,,ii ,calendar ,no4 #eba #aafth ,,congress #b;d ,session ,h4 ,r4 #c ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,december #af1 #bjai,received ,august #ac1 #bjbj,read the first time ,september #h1 #bjbj,read the second time and placed on the calendar ,,an ,,act ,to establish a fair price negotiation program1 protect the ,medicare program from excessive price increases1 and establish an out-of-pocket maximum for ,medicare part ,d enrollees1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,elijah ,e4 ,cummings ,lower ,drug ,costs ,now ,act4 7b7 ,table of contents ,the table of contents is as follows3 ,sec4 #a4 ,short title2 table of contents4,title ,i--,lowering ,prices ,through ,fair ,drug ,price ,negotiation,sec4 #aja4 ,providing for lower prices for certain high-priced single source drugs4,sec4 #ajb4 ,selected drug manufacturer excise tax imposed during noncompliance periods4,sec4 #ajc4 ,fair ,price ,negotiation ,implementation ,fund4,title ,,ii--,medicare ,parts ,b and ,d ,prescription ,drug ,inflation ,rebates,sec4 #bja4 ,medicare part ,b rebate by manufacturers4,sec4 #bjb4 ,medicare part ,d rebate by manufacturers4,sec4 #bjc4 ,provision regarding inflation rebates for group health plans and group health insurance coverage4,sec4 #bjd4 ,annual report on drug costs in group health plans and group health insurance coverage4,sec4 #bje4 ,collection of data4,title ,,iii--,part ,d ,improvements and ,maximum ,out-of-,pocket ,cap for ,medicare ,beneficiaries,sec4 #cja4 ,medicare part ,d benefit redesign4,sec4 #cjb4 ,allowing certain enrollees of prescription drugs plans and ,,ma-,,pd plans under ,medicare program to spread out cost-sharing under certain circumstances4,sec4 #cjc4 ,establishment of pharmacy quality measures under ,medicare part ,d4,title ,,iv--,drug ,price ,transparency,sec4 #dja4 ,drug price transparency4,title ,v--,program improvements for ,medicare low-income beneficiaries,sec4 #eja4 ,dissemination to ,medicare part ,d subsidy eligible individuals of information comparing premiums of certain prescription drug plans4,sec4 #ejb4 ,providing for intelligent assignment of certain subsidy eligible individuals auto-enrolled under ,medicare prescription drug plans and ,,ma-,,pd plans4,sec4 #ejc4 ,expanding eligibility for low-income subsidies under part ,d of the ,medicare program4,sec4 #ejd4 ,automatic eligibility of certain low-income territorial residents for premium and cost-sharing subsidies under the ,medicare program2 ,sunset of enhanced allotment program4,sec4 #eje4 ,automatic qualification of certain ,medicaid beneficiaries for premium and cost-sharing subsidies under part ,d of the ,medicare program4,sec4 #ejf4 ,providing for certain rules regarding the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost-sharing subsidies under part ,d of the ,medicare program4,sec4 #ejg4 ,reducing cost-sharing and other program improvements for low-income beneficiaries4,title ,,vi--,providing for ,dental1 ,vision1 and ,hearing ,coverage under the ,medicare program,sec4 #fja4 ,dental and oral health care4,sec4 #fjb4 ,providing coverage for hearing care under the ,medicare program4,sec4 #fjc4 ,providing coverage for vision care under the ,medicare program4,title ,,vii--,,nih1 ,,fda1 and ,opioids ,funding,subtitle ,a--,biomedical ,innovation ,expansion,sec4 #gja4 ,,nih ,innovation ,initiatives4,sec4 #gjb4 ,,nih clinical trial4,sec4 #gjc4 ,innovation ,network4,subtitle ,b--,investing in ,safety and ,innovation,sec4 #gaa4 ,food and ,drug ,administration4,sec4 #gab4 ,study on high-risk1 high-reward drugs4,subtitle ,c--,opioid ,epidemic ,response,sec4 #gba4 ,opioid ,epidemic ,response ,fund4,sec4 #gbb4 ,substance ,abuse and ,mental ,health ,services ,administration4,sec4 #gbc4 ,centers for ,disease ,control and ,prevention4,sec4 #gbd4 ,food and ,drug ,administration4,sec4 #gbe4 ,national ,institutes of ,health4,sec4 #gbf4 ,health ,resources and ,services ,administration4,sec4 #gbg4 ,administration for ,children and ,families4,subtitle ,d--,reducing ,administrative ,costs and ,burdens in ,health ,care,sec4 #gca4 ,reducing administrative costs and burdens in health care4,title ,,viii--,miscellaneous,sec4 #hja4 ,guaranteed issue of certain ,medigap policies4,sec4 #hjb4 ,reporting requirements for ,,pdp sponsors regarding point-of-sale rejections under ,medicare part ,d4,sec4 #hjc4 ,providing access to annual ,medicare notifications in multiple languages4,sec4 #hjd4 ,temporary increase in ,medicare part ,b payment for certain biosimilar biological products4,sec4 #hje4 ,waiving medicare coinsurance for colorectal cancer screening tests4,sec4 #hjf4 ,medicare coverage of certain lymphedema compression treatment items4,sec4 #hjg4 ,physician fee update4,sec4 #hjh4 ,additional community health center funding4,sec4 #hji4 ,grants to improve trauma support services and mental health care for children and youth in educational settings4,sec4 #haj4 ,pathway to ,health ,careers ,act4,sec4 #haa4 ,home ,visiting to ,reduce ,maternal ,mortality and ,morbidity ,act4,sec4 #hab4 ,addition of new measures based on access to biosimilar biological products to the #e-star rating system under medicare advantage4,sec4 #hac4 ,sense of ,congress regarding the impact of the high cost of prescription drugs on communities of color and persons living in rural or sparsely populated areas of the ,united ,states4,sec4 #had4 ,regulations requiring direct-to-consumer advertisements for prescription drugs and biological products to include truthful and not misleading pricing information4,sec4 #hae4 ,improving transparency and preventing the use of abusive spread pricing and related practices in ,medicaid4,sec4 #haf4 ,graduate medical education improvements in rural and underserved communities4 ,i ,lowering ,prices ,through ,fair ,drug ,price ,negotiation #aja4 ,providing for lower prices for certain high-priced single source drugs 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 et4 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 #ajb4 ,selected drug manufacturer excise tax imposed during noncompliance periods 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 #ajc4 ,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 and titles ,,ii and ,,iii 7and the amendments made by such titles74 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 ,,ii ,medicare ,parts ,b and ,d ,prescription ,drug ,inflation ,rebates #bja4 ,medicare part ,b rebate by manufacturers 7a7 ,in general ,section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is amended by adding at the end the following new subsection3 7x7 ,rebate by manufacturers for single source drugs with prices increasing faster than inflation 7#a7 ,requirements 7,a7 ,secretarial provision of information ,not later than #f months after the end of each calendar quarter beginning on or after ,july #a1 #bjba1 the ,secretary shall1 for each part ,b rebatable drug1 report to each manufacturer of such part ,b rebatable drug the following for such calendar quarter3 7i7 ,information on the total number of units of the billing and payment code described in subparagraph 7,a77i7 of paragraph 7#c7 with respect to such drug and calendar quarter4 7ii7 ,information on the amount 7if any7 of the excess average sales price increase described in subparagraph 7,a77ii7 of such paragraph for such drug and calendar quarter4 7iii7 ,the rebate amount specified under such paragraph for such part ,b rebatable drug and calendar quarter4 7,b7 ,manufacturer requirement ,for each calendar quarter beginning on or after ,july #a1 #bjba1 the manufacturer of a part ,b rebatable drug shall1 for such drug1 not later than #cj days after the date of receipt from the ,secretary of the information described in subparagraph 7,a7 for such calendar quarter1 provide to the ,secretary a rebate that is equal to the amount specified in paragraph 7#c7 for such drug for such calendar quarter4 7#b7 ,part ,b rebatable drug defined 7,a7 ,in general ,in this subsection1 the term part ,b rebatable drug means a single source drug or biological 7as defined in subparagraph 7,d7 of section #ahdg;,a7c77#f771 including a biosimilar biological product 7as defined in subparagraph 7,h7 of such section71 paid for under this part1 except such term shall not include such a drug or biological-- 7i7 if the average total allowed charges for a year per individual that uses such a drug or biological1 as determined by the ,secretary1 are less than1 subject to subparagraph 7,b71 #ajj2 or 7ii7 that is a vaccine described in subparagraph 7,a7 or 7,b7 of section #ahfa7s77#aj74 7,b7 ,increase ,the dollar amount applied under subparagraph 7,a77i7-- 7i7 for #bjbb1 shall be the dollar amount specified under such subparagraph for #bjba1 increased by the percentage increase in the consumer price index for all urban consumers 7,united ,states city average7 for the #ab month period ending with ,june of the previous year2 and 7ii7 for a subsequent year1 shall be the dollar amount specified in this clause 7or clause 7i77 for the previous year1 increased by the percentage increase in the consumer price index for all urban consumers 7,united ,states city average7 for the #ab month period ending with ,june of the previous year4 ,any dollar amount specified under this subparagraph that is not a multiple of #aj shall be rounded to the nearest multiple of #aj4 7#c7 ,rebate amount 7,a7 ,in general ,for purposes of paragraph 7#a71 the amount specified in this paragraph for a part ,b rebatable drug assigned to a billing and payment code for a calendar quarter is1 subject to paragraph 7#d71 the amount equal to the product of-- 7i7 subject to subparagraphs 7,b7 and 7,g71 the total number of units of the billing and payment code for such part ,b rebatable drug furnished under this part during the calendar quarter2 and 7ii7 the amount 7if any7 by which-- 7,i7 the payment amount under subparagraph 7,b7 or 7,c7 of section #ahdg;,a7b77#a71 as applicable1 for such part ,b rebatable drug during the calendar quarter2 exceeds 7,,ii7 the inflation-adjusted payment amount determined under subparagraph 7,c7 for such part ,b rebatable drug during the calendar quarter4 7,b7 ,excluded units ,for purposes of subparagraph 7,a77i71 the total number of units of the billing and payment code for each part ,b rebatable drug furnished during a calendar quarter shall not include-- 7i7 units packaged into the payment for a procedure or service under section #ahcc7t7 or under section #ahcc7;i7 7instead of separately payable under such respective section72 7ii7 units included under the single payment system for renal dialysis services under section #ahha7;b77#ad72 or 7iii7 units of a part ,b rebatable drug of a manufacturer furnished to an individual1 if such manufacturer1 with respect to the furnishing of such units of such drug1 provides for discounts under section #cdj;,b of the ,public ,health ,service ,act or for rebates under section #aibg4 7,c7 ,determination of inflation-adjusted payment amount ,the inflation-adjusted payment amount determined under this subparagraph for a part ,b rebatable drug for a calendar quarter is-- 7i7 the payment amount for the billing and payment code for such drug in the payment amount benchmark quarter 7as defined in subparagraph 7,d772 increased by 7ii7 the percentage by which the rebate period ,,cpi-,u 7as defined in subparagraph 7,f77 for the calendar quarter exceeds the benchmark period ,,cpi-,u 7as defined in subparagraph 7,e774 7,d7 ,payment amount benchmark quarter ,the term payment amount benchmark quarter means the calendar quarter beginning ,january #a1 #bjaf4 7,e7 ,benchmark period ,,cpi-,u ,the term benchmark period ,,cpi-,u means the consumer price index for all urban consumers 7,united ,states city average7 for ,july #bjae4 7,f7 ,rebate period ,,cpi-,u ,the term rebate period ,,cpi-,u means1 with respect to a calendar quarter described in subparagraph 7,c71 the greater of the benchmark period ,,cpi-,u and the consumer price index for all urban consumers 7,united ,states city average7 for the first month of the calendar quarter that is two calendar quarters prior to such described calendar quarter4 7,g7 ,counting units 7i7 ,cut-off period to count units ,for purposes of subparagraph 7,a77i71 subject to clause 7ii71 to count the total number of billing units for a part ,b rebatable drug for a quarter1 the ,secretary may use a cut-off period in order to exclude from such total number of billing units for such quarter claims for services furnished during such quarter that were not processed at an appropriate time prior to the end of the cut-off period4 7ii7 ,counting units for claims processed after cut-off period ,if the ,secretary uses a cut-off period pursuant to clause 7i71 in the case of units of a part ,b rebatable drug furnished during a quarter but pursuant to application of such cut-off period excluded for purposes of subparagraph 7,a77i7 from the total number of billing units for the drug for such quarter1 the ,secretary shall count such units of such drug so furnished in the total number of billing units for such drug for a subsequent quarter1 as the ,secretary determines appropriate4 7#d7 ,special treatment of certain drugs and exemption 7,a7 ,subsequently approved drugs ,subject to subparagraph 7,b71 in the case of a part ,b rebatable drug first approved or licensed by the ,food and ,drug ,administration after ,july #a1 #bjae1 clause 7i7 of paragraph 7#c77;,c7 shall be applied as if the term payment amount benchmark quarter were defined under paragraph 7#c77;,d7 as the third full calendar quarter after the day on which the drug was first marketed and clause 7ii7 of paragraph 7#c77;,c7 shall be applied as if the term benchmark period ,,cpi-,u were defined under paragraph 7#c77;,e7 as if the reference to ,july #bjae under such paragraph were a reference to the first month of the first full calendar quarter after the day on which the drug was first marketed4 7,b7 ,timeline for provision of rebates for subsequently approved drugs ,in the case of a part ,b rebatable drug first approved or licensed by the ,food and ,drug ,administration after ,july #a1 #bjae1 paragraph 7#a77;,b7 shall be applied as if the reference to ,july #a1 #bjba under such paragraph were a reference to the later of the #fth full calendar quarter after the day on which the drug was first marketed or ,july #a1 #bjba4 7,c7 ,exemption for shortages ,the ,secretary may reduce or waive the rebate amount under paragraph 7#a77;,b7 with respect to a part ,b rebatable drug that is described as currently in shortage on the shortage list in effect under section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act or in the case of other exigent circumstances1 as determined by the ,secretary4 7,d7 ,selected drugs ,in the case of a part ,b rebatable drug that is a selected drug 7as defined in section #aaib7;c77 for a price applicability period 7as defined in section #aaia7;b77#b77-- 7i7 for calendar quarters during such period for which a maximum fair price 7as defined in section #aaia7;c77#b77 for such drug has been determined and is applied under part ,e of title ,,xi1 the rebate amount under paragraph 7#a77;,b7 shall be waived2 and 7ii7 in the case such drug is determined 7pursuant to such section #aaib7;c77 to no longer be a selected drug1 for each applicable year beginning after the price applicability period with respect to such drug1 clause 7i7 of paragraph 7#c77;,c7 shall be applied as if the term payment amount benchmark quarter were defined under paragraph 7#c77;,d7 as the calendar quarter beginning ,january #a of the last year beginning during such price applicability period with respect to such selected drug and clause 7ii7 of paragraph 7#c77;,c7 shall be applied as if the term benchmark period ,,cpi-,u were defined under paragraph 7#c77;,e7 as if the reference to ,july #bjae under such paragraph were a reference to the ,july of the year preceding such last year4 7#e7 ,application to beneficiary coinsurance ,in the case of a part ,b rebatable drug1 if the payment amount for a quarter exceeds the inflation adjusted payment for such quarter-- 7,a7 in computing the amount of any coinsurance applicable under this title to an individual with respect to such drug1 the computation of such coinsurance shall be based on the inflation-adjusted payment amount determined under paragraph 7#c77;,c7 for such part ,b rebatable drug2 and 7,b7 the amount of such coinsurance is equal to #bj percent of such inflation-adjusted payment amount so determined4 7#f7 ,rebate deposits ,amounts paid as rebates under paragraph 7#a77;,b7 shall be deposited into the ,federal ,supplementary ,medical ,insurance ,trust ,fund established under section #ahda4 7#g7 ,civil money penalty ,if a manufacturer of a part ,b rebatable drug has failed to comply with the requirements under paragraph 7#a77;,b7 for such drug for a calendar quarter1 the manufacturer shall be subject to1 in accordance with a process established by the ,secretary pursuant to regulations1 a civil money penalty in an amount equal to at least #abe percent of the amount specified in paragraph 7#c7 for such drug for such calendar quarter4 ,the provisions of section #aabh;,a 7other than subsections 7a7 7with respect to amounts of penalties or additional assessments7 and 7b77 shall apply to a civil money penalty under this paragraph in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a7a74 7#h7 ,study and report 7,a7 ,study ,the ,secretary shall conduct a study of the feasibility of and operational issues involved with the following3 7i7 ,including multiple source drugs 7as defined in section #ahdg;,a7c77#f77;,c77 in the rebate system under this subsection4 7ii7 ,including drugs and biologicals paid for under ,,ma plans under part ,c in the rebate system under this subsection4 7iii7 ,including drugs excluded under paragraph 7#b77;,a7 and units of the billing and payment code of the drugs excluded under paragraph 7#c77;,b7 in the rebate system under this subsection4 7,b7 ,report ,not later than #c years after the date of the enactment of this subsection1 the ,secretary shall submit to ,congress a report on the study conducted under subparagraph 7,a74 7#i7 ,application to multiple source drugs ,the ,secretary may1 based on the report submitted under paragraph 7#h7 and pursuant to rulemaking1 apply the provisions of this subsection to multiple source drugs 7as defined in section #ahdg;,a7c77#f77;,c771 including1 for purposes of determining the rebate amount under paragraph 7#c71 by calculating manufacturer-specific average sales prices for the benchmark period and the rebate period4 4 7b7 ,amounts payable2 cost-,sharing ,section #ahcc of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#a7-- 7i7 in subparagraph 7,s71 by striking with respect to and inserting subject to subparagraph 7,,dd71 with respect to2 7ii7 by striking and 7,,cc7 and inserting 7,,cc72 and 7iii7 by inserting before the semicolon at the end the following3 1 and 7,,dd7 with respect to a part ,b rebatable drug 7as defined in paragraph 7#b7 of section #ahcd7x77 for which the payment amount for a calendar quarter under paragraph 7#c77;,a77ii77,i7 of such section for such quarter exceeds the inflation-adjusted payment under paragraph 7#c77;,a77ii77,,ii7 of such section for such quarter1 the amounts paid shall be the difference between 7i7 the payment amount under paragraph 7#c77;,a77ii77,i7 of such section for such drug1 and 7ii7 #bj percent of the inflation-adjusted payment amount under paragraph 7#c77;,a77ii77,,ii7 of such section for such drug2 7,b7 by adding at the end of the flush left matter following paragraph 7#i71 the following3 ,for purposes of applying paragraph 7#a77;,,dd71 subsections 7i77#i7 and 7t77#h77;,f71 and section #ahcd7x77#e71 the ,secretary shall make such estimates and use such data as the ,secretary determines appropriate1 and notwithstanding any other provision of law1 may do so by program instruction or otherwise4 2 7#b7 in subsection 7i71 by adding at the end the following new paragraph3 7#i7 ,in the case of a part ,b rebatable drug 7as defined in paragraph 7#b7 of section #ahcd7x77 for which payment under this subsection is not packaged into a payment for a covered ,,opd service 7as defined in subsection 7t77#a77;,b77 7or group of services7 furnished on or after ,july #a1 #bjba1 under the system under this subsection1 in lieu of calculation of coinsurance and the amount of payment otherwise applicable under this subsection1 the provisions of section #ahcd7x77#e71 paragraph 7#a77;,,dd7 of subsection 7a71 and the flush left matter following paragraph 7#i7 of subsection 7a71 shall1 as determined appropriate by the ,secretary1 apply under this subsection in the same manner as such provisions of section #ahcd7x77#e7 and subsection 7a7 apply under such section and subsection4 2 and 7#c7 in subsection 7t77#h71 by adding at the end the following new subparagraph3 7,f7 ,part ,b rebatable drugs ,in the case of a part ,b rebatable drug 7as defined in paragraph 7#b7 of section #ahcd7x77 for which payment under this part is not packaged into a payment for a service furnished on or after ,july #a1 #bjba1 under the system under this subsection1 in lieu of calculation of coinsurance and the amount of payment otherwise applicable under this subsection1 the provisions of section #ahcd7x77#e71 paragraph 7#a77;,,dd7 of subsection 7a71 and the flush left matter following paragraph 7#i7 of subsection 7a71 shall1 as determined appropriate by the ,secretary1 apply under this subsection in the same manner as such provisions of section #ahcd7x77#e7 and subsection 7a7 apply under such section and subsection4 4 7c7 ,conforming amendments 7#a7 ,to part ,b ,,asp calculation ,section #ahdg;,a7c77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#c77 is amended by inserting or section #ahcd7x7 after section #aibg4 7#b7 ,excluding parts ,b drug inflation rebate from best price ,section #aibg7;c77#a77;,c77ii77,i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#a77;,c77ii77,i77 is amended by inserting or section #ahcd7x7 after this section4 7#c7 ,coordination with ,medicaid rebate information disclosure ,section #aibg7;b77#c77;,d77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,d77i77 is amended by striking or to carry out section #ahdg;,b and inserting to carry out section #ahdg;,b or section #ahcd7x74 #bjb4 ,medicare part ,d rebate by manufacturers 7a7 ,in general ,part ,d of title ,,xviii of the ,social ,security ,act is amended by inserting after section #ahfj;,d-#ad;,a 7#db ,u4,s4,c4 #aciew-#aad;a7 the following new section3 #ahfj;,d-#ad;,b4 ,manufacturer rebate for certain drugs with prices increasing faster than inflation 7a7 ,in general 7#a7 ,in general ,subject to the provisions of this section1 in order for coverage to be available under this part for a part ,d rebatable drug 7as defined in subsection 7h77#a77 of a manufacturer 7as defined in section #aibg7k77#e77 dispensed during an applicable year1 the manufacturer must have entered into and have in effect an agreement described in subsection 7b74 7#b7 ,authorizing ,coverage for ,drugs ,not ,covered ,under ,agreements ,paragraph 7#a7 shall not apply to the dispensing of a covered part ,d drug if-- 7,a7 the ,secretary has made a determination that the availability of the drug is essential to the health of beneficiaries under this part2 or 7,b7 the ,secretary determines that in the period beginning on ,january #a1 #bjbb1 and ending on ,december #ca1 #bjbb1 there were extenuating circumstances4 7#c7 ,applicable year ,for purposes of this section the term applicable year means a year beginning with #bjbb4 7b7 ,agreements 7#a7 ,terms of agreement ,an agreement described in this subsection1 with respect to a manufacturer of a part ,d rebatable drug1 is an agreement under which the following shall apply3 7,a7 ,secretarial provision of information ,not later than #i months after the end of each applicable year with respect to which the agreement is in effect1 the ,secretary1 for each part ,d rebatable drug of the manufacturer1 shall report to the manufacturer the following for such year3 7i7 ,information on the total number of units 7as defined in subsection 7h77#b77 for each dosage form and strength with respect to such part ,d rebatable drug and year4 7ii7 ,information on the amount 7if any7 of the excess average manufacturer price increase described in subsection 7c77#a77;,b7 for each dosage form and strength with respect to such drug and year4 7iii7 ,the rebate amount specified under subsection 7c7 for each dosage form and strength with respect to such drug and year4 7,b7 ,manufacturer requirements ,for each applicable year with respect to which the agreement is in effect1 the manufacturer of the part ,d rebatable drug1 for each dosage form and strength with respect to such drug1 not later than #cj days after the date of receipt from the ,secretary of the information described in subparagraph 7,a7 for such year1 shall provide to the ,secretary a rebate that is equal to the amount specified in subsection 7c7 for such dosage form and strength with respect to such drug for such year4 7#b7 ,length of agreement 7,a7 ,in general ,an agreement under this section1 with respect to a part ,d rebatable drug1 shall be effective for an initial period of not less than one year and shall be automatically renewed for a period of not less than one year unless terminated under subparagraph 7,b74 7,b7 ,termination 7i7 ,by ,secretary ,the ,secretary may provide for termination of an agreement under this section for violation of the requirements of the agreement or other good cause shown4 ,such termination shall not be effective earlier than #cj days after the date of notice of such termination4 ,the ,secretary shall provide1 upon request1 a manufacturer with a hearing concerning such a termination1 but such hearing shall not delay the effective date of the termination4 7ii7 ,by a manufacturer ,a manufacturer may terminate an agreement under this section for any reason4 ,any such termination shall be effective1 with respect to a plan year-- 7,i7 if the termination occurs before ,january #cj of the plan year1 as of the day after the end of the plan year2 and 7,,ii7 if the termination occurs on or after ,january #cj of the plan year1 as of the day after the end of the succeeding plan year4 7,c7 ,effectiveness of termination ,any termination under this paragraph shall not affect rebates due under the agreement under this section before the effective date of its termination4 7,d7 ,delay before reentry ,in the case of any agreement under this section with a manufacturer that is terminated in a plan year1 the ,secretary may not enter into another such agreement with the manufacturer 7or a successor manufacturer7 before the subsequent plan year1 unless the ,secretary finds good cause for an earlier reinstatement of such an agreement4 7c7 ,rebate amount 7#a7 ,in general ,for purposes of this section1 the amount specified in this subsection for a dosage form and strength with respect to a part ,d rebatable drug and applicable year is1 subject to subparagraphs 7,b7 and 7,c7 of paragraph 7#e71 the amount equal to the product of-- 7,a7 the total number of units of such dosage form and strength with respect to such part ,d rebatable drug and year2 and 7,b7 the amount 7if any7 by which-- 7i7 the annual manufacturer price 7as determined in paragraph 7#b77 paid for such dosage form and strength with respect to such part ,d rebatable drug for the year2 exceeds 7ii7 the inflation-adjusted payment amount determined under paragraph 7#c7 for such dosage form and strength with respect to such part ,d rebatable drug for the year4 7#b7 ,determination of annual manufacturer price ,the annual manufacturer price determined under this paragraph for a dosage form and strength1 with respect to a part ,d rebatable drug and an applicable year1 is the sum of the products of-- 7,a7 the average manufacturer price 7as defined in subsection 7h77#f77 of such dosage form and strength1 as calculated for a unit of such drug1 with respect to each of the calendar quarters of such year2 and 7,b7 the ratio of-- 7i7 the total number of units of such dosage form and strength dispensed during each such calendar quarter of such year2 to 7ii7 the total number of units of such dosage form and strength dispensed during such year4 7#c7 ,determination of inflation-adjusted payment amount ,the inflation-adjusted payment amount determined under this paragraph for a dosage form and strength with respect to a part ,d rebatable drug for an applicable year1 subject to subparagraphs 7,a7 and 7,d7 of paragraph 7#e71 is-- 7,a7 the benchmark year manufacturer price determined under paragraph 7#d7 for such dosage form and strength with respect to such drug and an applicable year2 increased by 7,b7 the percentage by which the applicable year ,,cpi-,u 7as defined in subsection 7h77#e77 for the applicable year exceeds the benchmark period ,,cpi-,u 7as defined in subsection 7h77#d774 7#d7 ,determination of benchmark year manufacturer price ,the benchmark year manufacturer price determined under this paragraph for a dosage form and strength1 with respect to a part ,d rebatable drug and an applicable year1 is the sum of the products of-- 7,a7 the average manufacturer price 7as defined in subsection 7h77#f77 of such dosage form and strength1 as calculated for a unit of such drug1 with respect to each of the calendar quarters of the payment amount benchmark year 7as defined in subsection 7h77#c772 and 7,b7 the ratio of-- 7i7 the total number of units of such dosage form and strength dispensed during each such calendar quarter of such payment amount benchmark year2 to 7ii7 the total number of units of such dosage form and strength dispensed during such payment amount benchmark year4 7#e7 ,special treatment of certain drugs and exemption 7,a7 ,subsequently approved drugs ,in the case of a part ,d rebatable drug first approved or licensed by the ,food and ,drug ,administration after ,january #a1 #bjaf1 subparagraphs 7,a7 and 7,b7 of paragraph 7#d7 shall be applied as if the term payment amount benchmark year were defined under subsection 7h77#c7 as the first calendar year beginning after the day on which the drug was first marketed by any manufacturer and subparagraph 7,b7 of paragraph 7#c7 shall be applied as if the term benchmark period ,,cpi-,u were defined under subsection 7h77#d7 as if the reference to ,january #bjaf under such subsection were a reference to ,january of the first year beginning after the date on which the drug was first marketed by any manufacturer4 7,b7 ,exemption for shortages ,the ,secretary may reduce or waive the rebate under paragraph 7#a7 with respect to a part ,d rebatable drug that is described as currently in shortage on the shortage list in effect under section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act or in the case of other exigent circumstances1 as determined by the ,secretary4 7,c7 ,treatment of new formulations 7i7 ,in general ,in the case of a part ,d rebatable drug that is a line extension of a part ,d rebatable drug that is an oral solid dosage form1 the ,secretary shall establish a formula for determining the amount specified in this subsection with respect to such part ,d rebatable drug and an applicable year with consideration of the original part ,d rebatable drug4 7ii7 ,line extension defined ,in this subparagraph1 the term line extension means1 with respect to a part ,d rebatable drug1 a new formulation of the drug 7as determined by the ,secretary71 such as an extended release formulation1 but does not include an abuse-deterrent formulation of the drug 7as determined by the ,secretary71 regardless of whether such abuse-deterrent formulation is an extended release formulation4 7,d7 ,selected drugs ,in the case of a part ,d rebatable drug that is a selected drug 7as defined in section #aaib7;c77 for a price applicability period 7as defined in section #aaia7;b77#b77-- 7i7 for plan years during such period for which a maximum fair price 7as defined in section #aaia7;c77#b77 for such drug has been determined and is applied under part ,e of title ,,xi1 the rebate under subsection 7b77#a77;,b7 shall be waived2 and 7ii7 in the case such drug is determined 7pursuant to such section #aaib7;c77 to no longer be a selected drug1 for each applicable year beginning after the price applicability period with respect to such drug1 subparagraphs 7,a7 and 7,b7 of paragraph 7#d7 shall be applied as if the term payment amount benchmark year were defined under subsection 7h77#c7 as the last year beginning during such price applicability period with respect to such selected drug and subparagraph 7,b7 of paragraph 7#c7 shall be applied as if the term benchmark period ,,cpi-,u were defined under subsection 7h77#d7 as if the reference to ,january #bjaf under such subsection were a reference to ,january of the last year beginning during such price applicability period with respect to such drug4 7d7 ,rebate deposits ,amounts paid as rebates under subsection 7c7 shall be deposited into the ,medicare ,prescription ,drug ,account in the ,federal ,supplementary ,medical ,insurance ,trust ,fund established under section #ahda4 7e7 ,information ,for purposes of carrying out this section1 the ,secretary shall use information submitted by manufacturers under section #aibg7;b77#c74 7f7 ,civil money penalty ,in the case of a manufacturer of a part ,d rebatable drug with an agreement in effect under this section who has failed to comply with the terms of the agreement under subsection 7b77#a77;,b7 with respect to such drug for an applicable year1 the ,secretary may impose a civil money penalty on such manufacturer in an amount equal to #abe percent of the amount specified in subsection 7c7 for such drug for such year4 ,the provisions of section #aabh;,a 7other than subsections 7a7 7with respect to amounts of penalties or additional assessments7 and 7b77 shall apply to a civil money penalty under this subsection in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a7a74 7g7 ,judicial review ,there shall be no judicial review of the following3 7#a7 ,the determination of units under this section4 7#b7 ,the determination of whether a drug is a part ,d rebatable drug under this section4 7#c7 ,the calculation of the rebate amount under this section4 7h7 ,definitions ,in this section3 7#a7 ,part ,d rebatable drug defined 7,a7 ,in general ,the term part ,d rebatable drug means a drug or biological that would 7without application of this section7 be a covered part ,d drug1 except such term shall1 with respect to an applicable year1 not include such a drug or biological if the average annual total cost under this part for such year per individual who uses such a drug or biological1 as determined by the ,secretary1 is less than1 subject to subparagraph 7,b71 #ajj1 as determined by the ,secretary using the most recent data available or1 if data is not available1 as estimated by the ,secretary4 7,b7 ,increase ,the dollar amount applied under subparagraph 7,a7-- 7i7 for #bjbc1 shall be the dollar amount specified under such subparagraph for #bjbb1 increased by the percentage increase in the consumer price index for all urban consumers 7,united ,states city average7 for the #ab-month period beginning with ,january of #bjbb2 and 7ii7 for a subsequent year1 shall be the dollar amount specified in this subparagraph for the previous year1 increased by the percentage increase in the consumer price index for all urban consumers 7,united ,states city average7 for the #ab-month period beginning with ,january of the previous year4 ,any dollar amount specified under this subparagraph that is not a multiple of #aj shall be rounded to the nearest multiple of #aj4 7#b7 ,unit defined ,the term unit means1 with respect to a part ,d rebatable drug1 the lowest identifiable quantity 7such as a capsule or tablet1 milligram of molecules1 or grams7 of the part ,d rebatable drug that is dispensed to individuals under this part4 7#c7 ,payment amount benchmark year ,the term payment amount benchmark year means the year beginning ,january #a1 #bjaf4 7#d7 ,benchmark period ,,cpi-,u ,the term benchmark period ,,cpi-,u means the consumer price index for all urban consumers 7,united ,states city average7 for ,january #bjaf4 7#e7 ,applicable year ,,cpi-,u ,the term applicable year ,,cpi-,u means1 with respect to an applicable year1 the consumer price index for all urban consumers 7,united ,states city average7 for ,january of such year4 7#f7 ,average manufacturer price ,the term average manufacturer price has the meaning1 with respect to a part ,d rebatable drug of a manufacturer1 given such term in section #aibg7k77#a71 with respect to a covered outpatient drug of a manufacturer for a rebate period under section #aibg4 4 7b7 ,conforming amendments 7#a7 ,to part ,b ,,asp calculation ,section #ahdg;,a7c77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#c771 as amended by section #bja7;c77#a71 is further amended by striking section #aibg or section #ahcd7x7 and inserting section #aibg1 section #ahcd7x71 or section #ahfj;,d-#ad;,b4 7#b7 ,excluding part ,d drug inflation rebate from best price ,section #aibg7;c77#a77;,c77ii77,i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#a77;,c77ii77,i771 as amended by section #bja7;c77#b71 is further amended by striking or section #ahcd7x7 and inserting 1 section #ahcd7x71 or section #ahfj;,d-#ad;,b4 7#c7 ,coordination with ,medicaid rebate information disclosure ,section #aibg7;b77#c77;,d77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,d77i771 as amended by section #bja7;c77#c71 is further amended by striking or section #ahcd7x7 and inserting 1 section #ahcd7x71 or section #ahfj;,d-#ad;,b4 #bjc4 ,provision regarding inflation rebates for group health plans and group health insurance coverage 7a7 ,in general ,not later than ,december #ca1 #bjba1 the ,secretary of ,labor1 in consultation with the ,secretary of ,health and ,human ,services and the ,secretary of the ,treasury1 shall submit to ,congress a report on-- 7#a7 potential models for an agreement process with manufacturers of prescription drugs under which such manufacturers provide for inflation rebates with respect to such drugs that are furnished or dispensed to participants and beneficiaries of group health plans and health insurance coverage offered in the group market in a manner similar to how manufacturers provide for rebates under section #ahcd7x7 of the ,social ,security ,act1 as added by section #bja1 and section #ahfj;,d-#ad;,b of such ,act1 as added by section #bjb1 with respect to prescription drugs that are furnished or dispensed under part ,b of title ,,xviii of such ,act and part ,d of such title1 respectively2 and 7#b7 potential models for enforcement mechanisms with respect to such an agreement process that ensure that such inflation rebates are proportionally distributed1 with respect to costs1 to group health plans and health insurance issuers offering health insurance coverage in the group market1 to participants and beneficiaries of such plans and coverage1 or to both4 7b7 ,regulations ,not later than ,december #ca1 #bjbb1 the ,secretary of ,labor shall1 in consultation with the ,secretary of ,health and ,human ,services and the ,secretary of the ,treasury1 promulgate regulations to implement a model described in subsection 7a77#a7 and a model described in subsection 7a77#b71 if the ,secretary determines that-- 7#a7 the prices of a sufficient number 7as determined by the ,secretary7 of drugs described in subsection 7a77#a7 have increased over a period of time 7as determined by the ,secretary7 at a percentage that exceeds the percentage by which the consumer price index for all urban consumers 7,united ,states city average7 has increased over such period2 and 7#b7 such model described in subsection 7a77#a7 and such model described in subsection 7a77#b7 are feasible4 #bjd4 ,annual report on drug costs in group health plans and group health insurance coverage 7a7 ,initial report ,not later than ,december #ca1 #bjba1 the ,secretary of ,labor shall1 in consultation with the ,secretary of ,health and ,human ,services and the ,secretary of the ,treasury1 submit to ,congress a report1 with respect to a period 7as determined by the ,secretary of ,labor71 on-- 7#a7 whether the prices of prescription drugs that are furnished or dispensed to participants and beneficiaries of group health plans and health insurance coverage offered in the group market during such period have increased at a percentage that exceeds the percentage by which the consumer price index for all urban consumers 7,united ,states city average7 increased for such period2 and 7#b7 whether there are mechanisms by which manufacturers of prescription drugs have attempted to recover rebate payments required of such manufacturers under section #ahcd7x7 of the ,social ,security ,act1 as added by section #bja1 and section #ahfj;,d-#ad;,b of such ,act1 as added by section #bjb1 with respect to prescription drugs that are furnished or dispensed under part ,b of title ,,xviii of such ,act and part ,d of such title1 respectively1 through increased prices charged with respect to drugs that are furnished or dispensed to participants and beneficiaries of group health plans and health insurance coverage offered in the group market during such period4 7b7 ,annual report ,not later than ,december #ca of each year following #bjba1 the ,secretary of ,labor shall1 in consultation with the ,secretary of ,health and ,human ,services and the ,secretary of the ,treasury1 submit to ,congress a report updating the information and analysis included in the report required under subsection 7a71 reflecting1 in part1 new price and cost information and data for the #ab-month period after the period on which the prior year's report was based4 #bje4 ,collection of data 7a7 ,manufacturers of prescription drugs ,manufacturers of prescription drugs shall submit to the ,secretary of ,health and ,human ,services1 ,secretary of ,labor1 and the ,secretary of the ,treasury appropriate data as necessary for the ,secretaries to obtain information needed to provide the reports under sections #bjc and #bjd4 7b7 ,group health plans and health insurance issuers offering health insurance coverage in the group market ,group health plans and health insurance issuers offering health insurance coverage in the group market shall submit to the ,secretary of ,health and ,human ,services1 ,secretary of ,labor1 and the ,secretary of the ,treasury appropriate data as necessary for the ,secretaries to obtain information needed to provide the reports under sections #bjc and #bjd4 ,,iii ,part ,d ,improvements and ,maximum ,out-of-,pocket ,cap for ,medicare ,beneficiaries #cja4 ,medicare part ,d benefit redesign 7a7 ,benefit structure redesign ,section #ahfj;,d-#b7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a71 in the matter preceding clause 7i71 by inserting for a year preceding #bjbb and for costs above the annual deductible specified in paragraph 7#a7 and up to the annual out-of-pocket threshold specified in paragraph 7#d77;,b7 for #bjbb and each subsequent year after paragraph 7#c72 7,b7 in subparagraph 7,c7-- 7i7 in clause 7i71 in the matter preceding subclause 7,i71 by inserting for a year preceding #bjbb1 after paragraph 7#d712 and 7ii7 in clause 7ii77,,iii71 by striking and each subsequent year and inserting and #bjba2 and 7,c7 in subparagraph 7,d7-- 7i7 in clause 7i7-- 7,i7 in the matter preceding subclause 7,i71 by inserting for a year preceding #bjbb1 after paragraph 7#d712 and 7,,ii7 in subclause 7,i77bb71 by striking a year after #bjah and inserting each of years #bjah through #bjba2 and 7ii7 in clause 7ii77,v71 by striking #bjai and each subsequent year and inserting each of years #bjai through #bjba2 7#b7 in paragraph 7#c77;,a7-- 7,a7 in the matter preceding clause 7i71 by inserting for a year preceding #bjbb1 after and 7#d712 and 7,b7 in clause 7ii71 by striking for a subsequent year and inserting for each of years #bjjg through #bjba2 and 7#c7 in paragraph 7#d7-- 7,a7 in subparagraph 7,a7-- 7i7 in clause 7i7-- 7,i7 by redesignating subclauses 7,i7 and 7,,ii7 as items 7aa7 and 7bb71 respectively1 and moving the margin of each such redesignated item #b ems to the right2 7,,ii7 in the matter preceding item 7aa71 as redesignated by subclause 7,i71 by striking is equal to the greater of-- and inserting 8is equal to-- 7,i7 for a year preceding #bjbb1 the greater of-- 2 7,,iii7 by striking the period at the end of item 7bb71 as redesignated by subclause 7,i71 and inserting 2 and2 and 7,,iv7 by adding at the end the following3 7,,ii7 for #bjbb and each succeeding year1 #j4 2 and 7ii7 in clause 7ii71 by striking clause 7i77,i7 and inserting clause 7i77,i77aa72 7,b7 in subparagraph 7,b7-- 7i7 in clause 7i7-- 7,i7 in subclause 7,v71 by striking or at the end2 7,,ii7 in subclause 7,,vi7-- 7aa7 by striking for a subsequent year and inserting for #bjba2 and 7bb7 by striking the period at the end and inserting a semicolon2 and 7,,iii7 by adding at the end the following new subclauses3 7,,vii7 for #bjbb1 is equal to #b1jjj2 or 7,,viii7 for a subsequent year1 is equal to the amount specified in this subparagraph for the previous year1 increased by the annual percentage increase described in paragraph 7#f7 for the year involved4 2 and 7ii7 in clause 7ii71 by striking clause 7i77,,ii7 and inserting clause 7i72 7,c7 in subparagraph 7,c77i71 by striking and for amounts and inserting and1 for a year preceding #bjbb1 for amounts2 and 7,d7 in subparagraph 7,e71 by striking ,in applying and inserting ,for each of years #bjaa through #bjba1 in applying4 7b7 ,decreasing reinsurance payment amount ,section #ahfj;,d-#ae7;b77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;b77#a77 is amended by inserting after #hj percent the following3 7or1 with respect to a coverage year after #bjba1 #bj percent74 7c7 ,manufacturer discount program 7#a7 ,in general ,part ,d of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq471 as amended by section #bjb1 is further amended by inserting after section #ahfj;,d-#ad;,b the following new section3 #ahfj;,d-#ad;,c4 ,manufacturer discount program 7a7 ,establishment ,the ,secretary shall establish a manufacturer discount program 7in this section referred to as the program74 ,under the program1 the ,secretary shall enter into agreements described in subsection 7b7 with manufacturers and provide for the performance of the duties described in subsection 7c74 ,the ,secretary shall establish a model agreement for use under the program by not later than ,january #a1 #bjba1 in consultation with manufacturers1 and allow for comment on such model agreement4 7b7 ,terms of agreement 7#a7 ,in general 7,a7 ,agreement ,an agreement under this section shall require the manufacturer to provide applicable beneficiaries access to discounted prices for applicable drugs of the manufacturer that are dispensed on or after ,january #a1 #bjbb4 7,b7 ,provision of discounted prices at the point-of-sale ,the discounted prices described in subparagraph 7,a7 shall be provided to the applicable beneficiary at the pharmacy or by the mail order service at the point-of-sale of an applicable drug4 7,c7 ,timing of agreement 7i7 ,special rule for #bjbb ,in order for an agreement with a manufacturer to be in effect under this section with respect to the period beginning on ,january #a1 #bjbb1 and ending on ,december #ca1 #bjbb1 the manufacturer shall enter into such agreement not later than #cj days after the date of the establishment of a model agreement under subsection 7a74 7ii7 #bjbc and subsequent years ,in order for an agreement with a manufacturer to be in effect under this section with respect to plan year #bjbc or a subsequent plan year1 the manufacturer shall enter into such agreement 7or such agreement shall be renewed under paragraph 7#d77;,a77 not later than ,january #cj of the preceding year4 7#b7 ,provision of appropriate data ,each manufacturer with an agreement in effect under this section shall collect and have available appropriate data1 as determined by the ,secretary1 to ensure that it can demonstrate to the ,secretary compliance with the requirements under the program4 7#c7 ,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 subsection 7d77#c71 as applicable1 for purposes of administering the program1 including any determination under subparagraph 7,a7 of subsection 7c77#a7 or procedures established under such subsection 7c77#a74 7#d7 ,length of agreement 7,a7 ,in general ,an agreement under this section shall be effective for an initial period of not less than #ab months and shall be automatically renewed for a period of not less than #a year unless terminated under subparagraph 7,b74 7,b7 ,termination 7i7 ,by the ,secretary ,the ,secretary may provide for termination of an agreement under this section for a knowing and willful violation of the requirements of the agreement or other good cause shown4 ,such termination shall not be effective earlier than #cj days after the date of notice to the manufacturer of such termination4 ,the ,secretary shall provide1 upon request1 a manufacturer with a hearing concerning such a termination1 and such hearing shall take place prior to the effective date of the termination with sufficient time for such effective date to be repealed if the ,secretary determines appropriate4 7ii7 ,by a manufacturer ,a manufacturer may terminate an agreement under this section for any reason4 ,any such termination shall be effective1 with respect to a plan year-- 7,i7 if the termination occurs before ,january #cj of a plan year1 as of the day after the end of the plan year2 and 7,,ii7 if the termination occurs on or after ,january #cj of a plan year1 as of the day after the end of the succeeding plan year4 7iii7 ,effectiveness of termination ,any termination under this subparagraph shall not affect discounts for applicable drugs of the manufacturer that are due under the agreement before the effective date of its termination4 7iv7 ,notice to third party ,the ,secretary shall provide notice of such termination to a third party with a contract under subsection 7d77#c7 within not less than #cj days before the effective date of such termination4 7c7 ,duties described ,the duties described in this subsection are the following3 7#a7 ,administration of program ,administering the program1 including-- 7,a7 the determination of the amount of the discounted price of an applicable drug of a manufacturer2 7,b7 the establishment of procedures under which discounted prices are provided to applicable beneficiaries at pharmacies or by mail order service at the point-of-sale of an applicable drug2 7,c7 the establishment of procedures to ensure that1 not later than the applicable number of calendar days after the dispensing of an applicable drug 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 negotiated price of the applicable drug2 and 7ii7 the discounted price of the applicable drug2 7,d7 the establishment of procedures to ensure that the discounted price for an applicable drug under this section is applied before 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 applicable beneficiaries as the ,secretary may specify2 and 7,e7 providing a reasonable dispute resolution mechanism to resolve disagreements between manufacturers1 applicable beneficiaries1 and the third party with a contract under subsection 7d77#c74 7#b7 ,monitoring compliance 7,a7 ,in general ,the ,secretary shall monitor compliance by a manufacturer with the terms of an agreement under this section4 7,b7 ,notification ,if a third party with a contract under subsection 7d77#c7 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 subsection 7e74 7#c7 ,collection of data from prescription drug plans and ,,ma-,,pd plans ,the ,secretary may collect appropriate data from prescription drug plans and ,,ma-,,pd plans in a timeframe that allows for discounted prices to be provided for applicable drugs under this section4 7d7 ,administration 7#a7 ,in general ,subject to paragraph 7#b71 the ,secretary shall provide for the implementation of this section1 including the performance of the duties described in subsection 7c74 7#b7 ,limitation ,in providing for the implementation of this section1 the ,secretary shall not receive or distribute any funds of a manufacturer under the program4 7#c7 ,contract with third parties ,the ,secretary shall enter into a contract with #a or more third parties to administer the requirements established by the ,secretary in order to carry out this section4 ,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 section2 7,c7 provide adequate and timely information to manufacturers1 consistent with the agreement with the manufacturer under this section1 as necessary for the manufacturer to fulfill its obligations under this section2 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#d7 ,performance requirements ,the ,secretary shall establish performance requirements for a third party with a contract under paragraph 7#c7 and safeguards to protect the independence and integrity of the activities carried out by the third party under the program under this section4 7#e7 ,implementation ,notwithstanding any other provision of law1 the ,secretary may implement the program under this section by program instruction or otherwise4 7#f7 ,administration ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to the program under this section4 7e7 ,enforcement 7#a7 ,audits ,each manufacturer with an agreement in effect under this section shall be subject to periodic audit by the ,secretary4 7#b7 ,civil money penalty 7,a7 ,in general ,the ,secretary may impose a civil money penalty on a manufacturer that fails to provide applicable beneficiaries discounts for applicable drugs of the manufacturer in accordance with such agreement for each such failure in an amount the ,secretary determines is equal to the sum of-- 7i7 the amount that the manufacturer would have paid with respect to such discounts under the agreement1 which will then be used to pay the discounts which the manufacturer had failed to provide2 and 7ii7 #be percent of such amount4 7,b7 ,application ,the provisions of section #aabh;,a 7other than subsections 7a7 and 7b77 shall apply to a civil money penalty under this paragraph in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a7a74 7f7 ,clarification regarding availability of other covered part ,d drugs ,nothing in this section shall prevent an applicable beneficiary from purchasing a covered part ,d drug that is not an applicable drug 7including a generic drug or a drug that is not on the formulary of the prescription drug plan or ,,ma-,,pd plan that the applicable beneficiary is enrolled in74 7g7 ,definitions ,in this section3 7#a7 ,applicable beneficiary ,the term applicable beneficiary means an individual who1 on the date of dispensing a covered part ,d drug-- 7,a7 is enrolled in a prescription drug plan or an ,,ma-,,pd plan2 7,b7 is not enrolled in a qualified retiree prescription drug plan2 and 7,c7 has incurred costs1 as determined in accordance with section #ahfj;,d-#b7;b77#d77;,c71 for covered part ,d drugs in the year that exceed the annual deductible with respect to such individual for such year1 as specified in section #ahfj;,d-#b7;b77#a71 section #ahfj;,d-#ad7;a77#a77;,b71 or section #ahfj;,d-#ad7;a77#b77;,b71 as applicable4 7#b7 ,applicable drug ,the term applicable drug1 with respect to an applicable beneficiary-- 7,a7 means a covered part ,d drug-- 7i7 approved under a new drug application under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or1 in the case of a biologic product1 licensed under section #cea of the ,public ,health ,service ,act2 and 7ii7 7,i7 if the ,,pdp sponsor of the prescription drug plan or the ,,ma organization offering the ,,ma-,,pd plan uses a formulary1 which is on the formulary of the prescription drug plan or ,,ma-,,pd plan that the applicable beneficiary is enrolled in2 7,,ii7 if the ,,pdp sponsor of the prescription drug plan or the ,,ma organization offering the ,,ma-,,pd plan does not use a formulary1 for which benefits are available under the prescription drug plan or ,,ma-,,pd plan that the applicable beneficiary is enrolled in2 or 7,,iii7 is provided through an exception or appeal2 and 7,b7 does not include a selected drug 7as defined in section #aaib7;c77 during a price applicability period 7as defined in section #aaia7;b77#b77 with respect to such drug4 7#c7 ,applicable number of calendar days ,the term applicable number of calendar days means-- 7,a7 with respect to claims for reimbursement submitted electronically1 #ad days2 and 7,b7 with respect to claims for reimbursement submitted otherwise1 #cj days4 7#d7 ,discounted price 7,a7 ,in general ,the term discounted price means1 with respect to an applicable drug of a manufacturer dispensed during a year to an applicable beneficiary-- 7i7 who has not incurred costs1 as determined in accordance with section #ahfj;,d-#b7;b77#d77;,c71 for covered part ,d drugs in the year that are equal to or exceed the annual out-of-pocket threshold specified in section #ahfj;,d-#b7;b77#d77;,b77i7 for the year1 #ij percent of the negotiated price of such drug2 and 7ii7 who has incurred such costs1 as so determined1 in the year that are equal to or exceed such threshold for the year1 #gj percent of the negotiated price of such drug4 7,b7 ,clarification ,nothing in this section shall be construed as affecting the responsibility of an applicable beneficiary for payment of a dispensing fee for an applicable drug4 7,c7 ,special case for certain claims 7i7 ,claims spanning deductible ,in the case where the entire amount of the negotiated price of an individual claim for an applicable drug with respect to an applicable beneficiary does not fall above the annual deductible specified in section #ahfj;,d-#b7;b77#a7 for the year1 the manufacturer of the applicable drug shall provide the discounted price under this section on only the portion of the negotiated price of the applicable drug that falls above such annual deductible4 7ii7 ,claims spanning out-of-pocket threshold ,in the case where the entire amount of the negotiated price of an individual claim for an applicable drug with respect to an applicable beneficiary does not fall entirely below or entirely above the annual out-of-pocket threshold specified in section #ahfj;,d-#b7;b77#d77;,b77i7 for the year1 the manufacturer of the applicable drug shall provide the discounted price-- 7,i7 in accordance with subparagraph 7,a77i7 on the portion of the negotiated price of the applicable drug that falls below such threshold2 and 7,,ii7 in accordance with subparagraph 7,a77ii7 on the portion of such price of such drug that falls at or above such threshold4 7#e7 ,manufacturer ,the term manufacturer means any entity which is engaged in the production1 preparation1 propagation1 compounding1 conversion1 or processing of prescription drug products1 either directly or indirectly by extraction from substances of natural origin1 or independently by means of chemical synthesis1 or by a combination of extraction and chemical synthesis4 ,such term does not include a wholesale distributor of drugs or a retail pharmacy licensed under ,state law4 7#f7 ,negotiated price ,the term negotiated price has the meaning given such term in section #dbc4ajj of title #db1 ,code of ,federal ,regulations 7or any successor regulation71 except that1 with respect to an applicable drug1 such negotiated price shall not include any dispensing fee for the applicable drug4 7#g7 ,qualified retiree prescription drug plan ,the term qualified retiree prescription drug plan has the meaning given such term in section #ahfj;,d-#bb7;a77#b74 4 7#b7 ,sunset of ,medicare coverage gap discount program ,section #ahfj;,d-#ad;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #acie-aad;a7 is amended-- 7,a7 in subsection 7a71 in the first sentence1 by striking ,the ,secretary and inserting ,subject to subsection 7h71 the ,secretary2 and 7,b7 by adding at the end the following new subsection3 7h7 ,sunset of program 7#a7 ,in general ,the program shall not apply with respect to applicable drugs dispensed on or after ,january #a1 #bjbb1 and1 subject to paragraph 7#b71 agreements under this section shall be terminated as of such date4 7#b7 ,continued application for applicable drugs dispensed prior to sunset ,the provisions of this section 7including all responsibilities and duties7 shall continue to apply after ,january #a1 #bjbb1 with respect to applicable drugs dispensed prior to such date4 4 7#c7 ,inclusion of actuarial value of manufacturer discounts in bids ,section #ahfj;,d-#aa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7 is amended-- 7,a7 in subsection 7b77#b77;,c77iii7-- 7i7 by striking assumptions regarding the reinsurance and inserting 8assumptions regarding-- 7,i7 the reinsurance 2 and 7ii7 by adding at the end the following3 7,,ii7 for #bjbb and each subsequent year1 the manufacturer discounts provided under section #ahfj;,d-#ad;,c subtracted from the actuarial value to produce such bid2 and 2 and 7,b7 in subsection 7c77#a77;,c7-- 7i7 by striking an actuarial valuation of the reinsurance and inserting 8an actuarial valuation of-- 7i7 the reinsurance 2 7ii7 in clause 7i71 as inserted by clause 7i7 of this subparagraph1 by adding and at the end2 and 7iii7 by adding at the end the following3 7ii7 for #bjbb and each subsequent year1 the manufacturer discounts provided under section #ahfj;,d-#ad;,c2 4 7d7 ,conforming amendments 7#a7 ,section #ahfj;,d-#b of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7 is amended-- 7,a7 in subsection 7a77#b77;,a77i77,i71 by striking 1 or an increase in the initial and inserting or1 for a year preceding #bjbb1 an increase in the initial2 7,b7 in subsection 7c77#a77;,c7-- 7i7 in the subparagraph heading1 by striking at initial coverage limit2 and 7ii7 by inserting for a year preceding #bjbb or the annual out-of-pocket threshold specified in subsection 7b77#d77;,b7 for the year for #bjbb and each subsequent year after subsection 7b77#c7 for the year each place it appears2 and 7,c7 in subsection 7d77#a77;,a71 by striking or an initial and inserting or1 for a year preceding #bjbb1 an initial4 7#b7 ,section #ahfj;,d-#d7;a77#d77;,b77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;a77#d77;,b77i77 is amended by striking the initial and inserting for a year preceding #bjbb1 the initial4 7#c7 ,section #ahfj;,d-#ad7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77 is amended-- 7,a7 in paragraph 7#a7-- 7i7 in subparagraph 7,c71 by striking ,the continuation and inserting ,for a year preceding #bjbb1 the continuation2 7ii7 in subparagraph 7,d77iii71 by striking #ahfj;,d-#b7;b77#d77;,a77i77,i7 and inserting #ahfj;,d-#b7;b77#d77;,a77i77,i77aa72 and 7iii7 in subparagraph 7,e71 by striking ,the elimination and inserting ,for a year preceding #bjbb1 the elimination2 and 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,c71 by striking ,the continuation and inserting ,for a year preceding #bjbb1 the continuation2 and 7ii7 in subparagraph 7,e71 by striking #ahfj;,d-#b7;b77#d77;,a77i77,i7 and inserting #ahfj;,d-#b7;b77#d77;,a77i77,i77aa74 7#d7 ,section #ahfj;,d-#ba7;d77#g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aca7;d77#g77 is amended by striking section #ahfj;,d-#b7;b77#d77;,b77i7 and inserting section #ahfj;,d-#b7;b77#d77;,c77i74 7#e7 ,section #ahfj;,d-#bb7;a77#b77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#acb7;a77#b77;,a77 is amended-- 7,a7 by striking the value of any discount and inserting the following3 the value of-- 7i7 for years prior to #bjbb1 any discount 2 7,b7 in clause 7i71 as inserted by subparagraph 7,a7 of this paragraph1 by striking the period at the end and inserting 2 and2 and 7,c7 by adding at the end the following new clause3 7ii7 for #bjbb and each subsequent year1 any discount provided pursuant to section #ahfj;,d-#ad;,c4 4 7#f7 ,section #ahfj;,d-#da7;a77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aea7;a77#f77 is amended-- 7,a7 by inserting for a year before #bjbb after #ahfj;,d-#b7;b77#c72 and 7,b7 by inserting for such year before the period4 7#g7 ,section #ahfj;,d-#dc of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aec7 is amended-- 7,a7 in subsection 7a7-- 7i7 by striking paragraph 7#a7 and inserting the following3 7#a7 participate in-- 7,a7 for #bjaa through #bjba1 the ,medicare coverage gap discount program under section #ahfj;,d-#ad;,a2 and 7,b7 for #bjbb and each subsequent year1 the manufacturer discount program under section #ahfj;,d-#ad;,c2 2 7ii7 by striking paragraph 7#b7 and inserting the following3 7#b7 have entered into and have in effect-- 7,a7 for #bjaa through #bjba1 an agreement described in subsection 7b7 of section #ahfj;,d-#ad;,a with the ,secretary2 and 7,b7 for #bjbb and each subsequent year1 an agreement described in subsection 7b7 of section #ahfj;,d-#ad;,c with the ,secretary2 and 2 and 7iii7 by striking paragraph 7#c7 and inserting the following3 7#c7 have entered into and have in effect1 under terms and conditions specified by the ,secretary-- 7,a7 for #bjaa through #bjba1 a contract with a third party that the ,secretary has entered into a contract with under subsection 7d77#c7 of section #ahfj;,d-#ad;,a2 and 7,b7 for #bjbb and each subsequent year1 a contract with a third party that the ,secretary has entered into a contract with under subsection 7d77#c7 of section #ahfj;,d-#ad;,c4 2 and 7,b7 by striking subsection 7b7 and inserting the following3 7b7 ,effective date ,paragraphs 7#a77;,a71 7#b77;,a71 and 7#c77;,a7 of subsection 7a7 shall apply to covered part ,d drugs dispensed under this part on or after ,january #a1 #bjaa1 and before ,january #a1 #bjbb1 and paragraphs 7#a77;,b71 7#b77;,b71 and 7#c77;,b7 of such subsection shall apply to covered part ,d drugs dispensed under this part on or after ,january #a1 #bjbb4 4 7#h7 ,section #aibg of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7 is amended-- 7,a7 in subsection 7c77#a77;,c77i77,,vi71 by inserting before the period at the end the following3 or under the manufacturer discount program under section #ahfj;,d-#ad;,c2 and 7,b7 in subsection 7k77#a77;,b77i77,v71 by inserting before the period at the end the following3 or under section #ahfj;,d-#ad;,c4 7e7 ,effective date ,the amendments made by this section shall apply with respect to plan year #bjbb and subsequent plan years4 #cjb4 ,allowing certain enrollees of prescription drugs plans and ,,ma-,,pd plans under ,medicare program to spread out cost-sharing under certain circumstances ,section #ahfj;,d-#b7;b77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77#b771 as amended by section #cja1 is further amended-- 7#a7 in subparagraph 7,a71 by striking ,subject to subparagraphs 7,c7 and 7,d7 and inserting ,subject to subparagraphs 7,c71 7,d71 and 7,e72 and 7#b7 by adding at the end the following new subparagraph3 7,e7 ,enrollee option regarding spreading cost-sharing ,the ,secretary shall establish by regulation a process under which1 with respect to plan year #bjbb and subsequent plan years1 a prescription drug plan or an ,,ma-,,pd plan shall1 in the case of a part ,d eligible individual enrolled with such plan for such plan year who is not a subsidy eligible individual 7as defined in section #ahfj;,d-#ad7;a77#c77 and with respect to whom the plan projects that the dispensing of the first fill of a covered part ,d drug to such individual will result in the individual incurring costs that are equal to or above the annual out-of-pocket threshold specified in paragraph 7#d77;,b7 for such plan year1 provide such individual with the option to make the coinsurance payment required under subparagraph 7,a7 7for the portion of such costs that are not above such annual out-of-pocket threshold7 in the form of periodic installments over the remainder of such plan year4 4 #cjc4 ,establishment of pharmacy quality measures under ,medicare part ,d ,section #ahfj;,d-#d7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77 is amended-- 7#a7 by redesignating the paragraph 7#f71 as added by section #ejced of division ,e of the ,bipartisan ,budget ,act of #bjah 7,public ,law #aae-abc71 as paragraph 7#g72 and 7#b7 by adding at the end the following new paragraph3 7#h7 ,application of pharmacy quality measures 7,a7 ,in general ,a ,,pdp sponsor that implements incentive payments to a pharmacy or price concessions paid by a pharmacy based on quality measures shall use measures established or approved by the ,secretary under subparagraph 7,b7 with respect to payment for covered part ,d drugs dispensed by such pharmacy4 7,b7 ,standard pharmacy quality measures ,the ,secretary shall establish or approve standard quality measures from a consensus and evidence-based organization for payments described in subparagraph 7,a74 ,such measures shall focus on patient health outcomes and be based on proven criteria measuring pharmacy performance4 7,c7 ,effective date ,the requirement under subparagraph 7,a7 shall take effect for plan years beginning on or after ,january #a1 #bjba1 or such earlier date specified by the ,secretary if the ,secretary determines there are sufficient measures established or approved under subparagraph 7,b7 to meet the requirement under subparagraph 7,a74 4 ,,iv ,drug ,price ,transparency #dja4 ,drug price transparency ,part ,a of title ,,xi of the ,social ,security ,act is amended by adding at the end the following new sections3 #aaej;,c4 ,reporting on drug prices 7a7 ,definitions ,in this section3 7#a7 ,manufacturer ,the term manufacturer means the person-- 7,a7 that holds the application for a drug approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed under section #cea of the ,public ,health ,service ,act2 or 7,b7 who is responsible for setting the wholesale acquisition cost for the drug4 7#b7 ,qualifying drug ,the term qualifying drug means any drug that is approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act-- 7,a7 that has a wholesale acquisition cost of #ajj or more1 adjusted for inflation occurring after the date of enactment of this section1 for a month's supply or a typical course of treatment that lasts less than a month1 and is-- 7i7 subject to section #ejc7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 and 7ii7 not a preventative vaccine2 and 7,b7 for which1 during the previous calendar year1 at least #a dollar of the total amount of sales were for individuals enrolled under the ,medicare program under title ,,xviii or under a ,state ,medicaid plan under title ,,xix or under a waiver of such plan4 7#c7 ,wholesale acquisition cost ,the term wholesale acquisition cost has the meaning given that term in section #ahdg;,a7c77#f77;,b74 7b7 ,report 7#a7 ,report required ,the manufacturer of a qualifying drug shall submit a report to the ,secretary if1 with respect to the qualifying drug-- 7,a7 there is an increase in the price of the qualifying drug that results in an increase in the wholesale acquisition cost of that drug that is equal to-- 7i7 #aj percent or more within a #ab-month period beginning on or after ,january #a1 #bjai2 or 7ii7 #be percent or more within a #cf-month period beginning on or after ,january #a1 #bjai2 7,b7 the estimated price of the qualifying drug or spending per individual or per user of such drug 7as estimated by the ,secretary7 for the applicable year 7or per course of treatment in such applicable year as determined by the ,secretary7 is at least #bf1jjj beginning on or after ,january #a1 #bjba2 or 7,c7 there was an increase in the price of the qualifying drug that resulted in an increase in the wholesale acquisition cost of that drug that is equal to-- 7i7 #aj percent or more within a #ab-month period that begins and ends during the #e-year period preceding ,january #a1 #bjba2 or 7ii7 #be percent or more within a #cf-month period that begins and ends during the #e-year period preceding ,january #a1 #bjba4 7#b7 ,report deadline ,each report described in paragraph 7#a7 shall be submitted to the ,secretary-- 7,a7 in the case of a report with respect to an increase in the price of a qualifying drug that occurs during the period beginning on ,january #a1 #bjai1 and ending on the day that is #fj days after the date of the enactment of this section1 not later than #ij days after such date of enactment2 7,b7 in the case of a report with respect to an increase in the price of a qualifying drug that occurs after the period described in subparagraph 7,a71 not later than #cj days prior to the planned effective date of such price increase for such qualifying drug2 7,c7 in the case of a report with respect to a qualifying drug that meets the criteria under paragraph 7#a77;,b71 not later than #cj days after such drug meets such criteria2 and 7,d7 in the case of a report with respect to an increase in the price of a qualifying drug that occurs during a #ab-month or #cf-month period described in paragraph 7#a77;,c71 not later than ,april #a1 #bjba4 7c7 ,contents ,a report under subsection 7b71 consistent with the standard for disclosures described in section #bac4c7;d7 of title #ab1 ,code of ,federal ,regulations 7as in effect on the date of enactment of this section71 shall1 at a minimum1 include-- 7#a7 with respect to the qualifying drug-- 7,a7 the percentage by which the manufacturer will raise the wholesale acquisition cost of the drug within the #ab-month period or #cf-month period as described in subsection 7b77#a77;,a77i71 7b77#a77;,a77ii71 7b77#a77;,c77i71 or 7b77#a77;,c77ii71 as applicable1 and the effective date of such price increase or the cost associated with a qualifying drug if such drug meets the criteria under subsection 7b77#a77;,b7 and the effective date at which such drug meets such criteria2 7,b7 an explanation for1 and description of1 each price increase for such drug that will occur during the #ab-month period or the #cf-month period described in subsection 7b77#a77;,a77i71 7b77#a77;,a77ii71 7b77#a77;,c77i71 or 7b77#a77;,c77ii71 as applicable2 7,c7 an explanation for1 and description of1 the cost associated with a qualifying drug if such drug meets the criteria under subsection 7b77#a77;,b71 as applicable2 7,d7 if known and different from the manufacturer of the qualifying drug1 the identity of-- 7i7 the sponsor or sponsors of any investigational new drug applications under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act for clinical investigations with respect to such drug1 for which the full reports are submitted as part of the application-- 7,i7 for approval of the drug under section #eje of such ,act2 or 7,,ii7 for licensure of the drug under section #cea of the ,pubic ,health ,service ,act2 and 7ii7 the sponsor of an application for the drug approved under such section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed under section #cea of the ,public ,health ,service ,act2 7,e7 a description of the history of the manufacturer's price increases for the drug since the approval of the application for the drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or the issuance of the license for the drug under section #cea of the ,public ,health ,service ,act1 or since the manufacturer acquired such approved application or license1 if applicable2 7,f7 the current wholesale acquisition cost of the drug2 7,g7 the total expenditures of the manufacturer on-- 7i7 materials and manufacturing for such drug2 7ii7 acquiring patents and licensing for such drug2 and 7iii7 purchasing or acquiring such drug from another manufacturer1 if applicable2 7,h7 the percentage of total expenditures of the manufacturer on research and development for such drug that was derived from ,federal funds2 7,i7 the total expenditures of the manufacturer on research and development for such drug that is necessary to demonstrate that it meets applicable statutory standards for approval under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensure under section #cea of the ,public ,health ,service ,act1 as applicable2 7,j7 the total expenditures of the manufacturer on pursuing new or expanded indications or dosage changes for such drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea of the ,public ,health ,service ,act2 7,k7 the total expenditures of the manufacturer on carrying out postmarket requirements related to such drug1 including under section #eje7o77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7,l7 the total revenue and the net profit generated from the qualifying drug for each calendar year since the approval of the application for the drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or the issuance of the license for the drug under section #cea of the ,public ,health ,service ,act1 or since the manufacturer acquired such approved application or license2 and 7,m7 the total costs associated with marketing and advertising for the qualifying drug2 7#b7 with respect to the manufacturer-- 7,a7 the total revenue and the net profit of the manufacturer for each of the #ab-month period described in subsection 7b77#a77;,a77i7 or 7b77#a77;,c77i7 or the #cf-month period described in subsection 7b77#a77;,a77ii7 or 7b77#a77;,c77ii71 as applicable2 7,b7 all stock-based performance metrics used by the manufacturer to determine executive compensation for each of the #ab-month periods described in subsection 7b77#a77;,a77i7 or 7b77#a77;,c77i7 or the #cf-month periods described in subsection 7b77#a77;,a77ii7 or 7b77#a77;,c77ii71 as applicable2 and 7,c7 any additional information the manufacturer chooses to provide related to drug pricing decisions1 such as total expenditures on-- 7i7 drug research and development2 or 7ii7 clinical trials1 including on drugs that failed to receive approval by the ,food and ,drug ,administration2 and 7#c7 such other related information as the ,secretary considers appropriate and as specified by the ,secretary4 7d7 ,information provided ,the manufacturer of a qualifying drug that is required to submit a report under subsection 7b71 shall ensure that such report and any explanation for1 and description of1 each price increase described in subsection 7c77#a7 shall be truthful1 not misleading1 and accurate4 7e7 ,civil monetary penalty ,any manufacturer of a qualifying drug that fails to submit a report for the drug as required by this section1 following notification by the ,secretary to the manufacturer that the manufacturer is not in compliance with this section1 shall be subject to a civil monetary penalty of #ge1jjj for each day on which the violation continues4 7f7 ,false information ,any manufacturer that submits a report for a drug as required by this section that knowingly provides false information in such report is subject to a civil monetary penalty in an amount not to exceed #ajj1jjj for each item of false information4 7g7 ,public posting 7#a7 ,in general ,subject to paragraph 7#d71 the ,secretary shall post each report submitted under subsection 7b7 on the public website of the ,department of ,health and ,human ,services the day the price increase of a qualifying drug is scheduled to go into effect4 7#b7 ,format ,in developing the format in which reports will be publicly posted under paragraph 7#a71 the ,secretary shall consult with stakeholders1 including beneficiary groups1 and shall seek feedback from consumer advocates and readability experts on the format and presentation of the content of such reports to ensure that such reports are-- 7,a7 user-friendly to the public2 and 7,b7 written in plain language that consumers can readily understand4 7#c7 ,list ,in addition to the reports submitted under subsection 7b71 the ,secretary shall also post a list of each qualifying drug with respect to which the manufacturer was required to submit such a report in the preceding year and whether such manufacturer was required to submit such report based on a qualifying price increase or whether such drug meets the criteria under subsection 7b77#a77;,b74 7#d7 ,protected information ,in carrying out this section1 the ,secretary shall enforce applicable law concerning the protection of confidential commercial information and trade secrets4 #aaej;,d4 ,annual report to ,congress 7a7 ,in ,general ,subject to subsection 7b71 the ,secretary shall submit to the ,committees on ,energy and ,commerce and ,ways and ,means of the ,house of ,representatives and the ,committees on ,health1 ,education1 ,labor1 and ,pensions and ,finance of the ,senate1 and post on the public website of the ,department of ,health and ,human ,services in a way that is user-friendly to the public and written in plain language that consumers can readily understand1 an annual report-- 7#a7 summarizing the information reported pursuant to section #aaej;,c2 7#b7 including copies of the reports and supporting detailed economic analyses submitted pursuant to such section2 7#c7 detailing the costs and expenditures incurred by the ,department of ,health and ,human ,services in carrying out section #aaej;,c2 and 7#d7 explaining how the ,department of ,health and ,human ,services is improving consumer and provider information about drug value and drug price transparency4 7b7 ,protected information ,in carrying out this section1 the ,secretary shall enforce applicable law concerning the protection of confidential commercial information and trade secrets4 4 ,v ,program improvements for ,medicare low-income beneficiaries #eja4 ,dissemination to ,medicare part ,d subsidy eligible individuals of information comparing premiums of certain prescription drug plans ,section #ahfj;,d-#a7;c77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja7;c77#c77 is amended by adding at the end the following new subparagraph3 7,c7 ,information on premiums for subsidy eligible individuals 7i7 ,in general ,for plan year #bjbb and each subsequent plan year1 the ,secretary shall disseminate to each subsidy eligible individual 7as defined in section #ahfj;,d-#ad7;a77#c77 information under this paragraph comparing premiums that would apply to such individual for prescription drug coverage under ,,lis benchmark plans1 including1 in the case of an individual enrolled in a prescription drug plan under this part1 information that compares the premium that would apply if such individual were to remain enrolled in such plan to premiums that would apply if the individual were to enroll in other ,,lis benchmark plans4 7ii7 ,,lis benchmark plan ,for purposes of clause 7i71 the term ,,lis benchmark plan means1 with respect to an individual1 a prescription drug plan under this part that is offered in the region in which the individual resides and-- 7,i7 that provides for a premium that is not more than the low-income benchmark premium amount 7as defined in section #ahfj;,d-#ad7;b77#b77 for such region2 or 7,,ii7 with respect to which the premium would be waived as de minimis pursuant to section #ahfj;,d-#ad7;a77#e7 for such individual4 4 #ejb4 ,providing for intelligent assignment of certain subsidy eligible individuals auto-enrolled under ,medicare prescription drug plans and ,,ma-,,pd plans 7a7 ,in general ,section #ahfj;,d-#a7;b77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja7;b77#a77 is amended-- 7#a7 in subparagraph 7,c7-- 7,a7 by inserting after ,,pdp region the following3 or through use of an intelligent assignment process that is designed to maximize the access of such individual to necessary prescription drugs while minimizing costs to such individual and to the program under this part to the greatest extent possible4 ,in the case the ,secretary enrolls such individuals through use of an intelligent assignment process1 such process shall take into account the extent to which prescription drugs necessary for the individual are covered in the case of a ,,pdp sponsor of a prescription drug plan that uses a formulary1 the use of prior authorization or other restrictions on access to coverage of such prescription drugs by such a sponsor1 and the overall quality of a prescription drug plan as measured by quality ratings established by the ,secretary2 and 7,b7 by striking ,nothing in the previous sentence and inserting ,nothing in this subparagraph2 and 7#b7 in subparagraph 7,d7-- 7,a7 by inserting after ,,pdp region the following3 or through use of an intelligent assignment process that is designed to maximize the access of such individual to necessary prescription drugs while minimizing costs to such individual and to the program under this part to the greatest extent possible4 ,in the case the ,secretary enrolls such individuals through use of an intelligent assignment process1 such process shall take into account the extent to which prescription drugs necessary for the individual are covered in the case of a ,,pdp sponsor of a prescription drug plan that uses a formulary1 the use of prior authorization or other restrictions on access to coverage of such prescription drugs by such a sponsor1 and the overall quality of a prescription drug plan as measured by quality ratings established by the ,secretary2 and 7,b7 by striking ,nothing in the previous sentence and inserting ,nothing in this subparagraph4 7b7 ,effective date ,the amendments made by subsection 7a7 shall apply with respect to plan years beginning with plan year #bjbb4 #ejc4 ,expanding eligibility for low-income subsidies under part ,d of the ,medicare program ,section #ahfj;,d-#ad7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a771 as amended by section #cja7;d71 is further amended-- 7#a7 in the subsection heading1 by striking individuals and all that follows through line and inserting certain individuals2 7#b7 in paragraph 7#a7-- 7,a7 by striking the paragraph heading and inserting ,individuals with certain low incomes2 and 7,b7 in the matter preceding subparagraph 7,a71 by inserting 7or1 with respect to a plan year beginning on or after ,january #a1 #bjbb1 #aej percent7 after #ace percent2 and 7#c7 in paragraph 7#b7-- 7,a7 by striking the paragraph heading and inserting ,other low-income individuals2 and 7,b7 in the matter preceding subparagraph 7,a71 by striking ,in the case of a subsidy and inserting ,with respect to a plan year beginning before ,january #a1 #bjbb1 in the case of a subsidy4 #ejd4 ,automatic eligibility of certain low-income territorial residents for premium and cost-sharing subsidies under the ,medicare program2 ,sunset of enhanced allotment program 7a7 ,automatic eligibility of certain low-,income territorial residents for premium and cost-,sharing subsidies under the ,medicare program 7#a7 ,in general ,section #ahfj;,d-#ad7;a77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77#c77 is amended-- 7,a7 in subparagraph 7,b77v7-- 7i7 in subclause 7,i71 by striking and at the end2 7ii7 in subclause 7,,ii71 by striking the period and inserting 2 and2 and 7iii7 by inserting after subclause 7,,ii7 the following new subclause3 7,,iii7 with respect to plan years beginning on or after ,january #a1 #bjbd1 shall provide that any part ,d eligible individual who is enrolled for medical assistance under the ,state ,medicaid plan of a territory 7as defined in section #aice7;f77 under title ,,xix 7or a waiver of such a plan7 shall be treated as a subsidy eligible individual described in paragraph 7#a74 2 and 7,b7 in subparagraph 7,f71 by adding at the end the following new sentence3 ,the previous sentence shall not apply with respect to eligibility determinations for premium and cost-sharing subsidies under this section made on or after ,january #a1 #bjbd44 7#b7 ,conforming amendment ,section #ahfj;,d-#ca7;j77#b77;,d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ada7;j77#b77;,d77 is amended by adding at the end the following new sentence3 ,the previous sentence shall not apply with respect to amounts made available to a ,state under this paragraph on or after ,january #a1 #bjbd44 7b7 ,sunset of enhanced allotment program 7#a7 ,in general ,section #aice7;e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#e7;e77 is amended-- 7,a7 in paragraph 7#a77;,a71 by inserting after such ,state the following3 before ,january #a1 #bjba2 and 7,b7 in paragraph 7#c7-- 7i7 in subparagraph 7,a71 in the matter preceding clause 7i71 by inserting after a year the following3 7before #bjbd72 and 7ii7 in subparagraph 7,b77iii71 by striking a subsequent year and inserting each of fiscal years #bjjh through #bjbc4 7#b7 ,territory defined ,section #aice of the ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#e7 is amended by adding at the end the following new subsection3 7f7 ,territory defined ,in this section1 the term territory means ,puerto ,rico1 the ,virgin ,islands1 ,guam1 the ,northern ,mariana ,islands1 and ,american ,samoa4 4 #eje4 ,automatic qualification of certain ,medicaid beneficiaries for premium and cost-sharing subsidies under part ,d of the ,medicare program ,clause 7v7 of section #ahfj;,d-#ad7;a77#c77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77#c77;,b771 as amended by section #ejd1 is further amended-- 7#a7 in subclause 7,,ii71 by striking and at the end2 7#b7 in subclause 7,,iii71 by striking the period and inserting 2 and2 and 7#c7 by inserting after subclause 7,,iii7 the following new subclause3 7,,iv7 with respect to plan years beginning on or after ,january #a1 #bjbd1 shall1 notwithstanding the preceding clauses of this subparagraph1 provide that any part ,d eligible individual not described in subclause 7,i71 7,,ii71 or 7,,iii7 who is enrolled1 as of the day before the date on which such individual attains the age of #fe1 for medical assistance under a ,state plan under title ,,xix 7or a waiver of such plan7 pursuant to clause 7i77,,viii7 or 7ii77,,xx7 of section #aijb7;a77#aj77;,a71 and who has income below #bjj percent of the poverty line applicable to a family of the size involved1 shall be treated as a subsidy eligible individual described in paragraph 7#a7 for a limited period of time1 as specified by the ,secretary4 4 #ejf4 ,providing for certain rules regarding the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost-sharing subsidies under part ,d of the ,medicare program ,section #ahfj;,d-#ad7;a77#c77;,c77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77#c77;,c77i77 is amended1 by striking except that support and maintenance furnished in kind shall not be counted as income2 and and inserting except that-- 7,i7 support and maintenance furnished in kind shall not be counted as income2 and 7,,ii7 for plan years beginning on or after ,january #a1 #bjbd1 any distribution or withdrawal from an eligible retirement plan 7as defined in subparagraph 7,b7 of section #djb7;c77#h7 of the ,internal ,revenue ,code of #aihf1 but excluding any defined benefit plan described in clause 7iv7 or 7v7 of such subparagraph and any qualified trust 7as defined in subparagraph 7,a7 of such section7 which is part of such a defined benefit plan7 shall be counted as income2 and 4 #ejg4 ,reducing cost-sharing and other program improvements for low-income beneficiaries 7a7 ,increase in income eligibility to #aej percent of ,,fpl for qualified ,medicare beneficiaries 7#a7 ,in general ,section #aije7p77#b77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7p77#b77;,a77 is amended by striking shall be at least the percent provided under subparagraph 7,b7 7but not more than #ajj percent7 of the official poverty line and all that follows through the period at the end and inserting the following3 shall be-- 7i7 before ,january #a1 #bjbb1 at least the percent provided under subparagraph 7,b7 7but not more than #ajj percent7 of the official poverty line 7as defined by the ,office of ,management and ,budget1 and revised annually in accordance with section #fgc7b7 of the ,omnibus ,budget ,reconciliation ,act of #aiha7 applicable to a family of the size involved2 and 7ii7 on or after ,january #a1 #bjbb1 equal to #aej percent of the official poverty line 7as so defined and revised7 applicable to a family of the size involved4 4 7#b7 ,not counting in-kind support and maintenance as income ,section #aije7p77#b77;,d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7p77#b77;,d77 is amended by adding at the end the following new clause3 7iii7 ,in determining income under this subsection1 support and maintenance furnished in kind1 as described in section #afab7;a77#b77;,a71 shall not be counted as income4 4 7#c7 ,conforming amendments 7,a7 ,section #aijb7;a77#aj77;,e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77;,e77 is amended-- 7i7 in clause 7iii71 by striking for making medical and inserting before ,january #a1 #bjbb1 for making medical2 and 7ii7 in clause 7iv71 by striking subject to sections and inserting before ,january #a1 #bjbb1 subject to sections4 7,b7 ,section #aicc of the ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#c7 is amended-- 7i7 in subsection 7a71 by striking ,a ,state plan and inserting ,subject to subsection 7h71 a ,state plan2 and 7ii7 by adding at the end the following new subsection3 7h7 ,sunset ,the provisions of this section shall have no force or effect after ,december #ca1 #bjba4 4 7b7 #ajj percent ,,fmap ,section #aije of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7 is amended by adding at the end the following new subsection3 7gg7 ,increased ,,fmap for expanded medicare cost-,sharing populations 7#a7 ,in general ,notwithstanding subsection 7b71 with respect to expenditures described in paragraph 7#b7 the ,federal medical assistance percentage shall be equal to #ajj percent4 7#b7 ,expenditures described ,the expenditures described in this paragraph are expenditures made on or after ,january #a1 #bjbb1 for medical assistance for medicare cost-sharing provided to any individual under clause 7i7 or 7ii7 of section #aijb7;a77#aj77;,e7 who would not have been eligible for medicare cost-sharing under any such clause under the income or resource eligibility standards in effect on ,october #a1 #bjah4 4 ,,vi ,providing for ,dental1 ,vision1 and ,hearing ,coverage under the ,medicare program #fja4 ,dental and oral health care 7a7 ,coverage ,section #ahfa7s77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#b77 is amended-- 7#a7 in subparagraph 7,,gg71 by striking and after the semicolon at the end2 7#b7 in subparagraph 7,,hh71 by striking the period at the end and adding 2 and2 and 7#c7 by adding at the end the following new subparagraph3 7,,ii7 dental and oral health services 7as defined in subsection 7kkk772 4 7b7 ,dental and oral health services defined ,section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is amended by adding at the end the following new subsection3 7kkk7 ,dental and oral health services 7#a7 ,in general ,the term dental and oral health services means items and services 7other than such items and services for which payment may be made under part ,a as inpatient hospital services7 that are furnished during #bjbe or a subsequent year1 for which coverage was not provided under part ,b as of the date of the enactment of this subsection1 and that are-- 7,a7 the preventive and screening services described in paragraph 7#b7 furnished by a doctor of dental surgery or of dental medicine 7as described in subsection 7r77#b77 or an oral health professional 7as defined in paragraph 7#d772 or 7,b7 the basic treatments specified for such year by the ,secretary pursuant to paragraph 7#c77;,a7 and the major treatments specified for such year by the ,secretary pursuant to paragraph 7#c77;,b7 furnished by such a doctor or such a professional4 7#b7 ,preventive and screening services ,the preventive and screening services described in this paragraph are the following3 7,a7 ,oral exams4 7,b7 ,dental cleanings4 7,c7 ,dental x-rays performed in the office of a doctor or professional described in paragraph 7#a77;,a74 7,d7 ,fluoride treatments4 7#c7 ,basic and major treatments ,for #bjbe and each subsequent year1 the ,secretary shall specify-- 7,a7 basic treatments 7which may include basic tooth restorations1 basic periodontic services1 tooth extractions1 and oral disease management services72 and 7,b7 major treatments 7which may include major tooth restorations1 major periodontic services1 bridges1 crowns1 and root canals72 that shall be included as dental and oral health services for such year4 7#d7 ,oral health professional ,the term oral health professional means1 with respect to dental and oral health services1 a health professional who is licensed to furnish such services1 acting within the scope of such license1 by the ,state in which such services are furnished4 4 7c7 ,payment2 coinsurance2 and limitations 7#a7 ,in general ,section #ahcc7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77#a77 is amended-- 7,a7 in subparagraph 7,n71 by inserting and dental and oral health services 7as defined in section #ahfa7kkk77 after section #ahfa7;hhh77#a772 7,b7 by striking and before 7,,cc72 and 7,c7 by inserting before the semicolon at the end the following3 1 and 7,,dd7 with respect to dental and oral health services 7as defined in section #ahfa7kkk771 the amount paid shall be the payment amount specified under section #ahcd7x74 7#b7 ,payment and limits specified ,section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is amended by adding at the end the following new subsection3 7x7 ,payment and limits for dental and oral health services 7#a7 ,in general ,the payment amount under this part for dental and oral health services 7as defined in section #ahfa7kkk77 shall be1 subject to paragraph 7#c71 the applicable percent 7specified in paragraph 7#b77 of the lesser of the actual charge for the services or the amount determined under the payment basis determined under section #ahdh4 ,in determining such amounts determined under such payment basis1 the ,secretary shall consider payment rates paid to dentists for comparable services under ,state plans under title ,,xix1 under the ,,tricare program under chapter #ee of title #aj of the ,united ,states ,code1 and by other health care payers1 such as ,medicare ,advantage plans under part ,c4 7#b7 ,applicable percent ,for purposes of paragraph 7#a71 the applicable percent specified in this paragraph is1 with respect to dental and oral health services 7as defined in section #ahfa7kkk77 furnished in a year-- 7,a7 that are preventive and screening services described in paragraph 7#b7 or basic treatments specified for such year pursuant to paragraph 7#c77;,a7 of such section1 #hj percent2 and 7,b7 that are major treatments specified for such year pursuant to paragraph 7#c77;,b7 of such section-- 7i7 in the case such services are furnished during #bjbe1 #aj percent2 7ii7 in the case such services are furnished during #bjbf or a subsequent year before #bjbi1 the applicable percent specified under this subparagraph for the previous year1 increased by #aj percentage points2 and 7iii7 in the case such services are furnished during #bjbi or a subsequent year1 #ej percent4 7#c7 ,limitations ,with respect to dental and oral health services that are-- 7,a7 preventive and screening oral exams1 payment may be made under this part for not more than two such exams during a #ab-month period2 7,b7 dental cleanings1 payment may be made under this part for not more than two such cleanings during a #ab-month period2 and 7,c7 not described in subparagraph 7,a7 or 7,b71 payment may be made under this part only at such frequencies and under such circumstances determined appropriate by the ,secretary4 4 7d7 ,payment under physician fee schedule 7#a7 ,in general ,section #ahdh7;j77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;j77#c77 is amended by inserting 7#b77;,,ii71 before 7#c74 7#b7 ,exclusion from ,,mips ,section #ahdh7q77#a77;,c77ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7q77#a77;,c77ii77 is amended-- 7,a7 in subclause 7,,ii71 by striking or at the end2 7,b7 in subclause 7,,iii71 by striking the period at the end and inserting 2 or2 and 7,c7 by adding at the end the following new subclause3 7,,iv7 with respect to #bjbe and each subsequent year1 is a doctor of dental surgery or of dental medicine 7as described in section #ahfa7r77#b77 or is an oral health professional 7as defined in section #ahfa7kkk77#d774 4 7#c7 ,inclusion of oral health professionals as certain practitioners ,section #ahdb7;b77#ah77;,c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieu7b77#ah77;,c77 is amended by adding at the end the following new clause3 7vii7 ,with respect to #bjbe and each subsequent year1 an oral health professional 7as defined in section #ahfa7kkk77#d774 4 7e7 ,dentures 7#a7 ,in general ,section #ahfa7s77#h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#h77 is amended-- 7,a7 by striking 7other than dental72 and 7,b7 by inserting and excluding dental1 except for a full or partial set of dentures furnished on or after ,january #a1 #bjbe after colostomy care4 7#b7 ,special payment rules 7,a7 ,limitations ,section #ahcd7;h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77 is amended by adding at the end the following new paragraph3 7#f7 ,special payment rule for dentures ,payment may be made under this part with respect to an individual for dentures-- 7,a7 not more than once during any #e-year period 7except in the case that a doctor or professional described in section #ahfa7kkk77#a77;,a7 determines such dentures do not fit the individual72 and 7,b7 only to the extent that such dentures are furnished pursuant to a written order of such a doctor or professional4 4 7,b7 ,application of competitive acquisition 7i7 ,in general ,section #ahcd7;h77#a77;,h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77#a77;,h77 is amended-- 7,i7 in the subparagraph heading1 by inserting 1 dentures after orthotics2 7,,ii7 by inserting 1 of dentures described in paragraph 7#b77;,d7 of such section1 after #bjaa12 and 7,,iii7 in clause 7i71 by inserting 1 such dentures after orthotics4 7ii7 ,conforming amendment ,section #ahdg7;a77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#b77 is amended by adding at the end the following new subparagraph3 7,d7 ,dentures ,dentures described in section #ahfa7s77#h7 for which payment would otherwise be made under section #ahcd7;h74 4 7iii7 ,exemption of certain items from competitive acquisition ,section #ahdg7;a77#g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#g77 is amended by adding at the end the following new subparagraph3 7,c7 ,certain dentures ,those items and services described in paragraph 7#b77;,d7 if furnished by a physician or other practitioner 7as defined by the ,secretary7 to the physician's or practitioner's own patients as part of the physician's or practitioner's professional service4 4 7f7 ,exclusion modifications ,section #ahfb7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7a77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,o71 by striking and at the end2 7,b7 in subparagraph 7,p71 by striking the semicolon at the end and inserting 1 and2 and 7,c7 by adding at the end the following new subparagraph3 7,q7 in the case of dental and oral health services 7as defined in section #ahfa7kkk77 that are preventive and screening services described in paragraph 7#b7 of such section1 which are furnished more frequently than provided under section #ahcd7x77#c7 and under circumstances other than circumstances determined appropriate under such section2 2 and 7#b7 in paragraph 7#ab71 by inserting before the semicolon at the end the following3 and except that payment may be made under part ,b for dental and oral health services that are covered under section #ahfa7s77#b77;,,ii74 7g7 ,certain non-application 7#a7 ,in general ,paragraphs 7#a7 and 7#d7 of section #ahci7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acier7a77 are amended by adding at the end of each such paragraphs the following3 ,in applying this paragraph there shall not be taken into account benefits and administrative costs attributable to the amendments made by section #fja 7other than subsection 7g77 of the ,elijah ,e4 ,cummings ,lower ,drug ,costs ,now ,act and the ,government contribution under section #ahdd7;a77#d74 7#b7 ,payment ,section #ahdd7;a7 of such ,act 7#db ,u4,s4,c4 #aciew7a77 is amended-- 7,a7 in paragraph 7#c71 by striking the period at the end and inserting 2 plus2 and 7,b7 by adding at the end the following new paragraph3 7#d7 a ,government contribution equal to the amount that is estimated to be payable for benefits and related administrative costs incurred that are attributable to the amendments made by section #fja 7other than subsection 7g77 of the ,elijah ,e4 ,cummings ,lower ,drug ,costs ,now ,act4 4 7h7 ,implementation funding 7#a7 ,in general ,the ,secretary of ,health and ,human ,services 7in this subsection referred to as the ,secretary7 shall provide for the transfer from the ,federal ,supplementary ,medical ,insurance ,trust ,fund under section #ahda of the ,social ,security ,act 7#db ,u4,s4,c4 #aciet7 to the ,centers for ,medicare ,medicaid ,services ,program ,management ,account of-- 7,a7 #bj1jjj1jjj for each of fiscal years #bjbj through #bjbe for purposes of implementing the amendments made by this section2 and 7,b7 such sums as determined appropriate by the ,secretary for each subsequent fiscal year for purposes of administering the provisions of such amendments4 7#b7 ,availability and additional use of funds ,funds transferred pursuant to paragraph 7#a7 shall remain available until expended and may be used1 in addition to the purpose specified in paragraph 7#a77;,a71 to implement the amendments made by sections #fjb and #fjc4 #fjb4 ,providing coverage for hearing care under the ,medicare program 7a7 ,provision of aural rehabilitation and treatment services by qualified audiologists ,section #ahfa7ll77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7ll77#c77 is amended by inserting 7and1 beginning ,january #a1 #bjbc1 such aural rehabilitation and treatment services7 after assessment services4 7b7 ,coverage of hearing aids 7#a7 ,inclusion of hearing aids as prosthetic devices ,section #ahfa7s77#h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#h77 is amended by inserting 1 and including hearing aids furnished on or after ,january #a1 #bjbc1 to individuals diagnosed with profound or severe hearing loss before the semicolon at the end4 7#b7 ,payment limitations for hearing aids ,section #ahcd7;h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h771 as amended by section #fja7;e77#b77;,a71 is further amended by adding at the end the following new paragraph3 7#g7 ,limitations for hearing aids ,payment may be made under this part with respect to an individual1 with respect to hearing aids furnished on or after ,january #a1 #bjbc-- 7,a7 not more than once during a #e-year period2 7,b7 only for types of such hearing aids that are not over-the-counter hearing aids 7as defined in section #ebj7q77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act7 and that are determined appropriate by the ,secretary2 and 7,c7 only if furnished pursuant to a written order of a physician or qualified audiologist 7as defined in section #ahfa7ll77#d77;,b774 4 7#c7 ,application of competitive acquisition 7,a7 ,in general ,section #ahcd7;h77#a77;,h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77#a77;,h771 as amended by section #fja7;e77#b77;,b77i71 is further amended-- 7i7 in the header1 by inserting 1 hearing aids after dentures2 7ii7 by inserting 1 of hearing aids described in paragraph 7#b77;,e7 of such section1 after paragraph 7#b77;,d7 of such section2 and 7iii7 in clause 7i71 by inserting 1 such hearing aids after such dentures4 7,b7 ,conforming amendment 7i7 ,in general ,section #ahdg7;a77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#b771 as amended by section #fja7;e77#b77;,b77ii71 is further amended by adding at the end the following new subparagraph3 7,e7 ,hearing aids ,hearing aids described in section #ahfa7s77#h7 for which payment would otherwise be made under section #ahcd7;h74 4 7ii7 ,exemption of certain items from competitive acquisition ,section #ahdg7;a77#g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#g771 as amended by section #fja7;e77#b77;,b77iii71 is further amended by adding at the end the following new subparagraph3 7,d7 ,certain hearing aids ,those items and services described in paragraph 7#b77;,e7 if furnished by a physician or other practitioner 7as defined by the ,secretary7 to the physician's or practitioner's own patients as part of the physician's or practitioner's professional service4 4 7#d7 ,inclusion of audiologists as certain practitioners to receive payment on an assignment-related basis ,section #ahdb7;b77#ah77;,c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieu7b77#ah77;,c771 as amended by section #fja7;d77#d71 is further amended by adding at the end the following new clause3 7viii7 ,with respect to #bjbc and each subsequent year1 a qualified audiologist 7as defined in section #ahfa7ll77#d77;,b774 4 7c7 ,exclusion modification ,section #ahfb7;a77#g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7a77#g77 is amended by inserting 7except such hearing aids or examinations therefor as described in and otherwise allowed under section #ahfa7s77#h77 after hearing aids or examinations therefor4 7d7 ,certain non-application 7#a7 ,in general ,the last sentence of section #ahci7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acier7a77#a771 as added by section #fja7;g77#a71 is amended by striking section #fja 7other than subsection 7g77 and inserting sections #fja 7other than subsection 7g771 #fjb 7other than subsection 7d774 7#b7 ,payment ,paragraph 7#d7 of section #ahdd7;a7 of such ,act 7#db ,u4,s4,c4 #aciew7a771 as added by section #fja7;g77#b71 is amended by striking section #fja 7other than subsection 7g77 and inserting sections #fja 7other than subsection 7g771 #fjb 7other than subsection 7d774 7e7 ,report2 regulations 7#a7 ,report ,not later than the date that is #c years after the date of the enactment of this ,act1 the ,inspector ,general of the ,department of ,health and ,human ,services shall conduct a study to assess 7and submit to the ,secretary of ,health and ,human ,services a report on7 any program integrity or overutilization risks with respect to allowing qualified audiologists 7as defined in paragraph 7#d77;,b7 of #ahfa7ll7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7ll777 to furnish audiology services 7as defined in paragraph 7#c7 of such section7 to individuals entitled to benefits under part ,a of title ,,xviii of such ,act 7#db ,u4,s4,c4 #acie;c et seq47 and enrolled for benefits under part ,b of such title 7#db ,u4,s4,c4#acie;j et seq47 without such individuals being referred by a physician 7as defined in section #ahfa7r7 of such ,act 7#db ,u4,s4,c4 #aciex7r777 or practitioner 7as described in section #fjb4cb of title #db1 ,code of ,federal ,regulations7 to such qualified audiologists4 ,in conducting such study1 the ,inspector ,general may take into account experiences with audiologists furnishing audiology services to enrollees in other ,federal programs1 including in a health benefit plan under chapter #hi of title #e1 ,united ,states ,code or in health care benefits under the ,,tricare program under chapter #ee of title #aj of the ,united ,states ,code or under chapter #ag of title #ch of such ,code4 7#b7 ,regulations ,the ,secretary of ,health and ,human ,services may promulgate regulations to allow qualified audiologists 7as so defined7 to furnish audiology services 7as so defined7 without a referral from a physician or practitioner1 consistent with the findings submitted to the ,secretary pursuant to paragraph 7#a77;,b74 7f7 ,implementation funding 7#a7 ,in general ,the ,secretary of ,health and ,human ,services 7in this subsection referred to as the ,secretary7 shall provide for the transfer from the ,federal ,supplementary ,medical ,insurance ,trust ,fund under section #ahda of the ,social ,security ,act 7#db ,u4,s4,c4 #aciet7 to the ,centers for ,medicare ,medicaid ,services ,program ,management ,account of-- 7,a7 #bj1jjj1jjj for each of fiscal years #bjbj through #bjbd for purposes of implementing the amendments made by this section2 and 7,b7 such sums as determined appropriate by the ,secretary for each subsequent fiscal year for purposes of administering the provisions of such amendments4 7#b7 ,availability and additional use of funds ,funds transferred pursuant to paragraph 7#a7 shall remain available until expended and may be used1 in addition to the purpose specified in paragraph 7#a77;,a71 to implement the amendments made by sections #fja and #fjc4 #fjc4 ,providing coverage for vision care under the ,medicare program 7a7 ,coverage ,section #ahfa7s77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#b771 as amended by section #fja7;a71 is further amended-- 7#a7 in subparagraph 7,,hh71 by striking and after the semicolon at the end2 7#b7 in subparagraph 7,,ii71 by striking the period at the end and adding 2 and2 and 7#c7 by adding at the end the following new subparagraph3 7,,jj7 vision services 7as defined in subsection 7lll772 4 7b7 ,vision services defined ,section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex71 as amended by section #fja7;b71 is further amended by adding at the end the following new subsection3 7lll7 ,vision services ,the term vision services means-- 7#a7 routine eye examinations to determine the refractive state of the eyes1 including procedures performed during the course of such examination2 and 7#b7 contact lens fitting services2 furnished on or after ,january #a1 #bjbc1 by or under the direct supervision of an optometrist or ophthalmologist who is legally authorized to furnish such examinations1 procedures1 or fitting services 7as applicable7 under ,state law 7or the ,state regulatory mechanism provided by ,state law7 of the ,state in which the examinations1 procedures1 or fitting services are furnished4 4 7c7 ,payment limitations ,section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem71 as amended by section #fja7;c77#b71 is further amended by adding at the end the following new subsection3 7y7 ,limitation for vision services ,with respect to vision services 7as defined in section #ahfa7lll77 and an individual1 payment may be made under this part for only #a routine eye examination described in paragraph 7#a7 of such section and #a contact lens fitting service described in paragraph 7#b7 of such section during a #b-year period4 4 7d7 ,payment under physician fee schedule ,section #ahdh7;j77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;j77#c771 as amended by section #fja7;d77#a71 is further amended by inserting 7#b77;,,jj71 before 7#c74 7e7 ,coverage of conventional eyeglasses and contact lenses ,section #ahfa7s77#h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#h771 as amended by section #fjb7;b77#a71 is further amended by striking 1 and including one pair of conventional eyeglasses or contact lenses furnished subsequent to each cataract surgery with insertion of an intraocular lens and inserting 1 including one pair of conventional eyeglasses or contact lenses furnished subsequent to each cataract surgery with insertion of an intraocular lens1 if furnished before ,january #a1 #bjbc1 including conventional eyeglasses or contact lenses1 whether or not furnished subsequent to such a surgery1 if furnished on or after ,january #a1 #bjbd4 7f7 ,special payment rules for eyeglasses and contact lenses 7#a7 ,limitations ,section #ahcd7;h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h771 as amended by section #fja7;e77#b77;,a7 and section #fjb7;b77#b71 is further amended by adding at the end the following new paragraph3 7#h7 ,payment limitations for eyeglasses and contact lenses 7,a7 ,in general ,with respect to eyeglasses and contact lenses furnished to an individual on or after ,january #a1 #bjbc1 subject to subparagraph 7,b71 payment may be made under this part only-- 7i7 during a #b-year period1 for either #a pair of eyeglasses 7including lenses and frames7 or not more than a #b-year supply of contact lenses that is provided in not more than #ahj-;day increments2 7ii7 with respect to amounts attributable to the lenses and frames of such a pair of eyeglasses or amounts attributable to such a #b-year supply of contact lenses1 in an amount not greater than-- 7,i7 for a pair of eyeglasses furnished in1 or a #b-year supply of contact lenses beginning in1 #bjbc-- 7aa7 #he for the lenses of such pair of eyeglasses and #he for the frames of such pair of eyeglasses2 or 7bb7 #he for such #b-year supply of contact lenses2 and 7,,ii7 for the lenses and frames of a pair of eyeglasses furnished in1 or a #b-year supply of contact lenses beginning in1 a subsequent year1 the dollar amounts specified under this subparagraph for the previous year1 increased by the percentage change in the consumer price index for all urban consumers 7,united ,states city average7 for the #ab-month period ending with ,june of the previous year2 7iii7 for types of eyeglass lenses1 and for types of contact lenses1 as determined appropriate by the ,secretary2 7iv7 if furnished pursuant to a written order of a physician described in section #ahfa7lll72 and 7v7 if during the #b-year period described in clause 7i71 the individual did not already receive 7as described in subparagraph 7,b77 one pair of conventional eyeglasses or contact lenses subsequent to a cataract surgery with insertion of an intraocular lens furnished during such period4 7,b7 ,exception ,with respect to a #b-year period described in subparagraph 7,a77i71 in the case of an individual who receives cataract surgery with insertion of an intraocular lens1 notwithstanding subparagraph 7,a71 payment may be made under this part for one pair of conventional eyeglasses or contact lenses furnished subsequent to such cataract surgery during such period4 4 7#b7 ,application of competitive acquisition 7,a7 ,in general ,section #ahcd7;h77#a77;,h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77#a77;,h771 as amended by section #fja7;e77#b77;,b77i7 and section #fjb7;b77#c77;,a71 is further amended-- 7i7 in the header by inserting 1 eyeglasses1 and contact lenses after hearing aids2 7ii7 by inserting and of eyeglasses and contact lenses described in paragraph 7#b77;,f7 of such section1 after paragraph 7#b77;,e7 of such section12 and 7iii7 in clause 7i71 by inserting 1 or such eyeglasses and contact lenses after such hearing aids4 7,b7 ,conforming amendment 7i7 ,in general ,section #ahdg7;a77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#b771 as amended by section #fja7;e77#b77;,b77ii7 and section #fjb7;b77#c77;,b77i71 is further amended by adding at the end the following new subparagraph3 7,f7 ,eyeglasses and contact lenses ,eyeglasses and contact lenses described in section #ahfa7s77#h7 for which payment would otherwise be made under section #ahcd7;h74 4 7ii7 ,exemption of certain items from competitive acquisition ,section #ahdg7;a77#g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#g771 as amended by section #fja7;e77#b77;,b77iii7 and section #fjb7;b77#c77;,b77ii71 is further amended by adding at the end the following new subparagraph3 7,e7 ,certain eyeglasses and contact lenses ,those items and services described in paragraph 7#b77;,f7 if furnished by a physician or other practitioner 7as defined by the ,secretary7 to the physician's or practitioner's own patients as part of the physician's or practitioner's professional service4 4 7g7 ,exclusion modifications ,section #ahfb7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7a771 as amended by section #fja7;f71 is further amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,p71 by striking and at the end2 7,b7 in subparagraph 7,q71 by striking the semicolon at the end and inserting 1 and2 and 7,c7 by adding at the end the following new subparagraph3 7,r7 in the case of vision services 7as defined in section #ahfa7lll77 that are routine eye examinations and contact lens fitting services 7as described in paragraph 7#a7 or 7#b71 respectively1 of such section71 which are furnished more frequently than once during a #b-year period2 2 and 7#b7 in paragraph 7#g7-- 7,a7 by inserting 7other than such an examination that is a vision service that is covered under section #ahfa7s77#b77;,,jj77 after eye examinations2 and 7,b7 by inserting 7other than such a procedure that is a vision service that is covered under section #ahfa7s77#b77;,,jj77 after refractive state of the eyes4 7h7 ,certain non-application 7#a7 ,in general ,the last sentence of section #ahci7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acier7a77#a771 as added by section #fja7;g77#a7 and amended by section #fjb7;d77#a71 is further amended by inserting 1 and #fjc 7other than subsection 7h77 after #fjb 7other than subsection 7d774 7#b7 ,payment ,paragraph 7#d7 of section #ahdd7;a7 of such ,act 7#db ,u4,s4,c4 #aciew7a771 as added by section #fja7;g77#b7 and amended by section #fjb7;d77#b71 is further amended by inserting 1 and #fjc 7other than subsection 7h77 after #fjb 7other than subsection 7d774 7i7 ,implementation funding 7#a7 ,in general ,the ,secretary of ,health and ,human ,services 7in this subsection referred to as the ,secretary7 shall provide for the transfer from the ,federal ,supplementary ,medical ,insurance ,trust ,fund under section #ahda of the ,social ,security ,act 7#db ,u4,s4,c4 #aciet7 to the ,centers for ,medicare ,medicaid ,services ,program ,management ,account of-- 7,a7 #bj1jjj1jjj for each of fiscal years #bjbj through #bjbd for purposes of implementing the amendments made by this section2 and 7,b7 such sums as determined appropriate by the ,secretary for each subsequent fiscal year for purposes of administering the provisions of such amendments4 7#b7 ,availability and additional use of funds ,funds transferred pursuant to paragraph 7#a7 shall remain available until expended and may be used1 in addition to the purpose specified in paragraph 7#a77;,a71 to implement the amendments made by sections #fja and #fjb4 ,,vii ,,nih1 ,,fda1 and ,opioids ,funding ,a ,biomedical ,innovation ,expansion #gja4 ,,nih ,innovation ,initiatives 7a7 ,,nih ,innovation account 7#a7 ,in general ,section #ajja7;b7 of the #bast ,century ,cures ,act 7,public ,law #aad-bee7 is amended by adding at the end the following3 7#e7 ,supplemental funding and additional activities 7,a7 ,in general ,in addition to the funds made available under paragraph 7#b71 there are authorized to be appropriated1 and are hereby appropriated1 to the ,account1 out of any monies in the ,treasury not otherwise appropriated1 to be available until expended without further appropriation1 the following3 7i7 ,for fiscal year #bjba1 #bee1djj1jjj4 7ii7 ,for fiscal year #bjbb1 #bfj1djj1jjj4 7iii7 ,for fiscal year #bjbc1 #afc1djj1jjj4 7iv7 ,for fiscal year #bjbd1 #edg1jjj1jjj4 7v7 ,for fiscal year #bjbe1 #hdh1jjj1jjj4 7vi7 ,for fiscal year #bjbf1 #hdb1djj1jjj4 7vii7 ,for fiscal year #bjbg1 #a1jhi1fjj1jjj4 7viii7 ,for fiscal year #bjbh1 #a1aae1fjj1jjj4 7ix7 ,for fiscal year #bjbi1 #a1agj1fjj1jjj4 7x7 ,for fiscal year #bjcj1 #a1bjg1fjj1jjj4 7,b7 ,supplemental funding for certain projects ,of the total amounts made available under subparagraph 7,a7 for each of fiscal years #bjba through #bjcj1 a total amount not to exceed the following shall be made available for the following categories of ,,nih ,innovation ,projects3 7i7 ,for projects described in paragraph 7#d77;,a71 an amount not to exceed a total of #b1jgj1fjj1jjj as follows3 7,i7 ,for each of fiscal years #bjba and #bjbb1 #ej1jjj1jjj4 7,,ii7 ,for fiscal year #bjbd1 #ajj1jjj1jjj4 7,,iii7 ,for each of fiscal years #bjbe and #bjbf1 #cjj1jjj1jjj4 7,,iv7 ,for each of fiscal years #bjbg through #bjbi1 #cag1jjj1jjj4 7,v7 ,for fiscal year #bjcj1 #cai1fjj1jjj4 7ii7 ,for projects described in paragraph 7#d77;,b71 an amount not to exceed a total of #b1jda1ijj1jjj as follows3 7,i7 ,for each of fiscal years #bjba and #bjbb1 #ej1jjj1jjj4 7,,ii7 ,for fiscal year #bjbd1 #abh1jjj1jjj4 7,,iii7 ,for fiscal year #bjbe1 #bji1jjj1jjj4 7,,iv7 ,for fiscal year #bjbf1 #ajj1jjj1jjj4 7,v7 ,for fiscal year #bjbg1 #cbe1jjj1jjj4 7,,vi7 ,for fiscal year #bjbh1 #cej1jjj1jjj4 7,,vii7 ,for fiscal year #bjbi1 #djj1jjj1jjj4 7,,viii7 ,for fiscal year #bjcj1 #dbi1ijj1jjj4 7iii7 ,for projects described in paragraph 7#d77;,c71 an amount not to exceed a total of #a1eeh1djj1jjj as follows3 7,i7 ,for each of fiscal years #bjbd and #bjbe1 #aea1bjj1jjj4 7,,ii7 ,for each of fiscal years #bjbf through #bjcj1 #bea1bjj1jjj4 7iv7 ,for projects described in paragraph 7#d77;,d71 an amount not to exceed #ae1djj1jjj for each of fiscal years #bjba through #bjcj4 7,c7 ,additional ,,nih ,innovation ,projects ,in addition to funding ,,nih ,innovation ,projects pursuant to subparagraph 7,b71 of the total amounts made available under subparagraph 7,a71 a total amount not to exceed the following shall be made available for the following categories of ,,nih ,innovation ,projects3 7i7 ,to support research related to combating antimicrobial resistance and antibiotic resistant bacteria1 including research into new treatments1 diagnostics1 and vaccines1 research1 in consultation with the ,centers for ,disease ,control and ,prevention1 into stewardship1 and the development of strategies1 in coordination with the ,biomedical ,advanced ,research and ,development ,authority under section #cai,l of the ,public ,health ,service ,act1 to support commercialization of new antibiotics1 not to exceed a total of #a1add1ejj1jjj1 as follows3 7,i7 ,for each of fiscal years #bjba through #bjbd1 #ajj1jjj1jjj4 7,,ii7 ,for each of fiscal years #bjbe and #bjbf1 #abj1jjj1jjj4 7,,iii7 ,for each of fiscal years #bjbg through #bjbi1 #abe1jjj1jjj4 7,,iv7 ,for fiscal year #bjcj1 #abi1ejj1jjj4 7ii7 ,to support research and research activities related to rare diseases or conditions1 including studies or analyses that help to better understand the natural history of a rare disease or condition and translational studies related to rare diseases or conditions1 not to exceed a total of #ecj1fjj1jjj1 as follows3 7,i7 ,for fiscal year #bjba1 #dj1jjj1jjj4 7,,ii7 ,for fiscal year #bjbb1 #de1jjj1jjj4 7,,iii7 ,for fiscal year #bjbc1 #dh1jjj1jjj4 7,,iv7 ,for each of fiscal years #bjbd and #bjbe1 #eb1djj1jjj4 7,v7 ,for fiscal year #bjbf1 #ee1hjj1jjj4 7,,vi7 ,for fiscal year #bjbg1 #ef1jjj1jjj4 7,,vii7 ,for fiscal year #bjbh1 #eg1jjj1jjj4 7,,viii7 ,for each of fiscal years #bjbi and #bjcj1 #fb1jjj1jjj4 4 7#b7 ,conforming amendments ,section #ajja of the #bast ,century ,cures ,act 7,public ,law #aad-bee7 is amended-- 7,a7 in subsection 7a71 by striking subsection 7b77#d7 and inserting subsections 7b77#d7 and 7b77#e72 7,b7 in subsection 7b77#a71 by striking paragraph 7#d7 and inserting paragraphs 7#d7 and 7#e72 and 7,c7 in subsection 7c77#b77;,a77ii71 by inserting or pursuant to subsection 7b77#e7 after subsection 7b77#c72 and 7,d7 in subsection 7d71 by inserting or pursuant to subsection 7b77#e7 after subsection 7b77#c74 7b7 ,workplan ,section #ajja7;c77#a7 of the #bast ,century ,cures ,act 7,public ,law #aad-bee7 is amended by adding at the end the following3 7,d7 ,updates ,the ,director of ,,nih shall 1 after seeking recommendations in accordance with the process described in subparagraph 7,c71 update the work plan submitted under this subsection for each of fiscal years #bjba through #bjcj to reflect the amendments made to this section by the ,elijah ,e4 ,cummings ,lower ,drug ,costs ,now ,act4 4 7c7 ,annual reports ,section #ajja7;c77#b77;,a7 of the #bast ,century ,cures ,act 7,public ,law #aad-bee7 is amended by striking #bjbg and inserting #bjcj4 7d7 ,sunset ,section #ajja7;e7 of the #bast ,century ,cures ,act 7,public ,law #aad-bee7 is amended by striking ,september #cj1 #bjbf and inserting ,september #cj1 #bjcj4 #gjb4 ,,nih clinical trial ,part ,a of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bha et seq47 is amended by adding at the end the following3 #djd,o4 ,clinical ,trial ,acceleration ,pilot ,initiative 7a7 ,establishment of pilot program ,the ,secretary1 acting through the ,director of the ,national ,institutes of ,health1 shall1 not later than #b years after the date of enactment of this ,act1 establish and implement a pilot program to award multi-year contracts to eligible entities to support phase ,,ii clinical trials and phase ,,iii clinical trials-- 7#a7 to promote innovation in treatments and technologies supporting the advanced research and development and production of high need cures2 and 7#b7 to provide support for the development of medical products and therapies4 7b7 ,eligible entities ,to be eligible to receive assistance under the pilot program established under subsection 7a71 an entity shall-- 7#a7 be seeking to market a medical product or therapy that is the subject of clinical trial or trials to be supported using such assistance2 7#b7 be a public or private entity1 which may include a private or public research institution1 a contract research organization1 an institution of higher education 7as defined in section #aja of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajja771 a medical center1 a biotechnology company1 or an academic research institution2 and 7#c7 comply with requirements of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea of this ,act at all stages of development1 manufacturing1 review1 approval1 and safety surveillance of a medical product4 7c7 ,duties ,the ,secretary1 acting through the ,director of ,national ,institutes of ,health1 shall-- 7#a7 in establishing the pilot program under subsection 7a71 consult with-- 7,a7 the ,director of the ,national ,center for ,advancing ,translational ,sciences and the other national research institutes in considering their requests for new or expanded clinical trial support efforts2 and 7,b7 the ,commissioner of ,food and ,drugs and any other head of a ,federal agency as the ,secretary determines to be appropriate to ensure coordination and efficiently advance clinical trial activities2 7#b7 in implementing the pilot program under subsection 7a71 consider consulting with patients and patient advocates2 and 7#c7 in awarding contracts under the pilot program under subsection 7a71 consider-- 7,a7 the expected health impacts of the clinical trial or trials to be supported under the contract2 and 7,b7 the degree to which the medical product or therapy that is the subject of such clinical trial or trials is a high need cure4 7d7 ,exclusion ,a contract may not be awarded under the pilot program under subsection 7a7 if the drug that is the subject of the clinical trial or trials to be supported under the contract is a drug designated under section #ebf of the ,federal ,food1 ,drug1 and ,cosmetic ,act as a drug for a rare disease or condition4 7e7 ,,nih ,clinical ,trial ,accelerator ,account 7#a7 ,establishment ,there is established in the ,treasury an account1 to be known as the ,,nih ,clinical ,trial ,accelerator ,account 7referred to in this section as the ,account71 for purposes of carrying out this section4 7#b7 ,transfer of direct spending savings ,there shall be transferred to the ,account from the general fund of the ,treasury1 #fhj1jjj1jjj for each of fiscal years #bjba through #bjbe1 to be available until expended without further appropriation4 7#c7 ,work plan ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor and ,pensions of the ,senate a work plan that includes the proposed implementation of this section and the proposed allocation of funds in the ,account4 7f7 ,reports to ,congress ,not later than ,october #a of each fiscal year1 the ,secretary shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor and ,pensions of the ,senate a report on-- 7#a7 the implementation of this section2 7#b7 any available results on phase ,,ii clinical trials and phase ,,iii clinical trials supported under this section during such fiscal year2 and 7#c7 the extent to which ,federal funds are obligated to support such clinical trials1 including the specific amount of such support and awards pursuant to an allocation from the ,account under subsection 7e74 7g7 ,definitions ,in this section3 7#a7 ,phase ,,ii clinical trial ,the term phase ,,ii clinical trial means a phase ,,ii clinical investigation1 as described in section #cab4ba of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 7#b7 ,phase ,,iii clinical trials ,the term phase ,,iii clinical trial means a phase ,,iii clinical investigation1 as described in section #cab4ba of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 7#c7 ,high need cure ,the term high need cure has the meaning given such term in section #dhj7;a77#c74 4 #gjc4 ,innovation ,network ,part ,a of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bha et seq471 as amended by section #gjb1 is further amended by adding at the end the following3 #djd,p4 ,innovation ,network 7a7 ,funds ,the ,director of ,,nih shall award grants or contracts to eligible entities to develop1 expand1 and enhance the commercialization of biomedical products4 7b7 ,eligible entity ,in this section1 the term eligible entity means an entity receiving funding under-- 7#a7 the ,small ,business ,innovation ,research program of the ,national ,institutes of ,health2 or 7#b7 the ,small ,business ,technology ,transfer program of the ,national ,institutes of ,health4 7c7 ,use of funds ,an eligible entity shall use the funds received through such grant or contract to support-- 7#a7 the ,commercialization ,readiness ,pilot program of the ,national ,institutes of ,health2 7#b7 the ,innovation ,corps program of the ,national ,institutes of ,health2 7#c7 the ,commercialization ,accelerator program of the ,national ,institutes of ,health2 7#d7 the ,commercialization ,assistance program of the ,national ,institutes of ,health2 and 7#e7 such other programs and activities as the ,director of ,,nih determines to be appropriate1 to support the commercialization stage of research1 later stage research and development1 technology transfer1 and commercialization technical assistance4 7d7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this section #ajj1jjj1jjj for each of fiscal years #bjba through #bjbe1 to be available until expended4 4 ,b ,investing in ,safety and ,innovation #gaa4 ,food and ,drug ,administration 7a7 ,,fda ,innovation account 7#a7 ,in general ,section #ajjb7;b7 of the #bast ,century ,cures ,act 7,public ,law #aad-bee7 is amended-- 7,a7 in paragraph 7#a71 by striking paragraph 7#d7 and inserting paragraphs 7#d7 and 7#e72 and 7,b7 by adding at the end the following new paragraph3 7#e7 ,supplemental funding and additional activities 7,a7 ,in general ,in addition to the funds made available under paragraph 7#b71 there are authorized to be appropriated1 and are hereby appropriated1 to the ,account1 out of any monies in the ,treasury not otherwise appropriated1 to be available until expended without further appropriation1 the following3 7i7 ,for fiscal year #bjbj1 #dag1ejj1jjj4 7ii7 ,for each of fiscal years #bjba and #bjbb1 #aeg1ejj1jjj4 7iii7 ,for each of fiscal years #bjbc through #bjbe1 #aeb1ejj1jjj4 7iv7 ,for each of fiscal years #bjbf through #bjbi1 #bjb1ejj1jjj4 7,b7 ,supplemental funding for certain activities ,of the total amounts made available under subparagraph 7,a7 for each of fiscal years #bjbf through #bjbi1 a total amount not to exceed #ej1jjj1jjj for each such fiscal year1 shall be made available for the activities under subtitles ,a through ,f 7including the amendments made by such subtitles7 of title ,,iii of this ,act and section #ajad of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #cjgc of this ,act4 7,c7 ,additional ,,fda activities ,in addition to funding activities pursuant to subparagraph 7,b71 of the total amounts made available under subparagraph 7,a71 a total amount not to exceed the following shall be made available for the following categories of activities3 7i7 ,for modernization of the technical infrastructure of the ,food and ,drug ,administration1 including enhancements such as interoperability across the agency1 and additional capabilities to develop an advanced information technology infrastructure to support the agency's regulatory mission3 7,i7 ,for fiscal year #bjbj1 #ahj1jjj1jjj4 7,,ii7 ,for each of fiscal years #bjba through #bjbi1 #fj1jjj4 7ii7 ,for support for continuous manufacturing of drugs and biological products1 including complex biological products such as regenerative medicine therapies1 through grants to institutions of higher education and nonprofit organizations and other appropriate mechanisms1 for each of fiscal years #bjbj through #bjbi1 #bj1jjj1jjj4 7iii7 ,for support for the ,commissioner of ,food and ,drugs to engage experts1 such as through the formation and operation of public-private partnerships or other appropriate collaborative efforts1 to advance the development and delivery of individualized human gene therapy products3 7,i7 ,for fiscal year #bjbj1 #ej1jjj1jjj4 7,,ii7 ,for each of fiscal years #bjba through #bjbi1 #aj1jjj1jjj4 7iv7 ,for support for inspections1 enforcement1 and quality surveillance activities across the ,food and ,drug ,administration1 including foreign and domestic inspections across products1 for each of fiscal years #bjbj through #bjbi1 #bj1jjj1jjj4 7v7 ,for support for activities of the ,food and ,drug ,administration related to customs and border protection to provide improvements to technologies1 inspection capacity1 and sites of import 7including international mail facilities7 in which the ,food and ,drug ,administration operates1 for each of fiscal years #bjbj through #bjbi1 #aj1jjj1jjj4 7vi7 ,to further advance the development of a coordinated postmarket surveillance system for all medical products1 including drugs1 biological products1 and devices1 linked to electronic health records in furtherance of the ,food and ,drug ,administration's postmarket surveillance capabilities3 7,i7 ,for fiscal year #bjbj1 #aab1ejj1jjj4 7,,ii7 ,for each of fiscal years #bjba through #bjbi1 #ab1ejj1jjj4 7vii7 ,for support for ,food and ,drug ,administration activities to keep pace with the projected product development of regenerative therapies1 including cellular and somatic cell gene therapy products3 7,i7 ,for each of fiscal years #bjbj through #bjbb1 #aj1jjj1jjj4 7,,ii7 ,for each of fiscal years #bjbc through #bjbi1 #e1jjj1jjj4 7viii7 ,for carrying out section #gad;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;d-#c;a2 relating to hiring authority for scientific1 technical1 and professional personnel71 for each of fiscal years #bjbj through #bjbi1 #b1ejj1jjj4 7ix7 ,for the ,food and ,drug ,administration to support improvements to the technological infrastructure for reporting and analysis of adverse events associated with the use of drugs and biological products1 for each of fiscal years #bjbj through #bjbi1 #ab1ejj1jjj4 4 7#b7 ,conforming amendments ,section #ajjb of the #bast ,century ,cures ,act 7,public ,law #aad-bee7 is amended-- 7,a7 in subsection 7a71 by inserting before the period at the end the following3 or pursuant to subparagraph 7,a7 of subsection 7b77#e7 to carry out the activities described in subparagraphs 7,b7 and 7,c7 of such subsection2 and 7,b7 in subsection 7d7-- 7i7 by inserting or pursuant to subparagraph 7,a7 of subsection 7b77#e7 after subsection 7b77#c72 and 7ii7 by striking subsection 7b77#d7 and inserting subsections 7b77#d7 and 7b77#e74 7b7 ,annual ,report ,section #ajjb7;c77#b77;,a7 of the #bast ,century ,cures ,act 7,public ,law #aad-bee7 is amended1 in the matter preceding clause 7i71 by striking #bjbf and inserting #bjcj4 7c7 ,sunset ,section #ajjb7;e7 of the #bast ,century ,cures ,act 7,public ,law #aad-bee7 is amended by striking ,september #cj1 #bjbe and inserting ,september #cj1 #bjcj4 #gab4 ,study on high-risk1 high-reward drugs 7a7 ,in general ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall conduct a study to identify-- 7#a7 diseases or conditions that lack a treatment approved by the ,food and ,drug ,administration and instances in which development of a treatment for such diseases or conditions could fill an unmet medical need for the treatment of a serious or life-threatening disease or condition or a rare disease or condition2 and 7#b7 appropriate incentives that would lead to the development1 approval1 and marketing of such treatments4 7b7 ,report to ,congress2 recommendations ,not later than one year after the date of enactment of this ,act1 the ,secretary shall submit to the ,congress a report that includes-- 7#a7 findings from the study under subsection 7a72 and 7#b7 recommendations regarding legislation necessary to create appropriate incentives identified pursuant to subsection 7a77#b74 ,c ,opioid ,epidemic ,response #gba4 ,opioid ,epidemic ,response ,fund 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall use any funds made available pursuant to subsection 7b7 to carry out the programs and activities described in subsection 7c7 to address the opioid and substance use disorder epidemic4 ,such funds shall be in addition to any funds which are otherwise available to carry out such programs and activities4 7b7 ,opioid ,epidemic ,response ,fund 7#a7 ,establishment of account ,there is established in the ,treasury an account1 to be known as the ,opioid ,epidemic ,response ,fund 7referred to in this section as the ,fund71 for purposes of funding the programs and activities described in subsection 7c74 7#b7 ,funding ,there is authorized to be appropriated1 and there is appropriated1 to the ,fund1 out of any monies in the ,treasury not otherwise appropriated #a1ihj1jjj1jjj for each of fiscal years #bjba through #bjbe4 7#c7 ,availability ,amounts made available by paragraph 7#b7 shall be made available to the agencies specified in subsection 7c7 in accordance with such subsection4 ,amounts made available to an agency pursuant to the preceding sentence for a fiscal year shall remain available until expended4 7c7 ,programs and activities ,of the total amount in the ,fund for each of fiscal years #bjba through #bjbe1 such amount shall be allocated as follows3 7#a7 ,,samhsa ,for the ,substance ,abuse and ,mental ,health ,services ,administration to carry out programs and activities pursuant to section #gbb1 #a1ejj1jjj1jjj for each of fiscal years #bjba through #bjbe4 7#b7 ,,cdc ,for the ,centers for ,disease ,control and ,prevention to carry out programs and activities pursuant to section #gbc1 #abj1jjj1jjj for each of fiscal years #bjba through #bjbe4 7#c7 ,,fda ,for the ,food and ,drug ,administration to carry out programs and activities pursuant to section #gbd1 #aj1jjj1jjj for each of fiscal years #bjba through #bjbe4 7#d7 ,,nih ,for the ,national ,institutes of ,health to carry out programs and activities pursuant to section #gbe1 #bdj1jjj1jjj for each of fiscal years #bjba through #bjbe4 7#e7 ,,hrsa ,for the ,health ,resources and ,services ,administration to carry out programs and activities pursuant to section #gbf1 #ij1jjj1jjj for each of fiscal years #bjba through #bjbe4 7#f7 ,,acf ,for the ,administration for ,children and ,families to carry out programs and activities pursuant to section #gbg1 #bj1jjj1jjj for each of fiscal years #bjba through #bjbe4 7d7 ,accountability and oversight 7#a7 ,work plan 7,a7 ,in general ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate and the ,committee on ,energy and ,commerce1 the ,committee on ,appropriations1 and the ,committee on ,education and ,labor of the ,house of ,representatives1 a work plan including the proposed allocation of funds made available pursuant to subsection 7b7 for each of fiscal years #bjba through #bjbe and the contents described in subparagraph 7,b74 7,b7 ,contents ,the work plan submitted under subparagraph 7,a7 shall include-- 7i7 the amount of money to be obligated or expended out of the ,fund in each fiscal year for each program and activity described in subsection 7c72 and 7ii7 a description and justification of each such program and activity4 7#b7 ,annual reports ,not later than ,october #a of each of fiscal years #bjbb through #bjbf1 the ,secretary of ,health and ,human ,services shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate and the ,committee on ,energy and ,commerce1 the ,committee on ,appropriations1 and the ,committee on ,education and ,labor of the ,house of ,representatives1 a report including-- 7,a7 the amount of money obligated or expended out of the ,fund in the prior fiscal year for each program and activity described in subsection 7c72 7,b7 a description of all programs and activities using funds made available pursuant to subsection 7b72 and 7,c7 how the programs and activities are responding to the opioid and substance use disorder epidemic4 7e7 ,limitations ,notwithstanding any authority in this subtitle or any appropriations ,act1 any funds made available pursuant to subsection 7b7 may not be used for any purpose other than the programs and activities described in subsection 7c74 #gbb4 ,substance ,abuse and ,mental ,health ,services ,administration 7a7 ,in general ,the entirety of the funds made available pursuant to section #gba7;c77#a7 shall be for the ,assistant ,secretary for ,mental ,health and ,substance ,use to continue to award the ,state ,opioid ,response ,grants funded by the heading ,substance ,abuse ,and ,mental ,health ,services ,administration--,substance ,abuse ,treatment in title ,,ii of the ,departments of ,labor1 ,health and ,human ,services1 and ,education1 and ,related ,agencies ,appropriations ,act1 #bjah 7,public ,law #aae-ada74 ,subject to subsections 7b7 and 7c71 such grants shall be awarded in the same manner and subject to the same conditions as were applicable to such grants for fiscal year #bjah4 7b7 ,requirement that treatment be evidence-based ,as a condition on receipt of a grant pursuant to subsection 7a71 a grantee shall agree that-- 7#a7 treatments1 practices1 or interventions funded through the grant will be evidence-based2 and 7#b7 such treatments1 practices1 and interventions will include medication-assisted treatment for individuals diagnosed with opioid use disorder1 using drugs only if the drugs have been approved or licensed by the ,food and ,drug ,administration under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 7c7 ,reservations ,of the amount made available pursuant to section #gca7;c77#a7 for a fiscal year-- 7#a7 not less than #ge1jjj1jjj shall be reserved to make grants under subsection 7a7 to ,indian ,tribes or ,tribal organizations2 and 7#b7 not less than #ej1jjj1jjj shall be reserved to make grants under subsection 7a7 to political subdivisions of ,states1 such as counties1 cities1 or towns4 #gbc4 ,centers for ,disease ,control and ,prevention 7a7 ,addressing opioid use disorder ,the entirety of the funds made available pursuant to section #gba7;c77#b7 shall be for the ,director of the ,centers for ,disease ,control and ,prevention1 pursuant to applicable authorities in the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq471 to continue and expand programs of the ,centers for ,disease ,control and ,prevention to address opioid and substance use disorder1 including by-- 7#a7 improving the timeliness and quality of data on the opioid use disorder epidemic1 including improvement of-- 7,a7 data on fatal and nonfatal overdoses2 7,b7 syndromic surveillance2 7,c7 data on long-term sequelae 7including neonatal abstinence syndrome72 and 7,d7 cause of death reporting related to substance abuse or opioid overdose2 7#b7 expanding and strengthening evidence-based prevention and education strategies2 7#c7 supporting responsible prescribing practices1 including through development and dissemination of prescriber guidelines2 7#d7 improving access to and use of effective prevention1 treatment1 and recovery support1 including through grants and the provision of technical assistance to ,states and localities2 7#e7 strengthening partnerships with first responders1 including to protect their safety2 7#f7 considering the needs of vulnerable populations2 7#g7 addressing infectious diseases linked to the opioid crisis2 7#h7 strengthening prescription drug monitoring programs2 and 7#i7 providing financial and technical assistance to ,state and local health department efforts to treat and prevent substance use disorder4 7b7 ,limitation ,of the funds made available pursuant to section #gba7;c77#b7 for carrying out this section1 not more than #bj percent may be used for intramural purposes4 #gbd4 ,food and ,drug ,administration ,the entirety of the funds made available pursuant to section #gba7;c77#c7 shall be for the ,commissioner of ,food and ,drugs1 pursuant to applicable authorities in the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq47 or the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 and other applicable law1 to support widespread innovation in non-opioid and non-addictive medical products for pain treatment1 access to opioid addiction treatments1 appropriate use of approved opioids1 and efforts to reduce illicit importation of opioids4 ,such support may include the following3 7#a7 ,facilitating the development of non-opioid and non-addictive pain treatments4 7#b7 ,advancing guidance documents for sponsors of non-opioid pain products4 7#c7 ,developing evidence to inform the potential for nonprescription overdose therapies4 7#d7 ,examining expanded labeling indications for medication-assisted treatment4 7#e7 ,conducting public education and outreach1 including public workshops or public meetings1 regarding the benefits of medication-assisted treatment1 including all drugs approved by the ,food and ,drug ,administration1 and device treatment options approved or cleared by the ,food and ,drug ,administration4 7#f7 ,exploring the expansion and possible mandatory nature of prescriber education regarding pain management and appropriate opioid prescribing through authorities under section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a74 7#g7 ,examining options to limit the duration of opioid prescriptions for acute pain1 including through packaging options4 7#h7 ,increasing staff and infrastructure capacity to inspect and analyze packages at international mail facilities and pursue criminal investigations4 #gbe4 ,national ,institutes of ,health ,the entirety of the funds made available pursuant to section #gba7;c77#d7 shall be for the ,director of the ,national ,institutes of ,health1 pursuant to applicable authorities in the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq471 to carry out activities related to-- 7#a7 accelerating research for addressing the opioid use disorder epidemic1 including developing non-opioid medications and interventions1 including non-addictive medications1 to manage pain1 as well as developing medications and interventions to treat and to prevent substance use disorders2 7#b7 conducting and supporting research on which treatments 7in terms of pain management as well as treating and preventing substance use disorders7 are optimal for which patients2 and 7#c7 conducting and supporting research on creating longer-lasting or faster-acting antidotes for opioid overdose1 particularly in response to the prevalence of fentanyl and carfentanyl overdoses4 #gbf4 ,health ,resources and ,services ,administration ,the entirety of the funds made available pursuant to section #gba7;c77#e7 shall be for the ,administrator of the ,health ,resources and ,services ,administration1 pursuant to applicable authorities in titles ,,iii1 ,,vii1 and ,,viii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq471 to carry out activities that increase the availability and capacity of the behavioral health workforce4 ,such activities shall include providing loan repayment assistance for substance use disorder treatment providers4 #gbg4 ,administration for ,children and ,families ,of the funds made available pursuant to section #gba7;c77#f7 for each of fiscal years #bjba through #bjbe1 #bj1jjj1jjj for each such fiscal year shall be for the ,secretary of ,health and ,human ,services to carry out title ,i of the ,child ,abuse ,prevention and ,treatment ,act 7#db ,u4,s4,c4 #eaja et seq474 ,d ,reducing ,administrative ,costs and ,burdens in ,health ,care #gca4 ,reducing administrative costs and burdens in health care ,title ,,ii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bjb et seq47 is amended by adding at the end the following3 ,e ,reducing administrative costs and burdens in health care #bha4 ,eliminating unnecessary administrative burdens and costs 7a7 ,reducing administrative burdens and costs ,the ,secretary1 in consultation with providers of health services1 health care suppliers of services1 health care payers1 health professional societies1 health vendors and developers1 health care standard development organizations and operating rule entities1 health care quality organizations1 health care accreditation organizations1 public health entities1 ,states1 patients1 and other appropriate entities1 shall1 in accordance with subsection 7b7-- 7#a7 establish a goal of reducing unnecessary costs and administrative burdens across the health care system1 including the ,medicare program under title ,,xviii of the ,social ,security ,act1 the ,medicaid program under title ,,xix of such ,act1 and the private health insurance market1 by at least half over a period of #aj years from the date of enactment of this section2 7#b7 develop strategies and benchmarks for meeting the goal established under paragraph 7#a72 7#c7 develop recommendations for meeting the goal established under paragraph 7#a72 and 7#d7 take action to reduce unnecessary costs and administrative burdens based on recommendations identified in this subsection4 7b7 ,strategies1 recommendations1 and actions 7#a7 ,in general ,to achieve the goal established under subsection 7a77#a71 the ,secretary1 in consultation with the entities described in such subsection1 shall not later than #a year after the date of enactment of this section1 develop strategies and recommendations and take actions to meet such goal in accordance with this subsection4 ,no strategies1 recommendation1 or action shall undermine the quality of patient care or patient health outcomes4 7#b7 ,strategies ,the strategies developed under paragraph 7#a7 shall address unnecessary costs and administrative burdens4 ,such strategies shall include broad public comment and shall prioritize-- 7,a7 recommendations identified as a result of efforts undertaken to implement section #cjja2 7,b7 recommendations and best practices identified as a result of efforts undertaken under this part2 7,c7 a review of regulations1 rules1 and requirements of the ,department of ,health and ,human ,services that could be modified or eliminated to reduce unnecessary costs and administrative burden imposed on patients1 providers1 payers1 and other stakeholders across the health care system2 and 7,d7 feedback from stakeholders in rural or frontier areas on how to reduce unnecessary costs and administrative burdens on the health care system in those areas4 7#c7 ,recommendations ,the recommendations developed under paragraph 7#a7 shall include-- 7,a7 actions that improve the standardization and automation of administrative transactions2 7,b7 actions that integrate clinical and administrative functions2 7,c7 actions that improve patient care and reduce unnecessary costs and administrative burdens borne by patients1 their families1 and other caretakers2 7,d7 actions that advance the development and adoption of open application programming interfaces and other emerging technologies to increase transparency and interoperability1 empower patients1 and facilitate better integration of clinical and administrative functions2 7,e7 actions to be taken by the ,secretary and actions that need to be taken by other entities2 and 7,f7 other areas1 as the ,secretary determines appropriate1 to reduce unnecessary costs and administrative burdens required of health care providers4 7#d7 ,consistency ,any improvements in electronic processes proposed by the ,secretary under this section should leverage existing information technology definitions under ,federal ,law4 ,specifically1 any electronic processes should not be construed to include a facsimile1 a proprietary payer portal that does not meet standards specified by the ,secretary1 or an electronic form image4 7#e7 ,actions ,the ,secretary shall take action to achieve the goal established under subsection 7a77#a71 and1 not later than #a year after the date of enactment of this section1 and biennially thereafter1 submit to ,congress and make publically available1 a report describing the actions taken by the ,secretary pursuant to goals1 strategies1 and recommendations described in this subsection4 7#f7 ,,faca ,the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 shall not apply to the development of the goal1 strategies1 recommendations1 or actions described in this section4 7#g7 ,rule of construction ,nothing in this subsection shall be construed to authorize1 or be used by1 the ,federal ,government to inhibit or otherwise restrain efforts made to reduce waste1 fraud1 and abuse across the health care system4 #bhb4 ,grants to ,states to develop and implement recommendations to accelerate ,state innovation to reduce health care administrative costs 7a7 ,grants 7#a7 ,in general ,not later than #f months after the date of enactment of this section1 the ,secretary shall award grants to at least #ae ,states1 and one coordinating entity designated as provided for under subsection 7e71 to enable such ,states to establish and administer private-public multi-stakeholder commissions for the purpose of reducing health care administrative costs and burden within and across ,states4 ,not less than #c of such grants shall be awarded to ,states that are primarily rural1 frontier1 or a combination thereof1 in nature4 7#b7 ,entities ,for purposes of this section1 the term ,state means a ,state1 a ,state designated entity1 or a multi-,state collaborative 7as defined by the ,secretary74 7#c7 ,priority ,in awarding grants under this section1 the ,secretary shall give priority to applications submitted by ,states that propose to carry out a pilot program or support the adoption of electronic health care transactions and operating rules4 7b7 ,application 7#a7 ,in general ,to be eligible to receive a grant under subsection 7a7 a ,state shall submit to the ,secretary an application in such a manner and containing such information as the ,secretary may reasonably require1 including the information described in paragraph 7#b74 7#b7 ,required information ,in addition to any additional information required by the ,secretary under this subsection1 an application shall include a description of-- 7,a7 the size and composition of the commission to be established under the grant1 including the stakeholders represented and the degree to which the commission reflects important geographic and population characteristics of the ,state2 7,b7 the relationship of the commission to the ,state official responsible for coordinating and implementing the recommendations resulting from the commission1 and the role and responsibilities of the ,state with respect to the commission1 including any participation1 review1 oversight1 implementation or other related functions2 7,c7 the history and experience of the ,state in addressing health care administrative costs1 and any experience similar to the purpose of the commission to improve health care administrative processes and the exchange of health care administrative data2 7,d7 the resources and expertise that will be made available to the commission by commission members or other possible sources1 and how ,federal funds will be used to leverage and complement these resources2 7,e7 the governance structure and procedures that the commission will follow to make1 implement1 and pilot recommendations2 7,f7 the proposed objectives relating to the simplification of administrative transactions and operating rules1 increased standardization1 and the efficiency and effectiveness of the transmission of health information2 7,g7 potential cost savings and other improvements in meeting the objectives described in subparagraph 7,f72 and 7,h7 the method or methods by which the recommendations described in subsection 7c7 will be reviewed1 tested1 adopted1 implemented1 and updated as needed4 7c7 ,multi-,stakeholder commission 7#a7 ,in general ,not later than #ij days after the date on which a grant is awarded to a ,state under this section1 the ,state official described in subsection 7b77#b77;,b71 the ,state insurance commissioner1 or other appropriate ,state official shall convene a multi-stakeholder commission1 in accordance with this subsection4 7#b7 ,membership ,the commission convened under paragraph 7#a7 shall include representatives from health plans1 health care providers1 health vendors1 relevant ,state agencies1 health care standard development organizations1 and operating rule entities1 relevant professional and trade associations1 patients1 and other entities determined appropriate by the ,state4 7#c7 ,recommendations ,not later than one year after the date on which a grant is awarded to a ,state under this section1 the commission shall make recommendations and plans1 consistent with the application submitted by the ,state under subsection 7b71 and intended to meet the objectives defined in the application4 ,such recommendations shall comply with1 and build upon1 all relevant ,federal requirements and regulations1 and may include-- 7,a7 common1 uniform specifications1 best practices1 and conventions1 for the efficient1 effective exchange of administrative transactions adopted pursuant to the ,health ,insurance ,portability and ,accountability ,act of #aiif 7,public ,law #ajd-aia72 7,b7 the development of streamlined business processes for the exchange and use of health care administrative data2 and 7,c7 specifications1 incentives1 requirements1 tools1 mechanisms1 and resources to improve-- 7i7 the access1 exchange1 and use of health care administrative information through electronic means2 7ii7 the implementation of utilization management protocols2 and 7iii7 compliance with ,federal and ,state laws4 7d7 ,use of funds for implementation ,a ,state may use amounts received under a grant under this section for one or more of the following3 7#a7 ,the development1 implementation1 and best use of shared data infrastructure that supports the electronic transmission of administrative data4 7#b7 ,the development and provision of training and educational materials1 forums1 and activities as well as technical assistance to effectively implement1 use1 and benefit from electronic health care transactions and operating rules4 7#c7 ,to accelerate the early adoption and implementation of administrative transactions and operating rules designated by the ,secretary and that have been adopted pursuant to the ,health ,insurance ,portability and ,accountability ,act of #aiif 7,public ,law #ajd-aia71 including transactions and operating rules described in section #aagc7;a77#b7 of the ,social ,security ,act4 7#d7 ,to accelerate the early adoption and implementation of additional or updated administrative transactions1 operating rules1 and related data exchange standards that are being considered for adoption under the ,health ,insurance ,portability and ,accountability ,act of #aiif or are adopted pursuant to such ,act1 or as designated by the ,secretary1 including the electronic claim attachment4 7#e7 ,to conduct pilot projects to test approaches to implement and use the electronic health care transactions and operating rules in practice under a variety of different settings4 ,with respect to the electronic attachment transaction1 priority shall be given to pilot projects that test and evaluate methods and mechanisms to most effectively incorporate patient health data from electronic health records and other electronic sources with the electronic attachment transaction4 7#f7 ,to assess barriers to the adoption1 implementation1 and effective use of electronic health care transactions and operating rules1 as well as to explore1 identify1 and plan options1 approaches1 and resources to address barriers and make improvements4 7#g7 ,the facilitation of public and private initiatives to reduce administrative costs and accelerate the adoption1 implementation1 and effective use of electronic health care transactions and operating rules for ,state programs4 7#h7 ,developing1 testing1 implementing1 and assessing additional data exchange specifications1 operating rules1 incentives1 requirements1 tools1 mechanisms1 and resources to accelerate the adoption and effective use of the transactions and operating rules4 7#i7 ,ongoing needs assessments and planning related to the development and implementation of administrative simplification initiatives4 7e7 ,coordinating entity 7#a7 ,functions ,not later than #f months after the date of enactment of this section1 the ,secretary shall designate a coordinating entity under this subsection for the purpose of-- 7,a7 providing technical assistance to ,states relating to the simplification of administrative transactions and operating rules1 increased standardization1 and the efficiency and effectiveness of the transmission of health care information2 7,b7 evaluating pilot projects and other efforts conducted under this section for impact and best practices to inform broader national use2 7,c7 using consistent evaluation methodologies to compare return on investment across efforts conducted under this section2 7,d7 compiling1 synthesizing1 disseminating1 and adopting lessons learned to promote the adoption of electronic health care transactions and operating rules across the health care system2 and 7,e7 making recommendations to the ,secretary and the ,national ,committee on ,vital and ,health ,statistics regarding the national adoption of efforts conducted under this section4 7#b7 ,eligibility ,the entity designated under paragraph 7#a7 shall be a qualified nonprofit entity that-- 7,a7 focuses its mission on administrative simplification2 7,b7 has demonstrated experience using a multi-stakeholder and consensus-based process for the development of common1 uniform specifications1 operating rules1 best practices1 and conventions1 for the efficient1 effective exchange of administrative transactions that includes representation by or participation from health plans1 health care providers1 vendors1 ,states1 relevant ,federal agencies1 and other health care standard development organizations2 7,c7 has demonstrated experience providing technical assistance to health plans1 health care providers1 vendors1 and ,states relating to the simplification of administrative transactions and operating rules1 increased standardization1 and the efficiency and effectiveness of the transmission of health care information2 7,d7 has demonstrated experience evaluating and measuring the adoption and return on investment of administrative transactions and operating rules2 7,e7 has demonstrated experience gathering1 synthesizing1 and adopting common1 uniform specifications1 operating rules1 best practices1 and conventions for national use based on lessons learned to promote the adoption of electronic health care transactions and operating rules across the health care system2 7,f7 has a public set of guiding principles that ensure processes are open and transparent1 and supports nondiscrimination and conflict of interest policies that demonstrate a commitment to open1 fair1 and nondiscriminatory practices2 7,g7 builds on the transaction standards issued under ,health ,insurance ,portability and ,accountability ,act of #aiif2 and 7,h7 allows for public review and updates of common1 uniform specifications1 operating rules1 best practices1 and conventions to support administrative simplification4 7f7 ,period and amount ,a grant awarded to a ,state under this section shall be for a period of #e years and shall not exceed #ej1jjj1jjj for such #e-year period4 ,a grant awarded to the coordinating entity designated by the ,secretary under subsection 7e7 shall be for a period of #e years and shall not exceed #ae1jjj1jjj for such #e-year period4 7g7 ,reports 7#a7 ,states ,not later than #a year after receiving a grant under this section1 and biennially thereafter1 a ,state shall submit to the ,secretary a report on the outcomes experienced by the ,state under the grant4 7#b7 ,coordinating entity ,not later than #a year after receiving a grant under this section1 and at least biennially thereafter1 the coordinating entity shall submit to the ,secretary and the ,national ,committee on ,vital and ,health ,statistics a report of evaluations conducted under the grant under this section and recommendations regarding the national adoption of efforts conducted under this section4 7#c7 ,secretary ,not later than #f months after the date on which the ,states and coordinating entity submit the report required under paragraphs 7#a7 and 7#b71 the ,secretary1 in consultation with ,national ,committee on ,vital and ,health ,statistics1 shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a report on the outcomes achieved under the grants under this section4 7#d7 ,,gao ,not later than #f months after the date on which the ,secretary submits the final report under paragraph 7#c71 the ,comptroller ,general of the ,united ,states shall conduct a study1 and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a report on the outcomes of the activities carried out under this section which shall contain a list of best practices and recommendations to ,states concerning administrative simplification4 7h7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section1 #bej1jjj1jjj for the #e-;fiscal-year period beginning with fiscal year #bjbj4 4 ,,viii ,miscellaneous #hja4 ,guaranteed issue of certain ,medigap policies 7a7 ,guaranteed issue of ,medigap policies to all ,medigap-,eligible ,medicare beneficiaries 7#a7 ,in general ,section #ahhb7s7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciess7s77 is amended-- 7,a7 in paragraph 7#b77;,a71 by striking #fe years of age or older and is enrolled for benefits under part ,b and inserting entitled to1 or enrolled for1 benefits under part ,a and enrolled for benefits under part ,b2 7,b7 in paragraph 7#b77;,d71 by striking who is #fe years of age or older as of the date of issuance and2 7,c7 in paragraph 7#c77;,b77ii71 by striking is #fe years of age or older and2 and 7,d7 in paragraph 7#c77;,b77vi71 by striking at age #fe4 7#b7 ,additional enrollment period for certain individuals 7,a7 ,one-time enrollment period 7i7 ,in general ,in the case of a specified individual1 the ,secretary shall establish a one-time enrollment period described in clause 7iii7 during which such an individual may enroll in any medicare supplemental policy of the individual's choosing4 7ii7 ,application ,the provisions of-- 7,i7 paragraph 7#b7 of section #ahhb7s7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciess7s77 shall apply with respect to a specified individual who is described in subclause 7,i7 of subparagraph 7,b77iii7 as if references in such paragraph 7#b7 to the #f month period described in subparagraph 7,a7 of such paragraph were references to the one-time enrollment period established under clause 7i72 and 7,,ii7 paragraph 7#c7 of such section shall apply with respect to a specified individual who is described in subclause 7,,ii7 of subparagraph 7,b77iii7 as if references in such paragraph 7#c7 to the period specified in subparagraph 7,e7 of such paragraph were references to the one-time enrollment period established under clause 7i74 7iii7 ,period ,the enrollment period established under clause 7i7 shall be the #f-month period beginning on ,january #a1 #bjbd4 7,b7 ,specified individual ,for purposes of this paragraph1 the term specified individual means an individual who-- 7i7 is entitled to hospital insurance benefits under part ,a of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;c et seq47 pursuant to section #bbf7;b7 or section #bbf;,a of such ,act 7#db ,u4,s4,c4 #dbf7;b72 #dbf-a72 7ii7 is enrolled for benefits under part ,b of such ,act 7#db ,u4,s4,c4 #acie;j et seq472 and 7iii7 7,i7 would not1 but for the amendments made by subparagraphs 7,a7 and 7,b7 of paragraph 7#a7 and the provisions of this paragraph 7if such provisions applied to such individual71 be eligible for the guaranteed issue of a medicare supplemental policy under paragraph 7#b7 of section #ahhb7s7 of such ,act 7#db ,u4,s4,c4 #aciess7s772 or 7,,ii7 would not1 but for the amendments made by subparagraphs 7,c7 and 7,d7 of paragraph 7#a7 and the provisions of this paragraph 7if such provisions applied to such individual71 be eligible for the guaranteed issue of a medicare supplemental policy under paragraph 7#c7 of such section4 7,c7 ,outreach plan 7i7 ,in general ,the ,secretary shall develop an outreach plan to notify specified individuals of the one-time enrollment period established under subparagraph 7,a74 7ii7 ,consultation ,in implementing the outreach plan developed under clause 7i71 the ,secretary shall consult with consumer advocates1 brokers1 insurers1 the ,national ,association of ,insurance ,commissioners1 and ,state ,health ,insurance ,assistance ,programs4 7#c7 ,effective date ,the amendments made by paragraph 7#a7 shall apply to medicare supplemental policies effective on or after ,january #a1 #bjbd4 7b7 ,guaranteed issue of ,medigap policies for ,medicare ,advantage enrollees 7#a7 ,in general ,section #ahhb7s77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciess7s77#c771 as amended by subsection 7a71 is further amended-- 7,a7 in subparagraph 7,b71 by adding at the end the following new clause3 7vii7 ,the individual-- 7,i7 was enrolled in a ,medicare ,advantage plan under part ,c for not less than #ab months2 7,,ii7 subsequently disenrolled from such plan2 7,,iii7 elects to receive benefits under this title through the original ,medicare fee-for-service program under parts ,a and ,b2 and 7,,iv7 has not previously elected to receive benefits under this title through the original ,medicare fee-for-service program pursuant to disenrollment from a ,medicare ,advantage plan under part ,c4 2 7,b7 by striking subparagraph 7,c77iii7 and inserting the following3 7iii7 ,subject to subsection 7v77#a71 for purposes of an individual described in clause 7vi7 or 7vii7 of subparagraph 7,b71 a medicare supplemental policy described in this subparagraph shall include any medicare supplemental policy4 2 and 7,c7 in subparagraph 7,e7-- 7i7 in clause 7iv71 by striking and at the end2 7ii7 in clause 7v71 by striking the period at the end and inserting 2 and2 and 7iii7 by adding at the end the following new clause-- 7vi7 in the case of an individual described in subparagraph 7,b77vii71 the annual1 coordinated election period 7as defined in section #ahea7;e77#c77;,b77 or a continuous open enrollment period 7as defined in section #ahea7;e77#b77 during which the individual disenrolls from a ,medicare ,advantage plan under part ,c4 4 7#b7 ,effective date ,the amendments made by paragraph 7#a7 shall apply to medicare supplemental policies effective on or after ,january #a1 #bjbd4 #hjb4 ,reporting requirements for ,,pdp sponsors regarding point-of-sale rejections under ,medicare part ,d ,section #ahfj;,d-#d7;g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;g77 is amended by adding at the end the following new paragraph3 7#c7 ,reporting requirements regarding point-,of-,sale rejections 7,a7 ,in general ,with respect to a plan year beginning on or after ,january #a1 #bjbj1 a ,,pdp sponsor offering a prescription drug plan shall submit to the ,secretary1 in a form and manner specified by the ,secretary1 information on point-of-sale rejections made during a period of time occurring in such plan year 7as specified by the ,secretary71 including each of the following3 7i7 ,the reason for each point-of-sale rejection4 7ii7 ,identifying information for each drug with respect to which a point-of-sale rejection was made4 7iii7 ,with respect to applicable types of point-of-sale rejections 7as specified by the ,secretary71 each of the following3 7,i7 ,whether such a rejection was consistent with the formulary of the plan 7as approved by the ,secretary74 7,,ii7 ,whether a coverage determination or appeal of a coverage determination was requested for the drug with respect to which such a rejection was made4 7,,iii7 ,the outcome of any such coverage determination or appeal of a coverage determination4 7,,iv7 ,the length of time between when such a rejection was made and when the drug with respect to which such rejection was made is dispensed1 as applicable4 7,b7 ,public availability of information ,the ,secretary shall make publicly available on the public website of the ,centers for ,medicare ,medicaid ,services information submitted under subparagraph 7,a74 7,c7 ,use of information ,the ,secretary may use information submitted under subparagraph 7,a71 as determined appropriate1 in developing measures for the #e-star rating system under section #ahec7o77#d74 7,d7 ,implementation ,notwithstanding any other provision of law1 the ,secretary may implement this paragraph through program instruction or otherwise4 7,e7 ,funding ,the are authorized to be appropriated to the ,secretary from the ,federal ,supplementary ,medical ,insurance ,trust ,fund under section #ahda such sums as may be necessary to implement this paragraph4 4 #hjc4 ,providing access to annual ,medicare notifications in multiple languages 7a7 ,in general ,section #ahjd of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;b-#b7 is amended by adding at the end the following new subsection3 7e7 ,the notice provided under subsection 7a7 shall be translated into languages in addition to ,english and ,spanish4 ,in carrying out the previous sentence1 the ,secretary shall prioritize translation of the notice into languages in which documents provided by the ,commissioner of ,social ,security are translated and language that are the most frequently requested for translation for purposes of applying for old-age insurance benefits under title ,,ii4 4 7b7 ,effective date ,the amendment made by subsection 7a7 shall apply to notices distributed prior to each ,medicare open enrollment period beginning after ,january #a1 #bjbj4 #hjd4 ,temporary increase in ,medicare part ,b payment for certain biosimilar biological products ,section #ahdg;,a7b77#h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7b77#h77 is amended-- 7#a7 by redesignating subparagraphs 7,a7 and 7,b7 as clauses 7i7 and 7ii71 respectively1 and moving the margin of each such redesignated clause #b ems to the right2 7#b7 by striking product4--,the amount and inserting the following3 8product4-- 7,a7 ,in general ,subject to subparagraph 7,b71 the amount 2 and 7#c7 by adding at the end the following new subparagraph3 7,b7 ,temporary payment increase 7i7 ,in general ,in the case of a qualifying biosimilar biological product that is furnished during the applicable #e-year period for such product1 the amount specified in this paragraph for such product with respect to such period is the sum determined under subparagraph 7,a71 except that clause 7ii7 of such subparagraph shall be applied by substituting #h percent for #f percent4 7ii7 ,applicable #e-year period ,for purposes of clause 7i71 the applicable #e-year period for a biosimilar biological product is-- 7,i7 in the case of such a product for which payment was made under this paragraph as of ,december #ca1 #bjai1 the #e-year period beginning on ,january #a1 #bjbj2 and 7,,ii7 in the case of such a product for which payment is first made under this paragraph during a calendar quarter during the period beginning ,january #a1 #bjbj1 and ending ,december #ca1 #bjbd1 the #e-year period beginning on the first day of such calendar quarter during which such payment is first made4 7iii7 ,qualifying biosimilar biological product defined ,for purposes of this subparagraph1 the term qualifying biosimilar biological product means a biosimilar biological product described in paragraph 7#a77;,c7 with respect to which-- 7,i7 in the case of a product described in clause 7ii77,i71 the average sales price is not more than the average sales price for the reference biological product2 and 7,,ii7 in the case of a product described in clause 7ii77,,ii71 the wholesale acquisition cost is not more than the wholesale acquisition cost for the reference biological product4 4 #hje4 ,waiving medicare coinsurance for colorectal cancer screening tests ,section #ahcc7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77 is amended-- 7#a7 in the second sentence1 by striking section #ahcd7j7 and inserting section #ahcd7o72 7#b7 by moving such second sentence #b ems to the left2 and 7#c7 by inserting the following third sentence following such second sentence3 ,for services furnished on or after ,january #a1 #bjba1 paragraph 7#a77,y7 shall apply with respect to a colorectal cancer screening test regardless of the code that is billed for the establishment of a diagnosis as a result of the test1 or for the removal of tissue or other matter or other procedure that is furnished in connection with1 as a result of1 and in the same clinical encounter as the screening test44 #hjf4 ,medicare coverage of certain lymphedema compression treatment items 7a7 ,coverage 7#a7 ,in general ,section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex71 as amended by section #fja and section #fjc1 is further amended-- 7,a7 in subsection 7s77#b7-- 7i7 in subparagraph 7,,ii71 by striking and after the semicolon at the end2 7ii7 in subparagraph 7,,jj71 by striking the period at the end and inserting 2 and2 and 7iii7 by adding at the end the following new subparagraph3 7,,kk7 lymphedema compression treatment items 7as defined in subsection 7mmm772 2 and 7,b7 by adding at the end the following new subsection3 7mmm7 ,lymphedema compression treatment items ,the term lymphedema compression treatment items means compression garments1 devices1 bandaging systems1 components1 and supplies1 including multilayer compression bandaging systems1 standard fit gradient compression garments1 and other compression garments1 devices1 bandaging systems1 components1 or supplies 7as determined by the ,secretary71 that are-- 7#a7 furnished on or after ,january #a1 #bjbb1 to an individual with a diagnosis of lymphedema for the treatment of such condition2 7#b7 primarily and customarily used in the medical treatment of lymphedema1 as determined by the ,secretary2 and 7#c7 prescribed by a physician 7or a physician assistant1 nurse practitioner1 or a clinical nurse specialist 7as those terms are defined in section #ahfa7;aa77#e77 to the extent authorized under ,state law74 4 7#b7 ,payment 7,a7 ,in general ,section #ahcc7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77#a771 as amended by section #fja7;c77#a71 is further amended-- 7i7 by striking and before 7,,dd72 and 7ii7 by inserting before the semicolon at the end the following3 1 and 7,,ee7 with respect to lymphedema compression treatment items 7as defined in section #ahfa7mmm771 the amount paid shall be equal to #hj percent of the lesser of the actual charge or the amount determined under the payment basis determined under section #ahcd7z74 7,b7 ,payment basis and limitations ,section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem71 as amended by sections #fja7;c77#b7 and #fjc7;c71 is further amended by adding at the end the following new subsection3 7z7 ,payment for lymphedema compression treatment items 7#a7 ,in general ,the ,secretary shall determine an appropriate payment basis for lymphedema compression treatment items 7as defined in section #ahfa7mmm774 ,in making such a determination1 the ,secretary may take into account payment rates for such items under ,state plans 7or waivers of such plans7 under title ,,xix1 the ,veterans ,health ,administration1 and group health plans and health insurance coverage 7as such terms are defined in section #bgia of the ,public ,health ,service ,act71 and such other information as the ,secretary determines appropriate4 7#b7 ,frequency limitation ,no payment may be made under this part for lymphedema compression treatment items furnished other than at such frequency as the ,secretary may establish4 7#c7 ,application of competitive acquisition ,in the case of lymphedema compression treatment items that are included in a competitive acquisition program in a competitive acquisition area under section #ahdg7;a7-- 7,a7 the payment basis under this subsection for such items furnished in such area shall be the payment basis determined under such competitive acquisition program2 and 7,b7 the ,secretary may use information on the payment determined under such competitive acquisition programs to adjust the payment amount otherwise determined under this subsection for an area that is not a competitive acquisition area under section #ahdg1 and in the case of such adjustment1 paragraphs 7#h7 and 7#i7 of section #ahdb7;b7 shall not be applied4 4 7#c7 ,conforming amendments 7,a7 ,exclusions ,section #ahfb7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7a77#a771 as amended by section #fja7;f7 and section #fjc7;g71 is further amended-- 7i7 in subparagraph 7,q71 by striking and at the end2 7ii7 in subparagraph 7,r71 by striking the semicolon and inserting 1 and2 and 7iii7 by adding at the end the following new subparagraph3 7,s7 in the case of lymphedema compression treatment items 7as defined in section #ahfa7mmm771 which are furnished more frequently than is established pursuant to section #ahcd7z77#b72 4 7,b7 ,application of competitive acquisition 7i7 ,in general ,section #ahdg7;a77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#b771 as amended by sections #fja7;e77#b77;,b77ii71 #fjb7;b77#c77;,b77i71 and #fjc7;f77#b77;,b71 is further amended by adding at the end the following new subparagraph3 7,g7 ,lymphedema compression treatment items ,lymphedema compression treatment items 7as defined in section #ahfa7mmm77 for which payment would otherwise be made under section #ahcd7z74 4 7b7 ,inclusion in requirements for suppliers of medical equipment and supplies ,section #ahcd7;j77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7j77#e77 is amended-- 7#a7 by redesignating subparagraphs 7,e7 and 7,f7 as subparagraphs 7,f7 and 7,g71 respectively2 and 7#b7 by inserting after subparagraph 7,d7 the following new subparagraph3 7,e7 lymphedema compression treatment items 7as defined in section #ahfa7mmm772 4 7c7 ,study and report on implementation 7#a7 ,study ,the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall conduct a study on the implementation of ,medicare coverage of certain lymphedema compression treatment items under the amendments made by this ,act4 ,such study shall include an evaluation of the following3 7,a7 ,medicare beneficiary utilization of items and services under parts ,a and ,b of title ,,xviii of the ,social ,security ,act as a result of the implementation of such amendments4 7,b7 ,whether the ,secretary has determined1 pursuant to section #ahfa7mmm7 of the ,social ,security ,act1 as added by subsection 7a77#a71 that lymphedema compression treatment items other than compression bandaging systems and standard fit gradient compression garments are covered under such section4 7#b7 ,report ,not later than ,january #a1 #bjbd1 the ,secretary shall submit to ,congress and make available to the public a report on the study conducted under paragraph 7#a74 #hjg4 ,physician fee update ,section #ahdh7;d77#ai7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;d77#ai77 is amended to read as follows3 7#ai7 ,update for #bjbj through #bjbe ,the update to the single conversion factor established in paragraph 7#a77;,c7-- 7,a7 for each of #bjbj through #bjbb shall be #j4e percent2 and 7,b7 for each of #bjbc through #bjbe shall be #j4j percent4 4 #hjh4 ,additional community health center funding ,section #ajejc of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #bed;b-#b7 is amended by striking subsection 7c7 and inserting the following3 7c7 ,additional enhanced funding2 capital projects ,there is authorized to be appropriated1 and there is appropriated1 out of any monies in the ,treasury not otherwise appropriated1 to the ,,chc ,fund-- 7#a7 to be transferred to the ,secretary of ,health and ,human ,services to provide additional enhanced funding for the community health center program under section #ccj of the ,public ,health ,service ,act1 #a1jjj1jjj1jjj for each of fiscal years #bjba through #bjbe2 and 7#b7 to be transferred to the ,secretary of ,health and ,human ,services for capital projects of the community health center program under section #ccj of the ,public ,health ,service ,act1 #e1jjj1jjj1jjj for the period of fiscal years #bjba through #bjbe4 4 #hji4 ,grants to improve trauma support services and mental health care for children and youth in educational settings 7a7 ,grants1 contracts1 and cooperative agreements authorized ,the ,secretary1 in coordination with the ,assistant ,secretary for ,mental ,health and ,substance ,use1 is authorized to award grants to1 or enter into contracts or cooperative agreements with1 ,state educational agencies1 local educational agencies1 ,indian ,tribes 7as defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act7 or their tribal educational agencies1 a school operated by the ,bureau of ,indian ,education1 a ,regional ,corporation1 or a ,native ,hawaiian educational organization1 for the purpose of increasing student access to evidence-based trauma support services and mental health care by developing innovative initiatives1 activities1 or programs to link local school systems with local trauma-informed support and mental health systems1 including those under the ,indian ,health ,service4 7b7 ,duration ,with respect to a grant1 contract1 or cooperative agreement awarded or entered into under this section1 the period during which payments under such grant1 contract1 or agreement are made to the recipient may not exceed #d years4 7c7 ,use of funds ,an entity that receives a grant1 contract1 or cooperative agreement under this section shall use amounts made available through such grant1 contract1 or cooperative agreement for evidence-based activities1 which shall include any of the following3 7#a7 ,collaborative efforts between school-based service systems and trauma-informed support and mental health service systems to provide1 develop1 or improve prevention1 screening1 referral1 and treatment and support services to students1 such as providing trauma screenings to identify students in need of specialized support4 7#b7 ,to implement schoolwide positive behavioral interventions and supports1 or other trauma-informed models of support4 7#c7 ,to provide professional development to teachers1 teacher assistants1 school leaders1 specialized instructional support personnel1 and mental health professionals that-- 7,a7 fosters safe and stable learning environments that prevent and mitigate the effects of trauma1 including through social and emotional learning2 7,b7 improves school capacity to identify1 refer1 and provide services to students in need of trauma support or behavioral health services2 or 7,c7 reflects the best practices for trauma-informed identification1 referral1 and support developed by the ,interagency ,task ,force on ,trauma-,informed ,care4 7#d7 ,services at a full-service community school that focuses on trauma-informed supports1 which may include a full-time site coordinator1 or other activities consistent with section #dfbe of the ,elementary and ,secondary ,education ,act of #aife 7#bj ,u4,s4,c4 #gbge74 7#e7 ,engaging families and communities in efforts to increase awareness of child and youth trauma1 which may include sharing best practices with law enforcement regarding trauma-informed care and working with mental health professionals to provide interventions1 as well as longer term coordinated care within the community for children and youth who have experienced trauma and their families4 7#f7 ,to provide technical assistance to school systems and mental health agencies4 7#g7 ,to evaluate the effectiveness of the program carried out under this section in increasing student access to evidence-based trauma support services and mental health care4 7#h7 ,to establish partnerships with or provide subgrants to ,head ,start agencies 7including ,early ,head ,start agencies71 public and private preschool programs1 child care programs 7including home-based providers71 or other entities described in subsection 7a71 to include such entities described in this paragraph in the evidence-based trauma initiatives1 activities1 support services1 and mental health systems established under this section in order to provide1 develop1 or improve prevention1 screening1 referral1 and treatment and support services to young children and their families4 7d7 ,applications ,to be eligible to receive a grant1 contract1 or cooperative agreement under this section1 an entity described in subsection 7a7 shall submit an application to the ,secretary at such time1 in such manner1 and containing such information as the ,secretary may reasonably require1 which shall include the following3 7#a7 ,a description of the innovative initiatives1 activities1 or programs to be funded under the grant1 contract1 or cooperative agreement1 including how such program will increase access to evidence-based trauma support services and mental health care for students1 and1 as applicable1 the families of such students4 7#b7 ,a description of how the program will provide linguistically appropriate and culturally competent services4 7#c7 ,a description of how the program will support students and the school in improving the school climate in order to support an environment conducive to learning4 7#d7 ,an assurance that-- 7,a7 persons providing services under the grant1 contract1 or cooperative agreement are adequately trained to provide such services2 and 7,b7 teachers1 school leaders1 administrators1 specialized instructional support personnel1 representatives of local ,indian ,tribes or tribal organizations as appropriate1 other school personnel1 and parents or guardians of students participating in services under this section will be engaged and involved in the design and implementation of the services4 7#e7 ,a description of how the applicant will support and integrate existing school-based services with the program in order to provide mental health services for students1 as appropriate4 7#f7 ,a description of the entities in the community with which the applicant will partner or to which the applicant will provide subgrants in accordance with subsection 7c77#h74 7e7 ,interagency agreements 7#a7 ,local interagency agreements ,to ensure the provision of the services described in subsection 7c71 a recipient of a grant1 contract1 or cooperative agreement under this section1 or their designee1 shall establish a local interagency agreement among local educational agencies1 agencies responsible for early childhood education programs1 ,head ,start agencies 7including ,early ,head ,start agencies71 juvenile justice authorities1 mental health agencies1 child welfare agencies1 and other relevant agencies1 authorities1 or entities in the community that will be involved in the provision of such services4 7#b7 ,contents ,in ensuring the provision of the services described in subsection 7c71 the local interagency agreement shall specify with respect to each agency1 authority1 or entity that is a party to such agreement-- 7,a7 the financial responsibility for the services2 7,b7 the conditions and terms of responsibility for the services1 including quality1 accountability1 and coordination of the services2 and 7,c7 the conditions and terms of reimbursement among such agencies1 authorities1 or entities1 including procedures for dispute resolution4 7f7 ,evaluation ,the ,secretary shall reserve not more than #c percent of the funds made available under subsection 7l7 for each fiscal year to-- 7#a7 conduct a rigorous1 independent evaluation of the activities funded under this section2 and 7#b7 disseminate and promote the utilization of evidence-based practices regarding trauma support services and mental health care4 7g7 ,distribution of awards ,the ,secretary shall ensure that grants1 contracts1 and cooperative agreements awarded or entered into under this section are equitably distributed among the geographical regions of the ,united ,states and among tribal1 urban1 suburban1 and rural populations4 7h7 ,rule of construction ,nothing in this section shall be construed-- 7#a7 to prohibit an entity involved with a program carried out under this section from reporting a crime that is committed by a student to appropriate authorities2 or 7#b7 to prevent ,federal1 ,state1 and tribal law enforcement and judicial authorities from exercising their responsibilities with regard to the application of ,federal1 tribal1 and ,state law to crimes committed by a student4 7i7 ,supplement1 not supplant ,any services provided through programs carried out under this section shall supplement1 and not supplant1 existing mental health services1 including any special education and related services provided under the ,individuals with ,disabilities ,education ,act 7#bj ,u4,s4,c4 #adjj et seq474 7j7 ,consultation with ,indian tribes ,in carrying out subsection 7a71 the ,secretary shall1 in a timely manner1 meaningfully consult with ,indian ,tribes and their representatives to ensure notice of eligibility4 7k7 ,definitions ,in this section3 7#a7 ,elementary school ,the term elementary school has the meaning given such term in section #haja of the ,elementary and ,secondary ,education ,act of #aife 7#bj ,u4,s4,c4 #ghja74 7#b7 ,evidence-based ,the term evidence-based has the meaning given such term in section #haja7ba77;,a77i7 of the ,elementary and ,secondary ,education ,act of #aife 7#bj ,u4,s4,c4 #ghja7ba77;,a77i774 7#c7 ,native hawaiian educational organization ,the term ,native ,hawaiian educational organization has the meaning given such term in section #fbjg of the ,elementary and ,secondary ,education ,act of #aife 7#bj ,u4,s4,c4 #geag74 7#d7 ,local educational agency ,the term local educational agency has the meaning given such term in section #haja of the ,elementary and ,secondary ,education ,act of #aife 7#bj ,u4,s4,c4 #ghja74 7#e7 ,regional corporation ,the term ,regional ,corporation has the meaning given the term in section #c of the ,alaska ,native ,claims ,settlement ,act 7#dc ,u4,s4,c4 #afjb74 7#f7 ,school ,the term school means a public elementary school or public secondary school4 7#g7 ,school leader ,the term school leader has the meaning given such term in section #haja of the ,elementary and ,secondary ,education ,act of #aife 7#bj ,u4,s4,c4 #ghja74 7#h7 ,secondary school ,the term secondary school has the meaning given such term in section #haja of the ,elementary and ,secondary ,education ,act of #aife 7#bj ,u4,s4,c4 #ghja74 7#i7 ,secretary ,the term ,secretary means the ,secretary of ,education4 7#aj7 ,specialized instructional support personnel ,the term specialized instructional support personnel has the meaning given such term in section #haja of the ,elementary and ,secondary ,education ,act of #aife 7#bj ,u4,s4,c4 #ghja74 7#aa7 ,state educational agency ,the term ,state educational agency has the meaning given such term in section #haja of the ,elementary and ,secondary ,education ,act of #aife 7#bj ,u4,s4,c4 #ghja74 7l7 ,authorization of appropriations ,there is authorized to be appropriated1 and there is appropriated1 out of any money in the ,treasury not otherwise appropriated1 to carry out this section1 #bj1jjj1jjj for each of fiscal years #bjba through #bjbe4 #haj4 ,pathway to ,health ,careers ,act 7a7 ,short title ,this section may be cited as the ,pathways to ,health ,careers ,act4 7b7 ,extension through fiscal year #bjbj of funding for demonstration projects to address health professions workforce needs 7#a7 ,in general ,section #bjjh7;c77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;g7c77#a77 is amended by striking #bjai4 and inserting #bjbj1 and to provide technical assistance and cover administrative costs associated with implementing the successor to this section #ae1jjj1jjj for fiscal year #bjbj44 7#b7 ,availability of other funds ,upon the date of the enactment of this section-- 7,a7 amounts expended pursuant to section #aeja of division ,b of ,public ,law #aaf-ei1 or any other prior law making amounts available for fiscal year #bjbj for activities authorized by section #bjjh of the ,social ,security ,act1 shall be charged to the appropriation made by subsection 7c77#a7 of such section #bjjh for fiscal year #bjbj 7not including the amount for technical assistance and administrative costs72 and 7,b7 if such enactment occurs on or before ,november #ba1 #bjai1 the availability of funds appropriated in1 and the authority provided under1 such section #aeja shall terminate4 7c7 ,career pathways through health profession opportunity grants ,effective ,october #a1 #bjbj1 section #bjjh of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;g7 is amended to read as follows3 #bjjh4 ,career pathways through health profession opportunity grants 7a7 ,application requirements ,an eligible entity desiring a grant under this section for a project shall submit to the ,secretary an application for the grant1 that includes the following3 7#a7 ,a description of how the applicant will use a career pathways approach to train eligible individuals for health professions that pay well or will put eligible individuals on a career path to an occupation that pays well1 under the project4 7#b7 ,a description of the adult basic education and literacy activities1 work readiness activities1 training activities1 and case management and career coaching services that the applicant will use to assist eligible individuals to gain work experience1 connection to employers1 and job placement1 and a description of the plan for recruiting1 hiring1 and training staff to provide the case management1 mentoring1 and career coaching services1 under the project directly or through local governmental1 apprenticeship1 educational1 or charitable institutions4 7#c7 ,in the case of an application for a grant under this section for a demonstration project described in subsection 7c77#b77;,b77i77,i7-- 7,a7 a demonstration that the ,state in which the demonstration project is to be conducted has in effect policies or laws that permit certain allied health and behavioral health care credentials to be awarded to people with certain arrest or conviction records 7which policies or laws shall include appeals processes1 waivers1 certificates1 and other opportunities to demonstrate rehabilitation to obtain credentials1 licensure1 and approval to work in the proposed health careers71 and a plan described in the application that will use a career pathway to assist participants with such a record in acquiring credentials1 licensing1 and employment in the specified careers2 7,b7 a discussion of how the project or future strategic hiring decisions will demonstrate the experience and expertise of the project in working with job seekers who have arrest or conviction records or employers with experience working with people with arrest or conviction records2 7,c7 an identification of promising innovations or best practices that can be used to provide the training2 7,d7 a proof of concept or demonstration that the applicant has done sufficient research on workforce shortage or in-demand jobs for which people with certain types of arrest or conviction records can be hired2 7,e7 a plan for recruiting students who are eligible individuals into the project2 and 7,f7 a plan for providing post-employment support and ongoing training as part of a career pathway under the project4 7#d7 ,in the case of an application for a grant under this section for a demonstration project described in subsection 7c77#b77;,b77i77,,ii7-- 7,a7 a description of the partnerships1 strategic staff hiring decisions1 tailored program activities1 or other programmatic elements of the project1 such as training plans for doulas and other community health workers and training plans for midwives and other allied health professions1 that are designed to support a career pathway in pregnancy1 birth1 or post-partum services2 and 7,b7 a demonstration that the ,state in which the demonstration project is to be conducted recognizes doulas or midwives1 as the case may be4 7#e7 ,a demonstration that the applicant has experience working with low-income populations1 or a description of the plan of the applicant to work with a partner organization that has the experience4 7#f7 ,a plan for providing post-employment support and ongoing training as part of a career pathway under the project4 7#g7 ,a description of the support services that the applicant will provide under the project1 including a plan for how child care and transportation support services will be guaranteed and1 if the applicant will provide a cash stipend or wage supplement1 how the stipend or supplement would be calculated and distributed4 7#h7 ,a certification by the applicant that the project development included-- 7,a7 consultation with a local workforce development board established under section #ajg of the ,workforce ,innovation and ,opportunity ,act2 7,b7 consideration of apprenticeship and pre-apprenticeship models registered under the ,act of ,august #af1 #aicg 7also known as the ,national ,apprenticeship ,act72 7,c7 consideration of career pathway programs in the ,state in which the project is to be conducted2 and 7,d7 a review of the ,state plan under section #ajb or #ajc of the ,workforce ,innovation and ,opportunity ,act4 7#i7 ,a description of the availability and relevance of recent labor market information and other pertinent evidence of in-demand jobs or worker shortages4 7#aj7 ,a certification that the applicant will directly provide or contract for the training services described in the application4 7#aa7 ,a commitment by the applicant that1 if the grant is made to the applicant1 the applicant will-- 7,a7 during the planning period for the project1 provide the ,secretary with any information needed by the ,secretary to establish adequate data reporting and administrative structure for the project2 7,b7 hire a person to direct the project not later than the end of the planning period applicable to the project2 7,c7 accept all technical assistance offered by the ,secretary with respect to the grant2 7,d7 participate in such in-person grantee conferences as are regularly scheduled by the ,secretary2 7,e7 provide all data required by the ,secretary under subsection 7g72 and 7,f7 notify the local disabled veterans' outreach program specialists under section #dajc;,a of title #ch1 ,united ,states ,code1 and the local veterans' employment representatives under section #dajd of such title1 of the grantee's outreach plan for advertising training opportunities to potential participants in the project4 7b7 ,preferences in considering applications ,in considering applications for a grant under this section1 the ,secretary shall give preference to-- 7#a7 applications submitted by applicants to whom a grant was made under this section or any predecessor to this section2 7#b7 applications submitted by applicants who have business and community partners in each of the following categories3 7,a7 ,state and local government agencies and social service providers1 including a ,state or local entity that administers a ,state program funded under part ,a of this title2 7,b7 institutions of higher education1 apprenticeship programs1 and local workforce development boards established under section #ajg of the ,workforce ,innovation and ,opportunity ,act2 and 7,c7 health care employers1 health care industry or sector partnerships1 labor unions1 and labor-management partnerships2 7#c7 applications that include opportunities for mentoring or peer support1 and make career coaching available1 as part of the case management plan2 7#d7 applications which describe a project that will serve a rural area in which-- 7,a7 the community in which the individuals to be enrolled in the project reside is located2 7,b7 the project will be conducted2 or 7,c7 an employer partnership that has committed to hiring individuals who successfully complete all activities under the project is located2 7#e7 applications that include a commitment to providing project participants with a cash stipend or wage supplement2 and 7#f7 applications which have an emergency cash fund to assist project participants financially in emergency situations4 7c7 ,grants 7#a7 ,competitive grants 7,a7 ,grant authority 7i7 ,in general ,the ,secretary1 in consultation with the ,secretary of ,labor and the ,secretary of ,education1 may make a grant in accordance with this paragraph to an eligible entity whose application for the grant is approved by the ,secretary1 to conduct a project designed to train low-income individuals for allied health professions1 health information technology1 physicians assistants1 nursing assistants1 registered nurse1 advanced practice nurse1 and other professions considered part of a health care career pathway model4 7ii7 ,guarantee of grantees in each state and the district of columbia ,for each grant cycle1 the ,secretary shall award a grant under this paragraph to at least #b eligible entities in each ,state that is not a territory1 to the extent there are a sufficient number of applications submitted by the entities that meet the requirements applicable with respect to such a grant4 ,if1 for a grant cycle1 there are fewer than #b such eligible entities in a ,state1 the ,secretary shall include that information in the report required by subsection 7g77#b7 that covers the fiscal year4 7,b7 ,guarantee of grants for indian populations ,from the amount reserved under subsection 7i77#b77;,b7 for each fiscal year1 the ,secretary shall award a grant under this paragraph to at least #aj eligible entities that are an ,indian tribe1 a tribal organization1 or a tribal college or university1 to the extent there are a sufficient number of applications submitted by the entities that meet the requirements applicable with respect to such a grant4 7,c7 ,guarantee of grantees in the territories ,from the amount reserved under subsection 7i77#b77;,c7 for each fiscal year1 the ,secretary shall award a grant under this paragraph to at least #b eligible entities that are located in a territory1 to the extent there are a sufficient number of applications submitted by the entities that meet the requirements applicable with respect to such a grant4 7#b7 ,grants for demonstration projects 7,a7 ,grant authority ,the ,secretary1 in consultation with the ,secretary of ,labor and the ,secretary of ,education 7and1 with respect to demonstration projects of the type described in subparagraph 7,b77i77,i71 the ,attorney ,general7 shall make a grant in accordance with this subsection to an eligible entity whose application for the grant is approved by the ,secretary1 to conduct a demonstration project that meets the requirements of subparagraph 7,b74 7,b7 ,requirements ,the requirements of this subparagraph are the following3 7i7 ,type of project ,the demonstration project shall be of #a of the following types3 7,i7 ,individuals with arrest or conviction records demonstration ,the demonstration project shall be of a type designed to provide education and training for eligible individuals with arrest or conviction records to enter and follow a career pathway in the health professions through occupations that pay well and are expected to experience a labor shortage or be in high demand4 7,,ii7 ,pregnancy and childbirth career pathway demonstration ,the demonstration project shall be of a type designed to provide education and training for eligible individuals to enter and follow a career pathway in the field of pregnancy1 childbirth1 or post-partum1 in a ,state that recognizes doulas or midwives and that provides payment for services provided by doulas or midwives1 as the case may be1 under private or public health insurance plans4 7ii7 ,duration ,the demonstration project shall be conducted for not less than #e years4 7,c7 ,minimum allocation of funds for each type of demonstration project 7i7 ,individuals with arrest or conviction records demonstrations ,not less than #be percent of the amounts made available for grants under this paragraph shall be used to make grants for demonstration projects of the type described in subparagraph 7,b77i77,i74 7ii7 ,pregnancy and childbirth career pathway demonstrations ,not less than #be percent of the amounts made available for grants under this paragraph shall be used to make grants for demonstration projects of the type described in subparagraph 7,b77i77,,ii74 7#c7 ,grant cycle ,the grant cycle under this section shall be not less than #e years1 with a planning period of not more than the #ast #ab months of the grant cycle4 ,during the planning period1 the amount of the grant shall be in such lesser amount as the ,secretary determines appropriate4 7d7 ,use of grant 7#a7 ,in general ,an entity to which a grant is made under this section shall use the grant in accordance with the approved application for the grant4 7#b7 ,support to be provided 7,a7 ,required support ,a project for which a grant is made under this section shall include the following3 7i7 ,an assessment for adult basic skill competency1 and provision of adult basic skills education if necessary for lower-skilled eligible individuals to enroll in the project and go on to enter and complete post-secondary training1 through means including the following3 7,i7 ,establishing a network of partners that offer pre-training activities for project participants who need to improve basic academic skills or ,english language proficiency before entering a health occupational training career pathway program4 7,,ii7 ,offering resources to enable project participants to continue advancing adult basic skill proficiency while enrolled in a career pathway program4 7,,iii7 ,embedding adult basic skill maintenance as part of ongoing post-graduation career coaching and mentoring4 7ii7 ,a guarantee that child care is an available and affordable support service for project participants through means such as the following3 7,i7 ,referral to1 and assistance with1 enrollment in a subsidized child care program4 7,,ii7 ,direct payment to a child care provider if a slot in a subsidized child care program is not available or reasonably accessible4 7,,iii7 ,payment of co-payments or associated fees for child care4 7iii7 ,case management plans that include career coaching 7with the option to offer appropriate peer support and mentoring opportunities to help develop soft skills and social capital71 which may be offered on an ongoing basis before1 during1 and after initial training as part of a career pathway model4 7iv7 ,a plan to provide project participants with transportation through means such as the following3 7,i7 ,referral to1 and assistance with enrollment in1 a subsidized transportation program4 7,,ii7 ,if a subsidized transportation program is not reasonably available1 direct payments to subsidize transportation costs4 ,for purposes of this clause1 the term transportation includes public transit1 or gasoline for a personal vehicle if public transit is not reasonably accessible or available4 7v7 ,in the case of a demonstration project of the type described in subsection 7c77#b77;,b77i77,i71 access to legal assistance for project participants for the purpose of addressing arrest or conviction records and associated workforce barriers4 7,b7 ,allowed support ,the goods and services provided under a project for which a grant is made under this section may include the following3 7i7 ,a cash stipend that is at least monthly4 7ii7 ,a reserve fund for financial assistance to project participants in emergency situations4 7iii7 ,tuition1 and training materials such as books1 software1 uniforms1 shoes1 and hair nets4 7iv7 ,in-kind resource donations such as interview clothing and conference attendance fees4 7v7 ,assistance with accessing and completing high school equivalency or adult basic education courses as necessary to achieve success in the project and make progress toward career goals4 7vi7 ,assistance with programs and activities1 including legal assistance1 deemed necessary to address arrest or conviction records as an employment barrier4 7vii7 ,other support services as deemed necessary for family well-being1 success in the project1 and progress toward career goals4 7,c7 ,treatment of support for purposes of means-tested programs ,any goods or services provided to an eligible individual participating in a project for which a grant is made under this section shall not be considered income1 and shall not be taken into account for purposes of determining the eligibility of the individual for1 or amount of benefits to be provided to the individual1 under any means-tested program4 7#c7 ,training ,the number of hours of training provided to an eligible individual under a project for which a grant is made under this section1 for a recognized postsecondary credential1 including an industry-recognized credential1 which is awarded in recognition of attainment of measurable technical or occupational skills necessary to gain employment or advance within an occupation 7including a certificate awarded by a local workforce development board established under section #ajg of the ,workforce ,innovation and ,opportunity ,act71 shall be-- 7,a7 not less than the number of hours of training required for certification in that level of skill by the ,state in which the project is conducted2 or 7,b7 if there is no such requirement1 such number of hours of training as the ,secretary finds is necessary to achieve that skill level4 7#d7 ,income limitation ,an entity to which a grant is made under this section shall not use the grant to provide support to a person who is not an eligible individual4 7#e7 ,inclusion of ,,tanf recipients ,in the case of a project for which a grant is made under this section that is conducted in a ,state that has a program funded under part ,a of title ,,iv1 at least #aj percent of the eligible individuals to whom support is provided under the project shall meet the income eligibility requirements under that ,state program1 without regard to whether the individuals receive benefits or services directly under that ,state program4 7#f7 ,prohibition ,an entity to which a grant is made under this section shall not use the grant for purposes of entertainment1 except that case management and career coaching services may include celebrations of specific career-based milestones such as completing a semester1 graduation1 or job placement4 7e7 ,technical assistance 7#a7 ,in general ,the ,secretary shall provide technical assistance-- 7,a7 to assist eligible entities in applying for grants under this section2 7,b7 that is tailored to meet the needs of grantees at each stage of the administration of projects for which grants are made under this section2 7,c7 that is tailored to meet the specific needs of ,indian tribes1 tribal organizations1 and tribal colleges and universities2 7,d7 that is tailored to meet the specific needs of the territories2 7,e7 that is tailored to meet the specific needs of eligible entities in carrying out demonstration projects for which a grant is made under this section2 and 7,f7 to facilitate the exchange of information among eligible entities regarding best practices and promising practices used in the projects4 7#b7 ,continuation of peer technical assistance conferences ,the ,secretary shall continue to hold peer technical assistance conferences for entities to which a grant is made under this section or was made under the immediate predecessor of this section4 7f7 ,evaluation of demonstration projects 7#a7 ,in general ,the ,secretary shall1 by grant1 contract1 or interagency agreement1 conduct rigorous and well-designed evaluations of the demonstration projects for which a grant is made under this section4 7#b7 ,requirement applicable to individuals with arrest or conviction records demonstration ,in the case of a project of the type described in subsection 7c77#b77;,b77i77,i71 the evaluation shall include identification of successful activities for creating opportunities for developing and sustaining1 particularly with respect to low-income individuals with arrest or conviction records1 a health professions workforce that has accessible entry points1 that meets high standards for education1 training1 certification1 and professional development1 and that provides increased wages and affordable benefits1 including health care coverage1 that are responsive to the needs of the workforce4 7#c7 ,requirement applicable to pregnancy and childbirth career pathway demonstration ,in the case of a project of the type described in subsection 7c77#b77;,b77i77,,ii71 the evaluation shall include identification of successful activities for creating opportunities for developing and sustaining1 particularly with respect to low-income individuals and other entry-level workers1 a career pathway that has accessible entry points1 that meets high standards for education1 training1 certification1 and professional development1 and that provides increased wages and affordable benefits1 including health care coverage1 that are responsive to the needs of the birth1 pregnancy1 and post-partum workforce4 7#d7 ,rule of interpretation ,evaluations conducted pursuant to this subsection may include a randomized controlled trial1 but this subsection shall not be interpreted to require an evaluation to include such a trial4 7g7 ,reports 7#a7 ,to the ,secretary ,an eligible entity awarded a grant to conduct a project under this section shall submit interim reports to the ,secretary on the activities carried out under the project1 and1 on the conclusion of the project1 a final report on the activities4 ,each such report shall include data on participant outcomes related to earnings1 employment in health professions1 graduation rate1 graduation timeliness1 credential attainment1 participant demographics1 and other data specified by the ,secretary4 7#b7 ,to the ,congress ,during each ,congress1 the ,secretary shall submit to the ,committee on ,ways and ,means of the ,house of ,representatives and the ,committee on ,finance of the ,senate a report-- 7,a7 on the demographics of the participants in the projects for which a grant is made under this section2 7,b7 on the rate of which project participants completed all activities under the projects2 7,c7 on the employment credentials acquired by project participants2 7,d7 on the employment of project participants on completion of activities under the projects1 and the earnings of project participants at entry into employment2 7,e7 on best practices and promising practices used in the projects2 7,f7 on the nature of any technical assistance provided to grantees under this section2 7,g7 on1 with respect to the period since the period covered in the most recent prior report submitted under this paragraph-- 7i7 the number of applications submitted under this section1 with a separate statement of the number of applications referred to in subsection 7b77#e72 7ii7 the number of applications that were approved1 with a separate statement of the number of such applications referred to in subsection 7b77#e72 and 7iii7 a description of how grants were made in any case described in the last sentence of subsection 7c77#a77;,a77ii72 and 7,h7 that includes an assessment of the effectiveness of the projects with respect to addressing health professions workforce shortages or in-demand jobs4 7h7 ,definitions ,in this section3 7#a7 ,allied health profession ,the term allied health profession has the meaning given in section #gii;,b7#e7 of the ,public ,health ,service ,act4 7#b7 ,career pathway ,the term career pathway has the meaning given that term in section #c7g7 of the ,workforce ,innovation and ,opportunity ,act4 7#c7 ,doula ,the term doula means an individual who-- 7,a7 is certified by an organization that has been established for not less than #e years and that requires the completion of continuing education to maintain the certification1 to provide non-medical advice1 information1 emotional support1 and physical comfort to an individual during the individual's pregnancy1 childbirth1 and post-partum period2 and 7,b7 maintains the certification by completing the required continuing education4 7#d7 ,eligible entity ,the term eligible entity means any of the following entities that demonstrates in an application submitted under this section that the entity has the capacity to fully develop and administer the project described in the application3 7,a7 ,a local workforce development board established under section #ajg of the ,workforce ,innovation and ,opportunity ,act4 7,b7 ,a ,state or territory1 a political subdivision of a ,state or territory1 or an agency of a ,state1 territory1 or such a political subdivision1 including a ,state or local entity that administers a ,state program funded under part ,a of this title4 7,c7 ,an ,indian tribe1 a tribal organization1 or a tribal college or university4 7,d7 ,an institution of higher education 7as defined in the ,higher ,education ,act of #aife74 7,e7 ,a hospital 7as defined in section #ahfa7;e774 7,f7 ,a high-quality skilled nursing facility4 7,g7 ,a ,federally qualified health center 7as defined in section #ahfa7;aa77#d774 7,h7 ,a nonprofit organization described in section #eja7;c77#c7 of the ,internal ,revenue ,code of #aihf1 a labor organization1 or an entity with shared labor-management oversight1 that has a demonstrated history of providing health profession training to eligible individuals4 7,i7 ,in the case of a demonstration project of the type provided for in subsection 7c77#b77;,b77i77,,ii7 of this section1 an entity recognized by a ,state1 ,indian tribe1 or tribal organization as qualified to train doulas or midwives1 if midwives or doulas1 as the case may be1 are permitted to practice in the ,state involved4 7,j7 ,an opioid treatment program 7as defined in section #ahfa7;jjj77#b771 and other high quality comprehensive addiction care providers4 7#e7 ,eligible individual ,the term eligible individual means an individual whose family income does not exceed #bjj percent of the ,federal poverty level4 7#f7 ,federal poverty level ,the term ,federal poverty level means the poverty line 7as defined in section #fgc7b7 of the ,omnibus ,budget ,reconciliation ,act of #aiha1 including any revision required by such section applicable to a family of the size involved74 7#g7 ,indian tribe2 tribal organization ,the terms ,indian tribe and tribal organization have the meaning given the terms in section #d of the ,indian ,self-,determination and ,education ,assistance ,act 7#be ,u4,s4,c4 #dej;b74 7#h7 ,institution of higher education ,the term institution of higher education has the meaning given the term in section #aja or #ajb7;a77#a77;,b7 of the ,higher ,education ,act of #aife4 7#i7 ,territory ,the term territory means the ,commonwealth of ,puerto ,rico1 the ,united ,states ,virgin ,islands1 ,guam1 the ,northern ,mariana ,islands1 and ,american ,samoa4 7#aj7 ,tribal college or university ,the term tribal college or university has the meaning given the term in section #caf7;b7 of the ,higher ,education ,act of #aife4 7i7 ,funding 7#a7 ,in general ,out of any funds in the ,treasury of the ,united ,states not otherwise appropriated1 there are appropriated to the ,secretary to carry out this section #dbe1jjj1jjj for each of fiscal years #bjba through #bjbe4 7#b7 ,allocation of funds ,of the amount appropriated for a fiscal year under paragraph 7#a7 of this subsection-- 7,a7 #ge percent shall be available for grants under subsection 7c77#a77;,a72 7,b7 #d percent shall be reserved for grants under subsection 7c77#a77;,b72 7,c7 #e percent shall be reserved for grants under subsection 7c77#a77;,c72 7,d7 #f percent shall be available for demonstration project grants under subsection 7c77#b72 7,e7 #f percent1 plus all amounts referred to in subparagraphs 7,a7 through 7,d7 of this paragraph that remain unused after all grant awards are made for the fiscal year1 shall be available for the provision of technical assistance and associated staffing2 and 7,f7 #d percent shall be available for studying the effects of the demonstration and non-demonstration projects for which a grant is made under this section1 and for associated staffing1 for the purpose of supporting the rigorous evaluation of the demonstration projects1 and supporting the continued study of the short-1 medium-1 and long-term effects of all such projects1 including the effectiveness of new or added elements of the non-demonstration projects4 7j7 ,nonapplicability of preceding sections of this subtitle 7#a7 ,in general ,except as provided in paragraph 7#b71 the preceding sections of this subtitle shall not apply to a grant awarded under this section4 7#b7 ,exception for certain limitations on use of grants ,section #bjje7;a7 7other than paragraphs 7#b71 7#c71 7#e71 7#f71 and 7#h77 shall apply to a grant awarded under this section to the same extent and in the same manner as such section applies to payments to ,states under this subtitle4 4 #haa4 ,home ,visiting to ,reduce ,maternal ,mortality and ,morbidity ,act 7a7 ,short title ,this section may be cited as the ,home ,visiting to ,reduce ,maternal ,mortality and ,morbidity ,act4 7b7 ,increase in tribal set-aside percentage 7#a7 ,in general ,section #eaa7;j77#b77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #gaa7;j77#b77;,a77 is amended by striking #c and inserting #f4 7#b7 ,effective date ,the amendment made by paragraph 7#a7 shall take effect on ,october #a1 #bjbj4 7c7 ,increase in funding ,section #eaa7;j77#a7 of such ,act 7#db ,u4,s4,c4 #gaa7;j77#a77 is amended-- 7#a7 by striking and at the end of subparagraph 7,g72 and 7#b7 by striking subparagraph 7,h7 and inserting the following3 7,h7 #djj1jjj1jjj for each of fiscal years #bjag through #bjbj2 7,i7 #fjj1jjj1jjj for fiscal year #bjba2 and 7,j7 #hjj1jjj1jjj for fiscal year #bjbb4 4 7d7 ,use of additional funds ,section #eaa7;c7 of such ,act 7#db ,u4,s4,c4 #gaa7;c77 is amended by adding at the end the following3 7#f7 ,use of certain funds to provide additional resources to address high rates of maternal mortality and morbidity1 support unmet needs identified by the needs assessment1 or increase allocations to ,states and territories based on relative population or poverty ,the ,secretary shall ensure that any amounts exceeding #djj1jjj1jjj that are used for grants under this subsection for a fiscal year are used to-- 7,a7 provide additional funding priority to ,states1 tribes1 and territories to address high rates of maternal mortality and morbidity2 7,b7 address unmet needs identified by a needs assessment conducted under subsection 7b72 or 7,c7 increase the amounts allocated under this section to ,states and to ,puerto ,rico1 ,guam1 the ,virgin ,islands1 the ,northern ,mariana ,islands1 and ,american ,samoa1 based on the proportion of children who have not attained #e years of age and are living in poverty4 4 #hab4 ,addition of new measures based on access to biosimilar biological products to the #e-star rating system under medicare advantage 7a7 ,in general ,section #ahec7o77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bc7o77#d77 is amended by adding at the end the following new subparagraph3 7,e7 ,addition of new measures based on access to biosimilar biological products 7i7 ,in general ,for #bjba and subsequent years1 the ,secretary shall add a new set of measures to the #e-star rating system based on access to biosimilar biological products covered under part ,b and1 in the case of ,,ma-,,pd plans1 such products that are covered part ,d drugs4 ,such measures shall assess the impact a plan's benefit structure may have on enrollees' utilization of or ability to access biosimilar biological products1 including in comparison to the reference biological product1 and shall include measures1 as applicable1 with respect to the following3 7,i7 ,coverage ,assessing whether a biosimilar biological product is on the plan formulary in lieu of or in addition to the reference biological product4 7,,ii7 ,preferencing ,assessing tier placement or cost-sharing for a biosimilar biological product relative to the reference biological product4 7,,iii7 ,utilization management tools ,assessing whether and how utilization management tools are used with respect to a biosimilar biological product relative to the reference biological product4 7,,iv7 ,utilization ,assessing the percentage of enrollees prescribed the biosimilar biological product when the reference biological product is also available4 7ii7 ,definitions ,in this subparagraph1 the terms biosimilar biological product and reference biological product have the meaning given those terms in section #ahdg;,a7c77#f74 7iii7 ,protecting patient interests ,in developing such measures1 the ,secretary shall ensure that each measure developed to address coverage1 preferencing1 or utilization management is constructed such that patients retain equal access to appropriate therapeutic options without undue administrative burden4 4 7b7 ,clarification regarding application to prescription drug plans ,to the extent the ,secretary of ,health and ,human ,services applies the #e-star rating system under section #ahec7o77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bc7o77#d771 or a similar system1 to prescription drug plans under part ,d of title ,,xviii of such ,act1 the provisions of subparagraph 7,e7 of such section1 as added by subsection 7a7 of this section1 shall apply under the system with respect to such plans in the same manner as such provisions apply to the #e-star rating system under such section #ahec7o77#d74 #hac4 ,sense of ,congress regarding the impact of the high cost of prescription drugs on communities of color and persons living in rural or sparsely populated areas of the ,united ,states ,it is the sense of the ,congress that-- 7#a7 the ,united ,states has the highest drug prices in the world and for millions of ,americans the cost of prescription drugs is increasing as a barrier to proper disease treatment1 especially for communities of color and for persons living in rural or sparsely populated areas of the nation2 7#b7 the ,patient ,protection and ,affordable ,care ,act 7,public ,law #aaa-adh7 substantially reduced the number of uninsured ,americans1 but over #bh million ,americans remain without insurance and approximately #ee percent of uninsured ,americans under the age of #fe are persons of color2 7#c7 without health insurance1 paying retail prices for medications is invariably burdensome or financially impossible2 7#d7 the median net worth of ,caucasian households in #bjaf was #i4g times higher than ,african-,american households and #h4c times higher than ,hispanic households1 which contributes to disparities in negative health consequences1 including for example the underuse of insulin among insured adults with diabetes2 and 7#e7 due to the high cost of prescription drugs to communities of color and for persons living in rural or sparsely populated areas of the nation1 this ,act should positively impact such communities and persons 7and the ,secretaries of ,health and ,human ,services1 ,labor1 and ,treasury should monitor such impact74 #had4 ,regulations requiring direct-to-consumer advertisements for prescription drugs and biological products to include truthful and not misleading pricing information 7a7 ,in general ,not later than the date that is one year after the date of the enactment of the ,elijah ,e4 ,cummings ,lower ,drug ,costs ,now ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,administrator of the ,centers for ,medicare ,medicaid ,services 7referred to in this section as the ,administrator71 shall promulgate final regulations requiring each direct-to-consumer advertisement on television 7including broadcast1 cable1 streaming1 and satellite television7 for a prescription drug or biological product for which payment is available under title ,,xviii or ,,xix of the ,social ,security ,act to include a textual statement1 which shall be truthful and not misleading1 indicating the list price1 as determined on the first day of the quarter during which the advertisement is being aired or otherwise broadcast1 for a typical #cj-;day regimen or typical course of treatment 7whichever is most appropriate74 7b7 ,determinations ,in promulgating final regulations under subsection 7a71 the ,administrator shall determine-- 7#a7 whether such regulations should apply with respect to additional forms of advertising2 7#b7 the manner and format of textual statements described in such subsection2 7#c7 appropriate enforcement mechanisms2 and 7#d7 whether such textual statements should include any other price information1 as appropriate4 #hae4 ,improving transparency and preventing the use of abusive spread pricing and related practices in ,medicaid 7a7 ,pass-through pricing required 7#a7 ,in general ,section #aibg7;e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;e77 is amended by adding at the end the following3 7#f7 ,pass-through pricing required ,a contract between the ,state and a pharmacy benefit manager 7referred to in this paragraph as a ,,pbm71 or a contract between the ,state and a managed care entity or other specified entity 7as such terms are defined in section #aijc7m77#i77;,d77 that includes provisions making the entity responsible for coverage of covered outpatient drugs dispensed to individuals enrolled with the entity1 shall require that payment for such drugs and related administrative services 7as applicable71 including payments made by a ,,pbm on behalf of the ,state or entity1 is based on a pass-through pricing model under which-- 7,a7 any payment made by the entity or the ,,pbm 7as applicable7 for such a drug-- 7i7 is limited to-- 7,i7 ingredient cost2 and 7,,ii7 a professional dispensing fee that is not less than the professional dispensing fee that the ,state plan or waiver would pay if the plan or waiver was making the payment directly2 7ii7 is passed through in its entirety by the entity or ,,pbm to the pharmacy that dispenses the drug2 and 7iii7 is made in a manner that is consistent with section #aijb7;a77#cj77;,a7 and sections #ddg4eab1 #ddg4ead1 and #ddg4eah of title #db1 ,code of ,federal ,regulations 7or any successor regulation7 as if such requirements applied directly to the entity or the ,,pbm2 7,b7 payment to the entity or the ,,pbm 7as applicable7 for administrative services performed by the entity or ,,pbm is limited to a reasonable administrative fee that covers the reasonable cost of providing such services2 7,c7 the entity or the ,,pbm 7as applicable7 shall make available to the ,state1 and the ,secretary upon request1 all costs and payments related to covered outpatient drugs and accompanying administrative services incurred1 received1 or made by the entity or the ,,pbm1 including ingredient costs1 professional dispensing fees1 administrative fees1 post-sale and post-in-voice fees4 ,discounts1 or related adjustments such as direct and indirect remuneration fees1 and any and all remuneration2 and 7,d7 any form of spread pricing whereby any amount charged or claimed by the entity or the ,,pbm 7as applicable7 that is in excess of the amount paid to the pharmacies on behalf of the entity1 including any post-sale or post-invoice fees1 discounts1 or related adjustments such as direct and indirect remuneration fees or assessments 7after allowing for a reasonable administrative fee as described in subparagraph 7,b771 is not allowable for purposes of claiming ,federal matching payments under this title4 4 7#b7 ,conforming amendment ,clause 7xiii7 of section #aijc7m77#b77;,a7 of such ,act 7#db ,u4,s4,c4 #acif;b7m77#b77;,a77 is amended-- 7,a7 by striking and 7,,iii7 and inserting 7,,iii72 and 7,b7 by inserting before the period at the end the following3 1 and 7,,iv7 pharmacy benefit management services provided by the entity1 or provided by a pharmacy benefit manager on behalf of the entity under a contract or other arrangement between the entity and the pharmacy benefit manager1 shall comply with the requirements of section #aibg7;e77#f74 7#c7 ,effective date ,the amendments made by this subsection apply to contracts between ,states and managed care entities1 other specified entities1 or pharmacy benefits managers that are entered into or renewed on or after the date that is #ah months after the date of enactment of this ,act4 7b7 ,survey of retail prices 7#a7 ,in general ,section #aibg7;f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f77 is amended-- 7,a7 by striking and after the semicolon at the end of paragraph 7#a77;,a77i7 and all that precedes it through 7#a7 and inserting the following3 7#a7 ,survey of retail prices ,the ,secretary shall conduct a survey of retail community drug prices1 to include at least the national average drug acquisition cost1 as follows3 7,a7 ,use of vendor ,the ,secretary may contract services for-- 7i7 with respect to retail community pharmacies1 the determination on a monthly basis of retail survey prices of the national average drug acquisition cost for covered outpatient drugs for such pharmacies1 net of all discounts and rebates 7to the extent any information with respect to such discounts and rebates is available71 the average reimbursement received for such drugs by such pharmacies from all sources of payment1 including third parties1 and1 to the extent available1 the usual and customary charges to consumers for such drugs2 and 2 7,b7 by adding at the end of paragraph 7#a7 the following3 7,f7 ,survey reporting ,in order to meet the requirement of section #aijb7;a77#ed71 a ,state shall require that any retail community pharmacy in the ,state that receives any payment1 administrative fee1 discount1 or rebate related to the dispensing of covered outpatient drugs to individuals receiving benefits under this title1 regardless of whether such payment1 fee1 discount1 or rebate is received from the ,state or a managed care entity directly or from a pharmacy benefit manager or another entity that has a contract with the ,state or a managed care entity1 shall respond to surveys of retail prices conducted under this subsection4 7,g7 ,survey information ,information on retail community prices obtained under this paragraph shall be made publicly available and shall include at least the following3 7i7 ,the monthly response rate of the survey including a list of pharmacies not in compliance with subparagraph 7,f74 7ii7 ,the sampling frame and number of pharmacies sampled monthly4 7iii7 ,characteristics of reporting pharmacies1 including type 7such as independent or chain71 geographic or regional location1 and dispensing volume4 7iv7 ,reporting of a separate national average drug acquisition cost for each drug for independent retail pharmacies and chain operated pharmacies4 7v7 ,information on price concessions including on and off invoice discounts1 rebates1 and other price concessions4 7vi7 ,information on average professional dispensing fees paid4 7,h7 ,penalties 7i7 ,failure to provide timely information ,a retail community pharmacy that fails to respond to a survey conducted under this subsection on a timely basis may be subject to a civil monetary penalty in the amount of #aj1jjj for each day in which such information has not been provided4 7ii7 ,false information ,a retail community pharmacy that knowingly provides false information in response to a survey conducted under this subsection may be subject to a civil money penalty in an amount not to exceed #ajj1jjj for each item of false information4 7iii7 ,other penalties ,any civil money penalties imposed under this subparagraph shall be in addition to other penalties as may be prescribed by law4 ,the provisions of section #aabh;,a 7other than subsections 7a7 and 7b77 shall apply to a civil money penalty under this subparagraph in the same manner as such provisions apply to a penalty or proceedings under section #aabh;,a7a74 7,i7 ,report on specialty pharmacies 7i7 ,in general ,not later than #a year after the effective date of this subparagraph1 the ,secretary shall submit a report to ,congress examining specialty drug coverage and reimbursement under this title4 7ii7 ,content of report ,such report shall include a description of how ,state ,medicaid programs define specialty drugs1 how much ,state ,medicaid programs pay for specialty drugs1 how ,states and managed care plans determine payment for specialty drugs1 the settings in which specialty drugs are dispensed 7such as retail community pharmacies or specialty pharmacies71 whether acquisition costs for specialty drugs are captured in the national average drug acquisition cost survey1 and recommendations as to whether specialty pharmacies should be included in the survey of retail prices to ensure national average drug acquisition costs capture drugs sold at specialty pharmacies and how such specialty pharmacies should be defined4 2 7,c7 in paragraph 7#b7-- 7i7 in subparagraph 7,a71 by inserting 1 including payments rates under ,medicaid managed care plans1 after under this title2 and 7ii7 in subparagraph 7,b71 by inserting and the basis for such dispensing fees before the semicolon2 and 7,d7 in paragraph 7#d71 by inserting 1 and #e1jjj1jjj for fiscal year #bjbj and each fiscal year thereafter1 after #bjaj4 7#b7 ,effective date ,the amendments made by this subsection take effect on the #ast day of the #ast quarter that begins on or after the date that is #ah months after the date of enactment of this ,act4 7c7 ,manufacturer reporting of wholesale acquisition cost ,section #aibg7;b77#c7 of such ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77 is amended-- 7#a7 in subparagraph 7,a77i7-- 7,a7 in subclause 7,i71 by striking and after the semicolon2 7,b7 in subclause 7,,ii71 by adding and after the semicolon2 7,c7 by moving the left margins of subclause 7,i7 and 7,,ii7 #b ems to the right2 and 7,d7 by adding at the end the following3 7,,iii7 in the case of rebate periods that begin on or after the date of enactment of this subclause1 on the wholesale acquisition cost 7as defined in section #ahdg;,a7c77#f77;,b77 for covered outpatient drugs for the rebate period under the agreement 7including for all such drugs that are sold under a new drug application approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act72 2 and 7#b7 in subparagraph 7,d7-- 7,a7 in the matter preceding clause 7i71 by inserting and clause 7vii7 of this subparagraph after #ahdg;,a2 7,b7 in clause 7v71 by striking and after the comma2 7,c7 in clause 7vi71 by striking the period and inserting 1 and2 and 7,d7 by inserting after clause 7vi7 the following3 7vii7 to the ,secretary to disclose 7through a website accessible to the public7 the most recently reported wholesale acquisition cost 7as defined in section #ahdg;,a7c77#f77;,b77 for each covered outpatient drug 7including for all such drugs that are sold under a new drug application approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act71 as reported under subparagraph 7,a77i77,,iii74 4 #haf4 ,graduate medical education improvements in rural and underserved communities ,part ,p of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is amended by adding at the end the following new section3 #cii,v-#g4 ,graduate medical education improvements in rural and underserved communities 7a7 ,rural and underserved community ,,gme grant program ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary71 acting through the ,administrator of the ,health ,resources and ,services ,administration1 shall establish a rural and underserved community graduate medical education grant program under which the ,secretary shall award grants to specified hospitals 7as defined in subsection 7b77 that have not established an approved medical residency training program 7as defined for purposes of section #ahhf7;h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7h777 in order to encourage such hospitals to establish such a program1 or to establish an affiliation with a hospital that has established such a program in order to host residents under such program4 7b7 ,use of funds ,grants awarded under subsection 7a7 may be used by a specified hospital for any initial costs associated with establishing such a program or such an affiliation1 including costs associated with faculty development1 administration1 infrastructure1 supplies1 and legal and consultant services4 7c7 ,specified hospital defined ,for purposes of subsection 7a71 the term specified hospital means a hospital or critical access hospital 7as such terms are defined in section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex77 that-- 7#a7 is-- 7,a7 located in a rural area 7as defined in section #ahhf7;d77#b77;,d7 of such ,act 7#db ,u4,s4,c4 #acieww7d77#b77;,d7772 or 7,b7 treated as being located in a rural area pursuant to section #ahhf7;d77#h77;,e7 of such ,act 7#db ,u4,s4,c4 #acieww7d77#h77;,e772 and 7#b7 is located in a medically underserved area 7as defined in section #ccj;,i7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bed;c-#ad7;a7774 7d7 ,critical access hospital grant program ,not later than #a year after the date of the enactment of this ,act1 the ,secretary1 acting through the ,administrator of the ,health ,resources and ,services ,administration1 shall establish a grant program under which the ,secretary awards grants to critical access hospitals 7as defined in section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex77 that do not have in effect an affiliation with a hospital with an approved medical residency training program to host residents of such program in order to assist such critical access hospitals in setting up such affiliations in order to host such residents4 7e7 ,limitation on grant amounts ,no hospital may receive an aggregate amount of grants under this section in excess of #bej1jjj4 7f7 ,reports 7#a7 ,,hhs ,not later than #e years after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report on graduate medical residency training programs of hospitals that received a grant under subsection 7a7 or 7d74 ,such report shall include the following3 7,a7 ,the number of hospitals that applied for a grant under this section4 7,b7 ,the number of hospitals that were awarded such a grant4 7,c7 ,the number of residency positions created by hospitals receiving such a grant4 7,d7 ,an estimate of the number of such positions such hospitals will create after the date of the submission of such report4 7,e7 ,a description of any challenges faced by hospitals in applying for such a grant or using funds awarded under such a grant4 7#b7 ,,gao ,not later than #aj years after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report containing an analysis of-- 7,a7 the number of residents who trained at a hospital or critical access hospital that received a grant under subsection 7a7 or 7d72 and 7,b7 whether such residents continued to practice medicine in a rural area 7as defined in section #ahhf7;d77#b77;,d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#b77;,d777 or in a medically underserved area 7as defined in section #ccj;,i7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bed;c-#ad7;a777 after completing such training4 7g7 ,funding ,there are authorized to be appropriated such sums as are necessary for purposes of making grants under this section for each of fiscal years #bjbj through #bjbi4 4 ,passed the ,house of ,representatives ,december #ab1 #bjai4;,cheryl ,l4 ,johnson1,clerk4 ,september #h1 #bjbj,read the second time and placed on the calendar