ii71 through a certification for such termination signed by the ,governor of the ,state4 4 7b7 ,providing expedited approval of ,state waivers ,section #accb7;d7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjeb7;d77 is amended-- 7#a7 in paragraph 7#a7 by striking #ahj and inserting #ij2 and 7#b7 by adding at the end the following3 7#c7 ,expedited determination 7,a7 ,in general ,with respect to any application under subsection 7a77#a7 submitted on or after the date of this paragraph or any such application submitted prior to such date of enactment and under review by the ,secretary on such date of enactment1 the ,secretary shall make a determination on such application1 using the criteria for approval otherwise applicable under this section1 not later than #de days after the receipt of such application1 and shall allow the public notice and comment at the ,state and ,federal levels described under subsection 7a77#d7 to occur concurrently if such ,state application-- 7i7 is submitted in response to an urgent situation1 with respect to areas in the ,state that the ,secretary determines are at risk for excessive premium increases or having no health plans offered in the applicable health insurance market for the current or following plan year2 or 7ii7 is for a waiver that is the same or substantially similar to a waiver that the ,secretary already has approved for another ,state4 7,b7 ,approval 7i7 ,urgent situations 7,i7 ,provisional approval ,a waiver approved under the expedited determination process under subparagraph 7,a77i7 shall be in effect for a period of #c years1 unless the ,state requests a shorter duration4 7,,ii7 ,full approval ,subject to the requirements for approval otherwise applicable under this section1 not later than #a year before the expiration of a provisional waiver period described in subclause 7,i7 with respect to an application described in subparagraph 7,a77i71 the ,secretary shall make a determination on whether to extend the approval of such waiver for the full term of the waiver requested by the ,state1 for a total approval period not to exceed #f years4 ,the ,secretary may request additional information as the ,secretary determines appropriate to make such determination4 7ii7 ,approval of same or similar applications ,an approval of a waiver under subparagraph 7,a77ii7 shall be subject to the terms of subsection 7e74 7,c7 ,,gao study ,not later than #e years after the date of enactment of this paragraph1 the ,comptroller ,general of the ,united ,states shall conduct a review of all waivers approved pursuant to an application under subparagraph 7,a77ii7 to evaluate whether such waivers met the requirements of subsection 7b77#a7 and whether the applications should have qualified for such expedited process4 4 7c7 ,providing certainty for ,state-,based reforms ,section #accb7;e7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjeb7;e77 is amended by striking ,no waiver and all that follows through the period at the end and inserting the following3 8,a waiver under this section-- 7#a7 shall be in effect for a period of #f years unless the ,state requests a shorter duration2 7#b7 may be renewed1 subject to the ,state meeting the criteria for approval otherwise applicable under this section1 for unlimited additional #f-year periods upon application by the ,state2 and 7#c7 may not be suspended or terminated1 in whole or in part1 by the ,secretary at any time before the date of expiration of the waiver period 7including any renewal period under paragraph 7#b771 unless the ,secretary determines that the ,state materially failed to comply with the terms and conditions of the waiver4 4 7d7 ,ensuring ,patient ,access to ,more ,flexible ,health ,plans ,section #accb7;b77#a77;,b7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjeb7;b77#a77;,b77 is amended by striking at least as affordable and inserting of comparable affordability1 including for low-income individuals1 individuals with serious health needs1 and other vulnerable populations14 7e7 ,applicability ,the amendments made by this ,act to section #accb of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjeb7-- 7#a7 with respect to applications for waivers under such section #accb submitted after the date of enactment of this ,act and applications for such waivers submitted prior to such date of enactment and under review by the ,secretary on the date of enactment1 shall take effect on the date of enactment of this ,act2 and 7#b7 with respect to applications for waivers approved under such section #accb before the date of enactment of this ,act1 shall not require reconsideration of whether such applications meet the requirements of such section #accb1 except that1 at the request of a ,state1 the ,secretary shall recalculate the amount of funding provided under subsection 7a77#c7 of such section4 #bca4 ,enrollment periods 7a7 ,exchanges ,paragraph 7#g7 of section #acaa7;c7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjca7;c771 as added by section #ajf1 is amended by adding at the end the following new subparagraph3 7,b7 ,enrollments other than during initial1 open1 and special enrollment periods ,beginning with plan year #bjba1 an ,exchange may provide for enrollments during periods in addition to open enrollment periods described in subparagraph 7,a7 or paragraph 7#f7 and special enrollment periods described in paragraph 7#f74 4 7b7 ,health plans ,subpart ,i of part ,a of title ,,xxvii of the ,public ,health ,service ,act is amended by adding at the end the following new section3 #bgaj4 ,enrollment outside of initial1 open1 and special enrollment period ,beginning with plan year #bjba1 a group health plan and a health insurance issuer offering group or individual health insurance coverage may provide for enrollment in such plan or coverage during periods in addition to initial1 open1 or special enrollment periods4 ,in the case that an individual enrolls in such plan or coverage during a period pursuant to the previous sentence1 the plan or issuer may charge the individual a one-time enrollment fee4 4 #bcb4 ,state-operated ,exchanges flexibility for open enrollment periods ,section #acaa7;c7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjca7;c77 is amended-- 7#a7 in paragraph 7#f71 by striking ,the ,secretary and inserting ,subject to paragraph 7#g71 the ,secretary2 and 7#b7 by adding at the end the following new paragraph3 7#g7 ,flexibility for enrollment periods 7,a7 ,state-operated ,exchanges open enrollment periods ,in the case of an ,exchange operated by a ,state1 beginning with plan year #bjba1 the ,exchange may provide for open enrollment periods 7after the initial enrollment period7 every #ab1 #bd1 or #cf months1 as determined by the ,state4 4 #bcc4 ,promoting health plans that cover individuals in more than one ,state ,there are appropriated1 out of amounts in the ,treasury not otherwise appropriated1 #aj1jjj1jjj to be made available by ,december #ca1 #bjba1 to the ,center for ,medicare ,medicaid ,innovation to fund new research or pilot programs dedicated to pursuing viable methods of enrolling individuals in health insurance programs that cross ,state lines4 ,,iii ,competition1 ,transparency and ,accountability ,a ,provider and ,insurer ,competition #cja4 ,hospital consolidation 7a7 ,authorization of appropriations ,there is authorized to be appropriated #afj1jjj1jjj to the ,federal ,trade ,commission to hire staff to investigate1 as consistent with the ,sherman ,antitrust ,act and other relevant ,federal laws1 anti-competitive mergers and practices under such laws to the extent such mergers and practices relate to providers of inpatient and outpatient health care services1 as defined by the ,secretary of ,health and ,human ,services4 7b7 ,medicare ,advantage rates applied to certain ,,hhi hospitals 7#a7 ,in general ,section #ahff7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;cc7a77 is amended-- 7,a7 in paragraph 7#a7-- 7i7 in subparagraph 7,x71 by striking and at the end2 7ii7 in subparagraph 7,y71 by striking the period at the end and inserting 2 and2 and 7iii7 by inserting after subparagraph 7,y7 the following new subparagraph3 7,z7 subject to paragraph 7#d71 in the case of a hospital located in a county whose population density is above the median population density for all counties in the ,united ,states with respect to which there is a ,herfindahl-,hirschman ,index 7,,hhi7 of greater than #d1jjj1 to apply the average reimbursement rate with respect to individuals 7regardless of whether such an individual is entitled to or eligible for benefits under this title1 but excluding individuals eligible for medical assistance under a ,state plan under title ,,xix7 furnished items and services at such hospital that would be billable under this title for such items and services if furnished by such hospital to an individual enrolled under part ,c4 2 and 7,b7 by adding at the end the following new paragraph3 7#d7 7,a7 ,the requirement under paragraph 7#a77,z7 shall not apply in the case of a hospital in a hospital referral region if-- 7i7 the ,,hrr market share of such hospital 7as determined under subparagraph 7,b77 is less than #j4ae2 or 7ii7 the hospital is located in a rural area 7as defined in section #ahhf7;d77#b77;,d774 7,b7 ,for purposes of subparagraph 7,a71 the ,,hrr market share of a hospital in a hospital referral region is equal to-- 7i7 the total revenue of the hospital1 divided by 7ii7 the total revenue of all hospitals in the hospital referral region4 4 7#b7 ,effective date ,the amendments made by this subsection shall apply with respect to items and services furnished on or after ,january #a1 #bjba4 7c7 ,grants for hospital infrastructure improvement 7#a7 ,in general ,the ,secretary of ,health and ,human ,services shall carry out a grant program under which the ,secretary shall provide grants to eligible ,states1 in accordance with this subsection4 7#b7 ,uses ,an eligible ,state receiving a grant under this subsection may use such grant to improve the ,state hospital infrastructure and to supplement any other funds provided for a purpose authorized under a ,state or local hospital grant program under ,state law4 7#c7 ,eligibility 7,a7 ,in general ,an eligible ,state may receive not more than one grant under this subsection with respect to each qualifying criterion described in subparagraph 7,b7 that is met by the ,state4 7,b7 ,eligible ,state ,for purposes of this subsection1 the term eligible ,state means a ,state that meets any one or more of the following qualifying criteria3 7i7 ,the ,state does not have in effect any ,state certificate of need law that requires a health care provider to provide to a regulatory body a certification that the community needs the services provided by the health care provider4 7ii7 ,the ,state has in effect ,state scope of practice laws that-- 7,i7 allow advanced practice providers 7such as nurse practitioners1 advanced practice registered nurses1 clinical nurse specialists1 and physician assistants7 to evaluate patients2 diagnose1 order1 and interpret diagnostic tests2 and initiate and manage treatments2 or 7,,ii7 provide that the only justification for limiting the scope of practice of a health care provider is safety to the public4 7iii7 ,the ,state does not have in effect any ,state laws that require managed care plans to accept into the network of such plan any qualified provider who is willing to accept the terms and conditions of the managed care plan4 7iv7 ,the ,state does not have in effect any ,certificate of ,public ,advantage laws that clearly articulate the ,state's intent to displace competition in favor of regulation or that violate ,state or ,federal antitrust laws4 7v7 ,the ,state does not have in effect any network adequacy laws regulating a health plan's ability to deliver benefits by providing reasonable access to a sufficient number of in-network primary care and specialty physicians1 as well as all health care services included under the terms of an insuree's contract with a health insurer4 7#d7 ,funding ,there is authorized to be appropriated to carry out this subsection #a1jjj1jjj1jjj for each of the fiscal years #bjai through #bjbh4 ,funds appropriated under this paragraph shall remain available until expended4 7d7 ,critical access hospital reimbursement rates 7#a7 ,part ,a ,section #ahad7l77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;f7l77#a77 is amended by inserting 7or1 for #bjba1 #ajb1 plus #a percentage point for each subsequent year through #bjbi1 and #aaj for each subsequent year thereafter7 after #aja4 7#b7 ,part ,b ,section #ahcd7;g77#a7 of such ,act 7#db ,u4,s4,c4 #aciem7g77#a77 is amended by inserting 7or1 for #bjba1 #ajb1 plus #a percentage point for each subsequent year through #bjbi1 and #aaj for each subsequent year thereafter7 after #aja4 #cjb4 ,authority of ,federal ,trade ,commission over certain tax-exempt organizations ,section #d of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #dd7 is amended1 in the undesignated paragraph relating to the definition of the term ,corporation-- 7#a7 by striking 1 and any and inserting 1 any2 and 7#b7 by inserting before the period at the end the following3 1 and any organization described in section #eja7;c77#c7 of the ,internal ,revenue ,code of #aihf that is exempt from taxation under section #eja7;a7 of such ,code4 #cjc4 ,restoring the application of antitrust laws to the business of health insurance 7a7 ,amendment to ,mc,carran-,ferguson ,act ,section #c of the ,act of ,march #i1 #aide 7#ae ,u4,s4,c4 #ajac71 commonly known as the ,mc,carran-,ferguson ,act1 is amended by adding at the end the following3 7c7 7#a7 ,nothing contained in this ,act shall modify1 impair1 or supersede the operation of any of the antitrust laws with respect to the business of health insurance 7including the business of dental insurance and limited-scope dental benefits74 7#b7 ,paragraph 7#a7 shall not apply with respect to making a contract1 or engaging in a combination or conspiracy-- 7,a7 to collect1 compile1 or disseminate historical loss data2 7,b7 to determine a loss development factor applicable to historical loss data2 7,c7 to perform actuarial services if such contract1 combination1 or conspiracy does not involve a restraint of trade2 or 7,d7 to develop or disseminate a standard insurance policy form 7including a standard addendum to an insurance policy form and standard terminology in an insurance policy form7 if such contract1 combination1 or conspiracy is not to adhere to such standard form or require adherence to such standard form4 7#c7 ,for purposes of this subsection-- 7,a7 the term antitrust laws has the meaning given it in subsection 7a7 of the first section of the ,clayton ,act 7#ae ,u4,s4,c4 #ab71 except that such term includes section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to the extent that such section #e applies to unfair methods of competition2 7,b7 the term business of health insurance 7including the business of dental insurance and limited-scope dental benefits7 does not include-- 7i7 the business of life insurance 7including annuities72 or 7ii7 the business of property or casualty insurance1 including but not limited to-- 7,i7 any insurance or benefits defined as excepted benefits under paragraph 7#a71 subparagraph 7,b7 or 7,c7 of paragraph 7#b71 or paragraph 7#c7 of section #ihcb7;c7 of the ,internal ,revenue ,code of #aihf 7#bf ,u4,s4,c4 #ihcb7;c77 whether offered separately or in combination with insurance or benefits described in paragraph 7#b77;,a7 of such section2 and 7,,ii7 any other line of insurance that is classified as property or casualty insurance under ,state law2 7,c7 the term historical loss data means information respecting claims paid1 or reserves held for claims reported1 by any person engaged in the business of insurance2 and 7,d7 the term loss development factor means an adjustment to be made to reserves held for losses incurred for claims reported by any person engaged in the business of insurance1 for the purpose of bringing such reserves to an ultimate paid basis4 4 7b7 ,related provision ,for purposes of section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to the extent such section applies to unfair methods of competition1 section #c7;c7 of the ,mc,carran-,ferguson ,act shall apply with respect to the business of health insurance without regard to whether such business is carried on for profit1 notwithstanding the definition of ,corporation contained in section #d of the ,federal ,trade ,commission ,act4 #cjd4 ,leveling the playing field between payers and providers 7a7 ,exemption ,it shall not be a violation of the antitrust laws for one or more private health insurer issuers or their designated agents to jointly negotiate prices of particular hospital services with a hospital provider with regards to the reimbursement policies of the insurers for those services4 7b7 ,definitions ,for purposes of this section3 7#a7 ,antitrust laws ,the term antitrust laws has the meaning given it in subsection 7a7 of the #ast section of the ,clayton ,act 7#ae ,u4,s4,c4 #ab7;a771 except that such term includes section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to the extent such section #e applies to unfair methods of competition4 7#b7 ,health insurance issuer ,the term health insurance issuer means an insurance company1 insurance service1 or insurance organization 7including a health maintenance organization1 as defined in subparagraph 7,c77 which is licensed to engage in the business of insurance in a ,state and which is subject to ,state law which regulates insurance 7within the meaning of section #ead7;b77#b7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aadd7;b77#b774 ,such term does not include a group health plan4 7#c7 ,health maintenance organization ,the term health maintenance organization means-- 7,a7 a ,federally qualified health maintenance organization 7as defined in section #cjj;e7a7 of title #db of the ,united ,states ,code71 7,b7 an organization recognized under ,state law as a health maintenance organization1 or 7,c7 a similar organization regulated under ,state law for solvency in the same manner and to the same extent as such a health maintenance organization4 7c7 ,effective date ,this section shall take effect on the date of the enactment of this ,act but shall not apply with respect to conduct that occurs before such date4 #cje4 ,increasing transparency by removing gag clauses on price and quality information ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq471 as amended by the preceding sections1 is amended by adding at the end the following3 #bgbi;,b4 ,increasing transparency by removing gag clauses on price and quality information 7a7 ,increasing price and quality transparency for plan sponsors and group and individual market and consumers 7#a7 ,group health plans ,a group health plan or health insurance issuer offering group health insurance coverage may not enter into an agreement with a health care provider1 network or association of providers1 third-party administrator1 or other service provider offering access to a network of providers that would directly or indirectly restrict a group health plan or health insurance issuer from-- 7,a7 providing provider-specific cost or quality of care information1 through a consumer engagement tool or any other means1 to referring providers1 the plan sponsor1 enrollees1 or eligible enrollees of the plan or coverage2 7,b7 electronically accessing de-identified claims and encounter data for each enrollee in the plan or coverage1 upon request and consistent with the privacy regulations promulgated pursuant to section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act1 the amendments to this ,act made by the ,genetic ,information ,nondiscrimination ,act of #bjjh1 and the ,americans with ,disabilities ,act of #aiij1 with respect to the applicable health plan or health insurance coverage1 including1 on a per claim basis-- 7i7 financial information1 such as the allowed amount1 or any other claim-related financial obligations included in the provider contract2 7ii7 provider information1 including name and clinical designation2 7iii7 service codes2 or 7iv7 any other data element normally included in claim or encounter transactions when received by a plan or issuer2 or 7,c7 sharing data described in subparagraph 7,a7 or 7,b7 with a business associate as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or successor regulations71 consistent with the privacy regulations promulgated pursuant to section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act1 the amendments to this ,act made by the ,genetic ,information ,nondiscrimination ,act of #bjjh1 and the ,americans with ,disabilities ,act of #aiij4 7#b7 ,individual health insurance coverage ,a health insurance issuer offering individual health insurance coverage may not enter into an agreement with a health care provider1 network or association of providers1 or other service provider offering access to a network of providers that would directly or indirectly restrict the health insurance issuer from-- 7,a7 providing provider-specific price or quality of care information1 through a consumer engagement tool or any other means1 to referring providers1 enrollees1 or eligible enrollees of the plan or coverage2 or 7,b7 sharing1 for plan design1 plan administration1 and plan1 financial1 legal1 and quality improvement activities1 data described in subparagraph 7,a7 with a business associate as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or successor regulations71 consistent with the privacy regulations promulgated pursuant to section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act1 the amendments to this ,act made by the ,genetic ,information ,nondiscrimination ,act of #bjjh1 and the ,americans with ,disabilities ,act of #aiij4 7#c7 ,clarification regarding public disclosure of information ,nothing in paragraph 7#a77;,a7 or 7#b77;,a7 prevents a health care provider1 network or association of providers1 or other service provider from placing reasonable restrictions on the public disclosure of the information described in such paragraphs 7#a7 and 7#b74 7#d7 ,attestation ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall annually submit to1 as applicable1 the applicable authority described in section #bgbc or the ,secretary of ,labor1 an attestation that such plan or issuer is in compliance with the requirements of this subsection4 7#e7 ,rule of construction ,nothing in this section shall be construed to otherwise limit group health plan1 plan sponsor1 or health insurance issuer access to data currently permitted under the privacy regulations promulgated pursuant to section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act1 the amendments to this ,act made by the ,genetic ,information ,nondiscrimination ,act of #bjjh1 and the ,americans with ,disabilities ,act of #aiij4 4 #cjf4 ,banning anticompetitive terms in facility and insurance contracts that limit access to higher quality1 lower cost care 7a7 ,in general ,section #bgbi;,b of the ,public ,health ,service ,act1 as added by section #cja1 is amended by adding at the end the following3 7b7 ,protecting ,health ,plans ,network ,design ,flexibility 7#a7 ,in general ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall not enter into an agreement with a provider1 network or association of providers1 or other service provider offering access to a network of service providers if such agreement1 directly or indirectly-- 7,a7 restricts the group health plan or health insurance issuer from-- 7i7 directing or steering enrollees to other health care providers2 or 7ii7 offering incentives to encourage enrollees to utilize specific health care providers2 7,b7 requires the group health plan or health insurance issuer to enter into any additional contract with an affiliate of the provider1 such as an affiliate of the provider1 as a condition of entering into a contract with such provider2 7,c7 requires the group health plan or health insurance issuer to agree to payment rates or other terms for any affiliate not party to the contract of the provider involved2 or 7,d7 restricts other group health plans or health insurance issuers not party to the contract from paying a lower rate for items or services than the contracting plan or issuer pays for such items or services4 7#b7 ,additional requirement for self-insured plans ,a self-insured group health plan shall not enter into an agreement with a provider1 network or association of providers1 third-party administrator1 or other service provider offering access to a network of providers if such agreement directly or indirectly requires the group health plan to certify1 attest1 or otherwise confirm in writing that the group health plan is bound by restrictive contracting terms between the service provider and a third-party administrator that the group health plan is not party to1 without a disclosure that such terms exist4 7#c7 ,exception for certain group model issuers ,paragraph 7#a77;,a7 shall not apply to a group health plan or health insurance issuer offering group or individual health insurance coverage with respect to-- 7,a7 a health maintenance organization 7as defined in section #bgia7;b77#c771 if such health maintenance organization operates primarily through exclusive contracts with multi-specialty physician groups1 nor to any arrangement between such a health maintenance organization and its affiliates2 or 7,b7 a value-based network arrangement1 such as an exclusive provider network1 accountable care organization1 center of excellence1 a provider sponsored health insurance issuer that operates primarily through aligned multi-specialty physician group practices or integrated health systems1 or such other similar network arrangements as determined by the ,secretary through rulemaking4 7#d7 ,attestation ,a group health plan or health insurance issuer offering group or individual health insurance coverage shall annually submit to1 as applicable1 the applicable authority described in section #bgbc or the ,secretary of ,labor1 an attestation that such plan or issuer is in compliance with the requirements of this subsection4 7c7 ,maintenance of existing ,,hipaa1 ,,gina1 and ,,ada protections ,nothing in this section shall modify1 reduce1 or eliminate the existing privacy protections and standards provided by reason of ,state and ,federal law1 including the requirements of parts #afj and #afd of title #de1 ,code of ,federal ,regulations 7or any successor regulations74 7d7 ,regulations ,the ,secretary1 not later than #a year after the date of enactment of the ,fair ,care ,act of #bjbj1 shall promulgate regulations to carry out this section4 7e7 ,rule of construction ,nothing in this section shall be construed to limit network design or cost or quality initiatives by a group health plan or health insurance issuer1 including accountable care organizations1 exclusive provider organizations1 networks that tier providers by cost or quality or steer enrollees to centers of excellence1 or other pay-for-performance programs4 7f7 ,clarification with respect to antitrust laws ,compliance with this section does not constitute compliance with the antitrust laws1 as defined in subsection 7a7 of the first section of the ,clayton ,act 7#ae ,u4,s4,c4 #ab7;a774 4 7b7 ,effective date ,section #bgbi;,b of the ,public ,health ,service ,act 7as added by section #cja and amended by subsection 7a77 shall apply with respect to any contract entered into on or after the date that is #ah months after the date of enactment of this ,act4 ,with respect to an applicable contract that is in effect on the date of enactment of this ,act1 such section #bgbi;,b shall apply on the earlier of the date of renewal of such contract or #c years after such date of enactment4 #cjg4 ,repealing eligibility of certain ,a,c,os 7a7 ,in general ,section #ahii7;b77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;jjj7b77#a77 is amended by striking subparagraphs 7,c7 through 7,e74 7b7 ,effective date ,the amendment made by subsection 7a7 shall take effect on ,january #a1 #bjba4 #cjh4 ,repeal of health care reform provisions limiting ,medicare exception to the prohibition on certain physician referrals for hospitals ,sections #fjja and #ajfja of the ,patient ,protection and ,affordable ,care ,act 7,public ,law #aaa-adh2 #abd ,stat4 #fhd1 #ajje7 and section #aajf of the ,health ,care and ,education ,reconciliation ,act of #bjaj 7,public ,law #aaa-aeb2 #abd ,stat4 #ajdi7 are repealed and the provisions of law amended by such sections are restored as if such sections had never been enacted4 #cji4 ,alternative payment model for certain shoppable procedures 7a7 ,in general ,a group health plan and a health insurance issuer offering group or individual health insurance coverage 7as such terms are defined in section #bgia of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ia77 may elect1 with respect to a plan year1 to provide a set payment amount to an enrollee under such plan or coverage for certain shoppable procedures 7as defined in subsection 7b77 in accordance with the provisions of this section in lieu of otherwise providing coverage for such a procedure under such plan or coverage1 but only if the enrollee so agrees to such set payment amount4 7b7 ,definition ,for purposes of this section1 the term shoppable procedure means a procedure specified by the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 with respect to which individuals may be expected to compare prices for such procedure of health care providers and facilities1 including primary and preventive services1 prenatal care and childbirth1 common surgeries that can be scheduled1 and other similar services4 7c7 ,set payment rules ,a set payment described in subsection 7a7 under a group health plan or group or individual health insurance coverage offered by a health insurance issuer shall-- 7#a7 be disclosed prior to beginning of each plan year such payment is in effect and shall not vary during such plan year2 7#b7 be the same amount with respect to the same shoppable procedure furnished in a geographic area 7as defined by the ,secretary72 7#c7 not be less than the median negotiated rate for all group health plans and health insurance coverage offered in such area for such procedure2 7#d7 be made available to an enrolled under such plan or such coverage regardless of the provider or facility furnishing the shoppable procedure2 7#e7 represent the entirety of the payment obligation of such plan or such issuer with respect to such procedure2 and 7#f7 may be retained by such enrollee to the extent that the amount of such payment exceeds the amount charged by such provider or facility for such procedure4 7d7 ,provision of price information ,each health care provider and facility that may furnish a shoppable procedure during a year shall post in a public area a notice containing the prices that will be charged by such provider of facility with respect to each such procedure to individuals making payment for such services pursuant to a set payment amount described in subsection 7a74 7e7 ,,ehb waiver authority ,the ,secretary may waive such provisions of section #acjb7;b7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjbb7;b77 with respect to a group health plan1 health insurance issuer offering group or individual health insurance coverage1 and a plan year as the ,secretary determines necessary to allow for the provision of set payment amounts described in subsection 7a74 ,b ,price ,transparency #cba4 ,price transparency ,section #ahff of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;cc71 as amended by section #cja1 is further amended-- 7#a7 in subsection 7a77#a7-- 7,a7 in subparagraph 7,y71 by striking and at the end2 7,b7 in subparagraph 7,z71 by striking the period at the end and inserting 2 and2 and 7,c7 by inserting after subparagraph 7,z7 the following new subparagraph3 7,,aa7 in the case of a hospital1 to comply with the requirement under subsection 7l74 2 and 7#b7 by adding at the end the following new subsection3 7l7 ,requirement relating to publishing certain hospital prices 7#a7 ,in general ,for purposes of subsection 7a77#a77;,,aa71 the requirement described in this subsection is1 with respect to a hospital and year 7beginning with #bjba71 for the hospital to publicly post1 through the system established under paragraph 7#c71 for each common shoppable service included in the list published under paragraph 7#b7 for such year1 the volume-weighted average price charged by the hospital to-- 7,a7 individuals enrolled during such year in group health plans or health insurance coverage offered in the individual or group market 7as such terms are defined in section #bgia of the ,public ,health ,service ,act72 and 7,b7 individuals who are not enrolled in any health insurance coverage or health benefits plan and individuals who are enrolled in such coverage or plan but such coverage or plan does not provide benefits for the service4 7#b7 ,common shoppable services ,for purposes of subsection 7a77#a77;,,aa7 and this subsection1 the ,secretary shall1 for #bjba and each subsequent year1 publish a list of the #ajj common shoppable services that are the most highly utilized in a hospital-based setting4 7#c7 ,standardized digital reporting system ,not later than ,january #a1 #bjba1 the ,secretary shall establish a standardized digital system for purposes of paragraph 7#a74 4 #cbb4 ,price transparency requirements 7a7 ,hospitals ,section #bgah7;e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ah7;e77 is amended-- 7#a7 by striking ,each hospital and inserting the following3 7#a7 ,in general ,each hospital 2 7#b7 by inserting 1 in a machine-readable format1 via open application program interfaces 7,a,p,is7 after a list2 7#c7 by inserting 1 along with such additional information as the ,secretary may require with respect to such charges for purposes of promoting public awareness of hospital pricing in advance of receiving a hospital item or service before the period2 and 7#d7 by adding at the end the following3 7#b7 ,definition of standard charges ,notwithstanding any other provision of law1 for purposes of paragraph 7#a71 the term standard charges means the rates hospitals1 including providers or entities that contract with or practice at a hospital1 charge for all items and services at a minimum1 chargemaster rates1 rates that hospitals negotiate with third party payers across all plans1 including those related to a patient's specific plan1 discounted cash prices1 and other rates determined by the ,secretary4 7#c7 ,enforcement ,in addition to any other enforcement actions or penalties that may apply under subsection 7b77#c7 or another provision of law1 a hospital that fails to provide the information required by this subsection and has not completed a corrective action plan to comply with the requirements of such subsection shall be subject to a civil monetary penalty of an amount not to exceed #cjj per day that the violation is ongoing as determined by the ,secretary4 ,such penalty shall be imposed and collected in the same manner as civil money penalties under subsection 7a7 of section #aabh;,a of the ,social ,security ,act are imposed and collected4 4 7b7 ,transparency in coverage ,section #acaa7;e77#c7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjca7;e77#c77 is amended-- 7#a7 in subparagraph 7,a7-- 7,a7 in clause 7vii71 by inserting before the period the following3 1 including1 for all items and services covered under the plan1 aggregate information on specific payments the plan has made to out-of-network health care providers on behalf of plan enrollees2 7,b7 by designating clause 7ix7 as clause 7x72 and 7,c7 by inserting after clause 7viii71 the following3 7ix7 ,information on the specific negotiated payment rates between the plan and health care providers for all items and services covered under the plan4 2 7#b7 in subparagraph 7,b7-- 7,a7 in the heading1 by striking use and inserting delivery methods and use2 7,b7 by inserting 1 as applicable1 after ,english proficiency2 and 7,c7 by inserting after the second sentence1 the following3 ,the ,secretary shall establish standards for electronic delivery and access to such information by individuals1 free of charge1 in machine readable format1 through an ,internet website and via open ,a,p,is42 7#c7 in subparagraph 7,c7-- 7,a7 in the first sentence1 by inserting or out-of-network provider after item or service by a participating provider2 7,b7 in the second sentence1 by striking through an ,internet website and inserting free of charge1 in machine readable format1 through an ,internet website1 and via open ,a,p,is1 in accordance with standards established by the ,secretary12 and 7,c7 by adding at the end the following3 ,such information shall include specific negotiated rates that allow for comparison between providers and across plans1 and related to a patient's specific plan1 including after an enrollee has exceeded their deductible responsibility42 and 7#d7 in subparagraph 7,d7 by striking subparagraph 7,a7 and inserting subparagraphs 7,a71 7,b71 and 7,c74 #cbc4 ,designation of nongovernmental1 nonprofit transparency organizations to lower ,americans' health care costs 7a7 ,in general ,subpart ,c of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ia et seq471 as amended by the preceding sections1 is further amended by adding at the end the following3 #bgif4 ,designation of a nongovernmental1 nonprofit transparency organization to lower ,americans' health care costs 7a7 ,in general ,the ,secretary1 in consultation with the ,secretary of ,labor1 not later than #a year after the date of enactment of the ,fair ,care ,act of #bjbj1 shall enter into contracts with at least #b nonprofit entities to support the establishment and maintenance of a database that receives and utilizes health care claims information and related information and issues reports that are available to the public and authorized users1 and are submitted to the ,department of ,health and ,human ,services4 7b7 ,requirements 7#a7 ,in general ,the database established under subsection 7a7 shall-- 7,a7 improve transparency by using de-identified health care data to-- 7i7 inform patients about the cost1 quality1 and value of their care2 7ii7 assist providers and hospitals1 as they work with patients1 to make informed choices about care2 7iii7 enable providers1 hospitals1 and communities to improve services and outcomes for patients by benchmarking their performance against that of other providers1 hospitals1 and communities2 7iv7 enable purchasers1 including employers1 employee organizations1 and health plans1 to develop value-based purchasing models1 improve quality1 and reduce the cost of health care and insurance coverage for enrollees2 7v7 enable employers and employee organizations to evaluate network design and construction1 and the cost of care for enrollees2 7vi7 facilitate ,state-led initiatives to lower health care costs and improve quality2 and 7vii7 promote competition based on quality and cost2 7,b7 collect medical claims1 prescription drug claims1 and remittance data consistent with the protections and requirements of subsection 7d72 7,c7 be established in such a manner that allows the data collected pursuant to subparagraph 7,b7 to be shared with any ,state all-payer claims database or regional database operated with authorization from ,states1 at cost1 using a standardized format1 if such ,state or regional database also submits claims data to the database established under this section2 and 7,d7 be available to-- 7i7 the ,director of the ,congressional ,budget ,office1 the ,comptroller ,general of the ,united ,states1 the ,executive ,director of the ,medicare ,payment ,advisory ,commission1 and the ,executive ,director of the ,medicaid and ,,chip ,payment ,advisory ,commission1 upon request1 subject to the privacy and security requirements of authorized users under subsection 7e77#b72 and 7ii7 authorized users1 including employers1 employee organizations1 providers1 group health plans1 health insurance issuers1 researchers1 and policymakers1 subject to subsection 7e74 7#b7 ,privacy and security2 breach notifications 7,a7 ,regulations 7i7 ,in general ,the ,secretary shall issue regulations prescribing the extent to which1 and the manner in which1 the following rules 7and any successors of such rules7 shall apply to the activities under this section of an entity receiving a contract under subsection 7a73 7,i7 ,the ,privacy ,rule under part #afj and subparts ,a and ,e of part #afd of title #de1 ,code of ,federal ,regulations 7or any successor regulations74 7,,ii7 ,the ,security ,rule under part #afj and subparts ,a and ,c of part #afd of such title #de 7or any successor regulations74 7,,iii7 ,the ,breach ,notification ,rule under part #afj and subparts ,a and ,d of part #afd of such title #de 7or any successor regulations74 7ii7 ,supplemental regulations ,in order to ensure data privacy and security and the notification of breaches1 the ,secretary may issue such supplemental regulations on the subjects of the rules listed under clause 7i7 as the ,secretary determines appropriate to address differences between the activities described by this section and the activities covered by such rules4 7,b7 ,enforcement ,section #aagf of ,social ,security ,act shall apply with respect to a violation of this paragraph in the same manner such section #aagf applies to a violation of part ,c of title ,,xi of the ,social ,security ,act1 and the ,secretary may include in the regulations promulgated under this section provisions to apply such section to this paragraph4 7,c7 ,procedure 7i7 ,timing ,the ,secretary shall issue the initial set of regulations under this paragraph not later than #a year after the date of enactment of the ,fair ,care ,act of #bjbj4 7ii7 ,authority to use interim final procedures ,the ,secretary may make such initial set of regulations effective and final immediately upon issuance1 on an interim basis1 and provide for a period of public comment on such initial set of regulations after the date of publication4 7,d7 ,requirements of entity ,an entity receiving the contract under this section shall-- 7i7 not disclose to the public any individually identifiable health information or proprietary financial information2 7ii7 strictly limit staff access to the data to staff with appropriate training1 clearance1 and background checks and require regular privacy and security training2 7iii7 maintain effective security standards for transferring data or making data available to authorized users2 7iv7 develop a process for providing access to data to authorized users1 in a secure manner that maintains privacy and confidentiality of data2 and 7v7 adhere to current best security practices with respect to the management and use of such data for health services research1 in accordance with applicable ,federal privacy law4 7#c7 ,consultation 7,a7 ,advisory committee ,not later than #ahj days after the date of enactment of the ,fair ,care ,act of #bjbj1 the ,secretary shall convene an ,advisory ,committee 7referred to in this section as the ,committee71 consisting of #ac members1 to advise the ,secretary1 a contracting entity1 and ,congress on the establishment1 operations1 and use of the database established under this section4 7,b7 ,membership 7i7 ,appointment ,in accordance with clause 7ii71 the ,secretary1 in consultation with the ,secretary of ,labor and the ,comptroller ,general of the ,united ,states shall1 not later than #ahj days after the date of enactment of the ,fair ,care ,act of #bjbj1 appoint members to the ,committee who have distinguished themselves in the fields of health services research1 health economics1 health informatics1 or the governance of ,state all-payer claims databases1 or who represent organizations likely to submit data to or use the database1 including patients1 employers1 or employee organizations that sponsor group health plans1 health care providers1 health insurance issuers1 or third-party administrators of group health plans4 ,such members shall serve #c-year terms on a staggered basis4 ,vacancies on the ,committee shall be filled by appointment consistent with this subsection not later than #c months after the vacancy arises4 7ii7 ,composition ,in accordance with clause 7i7-- 7,i7 the ,secretary1 in consultation with the ,secretary of ,labor1 shall appoint to the ,committee-- 7aa7 #a member selected by the ,secretary1 in coordination with the ,secretary of ,labor1 to serve as the chair of the ,committee2 7bb7 the ,assistant ,secretary for ,planning and ,evaluation of the ,department of ,health and ,human ,services1 or a designee of such ,assistant ,secretary2 7cc7 #a representative of the ,centers for ,medicare ,medicaid ,services2 7dd7 #a representative of the ,agency for ,health ,research and ,quality2 7ee7 #a representative of the ,office for ,civil ,rights of the ,department of ,health and ,human ,services with expertise in data privacy and security2 7ff7 #a representative of the ,national ,center for ,health ,statistics2 and 7gg7 #a representative of the ,employee ,benefits and ,security ,administration of the ,department of ,labor2 and 7,,ii7 the ,comptroller ,general of the ,united ,states shall appoint to the ,committee-- 7aa7 #a representative of an employer that sponsors a group health plan2 7bb7 #a representative of an employee organization that sponsors a group health plan2 7cc7 #a academic researcher with expertise in health economics or health services research2 7dd7 #a consumer advocate2 and 7ee7 #b additional members4 7,c7 ,duties ,the ,committee shall-- 7i7 advise the ,secretary on the management of the contract under subsection 7a72 7ii7 assist and advise the entities receiving the contract under subsection 7a7 in establishing-- 7,i7 the scope and format of the data to be submitted under subsection 7d72 7,,ii7 best practices with respect to de-identification of data1 as appropriate2 7,,iii7 the appropriate uses of data by authorized users1 including developing standards for the approval of requests by organizations to access and use the data2 and 7,,iv7 the appropriate formats and methods for making reports and analyses based on the database to the public2 7iii7 conduct an annual review of whether data was used according to the appropriate uses as described in clause 7ii77,,ii71 and advise the designated entities on using the data for authorized purposes2 7iv7 report1 as appropriate1 to the ,secretary and ,congress on the operation of the database and opportunities to better achieve the objectives of this section2 7v7 establish additional restrictions on researchers who receive compensation from entities described in subsection 7e77#b77;,b77ii71 in order to protect proprietary financial information2 and 7vi7 establish objectives for research and public reporting4 7#d7 ,state requirements ,a ,state may require health insurance issuers and other payers to submit claims data to the database established under this section1 provided that such data is submitted to the entities awarded contracts under this section in a form and manner established by the ,secretary1 and pursuant to subsection 7d77#d77;,b74 7#e7 ,sanctions ,the ,secretary shall take appropriate action to sanction users who attempt to re-identify data accessed pursuant to paragraph 7#a77;,d74 7c7 ,contract requirements 7#a7 ,competitive procedures ,the ,secretary shall enter into the contract under subsection 7a7 using full and open competition procedures pursuant to chapter #cc of title #da1 ,united ,states ,code4 7#b7 ,eligible entities ,to be eligible to enter into a contract described in subsection 7a71 an entity shall-- 7,a7 be a private nonprofit entity governed by a board that includes representatives of the academic research community and individuals with expertise in employer-sponsored insurance1 research using health care claims data and actuarial analysis2 7,b7 conduct its business in an open and transparent manner that provides the opportunity for public comment on its activities2 and 7,c7 agree to comply with any requirements imposed under the rulemaking described in subsection 7d77#d77;,a74 7#c7 ,considerations ,in awarding a contract under subsection 7a71 the ,secretary shall consider an entity's experience in-- 7,a7 health care claims data collection1 aggregation1 quality assurance1 analysis1 and security2 7,b7 supporting academic research on health costs1 spending1 and utilization for and by privately insured patients2 7,c7 working with large health insurance issuers and third-party administrators to assemble a national claims database2 7,d7 effectively collaborating with and engaging stakeholders to develop reports2 7,e7 meeting budgets and timelines1 including in connection with report generation2 and 7,f7 facilitating the creation of1 or supporting1 ,state all-payer claims databases4 7#d7 ,contract term ,a contract awarded under this section shall be for a period of #e years1 and may be renewed after a subsequent competitive bidding process under this section4 7#e7 ,transition of contract ,if the ,secretary1 following a competitive process at the end of the contract period1 selects a new entity to maintain the database1 all data shall be transferred to the new entity according to a schedule and process to be determined by the ,secretary4 ,upon termination of a contract1 no entity may keep data held by the database or disclose such data to any entity other than the entity so designated by the ,secretary4 ,the ,secretary shall include enforcement terms in any contract with an organization chosen under this section1 to ensure the timely transfer of all data1 and any associated code or algorithms1 to a new entity in the event of contract termination4 7d7 ,receiving health information 7#a7 ,requirements 7,a7 ,in general ,the ,secretary of ,labor shall ensure that the applicable self-insured group health plan1 through its third-party administrator1 pharmacy benefit manager1 or other entity designated by the group health plan1 as applicable1 electronically submits all claims data with respect to the plan1 pursuant to subparagraph 7,b74 7,b7 ,scope of information and format of submission ,an entity awarded the contract under subsection 7a71 in consultation with the ,committee described in subsection 7b77#c71 and pursuant to the privacy and security requirements of subsection 7b77#b71 shall-- 7i7 specify the data elements required to be submitted under subparagraph 7,a71 which shall include all data related to transactions described in subparagraphs 7,a7 and 7,e7 of section #aagc7;a77#b7 of the ,social ,security ,act1 including all data elements normally present in such transactions when adjudicated1 and enrollment information2 7ii7 specify the form and manner for such submissions1 and the historical period to be included in the initial submission2 and 7iii7 offer an automated submission option to minimize administrative burdens for entities required to submit data4 7,c7 ,de-identification of data ,an entity awarded the contract under subsection 7a7 shall-- 7i7 establish a process under which data is de-identified consistent with the de-identification requirements under section #afd4ead of title #de1 ,code of ,federal ,regulations 7or any successor regulations71 while retaining the ability to link data longitudinally for the purposes of research on cost and quality1 and the ability to complete risk adjustment and geographic analysis2 7ii7 ensure that any third-party subcontractors who perform the de-identification process described in clause 7i7 retain only the minimum necessary information to perform such a process1 and adhere to effective security and encryption practices in data storage and transmission2 7iii7 store claims and other data collected under this subsection only in de-identified form1 in accordance with section #afd4ead of title #de1 ,code of ,federal ,regulations 7or any successor regulations72 and 7iv7 ensure that individually identifiable data is encrypted1 in accordance with guidance issued by the ,secretary under section #acdjb7;h77#b7 of the ,,hitech ,act4 7#b7 ,applicable self-insured group health plan ,for purposes of paragraph 7#a71 a self-insured group health plan is an applicable self-insured group health plan if such plan is self-administered1 or is administered by a third-party plan administrator that meets #a or both of the following criteria3 7,a7 ,administers health1 medical1 or pharmacy benefits for more than #ej1jjj enrollees4 7,b7 ,is one of the #e largest administrators or issuers of self-insured group health plans in a ,state in which such administrator operates1 as measured by the aggregate number of enrollees in plans administered by such administrator in such ,state1 as determined by the ,secretary4 7#c7 ,third-party administrators ,in the case of a third-party administrator that is required under this subsection to submit claims data with respect to an applicable self-insured group health plan1 such administrator shall submit claims data with respect to all self-insured group health plans that the administrator administers1 including such plans that are not applicable self-insured group health plans1 as described in paragraph 7#b74 7#d7 ,receiving other information 7,a7 ,medicare data ,the ,secretary1 through rulemaking1 shall ensure that the data made available to such entity is available to qualified entities under section #ahgd7;e7 of the ,social ,security ,act is made available to each entity awarded a contract under subsection 7a74 7,b7 ,state data ,an entity awarded a contract under subsection 7a7 shall collect data from ,state all payer claims databases that seek access to the database established under this section4 7#e7 ,availability of data ,an entity required to submit data under this subsection may not place any restrictions on the use of such data by authorized users4 7e7 ,uses of information 7#a7 ,in general ,an entity awarded a contract under subsection 7a7 shall make the database available to users who are authorized under this subsection1 at cost1 and reports and analyses based on the data available to the public with no charge4 7#b7 ,authorization of users 7,a7 ,in general ,an entity may request authorization by an entity awarded a contract under subsection 7a7 for access to the database in accordance with this paragraph4 7,b7 ,application ,an entity desiring authorization under this paragraph shall submit to an entity awarded a contract an application for such access1 which shall include-- 7i7 in the case of an entity requesting access for research purposes-- 7,i7 a description of the uses and methodologies for evaluating health system performance using such data2 and 7,,ii7 documentation of approval of the research by an institutional review board1 if applicable for a particular plan of research2 or 7ii7 in the case of an entity such as an employer1 health insurance issuer1 third-party administrator1 or health care provider1 requesting access for the purpose of quality improvement or cost-containment1 a description of the intended uses for such data4 7,c7 ,requirements 7i7 ,research ,upon approval of an application for research purposes under subparagraph 7,b77i71 the authorized user shall enter into a data use and confidentiality agreement with an entity awarded a contract under subsection 7a71 which shall include a prohibition on attempts to reidentify and disclose individually identifiable health information and proprietary financial information4 7ii7 ,quality improvement and cost-containment ,in consultation with the ,committee described in subsection 7b77#c71 the ,secretary shall1 through rulemaking1 establish the form and manner in which authorized users described in subparagraph 7,b77ii7 may access data4 ,data provided to such authorized users shall be provided in a form and manner such that users may not obtain individually identifiable price information with respect to direct competitors4 ,upon approval1 such authorized user shall enter into a data use and confidentiality agreement with the entity4 7iii7 ,customized reports ,employers and employer organizations may request customized reports from an entity awarded a contract under subsection 7a71 at cost1 subject to the requirements of this section with respect to privacy1 security1 and proprietary financial information4 7iv7 ,non-customized reports ,an entity awarded a contract under subsection 7a71 in consultation with the ,committee1 shall make available to all authorized users aggregate data sets1 free of charge4 7f7 ,funding 7#a7 ,initial funding ,there are authorized to be appropriated1 and there are appropriated1 out of monies in the ,treasury not otherwise appropriated1 #bj1jjj1jjj for fiscal year #bjbj1 for the implementation of the initial contract and establishment of the database under this section4 7#b7 ,ongoing funding ,there are authorized to be appropriated #ae1jjj1jjj for each of fiscal years #bjba through #bjbe1 for purposes of carrying out this section 7other than the grant program under subsection 7h774 7g7 ,annual report 7#a7 ,submission ,on each of the dates described in paragraph 7#b71 an entity receiving a contract under subsection 7a7 shall submit to ,congress1 the ,secretary of ,health and ,human ,services1 and the ,secretary of ,labor and publish online for access by the general public1 a report containing a description of-- 7,a7 trends in the price1 utilization1 and total spending on health care services1 including a geographic analysis of differences in such trends2 7,b7 limitations in the data set2 7,c7 progress towards the objectives of this section2 and 7,d7 the performance by the entity of the duties required under such contract4 7#b7 ,dates described ,the reports described in paragraph 7#a7 shall be submitted-- 7,a7 not later than #c years after the date of enactment of the ,fair ,care ,act of #bjbj2 7,b7 the later of #a year after the date that is #c years after such date of enactment or ,march #a of the year after the date that is #c years after such date of enactment2 and 7,c7 ,march #a of each year thereafter4 7#c7 ,public reports and research ,an entity receiving a contract under subsection 7a7 shall1 in coordination with authorized users1 make analyses and research available to the public on an ongoing basis to promote the objectives of this section4 7h7 ,grants to ,states 7#a7 ,in general ,the ,secretary1 in consultation with the ,secretary of ,labor1 may award grants to ,states for the purpose of establishing and maintaining ,state all-payer claims databases that improve transparency of data in order to meet the goals of subsection 7a77#a74 7#b7 ,requirement ,to be eligible to receive the funding under paragraph 7#a71 a ,state shall submit data to the database as described in subsection 7b77#a77;,c71 using the format described in subsection 7d77#a74 7#c7 ,funding ,there is authorized to be appropriated #ajj1jjj1jjj for the period of fiscal years #bjbj through #bjbi for the purpose of awarding grants to ,states under this subsection4 7i7 ,exemption from public disclosure 7#a7 ,in general ,claims data provided to the database1 and the database itself shall not be considered public records and shall be exempt from public disclosure requirements4 7#b7 ,restrictions on uses for certain proceedings ,data disclosed to authorized users shall not be subject to discovery or admission as public information1 or evidence in judicial or administrative proceedings without consent of the affected parties4 7j7 ,definitions 7#a7 ,individually identifiable health information ,the term individually identifiable health information has the meaning given such term in section #aaga7f7 of the ,social ,security ,act4 7#b7 ,proprietary financial information ,the term proprietary financial information means data that would disclose the terms of a specific contract between an individual health care provider or facility and a specific group health plan1 ,medicaid managed care organization or other managed care entity1 or health insurance issuer offering group or individual coverage4 7k7 ,rule of construction ,nothing in this section shall be construed to affect or modify enforcement of the privacy1 security1 or breach notification rules promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7or successor regulations74 4 7b7 ,,gao report 7#a7 ,in general ,the ,comptroller ,general of the ,united ,states shall conduct a study on-- 7,a7 the performance of the entity awarded a contract under section #bgie7;a7 of the ,public ,health ,service ,act1 as added by subsection 7a71 under such contract2 7,b7 the privacy and security of the information reported to the entity2 and 7,c7 the costs incurred by such entity in performing such duties4 7#b7 ,reports ,not later than #b years after the effective date of the first contract entered into under section #bgie7;a7 of the ,public ,health ,service ,act1 as added by subsection 7a71 and again not later than #d years after such effective date1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report containing the results of the study conducted under paragraph 7#a71 together with recommendations for such legislation and administrative action as the ,comptroller ,general determines appropriate4 #cbd4 ,protecting patients and improving the accuracy of provider directory information 7a7 ,in general ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq471 as amended by the preceding sections1 is further amended by adding at the end the following3 #bgbi;,c4 ,protecting patients and improving the accuracy of provider directory information 7a7 ,network status of providers 7#a7 ,in general ,beginning on the date that is one year after the date of enactment of this section1 a group health plan or a health insurance issuer offering group or individual health insurance coverage shall-- 7,a7 establish business processes to ensure that all enrollees in such plan or coverage receive proof of a health care provider's network status1 based on what a plan or issuer knows or could reasonably know-- 7i7 through a written electronic communication from the plan or issuer to the enrollee1 as soon as practicable and not later than #a business day after a telephone inquiry is made by such enrollee for such information2 7ii7 through an oral confirmation1 documented by such issuer or coverage1 and kept in the enrollee's file for a minimum of #b years2 and 7iii7 in real-time through an online health care provider directory search tool maintained by the plan or issuer2 and 7,b7 include in any print directory a disclosure that the information included in the directory is accurate as of the date of the last data update and that enrollees or prospective enrollees should consult the group health plan or issuer's electronic provider directory on its website or call a specified customer service telephone number to obtain the most current provider directory information4 7#b7 ,group health plan and health insurance issuer business processes ,beginning on the date that is one year after the date of enactment of the ,fair ,care ,act of #bjbj1 a group health plan or a health insurance issuer offering group or individual health insurance coverage shall establish business processes to-- 7,a7 verify and update1 at least once every #ij days1 the provider directory information for all providers included in the online health care provider directory search tool described in paragraph 7#a77;,a77iii72 and 7,b7 remove any provider from such online directory search tool if such provider has not verified the directory information within the previous #f months or the plan or issuer has been unable to verify the provider's network participation4 7b7 ,cost-,sharing limitations 7#a7 ,in general ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall not apply1 and shall ensure that no provider applies cost-sharing to an enrollee for treatment or services provided by a health care provider in excess of the normal cost-sharing applied for in-network care 7including any balance bill issued by the health care provider involved71 if such enrollee1 or health care provider referring such enrollee1 demonstrates 7based on the electronic1 written information described in subsection 7a77#a77;,a77i71 the oral confirmation described in subsection 7a77#a77;,a77ii71 or a copy of the online provider directory described in subsection 7a77#a77;,a77iii7 on the date the enrollee attempted to obtain the provider's network status7 that the enrollee relied on the information described in subsection 7a77#a71 if the provider's network status or directory information on such directory was incorrect at the time the treatment or services involved was provided4 7#b7 ,refunds to enrollees ,if a health care provider submits a bill to an enrollee in violation of paragraph 7#a71 and the enrollee pays such bill1 the provider shall reimburse the enrollee for the full amount paid by the enrollee in excess of the in-network cost-sharing amount for the treatment or services involved1 plus interest1 at an interest rate determined by the ,secretary4 7c7 ,provider business processes ,a health care provider shall have in place business processes to ensure the timely provision of provider directory information to a group health plan or a health insurance issuer offering group or individual health insurance coverage to support compliance by such plans or issuers with subsection 7a77#a74 ,such providers shall submit provider directory information to a plan or issuers1 at a minimum-- 7#a7 when the provider begins a network agreement with a plan or with an issuer with respect to certain coverage2 7#b7 when the provider terminates a network agreement with a plan or with an issuer with respect to certain coverage2 7#c7 when there are material changes to the content of provider directory information described in subsection 7a77#a72 and 7#d7 every #ij days throughout the duration of the network agreement with a plan or issuer4 7d7 ,enforcement 7#a7 ,in general ,subject to paragraph 7#b71 a health care provider that violates a requirement under subsection 7c7 or takes actions that prevent a group health plan or health insurance issuer from complying with subsection 7a77#a7 or 7b7 shall be subject to a civil monetary penalty of not more than #aj1jjj for each act constituting such violation4 7#b7 ,safe harbor ,the ,secretary may waive the penalty described under paragraph 7#a7 with respect to a health care provider that unknowingly violates subsection 7b77#a7 with respect to an enrollee if such provider rescinds the bill involved and1 if applicable1 reimburses the enrollee within #cj days of the date on which the provider billed the enrollee in violation of such subsection4 7#c7 ,procedure ,the provisions of section #aabh;,a of the ,social ,security ,act1 other than subsections 7a7 and 7b7 and the first sentence of subsection 7c77#a7 of such section1 shall apply to civil money penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a of the ,social ,security ,act4 7e7 ,savings clause ,nothing in this section shall prohibit a provider from requiring in the terms of a contract1 or contract termination1 with a group health plan or health insurance issuer-- 7#a7 that the plan or issuer remove1 at the time of termination of such contract1 the provider from a directory of the plan or issuer described in subsection 7a77#a72 or 7#b7 that the plan or issuer bear financial responsibility1 including under subsection 7b71 for providing inaccurate network status information to an enrollee4 7f7 ,definition ,for purposes of this section1 the term provider directory information includes the names1 addresses1 specialty1 and telephone numbers of individual health care providers1 and the names1 addresses1 and telephone numbers of each medical group1 clinic1 or facility contracted to participate in any of the networks of the group health plan or health insurance coverage involved4 7g7 ,rule of construction ,nothing in this section shall be construed to preempt any provision of ,state law relating to health care provider directories or network adequacy4 4 7b7 ,effective date ,section #bgbi;,c of the ,public ,health ,service ,act1 as added by subsection 7a71 shall take effect with respect to plan years beginning on or after the date that is #ah months after the date of enactment of this ,act4 #cbe4 ,ensuring enrollee access to cost-sharing information 7a7 ,in general ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq471 as amended by the preceding sections1 is further amended by adding at the end the following3 #bgbi;,f4 ,provision of cost-sharing information 7a7 ,provider disclosures ,a provider that is in-network with respect to a group health plan or a health insurance issuer offering group or individual health insurance coverage shall provide to an enrollee in the plan or coverage who submits a request for the information described in paragraph 7#a7 or 7#b71 together with accurate and complete information about the enrollee's coverage under the applicable plan or coverage-- 7#a7 as soon as practicable and not later than #b business days after the enrollee requests such information1 a good faith estimate of the expected enrollee cost-sharing for the provision of a particular health care service 7including any service that is reasonably expected to be provided in conjunction with such specific service72 and 7#b7 as soon as practicable and not later than #b business days after an enrollee requests such information1 the contact information for any ancillary providers for a scheduled health care service4 7b7 ,insurer disclosures ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall provide an enrollee in the plan or coverage with a good faith estimate of the enrollee's cost-sharing 7including deductibles1 copayments1 and coinsurance7 for which the enrollee would be responsible for paying with respect to a specific health care service 7including any service that is reasonably expected to be provided in conjunction with such specific service71 as soon as practicable and not later than #b business days after a request for such information by an enrollee4 7c7 ,enforcement 7#a7 ,in general ,subject to paragraph 7#b71 a health care provider that violates a requirement under subsection 7a7 shall be subject to a civil monetary penalty of not more than #aj1jjj for each act constituting such violation4 7#b7 ,procedure ,the provisions of section #aabh;,a of the ,social ,security ,act1 other than subsections 7a7 and 7b7 and the first sentence of subsection 7c77#a7 of such section1 shall apply to civil money penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a of the ,social ,security ,act4 4 7b7 ,effective date ,section #bgbi;,g of the ,public ,health ,service ,act1 as added by subsection 7a71 shall apply with respect to plan years beginning on or after the date that is #ah months after the date of enactment of this ,act4 #cbf4 ,access of individuals to protected health information ,the provisions of section #afd4ebd of title #de1 ,code of ,federal ,regulations1 as in effect on the day before the date of the enactment of this ,act1 shall have the force and effect of law4 #cbg4 ,timely bills for patients 7a7 ,in general 7#a7 ,amendment ,part ,p of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is amended by adding at the end the following3 #cii,v-#g4 ,timely bills for patients 7a7 ,in general ,the ,secretary shall require-- 7#a7 health care facilities1 or in the case of practitioners providing services outside of such a facility1 practitioners1 to provide to patients a list of services rendered during the visit to such facility or practitioner1 and1 in the case of a facility1 the name of the provider for each such service1 upon discharge or end of the visit or by postal or electronic communication as soon as practicable and not later than #e calendar days after discharge or date of visit2 and 7#b7 health care facilities and practitioners to furnish all adjudicated bills to the patient as soon as practicable1 but not later than #de calendar days after discharge or date of visit4 7b7 ,payment after billing ,no patient may be required to pay a bill for health care services any earlier than #ce days after the postmark date of a bill for such services4 7c7 ,effect of violation 7#a7 ,notification and refund requirements 7,a7 ,provider lists ,if a facility or practitioner fails to provide a patient a list as required under subsection 7a77#a71 such facility or practitioner shall report such failure to the ,secretary4 7,b7 ,billing ,if a facility or practitioner bills a patient after the #de-;calendar-day period described in subsection 7a77#b71 such facility or practitioner shall-- 7i7 report such bill to the ,secretary2 and 7ii7 refund the patient for the full amount paid in response to such bill with interest1 at a rate determined by the ,secretary4 7#b7 ,civil monetary penalties 7,a7 ,in general ,the ,secretary may impose civil monetary penalties of up to #aj1jjj a day on any facility or practitioner that-- 7i7 fails to provide a list required under subsection 7a77#a7 more than #aj times1 beginning on the date of such tenth failure2 7ii7 submits more than #aj bills outside of the period described in subsection 7a77#b71 beginning on the date on which such facility or practitioner sends the tenth such bill2 7iii7 fails to report to the ,secretary any failure to provide lists as required under paragraph 7#a77;,a71 beginning on the date that is #de calendar days after discharge or visit2 or 7iv7 fails to send any bill as required under subsection 7a77#b71 beginning on the date that is #de calendar days after the date of discharge or visit1 as applicable4 7,b7 ,procedure ,the provisions of section #aabh;,a of the ,social ,security ,act1 other than subsections 7a7 and 7b7 and the first sentence of subsection 7c77#a7 of such section1 shall apply to civil money penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a of the ,social ,security ,act4 7#c7 ,safe harbor ,the ,secretary may exempt a practitioner or facility from the penalties under paragraph 7#b77;,a7 or extend the period of time specified under subsection 7a77#b7 for compliance with such subsection if a practitioner or facility-- 7,a7 makes a good-faith attempt to send a bill within #cj days but is unable to do so because of an incorrect address2 or 7,b7 experiences extenuating circumstances 7as defined by the ,secretary71 such as a hurricane or cyberattack1 that may reasonably delay delivery of a timely bill4 4 7#b7 ,rulemaking ,not later than #a year after the date of enactment of this ,act1 the ,secretary shall promulgate final regulations to define the term extenuating circumstance for purposes of section #cii,v-#g7;c77#c77;,b7 of the ,public ,health ,service ,act1 as added by paragraph 7#a74 7b7 ,group health plan and health insurance issuer requirements ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa71 as amended by the preceding sections1 is further amended by adding at the end the following3 #bgbi;,d4 ,timely bills for patients 7a7 ,in general ,a group health plan or health insurance issuer offering group or individual health insurance coverage shall have in place business practices with respect to in-network facilities and practitioners to ensure that claims are adjudicated in order to facilitate facility and practitioner compliance with the requirements under section #cii,v-#g7;a74 7b7 ,clarification ,nothing in subsection 7a7 prohibits a provider and a group health plan or health insurance issuer from establishing in a contract the timeline for submission by either party to the other party of billing information1 adjudication1 sending of remittance information1 or any other coordination required between the provider and the plan or issuer necessary for meeting the deadline described in section #cii,v-#g7;a77#b74 4 7c7 ,effective date ,the amendments made by subsections 7a7 and 7b7 shall take effect #f months after the date of enactment of this ,act4 #cbh4 ,advisory group on reducing burden of hospital administrative requirements 7a7 ,in general ,not later than ,january #a1 #bjba1 the ,secretary of ,health and ,human ,services shall convene an advisory group to provide1 in accordance with this section1 recommendations on ways the ,federal ,government could reduce the burden of administrative requirements on hospitals4 7b7 ,recommendations ,not later than ,january #a1 #bjbb1 the advisory board convened under this section shall-- 7#a7 submit to the ,secretary of ,health and ,human ,services recommendations described under subsection 7a7 for executive action and any recommendations for ,state actions for potential consideration in making grants under section #b7;c7 to ,states2 and 7#b7 submit to ,congress recommendations described under subsection 7a7 for legislative proposals4 7c7 ,membership ,the advisory board under this section shall consist of the following members3 7#a7 ,three representatives of companies that have-- 7,a7 geographically distributed workforces2 7,b7 at least #aj1jjj employees2 and 7,c7 no more than #aj percent of such employees in any single ,state4 7#b7 ,three representatives of health insurance issuers and health plans1 consisting of-- 7,a7 one representative of for-profit health insurance issuers and health plans with at least #bj1jjj1jjj enrollees in the employer-sponsored market2 7,b7 one representative of non-profit health insurance issuers and health plans operating in at least #e ,states2 and 7,c7 one representative of non-profit health insurance issuers and health plans operating in a rural ,state 7as defined by the ,census ,bureau74 7#c7 ,seven public policy experts in the field of hospital consolidation4 #cbi4 ,data reporting to improve the transparency regarding how #cdj;,b hospital covered entities provide care for patients ,section #cdj;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7 is amended by adding at the end the following new subsection3 7f7 ,data reporting ,to improve the transparency regarding how hospital covered entities provide care for patients 7#a7 ,in general ,beginning on the date that is #ad months after the date of the enactment of this subsection1 and annually thereafter1 subject to subparagraph 7,c71 a covered entity described in subparagraph 7,l7 or 7,m7 of subsection 7a77#d71 unless otherwise indicated1 shall report on the following1 with respect to the previous year1 in such a manner and form as specified by the ,secretary3 7,a7 ,the following information3 7i7 ,with respect to such covered entity and with respect to each child site of such entity 7as referenced in paragraph 7#aa771 the number and percentage of individuals who are dispensed or administered drugs that are subject to an agreement under this section1 organized by form of health insurance coverage of such individuals 7including at least by the ,medicare program under title ,,xviii of the ,social ,security ,act1 the ,medicaid program under title ,,xix of such ,act1 health insurance coverage offered in the individual or group market or a group health plan 7as such terms are defined in section #bgia71 and uninsured74 7ii7 ,with respect to each such child site of such entity1 the total costs incurred at each such site and the cost incurred at each such site for charity care as defined in line #bc of worksheet ,s-#aj to the ,medicare cost report or in any successor form4 7,b7 ,the aggregate amount of gross reimbursement received by each such covered entity 7including child sites of such entity7 described in such subparagraph 7,l7 or 7,m7 for all drugs purchased that are subject to an agreement under this section and the entity's aggregate acquisition cost for such drugs4 7,c7 ,in the case of covered entity described in subparagraph 7,l7 of subsection 7a77#d71 at the time of application and recertification 7and at least annually thereafter71 the contract that is the basis for eligibility under the requirement under clause 7i7 of such subparagraph and any modifications to such contract for purposes of review by the ,secretary4 7,d7 ,with respect to such covered entity and with respect to each child site of such entity1 the name of all third-party vendors or other similar entities that the covered entity contracts with to provide services associated with the program under this section4 7#b7 ,availability of information 7,a7 ,in general ,the ,secretary shall make data reported by covered entities under subparagraphs 7,a71 7,c71 and 7,d7 of paragraph 7#a7 available on the public website of the ,department of ,health and ,human ,services in an electronic and searchable format1 which may include the #cdj;,b ,office of ,pharmacy ,affairs ,information ,system or a successor to such system4 7,b7 ,format ,data made available under subparagraph 7,a7 shall be made available in a manner that shows each category of data reported both in the aggregate and identified by covered entities described in subparagraphs 7,l7 and 7,m7 of subsection 7a77#d7 and child sites of such covered entities4 ,in carrying out this paragraph1 with respect to data reported pursuant to paragraph 7#a77;,c71 the ,secretary shall ensure that any proprietary information shall be redacted from contracts submitted pursuant to such paragraph 7#a77;,c7 before posting such data4 7#c7 ,interim final regulations ,the ,secretary shall issue interim final regulations no later than the date that is #f months after the date of the enactment of this subsection1 to carry out this subsection and shall finalize such regulations prior to the end of the moratorium period to which subsection 7a77#aa7 applies4 7#d7 ,reports to ,congress 7,a7 ,,oig report ,not later than #b years after the date of the enactment of this subsection1 the ,office of the ,inspector ,general shall submit to ,congress a final report on the level of charity care provided by covered entities described in subparagraphs 7,l7 and 7,m7 of subsection 7a77#d7 and separately by child sites of such covered entities1 as reported in paragraph 7#a77;,a74 7,b7 ,,gao reports 7i7 ,initial report ,not later than #a year after the date of the enactment of this subsection1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report-- 7,i7 analyzing the ,state and local government contracts intended to satisfy the requirement under subsection 7a77#d77,l77i7 for a covered entity to qualify as an entity described in subparagraph 7,l7 of subsection 7a77#d72 7,,ii7 assessing the amount of care such contracts obligate such entity to provide to low-income individuals ineligible for ,medicare under title ,,xviii of the ,social ,security ,act and ,medicaid under title ,,xix of such ,act2 and 7,,iii7 analyzing how these contracts define low-income individuals and whether the ,secretary reviews such determinations4 7ii7 ,subsequent report ,not later than #b years after the date of the enactment of this subsection1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a final report on the information collected under paragraph 7#a77;,b7 regarding the difference between the aggregate gross reimbursement and aggregate acquisition costs received by each such covered entity 7including child sites of such entity7 for drugs subject to an agreement under this section4 4 #ccj4 ,requiring #cdj;,b drug discount program reports by ,,dsh hospital covered entities on low-income utilization rate of outpatient hospital services 7a7 ,in general ,section #cdj;,b7d77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7d77#b77 is amended-- 7#a7 in subparagraph 7,b77i71 by inserting before the period at the end the following3 1 including1 with respect to such updates made on or after ,january #a1 #bjba1 by requiring covered entities described in subsection 7a77#d77,l7 to submit 7and to so regularly update7 information described in subparagraph 7,c72 and 7#b7 by adding at the end the following new subparagraph3 7,c7 ,information on low-income utilization rate of outpatient hospital services 7i7 ,in general ,for purposes of subparagraph 7,b77i71 the information described in this subparagraph1 with respect to a covered entity described in subsection 7a77#d77,l7 and an update under such subparagraph 7,b77i71 is-- 7,i7 the low-income outpatient utilization rate of such covered entity for the most recent fiscal year2 and 7,,ii7 the low-income outpatient utilization rate of off-site outpatient facilities1 clinics1 eligible off-site locations1 and associated sites of such entity identified as child sites of such entity pursuant to the identification system under subparagraph 7,b77iv7 for the most recent fiscal year4 7ii7 ,low-income outpatient utilization rate defined ,in this subparagraph1 the term low-income outpatient utilization rate has the meaning given the term low-income utilization rate under paragraph 7#c7 of section #aibc7;b7 of the ,social ,security ,act1 except that-- 7,i7 clauses 7i7 and 7ii7 of subparagraph 7,a7 of such paragraph shall be applied as if-- 7aa7 each reference to patient services were a reference to patient services furnished on an outpatient basis2 and 7bb7 for purposes of clause 7i77,,ii7 of this subparagraph1 each reference to hospital were a reference to off-site outpatient facilities1 clinics1 eligible off-site locations1 and associated sites of the hospital that are identified as child sites of the hospital pursuant to the identification system under section #cdj;,b7d77#b77;,b77iv7 of the ,public ,health ,service ,act2 and 7,,ii7 clauses 7i7 and 7ii7 of subparagraph 7,b7 of such paragraph shall be applied as if-- 7aa7 each reference to inpatient hospital services were a reference to outpatient hospital services2 and 7bb7 for purposes of clause 7i77,,ii7 each reference to hospital's charges were a reference to charges of the off-site outpatient facilities1 clinics1 eligible off-site locations1 and associated sites of the hospital that are identified as child sites of the hospital pursuant to the identification system under section #cdj;,b7d77#b77;,b77iv7 of the ,public ,health ,service ,act4 4 7b7 ,annual reports ,not later than ,january #a1 #bjba1 and annually thereafter1 the ,administrator of the ,health ,resources and ,services ,administration shall submit to ,congress a report on information submitted by covered entities for the previous year pursuant to the amendments made by subsection 7a74 #cca4 ,employer benefits reports 7a7 ,in general ,subject to subsection 7b71 for each plan year beginning on or after ,january #a1 #bjba1 a group health plan and a health insurance issuer offering group health insurance coverage shall provide to each individual enrolled in such plan or such coverage for such plan year a notification containing the following3 7#a7 ,the amount the sponsor of such group health plan expended with respect to such individual under such plan for such plan year 7or1 in the case of a health insurance issuer offering group health insurance coverage1 the amount the employer of such individual contributed for such coverage for such individual for such plan year74 7#b7 ,the amount the sponsor of such group health plan expended with respect to such individual under such plan for each previous plan year 7or1 in the case of a health insurance issuer offering group health insurance coverage1 the amount the employer of such individual contributed for such coverage for such individual for each previous plan year71 if applicable4 7b7 ,limitation ,subsection 7a7 shall not apply to a group health plan1 or a health insurance issuer offering group health insurance coverage1 for a plan year if1 for such plan year1 the number of individuals enrolled under such plan or such coverage was less than #ajj4 7c7 ,penalty ,in the case that the ,secretary of ,health and ,human ,services determines that a group health plan or a health insurance issuer offering group health insurance failed to provide the notice required under subsection 7a71 the ,secretary may impose a civil monetary penalty on the sponsor of such plan or such issuer1 as applicable1 in an amount not to exceed #ajj per individual enrolled in such plan or such coverage per day that such sponsor or issuer failed to provide such notification to such individual4 7d7 ,definitions ,in this section1 the terms group health plan1 group health insurance coverage1 health insurance issuer1 and sponsor have the meaning given such terms in section #bgia of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ia74 #ccb4 ,group health plan reporting requirements ,part ,c of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ia et seq471 as amended by the preceding sections1 is further amended by adding at the end the following3 #bgig4 ,group health plan reporting 7a7 ,in general ,a group health plan or health insurance issuer offering group or individual health insurance coverage shall submit to the ,secretary1 not later than ,march #a of each year1 the following information with respect to the health plan in the previous plan year3 7#a7 ,the beginning and end dates of the plan year4 7#b7 ,the number of enrollees4 7#c7 ,each ,state in which the plan is offered4 7#d7 ,the #ej brand prescription drugs most frequently dispensed by pharmacies for claims paid by the issuer1 and the total number of paid claims for each such drug4 7#e7 ,the #ej most costly prescription drugs with respect to the plan by total annual spending1 and the annual amount spent by the plan for each such drug4 7#f7 ,the #ej prescription drugs with the greatest increase in plan expenditures over the plan year preceding the plan year that is the subject of the report1 and1 for each such drug1 the change in amounts expended by the plan in each such plan year4 7#g7 ,total spending on health care services by such group health plan1 broken down by-- 7,a7 the type of costs1 including-- 7i7 hospital costs2 7ii7 health care provider and clinical service costs2 7iii7 costs for prescription drugs2 and 7iv7 other medical costs2 and 7,b7 spending on prescription drugs by-- 7i7 the health plan2 and 7ii7 the enrollees4 7#h7 ,the average monthly premium-- 7,a7 paid by employers on behalf of enrollees2 and 7,b7 paid by enrollees4 7#i7 ,any impact on premiums by rebates1 fees1 and any other remuneration paid by drug manufacturers to the plan or its administrators or service providers1 with respect to prescription drugs prescribed to enrollees in the plan1 including-- 7,a7 the amounts so paid for each therapeutic class of drugs2 and 7,b7 the amounts so paid for each of the #be drugs that yielded the highest amount of rebates and other remuneration under the plan from drug manufacturers during the plan year4 7#aj7 ,any reduction in premiums and out-of-pocket costs associated with rebates1 fees1 or other remuneration described in paragraph 7#i74 7b7 ,report ,not later than #ah months after the date on which the first report is required under subsection 7a7 and biannually thereafter1 the ,secretary1 acting through the ,assistant ,secretary of ,planning and ,evaluation and in coordination with the ,inspector ,general of the ,department of ,health and ,human ,services1 shall make available on the internet website of the ,department of ,health and ,human ,services a report on prescription drug reimbursements under group health plans1 prescription drug pricing trends1 and the role of prescription drug costs in contributing to premium increases or decreases under such plans1 aggregated in such a way as no drug or plan specific information will be made public4 7c7 ,privacy protections ,no confidential or trade secret information submitted to the ,secretary under subsection 7a7 shall be included in the report under subsection 7b74 4 #ccc4 ,government ,accountability ,office study on profit- and revenue-sharing in health care 7a7 ,study ,not later than #a year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a study to-- 7#a7 describe what is known about profit- and revenue-sharing relationships in the commercial health care markets1 including those relationships that-- 7,a7 involve one or more-- 7i7 physician groups that practice within a hospital included in the profit- or revenue-sharing relationship1 or refer patients to such hospital2 7ii7 laboratory1 radiology1 or pharmacy services that are delivered to privately insured patients of such hospital2 7iii7 surgical services2 7iv7 hospitals or group purchasing organizations2 or 7v7 rehabilitation or physical therapy facilities or services2 and 7,b7 include revenue- or profit-sharing whether through a joint venture1 management or professional services agreement1 or other form of gain-sharing contract2 7#b7 describe ,federal oversight of such relationships1 including authorities of the ,department of ,health and ,human ,services and the ,federal ,trade ,commission to review such relationships and their potential to increase costs for patients1 and identify limitations in such oversight2 and 7#c7 as appropriate1 make recommendations to improve ,federal oversight of such relationships4 7b7 ,report ,not later than #a year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall prepare and submit a report on the study conducted under subsection 7a7 to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,education and ,labor and ,committee on ,energy and ,commerce of the ,house of ,representatives4 ,c ,prescription ,drug ,competition and ,innovation #cda4 ,expedited development and priority review for generic complex drug products ,subchapter ,a of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by adding at the end the following3 #ebd;,b4 ,expedited development and priority review for generic complex drug products 7a7 ,establishment of program ,the ,secretary shall establish a program to expedite the development of1 and provide priority review under section #eje7;j7 for1 generic complex drug products4 7b7 ,request for designation ,a sponsor of a generic complex drug product may request that the ,secretary designate such product for expedited development and priority review under this section4 7c7 ,designation process 7#a7 ,in general ,not later than #fj calendar days after the receipt of a request under subsection 7c71 the ,secretary shall determine whether the product that is the subject of the request meets the criteria under subsection 7e7 to be considered a generic complex drug product4 ,if the ,secretary determines that the product meets the criteria1 the ,secretary shall designate the product for expedited development and priority review4 7#b7 ,review ,review of a request under subsection 7b7 shall be undertaken by a team that is composed of experienced staff and senior managers of the ,food and ,drug ,administration4 7#c7 ,withdrawal ,the ,secretary may not withdraw a designation granted under this section on the basis of the criteria under subsection 7e7 no longer applying because of the subsequent clearance or approval of any other product4 7d7 ,expedited development and priority review ,guidance 7#a7 ,content ,not later than ,december #ca1 #bjba1 the ,secretary shall issue guidance on the implementation of this section4 ,such guidance shall-- 7,a7 set forth the process by which a person may seek a designation under subsection 7c72 7,b7 provide a template for requests under subsection 7b72 7,c7 identify the criteria the ,secretary will use in evaluating a request for designation under this section2 and 7,d7 identify the criteria and processes the ,secretary will use to expedite the development and review of products designated under this section4 7#b7 ,process ,prior to finalizing the guidance under paragraph 7#a71 the ,secretary shall seek public comment on a draft version of that guidance4 7e7 ,generic complex drug product defined ,in this section1 the term generic complex drug product means a product that represents a complex therapy that consists of or includes a drug for approval under section #eje7;j7 and that-- 7#a7 7,a7 contains complex active ingredients 7such as peptides1 polymeric compounds1 complex mixtures of active ingredients1 and naturally sourced ingredients72 7,b7 is composed of complex formulations 7such as liposomes or colloids72 7,c7 requires a complex route of delivery 7such as locally acting drugs such as dermatological products and complex ophthalmological products and otic dosage forms that are formulated as suspensions1 emulsions1 or gels72 or 7,d7 involves a complex dosage form 7such as transdermals1 metered dose inhalers1 or extended release injectables72 7#b7 presents as a complex drug-device combination product 7such as auto injectors or metered dose inhalers72 or 7#c7 is a product that would benefit from early scientific engagement due to complexity or uncertainty concerning the approval pathway under section #eje7;j74 4 #cdb4 ,preventing blocking of generic drugs 7a7 ,in general ,section #eje7;j77#e77;,b77iv77,i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,b77iv77,i77 is amended-- 7#a7 by striking #ahj days after the date and inserting 8#ahj days after the earlier of the following3 7aa7 ,the date 2 and 7#b7 by adding at the end the following3 7bb7 ,the date on which all of the following conditions are first met1 provided no application submitted by any first applicant is approved on or before such date3 7,,aa7 ,an application for the drug submitted by an applicant other than a first applicant has received tentative approval and could receive approval1 if no first applicant were eligible for #ahj-;day exclusivity under this clause1 and such applicant has not entered into an agreement that would prevent commercial marketing upon approval and has submitted a notification to the ,secretary documenting that it has not entered into an agreement that would prevent commercial marketing4 7,,bb7 ,thirty-three months have passed since the date of submission of an application for the drug by one first applicant1 if there is only one first applicant1 or1 in the case of more than one first applicant1 #cc months have passed since the date of submission of all such applications4 7,,cc7 ,approval of an application for the drug submitted by at least one first applicant would not be precluded under clause 7iii74 4 7b7 ,information ,not later than #fj days of the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary7 shall publish1 as appropriate and available1 information sufficient to allow applicants to assess whether the conditions described in subitems 7,,aa7 through 7,,cc7 of section #eje7;j77#e77;,b77iv77,i77bb7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as amended by subsection 7a77 have been or will be satisfied for all applications where the exclusivity period under 7iv77,i7 of section #eje7;j77#e77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as so amended7 has not expired1 and shall provide updates to reflect the most recent information available to the ,secretary4 #cdc4 ,ensuring timely access to generics ,section #eje7q7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7q77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a77i71 by inserting 1 #aj4ca1 after #aj4cj2 7,b7 in subparagraph 7,e7-- 7i7 by striking application and and inserting application or2 7ii7 by striking ,if the ,secretary and inserting the following3 7i7 ,in general ,if the ,secretary 2 and 7iii7 by striking the second sentence and inserting the following3 7ii7 ,primary purpose of delaying 7,i7 ,in general ,in determining whether a petition was submitted with the primary purpose of delaying an application1 the ,secretary may consider the following factors3 7aa7 ,whether the petition was submitted in accordance with paragraph 7#b77;,b71 based on when the petitioner knew or reasonably should have known the relevant information relied upon to form the basis of such petition4 7bb7 ,whether the petitioner has submitted multiple or serial petitions or supplements to petitions raising issues that reasonably could have been known to the petitioner at the time of submission of the earlier petition or petitions4 7cc7 ,whether the petition was submitted close in time to a known1 first date upon which an application under subsection 7b77#b7 or 7j7 of this section or section #cea7k7 of the ,public ,health ,service ,act could be approved4 7dd7 ,whether the petition was submitted without relevant data or information in support of the scientific positions forming the basis of such petition4 7ee7 ,whether the petition raises the same or substantially similar issues as a prior petition to which the ,secretary has responded substantively already1 including if the subsequent submission follows such response from the ,secretary closely in time4 7ff7 ,whether the petition requests changing the applicable standards that other applicants are required to meet1 including requesting testing1 data1 or labeling standards that are more onerous or rigorous than the standards the ,secretary has determined to be applicable to the listed drug1 reference product1 or petitioner's version of the same drug4 7gg7 ,the petitioner's record of submitting petitions to the ,food and ,drug ,administration that have been determined by the ,secretary to have been submitted with the primary purpose of delay4 7hh7 ,other relevant and appropriate factors1 which the ,secretary shall describe in guidance4 7,,ii7 ,guidance ,the ,secretary may issue or update guidance1 as appropriate1 to describe factors the ,secretary considers in accordance with subclause 7,,ii74 2 7,c7 by adding at the end the following3 7iii7 ,referral to the ,federal ,trade ,commission ,the ,secretary shall establish procedures for referring to the ,federal ,trade ,commission any petition or supplement to a petition that the ,secretary determines was submitted with the primary purpose of delaying approval of an application4 ,such procedures shall include notification to the petitioner by the ,secretary4 2 7,d7 by striking subparagraph 7,f72 7,e7 by redesignating subparagraphs 7,g7 through 7,i7 as subparagraphs 7,f7 through 7,h71 respectively2 and 7,f7 in subparagraph 7,h71 as so redesignated1 by striking submission of this petition and inserting submission of this document2 7#b7 in paragraph 7#b7-- 7,a7 by redesignating subparagraphs 7,a7 through 7,c7 as subparagraphs 7,c7 through 7,e71 respectively2 7,b7 by inserting before subparagraph 7,c71 as so redesignated1 the following3 7,a7 ,in general ,a person shall submit a petition to the ,secretary under paragraph 7#a7 before filing a civil action in which the person seeks to set aside1 delay1 rescind1 withdraw1 or prevent submission1 review1 or approval of an application submitted under subsection 7b77#b7 or 7j7 of this section or section #cea7k7 of the ,public ,health ,service ,act4 ,such petition and any supplement to such a petition shall describe all information and arguments that form the basis of the relief requested in any civil action described in the previous sentence4 7,b7 ,timely submission of citizen petition ,a petition and any supplement to a petition shall be submitted within #fj days after the person knew1 or reasonably should have known1 the information that forms the basis of the request made in the petition or supplement4 2 7,c7 in subparagraph 7,c71 as so redesignated-- 7i7 in the heading1 by striking within #aej days2 7ii7 in clause 7i71 by striking during the #aej-;day period referred to in paragraph 7#a77;,f712 and 7iii7 by amending clause 7ii7 to read as follows3 7ii7 on or after the date that is #aea days after the date of submission of the petition1 the ,secretary approves or has approved the application that is the subject of the petition without having made such a final decision4 2 7,d7 by amending subparagraph 7,d71 as so redesignated1 to read as follows3 7,d7 ,dismissal of certain civil actions 7i7 ,petition ,if a person files a civil action against the ,secretary in which a person seeks to set aside1 delay1 rescind1 withdraw1 or prevent submission1 review1 or approval of an application submitted under subsection 7b77#b7 or 7j7 of this section or section #cea7k7 of the ,public ,health ,service ,act without complying with the requirements of subparagraph 7,a71 the court shall dismiss without prejudice the action for failure to exhaust administrative remedies4 7ii7 ,timeliness ,if a person files a civil action against the ,secretary in which a person seeks to set aside1 delay1 rescind1 withdraw1 or prevent submission1 review1 or approval of an application submitted under subsection 7b77#b7 or 7j7 of this section or section #cea7k7 of the ,public ,health ,service ,act without complying with the requirements of subparagraph 7,b71 the court shall dismiss with prejudice the action for failure to timely file a petition4 7iii7 ,final response ,if a civil action is filed against the ,secretary with respect to any issue raised in a petition timely filed under paragraph 7#a7 in which the petitioner requests that the ,secretary take any form of action that could1 if taken1 set aside1 delay1 rescind1 withdraw1 or prevent submission1 review1 or approval of an application submitted under subsection 7b77#b7 or 7j7 of this section or section #cea7k7 of the ,public ,health ,service ,act before the ,secretary has taken final agency action on the petition within the meaning of subparagraph 7,c71 the court shall dismiss without prejudice the action for failure to exhaust administrative remedies4 2 and 7,e7 in clause 7iii7 of subparagraph 7,e71 as so redesignated1 by striking as defined under subparagraph 7#b77;,a7 and inserting within the meaning of subparagraph 7,c72 and 7#c7 in paragraph 7#d7-- 7,a7 by striking ,exceptions and all that follows through ,this subsection does and inserting ,exceptions4--,this subsection does2 7,b7 by striking subparagraph 7,b72 and 7,c7 by redesignating clauses 7i7 and 7ii7 as subparagraphs 7,a7 and 7,b71 respectively1 and adjusting the margins accordingly4 #cdd4 ,preemption of ,state barriers to the substitution of biosimilar products ,no ,state1 or any political subdivision thereof1 may1 under any circumstances1 prohibit a pharmacy or pharmacist from dispensing1 in place of a biological reference product1 any biosimilar that the ,food and ,drug ,administration has designated as an interchangeable product for that biological reference product4 #cde4 ,increasing pharmaceutical options to treat an unmet medical need ,subsection 7b7 of section #ejf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 is amended by adding at the end the following3 7#d7 ,unmet medical need ,for purposes of paragraph 7#a71 a drug shall be deemed to address an unmet medical need for a disease or condition if fewer than #c available drugs exist for the treatment of such disease or condition4 4 #cdf4 ,provisional approval of new human drugs 7a7 ,in general ,subchapter ,a of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by adding at the end of the following3 #ebd;,b4 ,provisional approval of new human drugs 7a7 ,priority review and evaluation of applications 7#a7 ,in general ,the ,secretary shall establish a priority review system to evaluate applications submitted under this pathway for provisional approval within #ij days of receipt of a completed application4 7#b7 ,review of applications during epidemics and pandemics ,in the case of an epidemic or pandemic1 including with respect to ,,covid-#ai1 the ,secretary shall accept and review various portions of an application submitted under the pathway under this section for provisional approval on a rolling basis1 and the review of any part of an application so submitted shall be completed not later than #c weeks after submission4 7#c7 ,other designations ,if a drug submitted for review under the pathway under this section is eligible for a special designation by the ,secretary under this ,act1 including as a drug for a rare disease or condition under section #ebf1 all benefits of such other designation shall be available for use under provisional approval1 including any tax credits and waiving of fees under chapter ,,vii4 7b7 ,eligibility ,a drug may be eligible for provisional approval under this section if the ,secretary determines that the drug is intended for the treatment1 prevention1 or medical diagnosis of-- 7#a7 a serious or life-threatening disease or condition for which there is a reasonable likelihood that premature death will occur without early medical intervention for an individual contracting or being diagnosed with such disease or condition2 7#b7 a disease or condition that poses a threat of epidemic or pandemic2 or 7#c7 a disease or condition associated with morbidity that has a substantial impact on day-to-day functioning4 7c7 ,standard of review for approval 7#a7 ,requirements ,an application for provisional approval under this section may be approved only if the ,secretary determines that-- 7,a7 there is substantial evidence of safety for the drug1 such that there is evidence consisting of adequate and well-controlled investigations1 including clinical investigations1 by experts qualified by scientific training and experience to evaluate the safety of the drug involved1 on the basis of which it could fairly and responsibly be concluded that the drug will have the effect it purports or is represented to have under the conditions of use prescribed1 recommended1 or suggested in the labeling or proposed labeling2 and 7,b7 there is relevant early evidence based on adequate and well-controlled investigations1 including early-stage clinical investigations1 to establish that-- 7i7 the drug provides a positive therapeutic outcome2 and 7ii7 the outcome of the drug is consistent with or greater than currently marketed on-label therapies1 with equal or fewer side effects1 if there are currently marketed on-label therapies4 7#b7 ,protocols ,the ,secretary shall promulgate rules that establish the appropriate protocols for a sponsor of an application for provisional approval under this section and the ,commissioner to follow to enable rolling1 real-time1 mid-trial submission while preserving the integrity of the ongoing trial and without penalizing the sponsor for making use of this pathway4 7#c7 ,real world evidence ,the ,secretary shall allow the use of real world evidence 7as defined in section #eje;,f7b771 including real world data used to generate real world evidence1 to support an application for provisional approval under this section1 and to fulfill the follow-up requirements and support applications for full approval as described under section #eje or section #cea of the ,public ,health ,service ,act1 as applicable4 7#d7 ,use of scientifically substantiated surrogates 7,a7 ,in general ,the sponsor of an application for provisional approval under this section may use scientifically substantiated surrogates to support such application4 7,b7 ,definition ,in subparagraph 7,a71 the term scientifically substantiated surrogates means surrogate endpoints to predict clinical benefit other than such endpoints previously validated by the ,secretary1 based on-- 7i7 epidemiologic1 therapeutic1 pathophysiologic1 or other evidence2 or 7ii7 an effect on a clinical endpoint other than survival or irreversible morbidity of interest4 7d7 ,transparency and patient monitoring requirements 7#a7 ,registries 7,a7 ,in general ,the sponsor of a drug provisionally approved under this section shall require that all patients who use such drug participate in an observational registry and consent to the sponsor's collection1 and submission to the registry1 of data related to the patient's use of such drug until such drug receives full approval under section #eje or section #cea of the ,public ,health ,service ,act1 or the provisional approval is rescinded4 7,b7 ,requirements for registries ,an observational registry described in subparagraph 7,a7 may be run by a third party1 such as a government1 for profit1 or non-profit organization1 and shall track all patients who use the provisionally approved drug4 7,c7 ,accessibility ,an observational registry described in subparagraph 7,a7 shall be easily accessible for-- 7i7 all patients who are participating in any registry related to a provisionally approved drug that allows for easy1 unrestricted 7or transparent7 access for such patients to their patient data and related information regarding their usage of the provisionally approved drug2 and 7ii7 approved researchers and medical professionals who may access data maintained in the registry1 which access shall be for public health research and only in a de-identified1 aggregated manner4 7#b7 ,funding ,an observational registry under this subsection shall be maintained1 as applicable-- 7,a7 by the sponsor of the drug provisionally approved under this section that is the subject of the registry2 7,b7 by a third party1 such as a government1 for profit1 or nonprofit organization2 or 7,c7 the ,federal ,government1 in the case of any drug so approved that is intended to treat a disease or condition associated with an epidemic or pandemic4 7#c7 ,sponsor requirements 7,a7 ,in general ,for any drug application provisionally approved under this section1 the ,secretary shall notify the sponsor of the exact data such sponsor is required to submit to an observational registry4 7,b7 ,annual review of the registry2 penalties ,the ,secretary shall conduct an annual review of observational registries established under this subsection4 ,if1 at such an annual review1 less than #ij percent of patients are participating in an observational registry with respect to a drug approved under this section1 the ,secretary shall issue to the sponsor of such drug a civil monetary penalty of not more than #ajj1jjj4 ,if a violation of this section is not corrected within the #cj-;day period following notification1 the sponsor shall1 in addition to any penalty under this subparagraph be subject to a civil monetary penalty of not more than #aj1jjj for each day of the violation after such period until the violation is corrected4 ,if application patient participation in an observational registry is not at or above #ij percent within #f months of issuance of such penalty1 the provisional approval shall be withdrawn4 7#d7 ,annual report to ,congress ,the ,secretary shall submit an annual report to ,congress on all drugs granted provisional approval under this section4 ,such report shall include-- 7,a7 the number of patients treated with each such drug1 and the number of patients tracked in an observational registry with respect to each such drug2 7,b7 a discussion of the minimum amount of data required in the registries1 including patient treatments and uses1 length of use1 side effects encountered1 relevant biomarkers or scientifically substantiated surrogates1 scan results1 cause of death and how long the patient lived1 and adverse drug effects2 7,c7 a list of all such drugs for which an application for full approval under section #eje of this ,act or section #cea of the ,public ,health ,service ,act1 or an application for an extension of provisional approval under this section1 has been submitted2 and 7,d7 a list of all applications denied provisional approval under this section1 together with an explanation for the decisions to deny each such application4 7e7 ,withdrawal of provisional approval 7#a7 ,in general ,the ,secretary shall withdraw provisional approval under this section if there are a significant number of patients who experience serious adverse effects1 compared to the other currently marketed on-label therapies that are available for the applicable disease or condition4 7#b7 ,effect of withdrawal ,if a provisional approval is withdrawn under this subsection1 the sponsor may not make the drug available to any new patients1 but may be allowed to continue to make such drug available to patients who started taking the drug prior to the date of withdrawal1 for as long a period as dictated by patient need1 as determined by the ,secretary4 7f7 ,transparency ,any scientific1 medical1 academic1 or health care journal publishing an article explaining1 releasing1 conveying or announcing research findings which were funded by the ,department of ,health and ,human ,services shall be prohibited from publishing such research unless-- 7#a7 such article conveying research findings is made publicly available on the journal's internet website without a paywall or charge not later than #c months after the date on which such article was first provided to subscribers of such journal 7or first made available for purchase72 and 7#b7 the article's author or researcher or author's institution 7or1 in the case of multiple authors1 researchers1 or institutions1 all such authors1 researchers1 or institutions7 received less than #cj percent of funding for such research from the ,department of ,health and ,human ,services throughout the period of time the research was conducted4 7g7 ,informed consent ,prior to receiving a drug provisionally approved under this section1 the sponsor of the drug shall receive from each patient1 or the patient's representative1 informed consent1 through a signed informed consent form1 acknowledging that such patient understands that the drug did not undergo the usual process for full approval of a drug by the ,food and ,drug ,administration1 and that such patient is willing to accept the risks involved in taking such drug4 7h7 ,postmarket controls and labeling 7#a7 ,,fda annual review of registry data ,the ,secretary shall annually review the data made available through the observational registries under subsection 7d7 and make a determination regarding whether the side effect profile of any drug approved under this pathway does not support the benefit provided1 or the data shows the benefit is less than the benefits offered through other1 fully approved drugs4 7#b7 ,labeling ,the sponsor of the provisionally approved drug shall ensure that all labeling and promotional materials for the drug bear the statement provisionally approved by the ,,fda pending a full demonstration of effectiveness under application number 7specifying the application number assigned by the ,secretary in place of the blank74 ,all promotional1 educational and marketing materials for provisionally approved products shall be reviewed and approved by the ,secretary before such materials are distributed4 7#c7 ,rescission of provisional approval ,if the ,secretary determines that the side effect profile of any drug included in such observational registries does not support the benefit provided by such drug1 or that the data shows that the benefit is less than the benefits offered through other1 fully approved drugs1 the ,secretary shall rescind such provisional approval4 7i7 ,duration of provisional approval2 requirement ,to bring drug to market 7#a7 ,duration2 renewals ,the period of provisional approval for a drug approved under this section is effective for a #b-year period4 ,the sponsor may request renewal for provisional approval status for up to #c subsequent #b-year periods by the ,secretary4 ,provisional approval status with respect to a drug shall not exceed a total of #f years from the initial date the sponsor was awarded provisional approval status4 7#b7 ,marketing requirement ,if any drug that receives provisional approval status under this section is not brought to market within #ahj days of the approval1 such approval shall be rescinded4 7j7 ,limitation on liability ,with respect to any claim under ,state law alleging that a drug sold or otherwise made available pursuant to a grant of provisional approval under this section is unsafe or ineffective1 no liability in a cause of action shall lie against a sponsor or manufacturer1 unless the relevant conduct constitutes reckless or willful misconduct1 gross negligence1 or an intentional tort under any applicable ,state law4 7k7 ,applying for full approval 7#a7 ,in general ,except as provided under paragraph 7#b71 the sponsor of a drug granted provisional approval pursuant to this section may1 at any point1 submit an application for full approval of such drug under section #eje of this ,act or section #cea of the ,public ,health ,service ,act1 as applicable4 7#b7 ,effect of recession on approval and automatic approval 7,a7 ,in general ,the sponsor of a drug granted provisional approval pursuant to this section that has been rescinded under subsection 7h77#c71 may submit an application for full approval of such drug under section #eje of this ,act or section #cea of the ,public ,health ,service ,act at any time4 7,b7 ,automatic approval ,such full approval may be awarded at any time for any drug granted provisional approval pursuant to this section if the sponsor of the drug establishes a #ae percent improvement in an important endpoint1 including surrogate endpoints not validated by the ,food and ,drug ,administration1 compared to a standard drug4 7#c7 ,real-time epidemic and pandemic vaccine approval 7,a7 ,in general ,in the case of a vaccine developed in response to an epidemic or pandemic1 including ,,covid-#ai1 the ,secretary shall share data information regarding the approval of the vaccine with the ,advisory ,committee on ,immunization ,practices of the ,centers for ,disease ,control and ,prevention as the review nears completion4 7,b7 ,evaluation ,any vaccine that has been approved by the ,secretary for an epidemic or pandemic-related disease1 including ,,covid-#ai1 shall be evaluated by the ,advisory ,committee on ,immunization ,practices of the ,centers for ,disease ,control and ,prevention not later than #a week after the date of submission to the ,advisory ,committee by the ,secretary of the vaccine4 7l7 ,patient advocate general ,not later than #f months after the date of enactment of the ,promising ,pathway ,act1 the ,secretary shall establish within the ,office of the ,commissioner1 the position of ,patient ,advocate ,general1 who shall provide assistance to patients and their families who use drugs under evaluation in this pathway or drugs reviewed or approved under section #eje or section #cea of the ,public ,health ,service ,act4 ,such assistance shall include providing bi-informational communication about maintaining patient health1 delivery of proper informed consent1 participating in clinical investigations1 completing required documentation in order to participate in the applicable programs1 and providing other information4 4 7b7 ,conforming amendment ,section #eje7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;a77 is amended by inserting 1 or there is in effect a provisional approval under section #ebd;,b with respect to such drug before the period4 7c7 ,reimbursement 7#a7 ,private health insurers ,section #bgai;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 is amended by adding at the end the following3 7e7 ,treatment of certain drugs ,a group health plan or health insurance issuer of group or individual health insurance coverage shall not deny coverage of any drug provisionally approved under section #ebd;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act on the basis of such drug being experimental4 ,in determining coverage under the applicable plan or coverage1 a group health plan or health insurance issuer shall treat a drug provisionally approved under such section in the same manner as such plan or coverage would treat a drug approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea of this ,act4 ,nothing in this subsection shall be construed to require a group health plan or health insurance issuer to cover any specific drug provisionally approved under such section #ebd;,b4 4 7#b7 ,federal health care programs ,the requirement under subsection 7e7 of section #bgai;,a of the ,public ,health ,service ,act 7as added by paragraph 7#a77 shall apply with respect to coverage determinations under a ,federal health care program 7as defined in section #aabh;,b7f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;b7f777 in the same manner such requirement applies under such subsection 7e74 7#c7 ,conforming amendment ,section #aibg7k77#b77;,a77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#b77;,a77i77 is amended-- 7,a7 by striking or which and inserting 1 which2 and 7,b7 by inserting 1 or which is provisionally approved under section #ebd;,b of such ,act before the semicolon4 #cdg4 ,consolidating exclusivity periods for drugs treating rare diseases and conditions 7a7 ,in general ,subsection 7a7 of section #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 is amended to read as follows3 7a7 ,exclusivity 7#a7 ,in general ,except as provided in subsection 7b71 if the ,secretary approves an application filed pursuant to section #eje1 or issues a license under section #cea of the ,public ,health ,service ,act1 for a drug designated under section #ebf for a rare disease or condition1 the ,secretary may not approve an application filed pursuant to section #eje1 or issue a license under section #cea of the ,public ,health ,service ,act1 for the same drug for the same disease or condition for a person who is not the holder of such approved application or of such license until the expiration of the exclusivity period described in paragraph 7#b74 7#b7 ,exclusivity period described ,the exclusivity period described in this paragraph1 with respect to a drug designated under section #ebf for a rare disease or condition1 is-- 7,a7 a single #g-year period of exclusivity with respect to the first designation of such drug under such section for that rare disease or condition2 or 7,b7 in the case of a drug that has previously received a period of exclusivity under paragraph 7#a71 a single #c-year period of exclusivity with respect to any subsequent designation of such drug under such section for any other rare disease or condition4 7#c7 ,limitation ,in the case of a drug that has received two periods of exclusivity pursuant to paragraph 7#a71 no additional exclusivity period under this section is available with respect to such drug1 regardless of whether such drug has been designated under section #ebf for a rare disease or condition that is distinct from the rare disease or condition for which such exclusivity periods were granted4 4 7b7 ,conforming amendments 7#a7 ,section #eje7;j77#e77;,b77iv77,,ii77dd77,,aa7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 is amended by striking #g-year period and inserting exclusivity period4 7#b7 ,section #eje;,a7b77#a77;,a77ii7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 is amended by striking rather than seven years2 and inserting 1 or three years and six months1 rather than seven years or three years1 respectively24 7#c7 ,section #eje;,a7c77#a77;,a77ii7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 is amended by striking rather than seven years2 and inserting 1 or three years and six months1 rather than seven years or three years1 respectively24 7#d7 ,section #eje;,e7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 is amended by striking #g-year period and inserting exclusivity periods4 7#e7 ,section #ebg7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 is amended by striking the #g-year period and inserting any exclusivity period4 7#f7 ,section #cea7m77#b77;,b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 is amended by striking rather than #g years and inserting or #c years and #f months1 rather than #g years or #c years1 respectively4 7#g7 ,section #cea7m77#c77;,b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 is amended by striking rather than #g years and inserting or #c years and #f months1 rather than #g years or #c years1 respectively4 #cdh4 ,exclusivity period for brand name biological products 7a7 ,in general ,section #cea7k77#g77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77#g77;,a77 is amended by striking #ab years and inserting #e years4 7b7 ,conforming changes ,paragraphs 7#b77;,a7 and 7#c77;,a7 of section #cea7m7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7m77 is amended by striking #ab years each place it appears and inserting #e years4 7c7 ,applicability ,this ,act and the amendments made by this ,act apply only with respect to a biological product for which the reference product 7as such term is used in section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb77 is licensed under subsection 7a7 of such section on or after the date of enactment of this ,act4 #cdi4 ,protecting access to biological products ,section #cea7k77#g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77#g77 is amended by adding at the end the following3 7,d7 ,deemed licenses 7i7 ,no additional exclusivity through deeming ,an approved application that is deemed to be a license for a biological product under this section pursuant to section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji shall not be treated as having been first licensed under subsection 7a7 for purposes of subparagraphs 7,a7 and 7,b74 7ii7 ,application of limitations on exclusivity ,subparagraph 7,c7 shall apply with respect to a reference product referred to in such subparagraph that was the subject of an approved application that was deemed to be a license pursuant to section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji4 7iii7 ,applicability ,the exclusivity periods described in section #ebg1 section #eje;,a7b77#a77;,a77ii71 and section #eje;,a7c77#a77;,a77ii7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act shall continue to apply to a biological product after an approved application for the biological product is deemed to be a license for the biological product under subsection 7a7 pursuant to section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji4 4 #cej4 ,streamlining the transition of biological products ,section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji 7,public ,law #aaa-adh7 is amended by adding at the end the following3 ,with respect to an application for a biological product submitted under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 with a filing date that is not later than ,september #bc1 #bjai1 and that does not receive final approval on or before ,march #bc1 #bjbj1 such application shall be deemed to be withdrawn and the ,secretary shall refund the fee paid under section #gcf7;a77#a77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7a77#a77;,b774 ,notwithstanding any such withdrawal of the drug application1 the ,secretary shall consider any previously conducted scientific review and accelerate review of any such subsequent application with respect to such biological product under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 ,the ,secretary shall provide additional assistance to the sponsor or manufacturer of such application44 #cea4 ,regulation of manufacturer-sponsored copay contributions ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services may establish a mechanism to regulate drug manufacturers' financial contributions to patient out-of-pocket costs1 such as drug co-pays4 #ceb4 ,antitrust exemption for private health insurer issuers to negotiate wholesale acquisition prices of prescription drugs purchased from drug manufacturers 7a7 ,exemption ,it shall not be a violation of the antitrust laws for one or more private health insurer issuers or their designated agents to jointly negotiate wholesale acquisition prices of a prescription drug with a manufacturer of a prescription drug with regards to the reimbursement policies of the insurers of the manufacturer's drugs so long as no one single wholesale acquisition price is jointly determined between the insurance issuers or their designated agents4 7b7 ,definitions ,for purposes of this section3 7#a7 ,antitrust laws ,the term antitrust laws has the meaning given it in subsection 7a7 of the #ast section of the ,clayton ,act 7#ae ,u4,s4,c4 #ab7;a771 except that such term includes section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to the extent such section #e applies to unfair methods of competition4 7#b7 ,health insurance issuer ,the term health insurance issuer means an insurance company1 insurance service1 or insurance organization 7including a health maintenance organization1 as defined in subparagraph 7,c77 which is licensed to engage in the business of insurance in a ,state and which is subject to ,state law which regulates insurance 7within the meaning of section #ead7;b77#b7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aadd7;b77#b7774 ,such term does not include a group health plan4 7#c7 ,health maintenance organization ,the term health maintenance organization means-- 7,a7 a ,federally qualified health maintenance organization 7as defined in section #cjj;e7a7 of title #db of the ,united ,states ,code71 7,b7 an organization recognized under ,state law as a health maintenance organization1 or 7,c7 a similar organization regulated under ,state law for solvency in the same manner and to the same extent as such a health maintenance organization4 7#d7 ,manufacturer ,the term manufacturer means anyone who is engaged in manufacturing1 preparing1 propagating1 compounding1 processing1 packaging1 repackaging1 or labeling of a prescription drug4 7#e7 ,prescription drug ,the term prescription drug means any human drug required by ,federal law or regulation to be dispensed only by a prescription1 including finished dosage forms and active ingredients subject to section #ejc7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;b774 7c7 ,effective date ,this section shall take effect on the date of the enactment of this ,act but shall not apply with respect to conduct that occurs before such date4 #cec4 ,biological product innovation ,section #cea7;j7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;j77 is amended-- 7#a7 by striking except that a product and inserting 8except that-- 7#a7 a product 2 7#b7 by striking ,act4 and inserting ,act2 and2 and 7#c7 by adding at the end the following3 7#b7 no requirement under such ,act regarding an official compendium 7as defined in section #bja7;j7 of such ,act71 or other reference in such ,act to an official compendium 7as so defined71 shall apply with respect to a biological product subject to regulation under this section4 4 #ced4 ,clarifying the meaning of new chemical entity 7a7 ,in general ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended-- 7#a7 in section #eje 7#ba ,u4,s4,c4 #cee7-- 7,a7 in subsection 7c77#c77;,e71 by striking active ingredient 7including any ester or salt of the active ingredient7 each place it appears and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7,b7 in subsection 7j77#e77;,f71 by striking active ingredient 7including any ester or salt of the active ingredient7 each place it appears and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7,c7 in subsection 7l77#b77;,a7-- 7i7 by amending clause 7i7 to read as follows3 7i7 not later than #cj days after the date of approval of such applications-- 7,i7 for a drug1 no active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 of which has been approved in any other application under this section2 or 7,,ii7 for a biological product1 no active ingredient of which has been approved in any other application under section #cea of the ,public ,health ,service ,act2 and 2 and 7ii7 in clause 7ii71 by inserting or biological product before the period2 7,d7 by amending subsection 7s7 to read as follows3 7s7 ,referral to advisory committee ,the ,secretary shall-- 7#a7 refer a drug or biological product to a ,food and ,drug ,administration advisory committee for review at a meeting of such advisory committee prior to the approval of such drug or biological if it is-- 7,a7 a drug1 no active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 of which has been approved in any other application under this section2 or 7,b7 a biological product1 no active ingredient of which has been approved in any other application under section #cea of the ,public ,health ,service ,act2 or 7#b7 if the ,secretary does not refer a drug or biological product described in paragraph 7#a7 to a ,food and ,drug ,administration advisory committee prior to such approval1 provide in the action letter on the application for the drug or biological product a summary of the reasons why the ,secretary did not refer the drug or biological product to an advisory committee prior to approval4 2 and 7,e7 in subsection 7u77#a71 in the matter preceding subparagraph 7,a7-- 7i7 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 and 7ii7 by striking same active ingredient and inserting same active moiety2 7#b7 in section #eab7;c77#b77;,f7 7#ba ,u4,s4,c4 #cfj;b7c77#b77;,f771 by striking active ingredient 7including any ester or salt of the active ingredient7 each place it appears and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7#c7 in section #ebd7;a77#d7 7#ba ,u4,s4,c4 #cfjn7a77#d771 by amending subparagraph 7,c7 to read as follows3 7,c7 is for-- 7i7 a human drug1 no active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 of which has been approved in any other application under section #eje7;b77#a72 or 7ii7 a biological product1 no active ingredient of which has been approved in any other application under section #cea of the ,public ,health ,service ,act4 2 7#d7 in section #ebi7;a77#d7 7#ba ,u4,s4,c4 #cfj;ff7a77#d771 by striking subparagraphs 7,a7 and 7,b7 and inserting the following3 7,a7 is for a drug or biological product that is for the prevention or treatment of a rare pediatric disease2 7,b7 7i7 is for such a drug-- 7,i7 that contains no active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 that has been previously approved in any other application under subsection 7b77#a71 7b77#b71 or 7j7 of section #eje2 and 7,,ii7 that is the subject of an application submitted under section #eje7;b77#a72 or 7ii7 or is for such a biological product-- 7,i7 that contains no active ingredient that has been previously approved in any other application under section #cea7;a7 or #cea7k7 of the ,public ,health ,service ,act2 and 7,,ii7 that is the subject of an application submitted under section #cea7;a7 of the ,public ,health ,service ,act2 2 and 7#e7 in section #efe;,a7a77#d7 7#ba ,u4,s4,c4 #cfj;bbb-#d;a7a77#d771 by amending subparagraph 7,d7 to read as follows3 7,d7 is for-- 7i7 a human drug1 no active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 of which has been approved in any other application under section #eje7;b77#a72 or 7ii7 a biological product1 no active ingredient of which has been approved in any other application under section #cea of the ,public ,health ,service ,act4 4 7b7 ,technical corrections ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended-- 7#a7 in section #eje 7#ba ,u4,s4,c4 #cee7-- 7,a7 in subsection 7c77#c77;,e71 by repealing clause 7i72 and 7,b7 in subsection 7j77#e77;,f71 by repealing clause 7i72 and 7#b7 in section #eje;,a7c77#a77;,a77i77,,ii7 7#ba ,u4,s4,c4 #cee;a7c77#a77;,a77i771 by striking 7c77#c77;,d7 and inserting 7c77#c77;,e74 #cee4 ,prompt approval of drugs related to safety information ,section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is amended by adding at the end the following3 7z7 ,prompt ,approval of ,drugs ,when safety information ,is ,added to ,labeling 7#a7 ,general rule ,a drug for which an application has been submitted or approved under subsection 7b77#b7 or 7j7 shall not be considered ineligible for approval under this section or misbranded under section #ejb on the basis that the labeling of the drug omits safety information1 including contraindications1 warnings1 precautions1 dosing1 administration1 or other information pertaining to safety1 when the omitted safety information is protected by exclusivity under clause 7iii7 or 7iv7 of subsection 7j77#e77;,f71 clause 7iii7 or 7iv7 of subsection 7c77#c77;,e71 or section #ebg7;a71 or by an extension of such exclusivity under section #eje;,a or #eje;,e4 7#b7 ,labeling ,notwithstanding clauses 7iii7 and 7iv7 of subsection 7j77#e77;,f71 clauses 7iii7 and 7iv7 of subsection 7c77#c77;,e71 or section #ebg1 the ,secretary shall require that the labeling of a drug approved pursuant to an application submitted under subsection 7b77#b7 or 7j7 that omits safety information described in paragraph 7#a7 include a statement of any appropriate safety information that the ,secretary considers necessary to assure safe use4 7#c7 ,availability and scope of exclusivity ,this subsection does not affect-- 7,a7 the availability or scope of exclusivity or an extension of exclusivity described in subparagraph 7,a7 or 7,b7 of section #eje;,a7o77#c72 7,b7 the question of the eligibility for approval under this section of any application described in subsection 7b77#b7 or 7j7 that omits any other aspect of labeling protected by exclusivity under-- 7i7 clause 7iii7 or 7iv7 of subsection 7j77#e77;,f72 7ii7 clause 7iii7 or 7iv7 of subsection 7c77#c77;,e72 or 7iii7 section #ebg7;a72 or 7,c7 except as expressly provided in paragraphs 7#a7 and 7#b71 the operation of this section or section #ebg4 4 #cef4 ,conditions of use for biosimilar biological products ,section #cea7k77#b77;,a77iii7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77#b77;,a77iii77 is amended-- 7#a7 in subclause 7,i71 by striking 2 and and inserting a semicolon2 7#b7 in subclause 7,,ii71 by striking the period and inserting 2 and2 and 7#c7 by adding at the end the following3 7,,iii7 may include information to show that the conditions of use prescribed1 recommended1 or suggested in the labeling proposed for the biological product have been previously approved for the reference product4 4 #ceg4 ,education on biological products ,subpart #a of part ,f of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb et seq47 is amended by adding at the end the following3 #ceb;,a4 ,education on biological products 7a7 ,internet website 7#a7 ,in general ,the ,secretary may maintain and operate an internet website to provide educational materials for health care providers1 patients1 and caregivers1 regarding the meaning of the terms1 and the standards for review and licensing of1 biological products1 including biosimilar biological products and interchangeable biosimilar biological products4 7#b7 ,content ,educational materials provided under paragraph 7#a7 may include-- 7,a7 explanations of key statutory and regulatory terms1 including biosimilar and interchangeable1 and clarification regarding the use of interchangeable biosimilar biological products2 7,b7 information related to development programs for biological products1 including biosimilar biological products and interchangeable biosimilar biological products and relevant clinical considerations for prescribers1 which may include1 as appropriate and applicable1 information related to the comparability of such biological products2 7,c7 an explanation of the process for reporting adverse events for biological products1 including biosimilar biological products and interchangeable biosimilar biological products2 and 7,d7 an explanation of the relationship between biosimilar biological products and interchangeable biosimilar biological products licensed under section #cea7k7 and reference products 7as defined in section #cea7;i771 including the standards for review and licensing of each such type of biological product4 7#c7 ,format ,the educational materials provided under paragraph 7#a7 may be-- 7,a7 in formats such as webinars1 continuing medical education modules1 videos1 fact sheets1 infographics1 stakeholder toolkits1 or other formats as appropriate and applicable2 and 7,b7 tailored for the unique needs of health care providers1 patients1 caregivers1 and other audiences1 as the ,secretary determines appropriate4 7#d7 ,other information ,in addition to the information described in paragraph 7#b71 the ,secretary shall continue to publish the following information3 7,a7 ,the action package of each biological product licensed under subsection 7a7 or 7k74 7,b7 ,the summary review of each biological product licensed under subsection 7a7 or 7k74 7#e7 ,confidential and trade secret information ,this subsection does not authorize the disclosure of any trade secret1 confidential commercial or financial information1 or other matter described in section #eeb7;b7 of title #e4 7b7 ,continuing education ,the ,secretary shall advance education and awareness among health care providers regarding biological products1 including biosimilar biological products and interchangeable biosimilar biological products1 as appropriate1 including by developing or improving continuing medical education programs that advance the education of such providers on the prescribing of1 and relevant clinical considerations with respect to1 biological products1 including biosimilar biological products and interchangeable biosimilar biological products4 4 #ceh4 ,congressional review of the ,food and ,drug ,administration rulemaking 7a7 ,congressional review ,part ,i of title #e1 ,united ,states ,code1 is amended by adding at the end the following3 #aj ,congressional ,review of ,food and ,drug ,administration ,rulemaking ,sec4 #ibj4 ,applicability4 #iba4 ,congressional review4 #ibb4 ,congressional approval procedure for major rules4 #ibc4 ,congressional disapproval procedure for nonmajor rules4 #ibd4 ,definitions4 #ibe4 ,judicial review4 #ibf4 ,exemption for monetary policy4 #ibg4 ,effective date of certain rules4 #ibh4 ,regulatory cut-go requirement4 #ibi4 ,review of rules currently in effect4 #ibj4 ,applicability ,this chapter applies in lieu of chapter #h with respect to the ,food and ,drug ,administration4 #iba4 ,congressional review 7a7 7#a7 7,a7 ,before a rule may take effect1 the ,food and ,drug ,administration shall satisfy the requirements of section #ibh and shall publish in the ,federal ,register a list of information on which the rule is based1 including data1 scientific and economic studies1 and cost-benefit analyses1 and identify how the public can access such information online1 and shall submit to each ,house of the ,congress and to the ,comptroller ,general a report containing-- 7i7 a copy of the rule2 7ii7 a concise general statement relating to the rule2 7iii7 a classification of the rule as a major or nonmajor rule1 including an explanation of the classification specifically addressing each criteria for a major rule contained within sections #ibd7b77;,a71 #ibd7b77;,b71 and #ibd7b77;,c72 7iv7 a list of any other related regulatory actions intended to implement the same statutory provision or regulatory objective as well as the individual and aggregate economic effects of those actions2 and 7v7 the proposed effective date of the rule4 7,b7 ,on the date of the submission of the report under subparagraph 7,a71 the ,food and ,drug ,administration shall submit to the ,comptroller ,general and make available to each ,house of ,congress-- 7i7 a complete copy of the cost-benefit analysis of the rule1 if any1 including an analysis of any jobs added or lost1 differentiating between public and private sector jobs2 7ii7 the ,food and ,drug ,administration's actions pursuant to sections #fjc1 #fjd1 #fje1 #fjg1 and #fji of this title2 7iii7 the ,food and ,drug ,administration's actions pursuant to sections #bjb1 #bjc1 #bjd1 and #bje of the ,unfunded ,mandates ,reform ,act of #aiie2 and 7iv7 any other relevant information or requirements under any other ,act and any relevant ,executive orders4 7,c7 ,upon receipt of a report submitted under subparagraph 7,a71 each ,house shall provide copies of the report to the chairman and ranking member of each standing committee with jurisdiction under the rules of the ,house of ,representatives or the ,senate to report a bill to amend the provision of law under which the rule is issued4 7#b7 7,a7 ,the ,comptroller ,general shall provide a report on each major rule to the committees of jurisdiction by the end of #ae calendar days after the submission or publication date4 ,the report of the ,comptroller ,general shall include an assessment of the ,food and ,drug ,administration's compliance with procedural steps required by paragraph 7#a77;,b7 and an assessment of whether the major rule imposes any new limits or mandates on private-sector activity4 7,b7 ,the ,food and ,drug ,administration shall cooperate with the ,comptroller ,general by providing information relevant to the ,comptroller ,general's report under subparagraph 7,a74 7#c7 ,a major rule relating to a report submitted under paragraph 7#a7 shall take effect upon enactment of a joint resolution of approval described in section #ibb or as provided for in the rule following enactment of a joint resolution of approval described in section #ibb1 whichever is later4 7#d7 ,a nonmajor rule shall take effect as provided by section #ibc after submission to ,congress under paragraph 7#a74 7#e7 ,if a joint resolution of approval relating to a major rule is not enacted within the period provided in subsection 7b77#b71 then a joint resolution of approval relating to the same rule may not be considered under this chapter in the same ,congress by either the ,house of ,representatives or the ,senate4 7b7 7#a7 ,a major rule shall not take effect unless the ,congress enacts a joint resolution of approval described under section #ibb4 7#b7 ,if a joint resolution described in subsection 7a7 is not enacted into law by the end of #gj session days or legislative days1 as applicable1 beginning on the date on which the report referred to in section #iba7;a77#a77;,a7 is received by ,congress 7excluding days either ,house of ,congress is adjourned for more than #c days during a session of ,congress71 then the rule described in that resolution shall be deemed not to be approved and such rule shall not take effect4 7c7 7#a7 ,notwithstanding any other provision of this section 7except subject to paragraph 7#c771 a major rule may take effect for one #ij-;calendar-day period if the ,president makes a determination under paragraph 7#b7 and submits written notice of such determination to the ,congress4 7#b7 ,paragraph 7#a7 applies to a determination made by the ,president by ,executive order that the major rule should take effect because such rule is-- 7,a7 necessary because of an imminent threat to health or safety or other emergency2 7,b7 necessary for the enforcement of criminal laws2 7,c7 necessary for national security2 or 7,d7 issued pursuant to any statute implementing an international trade agreement4 7#c7 ,an exercise by the ,president of the authority under this subsection shall have no effect on the procedures under section #ibb4 7d7 7#a7 ,in addition to the opportunity for review otherwise provided under this chapter1 in the case of any rule for which a report was submitted in accordance with subsection 7a77#a77;,a7 during the period beginning on the date occurring-- 7,a7 in the case of the ,senate1 #fj session days2 or 7,b7 in the case of the ,house of ,representatives1 #fj legislative days1 before the date the ,congress is scheduled to adjourn a session of ,congress through the date on which the same or succeeding ,congress first convenes its next session1 sections #ibb and #ibc shall apply to such rule in the succeeding session of ,congress4 7#b7 7,a7 ,in applying sections #ibb and #ibc for purposes of such additional review1 a rule described under paragraph 7#a7 shall be treated as though-- 7i7 such rule were published in the ,federal ,register on-- 7,i7 in the case of the ,senate1 the #aeth session day2 or 7,,ii7 in the case of the ,house of ,representatives1 the #aeth legislative day1 after the succeeding session of ,congress first convenes2 and 7ii7 a report on such rule were submitted to ,congress under subsection 7a77#a7 on such date4 7,b7 ,nothing in this paragraph shall be construed to affect the requirement under subsection 7a77#a7 that a report shall be submitted to ,congress before a rule can take effect4 7#c7 ,a rule described under paragraph 7#a7 shall take effect as otherwise provided by law 7including other subsections of this section74 #ibb4 ,congressional approval procedure for major rules 7a7 7#a7 ,for purposes of this section1 the term joint resolution means only a joint resolution addressing a report classifying a rule as major pursuant to section #iba7;a77#a77;,a77iii7 that-- 7,a7 bears no preamble2 7,b7 bears the following title 7with blanks filled as appropriate73 ,approving the rule submitted by relating to 42 7,c7 includes after its resolving clause only the following 7with blanks filled as appropriate73 ,that ,congress approves the rule submitted by relating to 42 and 7,d7 is introduced pursuant to paragraph 7#b74 7#b7 ,after a ,house of ,congress receives a report classifying a rule as major pursuant to section #iba7;a77#a77;,a77iii71 the majority leader of that ,house 7or his or her respective designee7 shall introduce 7by request1 if appropriate7 a joint resolution described in paragraph 7#a7-- 7,a7 in the case of the ,house of ,representatives1 within #c legislative days2 and 7,b7 in the case of the ,senate1 within #c session days4 7#c7 ,a joint resolution described in paragraph 7#a7 shall not be subject to amendment at any stage of proceeding4 7b7 ,a joint resolution described in subsection 7a7 shall be referred in each ,house of ,congress to the committees having jurisdiction over the provision of law under which the rule is issued4 7c7 ,in the ,senate1 if the committee or committees to which a joint resolution described in subsection 7a7 has been referred have not reported it at the end of #ae session days after its introduction1 such committee or committees shall be automatically discharged from further consideration of the resolution and it shall be placed on the calendar4 ,a vote on final passage of the resolution shall be taken on or before the close of the #aeth session day after the resolution is reported by the committee or committees to which it was referred1 or after such committee or committees have been discharged from further consideration of the resolution4 7d7 7#a7 ,in the ,senate1 when the committee or committees to which a joint resolution is referred have reported1 or when a committee or committees are discharged 7under subsection 7c77 from further consideration of a joint resolution described in subsection 7a71 it is at any time thereafter in order 7even though a previous motion to the same effect has been disagreed to7 for a motion to proceed to the consideration of the joint resolution1 and all points of order against the joint resolution 7and against consideration of the joint resolution7 are waived4 ,the motion is not subject to amendment1 or to a motion to postpone1 or to a motion to proceed to the consideration of other business4 ,a motion to reconsider the vote by which the motion is agreed to or disagreed to shall not be in order4 ,if a motion to proceed to the consideration of the joint resolution is agreed to1 the joint resolution shall remain the unfinished business of the ,senate until disposed of4 7#b7 ,in the ,senate1 debate on the joint resolution1 and on all debatable motions and appeals in connection therewith1 shall be limited to not more than #b hours1 which shall be divided equally between those favoring and those opposing the joint resolution4 ,a motion to further limit debate is in order and not debatable4 ,an amendment to1 or a motion to postpone1 or a motion to proceed to the consideration of other business1 or a motion to recommit the joint resolution is not in order4 7#c7 ,in the ,senate1 immediately following the conclusion of the debate on a joint resolution described in subsection 7a71 and a single quorum call at the conclusion of the debate if requested in accordance with the rules of the ,senate1 the vote on final passage of the joint resolution shall occur4 7#d7 ,appeals from the decisions of the ,chair relating to the application of the rules of the ,senate to the procedure relating to a joint resolution described in subsection 7a7 shall be decided without debate4 7e7 ,in the ,house of ,representatives1 if any committee to which a joint resolution described in subsection 7a7 has been referred has not reported it to the ,house at the end of #ae legislative days after its introduction1 such committee shall be discharged from further consideration of the joint resolution1 and it shall be placed on the appropriate calendar4 ,on the second and fourth ,thursdays of each month it shall be in order at any time for the ,speaker to recognize a ,member who favors passage of a joint resolution that has appeared on the calendar for at least #e legislative days to call up that joint resolution for immediate consideration in the ,house without intervention of any point of order4 ,when so called up a joint resolution shall be considered as read and shall be debatable for #a hour equally divided and controlled by the proponent and an opponent1 and the previous question shall be considered as ordered to its passage without intervening motion4 ,it shall not be in order to reconsider the vote on passage4 ,if a vote on final passage of the joint resolution has not been taken by the third ,thursday on which the ,speaker may recognize a ,member under this subsection1 such vote shall be taken on that day4 7f7 7#a7 ,if1 before passing a joint resolution described in subsection 7a71 one ,house receives from the other a joint resolution having the same text1 then-- 7,a7 the joint resolution of the other ,house shall not be referred to a committee2 and 7,b7 the procedure in the receiving ,house shall be the same as if no joint resolution had been received from the other ,house until the vote on passage1 when the joint resolution received from the other ,house shall supplant the joint resolution of the receiving ,house4 7#b7 ,this subsection shall not apply to the ,house of ,representatives if the joint resolution received from the ,senate is a revenue measure4 7g7 ,if either ,house has not taken a vote on final passage of the joint resolution by the last day of the period described in section #iba7;b77#b71 then such vote shall be taken on that day4 7h7 ,this section and section #ibc are enacted by ,congress-- 7#a7 as an exercise of the rulemaking power of the ,senate and ,house of ,representatives1 respectively1 and as such is deemed to be part of the rules of each ,house1 respectively1 but applicable only with respect to the procedure to be followed in that ,house in the case of a joint resolution described in subsection 7a7 and superseding other rules only where explicitly so2 and 7#b7 with full recognition of the ,constitutional right of either ,house to change the rules 7so far as they relate to the procedure of that ,house7 at any time1 in the same manner and to the same extent as in the case of any other rule of that ,house4 #ibc4 ,congressional disapproval procedure for nonmajor rules 7a7 ,for purposes of this section1 the term joint resolution means only a joint resolution introduced in the period beginning on the date on which the report referred to in section #iba7;a77#a77;,a7 is received by ,congress and ending #fj days thereafter 7excluding days either ,house of ,congress is adjourned for more than #c days during a session of ,congress71 the matter after the resolving clause of which is as follows3 ,that ,congress disapproves the nonmajor rule submitted by the relating to 1 and such rule shall have no force or effect4 7,the blank spaces being appropriately filled in74 7b7 ,a joint resolution described in subsection 7a7 shall be referred to the committees in each ,house of ,congress with jurisdiction4 7c7 ,in the ,senate1 if the committee to which is referred a joint resolution described in subsection 7a7 has not reported such joint resolution 7or an identical joint resolution7 at the end of #ae session days after the date of introduction of the joint resolution1 such committee may be discharged from further consideration of such joint resolution upon a petition supported in writing by #cj ,members of the ,senate1 and such joint resolution shall be placed on the calendar4 7d7 7#a7 ,in the ,senate1 when the committee to which a joint resolution is referred has reported1 or when a committee is discharged 7under subsection 7c77 from further consideration of a joint resolution described in subsection 7a71 it is at any time thereafter in order 7even though a previous motion to the same effect has been disagreed to7 for a motion to proceed to the consideration of the joint resolution1 and all points of order against the joint resolution 7and against consideration of the joint resolution7 are waived4 ,the motion is not subject to amendment1 or to a motion to postpone1 or to a motion to proceed to the consideration of other business4 ,a motion to reconsider the vote by which the motion is agreed to or disagreed to shall not be in order4 ,if a motion to proceed to the consideration of the joint resolution is agreed to1 the joint resolution shall remain the unfinished business of the ,senate until disposed of4 7#b7 ,in the ,senate1 debate on the joint resolution1 and on all debatable motions and appeals in connection therewith1 shall be limited to not more than #aj hours1 which shall be divided equally between those favoring and those opposing the joint resolution4 ,a motion to further limit debate is in order and not debatable4 ,an amendment to1 or a motion to postpone1 or a motion to proceed to the consideration of other business1 or a motion to recommit the joint resolution is not in order4 7#c7 ,in the ,senate1 immediately following the conclusion of the debate on a joint resolution described in subsection 7a71 and a single quorum call at the conclusion of the debate if requested in accordance with the rules of the ,senate1 the vote on final passage of the joint resolution shall occur4 7#d7 ,appeals from the decisions of the ,chair relating to the application of the rules of the ,senate to the procedure relating to a joint resolution described in subsection 7a7 shall be decided without debate4 7e7 ,in the ,senate1 the procedure specified in subsection 7c7 or 7d7 shall not apply to the consideration of a joint resolution respecting a nonmajor rule-- 7#a7 after the expiration of the #fj session days beginning with the applicable submission or publication date2 or 7#b7 if the report under section #iba7;a77#a77;,a7 was submitted during the period referred to in section #iba7;d77#a71 after the expiration of the #fj session days beginning on the #aeth session day after the succeeding session of ,congress first convenes4 7f7 ,if1 before the passage by one ,house of a joint resolution of that ,house described in subsection 7a71 that ,house receives from the other ,house a joint resolution described in subsection 7a71 then the following procedures shall apply3 7#a7 ,the joint resolution of the other ,house shall not be referred to a committee4 7#b7 ,with respect to a joint resolution described in subsection 7a7 of the ,house receiving the joint resolution-- 7,a7 the procedure in that ,house shall be the same as if no joint resolution had been received from the other ,house2 but 7,b7 the vote on final passage shall be on the joint resolution of the other ,house4 #ibd4 ,definitions ,for purposes of this chapter3 7#a7 ,the term major rule means any rule of the ,food and ,drug ,administration1 including an interim final rule1 that the ,administrator of the ,office of ,information and ,regulatory ,affairs of the ,office of ,management and ,budget finds has resulted in or is likely to result in-- 7,a7 an annual cost on the economy of #ajj1jjj1jjj or more1 adjusted annually for inflation2 7,b7 a major increase in costs or prices for consumers1 individual industries1 ,federal1 ,state1 or local government agencies1 or geographic regions2 or 7,c7 significant adverse effects on competition1 employment1 investment1 productivity1 innovation1 or on the ability of ,united ,states-based enterprises to compete with foreign-based enterprises in domestic and export markets4 7#b7 ,the term nonmajor rule means any rule of the ,food and ,drug ,administration that is not a major rule4 7#c7 ,the term rule has the meaning given such term in section #eea1 except that such term does not include-- 7,a7 any rule of particular applicability2 7,b7 any rule relating to agency management or personnel2 or 7,c7 any rule of agency organization1 procedure1 or practice that does not substantially affect the rights or obligations of non-agency parties4 7#d7 ,the term submission date or publication date1 except as otherwise provided in this chapter1 means-- 7,a7 in the case of a major rule1 the date on which the ,congress receives the report submitted under section #iba7;a77#a72 and 7,b7 in the case of a nonmajor rule1 the later of-- 7i7 the date on which the ,congress receives the report submitted under section #iba7;a77#a72 and 7ii7 the date on which the nonmajor rule is published in the ,federal ,register1 if so published4 #ibe4 ,judicial review 7a7 ,no determination1 finding1 action1 or omission under this chapter shall be subject to judicial review4 7b7 ,notwithstanding subsection 7a71 a court may determine whether the ,food and ,drug ,administration has completed the necessary requirements under this chapter for a rule to take effect4 7c7 ,the enactment of a joint resolution of approval under section #ibb shall not be interpreted to serve as a grant or modification of statutory authority by ,congress for the promulgation of a rule1 shall not extinguish or affect any claim1 whether substantive or procedural1 against any alleged defect in a rule1 and shall not form part of the record before the court in any judicial proceeding concerning a rule except for purposes of determining whether or not the rule is in effect4 #ibf4 ,exemption for monetary policy ,nothing in this chapter shall apply to rules that concern monetary policy proposed or implemented by the ,board of ,governors of the ,federal ,reserve ,system or the ,federal ,open ,market ,committee4 #ibg4 ,effective date of certain rules ,notwithstanding section #iba1 any rule other than a major rule which the ,food and ,drug ,administration for good cause finds 7and incorporates the finding and a brief statement of reasons therefore in the rule issued7 that notice and public procedure thereon are impracticable1 unnecessary1 or contrary to the public interest1 shall take effect at such time as the ,food and ,drug ,administration determines4 #ibh4 ,regulatory cut-go requirement ,in making any new rule1 the ,food and ,drug ,administration shall identify a rule or rules that may be amended or repealed to completely offset any annual costs of the new rule to the ,united ,states economy4 ,before the new rule may take effect1 the ,food and ,drug ,administration shall make each such repeal or amendment4 ,in making such an amendment or repeal1 the ,food and ,drug ,administration shall comply with the requirements of subchapter ,,ii of chapter #e1 but the ,food and ,drug ,administration may consolidate proceedings under subchapter ,,ii 7of chapter #e7 with proceedings on the new rule4 #ibi4 ,review of rules currently in effect 7a7 ,annual review ,beginning on the date that is #f months after the date of enactment of this section and annually thereafter for the #i years following1 the ,food and ,drug ,administration shall designate not less than #aj percent of eligible rules made by the ,food and ,drug ,administration for review1 and shall submit a report including each such eligible rule in the same manner as a report under section #iba7;a77#a74 ,section #iba1 section #ibb1 and section #ibc shall apply to each such rule1 subject to subsection 7c7 of this section4 ,no eligible rule previously designated may be designated again4 7b7 ,sunset for eligible rules not extended ,beginning after the date that is #aj years after the date of enactment of this section1 if ,congress has not enacted a joint resolution of approval for that eligible rule1 that eligible rule shall not continue in effect4 7c7 ,consolidation2 severability ,in applying sections #iba1 #ibb1 and #ibc to eligible rules under this section1 the following shall apply3 7#a7 ,the words take effect shall be read as continue in effect4 7#b7 ,except as provided in paragraph 7#c71 a single joint resolution of approval shall apply to all eligible rules in a report designated for a year1 and the matter after the resolving clause of that joint resolution is as follows3 ,that ,congress approves the rules submitted by the for the year 4 7,the blank spaces being appropriately filled in74 7#c7 ,it shall be in order to consider any amendment that provides for specific conditions on which the approval of a particular eligible rule included in the joint resolution is contingent4 7#d7 ,a member of either ,house may move that a separate joint resolution be required for a specified rule4 7d7 ,definition ,in this section1 the term eligible rule means a rule that is in effect as of the date of enactment of this section4 4 7b7 ,budgetary effects of rules subject to section #ibb of title #e1 ,united ,states ,code ,section #beg7;b77#b7 of the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe is amended by adding at the end the following new subparagraph3 7,e7 ,budgetary effects of rules subject to section #ibb of title #e1 ,united ,states ,code ,any rules subject to the congressional approval procedure set forth in section #ibb of chapter #h of title #e1 ,united ,states ,code1 affecting budget authority1 outlays1 or receipts shall be assumed to be effective unless it is not approved in accordance with such section4 4 7c7 ,government ,accountability ,office study of rules 7#a7 ,in general ,the ,comptroller ,general of the ,united ,states shall conduct a study to determine1 as of the date of the enactment of this ,act-- 7,a7 how many rules 7as such term is defined in section #ibd of title #e1 ,united ,states ,code7 of the ,food and ,drug ,administration were in effect2 7,b7 how many major rules 7as such term is defined in section #ibd of title #e1 ,united ,states ,code7 of the ,food and ,drug ,administration were in effect2 and 7,c7 the total estimated economic cost imposed by all such rules4 7#b7 ,report ,not later than #a year after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit a report to ,congress that contains the findings of the study conducted under paragraph 7#a74 7d7 ,effective date ,subsections 7a7 and 7b71 and the amendments made by such sections1 shall take effect beginning on the date that is #a year after the date of enactment of this ,act4 #cei4 ,government ,accountability ,office study of rules 7a7 ,in general ,the ,comptroller ,general of the ,united ,states shall conduct a study to determine1 as of the date of the enactment of this ,act-- 7#a7 how many rules 7as such term is defined in section #hjd of title #e1 ,united ,states ,code7 were in effect2 7#b7 how many major rules 7as such term is defined in section #hjd of title #e1 ,united ,states ,code7 were in effect2 and 7#c7 the total estimated economic cost imposed by all such rules4 7b7 ,report ,not later than #a year after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit a report to ,congress that contains the findings of the study conducted under subsection 7a74 ,d ,prescription ,drug and ,pharmacy ,benefit ,manager ,transparency #cfa4 ,patent disclosure requirements 7a7 ,in general ,section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 is amended by adding at the end the following3 7o7 ,additional requirements with respect to patents 7#a7 ,approved application holder listing requirements 7,a7 ,in general ,beginning on the date of enactment of this subsection1 within #cj days of approval of an application under subsection 7a7 or 7k71 the holder of such approved application shall submit to the ,secretary a list of each patent required to be disclosed 7as described in paragraph 7#c774 7,b7 ,previously approved or licensed biological products 7i7 ,products approved under section #cea of the ,,phsa ,not later than #cj days after the date of enactment of the ,fair ,care ,act of #bjbj1 the holder of a biological product license that was approved under subsection 7a7 or 7k7 before the date of enactment of such ,act shall submit to the ,secretary a list of each patent required to be disclosed 7as described in paragraph 7#c774 7ii7 ,products approved under section #eje of the ,,ffdca ,not later than #cj days after ,march #bc1 #bjba1 the holder of an approved application for a biological product under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act that is deemed to be a license for the biological product under this section on ,march #bc1 #bjba1 shall submit a list of each patent required to be disclosed 7as described in paragraph 7#c774 7,c7 ,updates ,the holder of a biological product license approved under subsection 7a7 or 7k7 shall submit to the ,secretary a list that includes-- 7i7 any patent first required to be disclosed 7as described in paragraph 7#c77 after the submission under subparagraph 7,a7 or 7,b71 as applicable1 within #cj days of the earlier of-- 7,i7 the date of issuance of such patent by the ,united ,states ,patent and ,trademark ,office2 or 7,,ii7 the date of approval of a supplemental application for the biological product2 and 7ii7 any patent1 or any claim with respect to a patent1 included on the list pursuant to this paragraph with respect to the biological product subsequently determined to be invalid or unenforceable1 within #cj days of a determination of patent invalidity4 7#b7 ,publication of information 7,a7 ,in general ,within #a year of the date of enactment of the ,fair ,care ,act of #bjbj1 the ,secretary shall publish and make available to the public a single1 easily searchable1 list that includes-- 7i7 the official and proprietary name of each biological product licensed under subsection 7a7 or 7k71 and of each biological product application approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act and deemed to be a license for the biological product under this section on ,march #bc1 #bjba2 7ii7 with respect to each biological product described in clause 7i71 each patent submitted in accordance with paragraph 7#a72 7iii7 the date of licensure and application number for each such biological product2 7iv7 the marketing status1 dosage form1 route of administration1 strength1 and1 if applicable1 reference product1 for each such biological product2 7v7 the licensure status for each such biological product1 including whether the license at the time of listing is approved1 withdrawn1 or revoked2 7vi7 any period of any exclusivity under subsection 7k77#g77;,a7 or subsection 7k77#g77;,b7 of this section or section #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 and any extension of such period in accordance with subsection 7m7 of this section with respect to each such biological product1 and the date on which such exclusivity expires2 7vii7 information regarding any determination related to biosimilarity or interchangeability for each such biological product2 and 7viii7 information regarding approved indications for each such biological product1 in such manner as the ,secretary determines appropriate4 7,b7 ,updates ,every #cj days after the publication of the first list under subparagraph 7,a71 the ,secretary shall revise the list to include-- 7i7 7,i7 each biological product licensed under subsection 7a7 or 7k7 during the #cj-;day period2 and 7,,ii7 with respect to each biological product described in subclause 7,i71 the information described in clauses 7i7 through 7viii7 of subparagraph 7,a72 and 7ii7 any updates to information previously published in accordance with subparagraph 7,a74 7#c7 ,patents required to be disclosed ,in this section1 a patent required to be disclosed is any patent for which the holder of a biological product license approved under subsection 7a7 or 7k71 or a biological product application approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act and deemed to be a license for a biological product under this section on ,march #bc1 #bjba1 believes a claim of patent infringement could reasonably be asserted by the holder1 or by a patent owner that has granted an exclusive license to the holder with respect to the biological product that is the subject of such license1 if a person not licensed by the holder engaged in the making1 using1 offering to sell1 selling1 or importing into the ,united ,states of the biological product that is the subject of such license4 4 7b7 ,disclosure of patents ,section #cea7l77#c77;,a77i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7l77#c77;,a77i77 is amended by inserting included in the list provided by the reference product sponsor under subsection 7o77#a7 after a list of patents4 7c7 ,restriction on claims of patent infringement ,section #bga7;e7 of title #ce1 ,united ,states ,code1 is amended by adding at the end the following3 7#g7 ,the owner of a patent that should have been included in the list described in section #cea7o77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7o77#a771 including any updates required under subparagraph 7,c7 of that section1 but was not timely included in such list1 may not bring an action under this section for infringement of the patent4 4 7d7 ,regulations ,the ,secretary of ,health and ,human ,services may promulgate regulations to carry out subsection 7o7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 as added by subsection 7a74 7e7 ,rule of construction ,nothing in this ,act1 including an amendment made by this ,act1 shall be construed to require or allow the ,secretary of ,health and ,human ,services to delay the licensing of a biological product under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 #cfb4 ,biological product patent transparency 7a7 ,in general ,section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 is amended by adding at the end the following3 7o7 ,additional requirements with respect to patents 7#a7 ,approved application holder listing requirements 7,a7 ,in general ,beginning on the date of enactment of the ,fair ,care ,act of #bjbj1 within #fj days of approval of an application under subsection 7a7 or 7k71 the holder of such approved application shall submit to the ,secretary a list of each patent required to be disclosed 7as described in paragraph 7#c774 7,b7 ,previously approved or licensed biological products 7i7 ,products licensed under section #cea of the ,,phsa ,not later than #cj days after the date of enactment of the ,fair ,care ,act of #bjbj1 the holder of a biological product license that was approved under subsection 7a7 or 7k7 before the date of enactment of such ,act shall submit to the ,secretary a list of each patent required to be disclosed 7as described in paragraph 7#c774 7ii7 ,products approved under section #eje of the ,,ffdca ,not later than #cj days after ,march #bc1 #bjbj1 the holder of an approved application for a biological product under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act that is deemed to be a license for the biological product under this section on ,march #bc1 #bjbj1 shall submit to the ,secretary a list of each patent required to be disclosed 7as described in paragraph 7#c774 7,c7 ,updates ,the holder of a biological product license that is the subject of an application under subsection 7a7 or 7k7 shall submit to the ,secretary a list that includes-- 7i7 any patent not previously required to be disclosed 7as described in paragraph 7#c77 under subparagraph 7,a7 or 7,b71 as applicable1 within #cj days of the earlier of-- 7,i7 the date of issuance of such patent by the ,united ,states ,patent and ,trademark ,office2 or 7,,ii7 the date of approval of a supplemental application for the biological product2 and 7ii7 any patent1 or any claim with respect to a patent1 included on the list pursuant to this paragraph1 that the ,patent ,trial and ,appeal ,board of the ,united ,states ,patent and ,trademark ,office determines in a written decision to cancel as unpatentable1 within #cj days of such decision4 7#b7 ,publication of information 7,a7 ,in general ,within #a year of the date of enactment of the ,fair ,care ,act of #bjbj1 the ,secretary shall publish and make available to the public a single1 easily searchable list that includes-- 7i7 the official and proprietary name of each biological product licensed1 or deemed to be licensed1 under subsection 7a7 or 7k72 7ii7 with respect to each biological product described in clause 7i71 each patent submitted in accordance with paragraph 7#a72 7iii7 the date of licensure and application number for each such biological product2 7iv7 the marketing status1 dosage form1 route of administration1 strength1 and1 if applicable1 reference product1 for each such biological product2 7v7 the licensure status for each such biological product1 including whether the license at the time of listing is approved1 withdrawn1 or revoked2 7vi7 with respect to each such biological product1 any period of exclusivity under paragraph 7#f71 7#g77;,a71 or 7#g77;,b7 of subsection 7k7 of this section or section #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 and any extension of such period in accordance with subsection 7m7 of this section1 for which the ,secretary has determined such biological product to be eligible1 and the date on which such exclusivity expires2 7vii7 any determination of biosimilarity or interchangeability for each such biological product2 and 7viii7 information regarding approved indications for each such biological product1 in such manner as the ,secretary determines appropriate4 7,b7 ,updates ,every #cj days after the publication of the first list under subparagraph 7,a71 the ,secretary shall revise the list to include-- 7i7 7,i7 each biological product licensed under subsection 7a7 or 7k7 during the #cj-;day period2 and 7,,ii7 with respect to each biological product described in subclause 7,i71 the information described in clauses 7i7 through 7viii7 of subparagraph 7,a72 and 7ii7 any updates to information previously published in accordance with subparagraph 7,a74 7,c7 ,noncompliance ,beginning #ah months after the date of enactment of the ,fair ,care ,act of #bjbj1 the ,secretary1 in consultation with the ,director of the ,united ,states ,patent and ,trademark ,office1 shall publish and make available to the public a list of any holders of biological product licenses1 and the corresponding biological product or products1 that failed to submit information as required under paragraph 7#a71 including any updates required under paragraph 7#a77;,c71 in such manner and format as the ,secretary determines appropriate4 ,if information required under paragraph 7#a7 is submitted following publication of such list1 the ,secretary shall remove such holders of such biological product licenses from the public list in a reasonable period of time4 7#c7 ,patents required to be disclosed ,in this section1 a patent required to be disclosed is any patent for which the holder of a biological product license approved under subsection 7a7 or 7k71 or a biological product application approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act and deemed to be a license for a biological product under this section on ,march #bc1 #bjbj1 believes a claim of patent infringement could reasonably be asserted by the holder1 or by a patent owner that has granted an exclusive license to the holder with respect to the biological product that is the subject of such license1 if a person not licensed by the owner engaged in the making1 using1 offering to sell1 selling1 or importing into the ,united ,states of the biological product that is the subject of such license4 4 7b7 ,disclosure of patents ,section #cea7l77#c77;,a77i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7l77#c77;,a77i77 is amended by inserting included in the list provided by the reference product sponsor under subsection 7o77#a7 after a list of patents4 7c7 ,review and ,report on ,noncompliance ,not later than #cj months after the date of enactment of this ,act1 the ,secretary shall-- 7#a7 solicit public comments regarding appropriate remedies1 in addition to the publication of the list under subsection 7o77#b77;,c7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 as added by subsection 7a71 with respect to holders of biological product licenses who fail to timely submit information as required under subsection 7o77#a7 of such section #cea1 including any updates required under subparagraph 7,c7 of such subsection 7o77#a72 and 7#b7 submit to ,congress an evaluation of comments received under paragraph 7#a7 and the recommendations of the ,secretary concerning appropriate remedies4 7d7 ,regulations ,the ,secretary of ,health and ,human ,services may promulgate regulations to carry out subsection 7o7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 as added by subsection 7a74 7e7 ,rule of construction ,nothing in this ,act1 including an amendment made by this ,act1 shall be construed to require or allow the ,secretary of ,health and ,human ,services to delay the licensing of a biological product under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 #cfc4 ,orange ,book modernization 7a7 ,submission of patent information for brand name drugs 7#a7 ,in general ,paragraph 7#a7 of section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 is amended to read as follows3 7b7 7#a7 7,a7 ,any person may file with the ,secretary an application with respect to any drug subject to the provisions of subsection 7a74 ,such persons shall submit to the ,secretary as part of the application-- 7i7 full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use2 7ii7 a full list of the articles used as components of such drug2 7iii7 a full statement of the composition of such drug2 7iv7 a full description of the methods used in1 and the facilities and controls used for1 the manufacture1 processing1 and packing of such drug2 7v7 such samples of such drug and of the articles used as components thereof as the ,secretary may require2 7vi7 specimens of the labeling proposed to be used for such drug2 7vii7 any assessments required under section #eje;,b2 and 7viii7 the patent number and expiration date1 of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture1 use1 or sale of the drug1 and that-- 7,i7 claims the drug for which the applicant submitted the application and is a drug substance patent or a drug product patent2 or 7,,ii7 claims the method of using the drug for which approval is sought or has been granted in the application4 7,b7 ,if an application is filed under this subsection for a drug1 and a patent of the type described in subparagraph 7,a77viii7 that claims such drug or a method of using such drug is issued after the filing date1 the applicant shall amend the application to include such patent information4 4 7#b7 ,guidance ,the ,secretary of ,health and ,human ,services shall1 in consultation with the ,director of the ,national ,institutes of ,health and with representatives of the drug manufacturing industry1 review and develop guidance1 as appropriate1 on the inclusion of women and minorities in clinical trials required under subsection 7b77#a77;,a77i7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 as amended by paragraph 7#a74 7b7 ,conforming changes to requirements for subsequent submission of patent information ,section #eje7;c77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77#b77 is amended-- 7#a7 by inserting before the first sentence the following3 ,not later than #cj days after the date of approval of an application under subsection 7b71 the holder of the approved application shall file with the ,secretary the patent number and the expiration date of any patent described in subclause 7,i7 or 7,,ii7 of subsection 7b77#a77;,a77viii71 except that a patent that is identified as claiming a method of using such drug shall be filed only if the patent claims a method of use approved in the application4 ,the holder of the approved application shall file with the ,secretary the patent number and the expiration date of any patent described in subclause 7,i7 or 7,,ii7 of subsection 7b77#a77;,a77viii7 that is issued after the date of approval of the application1 not later than #cj days after the date of issuance of the patent1 except that a patent that claims a method of using such drug shall be filed only if approval for such use has been granted in the application42 7#b7 by inserting after the patent number and the expiration date of any patent which the following3 fulfills the criteria in subsection 7b7 and2 7#c7 by inserting after the third sentence 7as amended by paragraph 7#a77 the following3 ,patent information that is not the type of patent information required by subsection 7b77#a77;,a77viii7 shall not be submitted under this paragraph42 and 7#d7 by inserting after could not file patent information under subsection 7b7 because no patent the following3 of the type required to be submitted in subsection 7b77#a77;,a77viii74 7c7 ,listing of exclusivities ,subparagraph 7,a7 of section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is amended by adding at the end the following3 7iv7 ,for each drug included on the list1 the ,secretary shall specify any exclusivity period that is applicable1 for which the ,secretary has determined the expiration date1 and for which such period has not yet expired under-- 7,i7 clause 7ii71 7iii71 or 7iv7 of subsection 7c77#c77;,e7 of this section2 7,,ii7 clause 7iv7 or 7v7 of paragraph 7#e77;,b7 of this subsection2 7,,iii7 clause 7ii71 7iii71 or 7iv7 of paragraph 7#e77;,f7 of this subsection2 7,,iv7 section #eje;,a2 7,v7 section #eje;,e2 7,,vi7 section #ebg7;a72 or 7,,vii7 subsection 7u7 4 7d7 ,orange book updates with respect to invalidated patents 7#a7 ,in general 7,a7 ,amendments ,section #eje7;j77#g77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77;,a771 as amended by subsection 7c71 is further amended by adding at the end the following3 7v7 ,in the case of a listed drug for which the list under clause 7i7 includes a patent for such drug1 and where the ,under ,secretary of ,commerce for ,intellectual ,property and ,director of the ,united ,states ,patent and ,trademark ,office have cancelled any claim of the patent pursuant to a decision by the ,patent ,trial and ,appeal ,board in an inter partes review conducted under chapter #ca of title #ce1 ,united ,states ,code1 or a post-grant review conducted under chapter #cb of that title1 and from which no appeal has been taken1 or can be taken1 the holder of the applicable approved application shall notify the ,secretary1 in writing1 within #ad days of such cancellation1 and1 if the patent has been deemed wholly inoperative or invalid1 or if a patent claim has been cancelled1 the revisions required under clause 7iii7 shall include striking the patent or information regarding such patent claim from the list with respect to such drug1 as applicable1 except that the ,secretary shall not remove a patent from the list before the expiration of any #ahj-;day exclusivity period under paragraph 7#e77;,b77iv7 that relies on a certification described in paragraph 7#b77;,a77vii77,,iv7 with respect to such patent4 4 7,b7 ,application ,the amendment made by subparagraph 7,a7 shall not apply with respect to any determination with respect to a patent or patent claim that is made prior to the date of enactment of this ,act4 7#b7 ,no effect on first applicant exclusivity period ,section #eje7;j77#e77;,b77iv77,i71 as amended by the preceding sections1 is amended by adding at the end the following3 ,this subclause shall apply even if a patent is stricken from the list under paragraph 7#g77;,a71 pursuant to paragraph 7#g77;,a77v71 provided that1 at the time that the first applicant submitted an application under this subsection containing a certification described in paragraph 7#b77;,a77vii77,,iv71 the patent that was the subject of such certification was included in such list with respect to the listed drug44 #cfd4 ,modernizing the labeling of certain generic drugs ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #ejc;,c the following3 #ejc;,d4 ,process to update labeling for certain drugs 7a7 ,definitions ,for purposes of this section3 7#a7 ,the term covered drug means a drug approved under section #eje7;c7-- 7,a7 for which there are no unexpired patents included in the list under section #eje7;j77#g7 and no unexpired period of exclusivity2 7,b7 for which the approval of the application has been withdrawn for reasons other than safety or effectiveness2 and 7,c7 for which1 with respect to the labeling-- 7i7 new scientific evidence is available regarding the conditions of use of the drug2 7ii7 there is a relevant accepted use in clinical practice that is not reflected in the approved labeling2 or 7iii7 the labeling of such drug does not reflect current legal and regulatory requirements4 7#b7 ,the term period of exclusivity1 with respect to a drug approved under section #eje7;c71 means any period of exclusivity under clause 7ii71 7iii71 or 7iv7 of section #eje7;c77#c77;,e71 clause 7ii71 7iii71 or 7iv7 of section #eje7;j77#e77;,f71 or section #eje;,a1 #eje;,e1 or #ebg4 7#c7 ,the term generic version means a drug approved under section #eje7;j7 whose reference drug is a covered drug4 7#d7 ,the term relevant accepted use means a use for a drug in clinical practice that is supported by scientific evidence that appears to the ,secretary to meet the standards for approval under section #eje4 7#e7 ,the term selected drug means a covered drug for which the ,secretary has determined through the process under subsection 7c7 that the labeling should be changed4 7b7 ,identification of covered drugs ,the ,secretary may identify covered drugs for which labeling updates would provide a public health benefit4 ,to assist in identifying covered drugs1 the ,secretary may do one or both of the following3 7#a7 ,enter into cooperative agreements or contracts with public or private entities to review the available scientific evidence concerning such drugs4 7#b7 ,seek public input concerning such drugs1 including input on whether there is a relevant accepted use in clinical practice that is not reflected in the approved labeling of such drugs or whether new scientific evidence is available regarding the conditions of use for such drug1 by-- 7,a7 holding one or more public meetings2 7,b7 opening a public docket for the submission of public comments2 or 7,c7 other means1 as the ,secretary determines appropriate4 7c7 ,selection of drugs for updating ,if the ,secretary determines1 with respect to a covered drug1 that the available scientific evidence meets the standards under section #eje for adding or modifying information to the labeling or providing supplemental information to the labeling regarding the use of the covered drug1 the ,secretary may initiate the process under subsection 7d74 7d7 ,initiation of the process of updating ,if the ,secretary determines that labeling changes are appropriate for a selected drug pursuant to subsection 7c71 the ,secretary shall provide notice to the holders of approved applications for a generic version of such drug that-- 7#a7 summarizes the findings supporting the determination of the ,secretary that the available scientific evidence meets the standards under section #eje for adding or modifying information or providing supplemental information to the labeling of the covered drug pursuant to subsection 7c72 7#b7 provides a clear statement regarding the additional1 modified1 or supplemental information for such labeling1 according to the determination by the ,secretary 7including1 as applicable1 modifications to add the relevant accepted use to the labeling of the drug as an additional indication for the drug72 and 7#c7 states whether the statement under paragraph 7#b7 applies to the selected drug as a class of covered drugs or only to a specific drug product4 7e7 ,response to notification ,within #cj days of receipt of notification provided by the ,secretary pursuant to subsection 7d71 the holder of an approved application for a generic version of the selected drug shall-- 7#a7 agree to change the approved labeling to reflect the additional1 modified1 or supplemental information the ,secretary has determined to be appropriate2 or 7#b7 notify the ,secretary that the holder of the approved application does not believe that the requested labeling changes are warranted and submit a statement detailing the reasons why such changes are not warranted4 7f7 ,review of application holder's response 7#a7 ,in general ,upon receipt of the application holder's response1 the ,secretary shall promptly review each statement received under subsection 7e77#b7 and determine which labeling changes pursuant to the ,secretary's notice under subsection 7d7 are appropriate1 if any4 ,if the ,secretary disagrees with the reasons why such labeling changes are not warranted1 the ,secretary shall provide opportunity for discussions with the application holders to reach agreement on whether the labeling for the covered drug should be updated to reflect current scientific evidence1 and if so1 the content of such labeling changes4 7#b7 ,changes to labeling ,after considering all responses from the holder of an approved application under paragraph 7#a7 or 7#b7 of subsection 7e71 and any discussion under paragraph 7#a71 the ,secretary may order such holder to make the labeling changes the ,secretary determines are appropriate4 ,such holder of an approved application shall-- 7,a7 update its paper labeling for the drug at the next printing of that labeling2 7,b7 update any electronic labeling for the drug within #cj days2 and 7,c7 submit the revised labeling through the form1 ,supplement--,changes ,being ,effected4 7g7 ,violation ,if the holder of an approved application for the generic version of the selected drug does not comply with the requirements of subsection 7f77#b71 such generic version of the selected drug shall be deemed to be misbranded under section #ejb4 7h7 ,limitations2 generic drugs 7#a7 ,in general ,with respect to any labeling change required under this section1 the generic version shall be deemed to have the same conditions of use and the same labeling as a reference drug for purposes of clauses 7i7 and 7v7 of section #eje7;j77#b77;,a74 ,any labeling change so required shall not have any legal effect for the applicant that is different than the legal effect that would have resulted if a supplemental application had been submitted and approved to conform the labeling of the generic version to a change in the labeling of the reference drug4 7#b7 ,supplemental applications ,changes to labeling made in accordance with this paragraph shall not be eligible for an exclusivity period under this ,act4 7i7 ,drug product classes ,in the case of a selected drug for which the labeling changes ordered by the ,secretary under subsection 7d77#b7 are required for a class of covered drugs1 such labeling changes shall be made for generic versions of such drug in that class4 7j7 ,rules of construction 7#a7 ,approval standards ,this section shall not be construed as altering the applicability of the standards for approval of an application under section #eje4 ,no order shall be issued under this subsection unless the evidence supporting the changed labeling meets the standards for approval applicable to any change to labeling under section #eje4 7#b7 ,removal of information ,nothing in this section shall be construed to give the ,secretary additional authority to remove approved indications for drugs1 other than the authority described in this section4 7k7 ,reports ,not later than #d years after the date of the enactment of the ,fair ,care ,act of #bjbj and every #d years thereafter1 the ,secretary shall prepare and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a report that-- 7#a7 describes the actions of the ,secretary under this section1 including-- 7,a7 the number of covered drugs and description of the types of drugs the ,secretary has selected for labeling changes and the rationale for such recommended changes2 and 7,b7 the number of times the ,secretary entered into discussions concerning a disagreement with an application holder or holders and a summary of the decision regarding a labeling change1 if any2 and 7#b7 includes any recommendations of the ,secretary for modifying the program under this section4 4 #cfe4 ,requirements with respect to prescription drug benefits 7a7 ,in general ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq47 is amended by adding at the end the following3 #bgbi;,a4 ,requirements with respect to prescription drug benefits ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall not1 and shall ensure that any entity that provides pharmacy benefits management services under a contract with any such health plan or health insurance coverage does not1 receive from a drug manufacturer a reduction in price or other remuneration with respect to any prescription drug received by an enrollee in the plan or coverage and covered by the plan or coverage1 unless-- 7#a7 any such reduction in price is reflected at the point of sale to the enrollee2 and 7#b7 any such other remuneration is a flat fee-based service fee that a manufacturer of prescription drugs pays to a pharmacy benefit manager for services rendered to the manufacturer that relate to arrangements by the pharmacy benefit manager to provide pharmacy benefit management services to a health plan or health insurance issuer1 if certain conditions established by the ,secretary are met1 including requirements that the fees are transparent to the health plan or health insurance issuer4 4 7b7 ,effective date ,section #bgbi;,a of the ,public ,health ,service ,act1 as added by subsection 7a71 shall take effect on ,january #a1 #bjba4 #cff4 ,,pbm transparency and elimination of ,,dir fees 7a7 ,prohibiting medicare ,,pdp sponsors and ,,ma-,,pd organizations from retroactively reducing payment on clean claims submitted by pharmacies 7#a7 ,in general ,section #ahfj;,d-#ab7;b77#d77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77#d77;,a77 is amended by adding at the end the following new clause3 7iv7 ,prohibiting retroactive reductions in payments on clean claims ,each contract entered into with a ,,pdp sponsor under this part with respect to a prescription drug plan offered by such sponsor shall provide that after the date of receipt of a clean claim submitted by a pharmacy1 the ,,pdp sponsor 7or an agent of the ,,pdp sponsor7 may not retroactively reduce payment on such claim directly or indirectly through aggregated effective rate or otherwise except in the case such claim is found to not be a clean claim 7such as in the case of a claim lacking required substantiating documentation7 during the course of a routine audit as permitted pursuant to written agreement between the ,,pdp sponsor 7or such an agent7 and such pharmacy4 ,the previous sentence shall not prohibit any retroactive increase in payment to a pharmacy pursuant to a written agreement between a ,,pdp sponsor 7or an agent of such sponsor7 and such pharmacy4 4 7#b7 ,effective date ,the amendment made by subsection 7a7 shall apply with respect to contracts entered into on or after ,january #a1 #bjba4 7b7 ,elimination of ,,dir fees 7#a7 ,pharmacy benefits manager standards under the ,medicare program for prescription drug plans and ,,ma-,,pd plans 7,a7 ,in general ,section #ahfj;,d-#ab7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77 is amended by adding at the end the following new paragraph3 7#g7 ,pharmacy benefits manager transparency requirements ,each contract entered into with a ,,pdp sponsor under this part with respect to a prescription drug plan offered by such sponsor or with an ,,ma organization offering an ,,ma-,,pd plan under part ,c shall provide that the sponsor or organization1 respectively1 may not enter into a contract with any pharmacy benefits manager 7referred to in this paragraph as a ,,pbm7 to manage the prescription drug coverage provided under such plan1 or to control the costs of the prescription drug coverage under such plan1 unless the ,,pbm adheres to the following criteria when handling personally identifiable utilization and claims data or other sensitive patient data3 7,a7 ,the ,,pbm may not transmit any personally identifiable utilization1 protected health information1 or claims data1 with respect to a plan enrollee1 to a pharmacy owned by a ,,pbm if the plan enrollee has not voluntarily elected in writing or via secure electronic means to fill that particular prescription at the ,,pbm-owned pharmacy4 7,b7 ,the ,,pbm may not require that a plan enrollee use a retail pharmacy1 mail order pharmacy1 specialty pharmacy1 or other pharmacy entity providing pharmacy services in which the ,,pbm has an ownership interest or that has an ownership interest in the ,,pbm1 or provide an incentive to a plan enrollee to encourage the enrollee to use a retail pharmacy1 mail order pharmacy1 specialty pharmacy1 or other pharmacy entity providing pharmacy services in which the ,,pbm has an ownership interest or that has an ownership interest in the ,,pbm1 if the incentive is applicable only to such pharmacies4 4 7,b7 ,regular update of prescription drug pricing standard ,paragraph 7#f7 of section #ahfj;,d-#ab7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77 is amended to read as follows3 7#f7 ,regular update of prescription drug pricing standard 7,a7 ,in general ,if the ,,pdp sponsor of a prescription drug plan 7or ,,ma organization offering an ,,ma-,,pd plan7 uses a standard for reimbursement 7as described in subparagraph 7,b77 of pharmacies based on the cost of a drug1 each contract entered into with such sponsor under this part 7or organization under part ,c7 with respect to the plan shall provide that the sponsor 7or organization7 shall-- 7i7 update such standard not less frequently than once every #g days1 beginning with an initial update on ,january #a of each year1 to accurately reflect the market price of acquiring the drug2 7ii7 disclose to applicable pharmacies and the contracting entities of such pharmacies the sources used for making any such update immediately without requirement of request2 7iii7 if the source for such a standard for reimbursement is not publicly available1 disclose to the applicable pharmacies and the respective contracting entities of such pharmacies all individual drug prices to be so updated in advance of the use of such prices for the reimbursement of claims2 7iv7 establish a process to appeal1 investigate1 and resolve disputes regarding individual drug prices that are less than the pharmacy acquisition price for such drug1 which must be adjudicated within #g days of the pharmacy filing its appeal2 and 7v7 provide all such pricing data in an 4xml spreadsheet format or a comparable easily accessible and complete spreadsheet format4 7,b7 ,prescription drug pricing standard defined ,for purposes of subparagraph 7,a71 a standard for reimbursement of a pharmacy is any methodology or formula for varying the pricing of a drug or drugs during the term of the pharmacy reimbursement contract that is based on the cost of the drug involved1 including drug pricing references and amounts that are based upon average wholesale price1 wholesale average cost1 average manufacturer price1 average sales price1 maximum allowable cost 7,,mac71 or other costs1 whether publicly available or not4 4 7,c7 ,effective date ,the amendments made by this section shall apply to plan years beginning on or after ,january #a1 #bjba4 7#b7 ,regular update of prescription drug pricing standard under ,,tricare retail pharmacy program ,section #ajgd;g7d7 of title #aj1 ,united ,states ,code1 is amended by adding at the end the following new paragraph3 7#c7 ,to the extent practicable1 with respect to the ,,tricare retail pharmacy program described in subsection 7a77#b77;,e77ii71 the ,secretary shall ensure that a contract entered into with a ,,tricare managed care support contractor includes requirements described in section #ahfj;,d-#ab7;b77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77#f77 to ensure the provision of information regarding the pricing standard for prescription drugs4 4 7#c7 ,prescription drug transparency in the ,federal ,employees ,health ,benefits program 7,a7 ,in general ,section #hijb of title #e1 ,united ,states ,code1 is amended by adding at the end the following new subsections3 7p7 ,a contract may not be made or a plan approved under this chapter under which a carrier has an agreement with a pharmacy benefits manager 7in this subsection referred to as a ,,pbm7 to manage prescription drug coverage or to control the costs of the prescription drug coverage unless the carrier and ,,pbm adhere to the following criteria3 7#a7 ,the ,,pbm may not transmit any personally identifiable utilization1 protected health information1 or claims data with respect to an individual enrolled under such contract or plan to a pharmacy owned by the ,,pbm if the individual has not voluntarily elected in writing or via secure electronic means to fill that particular prescription at such a pharmacy4 7#b7 ,the ,,pbm may not require that an individual enrolled under such contract or plan use a retail pharmacy1 mail order pharmacy1 specialty pharmacy1 or other pharmacy entity providing pharmacy services in which the ,,pbm has an ownership interest or that has an ownership interest in the ,,pbm or provide an incentive to a plan enrollee to encourage the enrollee to use a retail pharmacy1 mail order pharmacy1 specialty pharmacy1 or other pharmacy entity providing pharmacy services in which the ,,pbm has an ownership interest or that has an ownership interest in the ,,pbm1 if the incentive is applicable only to such pharmacies4 7q7 7#a7 ,if a contract made or plan approved under this chapter provides for a standard for reimbursement 7as described in paragraph 7#b77 with respect to a prescription drug plan1 such contract or plan shall provide that the applicable carrier-- 7,a7 update such standard not less frequently than once every #g days1 beginning with an initial update on ,january #a of each year1 to accurately reflect the market price of acquiring the drug2 7,b7 disclose to applicable pharmacies and the contracting entities of such pharmacies the sources used for making any such update immediately without requirement of request2 7,c7 if the source for such a standard for reimbursement is not publicly available1 disclose to the applicable pharmacies and contracting entities of such pharmacies all individual drug prices to be so updated in advance of the use of such prices for the reimbursement of claims2 7,d7 establish a process to appeal1 investigate1 and resolve disputes regarding individual drug prices that are less than the pharmacy acquisition price for such drug1 which must be adjudicated within #g days of the pharmacy filing its appeal2 and 7,e7 provide all such pricing data in an 4xml spreadsheet format or a comparable easily accessible and complete spreadsheet format4 7#b7 ,for purposes of paragraph 7#a71 a standard for reimbursement of a pharmacy is any methodology or formula for varying the pricing of a drug or drugs during the term of the pharmacy reimbursement contract that is based on the cost of the drug involved1 including drug pricing references and amounts that are based upon average wholesale price1 wholesale average cost1 average manufacturer price1 average sales price1 maximum allowable cost1 or other costs1 whether publicly available or not4 4 7,b7 ,application ,the amendment made by subparagraph 7,a7 shall apply to any contract entered into under section #hijb of title #e1 ,united ,states ,code1 on or after the date of enactment of this section4 #cfg4 ,health plan oversight of pharmacy benefit manager services ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq471 as amended by the preceding sections1 is further amended by adding at the end the following3 #bgbi;,e4 ,health plan oversight of pharmacy benefit manager services 7a7 ,in general ,a group health plan or health insurance issuer offering group health insurance coverage or an entity or subsidiary providing pharmacy benefits management services shall not enter into a contract with a drug manufacturer1 distributor1 wholesaler1 subcontractor1 rebate aggregator1 or any associated third party that limits the disclosure of information to plan sponsors in such a manner that prevents the plan or coverage1 or an entity or subsidiary providing pharmacy benefits management services on behalf of a plan or coverage from making the reports described in subsection 7b74 7b7 ,reports to group plan sponsors 7#a7 ,in general ,beginning with the first plan year that begins after the date of enactment of the ,fair ,care ,act of #bjbj1 not less frequently than once every #f months1 a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefits management services on behalf of a group health plan shall submit to the plan sponsor 7as defined in section #c7af77;,b7 of the ,employee ,retirement ,income ,security ,act of #aigd7 of such group health plan or health insurance coverage a report in accordance with this subsection and make such report available to the plan sponsor in a machine-readable format4 ,each such report shall include1 with respect to the applicable group health plan or health insurance coverage-- 7,a7 information collected from drug manufacturers by such issuer or entity on the total amount of copayment assistance dollars paid1 or copayment cards applied1 that were funded by the drug manufacturer with respect to the enrollees in such plan or coverage2 7,b7 a list of each covered drug dispensed during the reporting period1 including1 with respect to each such drug during the reporting period-- 7i7 the brand name1 chemical entity1 and ,national ,drug ,code2 7ii7 the number of enrollees for whom the drug was filled during the plan year1 the total number of prescription fills for the drug 7including original prescriptions and refills71 and the total number of dosage units of the drug dispensed across the plan year1 including whether the dispensing channel was by retail1 mail order1 or specialty pharmacy2 7iii7 the wholesale acquisition cost1 listed as cost per days supply and cost per pill1 or in the case of a drug in another form1 per dose2 7iv7 the total out-of-pocket spending by enrollees on such drug1 including enrollee spending through copayments1 coinsurance1 and deductibles2 and 7v7 for any drug for which gross spending of the group health plan or health insurance coverage exceeded #aj1jjj during the reporting period-- 7,i7 a list of all other available drugs in the same therapeutic category or class1 including brand name drugs and biological products and generic drugs or biosimilar biological products that are in the same therapeutic category or class2 and 7,,ii7 the rationale for preferred formulary placement of a particular drug or drugs in that therapeutic category or class2 7,c7 a list of each therapeutic category or class of drugs that were dispensed under the health plan or health insurance coverage during the reporting period1 and1 with respect to each such therapeutic category or class of drugs1 during the reporting period-- 7i7 total gross spending by the plan1 before manufacturer rebates1 fees1 or other manufacturer remuneration2 7ii7 the number of enrollees who filled a prescription for a drug in that category or class2 7iii7 if applicable to that category or class1 a description of the formulary tiers and utilization mechanisms 7such as prior authorization or step therapy7 employed for drugs in that category or class2 7iv7 the total out-of-pocket spending by enrollees1 including enrollee spending through copayments1 coinsurance1 and deductibles2 and 7v7 for each therapeutic category or class under which #c or more drugs are included on the formulary of such plan or coverage-- 7,i7 the amount received1 or expected to be received1 from drug manufacturers in rebates1 fees1 alternative discounts1 or other remuneration-- 7aa7 to be paid by drug manufacturers for claims incurred during the reporting period2 or 7bb7 that is related to utilization of drugs1 in such therapeutic category or class2 7,,ii7 the total net spending1 after deducting rebates1 price concessions1 alternative discounts or other remuneration from drug manufacturers1 by the health plan or health insurance coverage on that category or class of drugs2 and 7,,iii7 the net price per course of treatment or #cj-;day supply incurred by the health plan or health insurance coverage and its enrollees1 after manufacturer rebates1 fees1 and other remuneration for drugs dispensed within such therapeutic category or class during the reporting period2 7,d7 total gross spending on prescription drugs by the plan or coverage during the reporting period1 before rebates and other manufacturer fees or remuneration2 7,e7 total amount received1 or expected to be received1 by the health plan or health insurance coverage in drug manufacturer rebates1 fees1 alternative discounts1 and all other remuneration received from the manufacturer or any third party1 other than the plan sponsor1 related to utilization of drug or drug spending under that health plan or health insurance coverage during the reporting period2 7,f7 the total net spending on prescription drugs by the health plan or health insurance coverage during the reporting period2 and 7,g7 amounts paid directly or indirectly in rebates1 fees1 or any other type of remuneration to brokers1 consultants1 advisors1 or any other individual or firm who referred the group health plan's or health insurance issuer's business to the pharmacy benefit manager4 7#b7 ,privacy requirements ,health insurance issuers offering group health insurance coverage and entities providing pharmacy benefits management services on behalf of a group health plan shall provide information under paragraph 7#a7 in a manner consistent with the privacy1 security1 and breach notification regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7or successor regulations71 and shall restrict the use and disclosure of such information according to such privacy regulations4 7#c7 ,disclosure and redisclosure 7,a7 ,limitation to business associates ,a group health plan receiving a report under paragraph 7#a7 may disclose such information only to business associates of such plan as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7,b7 ,clarification regarding public disclosure of information ,nothing in this section prevents a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefits management services on behalf of a group health plan from placing reasonable restrictions on the public disclosure of the information contained in a report described in paragraph 7#a71 except that such issuer or entity may not restrict disclosure of such report to governmental agencies pursuant to an investigation or enforcement action4 7,c7 ,limited form of report ,the ,secretary shall define through rulemaking a limited form of the report under paragraph 7#a7 required of plan sponsors who are drug manufacturers1 drug wholesalers1 or other direct participants in the drug supply chain1 in order to prevent anti-competitive behavior4 7c7 ,limitations on spread pricing 7#a7 ,prescription drug transactions with pharmacies independent of the issuer or pharmacy benefits manager ,if the pharmacy that dispenses a prescription drug to an enrollee in a group health plan or group or individual health insurance coverage is not wholly or partially owned by such plan1 such issuer1 or an entity providing pharmacy benefit management services under such plan or coverage1 such plan1 issuer1 or entity shall not charge the plan1 issuer1 or enrollee a price for such prescription drug that exceeds the price paid to the pharmacy4 7#b7 ,intra-company prescription drug transactions ,if the mail order1 specialty1 or retail pharmacy that dispenses a prescription drug to an enrollee in a group health plan or health insurance coverage is wholly or partially owned by1 and submits claims to1 such health insurance issuer or an entity providing pharmacy benefit management services under a group health plan or group or individual health insurance coverage1 the price charged for such drug by such pharmacy to such group health plan or health insurance issuer offering group or individual health insurance coverage may not exceed the lesser of-- 7,a7 the amount paid to the pharmacy for acquisition of the drug2 or 7,b7 the median price charged to the group health plan or health insurance issuer when the same drug is dispensed to enrollees in the plan or coverage by other similarly situated pharmacies not wholly or partially owned by the health insurance issuer or entity providing pharmacy benefits management services1 as described in paragraph 7#a74 7#c7 ,supplementary reporting for intra-company prescription drug transactions ,a health insurance issuer of group health insurance coverage or an entity providing pharmacy benefits management services under a group health plan or group health insurance coverage that conducts transactions with a wholly or partially owned pharmacy1 as described in paragraph 7#b71 shall submit1 together with the report under subsection 7b71 a supplementary report every #f months to the plan sponsor that includes-- 7,a7 an explanation of any benefit design parameters that encourage enrollees in the plan or coverage to fill prescriptions at mail order1 specialty1 or retail pharmacies that are wholly or partially owned by that issuer or entity2 7,b7 the percentage of total prescriptions charged to the plan1 coverage1 or enrollees in the plan or coverage1 that were dispensed by mail order1 specialty1 or retail pharmacies that are wholly or partially owned by the issuer or entity providing pharmacy benefits management services2 and 7,c7 a list of all drugs dispensed by such wholly or partially owned pharmacy and charged to the plan or coverage1 or enrollees of the plan or coverage1 during the applicable quarter1 and1 with respect to each drug-- 7i7 the amount charged per course of treatment or #cj-;day supply with respect to enrollees in the plan or coverage1 including amounts charged to the plan or coverage and amounts charged to the enrollee2 7ii7 the median amount charged to the plan or coverage1 per course of treatment or #cj-;day supply1 including amounts paid by the enrollee1 when the same drug is dispensed by other pharmacies that are not wholly or partially owned by the issuer or entity and that are included in the pharmacy network of that plan or coverage2 7iii7 the interquartile range of the costs1 per course of treatment or #cj-;day supply1 including amounts paid by the enrollee1 when the same drug is dispensed by other pharmacies that are not wholly or partially owned by the issuer or entity and that are included in the pharmacy network of that plan or coverage2 and 7iv7 the lowest cost per course of treatment or #cj-;day supply1 for such drug1 including amounts charged to the plan or issuer and enrollee1 that is available from any pharmacy included in the network of the plan or coverage4 7d7 ,full rebate pass-,through to plan 7#a7 ,in general ,a pharmacy benefits manager1 a third-party administrator of a group health plan1 a health insurance issuer offering group health insurance coverage1 or an entity providing pharmacy benefits management services under such health plan or health insurance coverage shall remit #ajj percent of rebates1 fees1 alternative discounts1 and all other remuneration received from a pharmaceutical manufacturer1 distributor or any other third party1 that are related to utilization of drugs under such health plan or health insurance coverage1 to the group health plan4 7#b7 ,form and manner of remittance ,such rebates1 fees1 alternative discounts1 and other remuneration shall be-- 7,a7 remitted to the group health plan in a timely fashion after the period for which such rebates1 fees1 or other remuneration is calculated1 and in no case later than #ij days after the end of such period2 7,b7 fully disclosed and enumerated to the group health plan sponsor1 as described in 7b77#a72 7,c7 available for audit by the plan sponsor1 or a third party designated by a plan sponsor no less than once per plan year2 and 7,d7 returned to the issuer or entity providing pharmaceutical benefit management services by the group health plan if audits by such issuer or entity indicate that the amounts received are incorrect after such amounts have been paid to the group health plan4 7#c7 ,audit of rebate contracts ,a pharmacy benefits manager1 a third-party administrator of a group health plan1 a health insurance issuer offering group health insurance coverage1 or an entity providing pharmacy benefits management services under such health plan or health insurance coverage shall make rebate contracts with drug manufacturers available for audit by such plan sponsor or designated third party1 subject to confidentiality agreements to prevent re-disclosure of such contracts4 7e7 ,enforcement 7#a7 ,in general ,the ,secretary1 in consultation with the ,secretary of ,labor and the ,secretary of the ,treasury1 shall enforce this section4 7#b7 ,failure to provide timely information ,a health insurance issuer or an entity providing pharmacy benefit management services that violates subsection 7a71 fails to provide information required under subsection 7b71 engages in spread pricing as defined in subsection 7c71 or fails to comply with the requirements of subsection 7d71 or a drug manufacturer that fails to provide information under subsection 7b77#a77;,a71 in a timely manner shall be subject to a civil monetary penalty in the amount of #aj1jjj for each day during which such violation continues or such information is not disclosed or reported4 7#c7 ,false information ,a health insurance issuer1 entity providing pharmacy benefit management services1 or drug manufacturer that knowingly provides false information under this section shall be subject to a civil money penalty in an amount not to exceed #ajj1jjj for each item of false information4 ,such civil money penalty shall be in addition to other penalties as may be prescribed by law4 7#d7 ,procedure ,the provisions of section #aabh;,a of the ,social ,security ,act1 other than subsection 7a7 and 7b7 and the first sentence of subsection 7c77#a7 of such section shall apply to civil monetary penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a of the ,social ,security ,act4 7#e7 ,safe harbor ,the ,secretary may waive penalties under paragraph 7#b71 or extend the period of time for compliance with a requirement of this section1 for an entity in violation of this section that has made a good-faith effort to comply with this section4 7f7 ,rule of construction ,nothing in this section shall be construed to prohibit payments to entities offering pharmacy benefits management services for bona fide services using a fee structure not contemplated by this section1 provided that such fees are transparent to group health plans and health insurance issuers4 7g7 ,definitions ,in this section-- 7#a7 the term similarly situated pharmacy means1 with respect to a particular pharmacy1 another pharmacy that is approximately the same size 7as measured by the number of prescription drugs dispensed71 and that serves patients in the same geographical area1 whether through physical locations or mail order2 and 7#b7 the term wholesale acquisition cost has the meaning given such term in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act4 4 #cfh4 ,study by ,comptroller ,general of ,united ,states 7a7 ,in general ,the ,comptroller ,general of the ,united ,states 7referred to in this section as the ,comptroller ,general7 shall1 in consultation with appropriate stakeholders1 conduct a study on the role of pharmacy benefit managers4 7b7 ,permissible examination ,in conducting the study required under subsection 7a71 the ,comptroller ,general may examine various qualitative and quantitative aspects of the role of pharmacy benefit managers1 such as the following3 7#a7 ,the role that pharmacy benefit managers play in the pharmaceutical supply chain4 7#b7 ,the state of competition among pharmacy benefit managers1 including the market share for the ,nation's largest pharmacy benefit managers4 7#c7 ,the use of rebates and fees by pharmacy benefit managers1 including-- 7,a7 the extent to which rebates are passed on to health plans and whether such rebates are passed on to individuals enrolled in such plans2 7,b7 the extent to which rebates are kept by such pharmacy benefit managers2 and 7,c7 the role of any fees charged by such pharmacy benefit managers4 7#d7 ,whether pharmacy benefit managers structure their formularies in favor of high-rebate prescription drugs over lower-cost1 lower-rebate alternatives4 7#e7 ,the average prior authorization approval time for pharmacy benefit managers4 7#f7 ,factors affecting the use of step therapy by pharmacy benefit managers4 7c7 ,report ,not later than #c years after the date of enactment of this ,act1 the ,comptroller ,general shall submit to the ,secretary of ,health and ,human ,services1 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report containing the results of the study conducted under subsection 7a71 including policy recommendations4 ,e ,medicare and ,medicaid ,prescription ,drug ,reforms #cga4 ,medicare part ,b rebate by manufacturers for drugs or biologicals with prices increasing faster than inflation 7a7 ,in general ,section #ahdg;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is amended by adding at the end the following new subsection3 7h7 ,rebate by manufacturers for drugs or biologicals with prices increasing faster than inflation 7#a7 ,requirements 7,a7 ,secretarial provision of information ,not later than #f months after the end of each rebate period 7as defined in paragraph 7#b77;,a77 beginning on or after ,january #a1 #bjba1 the ,secretary shall1 for each rebatable drug 7as defined in paragraph 7#b77;,b771 report to each manufacturer of such rebatable drug the following for such rebate period3 7i7 ,information on the total number of units of the billing and payment code described in subparagraph 7,a77i7 of paragraph 7#c7 with respect to such rebatable drug and rebate period4 7ii7 ,information on the amount 7if any7 of the excess average sales price increase described in subparagraph 7,a77ii7 of such paragraph for such rebatable drug and rebate period4 7iii7 ,the rebate amount specified under such paragraph for such rebatable drug and rebate period4 7,b7 ,manufacturer rebate 7i7 ,in general ,subject to clause 7ii71 for each rebate period beginning on or after ,january #a1 #bjba1 the manufacturer of a rebatable drug shall1 for such drug1 not later than #cj days after the date of receipt from the ,secretary of the information and rebate amount pursuant to subparagraph 7,a7 for such rebate period1 provide to the ,secretary a rebate that is equal to the amount specified in paragraph 7#c7 for such drug for such rebate period4 7ii7 ,exemption for shortages ,the ,secretary may reduce or waive the rebate under this subparagraph with respect to a rebatable drug that is listed on the drug shortage list maintained by the ,food and ,drug ,administration pursuant to section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7,c7 ,request for reconsideration ,the ,secretary shall establish procedures under which a manufacturer of a rebatable drug may request a reconsideration by the ,secretary of the rebate amount specified under paragraph 7#c7 for such rebatable drug and rebate period1 as reported to the manufacturer pursuant to subparagraph 7,a77iii74 7#b7 ,rebate period and rebatable drug defined ,in this subsection3 7,a7 ,rebate period ,the term rebate period means a calendar quarter beginning on or after ,january #a1 #bjba4 7,b7 ,rebatable drug ,the term rebatable drug means a single source drug or biological 7other than a biosimilar biological product7-- 7i7 described in section #ahdb7o77#a77;,c7 for which the payment amount is provided under this section2 or 7ii7 for which payment is made separately under section #ahcc7;i7 or section #ahcc7t7 and for which the payment amount is calculated based on the payment amount under this section4 7#c7 ,rebate amount 7,a7 ,in general ,for purposes of paragraph 7#a77;,b71 the amount specified in this paragraph for a rebatable drug assigned to a billing and payment code for a rebate period is1 subject to paragraph 7#d71 the amount equal to the product of-- 7i7 subject to subparagraph 7,b71 the total number of units of the billing and payment code for such rebatable drug furnished during the rebate period2 and 7ii7 the amount 7if any7 by which-- 7,i7 the amount determined under subsection 7b77#d7 for such rebatable drug during the rebate period2 exceeds 7,,ii7 the inflation-adjusted base payment amount determined under subparagraph 7,c7 of this paragraph for such rebatable drug during the rebate period4 7,b7 ,excluded units ,for purposes of subparagraph 7,a77i71 the total number of units of the billing and payment code for rebatable drugs furnished during a rebate period shall not include units with respect to which the manufacturer provides a discount under the program under section #cdj;,b of the ,public ,health ,service ,act or a rebate under section #aibg4 7,c7 ,determination of inflation-adjusted payment amount ,the inflation-adjusted payment amount determined under this subparagraph for a rebatable drug for a rebate period is-- 7i7 the amount determined under subsection 7b77#d7 for such rebatable drug in the payment amount benchmark quarter 7as defined in subparagraph 7,d772 increased by 7ii7 the percentage by which the rebate period ,,cpi-,u 7as defined in subparagraph 7,f77 for the rebate period exceeds the benchmark period ,,cpi-,u 7as defined in subparagraph 7,e774 7,d7 ,payment amount benchmark quarter ,the term payment amount benchmark quarter means the calendar quarter beginning ,july #a1 #bjai4 7,e7 ,benchmark period cpi-u ,the term benchmark period ,,cpi-,u means the consumer price index for all urban consumers 7,united ,states city average7 for ,july #bjai4 7,f7 ,rebate period cpi-u ,the term rebate period ,,cpi-,u means1 with respect to a rebate period1 the consumer price index for all urban consumers 7,united ,states city average7 for the last month of the calendar quarter that is two calendar quarters prior to the rebate period4 7#d7 ,application to new drugs ,in the case of a rebatable drug first approved or licensed by the ,food and ,drug ,administration after ,july #a1 #bjai1 the following shall apply3 7,a7 ,during initial period ,for quarters during the initial period in which the payment amount for such drug is determined using the methodology described in subsection 7c77#d7-- 7i7 clause 7ii77,i7 of paragraph 7#c77;,a7 shall be applied as if the reference to the amount determined under subsection 7b77#d71 were a reference to the wholesale acquisition cost applicable under subsection 7c77#d72 7ii7 clause 7i7 of paragraph 7#c77;,c7 shall be applied-- 7,i7 as if the reference to the amount determined under subsection 7b77#d71 were a reference to the wholesale acquisition cost applicable under subsection 7c77#d72 and 7,,ii7 as if the term payment amount benchmark quarter were defined under paragraph 7#c77;,d7 as the first full calendar quarter after the day on which the drug was first marketed2 and 7iii7 clause 7ii7 of paragraph 7#c77;,c7 shall be applied as if the term benchmark period ,,cpi-,u were defined under paragraph 7#d77;,e7 as if the reference to ,july #bjai under such paragraph were a reference to the first month of the first full calendar quarter after the day on which the drug was first marketed4 7,b7 ,after initial period ,for quarters beginning after such initial period-- 7i7 clause 7i7 of paragraph 7#c77;,c7 shall be applied as if the term payment amount benchmark quarter were defined under paragraph 7#c77;,d7 as the first full calendar quarter for which the ,secretary is able to compute an average sales price for the rebatable drug2 and 7ii7 clause 7ii7 of paragraph 7#c77;,c7 shall be applied as if the term benchmark period ,,cpi-,u were defined under paragraph 7#d77;,e7 as if the reference to ,july #bjai under such paragraph were a reference to the first month of the first full calendar quarter for which the ,secretary is able to compute an average sales price for the rebatable drug4 7#e7 ,rebate deposits ,amounts paid as rebates under paragraph 7#a77;,b7 shall be deposited into the ,federal ,supplementary ,medical ,insurance ,trust ,fund established under section #ahda4 7#f7 ,enforcement 7,a7 ,civil money penalty 7i7 ,in general ,the ,secretary shall impose a civil money penalty on a manufacturer that fails to comply with the requirements under paragraph 7#a77;,b7 with respect to providing a rebate for a rebatable drug for a rebate period for each such failure in an amount equal to the sum of-- 7,i7 the rebate amount specified pursuant to paragraph 7#c7 for such drug for such rebate period2 and 7,,ii7 #be percent of such amount4 7ii7 ,application ,the provisions of section #aabh;,a 7other than subsections 7a7 7with respect to amounts of penalties or additional assessments7 and 7b77 shall apply to a civil money penalty under this subparagraph in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a7a74 7,b7 ,no payment for manufacturers who fail to pay penalty ,if the manufacturer of a rebatable drug fails to pay a civil money penalty under subparagraph 7,a7 with respect to the failure to provide a rebate for a rebatable drug for a rebate period by a date specified by the ,secretary after the imposition of such penalty1 no payment shall be available under this part for such rebatable drug for calendar quarters beginning on or after such date until the ,secretary determines the manufacturer has paid the penalty due under such subparagraph4 4 7b7 ,implementation ,section #ahdg;,a7g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;g77 is amended-- 7#a7 in paragraph 7#d71 by striking and at the end2 7#b7 in paragraph 7#e71 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following new paragraph3 7#f7 determination of the rebate amount for a rebatable drug under paragraph 7#c7 of subsection 7h71 including with respect to a new drug pursuant to paragraph 7#d7 of such subsection1 including-- 7,a7 a decision by the ,secretary with respect to a request for reconsideration under paragraph 7#a77;,c72 and 7,b7 the determination of-- 7i7 the total number of units of the billing and payment code under paragraph 7#c77;,a77i72 and 7ii7 the inflation-adjusted payment amount under paragraph 7#c77;,c74 4 7c7 ,conforming amendment to part ,b ,,asp calculation ,section #ahdg;,a7c77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#c77 is amended by inserting or subsection 7h7 after section #aibg4 #cgb4 ,market based part ,b pricing index ,notwithstanding any provision of part ,b of title ,,xviii of the ,social ,security ,act1 the ,secretary of ,health and ,human ,services may make payments for drugs payable under such part based on an international pricing index4 ,in using such an index1 the ,secretary shall take into account whether the market of each country included in such index is a price-controlled or free market and give more weight under such index to countries with market-based drug policies4 #cgc4 ,innovation model testing of ,medicare drug payments ,notwithstanding any provision of section #aaae;,a1 the ,secretary of ,health and ,human ,services may1 under such section1 test a model to integrate benefits provided for drugs under parts ,a1 ,b1 and ,d of title ,,xviii of the ,social ,security ,act4 #cgd4 ,modification of maximum rebate amount under ,medicaid drug rebate program 7a7 ,in general ,subparagraph 7,d7 of section #aibg7;c77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#b77 is amended to read as follows3 7,d7 ,maximum rebate amount 7i7 ,in general ,except as provided in clause 7ii71 in no case shall the sum of the amounts applied under paragraph 7#a77;,a77ii7 and this paragraph with respect to each dosage form and strength of a single source drug or an innovator multiple source drug for a rebate period exceed-- 7,i7 for rebate periods beginning after ,december #ca1 #bjji1 and before ,september #cj1 #bjbb1 #ajj percent of the average manufacturer price of the drug2 and 7,,ii7 for rebate periods beginning on or after ,october #a1 #bjbb1 #abe percent of the average manufacturer price of the drug4 7ii7 ,no maximum amount for drugs if ,,amp increases outpace inflation 7,i7 ,in general ,if the average manufacturer price with respect to each dosage form and strength of a single source drug or an innovator multiple source drug increases on or after ,october #a1 #bjba1 and such increased average manufacturer price exceeds the inflation-adjusted average manufacturer price determined with respect to such drug under subclause 7,,ii7 for the rebate period1 clause 7i7 shall not apply and there shall be no limitation on the sum of the amounts applied under paragraph 7#a77;,a77ii7 and this paragraph for the rebate period with respect to each dosage form and strength of the single source drug or innovator multiple source drug4 7,,ii7 ,inflation-adjusted average manufacturer price defined ,in this clause1 the term inflation-adjusted average manufacturer price means1 with respect to a single source drug or an innovator multiple source drug and a rebate period1 the average manufacturer price for each dosage form and strength of the drug for the calendar quarter beginning ,july #a1 #aiij 7without regard to whether or not the drug has been sold or transferred to an entity1 including a division or subsidiary of the manufacturer1 after the #ast day of such quarter71 increased by the percentage by which the consumer price index for all urban consumers 7,united ,states city average7 for the month before the month in which the rebate period begins exceeds such index for ,september #aiij4 4 7b7 ,treatment of subsequently approved drugs ,section #aibg7;c77#b77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#b77;,b77 is amended by inserting and clause 7ii77,,ii7 of subparagraph 7,d7 after clause 7ii77,,ii7 of subparagraph 7,a74 7c7 ,technical amendments ,section #aibg7;c77#c77;,c77ii77,,iv7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#i7;c77#c77;,c77ii77,,iv77 is amended-- 7#a7 by striking subparagraph 7,a7 and inserting paragraph 7#c77;,a72 and 7#b7 by striking this subparagraph and inserting paragraph 7#c77;,c74 ,f ,medical ,malpractice ,reform #cha4 ,definitions ,in this ,act3 7#a7 ,alternative dispute resolution system2 ,,adr ,the term alternative dispute resolution system or ,,adr means a system that provides for the resolution of health care lawsuits in a manner other than through a civil action brought in a ,state or ,federal court4 7#b7 ,claimant ,the term claimant means any person who brings a health care lawsuit1 including a person who asserts or claims a right to legal or equitable contribution1 indemnity1 or subrogation1 arising out of a health care liability claim or action1 and any person on whose behalf such a claim is asserted or such an action is brought1 whether deceased1 incompetent1 or a minor4 7#c7 ,collateral source benefits ,the term collateral source benefits means any amount paid or reasonably likely to be paid in the future to or on behalf of the claimant1 or any service1 product1 or other benefit provided or reasonably likely to be provided in the future to or on behalf of the claimant1 as a result of the injury or wrongful death1 pursuant to-- 7,a7 any ,state or ,federal health1 sickness1 income-disability1 accident1 or workers' compensation law2 7,b7 any health1 sickness1 income-disability1 or accident insurance that provides health benefits or income-disability coverage2 7,c7 any contract or agreement of any group1 organization1 partnership1 or corporation to provide1 pay for1 or reimburse the cost of medical1 hospital1 dental1 or income-disability benefits2 and 7,d7 any other publicly or privately funded program4 7#d7 ,contingent fee ,the term contingent fee includes all compensation to any person or persons which is payable only if a recovery is effected on behalf of one or more claimants4 7#e7 ,economic damages ,the term economic damages means objectively verifiable monetary losses incurred as a result of the provision or use of 7or failure to provide or use7 health care services or medical products1 such as past and future medical expenses1 loss of past and future earnings1 cost of obtaining domestic services1 loss of employment1 and loss of business or employment opportunities1 unless otherwise defined under applicable ,state law4 ,in no circumstances shall damages for health care services or medical products exceed the amount actually paid or incurred by or on behalf of the claimant4 7#f7 ,future damages ,the term future damages means any damages that are incurred after the date of judgment1 settlement1 or other resolution 7including mediation1 or any other form of alternative dispute resolution74 7#g7 ,health care lawsuit ,the term health care lawsuit means any health care liability claim concerning the provision of goods or services for which coverage was provided in whole or in part via a ,federal program1 subsidy or tax benefit1 or any health care liability action concerning the provision of goods or services for which coverage was provided in whole or in part via a ,federal program1 subsidy or tax benefit1 brought in a ,state or ,federal court or pursuant to an alternative dispute resolution system1 against a health care provider regardless of the theory of liability on which the claim is based1 or the number of claimants1 plaintiffs1 defendants1 or other parties1 or the number of claims or causes of action1 in which the claimant alleges a health care liability claim4 ,such term does not include a claim or action which is based on criminal liability2 which seeks civil fines or penalties paid to ,federal1 ,state1 or local government2 or which is grounded in antitrust4 7#h7 ,health care liability action ,the term health care liability action means a civil action brought in a ,state or ,federal court or pursuant to an alternative dispute resolution system1 against a health care provider regardless of the theory of liability on which the claim is based1 or the number of plaintiffs1 defendants1 or other parties1 or the number of causes of action1 in which the claimant alleges a health care liability claim4 7#i7 ,health care liability claim ,the term health care liability claim means a demand by any person1 whether or not pursuant to ,,adr1 against a health care provider1 including1 but not limited to1 third-party claims1 cross-claims1 counter-claims1 or contribution claims1 which are based upon the provision or use of 7or the failure to provide or use7 health care services or medical products1 regardless of the theory of liability on which the claim is based1 or the number of plaintiffs1 defendants1 or other parties1 or the number of causes of action4 7#aj7 ,health care provider ,the term health care provider means any person or entity required by ,state or ,federal laws or regulations to be licensed1 registered1 or certified to provide health care services1 and being either so licensed1 registered1 or certified1 or exempted from such requirement by other statute or regulation1 as well as any other individual or entity defined as a health care provider1 health care professional1 or health care institution under ,state law4 7#aa7 ,health care services ,the term health care services means the provision of any goods or services 7including safety1 professional1 or administrative services directly related to health care7 by a health care provider1 or by any individual working under the supervision of a health care provider1 that relates to the diagnosis1 prevention1 or treatment of any human disease or impairment1 or the assessment or care of the health of human beings4 7#ab7 ,medical product ,the term medical product means a drug1 device1 or biological product intended for humans1 and the terms drug1 device1 and biological product have the meanings given such terms in sections #bja7;g77#a7 and #bja7;h7 of the ,federal ,food1 ,drug and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g77#a7 and 7h77 and section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a771 respectively1 including any component or raw material used therein1 but excluding health care services4 7#ac7 ,noneconomic damages ,the term noneconomic damages means damages for physical and emotional pain1 suffering1 inconvenience1 physical impairment1 mental anguish1 disfigurement1 loss of enjoyment of life1 loss of society and companionship1 loss of consortium 7other than loss of domestic service71 hedonic damages1 injury to reputation1 and all other nonpecuniary losses of any kind or nature incurred as a result of the provision or use of 7or failure to provide or use7 health care services or medical products1 unless otherwise defined under applicable ,state law4 7#ad7 ,recovery ,the term recovery means the net sum recovered after deducting any disbursements or costs incurred in connection with prosecution or settlement of the claim1 including all costs paid or advanced by any person4 ,costs of health care incurred by the plaintiff and the attorneys' office overhead costs or charges for legal services are not deductible disbursements or costs for such purpose4 7#ae7 ,representative ,the term representative means a legal guardian1 attorney1 person designated to make decisions on behalf of a patient under a medical power of attorney1 or any person recognized in law or custom as a patient's agent4 7#af7 ,state ,the term ,state means each of the several ,states1 the ,district of ,columbia1 the ,commonwealth of ,puerto ,rico1 the ,virgin ,islands1 ,guam1 ,american ,samoa1 the ,northern ,mariana ,islands1 the ,trust ,territory of the ,pacific ,islands1 and any other territory or possession of the ,united ,states1 or any political subdivision thereof4 #chb4 ,encouraging speedy resolution of claims 7a7 ,statute of limitations 7#a7 ,in general ,except as provided in paragraph 7#b71 the time for the commencement of a health care lawsuit shall be1 whichever occurs first of the following3 7,a7 ,three years after the date of the occurrence of the breach or tort4 7,b7 ,three years after the date the medical or health care treatment that is the subject of the claim is completed4 7,c7 ,one year after the claimant discovers1 or through the use of reasonable diligence should have discovered1 the injury4 7#b7 ,tolling ,in no event shall the time for commencement of a health care lawsuit exceed #c years after the date of the occurrence of the breach or tort or #c years after the date the medical or health care treatment that is the subject of the claim is completed 7whichever occurs first7 unless tolled for any of the following-- 7,a7 upon proof of fraud2 7,b7 intentional concealment2 or 7,c7 the presence of a foreign body1 which has no therapeutic or diagnostic purpose or effect1 in the person of the injured person4 7#c7 ,actions by a minor ,actions by a minor shall be commenced within #c years after the date of the occurrence of the breach or tort or #c years after the date of the medical or health care treatment that is the subject of the claim is completed 7whichever occurs first7 except that actions by a minor under the full age of #f years shall be commenced within #c years after the date of the occurrence of the breach or tort1 #c years after the date of the medical or health care treatment that is the subject of the claim is completed1 or #a year after the injury is discovered1 or through the use of reasonable diligence should have been discovered1 or prior to the minor's #hth birthday1 whichever provides a longer period4 ,such time limitation shall be tolled for minors for any period during which a parent or guardian and a health care provider have committed fraud or collusion in the failure to bring an action on behalf of the injured minor4 7b7 ,state flexibility ,no provision of subsection 7a7 shall be construed to preempt any ,state law 7whether effective before1 on1 or after the date of the enactment of this ,act7 that-- 7#a7 specifies a time period of less than #c years after the date of injury or less than #a year after the claimant discovers1 or through the use of reasonable diligence should have discovered1 the injury1 for the filing of a health care lawsuit2 7#b7 that specifies a different time period for the filing of lawsuits by a minor2 7#c7 that triggers the time period based on the date of the alleged negligence2 or 7#d7 establishes a statute of repose for the filing of a health care lawsuit4 #chc4 ,compensating patient injury 7a7 ,unlimited amount of damages for actual economic losses in health care lawsuits ,in any health care lawsuit1 nothing in this ,act shall limit a claimant's recovery of the full amount of the available economic damages1 notwithstanding the limitation in subsection 7b74 7b7 ,additional noneconomic damages ,in any health care lawsuit1 the amount of noneconomic damages1 if available1 shall not exceed #bej1jjj1 regardless of the number of parties against whom the action is brought or the number of separate claims or actions brought with respect to the same injury4 7c7 ,no discount of award for noneconomic damages ,for purposes of applying the limitation in subsection 7b71 future noneconomic damages shall not be discounted to present value4 ,the jury shall not be informed about the maximum award for noneconomic damages4 ,an award for noneconomic damages in excess of #bej1jjj shall be reduced either before the entry of judgment1 or by amendment of the judgment after entry of judgment1 and such reduction shall be made before accounting for any other reduction in damages required by law4 ,if separate awards are rendered for past and future noneconomic damages and the combined awards exceed #bej1jjj1 the future noneconomic damages shall be reduced first4 7d7 ,fair share rule ,in any health care lawsuit1 each party shall be liable for that party's several share of any damages only and not for the share of any other person4 ,each party shall be liable only for the amount of damages allocated to such party in direct proportion to such party's percentage of responsibility4 ,whenever a judgment of liability is rendered as to any party1 a separate judgment shall be rendered against each such party for the amount allocated to such party4 ,for purposes of this section1 the trier of fact shall determine the proportion of responsibility of each party for the claimant's harm4 7e7 ,state flexibility ,no provision of this section shall be construed to preempt any ,state law 7whether effective before1 on1 or after the date of the enactment of this ,act7 that specifies a particular monetary amount of economic or noneconomic damages 7or the total amount of damages7 that may be awarded in a health care lawsuit1 regardless of whether such monetary amount is greater or lesser than is provided for under this section4 #chd4 ,maximizing patient recovery 7a7 ,court supervision of share of damages actually paid to claimants ,in any health care lawsuit1 the court shall supervise the arrangements for payment of damages to protect against conflicts of interest that may have the effect of reducing the amount of damages awarded that are actually paid to claimants4 ,in particular1 in any health care lawsuit in which the attorney for a party claims a financial stake in the outcome by virtue of a contingent fee1 the court shall have the power to restrict the payment of a claimant's damage recovery to such attorney1 and to redirect such damages to the claimant based upon the interests of justice and principles of equity4 ,in no event shall the total of all contingent fees for representing all claimants in a health care lawsuit exceed the following limits3 7#a7 ,forty percent of the first #ej1jjj recovered by the claimant7s74 7#b7 ,thirty-three and one-third percent of the next #ej1jjj recovered by the claimant7s74 7#c7 ,twenty-five percent of the next #ejj1jjj recovered by the claimant7s74 7#d7 ,fifteen percent of any amount by which the recovery by the claimant7s7 is in excess of #fjj1jjj4 7b7 ,applicability ,the limitations in this section shall apply whether the recovery is by judgment1 settlement1 mediation1 arbitration1 or any other form of alternative dispute resolution4 ,in a health care lawsuit involving a minor or incompetent person1 a court retains the authority to authorize or approve a fee that is less than the maximum permitted under this section4 ,the requirement for court supervision in the first two sentences of subsection 7a7 applies only in civil actions4 7c7 ,state flexibility ,no provision of this section shall be construed to preempt any ,state law 7whether effective before1 on1 or after the date of the enactment of this ,act7 that specifies a lesser percentage or lesser total value of damages which may be claimed by an attorney representing a claimant in a health care lawsuit4 #che4 ,authorization of payment of future damages to claimants in health care lawsuits 7a7 ,in general ,in any health care lawsuit1 if an award of future damages1 without reduction to present value1 equaling or exceeding #ej1jjj is made against a party with sufficient insurance or other assets to fund a periodic payment of such a judgment1 the court shall1 at the request of any party1 enter a judgment ordering that the future damages be paid by periodic payments1 in accordance with the ,uniform ,periodic ,payment of ,judgments ,act promulgated by the ,national ,conference of ,commissioners on ,uniform ,state ,laws4 7b7 ,applicability ,this section applies to all actions which have not been first set for trial or retrial before the effective date of this ,act4 7c7 ,state ,flexibility ,no provision of this section shall be construed to preempt any ,state law 7whether effective before1 on1 or after the date of the enactment of this ,act7 that specifies periodic payments for future damages at any amount other than #ej1jjj or that mandates such payments absent the request of either party4 #chf4 ,product liability for health care providers ,a health care provider who prescribes1 or who dispenses pursuant to a prescription1 a medical product approved1 licensed1 or cleared by the ,food and ,drug ,administration shall not be named as a party to a product liability lawsuit involving such product and shall not be liable to a claimant in a class action lawsuit against the manufacturer1 distributor1 or seller of such product4 #chg4 ,effect on other laws 7a7 ,vaccine injury 7#a7 ,to the extent that title ,,xxi of the ,public ,health ,service ,act establishes a ,federal rule of law applicable to a civil action brought for a vaccine-related injury or death-- 7,a7 this ,act does not affect the application of the rule of law to such an action2 and 7,b7 any rule of law prescribed by this subtitle in conflict with a rule of law of such title ,,xxi shall not apply to such action4 7#b7 ,if there is an aspect of a civil action brought for a vaccine-related injury or death to which a ,federal rule of law under title ,,xxi of the ,public ,health ,service ,act does not apply1 then this subtitle or otherwise applicable law 7as determined under this subtitle7 will apply to such aspect of such action4 7b7 ,other ,federal law ,except as provided in this section1 nothing in this subtitle shall be deemed to affect any defense available to a defendant in a health care lawsuit or action under any other provision of ,federal law4 #chh4 ,limitation on expert witness testimony 7a7 ,in general ,no person in a health care profession requiring licensure under the laws of a ,state shall be competent to testify in any court of law to establish the following facts-- 7#a7 the recognized standard of acceptable professional practice and the specialty thereof1 if any1 that the defendant practices1 which shall be the type of acceptable professional practice recognized in the defendant's community or in a community similar to the defendant's community that was in place at the time the alleged injury or wrongful action occurred2 7#b7 that the defendant acted with less than or failed to act with ordinary and reasonable care in accordance with the recognized standard2 and 7#c7 that as a proximate result of the defendant's negligent act or omission1 the claimant suffered injuries which would not otherwise have occurred1 unless the person was licensed to practice1 in the ,state or a contiguous bordering ,state1 a profession or specialty which would make the person's expert testimony relevant to the issues in the case and had practiced this profession or specialty in one of these ,states during the year preceding the date that the alleged injury or wrongful act occurred4 7b7 ,applicability ,the requirements set forth in subsection 7a7 shall also apply to expert witnesses testifying for the defendant as rebuttal witnesses4 7c7 ,waiver authority ,the court may waive the requirements in this subsection if it determines that the appropriate witnesses otherwise would not be available4 #chi4 ,expert witness qualifications 7a7 ,in general ,in any health care lawsuit1 an individual shall not give expert testimony on the appropriate standard of practice or care involved unless the individual is licensed as a health professional in one or more ,states and the individual meets the following criteria3 7#a7 ,if the party against whom or on whose behalf the testimony is to be offered is or claims to be a specialist1 the expert witness shall specialize at the time of the occurrence that is the basis for the lawsuit in the same specialty or claimed specialty as the party against whom or on whose behalf the testimony is to be offered4 ,if the party against whom or on whose behalf the testimony is to be offered is or claims to be a specialist who is board certified1 the expert witness shall be a specialist who is board certified in that specialty or claimed specialty4 7#b7 ,during the #a-year period immediately preceding the occurrence of the action that gave rise to the lawsuit1 the expert witness shall have devoted a majority of the individual's professional time to one or more of the following3 7,a7 ,the active clinical practice of the same health profession as the defendant and1 if the defendant is or claims to be a specialist1 in the same specialty or claimed specialty4 7,b7 ,the instruction of students in an accredited health professional school or accredited residency or clinical research program in the same health profession as the defendant and1 if the defendant is or claims to be a specialist1 in an accredited health professional school or accredited residency or clinical research program in the same specialty or claimed specialty4 7#c7 ,if the defendant is a general practitioner1 the expert witness shall have devoted a majority of the witness's professional time in the #a-year period preceding the occurrence of the action giving rise to the lawsuit to one or more of the following3 7,a7 ,active clinical practice as a general practitioner4 7,b7 ,instruction of students in an accredited health professional school or accredited residency or clinical research program in the same health profession as the defendant4 7b7 ,lawsuits against entities ,if the defendant in a health care lawsuit is an entity that employs a person against whom or on whose behalf the testimony is offered1 the provisions of subsection 7a7 apply as if the person were the party or defendant against whom or on whose behalf the testimony is offered4 7c7 ,power of court ,nothing in this section shall limit the power of the trial court in a health care lawsuit to disqualify an expert witness on grounds other than the qualifications set forth under this subsection4 7d7 ,limitation ,an expert witness in a health care lawsuit shall not be permitted to testify if the fee of the witness is in any way contingent on the outcome of the lawsuit4 7e7 ,state flexibility ,no provision of this section shall be construed to preempt any ,state law 7whether effective before1 on1 or after the date of the enactment of this ,act7 that places additional qualification requirements upon any individual testifying as an expert witness4 #cij4 ,communications following unanticipated outcome 7a7 ,provider communications ,in any health care liability action1 any and all statements1 affirmations1 gestures1 or conduct expressing apology1 fault1 sympathy1 commiseration1 condolence1 compassion1 or a general sense of benevolence which are made by a health care provider or an employee of a health care provider to the patient1 a relative of the patient1 or a representative of the patient and which relate to the discomfort1 pain1 suffering1 injury1 or death of the patient as the result of the unanticipated outcome of medical care shall be inadmissible for any purpose as evidence of an admission of liability or as evidence of an admission against interest4 7b7 ,state flexibility ,no provision of this section shall be construed to preempt any ,state law 7whether effective before1 on1 or after the date of the enactment of this ,act7 that makes additional communications inadmissible as evidence of an admission of liability or as evidence of an admission against interest4 #cia4 ,affidavit of merit 7a7 ,required filing ,subject to subsection 7b71 the plaintiff in a health care lawsuit alleging negligence or1 if the plaintiff is represented by an attorney1 the plaintiff's attorney shall file simultaneously with the health care lawsuit an affidavit of merit signed by a health professional who meets the requirements for an expert witness under section #bdb of this ,act4 ,the affidavit of merit shall certify that the health professional has reviewed the notice and all medical records supplied to him or her by the plaintiff's attorney concerning the allegations contained in the notice and shall contain a statement of each of the following3 7#a7 ,the applicable standard of practice or care4 7#b7 ,the health professional's opinion that the applicable standard of practice or care was breached by the health professional or health facility receiving the notice4 7#c7 ,the actions that should have been taken or omitted by the health professional or health facility in order to have complied with the applicable standard of practice or care4 7#d7 ,the manner in which the breach of the standard of practice or care was the proximate cause of the injury alleged in the notice4 7#e7 ,a listing of the medical records reviewed4 7b7 ,filing extension ,upon motion of a party for good cause shown1 the court in which the complaint is filed may grant the plaintiff or1 if the plaintiff is represented by an attorney1 the plaintiff's attorney an additional #bh days in which to file the affidavit required under subsection 7a74 7c7 ,state flexibility ,no provision of this section shall be construed to preempt any ,state law 7whether effective before1 on1 or after the date of the enactment of this ,act7 that establishes additional requirements for the filing of an affidavit of merit or similar pre-litigation documentation4 #cib4 ,notice of intent to commence lawsuit 7a7 ,advance notice ,a person shall not commence a health care lawsuit against a health care provider unless the person has given the health care provider #ij days written notice before the action is commenced4 7b7 ,exceptions ,a health care lawsuit against a health care provider filed within #f months of the statute of limitations expiring as to any claimant1 or within #a year of the statute of repose expiring as to any claimant1 shall be exempt from compliance with this section4 7c7 ,state flexibility ,no provision of this section shall be construed to preempt any ,state law 7whether effective before1 on1 or after the date of the enactment of this ,act7 that establishes a different time period for the filing of written notice4 #cic4 ,limitation on liability for volunteer health care professionals 7a7 ,in general ,title ,,ii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bjb et seq47 is amended by inserting after section #bbd the following3 #bbd;,a4 ,limitation on liability for volunteer health care professionals 7a7 ,limitation on liability ,a physician shall not be liable under ,federal or ,state law in any civil action for any harm caused by an act or omission of such physician1 or attending medical personnel supporting such physician1 if such act or omission-- 7#a7 occurs in the course of furnishing qualified charity care 7as such term is defined in section #aii;,b of the ,internal ,revenue ,code of #aihf72 and 7#b7 was not grossly negligent4 7b7 ,preemption ,this section preempts the laws of a ,state or any political subdivision of a ,state to the extent that such laws are inconsistent with this section1 unless such laws provide greater protection from liability for a defendant4 7c7 ,definitions ,in this section3 7#a7 ,physician ,the term physician has the meaning given such term by section #ahfa7r7 of the ,social ,security ,act4 7#b7 ,attending medical personnel ,the term attending medical personnel means an individual who is licensed to directly support a physician in furnishing medical services4 4 7b7 ,effective date ,the amendments made by this section shall apply to any claim filed to the extent that it is with respect to acts or omissions occurring after the date of the enactment of this ,act4 #cid4 ,rules of construction 7a7 ,health care lawsuits ,unless otherwise specified in this subtitle1 the provisions governing health care lawsuits set forth in this subtitle preempt1 subject to subsections 7b7 and 7c71 ,state law to the extent that ,state law prevents the application of any provisions of law established by or under this subtitle4 ,the provisions governing health care lawsuits set forth in this subtitle supersede chapter #aga of title #bh1 ,united ,states ,code1 to the extent that such chapter-- 7#a7 provides for a greater amount of damages or contingent fees1 a longer period in which a health care lawsuit may be commenced1 or a reduced applicability or scope of periodic payment of future damages1 than provided in this subtitle2 or 7#b7 prohibits the introduction of evidence regarding collateral source benefits1 or mandates or permits subrogation or a lien on collateral source benefits4 7b7 ,protection of ,states' rights and other laws ,any issue that is not governed by any provision of law established by or under this subtitle 7including ,state standards of negligence7 shall be governed by otherwise applicable ,state or ,federal law4 7c7 ,state ,flexibility ,no provision of this subtitle shall be construed to preempt any defense available to a party in a health care lawsuit under any other provision of ,state or ,federal law4 #cie4 ,effective date ,this subtitle shall apply to any health care lawsuit brought in a ,federal or ,state court1 or subject to an alternative dispute resolution system1 that is initiated on or after the date of the enactment of this subtitle1 except that any health care lawsuit arising from an injury occurring prior to the date of the enactment of this subtitle shall be governed by the applicable statute of limitations provisions in effect at the time the cause of action accrued4 ,,iv ,medicare and ,medicaid ,reforms ,a ,medicaid ,reforms #dja4 ,medicaid payment reform 7a7 ,in general ,title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 is amended by inserting after section #aijc the following section3 #aijc;,a4 ,reformed payment to ,states 7a7 ,reformed payment system 7#a7 ,in general ,for quarters beginning on or after the implementation date 7as defined in subsection 7k77#a771 in the case of a ,state that elects 7in a time and manner specified by the ,secretary7 to apply this section1 in lieu of amounts otherwise payable to such ,state under this title 7including any payments attributable to section #aibc71 except as otherwise provided in this section1 the amount payable to such ,state shall be equal to the sum of the following3 7,a7 ,adjusted aggregate beneficiary-based amount ,the aggregate beneficiary-based amount specified in subsection 7b7 for the quarter and the ,state1 adjusted under subsection 7e74 7,b7 ,chronic care quality bonus ,the amount 7if any7 of the chronic care quality bonus payment specified in subsection 7f7 for the quarter for the ,state4 7#b7 ,requirement of ,state share 7,a7 ,in general ,a ,state shall make1 from non-,federal funds1 expenditures in an amount equal to its ,state share 7as determined under subparagraph 7,b77 for a quarter for items1 services1 and other costs for which1 but for paragraph 7#a71 ,federal funds would have been payable under this title4 7,b7 ,state share ,the ,state share for a ,state for a quarter in a fiscal year is equal to the product of-- 7i7 the aggregate beneficiary-based amount specified in subsection 7b7 for the quarter and the ,state2 and 7ii7 the ratio of-- 7,i7 the ,state percentage described in subparagraph 7,d77ii7 for such ,state and fiscal year2 to 7,,ii7 the ,federal percentage described in subparagraph 7,d77i7 for such ,state and fiscal year4 7,c7 ,nonpayment for failure to pay state share 7i7 ,in general ,if a ,state fails to expend the amount required under subparagraph 7,a7 for a quarter in a fiscal year1 the amount payable to the ,state under paragraph 7#a7 shall be reduced by the product of the amount by which the ,state payment is less than the ,state share and the ratio of-- 7,i7 the ,federal percentage described in subparagraph 7,d77i7 for such ,state and fiscal year2 to 7,,ii7 the ,state percentage described in subparagraph 7,d77ii7 for such ,state and fiscal year4 7ii7 ,grace period ,a ,state shall not be considered to have failed to provide payment of its required ,state share for a quarter under subparagraph 7,a7 if the aggregate ,state payment towards the ,state's required ,state share for the #d-quarter period beginning with such quarter exceeds the required ,state share amount for such #d-quarter period4 7,d7 ,federal and ,state percentages ,in this paragraph1 with respect to a ,state and a fiscal year3 7i7 ,federal percentage ,the ,federal percentage described in this clause is #ge percent or1 if higher1 the ,federal medical assistance percentage for such ,state for such fiscal year4 7ii7 ,state percentage ,the ,state percentage described in this clause is #ajj percent minus the ,federal percentage described in clause 7i74 7,e7 ,rules for crediting toward ,state share 7i7 ,general limitation to matchable expenditures ,a payment for expenditures shall not be counted toward the ,state share under subparagraph 7,a7 unless ,federal payments may be used for such expenditures consistent with paragraph 7#c77;,b74 7ii7 ,further limitations on allowable expenditures ,a payment for expenditures shall not be counted towards the ,state share under subparagraph 7,a7 if the expenditure is for any of the following3 7,i7 ,abortion ,expenditures for an abortion4 7,,ii7 ,intergovernmental transfers ,an expenditure that is attributable to an intergovernmental transfer4 7,,iii7 ,certified public expenditures ,an expenditure that is attributable to certified public expenditures4 7iii7 ,crediting fraud and abuse recoveries ,amounts recovered by a ,state through the operation of its ,medicaid fraud and abuse control unit described in section #aijc7q7 shall be fully counted toward the ,state share under subparagraph 7,a74 7,f7 ,construction ,nothing in the paragraph shall be construed as preventing a ,state from expending1 from non-,federal funds1 an amount under this title in excess of the amount of the ,state share4 7,g7 ,determination based upon submitted claims ,in applying this paragraph with respect to expenditures of a ,state for a quarter1 the determination of the expenditures for such ,state for such quarter shall be made after the end of the period 7which1 as of the date of the enactment of this section1 is #b years7 for which the ,secretary accepts claims for payment under this title with respect to such quarter4 7#c7 ,use of ,federal payments 7,a7 ,application of ,medicaid limitations ,a ,state may only use ,federal payments received under subsection 7a7 for expenditures for which ,federal funds would have been payable under this title but for this section4 7,b7 ,limitation for certain eligibles 7i7 ,application of #ajj percent federal poverty line limit on eligibility ,subject to clause 7iii71 a ,state may not use such ,federal payments to provide medical assistance for an individual who has an income 7as determined under clause 7ii77 that exceeds #ajj percent of the poverty line 7as defined in section #baaj7;c77#e77 applicable to a family of the size involved4 7ii7 ,determination of income using modified adjusted gross income without any #e percent increase ,in determining income for purposes of clause 7i7 under section #aijb7;e77#ad7 7relating to modified adjusted gross income71 the following rules shall apply3 7,i7 ,application of spend down ,the ,state shall take into account the costs incurred for medical care or for any other type of remedial care recognized under ,state law in the same manner and to the same extent that such ,state takes such costs into account for purposes of section #aijb7;a77#ag74 7,,ii7 ,disregard of #e percent increase ,subparagraph 7,i7 of section #aijb7;e77#ad7 7relating to a #e percent reduction7 shall not apply4 7iii7 ,exception ,clause 7i7 shall not apply to an individual who is-- 7,i7 a woman described in clause 7i7 of section #aijc7v77#d77;,a72 7,,ii7 a child who is an individual described in clause 7i7 of section #aije7;a72 7,,iii7 enrolled in a ,state plan under this title as of the date of the enactment of this section for the period of continuous enrollment2 or 7,,iv7 described in section #aijb7;e77#ad77;,d7 7relating to modified adjusted gross income74 7iv7 ,clarification related to community spouse ,nothing in this subparagraph shall supersede the application of section #aibd 7related to community spouse income and assets74 7#d7 ,exceptions for pass-through payments 7,a7 ,in general ,paragraph 7#a7 shall not apply1 and amounts shall continue to be payable under this title 7and not under subsection 7a771 in the case of the following payments 7and related administrative costs and expenditures73 7i7 ,payments to territories ,payments to a ,state other than the #ej ,states and the ,district of ,columbia4 7ii7 ,medicare cost-sharing ,payments attributable to ,medicare cost-sharing under section #aije7p74 7iii7 ,pediatric vaccines ,payments attributable to section #aibh4 7iv7 ,emergency services for certain individuals ,payments for treatment of emergency medical conditions attributable to the application of section #aijc7v77#b74 7v7 ,indian health care facilities ,payments for medical assistance described in the third sentence of section #aije7;b74 7vi7 ,employer-sponsored insurance 7,,esi7 ,payments for medical assistance attributable to payments to employers for employer-sponsored health benefits coverage4 7vii7 ,other populations with limited benefit coverage ,other payments that are determined by the ,secretary to be related to a specified population for which the medical assistance under this title is limited and does not include any inpatient1 nursing facility1 or long-term care services4 7,b7 ,certain expenses ,paragraph 7#a7 shall not apply1 and amounts shall continue to be payable under this title 7and not under subsection 7a771 in the case of the following3 7i7 ,administration of medicare prescription drug benefit ,expenditures described in section #aice7;b7 7relating to administration of the ,medicare prescription drug benefit74 7ii7 ,payments for ,,hit bonuses ,payments under section #aijc7;a77#c77;,f7 7relating to payments to encourage the adoption and use of certified ,,ehr technology74 7iii7 ,payments for design1 development1 and installation of ,,mmis and eligibility systems ,payments under subparagraphs 7,a77i7 and 7,h77i7 of section #aijc7;a77#c7 for expenditures for design1 development1 and installation of the ,medicaid management information systems and mechanized verification and information retrieval systems 7related to eligibility74 7#e7 ,payment of amounts 7,a7 ,in general ,except as the ,secretary may otherwise provide1 amounts shall be payable to a ,state under subsection 7a7 in the same manner as amounts are payable under subsection 7d7 of section #aijc to a ,state under subsection 7a7 of such section4 7,b7 ,information and forms 7i7 ,submission ,as a condition of receiving payment under subsection 7a71 a ,state shall submit such information1 in such form1 and manner1 as the ,secretary shall specify1 including information necessary to make the computations under subsections 7c77#b77;,c7 and 7e74 7ii7 ,uniform reporting ,the ,secretary shall develop such forms as may be needed to assure a system of uniform reporting of such information across ,states4 7,c7 ,required reporting of information on medical loss ratios for managed care ,the information required to be reported under subparagraph 7,b77i7 shall include information on the medical loss ratio with respect to coverage provided under each ,medicaid managed care plan with a contract with the ,state under section #aijc7m7 or #aicb4 7b7 ,aggregate beneficiary-,based amount 7#a7 ,in general ,the aggregate beneficiary-based amount specified in this subsection for a ,state for a quarter is equal to the sum of the products1 for each of the categories of ,medicaid beneficiaries specified in paragraph 7#b71 of the following3 7,a7 ,beneficiary-based quarterly amount ,the beneficiary-based quarterly amount for such category computed under subsection 7c7 for such ,state for such quarter4 7,b7 ,number of individuals in category ,subject to subsection 7d71 the average number of ,medicaid beneficiaries enrolled in such category in the ,state in such quarter4 7#b7 ,categories ,the categories specified in this paragraph are the following3 7,a7 ,elderly ,a category of ,medicaid beneficiaries who are #fe years of age or older4 7,b7 ,blind or disabled ,a category of ,medicaid beneficiaries not described in subparagraph 7,a7 who are described in section #aicg7;a77#b77;,b77ii74 7,c7 ,children ,a category of ,medicaid beneficiaries not described in subparagraph 7,b7 who are under #ba years of age4 7,d7 ,other adults ,a category of any ,medicaid beneficiaries who are not described in a previous subparagraph of this paragraph4 7c7 ,computation of per beneficiary1 per category quarterly amount 7#a7 ,in general ,for a ,state1 for each category of beneficiary for a quarter-- 7,a7 ,first reform year ,for quarters in the first reform year 7as defined in subsection 7k77#b771 the beneficiary-based quarterly amount is equal to #a_/d of the base average per beneficiary ,federal payments for such ,state for such category determined under paragraph 7#b71 increased by a factor that reflects the sum of the following3 7i7 ,historical medical care component of ,,cpi through previous reform year ,the percentage increase in the historical medical care component of the ,consumer ,price ,index for all urban consumers 7,u4,s4 city average7 from the midpoint of the base fiscal year 7as defined in paragraph 7#f77 to the midpoint of the fiscal year preceding the first reform year4 7ii7 ,projected medical care component of ,,cpi for the first reform year ,the percentage increase in the projected medical care component of the ,consumer ,price ,index for all urban consumers 7,u4,s4 city average7 from the midpoint of the previous fiscal year referred to in clause 7i7 to the midpoint of the first reform year4 7,b7 ,second and third reform years ,the beneficiary-based quarterly amount for a ,state for a category for quarters in the second reform year or the third reform year is equal to the beneficiary-based quarterly amount under this paragraph for such ,state and category for the previous reform year increased by the per beneficiary percentage increase 7as defined in subparagraph 7,e77 for such category and reform year4 7,c7 ,fourth through tenth reform years ,the beneficiary-based quarterly amount for a ,state for a category for quarters in a reform year beginning with the fourth reform year and ending with the tenth reform year is-- 7i7 in the case of a ,state that is a high per beneficiary ,state or a low per beneficiary ,state 7as defined in paragraph 7#d77;,b77iii77 for the category1 the amount determined under clause 7i7 or 7ii7 of paragraph 7#d77;,b7 for such ,state1 category1 and reform year2 or 7ii7 in the case of any other ,state1 the beneficiary-based quarterly amount under this paragraph for such ,state and category for the previous reform year increased by the per beneficiary percentage increase for such category and reform year4 7,d7 ,eleventh reform year and subsequent reform years ,the beneficiary-based quarterly amount for a ,state for a category for quarters in a reform year beginning with the eleventh reform year is equal to the beneficiary-based quarterly amount under this paragraph for such ,state and category for the previous reform year increased by the per beneficiary percentage increase for such category and reform year4 7,e7 ,annual percentage increase beginning with second reform year ,for purposes of this subsection1 the term per beneficiary percentage increase means1 for a reform year1 the sum of-- 7i7 the projected percentage change in nominal gross domestic product from the midpoint of the previous reform year to the midpoint of the reform year for which the percentage increase is being applied2 and 7ii7 one percentage point4 7#b7 ,base per beneficiary1 per category amount for each ,state 7,a7 ,average per category 7i7 ,in general ,the ,secretary shall determine1 consistent with this paragraph and paragraph 7#c71 a base per beneficiary1 per category amount for each of the #ej ,states and the ,district of ,columbia equal to the average amount1 per ,medicaid beneficiary1 of ,federal payments under this title1 including payments attributable to disproportionate share hospital payments under section #aibc1 for each of the categories of beneficiaries under subsection 7b77#b7 for the base fiscal year for each of the #ej ,states and the ,district of ,columbia4 7ii7 ,best available data ,the determination under clause 7i7 shall initially be estimated by the ,secretary1 based upon the best available data at the time the determination is made4 7iii7 ,updates ,the determination under clause 7i7 shall be updated by the ,secretary on an annual basis based upon improved data4 ,the ,secretary shall adjust the amounts under subsection 7a77#a77;,a7 to reflect changes in the amounts so determined based on such updates4 7,b7 ,exclusion of pass-through payments ,in computing base per beneficiary1 per category amounts under subparagraph 7,a77i7 the ,secretary shall exclude payments described in subsection 7a77#d74 7,c7 ,standardization 7i7 ,in general ,in computing each such amount1 the ,secretary shall standardize the amount in order to remove the variation attributable to the following3 7,i7 ,risk factors ,such risk factors as age1 health and disability status 7including high cost medical conditions71 gender1 institutional status1 and such other factors as the ,secretary determines to be appropriate1 so as to ensure actuarial equivalence4 7,,ii7 ,geographic ,variations in costs on a county-by-county basis4 7ii7 ,method of standardization 7,i7 ,consultation in development of risk standardization ,in developing the methodology for risk standardization for purposes of clause 7i77,i71 the ,secretary shall consult with the ,medicaid and ,,chip ,payment and ,access ,commission1 the ,medicare ,payment ,advisory ,commission1 and the ,national ,association of ,medicaid ,directors4 7,,ii7 ,method for risk standardization ,in carrying out clause 7i77,i71 the ,secretary may apply the hierarchal condition category methodology under section #ahec7;a77#a77;,c74 ,if the ,secretary uses such methodology1 the ,secretary shall adjust the application of such methodology to take into account the differences in services provided under this title compared to title ,,xviii1 such as the coverage of long term care1 pregnancy1 and pediatric services4 7,,iii7 ,method for geographic standardization ,the ,secretary shall apply the standardization under clause 7i77,,ii7 in a manner similar to that applied under section #ahec7;c77#d77;,a77iii74 7iii7 ,application on a national1 budget neutral basis ,the standardization under clause 7i7 shall be designed and implemented on a uniform national basis and shall be budget neutral so as to not result in any aggregate change in payments under subsection 7a74 7iv7 ,response to new risk ,subject to clause 7iii71 the ,secretary may adjust the standardization under clause 7i7 to respond promptly to new instances of communicable diseases and other public health hazards4 7v7 ,reference to application of risk adjustment ,for rules related to the application of risk adjustment to amounts under subsection 7a77#a77;,a71 see subsection 7e74 7,d7 ,adjustment for temporary ,,fmap increases ,in computing each base per beneficiary1 per category amounts under subparagraph 7,a77i7 the ,secretary shall disregard portions of payments that are attributable to a temporary increase in the ,federal matching rates1 including those attributable to the following3 7i7 ,,ppaca disaster ,,fmap ,section #aije7;aa74 7ii7 ,,arra ,section #ejja of the ,american ,recovery and ,reinvestment ,act of #bjji 7#db ,u4,s4,c4 #acif;d note74 7iii7 ,extraordinary employer pension contribution ,section #fad of the ,children's ,health ,insurance ,program ,reauthorization ,act of #bjji 7#db ,u4,s4,c4 #acif;d note74 7#c7 ,allocation of nonmedical assistance payments ,the ,secretary shall establish rules for the allocation of payments under this title 7other than those payments described in paragraph 7#a7 or 7#e7 of section #aijc7;a7 and including such payments attributable to section #aibc7-- 7,a7 among different categories of beneficiaries2 and 7,b7 between payments included under subsection 7a77#a7 and payments described in subsection 7a77#d74 7#d7 ,transition to a corridor around the national average 7,a7 ,determination of national average base per beneficiary1 per category amount ,subject to subparagraph 7,c71 the ,secretary shall determine a national average base per beneficiary1 per category amount equal to the average of the base per beneficiary1 per category amounts for each of the #ej ,states and the ,district of ,columbia determined under paragraph 7#b71 weighted by the average number of beneficiaries in each such category and ,state as determined by the ,secretary consistent with subsection 7d7 for the base fiscal year4 7,b7 ,transition adjustment 7i7 ,high per beneficiary states ,in the case of a high per beneficiary ,state 7as defined in clause 7iii77,i77 for a category1 the beneficiary-based quarterly amount for such ,state and category for a quarter in a reform year 7beginning with the fourth reform year and ending with the tenth reform year7 is equal to the sum of-- 7,i7 the product of the ,state-specific factor for such reform year 7as defined in clause 7iv77 and the beneficiary-based quarterly amount that would otherwise be determined under paragraph 7#a7 for such ,state and category if the ,state were a ,state described in clause 7ii7 of paragraph 7#a77;,c71 instead of a ,state described in clause 7i7 of such paragraph2 and 7,,ii7 the product of #a minus the ,state-specific factor for such reform year and the beneficiary-based quarterly amount that would otherwise be determined under paragraph 7#a7 for a ,state and category if the base per beneficiary1 per category amount determined under paragraph 7#b7 for the ,state and category were equal to #aaj percent of the national average base per beneficiary1 per category amount determined under subparagraph 7,a7 for such category4 7ii7 ,low per beneficiary states ,in the case of a low per beneficiary ,state 7as defined in clause 7iii77,,ii77 for a category1 the beneficiary-based quarterly amount for such ,state and category for a quarter in a reform year 7beginning with the fourth reform year and ending with the tenth reform year7 is equal to the sum of-- 7,i7 the product of the ,state-specific factor for such reform year and the beneficiary-based quarterly amount that would otherwise be determined under paragraph 7#a7 for such ,state and category if the ,state were a ,state described in clause 7ii7 of paragraph 7#a77;,c71 instead of a ,state described in clause 7i7 of such paragraph2 and 7,,ii7 the product of #a minus the ,state-specific factor for such reform year and the beneficiary-based quarterly amount that would otherwise be determined under paragraph 7#a7 for a ,state and category if the base per beneficiary1 per category amount determined under paragraph 7#b7 for the ,state and category were equal to #ij percent of the national average base per beneficiary1 per category amount determined under subparagraph 7,a7 for such category4 7iii7 ,high and low per beneficiary ,states defined ,in this subparagraph3 7,i7 ,high per beneficiary ,state ,the term high per beneficiary ,state means1 with respect to a category1 a ,state for which the base per beneficiary1 per category amount determined under paragraph 7#b7 for such category is greater than #aaj percent of the national average base per beneficiary1 per category amount determined under subparagraph 7,a7 for such category4 7,,ii7 ,low per beneficiary ,state ,the term low per beneficiary ,state means1 with respect to a category1 a ,state for which the base per beneficiary1 per category amount determined under paragraph 7#b7 for such category is less than #ij percent of the national average base per beneficiary1 per category amount determined under subparagraph 7,a7 for such category4 7iv7 ,state-specific factor ,in this subparagraph1 the term ,state-specific factor means-- 7,i7 for the fourth reform year1 #g_/h2 and 7,,ii7 for a subsequent reform year1 the ,state-specific factor under this clause for the previous reform year minus #a_/h4 7,c7 ,no additional expenditures 7i7 ,determination of increase in ,federal expenditures ,for each category for each reform year 7beginning with the fourth reform year and ending with the tenth reform year71 the ,secretary shall determine whether the application of this paragraph-- 7,i7 to the category for the reform year will result in an aggregate increase in the aggregate ,federal expenditures under subsection 7a72 and 7,,ii7 to all the categories for the reform year will result in a net aggregate increase in the aggregate ,federal expenditures under subsection 7a74 7ii7 ,adjustment ,if the ,secretary determines under clause 7i77,,ii7 that the application of this paragraph to all the categories for a reform year will result in a net aggregate increase in the aggregate ,federal expenditures under subsection 7a71 the ,secretary shall reduce the national average base per beneficiary1 per category amount computed under subparagraph 7,a7 for each of the categories determined under clause 7i77,i7 for which there will be an aggregate increase in the aggregate ,federal expenditures under subsection 7a7 by such uniform percentage as will ensure that there is no net aggregate ,federal expenditure increase described in clause 7i77,,ii7 for the reform year4 7#e7 ,reports on per beneficiary rates2 appeals 7,a7 ,report to states ,not later than #h months after the date of the enactment of this section1 the ,secretary shall submit to each ,state the ,secretary's initial determination of-- 7i7 the base per beneficiary1 per category amounts under paragraph 7#b7 for such ,state2 and 7ii7 the national average base per beneficiary1 per category amounts under paragraph 7#d77;,a74 7,b7 ,opportunity to appeal ,not later than #c months after the date a ,state receives notice of the ,secretary's initial determination of such base per beneficiary1 per category amounts for such ,state under subparagraph 7,a77i71 the ,state may file with the ,secretary1 in a form and manner specified by the ,secretary1 an appeal of such determination4 7,c7 ,determination on appeal ,not later than #c months after receiving such an appeal1 the ,secretary shall make a final determination on such amounts for such ,state4 ,if no such appeal is received for a ,state1 the ,secretary's initial determination under subparagraph 7,a77i7 shall become final4 7#f7 ,base fiscal year defined ,in this section1 the term base fiscal year means the latest fiscal year1 ending before the date of the enactment of this section1 for which the ,secretary determines that adequate data are available to make the computations required under this subsection4 7d7 ,not counting individuals ,to account for excluded payments ,under rules specified by the ,secretary1 individuals shall not be counted as ,medicaid beneficiaries for purposes of subsection 7b77#a77;,b7 and subsection 7c77#b77;,a7 to the extent that such individuals-- 7#a7 are receiving medical assistance for which payments described under subsection 7a77#d77;,a7 are made2 or 7#b7 would not have been eligible to enroll under the ,state plan 7or waiver of such plan7 in the ,state in which such individual is so enrolled if the rules for eligibility for enrollment under such plan 7or waiver7 were the same as such rules for eligibility in effect as of ,january #a1 #bjji4 7e7 ,risk ,adjustment 7#a7 ,in general ,the amount under subsection 7a77#a77;,a7 shall be adjusted under this subsection in an appropriate manner1 specified by the ,secretary and consistent with paragraph 7#b71 to take into account-- 7,a7 the factors described in subsection 7c77#b77;,c77i77,i7 within a category of beneficiaries2 and 7,b7 variations in costs on a county-by-county basis for medical assistance and administrative expenses4 7#b7 ,method of adjustment 7,a7 ,in general ,the adjustments under paragraph 7#a7 shall be made in a manner similar to the manner in which similar adjustments are made under subsection 7c77#b77;,c7 and consistent with the requirements of clause 7iii7 of such subsection and subparagraph 7,b74 7,b7 ,biannual update of risk adjustment methodology ,in applying clause 7i77,i7 of subsection 7c77#b77;,c7 for purposes of subparagraph 7,a71 the ,secretary shall1 in consultation with the entities described in clause 7ii77,i7 of such subsection1 update the risk adjustment methodology applied as appropriate not less often than every #b years4 7f7 ,chronic care quality bonus payments 7#a7 ,determination of bonus payments ,if the ,secretary determines that1 based on the reports under paragraph 7#e71 with respect to categories of chronic disease for which chronic care performance targets had been established under paragraph 7#c7 for each category of ,medicaid beneficiaries specified under subsection 7b77#b7 such targets have been met by a ,state for a reform year1 the ,secretary shall make an additional payment to such ,state in the amount specified in paragraph 7#f7 for each quarter in the succeeding reform year4 ,such payments shall be made in a manner specified by the ,secretary and may only be used consistent with subsection 7a77#c74 7#b7 ,identification of categories of chronic disease ,the ,secretary shall determine the categories of chronic disease for which bonus payments may be available under this subsection for each category of ,medicaid beneficiaries4 7#c7 ,adoption of quality measurement system and identification of performance targets 7,a7 ,system and data ,with respect to the categories of chronic disease under paragraph 7#b71 the ,secretary shall adopt a quality measurement system that uses data described in paragraph 7#d7 and is similar to the ,five-,star ,quality ,rating ,system used to indicate the performance of ,medicare ,advantage plans under part ,c of title ,,xviii4 7,b7 ,targets ,using such system and data1 the ,secretary shall establish for each reform year the chronic care performance targets for purposes of the payments under paragraph 7#a74 ,such performance targets shall be established in consultation with ,states1 associations representing individuals with chronic illnesses1 entities providing treatment to such individuals for such chronic illnesses1 and other stakeholders1 including the ,national ,association of ,medicaid ,directors and the ,national ,governors ,association4 7#d7 ,data to be used ,the data to be used under paragraph 7#c7 shall include-- 7,a7 data collected through methods such as-- 7i7 the ,healthcare ,effectiveness ,data and ,information ,set 7also known as ,,hedis7 7or an appropriate successor performance measurement tool72 7ii7 the ,consumer ,assessment of ,healthcare ,providers and ,systems 7also known as ,,cahps7 7or an appropriate successor performance measurement tool72 and 7iii7 the ,health ,outcomes ,survey 7also known as ,,hos7 7or an appropriate successor performance measurement tool72 and 7,b7 other data collected by the ,state4 7#e7 ,reports 7,a7 ,in general ,each ,state shall collect1 analyze1 and report to the ,secretary1 at a frequency and in a manner to be established by the ,secretary1 data described in paragraph 7#d7 that permit the ,secretary to monitor the ,state's performance relative to the chronic care performance targets established under paragraph 7#c74 7,b7 ,review and verification ,the ,secretary may review the data collected by the ,state under subparagraph 7,a7 to verify the ,state's analysis of such data with respect to the performance targets under paragraph 7#c74 7#f7 ,amount of bonus payments 7,a7 ,in general ,subject to subparagraphs 7,b7 and 7,c71 with respect to each category of ,medicaid beneficiaries1 in the case of a ,state that the ,secretary determines1 based on the chronic care performance targets set under paragraph 7#c7 for a reform year for such category1 performs-- 7i7 in the top five ,states in such category1 subject to subparagraph 7,c77ii71 the amount of the bonus for each quarter in the succeeding reform year shall be #aj percent of the payment amount otherwise paid to the ,state under subsection 7a7 for individuals enrolled under the plan within such category2 7ii7 in the next five ,states in such category1 subject to subparagraph 7,c77ii71 the amount of the bonus for each such quarter shall be #e percent of the payment amount otherwise paid to the ,state under subsection 7a7 for individuals enrolled under the plan within such category2 7iii7 in the next five ,states in such category1 subject to clauses 7i7 and 7iii7 of subparagraph 7,c71 the amount of the bonus for each such quarter shall be #c percent of the payment amount otherwise paid to the ,state under subsection 7a7 for individuals enrolled under the plan within such category2 7iv7 in the next five ,states in such category1 subject to clauses 7i7 and 7iii7 of subparagraph 7,c71 the amount of the bonus for each such quarter shall be #b percent of the payment amount otherwise paid to the ,state under subsection 7a7 for individuals enrolled under the plan within such category2 and 7v7 in the next five ,states in such category1 subject to clauses 7i7 and 7iii7 of subparagraph 7,c71 the amount of the bonus for each such quarter shall be #a percent of the payment amount otherwise paid to the ,state under subsection 7a7 for individuals enrolled under the plan within such category4 7,b7 ,aggregate annual limit for each category of ,medicaid beneficiaries 7i7 ,in general ,in no case may the aggregate amount of bonuses under this subsection for quarters in a reform year for a category of ,medicaid beneficiaries exceed the limit specified in clause 7ii7 for the reform year4 7ii7 ,limit ,the limit specified in this clause-- 7,i7 for the second reform year is equal to #bej1jjj1jjj2 or 7,,ii7 for a subsequent reform year is equal to the limit specified in this clause for the previous reform year increased by the per beneficiary percentage increase determined under paragraph 7#a77;,e7 of subsection 7c74 7,c7 ,limitation and proration of bonuses based on application of aggregate limit 7i7 ,no bonus for third or subsequent tiers unless aggregate limit not reached on first two tiers ,no bonus shall be payable under clause 7iii71 7iv71 or 7v7 of subparagraph 7,a7 for a category of ,medicaid beneficiaries for a quarter in a reform year unless the aggregate amount of bonuses under clauses 7i7 and 7ii7 of such subparagraph for such category and reform year is less than the limit specified in subparagraph 7,b77ii7 for the reform year4 7ii7 ,proration for first two tiers ,if the aggregate amount of bonuses under clauses 7i7 and 7ii7 of subparagraph 7,a7 for a category of ,medicaid beneficiaries for quarters in a reform year exceeds the limit specified in subparagraph 7,b77ii7 for the reform year1 the amount of each such bonus shall be prorated in a manner so the aggregate amount of such bonuses is equal to such limit4 7iii7 ,proration for next three tiers ,if the aggregate amount of bonuses under clauses 7i7 and 7ii7 of subparagraph 7,a7 for a category of ,medicaid beneficiaries for quarters in a reform year is less than the limit specified in subparagraph 7,b77ii7 for the reform year1 but the aggregate amount of bonuses under clauses 7i7 through 7v7 of subparagraph 7,a7 for the category and such quarters in the reform year exceeds the limit specified in subparagraph 7,b77ii7 for the reform year1 the amount of each bonus in clauses 7iii71 7iv71 and 7v7 of subparagraph 7,a7 shall be prorated in a manner so the aggregate amount of all the bonuses under subparagraph 7,a7 is equal to such limit4 7g7 ,state option for receiving ,medicare payments for full-,benefit dual eligible individuals 7#a7 ,in general ,under this subsection a ,state may elect for quarters beginning on or after the implementation date in a reform year to receive payment from the ,secretary under paragraph 7#c74 ,as a condition of receiving such payment1 the ,state shall agree to provide to full-benefit dual eligible individuals eligible for medical assistance under the ,state plan-- 7,a7 the medical assistance to which such eligible individuals would otherwise be entitled under this title2 and 7,b7 any items and services which such eligible individuals would otherwise receive under title ,,xviii4 7#b7 ,provider payment requirement 7,a7 ,in general ,a ,state electing the option under this subsection shall provide payment to health care providers for the items and services described under paragraph 7#a77;,b7 at a rate that is not less than the rate at which payments would be made to such providers for such items and services under title ,,xviii4 7,b7 ,flexibility in payment methods ,nothing in subparagraph 7,a7 shall be construed as preventing a ,state from using alternative payment methodologies 7such as bundled payments or the use of accountable care organizations 7as such term is used in section #ahii77 for purposes of making payments to health care providers for items and services provided to dual eligible individuals in the ,state under the option under this subsection4 7#c7 ,payments to ,states in lieu of ,medicare payments ,with respect to a full-benefit dual eligible individual1 in the case of a ,state that elects the option under paragraph 7#a7 for quarters in a reform year-- 7,a7 the ,secretary shall not make any payment under title ,,xviii for items and services furnished to such individual for such quarters2 and 7,b7 the ,secretary shall pay to the ,state1 in addition to the amounts paid to such ,state under subsection 7a71 the amount that the ,secretary would1 but for this subsection1 otherwise pay under title ,,xviii for items and services furnished to such an individual in such ,state for such quarters4 7#d7 ,full-benefit dual eligible individual defined ,in this subsection1 the term full-benefit dual eligible individual means an individual who meets the requirements of section #aice7;c77#f77;,a77ii74 7h7 ,audits ,the ,secretary shall conduct such audits on the number and classification of ,medicaid beneficiaries under such subsections and expenditures under this section as may be necessary to ensure appropriate payments under this section4 7i7 ,treatment of waivers 7#a7 ,no impact on current waivers ,in the case of a waiver of requirements of this title pursuant to section #aaae or other law that is in effect as of the date of the enactment of this section1 nothing in this section shall be construed to affect such waiver for the period of the waiver as approved as of such date4 7#b7 ,application of budget neutrality to subsequent waivers and renewals taking section into account ,in the case of a waiver of requirements of this title pursuant to section #aaae or other law that is approved or renewed after the date of the enactment of this section1 to the extent that such approval or renewal is conditioned upon a demonstration of budget neutrality1 budget neutrality shall be determined taking into account the application of this section4 7j7 ,report to ,congress ,not later than ,january #a of the second reform year1 the ,secretary shall submit to ,congress a report on the implementation of this section4 7k7 ,definitions ,in this section3 7#a7 ,implementation date ,the term implementation date means-- 7,a7 ,july #a1 #bjba1 if this section is enacted on or before ,july #a1 #bjbj2 or 7,b7 ,july #a1 #bjbb1 if this section is enacted after ,july #a1 #bjbj4 7#b7 ,reform years 7,a7 ,the term reform year means a fiscal year beginning with the first reform year4 7,b7 ,the term first reform year means the fiscal year in which the implementation date occurs4 7,c7 ,the terms second1 third1 and successive similar terms mean1 with respect to a reform year1 the second1 third1 or successive reform year1 respectively1 succeeding the first reform year4 4 7b7 ,conforming amendments 7#a7 ,continued application of clawback provisions 7,a7 ,continued application ,subsections 7a7 and 7c77#a77;,c7 of section #aice of such ,act 7#db ,u4,s4,c4 #acifu-#e7 are each amended by inserting or #aijc;,a7a7 after #aijc7;a74 7,b7 ,technical amendment ,section #aice7;d77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#e7;d77#a77 is amended by inserting except as provided in section #aijc;,a7g7 after any other provision of this title4 7#b7 ,payment rules under section #aijc 7,a7 ,section #aijc7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7a77 is amended1 in the matter before paragraph 7#a71 by inserting and section #aijc;,a after except as otherwise provided in this section4 7,b7 ,section #aijc7;d7 of such ,act 7#db ,u4,s4,c4 #acif;b7d77 is amended-- 7i7 in paragraph 7#a71 by inserting and under section #aijc;,a after subsections 7a7 and 7b72 7ii7 in paragraph 7#b7-- 7,i7 in subparagraph 7,a71 by inserting or section #aijc;,a after was made under this section2 and 7,,ii7 in subparagraph 7,b71 by inserting or section #aijc;,a after under subsection 7a72 7iii7 in paragraph 7#d7-- 7,i7 by striking under this subsection and inserting 1 with respect to this section or section #aijc;,a1 under this subsection2 and 7,,ii7 by striking under this section and inserting under the respective section2 and 7iv7 in paragraph 7#e71 by inserting or section #aijc;,a after overpayment under this section4 7#c7 ,conforming waiver authority ,section #aaae7;a77#b77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acae7;a77#b77;,a77 is amended by striking or #aijc and inserting #aijc1 or #aijc;,a4 7#d7 ,report on additional conforming amendments needed ,not later than #f months after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit to ,congress a report that includes a description of any additional technical and conforming amendments to law that are required to properly carry out this ,act4 #djb4 ,income limitations for refundable credits for coverage under a qualified health plan 7a7 ,in general ,subparagraphs 7,a7 and 7,b7 of section #cf;,b7c77#a7 of the ,internal ,revenue ,code of #aihf are amended by inserting after #ajj percent each place such term appears the following3 7or1 in the case of a taxpayer enrolled through an ,exchange utilized by such ,state that makes the election described in section #aijc;,a of the ,social ,security ,act1 the percentage established by such ,state under part ,a of title ,,iv of such ,act for purposes of eligibility under title ,,xix of such ,act as of ,january #a1 #bjji74 7b7 ,effective date ,the amendments made by this section shall apply with respect to taxable years beginning after the date of the enactment of this ,act4 #djc4 ,medicaid eligibility determinations 7a7 ,state flexibility ,to use contractors ,to make eligibility determinations on behalf of ,state ,section #aijb7;a77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#e77 is amended by inserting before the semicolon at the end the following3 1 but such determinations of eligibility may be made1 at the option of a ,state1 under a contract with another ,state or local agency or a contractor so long as the contract does not provide incentives for the agency or contractor to delay eligibility determinations or to deny eligibility for individuals otherwise eligible for medical assistance4 7b7 ,frequency of eligibility redeterminations ,section #aijb7;e77#ad7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7e77#ad77 is amended by adding at the end the following3 7,l7 ,frequency of eligibility redeterminations ,beginning on ,october #a1 #bjai1 and notwithstanding subparagraph 7,h71 in the case of an individual whose eligibility for medical assistance under the ,state plan under this title 7or a waiver of such plan7 is determined based on the application of modified adjusted gross income under subparagraph 7,a7 and who is so eligible on the basis of clause 7i77,,viii71 7ii77,,xx71 or 7ii77,,xxiii7 of subsection 7a77#aj77;,a71 at the option of the ,state1 the ,state plan may provide that the individual's eligibility shall be redetermined every #f months 7or such shorter number of months as the ,state may elect74 4 #djd4 ,lowering safe harbor threshold with respect to ,state taxes on health care providers ,section #aijc7w77#d77;,c77ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7w77#d77;,c77ii77 is amended-- 7#a7 by striking of fiscal years beginning and inserting of fiscal years-- 7,i7 beginning 2 and 7#b7 by striking it appears4 and inserting the following3 it appears2 7,,ii7 beginning on or after ,january #a1 #bjba1 and before ,january #a1 #bjcj1 #d percent shall be substituted for #f percent each place it appears2 7,,iii7 beginning on or after ,january #a1 #bjcj1 and before ,january #a1 #bjce1 #c percent shall be substituted for #f percent each place it appears2 7,,iv7 beginning on or after ,january #a1 #bjce1 and before ,january #a1 #bjdj1 #b percent shall be substituted for #f percent each place it appears2 7,v7 beginning on or after ,january #a1 #bjdj1 and before ,january #a1 #bjde1 #a percent shall be substituted for #f percent each place it appears2 and 7,,vi7 beginning on or after ,january #a1 #bjde1 #j percent shall be substituted for #f percent each place it appears4 4 #dje4 ,providing for ,state approval and implementation of specified waivers under the ,medicaid program ,section #aaae of the ,social ,security ,act 7#db ,u4,s4,c4 #acae7 is amended-- 7#a7 in subsection 7d7-- 7,a7 in paragraph 7#a71 by striking ,an application and inserting ,subject to paragraph 7#d71 an application2 and 7,b7 by adding at the end the following new paragraph3 7#d7 7,a7 ,an experimental1 pilot1 or demonstration project undertaken under subsection 7a7 may be approved or renewed by a ,state if such project is described in subparagraph 7,b74 7,b7 ,an experimental1 pilot1 or demonstration project is described in this subparagraph if such project provides for a waiver of requirements with respect to a ,state plan 7or a waiver of such plan7 under title ,,xix such that-- 7i7 individuals enrolled under such plan 7or such waiver7 may elect to participate in such project with respect to a year2 and 7ii7 such individuals who elect to so participate are furnished with primary care services 7as described in section #bbc7;c77#a77;,d77ii77,i7 of the ,internal ,revenue ,code of #aihf7 through a direct primary care service arrangement 7as defined in such section74 7,c7 ,for purposes of a ,state's approval or renewal of an experimental1 pilot1 or demonstration project under subparagraph 7,a71 each reference to the ,secretary in subsection 7a7 shall be deemed to be a reference to the ,state4 2 and 7#b7 in subsection 7e71 by inserting 7other than such a project that is described in paragraph 7#d77;,b77 before the period at the end4 #djf4 ,deduction for qualified charity care 7a7 ,in general ,part ,,vi of subchapter ,b of chapter #a of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new section3 #aii;,b4 ,qualified charity care 7a7 ,in general ,there shall be allowed as a deduction for the taxable year an amount equal to-- 7#a7 in the case of a direct primary care physician1 an amount equal to the sum of-- 7,a7 the fee 7as published on a publicly available website of such physician7 for physicians' services that are qualified charity care furnished by such taxpayer during such year1 and 7,b7 for each visit by a patient to such physician during which qualified charity care is furnished1 half of so much of the lowest subscription fee of such physician that is attributable to a month1 and 7#b7 in the case of any other individual1 the unreimbursed ,medicare-based value of qualified charity care furnished by such taxpayer during such year4 7b7 ,definitions ,for purposes of this section3 7#a7 ,unreimbursed medicare-based value ,the term unreimbursed ,medicare-based value means1 with respect to physicians' services1 the amount payable for such services under the physician fee schedule established under section #ahdh of the ,social ,security ,act4 7#b7 ,qualified charity care ,the term qualified charity care means physicians' services that are furnished-- 7,a7 without expectation of reimbursement1 and 7,b7 to an individual enrolled-- 7i7 under a ,state plan under title ,,xix of the ,social ,security ,act 7or a waiver of such plan71 or 7ii7 under a ,state child health plan under title ,,xxi of the ,social ,security ,act 7or a waiver of such plan74 7#c7 ,direct primary care physician ,the term direct primary care physician means a physician 7as defined in section #ahfa7r7 of the ,social ,security ,act7 who provides primary care-- 7,a7 to individuals who have paid a periodic subscription fee1 and 7,b7 in exchange for a fee that is published on a publicly available website of such physician4 7#d7 ,physicians' services ,the term physicians services' has the meaning given such term by section #ahfa7q7 of the ,social ,security ,act4 7c7 ,limitation ,the amount allowed as a deduction under subsection 7a7 for a taxable year shall not exceed the gross receipts attributable to physicians' services furnished by the taxpayer during the taxable year4 4 7b7 ,clerical amendment ,the table of sections for part ,,vi of subchapter ,b of chapter #a of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new item3 ,sec4 #aii;,b4 ,qualified charity care4 4 ,b ,medicare ,reforms #daa4 ,off-campus provider-based department ,medicare site neutral payment 7a7 ,in general ,section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is amended by adding at the end the following new subsection3 7x7 ,off-,campus provider-,based department ,medicare site neutral payment 7#a7 ,in general ,with respect to items and services furnished in an off-campus provider-based department1 payment under this section for such items and services shall be the amount determined under the fee schedule under section #ahdh for such items and services furnished if furnished in a physician office setting4 7#b7 ,off-campus provider-based department ,for purposes of this subsection1 the term off-campus provider-based department has such meaning as specified by the ,secretary4 4 7b7 ,effective date ,the amendment made by subsection 7a7 shall apply with respect to items and services furnished on or after ,january #a1 #bjba4 #dab4 ,eliminating ,,fehbp eligibility for annuitants ,section #hije7;b7 of title #e1 ,united ,states ,code1 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by striking ,an and inserting ,consistent with the last sentence of this subsection1 an2 and 7#b7 by adding at the end the following3 4 ,an individual who is entitled to benefits under part ,a of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;c et seq47 by reason of section #bbf or #bbf;,a of such ,act 7#db ,u4,s4,c4 #dbf1 #dbf-a71 or otherwise eligible to enroll under such part pursuant to section #ahah or #ahah;,a of such ,act 7#db ,u4,s4,c4 #acie;i-#b1 #acie;i-#b;a71 and who first becomes an annuitant after the date of enactment of this sentence may not continue enrollment in any health benefits plan under this chapter44 #dac4 ,elimination of ,medicare eligibility for certain individuals 7a7 ,enrollment prohibition 7#a7 ,part ,b ,section #ahcf of the ,social ,security ,act 7#db ,u4,s4,c4 #acieo7 is amended by striking the period at the end and inserting 1 except that an individual who attains age #fe on or after ,january #a1 #bjcj1 and is an individual who1 upon attaining such age1 has earned #aj1jjj1jjj or more in lifetime wages1 shall not be eligible to so enroll44 7#b7 ,part ,d ,section #ahfj;,d-#a7;a77#c77;,a7 of such ,act 7#db ,u4,s4,c4 #aciew-#aja7;a77#c77;,a77 is amended by striking the period at the end and inserting 1 excluding an individual who1 upon attaining age #fe1 has earned #aj1jjj1jjj or more in lifetime wages44 7b7 ,medigap ,section #ahhb of the ,social ,security ,act 7#db ,u4,s4,c4 #aciess7 is amended by adding at the end the following new subsection3 7aa7 ,additional limitation on newly eligible beneficiaries 7#a7 ,in general ,notwithstanding any other provision of this section1 on or after ,january #a1 #bjcj1 a medicare supplemental policy may not be sold or issued to a targeted newly eligible ,medicare beneficiary4 7#b7 ,targeted newly eligible ,medicare beneficiary ,for purposes of this subsection1 the term targeted newly eligible ,medicare beneficiary means an individual who1 upon attaining the age of #fe1 has earned #aj1jjj1jjj or more in lifetime wages4 4 #dad4 ,medicare part ,d tax deduction 7a7 ,in general ,section #aci;,a of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following3 ,this section shall not be taken into account for purposes of determining whether any deduction is allowable with respect to any cost taken into account in determining such payment44 7b7 ,effective date ,the amendment made by this section shall apply to taxable years beginning after ,december #ca1 #bjah4 #dae4 ,repeal of net investment income tax 7a7 ,in general ,subtitle ,a of the ,internal ,revenue ,code of #aihf is amended by striking chapter #b;,a4 7b7 ,effective date ,the amendment made by this section shall apply to taxable years beginning after ,december #ca1 #bjai4 #daf4 ,medicare coverage of bad debt ,section #ahfa7v77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie7v77#a77 is amended-- 7#a7 in subparagraph 7,t7-- 7,a7 in clause 7iv71 by striking and at the end2 7,b7 in clause 7v7-- 7i7 by striking during fiscal year and inserting during fiscal years2 7ii7 by striking or a subsequent fiscal year and inserting through #bjba2 and 7iii7 by striking the period at the end and inserting 1 and2 and 7,c7 by adding at the end the following new clause3 7vi7 for cost reporting periods beginning during fiscal year #bjba or a subsequent fiscal year1 by the percent applicable for cost reporting periods beginning during the previous fiscal year1 increased 7through fiscal year #bjbd7 by #aj percentage points4 2 7#b7 in subparagraph 7,v7-- 7,a7 in clause 7i7-- 7i7 in subclause 7,,iii71 by striking and at the end2 7ii7 in subclause 7,,iv7-- 7,i7 by striking during fiscal year and inserting during fiscal years #bjae through #bjba2 and 7,,ii7 by striking the period at the end and inserting 2 and2 and 7iii7 by adding at the end the following new subclause3 7,v7 for cost reporting periods beginning during fiscal year #bjba or a subsequent fiscal year1 the percent applicable for cost reporting periods beginning during the previous fiscal year1 increased 7through fiscal year #bjbd7 by #aj percentage points4 2 and 7,b7 in clause 7ii7-- 7i7 in subclause 7,,iii71 by striking and at the end2 and 7ii7 in subclause 7,,iv7-- 7,i7 by striking a subsequent fiscal year and inserting fiscal years #bjae through #bjba2 7,,ii7 by striking the period at the end and inserting 2 and2 and 7,,iii7 by adding at the end the following new subclause3 7,v7 for cost reporting periods beginning during fiscal year #bjba or a subsequent fiscal year1 shall be reduced by the percent applicable for cost reporting periods beginning during the previous fiscal year1 increased 7through fiscal year #bjbd7 by #aj percentage points4 2 and 7#c7 in subparagraph 7,w77i7-- 7,a7 in subclause 7,,ii71 by striking and at the end2 7,b7 in subclause 7,,iii7-- 7i7 by striking during a subsequent fiscal year and inserting during fiscal years #bjae through #bjba2 and 7ii7 by striking the period at the end and inserting 2 and2 and 7,c7 by adding at the end the following new subclause3 7,,iv7 for cost reporting periods beginning during fiscal year #bjba or a subsequent fiscal year1 by the percent applicable for cost reporting periods beginning during the previous fiscal year1 increased 7through fiscal year #bjbd7 by #aj percentage points4 4 ,c ,medicare ,choice and ,competition #dba4 ,competitive bidding and premiums under unified ,medicare 7a7 ,in general ,part ,e of title ,,xviii of the ,social ,security ,act1 as added by section #aja and amended by section #ajc1 is further amended by adding at the end the following3 #c ,competitive bidding and premiums #ahfj;,e-#ca4 ,application of competitive bidding in enrollment 7a7 ,in general ,notwithstanding any other provision of this title1 the ,secretary shall1 beginning with plan year #bjba1 establish a method whereby individuals enrolling under this title so enroll through an online process designed to highlight enrollment options for such individuals and allow such individuals to compare costs of enrollment in such options4 7b7 ,enrollment options ,for purposes of subsection 7a71 the ,secretary shall make the following options available to individuals for enrollment under this title3 7#a7 ,traditional fee-for-service coverage4 7#b7 provider-led risk-bearing plans 7also known as ,a,c,os74 7#c7 ,medicare ,advantage plans4 7c7 ,medicare advantage plan actuarial value requirement ,each ,medicare ,advantage plan offered through the process described in subsection 7a7 shall have an actuarial value equal to traditional fee-for-service coverage under parts ,a and ,b4 7d7 ,,ma direct deposit of certain rebates ,in the case of an ,medicare ,advantage plan with a bid for a year that involves a premium differential between such bid and the benchmark for such year and plan1 such plan shall provide for a direct deposit of such differential if the applicable enrollee in such plan does not elect any supplemental coverage under such plan4 7e7 ,enrollment in prescription drug coverage ,as part of the method described in subsection 7a71 the ,secretary shall establish a process to allow an individual to enroll in prescription drug coverage4 ,in the case of an individual who enrolls in a ,medicare ,advantage plan1 such coverage shall be provided under such plan4 ,in a case of an individual who enrolls in an ,,aco1 such coverage shall be provided under such network4 ,in the case of an individual who enrolls under traditional fee-for-service coverage1 such drug coverage shall be provided through a prescription drug plan4 7f7 ,supplemental benefits 7#a7 ,,ma plans ,an ,,ma plan is allowed to offer two different packages of supplemental benefits 7these packages are available only to individuals who select such plans74 7#b7 ,a,c,os ,a,c,os may limit supplemental options for their enrollees to ,medigap plans with contractual ties4 7#c7 ,fee-for-service ,fee-for-service individuals may select supplemental coverage from ,medigap policies4 #ahfj;,e-#cb4 ,competition 7a7 ,bid areas ,market areas used for bid submissions for ,medicare ,advantage plans1 ,a,c,os1 and for calculation per person fee-for-services costs shall be metropolitan statistical regions plus associated regions4 7b7 ,premiums ,medicare payment benchmark by market area shall be calculated based on weighted average 7by enrollment in previous year7 of the premium bids from ,,ma plans1 ,a,c,os1 and the per person costs of fee-for-service1 less the statutory part ,b premium4 7c7 ,beneficiary responsibility ,beneficiaries shall pay the difference between ,medicare payment and required premium of the plan they choose1 and get #ajj percent of the savings by choosing a plan with a premium below the benchmark4 7d7 ,transition ,for beneficiaries who are in fee-for-service at the time of the enactment of this section1 there shall be a limit on the amount of a premium increase allowable by year of no more than #bj per month compared to what such premium would have otherwise been if this subpart had not been enacted for each year through the fifth year4 7e7 ,multiyear contracts ,a ,medicare ,advantage plan may offer to beneficiaries multiyear contracts with guaranteed premiums over such years1 bearing the risk of any change in payments from the ,secretary in subsequent years4 ,a beneficiary enrolling under such a contract shall be exempt from the method described in subsection 7a74 4 7b7 ,conforming amendments 7#a7 ,section #ahec7;a77#a77;,a7 of the ,social ,security ,act is amended by striking and section #ahei7;e77#d7 and inserting 1 section #ahei7;e77#d71 and subpart #c of part ,e4 7#b7 ,section #ahec7;j7 of such ,act is amended by inserting and subpart #c of part ,e after subsection 7o74 7#c7 ,section #ahed of such ,act is amended-- 7,a7 in subsection 7a71 after the heading1 by inserting ,subject to subpart #c of part ,e32 7,b7 in subsection 7b71 after the heading1 by inserting ,subject to subpart #c of part ,e32 7,c7 in subsection 7d71 after the heading1 by inserting ,subject to subpart #c of part ,e32 and 7,d7 in subsection 7e71 after the heading1 by inserting ,subject to subpart #c of part ,e34 #dbb4 ,new unified eligibility and enrollment rules 7a7 ,in general ,title ,,xviii of the ,social ,security ,act is amended-- 7#a7 by redesignating part ,e as part ,f2 and 7#b7 by inserting after part ,d the following new part3 ,e ,medicare with ,choice and ,competition #a ,opt-,out and auto-,enrollment #ahfj;,e-#aa4 ,part ,a opt-out and ,,ma auto-enrollment 7a7 ,permitting individuals ,to opt out of part ,a coverage without losing social security benefits 7#a7 ,in general ,the ,secretary shall establish-- 7,a7 a process by which an individual otherwise entitled to benefits under part ,a may elect 7at a time and in a manner specified under the process7 to waive such entitlement2 and 7,b7 a process by which an individual who elects to waive such entitlement may revoke 7at a time and in a manner specified under the process7 such waiver4 ,the process under subparagraph 7,b7 shall be coordinated with the enrollment process under section #ahcg for part ,b4 7#b7 ,application of late enrollment penalty ,an individual who revokes a waiver under paragraph 7#a77;,b7 shall be subject to a late enrollment penalty as applied under section #ahfj;,e-#cb7;c77#b77;,c74 7#c7 ,no impact on title ,,ii benefits ,notwithstanding any other provision of law1 an election of an individual to waive entitlement to benefits under part ,a under paragraph 7#a77;,a7 shall not result in any loss of benefits under title ,,ii4 7#d7 ,deemed opt-out 7,a7 ,an election of an individual to waive entitlement to benefits under part ,a under paragraph 7#a77;,a7 is also deemed the filing of a notice of termination of benefits under part ,b pursuant to section #ahch7;b77#a74 7,b7 ,the termination of benefits under part ,b pursuant to section #ahch7;b7 is also deemed to be a waiver of any entitlement to benefits under part ,a4 7b7 ,special open enrollment period without late enrollment penalty for current part ,a only or part ,b only enrollees ,notwithstanding any other provision of law1 in the case of an individual who as of the general effective date1 is entitled to benefits under part ,a but not enrolled under part ,b1 or who is enrolled under part ,b but not entitled to benefits 7or enrolled7 under part ,a1 beginning as of such date1 such individual shall be deemed to be enrolled under part ,b or part ,a1 respectively1 unless such individual elects to be enrolled 7or entitled to benefits7 under neither of such parts during a special open enrollment period specified by the ,secretary4 ,no increase in the monthly premium of an individual pursuant to section #ahci7;b7 or section #ahah7;c7 shall be effected in the case of any such individual who is deemed enrolled under part ,b or part ,a pursuant to the previous sentence with respect to any period prior to the date of such enrollment4 7c7 ,auto enrollment of dual eligible individuals under ,medicare ,advantage plans 7#a7 ,in general ,except in the case of a ,state that has elected the maintenance of effort option described in section #aidd7;b77#b71 in the case of an individual described in subparagraph 7,a77ii7 of section #aice7;c77#f7 7taking into account the application of subparagraph 7,b7 of such section71 the ,secretary shall establish a process for the enrollment in an ,,ma-,,pd plan that is a managed care plan under part ,c that has a monthly beneficiary premium that does not exceed the premium assistance available under section #ahfj;,e-#da7;b77#a77;,a74 ,if there is more than one such plan available1 the ,secretary shall enroll such an individual on a random basis among all such plans in the ,,pdp region4 7#b7 ,right to disenroll ,nothing in paragraph 7#a7 shall prevent such an individual from declining enrollment in any such plan 7and thereby obtaining coverage under ,medicare fee-for-service7 or from changing enrollment in such a plan to another ,,ma-,,pd plan4 #ahfj;,e-#ab4 ,coordination with part ,d 7a7 ,deemed enrollment under part ,d 7#a7 ,in general ,the ,secretary shall establish a process that1 beginning as of the general effective date1 provides for the enrollment in a prescription drug plan that has a monthly base beneficiary premium that does not exceed the weighted average of premiums for such plans that provide standard prescription drug coverage 7as defined in section #ahfj;,d-#b7;b77 with respect to the area involved 7on a random basis among all such plans in the applicable ,,pdp region7 of each ,medicare enrollee 7as defined in section #ahfj;,e-#ea7 who-- 7,a7 failed to enroll in such a prescription drug plan during the applicable enrollment or coverage election period under section #ahfj;,d-#a7;b72 and 7,b7 failed to elect not to enroll in such a prescription drug plan during an applicable opt-out period described in paragraph 7#b74 ,nothing in the previous sentence shall prevent such an individual from declining or changing such enrollment4 ,such process shall be carried out in the same manner as the process described in section #ahfj;,d-#a7;b77#a77;,c74 7#b7 ,opt-out periods ,the process under paragraph 7#a7 shall provide for the opportunity to make an election described in subparagraph 7,b7 of such paragraph during an opt-out period that is coordinated with the relevant enrollment or coverage election period under section #ahfj;,d-#a4 7#c7 ,late enrollment penalties ,in the case of an individual who makes an election described in paragraph 7#a77;,b7 and then enrolls in a prescription drug plan1 the late enrollment penalty under section #ahfj;,d-#ac7;b7 shall apply to the monthly beneficiary premium of such individual1 except that in applying such section1 any reference to the initial enrollment period of such individual shall be deemed to be a reference to the opt-out period under paragraph 7#b7 during which the individual elected not to enroll in a prescription drug plan4 7#d7 ,no late enrollment penalty for current fee-for-service beneficiaries without drug coverage ,in the case of an individual who is a ,medicare enrollee before the date of enactment of this section and who was not enrolled under a prescription drug plan before being enrolled under such a plan pursuant to paragraph 7#a71 there shall be no increase in the base beneficiary premium of an individual under section #ahfj;,d-#ac by a late enrollment penalty under subsection 7b7 of such section with respect to any period prior to the date of such enrollment4 7b7 ,reference to required prescription drug coverage under part ,c ,for provision requiring coverage under ,,ma plans to include prescription drug coverage1 see section #ahfj;,e-#bf4 4 7b7 ,limitation on ,medicaid benefits for full-,benefit dual eligible individuals ,section #aijb of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7 is amended by adding at the end the following new subsection3 7ll7 ,limitation on benefits for full-,benefit dual eligible individuals ,effective as of the general effective date 7as specified in section #ahfj;,e-#fb71 except in the case of a ,state which has elected the option described in section #aidd7;b77#b71 in the case of an individual described in subparagraph 7,a77ii7 of section #aice7;c77#f7 7taking into account the application of subparagraph 7,b7 of such section71 notwithstanding any other provision of law1 medical assistance shall not be available under this title for any items and services for which payment may be made under title ,,xviii4 4 7c7 ,medicaid maintenance of effort and alternatives ,title ,,xix of the ,social ,security ,act is amended by inserting after section #aidc the following new section3 #aidd4 ,maintenance of effort options for full-benefit dual eligible individuals 7a7 ,in general ,effective as of the general effective date 7as specified in section #ahfj;,e-#fb71 a ,state shall elect1 in a form and manner specified by the ,secretary1 a maintenance of effort option described in subsection 7b74 ,in the case of a ,state that fails to make such an election1 the ,state shall be deemed to have elected the option described in subsection 7b77#c74 7b7 ,maintenance of effort options described ,the following are maintenance of effort options described in this subsection for a ,state1 which shall apply to all individuals described in subparagraph 7,a77ii7 of section #aice7;c77#f7 7taking into account the application of subparagraph 7,b7 of such section7 for such ,state3 7#a7 ,enrollment of dual eligibles in comprehensive ,medicaid managed care plan 7,a7 ,in general ,the ,state enrolls all such individuals in a comprehensive ,medicaid managed care plan offered by a managed care entity under section #aicb4 7,b7 ,payment of subsidy amount to ,state ,in the case of a ,state that elects the option under this paragraph with respect to an individual1 the ,secretary established under section #ahfj;,e-#ea shall pay to the ,state the same amount that the individual would be entitled to have paid as an income-related premium subsidy under section #ahfj;,e-#da7;b77#a77;,a7 plus the amount that the ,secretary estimates would have been paid with respect to the individual under part ,d 7including the actuarial value of subsidy payments under sections #ahfj;,d-#ac and #ahfj;,d-#ad74 ,such payment shall be made in appropriate part from the ,federal ,hospital ,insurance ,trust ,fund under section #ahag and the ,federal ,supplementary ,medical ,insurance ,trust ,fund under section #ahda4 7,c7 ,relation to part ,d rules ,in the case of a ,state that has elected the option under this paragraph1 notwithstanding any other provision of law-- 7i7 the coverage provided under this option shall be in lieu of any coverage that may otherwise be provided under part ,d2 and 7ii7 the payment to the ,state under subparagraph 7,b7 shall be in lieu of any payments otherwise made with respect to such individual under such part4 7#b7 ,other innovative alternatives 7,a7 ,in general ,the ,state submits to the ,secretary1 and has approved by the ,secretary1 an innovative alternative proposal relating to coordinating coverage of such individuals under ,medicare and the ,state plan under title ,,xix4 7,b7 ,process for review ,with respect to proposals submitted to the ,secretary under subparagraph 7,a71 the ,secretary shall approve such a proposal if the ,state demonstrates with respect to the proposal that-- 7i7 there would be no increased cost to the ,federal ,government if it were approved2 and 7ii7 there would be no reduction in the quality of care provided to such individuals if the proposal were approved4 4 7d7 ,conforming amendments 7#a7 ,section #bbf ,section #bbf of the ,social ,security ,act 7#db ,u4,s4,c4 #dbf7 is amended-- 7,a7 in subsection 7a71 in the matter preceding paragraph 7#a71 by inserting 1 subject to section #ahfj;,e-#aa7;a7 after individual who2 7,b7 in subsection 7b71 in the matter preceding paragraph 7#a71 by inserting 1 subject to section #ahfj;,e-#aa7;a7 after individual who2 and 7,c7 in subsection 7c71 in the matter preceding paragraph 7#a71 by inserting 1 subject to section #ahfj;,e-#aa7;a7 after subsection 7a74 7#b7 ,section #bbf;,a ,section #bbf;,a7a7 of such ,act 7#db ,u4,s4,c4 #dbf-a7;a77 is amended1 in the matter preceding paragraph 7#a71 by inserting and subject to section #ahfj;,e-#aa7;a7 after or title ,,xviii4 7#c7 ,section #aicb ,section #aicb7;a77#b77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#b7;a77#b77;,b77 is amended by striking ,a ,state and inserting ,except in the case of a ,state that has elected the maintenance of effort option described in section #aidd7;b77#b71 a ,state4 #dbc4 ,new benefit structure under unified ,medicare 7a7 ,in general ,part ,e of title ,,xviii of the ,social ,security ,act1 as added by section #bea1 is amended by adding at the end the following3 #b ,out-of-,pocket limit #ahfj;,e-#ba4 ,out-of-pocket limit 7a7 ,in general ,beginning with #bjba1 in the case of a ,medicare enrollee1 if the amount of the out-of-pocket cost-sharing of such enrollee for a calendar year equals or exceeds the catastrophic limit under subsection 7b7 for that year-- 7#a7 the enrollee shall not be responsible for additional out-of-pocket cost-sharing incurred during that year2 and 7#b7 the ,secretary shall establish procedures under which the ,secretary shall1 in appropriate part from the ,part ,a ,medicare ,,ffs ,account under section #ahag and the ,part ,b ,medicare ,,ffs ,account under section #ahda-- 7,a7 pay on behalf of the enrollee the amount of the additional out-of-pocket cost-sharing described in paragraph 7#a7 attributable to deductibles and coinsurance described in subsection 7c77#a72 and 7,b7 reimburse the enrollee the amount of the additional out-of-pocket cost-sharing described in paragraph 7#a7 attributable to deductibles and coinsurance described in subsection 7c77#b74 7b7 ,catastrophic limit ,the amount of the catastrophic limit under this subsection for a year shall be the dollar amount in effect under section #bbc7;c77#b77;,a77ii7 of the ,internal ,revenue ,code of #aihf for self-only coverage for taxable years beginning in such year4 7c7 ,out-of-,pocket cost-,sharing defined ,in this section1 the term out-of-pocket cost-sharing means1 with respect to an individual1 the amount of costs incurred by the individual that are attributable to-- 7#a7 deductibles and coinsurance imposed under part ,a or part ,b2 and 7#b7 deductibles and coinsurance imposed under standard prescription drug coverage pursuant to section #ahfj;,d-#b7;b7 or alternative prescription drug coverage pursuant to section #ahfj;,d-#b7;c7 offered by a prescription drug plan4 4 7b7 ,application of out-of-,pocket limit to ,,ma-,,pd plans 7#a7 ,in general ,section #aheb7;a77#a77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;a77#a77;,b77 is amended-- 7,a7 in clause 7i71 by striking clause 7iii7 and inserting clauses 7iii7 and 7vi72 and 7,b7 by adding at the end the following new clause3 7vi7 ,out-of-pocket limit ,the provisions of section #ahfj;,e-#ba-- 7,i7 shall apply to individuals enrolled under an ,,ma-,,pd plan in the same manner as such provisions apply to ,medicare enrollees under such section1 except that in lieu of the application of subsection 7a77#b7 of such section the ,,ma-,,pd plan shall establish procedures to provide for payment of any additional out-of-pocket cost-sharing described in subsection 7a77#a7 of such section incurred by individuals enrolled under the ,,ma-,,pd plan2 and 7,,ii7 as applied under subclause 7,i71 may not be waived by application of this subparagraph4 ,in applying subsection 7b7 of section #ahfj;,e-#ba pursuant to the previous sentence1 an ,,ma-,,pd plan may substitute a dollar amount that is less than the dollar amount specified under such subsection4 4 7#b7 ,exempting ,,ma-,,pd plans offering alternative prescription drug coverage from part ,d deductible and out-of-pocket limit requirements ,section #ahfj;,d-#b7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;c77 is amended-- 7,a7 in paragraph 7#b71 by striking ,the deductible and inserting ,in the case of a prescription drug plan1 the deductible2 and 7,b7 in paragraph 7#c71 by striking ,the coverage provides and inserting ,in the case of a prescription drug plan1 the coverage provides4 7c7 ,prescription drug plans required ,to report enrollees' out-of-,pocket cost-,sharing ,section #ahfj;,d-#ab7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77 is amended by adding at the end the following new paragraph3 7#g7 ,out-of-pocket cost-sharing reports ,each contract entered into with a ,,pdp sponsor under this part with respect to a prescription drug plan offered by such sponsor shall require that1 with respect to each claim submitted for items or services furnished to an individual enrolled under the plan pursuant to the contract1 the sponsor submits to the ,secretary information on the amount of out-of-pocket cost-sharing 7as defined in section #ahfj;,e-#bc7;c77 applicable to such enrollee for such items or services4 4 7d7 ,conforming amendments 7#a7 ,section #ahac of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;e7 is amended-- 7,a7 in subsection 7a71 by inserting ,subject to subpart #b of part ,e3 before paragraph 7#a72 and 7,b7 in subsection 7b71 by inserting ,subject to subpart #b of part ,e3 before paragraph 7#a74 7#b7 ,section #ahcc of such ,act 7#db ,u4,s4,c4 #aciel7 is amended-- 7,a7 in subsection 7a71 in the matter preceding paragraph 7#a71 by inserting and subpart #b of part ,e after succeeding provisions of this section2 7,b7 in subsection 7b71 in the first sentence1 by striking ,before applying and inserting ,subject to subpart #b of part ,e1 before applying2 7,c7 in subsection 7c77#a71 in the matter preceding subparagraph 7,a71 by inserting subject to subpart #b of part ,e1 after this part12 7,d7 in subsection 7f71 by striking ,in establishing and inserting ,subject to subpart #b of part ,e1 in establishing2 and 7,e7 in subsection 7g77#a71 by inserting and subpart #b of part ,e and paragraphs 7#d7 and 7#e74 7#c7 ,section #ahhb7;a77#b7 of such ,act is amended by striking ,no medicare and inserting ,subject to section #ahfj;,e-#bd7;c71 no medicare4 #dbd4 ,late enrollment penalty not to apply for months of any health coverage 7a7 ,in general ,section #ahci7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acier7 is amended in the second sentence1 by inserting before the period at the end the following3 or months during which the individual has any other health coverage4 7b7 ,effective date ,the amendment made by paragraph 7#a7 shall apply for months of coverage beginning after the date of the enactment of this ,act4 #dbe4 ,medigap reform ,notwithstanding any provision of section #ahhb of the ,social ,security ,act 7#db ,u4,s4,c4 #aciess71 as of the date of the enactment of this ,act1 no policy may be offered under such section that does not provide guaranteed coverage 7without regard to an individual's preexisting conditions1 if any7 to all individuals eligible to enroll under such policy4 #dbf4 ,,aco revision 7a7 ,enrollment ,enrollment in such an ,,aco under such title shall be based on the method established under part ,e of such title4 ,such a network shall bear full risk in the event payments under such title do not equal or exceed liabilities under such network4 7b7 ,direction of payment ,an ,,aco may direct that any payments under such title be made to a centralized entity rather than to an individual provider or supplier4 7c7 ,bids ,the ,secretary of ,health and ,human ,services shall establish a process whereby such networks compete using a bidding process similar to that described in part ,e of such title for ,medicare ,advantage plans4 #dbg4 ,primary care options 7a7 ,selection of primary care physician ,the ,secretary shall establish a mechanism under which an individual enrolled under part ,b of title ,,xviii of the ,social ,security ,act may select such individual's primary care physician4 ,such an individual shall not be liable for more than #e for each visit to such selected physician4 7b7 ,payment to physician ,a physician selected under subsection 7a7 shall receive a monthly fee in lieu of any other payment under such part ,b for evaluation and monitoring of such individual4 ,the ,secretary shall provide a list of standardized benefits that are included in such payment1 including telephone and email communications1 office visits1 preventive care1 and vaccinations4 #dbh4 ,general provisions2 effective date ,part ,e of title ,,xviii of the ,social ,security ,act1 as inserted by section #aja7;a77#b7 and as previously amended1 is further amended by adding at the end the following new subpart3 #e4 ,general provisions #ahfj;,e-#ea4 ,applicability2 definitions 7a7 ,in general ,the provisions of this ,act are superseded to the extent inconsistent with the provisions of this part4 7b7 ,terminology ,for purposes of this part3 7#a7 ,medicare enrollee 7,a7 ,in general ,the term ,medicare enrollee means-- 7i7 an individual entitled to 7or enrolled for benefits7 under part ,a and enrolled under part ,b2 and 7ii7 except as otherwise specified1 an individual described in section #ahfj;,e-#aa7;a77#c74 7,b7 ,treatment ,any reference in this ,act 7or any other ,act7 in effect before the date of the enactment of this part1 to an individual entitled to benefits under part ,a or enrolled under part ,b shall be deemed a reference to a ,medicare enrollee4 7#b7 ,medicare fee-for-service ,the term ,medicare fee-for-service means the original ,medicare fee-for-service program under parts ,a and ,b1 as modified by this part1 and does not include part ,c or part ,d4 7#c7 ,medicare fee-for-service enrollee ,the term ,medicare fee-for-service enrollee means a ,medicare enrollee who is not enrolled under a ,medicare ,advantage plan under part ,c4 #ahfj;,e-#fa4 ,general effective date ,except as otherwise specified1 the provisions of this part shall apply to items and services furnished on or after ,january #a1 #bjba1 and to plan years beginning on or after such date 7referred to in this title as the general effective date74 4 ,d ,telehealth ,improvements and ,expansion #dca4 ,expansion of coverage of telehealth services 7a7 ,covered services ,section #ahcd7m77#d77;,f77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,f77i77 is amended-- 7#a7 by striking and office and inserting office2 and 7#b7 by inserting3 respiratory services1 audiology services 7as defined in section #ahfa7ll771 outpatient therapy services 7including physical therapy1 occupational therapy1 and speech-language pathology services7 after the ,secretary7714 7b7 ,providers ,subsection 7m7 of section #ahcd of such ,act 7#db ,u4,s4,c4 #aciem7 is amended-- 7#a7 in paragraph 7#a71 by striking or a practitioner 7described in section #ahdb7;b77#ah77;,c77 and inserting 1 a practitioner 7described in section #ahdb7;b77#ah77;,c771 or an applicable professional 7as defined in paragraph 7#d77;,g772 7#b7 by striking physician or practitioner each time it appears in such subsection and inserting physician1 practitioner1 or applicable professional2 7#c7 in paragraph 7#c77;,a7-- 7,a7 in the heading1 by striking ,physician and practitioner and inserting ,physician1 practitioner1 and applicable professional2 and 7,b7 by striking physicians or practitioners and inserting physicians1 practitioners1 or applicable professionals2 and 7#d7 in paragraph 7#d71 by adding at the end the following new subparagraph3 7,g7 ,applicable professional ,the term applicable professional means1 with respect to services furnished on or after the date that is #f months after the date of the enactment of this subparagraph1 a certified diabetes educator or licensed-- 7i7 respiratory therapist2 7ii7 audiologist2 7iii7 occupational therapist2 7iv7 physical therapist2 or 7v7 speech language pathologist4 4 7c7 ,home-,based monitoring services for congestive heart failure and chronic obstructive pulmonary disease 7#a7 ,coverage of remote patient monitoring services for certain chronic health conditions 7,a7 ,in general ,section #ahfa7s77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#b77 is amended-- 7i7 in subparagraph 7,,gg71 by striking and at the end2 7ii7 in subparagraph 7,,hh71 by inserting and at the end2 and 7iii7 by inserting after subparagraph 7,,hh7 the following new subparagraph3 7,,ii7 applicable remote patient monitoring services 7as defined in paragraph 7#a77;,a7 of subsection 7iii772 4 7#b7 ,services described ,section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is amended by adding at the end the following new subsection3 7kkk7 ,remote ,patient ,monitoring ,services for ,chronic ,health ,conditions 7#a7 7,a7 ,the term applicable remote patient monitoring services means remote patient monitoring services 7as defined in subparagraph 7,b77 furnished to provide for the monitoring1 evaluation1 and management of an individual with a covered chronic condition 7as defined in paragraph 7#b771 insofar as such services are for the management of such chronic condition4 7,b7 ,the term remote patient monitoring services means services furnished through remote patient monitoring technology 7as defined in subparagraph 7,c774 7,c7 ,the term remote patient monitoring technology means a coordinated system that uses one or more home-based or mobile monitoring devices that automatically transmit vital sign data or information on activities of daily living and may include responses to assessment questions collected on the devices wirelessly or through a telecommunications connection to a server that complies with the ,federal regulations 7concerning the privacy of individually identifiable health information7 promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif1 as part of an established plan of care for that patient that includes the review and interpretation of that data by a health care professional4 7#b7 ,for purposes of paragraph 7#a71 the term covered chronic health condition means applicable conditions 7as defined in and applied under section #ahhf7q77#e77 when under chronic care management 7identified as of ,july #a1 #bjae1 by ,,hcpcs code #iidij 7and as subsequently modified by the ,secretary774 7#c7 7,a7 ,payment may be made under this part for applicable remote patient monitoring services provided to an individual during a period of up to #ij days and such additional period as provided for under subparagraph 7,b74 7,b7 ,the #ij-;day period described in subparagraph 7,a71 with respect to an individual1 may be renewed by the physician who provides chronic care management to such individual if the individual continues to qualify for such management4 4 7#c7 ,payment under the physician fee schedule ,section #ahdh of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7 is amended-- 7,a7 in subsection 7c7-- 7i7 in paragraph 7#b77;,b7-- 7,i7 in clause 7ii77,,ii71 by striking and 7v7 and inserting 7v71 and 7vii72 and 7,,ii7 by adding at the end the following new clause3 7vii7 ,budgetary treatment of certain services ,the additional expenditures attributable to services described in section #ahfa7s77#b77;,,ii7 shall not be taken into account in applying clause 7ii77,,ii74 2 and 7ii7 by adding at the end the following new paragraph3 7#g7 ,treatment of applicable remote patient monitoring services 7,a7 ,in determining relative value units for applicable remote patient monitoring services 7as defined in section #ahfa7;iii77#a77;,a771 the ,secretary1 in consultation with appropriate physician groups1 practitioner groups1 and supplier groups1 shall take into consideration-- 7i7 physician or practitioner resources1 including physician or practitioner time and the level of intensity of services provided1 based on-- 7,i7 the frequency of evaluation necessary to manage the individual being furnished the services2 7,,ii7 the complexity of the evaluation1 including the information that must be obtained1 reviewed1 and analyzed2 and 7,,iii7 the number of possible diagnoses and the number of management options that must be considered2 7ii7 practice expense costs associated with such services1 including the direct costs associated with installation and information transmission1 costs of remote patient monitoring technology 7including equipment and software71 device delivery costs1 and resource costs necessary for patient monitoring and followup 7but not including costs of any related item or non-physician service otherwise reimbursed under this title72 and 7iii7 malpractice expense resources4 7,b7 ,using the relative value units determined in subparagraph 7,a71 the ,secretary shall provide for separate payment for such services and shall not adjust the relative value units assigned to other services that might otherwise have been determined to include such separately paid remote patient monitoring services4 2 and 7,b7 in subsection 7j77#c71 by inserting 7#b77;,,ii71 after health risk assessment714 #dcb4 ,expanding the use of telehealth through the waiver of certain requirements 7a7 ,in general ,section #ahcd7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77 is amended-- 7#a7 in paragraph 7#d77;,c77i71 by striking and 7#g7 and inserting 7#g71 and 7#h72 and 7#b7 by adding at the end the following3 7#h7 ,authority to waive requirements and limitations if certain conditions met 7,a7 ,in general ,notwithstanding the preceding provisions of this subsection1 in the case of telehealth services furnished on or after ,january #a1 #bjba1 the ,secretary may waive any restriction applicable to payment for telehealth services under this subsection that is described in subparagraph 7,b71 but only if the ,secretary determines that such waiver would not deny or limit the coverage or provision of benefits under this title1 and-- 7i7 the ,secretary determines that the waiver is expected to reduce spending under this title without reducing the quality of care or improve the quality of patient care without increasing spending2 or 7ii7 the waiver would apply to telehealth services furnished in originating sites located in a high-need health professional shortage area 7as designated pursuant to section #ccb7;a77#a77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bed;e7a77#a77;,a7774 7,b7 ,restrictions described ,for purposes of this paragraph1 restrictions applicable to payment for telehealth services under paragraph 7#a7 are-- 7i7 requirements relating to qualifications for an originating site under paragraph 7#d77;,c77ii72 7ii7 any geographic limitations under paragraph 7#d77;,c77i7 7other than applicable ,state law requirements1 including ,state licensure requirements72 7iii7 any limitation on the type of technology used to furnish telehealth services2 7iv7 any limitation on the type of provider of services or supplier who may furnish telehealth services 7other than the requirement that the provider of services or supplier is enrolled under this title72 7v7 any limitation on specific services designated as telehealth services pursuant to this subsection 7provided the ,secretary determines that such services are clinically appropriate to furnish remotely72 or 7vi7 any other limitation relating to the furnishing of telehealth services under this title identified by the ,secretary4 7,c7 ,public comment ,the ,secretary shall establish a process by which stakeholders may 7on at least an annual basis7 provide public comment for waivers under this paragraph4 7,d7 ,periodic review of waivers ,the ,secretary shall periodically1 but not more often than every #c years1 reassess each waiver under this paragraph to determine whether the waiver continues to meet the conditions applicable under subparagraph 7,a74 4 7b7 ,posting of information ,not later than #b years after the date on which a waiver under section #ahcd7m77#h7 of the ,social ,security ,act1 as added by subsection 7a71 first becomes effective1 and at least biennially thereafter1 the ,secretary of ,health and ,human ,services shall post on the internet website of the ,centers for ,medicare ,medicaid ,services-- 7#a7 the number of ,medicare beneficiaries receiving telehealth services by reason of each waiver under such section2 7#b7 the impact of such waivers on expenditures and utilization under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq472 and 7#c7 other outcomes1 as determined appropriate by the ,secretary4 #dcc4 ,expanding the use of telehealth for mental health services 7a7 ,in general ,section #ahcd7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m771 as amended by the preceding sections1 is amended-- 7#a7 in paragraph 7#d77;,c77i71 by striking and 7#h7 and inserting 7#h71 and 7#i72 and 7#b7 by adding at the end the following3 7#i7 ,treatment of mental health services furnished through telehealth ,the geographic requirements described in paragraph 7#d77;,c77i7 7other than applicable ,state law requirements1 including ,state licensure requirements7 shall not apply with respect to telehealth services that are mental health services 7as determined by the ,secretary7 furnished on or after ,january #a1 #bjba1 to an eligible telehealth individual at an originating site described in paragraph 7#d77;,c77ii7 7other than an originating site described in subclause 7,,ix7 of such paragraph74 4 7b7 ,inclusion of the home as an originating site ,section #ahcd7m77#d77;,c77ii77,x7 of such ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,c77ii77,x77 is amended by striking paragraph 7#g7 and inserting paragraphs 7#g7 and 7#i74 7c7 ,additional services ,as part of the implementation of the amendments made by this section1 the ,secretary of ,health and ,human ,services shall consider whether additional services should be added to the services specified in paragraph 7#d77;,f77i7 of section #ahcd7m7 of such ,act 7#db ,u4,s4,c4 #aciem7 for authorized payment under paragraph 7#a7 of such section4 #dcd4 ,use of telehealth in emergency medical care 7a7 ,in general ,section #ahcd7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m771 as amended by the preceding sections1 is amended-- 7#a7 in paragraph 7#d77;,c77i71 by striking and 7#i7 and inserting 7#i71 and 7#aj72 and 7#b7 by adding at the end the following3 7#aj7 ,treatment of emergency medical care furnished through telehealth ,the geographic requirements described in paragraph 7#d77;,c77i7 7other than applicable ,state law requirements1 including ,state licensure requirements7 shall not apply with respect to telehealth services that are services for emergency medical care 7as determined by the ,secretary7 furnished on or after ,january #a1 #bjba1 to an eligible telehealth individual at an originating site described in subclause 7,,ii71 7,v71 or 7,,vii7 of paragraph 7#d77;,c77ii74 4 7b7 ,additional services ,as part of the implementation of the amendments made by this section1 the ,secretary of ,health and ,human ,services shall consider whether additional services should be added to the services specified in paragraph 7#d77;,f77i7 of section #ahcd7m7 of such ,act 7#db ,u4,s4,c4 #aciem7 for authorized payment under paragraph 7#a7 of such section4 #dce4 ,improvements to the process for adding telehealth services ,the ,secretary shall undertake a review of the process established pursuant to section #ahcd7m77#d77;,f77ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,f77ii771 and based on the results of such review-- 7#a7 implement revisions to the process so that the criteria to add services prioritizes1 as appropriate1 improved access to care through telehealth services2 and 7#b7 provide clarification on what requests to add telehealth services under such process should include4 #dcf4 ,rural health clinics and ,federally qualified health centers 7a7 ,expansion of originating sites ,section #ahcd7m77#d77;,c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,c771 as amended by the preceding sections1 is amended-- 7#a7 in clause 7i71 by striking and 7#aj7 and inserting and 7#aj71 and subject to clause 7iii712 and 7#b7 by adding at the end the following new clause3 7iii7 ,rural health clinics and ,federally qualified health centers ,the term originating site shall also include any ,federally qualified health center and any rural health clinic 7as such terms are defined in section #ahfa7;aa77 at which the eligible telehealth individual is located at the time the service is furnished via a telecommunications system1 whether or not the individual is located in an area described in clause 7i71 insofar as such sites are not otherwise included in the definition of originating site under such clause1 subject to applicable ,state law requirements1 including ,state licensure requirements4 4 7b7 ,expansion of distant sites ,section #ahcd7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77 is amended-- 7#a7 in the first sentence of paragraph 7#a7-- 7,a7 by striking or a practitioner 7described in section #ahdb7;b77#ah77;,c77 and inserting 1 a practitioner 7described in section #ahdb7;b77#ah77;,c771 a ,federally qualified health center1 or a rural health clinic2 and 7,b7 by striking or practitioner and inserting 1 practitioner1 ,federally qualified health center1 or rural health clinic2 7#b7 in paragraph 7#b77;,a7-- 7,a7 by inserting or to a ,federally qualified health center or rural health clinic that serves as a distant site after a distant site2 and 7,b7 by striking such physician or practitioner and inserting such physician1 practitioner1 ,federally qualified health center1 or rural health clinic2 and 7#c7 in paragraph 7#d7-- 7,a7 in subparagraph 7,a71 by inserting and includes a ,federally qualified health center or rural health clinic that furnishes a telehealth service to an eligible individual before the period at the end2 and 7,b7 in subparagraph 7,f71 by adding at the end the following new clause3 7iii7 ,inclusion of rural health clinic services and ,federally qualified health center services furnished using telehealth ,for purposes of this subparagraph1 the term telehealth services includes a rural health clinic service or ,federally qualified health center service that is furnished using telehealth to the extent that payment codes corresponding to services identified by the ,secretary under clause 7i7 or 7ii7 are listed on the corresponding claim for such rural health clinic service or ,federally qualified health center service4 4 7c7 ,effective date ,the amendments made by this section shall apply to services furnished on or after ,january #a1 #bjba4 #dcg4 ,native ,american health facilities 7a7 ,in general ,section #ahcd7m77#d77;,c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,c771 as amended by the preceding sections1 is amended-- 7#a7 in clause 7i71 by striking clause 7iii7 and inserting clauses 7iii7 and 7iv72 and 7#b7 by adding at the end the following new clause3 7iv7 ,native ,american health facilities ,the originating site requirements described in clauses 7i7 and 7ii7 shall not apply with respect to a facility of the ,indian ,health ,service1 whether operated by such ,service1 or by an ,indian tribe 7as that term is defined in section #d of the ,indian ,health ,care ,improvement ,act 7#be ,u4,s4,c4 #afjc77 or a tribal organization 7as that term is defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act 7#be ,u4,s4,c4 #ecjd771 or a facility of the ,native ,hawaiian health care systems authorized under the ,native ,hawaiian ,health ,care ,improvement ,act 7#db ,u4,s4,c4 #aagja et seq474 4 7b7 ,no originating site facility fee for new sites ,section #ahcd7m77#b77;,b77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#b77;,b77i77 is amended1 in the matter preceding subclause 7,i71 by inserting 7other than an originating site that is only described in clause 7iv7 of paragraph 7#d77;,c71 and does not meet the requirement for an originating site under clause 7i7 of such paragraph7 after the originating site4 7c7 ,effective date ,the amendments made by this section shall apply to services furnished on or after ,january #a1 #bjba4 #dch4 ,waiver of telehealth restrictions during national emergencies ,section #aace7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#e7;b77 is amended-- 7#a7 in paragraph 7#f71 by striking and after the semicolon2 7#b7 in paragraph 7#g71 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following3 7#h7 requirements for payment for telehealth services under section #ahcd7m74 4 #dci4 ,use of telehealth in recertification for hospice care 7a7 ,in general ,section #ahad7;a77#g77;,d77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;f7a77#g77;,d77i77 is amended by inserting 7including through use of telehealth1 notwithstanding the requirements in section #ahcd7m77#d77;,c77 after face-to-face encounter4 7b7 ,,gao report ,not later than #c years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit a report to ,congress evaluating the impact of the amendment made by subsection 7a7 on-- 7#a7 the number and percentage of beneficiaries recertified for the ,medicare hospice benefit at #ahj days and for subsequent benefit periods2 7#b7 the appropriateness for hospice care of the patients recertified through the use of telehealth2 and 7#c7 any other factors determined appropriate by the ,comptroller ,general4 #ddj4 ,clarification for fraud and abuse laws regarding technologies provided to beneficiaries ,section #aabh;,a7i77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;a7i77#f77 is amended-- 7#a7 in subparagraph 7,i71 by striking 2 or and inserting a semicolon2 7#b7 in subparagraph 7,j71 by striking the period at the end and inserting 2 or2 and 7#c7 by adding at the end the following new subparagraph3 7,k7 the provision of technologies 7as defined by the ,secretary7 on or after the date of the enactment of this subparagraph1 by a provider of services or supplier 7as such terms are defined for purposes of title ,,xviii7 directly to an individual who is entitled to benefits under part ,a of title ,,xviii1 enrolled under part ,b of such title1 or both1 for the purpose of furnishing telehealth services1 remote patient monitoring services1 or other services furnished through the use of technology 7as defined by the ,secretary71 if-- 7i7 the technologies are not offered as part of any advertisement or solicitation2 and 7ii7 the provision of the technologies meets any other requirements set forth in regulations promulgated by the ,secretary4 4 #dda4 ,study and report on increasing access to telehealth services in the home 7a7 ,med,p,a,c study ,the ,medicare ,payment ,advisory ,commission 7in this section referred to as the ,commission7 shall conduct a study on increasing access under the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 to telehealth services in the home4 ,such study shall include an analysis of the following3 7#a7 ,how different payers allow the home to be an originating site for telehealth services4 7#b7 ,particular types of telehealth services or subgroups of beneficiaries with respect to which allowing the home to be an originating site under the ,medicare program would be suitable4 7b7 ,report ,not later than #bd months after the date of the enactment of this ,act1 the ,commission shall submit to ,congress a report containing the results of the study conducted under subsection 7a71 together with recommendations for such legislation and administrative action as the ,commission determines appropriate4 #ddb4 ,analysis of telehealth waivers in alternative payment models ,the second sentence of section #aaae;,a7g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acae;a7g77 is amended by inserting an analysis of waivers under section 7d77#a7 related to telehealth and the impact on quality and spending under the applicable titles of such waivers1 after subsection 7c714 #ddc4 ,model to allow additional health professionals to furnish telehealth services ,section #aaae;,a7b77#b77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acae;a7b77#b77;,b77 is amended by adding at the end the following new clause3 7xxviii7 ,allowing health professionals who are not otherwise eligible under section #ahcd7m7 to furnish telehealth services to furnish such services4 4 #ddd4 ,testing of models to examine the use of telehealth under the ,medicare program ,section #aaae;,a7b77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acae;a7b77#b77 is amended by adding at the end the following new subparagraph3 7,d7 ,testing models to examine use of telehealth under ,medicare ,the ,secretary shall consider testing under this subsection models to examine the use of telehealth under title ,,xviii4 4