,,ii ,calendar ,no4 #ebc #aafth ,,congress #b;d ,session ,h4 ,r4 #adbe ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #cj1 #bjbj,received ,august #ac1 #bjbj ,read the first time ,september #h1 #bjbj,read the second time and placed on the calendar ,,an ,,act ,to amend the ,patient ,protection and ,affordable ,care ,act to provide for a ,improve ,health ,insurance ,affordability ,fund to provide for certain reinsurance payments to lower premiums in the individual health insurance market4 #a4 ,short title ,this ,act may be cited as the ,patient ,protection and ,affordable ,care ,enhancement ,act4 #b4 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title4,sec4 #b4 ,table of contents4,title ,i--,lowering ,health ,care ,costs and ,protecting ,people with ,preexisting ,conditions,sec4 #aja4 ,improving affordability by expanding premium assistance for consumers4,sec4 #ajb4 ,improving affordability by reducing out-of-pocket and premium costs for consumers4,sec4 #ajc4 ,expanding affordability for working families to fix the family glitch4,sec4 #ajd4 ,tax credit reconciliation protections for individuals receiving social security lump-sum payments4,sec4 #aje4 ,preserving ,state option to implement health care ,marketplaces4,sec4 #ajf4 ,establishing a ,health ,insurance ,affordability ,fund4,sec4 #ajg4 ,rescinding the short-term limited duration insurance regulation4,sec4 #ajh4 ,revoking section #accb guidance4,sec4 #aji4 ,requiring ,marketplace outreach1 educational activities1 and annual enrollment targets4,sec4 #aaj4 ,report on effects of website maintenance during open enrollment4,sec4 #aaa4 ,promoting consumer outreach and education4,sec4 #aab4 ,improving transparency and accountability in the ,marketplace4,sec4 #aac4 ,improving awareness of health coverage options4,sec4 #aad4 ,promoting ,state innovations to expand coverage4,sec4 #aae4 ,strengthening network adequacy4,sec4 #aaf4 ,protecting consumers from unreasonable rate hikes4,sec4 #aag4 ,eligibility of ,,daca recipients for qualified health plans offered through ,exchanges4,title ,,ii--,encouraging ,medicaid ,expansion and ,strengthening the ,medicaid ,program,sec4 #bja4 ,incentivizing ,medicaid expansion4,sec4 #bjb4 ,providing #ab-months of continuous eligibility for ,medicaid and ,,chip4,sec4 #bjc4 ,mandatory #ab-months of postpartum ,medicaid eligibility4,sec4 #bjd4 ,reducing the administrative ,,fmap for nonexpansion ,states4,sec4 #bje4 ,enhanced reporting requirements for nonexpansion states4,sec4 #bjf4 ,primary care pay increase4,sec4 #bjg4 ,permanent funding for ,,chip4,sec4 #bjh4 ,permanent extension of ,,chip enrollment and quality measures4,sec4 #bji4 ,state option to increase children's eligibility for ,medicaid and ,,chip4,sec4 #baj4 ,medicaid coverage for citizens of ,freely ,associated ,states4,sec4 #baa4 ,extension of full ,federal medical assistance percentage to ,indian health care providers4,title ,,iii--,lowering ,prices ,through ,fair ,drug ,price ,negotiation,sec4 #cja4 ,establishing a ,fair ,drug ,pricing ,program4,sec4 #cjb4 ,drug manufacturer excise tax for noncompliance4,sec4 #cjc4 ,fair ,price ,negotiation ,implementation ,fund4,title ,,iv--,public ,health ,investments,sec4 #dja4 ,supporting increased innovation4 ,i ,lowering ,health ,care ,costs and ,protecting ,people with ,preexisting ,conditions #aja4 ,improving affordability by expanding premium assistance for consumers 7a7 ,in general ,section #cf;,b7b77#c77;,a7 of the ,internal ,revenue ,code of #aihf is amended to read as follows3 7,a7 ,applicable percentage ,the applicable percentage for any taxable year shall be the percentage such that the applicable percentage for any taxpayer whose household income is within an income tier specified in the following table shall increase1 on a sliding scale in a linear manner1 from the initial premium percentage to the final premium percentage specified in such table for such income tier3 ,in the case of household income 7expressed as a percent of poverty line7 within the following income tier3,the initial premiumpercentage is--,the final premium percentage is--,up to #aej4j percent#j4jj4jaej4j percent up to #bjj4j percent#j4jc4jbjj4j percent up to #bej4j percent#c4jd4jbej4j percent up to #cjj4j percent#d4jf4jcjj4j percent up to #djj4j percent#f4jh4edjj4j percent and higher#h4eh4e 4 7b7 ,conforming amendment ,section #cf;,b7c77#a77;,a7 of the ,internal ,revenue ,code of #aihf is amended by striking but does not exceed #djj percent4 7c7 ,effective date ,the amendments made by this section shall apply to taxable years beginning after ,december #ca1 #bjai4 #ajb4 ,improving affordability by reducing out-of-pocket and premium costs for consumers ,section #acjb7;c77#d7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjbb7;c77#d77 is amended by striking calendar year7 and inserting calendar year1 based on estimates and projections for the applicable calendar year of the percentage 7if any7 by which the average per enrollee premium for eligible employer-sponsored health plans 7as defined in section #ejjj;,a7f77#b7 of the ,internal ,revenue ,code of #aihf7 exceeds such average per enrollee premium for the preceding calendar year1 as published in the ,national ,health ,expenditure ,accounts74 #ajc4 ,expanding affordability for working families to fix the family glitch 7a7 ,in general ,clause 7i7 of section #cf;,b7c77#b77;,c7 of the ,internal ,revenue ,code of #aihf is amended to read as follows3 7i7 ,coverage must be affordable 7,i7 ,employees ,an employee shall not be treated as eligible for minimum essential coverage if such coverage consists of an eligible employer-sponsored plan 7as defined in section #ejjj;,a7f77#b77 and the employee's required contribution 7within the meaning of section #ejjj;,a7e77#a77;,b77 with respect to the plan exceeds #i4e percent of the employee's household income4 7,,ii7 ,family members ,an individual who is eligible to enroll in an eligible employer-sponsored plan 7as defined in section #ejjj;,a7f77#b77 by reason of a relationship the individual bears to the employee shall not be treated as eligible for minimum essential coverage by reason of such eligibility to enroll if the employee's required contribution 7within the meaning of section #ejjj;,a7e77#a77;,b71 determined by substituting family for self-only7 with respect to the plan exceeds #i4e percent of the employee's household income4 4 7b7 ,conforming amendments 7#a7 ,clause 7ii7 of section #cf;,b7c77#b77;,c7 of the ,internal ,revenue ,code of #aihf is amended by striking ,except as provided in clause 7iii71 an employee and inserting ,an individual4 7#b7 ,clause 7iii7 of section #cf;,b7c77#b77;,c7 of such ,code is amended by striking the last sentence of clause 7i7 and inserting clause 7i77,,ii74 7#c7 ,clause 7iv7 of section #cf;,b7c77#b77;,c7 of such ,code is amended by striking the #i4e percent under clause 7i77,,ii7 and inserting the #i4e percent under clauses 7i77,i7 and 7i77,,ii74 7c7 ,effective date ,the amendments made by this section shall apply to taxable years beginning after ,december #ca1 #bjba4 #ajd4 ,tax credit reconciliation protections for individuals receiving social security lump-sum payments 7a7 ,in general ,section #cf;,b7d77#b7 of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new subparagraph3 7,c7 ,exclusion of portion of lump-sum social security benefits 7i7 ,in general ,the term modified adjusted gross income shall not include so much of any lump-sum social security benefit payment as is attributable to months ending before the beginning of the taxable year4 7ii7 ,lump-sum social security benefit payment ,for purposes of this subparagraph1 the term lump-sum social security benefit payment means any payment of social security benefits 7as defined in section #hf7;d77#a77 which constitutes more than #a month of such benefits4 7iii7 ,election to include excludable amount ,a taxpayer may elect 7at such time and in such manner as the ,secretary may provide7 to have this subparagraph not apply for any taxable year4 4 7b7 ,effective date ,the amendment made by this section shall apply to taxable years beginning after ,december #ca1 #bjai4 #aje4 ,preserving ,state option to implement health care ,marketplaces 7a7 ,in general ,section #acaa of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjca7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#d77;,b71 by striking under this subsection and inserting under this paragraph or paragraph 7#a72 and 7,b7 by adding at the end the following new paragraph3 7#f7 ,additional planning and establishment grants 7,a7 ,in general ,there shall be appropriated to the ,secretary1 out of any moneys in the ,treasury not otherwise appropriated1 #bjj million to award grants to eligible ,states for the uses described in paragraph 7#c74 7,b7 ,duration and renewability ,a grant awarded under subparagraph 7,a7 shall be for a period of #b years and may not be renewed4 7,c7 ,limitation ,a grant may not be awarded under subparagraph 7,a7 after ,december #ca1 #bjbc4 7,d7 ,eligible ,state defined ,for purposes of this paragraph1 the term eligible ,state means a ,state that1 as of the date of the enactment of this paragraph1 is not operating an ,exchange 7other than an ,exchange described in section #aee4bjj7;f7 of title #de1 ,code of ,federal ,regulations74 2 and 7#b7 in subsection 7d77#e77;,a7-- 7,a7 by striking operations4--,in establishing an ,exchange under this section and inserting operations4-- 7i7 ,in general ,in establishing an ,exchange under this section 7other than in establishing an ,exchange pursuant to a grant awarded under subsection 7a77#f77 2 and 7,b7 by adding at the end the following3 7ii7 ,additional planning and establishment grants ,in establishing an ,exchange pursuant to a grant awarded under subsection 7a77#f71 the ,state shall ensure that such ,exchange is self-sustaining beginning on ,january #a1 #bjbe1 including allowing the ,exchange to charge assessments or user fees to participating health insurance issuers1 or to otherwise generate funding1 to support its operations4 4 7b7 ,clarification regarding failure to establish ,exchange or implement requirements ,section #acba7;c7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjda7;c77 is amended-- 7#a7 in paragraph 7#a71 by striking ,if and inserting ,subject to paragraph 7#c71 if2 and 7#b7 by adding at the end the following new paragraph3 7#c7 ,clarification ,this subsection shall not apply in the case of a ,state that elects to apply the requirements described in subsection 7a7 and satisfies the requirement described in subsection 7b7 on or after ,january #a1 #bjad4 4 #ajf4 ,establishing a ,health ,insurance ,affordability ,fund ,subtitle ,d of title ,i of the ,patient ,protection and ,affordable ,care ,act is amended by inserting after part #e 7#db ,u4,s4,c4 #ahjfa et seq47 the following new part3 #f ,improve ,health ,insurance ,affordability ,fund #acea4 ,establishment of program ,there is hereby established the ,improve ,health ,insurance ,affordability ,fund to be administered by the ,secretary of ,health and ,human ,services1 acting through the ,administrator of the ,centers for ,medicare ,medicaid ,services 7in this section referred to as the ,administrator71 to provide funding1 in accordance with this part1 to the #ej ,states and the ,district of ,columbia 7each referred to in this section as a ,state7 beginning on ,january #a1 #bjbb1 for the purposes described in section #aceb4 #aceb4 ,use of funds 7a7 ,in general ,a ,state shall use the funds allocated to the ,state under this part for one of the following purposes3 7#a7 ,to provide reinsurance payments to health insurance issuers with respect to individuals enrolled under individual health insurance coverage 7other than through a plan described in subsection 7b77 offered by such issuers4 7#b7 ,to provide assistance 7other than through payments described in paragraph 7#a77 to reduce out-of-pocket costs1 such as copayments1 coinsurance1 premiums1 and deductibles1 of individuals enrolled under qualified health plans offered on the individual market through an ,exchange4 7b7 ,exclusion of certain grandfathered and transitional plans ,for purposes of subsection 7a71 a plan described in this subsection is the following3 7#a7 ,a grandfathered health plan 7as defined in section #abea74 7#b7 ,a plan 7commonly referred to as a transitional plan7 continued under the letter issued by the ,centers for ,medicare ,medicaid ,services on ,november #ad1 #bjac1 to the ,state ,insurance ,commissioners outlining a transitional policy for coverage in the individual and small group markets to which section #abea does not apply1 and under the extension of the transitional policy for such coverage set forth in the ,insurance ,standards ,bulletin ,series guidance issued by the ,centers for ,medicare ,medicaid ,services on ,march #e1 #bjad1 ,february #bi1 #bjaf1 ,february #ac1 #bjag1 ,april #i1 #bjah1 ,march #be1 #bjai1 and ,january #ca1 #bjbj1 or under any subsequent extensions thereof4 7#c7 ,student health insurance coverage 7as defined in section #adg4ade of title #de1 ,code of ,federal ,regulations74 #acec4 ,state eligibility and approval2 ,default safeguard 7a7 ,encouraging ,state options for allocations 7#a7 ,in general ,to be eligible for an allocation of funds under this part for a year 7beginning with #bjbb71 a ,state shall submit to the ,administrator an application at such time 7but1 in the case of allocations for #bjbb1 not later than #ij days after the date of the enactment of this part and1 in the case of allocations for a subsequent year1 not later than ,march #a of the previous year7 and in such form and manner as specified by the ,administrator containing-- 7,a7 a description of how the funds will be used2 and 7,b7 such other information as the ,administrator may require4 7#b7 ,automatic approval ,an application so submitted is approved unless the ,administrator notifies the ,state submitting the application1 not later than #fj days after the date of the submission of such application1 that the application has been denied for not being in compliance with any requirement of this part and of the reason for such denial4 7#c7 #e-year application approval ,if an application of a ,state is approved for a purpose described in section #aceb for a year1 such application shall be treated as approved for such purpose for each of the subsequent #d years4 7#d7 ,revocation of approval ,the approval of an application of a ,state1 with respect to a purpose described in section #aceb1 may be revoked if the ,state fails to use funds provided to the ,state under this section for such purpose or otherwise fails to comply with the requirements of this section4 7b7 ,default ,federal safeguard 7#a7 #bjbb ,for #bjbb1 in the case of a ,state that does not submit an application under subsection 7a7 by the #ij-;day submission date applicable to such year under subsection 7a77#a7 and in the case of a ,state that does submit such an application by such date that is not approved1 the ,administrator1 in consultation with the ,state insurance commissioner1 shall1 from the amount calculated under paragraph 7#d7 for such year1 carry out the purpose described in paragraph 7#c7 in such ,state for such year4 7#b7 #bjbc and subsequent years ,for #bjbc or a subsequent year1 in the case of a ,state that does not have in effect an approved application under this section for such year1 the ,administrator1 in consultation with the ,state insurance commissioner1 shall1 from the amount calculated under paragraph 7#d7 for such year1 carry out the purpose described in paragraph 7#c7 in such ,state for such year4 7#c7 ,specified use ,the amount described in paragraph 7#d71 with respect to #bjbb or a subsequent year1 shall be used to carry out the purpose described in section #aceb7;a77#a7 in each ,state described in paragraph 7#a7 or 7#b7 for such year1 as applicable1 by providing reinsurance payments to health insurance issuers with respect to attachment range claims 7as defined in section #aced7;b77#b771 using the dollar amounts specified in subparagraph 7,b7 of such section for such year7 in an amount equal to1 subject to paragraph 7#e71 the percentage 7specified for such year by the ,secretary under such subparagraph7 of the amount of such claims4 7#d7 ,amount described ,the amount described in this paragraph1 with respect to #bjbb or a subsequent year1 is the amount equal to the total sum of amounts that the ,secretary would otherwise estimate under section #aced7;b77#b77;,a77i7 for such year for each ,state described in paragraph 7#a7 or 7#b7 for such year1 as applicable1 if each such ,state were not so described for such year4 7#e7 ,adjustment ,for purposes of this subsection1 the ,secretary may apply a percentage under paragraph 7#c7 with respect to a year that is less than the percentage otherwise specified in section #aced7;b77#b77;,b7 for such year1 if the cost of paying the total eligible attachment range claims for ,states described in this subsection for such year at such percentage otherwise specified would exceed the amount calculated under paragraph 7#d7 for such year4 #aced4 ,allocations 7a7 ,appropriation ,for the purpose of providing allocations for ,states under subsection 7b7 and payments under section #acec7;b7 there is appropriated1 out of any money in the ,treasury not otherwise appropriated1 #aj1jjj1jjj1jjj for #bjbb and each subsequent year4 7b7 ,allocations 7#a7 ,payment 7,a7 ,in general ,from amounts appropriated under subsection 7a7 for a year1 the ,secretary shall1 with respect to a ,state not described in section #acec7;b7 for such year and not later than the date specified under subparagraph 7,b7 for such year1 allocate for such ,state the amount determined for such ,state and year under paragraph 7#b74 7,b7 ,specified date ,for purposes of subparagraph 7,a71 the date specified in this subparagraph is-- 7i7 for #bjbb1 the date that is #de days after the date of the enactment of this part2 and 7ii7 for #bjbc or a subsequent year1 ,january #a of the respective year4 7,c7 ,notifications of allocation amounts ,for #bjbc and each subsequent year1 the ,secretary shall notify each ,state of the amount determined for such ,state under paragraph 7#b7 for such year by not later than ,january #a of the previous year4 7#b7 ,allocation amount determinations 7,a7 ,in general ,for purposes of paragraph 7#a71 the amount determined under this paragraph for a year for a ,state described in paragraph 7#a77;,a7 for such year is the amount equal to-- 7i7 the amount that the ,secretary estimates would be expended under this part for such year on attachment range claims of individuals residing in such ,state if such ,state used such funds only for the purpose described in paragraph 7#a7 of section #aceb7;a7 at the dollar amounts and percentage specified under subparagraph 7,b7 for such year2 minus 7ii7 the amount1 if any1 by which the ,secretary determines-- 7,i7 the estimated amount of premium tax credits under section #cf;,b of the ,internal ,revenue ,code of #aihf that would be attributable to individuals residing in such ,state for such year without application of this part2 exceeds 7,,ii7 the estimated amount of premium tax credits under section #cf;,b of the ,internal ,revenue ,code of #aihf that would be attributable to individuals residing in such ,state for such year if such ,state were a ,state described in section #acec7;b7 for such year4 ,for purposes of the previous sentence and section #acec7;b77#c71 the term attachment range claims means1 with respect to an individual1 the claims for such individual that exceed a dollar amount specified by the ,secretary for a year1 but do not exceed a ceiling dollar amount specified by the ,secretary for such year1 under subparagraph 7,b74 7,b7 ,specifications ,for purposes of subparagraph 7,a7 and section #acec7;b77#c71 the ,secretary shall determine the dollar amounts and the percentage to be specified under this subparagraph for a year in a manner to ensure that the total amount of expenditures under this part for such year is estimated to equal the total amount appropriated for such year under subsection 7a7 if such expenditures were used solely for the purpose described in paragraph 7#a7 of section #aceb7;a7 for attachment range claims at the dollar amounts and percentage so specified for such year4 7#c7 ,availability ,funds allocated to a ,state under this subsection for a year shall remain available through the end of the subsequent year4 4 #ajg4 ,rescinding the short-term limited duration insurance regulation 7a7 ,findings ,congress finds the following3 7#a7 ,on ,august #c1 #bjah1 the ,administration issued a final rule entitled ,short-,term1 ,limited-,duration ,insurance 7#hc ,fed4 ,reg4 #chbab74 7#b7 ,the final rule dramatically expands the sale and marketing of insurance that-- 7,a7 may discriminate against individuals living with preexisting health conditions1 including children with complex medical needs and disabilities and their families2 7,b7 lacks important financial protections provided by the ,patient ,protection and ,affordable ,care ,act 7,public ,law #aaa-adh71 including the prohibition of annual and lifetime coverage limits and annual out-of-pocket limits1 that may increase the cost of treatment and cause financial hardship to those requiring medical care1 including children with complex medical needs and disabilities and their families2 and 7,c7 excludes coverage of essential health benefits including hospitalization1 prescription drugs1 and other lifesaving care4 7#c7 ,the implementation and enforcement of the final rule weakens critical protections for up to #acj million ,americans living with preexisting health conditions and may place a large financial burden on those who enroll in short-term limited-duration insurance1 which jeopardizes ,americans' access to quality1 affordable health insurance4 7b7 ,prohibition ,the ,secretary of ,health and ,human ,services1 the ,secretary of the ,treasury1 and the ,secretary of ,labor-- 7#a7 may not take any action to implement1 enforce1 or otherwise give effect to the rule entitled ,short-,term1 ,limited ,duration ,insurance 7#hc ,fed4 ,reg4 #chbab 7,august #c1 #bjah772 7#b7 shall apply any regulation revised by such rule as if such rule had not been issued2 and 7#c7 may not promulgate any substantially similar rule4 #ajh4 ,revoking section #accb guidance 7a7 ,findings ,congress finds the following3 7#a7 ,on ,october #bd1 #bjah1 the administration published new guidance to carry out section #accb of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjeb7 entitled 8,state ,relief and ,empowerment ,waivers0 7#hc ,fed4 ,reg4 #ecege74 7#b7 ,the new guidance encourages ,states to provide health insurance coverage through insurance plans that may discriminate against individuals with preexisting health conditions1 including the one in four ,americans living with a disability4 7#c7 ,the implementation and enforcement of the new guidance weakens protections for the millions of ,americans living with preexisting health conditions and jeopardizes ,americans' access to quality1 affordable health insurance coverage4 7b7 ,providing that certain guidance related to waivers for ,state innovation under the ,patient ,protection and ,affordable ,care ,act shall have no force or effect ,beginning ,july #a1 #bjbj1 the ,secretary of ,health and ,human ,services and the ,secretary of the ,treasury may not take any action to implement1 enforce1 or otherwise give effect to the guidance entitled ,state ,relief and ,empowerment ,waivers 7#hc ,fed4 ,reg4 #ecege 7,october #bd1 #bjah771 including any such action that would result in individuals losing health insurance coverage that includes the essential health benefits package 7as defined in subsection 7a7 of section #acjb of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjbb7;a77 without regard to any waiver of any provision of such package under a waiver under such section #accb71 including the maternity and newborn care essential health benefit described in subsection 7b77#a77;,d7 of such section1 including any such action that would result in a decrease in the number of such individuals enrolled in coverage that is at least as comprehensive as the coverage defined in section #acjb7;a7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjbb7;a77 compared to the number of such individuals who would have been so enrolled in such coverage had such action not been taken1 including any such action that would1 with respect to individuals with substance use disorders1 including opioid use disorders1 reduce the availability or affordability of coverage that is at least as comprehensive as the coverage defined in section #acjb7;a7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjbb7;a77 compared to the availability or affordability1 respectively1 of such coverage had such action not been taken1 including any such action that would result1 with respect to vulnerable populations 7including low-income individuals1 elderly individuals1 and individuals with serious health issues or who have a greater risk of developing serious health issues71 in a decrease in the availability of coverage that is at least as comprehensive as the coverage defined in section #acjb7;a7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjbb7;a77 with coverage and cost sharing protections required under section #accb7;b77#a77;,b7 of such ,act 7#db ,u4,s4,c4 #ahjeb7;b77#a77;,b771 including any such action that would1 with respect to individuals with preexisting conditions1 reduce the affordability of coverage that is at least as comprehensive as the coverage defined in section #acjb7;a7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjbb7;a77 compared to the affordability of such coverage had such action not been taken1 including any such action that would result in higher health insurance premiums for individuals enrolled in health insurance coverage that is at least as comprehensive as the coverage defined in section #acjb7;b7 of such ,act 7#db ,u4,s4,c4 #ahjbb7;b771 and the ,secretaries may not promulgate any substantially similar guidance or rule4 ,nothing in the previous sentence shall be construed to affect the approval of waivers under section #accb of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjeb7 that establish reinsurance programs that are consistent with the requirements under subsection 7b77#a7 of such section 7#db ,u4,s4,c4 #ahjeb7;b77#a771 lower health insurance premiums1 and protect health insurance coverage for people with preexisting conditions4 7c7 ,,gao report on affect of ,state innovation waivers on coverage of individuals and on mental health health care treatment ,not later than #a year after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report on the number of individuals expected to lose access to health insurance coverage 7as defined in section #bgia of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ia77 if subsection 7b7 were not enacted and waivers under section #accb of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjeb7 were approved under the guidance described in such subsection 7b74 ,such report shall include an analysis of the expected effect such waivers approved under such guidance would have on mental health care treatment4 #aji4 ,requiring ,marketplace outreach1 educational activities1 and annual enrollment targets 7a7 ,in general ,section #acba7;c7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjda7;c771 as amended by section #aje7;b71 is further amended by adding at the end the following new paragraphs3 7#d7 ,outreach and educational activities 7,a7 ,in general ,in the case of an ,exchange established or operated by the ,secretary within a ,state pursuant to this subsection1 the ,secretary shall carry out outreach and educational activities for purposes of informing individuals about qualified health plans offered through the ,exchange1 including by informing such individuals of the availability of coverage under such plans and financial assistance for coverage under such plans4 ,such outreach and educational activities shall be provided in a manner that is culturally and linguistically appropriate to the needs of the populations being served by the ,exchange 7including hard-to-reach populations1 such as racial and sexual minorities1 limited ,english proficient populations1 individuals in rural areas1 veterans1 and young adults7 and shall be provided to populations residing in high health disparity areas 7as defined in subparagraph 7,e77 served by the ,exchange1 in addition to other populations served by the ,exchange4 7,b7 ,limitation on use of funds ,no funds appropriated under this paragraph shall be used for expenditures for promoting non-,,aca compliant health insurance coverage4 7,c7 ,non-aca compliant health insurance coverage ,for purposes of subparagraph 7,b73 7i7 ,the term non-,,aca compliant health insurance coverage means health insurance coverage1 or a group health plan1 that is not a qualified health plan4 7ii7 ,such term includes the following3 7,i7 ,an association health plan4 7,,ii7 ,short-term limited duration insurance4 7,d7 ,funding ,out of any funds in the ,treasury not otherwise appropriated1 there are hereby appropriated for fiscal year #bjbb and each subsequent fiscal year1 #ajj1jjj1jjj to carry out this paragraph4 ,funds appropriated under this subparagraph shall remain available until expended4 7,e7 ,high health disparity area defined ,for purposes of subparagraph 7,a71 the term high health disparity area means a contiguous geographic area that-- 7i7 is located in one census tract or ,,zip code2 7ii7 has measurable and documented racial1 ethnic1 or geographic health disparities2 7iii7 has a low-income population1 as demonstrated by-- 7,i7 average income below #ach percent of the ,federal poverty line2 or 7,,ii7 a rate of participation in the special supplemental nutrition program under section #ag of the ,child ,nutrition ,act of #aiff 7#db ,u4,s4,c4 #aghf7 that is higher than the national average rate of participation in such program2 7iv7 has poor health outcomes1 as demonstrated by-- 7,i7 lower life expectancy than the national average2 or 7,,ii7 a higher percentage of instances of low birth weight than the national average2 and 7v7 is part of a ,metropolitan ,statistical ,area identified by the ,office of ,management and ,budget4 7#e7 ,annual enrollment targets ,for plan year #bjba and each subsequent plan year1 in the case of an ,exchange established or operated by the ,secretary within a ,state pursuant to this subsection1 the ,secretary shall establish annual enrollment targets for such ,exchange for such year4 4 7b7 ,study and report ,not later than #cj days after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall release to ,congress all aggregated documents relating to studies and data sets that were created on or after ,january #a1 #bjad1 and related to marketing and outreach with respect to qualified health plans offered through ,exchanges under title ,i of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjja et seq474 #aaj4 ,report on effects of website maintenance during open enrollment ,not later than #a year after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report examining whether the ,department of ,health and ,human ,services has been conducting maintenance on the website commonly referred to as ,healthcare4gov during annual open enrollment periods 7as described in section #acaa7;c77#f77;,b7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjca7;c77#f77;,b77 in such a manner so as to minimize any disruption to the use of such website resulting from such maintenance4 #aaa4 ,promoting consumer outreach and education 7a7 ,in general ,section #acaa7;i7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjca7;i77 is amended-- 7#a7 in paragraph 7#b71 by adding at the end the following new subparagraph3 7,c7 ,selection of recipients ,in the case of an ,exchange established and operated by the ,secretary within a ,state pursuant to section #acba7;c71 in awarding grants under paragraph 7#a71 the ,exchange shall-- 7i7 select entities to receive such grants based on an entity's demonstrated capacity to carry out each of the duties specified in paragraph 7#c72 7ii7 not take into account whether or not the entity has demonstrated how the entity will provide information to individuals relating to group health plans offered by a group or association of employers described in section #beaj4c-e7;b7 of title #bi1 ,code of ,federal ,regulations 7or any successor regulation71 or short-term limited duration insurance 7as defined by the ,secretary for purposes of section #bgia7;b77#e7 of the ,public ,health ,service ,act72 and 7iii7 ensure that1 each year1 the ,exchange awards such a grant to-- 7,i7 at least one entity described in this paragraph that is a community and consumer-focused nonprofit group2 and 7,,ii7 at least one entity described in subparagraph 7,b71 which may include another community and consumer-focused nonprofit group in addition to any such group awarded a grant pursuant to subclause 7,i74 ,in awarding such grants1 an ,exchange may consider an entity's record with respect to waste1 fraud1 and abuse for purposes of maintaining the integrity of such ,exchange4 2 7#b7 in paragraph 7#c7-- 7,a7 by amending subparagraph 7,c7 to read as follows3 7,c7 facilitate enrollment1 including with respect to individuals with limited ,english proficiency and individuals with chronic illnesses1 in qualified health plans1 ,state medicaid plans under title ,,xix of the ,social ,security ,act1 and ,state child health plans under title ,,xxi of such ,act2 2 7,b7 in subparagraph 7,d71 by striking and at the end2 7,c7 in subparagraph 7,e71 by striking the period at the end and inserting 2 and2 7,d7 by inserting after subparagraph 7,e7 the following new subparagraph3 7,f7 provide referrals to community-based organizations that address social needs related to health outcomes4 2 and 7,e7 by adding at the end the following flush left sentence3 ,the duties specified in the preceding sentence may be carried out by such a navigator at any time during a year4 2 7#c7 in paragraph 7#d77;,a7-- 7,a7 in the matter preceding clause 7i71 by striking not2 7,b7 in clause 7i7-- 7i7 by inserting not before be2 and 7ii7 by striking 2 or and inserting a semicolon2 7,c7 in clause 7ii7-- 7i7 by inserting not before receive2 and 7ii7 by striking the period and inserting a semicolon2 and 7,d7 by adding at the end the following new clauses3 7iii7 maintain physical presence in the ,state of the ,exchange so as to allow in-person assistance to consumers2 and 7iv7 receive opioid specific education and training that ensures the navigator can best educate individuals on qualified health plans offered through an ,exchange1 specifically coverage under such plans for opioid health care treatment4 2 and 7#d7 in paragraph 7#f7-- 7,a7 by striking ,funding4--,grants under and inserting ,funding4-- 7,a7 ,state ,exchanges ,grants under 2 and 7,b7 by adding at the end the following new subparagraph3 7,b7 ,federal ,exchanges ,for purposes of carrying out this subsection1 with respect to an ,exchange established and operated by the ,secretary within a ,state pursuant to section #acba7;c71 the ,secretary shall obligate #ajj1jjj1jjj out of amounts collected through the user fees on participating health insurance issuers pursuant to section #aef4ej of title #de1 ,code of ,federal ,regulations 7or any successor regulations71 for fiscal year #bjbb and each subsequent fiscal year4 ,such amount for a fiscal year shall remain available until expended4 4 7b7 ,effective date ,the amendments made by this section shall apply with respect to plan years beginning on or after ,january #a1 #bjba4 #aab4 ,improving transparency and accountability in the ,marketplace 7a7 ,open enrollment reports ,for plan year #bjba and each subsequent year1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 in coordination with the ,secretary of the ,treasury and the ,secretary of ,labor1 shall issue biweekly public reports during the annual open enrollment period on the performance of the federally facilitated ,exchange operated pursuant to section #acba7;c7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjda7;c774 ,each such report shall include a summary1 including information on a ,state-by-,state basis where available1 of-- 7#a7 the number of unique website visits2 7#b7 the number of individuals who create an account2 7#c7 the number of calls to the call center2 7#d7 the average wait time for callers contacting the call center2 7#e7 the number of individuals who enroll in a qualified health plan2 and 7#f7 the percentage of individuals who enroll in a qualified health plan through each of-- 7,a7 the website2 7,b7 the call center2 7,c7 navigators2 7,d7 agents and brokers2 7,e7 the enrollment assistant program2 7,f7 directly from issuers or web brokers2 and 7,g7 other means4 7b7 ,open ,enrollment ,after ,action ,report ,for plan year #bjba and each subsequent year1 the ,secretary1 in coordination with the ,secretary of the ,treasury and the ,secretary of ,labor1 shall publish an after action report not later than #c months after the completion of the annual open enrollment period regarding the performance of the ,exchange described in subsection 7a7 for the applicable plan year4 ,each such report shall include a summary1 including information on a ,state-by-,state basis where available1 of-- 7#a7 the open enrollment data reported under subsection 7a7 for the entirety of the enrollment period2 and 7#b7 activities related to patient navigators described in section #acaa7;i7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjca7;i771 including-- 7,a7 the performance objectives established by the ,secretary for such patient navigators2 7,b7 the number of consumers enrolled by such a patient navigator2 7,c7 an assessment of how such patient navigators have met established performance metrics1 including a detailed list of all patient navigators1 funding received by patient navigators1 and whether established performance objectives of patient navigators were met2 and 7,d7 with respect to the performance objectives described in subparagraph 7,a7-- 7i7 whether such objectives assess the full scope of patient navigator responsibilities1 including general education1 plan selection1 and determination of eligibility for tax credits1 cost-sharing reductions1 or other coverage2 7ii7 how the ,secretary worked with patient navigators to establish such objectives2 and 7iii7 how the ,secretary adjusted such objectives for case complexity and other contextual factors4 7c7 ,report on advertising and consumer outreach ,not later than #c months after the completion of the annual open enrollment period for plan year #bjba1 the ,secretary shall issue a report on advertising and outreach to consumers for the open enrollment period for plan year #bjba4 ,such report shall include a description of-- 7#a7 the division of spending on individual advertising platforms1 including television and radio advertisements and digital media1 to raise consumer awareness of open enrollment2 7#b7 the division of spending on individual outreach platforms1 including email and text messages1 to raise consumer awareness of open enrollment2 and 7#c7 whether the ,secretary conducted targeted outreach to specific demographic groups and geographic areas4 7b7 ,promoting transparency and accountability in the administration's expenditures of exchange user fees ,for plan year #bjba and each subsequent plan year1 not later than the date that is #c months after the end of such plan year1 the ,secretary of ,health and ,human ,services shall submit to the appropriate committees of ,congress and make available to the public an annual report on the expenditures by the ,department of ,health and ,human ,services of user fees collected pursuant to section #aef4ej of title #de1 ,code of ,federal ,regulations 7or any successor regulations74 ,each such report for a plan year shall include a detailed accounting of the amount of such user fees collected during such plan year and of the amount of such expenditures used during such plan year for the federally facilitated ,exchange operated pursuant to section #acba7;c7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjda7;c77 on outreach and enrollment activities1 navigators1 maintenance of ,healthcare4gov1 and operation of call centers4 #aac4 ,improving awareness of health coverage options 7a7 ,in general ,not later than #ij days after the date of the enactment of this ,act1 the ,secretary of ,labor1 in consultation with the ,secretary of ,health and ,human ,services1 shall update1 and make publicly available in a prominent location on the website of the ,department of ,labor1 the model ,consolidated ,omnibus ,budget ,reconciliation ,act of #aihe 7referred to in this section as ,,cobra7 continuation coverage general notice and the model ,,cobra continuation coverage election notice developed by the ,secretary of ,labor for purposes of facilitating compliance of group health plans with the notification requirements under section #fjf of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aaff74 ,in updating each such notice1 the ,secretary of ,labor shall include information regarding any ,exchange established under title ,i of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjja et seq47 through which a qualified beneficiary may be eligible to enroll in a qualified health plan1 including-- 7#a7 the publicly accessible ,internet website address for such ,exchange2 7#b7 the publicly accessible ,internet website address for the ,find ,local ,help directory maintained by the ,department of ,health and ,human ,services on the healthcare4gov ,internet website 7or a successor website72 7#c7 a clear explanation that-- 7,a7 an individual who is eligible for continuation coverage may also be eligible to enroll1 with financial assistance1 in a qualified health plan offered through such ,exchange1 but1 in the case that such individual elects to enroll in such continuation coverage and subsequently elects to terminate such continuation coverage before the period of such continuation coverage expires1 such individual will not be eligible to enroll in a qualified health plan offered through such ,exchange during a special enrollment period2 and 7,b7 an individual who elects to enroll in continuation coverage will remain eligible to enroll in a qualified health plan offered through such ,exchange during an open enrollment period and may be eligible for financial assistance with respect to enrolling in such a qualified health plan2 7#d7 information on consumer protections with respect to enrolling in a qualified health plan offered through such ,exchange1 including the requirement for such a qualified health plan to provide coverage for essential health benefits 7as defined in section #acjb7;b7 of such ,act 7#db ,u4,s4,c4 #ahjbb7;b77 and the requirements applicable to such a qualified health plan under part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg et seq472 and 7#e7 information on the availability of financial assistance with respect to enrolling in a qualified health plan1 including the maximum income limit for eligibility for a premium tax credit under section #cf;,b of the ,internal ,revenue ,code of #aihf4 7b7 ,name of notices ,in addition to updating the model ,,cobra continuation coverage general notice and the model ,,cobra continuation coverage election notice under paragraph 7#a71 the ,secretary of ,labor shall rename each such notice as the model ,,cobra continuation coverage and ,affordable ,care ,act coverage general notice and the model ,,cobra continuation coverage and ,affordable ,care ,act coverage election notice1 respectively4 7c7 ,consumer testing ,prior to making publicly available the model ,,cobra continuation coverage general notice and the model ,,cobra continuation coverage election notice updated under paragraph 7#a71 the ,secretary of ,labor shall provide an opportunity for consumer testing of each such notice1 as so updated1 to ensure that each such notice is clear and understandable to the average participant or beneficiary of a group health plan4 7d7 ,definitions ,in this subsection3 7#a7 ,continuation coverage ,the term continuation coverage1 with respect to a group health plan1 has the meaning given such term in section #fjb of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aafb74 7#b7 ,group health plan ,the term group health plan has the meaning given such term in section #fjg of such ,act 7#bi ,u4,s4,c4 #aafg74 7#c7 ,qualified beneficiary ,the term qualified beneficiary has the meaning given such term in such section #fjg4 7#d7 ,qualified health plan ,the term qualified health plan has the meaning given such term in section #acja of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjba74 #aad4 ,promoting ,state innovations to expand coverage 7a7 ,in general ,subject to subsection 7d71 the ,secretary of ,health and ,human ,services shall award grants to eligible ,state agencies to enable such ,states to explore innovative solutions to promote greater enrollment in health insurance coverage in the individual and small group markets1 including activities described in subsection 7c74 7b7 ,eligibility ,for purposes of subsection 7a71 eligible ,state agencies are ,exchanges established by a ,state under title ,i of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjja et seq47 and ,state agencies with primary responsibility over health and human services for the ,state involved4 7c7 ,use of funds ,for purposes of subsection 7a71 the activities described in this subsection are the following3 7#a7 ,state efforts to streamline health insurance enrollment procedures in order to reduce burdens on consumers and facilitate greater enrollment in health insurance coverage in the individual and small group markets1 including automatic enrollment and reenrollment of1 or pre-populated applications for1 individuals without health insurance who are eligible for tax credits under section #cf;,b of the ,internal ,revenue ,code of #aihf1 with the ability to opt out of such enrollment4 7#b7 ,state investment in technology to improve data sharing and collection for the purposes of facilitating greater enrollment in health insurance coverage in such markets4 7#c7 ,implementation of a ,state version of an individual mandate to be enrolled in health insurance coverage4 7#d7 ,feasibility studies to develop comprehensive and coherent ,state plan for increasing enrollment in the individual and small group market4 7d7 ,funding ,for purposes of carrying out this section1 there is hereby appropriated1 out of any funds in the ,treasury not otherwise appropriated1 #bjj1jjj1jjj for each of the fiscal years #bjbb through #bjbd4 ,such amount shall remain available until expended4 #aae4 ,strengthening network adequacy 7a7 ,in general ,section #acaa7;d7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjca7;d77 is amended by adding at the end the following new paragraph3 7#h7 ,network adequacy standards 7,a7 ,certain ,exchanges ,in the case of an ,exchange operated by the ,secretary pursuant section #acba7;c77#a7 or an ,exchange described in section #aee4bjj7;f7 of title #db1 ,code of ,federal ,regulations 7or a successor regulation71 the ,exchange shall require each qualified health plan offered through such ,exchange to meet such quantitative network adequacy standards as the ,secretary may prescribe for purposes of this subparagraph4 7,b7 ,state ,exchanges ,in the case of an ,exchange not described in subparagraph 7,a71 the ,exchange shall establish quantitative network adequacy standards with respect to qualified health plans offered through such ,exchange and require such plans to meet such standards4 4 7b7 ,effective date ,the amendment made by this section shall apply with respect to plan years beginning on or after ,january #a1 #bjbb4 #aaf4 ,protecting consumers from unreasonable rate hikes 7a7 ,protection from excessive1 unjustified1 or unfairly discriminatory rates ,the first section #bgid of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#id71 as added by section #ajjc of the ,patient ,protection and ,affordable ,care ,act 7,public ,law #aaa-adh71 is amended by adding at the end the following new subsection3 7e7 ,protection from excessive1 unjustified1 or unfairly discriminatory rates 7#a7 ,authority of ,states ,nothing in this section shall be construed to prohibit a ,state from imposing requirements 7including requirements relating to rate review standards and procedures and information reporting7 on health insurance issuers with respect to rates that are in addition to the requirements of this section and are more protective of consumers than such requirements4 7#b7 ,consultation in rate review process ,in carrying out this section1 the ,secretary shall consult with the ,national ,association of ,insurance ,commissioners and consumer groups4 7#c7 ,determination of who conducts reviews for each ,state ,the ,secretary shall determine1 after the date of enactment of this section and periodically thereafter1 the following3 7,a7 ,in which markets in each ,state the ,state insurance commissioner or relevant ,state regulator shall undertake the corrective actions under paragraph 7#d71 based on the ,secretary's determination that the ,state regulator is adequately undertaking and utilizing such actions in that market4 7,b7 ,in which markets in each ,state the ,secretary shall undertake the corrective actions under paragraph 7#d71 in cooperation with the relevant ,state insurance commissioner or ,state regulator1 based on the ,secretary's determination that the ,state is not adequately undertaking and utilizing such actions in that market4 7#d7 ,corrective action for excessive1 unjustified1 or unfairly discriminatory rates ,in accordance with the process established under this section1 the ,secretary or the relevant ,state insurance commissioner or ,state regulator shall take corrective actions to ensure that any excessive1 unjustified1 or unfairly discriminatory rates are corrected prior to implementation1 or as soon as possible thereafter1 through mechanisms such as-- 7,a7 denying rates2 7,b7 modifying rates2 or 7,c7 requiring rebates to consumers4 7#e7 ,noncompliance ,failure to comply with any corrective action taken by the ,secretary under this subsection may result in the application of civil monetary penalties under section #bgbc and1 if the ,secretary determines appropriate1 make the plan involved ineligible for classification as a qualified health plan4 4 7b7 ,clarification of ,regulatory ,authority ,such section is further amended-- 7#a7 in subsection 7a7-- 7,a7 in the heading1 by striking premium and inserting rate2 7,b7 in paragraph 7#a71 by striking unreasonable increases in premiums and inserting potentially excessive1 unjustified1 or unfairly discriminatory rates1 including premiums12 and 7,c7 in paragraph 7#b7-- 7i7 by striking an unreasonable premium increase and inserting a potentially excessive1 unjustified1 or unfairly discriminatory rate2 7ii7 by striking the increase and inserting the rate2 and 7iii7 by striking such increases and inserting such rates2 and 7#b7 in subsection 7b7-- 7,a7 by striking premium increases each place it appears and inserting rates2 and 7,b7 in paragraph 7#b77;,b71 by striking premium and inserting rate4 7c7 ,conforming amendments ,title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg et seq47 is amended-- 7#a7 in section #bgbc 7#db ,u4,s4,c4 #cjj;gg-#bb71 as redesignated by the ,patient ,protection and ,affordable ,care ,act-- 7,a7 in subsection 7a7-- 7i7 in paragraph 7#a71 by inserting and section #bgid after this part2 and 7ii7 in paragraph 7#b71 by inserting or section #bgid after this part2 and 7,b7 in subsection 7b7-- 7i7 in paragraph 7#a71 by inserting and section #bgid after this part2 and 7ii7 in paragraph 7#b7-- 7,i7 in subparagraph 7,a71 by inserting or section #bgid that is after this part2 and 7,,ii7 in subparagraph 7,c77ii71 by inserting or section #bgid after this part2 and 7#b7 in section #bgfa 7#db ,u4,s4,c4 #cjj;gg-#fa7-- 7,a7 in subsection 7a7-- 7i7 in paragraph 7#a71 by inserting and section #bgid after this part2 and 7ii7 in paragraph 7#b7-- 7,i7 by inserting or section #bgid after set forth in this part2 and 7,,ii7 by inserting and section #bgid after the requirements of this part2 and 7,b7 in subsection 7b7-- 7i7 by inserting and section #bgid after this part2 and 7ii7 by inserting and section #bgid after part ,a4 7d7 ,applicability to grandfathered plans ,section #abea7;a77#d77;,a7 of the ,patient ,protection and ,affordable ,care ,act 7,public ,law #aaa-adh71 as added by section #bcja of the ,health ,care and ,education ,reconciliation ,act of #bjaj 7,public ,law #aaa-aeb71 is amended by adding at the end the following3 7v7 ,section #bgid 7relating to reasonableness of rates with respect to health insurance coverage74 4 7e7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this ,act such sums as may be necessary4 7f7 ,effective date ,the amendments made by this section shall take effect on the date of enactment of this ,act and shall be implemented with respect to health plans beginning not later than ,january #a1 #bjbb4 #aag4 ,eligibility of ,,daca recipients for qualified health plans offered through ,exchanges 7a7 ,in general ,section #acab7;f77#c7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjcb7;f77#c77 is amended-- 7#a7 by striking or an alien lawfully present in the ,united ,states and inserting 1 an alien lawfully present in the ,united ,states1 or a ,,daca recipient2 and 7#b7 by adding at the end the following3 ,for purposes of the previous sentence1 the term ,,daca recipient means an individual who was granted deferred action pursuant to the ,deferred ,action for ,childhood ,arrivals ,program announced in the memorandum of the ,secretary of ,homeland ,security dated ,june #ae1 #bjab1 and for whom such grant remains valid44 7b7 ,application of reduced cost-,sharing ,section #adjb7;e77#b7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjga7;e77#b77 is amended by adding at the end the following3 ,a ,,daca recipient 7as defined in section #acab7;f77#c77 shall be treated as lawfully present for purposes of this section44 7c7 ,eligibility for advance payments ,section #adab7;d7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjhb7;d77 is amended by adding at the end the following3 ,for purposes of the previous sentence1 a ,,daca recipient 7as defined in section #acab7;f77#c77 shall be treated as lawfully present in the ,united ,states44 7d7 ,verification of eligibility ,section #adaa7;c77#b77;,b7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjha7;c77#b77;,b77 is amended-- 7#a7 in clause 7i77,i71 by inserting or a ,,daca recipient 7as defined in section #acab7;f77#c77 after an alien lawfully present in the ,united ,states2 and 7#b7 in clause 7ii71 by inserting or a ,,daca recipient 7as defined in section #acab7;f77#c77 after an alien lawfully present in the ,united ,states4 7e7 ,application of tax credit for coverage under a qualified health plan ,section #cf;,b7e77#b7 of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following3 ,a ,,daca recipient 7as defined in section #acab7;f77#c7 of the ,patient ,protection and ,affordable ,care ,act7 shall be treated as lawfully present for purposes of this section44 7f7 ,effective date ,the amendments made by this section shall take effect on ,january #a1 #bjba4 ,,ii ,encouraging ,medicaid ,expansion and ,strengthening the ,medicaid ,program #bja4 ,incentivizing ,medicaid expansion 7a7 ,in general ,section #aije7y77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7y77#a77 is amended-- 7#a7 in subparagraph 7,a71 by striking #bjad1 #bjae1 and #bjaf and inserting each of the first #c consecutive #ab-month periods in which the ,state provides medical assistance to newly eligible individuals2 7#b7 in subparagraph 7,b71 by striking #bjag and inserting the fourth consecutive #ab-month period in which the ,state provides medical assistance to newly eligible individuals2 7#c7 in subparagraph 7,c71 by striking #bjah and inserting the fifth consecutive #ab-month period in which the ,state provides medical assistance to newly eligible individuals2 7#d7 in subparagraph 7,d71 by striking #bjai and inserting the sixth consecutive #ab-month period in which the ,state provides medical assistance to newly eligible individuals2 and 7#e7 in subparagraph 7,e71 by striking #bjbj and each year thereafter and inserting the seventh consecutive #ab-month period in which the ,state provides medical assistance to newly eligible individuals and each such period thereafter4 7b7 ,effective date ,beginning on ,january #a1 #bjbb1 the amendments made by subsection 7a7 shall take effect as if included in the enactment of the ,patient ,protection and ,affordable ,care ,act 7,public ,law #aaa-adh74 #bjb4 ,providing #ab-months of continuous eligibility for ,medicaid and ,,chip 7a7 ,requirement of #ab-,month continuous enrollment under ,medicaid ,section #aijb7;e77#ab7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7e77#ab77 is amended to read as follows3 7#ab7 #ab-month continuous enrollment ,notwithstanding any other provision of this title1 a ,state plan approved under this title 7or under any waiver of such plan approved pursuant to section #aaae or section #aiae71 shall provide that an individual who is determined to be eligible for benefits under such plan 7or waiver7 shall remain eligible and enrolled for such benefits through the end of the month in which the #ab-month period 7beginning on the date of determination of eligibility7 ends4 4 7b7 ,requirement of #ab-,month continuous enrollment under ,,chip 7#a7 ,in general ,section #bajb7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;bb7b77 is amended by adding at the end the following new paragraph3 7#f7 ,requirement for #ab-month continuous enrollment ,notwithstanding any other provision of this title1 a ,state child health plan that provides child health assistance under this title through a means other than described in section #baja7;a77#b71 shall provide that an individual who is determined to be eligible for benefits under such plan shall remain eligible and enrolled for such benefits through the end of the month in which the #ab-month period 7beginning on the date of determination of eligibility7 ends4 4 7#b7 ,conforming amendment ,section #baje7;a77#d77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;ee7a77#d77;,a77 is amended-- 7,a7 by striking has elected the option of and inserting is in compliance with the requirement for2 and 7,b7 by striking applying such policy under its ,state child health plan under this title and inserting in compliance with section #bajb7;b74 7c7 ,effective date 7#a7 ,in general ,except as provided in paragraph 7#b7 or 7#c71 the amendments made by subsections 7a7 and 7b7 shall apply to determinations 7and redeterminations7 of eligibility made on or after the date that is #ab months after the last day of the emergency period described in section #aace7;g77#a77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#e7;g77#a77;,b774 7#b7 ,extension of effective date for ,state law amendment ,in the case of a ,state plan under title ,,xix or ,state child health plan under title ,,xxi of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq42 #db ,u4,s4,c4 #acig;aa et seq47 which the ,secretary of ,health and ,human ,services determines requires ,state legislation 7other than legislation appropriating funds7 in order for the respective plan to meet the additional requirement imposed by the amendment made by subsection 7a7 or 7b71 respectively1 the respective plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such applicable additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the ,state legislature that begins after the date of enactment of this ,act4 ,for purposes of the previous sentence1 in the case of a ,state that has a #b-year legislative session1 each year of the session is considered to be a separate regular session of the ,state legislature4 7#c7 ,option to implement #ab-month continuous eligibility prior to effective date ,a ,state may elect through a ,state plan amendment under title ,,xix or ,,xxi of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq42 #db ,u4,s4,c4 #acig;aa et seq47 to apply the amendment made by subsection 7a7 or 7b71 respectively1 on any date prior to the date specified in paragraph 7#a71 but not sooner than the date of the enactment of this ,act4 #bjc4 ,mandatory #ab-months of postpartum ,medicaid eligibility 7a7 ,extending continuous ,medicaid and ,,chip coverage for pregnant and postpartum women 7#a7 ,medicaid ,title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 is amended-- 7,a7 in section #aijb7l77#a77;,a71 by striking #fj-;day period and inserting #cfe-;day period2 7,b7 in section #aijb7;e77#f71 by striking #fj-;day period and inserting #cfe-;day period2 7,c7 in section #aijc7v77#d77;,a77i71 by striking #fj-;day period and inserting #cfe-;day period2 and 7,d7 in section #aije7;a71 in the #dth sentence in the matter following paragraph 7#cj71 by striking #fj-;day period and inserting #cfe-;day period4 7#b7 ,,chip ,section #baab of the ,social ,security ,act 7#db ,u4,s4,c4 #acigll7 is amended by striking #fj-;day period each place it appears and inserting #cfe-;day period4 7b7 ,requiring full benefits for pregnant and postpartum women 7#a7 ,medicaid 7,a7 ,in general ,paragraph 7#e7 of section #aijb7;e7 of the ,social ,security ,act 7#bd ,u4,s4,c4 #acif;a7e77 is amended to read as follows3 7#e7 ,any woman who is eligible for medical assistance under the ,state plan or a waiver of such plan and who is1 or who while so eligible becomes1 pregnant1 shall continue to be eligible under the plan or waiver for medical assistance through the end of the month in which the #cfe-;day period 7beginning on the last day of her pregnancy7 ends1 regardless of the basis for the woman's eligibility for medical assistance1 including if the woman's eligibility for medical assistance is on the basis of being pregnant4 4 7,b7 ,conforming amendment ,section #aijb7;a77#aj7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77 is amended in the matter following subparagraph 7,g7 by striking 7,,vii7 the medical assistance and all that follows through complicate pregnancy14 7#b7 ,,chip ,section #bajg7;e77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;gg7e77#a77 is amended-- 7,a7 by redesignating subparagraphs 7,h7 through 7,s7 as subparagraphs 7,i7 through 7,t71 respectively2 and 7,b7 by inserting after subparagraph 7,g71 the following3 7,h7 ,section #aijb7;e77#e7 7requiring #cfe-;day continuous coverage for pregnant and postpartum women74 4 7c7 ,maintenance of effort 7#a7 ,medicaid ,section #aijb of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7 is amended-- 7,a7 in paragraph 7#gd71 by striking subsection 7gg72 and and inserting subsections 7gg7 and 7qq722 and 7,b7 by adding at the end the following new subsection3 7qq7 ,maintenance of effort related to low-,income pregnant women ,for calendar quarters beginning on or after the effective date described in section #bjc7;d7 of the ,patient ,protection and ,affordable ,care ,enhancement ,act1 and before ,january #a1 #bjbc1 no ,federal payment shall be made to a ,state under section #aijc7;a7 for amounts expended under a ,state plan under this title or a waiver of such plan if the ,state-- 7#a7 has in effect under such plan eligibility standards1 methodologies1 or procedures for individuals described in subsection 7l77#a7 who are eligible for medical assistance under the ,state plan or waiver under subsection 7a77#aj77;,a77ii77,,ix7 that are more restrictive than the eligibility standards1 methodologies1 or procedures1 respectively1 for such individuals under such plan or waiver that are in effect on the date of the enactment of this subsection2 or 7#b7 provides medical assistance to individuals described in subsection 7l77#a7 who are eligible for medical assistance under such plan or waiver under subsection 7a77#aj77;,a77ii77,,ix7 at a level that is less than the level at which the ,state provides such assistance to such individuals under such plan or waiver on the date of the enactment of this subsection4 4 7#b7 ,,chip ,section #baab of the ,social ,security ,act 7#db ,u4,s4,c4 #acigll71 as amended by subsection 7b71 is further amended by adding at the end the following subsection3 7g7 ,maintenance of effort ,for calendar quarters beginning on or after the effective date described in section #bjc7;d7 of the ,patient ,protection and ,affordable ,care ,enhancement ,act1 and before ,january #a1 #bjbc1 no payment may be made under section #baje7;a7 with respect to a ,state child health plan if the ,state-- 7#a7 has in effect under such plan eligibility standards1 methodologies1 or procedures for targeted low-income pregnant women that are more restrictive than the eligibility standards1 methodologies1 or procedures1 respectively1 under such plan that are in effect on the date of the enactment of this subsection2 or 7#b7 provides pregnancy-related assistance to targeted low-income pregnant women under such plan at a level that is less than the level at which the ,state provides such assistance to such women under such plan on the date of the enactment of this subsection4 4 7d7 ,effective date 7#a7 ,in general ,except as provided under paragraph 7#b71 the amendments made by subsections 7a7 and 7b7 shall take effect on 7and the effective date described in this subsection shall be7 the first day of the calendar quarter during which the last day of the emergency period described in section #aace7;g77#a77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#e7;g77#a77;,b77 occurs4 7#b7 ,extension of effective date for ,state law amendment ,in the case of a ,state plan under title ,,xix or ,state child health plan under title ,,xxi of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq42 #db ,u4,s4,c4 #acig;aa et seq47 which the ,secretary of ,health and ,human ,services determines requires ,state legislation 7other than legislation appropriating funds7 in order for the respective plan to meet the additional requirement imposed by the amendments made by subsection 7a7 or 7b71 respectively1 the respective plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such applicable additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the ,state legislature that begins after the date of enactment of this ,act4 ,for purposes of the previous sentence1 in the case of a ,state that has a #b-year legislative session1 each year of the session is considered to be a separate regular session of the ,state legislature4 #bjd4 ,reducing the administrative ,,fmap for nonexpansion ,states ,section #aijc of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7 is amended-- 7#a7 in subsection 7a77#g71 by inserting subsection 7bb7 and before section #aiai7;g77#c77;,b72 and 7#b7 by adding at the end the following new subsection3 7bb7 ,reduction of ,federal payments for certain administrative costs of nonexpansion ,states 7#a7 ,in general ,in the case of a ,state that does not provide under the ,state plan of such ,state 7or waiver of such plan7 for making medical assistance available in accordance with section #aijb7k77#a7 to all individuals described in section #aijb7;a77#aj77;i77,,viii7 for a calendar quarter beginning on or after ,october #a1 #bjbb1 the ,secretary may reduce the percentage specified in subsection 7a77#g7 for amounts described in such subsection expended during such quarter by such ,state by the number of percentage points specified in paragraph 7#b7 for such quarter4 7#b7 ,amount of reduction ,for purposes of paragraph 7#a71 the number of percentage points specified in this paragraph for a calendar quarter is the following3 7,a7 ,for the calendar quarter beginning on ,october #a1 #bjbb1 #j4e4 7,b7 ,for a calendar quarter beginning on or after ,january #a1 #bjbc1 and ending before ,july #a1 #bjbg1 the number of percentage points specified under this paragraph for the previous quarter1 plus #j4e4 7,c7 ,for a calendar quarter beginning on or after ,july #a1 #bjbg1 #aj4 7#c7 ,definition ,for purposes of this subsection1 the term ,state means a ,state that is one of the #ej ,states or the ,district of ,columbia4 4 #bje4 ,enhanced reporting requirements for nonexpansion states ,section #aijc of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b71 as amended by section #bjd1 is further amended-- 7#a7 in subsection 7a77#g71 by striking subsection 7bb7 and inserting subsections 7bb7 and 7cc72 and 7#b7 by adding at the end the following new subsection3 7cc7 ,reduction of ,federal payments for certain administrative costs of nonexpansion ,states that do not satisfy reporting requirements 7#a7 ,in general 7,a7 ,reduction ,in the case of a nonexpansion ,state1 with respect to a fiscal year 7beginning with fiscal year #bjbc7 that does not satisfy the reporting requirement under paragraph 7#b7 for such fiscal year1 the percentage specified in subsection 7a77#g7 for amounts described in such subsection expended by such ,state during a calendar quarter described in paragraph 7#d7 with respect to such fiscal year1 subject to subparagraph 7,b71 shall be reduced by the number of percentage points specified in paragraph 7#d7 for the respective calendar quarter4 7,b7 ,exception ,in the case of a nonexpansion ,state that is subject to a reduction under subparagraph 7,a7 for the calendar quarter described in paragraph 7#d77;,a7 with respect to a fiscal year1 if the ,state satisfies the criteria described in subparagraphs 7,a71 7,b71 and 7,c7 of paragraph 7#b7 7without regard to the dates specified in such subparagraph 7,a7 and 7,c77 before the beginning of a subsequent calendar quarter described in paragraph 7#d7 with respect to such fiscal year1 then such ,state shall not be subject to a reduction under subparagraph 7,a7 for such subsequent calendar quarter4 7#b7 ,reporting requirement ,for purposes of paragraph 7#a71 a nonexpansion ,state satisfies the reporting requirement under this paragraph for a fiscal year1 if the nonexpansion ,state-- 7,a7 by not later than ,january #a of such year1 posts on the public website of the ,state agency administering the ,state plan1 the information described in paragraph 7#c7 with respect to such ,state for the previous year2 7,b7 provides for at least a #cj-;day period for notice and comment on such information2 and 7,c7 by not later than ,march #a of such year1 submits to the ,secretary a complete report including such information1 comments submitted pursuant to subparagraph 7,b71 and a response by the ,state to each such comment4 7#c7 ,information described ,the information described in this paragraph1 with respect to a ,state and year1 is the following3 7,a7 ,the the estimated number of individuals who were uninsured for at least #f months1 shown by age-groups of #j to #ah years of age and of #ai years of age to #fd years of age1 as well as a detailed description of the basis for the estimates4 7,b7 ,the estimated number of the individuals estimated under subparagraph 7,a7 in the ,state who would be eligible for medical assistance under the ,state plan if the ,state were to make medical assistance under the ,state plan available in accordance with section #aijb7k77#a7 to all individuals described in section #aijb7;a77#aj77;i77,,viii71 and a detailed description of the basis for the estimates4 7,c7 ,a comprehensive listing of ,state income eligibility criteria for all mandatory and optional ,medicaid eligibility groups for which the ,state plan provides medical assistance 7other than with respect to individuals described in clause 7i77,,ii71 7ii77,,vi71 or 7ii77,,xxii7 of section #aijb7;a77#aj77;,a774 7,d7 ,the total amount of hospital uncompensated-care costs and a breakdown of the source of such costs1 as well as a breakdown for rural and non-rural hospitals4 7#d7 ,percentage described ,for purposes of paragraph 7#a71 a calendar quarter described in this paragraph1 with respect to a fiscal year1 and the percentage points described in this paragraph for such quarter1 with respect to a ,state1 are-- 7,a7 for the calendar quarter beginning on the ,april #a occurring during such fiscal year1 #j4e percentage points2 7,b7 for the calendar quarter beginning on the ,july #a occurring during such fiscal year1 #a4j percentage point2 and 7,c7 for the calendar quarter beginning on the ,october #a occurring during the subsequent fiscal year1 #a4e percentage points4 7#e7 ,payment in case of reporting ,state ,the expenses incurred by a non-expansion ,state1 with respect to any calendar quarter with respect to a fiscal year 7beginning with #bjba71 for carrying out subparagraphs 7,a7 through 7,c7 of paragraph 7#b7 shall1 for purposes of section #aijc7;a77#g71 be considered to be expenses necessary for the proper and efficient administration of the ,state plan under this title4 7#f7 ,nonexpanion ,state defined ,for purposes of this subsection1 the term nonexpansion ,state means1 with respect to a fiscal year1 a ,state that as of the first quarter of such fiscal year does not provide under the ,state plan of such ,state 7or waiver of such plan7 for making medical assistance available in accordance with section #aijb7k77#a7 to all individuals described in section #aijb7;a77#aj77;i77,,viii74 4 #bjf4 ,primary care pay increase 7a7 ,renewal of payment floor2 additional providers 7#a7 ,in general ,section #aijb7;a77#ac7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#ac77 is amended by striking subparagraph 7,c7 and inserting the following3 7,c7 payment for primary care services 7as defined in subsection 7jj77 at a rate that is not less than #ajj percent of the payment rate that applies to such services and physician under part ,b of title ,,xviii 7or1 if greater1 the payment rate that would be applicable under such part if the conversion factor under section #ahdh7;d7 for the year involved were the conversion factor under such section for #bjji71 and that is not less than the rate that would otherwise apply to such services under this title if the rate were determined without regard to this subparagraph1 and that are-- 7i7 furnished during #bjac and #bjad1 by a physician with a primary specialty designation of family medicine1 general internal medicine1 or pediatric medicine2 or 7ii7 furnished during the period that begins on the first day of the first month that begins one year after the date of enactment of the ,patient ,protection and ,affordable ,care ,enhancement ,act and ends ,september #cj1 #bjbd-- 7,i7 by a physician with a primary specialty designation of family medicine1 general internal medicine1 or pediatric medicine1 but only if the physician self-attests that the physician is ,board certified in family medicine1 general internal medicine1 or pediatric medicine2 7,,ii7 by a physician with a primary specialty designation of obstetrics and gynecology1 but only if the physician self-attests that the physician is ,board certified in obstetrics and gynecology2 7,,iii7 by an advanced practice clinician1 as defined by the ,secretary1 that works under the supervision of-- 7aa7 a physician that satisfies the criteria specified in subclause 7,i7 or 7,,ii72 or 7bb7 a nurse practitioner or a physician assistant 7as such terms are defined in section #ahfa7;aa77#e77;,a77 who is working in accordance with ,state law1 or a certified nurse-midwife 7as defined in section #ahfa7;gg77 who is working in accordance with ,state law2 7,,iv7 by a rural health clinic1 ,federally-qualified health center1 or other health clinic that receives reimbursement on a fee schedule applicable to a physician1 a nurse practitioner or a physician assistant 7as such terms are defined in section #ahfa7;aa77#e77;,a77 who is working in accordance with ,state law1 or a certified nurse-midwife 7as defined in section #ahfa7;gg77 who is working in accordance with ,state law1 for services furnished by a physician1 nurse practitioner1 physician assistant1 or certified nurse-midwife1 or services furnished by an advanced practice clinician supervised by a physician described in subclause 7,i77aa7 or 7,,ii77aa71 another advanced practice clinician1 or a certified nurse-midwife2 or 7,v7 by a nurse practitioner or a physician assistant 7as such terms are defined in section #ahfa7;aa77#e77;,a77 who is working in accordance with ,state law1 or a certified nurse-midwife 7as defined in section #ahfa7;gg77 who is working in accordance with ,state law1 in accordance with procedures that ensure that the portion of the payment for such services that the nurse practitioner1 physician assistant1 or certified nurse-midwife is paid is not less than the amount that the nurse practitioner1 physician assistant1 or certified nurse-midwife would be paid if the services were provided under part ,b of title ,,xviii2 4 7#b7 ,conforming amendments ,section #aije7;dd7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7dd77 is amended-- 7,a7 by striking ,notwithstanding and inserting the following3 7#a7 ,in general ,notwithstanding 2 7,b7 by inserting or furnished during the additional period specified in paragraph 7#b71 after #bjae12 and 7,c7 by adding at the end the following3 7#b7 ,additional period ,for purposes of paragraph 7#a71 the additional period specified in this paragraph is the period that begins on the first day of the first month that begins one year after the date of enactment of the ,patient ,protection and ,affordable ,care ,enhancement ,act4 4 7b7 ,improved targeting of primary care ,section #aijb7;jj7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7jj77 is amended-- 7#a7 by redesignating paragraphs 7#a7 and 7#b7 as subparagraphs 7,a7 and 7,b71 respectively and realigning the left margins accordingly2 7#b7 by striking ,for purposes of and inserting the following3 7#a7 ,in general ,for purposes of 2 and 7#c7 by adding at the end the following3 7#b7 ,exclusions ,such term does not include any services described in subparagraph 7,a7 or 7,b7 of paragraph 7#a7 if such services are provided in an emergency department of a hospital4 4 7c7 ,ensuring payment by managed care entities 7#a7 ,in general ,section #aijc7m77#b77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7m77#b77;,a77 is amended-- 7,a7 in clause 7xii71 by striking and after the semicolon2 7,b7 by realigning the left margin of clause 7xiii7 so as to align with the left margin of clause 7xii7 and by striking the period at the end of clause 7xiii7 and inserting 2 and2 and 7,c7 by inserting after clause 7xiii7 the following3 7xiv7 such contract provides that 7,i7 payments to providers specified in section #aijb7;a77#ac77;,c7 for primary care services defined in section #aijb7;jj7 that are furnished during a year or period specified in section #aijb7;a77#ac77;,c7 and section #aije7;dd7 are at least equal to the amounts set forth and required by the ,secretary by regulation1 7,,ii7 the entity shall1 upon request1 provide documentation to the ,state1 sufficient to enable the ,state and the ,secretary to ensure compliance with subclause 7,i71 and 7,,iii7 the ,secretary shall approve payments described in subclause 7,i7 that are furnished through an agreed upon capitation1 partial capitation1 or other value-based payment arrangement if the capitation1 partial capitation1 or other value-based payment arrangement is based on a reasonable methodology and the entity provides documentation to the ,state sufficient to enable the ,state and the ,secretary to ensure compliance with subclause 7,i74 4 7#b7 ,conforming amendment ,section #aicb7;f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#b7;f77 is amended by inserting and clause 7xiv7 of section #aijc7m77#b77;,a7 before the period4 #bjg4 ,permanent funding for ,,chip 7a7 ,in general ,section #bajd7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;dd7a77 is amended-- 7#a7 in paragraph 7#bf71 by inserting at the end and2 7#b7 by amending paragraph 7#bg7 to read as follows3 7#bg7 for each fiscal year beginning with fiscal year #bjbd1 such sums as are necessary to fund allotments to ,states under subsections 7c7 and 7m74 2 and 7#c7 by striking paragraph 7#bh74 7b7 ,in general ,section #bajd7;a77#bh7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;dd7a77#bh77 is amended to read as follows3 7#bh7 for fiscal year #bjbg and each subsequent year1 such sums as are necessary to fund allotments to ,states under subsections 7c7 and 7m74 4 7c7 ,allotments 7#a7 ,in general ,section #bajd7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;dd7m77 is amended-- 7,a7 in paragraph 7#b77;,b77i71 by striking 11 #bjbc1 and #bjbg and inserting and #bjbc2 7,b7 in paragraph 7#g7-- 7i7 in subparagraph 7,a71 by striking and ending with fiscal year #bjbg12 and 7ii7 in the flush left matter at the end1 by striking or fiscal year #bjbf and inserting fiscal year #bjbf1 or a subsequent even-numbered fiscal year2 7,c7 in paragraph 7#i7-- 7i7 by striking 7#aj71 or 7#aa7 and inserting or 7#aj72 and 7ii7 by striking #bjbc1 or #bjbg1 and inserting or #bjbc2 and 7,d7 by striking paragraph 7#aa74 7#b7 ,conforming amendment ,section #ejaja7;b77#b7 of the ,bipartisan ,budget ,act of #bjah 7,public ,law #aae-abc7 is repealed4 #bjh4 ,permanent extension of ,,chip enrollment and quality measures 7a7 ,pediatric quality measures program ,section #aaci;,a7i77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#i;a7i77#a77 is amended-- 7#a7 in subparagraph 7,c71 by striking at the end and2 7#b7 in subparagraph 7,d71 by striking the period at the end and insert a semicolon2 and 7#c7 by adding at the end the following new subparagraphs3 7,e7 for fiscal year #bjbh1 #ae1jjj1jjj for the purpose of carrying out this section 7other than subsections 7e71 7f71 and 7g772 and 7,f7 for a subsequent fiscal year1 the amount appropriated under this paragraph for the previous fiscal year1 increased by the percentage increase in the consumer price index for all urban consumers 7all items2 ,united ,states city average7 over such previous fiscal year1 for the purpose of carrying out this section 7other than subsections 7e71 7f71 and 7g774 4 7b7 ,express lane eligibility option ,section #aijb7;e77#ac7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7e77#ac77 is amended by striking subparagraph 7,i74 7c7 ,assurance of affordability standard for children and families 7#a7 ,in general ,section #baje7;d77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;ee7d77#c77 is amended-- 7,a7 in the paragraph heading1 by striking through ,september #cj1 #bjbg2 and 7,b7 in subparagraph 7,a71 in the matter preceding clause 7i7-- 7i7 by striking ,during the period that begins on the date of enactment of the ,patient ,protection and ,affordable ,care ,act and ends on ,september #cj1 #bjbg and inserting ,beginning on the date of the enactment of the ,patient ,protection and ,affordable ,care ,act2 7ii7 by striking ,during the period that begins on ,october #a1 #bjai1 and ends on ,september #cj1 #bjbg and inserting ,beginning on ,october #a1 #bjai2 and 7iii7 by striking ,the preceding sentences shall not be construed as preventing a ,state during any such periods from and inserting ,the preceding sentences shall not be construed as preventing a ,state from4 7#b7 ,conforming amendments ,section #aijb7;gg77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7gg77#b77 is amended-- 7,a7 in the paragraph heading1 by striking through ,september #cj1 #bjbg2 and 7,b7 by striking through ,september #cj and all that follows through ends on ,september #cj1 #bjbg and inserting 7but beginning on ,october #a1 #bjai14 7d7 ,qualifying states option ,section #baje7;g77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;ee7g77#d77 is amended-- 7#a7 in the paragraph heading1 by striking for fiscal years #bjji through #bjbg and inserting after fiscal year #bjjh2 and 7#b7 in subparagraph 7,a71 by striking for any of fiscal years #bjji through #bjbg and inserting for any fiscal year after fiscal year #bjjh4 7e7 ,outreach and enrollment program ,section #baac of the ,social ,security ,act 7#db ,u4,s4,c4 #acigmm7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#a71 by striking during the period of fiscal years #bjji through #bjbg and inserting 1 beginning with fiscal year #bjji12 7,b7 in paragraph 7#b7-- 7i7 by striking #aj percent of such amounts and inserting #aj percent of such amounts for the period or the fiscal year for which such amounts are appropriated2 and 7ii7 by striking during such period and inserting 1 during such period or such fiscal year12 and 7,c7 in paragraph 7#c71 by striking ,for the period of fiscal years #bjbd through #bjbg1 an amount equal to #aj percent of such amounts and inserting ,beginning with fiscal year #bjbd1 an amount equal to #aj percent of such amounts for the period or the fiscal year for which such amounts are appropriated2 and 7#b7 in subsection 7g7-- 7,a7 by striking #bjag11 and inserting #bjag12 7,b7 by striking and #dh1jjj1jjj and inserting #dh1jjj1jjj2 and 7,c7 by inserting after through #bjbg the following3 1 #ab1jjj1jjj for fiscal year #bjbh1 and1 for each fiscal year after fiscal year #bjbh1 the amount appropriated under this subsection for the previous fiscal year1 increased by the percentage increase in the consumer price index for all urban consumers 7all items2 ,united ,states city average7 over such previous fiscal year4 7f7 ,child enrollment contingency fund ,section #bajd7n7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;dd7n77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a77ii7-- 7i7 by striking and #bjbd through #bjbf and inserting beginning with fiscal year #bjbd2 and 7ii7 by striking #bjbc1 and #bjbg and inserting 1 and #bjbc2 and 7,b7 in subparagraph 7,b7-- 7i7 by striking #bjbd through #bjbf and inserting beginning with fiscal year #bjbd2 and 7ii7 by striking #bjbc1 and #bjbg and inserting 1 and #bjbc2 and 7#b7 in paragraph 7#c77;,a7-- 7,a7 by striking fiscal years #bjbd through #bjbf and inserting beginning with fiscal year #bjbd2 and 7,b7 by striking #bjbc1 or #bjbg and inserting 1 or #bjbc4 #bji4 ,state option to increase children's eligibility for ,medicaid and ,,chip ,section #baaj7;b77#a77;,b77ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;jj7b77#a77;,b77ii77 is amended-- 7#a7 in subclause 7,,ii71 by striking or at the end2 7#b7 in subclause 7,,iii71 by striking and at the end and inserting or2 and 7#c7 by inserting after subclause 7,,iii7 the following new subclause3 7,,iv7 at the option of the ,state1 whose family income exceeds the maximum income level otherwise established for children under the ,state child health plan as of the date of the enactment of this subclause2 and 4 #baj4 ,medicaid coverage for citizens of ,freely ,associated ,states 7a7 ,in general ,section #djb7;b77#b7 of the ,personal ,responsibility and ,work ,opportunity ,reconciliation ,act of #aiif 7#h ,u4,s4,c4 #afab7;b77#b77 is amended by adding at the end the following new subparagraph3 7,g7 ,medicaid exception for citizens of ,freely ,associated ,states ,with respect to eligibility for benefits for the designated ,federal program defined in paragraph 7#c77;,c7 7relating to the ,medicaid program71 section #dja7;a7 and paragraph 7#a7 shall not apply to any individual who lawfully resides in #a of the #ej ,states or the ,district of ,columbia in accordance with the ,compacts of ,free ,association between the ,government of the ,united ,states and the ,governments of the ,federated ,states of ,micronesia1 the ,republic of the ,marshall ,islands1 and the ,republic of ,palau and shall not apply1 at the option of the ,governor of ,puerto ,rico1 the ,virgin ,islands1 ,guam1 the ,northern ,mariana ,islands1 or ,american ,samoa as communicated to the ,secretary of ,health and ,human ,services in writing1 to any individual who lawfully resides in the respective territory in accordance with such ,compacts4 4 7b7 ,exception to #e-,year limited eligibility ,section #djc7;d7 of such ,act 7#h ,u4,s4,c4 #afac7;d77 is amended-- 7#a7 in paragraph 7#a71 by striking or at the end2 7#b7 in paragraph 7#b71 by striking the period at the end and inserting 2 or2 and 7#c7 by adding at the end the following new paragraph3 7#c7 an individual described in section #djb7;b77#b77;,g71 but only with respect to the designated ,federal program defined in section #djb7;b77#c77;,c74 4 7c7 ,definition of qualified alien ,section #dca7;b7 of such ,act 7#h ,u4,s4,c4 #afda7;b77 is amended-- 7#a7 in paragraph 7#f71 by striking 2 or at the end and inserting a comma2 7#b7 in paragraph 7#g71 by striking the period at the end and inserting 1 or2 and 7#c7 by adding at the end the following new paragraph3 7#h7 an individual who lawfully resides in the ,united ,states in accordance with a ,compact of ,free ,association referred to in section #djb7;b77#b77;,g71 but only with respect to the designated ,federal program defined in section #djb7;b77#c77;,c7 7relating to the ,medicaid program74 4 7d7 ,application to ,state plans ,section #aijb7;a77#aj77;,a77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77;,a77i77 is amended by inserting after subclause 7,,ix7 the following3 7,x7 who are described in section #djb7;b77#b77;,g7 of the ,personal ,responsibility and ,work ,opportunity ,reconciliation ,act of #aiif and eligible for benefits under this title by reason of application of such section2 4 7e7 ,conforming amendments ,section #aajh of the ,social ,security ,act 7#db ,u4,s4,c4 #acjh7 is amended-- 7#a7 in subsection 7f71 in the matter preceding paragraph 7#a71 by striking subsections 7g7 and 7h7 and section #aice7;e77#a77;,b7 and inserting subsections 7g71 7h71 and 7i7 and section #aice7;e77#a77;,b72 and 7#b7 by adding at the end the following3 7i7 ,exclusion of medical assistance expenditures for citizens of ,freely ,associated ,states ,expenditures for medical assistance provided to an individual described in section #dca7;b77#h7 of the ,personal ,responsibility and ,work ,opportunity ,reconciliation ,act of #aiif 7#h ,u4,s4,c4 #afda7;b77#h77 shall not be taken into account for purposes of applying payment limits under subsections 7f7 and 7g74 4 7f7 ,effective date ,the amendments made by this section shall apply to benefits for items and services furnished on or after the date of the enactment of this ,act4 #baa4 ,extension of full ,federal medical assistance percentage to ,indian health care providers 7a7 ,in general ,section #aije of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7 is amended-- 7#a7 in subsection 7a71 by amending paragraph 7#i7 to read as follows3 7#i7 clinic services furnished by or under the direction of a physician1 without regard to whether the clinic itself is administered by a physician1 including-- 7,a7 such services furnished outside the clinic by clinic personnel to an eligible individual who does not reside in a permanent dwelling or does not have a fixed home or mailing address2 and 7,b7 such services provided outside the clinic on the basis of a referral from a clinic administered by an ,indian ,health ,program 7as defined in paragraph 7#ab7 of section #d of the ,indian ,health ,care ,improvement ,act1 or an ,urban ,indian ,organization as defined in paragraph 7#bi7 of section #d of such ,act that has a grant or contract with the ,indian ,health ,service under title ,v of such ,act2 4 7#b7 in subsection 7b71 by inserting after 7as defined in section #d of the ,indian ,health ,care ,improvement ,act7 the following3 2 the ,federal medical assistance percentage shall also be #ajj per centum with respect to amounts expended as medical assistance for services which are received through an ,urban ,indian organization 7as defined in section #d of the ,indian ,health ,care ,improvement ,act7 that has a grant or contract with the ,indian ,health ,service under title ,v of such ,act4 7b7 ,extension of full ,federal medical assistance percentage to services furnished by ,native ,hawaiian ,health ,care systems 7#a7 ,in general ,beginning on the date of enactment of this ,act-- 7,a7 for purposes of section #aije7;a77#i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7a77#i771 services described in subsection 7b7 that are furnished in any location shall be deemed to be clinic services2 and 7,b7 notwithstanding section #aije7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7b771 the ,federal medical assistance percentage with respect to amounts expended as medical assistance for such services shall be #ajj percent4 7#b7 ,services described ,the services described in this subsection are services for which payment is available under the ,state plan under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 of ,hawaii 7or any waiver of such plan7 that-- 7,a7 are furnished on or after the date of enactment of this ,act2 7,b7 are furnished to an individual who-- 7i7 is a ,native ,hawaiian2 and 7ii7 is eligible for medical assistance under such plan2 and 7,c7 are furnished by an ,indian health care provider 7as such term is defined in section #aicb7;h77#d77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#b7;h77#d77;,a77 or a ,native ,hawaiian health care system 7without regard to whether such services are furnished through an ,indian ,health ,service facility74 ,,iii ,lowering ,prices ,through ,fair ,drug ,price ,negotiation #cja4 ,establishing a ,fair ,drug ,pricing ,program 7a7 ,program ,to lower prices for certain high-,priced single source drugs ,title ,,xi of the ,social ,security ,act 7#db ,u4,s4,c4 #acja et seq47 is amended by adding at the end the following new part3 ,e ,fair ,price ,negotiation ,program to ,lower ,prices for ,certain ,high-,priced ,single ,source ,drugs #aaia4 ,establishment of program 7a7 ,in general ,the ,secretary shall establish a ,fair ,price ,negotiation ,program 7in this part referred to as the program74 ,under the program1 with respect to each price applicability period1 the ,secretary shall-- 7#a7 publish a list of selected drugs in accordance with section #aaib2 7#b7 enter into agreements with manufacturers of selected drugs with respect to such period1 in accordance with section #aaic2 7#c7 negotiate and1 if applicable1 renegotiate maximum fair prices for such selected drugs1 in accordance with section #aaid2 and 7#d7 carry out the administrative duties described in section #aaif4 7b7 ,definitions relating to timing ,for purposes of this part3 7#a7 ,initial price applicability year ,the term initial price applicability year means a plan year 7beginning with plan year #bjbc7 or1 if agreed to in an agreement under section #aaic by the ,secretary and manufacturer involved1 a period of more than one plan year 7beginning on or after ,january #a1 #bjbc74 7#b7 ,price applicability period ,the term price applicability period means1 with respect to a drug1 the period beginning with the initial price applicability year with respect to which such drug is a selected drug and ending with the last plan year during which the drug is a selected drug4 7#c7 ,selected drug publication date ,the term selected drug publication date means1 with respect to each initial price applicability year1 ,april #ae of the plan year that begins #b years prior to such year4 7#d7 ,voluntary negotiation period ,the term voluntary negotiation period means1 with respect to an initial price applicability year with respect to a selected drug1 the period-- 7,a7 beginning on the sooner of-- 7i7 the date on which the manufacturer of the drug and the ,secretary enter into an agreement under section #aaic with respect to such drug2 or 7ii7 ,june #ae following the selected drug publication date with respect to such selected drug2 and 7,b7 ending on ,march #ca of the year that begins one year prior to the initial price applicability year4 7c7 ,other definitions ,for purposes of this part3 7#a7 ,fair price eligible individual ,the term fair price eligible individual means1 with respect to a selected drug-- 7,a7 in the case such drug is furnished or dispensed to the individual at a pharmacy or by a mail order service-- 7i7 an individual who is enrolled under a prescription drug plan under part ,d of title ,,xviii or an ,,ma-,,pd plan under part ,c of such title if coverage is provided under such plan for such selected drug2 and 7ii7 an individual who is enrolled under a group health plan or health insurance coverage offered in the group or individual market 7as such terms are defined in section #bgia of the ,public ,health ,service ,act7 with respect to which there is in effect an agreement with the ,secretary under section #aaig with respect to such selected drug as so furnished or dispensed2 and 7,b7 in the case such drug is furnished or administered to the individual by a hospital1 physician1 or other provider of services or supplier-- 7i7 an individual who is entitled to benefits under part ,a of title ,,xviii or enrolled under part ,b of such title if such selected drug is covered under the respective part2 and 7ii7 an individual who is enrolled under a group health plan or health insurance coverage offered in the group or individual market 7as such terms are defined in section #bgia of the ,public ,health ,service ,act7 with respect to which there is in effect an agreement with the ,secretary under section #aaig with respect to such selected drug as so furnished or administered4 7#b7 ,maximum fair price ,the term maximum fair price means1 with respect to a plan year during a price applicability period and with respect to a selected drug 7as defined in section #aaib7;c77 with respect to such period1 the price published pursuant to section #aaie in the ,federal ,register for such drug and year4 7#c7 ,average international market price defined 7,a7 ,in general ,the terms average international market price and ,,aim price mean1 with respect to a drug1 the average price 7which shall be the net average price1 if practicable1 and volume-weighted1 if practicable7 for a unit 7as defined in paragraph 7#d77 of the drug for sales of such drug 7calculated across different dosage forms and strengths of the drug and not based on the specific formulation or package size or package type71 as computed 7as of the date of publication of such drug as a selected drug under section #aaib7;a77 in all countries described in clause 7ii7 of subparagraph 7,b7 that are applicable countries 7as described in clause 7i7 of such subparagraph7 with respect to such drug4 7,b7 ,applicable countries 7i7 ,in general ,for purposes of subparagraph 7,a71 a country described in clause 7ii7 is an applicable country described in this clause with respect to a drug if there is available an average price for any unit for the drug for sales of such drug in such country4 7ii7 ,countries described ,for purposes of this paragraph1 the following are countries described in this clause3 7,i7 ,australia4 7,,ii7 ,canada4 7,,iii7 ,france4 7,,iv7 ,germany4 7,v7 ,japan4 7,,vi7 ,the ,united ,kingdom4 7#d7 ,unit ,the term unit means1 with respect to a drug1 the lowest identifiable quantity 7such as a capsule or tablet1 milligram of molecules1 or grams7 of the drug that is dispensed4 #aaib4 ,selection of negotiation-eligible drugs as selected drugs 7a7 ,in general ,not later than the selected drug publication date with respect to an initial price applicability year1 subject to subsection 7h71 the ,secretary shall select and publish in the ,federal ,register a list of-- 7#a7 7,a7 with respect to an initial price applicability year during #bjbc1 at least #be negotiation-eligible drugs described in subparagraphs 7,a7 and 7,b71 but not subparagraph 7,c71 of subsection 7d77#a7 7or1 with respect to an initial price applicability year during such period beginning after #bjbc1 the maximum number 7if such number is less than #be7 of such negotiation-eligible drugs for the year7 with respect to such year2 and 7,b7 with respect to an initial price applicability year during #bjbd or a subsequent year1 at least #ej negotiation-eligible drugs described in subparagraphs 7,a7 and 7,b71 but not subparagraph 7,c71 of subsection 7d77#a7 7or1 with respect to an initial price applicability year during such period1 the maximum number 7if such number is less than #ej7 of such negotiation-eligible drugs for the year7 with respect to such year2 7#b7 all negotiation-eligible drugs described in subparagraph 7,c7 of such subsection with respect to such year2 and 7#c7 all new-entrant negotiation-eligible drugs 7as defined in subsection 7g77#a77 with respect to such year4 ,each drug published on the list pursuant to the previous sentence shall be subject to the negotiation process under section #aaid for the voluntary negotiation period with respect to such initial price applicability year 7and the renegotiation process under such section as applicable for any subsequent year during the applicable price applicability period74 ,in applying this subsection1 any negotiation-eligible drug that is selected under this subsection for an initial price applicability year shall not count toward the required minimum amount of drugs to be selected under paragraph 7#a7 for any subsequent year1 including such a drug so selected that is subject to renegotiation under section #aaid4 7b7 ,selection of drugs ,in carrying out subsection 7a77#a7 the ,secretary shall select for inclusion on the published list described in subsection 7a7 with respect to a price applicability period1 the negotiation-eligible drugs that the ,secretary projects will result in the greatest savings to the ,federal ,government or fair price eligible individuals during the price applicability period4 ,in making this projection of savings for drugs for which there is an ,,aim price for a price applicability period1 the savings shall be projected across different dosage forms and strengths of the drugs and not based on the specific formulation or package size or package type of the drugs1 taking into consideration both the volume of drugs for which payment is made1 to the extent such data is available1 and the amount by which the net price for the drugs exceeds the ,,aim price for the drugs4 7c7 ,selected drug ,for purposes of this part1 each drug included on the list published under subsection 7a7 with respect to an initial price applicability year shall be referred to as a selected drug with respect to such year and each subsequent plan year beginning before the first plan year beginning after the date on which the ,secretary determines two or more drug products-- 7#a7 are approved or licensed 7as applicable7-- 7,a7 under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act using such drug as the listed drug2 or 7,b7 under section #cea7k7 of the ,public ,health ,service ,act using such drug as the reference product2 and 7#b7 continue to be marketed4 7d7 ,negotiation-,eligible drug 7#a7 ,in general ,for purposes of this part1 the term negotiation-eligible drug means1 with respect to the selected drug publication date with respect to an initial price applicability year1 a qualifying single source drug1 as defined in subsection 7e71 that meets any of the following criteria3 7,a7 ,covered part ,d drugs ,the drug is among the #abe covered part ,d drugs 7as defined in section #ahfj;,d-#b7;e77 for which there was an estimated greatest net spending under parts ,c and ,d of title ,,xviii1 as determined by the ,secretary1 during the most recent plan year prior to such drug publication date for which data are available4 7,b7 ,other drugs ,the drug is among the #abe drugs for which there was an estimated greatest net spending in the ,united ,states 7including the #ej ,states1 the ,district of ,columbia1 and the territories of the ,united ,states71 as determined by the ,secretary1 during the most recent plan year prior to such drug publication date for which data are available4 7,c7 ,insulin ,the drug is a qualifying single source drug described in subsection 7e77#c74 7#b7 ,clarification ,in determining whether a qualifying single source drug satisfies any of the criteria described in paragraph 7#a71 the ,secretary shall1 to the extent practicable1 use data that is aggregated across dosage forms and strengths of the drug and not based on the specific formulation or package size or package type of the drug4 7#c7 ,publication ,not later than the selected drug publication date with respect to an initial price applicability year1 the ,secretary shall publish in the ,federal ,register a list of negotiation-eligible drugs with respect to such selected drug publication date4 7e7 ,qualifying single source drug ,for purposes of this part1 the term qualifying single source drug means any of the following3 7#a7 ,drug products ,a drug that-- 7,a7 is approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act and continues to be marketed pursuant to such approval2 and 7,b7 is not the listed drug for any drug that is approved and continues to be marketed under section #eje7;j7 of such ,act4 7#b7 ,biological products ,a biological product that-- 7,a7 is licensed under section #cea7;a7 of the ,public ,health ,service ,act1 including any product that has been deemed to be licensed under section #cea of such ,act pursuant to section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji1 and continues to be marketed under section #cea of such ,act2 and 7,b7 is not the reference product for any biological product that is licensed and continues to be marketed under section #cea7k7 of such ,act4 7#c7 ,insulin product ,notwithstanding paragraphs 7#a7 and 7#b71 any insulin product 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 the ,public ,health ,service ,act and continues to be marketed under such section #eje or #cea1 including any insulin product that has been deemed to be licensed under section #cea7;a7 of the ,public ,health ,service ,act pursuant to section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji and continues to be marketed pursuant to such licensure4 ,for purposes of applying paragraphs 7#a7 and 7#b71 a drug or biological product that is marketed by the same sponsor or manufacturer 7or an affiliate thereof or a cross-licensed producer or distributor7 as the listed drug or reference product described in such respective paragraph shall not be taken into consideration4 7f7 ,information on international drug prices ,for purposes of determining which negotiation-eligible drugs to select under subsection 7a7 and1 in the case of such drugs that are selected drugs1 to determine the maximum fair price for such a drug and whether such maximum fair price should be renegotiated under section #aaid1 the ,secretary shall use data relating to the ,,aim price with respect to such drug as available or provided to the ,secretary and shall on an ongoing basis request from manufacturers of selected drugs information on the ,,aim price of such a drug4 7g7 ,new-,entrant negotiation-,eligible drugs 7#a7 ,in general ,for purposes of this part1 the term new-entrant negotiation-eligible drug means1 with respect to the selected drug publication date with respect to an initial price applicability year1 a qualifying single source drug-- 7,a7 that is first approved or licensed1 as described in paragraph 7#a71 7#b71 or 7#c7 of subsection 7e71 as applicable1 during the year preceding such selected drug publication date2 and 7,b7 that the ,secretary determines under paragraph 7#b7 is likely to be included as a negotiation-eligible drug with respect to the subsequent selected drug publication date4 7#b7 ,determination ,in the case of a qualifying single source drug that meets the criteria described in subparagraph 7,a7 of paragraph 7#a71 with respect to an initial price applicability year1 if the wholesale acquisition cost at which such drug is first marketed in the ,united ,states is equal to or greater than the median household income 7as determined according to the most recent data collected by the ,united ,states ,census ,bureau71 the ,secretary shall determine before the selected drug publication date with respect to the initial price applicability year1 if the drug is likely to be included as a negotiation-eligible drug with respect to the subsequent selected drug publication date1 based on the projected spending under title ,,xviii or in the ,united ,states on such drug4 ,for purposes of this paragraph the term ,united ,states includes the #ej ,states1 the ,district of ,columbia1 and the territories of the ,united ,states4 7h7 ,conflict of interest 7#a7 ,in general ,in the case the ,inspector ,general of the ,department of ,health and ,human ,services determines the ,secretary has a conflict1 with respect to a matter described in paragraph 7#b71 the individual described in paragraph 7#c7 shall carry out the duties of the ,secretary under this part1 with respect to a negotiation-eligible drug1 that would otherwise be such a conflict4 7#b7 ,matter described ,a matter described in this paragraph is-- 7,a7 a financial interest 7as described in section #bfce4djb of title #e1 ,code of ,federal ,regulations 7except for an interest described in subsection 7b77#b77;iv7 of such section77 on the date of the selected drug publication date1 with respect the price applicability year 7as applicable72 7,b7 a personal or business relationship 7as described in section #bfce4ejb of such title7 on the date of the selected drug publication date1 with respect the price applicability year2 7,c7 employment by a manufacturer of a negotiation-eligible drug during the preceding #aj-year period beginning on the date of the selected drug publication date1 with respect to each price applicability year2 and 7,d7 any other matter the ,general ,counsel determines appropriate4 7#c7 ,individual described ,an individual described in this paragraph is-- 7,a7 the highest-ranking officer or employee of the ,department of ,health and ,human ,services 7as determined by the organizational chart of the ,department7 that does not have a conflict under this subsection2 and 7,b7 is nominated by the ,president and confirmed by the ,senate with respect to the position4 #aaic4 ,manufacturer agreements 7a7 ,in general ,for purposes of section #aaia7;a77#b71 the ,secretary shall enter into agreements with manufacturers of selected drugs with respect to a price applicability period1 by not later than ,june #ae following the selected drug publication date with respect to such selected drug1 under which-- 7#a7 during the voluntary negotiation period for the initial price applicability year for the selected drug1 the ,secretary and manufacturer1 in accordance with section #aaid1 negotiate to determine 7and1 by not later than the last date of such period and in accordance with subsection 7c71 agree to7 a maximum fair price for such selected drug of the manufacturer in order to provide access to such price-- 7,a7 to fair price eligible individuals who with respect to such drug are described in subparagraph 7,a7 of section #aaia7;c77#a7 and are furnished or dispensed such drug during1 subject to subparagraph 7#b71 the price applicability period2 and 7,b7 to hospitals1 physicians1 and other providers of services and suppliers with respect to fair price eligible individuals who with respect to such drug are described in subparagraph 7,b7 of such section and are furnished or administered such drug during1 subject to subparagraph 7#b71 the price applicability period2 7#b7 the ,secretary and the manufacturer shall1 in accordance with a process and during a period specified by the ,secretary pursuant to rulemaking1 renegotiate 7and1 by not later than the last date of such period and in accordance with subsection 7c71 agree to7 the maximum fair price for such drug if the ,secretary determines that there is a material change in any of the factors described in section #aaid7;d7 relating to the drug1 including changes in the ,,aim price for such drug1 in order to provide access to such maximum fair price 7as so renegotiated7-- 7,a7 to fair price eligible individuals who with respect to such drug are described in subparagraph 7,a7 of section #aaia7;c77#a7 and are furnished or dispensed such drug during any year during the price applicability period 7beginning after such renegotiation7 with respect to such selected drug2 and 7,b7 to hospitals1 physicians1 and other providers of services and suppliers with respect to fair price eligible individuals who with respect to such drug are described in subparagraph 7,b7 of such section and are furnished or administered such drug during any year described in subparagraph 7,a72 7#c7 the maximum fair price 7including as renegotiated pursuant to paragraph 7#b771 with respect to such a selected drug1 shall be provided to fair price eligible individuals1 who with respect to such drug are described in subparagraph 7,a7 of section #aaia7;c77#a71 at the pharmacy or by a mail order service at the point-of-sale of such drug2 7#d7 the manufacturer1 subject to subsection 7d71 submits to the ,secretary1 in a form and manner specified by the ,secretary-- 7,a7 for the voluntary negotiation period for the price applicability period 7and1 if applicable1 before any period of renegotiation specified pursuant to paragraph 7#b77 with respect to such drug all information that the ,secretary requires to carry out the negotiation 7or renegotiation process7 under this part1 including information described in section #aaib7;f7 and section #aaid7;d77#a72 and 7,b7 on an ongoing basis1 information on changes in prices for such drug that would affect the ,,aim price for such drug or otherwise provide a basis for renegotiation of the maximum fair price for such drug pursuant to paragraph 7#b72 7#e7 the manufacturer agrees that in the case the selected drug of a manufacturer is a drug described in subsection 7c71 the manufacturer will1 in accordance with such subsection1 make any payment required under such subsection with respect to such drug2 and 7#f7 the manufacturer complies with requirements imposed by the ,secretary for purposes of administering the program1 including with respect to the duties described in section #aaif4 7b7 ,agreement in effect until drug is no longer a selected drug ,an agreement entered into under this section shall be effective1 with respect to a drug1 until such drug is no longer considered a selected drug under section #aaib7;c74 7c7 ,special rule for certain selected drugs without ,,aim price 7#a7 ,in general ,in the case of a selected drug for which there is no ,,aim price available with respect to the initial price applicability year for such drug and for which an ,,aim price becomes available beginning with respect to a subsequent plan year during the price applicability period for such drug1 if the ,secretary determines that the amount described in paragraph 7#b77;,a7 for a unit of such drug is greater than the amount described in paragraph 7#b77;,b7 for a unit of such drug1 then by not later than one year after the date of such determination1 the manufacturer of such selected drug shall pay to the ,treasury an amount equal to the product of-- 7,a7 the difference between such amount described in paragraph 7#b77;,a7 for a unit of such drug and such amount described in paragraph 7#b77;,b7 for a unit of such drug2 and 7,b7 the number of units of such drug sold in the ,united ,states1 including the #ej ,states1 the ,district of ,columbia1 and the territories of the ,united ,states1 during the period described in paragraph 7#b77;,b74 7#b7 ,amounts described 7,a7 ,weighted average price before ,,aim price available ,for purposes of paragraph 7#a71 the amount described in this subparagraph for a selected drug described in such paragraph1 is the amount equal to the weighted average manufacturer price 7as defined in section #aibg7k77#a77 for such dosage strength and form for the drug during the period beginning with the first plan year for which the drug is included on the list of negotiation-eligible drugs published under section #aaib7;d7 and ending with the last plan year during the price applicability period for such drug with respect to which there is no ,,aim price available for such drug4 7,b7 ,amount multiplier after ,,aim price available ,for purposes of paragraph 7#a71 the amount described in this subparagraph for a selected drug described in such paragraph1 is the amount equal to #bjj percent of the ,,aim price for such drug with respect to the first plan year during the price applicability period for such drug with respect to which there is an ,,aim price available for such drug4 7d7 ,confidentiality of information ,information submitted to the ,secretary under this part by a manufacturer of a selected drug that is proprietary information of such manufacturer 7as determined by the ,secretary7 may be used only by the ,secretary or disclosed to and used by the ,comptroller ,general of the ,united ,states or the ,medicare ,payment ,advisory ,commission for purposes of carrying out this part4 7e7 ,regulations 7#a7 ,in general ,the ,secretary shall1 pursuant to rulemaking1 specify1 in accordance with paragraph 7#b71 the information that must be submitted under subsection 7a77#d74 7#b7 ,information specified ,information described in paragraph 7#a71 with respect to a selected drug1 shall include information on sales of the drug 7by the manufacturer of the drug or by another entity under license or other agreement with the manufacturer1 with respect to the sales of such drug1 regardless of the name under which the drug is sold7 in any foreign country that is part of the ,,aim price4 ,the ,secretary shall verify1 to the extent practicable1 such sales from appropriate officials of the government of the foreign country involved4 7f7 ,compliance with requirements for administration of program ,each manufacturer with an agreement in effect under this section shall comply with requirements imposed by the ,secretary or a third party with a contract under section #aaif7;c77#a71 as applicable1 for purposes of administering the program4 #aaid4 ,negotiation and renegotiation process 7a7 ,in general ,for purposes of this part1 under an agreement under section #aaic between the ,secretary and a manufacturer of a selected drug1 with respect to the period for which such agreement is in effect and in accordance with subsections 7b7 and 7c71 the ,secretary and the manufacturer-- 7#a7 shall during the voluntary negotiation period with respect to the initial price applicability year for such drug1 in accordance with this section1 negotiate a maximum fair price for such drug for the purpose described in section #aaic7;a77#a72 and 7#b7 as applicable pursuant to section #aaic7;a77#b7 and in accordance with the process specified pursuant to such section1 renegotiate such maximum fair price for such drug for the purpose described in such section4 7b7 ,negotiating methodology and objective 7#a7 ,in general ,the ,secretary shall develop and use a consistent methodology for negotiations under subsection 7a7 that1 in accordance with paragraph 7#b7 and subject to paragraph 7#c71 achieves the lowest maximum fair price for each selected drug while appropriately rewarding innovation4 7#b7 ,prioritizing factors ,in considering the factors described in subsection 7d7 in negotiating 7and1 as applicable1 renegotiating7 the maximum fair price for a selected drug1 the ,secretary shall1 to the extent practicable1 consider all of the available factors listed but shall prioritize the following factors3 7,a7 ,research and development costs ,the factor described in paragraph 7#a77;,a7 of subsection 7d74 7,b7 ,market data ,the factor described in paragraph 7#a77;,b7 of such subsection4 7,c7 ,unit costs of production and distribution ,the factor described in paragraph 7#a77;,c7 of such subsection4 7,d7 ,comparison to existing therapeutic alternatives ,the factor described in paragraph 7#b77;,a7 of such subsection4 7#c7 ,requirement 7,a7 ,in general ,in negotiating the maximum fair price of a selected drug1 with respect to an initial price applicability year for the selected drug1 and1 as applicable1 in renegotiating the maximum fair price for such drug1 with respect to a subsequent year during the price applicability period for such drug1 in the case that the manufacturer of the selected drug offers under the negotiation or renegotiation1 as applicable1 a price for such drug that is not more than the target price described in subparagraph 7,b7 for such drug for the respective year1 the ,secretary shall agree under such negotiation or renegotiation1 respectively1 to such offered price as the maximum fair price4 7,b7 ,target price 7i7 ,in general ,subject to clause 7ii71 the target price described in this subparagraph for a selected drug with respect to a year1 is the average price 7which shall be the net average price1 if practicable1 and volume-weighted1 if practicable7 for a unit of such drug for sales of such drug1 as computed 7across different dosage forms and strengths of the drug and not based on the specific formulation or package size or package type of the drug7 in the applicable country described in section #aaia7;c77#c77;,b7 with respect to such drug that1 with respect to such year1 has the lowest average price for such drug as compared to the average prices 7as so computed7 of such drug with respect to such year in the other applicable countries described in such section with respect to such drug4 7ii7 ,selected drugs without ,,aim price ,in applying this paragraph in the case of negotiating the maximum fair price of a selected drug for which there is no ,,aim price available with respect to the initial price applicability year for such drug1 or1 as applicable1 renegotiating the maximum fair price for such drug with respect to a subsequent year during the price applicability period for such drug before the first plan year for which there is an ,,aim price available for such drug1 the target price described in this subparagraph for such drug and respective year is the amount that is #hj percent of the average manufacturer price 7as defined in section #aibg7k77#a77 for such drug and year4 7#d7 ,annual report ,after the completion of each voluntary negotiation period1 the ,secretary shall submit to ,congress a report on the maximum fair prices negotiated 7or1 as applicable1 renegotiated7 for such period4 ,such report shall include information on how such prices so negotiated 7or renegotiated7 meet the requirements of this part1 including the requirements of this subsection4 7c7 ,limitation 7#a7 ,in general ,subject to paragraph 7#b71 the maximum fair price negotiated 7including as renegotiated7 under this section for a selected drug1 with respect to each plan year during a price applicability period for such drug1 shall not exceed #abj percent of the ,,aim price applicable to such drug with respect to such year4 7#b7 ,selected drugs without ,,aim price ,in the case of a selected drug for which there is no ,,aim price available with respect to the initial price applicability year for such drug1 for each plan year during the price applicability period before the first plan year for which there is an ,,aim price available for such drug1 the maximum fair price negotiated 7including as renegotiated7 under this section for the selected drug shall not exceed the amount equal to #he percent of the average manufacturer price for the drug with respect to such year4 7d7 ,considerations ,for purposes of negotiating and1 as applicable1 renegotiating 7including for purposes of determining whether to renegotiate7 the maximum fair price of a selected drug under this part with the manufacturer of the drug1 the ,secretary1 consistent with subsection 7b77#b71 shall take into consideration the factors described in paragraphs 7#a71 7#b71 7#c71 and 7#e71 and may take into consideration the factor described in paragraph 7#d73 7#a7 ,manufacturer-specific information ,the following information1 including as submitted by the manufacturer3 7,a7 ,research and development costs of the manufacturer for the drug and the extent to which the manufacturer has recouped research and development costs4 7,b7 ,market data for the drug1 including the distribution of sales across different programs and purchasers and projected future revenues for the drug4 7,c7 ,unit costs of production and distribution of the drug4 7,d7 ,prior ,federal financial support for novel therapeutic discovery and development with respect to the drug4 7,e7 ,data on patents and on existing and pending exclusivity for the drug4 7,f7 ,national sales data for the drug4 7,g7 ,information on clinical trials for the drug in the ,united ,states or in applicable countries described in section #aaia7;c77#c77;,b74 7#b7 ,information on alternative products ,the following information3 7,a7 ,the extent to which the drug represents a therapeutic advance as compared to existing therapeutic alternatives and1 to the extent such information is available1 the costs of such existing therapeutic alternatives4 7,b7 ,information on approval by the ,food and ,drug ,administration of alternative drug products4 7,c7 ,information on comparative effectiveness analysis for such products1 taking into consideration the effects of such products on specific populations1 such as individuals with disabilities1 the elderly1 terminally ill1 children1 and other patient populations4 ,in considering information described in subparagraph 7,c71 the ,secretary shall not use evidence or findings from comparative clinical effectiveness research in a manner that treats extending the life of an elderly1 disabled1 or terminally ill individual as of lower value than extending the life of an individual who is younger1 nondisabled1 or not terminally ill4 ,nothing in the previous sentence shall affect the application or consideration of an ,,aim price for a selected drug4 7#c7 ,foreign sales information ,to the extent available on a timely basis1 including as provided by a manufacturer of the selected drug or otherwise1 information on sales of the selected drug in each of the countries described in section #aaia7;c77#c77;,b74 7#d7 ,,va drug pricing information ,information disclosed to the ,secretary pursuant to subsection 7f74 7#e7 ,additional information ,information submitted to the ,secretary1 in accordance with a process specified by the ,secretary1 by other parties that are affected by the establishment of a maximum fair price for the selected drug4 7e7 ,request for information ,for purposes of negotiating and1 as applicable1 renegotiating 7including for purposes of determining whether to renegotiate7 the maximum fair price of a selected drug under this part with the manufacturer of the drug1 with respect to a price applicability period1 and other relevant data for purposes of this section-- 7#a7 the ,secretary shall1 not later than the selected drug publication date with respect to the initial price applicability year of such period1 request drug pricing information from the manufacturer of such selected drug1 including information described in subsection 7d77#a72 and 7#b7 by not later than ,october #a following the selected drug publication date1 the manufacturer of such selected drug shall submit to the ,secretary such requested information in such form and manner as the ,secretary may require4 ,the ,secretary shall request1 from the manufacturer or others1 such additional information as may be needed to carry out the negotiation and renegotiation process under this section4 7f7 ,disclosure of information ,for purposes of this part1 the ,secretary of ,veterans ,affairs may disclose to the ,secretary of ,health and ,human ,services the price of any negotiation-eligible drug that is purchased pursuant to section #habf of title #ch1 ,united ,states ,code4 #aaie4 ,publication of maximum fair prices 7a7 ,in general ,with respect to an initial price applicability year and selected drug with respect to such year1 not later than ,april #a of the plan year prior to such initial price applicability year1 the ,secretary shall publish in the ,federal ,register the maximum fair price for such drug negotiated under this part with the manufacturer of such drug4 7b7 ,updates 7#a7 ,subsequent year maximum fair prices ,for a selected drug1 for each plan year subsequent to the initial price applicability year for such drug with respect to which an agreement for such drug is in effect under section #aaic1 the ,secretary shall publish in the ,federal ,register-- 7,a7 subject to subparagraph 7,b71 the amount equal to the maximum fair price published for such drug for the previous year1 increased by the annual percentage increase in the consumer price index for all urban consumers 7all items2 ,u4,s4 city average7 as of ,september of such previous year2 or 7,b7 in the case the maximum fair price for such drug was renegotiated1 for the first year for which such price as so renegotiated applies1 such renegotiated maximum fair price4 7#b7 ,prices negotiated after deadline ,in the case of a selected drug with respect to an initial price applicability year for which the maximum fair price is determined under this part after the date of publication under this section1 the ,secretary shall publish such maximum fair price in the ,federal ,register by not later than #cj days after the date such maximum price is so determined4 #aaif4 ,administrative duties2 coordination provisions 7a7 ,administrative duties 7#a7 ,in general ,for purposes of section #aaia1 the administrative duties described in this section are the following3 7,a7 ,the establishment of procedures 7including through agreements with manufacturers under this part1 contracts with prescription drug plans under part ,d of title ,,xviii and ,,ma-,,pd plans under part ,c of such title1 and agreements under section #aaig with group health plans and health insurance issuers of health insurance coverage offered in the individual or group market7 under which the maximum fair price for a selected drug is provided to fair price eligible individuals1 who with respect to such drug are described in subparagraph 7,a7 of section #aaia7;c77#a71 at pharmacies or by mail order service at the point-of-sale of the drug for the applicable price period for such drug and providing that such maximum fair price is used for determining cost-sharing under such plans or coverage for the selected drug4 7,b7 ,the establishment of procedures 7including through agreements with manufacturers under this part and contracts with hospitals1 physicians1 and other providers of services and suppliers and agreements under section #aaig with group health plans and health insurance issuers of health insurance coverage offered in the individual or group market7 under which1 in the case of a selected drug furnished or administered by such a hospital1 physician1 or other provider of services or supplier to fair price eligible individuals 7who with respect to such drug are described in subparagraph 7,b7 of section #aaia7;c77#a771 the maximum fair price for the selected drug is provided to such hospitals1 physicians1 and other providers of services and suppliers 7as applicable7 with respect to such individuals and providing that such maximum fair price is used for determining cost-sharing under the respective part1 plan1 or coverage for the selected drug4 7,c7 ,the establishment of procedures 7including through agreements and contracts described in subparagraphs 7,a7 and 7,b77 to ensure that1 not later than #ij days after the dispensing of a selected drug to a fair price eligible individual by a pharmacy or mail order service1 the pharmacy or mail order service is reimbursed for an amount equal to the difference between-- 7i7 the lesser of-- 7,i7 the wholesale acquisition cost of the drug2 7,,ii7 the national average drug acquisition cost of the drug2 and 7,,iii7 any other similar determination of pharmacy acquisition costs of the drug1 as determined by the ,secretary2 and 7ii7 the maximum fair price for the drug4 7,d7 ,the establishment of procedures to ensure that the maximum fair price for a selected drug is applied before-- 7i7 any coverage or financial assistance under other health benefit plans or programs that provide coverage or financial assistance for the purchase or provision of prescription drug coverage on behalf of fair price eligible individuals as the ,secretary may specify2 and 7ii7 any other discounts4 7,e7 ,the establishment of procedures to enter into appropriate agreements and protocols for the ongoing computation of ,,aim prices for selected drugs1 including1 to the extent possible1 to compute the ,,aim price for selected drugs and including by providing that the manufacturer of such a selected drug should provide information for such computation not later than #c months after the first date of the voluntary negotiation period for such selected drug4 7,f7 ,the establishment of procedures to compute and apply the maximum fair price across different strengths and dosage forms of a selected drug and not based on the specific formulation or package size or package type of the drug4 7,g7 ,the establishment of procedures to negotiate and apply the maximum fair price in a manner that does not include any dispensing or similar fee4 7,h7 ,the establishment of procedures to carry out the provisions of this part1 as applicable1 with respect to-- 7i7 fair price eligible individuals who are enrolled under a prescription drug plan under part ,d of title ,,xviii or an ,,ma-,,pd plan under part ,c of such title2 7ii7 fair price eligible individuals who are enrolled under a group health plan or health insurance coverage offered by a health insurance issuer in the individual or group market with respect to which there is an agreement in effect under section #aaig2 and 7iii7 fair price eligible individuals who are entitled to benefits under part ,a of title ,,xviii or enrolled under part ,b of such title4 7,i7 ,the establishment of a negotiation process and renegotiation process in accordance with section #aaid1 including a process for acquiring information described in subsection 7d7 of such section and determining amounts described in subsection 7b7 of such section4 7,j7 ,the provision of a reasonable dispute resolution mechanism to resolve disagreements between manufacturers1 fair price eligible individuals1 and the third party with a contract under subsection 7c77#a74 7#b7 ,monitoring compliance 7,a7 ,in general ,the ,secretary shall monitor compliance by a manufacturer with the terms of an agreement under section #aaic1 including by establishing a mechanism through which violations of such terms may be reported4 7,b7 ,notification ,if a third party with a contract under subsection 7c77#a7 determines that the manufacturer is not in compliance with such agreement1 the third party shall notify the ,secretary of such noncompliance for appropriate enforcement under section #daib of the ,internal ,revenue ,code of #aihf or section #aaih1 as applicable4 7b7 ,collection of data 7#a7 ,from prescription drug plans and ,,ma-,,pd plans ,the ,secretary may collect appropriate data from prescription drug plans under part ,d of title ,,xviii and ,,ma-,,pd plans under part ,c of such title in a timeframe that allows for maximum fair prices to be provided under this part for selected drugs4 7#b7 ,from health plans ,the ,secretary may collect appropriate data from group health plans or health insurance issuers offering group or individual health insurance coverage in a timeframe that allows for maximum fair prices to be provided under this part for selected drugs4 7#c7 ,coordination of data collection ,to the extent feasible1 as determined by the ,secretary1 the ,secretary shall ensure that data collected pursuant to this subsection is coordinated with1 and not duplicative of1 other ,federal data collection efforts4 7c7 ,contract with third parties 7#a7 ,in general ,the ,secretary may enter into a contract with #a or more third parties to administer the requirements established by the ,secretary in order to carry out this part4 ,at a minimum1 the contract with a third party under the preceding sentence shall require that the third party-- 7,a7 receive and transmit information between the ,secretary1 manufacturers1 and other individuals or entities the ,secretary determines appropriate2 7,b7 receive1 distribute1 or facilitate the distribution of funds of manufacturers to appropriate individuals or entities in order to meet the obligations of manufacturers under agreements under this part2 7,c7 provide adequate and timely information to manufacturers1 consistent with the agreement with the manufacturer under this part1 as necessary for the manufacturer to fulfill its obligations under this part2 and 7,d7 permit manufacturers to conduct periodic audits1 directly or through contracts1 of the data and information used by the third party to determine discounts for applicable drugs of the manufacturer under the program4 7#b7 ,performance requirements ,the ,secretary shall establish performance requirements for a third party with a contract under paragraph 7#a7 and safeguards to protect the independence and integrity of the activities carried out by the third party under the program under this part4 #aaig4 ,voluntary participation by other health plans 7a7 ,agreement to participate under program 7#a7 ,in general ,subject to paragraph 7#b71 under the program under this part the ,secretary shall be treated as having in effect an agreement with a group health plan or health insurance issuer offering group or individual health insurance coverage 7as such terms are defined in section #bgia of the ,public ,health ,service ,act71 with respect to a price applicability period and a selected drug with respect to such period-- 7,a7 with respect to such selected drug furnished or dispensed at a pharmacy or by mail order service if coverage is provided under such plan or coverage during such period for such selected drug as so furnished or dispensed2 and 7,b7 with respect to such selected drug furnished or administered by a hospital1 physician1 or other provider of services or supplier if coverage is provided under such plan or coverage during such period for such selected drug as so furnished or administered4 7#b7 ,opting out of agreement ,the ,secretary shall not be treated as having in effect an agreement under the program under this part with a group health plan or health insurance issuer offering group or individual health insurance coverage with respect to a price applicability period and a selected drug with respect to such period if such a plan or issuer affirmatively elects1 through a process specified by the ,secretary1 not to participate under the program with respect to such period and drug4 7b7 ,publication of election ,with respect to each price applicability period and each selected drug with respect to such period1 the ,secretary and the ,secretary of ,labor and the ,secretary of the ,treasury1 as applicable1 shall make public a list of each group health plan and each health insurance issuer offering group or individual health insurance coverage1 with respect to which coverage is provided under such plan or coverage for such drug1 that has elected under subsection 7a7 not to participate under the program with respect to such period and drug4 #aaih4 ,civil monetary penalty 7a7 ,violations relating ,to offering of maximum fair price ,any manufacturer of a selected drug that has entered into an agreement under section #aaic1 with respect to a plan year during the price applicability period for such drug1 that does not provide access to a price that is not more than the maximum fair price 7or a lesser price7 for such drug for such year-- 7#a7 to a fair price eligible individual who with respect to such drug is described in subparagraph 7,a7 of section #aaia7;c77#a7 and who is furnished or dispensed such drug during such year2 or 7#b7 to a hospital1 physician1 or other provider of services or supplier with respect to fair price eligible individuals who with respect to such drug is described in subparagraph 7,b7 of such section and is furnished or administered such drug by such hospital1 physician1 or provider or supplier during such year2 shall be subject to a civil monetary penalty equal to ten times the amount equal to the difference between the price for such drug made available for such year by such manufacturer with respect to such individual or hospital1 physician1 provider1 or supplier and the maximum fair price for such drug for such year4 7b7 ,violations of certain terms of agreement ,any manufacturer of a selected drug that has entered into an agreement under section #aaic1 with respect to a plan year during the price applicability period for such drug1 that is in violation of a requirement imposed pursuant to section #aaic7;a77#f7 shall be subject to a civil monetary penalty of not more than #a1jjj1jjj for each such violation4 7c7 ,application ,the provisions of section #aabh;,a 7other than subsections 7a7 and 7b77 shall apply to a civil monetary penalty under this section in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a7a74 #aaii4 ,miscellaneous provisions 7a7 ,paperwork ,reduction ,act ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to data collected under this part4 7b7 ,national ,academy of ,medicine study ,not later than ,december #ca1 #bjbe1 the ,national ,academy of ,medicine shall conduct a study1 and submit to ,congress a report1 on recommendations for improvements to the program under this part1 including the determination of the limits applied under section #aaid7;c74 7c7 ,med,p,a,c study ,not later than ,december #ca1 #bjbe1 the ,medicare ,payment ,advisory ,commission shall conduct a study1 and submit to ,congress a report1 on the program under this part with respect to the ,medicare program under title ,,xviii1 including with respect to the effect of the program on individuals entitled to benefits or enrolled under such title4 7d7 ,limitation on judicial review ,the following shall not be subject to judicial review3 7#a7 ,the selection of drugs for publication under section #aaib7;a74 7#b7 ,the determination of whether a drug is a negotiation-eligible drug under section #aaib7;d74 7#c7 ,the determination of the maximum fair price of a selected drug under section #aaid4 7#d7 ,the determination of units of a drug for purposes of section #aaia7;c77#c74 7e7 ,coordination ,in carrying out this part with respect to group health plans or health insurance coverage offered in the group market that are subject to oversight by the ,secretary of ,labor or the ,secretary of the ,treasury1 the ,secretary of ,health and ,human ,services shall coordinate with such respective ,secretary4 7f7 ,data sharing ,the ,secretary shall share with the ,secretary of the ,treasury such information as is necessary to determine the tax imposed by section #daib of the ,internal ,revenue ,code of #aihf4 7g7 ,,gao study ,not later than ,december #ca1 #bjbe1 the ,comptroller ,general of the ,united ,states shall conduct a study of1 and submit to ,congress a report on1 the implementation of the ,fair ,price ,negotiation ,program under this part4 4 7b7 ,application of maximum fair prices and conforming amendments 7#a7 ,under ,medicare 7,a7 ,application to payments under part ,b ,section #ahdg;,a7b77#a77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7b77#a77;,b77 is amended by inserting or in the case of such a drug or biological that is a selected drug 7as defined in section #aaib7;c771 with respect to a price applicability period 7as defined in section #aaia7;b77#b771 #ajf percent of the maximum fair price 7as defined in section #aaia7;c77#b7 applicable for such drug and a plan year during such period after paragraph 7#d74 7,b7 ,exception to part ,d non-interference ,section #ahfj;,d-#aa7;i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;i77 is amended by inserting 1 except as provided under part ,e of title ,,xi after the ,secretary4 7,c7 ,application as negotiated price under part ,d ,section #ahfj;,d-#b7;d77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;d77#a77 is amended-- 7i7 in subparagraph 7,b71 by inserting 1 subject to subparagraph 7,d71 after negotiated prices2 and 7ii7 by adding at the end the following new subparagraph3 7,d7 ,application of maximum fair price for selected drugs ,in applying this section1 in the case of a covered part ,d drug that is a selected drug 7as defined in section #aaib7;c771 with respect to a price applicability period 7as defined in section #aaia7;b77#b771 the negotiated prices used for payment 7as described in this subsection7 shall be the maximum fair price 7as defined in section #aaia7;c77#b77 for such drug and for each plan year during such period4 4 7,d7 ,information from prescription drug plans and ,,ma-,,pd plans required 7i7 ,prescription drug plans ,section #ahfj;,d-#ab7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77 is amended by adding at the end the following new paragraph3 7#h7 ,provision of information related to maximum fair prices ,each contract entered into with a ,,pdp sponsor under this part with respect to a prescription drug plan offered by such sponsor shall require the sponsor to provide information to the ,secretary as requested by the ,secretary in accordance with section #aaif7;b74 4 7ii7 ,,ma-,,pd plans ,section #aheg7;f77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;f77#c77 is amended by adding at the end the following new subparagraph3 7,e7 ,provision of information related to maximum fair prices ,section #ahfj;,d-#ab7;b77#h74 4 7#b7 ,under group health plans and health insurance coverage 7,a7 ,,phsa ,part ,a of title ,,xxvii of the ,public ,health ,service ,act is amended by inserting after section #bgbi the following new section3 #bgbi;,a4 ,fair ,price ,negotiation ,program and application of maximum fair prices 7a7 ,in general ,in the case of a group health plan or health insurance issuer offering group or individual health insurance coverage that is treated under section #aaig of the ,social ,security ,act as having in effect an agreement with the ,secretary under the ,fair ,price ,negotiation ,program under part ,e of title ,,xi of such ,act1 with respect to a price applicability period 7as defined in section #aaia7;b7 of such ,act7 and a selected drug 7as defined in section #aaib7;c7 of such ,act7 with respect to such period with respect to which coverage is provided under such plan or coverage-- 7#a7 the provisions of such part shall apply-- 7,a7 if coverage of such selected drug is provided under such plan or coverage if the drug is furnished or dispensed at a pharmacy or by a mail order service1 to the plans or coverage offered by such plan or issuer1 and to the individuals enrolled under such plans or coverage1 during such period1 with respect to such selected drug1 in the same manner as such provisions apply to prescription drug plans and ,,ma-,,pd plans1 and to individuals enrolled under such prescription drug plans and ,,ma-,,pd plans during such period2 and 7,b7 if coverage of such selected drug is provided under such plan or coverage if the drug is furnished or administered by a hospital1 physician1 or other provider of services or supplier1 to the plans or coverage offered by such plan or issuers1 to the individuals enrolled under such plans or coverage1 and to hospitals1 physicians1 and other providers of services and suppliers during such period1 with respect to such drug in the same manner as such provisions apply to the ,secretary1 to individuals entitled to benefits under part ,a of title ,,xviii or enrolled under part ,b of such title1 and to hospitals1 physicians1 and other providers and suppliers participating under title ,,xviii during such period2 7#b7 the plan or issuer shall apply any cost-sharing responsibilities under such plan or coverage1 with respect to such selected drug1 by substituting an amount not more than the maximum fair price negotiated under such part ,e of title ,,xi for such drug in lieu of the drug price upon which the cost-sharing would have otherwise applied1 and such cost-sharing responsibilities with respect to such selected drug may not exceed such maximum fair price2 and 7#c7 the ,secretary shall apply the provisions of such part ,e to such plan1 issuer1 and coverage1 such individuals so enrolled in such plans and coverage1 and such hospitals1 physicians1 and other providers and suppliers participating in such plans and coverage4 7b7 ,notification regarding nonparticipation in ,fair ,price ,negotiation ,program ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall publicly disclose in a manner and in accordance with a process specified by the ,secretary any election made under section #aaig of the ,social ,security ,act by the plan or issuer to not participate in the ,fair ,price ,negotiation ,program under part ,e of title ,,xi of such ,act with respect to a selected drug 7as defined in section #aaib7;c7 of such ,act7 for which coverage is provided under such plan or coverage before the beginning of the plan year for which such election was made4 4 7,b7 ,,erisa 7i7 ,in general ,subpart ,b of part #g of subtitle ,b of title ,i of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aaha et seq47 is amended by adding at the end the following new section3 #gaf4 ,fair ,price ,negotiation ,program and application of maximum fair prices 7a7 ,in general ,in the case of a group health plan or health insurance issuer offering group health insurance coverage that is treated under section #aaig of the ,social ,security ,act as having in effect an agreement with the ,secretary under the ,fair ,price ,negotiation ,program under part ,e of title ,,xi of such ,act1 with respect to a price applicability period 7as defined in section #aaia7;b7 of such ,act7 and a selected drug 7as defined in section #aaib7;c7 of such ,act7 with respect to such period with respect to which coverage is provided under such plan or coverage-- 7#a7 the provisions of such part shall apply1 as applicable-- 7,a7 if coverage of such selected drug is provided under such plan or coverage if the drug is furnished or dispensed at a pharmacy or by a mail order service1 to the plans or coverage offered by such plan or issuer1 and to the individuals enrolled under such plans or coverage1 during such period1 with respect to such selected drug1 in the same manner as such provisions apply to prescription drug plans and ,,ma-,,pd plans1 and to individuals enrolled under such prescription drug plans and ,,ma-,,pd plans during such period2 and 7,b7 if coverage of such selected drug is provided under such plan or coverage if the drug is furnished or administered by a hospital1 physician1 or other provider of services or supplier1 to the plans or coverage offered by such plan or issuers1 to the individuals enrolled under such plans or coverage1 and to hospitals1 physicians1 and other providers of services and suppliers during such period1 with respect to such drug in the same manner as such provisions apply to the ,secretary1 to individuals entitled to benefits under part ,a of title ,,xviii or enrolled under part ,b of such title1 and to hospitals1 physicians1 and other providers and suppliers participating under title ,,xviii during such period2 7#b7 the plan or issuer shall apply any cost-sharing responsibilities under such plan or coverage1 with respect to such selected drug1 by substituting an amount not more than the maximum fair price negotiated under such part ,e of title ,,xi for such drug in lieu of the drug price upon which the cost-sharing would have otherwise applied1 and such cost-sharing responsibilities with respect to such selected drug may not exceed such maximum fair price2 and 7#c7 the ,secretary shall apply the provisions of such part ,e to such plan1 issuer1 and coverage1 and such individuals so enrolled in such plans4 7b7 ,notification regarding nonparticipation in ,fair ,price ,negotiation ,program ,a group health plan or a health insurance issuer offering group health insurance coverage shall publicly disclose in a manner and in accordance with a process specified by the ,secretary any election made under section #aaig of the ,social ,security ,act by the plan or issuer to not participate in the ,fair ,price ,negotiation ,program under part ,e of title ,,xi of such ,act with respect to a selected drug 7as defined in section #aaib7;c7 of such ,act7 for which coverage is provided under such plan or coverage before the beginning of the plan year for which such election was made4 4 7ii7 ,application to retiree and certain small group health plans ,section #gcb7;a7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aaia;a7a77 is amended by striking section #gaa and inserting sections #gaa and #gaf4 7iii7 ,clerical amendment ,the table of sections for subpart ,b of part #g of subtitle ,b of title ,i of the ,employee ,retirement ,income ,security ,act of #aigd is amended by adding at the end the following3 ,sec4 #gaf4 ,fair ,price ,negotiation ,program and application of maximum fair prices4 4 7,c7 ,,irc 7i7 ,in general ,subchapter ,b of chapter #ajj of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new section3 #ihaf4 ,fair ,price ,negotiation ,program and application of maximum fair prices 7a7 ,in general ,in the case of a group health plan that is treated under section #aaig of the ,social ,security ,act as having in effect an agreement with the ,secretary under the ,fair ,price ,negotiation ,program under part ,e of title ,,xi of such ,act1 with respect to a price applicability period 7as defined in section #aaia7;b7 of such ,act7 and a selected drug 7as defined in section #aaib7;c7 of such ,act7 with respect to such period with respect to which coverage is provided under such plan-- 7#a7 the provisions of such part shall apply1 as applicable-- 7,a7 if coverage of such selected drug is provided under such plan if the drug is furnished or dispensed at a pharmacy or by a mail order service1 to the plan1 and to the individuals enrolled under such plan during such period1 with respect to such selected drug1 in the same manner as such provisions apply to prescription drug plans and ,,ma-,,pd plans1 and to individuals enrolled under such prescription drug plans and ,,ma-,,pd plans during such period2 and 7,b7 if coverage of such selected drug is provided under such plan if the drug is furnished or administered by a hospital1 physician1 or other provider of services or supplier1 to the plan1 to the individuals enrolled under such plan1 and to hospitals1 physicians1 and other providers of services and suppliers during such period1 with respect to such drug in the same manner as such provisions apply to the ,secretary1 to individuals entitled to benefits under part ,a of title ,,xviii or enrolled under part ,b of such title1 and to hospitals1 physicians1 and other providers and suppliers participating under title ,,xviii during such period2 7#b7 the plan shall apply any cost-sharing responsibilities under such plan1 with respect to such selected drug1 by substituting an amount not more than the maximum fair price negotiated under such part ,e of title ,,xi for such drug in lieu of the drug price upon which the cost-sharing would have otherwise applied1 and such cost-sharing responsibilities with respect to such selected drug may not exceed such maximum fair price2 and 7#c7 the ,secretary shall apply the provisions of such part ,e to such plan and such individuals so enrolled in such plan4 7b7 ,notification regarding nonparticipation in ,fair ,price ,negotiation ,program ,a group health plan shall publicly disclose in a manner and in accordance with a process specified by the ,secretary any election made under section #aaig of the ,social ,security ,act by the plan to not participate in the ,fair ,price ,negotiation ,program under part ,e of title ,,xi of such ,act with respect to a selected drug 7as defined in section #aaib7;c7 of such ,act7 for which coverage is provided under such plan before the beginning of the plan year for which such election was made4 4 7ii7 ,application to retiree and certain small group health plans ,section #ihca7;a77#b7 of the ,internal ,revenue ,code of #aihf is amended by inserting other than with respect to section #ihaf1 before any group health plan4 7iii7 ,clerical amendment ,the table of sections for subchapter ,b of chapter #ajj of such ,code is amended by adding at the end the following new item3 ,sec4 #ihaf4 ,fair ,price ,negotiation ,program and application of maximum fair prices4 4 7#c7 ,fair price negotiation program prices included in best price and ,,amp ,section #aibg of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7 is amended-- 7,a7 in subsection 7c77#a77;,c77ii7-- 7i7 in subclause 7,,iii71 by striking at the end 2 and2 7ii7 in subclause 7,,iv71 by striking at the end the period and inserting 2 and2 and 7iii7 by adding at the end the following new subclause3 7,v7 in the case of a rebate period and a covered outpatient drug that is a selected drug 7as defined in section #aaib7;c77 during such rebate period1 shall be inclusive of the price for such drug made available from the manufacturer during the rebate period by reason of application of part ,e of title ,,xi to any wholesaler1 retailer1 provider1 health maintenance organization1 nonprofit entity1 or governmental entity within the ,united ,states4 2 and 7,b7 in subsection 7k77#a77;,b71 by adding at the end the following new clause3 7iii7 ,clarification ,notwithstanding clause 7i71 in the case of a rebate period and a covered outpatient drug that is a selected drug 7as defined in section #aaib7;c77 during such rebate period1 any reduction in price paid during the rebate period to the manufacturer for the drug by a wholesaler or retail community pharmacy described in subparagraph 7,a7 by reason of application of part ,e of title ,,xi shall be included in the average manufacturer price for the covered outpatient drug4 4 7#d7 ,,fehbp ,section #hijb of title #e1 ,united ,states ,code1 is amended by adding at the end the following3 7p7 ,a contract may not be made or a plan approved under this chapter with any carrier that has affirmatively elected1 pursuant to section #aaig of the ,social ,security ,act1 not to participate in the ,fair ,price ,negotiation ,program established under section #aaia of such ,act for any selected drug 7as that term is defined in section #aaib7;c7 of such ,act74 4 7#e7 ,option of ,secretary of ,veterans ,affairs to purchase covered drugs at maximum fair prices ,section #habf of title #ch1 ,united ,states ,code1 is amended-- 7,a7 in subsection 7a77#b71 by inserting 1 subject to subsection 7j71 after may not exceed2 7,b7 in subsection 7d71 in the matter preceding paragraph 7#a71 by inserting 1 subject to subsection 7j7 after for the procurement of the drug2 and 7,c7 by adding at the end the following new subsection3 7j7 7#a7 ,in the case of a covered drug that is a selected drug1 for any year during the price applicability period for such drug1 if the ,secretary determines that the maximum fair price of such drug for such year is less than the price for such drug otherwise in effect pursuant to this section 7including after application of any reduction under subsection 7a77#b7 and any discount under subsection 7c771 at the option of the ,secretary1 in lieu of the maximum price 7determined after application of the reduction under subsection 7a77#b7 and any discount under subsection 7c71 as applicable7 that would be permitted to be charged during such year for such drug pursuant to this section without application of this subsection1 the maximum price permitted to be charged during such year for such drug pursuant to this section shall be such maximum fair price for such drug and year4 7#b7 ,for purposes of this subsection3 7,a7 ,the term maximum fair price means1 with respect to a selected drug and year during the price applicability period for such drug1 the maximum fair price 7as defined in section #aaia7;c77#b7 of the ,social ,security ,act7 for such drug and year4 7,b7 ,the term negotiation eligible drug has the meaning given such term in section #aaib7;d77#a7 of the ,social ,security ,act4 7,c7 ,the term price applicability period has1 with respect to a selected drug1 the meaning given such term in section #aaia7;b77#b7 of such ,act4 7,d7 ,the term selected drug means1 with respect to a year1 a drug that is a selected drug under section #aaib7;c7 of such ,act for such year4 4 #cjb4 ,drug manufacturer excise tax for noncompliance 7a7 ,in general ,subchapter ,e of chapter #cb of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new section3 #daib4 ,selected drugs during noncompliance periods 7a7 ,in general ,there is hereby imposed on the sale by the manufacturer1 producer1 or importer of any selected drug during a day described in subsection 7b7 a tax in an amount such that the applicable percentage is equal to the ratio of-- 7#a7 such tax1 divided by 7#b7 the sum of such tax and the price for which so sold4 7b7 ,noncompliance periods ,a day is described in this subsection with respect to a selected drug if it is a day during one of the following periods3 7#a7 ,the period beginning on the ,june #afth immediately following the selected drug publication date and ending on the first date during which the manufacturer of the drug has in place an agreement described in subsection 7a7 of section #aaic of the ,social ,security ,act with respect to such drug4 7#b7 ,the period beginning on the ,april #ast immediately following the ,june #afth described in paragraph 7#a7 and ending on the first date during which the manufacturer of the drug has agreed to a maximum fair price under such agreement4 7#c7 ,in the case of a selected drug with respect to which the ,secretary of ,health and ,human ,services has specified a renegotiation period under such agreement1 the period beginning on the first date after the last date of such renegotiation period and ending on the first date during which the manufacturer of the drug has agreed to a renegotiated maximum fair price under such agreement4 7#d7 ,with respect to information that is required to be submitted to the ,secretary of ,health and ,human ,services under such agreement1 the period beginning on the date on which such ,secretary certifies that such information is overdue and ending on the date that such information is so submitted4 7#e7 ,in the case of a selected drug with respect to which a payment is due under subsection 7c7 of such section #aaic1 the period beginning on the date on which the ,secretary of ,health and ,human ,services certifies that such payment is overdue and ending on the date that such payment is made in full4 7c7 ,applicable percentage ,for purposes of this section1 the term applicable percentage means-- 7#a7 in the case of sales of a selected drug during the first #ij days described in subsection 7b7 with respect to such drug1 #fe percent1 7#b7 in the case of sales of such drug during the #iast day through the #ahjth day described in subsection 7b7 with respect to such drug1 #ge percent1 7#c7 in the case of sales of such drug during the #ahast day through the #bgjth day described in subsection 7b7 with respect to such drug1 #he percent1 and 7#d7 in the case of sales of such drug during any subsequent day1 #ie percent4 7d7 ,selected drug ,for purposes of this section-- 7#a7 ,in general ,the term selected drug means any selected drug 7within the meaning of section #aaib of the ,social ,security ,act7 which is manufactured or produced in the ,united ,states or entered into the ,united ,states for consumption1 use1 or warehousing4 7#b7 ,united ,states ,the term ,united ,states has the meaning given such term by section #dfab7;a77#d74 7#c7 ,coordination with rules for possessions of the ,united ,states ,rules similar to the rules of paragraphs 7#b7 and 7#d7 of section #dacb7;c7 shall apply for purposes of this section4 7e7 ,other definitions ,for purposes of this section1 the terms selected drug publication date and maximum fair price have the meaning given such terms in section #aaia of the ,social ,security ,act4 7f7 ,anti-,abuse rule ,in the case of a sale which was timed for the purpose of avoiding the tax imposed by this section1 the ,secretary may treat such sale as occurring during a day described in subsection 7b74 4 7b7 ,no deduction for excise tax payments ,section #bge of the ,internal ,revenue ,code of #aihf is amended by adding or by section #daib before the period at the end of subsection 7a77#f74 7c7 ,conforming amendments 7#a7 ,section #dbba7;a7 of the ,internal ,revenue ,code of #aihf is amended by inserting or #daib after section #daia4 7#b7 ,section #fdaf7;b77#b7 of such ,code is amended by inserting or #daib after section #daia4 7d7 ,clerical amendments 7#a7 ,the heading of subchapter ,e of chapter #cb of the ,internal ,revenue ,code of #aihf is amended by striking ,medical devices and inserting ,other medical products4 7#b7 ,the table of subchapters for chapter #cb of such ,code is amended by striking the item relating to subchapter ,e and inserting the following new item3 ,subchapter ,e4 ,other medical products 4 7#c7 ,the table of sections for subchapter ,e of chapter #cb of such ,code is amended by adding at the end the following new item3 ,sec4 #daib4 ,selected drugs during noncompliance periods4 4 7e7 ,effective date ,the amendments made by this section shall apply to sales after the date of the enactment of this ,act4 #cjc4 ,fair ,price ,negotiation ,implementation ,fund 7a7 ,in general ,there is hereby established a ,fair ,price ,negotiation ,implementation ,fund 7referred to in this section as the ,fund74 ,the ,secretary of ,health and ,human ,services may obligate and expend amounts in the ,fund to carry out this title 7and the amendments made by such title74 7b7 ,funding ,there is authorized to be appropriated1 and there is hereby appropriated1 out of any monies in the ,treasury not otherwise appropriated1 to the ,fund #c1jjj1jjj1jjj1 to remain available until expended1 of which-- 7#a7 #fjj1jjj1jjj shall become available on the date of the enactment of this ,act2 7#b7 #fjj1jjj1jjj shall become available on ,october #a1 #bjbj2 7#c7 #fjj1jjj1jjj shall become available on ,october #a1 #bjba2 7#d7 #fjj1jjj1jjj shall become available on ,october #a1 #bjbb2 and 7#e7 #fjj1jjj1jjj shall become available on ,october #a1 #bjbc4 7c7 ,supplement not supplant ,any amounts appropriated pursuant to this section shall be in addition to any other amounts otherwise appropriated pursuant to any other provision of law4 ,,iv ,public ,health ,investments #dja4 ,supporting increased innovation 7a7 ,in general ,the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,national ,institutes of ,health1 shall continue to support and to expand1 as applicable1 biomedical research carried out through the ,national ,institutes of ,health innovation projects described in section #ajja7;b77#d7 of the #bast ,century ,cures ,act 7,public ,law #aad-bee74 ,the ,secretary shall ensure that any such research 7and related activities7 is conducted in compliance with section #dib;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhi;a-#b7 7relating to the inclusion of women and members of minority groups in research74 7b7 ,authorization of appropriations ,to carry out this subsection1 in addition to funds made available under paragraph 7#b7 of section #ajja7;b7 of the #bast ,century ,cures ,act 7,public ,law #aad-bee71 there is authorized to be appropriated1 and there is appropriated to the ,,nih ,innovation ,account established under such section #ajja7;b71 out of any moneys in the ,treasury not otherwise obligated1 #b1jjj1jjj1jjj for fiscal year #bjba1 to remain available until expended4 ,passed the ,house of ,representatives ,june #bi1 #bjbj4;,cheryl ,l4 ,johnson1,clerk4 ,september #h1 #bjbj,read the second time and placed on the calendar