,i #aafth ,,congress #ast ,session ,h4 ,r4 #accb ,,in ,,the ,,house ,,of ,,representatives ,february #be1 #bjai ,mr4 ,westerman introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committees on ,ways and ,means1 the ,judiciary1 ,oversight and ,reform1 ,education and ,labor1 ,rules1 the ,budget1 ,armed ,services1 and ,house ,administration1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,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 #bjai4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,title ,i--,private-,sector ,health ,insurance ,reforms ,subtitle ,a--,commercial ,health ,insurance ,provisions ,sec4 #aja4 ,invisible high risk pool reinsurance program2 tax on exchange plans4 ,sec4 #ajb4 ,change in permissible age variation in health insurance premium rates4 ,sec4 #ajc4 ,employer health insurance mandate repeal4 ,sec4 #ajd4 ,employer benefits reports4 ,sec4 #aje4 ,waivers for ,state innovation4 ,sec4 #ajf4 ,state-operated ,exchanges flexibility for open enrollment periods4 ,sec4 #ajg4 ,enrollment periods4 ,sec4 #ajh4 ,short-term limited duration insurance4 ,sec4 #aji4 ,promoting health plans that cover individuals in more than one ,state4 ,sec4 #aaj4 ,restoring the application of antitrust laws to the business of health insurance4 ,sec4 #aaa4 ,health plans created under ,,ppaca or offered through ,exchanges to be only health plans ,federal ,government may make available to ,president1 ,vice ,president1 ,members of ,congress1 and ,federal employees4 ,sec4 #aab4 ,cost-sharing reductions4 ,sec4 #aac4 ,health savings accounts4 ,sec4 #aad4 ,adding copper plans to ,exchanges4 ,sec4 #aae4 ,eliminating ,,fehbp eligibility for annuitants4 ,subtitle ,b--,association health plans ,sec4 #aba4 ,rules governing association health plans4 ,sec4 #abb4 ,clarification of treatment of single employer arrangements4 ,sec4 #abc4 ,enforcement provisions relating to association health plans4 ,sec4 #abd4 ,cooperation between ,federal and ,state authorities4 ,sec4 #abe4 ,effective date and transitional and other rules4 ,subtitle ,c--,tax-,related ,provisions ,sec4 #aca4 ,premium assistance adjustment to reflect age4 ,sec4 #acb4 ,repeal of annual fee on health insurance providers4 ,sec4 #acc4 ,repeal of medical device excise tax4 ,sec4 #acd4 ,inclusion in income of certain costs of employer-provided coverage under health plans4 ,sec4 #ace4 ,inclusion of certain over-the-counter medical products as qualified medical expenses4 ,sec4 #acf4 ,repeal of limitation on health flexible spending arrangements4 ,sec4 #acg4 ,medicare part ,d tax deduction4 ,sec4 #ach4 ,repeal of net investment income tax4 ,sec4 #aci4 ,basis for purposes of determining gain or loss4 ,sec4 #adj4 ,deduction for qualified charity care4 ,sec4 #ada4 ,limitation on liability for volunteer health care professionals4 ,title ,,ii--,medicare and ,medicaid ,reforms ,subtitle ,a--,medicare and ,medicaid ,reforms ,sec4 #bja4 ,flexible block grant option for ,states4 ,sec4 #bjb4 ,medicaid eligibility determinations4 ,sec4 #bjc4 ,lowering safe harbor threshold with respect to ,state taxes on health care providers4 ,sec4 #bjd4 ,income limitations for refundable credits for coverage under a qualified health plan4 ,subtitle ,b--,medicare ,sec4 #bba4 ,off-campus provider-based department medicare site neutral payment4 ,sec4 #bbb4 ,elimination of ,medicare eligibility for certain individuals4 ,sec4 #bbc4 ,medicare coverage of bad debt4 ,subtitle ,c--,medical ,malpractice ,reform ,sec4 #bca4 ,encouraging speedy resolution of claims4 ,sec4 #bcb4 ,compensating patient injury4 ,sec4 #bcc4 ,maximizing patient recovery4 ,sec4 #bcd4 ,authorization of payment of future damages to claimants in health care lawsuits4 ,sec4 #bce4 ,product liability for health care providers4 ,sec4 #bcf4 ,definitions4 ,sec4 #bcg4 ,effect on other laws4 ,sec4 #bch4 ,rules of construction4 ,sec4 #bci4 ,effective date4 ,sec4 #bdj4 ,limitation on expert witness testimony4 ,sec4 #bda4 ,communications following unanticipated outcome4 ,sec4 #bdb4 ,expert witness qualifications4 ,sec4 #bdc4 ,affidavit of merit4 ,sec4 #bdd4 ,notice of intent to commence lawsuit4 ,title ,,iii--,prescription drug competition ,subtitle ,a--,eliminating ,delays of ,generic ,drugs and ,biosimilar ,products ,sec4 #cja4 ,actions for delays of generic drugs and biosimilar biological products4 ,sec4 #cjb4 ,,rems approval process for subsequent filers4 ,subtitle ,b--,increasing ,access to ,drugs and ,biosimilar ,products ,sec4 #caa4 ,expedited development and priority review for generic complex drug products4 ,sec4 #cab4 ,increasing pharmaceutical options to treat an unmet medical need4 ,sec4 #cac4 ,preemption of ,state barriers to the substitution of biosimilar products4 ,subtitle ,c--,limiting ,exclusivity ,periods ,delaying ,competition ,sec4 #cba4 ,limiting exclusivity periods for drugs treating rare diseases and conditions4 ,sec4 #cbb4 ,limiting exclusivity for biosimilar products4 ,subtitle ,d--,congressional ,review of ,agency ,rulemaking ,sec4 #cca4 ,congressional review of the ,food and ,drug ,administration rulemaking4 ,sec4 #ccb4 ,government ,accountability ,office study of rules4 ,subtitle ,e--,medicare ,prescription ,drug ,competition ,sec4 #cda4 ,medicare drug coverage4 ,sec4 #cdb4 ,,pbm transparency and elimination of ,,dir fees4 ,sec4 #cdc4 ,sunset of limit on maximum rebate amount for single source drugs and innovator multiple source drugs4 ,sec4 #cdd4 ,regulation of manufacturer-sponsored copay contributions4 ,sec4 #cde4 ,data reporting to improve the transparency regarding how #cdj;,b hospital covered entities provide care for patients4 ,sec4 #cdf4 ,requiring #cdj;,b drug discount program reports by ,,dsh hospital covered entities on low-income utilization rate of outpatient hospital services4 ,title ,,iv--,provider ,competition ,sec4 #dja4 ,hospital consolidation4 ,sec4 #djb4 ,price transparency4 ,sec4 #djc4 ,repealing shared savings incentives from ,medicare shared savings program4 ,sec4 #djd4 ,repeal of health care reform provisions limiting ,medicare exception to the prohibition on certain physician referrals for hospitals4 ,sec4 #dje4 ,advisory group on reducing burden of hospital administrative requirements4 ,sec4 #djf4 ,authority of ,federal ,trade ,commission over certain tax-exempt organizations4 ,title ,v--,digital ,health ,care ,sec4 #eja4 ,access of individuals to protected health information4 ,sec4 #ejb4 ,expansion of coverage of telehealth services4 ,sec4 #ejc4 ,,stark and ,,aks exemptions4 ,sec4 #ejd4 ,,stark technical penalty4 ,i ,private-,sector ,health ,insurance ,reforms ,a ,commercial ,health ,insurance ,provisions #aja4 ,invisible high risk 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 ,high ,risk ,pool ,reinsurance ,program 7in this section referred to as the ,,ihrpr program74 7b7 ,state grants ,under the ,,ihrpr 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 high risk 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 high risk 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 high risk pool described in paragraph 7#b74 7#b7 ,federal default qualifying invisible high risk 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 high risk 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 #bjbj1 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 high risk pool ,for purposes of this section1 the term qualifying invisible high risk 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 #bjbj 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 #ajb4 ,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 #bjbj1 as the ,secretary may implement through interim final regulation1 #e to #a for adults 7consistent with section #bgjg7;c774 #ajc4 ,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 #bjbj4 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 #ajd4 ,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 #aje4 ,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 #ajf4 ,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 #ajg4 ,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 period 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 #ajh4 ,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 #bjbj4 #aji4 ,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 #bjbj1 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 #aaj4 ,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 #aaa4 ,health plans created under ,,ppaca or offered through ,exchanges to be only health plans ,federal ,government may make available to ,president1 ,vice ,president1 ,members of ,congress1 and ,federal employees ,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 #aab4 ,cost-sharing reductions 7a7 ,cost-sharing reduction 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 ,there is appropriated1 from any money in the ,treasury not otherwise appropriated1 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 #bjai through #bjbb4 7#b7 ,adjustments ,notwithstanding any other provision of law1 payments and other actions for adjustments to obligations incurred prior to ,december #ca1 #bjbj1 may be made through ,december #ca1 #bjba4 7#c7 ,limitation ,amounts appropriated under paragraph 7#a7 for each of plan years #bjai through #bjbb 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 7b7 ,election ,in the case of an election under this subsection by a ,state and a certification by the ,secretary of ,health and ,human ,services that such election will not result in an increase in ,federal expenditures1 in lieu of the amounts that would be paid to health insurance issuers in such ,state under section #adjb of the ,patient ,protection and ,affordable ,care ,act1 the ,secretary may pay to such ,state an amount equal to such amounts4 ,prior to such payment1 such ,state shall make such assurances as the ,secretary deems necessary to ensure that such ,state shall redistribute such payments to health savings accounts of individuals-- 7#a7 enrolled in qualified health plans 7as defined in section #cf;,b of the ,internal ,revenue ,code of #aihf7 offered by such issuers1 and 7#b7 whose income is less than #bej percent of the ,federal poverty line4 #aac4 ,health savings accounts 7a7 ,no high deductible health plans required for health savings account contributions 7#a7 ,in general ,section #bbc of the ,internal ,revenue ,code of #aihf is amended by inserting or qualified health plan after high deductible health plan each place such term appears4 7#b7 ,qualified health plan defined ,section #bbc7;c7 of such ,code is amended to read as follows3 7c7 ,eligible individual ,for purposes of this section-- 7#a7 ,in general ,the term eligible individual means1 with respect to any month1 any individual if such individual is covered under a qualified health plan as of the #ast day of such month4 7#b7 ,qualified health plan ,the term qualified health plan has the meaning given such term in section #cf;,b4 4 7b7 ,premiums for plans as qualified medical expenses2 treatment of abortions 7#a7 ,in general ,section #bbc7;d77#b77;,b7 of such ,code is amended to read as follows3 7,b7 ,abortions 7i7 ,payments for health insurance with abortion coverage ,the term qualified medical expense shall not include amounts paid for insurance that includes coverage for abortions4 7ii7 ,payments for abortions ,the term qualified medical expense shall not include amounts paid for an abortion4 7iii7 ,exception ,clauses 7i7 and 7ii7 shall not apply to an abortion1 or to coverage for an abortion-- 7,i7 if the pregnancy is the result of an act of rape or incest1 or 7,,ii7 in the case where a woman suffers from a physical disorder1 physical injury1 or physical illness that would1 as certified by a physician1 place the woman in danger of death unless an abortion is performed1 including a life-endangering physical condition caused by or arising from the pregnancy itself4 4 7#b7 ,conforming amendment ,subsection #bbc7;d77#b7 is amended by striking subparagraph 7,c74 #aad4 ,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 plan4 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 #bjbj4 #aae4 ,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 ,b ,association health plans #aba4 ,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 sponsor1 7,b7 the sponsor1 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 #ejj1jjj1 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 #abb4 ,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 #abc4 ,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 #abd4 ,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 #abe4 ,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 subtitle77 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 ,c ,tax-,related ,provisions #aca4 ,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 #ajjjjjjjjjjjj #ajj-accbbbbbbbbbb #acc-aejcdcdcdcdcd #aej-bjjdd4cde4cdf4cdg4cdh4c #bjj-bejd4cd4ce4ce4if4ch4jeg4cih4caj #bej-cjjd4cd4ce4ie4ih4jeh4ceiaj4eajaa4e #cjj-djjd4cd4ce4ie4ih4ceh4ceaj4eaj4eaa4e aa4e 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 #bjbj1 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 #bjbj1 over the rate of growth in the consumer price index for calendar year #bjbj4 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 calendar year #bjah exceeds an amount equal to #j4ejd percent of the gross domestic product for such calendar year4 4 7b7 ,effective date ,the amendment made by this section shall apply to taxable years beginning after ,december #ca1 #bjbj4 #acb4 ,repeal of annual fee on health insurance providers 7a7 ,in general ,the ,patient ,protection and ,affordable ,care ,act is amended by striking section #ijaj4 7b7 ,effective date ,the amendments made by this section shall apply with respect to calendar years beginning after ,december #ca1 #bjai4 #acc4 ,repeal of medical device excise tax 7a7 ,in general ,chapter #cb of the ,internal ,revenue ,code of #aihf is amended by striking subchapter ,e4 7b7 ,conforming amendments 7#a7 ,subsection 7a7 of section #dbba of such ,code is amended by striking the last sentence4 7#b7 ,paragraph 7#b7 of section #fdaf7;b7 of such ,code is amended by striking the last sentence4 7c7 ,clerical amendment ,the table of subchapters for chapter #cb of such ,code is amended by striking the item relating to subchapter ,e4 7d7 ,effective date ,the amendments made by this section shall apply to sales after ,december #ca1 #bjag4 #acd4 ,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 #bjbj 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 #bjbj 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 ,repeal of employer-,sponsored health coverage excise tax ,the ,internal ,revenue ,code of #aihf is amended by striking section #dihj;,i4 7c7 ,effective date ,the amendments made by this section shall apply with respect to taxable years beginning after ,december #ca1 #bjbj4 #ace4 ,inclusion of certain over-the-counter medical products as qualified medical expenses 7a7 ,,hsas ,section #bbc7;d77#b7 of the ,internal ,revenue ,code of #aihf is amended-- 7#a7 by striking the last sentence of subparagraph 7,a7 and inserting the following3 ,for purposes of this subparagraph1 amounts paid for menstrual care products shall be treated as paid for medical care41 and 7#b7 by adding at the end the following new subparagraph3 7,d7 ,menstrual care product ,for purposes of this paragraph1 the term menstrual care product means a tampon1 pad1 liner1 cup1 sponge1 or similar product used by women with respect to menstruation or other genital-tract secretions4 4 7b7 ,archer ,,msas ,section #bbj7;d77#b77;,a7 of such ,code is amended by striking the last sentence and inserting the following3 ,for purposes of this subparagraph1 amounts paid for menstrual care products 7as defined in section #bbc7;d77#b77;,d77 shall be treated as paid for medical care44 7c7 ,health flexible spending arrangements and health reimbursement arrangements ,section #ajf of such ,code is amended by striking subsection 7f7 and inserting the following new subsection3 7f7 ,reimbursements for menstrual care products ,for purposes of this section and section #aje1 expenses incurred for menstrual care products 7as defined in section #bbc7;d77#b77;,d77 shall be treated as incurred for medical care4 4 7d7 ,effective dates 7#a7 ,distributions from health savings accounts ,the amendments made by subsections 7a7 and 7b7 shall apply to amounts paid after ,december #ca1 #bjbj4 7#b7 ,reimbursements ,the amendment made by subsection 7c7 shall apply to expenses incurred after ,december #ca1 #bjbj4 #acf4 ,repeal of limitation on health flexible spending arrangements 7a7 ,in general ,section #abe of the ,internal ,revenue ,code of #aihf is amended by striking subsection 7i74 7b7 ,effective date ,the amendment made by this section shall apply to taxable years beginning after ,december #ca1 #bjah4 #acg4 ,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 #ach4 ,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 #aci4 ,basis for purposes of determining gain or loss ,nothing in the ,internal ,revenue ,code of #aihf shall be construed to prevent the ,secretary of the ,treasury 7or any designee of the ,secretary7 from providing that the basis for determining gain or loss 7whether on the basis of cost or otherwise7 is adjusted on the basis of inflation4 #adj4 ,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 #ada4 ,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 ,,ii ,medicare and ,medicaid ,reforms ,a #bja4 ,flexible block grant option for ,states ,title ,,xix of the ,social ,security ,act is amended-- 7#a7 in section #aijc 7#db ,u4,s4,c4 #acif;b7-- 7,a7 in subsection 7a71 in the matter before paragraph 7#a71 by inserting and section #aijc;,a7a7 after except as otherwise provided in this section2 and 7,b7 in subsection 7d77#a71 by striking to which and inserting to which1 subject to section #aijc;,a7a712 and 7#b7 by inserting after such section #aijc the following new section3 #aijc;,a4 ,flexible block grant option for ,states 7a7 ,in general ,in the case of a ,state that elects the option of applying this section for a #aj-;fiscal-year period 7beginning no earlier than fiscal year #bjbj and1 at the ,state option1 for any succeeding #aj-;fiscal-year period7 and that has a plan approved by the ,secretary under subsection 7b7 to carry out the option for such period-- 7#a7 the ,state shall receive1 instead of amounts otherwise payable to the ,state under this title for medical assistance for block grant individuals within the applicable block grant category 7as defined in subsection 7f77 for the ,state during the period in which the election is in effect1 the amount specified in subsection 7d72 7#b7 the payment under this section may only be used consistent with the ,state plan under subsection 7b7 for block grant health care assistance 7as defined in subsection 7g772 and 7#c7 with respect to block grant individuals within the applicable block grant category for the ,state for which block grant health care assistance is made available under this section1 such assistance shall be instead of medical assistance otherwise provided to the individual under this title4 7b7 ,state plan for administering block grant option 7#a7 ,in general ,no payment shall be made under this section to a ,state pursuant to an election for a #aj-;fiscal-year period under subsection 7a7 unless the ,state has a plan1 approved under paragraph 7#b71 for such period that specifies-- 7,a7 the applicable block grant category with respect to which the ,state will apply the option under this section for such period2 7,b7 the conditions for eligibility of block grant individuals within such applicable block grant category for block grant health care assistance under the option1 which shall be instead of other conditions for eligibility under this title1 except that in the case of a ,state that has elected the applicable block grant category described in-- 7i7 paragraph 7#a7 of subsection 7f71 the plan must provide for eligibility for pregnant women and children required to be provided medical assistance under subsections 7a77#aj77;,a77i7 and 7e77#d7 of section #aijb2 or 7ii7 paragraph 7#b7 of subsection 7f71 the plan must provide for eligibility for pregnant women required to be provided medical assistance under subsection 7a77#aj77;,a77i72 and 7,c7 the types of items and services1 the amount1 duration1 and scope of such services1 the cost-sharing with respect to such services1 and the method for delivery of block grant health care assistance under this section1 which shall be instead of the such types1 amount1 duration1 and scope1 cost-sharing1 and methods of delivery for medical assistance otherwise required under this title1 except that the plan must provide for assistance for-- 7i7 hospital care2 7ii7 surgical care and treatment2 7iii7 medical care and treatment2 7iv7 obstetrical and prenatal care and treatment2 7v7 prescribed drugs1 medicines1 and prosthetic devices2 7vi7 other medical supplies and services2 and 7vii7 health care for children under #ah years of age4 7#b7 ,review and approval ,a plan described in paragraph 7#a7 shall be deemed approved by the ,secretary unless the ,secretary determines1 within #cj days after the date of the ,secretary's receipt of the plan1 that the plan is incomplete or actuarially unsound and1 with respect to such plan and its implementation under this section1 the requirements of paragraphs 7#a71 7#aj77;,b71 7#ag71 and 7#bc7 of section #aijb7;a7 shall not apply4 7c7 ,amount of block grant funds 7#a7 ,for initial fiscal year ,the block grant amount under this subsection for a ,state for the initial fiscal year in the first #aj-;fiscal-year period is equal to an amount determined by the ,secretary to equal the per capita spending on the population covered by the ,state plan established in subsection 7b7 of section #aijc;,a4 7#b7 ,for any subsequent fiscal year ,the block grant amount under this section for a ,state for each succeeding fiscal year 7in any #aj-;fiscal-year period7 is equal to the block grant amount under paragraph 7#a7 7or this paragraph7 for the ,state for the previous fiscal year increased by the annual increase in the consumer price index for all urban consumers 7all items2 ,u4,s4 city average7 for the fiscal year involved4 7#c7 ,availability of rollover funds ,the block grant amount under this subsection for a ,state for a fiscal year shall remain available to the ,state for expenditures under this section for the succeeding fiscal year but only if an election is in effect under this section for the ,state in such succeeding fiscal year4 7d7 ,federal payment and ,state responsibility ,the ,secretary shall pay to each ,state with an election in effect under this section for a fiscal year1 from its block grant amount under subsection 7c7 available for such fiscal year1 an amount for each quarter of such fiscal year equal to the enhanced ,,fmap described in the first sentence of section #baje7;b7 of the total amount expended under the ,state plan under this section during such quarter1 and the ,state is responsible for the balance of funds to carry out such plan4 7e7 ,block grant individual defined ,in this section1 the term block grant individual means1 with respect to a ,state for a #aj-;fiscal-year period1 an individual who is within an applicable block grant category for the ,state and such period4 7f7 ,applicable block grant category defined ,in this section1 the term applicable block grant category means with respect to a ,state for a #aj-;fiscal-year period1 either of the following as specified by the ,state for such period in its plan under subsection 7b77#a77;,a73 7#a7 ,elderly1 blind1 disabled ,both of the following categories3 7,a7 ,elderly ,individuals who are #fe years of age or older4 7,b7 ,blind and disabled ,individuals 7not described in the previous subparagraph7 who are eligible for medical assistance under this title on the basis of being blind or disabled4 7#b7 ,elderly1 blind1 disabled1 and others ,all of the following categories3 7,a7 ,elderly ,individuals who are #fe years of age or older4 7,b7 ,blind and disabled ,individuals 7not described in the previous subparagraph7 who are eligible for medical assistance under this title on the basis of being blind or disabled4 7,c7 ,children ,individuals 7not described in a previous subparagraph7 who are children under #ai years of age4 7,d7 ,expansion enrollees ,individuals 7not described in a previous subparagraph7 for whom the amounts expended for medical assistance are subject to an increase or change in the ,federal medical assistance percentage under subsection 7y7 or 7z77#b71 respectively1 of section #aije4 7,e7 ,other nonelderly1 nondisabled1 non-expansion adults ,individuals who are not described in any of the previous subparagraphs and whose income does not exceed #fj percent of the poverty line 7as defined in section #baaj7;c77#e77 applicable to a family of the size involved4 7g7 ,block grant health care assistance ,in this section1 the term block grant health care assistance means assistance for health-care-related items and medical services for block grant individuals within the applicable block grant category for the ,state and #aj-;fiscal-year period involved who are low-income individuals 7as defined by the ,state74 7h7 ,auditing ,as a condition of receiving funds under this section1 a ,state shall contract with an independent entity to conduct audits of its expenditures made with respect to activities funded under this section for each fiscal year for which the ,state elects to apply this section to ensure that such funds are used consistent with this section and shall make such audits available to the ,secretary upon the request of the ,secretary4 4 #bjb4 ,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 #bjc4 ,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 #bjbj1 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 #bjd4 ,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 7#fj percent in the case of an individual enrolled through an ,exchange utilized by a ,state that makes the election described in section #aijc;,a of the ,social ,security ,act74 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 ,b ,medicare #bba4 ,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 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 #bbb4 ,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 #bbc4 ,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 #bjbj2 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 #bjbj2 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 #bjbj2 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 #bjbj2 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 ,medical ,malpractice ,reform #bca4 ,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 #bcb4 ,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 #bcc4 ,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 #bcd4 ,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 #bce4 ,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 #bcf4 ,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 #bcg4 ,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 #bch4 ,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 #bci4 ,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 #bdj4 ,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 #bda4 ,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 #bdb4 ,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 subsection 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 #bdc4 ,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 #bdd4 ,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 ,,iii ,prescription drug competition ,a ,eliminating ,delays of ,generic ,drugs and ,biosimilar ,products #cja4 ,actions for delays of generic drugs and biosimilar biological products 7a7 ,definitions ,in this section-- 7#a7 the term covered product-- 7,a7 means-- 7i7 any drug approved under subsection 7b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or biological product licensed under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb72 7ii7 any combination of a drug or biological product described in clause 7i72 or 7iii7 when reasonably necessary to demonstrate sameness1 biosimilarity1 or interchangeability for purposes of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 as applicable1 any product1 including any device1 that is marketed or intended for use with such drug or biological product2 and 7,b7 does not include any drug or biological product that the ,secretary has determined to be currently in shortage and that appears on the drug shortage list in effect under section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e71 unless the shortage will not be promptly resolved-- 7i7 as demonstrated by the fact that the drug or biological product has been in shortage for more than #f months2 or 7ii7 as otherwise determined by the ,secretary2 7#b7 the term device has the meaning given the term in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba72 7#c7 the term eligible product developer means a person that seeks to develop a product for approval pursuant to an application for approval under subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or for licensing pursuant to an application under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k772 7#d7 the term license holder means the holder of an application approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or the holder of a license under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 for a covered product2 7#e7 the term ,,rems means a risk evaluation and mitigation strategy under section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a72 7#f7 the term ,,rems with ,,etasu means a ,,rems that contains elements to assure safe use under section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a72 7#g7 the term ,secretary means the ,secretary of ,health and ,human ,services2 7#h7 the term single1 shared system of elements to assure safe use means a single1 shared system of elements to assure safe use under section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a72 and 7#i7 the term sufficient quantities means an amount of a covered product that allows the eligible product developer to-- 7,a7 conduct testing to support an application-- 7i7 for approval under subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 or 7ii7 for licensing under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k772 and 7,b7 fulfill any regulatory requirements relating to such an application for approval or licensing4 7b7 ,civil action for failure ,to provide sufficient quantities of a covered product 7#a7 ,in general ,an eligible product developer may bring a civil action against the license holder for a covered product seeking relief under this subsection in an appropriate district court of the ,united ,states alleging that the license holder has declined to provide sufficient quantities of the covered product to the eligible product developer on commercially reasonable1 market-based terms4 7#b7 ,elements 7,a7 ,in general ,to prevail in a civil action brought under paragraph 7#a71 an eligible product developer shall prove1 by a preponderance of the evidence-- 7i7 that-- 7,i7 the covered product is not subject to a ,,rems with ,,etasu2 or 7,,ii7 if the covered product is subject to a ,,rems with ,,etasu-- 7aa7 the eligible product developer has obtained a covered product authorization from the ,secretary in accordance with subparagraph 7,b72 and 7bb7 the eligible product developer has provided a copy of the covered product authorization to the license holder2 7ii7 that1 as of the date on which the civil action is filed1 the product developer has not obtained sufficient quantities of the covered product on commercially reasonable1 market-based terms2 7iii7 that the eligible product developer has requested to purchase sufficient quantities of the covered product from the license holder2 and 7iv7 that the license holder has not delivered to the eligible product developer sufficient quantities of the covered product on commercially reasonable1 market-based terms-- 7,i7 for a covered product that is not subject to a ,,rems with ,,etasu1 by the date that is #ca days after the date on which the license holder received the request for the covered product2 and 7,,ii7 for a covered product that is subject to a ,,rems with ,,etasu1 by #ca days after the later of-- 7aa7 the date on which the license holder received the request for the covered product2 or 7bb7 the date on which the license holder received a copy of the covered product authorization issued by the ,secretary in accordance with subparagraph 7,b74 7,b7 ,authorization for covered product subject to a ,,rems with ,,etasu 7i7 ,request ,an eligible product developer may submit to the ,secretary a written request for the eligible product developer to be authorized to obtain sufficient quantities of an individual covered product subject to a ,,rems with ,,etasu4 7ii7 ,authorization ,not later than #ij days after the date on which a request under clause 7i7 is received1 the ,secretary shall1 by written notice1 authorize the eligible product developer to obtain sufficient quantities of an individual covered product subject to a ,,rems with ,,etasu for purposes of-- 7,i7 development and testing that does not involve human clinical trials1 if the eligible product developer has agreed to comply with any conditions the ,secretary determines necessary2 or 7,,ii7 development and testing that involves human clinical trials1 if the eligible product developer has-- 7aa7 7,,aa7 submitted protocols1 informed consent documents1 and informational materials for testing that include protections that provide safety protections comparable to those provided by the ,,rems for the covered product2 or 7,,bb7 otherwise satisfied the ,secretary that such protections will be provided2 and 7bb7 met any other requirements the ,secretary may establish4 7iii7 ,notice ,a covered product authorization issued under this subparagraph shall state that the provision of the covered product by the license holder under the terms of the authorization will not be a violation of the ,,rems for the covered product4 7#c7 ,affirmative defense ,in a civil action brought under paragraph 7#a71 it shall be an affirmative defense1 on which the defendant has the burden of persuasion by a preponderance of the evidence-- 7,a7 that1 on the date on which the eligible product developer requested to purchase sufficient quantities of the covered product from the license holder-- 7i7 neither the license holder nor any of its agents1 wholesalers1 or distributors was engaged in the manufacturing or commercial marketing of the covered product2 and 7ii7 neither the license holder nor any of its agents1 wholesalers1 or distributors otherwise had access to inventory of the covered product to supply to the eligible product developer on commercially reasonable1 market-based terms2 or 7,b7 that-- 7i7 the license holder sells the covered product through agents1 distributors1 or wholesalers2 7ii7 the license holder has placed no restrictions1 explicit or implicit1 on its agents1 distributors1 or wholesalers to sell covered products to eligible product developers2 and 7iii7 the covered product can be purchased by the eligible product developer in sufficient quantities on commercially reasonable1 market-based terms from the agents1 distributors1 or wholesalers of the license holder4 7#d7 ,remedies 7,a7 ,in general ,if an eligible product developer prevails in a civil action brought under paragraph 7#a71 the court shall-- 7i7 order the license holder to provide to the eligible product developer without delay sufficient quantities of the covered product on commercially reasonable1 market-based terms2 7ii7 award to the eligible product developer reasonable attorney fees and costs of the civil action2 and 7iii7 award to the eligible product developer a monetary amount sufficient to deter the license holder from failing to provide other eligible product developers with sufficient quantities of a covered product on commercially reasonable1 market-based terms1 if the court finds1 by a preponderance of the evidence-- 7,i7 that the license holder delayed providing sufficient quantities of the covered product to the eligible product developer without a legitimate business justification2 or 7,,ii7 that the license holder failed to comply with an order issued under clause 7i74 7,b7 ,maximum monetary amount ,a monetary amount awarded under subparagraph 7,a77iii7 shall not be greater than the revenue that the license holder earned on the covered product during the period-- 7i7 beginning on-- 7,i7 for a covered product that is not subject to a ,,rems with ,,etasu1 the date that is #ca days after the date on which the license holder received the request2 or 7,,ii7 for a covered product that is subject to a ,,rems with ,,etasu1 the date that is #ca days after the later of-- 7aa7 the date on which the license holder received the request2 or 7bb7 the date on which the license holder received a copy of the covered product authorization issued by the ,secretary in accordance with paragraph 7#b77;,b72 and 7ii7 ending on the date on which the eligible product developer received sufficient quantities of the covered product4 7,c7 ,avoidance of delay ,the court may issue an order under subparagraph 7,a77i7 before conducting further proceedings that may be necessary to determine whether the eligible product developer is entitled to an award under clause 7ii7 or 7iii7 of subparagraph 7,a71 or the amount of any such award4 7c7 ,limitation of liability ,a license holder for a covered product shall not be liable for any claim arising out of the failure of an eligible product developer to follow adequate safeguards to assure safe use of the covered product during development or testing activities described in this section1 including transportation1 handling1 use1 or disposal of the covered product by the eligible product developer4 7d7 ,rule of construction 7#a7 ,definition ,in this subsection1 the term antitrust laws-- 7,a7 has the meaning given the term in subsection 7a7 of the first section of the ,clayton ,act 7#ae ,u4,s4,c4 #ab72 and 7,b7 includes section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to the extent that such section applies to unfair methods of competition4 7#b7 ,antitrust laws ,nothing in this section shall be construed to limit the operation of any provision of the antitrust laws4 #cjb4 ,,rems approval process for subsequent filers ,section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7 is amended-- 7#a7 in subsection 7g77#d77;,b7-- 7,a7 in clause 7i7 by striking or after the semicolon2 7,b7 in clause 7ii7 by striking the period at the end and inserting 2 or2 and 7,c7 by adding at the end the following3 7iii7 accommodate different approved risk evaluation and mitigation strategies for a reference drug product and a drug that is the subject of an abbreviated new drug application4 2 and 7#b7 in subsection 7i77#a71 by striking subparagraph 7,b7 and inserting the following3 7,b7 ,elements to assure safe use1 if required under subsection 7f7 for the listed drug in accordance with the following3 7i7 ,subject to clause 7ii71 a drug that is the subject of an abbreviated new drug application may use-- 7,i7 a single1 shared system with the listed drug under subsection 7f72 or 7,,ii7 a different1 comparable aspect of the elements to assure safe use under subsection 7f74 7ii7 ,the ,secretary may require a drug that is the subject of an abbreviated new drug application and the listed drug to use a single1 shared system under subsection 7f71 if the ,secretary determines that no different1 comparable aspect of the elements to assure safe use could satisfy the requirements of subsection 7f74 4 ,b ,increasing ,access to ,drugs and ,biosimilar ,products #caa4 ,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 #cab4 ,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 #cac4 ,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 ,c ,limiting ,exclusivity ,periods ,delaying ,competition #cba4 ,limiting 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 #cbb4 ,limiting exclusivity for biosimilar products ,paragraph 7#g7 of section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77 is amended in subparagraph 7,a71 by striking #ab and inserting #e4 ,d ,congressional ,review of ,agency ,rulemaking #cca4 ,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 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 #ccb4 ,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 ,e ,medicare ,prescription ,drug ,competition #cda4 ,medicare drug coverage ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services may alter the reimbursement mechanism for prescription drugs provided through the ,medicare ,part ,b program by reimbursing at a rate that1 based on ,,asp#f in the year of implementation of this ,act1 grows at ,,cpi4 #cdb4 ,,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 #bjbj4 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 #cdc4 ,sunset of limit on maximum rebate amount for single source drugs and innovator multiple source drugs ,section #aibg7;c77#b77;,d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#b77;,d77 is amended by inserting after ,december #ca1 #bjji1 the following3 and before ,december #ca1 #bjbd14 #cdd4 ,regulation of manufacturer-sponsored copay contributions ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services may establish a mechanism prohibiting drug manufacturers from contributing financially to patient copays1 and establish a system of penalizing such behavior4 #cde4 ,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 #cdf4 ,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 #bjbj1 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 ,,iv ,provider ,competition #dja4 ,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 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 in an urban area and with respect to which there is a ,herfindahl-,hirschman ,index 7,,hhi7 of greater than #d1jjj and in the case of a hospital in a rural area and with respect to which there is ,herfindahl-,hirschman ,index 7,,hhi7 of greater than #e1jjj1 to apply the 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 entitled to or enrolled for benefits under this title4 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 the ,,hrr market share of such hospital 7as determined under subparagraph 7,b77 is less than #j4ae4 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 hospital 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 programs 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 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 #djb4 ,price transparency ,section #ahff of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;cc71 as amended by section #dja1 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 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 ,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 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 #djc4 ,repealing shared savings incentives from ,medicare shared savings program 7a7 ,in general ,section #ahii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;jjj7 is amended-- 7#a7 in subsection 7a77#a7-- 7,a7 by striking subparagraph 7,b72 and 7,b7 by striking such program-- 7,a7 groups of providers and inserting such program1 groups of providers 2 7#b7 in subsection 7b77#b7-- 7,a7 in subparagraph 7,c71 by striking that would allow the organization to receive and distribute payments for shared savings under subsection 7d77#b7 to participating providers of services and suppliers2 and 7,b7 in subparagraph 7,e7-- 7i7 by striking the implementation and inserting and the implementation2 and 7ii7 by striking 1 and the determination of payments for shared savings under subsection 7d77#b72 7#c7 in subsection 7d7-- 7,a7 in paragraph 7#a7-- 7i7 in subparagraph 7,a71 by striking except and all that follows through subparagraph 7,b77i742 and 7ii7 by striking subparagraph 7,b72 and 7,b7 by striking paragraph 7#b72 and 7#d7 in subsection 7g71 by striking paragraph 7#d7 and redesignating paragraphs 7#e7 and 7#f7 as paragraphs 7#d7 and 7#e71 respectively4 7b7 ,effective date ,the amendments made by subsection 7a7 shall take effect on ,january #a1 #bjba4 #djd4 ,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 #dje4 ,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 #djf4 ,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 ,v ,digital ,health ,care #eja4 ,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 #ejb4 ,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 #ejc4 ,,stark and ,,aks exemptions ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services may exempt value-based arrangements1 alternative payment models1 and technologies 7as defined by the ,secretary7 from any provision of section #aabh;,b or #ahgg of the ,social ,security ,act for purposes of maintaining1 analyzing1 or transferring electronic health records4 #ejd4 ,,stark technical penalty ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services may institute a civil monetary penalty for technical1 nonegregious violations of section #ahgg of the ,social ,security ,act in lieu of any penalty otherwise applicable for such violations under such section4