,i #aaeth ,,congress #b;d ,session ,h4 ,r4 #gcci ,,in ,,the ,,house ,,of ,,representatives ,december #ai1 #bjah,ms4 ,de,lauro 7for herself and ,ms4 ,schakowsky7 introduced the following bill2 which was referred to the ,committee on ,ways and ,means1 and in addition to the ,committees on ,energy and ,commerce1 ,education and the ,workforce1 ,natural ,resources1 and the ,judiciary1 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 amend the ,social ,security ,act to establish a ,medicare for ,america health program to provide for comprehensive health coverage for all ,americans4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,medicare for ,america ,act of #bjah4 7b7 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,title ,i--,transitioning to and ,establishing ,medicare for ,america ,subtitle ,a--,transitional public health option ,sec4 #aja4 ,establishment4 ,sec4 #ajb4 ,eligibility4 ,sec4 #ajc4 ,benefits4 ,sec4 #ajd4 ,premiums4 ,sec4 #aje4 ,providers and reimbursement rates4 ,sec4 #ajf4 ,account2 funding4 ,subtitle ,b--,medicare for ,america ,sec4 #aaa4 ,establishment and administration of ,medicare for ,america4 ,sec4 #aab4 ,modifications to and coordination with existing ,federal health programs4 ,subtitle ,c--,targeted ,reforms ,sec4 #aba4 ,limitation on removal of ,medicare ,advantage providers by ,,ma organizations4 ,sec4 #abb4 ,network adequacy4 ,sec4 #abc4 ,eliminating the #bd-month waiting period for ,medicare coverage for individuals with disabilities4 ,sec4 #abd4 ,employer health plan options4 ,sec4 #abe4 ,prohibition on step therapy and prior authorization under group health plans4 ,sec4 #abf4 ,medicare outpatient observation services4 ,sec4 #abg4 ,abortion coverage4 ,title ,,ii--,tax ,provisions ,sec4 #bja4 ,sunset of ,public ,law #aae-ig4 ,sec4 #bjb4 ,surtax4 ,sec4 #bjc4 ,basis of property acquired from a decedent4 ,sec4 #bjd4 ,medicare payroll tax4 ,sec4 #bje4 ,net investment income tax4 ,sec4 #bjf4 ,termination of health savings accounts4 ,sec4 #bjg4 ,termination of flexible spending arrangements4 ,sec4 #bjh4 ,increase in excise tax on small cigars and cigarettes and other tobacco products4 ,sec4 #bji4 ,excise tax on alcohol4 ,sec4 #baj4 ,tax on sugared drinks4 ,title ,,iii--,drug-,related ,provisions ,sec4 #cja4 ,establishment of the prescription drug and medical device review board4 ,sec4 #cjb4 ,membership2 staff4 ,sec4 #cjc4 ,reporting requirements4 ,sec4 #cjd4 ,prohibition against excessive price4 ,sec4 #cje4 ,enforcement provisions4 ,sec4 #cjf4 ,authority4 ,sec4 #cjg4 ,regulations4 ,sec4 #cjh4 ,report to ,federal agencies4 ,sec4 #cji4 ,definitions4 ,sec4 #caj4 ,moratorium on direct-to-consumer drug advertising4 ,sec4 #caa4 ,reporting on justification for drug price increases4 ,i ,transitioning to and ,establishing ,medicare for ,america ,a ,transitional public health option #aja4 ,establishment ,the ,secretary of ,health and ,human ,services 7in this subtitle referred to as the ,secretary7 shall establish a public health plan option that is offered in the individual market through the ,federal and ,state ,exchanges under title ,i of the ,patient ,protection and ,affordable ,care ,act to eligible individuals for plan years #bjbj and #bjba in accordance with this subtitle4 #ajb4 ,eligibility 7a7 ,in general ,subject to subsection 7b71 an individual is eligible to enroll in such public health plan option if the individual is otherwise eligible to purchase individual health insurance coverage through an ,exchange and the individual resides in a rating area in which the ,secretary makes the public health plan option available4 7b7 ,priority ,in determining in which rating areas the ,secretary initially will make the public health plan option available1 the ,secretary shall give priority to rating areas in which-- 7#a7 not more than #a health insurance issuer offers plans on the applicable ,state or ,federal ,american ,health ,benefit ,exchange2 or 7#b7 there is a shortage of health providers or lack of competition that results in a high cost of health care services1 including health professional shortage areas and rural areas4 #ajc4 ,benefits 7a7 ,in general ,the public health plan option shall be a qualified health plan within the meaning of section #acja7;a7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjba7;a77 that-- 7#a7 meets all requirements applicable to qualified health plans under subtitle ,d of title ,i of the ,patient ,protection and ,affordable ,care ,act 7other than the requirement under section #acja7;a77#a77;,c77ii7 of such ,act 7#db ,u4,s4,c4 #ahjba7;a77#a77;,c77ii777 and title ,,xxvii of the ,public ,health ,service ,act2 7#b7 provides coverage of the essential health benefits described in section #acjb7;b7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjbb7;b772 7#c7 provides silver and gold-level coverage described in section #acjb7;d77#a77;,c7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjbb7;d77#a77;,c772 and 7#d7 provides coverage of abortions and all other reproductive health services4 7b7 ,preemption ,notwithstanding section #acjc7;a77#a7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjbc7;a77#a77-- 7#a7 a ,state may not prohibit the public health plan option from offering the coverage described in subsection 7a77#d72 and 7#b7 no ,state law that would prohibit such a plan from offering such coverage shall apply to such plan4 #ajd4 ,premiums ,the ,secretary shall establish premium rates for the public health plan option that-- 7#a7 are adjusted based on the applicable rating area2 7#b7 are at a level sufficient to fully finance-- 7,a7 the costs of health benefits provided by such plans2 and 7,b7 administrative costs related to operating the plans2 and 7#c7 comply with the requirements under section #bgja of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg74 #aje4 ,providers and reimbursement rates 7a7 ,in general ,the ,secretary shall establish a rate schedule for reimbursing types of health care providers furnishing items and services under the public health insurance plan option at rates based on rates applied for such items and services under title ,,xviii of the ,social ,security ,act1 as of the date of the enactment of this ,act1 that are necessary to maintain network adequacy4 ,the ,secretary shall establish a rate schedule for items and services not currently covered under title ,,xviii of the ,social ,security ,act at a level to ensure adequate access to providers4 7b7 ,participating providers 7#a7 ,in general ,a health care provider that is a participating provider of services or supplier under the ,medicare program under title ,,xviii of the ,social ,security ,act or under the ,medicaid program under title ,,xix of such ,act on the date of enactment of this title shall be a participating provider for public health insurance plan option4 7#b7 ,additional providers ,the ,secretary shall establish a process to allow health care providers not described in paragraph 7#a7 to become participating providers for the public health insurance plan option4 7c7 ,prescription drugs ,the ,secretary shall apply the provisions of section #ahfj;,d-#aa7;i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;i77 to prescription drugs under the public health plan option in the same manner as such provisions apply with respect to applicable covered part ,d drugs under such section4 #ajf4 ,account2 funding 7a7 ,establishment ,there is established in the ,treasury of the ,united ,states an account for the receipts and disbursements attributable to the operation of the public health plan option4 7b7 ,appropriation ,there is appropriated to the account established under subsection 7a71 out of any funds in the ,treasury not otherwise obligated1 such sums as may be necessary to be used by the ,secretary for purposes of carrying out this part4 7c7 ,prohibition of ,state imposition of taxes ,section #ahed7;g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bd7;g77 shall apply to receipts and disbursements described in subsection 7a7 in the same manner as such section applies to payments or premiums described in such section4 7d7 ,clarification ,any provision of law restricting the use of ,federal funds with respect to any reproductive health service shall not apply to funds appropriated under subsection 7b7 or with respect to the account under subsection 7a74 ,b ,medicare for ,america #aaa4 ,establishment and administration of ,medicare for ,america ,the ,social ,security ,act is amended by adding at the end the following new title3 ,,xxii ,medicare for ,america ,a ,comprehensive ,health ,coverage #bbja4 ,establishment ,the ,secretary shall establish a public health insurance program1 to be known as ,medicare for ,america1 which shall for calendar year #bjbb and each subsequent calendar year provide comprehensive health benefits in accordance with this part to individuals enrolled for coverage under this title4 #bbjb4 ,eligibility2 ,automatic enrollment 7a7 ,eligible individuals ,for purposes of this title1 every individual who is a resident of the ,united ,states is entitled to benefits for health care services under this title4 ,the ,secretary shall promulgate a rule that provides criteria for determining residency for eligibility purposes under this title4 7b7 ,enrollments ,subject to subsection 7c73 7#a7 ,in general ,beginning in #bjbb1 the ,secretary shall provide a mechanism for the enrollment of individuals entitled to benefits under this title and1 in conjunction with such enrollment1 the issuance of a ,medicare card which may be used for purposes of identification and processing of claims for benefits under this title4 ,as a condition of participation in the program1 participating providers shall facilitate enrollment as specified by the ,secretary4 7#b7 ,automatic enrollments ,the mechanism provided under paragraph 7#a7 shall1 subject to paragraph 7#d71 provide1 for plan years beginning with plan year #bjbb1 for the following automatic enrollments under ,medicare for ,america3 7,a7 ,enrollment at birth ,for plan years 7beginning with plan year #bjbb71 a process1 established by the ,secretary in consultation with the ,commissioner of ,social ,security1 for the automatic enrollment of eligible individuals born during such plan year4 7,b7 ,current ,medicare beneficiaries 7i7 ,current ,medicare beneficiaries ,for plan years 7beginning with plan year #bjbb71 a process established by the ,secretary for the automatic enrollment of all individuals who are enrolled for benefits under part ,a or ,b of title ,,xviii 7other than individuals who are enrolled for such benefits and receiving benefits under title ,,xix74 7ii7 ,continuing population ,for plan years 7beginning with plan year #bjbb71 a process established by the ,secretary for the automatic enrollment of eligible individuals who attain the age of #fe during such plan year4 7iii7 ,duals ,for plan years 7beginning with plan year #bjbd71 a process established by the ,secretary for the automatic enrollment of eligible individuals who are enrolled for benefits under part ,a or ,b of title ,,xviii and receiving benefits under title ,,xix4 7,c7 ,other individuals without qualified health coverage ,for plan years 7beginning with plan year #bjbb71 a process established by the ,secretary for the automatic enrollment of eligible individuals who are not enrolled in other qualified health coverage 7as defined in paragraph 7#d77;,b77 for such plan year4 7#c7 ,other enrollments ,the mechanism provided under paragraph 7#a7 shall provide for the following3 7,a7 ,in general ,enrollment periods and processes for each plan year 7beginning with plan year #bjbb7 for enrollment under ,medicare for ,america of any eligible individual not otherwise described in paragraph 7#b74 7,b7 ,small employers ,for plan years 7beginning with plan year #bjbb71 a process and methodology under which a small employer1 as defined in section #abd7;d77#c7 of the ,medicare for ,america ,act1 may provide for the enrollment of the employees of such employer under ,medicare for ,america4 ,for purposes of the previous sentence1 the term small employer means any employer for any calendar year if the annual payroll of such employer for the preceding calendar year does not exceed #b1jjj1jjj or has fewer than #ajj employees4 7,c7 ,large employers ,for plan years 7beginning with plan year #bjbf71 the ,secretary shall provide for a process and methodology under which a large employer may provide for the enrollment of the employees of such employer under ,medicare for ,america4 ,for purposes of the preceding sentence1 the term large employer means an employer with at least #ajj employees4 7#d7 ,opt out for individuals enrolled under qualified health coverage 7,a7 ,in general ,the mechanism provided under paragraph 7#a7 shall provide1 with respect to a plan year1 for a process that enables individuals who are enrolled in qualified health coverage for such plan year to opt out of coverage under ,medicare for ,america for such year4 7,b7 ,qualified health coverage defined ,for purposes of this section1 the term qualified health coverage means coverage under any of the following3 7i7 ,for plan years #bjbb and #bjbc3 7,i7 ,qualified employer coverage1 as defined in section #abd of the ,medicare for ,america ,act4 7,,ii7 ,medical coverage under chapter #ee of title #aj1 ,united ,states ,code1 including coverage under the ,,tricare program4 7,,iii7 ,a health care program under chapter #ag or #ah of title #ch1 ,united ,states ,code1 as determined by the ,secretary of ,veterans ,affairs1 in coordination with the ,secretary of ,health and ,human ,services and the ,secretary4 7,,iv7 ,the health benefit program under chapter #hi of title #e1 ,united ,states ,code4 7,v7 ,medical benefits and services provided by or through the ,indian ,health ,service4 7,,vi7 ,the ,medicaid program under title ,,xix of the ,social ,security ,act4 7,,vii7 ,the ,,chip program under title ,,xxi of the ,social ,security ,act4 7ii7 ,for plan years #bjbd and #bjbe3 7,i7 ,coverage described in subclause 7,i71 7,,ii71 7,,iii71 7,,iv71 or 7,v7 of clause 7i74 7,,ii7 ,coverage described in subclause 7,,vi7 of clause 7i71 but only with respect to coverage that is not for individuals described in subclause 7,,viii7 of section #aijb7;a77#aj77;,a77i7 or who are also enrolled for benefits under title ,,xviii4 7iii7 ,for each subsequent plan year1 coverage described in subclause 7,i71 7,,ii71 7,,iii71 7,,iv71 or 7,v7 of clause 7i74 7c7 ,waiver ,the ,secretary shall establish a process under which the ,secretary may grant waivers to ,states for additional time before populations described in a previous subsection of this section of such ,state are automatically enrolled under ,medicare for ,america4 #bbjc4 ,benefits 7a7 ,in general ,medicare for ,america shall1 in accordance with this section1 provide coverage for all the benefits1 as determined to be medically necessary and reasonable1 as covered and defined under parts ,a and ,b of title ,,xviii and title ,,xix as of the date of the enactment of this title1 including the following3 7#a7 ,ambulatory patient services4 7#b7 ,emergency care and urgent care services4 7#c7 ,hospitalization4 7#d7 ,maternity and newborn care4 7#e7 ,behavioral health1 mental health and substance use disorder services1 including the following3 7,a7 ,home-based services4 7,b7 ,acute services for mental health crises1 including crisis stabilization services such as mobile crisis services1 including emergency mobile psychiatric services4 7,c7 #bc-;hour observation4 7,d7 ,outpatient services provided by hospitals1 freestanding clinics1 and behavioral health providers in independent practice4 7,e7 ,smoking and tobacco cessation4 7,f7 ,case management4 7,g7 ,peer support services4 7,h7 ,counseling4 7,i7 ,other intensive outpatient community-based services1 such as ,assertive ,community ,treatment and supported employment1 provided through the ,,ltss benefit4 7,j7 ,other intensive community-based services provided through the ,early and ,periodic ,screening1 ,diagnostic1 and ,treatment 7,,epsdt7 benefit 7as defined in subpart ,b of part #dda of title #db of the ,code of ,federal ,regulations74 7,k7 ,medication assisted treatment and maintenance services4 7,l7 ,inpatient detoxification4 7,m7 ,ambulatory detoxification4 7,n7 ,psychological testing4 7,o7 ,home health agency services4 7#f7 ,prescription drugs4 7#g7 ,rehabilitative and habilitative services and devices1 including the following3 7,a7 ,physical therapy4 7,b7 ,speech therapy4 7,c7 ,occupational therapy4 7#h7 ,laboratory services4 7#i7 ,preventive and wellness services and chronic disease management4 7#aj7 ,pediatric services1 including oral and vision care and all services that would otherwise be covered under ,early and ,periodic ,screening1 ,diagnostic1 and ,treatment under the ,medicaid program under title ,,xix4 7#aa7 ,dental4 7#ab7 ,hearing health services including aids and exams4 7#ac7 ,home and community-based long-term supports and services4 7#ad7 ,chiropractic services4 7#ae7 ,durable medical equipment1 including the following3 7,a7 ,wheelchairs and accessories4 7,b7 ,walking aides such as walkers1 canes1 and crutches4 7,c7 ,bathroom equipment such as commodes and safety equipment4 7,d7 ,inhalation therapy equipment such as nebulizers4 7,e7 ,hospital beds and accessories4 7,f7 ,other devices such as continuous positive airway pressure 7,,cpap7 machines1 apnea monitors1 and ventilators4 7,g7 ,insulin pumps and glucometers4 7,h7 ,breast pumps4 7,i7 ,lymphedema compression treatment items4 7,j7 ,wigs4 7,k7 ,augmentative and alternative communication devices1 including dual-use devices4 7#af7 ,family planning1 including the following3 7,a7 ,reproductive health exams4 7,b7 ,patient counseling and education related to family planning4 7,c7 ,abortion4 7,d7 ,screening1 testing1 treatment1 and pre- and post-test counseling for sexually transmitted diseases and ,,hiv4 7,e7 ,contraceptives including pill1 patch1 medication1 condom1 implant1 or other devices used to prevent pregnancy4 7,f7 ,sterilization for beneficiaries over the age of #ba4 7,g7 ,infertility treatment4 7#ag7 ,gender-confirming medical procedures and treatment4 7#ah7 ,dietary and nutrition counseling4 7#ai7 ,medically necessary food and vitamins for digestive and inherited metabolic disorders4 7#bj7 ,nursing facilities4 7#ba7 ,orthotic and prosthetics devices4 7#bb7 ,oxygen4 7#bc7 ,acupuncture4 7#bd7 ,telehealth4 7#be7 ,services otherwise included under the maternal1 infant1 and early childhood home visiting program under section #eaa of the ,social ,security ,act1 as of the date of the enactment of this title4 7#bf7 ,any additional benefit or service not included in this section that is covered by any ,state plan 7or waiver of such ,state plan7 under title ,,xix on the date of the enactment of this title4 7b7 ,updates ,benefits covered under ,medicare for ,america shall be updated in accordance with the ,national ,coverage ,determination process that had1 as of the date before the date of the enactment of this title1 applied with respect to benefits covered under title ,,xviii4 7c7 ,prohibition against duplicating coverage 7#a7 ,in general ,it is unlawful for a private health insurer 7other than an insurer with respect to a ,medicare ,advantage for ,america plan under part ,c of this title or qualified employer-based coverage7 to sell health insurance coverage that duplicates the benefits provided under ,medicare for ,america under this part4 7#b7 ,construction ,nothing in paragraph 7#a7 shall be construed as prohibiting the sale of health insurance coverage for any additional benefits not covered by this part1 insofar as the coverage satisfies the conditions of paragraph 7#c74 7#c7 ,application of protections ,for purposes of paragraph 7#b71 health insurance coverage for any additional benefits must satisfy the following conditions3 7,a7 ,the provisions of section #bgah of the ,public ,health ,service ,act1 relating to a medical loss ratio4 7,b7 ,the provisions of section #bgjb of the ,public ,health ,service ,act1 relating to guaranteed issue4 7,c7 ,the provisions of section #bgja of the ,public ,health ,service ,act1 relating to community rating4 7,d7 ,the provisions of section #bgjd of the ,public ,health ,service ,act1 relating to the ban on pre-existing conditions exclusions4 7d7 ,states may provide additional benefits ,individual ,states may provide additional benefits for the residents of such ,states at the expense of the ,state4 7e7 ,prohibition against step therapy and prior authorization ,items and services covered under ,medicare for ,america shall be covered without any need for any prior authorization determination and without any limitation applied through the use of step therapy protocols4 #bbjd4 ,premiums 7a7 ,in general 7#a7 ,subject to paragraph 7#b71 each individual enrolled for benefits under this title for a year shall pay monthly community-rated premiums for such year in an amount determined by the ,secretary in accordance with subsection 7b74 7#b7 ,grandfathered ,medicare beneficiaries ,in the case of an individual enrolled under part ,b of title ,,xviii as of the date of the enactment of this part1 the premium applied under this section for such individual for benefits under this title shall be the lesser of-- 7,a7 the premium otherwise applicable to such individual under such title ,,xviii if this title had not been enacted2 or 7,b7 the premium that would be applied to such individual under this title without the application of this paragraph4 7b7 ,premium contribution based on income ,the amount of a monthly premium1 with respect to a plan year 7beginning with #bjbb71 under this section shall be established by the ,secretary in accordance with the following3 7#a7 ,such premium shall be determined such that the collective premiums for the plan year are with respect to the costs of health benefits provided under this title for such year and related administrative costs4 7#b7 ,premiums shall vary by family composition only4 7#c7 ,federal subsidies shall be provided to ensure that the premium shall be-- 7,a7 zero in the case of an individual whose annual household income is below #bjj percent of the poverty line2 7,b7 determined by a linear sliding scale1 in the case of an individual whose household income is at least #bjj percent of the poverty line1 but not more than #fjj percent of the poverty line1 with the premiums ranging between the amount determined for individuals described in clause 7i7 and for individuals described in clause 7iii72 and 7,c7 no individual or household will pay more than #i4fi percent of monthly income toward such monthly premium4 7#d7 ,for an individual whose employer will be making a firm-wide contribution under this title in lieu of offering employer sponsored insurance 7as specified in section #abd7;b77#a77;,b7 of the ,medicare for ,america ,act71 such individual shall pay a premium in accordance with this subsection4 7#e7 ,for an individual who has opted out of their employer sponsored insurance in order to enroll in ,medicare for ,america as specified in section #abd7;c7 of such ,act1 the individual shall pay the premium described in this subsection4 7c7 ,deposits ,amounts paid under this section for coverage under this title shall be deposited in the ,treasury to the credit of the ,trust ,fund established under section #bbjf4 7d7 ,appeals for certain ,medicare grandfathered population ,in calculating premiums for purposes of subsection 7a77#b73 7#a7 ,any individual that was subject to a late enrollment penalty under part ,b of title ,,xviii shall have the right to appeal the assessment of the penalty for good faith enrollment mistakes4 7#b7 ,in any case in which the ,secretary finds that an individual's enrollment or nonenrollment in the insurance program established by this part or part ,a of title ,,xviii pursuant to section #ahah is unintentional1 inadvertent1 or erroneous1 whether the result of the error1 misrepresentation1 or inaction of an officer1 employee1 or agent of the ,federal ,government or its instrumentalities1 an employer1 a representative of a group health plan1 a ,state1 or for any other good faith reason on the part of such individual1 the ,secretary shall take such action 7including the designation for such individual of a special initial or subsequent enrollment period1 including retroactive enrollment1 with a coverage period determined on the basis thereof and with appropriate adjustments of premiums7 as may be necessary to correct or eliminate the effects of such error1 misrepresentation1 or inaction4 ,the failure of an individual to enroll in the insurance program established by this part or part ,a pursuant to section #ahah due to enrollment under a group health plan2 coverage pursuant to title ,,xxii of the ,public ,health ,service ,act1 section #dihj;,b of the ,internal ,revenue ,code of #aihf1 title ,,vi of the ,employee ,retirement ,income ,security ,act of #aigd1 or title ,,xix2 or enrollment under a qualified health plan offered through an ,exchange established under title ,i of the ,patient ,protection and ,affordable ,care ,act shall under this subsection absent exceptional circumstances1 as determined by the ,secretary4 7#c7 ,the ,secretary1 in consultation with the ,commissioner of ,social ,security1 shall develop and publish a formal application for requesting an action of the ,secretary under paragraph 7#a7 to correct or eliminate the effects of an error1 misrepresentation1 or inaction described in such paragraph and determine and publish specific timelines for timely resolution of such a request4 7#d7 ,the ,secretary shall also require that all such determinations with respect to such requests shall be reached within #ae business days of the submission of such application4 ,all determinations shall be in writing through a standard decision notice which shall include an explanation of the reasons for the determination4 7#e7 ,the ,commissioner of ,social ,security shall enter into contracts with independent review organizations in accordance with this subsection for the purpose of reviewing and determining individual appeals of determinations under paragraph 7#c7 with respect to an application submitted pursuant to paragraph 7#b7 relating to enrollment under part ,a or part ,b4 7#f7 ,an individual who receives an adverse determination under paragraph 7#c7 with respect to an application submitted pursuant to paragraph 7#b7 may appeal to an independent review organization designated by the ,commission4 ,any such appeal must be sent to the independent review organization within #ij days of the date the individual received the determination to be eligible for review4 ,the independent review organization shall review and reach a determination of the review in writing within #de days of the receipt of any such appeal4 7#g7 ,the ,secretary of the ,treasury may not enter into a contract under paragraph 7#e7 with an independent review organization-- 7,a7 unless the organization has staff that has the appropriate knowledge of1 and experience with1 the eligibility and coordination of benefits rules and regulations under this title2 and 7,b7 to the extent the organization is a fiscal intermediary under section #ahaf1 a carrier under section #ahdb1 or a ,medicare administrative contractor under section #ahgd;,a4 7#h7 ,the ,secretary of ,health and ,human ,services shall provide for access by independent review organizations conducting appeal determinations under this subsection1 to the database of the ,coordination of ,benefits ,contractor of the ,centers for ,medicare ,medicaid ,services as necessary in order to conduct the duties of such organizations to determine appeals pursuant to this subsection4 #bbje4 ,payment of benefits2 cost-sharing2 out-of-pocket limits 7a7 ,payment of benefits2 cost-,sharing ,there shall be paid1 in the case of each individual who is enrolled under ,medicare for ,america and incurs expenses for items and services with respect to which benefits are payable under this part1 after application of subsection 7b7 and subject to subsection 7c71 #hj percent of the reimbursement rates established pursuant to section #bbjf for such items and services1 except that with respect to ,,usptf recommended preventive and chronic disease services1 and generic drugs1 the amounts paid under this section shall be equal to #ajj percent of the reimbursement rates established pursuant to section #bbjf for such items and services4 7b7 ,deductible 7#a7 ,in general ,there shall be a deductible applied under this part for each plan year that shall be determined on a linear sliding scale for household income that is at least #bjj percent of the poverty line1 but not more than #fjj percent of the poverty line1 and shall not exceed1 subject to paragraphs 7#b7 and 7#c7-- 7,a7 #cej for an individual2 or 7,b7 #ejj total for all members of a household4 7#b7 ,indexing ,in the case of plan years beginning after #bjba1 the dollar amounts described in paragraph 7#a7 shall be increased by the percentage increase over the previous year in the medical care expenditure category of the ,consumer ,price ,index for ,all ,urban ,consumers 7,united ,states city average71 published by the ,bureau of ,labor ,statistics4 7#c7 ,exception ,there shall be no deductible applied under this part for months in a plan year for individuals and households with annual income below #bjj percent of the federal poverty line4 7c7 ,maximum out-of-,pocket limit 7#a7 ,in general ,the coverage under ,medicare shall provide benefits1 after the eligible individual has incurred out-of-pocket expenses for items and services with respect to which benefits are payable under this part in a year equal to the annual out-of-pocket threshold specified in paragraph 7#b71 with cost-sharing that is equal to #j4 7#b7 ,annual out-of-pocket threshold 7,a7 ,in general ,for purposes of paragraph 7#a71 subject to subparagraphs 7,b7 and 7,c71 the annual out-of-pocket threshold specified in this paragraph is a threshold that shall be determined on a linear sliding scale for household income that is at least #bjj percent of the poverty line1 but not more than #fjj percent of the poverty line1 and that shall not exceed-- 7i7 with respect to an individual1 #c1ejj2 or 7ii7 with respect to a household1 #e1jjj4 7,b7 ,indexing ,in the case of plan years beginning after #bjba1 the threshold described in subparagraph 7,a7 7as in effect for the preceding plan year after application of this subparagraph7 shall be increased by the percentage increase over the previous year in the medical care expenditure category of the ,consumer ,price ,index for ,all ,urban ,consumers 7,united ,states city average71 published by the ,bureau of ,labor ,statistics4 7,c7 ,exception ,for purposes of paragraph 7#a71 the annual out-of-pocket threshold for individuals and households with annual income below #bjj percent of the federal poverty line is #j4 7d7 ,no balance billing ,no provider may impose a charge to an enrolled individual for covered services for which benefits are provided under this part in an amount higher than the reimbursement rate for such services under section #bbjf and may not impose a charge to such individual for such service other than with respect to the deductible or other cost-sharing described in this section4 #bbjf4 ,providers network and reimbursement rates 7a7 ,in general ,the ,secretary shall establish a rate schedule for reimbursing types of health care providers furnishing items and services under ,medicare for ,america at rates that are consistent with subsection 7b7 and are necessary to maintain network adequacy4 7b7 ,rates 7#a7 ,in general ,except as provided in paragraphs 7#b7 and 7#c71 the ,secretary shall provide for rates to be provided to health care providers and suppliers furnishing items and services under ,medicare for ,america based on rates that would be applied 7including as computed1 updated1 and adjusted7 under title ,,xviii for such type of health care providers and suppliers and item and service if such title remained in effect and1 in the case of a type of provider and supplier or item or service covered under ,medicare for ,america but not otherwise covered under title ,,xviii1 shall provide for rates that ensure adequate access to care4 7#b7 ,exceptions ,for purposes of this section1 in applying paragraph 7#a7 the ,secretary shall ensure that rates to hospitals for inpatient services or outpatient services furnished under ,medicare for ,america are at least #aaj percent of such rates on average or in the aggregate for furnishing such inpatient or outpatient services otherwise applied under title ,,xviii1 except that for hospitals serving underserved areas as specified by the ,secretary1 such rates are increased as necessary to ensure adequate access to care4 7#c7 ,application ,in applying rates under title ,,xviii for purposes of this part1 the following shall apply3 7,a7 ,the ,secretary shall provide for site-neutral payments for items and services furnished in an outpatient hospital and physician office1 the rate of payment for such service shall be the same4 7,b7 ,the ,secretary shall increase the average relative value of primary care and other mental and behavioral health and cognitive services by not less than #bj percent in order to ensure adequate access to inpatient and outpatient care4 7,c7 ,as a condition of participation in the program1 participating providers shall accept ,medicare for ,america rates paid by employer-sponsored insurance plans and ,medicare ,advantage plans4 7c7 ,participating providers 7#a7 ,in general ,a health care provider that is a participating provider of services or supplier under the ,medicare program under title ,,xviii on the date of enactment of this title shall remain a participating provider for ,medicare for ,america4 7#b7 ,additional providers ,the ,secretary shall establish a process to allow health care providers not described in paragraph 7#a7 to become participating providers for ,medicare for ,america4 7d7 ,prescription drugs 7#a7 ,in general ,any payment rate under this part for a prescription drug shall be at a rate negotiated by the ,secretary based on value assessments by one or more independent nonprofit organizations certified by the ,national ,academy of ,medicine and ,med,p,a,c4 ,if the ,secretary is unable to reach a negotiated agreement on such a reimbursement rate1 the ,secretary shall apply prices paid by the ,department of ,veterans ,affairs for such drugs or the average price of such drugs in nations which are members of the ,organization for ,economic ,cooperation and ,development1 whichever is lower4 7#b7 ,failure to negotiate ,if a drug manufacturer refuses to negotiate with the ,secretary1 then ,medicare for ,america will not cover any of the manufacturer's products4 ,there shall be an exceptions process for drugs that are otherwise unavailable for people with chronic conditions4 ,individuals shall continue to have access to drugs during the appeals process4 ,the ,secretary shall modify such rates in order to accommodate payments for drugs that are not otherwise covered under the original ,medicare fee-for-service program under title ,,xviii4 7#c7 ,value or cost-effectiveness assessments ,the use of ,quality-,adjusted ,life ,years1 ,disability-,adjusted ,life ,years1 or other similar mechanisms is prohibited for use in value or cost-effectiveness assessments for purposes of this subsection4 #bbjg4 ,trust ,fund2 funding 7a7 ,trust ,fund ,there shall be established a unified ,medicare ,trust ,fund in which funds provided under this title are deposited and from which expenditures under this title are made4 ,the ,trust ,fund shall consist of such gifts and bequests as may be made and such amounts as may be deposited in1 or appropriated to1 such ,trust ,fund as provided in this ,act4 7b7 ,funding 7#a7 ,taxes ,there are hereby appropriated to the ,trust ,fund for each fiscal year beginning with fiscal year #bjbb1 out of any moneys in the ,treasury not otherwise appropriated1 amounts equivalent to #ajj percent of the net increase in revenues to the ,treasury which is attributable to the amendments made by title ,,ii of the ,medicare for ,america ,act and premiums collected under this title4 ,the amounts appropriated by the preceding sentence shall be transferred from time to time 7but not less frequently than monthly7 from the general fund in the ,treasury to the ,trust ,fund1 such amounts to be determined on the basis of estimates by the ,secretary of the ,treasury of the taxes paid to or deposited into the ,treasury2 and proper adjustments shall be made in amounts subsequently transferred to the extent prior estimates were in excess of or were less than the amounts that should have been so transferred4 7#b7 ,current program receipts ,notwithstanding any other provision of law1 there are hereby appropriated to the ,trust ,fund for each fiscal year1 beginning with fiscal year #bjbb1 the amounts that would otherwise have been appropriated to carry out the following programs3 7,a7 ,the ,medicare program under title ,,xviii4 7,b7 ,the ,medicaid program under title ,,xix1 beginning as of #bjbf4 7#c7 ,additional appropriations ,additional sums are authorized to be appropriated annually as needed to maintain maximum quality1 efficiency1 and access under this part4 7#d7 ,medicaid maintenance of effort payments ,there shall be transferred to the ,trust ,fund the maintenance of effort payments made under section #bbji4 7c7 ,restrictions shall not apply ,any other provision of law in effect on the date of enactment of this title restricting the use of ,federal funds for any reproductive health service1 including abortion1 shall not apply to monies in the ,trust ,fund4 7d7 ,incorporation of provisions ,the provisions of subsections 7b7 through 7i7 of section #ahag shall apply to the ,trust ,fund under this section in the same manner as such provisions applied to the ,federal ,hospital ,insurance ,trust ,fund under such section #ahag1 except that1 for purposes of applying such subsections to this section1 the ,board of ,trustees of the ,trust ,fund shall mean the ,secretary4 7e7 ,transfer of funds ,any amounts remaining in the ,federal ,hospital ,insurance ,trust ,fund under section #ahag or the ,federal ,supplementary ,medical ,insurance ,trust ,fund under section #ahda after the payment of claims for items and services furnished under title ,,xviii have been completed1 shall be transferred into the ,trust ,fund under this section4 #bbjh4 ,administrative provisions 7a7 ,center for ,medicare ,beginning #bjbb1 the ,centers for ,medicare ,medicaid ,services shall be renamed the ,center for ,medicare and all references in law and regulation to such ,centers shall be deemed a reference to such ,center4 ,all powers1 duties1 and responsibilities of the ,centers for ,medicare ,medicaid ,services shall be transferred to the ,center for ,medicare4 7b7 ,authority ,the ,secretary shall have the authority to issue interim final rules with respect to any provision in this part4 7c7 ,administrative law judges 7#a7 ,in general ,the ,center for ,medicare is not authorized to appoint administrative law judges1 in accordance with pages #aadbj through #dii of title #gj of the ,federal ,register 7,march #h1 #bjje74 7#b7 ,timing ,under this title1 administrative law judges must issue a decision within #ij days of receipt of a hearing request1 as specified in subsections 7a7 and 7c7 of section #dje4ajaf of title #b1 ,code of ,federal ,regulations4 7d7 ,coverage determinations appeals 7#a7 ,individuals may appeal a coverage determination under this title before the individual obtains the service or item that is the subject of the appeal4 7#b7 ,the ,secretary shall eliminate the redetermination by a ,medicare administrative contractor from the appeals process under the ,medicare program for beneficiaries4 7e7 ,private right of action 7#a7 ,in general ,an applicant or recipient aggrieved by any law1 regulation1 policy or practice in violation of a provision of this title may bring a civil action seeking any remedy available in law or equity to remedy that violation4 ,in addition to any cause of action that may be available in a ,state court1 the district courts of the ,united ,states shall have concurrent jurisdiction in the matters under the provisions of this title4 7#b7 ,reasonable attorney fees ,in any action or proceeding to enforce this title1 the court may award reasonable attorneys' fees and litigation costs 7including expert fees7 reasonably incurred against the defendant or defendants4 7#c7 ,appeal ,any civil action brought under this section shall be subject to appeal as provided in sections #abia and #abib of title #bh of the ,united ,states ,code4 #bbji4 ,maintenance of effort requirement 7a7 ,in general ,a ,state is not eligible for payment under any program specified in subsection 7d7 for a calendar quarter in a plan year beginning after #bjbf unless the ,state makes to the ,secretary for transfer to the unified ,medicare ,trust ,fund under section #bbjg the maintenance of effort payment applicable to such ,state and plan year under subsection 7b74 ,the ,secretary shall extend such a waiver 7including the availability of ,federal financial participation under such waiver7 for such period as may be required for a ,state to meet the requirement of the previous sentence4 7b7 ,maintenance of effort payments ,for purposes of this section1 a maintenance of effort payment with respect to a ,state and plan year is-- 7#a7 for plan year #bjbg and a ,state1 a payment in an amount equal to the total amount of expenditures of the ,state for medical assistance under title ,,xix and child health assistance under title ,,xxi including administrative costs for the plan year before the date of the enactment of this title2 7#b7 for plan year #bjbh and each subsequent plan year before plan year #bjcb-- 7,a7 in the case of a ,state that is a ,,ppaca expansion ,state1 the payment amount applied under this subsection for the previous plan year1 increased by growth in ,,gdp per capita plus #j4d percent2 and 7,b7 in the case of a ,state that is not a ,,ppaca expansion ,state1 the payment amount applied under this subsection for the previous plan year1 increased by growth in ,,gdp per capita plus #j4g percent2 and 7#c7 beginning in #bjcb1 for each subsequent plan year1 with respect to any ,state1 the payment amount applied under this subsection for the previous year1 increased by growth in ,,gdp per capita plus #j4g percent4 7c7 ,programs specified ,for purposes of this section1 the programs specified in this subsection are each of the following3 7#a7 ,block grants for community mental health services under subpart ,i of part ,b of title ,,xix of the ,public ,health ,service ,act4 7#b7 ,block grants and programs for social services and elder justice under title ,,xx of the ,social ,security ,act4 7#c7 ,maternal and child health services block grants under title ,v of the ,social ,security ,act4 7#d7 ,block grants for prevention and treatment of substance abuse under subpart ,,ii of part ,b of title ,,xix of the ,public ,health ,service ,act4 7#e7 ,state ,targeted ,response to ,opioid ,crisis ,grant ,community ,services ,block ,grant4 7#f7 ,grants under section #ccj of the ,public ,health ,service ,act4 7#g7 ,ryan ,white ,,hiv_/,,aids ,program grants under title ,,xxvi of the ,public ,health ,service ,act4 #bbaj4 ,application of title ,,xviii provisions ,except as specified otherwise in this title1 in implementing ,medicare for ,america1 the ,secretary shall to the greatest extent practicable apply the following provisions of title ,,xviii to the program under this title1 benefits covered under this title1 individuals entitled to benefits under this title1 and providers of services and suppliers participating under the program under this title in a similar manner as such provisions applied to the program under title ,,xviii1 benefits covered under such title1 individuals entitled to benefits or enrolled under such title1 and providers of services and suppliers participating under the program under such title3 7#a7 ,section #ahja4 7#b7 ,section #ahje4 7#c7 ,section #ahjf4 7#d7 ,section #ahjg4 7#e7 ,section #ahji4 7#f7 ,section #ahab4 7#g7 ,section #ahad4 7#h7 ,section #ahae4 7#i7 ,section #ahaf4 7#aj7 ,section #ahah4 7#aa7 ,section #ahah;,a4 7#ab7 ,section #ahai4 7#ac7 ,section #ahbj4 7#ad7 ,section #ahcb4 7#ae7 ,section #ahcd4 7#af7 ,section #ahcd;,a4 7#ag7 ,section #ahce4 7#ah7 ,section #ahdc4 7#ai7 ,section #ahdf4 7#bj7 ,section #ahdg4 7#ba7 ,section #ahea4 7#bb7 ,section #aheb4 7#bc7 ,section #ahee4 7#bd7 ,section #ahef4 7#be7 ,section #aheg4 7#bf7 ,section #aheh4 7#bg7 ,section #ahfa4 7#bh7 ,section #ahfc4 7#bi7 ,section #ahfd4 7#cj7 ,section #ahff;,b4 7#ca7 ,section #ahff;,c4 7#cb7 ,section #ahff;,e4 7#cc7 ,section #ahfg4 7#cd7 ,section #ahfh4 7#ce7 ,section #ahfi4 7#cf7 ,section #ahga4 7#cg7 ,section #ahgd;,a4 7#ch7 ,section #ahhj4 7#ci7 ,section #ahha4 7#dj7 ,section #ahha;,a4 7#da7 ,section #ahia4 7#db7 ,section #ahid4 7#dc7 ,section #ahie4 7#dd7 ,section #ahif4 ,b ,long-term services and supports #bbba4 ,long-term services and supports benefit ,all individuals enrolled under ,medicare for ,america under this title shall have coverage for long-term services and supports benefits4 #bbbb4 ,eligibility 7a7 ,eligible individuals ,an individual who is eligible for long-term care benefits under this part is an individual who satisfies each of the following3 7#a7 ,the individual is eligible for ,medicare for ,america4 7#b7 ,the individual is determined to have a condition1 as certified by a licensed health care practitioner1 that results in substantially reduced functional capacity in one or more of the following areas3 7,a7 ,communication4 7,b7 ,social interaction4 7,c7 ,learning4 7,d7 ,mobility4 7,e7 ,self-care4 7,f7 ,self-management4 7,g7 ,impairments that affect the person's capacity for social or economic participation4 7b7 ,clarification ,under this part1 in the case of an individual described in subsection 7a7 who1 due to the nature of the condition of the individual1 experience periods in which their functional capacity changes or improves1 such individual shall continue to have access to benefits under this part as needed4 ,if such an individual's functional capacity improves to a point in which the individual no longer requires long term supports and services1 or requires fewer services1 the individual shall be able to immediately and seamlessly resume receiving all needed services if and when their functional needs recur4 ,eligibility for services shall be maintained if1 without the services1 the individual would have reduced functional capacity4 ,the presence of supports and services or other mitigating measures shall not be taken into account when looking at functional impairment4 7c7 ,benefits 7#a7 ,definition ,for purposes of this title1 the term long-term services and supports benefit means the daily living supports needed by eligible individuals and includes all long-term services and supports covered1 as of the date of the enactment of this title1 under any ,state plan under title ,,xix1 including-- 7,a7 home and community-based services2 and 7,b7 any additional services and supports developed to help people with disabilities live1 work1 and participate in their communities1 including-- 7i7 home health aides and homemakers2 7ii7 direct support professionals and personal attendant care services2 7iii7 hospice2 7iv7 nursing care2 7v7 medical social services2 7vi7 case management1 fiscal intermediary1 and support brokerage services2 7vii7 short-term inpatient care1 including respite care and care for pain control2 7viii7 behavioral health long-term services and supports1 including assertive community treatment1 peer support services1 intensive case management1 supported employment1 and supported housing wraparound2 and 7ix7 all additional services coverable in ,medicaid under state plan services1 sections #aaae1 #aiae7;c71 #aiae7k71 #aiae7;i71 and #aiae7;j71 for people with disabilities4 7#b7 ,self-directed model ,all eligible individuals shall be defaulted into a self-directed care option 7as defined by the ,secretary74 7#c7 ,community first ,the benefit under this part shall be provided with a community-first presumption and eligible individuals should be initially provided home and community-based services1 as defined for purposes of section #aiae7;i74 ,before an eligible individual is admitted into a long term care institution1 the ,state mental health or developmental disability authority or ,state agency that administers the ,state plan under title ,,xix shall conduct a mandatory assessment to determine whether their needs could be met through home and community-based services and if so1 the services would have to be arranged for by the ,state and the coverage would not be provided for the individual with respect to such an admission4 ,this assessment shall be conducted at least annually or upon a change in condition for all individual already admitted to an institution4 7d7 ,coordination with other ,federal benefits 7#a7 ,rule of construction ,nothing in this part shall be construed as prohibiting benefits paid under this part from being used to compensate a caregiver who provides community living assistance services and supports to a dependent relative not less than #hj hours a month for providing community living assistance services and supports to an eligible individual under this part4 7#b7 ,dependent relative defined ,the term dependent relative means-- 7,a7 a child1 grandchild1 niece1 or nephew 7of such caregiver or such caregiver's spouse or domestic partner72 7,b7 a child to which the caregiver or the caregiver's spouse or domestic partner is standing in loco parentis2 7,c7 a parent1 grandparent1 sibling1 aunt1 or uncle 7of such caregiver or his or her spouse or domestic partner72 or 7,d7 such caregiver's spouse or domestic partner1 if such child1 grandchild1 niece1 nephew1 parent1 grandparent1 sibling1 aunt1 uncle1 spouse1 or domestic partner is an eligible individual4 7#c7 ,supplement not supplant ,benefits received under this part by a caregiver shall supplement1 but not supplant1 other benefits for which the individual is eligible under any other ,federally funded program that provides benefits or assistance4 7#d7 ,disregard ,benefits paid to a caregiver under this part shall be disregarded for purposes of determining or continuing the eligibility of the individual or the spouse of the individual for receipt of benefits under any other ,federal1 ,state1 or locally funded assistance program1 including benefits paid under titles ,,ii or ,,xvi under the laws administered by the ,secretary of ,veterans ,affairs1 under low-income housing assistance programs1 under the supplemental nutrition assistance program established under the ,food and ,nutrition ,act of #bjjh1 or under programs administered by ,state vocational rehabilitation agencies4 ,c ,medicare ,advantage for ,america #bbca4 ,all private plans 7a7 ,in general ,for plan years beginning with plan year #bjbf1 a health insurance issuer may offer health insurance coverage in the individual market only if such issuer has entered into a contract with the ,secretary under subsection 7b7 to offer such coverage4 7b7 ,agreements ,the ,secretary shall enter into an agreement with an ,,ma for ,america sponsor to offer ,,ma for ,america plans under this part for the coverage of individuals enrolled under ,medicare for ,america who elect to receive benefits under part ,a through such a plan4 7c7 ,,ma for ,america plan2 ,,ma for ,america sponsor ,for purposes of this part-- 7#a7 ,,ma for ,america plan ,an ,,ma for ,america plan is a ,medicare ,advantage plan under part ,c of title ,,xviii1 except such plan shall provide coverage for individuals enrolled under ,medicare for ,america under part ,a of this title1 with respect to at least the benefits covered under such part ,a4 7#b7 ,,ma for ,america sponsor ,an ,,ma for ,america sponsor is a sponsor of an ,,ma for ,america plan4 #bbcb4 ,application of ,medicare ,advantage provisions ,for purposes of applying this part1 except as otherwise specified under this part1 the provisions of part ,c of title ,,xviii1 as in effect as of the date of the enactment of this title shall apply with respect to an ,,ma for ,america sponsor1 ,,ma for ,america plan1 individuals eligible for coverage under this part1 individuals enrolled under such plan1 and benefits covered under part ,a in a similar manner and to a similar extent as such provisions applied to an ,,ma organization1 ,,ma plan1 individuals eligible for under part ,c of such title1 individuals enrolled under an ,,ma plan1 and benefits covered under fee-for-service ,medicare as of such date4 #bbcc4 ,increased premium for ,medicare ,advantage for ,america plans ,nothing in this part shall preclude an individual from choosing a ,medicare ,advantage for ,america plan which requires the individual to pay an additional amount because of supplemental benefits or because it is a more expensive plan4 ,in such case the individual enrolled under such plan would be responsible for the increased monthly premium4 #bbcd4 ,references ,beginning in #bjbb1 all references in law and regulation to ,medicare ,advantage shall be deemed a reference to ,medicare ,advantage for ,america4 4 #aab4 ,modifications to and coordination with existing ,federal health programs 7a7 ,medicare1 ,medicaid1 and ,state ,children's ,health ,insurance ,program 7,,schip7 7#a7 ,in general ,notwithstanding any other provision of law1 subject to paragraphs 7#b7 and 7#c7 and section #bbjb7;c7 of the ,social ,security ,act1 as added by section #aaa-- 7,a7 no benefits shall be available under title ,,xviii of the ,social ,security ,act for any item or service furnished-- 7i7 beginning on or after ,january #a1 #bjbb 7except in the case of an individual enrolled under such title and title ,,xix of such ,act72 and 7ii7 beginning on or after ,january #a1 #bjbd1 with respect to all individuals1 including individuals enrolled under such title and title ,,xix of such ,act2 7,b7 no individual is entitled to medical assistance under a ,state plan approved under title ,,xix of such ,act-- 7i7 for any item or service furnished on or after ,january #a1 #bjbd1 in the case of an individual enrolled under such title and title ,,xviii of the ,social ,security ,act or an individual described in subclause 7,,viii7 of section #aijb7;a77#aj77;,a77i72 and 7ii7 for any item or service furnished on or after ,january #a1 #bjbf2 7,c7 no individual is entitled to medical assistance under a ,state child health plan under title ,,xxi of such ,act for any item or service furnished on or after ,january #a1 #bjbd2 and 7,d7 no payment shall be made to a ,state under section #aijc7;a7 or #baje7;a7 of such ,act with respect to medical assistance or child health assistance-- 7i7 for any item or service furnished on or after ,january #a1 #bjbd1 in the case of an individual enrolled under such title and title ,,xviii of the ,social ,security ,act or an individual described in subclause 7,,viii7 of section #aijb7;a77#aj77;,a77i72 and 7ii7 for any item or service furnished on or after ,january #a1 #bjbf4 7#b7 ,transition ,in the case of inpatient hospital services and extended care services during a continuous period of stay which began before ,january #a1 #bjbd for ,medicare and #bjbf for ,medicaid or ,,chip1 and which had not ended as of such date1 for which benefits are provided under title ,,xviii of the ,social ,security ,act1 under a ,state plan under title ,,xix of such ,act1 or under a ,state child health plan under title ,,xxi such ,act1 the ,secretary of ,health and ,human ,services shall provide for continuation of benefits under such title or plan until the end of the period of stay4 7b7 ,other ,federal health programs 7#a7 ,federal employees health benefits program ,nothing in this ,act1 or the amendments made by this ,act1 shall affect benefits made available under chapter #hi of title #e1 ,united ,states ,code4 7#b7 ,,tricare ,nothing in this ,act1 or the amendments made by this ,act1 shall affect benefits made available under sections #ajgi and #ajhf of title #aj1 ,united ,states ,code4 7#c7 ,treatment of benefits for veterans and native ,americans 7,a7 ,in general ,nothing in this ,act1 or the amendments made by this ,act1 shall affect the eligibility of veterans for the medical benefits and services provided under title #ch1 ,united ,states ,code1 or of ,indians for the medical benefits and services provided by or through the ,indian ,health ,service4 7,b7 ,reevaluation ,no reevaluation of the ,indian ,health ,service shall be undertaken without consultation with tribal leaders and stakeholders4 7c7 ,sunset of provisions related to the ,state ,exchanges ,effective ,january #a1 #bjbb1 the ,federal and ,state ,exchanges established pursuant to title ,i of the ,patient ,protection and ,affordable ,care ,act 7,public ,law #aaa-adh7 shall terminate1 and any other provision of law that relies upon participation in or enrollment through such an ,exchange1 including such provisions of the ,internal ,revenue ,code of #aihf1 shall cease to have force or effect4 7d7 ,severability ,every provision in this ,act and every application of the provisions in this ,act are severable from each other as a matter of ,federal law4 ,if any application of any provision in this ,act to any person or group of persons or circumstances is found by a court to be invalid1 the remainder of this ,act and the application of the ,act's provisions to all other persons and circumstances may not be affected4 ,c ,targeted ,reforms #aba4 ,limitation on removal of ,medicare ,advantage providers by ,,ma organizations 7a7 ,limitation ,section #aheb7;d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;d77 is amended by adding at the end the following3 7#g7 ,limitation on removal of providers from ma plans by ,,ma organizations 7,a7 ,removal of providers with cause ,beginning with plan year #bjai1 except as provided in subparagraph 7,c71 an ,,ma organization offering an ,,ma plan may only remove a provider of services or a supplier from a network of such plan if the organization has cause to remove such provider or supplier4 7,b7 ,cause to remove providers 7i7 ,in general ,an ,,ma organization offering an ,,ma plan has cause to remove a provider of services or a supplier from a network of such plan if the ,secretary determines that the provider or supplier is-- 7,i7 medically negligent2 7,,ii7 in violation of any legal or contractual requirement applicable to the provider or supplier acting within the lawful scope of practice1 including any participation or other requirement applicable to such provider or supplier under this title or under any contractual term for such plan2 or 7,,iii7 otherwise unfit to furnish items and services in accordance with requirements of this title4 7ii7 ,consideration of cost to ma organizations ,for purposes of subparagraph 7,a71 cost to an ,,ma organization offering an ,,ma plan due to the participation of a provider of services or supplier in a network of such plan does not constitute cause for the ,,ma organization to remove such provider or supplier from the network mid-year1 and such cost may not be considered as a factor in favor of a determination that such organization has cause to remove the provider4 7,c7 ,exception ,with respect to each upcoming plan year1 beginning with plan year #bjai1 an ,,ma organization offering an ,,ma plan may only remove a provider of services or supplier from a network of such plan for reasons not specified in subparagraph 7,b77i7 before the date that is #fj days before the first day of the annual coordinated election period for such plan year under section #ahea7;e77#c74 7,d7 ,notice and appeal process 7i7 ,in general ,any removal of a provider of services or supplier from a network of an ,,ma plan may occur only after the completion of a fair notice and appeal process that the ,secretary shall establish by regulation4 ,such process shall require the ,,ma organization to provide to such provider or supplier and to the ,secretary an explanation of the reason or reasons for the removal4 7ii7 ,application 7,i7 ,application of new process ,in the case of a removal of a provider of services or supplier from a network of an ,,ma plan occurring on or after the effective date published in a final rule for such fair notice and appeal process1 such process shall apply in lieu of the process for the termination or suspension of a provider contract under section #dbb4bjb7;a7 of title #db1 ,code of ,federal ,regulations4 7,,ii7 ,continuation of old process ,in the case of a removal of a provider of services or supplier from a network of an ,,ma plan occurring before such effective date1 the process for the termination or suspension of a provider contract under section #dbb4bjb7;a7 of title #db1 ,code of ,federal ,regulations1 shall apply4 7,e7 ,participant notice and protection 7i7 ,notice to participants of provider removal ,not less than #fj days before the date on which a provider of services or supplier is removed from a network of an ,,ma plan1 the ,,ma organization offering such plan shall provide written notification of the removal to each individual enrolled in such plan receiving items or services from the provider or supplier during the plan year in effect on the date of removal or during the previous plan year4 ,such notification shall include at the minimum-- 7,i7 the names and telephone numbers of available in-network providers of services and suppliers offering items and services that are the same or similar to the items and services offered by the removed provider or supplier2 7,,ii7 information regarding the options available to an individual enrolled in such plan to request the continuation of medical treatment or therapy with the removed provider or supplier2 and 7,,iii7 one or more customer service telephone numbers that an individual enrolled in such plan may access to obtain information regarding changes to the network of the plan4 7ii7 ,annual notice of change ,in addition to providing the notification of removal as required under clause 7i71 the ,,ma organization offering such ,,ma plan shall include such notification in the annual notice of change for the ,,ma plan for the upcoming plan year4 7iii7 ,continuity of care ,in any case in which a provider of services or supplier is removed from a network of an ,,ma plan1 such plan shall ensure that the removal satisfies the continuity of care requirements under paragraph 7#a77;,a7 with respect to each individual enrolled in such plan receiving items or services from the provider or supplier during the plan year in effect on the date of removal or during the previous plan year4 7,f7 ,rule of construction ,nothing in this paragraph shall be construed as affecting the ability of a provider of services or supplier to decline to participate in a network of an ,,ma plan4 7#h7 ,transparency in measures used by ma organizations to establish or modify provider networks 7,a7 ,in general ,beginning with plan year #bjai1 an ,,ma organization offering an ,,ma plan shall include the information described in subparagraph 7,b7-- 7i7 in the annual bid information submitted by the ,,ma organization with respect to the ,,ma plan under section #ahed2 and 7ii7 on the ,internet ,web ,site for the ,,ma plan4 7,b7 ,information described ,the information described in this subparagraph is the following3 7i7 ,information regarding the measures used by the ,,ma organization to establish or modify the provider network of the ,,ma plan1 including measures of the quality and efficiency of providers4 ,such information shall include the specifications1 methodology1 and sample size of such measures4 7ii7 ,other information related to the establishment or modification of such provider network that the ,secretary determines appropriate4 7,c7 ,limitation ,the information described in subparagraph 7,b7 shall not include any individually identifiable information of any provider or supplier of services4 4 7b7 ,enforcement 7#a7 ,sanctions for noncompliance ,section #aheg7;g77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;g77#a77 is amended-- 7,a7 in subparagraph 7,j71 by striking or2 7,b7 by redesignating subparagraph 7,k7 as subparagraph 7,l72 7,c7 by inserting after subparagraph 7,j7 the following new subparagraph3 7,k7 fails to comply with section #aheb7;d77#g7 or #aheb7;d77#h72 or 2 and 7,d7 in subparagraph 7,l7 7as so redesignated71 by striking through 7,j7 and inserting through 7,k74 7#b7 ,sanctions not applicable to part d ,title ,,xviii of the ,social ,security ,act is amended-- 7,a7 in section #ahfj;,d-#ab7;b77#c77;,e7 7#db ,u4,s4,c4 #aciew-#aab7;b77#c77;,e771 by striking paragraph 7#a77;,f7 and inserting paragraphs 7#a77;,f7 and 7#a77,k72 and 7,b7 in section #ahid7;e77#f77;,b7 7#db ,u4,s4,c4 #acie;eee7e77#f77;,b771 by inserting 7other than paragraph 7#a77,k7 of such section7 after #aheg7;g77#a74 7c7 ,medicare advantage plan compare tool ,not later than one year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall take such measures as are necessary to ensure that the ,medicare ,advantage ,compare ,tool takes into account the preferences and utilization needs of such individuals4 #abb4 ,network adequacy 7a7 ,in general ,section #aheb7;d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;d77 is amended by adding at the end the following3 7#i7 ,network adequacy requirements ,beginning in plan year #bjai1 notwithstanding any other provision of law1 the following shall apply3 7,a7 ,provider availability ,when establishing a plan network1 a ,medicare ,advantage organization offering an ,,ma plan shall1 among other factors determined by the ,secretary1 consider the following3 7i7 ,the anticipated enrollment in the plan4 7ii7 ,the expected types of services provided and utilization of services by enrollees under the plan4 7iii7 ,the number and types of providers needed to provide such services4 7iv7 ,the number of network providers who are not accepting new patients4 7v7 ,the location of providers and enrollees4 7vi7 ,the full-time equivalent availability of a provider to provide such services4 7,b7 ,provision of care in a timely manner ,a ,medicare ,advantage organization offering an ,,ma plan shall ensure that providers are able to provide services in a timely manner1 as defined by the ,secretary1 under the plan4 7,c7 ,application of network access adequacy standards ,in applying the network access adequacy standards pursuant to paragraph 7#a71 the ,secretary shall seek input from patient advocacy groups1 providers of services and suppliers1 and ,,ma plans under this part4 7,d7 ,certification ,each plan year1 a ,medicare ,advantage organization shall certify to the ,secretary1 with respect to each ,,ma plan offered by the organization1 that the providers1 including specialists and subspecialists1 in the plan network are able to provide the services required under the organization's contract with the ,secretary under section #aheg with respect to the offering of such plan and to meet the needs of the enrollees within the plan service area during the year4 7,e7 ,annual reporting ,each plan year1 a ,medicare ,advantage organization shall report to the ,secretary the following with respect to each ,,ma plan offered by the organization3 7i7 ,average wait time ,the average wait time for primary and specialty care for enrollees under the plan4 7ii7 ,utilization of out-of-network providers ,the utilization of out-of-network providers under the plan4 7iii7 ,average cost per patient ,the average annual spending per patient for primary and specialty care for enrollees under the plan4 7,f7 ,certification ,in advance of the annual1 coordinated election period under section #ahea7;e77#c71 a ,medicare ,advantage organization shall certify to the ,secretary the accuracy of provider directories for each plan offered by the organization4 7,g7 ,network review ,the ,secretary shall ensure that the network of each ,,ma plan offered by a ,medicare ,advantage organization meets the network adequacy guidelines established under this paragraph and under section #dbb4aab7;a77#d7 of title #db1 ,code of ,federal ,regulations 7or any successor regulation to such section71 at least once every #c years or when a material change in network occurs4 4 7b7 ,enforcement ,section #aheg7;g77#a77,k7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;g77#a77,k771 as added by section #b7;b71 is amended by striking or #aheb7;d77#h7 and inserting 1 #aheb7;d77#h71 or #aheb7;d77#i74 #abc4 ,eliminating the #bd-month waiting period for ,medicare coverage for individuals with disabilities 7a7 ,in general ,section #bbf7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #dbf7;b77 is amended-- 7#a7 in paragraph 7#b77;,a71 by striking 1 and has for #bd calendar months been entitled to12 7#b7 in paragraph 7#b77;,b71 by striking 1 and has been for not less than #bd months12 7#c7 in paragraph 7#b77;,c77ii71 by striking 1 including the requirement that he has been entitled to the specified benefits for #bd months12 7#d7 in the first sentence1 by striking for each month beginning with the later of 7,i7 ,july #aigc or 7,,ii7 the twenty-fifth month of his entitlement or status as a qualified railroad retirement beneficiary described in paragraph 7#b71 and and inserting for each month for which the individual meets the requirements of paragraph 7#b71 beginning with the month following the month in which the individual meets the requirements of such paragraph1 and2 and 7#e7 in the second sentence1 by striking the twenty-fifth month of his entitlement and all that follows through paragraph 7#b77;,c7 and4 7b7 ,conforming amendments 7#a7 ,section #bbf ,section #bbf of the ,social ,security ,act 7#db ,u4,s4,c4 #dbf7 is amended by-- 7,a7 striking subsections 7e77#a77;,b71 7f71 and 7h72 and 7,b7 redesignating subsections 7g7 and 7i7 as subsections 7f7 and 7g71 respectively4 7#b7 ,medicare description ,section #ahaa7b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;c7#b77 is amended by striking have been entitled for not less than #bd months and inserting are entitled4 7#c7 ,medicare coverage ,section #ahcg7;g77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciep7g77#a77 is amended by striking #beth month of and inserting month following the first month of4 7#d7 ,railroad retirement system ,section #g7;d77#b77;ii7 of the ,railroad ,retirement ,act of #aigd 7#de ,u4,s4,c4 #bca;f7d77#b77;ii77 is amended-- 7,a7 by striking has been entitled to an annuity and inserting is entitled to an annuity2 7,b7 by striking 1 for not less than #bd months2 and 7,c7 by striking could have been entitled for #bd calendar months1 and4 7c7 ,effective date ,the amendments made by this section shall apply to insurance benefits under title ,,xviii of the ,social ,security ,act with respect to items and services furnished in months beginning after the date of enactment of this ,act4 #abd4 ,employer health plan options 7a7 ,definition ,a qualifying employer sponsored plan is-- 7#a7 a governmental plan 7within the meaning of section #bgia7;d77#h7 of the ,public ,health ,service ,act72 or 7#b7 any other plan or coverage that meets the benefits criteria of title ,,xxii of the ,social ,security ,act1 as added by section #aaa1 and the criteria under subsection 7b71 that provides health coverage that is equivalent to an actuarial value of at least #hj percent and makes a premium contribution of at least #gj percent4 7b7 ,obligation ,large employers shall1 with respect to any full-time employee of such employer-- 7#a7 offer a qualifying employer sponsored plan to such employee1 in accordance with subsection 7c72 or 7#b7 make a contribution of #h percent of their annual payroll to the ,medicare ,trust ,fund under title ,,xxii of the ,social ,security ,act4 7c7 ,employee choice ,an employee may opt out of a qualifying employer sponsored plan as satisfied by subsection 7b77#a7 in order to enroll in ,medicare for ,america4 ,the employer shall be exempt from the contribution specified in subsection 7b77#b74 ,the ,secretary of ,health and ,human ,services shall have authority to set standards for determining whether employers or insurers are undertaking any actions to affect the risk pool within ,medicare for ,america by inducing individuals to decline coverage under a qualifying employer sponsored plan and instead to enroll in ,medicare for ,america4 ,an employer violating such standards shall be treated as not meeting the requirements of subsection 7a74 7d7 ,special rules 7#a7 ,annual payroll ,for purposes of this paragraph1 the term annual payroll means1 with respect to any employer for any calendar year1 the aggregate wages paid by the employer during such calendar year4 7#b7 ,aggregation rules ,related employers and predecessors shall be treated as a single employer for purposes of this subsection4 7#c7 ,reduction for part-time employees ,in the case of a part-time employee1 the employer contribution requirements of paragraph 7#a7 shall be treated as satisfied if the employer contribution with respect to such employee is not less than the part-time employment ratio of the contribution required under paragraph 7#a74 7#d7 ,rules related to part-time employment ,for purposes of this subsection-- 7,a7 ,part-time employee ,the term part-time employee means1 with respect to any month1 an employee who works on average fewer than #cj hours per week4 7,b7 ,part-time employment ratio ,the term part-time employment ratio means1 with respect to a part-time employee of an employer in a month1 a fraction-- 7i7 the numerator of which is the number of hours in the employee's normal work week1 and 7ii7 the denominator of which is #cj hours4 7,c7 ,special rules ,under rules prescribed by the ,secretary of ,health and ,human ,services1 in consultation with the ,secretary of the ,treasury1 in the case of an employee for an employer whose defined work week for full-time employees is less than #cj hours1 any reference in this subsection to #cj hours is deemed a reference to the number of hours in the work week so defined4 7,d7 ,conversion to hours of employment ,the ,secretary of ,health and ,human ,services1 in consultation with the ,secretary of the ,treasury1 shall establish rules for the conversion of compensation to hours of employment1 for purposes of this subsection in the case of employees that receive compensation on a salaried basis1 or on the basis of a commission1 or other contingent or bonus basis1 rather than based on an hourly wage4 7e7 ,timing and ,manner ,each employer that makes a financial contribution under subsection 7b77#b7 under this section 7other than with respect to coverage under a group health plan7 shall pay such contribution in a form and manner1 specified by the ,secretary of the ,treasury1 based upon the form and manner in which employer excise taxes are required to be paid under section #caaa of the ,internal ,revenue ,code of #aihf4 7f7 ,non-,discrimination 7#a7 ,in general ,except as otherwise provided for in this title 7or an amendment made by this title71 an individual shall not1 on the ground prohibited under title ,,vi of the ,civil ,rights ,act of #aifd 7#db ,u4,s4,c4 #bjjj;d et seq471 title ,,ix of the ,education ,amendments of #aigb 7#bj ,u4,s4,c4 #afha et seq471 the ,age ,discrimination ,act of #aige 7#db ,u4,s4,c4 #faja et seq471 or section #ejd of the ,rehabilitation ,act of #aigc 7#bi ,u4,s4,c4 #gid71 be excluded from participation in1 be denied the benefits of1 or be subjected to discrimination under1 any health program or activity1 any part of which is receiving ,federal financial assistance1 including credits1 subsidies1 or contracts of insurance1 or under any program or activity that is administered by an ,executive ,agency or any entity established under this title 7or amendments7 or any employer-sponsored insurance4 7#b7 ,continued ,application of ,laws ,nothing in this title 7or an amendment made by this title7 shall be construed to invalidate or limit the rights1 remedies1 procedures1 or legal standards available to individuals aggrieved under title ,,vi of the ,civil ,rights ,act of #aifd 7#db ,u4,s4,c4 #bjjj;d et seq471 title ,,vii of the ,civil ,rights ,act of #aifd 7#db ,u4,s4,c4 #bjjj;e et seq471 title ,,ix of the ,education ,amendments of #aigb 7#bj ,u4,s4,c4 #afha et seq471 section #ejd of the ,rehabilitation ,act of #aigc 7#bi ,u4,s4,c4 #gid71 or the ,age ,discrimination ,act of #aige 7#db ,u4,s4,c4 #faa et seq471 or to supersede ,state laws that provide additional protections against discrimination on any basis described in paragraph 7#a74 7#c7 ,regulations ,the ,secretary of ,health and ,human ,services may promulgate regulations to implement this subsection4 #abe4 ,prohibition on step therapy and prior authorization under group health plans ,section #bgai;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 is amended by adding at the end the following new subsection3 7e7 ,prohibition against step therapy and prior authorization ,beginning with the first plan year following the date of the enactment of this subsection1 a group health plan may not require a prior authorization determination for coverage of any benefit under such plan and may not apply treatment limitations through the use of step therapy protocols4 4 #abf4 ,medicare outpatient observation services ,section #ahfa7;i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7i77 is amended by adding at the end the following3 ,for purposes of this subsection1 an individual receiving outpatient observation services shall be deemed to be an inpatient during such period1 and the date such individual ceases receiving such services shall be deemed the hospital discharge date 7unless such individual is admitted as a hospital inpatient at the end of such period744 #abg4 ,abortion coverage ,notwithstanding any other provision of law1 ,federal funds may be used to provide for abortion services under any health program under any of the following3 7#a7 ,indian ,health ,service4 7#b7 ,benefits provided to women veterans4 7#c7 ,benefits provided through the ,united ,states ,immigration and ,customs ,enforcement to women in detention centers under the jurisdiction of such agency4 ,,ii ,tax ,provisions #bja4 ,sunset of ,public ,law #aae-ig 7a7 ,in general ,all provisions of1 and amendments made by1 ,public ,law #aae-ig shall not apply to calendar1 taxable1 plan1 or limitation years beginning after ,december #bb1 #bjag4 7b7 ,application of certain laws ,the ,internal ,revenue ,code of #aihf shall be applied and administered to years described in subsection 7a7 as if the provisions and amendments described in subsection 7a7 had never been enacted4 #bjb4 ,surtax ,there is hereby imposed a tax of #e percent on the adjusted gross income of each taxpayer to the extent such income exceeds #ejj1jjj4 #bjc4 ,basis of property acquired from a decedent 7a7 ,in general ,section #ajad of the ,internal ,revenue ,code of #aihf is amended by striking person1 be and all that follows through the period at the end and inserting the following3 person1 be the basis in the hands of the decedent44 7b7 ,effective date ,the amendments made by this section to property acquired or passed after the date of enactment of this ,act4 #bjd4 ,medicare payroll tax 7a7 ,in general ,section #caja7;b77#b7 of the ,internal ,revenue ,code of #aihf is amended by striking #j4i percent and inserting #d percent4 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 #bje4 ,net investment income tax 7a7 ,in general ,section #adaa7;a7 of the ,internal ,revenue ,code of #aihf is amended by striking #c4h percent each place such term appears and inserting #f4i percent4 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 #bjf4 ,termination of health savings accounts ,section #bbc7;a7 of the ,internal ,revenue ,code of #aihf is amended by inserting after during such taxable year the following3 and before ,december #ca1 #bjai4 #bjg4 ,termination of flexible spending arrangements ,section #abe7;i77#a7 of the ,internal ,revenue ,code of #aihf is amended by striking may not elect for any taxable year to have salary reduction contributions in excess of #b1ejj made to such arrangement and inserting the following3 may not elect to have salary reduction contributions made to such arrangement-- 7,a7 for taxable years beginning before ,january #a1 #bjbj1 in excess of #b1ejj1 and 7,b7 for taxable years beginning after ,december #ca1 #bjai1 in excess of #j4 4 #bjh4 ,increase in excise tax on small cigars and cigarettes and other tobacco products 7a7 ,small cigars ,section #egja7;a77#a7 of the ,internal ,revenue ,code of #aihf is amended by striking #ej4cc and inserting #ajj4ff4 7b7 ,cigarettes ,section #egja7;b7 of such ,code is amended-- 7#a7 by striking #ej4cc in paragraph 7#a7 and inserting #ajj4ff1 and 7#b7 by striking #aje4fi in paragraph 7#b7 and inserting #baa4ch4 7c7 ,pipe tobacco ,section #egja7;f7 of the ,internal ,revenue ,code of #aihf is amended by striking #b4hcaa cents and inserting #ej4jj4 7d7 ,roll-,your-,own tobacco ,section #egja7;g7 of such ,code is amended by striking #bd4gh and inserting #di4ef4 7e7 ,large cigars ,paragraph 7#b7 of section #egja7;a7 of the ,internal ,revenue ,code of #aihf is amended by striking #eb4ge percent and all that follows through the period and inserting #bd4gh per pound 7and a proportionate tax at the like rate on all fractional parts of a pound7 but not less than #e4jcc cents per cigar44 7f7 ,smokeless tobacco 7#a7 ,in general ,section #egja7;e7 of the ,internal ,revenue ,code of #aihf is amended-- 7,a7 in paragraph 7#a71 by striking #a4ea and inserting #bh4jd1 7,b7 in paragraph 7#b71 by striking #ej4cc cents and inserting #ab4db1 and 7,c7 by adding at the end the following3 7#c7 ,smokeless tobacco sold in discrete single-use units ,on discrete single-use units1 #ajg4fe per each #a1jjj single-use units4 4 7#b7 ,discrete single-use unit ,section #egjb7m7 of such ,code is amended-- 7,a7 in paragraph 7#a71 by striking or chewing tobacco and inserting chewing tobacco1 discrete single-use unit2 7,b7 in paragraphs 7#b7 and 7#c71 by inserting that is not a discrete single-use unit before the period in each such paragraph2 and 7,c7 by adding at the end the following3 7#d7 ,discrete single-use unit ,the term discrete single-use unit means any product containing tobacco that-- 7,a7 is not intended to be smoked1 and 7,b7 is in the form of a lozenge1 tablet1 pill1 pouch1 dissolvable strip1 or other discrete single-use or single-dose unit4 4 #bji4 ,excise tax on alcohol 7a7 ,distilled ,spirits ,section #ejja7;a77#a7 of the ,internal ,revenue ,code of #aihf is amended by striking #ac4ej and inserting #af4jj4 7b7 ,wine 7#a7 ,section #ejda7;b77#a7 of the ,internal ,revenue ,code of #aihf is amended by striking #a4jg per wine gallon and inserting #af4jj per proof gallon4 7#b7 ,section #ejda7;b77#b7 of the ,internal ,revenue ,code of #aihf is amended by striking #a4eg per wine gallon and inserting #af4jj per proof gallon4 7#c7 ,section #ejda7;b77#c7 of the ,internal ,revenue ,code of #aihf is amended by striking #c4ae per wine gallon and inserting #af4jj per proof gallon4 7#d7 ,section #ejda7;b77#d7 of the ,internal ,revenue ,code of #aihf is amended by striking #c4dj per wine gallon and inserting #af4jj per proof gallon4 7#e7 ,section #ejda7;b77#e7 of the ,internal ,revenue ,code of #aihf is amended by striking #c4cj per wine gallon and inserting #af4jj per proof gallon4 7#f7 ,section #ejda7;b77#c7 of the ,internal ,revenue ,code of #aihf is amended by striking #bb4f cents per wine gallon and inserting #af4jj per proof gallon4 7c7 ,beer ,section #ejea7;,b7 of the ,internal ,revenue ,code of #aihf is amended by striking #ah for per barrel and inserting #af per proof gallon4 #baj4 ,tax on sugared drinks 7a7 ,in general ,subchapter ,d of chapter #cb of the ,internal ,revenue ,code of #aihf is amended by inserting after part ,i the following new part3 ,,ii ,sugar-,sweetened beverages ,sec4 #daga4 ,imposition of tax4 ,sec4 #dagb4 ,definitions4 ,sec4 #dagc4 ,special rules4 #daga4 ,imposition of tax 7a7 ,in general ,there is hereby imposed a tax on the sale or transfer of any specified sugar-sweetened beverage product by the manufacturer1 producer1 or importer thereof4 7b7 ,rate of tax ,the rate of tax imposed under subsection 7a7 shall be equal to one cent per #d4b grams of caloric sweetener contained in such specified sugar-sweetened beverage product4 7c7 ,persons liable for tax ,the manufacturer1 producer1 or importer referred to in subsection 7a7 shall be liable for the tax imposed by such subsection4 #dagb4 ,definitions 7a7 ,specified sugar-,sweetened beverage product ,for purposes of this part-- 7#a7 ,in general ,for purposes of this part1 the term specified sugar-sweetened beverage product means-- 7,a7 any liquid intended for human consumption which contains a caloric sweetener1 and 7,b7 any liquid1 or solid mixture of ingredients1 which-- 7i7 contains a caloric sweetener1 and 7ii7 is intended for use as an ingredient in a liquid described in subparagraph 7,a74 7#b7 ,exceptions ,the following shall not be treated as liquids described in paragraph 7#a77;,a73 7,a7 ,any liquid the primary ingredients of which are milk or soy1 rice1 or similar plant-based milk substitute4 7,b7 ,any liquid composed entirely of one or more of the following3 7i7 ,the original liquid resulting from the pressing of fruit or vegetables4 7ii7 ,the liquid resulting from the reconstitution of fruit or vegetable juice concentrate4 7iii7 ,the liquid resulting from the restoration of water to dehydrated fruit or vegetable juice4 7,c7 ,infant formula4 7,d7 ,any liquid products manufactured for use as-- 7i7 an oral nutritional therapy for persons who cannot absorb or metabolize dietary nutrients from food or beverages1 7ii7 a source of necessary nutrition used due to a medical condition1 or 7iii7 an oral electrolyte solution for infants and children formulated to prevent dehydration due to illness4 7,e7 ,any liquid with respect to which tax is imposed under chapter #ea 7relating to distilled spirits1 wines1 and beer7 or under section #gfeb by reason of the tax imposed under chapter #ea being imposed on like articles of domestic manufacture4 7b7 ,caloric sweetener ,for purposes of this part1 the term caloric sweetener means monosaccharides1 disaccharides1 and high-fructose corn syrup4 #dagc4 ,special rules 7a7 ,sweetener taxed only once ,in the case of any specified sugar-sweetened beverage product which is manufactured or produced by including one or more other specified sugar-sweetened beverage products1 no tax shall be imposed under this section on any caloric sweetener contained in the resulting specified sugar-sweetened beverage product if tax was previously imposed under this section on such caloric sweetener when contained in the specified sugar-sweetened beverage product so included4 7b7 ,inflation adjustment ,in the case of any sale after ,december #ca1 #bjae1 the one cent amount in section #daga7;b7 shall be increased by an amount equal to-- 7#a7 such amount1 multiplied by 7#b7 the cost-of-living adjustment determined under section #a7;f77#c7 for the calendar year in which such sale occurs1 determined by substituting calendar year #bjad for calendar year #aiib in subparagraph 7,b7 thereof4 ,any increase determined under this subsection shall be rounded to the nearest multiple of one-tenth of a cent4 4 7b7 ,conforming amendments 7#a7 ,section #dbba7;a7 is amended by adding at the end the following3 ,paragraphs 7#a71 7#d71 7#e71 and 7#f7 shall not apply to the tax imposed under section #daga44 7#b7 ,the table of parts for subchapter ,d of chapter #cb of such ,code is amended by inserting after the item relating to part ,i the following new item3 ,part ,,ii--,sugar-,sweetened beverages 4 7c7 ,revenues used for prevention1 treatment1 and research of diet-,related health conditions in priority populations 7#a7 ,transfer to prevention and public health fund ,there are hereby appropriated to the ,prevention and ,public ,health ,fund created under section #djjb of the ,patient ,protection and ,affordable ,care ,act 7in addition to any other amounts appropriated to such ,fund7 amounts equivalent to taxes received in the ,treasury under part ,,ii of subchapter ,d of chapter #cb4 ,rules similar to the rules of section #ifja of the ,internal ,revenue ,code of #aihf shall apply with respect to amounts appropriated under this paragraph4 7#b7 ,restriction on use of funds ,notwithstanding subsections 7c7 and 7d7 of section #djjb of the ,patient ,protection and ,affordable ,care ,act1 amounts appropriated to the ,prevention and ,public ,health ,fund under paragraph 7#a7 may be transferred to accounts in the ,department of ,health and ,human ,services only for the purpose of making expenditures for programs and research designed to reduce the human and economic costs of diabetes1 obesity1 dental caries1 and other diet-related health conditions in priority populations 7within the meaning of section #ija7;c7 of the ,public ,health ,service ,act74 7d7 ,effective date 7#a7 ,in general ,except as provided in paragraph 7#b71 the amendments made by this section shall take effect on the date of the enactment of this ,act4 7#b7 ,excise tax ,the amendments made by subsections 7a7 and 7b7 shall apply to sales after the date of the enactment of this ,act4 ,,iii ,drug-,related ,provisions #cja4 ,establishment of the prescription drug and medical device review board ,there is established in the ,department of ,health and ,human ,services a board to be known as the ,prescription ,drug and ,medical ,device ,price ,review ,board 7in this ,act referred to as the ,board74 #cjb4 ,membership2 staff 7a7 ,members ,the ,board shall be composed of the members as follows3 7#a7 ,the ,assistant ,secretary for ,planning and ,evaluation of the ,department of ,health and ,human ,services 7or the ,assistant ,secretary's designee74 7#b7 ,the ,administrator of the ,centers for ,medicare ,medicaid ,services or1 beginning with #bjbb1 the ,administrator of the ,center for ,medicare 7or the ,administrator's designee74 7#c7 ,the ,assistant ,director for the ,health ,services ,division of the ,federal ,bureau of ,prisons 7or the ,assistant ,director's designee74 7#d7 ,the ,secretary of ,defense 7or the ,secretary's designee74 7#e7 ,the ,secretary of ,veterans ,affairs 7or the ,secretary's designee74 7#f7 ,the ,commissioner of ,food and ,drugs 7or the ,commissioner's designee74 7#g7 ,the ,director of the ,national ,institutes of ,health4 7b7 ,chairperson ,the ,board shall designate #a member of the ,board to serve as the chairperson4 7c7 ,director and staff 7#a7 ,director ,the ,board shall have a director who shall be appointed by the chairperson of the ,board1 subject to rules prescribed by the ,board4 7#b7 ,staff ,the director may appoint and fix the pay of such additional personnel as the chairperson considers appropriate1 subject to rules prescribed by the ,board4 7#c7 ,applicability of certain civil service laws ,the director and staff of the ,board shall be appointed subject to the provisions of title #e1 ,united ,states ,code1 governing appointments in the competitive service1 and shall be paid in accordance with the requirements of chapter #ea and subchapter ,,iii of chapter #ec of such title relating to classification and ,general ,schedule pay rates2 except that an individual so appointed may not receive pay in excess of the maximum annual rate of basic pay payable for grade ,,gs-#ae of the ,general ,schedule4 7d7 ,assistance for the board ,subject to section #cjf7;g71 in carrying out this title1 the ,board-- 7#a7 may seek assistance from outside experts in the fields of consumer advocacy1 medicine1 pharmacology1 pharmacy1 and prescription drug reimbursement2 and 7#b7 shall establish and maintain an advisory group and a stakeholder group for purposes of seeking such assistance4 7e7 ,initial meeting ,the ,board shall hold its initial meeting not later than #ij days after the date of the enactment of this ,act4 #cjc4 ,reporting requirements 7a7 ,reporting by manufacturers ,the ,board shall require each manufacturer of a prescription drug or medical device that is sold in the ,united ,states to submit to the ,board on a periodic basis1 at a level of specificity determined by the ,board to be necessary to make a determination under section #cjd1 the following information with respect to the reporting period3 7#a7 ,each type of prescription drug and medical device that is sold by the manufacturer or an affiliate of the manufacturer-- 7,a7 in the ,united ,states2 or 7,b7 in a country that is a member of the ,organization for ,economic ,co-operation and ,development4 7#b7 ,the price charged by the manufacturer and the affiliate for the prescription drug or medical device in the ,united ,states and in any such country1 as applicable4 7#c7 ,the costs of the manufacturer and the affiliate to produce and market the prescription drug or medical device for sale in the ,united ,states and in any such country1 as applicable4 7b7 ,reporting by ,,cbo ,the ,director of the ,congressional ,budget ,office shall submit an annual report to the ,board on trends in the prices charged for prescription drugs and medical devices4 #cjd4 ,prohibition against excessive price 7a7 ,prohibition ,beginning on the effective date of the regulation required by subsection 7b71 the manufacturer of a prescription drug or medical device shall not charge an excessive price1 as determined pursuant to such regulation1 for such drug or device4 7b7 ,formula ,the ,board shall by regulation prescribe a formula for determining whether the average manufacturer price of such drug or device over an annual quarter is an excessive price4 7c7 ,determination of excessive price ,if the ,board determines1 on its own initiative or in response to a petition submitted under subsection 7d71 that the manufacturer of a prescription drug or medical device charges an excessive price for such drug or device in violation of subsection 7a7-- 7#a7 the ,board shall give the manufacturer-- 7,a7 notice of such violation2 and 7,b7 subject to subsection 7d71 a period to correct such violation2 and 7#b7 if the manufacturer fails to correct the violation by the end of such period1 the manufacturer shall be subject to section #cje1 section #aibg7;c77#b77;,e7 of the ,social ,security ,act 7as added by subsection 7c7 of section #cje71 and section #daib of the ,internal ,revenue ,code of #aihf1 as added by subsection 7d7 of section #cje4 7d7 ,petitions ,any person may petition the ,board to make a determination under subsection 7c7 regarding the pricing of a prescription drug or medical device4 ,not later than #ij days after the date of receipt of such a petition1 the ,board shall-- 7#a7 make a determination under subsection 7c7 regarding such pricing2 or 7#b7 decline to make such a determination4 7e7 ,continuing violation ,the ,board shall not be required to give a manufacturer an opportunity to correct a violation1 as described in subsection 7c77#a77;,b71 before the manufacturer becomes subject to the provisions described in subsection 7c77#b7 for such violation1 if-- 7#a7 the ,board has already provided such an opportunity to correct to the manufacturer2 and 7#b7 the ,board finds that the violation of subsection 7a7 is a continuation of an earlier violation with respect to which such an opportunity was provided4 7f7 ,considerations ,the formula required by subsection 7a7 shall at a minimum take into consideration-- 7#a7 the average manufacturer price of the prescription drug or medical device over the respective annual quarter or quarters2 7#b7 the average manufacturer price of other prescription drugs or medical devices in the same therapeutic class over the same quarter or quarters2 7#c7 the average price at which the prescription drug or medical device and other prescription drugs and medical devices in the same therapeutic class have been sold by manufacturers in countries other than the ,united ,states2 7#d7 the costs associated with producing and marketing the prescription drug or medical device1 the value of the drug or device to patients where sufficient data is available to determine such value1 the total ,federal investment in the development of the drug or device1 the size of the patient population receiving the drug or device1 and other factors determinative as to the true cost of production2 and 7#e7 whether the price of the prescription drug or medical device increased during any annual quarter by a percentage that is more than #b percent greater than the ,,cpi increase percentage 7as defined in section #bae7;i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #dae77 for the respective annual quarter4 #cje4 ,enforcement provisions 7a7 ,reduced patent term ,if the ,board finds that the manufacturer of a prescription drug or medical device1 who is also an owner of a patent for such drug or device1 charged an excessive price for such drug or device in violation of section #cjd7;a71 the ,board may-- 7#a7 reduce the term1 by not more than #e years1 of any patent issued under title #ce1 ,united ,states ,code1 relating to such drug or device2 or 7#b7 if the term of each patent for such drug or device has expired1 reduce the term1 by not more than #e years1 of another patent owned by the patent owner relating to a prescription drug or medical device4 7b7 ,civil penalties ,if the ,board determines under section #cjd7;c7 that a manufacturer of a prescription drug or medical device charged an excessive price for a prescription drug or medical device in violation of section #cjd7;a71 the ,board may impose a civil penalty on the manufacturer of not more than #aj percent of the manufacturer's gross sales of the drug or device during the period beginning on the date on which an excessive price is first charged and ending on the date on which the manufacturer ceases to charge an excessive price4 7c7 ,enforcement through increased medicaid rebates 7#a7 ,in general ,section #aibg7;c77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#b77 is amended-- 7,a7 in subparagraph 7,a71 by inserting 1 subject to subparagraph 7,e71 after increased by2 and 7,b7 by adding at the end the following new subparagraph3 7,e7 ,discouraging excessive prices 7i7 ,in general ,in the case of a manufacturer of a single source drug or an innovator multiple source drug with a rebate agreement under this section1 if the ,prescription ,drug and ,medical ,device ,price ,review ,board established under section #cja of the ,medicare for ,america ,act determines under section #cjd7;a7 of such ,act that such manufacturer charged1 with respect to a #cj-;day period1 an excessive price for such drug1 and the ,board determines under clause 7ii7 to apply an increased amount described in such clause with respect to such manufacturer and drug1 the amount of the rebate determined under subparagraph 7,a7 for such manufacturer and drug shall be1 subject to subparagraph 7,d71 increased by such amount for the #d rebate periods following such #cj-;day period4 7ii7 ,increased amount determination ,for purposes of clause 7i71 if the ,board described in such clause makes such a determination under such section #cjd7;a71 with respect to a manufacturer and drug described in such clause1 the ,board may determine an increased amount to apply with respect to such manufacturer and drug and rebate period described in such clause4 ,such increased amount may not exceed the rebate amount that would otherwise be applied to such manufacturer and drug under this section for such rebate period1 without regard to this subparagraph4 4 7#b7 ,effective date ,this subsection and the amendments made by this subsection shall apply with respect to rebate agreements entered into after the date that is #fj days after the date of the enactment of this ,act4 7d7 ,tax on excess prescription drug and medical device profits 7#a7 ,determination of amount ,if the ,board determines under section #cjd7;a7 that a manufacturer1 producer1 or importer of a prescription drug or medical device charged an excessive price for such prescription drug or medical device during a taxable year1 the ,board may determine under this paragraph a reasonable price for such drug or device for such taxable year4 7#b7 ,imposition of tax 7,a7 ,in general ,the ,internal ,revenue ,code of #aihf is amended by inserting after section #daia the following new section3 #daib4 ,excessive prescription drug and medical device price 7a7 ,in general ,there is hereby imposed on the sale of any prescription drug or medical device by the manufacturer1 producer1 or importer a tax equal to the difference between the price at which such drug or device is so sold and the reasonable price determined by the ,prescription ,drug and ,medical ,device ,price ,review ,board under section #cje7;d77#a7 of the ,medicare for ,america ,act for such drug or device for the taxable year for sales after the determination4 7b7 ,prescription drug or medical device ,for purposes of this section1 the term prescription drug or medical device means any prescription drug 7as defined in section #ijjh of the ,patient ,protection and ,affordable ,care ,act7 or device 7as defined in section #bja7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act7 intended for humans4 4 7,b7 ,clerical amendment ,the table of parts for chapter #cb of such ,code is amended-- 7i7 in the item relating to subchapter ,e1 by striking ,medical and inserting ,drugs and medical1 and 7ii7 by inserting after the item relating to section #daia the following new item3 #daib4 ,excessive prescription drug and medical device price 4 7#c7 ,effective date ,this subsection and the amendments made by this subsection shall apply with respect to sales after ,december #ca1 #bjah4 #cjf4 ,authority 7a7 ,obtaining official data ,the chairperson of the ,board may secure directly from any ,federal agency information necessary to enable the ,board to carry out its duties4 ,upon request of the chairperson1 the head of the agency shall furnish such information to the ,board to the extent such information is not prohibited from disclosure by law4 7b7 ,mails ,the ,board may use the ,united ,states mails in the same manner and under the same conditions as other ,federal agencies4 7c7 ,administrative support services ,upon the request of the chairperson of the ,board1 the ,administrator of ,general ,services shall provide to the ,board1 on a reimbursable basis1 the administrative support services necessary for the ,board to carry out its duties4 7d7 ,contract authority ,the ,board may contract with and compensate government and private agencies or persons for the purpose of conducting research1 surveys1 and other services necessary to enable the ,board to carry out its duties4 7e7 ,investigations ,the ,board may make such investigations as it considers necessary to determine whether there is or may be a violation of any regulation promulgated under this ,act and may require or permit any person to file with it a statement in writing1 under oath or otherwise as the ,board shall determine1 as to all the facts and circumstances concerning the matter to be investigated4 7f7 ,subpoena power 7#a7 ,in general ,the ,board may issue subpoenas requiring the attendance and testimony of witnesses and the production of any evidence relating to any matter under investigation by the ,board4 ,the attendance of witnesses and the production of evidence may be required from any place within the ,united ,states at any designated place of hearing within the ,united ,states4 7#b7 ,failure to obey a subpoena ,if a person refuses to obey a subpoena issued under paragraph 7#a71 the ,board may apply to a ,united ,states district court for an order requiring that person to appear before the ,board to give testimony1 produce evidence1 or both1 relating to the matter under investigation4 ,the application may be made within the judicial district where the hearing is conducted or where that person is found1 resides1 or transacts business4 ,any failure to obey the order of the court may be punished by the court as civil contempt4 7#c7 ,service of subpoenas ,the subpoenas of the ,board shall be served in the manner provided for subpoenas issued by a ,united ,states district court under the ,federal ,rules of ,civil ,procedure for the ,united ,states district courts4 7#d7 ,service of process ,all process of any court to which application is made under paragraph 7#b7 may be served in the judicial district in which the person required to be served resides or may be found4 7#e7 ,notice ,upon issuing any subpoena under this subsection1 the ,board shall give notice of such issuance to the appropriate committees of ,congress1 including the ,committee on ,appropriations of the ,house of ,representatives and the ,committee on ,appropriations of the ,senate4 7g7 ,confidentiality ,nothing in this title shall be construed as authorizing the ,board to disclose any information that is a trade secret or confidential information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 #cjg4 ,regulations 7a7 ,in general ,not later than #a year after the date of the initial meeting held under section #cjb7;e71 the ,board shall issue final regulations to carry out this ,act4 7b7 ,notice and comment requirement ,the regulations developed under subsection 7a7 shall be issued in accordance with the notice and comment procedures established under section #eec of title #e1 ,united ,states ,code4 #cjh4 ,report to ,federal agencies ,not later than #a year after the effective date of the regulations under section #cjg and annually thereafter1 the ,board shall submit to each ,federal agency that dispenses or makes payments for the dispensing of prescription drugs or medical devices a report containing-- 7#a7 a list of each prescription drug and medical device for which an excessive price was charged during the preceding calendar year1 as determined by the ,board under section #cjd2 7#b7 recommendations to the ,federal agency against dispensing or making payments for the dispensing of the prescription drug or medical device2 and 7#c7 recommendations to the ,federal agency to substitute1 in place of any drug or device listed pursuant to paragraph 7#a71 a similar prescription drug or medical device that is not sold at an excessive price4 #cji4 ,definitions ,in this title3 7#a7 ,the term affiliate means1 with respect to a manufacturer1 any entity that controls1 is controlled by1 or is under common control with such manufacturer4 7#b7 ,the term average manufacturer price means the average price charged by the manufacturer of a prescription drug or medical device1 as applicable1 for sales of the drug or device by the manufacturer in the ,united ,states over the respective annual quarter4 7#c7 ,the term medical device means a device 7as defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba774 7#d7 ,the term prescription drug means a drug 7as defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba77 that is subject to section #ejc7;b77#a7 of such ,act 7#ba ,u4,s4,c4 #cec7;b77#a774 #caj4 ,moratorium on direct-to-consumer drug advertising ,the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 is amended-- 7#a7 in section #cja 7#ba ,u4,s4,c4 #cca71 by adding at the end the following3 7eee7 ,the conduct of direct-to-consumer advertising of a drug in violation of section #ejf;,j4 2 and 7#b7 in chapter ,v1 by inserting after section #ejf;,i 7#ba ,u4,s4,c4 #cef;f7 the following3 #ejf;,j4 ,direct-to-consumer drug advertising 7a7 ,prohibitions 7#a7 ,first three years 7,a7 ,in general ,subject to subparagraph 7,b71 no person shall conduct direct-to-consumer advertising of a drug for which an application is submitted under section #eje7;b7 before the end of the #c-year period beginning on the date of the approval of such application4 7,b7 ,waiver ,the ,secretary may waive the application of subparagraph 7,a7 to a drug during the third year of the #c-year period described in such subparagraph if-- 7i7 the sponsor of the drug submits an application to the ,secretary pursuant to subparagraph 7,c72 and 7ii7 the ,secretary1 after considering the application and any accompanying materials1 determines that direct-to-consumer advertising of the drug would have an affirmative value to public health4 7,c7 ,application for waiver ,to seek a waiver under subparagraph 7,b71 the sponsor of a drug shall submit an application to the ,secretary at such time1 in such manner1 and containing such information as the ,secretary may require4 7#b7 ,subsequent years ,the ,secretary may prohibit direct-to-consumer advertising of a drug during the period beginning at the end of the #c-year period described in paragraph 7#a77;,a7 if the ,secretary determines that the drug has significant adverse health effects based on post-approval studies1 risk-benefit analyses1 adverse event reports1 the scientific literature1 any clinical or observational studies1 or any other appropriate resource4 7b7 ,regulations ,not later than #a year after the date of the enactment of this section1 the ,secretary shall revise the regulations promulgated under this ,act governing drug advertisements to the extent necessary to implement this section4 7c7 ,rule of construction ,this section shall not be construed to diminish the authority of the ,secretary to prohibit or regulate direct-to-consumer advertising of drugs under other provisions of law4 4 #caa4 ,reporting on justification for drug price increases ,title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq47 is amended by adding at the end the following3 ,w ,,drug ,,price ,,reporting2 ,,drug ,,value ,,fund #cii,,oo4 ,reporting on justification for drug price increases 7a7 ,definitions ,in this section3 7#a7 ,manufacturer ,the term manufacturer means the person-- 7,a7 that holds the application for a drug approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or the license issued under section #cea of the ,public ,health ,service ,act2 or 7,b7 who is responsible for setting the price for the drug4 7#b7 ,qualifying drug ,the term qualifying drug means any drug that is approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed under subsection 7a7 or 7k7 of section #cea of this ,act-- 7,a7 that has a wholesale acquisition cost of #ajj or more per month supply or per a course of treatment that lasts less than a month and is-- 7i7 7,i7 subject to section #ejc7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 or 7,,ii7 commonly administered by hospitals 7as determined by the ,secretary72 7ii7 not designated as a drug for a rare disease or condition under section #ebf of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 and 7iii7 not designated by the ,secretary as a vaccine2 and 7,b7 for which1 during the previous calendar year1 at least #a dollar of the total amount of sales were for individuals enrolled under the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 or under a ,state ,medicaid plan under title ,,xix of such ,act 7#db ,u4,s4,c4 #acif et seq47 or under a waiver of such plan4 7#c7 ,wholesale acquisition cost ,the term wholesale acquisition cost has the meaning given that term in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 7b7 ,report 7#a7 ,report required ,the manufacturer of a qualifying drug shall submit a report to the ,secretary for each price increase of a qualifying drug that will result in an increase in the wholesale acquisition cost of that drug that is equal to-- 7,a7 #aj percent or more over a #ab-month period2 or 7,b7 #be percent or more over a #cf-month period4 7#b7 ,report deadline ,each report described in paragraph 7#a7 shall be submitted to the ,secretary not later than #cj days prior to the planned effective date of such price increase4 7c7 ,contents ,a report under subsection 7b7 shall1 at a minimum1 include-- 7#a7 with respect to the qualifying drug-- 7,a7 the percentage by which the manufacturer will raise the wholesale acquisition cost of the drug on the planned effective date of such price increase2 7,b7 a justification for1 and description of1 each manufacturer's price increase that occurred during the #ab-month period described in subsection 7b77#a77;,a7 or the #cf-month period described in subsection 7b77#a77;,b71 as applicable2 7,c7 the identity of the initial developer of the drug2 7,d7 a description of the history of the manufacturer's price increases for the drug since the approval of the application for the drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or the issuance of the license for the drug under section #cea1 or since the manufacturer acquired such approved application or license2 7,e7 the current list price of the drug2 7,f7 the total expenditures of the manufacturer on-- 7i7 materials and manufacturing for such drug2 and 7ii7 acquiring patents and licensing for such drug2 7,g7 the percentage of total expenditures of the manufacturer on research and development for such drug that was derived from ,federal funds2 7,h7 the total expenditures of the manufacturer on research and development for such drug that is used for-- 7i7 basic and preclinical research2 7ii7 clinical research2 7iii7 new drug development2 7iv7 pursuing new or expanded indications for such drug through supplemental applications under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 and 7v7 carrying out postmarket requirements related to such drug1 including those under section #eje7o77#c7 of such ,act2 7,i7 the total revenue and the net profit generated from the qualifying drug for each calendar year since the approval of the application for the drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or the issuance of the license for the drug under section #cea1 or since the manufacturer acquired such approved application or license2 and 7,j7 the total costs associated with marketing and advertising for the qualifying drug2 7#b7 with respect to the manufacturer-- 7,a7 the total revenue and the net profit of the manufacturer for the #ab-month period described in subsection 7b77#a77;,a7 or the #cf-month period described in subsection 7b77#a77;,b71 as applicable2 7,b7 all stock-based performance metrics used by the manufacturer to determine executive compensation for the #ab-month period described in subsection 7b77#a77;,a7 or the #cf-month period described in subsection 7b77#a77;,b71 as applicable2 and 7,c7 any additional information the manufacturer chooses to provide related to drug pricing decisions1 such as total expenditures on-- 7i7 drug research and development2 or 7ii7 clinical trials on drugs that failed to receive approval by the ,food and ,drug ,administration2 and 7#c7 such other related information as the ,secretary considers appropriate4 7d7 ,civil penalty ,any manufacturer of a qualifying drug that fails to submit a report for the drug as required by this section shall be subject to a civil penalty of #ajj1jjj for each day on which the violation continues4 7e7 ,public posting 7#a7 ,in general ,subject to paragraph 7#c71 not later than #cj days after the submission of a report under subsection 7b71 the ,secretary shall post the report on the public website of the ,department of ,health and ,human ,services4 7#b7 ,format ,in developing the format of such report for public posting1 the ,secretary shall consult stakeholders1 including beneficiary groups1 and shall seek feedback on the content and format from consumer advocates and readability experts to ensure such public reports are user-friendly to the public and are written in plain language that consumers can readily understand4 7#c7 ,trade secrets and confidential information ,in carrying out this section1 the ,secretary shall enforce applicable law concerning the protection of confidential commercial information and trade secrets4 #cii,,oo-#a4 ,use of civil penalty amounts ,the ,secretary shall collect the civil penalties under section #cii,,oo1 in addition to any other amounts available1 and without further appropriation1 and shall use such funds to carry out activities described in this part and to improve consumer and provider information about drug value and drug price transparency4 #cii,,oo-#b4 ,annual report to ,congress 7a7 ,in general ,subject to subsection 7b71 the ,secretary shall submit to ,congress1 and post on the public website of the ,department of ,health and ,human ,services in a way that is easy to use and understand1 an annual report-- 7#a7 summarizing the information reported pursuant to section #cii,,oo2 and 7#b7 including copies of the reports and supporting detailed economic analyses submitted pursuant to such section4 7b7 ,trade secrets and confidential information ,in carrying out this section1 the ,secretary shall enforce applicable law concerning the protection of confidential commercial information and trade secrets4 4