,,ii #aaith ,,congress #b;d ,session ,s4 #edif ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,september #bd1 #bjbf,mr4 ,warner introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to expand access to and lower the cost of health care4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,health for the ,commonwealth through ,affordability1 ,reform1 and ,expansion ,act of #bjbf or the ,health ,,care ,act of #bjbf4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,,title ,i--,restoring health care and lowering costs,sec4 #aja4 ,repeal of reconciliation health provisions4,sec4 #ajb4 ,permanent extension of enhanced tax credit4,sec4 #ajc4 ,promoting consumer outreach and education4,,title ,,ii--,pathway to universal coverage,sec4 #bja4 ,establishment of health plan4,sec4 #bjb4 ,availability of plan4,sec4 #bjc4 ,affordability4,sec4 #bjd4 ,participating providers4,sec4 #bje4 ,provider payment rates4,sec4 #bjf4 ,no effect on ,medicare benefits or ,medicare trust funds4,,title ,,iii--,strengthening ,medicaid,sec4 #cja4 ,increased ,,fmap for medical assistance to newly eligible individuals4,sec4 #cjb4 ,supporting ,state ,medicaid programs through economic downturns4,,title ,,iv--,lowering drug costs,sec4 #dja4 ,expanding ,medicare drug price negotiation4,sec4 #djb4 ,application of prescription drug inflation rebates to drugs furnished in the commercial market4,sec4 #djc4 ,establishing an out-of-pocket limit on expenditures for prescription drugs under group health plans and group and individual health insurance coverage4,sec4 #djd4 ,requirements with respect to cost-sharing for insulin products4,,title ,v--,ensuring quality health insurance and removing barriers to care,sec4 #eja4 ,required exceptions process for medication step therapy protocols4,sec4 #ejb4 ,establishing requirements with respect to the use of prior authorization under ,medicare ,advantage plans4,sec4 #ejc4 ,special enrollment period for provider terminations4,sec4 #ejd4 ,providing coverage for hearing care under the ,medicare program4,,title ,,vi--,lowering the cost of care,sec4 #fja4 ,strengthening hospital price transparency4,sec4 #fjb4 ,clinical diagnostic laboratory price transparency4,sec4 #fjc4 ,imaging services price transparency4,sec4 #fjd4 ,ambulatory surgical center price transparency4,sec4 #fje4 ,strengthening health coverage transparency requirements4,sec4 #fjf4 ,increasing group health plan access to health data4,sec4 #fjg4 ,oversight of administrative service providers4,sec4 #fjh4 ,state preemption only in event of conflict4,sec4 #fji4 ,requirement for explanation of benefits4,sec4 #faj4 ,transparency in billing4,sec4 #faa4 ,technical amendments4,sec4 #fab4 ,implementation and enforcement funding4,,title ,,vii--,reforming ,p,b,ms and ,protecting ,pharmacies,sec4 #gja4 ,ensuring accurate payments to pharmacies under ,medicaid4,sec4 #gjb4 ,preventing the use of abusive spread pricing in ,medicaid4 ,i ,restoring health care and lowering costs #aja4 ,repeal of reconciliation health provisions 7a7 ,in general ,except as provided in subsection 7b71 subtitle ,b of title ,,vii of the ,act titled ,an ,act to provide for reconciliation pursuant to title ,,ii of ,h4 ,con4 ,res4 #ad 7,public ,law #aai-ba7 is repealed and any law or regulation referred to in such subtitle shall be applied as if such subtitle and the amendments made by such subtitle had not been enacted4 7b7 ,exceptions ,subsection 7a7 shall not apply to the provisions of and amendments made by sections #gabjb1 #gacjf1 and #gadja of such ,act4 7c7 ,rescission 7#a7 ,,obbba implementation funding ,the unobligated amounts appropriated under the following provisions of the ,act titled ,an ,act to provide for reconciliation pursuant to title ,,ii of ,h4 ,con4 ,res4 #ad 7,public ,law #aai-ba7 are hereby rescinded3 7,a7 ,section #gaaja7;b74 7,b7 ,section #gaajg7;c74 7,c7 ,section #gaaji7;c74 7,d7 ,section #gaaaj7;b74 7,e7 ,section #gaaab7;e74 7,f7 ,section #gaaac7;c74 7,g7 ,section #gaaae7;c74 7,h7 ,section #gaaaf7;e74 7,i7 ,section #gaaah7;b74 7,j7 ,subsections 7e7 and 7f7 of section #gaaai4 7,k7 ,section #gaabj7;c74 7,l7 ,section #gaaba7;b74 7#b7 ,title ,,xix funding ,the unobligated amounts appropriated under section #aijb7uu77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7uu77#c771 as repealed by subsection 7a71 are hereby rescinded4 #ajb4 ,permanent extension of enhanced tax credit 7a7 ,in general ,subparagraph 7,a7 of section #cf;,b7c77#a7 of the ,internal ,revenue ,code of #aihf is amended by striking but does not exceed #djj percent4 7b7 ,applicable percentages 7#a7 ,in general ,subparagraph 7,a7 of section #cf;,b7b77#c7 of the ,internal ,revenue ,code of #aihf is amended to read as follows3 7,a7 ,applicable percentage ,the applicable percentage for any taxable year shall be the percentage such that the applicable percentage for any taxpayer whose household income is within an income tier specified in the following table shall increase1 on a sliding scale in a linear manner1 from the initial premium percentage to the final premium percentage specified in such table for such income tier3 ,in the case of household income 7expressed as a percent of poverty line7 within the following income tier3,the initial premium percentage is--,the final premium percentage is--,up to #aej percent#jjaej percent up to #bjj percent#jb4jbjj percent up to #bej percent#b4jd4jbej percent up to #cjj percent#d4jf4jcjj percent up to #djj percent#f4jh4edjj percent and higher#h4eh4e4 4 7#b7 ,conforming amendments relating to affordability of coverage 7,a7 ,paragraph 7#a7 of section #cf;,b7c7 of such ,code is amended by striking subparagraph 7,e74 7,b7 ,subparagraph 7,c7 of section #cf;,b7c77#b7 of such ,code is amended by striking clause 7iv74 7,c7 ,paragraph 7#d7 of section #cf;,b7c7 of such ,code is amended by striking subparagraph 7,f74 7c7 ,effective date ,the amendments made by this section shall apply to taxable years beginning after ,december #ca1 #bjbf4 #ajc4 ,promoting consumer outreach and education 7a7 ,in general ,section #acaa7;i7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjca7;i77 is amended-- 7#a7 in paragraph 7#b71 by adding at the end the following new subparagraph3 7,c7 ,selection of recipients ,in the case of an ,exchange established and operated by the ,secretary within a ,state pursuant to section #acba7;c71 in awarding grants under paragraph 7#a71 the ,exchange shall-- 7i7 select entities to receive such grants based on an entity's demonstrated capacity to carry out each of the duties specified in paragraph 7#c72 7ii7 not take into account whether or not the entity has demonstrated how the entity will provide information to individuals relating to group health plans offered by a group or association of employers or short-term limited duration insurance 7as defined by the ,secretary for purposes of section #bgia7;b77#e7 of the ,public ,health ,service ,act72 and 7iii7 ensure that1 each year1 the ,exchange awards such a grant to-- 7,i7 at least one entity described in this paragraph that is a community and consumer-focused nonprofit group2 and 7,,ii7 at least one entity described in subparagraph 7,b71 which may include another community and consumer-focused nonprofit group in addition to any such group awarded a grant pursuant to subclause 7,i74 ,in awarding such grants1 an ,exchange may consider an entity's record with respect to waste1 fraud1 and abuse for purposes of maintaining the integrity of such ,exchange4 2 7#b7 in paragraph 7#c7-- 7,a7 by amending subparagraph 7,c7 to read as follows3 7,c7 facilitate enrollment1 including with respect to individuals with limited ,english proficiency and individuals with chronic illnesses1 in qualified health plans1 ,state ,medicaid plans under title ,,xix of the ,social ,security ,act1 and ,state child health plans under title ,,xxi of such ,act2 2 7,b7 in subparagraph 7,d71 by striking and at the end2 7,c7 in subparagraph 7,e71 by striking the period at the end and inserting 2 and2 7,d7 by inserting after subparagraph 7,e7 the following new subparagraph3 7,f7 provide referrals to community-based organizations that address social needs related to health outcomes4 2 and 7,e7 by adding at the end the following flush text3 ,the duties specified in the preceding sentence may be carried out by such a navigator at any time during a year4 2 7#c7 in paragraph 7#d77;,a7-- 7,a7 in the matter preceding clause 7i71 by striking not2 7,b7 in clause 7i7-- 7i7 by inserting not before be2 and 7ii7 by striking 2 or and inserting a semicolon2 7,c7 in clause 7ii7-- 7i7 by inserting not before receive2 and 7ii7 by striking the period and inserting a semicolon2 and 7,d7 by adding at the end the following new clauses3 7iii7 maintain physical presence in the ,state of the ,exchange so as to allow in-person assistance to consumers2 and 7iv7 receive opioid specific education and training that ensures the navigator can best educate individuals on qualified health plans offered through an ,exchange1 specifically coverage under such plans for opioid health care treatment4 2 and 7#d7 in paragraph 7#f7-- 7,a7 by striking ,grants under and inserting the following3 7,a7 ,state exchanges ,grants under 2 and 7,b7 by adding at the end the following new subparagraph3 7,b7 ,federal exchanges ,for purposes of carrying out this subsection1 with respect to an ,exchange established and operated by the ,secretary within a ,state pursuant to section #acba7;c71 the ,secretary shall obligate #ajj1jjj1jjj out of amounts collected through the user fees on participating health insurance issuers pursuant to section #aef4ej of title #de1 ,code of ,federal ,regulations 7or any successor regulations71 for fiscal year #bjbg and each subsequent fiscal year4 ,such amount for a fiscal year shall remain available until expended4 4 7b7 ,effective date ,the amendments made by this section shall apply with respect to plan years beginning on or after ,january #a1 #bjbg4 ,,ii ,pathway to universal coverage #bja4 ,establishment of health plan 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this title as the ,secretary7 shall establish a coordinated and low-cost health plan 7referred to in this title as the health plan7 to provide access to quality health care for enrollees4 7b7 ,individual market availability ,the ,secretary shall make the health plan available in the individual market for plan year #bjbh and each subsequent plan year4 7c7 ,rulemaking ,the ,secretary may promulgate such regulations as may be necessary to carry out this title4 7d7 ,authorization of appropriations ,there are authorized to be appropriated such sums as may be necessary to carry out this title4 #bjb4 ,availability of plan 7a7 ,eligibility ,an individual shall be eligible to enroll in the health plan if such individual1 for the entire period for which enrollment is sought-- 7#a7 is a qualified individual within the meaning of section #acab of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjcb72 7#b7 is not eligible for benefits under the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq472 and 7#c7 is not otherwise eligible for1 or has been otherwise offered1 employer-sponsored health care coverage4 7b7 ,exchanges ,the health plan shall be made available through the ,exchanges1 including the ,small ,business ,health ,options ,program ,exchange4 #bjc4 ,affordability ,the ,secretary shall ensure that coverage options for the health plan are not more costly than comparable options offered on the ,exchange in the applicable market4 #bjd4 ,participating providers 7a7 ,requirement ,to participate in order ,to be enrolled under ,medicare ,beginning ,january #a1 #bjbh1 the ,secretary may require a health care provider enrolled under the ,medicare program under section #ahff7;j7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;cc7j77 to be a participating provider under the health plan4 7b7 ,requirement ,to participate in order ,to participate in ,medicaid ,beginning ,january #a1 #bjbh1 the ,secretary may require a health care provider under a ,state ,medicaid plan under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 to also be a participating provider under the health plan4 #bje4 ,provider payment rates ,the ,secretary shall set competitive provider payment rates under the health plan using the best information publicly available and data otherwise accessible to the ,secretary4 ,the ,secretary shall give consideration to existing provider payment rates for commercial health plans and provider costs to deliver care1 giving special consideration to increased costs for providers to deliver care in rural and medically underserved areas4 #bjf4 ,no effect on ,medicare benefits or ,medicare trust funds ,nothing in this title shall-- 7#a7 affect the benefits available under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq472 or 7#b7 impact the ,federal ,hospital ,insurance ,trust ,fund under section #ahag of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;i7 or the ,federal ,supplementary ,medical ,insurance ,trust ,fund under section #ahda of the ,social ,security ,act 7#db ,u4,s4,c4 #aciet7 7including the ,medicare ,prescription ,drug ,account within such ,trust ,fund74 ,,iii ,strengthening ,medicaid #cja4 ,increased ,,fmap for medical assistance to newly eligible individuals 7a7 ,in general ,section #aije of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7 is amended-- 7#a7 in subsection 7y77#a7-- 7,a7 in subparagraph 7,a71 by striking #bjad1 #bjae1 and #bjaf and inserting each of the first #c consecutive #ab-month periods in which the ,state provides medical assistance to newly eligible individuals2 7,b7 in subparagraph 7,b71 by striking #bjag and inserting the fourth consecutive #ab-month period in which the ,state provides medical assistance to newly eligible individuals2 7,c7 in subparagraph 7,c71 by striking #bjah and inserting the fifth consecutive #ab-month period in which the ,state provides medical assistance to newly eligible individuals2 7,d7 in subparagraph 7,d71 by striking #bjai and inserting the sixth consecutive #ab-month period in which the ,state provides medical assistance to newly eligible individuals2 and 7,e7 in subparagraph 7,e71 by striking #bjbj and each year thereafter and inserting the seventh consecutive #ab-month period in which the ,state provides medical assistance to newly eligible individuals and each such period thereafter2 and 7#b7 in subsection 7z77#b77;,b77i77,,ii71 by inserting 7as in effect on the day before the enactment of the ,health ,,care ,act of #bjbf7 after subsection 7y77#a74 7b7 ,retroactive application ,the amendments made by subsection 7a77#a7 shall take effect as if included in the enactment of ,public ,law #aaa-adh and shall apply to amounts expended by any ,state for medical assistance for newly eligible individuals described in subclause 7,,viii7 of section #aijb7;a77#aj77;,a77i7 of the ,social ,security ,act under a ,state ,medicaid plan 7or a waiver of such plan7 during the period before the date of enactment of this ,act4 #cjb4 ,supporting ,state ,medicaid programs through economic downturns 7a7 ,in general ,section #aije of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7 is amended-- 7#a7 in subsection 7b71 by striking and 7ii7 and inserting 7ii71 and 7ll72 and 7#b7 by adding at the end the following new subsection3 7ll7 ,increased ,,fmap during economic downturns 7#a7 ,in general ,if a fiscal quarter that begins on or after ,january #a1 #bjbf1 is an economic downturn quarter 7as defined in paragraph 7#b77 with respect to a ,state1 then the ,federal medical assistance percentage determined for each ,state for such quarter under subsection 7b7 shall be equal to the percentage determined for the ,state and quarter under paragraph 7#c74 7#b7 ,economic downturn quarter 7,a7 ,in general 7i7 ,in general ,in this subsection1 the term economic downturn quarter means1 with respect to a ,state1 a fiscal quarter during which the ,state's unemployment rate for the quarter exceeds the percentage determined for the ,state and quarter under clause 7ii74 7ii7 ,threshold percentage ,the percentage determined under this clause for a ,state and fiscal quarter is the percentage equal to the lower of-- 7,i7 the ,state unemployment rate at the #bjth percentile of the distribution of the ,state's quarterly unemployment rates for the #fj-quarter period preceding the quarter involved1 increased by #a percentage point2 and 7,,ii7 the ,state's average quarterly unemployment rate for the #ab-quarter period preceding the quarter involved1 increased by #a percentage point4 7,b7 ,unemployment data 7i7 ,in general ,except as provided in clause 7ii71 for purposes of determining unemployment rates for a ,state and a quarter under this paragraph1 the ,secretary shall use data from the ,local ,area ,unemployment ,statistics from the ,bureau of ,labor ,statistics4 7ii7 ,application to certain territories ,in the case of the ,virgin ,islands1 ,guam1 the ,northern ,mariana ,islands1 ,american ,samoa1 or any other jurisdiction for which suitable data from the ,local ,area ,unemployment ,statistics from the ,bureau of ,labor ,statistics are unavailable1 the ,secretary shall use data from the ,u-#c unemployment measure of the ,bureau of ,labor ,statistics to make any necessary determinations under subparagraph 7,a74 7#c7 ,increased ,,fmap during economic downturn quarter 7,a7 ,in general ,during a fiscal quarter that is an economic downturn quarter with respect to a ,state1 the ,federal medical assistance percentage for the ,state and quarter determined under subsection 7b7 shall be equal to-- 7i7 the ,federal medical assistance percentage determined for the ,state and quarter under subsection 7b7 without regard to this subsection2 increased by 7ii7 the number of percentage points 7rounded to the nearest tenth of a percentage point7 equal to the product of-- 7,i7 the number of percentage points 7rounded to the nearest tenth of a percentage point7 by which the unemployment rate for the ,state and quarter exceeds the percentage determined for the ,state and quarter under paragraph 7#b77;,a77ii72 and 7,,ii7 #d4h4 7,b7 ,rules of application ,the following rules shall apply with respect to the ,federal medical assistance percentage determined for a ,state and an economic downturn quarter under this subsection3 7i7 ,scope of application ,such ,federal medical assistance percentage shall not apply for purposes of-- 7,i7 disproportionate share hospital payments described in section #aibc2 7,,ii7 payments under part ,d of title ,,iv2 or 7,,iii7 any payments under this title that are based on a ,federal medical assistance percentage determined for a ,state under subsection 7aa7 7but only to the extent that such ,federal medical assistance percentage is higher than the economic recovery ,,fmap74 7ii7 ,limitation ,in no case shall-- 7,i7 the ,federal medical assistance percentage determined for a ,state and quarter pursuant to this subsection exceed #ie percent2 or 7,,ii7 any increase to the ,federal medical assistance percentage determined for a ,state and quarter pursuant to this subsection result in the application of a ,federal medical assistance percentage that exceeds #ie percent4 7iii7 ,application to ,,chip ,notwithstanding the first sentence of section #baje7;b71 the application of this subsection may result in the enhanced ,,fmap of a ,state for a fiscal year under such section exceeding #he percent1 but in no case may the application of this subsection before application of the second sentence of such section result in the enhanced ,,fmap of the ,state exceeding #ie percent4 7#d7 ,advance payment2 retrospective adjustment 7,a7 ,in general ,prior to the beginning of the second fiscal quarter that begins after the date of enactment of this subsection1 and each subsequent fiscal quarter1 the ,secretary shall1 with respect to each ,state-- 7i7 make an initial determination1 based on the projections made for the ,state and quarter under subparagraph 7,b71 as to-- 7,i7 whether the application of this subsection is expected to result in the application of a higher ,federal medical assistance percentage for the ,state and quarter than the percentage that would otherwise apply without regard to this subsection2 and 7,,ii7 if the application of this subsection is expected to result in such a higher ,federal medical assistance percentage for the ,state and quarter1 what such higher percentage is expected to be2 and 7ii7 if the ,secretary determines under clause 7i7 that the application of this subsection is expected to result in the application of a higher ,federal medical assistance percentage for the ,state and quarter than the percentage that would otherwise apply without regard to this subsection-- 7,i7 apply such higher ,federal medical assistance percentage of the ,state for purposes of making payments to the ,state for amounts expended during such quarter as medical assistance under the ,state plan2 and 7,,ii7 take into account such higher ,federal medical assistance percentage of the ,state for purposes of calculating the enhanced ,,fmap for the ,state and quarter under section #baje7;b74 7,b7 ,projection of ,state unemployment rates ,prior to the beginning of the second fiscal quarter that begins after the date of enactment of this subsection1 and each subsequent fiscal quarter1 the ,secretary1 acting through the ,chief ,actuary of the ,centers for ,medicare ,medicaid ,services1 shall1 using the most recently available data described in paragraph 7#b77;,b71 make projections with respect to-- 7i7 the unemployment rates for each ,state for such quarter2 7ii7 the threshold percentages described in paragraph 7#b77;,a77ii7 for each ,state for such quarter2 and 7iii7 the national unemployment rate for such quarter4 7,c7 ,retrospective adjustment ,as soon as practicable after final unemployment data becomes available for a fiscal quarter for which the ,secretary made an initial determination under this paragraph1 the ,secretary shall1 with respect to each ,state-- 7i7 make a final determination with respect to the application of this subsection for purposes of determining the ,federal medical assistance percentage and enhanced ,,fmap of the ,state for the quarter2 and 7ii7 in accordance with section #aijc7;d77#b7 and section #baje7;e71 reduce or increase the amount payable to the ,state under section #aijc7;a7 or section #baje for a subsequent fiscal quarter to the extent of any overpayment or underpayment under either such section which the ,secretary determines was made as a result of an incorrect initial determination under subparagraph 7,a77i7 with respect to the application of this subsection for purposes of determining the ,federal medical assistance percentage and enhanced ,,fmap of the ,state for such prior fiscal quarter4 7#e7 ,retrospective application of over-the-limit ,,fmap increases 7,a7 ,in general ,if a ,state has excess percentage points with respect to an economic downturn quarter and an applicable ,,fmap 7as determined under subparagraph 7,b771 the ,state may elect to apply such excess percentage points to increase such applicable ,,fmap for one or more quarters during the look-back period for the ,state and economic downturn quarter in accordance with this paragraph4 7,b7 ,excess percentage points ,for purposes of this paragraph1 the number of excess percentage points for a ,state1 economic downturn quarter1 and an applicable ,,fmap shall be equal to the number of percentage points by which-- 7i7 the applicable ,,fmap for the ,state and quarter 7after application of paragraph 7#c7 but without regard to subparagraph 7,b77ii7 of such paragraph72 exceeds 7ii7 #ie percent4 7,c7 ,effect of application of excess percentage points ,if a ,state elects to apply excess percentage points to an applicable ,,fmap to a quarter during a look-back period under this paragraph1 the ,secretary shall determine the additional amount of payment under section #aijc7;a7 to which the ,state would have been entitled for such quarter if the applicable ,,fmap 7as so increased7 had been in effect for such quarter1 and shall treat such additional amount as an underpayment for such quarter4 7,d7 ,distribution of excess percentage points ,a ,state that has excess percentage points with respect to an economic downturn quarter and applicable ,,fmap may elect to divide such points among more than #a quarter during the look-back period for such ,state and quarter provided that no excess percentage point 7or fraction of an excess percentage point7 is applied to the applicable ,,fmap of more than #a quarter4 7,e7 ,limitations 7i7 ,no increases over #ajj percent ,a ,state may not increase an applicable ,,fmap for any quarter during a look-back period under this paragraph if such increase would result in the applicable ,,fmap for such quarter exceeding #ajj percent4 7ii7 ,scope of application ,any increase to an applicable ,,fmap of a ,state for a fiscal quarter under this paragraph-- 7,i7 shall only apply with respect to payments for amounts expended by the ,state for medical assistance for services furnished during such quarter to which such applicable ,,fmap is applicable2 and 7,,ii7 shall not apply with respect to payments described in paragraph 7#c77;,b77i74 7,f7 ,definitions ,in this paragraph3 7i7 ,applicable ,,fmap ,the term applicable ,,fmap means1 with respect to a ,state and fiscal quarter-- 7,i7 the ,federal medical assistance percentage determined for the ,state and quarter under subsection 7b72 7,,ii7 the ,federal medical assistance percentage applicable under subsection 7y72 7,,iii7 the ,federal medical assistance percentage applicable under subsection 7z77#b72 7,,iv7 the ,federal medical assistance percentage determined for the ,state and quarter under subsection 7ff72 or 7,v7 the enhanced ,,fmap determined for the ,state and quarter under section #baje7;b74 7ii7 ,look-back period ,the term look-back period means1 with respect to a ,state and a fiscal quarter that is an economic downturn quarter for the ,state1 the period of #d fiscal quarters that ends with the fourth quarter which precedes the most recent fiscal quarters that was not an economic downturn quarter for the ,state4 7#f7 ,requirement for all ,states ,this subsection shall not apply to a ,state with respect to a fiscal quarter1 if-- 7,a7 eligibility standards1 methodologies1 or procedures under the ,state plan or a waiver of such plan are more restrictive during such quarter than the eligibility standards1 methodologies1 or procedures1 respectively1 under such plan 7or waiver7 as in effect on the last day of the most recent fiscal quarter that was not an economic downturn quarter for the ,state2 7,b7 the amount of any premium imposed by the ,state pursuant to section #aiaf or #aiaf;,a during such quarter1 with respect to an individual enrolled under such plan 7or waiver71 exceeds the amount of such premium as of the date described in subparagraph 7,a72 or 7,c7 the ,state fails to provide that an individual who is enrolled for benefits under such plan 7or waiver7 as of the date described in subparagraph 7,a7 or enrolls for benefits under such plan 7or waiver7 during the period beginning with such date and ending with the day before the first day of the next quarter that is not an economic downturn quarter for the ,state shall be treated as eligible for such benefits for not less than #ab months after such date or 7if later7 the date that such individual so enrolls unless the individual requests a voluntary termination of eligibility or the individual ceases to be a resident of the ,state4 4 7b7 ,exclusion of economic downturn ,,fmap increases from territorial caps2 special rule for ,,chip allotments 7#a7 ,exclusion from territorial caps ,section #aajh of the ,social ,security ,act 7#db ,u4,s4,c4 #acjh7 is amended-- 7,a7 in subsection 7f71 in the matter preceding paragraph 7#a71 by striking subsections 7g7 and 7h7 and inserting subsections 7g71 7h71 and 7j72 and 7,b7 by adding at the end the following3 7j7 ,exclusion from caps of amounts attributable to economic downturn ,,fmap ,any payment made to a territory for a fiscal year in which the ,federal medical assistance percentage for the territory is determined under section #aije7ll7 shall not be taken into account for purposes of applying payment limits under subsections 7f7 and 7g7 to the extent that such payment exceeds the amount of the payment that would have been made to the territory for the year if the ,federal medical assistance percentage for the territory had been determined without regard to such section4 4 7#b7 ,,chip allotments ,section #bajd7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;dd7m77 is amended-- 7,a7 in paragraph 7#b77;,b71 in the matter preceding clause 7i71 by striking paragraphs 7#e71 7#g71 and 7#ab7 and inserting paragraphs 7#e71 7#g71 7#ab71 and 7#ac72 and 7,b7 by adding at the end the following new paragraph3 7#ac7 ,special rule for adjusting allotments during fiscal years with economic downturn quarters 7,a7 ,in general ,if a fiscal quarter is determined under section #aije7ll7 to be an economic downturn quarter with respect to a ,state then1 as soon as practicable after such determination1 the ,secretary shall increase the allotment for the ,state and the fiscal year in which such fiscal quarter occurs in accordance with subparagraph 7,b74 7,b7 ,amount of increase 7i7 ,in general ,the amount of an increase to the allotment of a ,state described in subparagraph 7,a7 for a fiscal year shall be equal to the amount by which ,federal payments made to the ,state for the preceding fiscal year under this title would have been increased 7without regard to whether such payments would exceed the amount of the ,state's allotment for such preceding fiscal year7 if the enhanced ,,fmap determined for the ,state for such preceding fiscal year had been increased to the same extent that the ,state's enhanced ,,fmap for the fiscal year involved is expected to be increased as a result of the application of section #aije7ll7 relative to the enhanced ,,fmap that would apply to the ,state for the fiscal year involved without the application of such section4 7ii7 ,inclusion of projected increases ,in increasing the allotment of a ,state for a fiscal year under this paragraph1 the ,secretary may base the calculation of such increase on projections made by the ,secretary with respect to-- 7,i7 the number of fiscal quarters during such fiscal year that will be economic downturn quarters2 and 7,,ii7 the effect that the application of section #aije7ll7 is expected to have on the enhanced ,,fmap of the ,state for such fiscal year4 7,c7 ,disregard of increased payments for purposes of future allotments ,any ,federal payment made to a ,state under this title for a fiscal year in which the ,federal medical assistance percentage for the ,state is determined under section #aije7ll7 shall be disregarded when determining the allotment of the ,state for any subsequent year1 including for purposes of applying this paragraph1 to the extent that such payment exceeds the amount of the payment that would have been made to the ,state for the year if the ,federal medical assistance percentage for the ,state and year had been determined without regard to such section4 4 ,,iv ,lowering drug costs #dja4 ,expanding ,medicare ,drug price negotiation 7a7 ,in general ,section #aaib7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;f-#a7;a77 is amended-- 7#a7 in paragraph 7#c71 by striking and at the end2 7#b7 in paragraph 7#d7-- 7,a7 by striking or a subsequent year2 and 7,b7 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following3 7#e7 with respect to the initial price applicability year #bjcj1 #cj negotiation-eligible drugs described in subparagraph 7,a7 or 7,b7 of subsection 7d77#a7 with respect to such year 7or1 all 7if such number is less than #cj7 such negotiation-eligible drugs with respect to such year72 7#f7 with respect to the initial price applicability year #bjca1 #dj negotiation-eligible drugs described in subparagraph 7,a7 or 7,b7 of subsection 7d77#a7 with respect to such year 7or1 all 7if such number is less than #dj7 such negotiation-eligible drugs with respect to such year72 and 7#g7 with respect to the initial price applicability year #bjcb or a subsequent year1 #ej negotiation-eligible drugs described in subparagraph 7,a7 or 7,b7 of subsection 7d77#a74 4 7b7 ,expansion of definition of maximum fair price eligible individual ,section #aaia7;c77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;f7c77#b77 is amended-- 7#a7 in subparagraph 7,a71 by inserting 1 or a participant1 beneficiary1 or enrollee 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 dispensed after such selected drug2 and 7#b7 in subparagraph 7,b71 by inserting 1 or a participant1 beneficiary1 or enrollee 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 administered after such selected drug4 7c7 ,application of administrative procedures to new maximum fair price eligible individuals ,section #aaif7;a77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;f-#e7;a77#c77 is amended-- 7#a7 in subparagraph 7,a71 by striking and at the end2 7#b7 in subparagraph 7,b71 by striking the period and inserting 2 and2 and 7#c7 by adding at the end the following new subparagraph3 7,c7 maximum fair price eligible individuals not described in subparagraph 7,a7 or 7,b74 4 7d7 ,health insurer agreements ,part ,e of title ,,xi of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;f et seq47 is amended-- 7#a7 by redesignating sections #aaig and #aaih as sections #aaih and #aaii1 respectively2 and 7#b7 by inserting after section #aaif the following new section3 #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 in the case 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 in the case 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 ,secretary1 the ,secretary of ,labor1 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 4 7e7 ,application to group health plans and health insurance coverage 7#a7 ,,phsa ,part ,d of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aaa et seq47 is amended by adding at the end the following new section3 #bgii;,a-#ab4 ,drug ,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 ,drug ,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 for which coverage is provided under such plan or coverage-- 7#a7 the provisions of such part shall apply-- 7,a7 in the case the drug is furnished or dispensed at a pharmacy or by a mail order service1 to such plan or coverage1 and to the participants1 beneficiaries1 and enrollees enrolled under such plan 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 participants1 beneficiaries1 and enrollees enrolled under such prescription drug plans and ,,ma-,,pd plans during such period2 and 7,b7 in the case the drug is furnished or administered by a hospital1 physician1 or other provider of services or supplier1 to such plan or coverage1 and to the participants1 beneficiaries1 and enrollees enrolled under such plan 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 participants1 beneficiaries1 and enrollees 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 participants1 beneficiaries1 and enrollees 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 ,drug ,price ,negotiation ,program ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall publicly disclose1 in a manner and in accordance with a process specified by the ,secretary1 any election made under section #aaig of the ,social ,security ,act by such plan or issuer to not participate in the ,drug ,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 7,a7 ,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 #aahe et seq47 is amended by adding at the end the following new section3 #gbg4 ,drug ,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 of ,health and ,human ,services under the ,drug ,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 for which coverage is provided under such plan or coverage-- 7#a7 the provisions of such part shall apply1 as applicable-- 7,a7 in the case the drug is furnished or dispensed at a pharmacy or by a mail order service1 to such plan or coverage1 and to the participants and beneficiaries enrolled under such plan 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 participants and beneficiaries enrolled under such prescription drug plans and ,,ma-,,pd plans during such period2 and 7,b7 in the case the drug is furnished or administered by a hospital1 physician1 or other provider of services or supplier1 to the group health plan or coverage offered by an issuer1 to the participants and beneficiaries 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 ,secretary of ,health and ,human ,services1 to participants and beneficiaries 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 participants and beneficiaries so enrolled in such plans4 7b7 ,notification regarding nonparticipation in ,drug ,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 ,drug ,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 ,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 and #gbf and inserting #gbf1 and #gbg4 7,c7 ,clerical amendment ,the table of contents in section #a of such ,act is amended by inserting after the item relating to section #gbf the following new item3 ,sec4 #gbg4 ,drug ,price ,negotiation ,program and application of maximum fair prices4 4 7#c7 ,,irc 7,a7 ,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 #ihbg4 ,drug ,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 of ,health and ,human ,services under the ,drug ,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 for 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 participants and beneficiaries 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 participants and beneficiaries 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 participants and beneficiaries 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 ,secretary of ,health and ,human ,services1 to participants and beneficiaries 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 participants and beneficiaries so enrolled in such plan4 7b7 ,notification regarding nonparticipation in ,drug ,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 ,drug ,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 7,b7 ,application to retiree and certain small group health plans ,section #ihca7;a77#b7 of the ,internal ,revenue ,code of #aihf is amended by inserting or #ihbg after section #ihbf4 7,c7 ,clerical amendment ,the table of sections for subchapter ,b of chapter #ajj of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new item3 ,sec4 #ihbg4 ,drug ,price ,negotiation ,program and application of maximum fair prices4 4 #djb4 ,application of prescription drug inflation rebates to drugs furnished in the commercial market 7a7 ,part ,b drugs 7#a7 ,application of prescription drug inflation rebates to drugs furnished in the commercial market ,section #ahdg;,a7i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7i77 is amended-- 7,a7 in paragraph 7#a77;,a77i71 by striking units and inserting billing units2 7,b7 in paragraph 7#b77;,a71 by striking for which payment is made under this part and inserting that would be payable under this part if such drug were furnished to an individual enrolled under this part2 and 7,c7 in paragraph 7#c7-- 7i7 in subparagraph 7,a77i71 by striking units and inserting billing units2 and 7ii7 by striking subparagraph 7,b7 and inserting the following3 7,b7 ,total number of billing units ,for purposes of subparagraph 7,a77i71 the total number of billing units with respect to a part ,b rebatable drug is determined as follows3 7i7 ,determine the total number of units equal to-- 7,i7 the total number of units1 as reported under subsection 7c77#a77;,b71 for each ,national ,drug ,code of such drug during the calendar quarter that is #b calendar quarters prior to the calendar quarter as described in subparagraph 7,a71 minus 7,,ii7 the total number of units with respect to each ,national ,drug ,code of such drug for which payment was made under a ,state plan under title ,,xix 7or waiver of such plan71 as reported by ,states under section #aibg7;b77#b77;,a7 for the rebate period that is the same calendar quarter as described in subclause 7,i74 7ii7 ,convert the units determined under clause 7i7 to billing units for the billing and payment code of such drug1 using a methodology similar to the methodology used under this section1 by dividing the units determined under clause 7i7 for each ,national ,drug ,code of such drug by the billing unit for the billing and payment code of such drug4 7iii7 ,compute the sum of the billing units for each ,national ,drug ,code of such drug in clause 7ii74 4 7#b7 ,effective date ,the amendments made by this subsection shall apply with respect to calendar quarters beginning after the date of the enactment of this ,act4 7b7 ,covered part ,d drugs 7#a7 ,application of prescription drug inflation rebates to drugs furnished in the commercial market ,section #ahfj;,d-#ad;,b of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad;b7 is amended-- 7,a7 in subsection 7b7-- 7i7 in paragraph 7#a7-- 7,i7 in subparagraph 7,a77i71 by striking the total number of units and all that follows through the semicolon and inserting the following3 the total number of units that are used to calculate the average manufacturer price of such dosage form and strength with respect to such part ,d rebatable drug1 as reported by the manufacturer of such drug under section #aibg for each month1 with respect to such period22 and 7,,ii7 by striking subparagraph 7,b7 and inserting the following3 7,b7 ,excluded units ,for purposes of subparagraph 7,a77i71 the ,secretary shall exclude from the total number of units for a dosage form and strength with respect to a part ,d rebatable drug1 with respect to an applicable period1 the following3 7i7 ,units of each dosage form and strength of such part ,d rebatable drug for which payment was made under a ,state plan under title ,,xix 7or waiver of such plan71 as reported by ,states under section #aibg7;b77#b77;,a74 7ii7 ,units of each dosage form and strength of such part ,d rebatable drug for which a rebate is paid under section #ahdg;,a7i74 7iii7 ,beginning with plan year #bjbh1 units of each dosage form and strength of such part ,d rebatable drug for which the manufacturer provides a discount under the program under section #cdj;,b of the ,public ,health ,service ,act4 2 and 7ii7 in paragraph 7#f71 by striking information and all that follows through rebatable covered part ,d drug dispensed and inserting the following3 ,,amp reports4--,the ,secretary shall provide for a method and process under which1 in the case of a manufacturer of a part ,d rebatable drug that submits revisions to information submitted under section #aibg by the manufacturer with respect to such drug2 and 7,b7 by striking subsection 7d7 and inserting the following3 7d7 ,information ,for purposes of carrying out this section1 the ,secretary shall use information submitted by manufacturers under section #aibg7;b77#c7 and information submitted by ,states under section #aibg7;b77#b77;,a74 4 7#b7 ,effective date ,the amendments made by this subsection shall apply with respect to applicable periods 7as defined in section #ahfj;,d-#ad;,b7g77#g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad;b7g77#g777 beginning after the date of the enactment of this ,act4 #djc4 ,establishing an out-of-pocket limit on expenditures for prescription drugs under group health plans and group and individual health insurance coverage 7a7 ,,phsa ,title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg et seq47 is amended-- 7#a7 in section #bgjg1 by adding at the end the following new subsection3 7e7 ,sunset ,the preceding provisions of this section shall not apply with respect to plan years beginning on or after ,january #a1 #bjbh4 2 and 7#b7 in part ,d1 as amended by section #dja1 by adding at the end the following new section3 #bgii;,a-#ac4 ,comprehensive coverage 7a7 ,coverage for essential health benefits package ,a health insurance issuer that offers health insurance coverage in the individual or small group market shall ensure that such coverage includes the essential health benefits package required under section #acjb7;a7 of the ,patient ,protection and ,affordable ,care ,act4 7b7 ,cost-,sharing limitation 7#a7 ,in general ,a group health plan and a health insurance issuer offering group or individual health insurance coverage shall ensure that-- 7,a7 any annual cost-sharing imposed under the plan or coverage 7including any such cost-sharing so imposed with respect to prescription drugs7 does not exceed the dollar amounts specified in paragraph 7#b72 and 7,b7 any annual cost-sharing imposed under the plan or coverage with respect to prescription drugs does not exceed the dollar amounts specified in paragraph 7#c74 7#b7 ,limitation on overall out-of-pocket cost-sharing ,for purposes of paragraph 7#a77;,a71 the dollar amounts specified in this paragraph are the following3 7,a7 ,with respect to self-only coverage-- 7i7 for plan years beginning in #bjbh1 the dollar amount in effect under section #acjb7;c77#a7 of the ,patient ,protection and ,affordable ,care ,act for such coverage for plan years beginning in #bjad1 increased by an amount equal to the product of that amount and the premium adjustment percentage specified in paragraph 7#d7 of such section for the calendar year2 and 7ii7 for plan years beginning in #bjbi or a subsequent year1 the dollar amount in effect under this subparagraph for plan years beginning in #bjbg1 increased by an amount equal to the product of that amount the premium adjustment percentage specified in paragraph 7#d7 for the calendar year4 7,b7 ,with respect to coverage other than self-only coverage1 for plan years beginning in #bjbh or a subsequent year1 twice the amount in effect under subparagraph 7,a7 for such plan year4 ,if the amount of any increase under subparagraph 7,a7 is not a multiple of #ej1 such increase shall be rounded to the next lowest multiple of #ej4 7#c7 ,limitation on prescription drug out-of-pocket cost-sharing ,for purposes of paragraph 7#a77;,b71 the dollar amounts specified in this paragraph are the following3 7,a7 ,with respect to self-only coverage-- 7i7 for plan years beginning in #bjbh1 #b1jjj2 and 7ii7 for plan years beginning in #bjbi or a subsequent year1 the dollar amount in effect under this subparagraph for plan years beginning in #bjbh1 increased by an amount equal to the product of that amount and the premium adjustment percentage under paragraph 7#d7 for the calendar year4 7,b7 ,with respect to coverage other than self-only coverage1 for plan years beginning in #bjbh or a subsequent year1 twice the amount in effect under subparagraph 7,a7 for such plan year4 ,if the amount of any increase under subparagraph 7,a7 is not a multiple of #ej1 such increase shall be rounded to the next lowest multiple of #ej4 7#d7 ,premium adjustment percentage ,for purposes of paragraphs 7#b77;,a77ii7 and 7#c77;,a77ii71 the premium adjustment percentage for any calendar year is the percentage 7if any7 by which the average per capita premium for health insurance coverage in the ,united ,states for the preceding calendar year 7as estimated by the ,secretary no later than ,october #a of such preceding calendar year7 exceeds such average per capita premium for #bjbf 7as determined by the ,secretary74 7#e7 ,cost-sharing ,in this section3 7,a7 ,in general ,the term cost-sharing includes-- 7i7 deductibles1 coinsurance1 copayments1 or similar charges2 and 7ii7 any other expenditure required of an insured individual which is a qualified medical expense 7within the meaning of section #bbc7;d77#b7 of the ,internal ,revenue ,code of #aihf7 with respect to essential health benefits covered under the plan or coverage4 7,b7 ,exceptions ,such term does not include premiums1 balance billing amounts for non-network providers1 or spending for non-covered services4 7#f7 ,implementation ,the ,secretary may implement the provisions of this subsection by subregulatory guidance1 interim final rule1 or otherwise4 7c7 ,child-,only plans ,if a health insurance issuer offers health insurance coverage in any level of coverage specified under section #acjb7;d7 of the ,patient ,protection and ,affordable ,care ,act1 the issuer shall also offer such coverage in that level as a plan in which the only enrollees are individuals who1 as of the beginning of a plan year1 have not attained the age of #ba4 7d7 ,dental only ,this section shall not apply to a plan described in section #acaa7;d77#b77;,b77ii7 of the ,patient ,protection and ,affordable ,care ,act4 4 7b7 ,,erisa 7#a7 ,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 #aahe et seq471 as amended by section #dja1 is further amended by adding at the end the following new section3 #gbh4 ,comprehensive coverage 7a7 ,coverage for essential health benefits package ,a health insurance issuer that offers health insurance coverage in the small group market shall ensure that such coverage includes the essential health benefits package required under section #acjb7;a7 of the ,patient ,protection and ,affordable ,care ,act4 7b7 ,cost-,sharing limitation 7#a7 ,in general ,a group health plan and a health insurance issuer offering group health insurance coverage shall ensure that-- 7,a7 any annual cost-sharing imposed under the plan or coverage 7including any such cost-sharing so imposed with respect to prescription drugs7 does not exceed the dollar amounts specified in paragraph 7#b72 and 7,b7 any annual cost-sharing imposed under the plan or coverage with respect to prescription drugs does not exceed the dollar amounts specified in paragraph 7#c74 7#b7 ,limitation on overall out-of-pocket cost-sharing ,for purposes of paragraph 7#a77;,a71 the dollar amounts specified in this paragraph are the following3 7,a7 ,with respect to self-only coverage-- 7i7 for plan years beginning in #bjbh1 the dollar amount in effect under section #acjb7;c77#a7 of the ,patient ,protection and ,affordable ,care ,act for such coverage for plan years beginning in #bjad1 increased by an amount equal to the product of that amount and the premium adjustment percentage specified in paragraph 7#d7 of such section for the calendar year2 and 7ii7 for plan years beginning in #bjbi or a subsequent year1 the dollar amount in effect under this subparagraph for plan years beginning in #bjbh1 increased by an amount equal to the product of that amount the premium adjustment percentage specified in paragraph 7#d7 for the calendar year4 7,b7 ,with respect to coverage other than self-only coverage1 for plan years beginning in #bjbh or a subsequent year1 twice the amount in effect under subparagraph 7,a7 for such plan year4 ,if the amount of any increase under subparagraph 7,a7 is not a multiple of #ej1 such increase shall be rounded to the next lowest multiple of #ej4 7#c7 ,limitation on prescription drug out-of-pocket cost-sharing ,for purposes of paragraph 7#a77;,b71 the dollar amounts specified in this paragraph are the following3 7,a7 ,with respect to self-only coverage-- 7i7 for plan years beginning in #bjbh1 #b1jjj2 and 7ii7 for plan years beginning in #bjbi or a subsequent year1 the dollar amount in effect under this subparagraph for plan years beginning in #bjbh1 increased by an amount equal to the product of that amount and the premium adjustment percentage under paragraph 7#d7 for the calendar year4 7,b7 ,with respect to coverage other than self-only coverage1 for plan years beginning in #bjbh or a subsequent year1 twice the amount in effect under subparagraph 7,a7 for such plan year4 ,if the amount of any increase under subparagraph 7,a7 is not a multiple of #ej1 such increase shall be rounded to the next lowest multiple of #ej4 7#d7 ,premium adjustment percentage ,for purposes of paragraphs 7#b77;,a77ii7 and 7#c77;,a77ii71 the premium adjustment percentage for any calendar year is the percentage 7if any7 by which the average per capita premium for health insurance coverage in the ,united ,states for the preceding calendar year 7as estimated by the ,secretary no later than ,october #a of such preceding calendar year7 exceeds such average per capita premium for #bjbg 7as determined by the ,secretary74 7#e7 ,cost-sharing ,in this section3 7,a7 ,in general ,the term cost-sharing includes-- 7i7 deductibles1 coinsurance1 copayments1 or similar charges2 and 7ii7 any other expenditure required of an insured individual which is a qualified medical expense 7within the meaning of section #bbc7;d77#b7 of the ,internal ,revenue ,code of #aihf7 with respect to essential health benefits covered under the plan or coverage4 7,b7 ,exceptions ,such term does not include premiums1 balance billing amounts for non-network providers1 or spending for non-covered services4 7#f7 ,implementation ,the ,secretary may implement the provisions of this subsection by subregulatory guidance1 interim final rule1 or otherwise4 7c7 ,child-,only plans ,if a health insurance issuer offers health insurance coverage in any level of coverage specified under section #acjb7;d7 of the ,patient ,protection and ,affordable ,care ,act1 the issuer shall also offer such coverage in that level as a plan in which the only enrollees are individuals who1 as of the beginning of a plan year1 have not attained the age of #ba4 7d7 ,dental only ,this section shall not apply to a plan described in section #acaa7;d77#b77;,b77ii7 of the ,patient ,protection and ,affordable ,care ,act4 4 7#b7 ,clerical amendment ,the table of contents in section #a of such ,act1 as amended by section #dja1 is further amended by inserting after the item relating to section #gbg the following new item3 ,sec4 #gbh4 ,comprehensive coverage4 4 7c7 ,,irc 7#a7 ,in general ,subchapter ,b of chapter #ajj of the ,internal ,revenue ,code of #aihf1 as amended by section #dja1 is further amended by adding at the end the following new section3 #ihbh4 ,comprehensive coverage 7a7 ,cost-,sharing limitation 7#a7 ,in general ,a group health plan shall ensure that-- 7,a7 any annual cost-sharing imposed under the plan 7including any such cost-sharing so imposed with respect to prescription drugs7 does not exceed the dollar amounts specified in paragraph 7#b72 and 7,b7 any annual cost-sharing imposed under the plan with respect to prescription drugs does not exceed the dollar amounts specified in paragraph 7#c74 7#b7 ,limitation on overall out-of-pocket cost-sharing ,for purposes of paragraph 7#a77;,a71 the dollar amounts specified in this paragraph are the following3 7,a7 ,with respect to self-only coverage-- 7i7 for plan years beginning in #bjbh1 the dollar amount in effect under section #acjb7;c77#a7 of the ,patient ,protection and ,affordable ,care ,act for such coverage for plan years beginning in #bjad1 increased by an amount equal to the product of that amount and the premium adjustment percentage specified in paragraph 7#d7 of such section for the calendar year2 and 7ii7 for plan years beginning in #bjbi or a subsequent year1 the dollar amount in effect under this subparagraph for plan years beginning in #bjbh1 increased by an amount equal to the product of that amount the premium adjustment percentage specified in paragraph 7#d7 for the calendar year4 7,b7 ,with respect to coverage other than self-only coverage1 for plan years beginning in #bjbh or a subsequent year1 twice the amount in effect under subparagraph 7,a7 for such plan year4 ,if the amount of any increase under subparagraph 7,a7 is not a multiple of #ej1 such increase shall be rounded to the next lowest multiple of #ej4 7#c7 ,limitation on prescription drug out-of-pocket cost-sharing ,for purposes of paragraph 7#a77;,b71 the dollar amounts specified in this paragraph are the following3 7,a7 ,with respect to self-only coverage-- 7i7 for plan years beginning in #bjbh1 #b1jjj2 and 7ii7 for plan years beginning in #bjbi or a subsequent year1 the dollar amount in effect under this subparagraph for plan years beginning in #bjbh1 increased by an amount equal to the product of that amount and the premium adjustment percentage under paragraph 7#d7 for the calendar year4 7,b7 ,with respect to coverage other than self-only coverage1 for plan years beginning in #bjbh or a subsequent year1 twice the amount in effect under subparagraph 7,a7 for such plan year4 ,if the amount of any increase under subparagraph 7,a7 is not a multiple of #ej1 such increase shall be rounded to the next lowest multiple of #ej4 7#d7 ,premium adjustment percentage ,for purposes of paragraphs 7#b77;,a77ii7 and 7#c77;,a77ii71 the premium adjustment percentage for any calendar year is the percentage 7if any7 by which the average per capita premium for health insurance coverage in the ,united ,states for the preceding calendar year 7as estimated by the ,secretary no later than ,october #a of such preceding calendar year7 exceeds such average per capita premium for #bjbf 7as determined by the ,secretary74 7#e7 ,cost-sharing ,in this section3 7,a7 ,in general ,the term cost-sharing includes-- 7i7 deductibles1 coinsurance1 copayments1 or similar charges2 and 7ii7 any other expenditure required of an insured individual which is a qualified medical expense 7within the meaning of section #bbc7;d77#b7 of the ,internal ,revenue ,code of #aihf7 with respect to essential health benefits covered under the plan4 7,b7 ,exceptions ,such term does not include premiums1 balance billing amounts for non-network providers1 or spending for non-covered services4 7#f7 ,implementation ,the ,secretary may implement the provisions of this subsection by subregulatory guidance1 interim final rule1 or otherwise4 7b7 ,dental only ,this section shall not apply to a plan described in section #acaa7;d77#b77;,b77ii7 of the ,patient ,protection and ,affordable ,care ,act4 4 7#b7 ,clerical amendment ,the table of sections for subchapter ,b of chapter #ajj of the ,internal ,revenue ,code of #aihf1 as amended by section #dja1 is further amended by adding at the end the following new item3 ,sec4 #ihbh4 ,comprehensive coverage4 4 7d7 ,conforming amendments ,the ,patient ,protection and ,affordable ,care ,act 7,public ,law #aaa-adh7 is amended-- 7#a7 in section #acjb-- 7,a7 in subsection 7a77#b71 by inserting with respect to plan years beginning before ,january #a1 #bjbg1 before limits cost-sharing2 and 7,b7 in subsection 7e77#a77;,b77i7-- 7i7 by inserting 7or1 with respect to plan years beginning on or after ,january #a1 #bjbh1 in effect under section #bgii;,a-#ac7;b77#a77;,a7 of the ,public ,health ,service ,act7 after subsection 7c77#a72 and 7ii7 by inserting and except1 with respect to plan years beginning on or after ,january #a1 #bjbh1 in the case of an individual who has incurred cost-sharing expenses with respect to prescription drugs in an amount equal to the annual limitation in effect under section #bgii;,a-#ac7;b77#a77;,b7 of such ,act1 for benefits consisting of prescription drugs after section #bgac2 and 7#b7 in section #adjb7;c77#a77;,a71 by inserting 7or1 with respect to plan years beginning on or after ,january #a1 #bjbh1 the applicable out-of-pocket limit under section #bgii;,a-#ac7;b77#a77;,a7 of the ,public ,health ,service ,act7 after section #acjb7;c77#a74 7e7 ,effective date ,the amendments made by this section shall apply with respect to plan years beginning on or after ,january #a1 #bjbh4 #djd4 ,requirements with respect to cost-sharing for insulin products 7a7 ,,phsa ,part ,d of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aaa et seq471 as amended by section #djc1 is further amended by adding at the end the following new section3 #bgii;,a-#ad4 ,requirements with respect to cost-sharing for certain insulin products 7a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbh1 a group health plan or health insurance issuer offering group or individual health insurance coverage shall provide coverage of selected insulin products1 and with respect to such products1 shall not-- 7#a7 apply any deductible2 or 7#b7 impose any cost-sharing in excess of the lesser of1 per #cj-;day supply-- 7,a7 #ce2 or 7,b7 the amount equal to #be percent of the negotiated price of the selected insulin product net of all price concessions received by or on behalf of the plan or coverage1 including price concessions received by or on behalf of third-party entities providing services to the plan or coverage1 such as pharmacy benefit management services4 7b7 ,definitions ,in this section3 7#a7 ,selected insulin products ,the term selected insulin products means at least one of each dosage form 7such as vial1 pump1 or inhaler dosage forms7 of each different type 7such as rapid-acting1 short-acting1 intermediate-acting1 long-acting1 ultra long-acting1 and premixed7 of insulin 7as defined below71 when available1 as selected by the group health plan or health insurance issuer4 7#b7 ,insulin defined ,the term insulin means insulin that is licensed under subsection 7a7 or 7k7 of section #cea and continues to be marketed under such section4 7c7 ,out-of-,network providers ,nothing in this section requires a plan or issuer that has a network of providers to provide benefits for selected insulin products described in this section that are delivered by an out-of-network provider1 or precludes a plan or issuer that has a network of providers from imposing higher cost-sharing than the levels specified in subsection 7a7 for selected insulin products described in this section that are delivered by an out-of-network provider4 7d7 ,rule of construction ,subsection 7a7 shall not be construed to require coverage of1 or prevent a group health plan or health insurance coverage from imposing cost-sharing other than the levels specified in subsection 7a7 on1 insulin products that are not selected insulin products1 to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under ,federal and applicable ,state law4 7e7 ,application of cost-,sharing towards deductibles and out-of-,pocket maximums ,any cost-sharing payments made pursuant to subsection 7a77#b7 shall be counted toward any deductible or out-of-pocket maximum that applies under the plan or coverage4 4 7b7 ,,erisa 7#a7 ,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 #aahe et seq471 as amended by section #djc1 is further amended by adding at the end the following new section3 #gbi4 ,requirements with respect to cost-sharing for certain insulin products 7a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbh1 a group health plan or health insurance issuer offering group health insurance coverage shall provide coverage of selected insulin products1 and with respect to such products1 shall not-- 7#a7 apply any deductible2 or 7#b7 impose any cost-sharing in excess of the lesser of1 per #cj-;day supply-- 7,a7 #ce2 or 7,b7 the amount equal to #be percent of the negotiated price of the selected insulin product net of all price concessions received by or on behalf of the plan or coverage1 including price concessions received by or on behalf of third-party entities providing services to the plan or coverage1 such as pharmacy benefit management services4 7b7 ,definitions ,in this section3 7#a7 ,selected insulin products ,the term selected insulin products means at least one of each dosage form 7such as vial1 pump1 or inhaler dosage forms7 of each different type 7such as rapid-acting1 short-acting1 intermediate-acting1 long-acting1 ultra long-acting1 and premixed7 of insulin 7as defined below71 when available1 as selected by the group health plan or health insurance issuer4 7#b7 ,insulin defined ,the term insulin means insulin that is licensed under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 and continues to be marketed under such section4 7c7 ,out-of-,network providers ,nothing in this section requires a plan or issuer that has a network of providers to provide benefits for selected insulin products described in this section that are delivered by an out-of-network provider1 or precludes a plan or issuer that has a network of providers from imposing higher cost-sharing than the levels specified in subsection 7a7 for selected insulin products described in this section that are delivered by an out-of-network provider4 7d7 ,rule of construction ,subsection 7a7 shall not be construed to require coverage of1 or prevent a group health plan or health insurance coverage from imposing cost-sharing other than the levels specified in subsection 7a7 on1 insulin products that are not selected insulin products1 to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under ,federal and applicable ,state law4 7e7 ,application of cost-,sharing towards deductibles and out-of-,pocket maximums ,any cost-sharing payments made pursuant to subsection 7a77#b7 shall be counted toward any deductible or out-of-pocket maximum that applies under the plan or coverage4 4 7#b7 ,clerical amendment ,the table of contents in section #a of such ,act is amended by inserting after the item relating to section #gbh 7as inserted by section #djc7 the following new item3 ,sec4 #gbi4 ,requirements with respect to cost-sharing for certain insulin products4 4 7c7 ,,irc 7#a7 ,in general ,subchapter ,b of chapter #ajj of the ,internal ,revenue ,code of #aihf1 as amended by section #djc1 is further amended by adding at the end the following new section3 #ihbi4 ,requirements with respect to cost-sharing for certain insulin products 7a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbh1 a group health plan shall provide coverage of selected insulin products1 and with respect to such products1 shall not-- 7#a7 apply any deductible2 or 7#b7 impose any cost-sharing in excess of the lesser of1 per #cj-;day supply-- 7,a7 #ce2 or 7,b7 the amount equal to #be percent of the negotiated price of the selected insulin product net of all price concessions received by or on behalf of the plan1 including price concessions received by or on behalf of third-party entities providing services to the plan1 such as pharmacy benefit management services4 7b7 ,definitions ,in this section3 7#a7 ,selected insulin products ,the term selected insulin products means at least one of each dosage form 7such as vial1 pump1 or inhaler dosage forms7 of each different type 7such as rapid-acting1 short-acting1 intermediate-acting1 long-acting1 ultra long-acting1 and premixed7 of insulin 7as defined below71 when available1 as selected by the group health plan4 7#b7 ,insulin defined ,the term insulin means insulin that is licensed under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 and continues to be marketed under such section4 7c7 ,out-of-,network providers ,nothing in this section requires a plan that has a network of providers to provide benefits for selected insulin products described in this section that are delivered by an out-of-network provider1 or precludes a plan that has a network of providers from imposing higher cost-sharing than the levels specified in subsection 7a7 for selected insulin products described in this section that are delivered by an out-of-network provider4 7d7 ,rule of construction ,subsection 7a7 shall not be construed to require coverage of1 or prevent a group health plan from imposing cost-sharing other than the levels specified in subsection 7a7 on1 insulin products that are not selected insulin products1 to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under ,federal and applicable ,state law4 7e7 ,application of cost-,sharing towards deductibles and out-of-,pocket maximums ,any cost-sharing payments made pursuant to subsection 7a77#b7 shall be counted toward any deductible or out-of-pocket maximum that applies under the plan4 4 7#b7 ,clerical amendment ,the table of sections for subchapter ,b of chapter #ajj of the ,internal ,revenue ,code of #aihf1 as amended by section #djc1 is further amended by adding at the end the following new item3 ,sec4 #ihbi4 ,requirements with respect to cost-sharing for certain insulin products4 4 7d7 ,no effect on other cost-,sharing ,section #acjb7;d77#b7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjbb7;d77#b77 is amended by adding at the end the following new subparagraph3 7,d7 ,special rule relating to insulin coverage ,the exemption of coverage of selected insulin products 7as defined in section #bgii;,a-#ad7;b7 of the ,public ,health ,service ,act7 from the application of any deductible pursuant to section #bgii;,a-#ad7;a77#a7 of such ,act1 section #gbi7;a77#a7 of the ,employee ,retirement ,income ,security ,act of #aigd1 or section #ihbi7;a77#a7 of the ,internal ,revenue ,code of #aihf shall not be considered when determining the actuarial value of a qualified health plan under this subsection4 4 7e7 ,coverage of certain insulin products under catastrophic plans ,section #acjb7;e7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjbb7;e77 is amended by adding at the end the following new paragraph3 7#d7 ,coverage of certain insulin products 7,a7 ,in general ,notwithstanding paragraph 7#a77;,b77i71 a health plan described in paragraph 7#a7 shall provide coverage of selected insulin products1 in accordance with section #bgii;,a-#ad of the ,public ,health ,service ,act1 for a plan year before an enrolled individual has incurred cost-sharing expenses in an amount equal to the annual limitation in effect under subsection 7c77#a7 for the plan year4 7,b7 ,terminology ,for purposes of subparagraph 7,a7-- 7i7 the term selected insulin products has the meaning given such term in section #bgii;,a-#ad7;b7 of the ,public ,health ,service ,act2 and 7ii7 the requirements of section #bgii;,a-#ad of such ,act shall be applied by deeming each reference in such section to individual health insurance coverage to be a reference to a plan described in paragraph 7#a74 4 ,v ,ensuring quality health insurance and removing barriers to care #eja4 ,required exceptions process for medication step therapy protocols 7a7 ,required exceptions process for medication step therapy protocols ,the ,employee ,retirement ,income ,security ,act of #aigd is amended by inserting after section #gac of such ,act 7#bi ,u4,s4,c4 #aahe;b7 the following new section3 #gac;,a4 ,required exceptions process for medication step therapy protocols 7a7 ,in general ,in the case of a group health plan or health insurance issuer offering coverage offered in connection with such a plan that provides coverage of a prescription drug pursuant to a medication step therapy protocol1 the plan or issuer shall-- 7#a7 implement a clear1 prompt1 and transparent process for a participant or beneficiary 7or the prescribing health care provider 7referred to in this section as the prescriber7 on behalf of the participant or beneficiary7 to request an exception to such medication step therapy protocol1 pursuant to subsection 7b72 and 7#b7 where the participant or beneficiary or prescriber's request for an exception to the medication step therapy protocols satisfies the criteria and requirements of subsection 7b71 cover the requested drug in accordance with the terms established by the plan or coverage for patient cost-sharing rates or amounts at the beginning of the plan year4 7b7 ,circumstances for exception approval ,the circumstances requiring an exception to a medication step therapy protocol1 pursuant to a request under subsection 7a71 are any of the following3 7#a7 ,any treatments otherwise required under the protocol1 or treatments in the same pharmacological class or having the same mechanism of action1 including treatments provided prior to the effective date of the participant's or beneficiary's coverage under the plan or coverage1 have been ineffective in the treatment of the disease or condition of the participant or beneficiary1 when prescribed consistent with clinical indications1 clinical guidelines1 or other peer-reviewed evidence1 based on the prescribing health care professional's judgement or relevant information provided by the participant or beneficiary 7including the medical records of the participant or beneficiary74 7#b7 ,delay of effective treatment would lead to severe or irreversible consequences1 or worsen disease progression or a comorbidity and the treatment otherwise required under the protocol is reasonably expected by the prescriber to be ineffective based upon the documented physical or mental characteristics of the participant or beneficiary and the known characteristics of such treatment4 7#c7 ,any treatments otherwise required under the protocol are contraindicated for the participant or beneficiary or have caused1 or are likely to cause1 based on clinical1 peer-reviewed evidence1 an adverse reaction or other physical or mental harm to the participant or beneficiary4 7#d7 ,any treatment otherwise required under the protocol has prevented1 will prevent1 or is likely to prevent a participant or beneficiary from achieving or maintaining reasonable and safe functional ability in performing occupational responsibilities or activities of daily living 7as defined in section #dda4eje of title #db1 ,code of ,federal ,regulations 7or successor regulations774 7#e7 ,the participant or beneficiary is stable for his or her disease or condition on the prescription drug or drugs selected by the prescriber and has previously received approval for coverage of the relevant drug or drugs for the disease or condition by any public or private health plan4 7#f7 ,other circumstances1 as determined by the ,secretary4 7c7 ,requirement of a clear process 7#a7 ,in general ,the process required by subsection 7a7 shall-- 7,a7 provide the prescriber or participant or beneficiary an opportunity to present such prescriber's clinical rationale and relevant medical information for the group health plan or health insurance issuer to evaluate such request for exception2 7,b7 develop and use a standard form and instructions for the request of an exception under subsection 7b71 available in paper and electronic forms1 and allow for submission of such form by paper and electronic means2 7,c7 provide both paper and electronic means for the submission of requests for additional information2 7,d7 clearly set forth all required information and the specific criteria that will be used to determine whether an exception is warranted1 which may require disclosure of-- 7i7 the medical history or other health records of the participant or beneficiary demonstrating that the participant or beneficiary seeking an exception-- 7,i7 has tried other drugs included in the drug therapy class without success2 or 7,,ii7 has taken the requested drug for a clinically appropriate amount of time to establish stability1 in relation to the condition being treated and prescription guidelines given by the prescribing physician2 or 7ii7 other clinical information that may be relevant to conducting the exception review2 7,e7 not require the submission of any information or supporting documentation beyond what is strictly necessary 7as determined by the ,secretary7 to determine whether a circumstance listed in subsection 7b7 exists2 7,f7 clearly outline conditions under which an exception request warrants expedited resolution from the group health plan or health insurance issuer1 pursuant to subsection 7d77#b72 and 7,g7 allow a representative of a participant or beneficiary1 which may include a designated third-party advocate1 to act on behalf of the participant or beneficiary4 7#b7 ,availability of process information ,the group health plan or health insurance issuer shall make information regarding the process required under subsection 7a7 readily available in the relevant plan materials1 including the summary of benefits and1 if available1 on the website of the group health plan or health insurance issuer4 ,such information shall include-- 7,a7 the requirements for requesting an exception to a medication step therapy protocol pursuant to this section2 and 7,b7 any forms1 supporting information1 and contact information1 as appropriate4 7d7 ,timing for determination of exception ,the process required under subsection 7a77#a7 shall provide for the disposition of requests received under such paragraph in accordance with the following3 7#a7 ,subject to paragraph 7#b71 not later than #gb hours after receiving an initial exception request1 the plan or issuer shall respond to the participant or beneficiary and1 if applicable1 the requesting prescriber with either a determination of exception eligibility or a request for additional required information strictly necessary to make a determination of whether the conditions specified in subsection 7b7 are met4 ,the plan or issuer shall respond to the participant or beneficiary and1 if applicable1 the requesting prescriber1 with a determination of exception eligibility no later than #gb hours after receipt of the additional required information4 7#b7 ,in the case of a request under circumstances in which the applicable medication step therapy protocol may seriously jeopardize the life or health of the participant or beneficiary1 may jeopardize the ability of the participant or beneficiary to regain maximum function1 or may subject the participant or beneficiary to severe pain that cannot be adequately managed without the treatment that is the subject of the request1 the plan or issuer shall conduct a review of the request and respond to the participant or beneficiary and1 if applicable1 the requesting prescriber1 with either a determination of exception eligibility or a request for additional required information strictly necessary to make a determination of whether the conditions specified in subsection 7b7 are met1 in accordance with the following3 7,a7 ,if the plan or issuer can make a determination of exception eligibility without additional information1 such determination shall be made on an expedited basis1 and no later than #bd hours after receipt of such request4 7,b7 ,if the plan or issuer requires additional information before making a determination of exception eligibility1 the plan or issuer shall respond to the participant or beneficiary and1 if applicable1 the requesting prescriber1 with a request for such information within #bd hours of the request for a determination1 and shall respond with a determination of exception eligibility as quickly as the condition or disease requires1 and no later than #bd hours after receipt of the additional required information4 7e7 ,duration of a grant ,if an exception to a medication step therapy protocol is granted under this section to a participant or beneficiary1 coverage for the requested drug shall remain in effect with respect to such participant or beneficiary for not less than #a year4 7f7 ,medication step therapy protocol ,in this section1 the term medication step therapy protocol means a drug therapy utilization management protocol or program under which a group health plan or health insurance issuer offering group health insurance coverage of prescription drugs requires a participant or beneficiary to try an alternative preferred prescription drug or drugs before the plan or health insurance issuer approves coverage for the non-preferred drug therapy prescribed4 7g7 ,clarification ,this section shall apply with respect to any group health plan or health insurance coverage offered in connection with such a plan that provides coverage of a prescription drug pursuant to a policy that meets the definition of the term medication step therapy protocol in subsection 7f71 regardless of whether such policy is described by such group health plan or health insurance coverage as a step therapy protocol4 7h7 ,reporting 7#a7 ,reporting to the ,secretary ,not later than #c years after the date of enactment of the ,health ,,care ,act of #bjbf1 and not later than ,october #a of each year thereafter1 each group health plan and health insurance issuer offering group health insurance coverage shall report to the ,secretary1 in such manner as the ,secretary shall require1 the following3 7,a7 ,the number of step therapy exception requests received for each exception circumstance described in paragraphs 7#a7 through 7#f7 of subsection 7b71 and the numbers of such requests for each such circumstance that were-- 7i7 approved2 7ii7 denied1 and the reasons for the denials2 7iii7 initially denied and appealed2 and 7iv7 initially denied and then subsequently reversed by internal appeals or external reviews4 7,b7 ,the number of times a plan or issuer requested additional information in response to a step therapy exception request1 by exception circumstance described in paragraphs 7#a7 through 7#f7 of subsection 7b74 7,c7 ,the number of exception requests submitted by participants or beneficiaries1 and the number of exception requests submitted by prescribers1 by medical specialty4 7,d7 ,the medical conditions for which participants and beneficiaries were granted exceptions due to the likelihood that switching from a prescription drug will likely cause an adverse reaction by1 or physical or mental harm to1 the participant or beneficiary1 as described in subsection 7b77#c74 7,e7 ,the entities responsible for providing pharmacy benefit management services for the group health plan or health insurance coverage4 7#b7 ,information ,a group health plan or health insurance issuer offering group health insurance coverage shall not enter into a contract with a third-party administrator or an entity providing pharmacy benefit management services on behalf of the plan or coverage that prevents the plan or issuer from obtaining from the third-party administrator or the entity providing pharmacy benefit management services any information needed for the plan or issuer to comply with the reporting requirements under paragraph 7#a74 7#c7 ,reports to ,congress ,not later than #c years after the date of enactment of the ,health ,,care ,act of #bjbf1 and not later than ,october #a of each year thereafter1 the ,secretary shall submit to ,congress1 and make publicly available1 a report that contains a summary and analysis of the information reported under paragraph 7#a71 including an analysis of1 with respect to requests for exceptions under this section1 approvals1 and denials1 including the reasons for denials2 appeals and external reviews2 and trends1 if any1 in exception requests by medical specialty or medical condition4 4 7b7 ,clerical amendment ,the table of contents in section #a of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #ajja et seq47 is amended by inserting after the item relating to section #gac the following new item3 ,sec4 #gac;,a4 ,required exceptions process for medication step therapy protocols4 4 7c7 ,effective date 7#a7 ,in general ,the amendment made by subsection 7a7 applies with respect to plan years beginning with the first plan year that begins at least #f months after the date of the enactment of this ,act4 7#b7 ,regulations ,not later than #f months after the date of the enactment of this ,act1 the ,secretary of ,labor shall issue final regulations1 through notice and comment rulemaking1 to implement the provisions of section #gac;,a of the ,employee ,retirement ,income ,security ,act of #aigd1 as added by subsection 7a74 #ejb4 ,establishing requirements with respect to the use of prior authorization under ,medicare ,advantage plans 7a7 ,in general ,section #aheb of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7 is amended by adding at the end the following new subsection3 7o7 ,prior authorization requirements 7#a7 ,in general ,in the case of a ,medicare ,advantage plan that imposes any prior authorization requirement with respect to any applicable item or service 7as defined in paragraph 7#e77 during a plan year1 such plan shall-- 7,a7 beginning with plan years beginning on or after ,january #a1 #bjbi-- 7i7 establish the electronic prior authorization program described in paragraph 7#b72 and 7ii7 meet the enrollee protection standards specified pursuant to paragraph 7#d72 and 7,b7 beginning with plan years beginning on or after ,january #a1 #bjbh1 meet the transparency requirements specified in paragraph 7#c74 7#b7 ,electronic prior authorization program 7,a7 ,in general ,for purposes of paragraph 7#a77;,a71 the electronic prior authorization program described in this paragraph is a program that provides for the secure electronic transmission of-- 7i7 a prior authorization request from a provider or supplier to a ,medicare ,advantage plan with respect to an applicable item or service to be furnished to an individual and a response1 in accordance with this paragraph1 from such plan to such provider or supplier2 and 7ii7 any supporting documentation relating to such request or response4 7,b7 ,electronic transmission 7i7 ,exclusions ,for purposes of this paragraph1 a facsimile1 a proprietary payer portal that does not meet standards specified by the ,secretary1 or an electronic form shall not be treated as an electronic transmission described in subparagraph 7,a74 7ii7 ,standards ,an electronic transmission described in subparagraph 7,a7 shall comply with applicable technical standards and other requirements to promote the standardization and streamlining of electronic transactions adopted by the ,secretary4 7#c7 ,transparency requirements 7,a7 ,in general ,for purposes of paragraph 7#a77;,b71 the transparency requirements specified in this paragraph are1 with respect to a ,medicare ,advantage plan1 the following3 7i7 ,the plan1 annually and in a manner specified by the ,secretary1 shall submit to the ,secretary the following information3 7,i7 ,a list of all applicable items and services that were subject to a prior authorization requirement under the plan during the previous plan year4 7,,ii7 ,the percentage and number of specified requests 7as defined in subparagraph 7,f77 approved during the previous plan year by the plan in an initial determination and the percentage and number of specified requests denied during such plan year by such plan in an initial determination 7both in the aggregate and categorized by each item and service74 7,,iii7 ,the percentage and number of specified requests that were denied during the previous plan year by the plan in an initial determination and that were subsequently appealed4 7,,iv7 ,the number of appeals of specified requests resolved during the preceding plan year1 and the percentage and number of such resolved appeals that resulted in approval of the furnishing of the item or service that was the subject of such request1 categorized by each applicable item and service and categorized by each level of appeal 7including judicial review74 7,v7 ,the percentage and number of specified requests that were denied1 and the percentage and number of specified requests that were approved1 by the plan during the previous plan year through the utilization of decision support technology1 artificial intelligence technology1 machine-learning technology1 clinical decision-making technology1 or any other technology specified by the ,secretary4 7,,vi7 ,the average and the median amount of time 7in hours7 that elapsed during the previous plan year between the submission of a specified request to the plan and a determination by the plan with respect to such request for each such item and service1 excluding any such requests that were not submitted with the medical or other documentation required to be submitted by the plan4 7,,vii7 ,the percentage and number of specified requests that were excluded from the calculation described in subclause 7,,vi7 based on the plan's determination that such requests were not submitted with the medical or other documentation required to be submitted by the plan4 7,,viii7 ,information on each occurrence during the previous plan year in which1 during a surgical or medical procedure involving the furnishing of an applicable item or service with respect to which such plan had approved a prior authorization request1 the provider or supplier furnishing such item or service determined that a different or additional item or service was medically necessary1 including a specification of whether such plan subsequently approved the furnishing of such different or additional item or service4 7,,ix7 ,a disclosure and description of any technology described in subclause 7,v7 that the plan utilized during the previous plan year in making determinations with respect to specified requests4 7,x7 ,the number of grievances 7as described in subsection 7f77 received by such plan during the previous plan year that were related to a prior authorization requirement4 7,,xi7 ,such other information as the ,secretary determines appropriate4 7ii7 ,the plan shall provide-- 7,i7 to each provider or supplier who seeks to enter into a contract with such plan to furnish applicable items and services under such plan1 the list described in clause 7i77,i7 and any policies or procedures used by the plan for making determinations with respect to prior authorization requests2 7,,ii7 to each such provider and supplier that enters into such a contract1 access to the criteria used by the plan for making such determinations and an itemization of the medical or other documentation required to be submitted by a provider or supplier with respect to such a request2 and 7,,iii7 to an enrollee of the plan1 upon request1 access to the criteria used by the plan for making determinations with respect to prior authorization requests for an item or service4 7,b7 ,option for plan to provide certain additional information ,as part of the information described in subparagraph 7,a77i7 provided to the ,secretary during a plan year1 a ,medicare ,advantage plan may elect to include information regarding the percentage and number of specified requests made with respect to an individual and an item or service that were denied by the plan during the preceding plan year in an initial determination based on such requests failing to demonstrate that such individuals met the clinical criteria established by such plan to receive such items or services4 7,c7 ,regulations ,the ,secretary shall1 through notice and comment rulemaking1 establish requirements for ,medicare ,advantage plans regarding the provision of-- 7i7 access to criteria described in subparagraph 7,a77ii77,,ii7 to providers of services and suppliers in accordance with such subparagraph2 and 7ii7 access to such criteria to enrollees in accordance with subparagraph 7,a77ii77,,iii74 7,d7 ,publication of information ,the ,secretary shall publish information described in subparagraph 7,a77i7 and subparagraph 7,b7 on a public website of the ,centers for ,medicare ,medicaid ,services4 ,such information shall be so published on an individual plan level and may in addition be aggregated in such manner as determined appropriate by the ,secretary4 7,e7 ,med,pac report ,not later than #c years after the date information is first submitted under subparagraph 7,a77i71 the ,medicare ,payment ,advisory ,commission shall submit to ,congress a report on such information that includes a descriptive analysis of the use of prior authorization4 ,as appropriate1 the ,commission should report on statistics including the frequency of appeals and overturned decisions4 ,the ,commission shall provide recommendations1 as appropriate1 on any improvement that should be made to the electronic prior authorization programs of ,medicare ,advantage plans4 7,f7 ,specified request defined ,for purposes of this paragraph1 the term specified request means a prior authorization request made with respect to an applicable item or service4 7#d7 ,enrollee protection standards ,for purposes of paragraph 7#a77;,a77ii71 with respect to the use of prior authorization by ,medicare ,advantage plans for applicable items and services1 the enrollee protection standards specified in this paragraph are-- 7,a7 the adoption of transparent prior authorization programs developed in consultation with enrollees and with providers and suppliers with contracts in effect with such plans for furnishing such items and services under such plans2 7,b7 allowing for the waiver or modification of prior authorization requirements based on the performance of such providers and suppliers in demonstrating compliance with such requirements1 such as adherence to evidence-based medical guidelines and other quality criteria2 and 7,c7 conducting annual reviews of such items and services for which prior authorization requirements are imposed under such plans through a process that takes into account input from enrollees and from providers and suppliers with such contracts in effect and is based on consideration of prior authorization data from previous plan years and analyses of current coverage criteria4 7#e7 ,applicable item or service defined ,for purposes of this subsection1 the term applicable item or service means1 with respect to a ,medicare ,advantage plan1 any item or service for which benefits are available under such plan1 other than a covered part ,d drug4 7#f7 ,reports to ,congress 7,a7 ,,gao ,not later than ,january #a1 #bjcc1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report containing an evaluation of the implementation of the requirements of this subsection and an analysis of issues in implementing such requirements faced by ,medicare ,advantage plans4 7,b7 ,,hhs 7i7 ,the ,secretary ,not later than the end of the fifth plan year beginning after the date of the enactment of this subsection1 and biennially thereafter through the date that is #aj years after such date of enactment1 the ,secretary shall submit to ,congress a report containing a description of the information submitted under paragraph 7#c77;,a77i7 during-- 7,i7 in the case of the first such report1 the fourth plan year beginning after the date of the enactment of this subsection2 and 7,,ii7 in the case of a subsequent report1 the #b plan years preceding the year of the submission of such report4 7ii7 ,,cms ,not later than ,january #a1 #bjbi1 the ,centers for ,medicare ,medicaid ,services and the ,office of the ,national ,coordinator for ,health ,information ,technology shall submit to ,congress and publish on the internet website of the ,centers for ,medicare ,medicaid ,services a report that-- 7,i7 defines the term real-time decision and details how the definition for such term may be updated based on any technological advances2 7,,ii7 using the data submitted to the ,secretary under paragraph 7#c77;,a77i71 details a process for real-time decisions for routinely approved items and services for purposes of the electronic prior authorization program described in paragraph 7#b72 and 7,,iii7 includes an analysis of-- 7aa7 items and services that are routinely approved2 7bb7 items and services identified in item 7aa7 that could be eligible for real-time decisions2 7cc7 whether establishing real-time decisions for such items and services could-- 7,,aa7 improve enrollee access to benefits under this part2 7,,bb7 produce operational efficiencies for providers and suppliers and ,medicare ,advantage plans2 and 7,,cc7 reduce health disparities for ,medicare ,advantage enrollees in rural and low-income communities2 and 7dd7 how determinations of routinely approved items and services made solely through automation and artificial intelligence by ,medicare ,advantage plans impact patient access1 including disparities in access for rural and low-income beneficiaries4 4 7b7 ,providing the ,secretary authority ,to enforce timely responses for all prior authorization requests submitted under part ,c ,section #aheb7;g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;g77 is amended-- 7#a7 in paragraph 7#a77;,a71 by inserting and in accordance with any timeframe established by the ,secretary under paragraph 7#f7 after paragraph 7#c72 7#b7 in paragraph 7#c77;,b77iii71 by inserting 7with respect to prior authorization requests submitted on or after the first day of the third plan year beginning after the date of the enactment of the ,health ,,care ,act of #bjbf1 any timeframe established by the ,secretary under paragraph 7#f77 after #gb hours2 and 7#c7 by adding at the end the following new paragraph3 7#f7 ,timeframe for response to prior authorization requests ,subject to paragraph 7#c71 the ,secretary may establish1 for purposes of an organization determination made with respect to a prior authorization request for an item or service to be furnished to an individual1 timeframes1 such as #bd hours1 for the organization to notify the enrollee 7and the physician involved1 as appropriate7 of such determination for-- 7,a7 a request for expedited determination described in paragraph 7#c77;,a72 7,b7 a real time decision for routinely approved items and services2 and 7,c7 any other prior authorization request4 4 #ejc4 ,special enrollment period for provider terminations ,section #ahea7;e77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ba7;e77#d77 is amended-- 7#a7 by redesignating subparagraph 7,d7 as subparagraph 7,e72 and 7#b7 by inserting after subparagraph 7,c7 the following new subparagraph3 7,d7 the individual demonstrates or the ,secretary or organization determines that the individual is assigned to1 currently receiving care from1 or has received care in the previous #c months from1 a provider of services or supplier that is terminated from the provider network of the plan2 4 #ejd4 ,providing coverage for hearing care under the ,medicare program 7a7 ,provision of audiology services by qualified audiologists and qualified hearing aid professionals 7#a7 ,in general ,section #ahfa7ll7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7ll77 is amended-- 7,a7 in paragraph 7#c7-- 7i7 by inserting 7and1 beginning ,january #a1 #bjbh1 such aural rehabilitation and treatment services7 after assessment services2 7ii7 by inserting 1 and1 beginning on ,january #a1 #bjbh1 such hearing assessment services furnished by a qualified hearing aid professional1 after by a qualified audiologist2 and 7iii7 by striking the audiologist and inserting the audiologist or qualified hearing aid professional2 and 7,b7 in paragraph 7#d71 by adding at the end the following new subparagraph3 7,c7 ,the term qualified hearing aid professional means1 with respect to hearing assessment services described in paragraph 7#c71 an individual who-- 7i7 is licensed or registered as a hearing aid dispenser1 hearing aid specialist1 hearing instrument dispenser1 or related professional by the ,state in which the individual furnishes such services2 and 7ii7 meets such other requirements as the ,secretary determines appropriate 7including requirements relating to educational certifications or accreditations71 taking into account any additional requirements for hearing aid specialists1 hearing aid dispensers1 and hearing instrument dispensers established by ,medicare ,advantage organizations under part ,c1 ,state plans 7or waivers of such plans7 under title ,,xix1 and the group health plans and health insurance issuers 7as such terms are defined in section #bgia of the ,public ,health ,service ,act74 4 7#b7 ,payment for qualified hearing aid professionals ,section #ahcc7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77#a77 is amended-- 7,a7 by striking and before 7,,hh72 and 7,b7 by inserting before the semicolon at the end the following3 and 7,,ii7 with respect to hearing assessment services 7as described in paragraph 7#c7 of section #ahfa7ll77 furnished by a qualified hearing aid professional 7as defined in paragraph 7#d77;,c7 of such section71 the amounts paid shall be equal to #hj percent of the lesser of the actual charge for such services or #he percent of the amount for such services determined under the payment basis determined under section #ahdh4 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 7as described in section #ahcd7;h77#g77 furnished on or after ,january #a1 #bjbh1 to individuals diagnosed with moderately severe1 severe1 or profound 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 #aciem7h77 is amended by adding at the end the following new paragraphs3 7#f7 ,payment only on an assignment-related basis ,payment for hearing aids for which payment may be made under this part may be made only on an assignment-related basis4 ,the provisions of section #ahdb7;b77#ah77;,b7 shall apply to hearing aids in the same manner as they apply to services furnished by a practitioner described in subsection 7b77#ah77;,c74 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 #bjbh-- 7,a7 not more than once per ear during a #e-year period2 7,b7 only for types of such hearing aids that are determined appropriate by the ,secretary2 and 7,c7 only if furnished pursuant to a written order of a physician1 qualified audiologist 7as defined in section #ahfa7ll77#d771 qualified hearing aid professional 7as so defined71 physician assistant1 nurse practitioner1 or clinical nurse specialist4 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;,h77 is amended-- 7i7 in the header1 by inserting and hearing aids after orthotics2 7ii7 in the matter preceding clause 7i71 by inserting 1 or of hearing aids described in paragraph 7#b77;,e7 of such section1 after #bjaa12 and 7iii7 in clause 7i71 by inserting or such hearing aids after such orthotics4 7,b7 ,conforming amendment 7i7 ,in general ,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,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#g77 is amended by adding at the end the following new subparagraph3 7,c7 ,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 qualified audiologists and qualified hearing aid professionals 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 is amended by adding at the end the following new clauses3 7ix7 ,beginning on ,january #a1 #bjbh1 a qualified audiologist 7as defined in section #ahfa7ll77#d77;,b774 7x7 ,a qualified hearing aid professional 7as defined in section #ahfa7ll77#d77;,c774 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 ,inclusion as excepted medical treatment ,section #ahba7;b77#e77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;i-#e7;b77#e77;,a77 is amended-- 7#a7 in clause 7ii71 by striking or2 7#b7 in clause 7iii71 by striking the period and inserting 1 or2 and 7#c7 by adding at the end the following new clause3 7iv7 consisting of audiology services described in subsection 7ll77#c7 of section #ahfa1 or hearing aids described in subsection 7s77#h7 of such section1 that are payable under part ,b as a result of the amendments made by the ,health ,,care ,act of #bjbf4 4 7e7 ,rural health clinics and ,federally qualified health centers 7#a7 ,clarifying coverage of audiology services as physicians' services ,section #ahfa7;aa77#a77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7aa77#a77;,a77 is amended by inserting 7including audiology services 7as defined in subsection 7ll77#c777 after physicians' services4 7#b7 ,inclusion of qualified audiologists and qualified hearing aid professionals as ,,rhc and ,,fqhc practitioners ,section #ahfa7;aa77#a77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7aa77#a77;,b77 is amended by inserting or by a qualified audiologist or a qualified hearing aid professional 7as such terms are defined in subsection 7ll771 after 7as defined in subsection 7hh77#a7714 7#c7 ,temporary payment rates for certain services under the ,,rhc ,,air and ,,fqhc ,,pps 7,a7 ,,air ,section #ahcc of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7 is amended-- 7i7 in subsection 7a77#c77;,a71 by inserting 7which shall1 in the case of audiology services 7as defined in section #ahfa7ll77#c771 in lieu of any limits on reasonable charges otherwise applicable1 be based on the rates payable for such services under the payment basis determined under section #ahdh until such time as the ,secretary determines sufficient data has been collected to otherwise apply such limits 7or ,january #a1 #bjcd1 if no such determination has been made as of such date77 after may prescribe in regulations2 and 7ii7 by adding at the end the following new subsection3 7ee7 ,disregard of costs attributable to certain services from calculation of ,,rhc ,,air ,payments for rural health clinic services other than audiology services 7as defined in section #ahfa7ll77#c77 under the methodology for all-inclusive rates 7established by the ,secretary7 under subsection 7a77#c7 shall not take into account the costs of such services while rates for such services are based on rates payable for such services under the payment basis established under section #ahdh4 4 7,b7 ,,pps ,section #ahcd7o7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7o77 is amended by adding at the end the following new paragraph3 7#f7 ,temporary payment rates based on ,,pfs for certain services ,the ,secretary shall1 in establishing payment rates for audiology services 7as defined in section #ahfa7ll77#c77 that are ,federally qualified health center services under the prospective payment system established under this subsection1 in lieu of the rates otherwise applicable under such system1 base such rates on rates payable for such services under the payment basis established under section #ahdh until such time as the ,secretary determines sufficient data has been collected to otherwise establish rates for such services under such system 7or ,january #a1 #bjcd1 if no such determination has been made as of such date74 ,payments for ,federally qualified health center services other than such audiology services under such system shall not take into account the costs of such services while rates for such services are based on rates payable for such services under the payment basis established under section #ahdh4 4 7f7 ,implementation 7#a7 ,in general ,in addition to amounts otherwise available1 there is appropriated to the ,secretary of ,health and ,human ,services for fiscal year #bjbg1 out of any money in the ,treasury not otherwise appropriated1 #cgj1jjj1jjj1 to remain available until expended1 for purposes of implementing the amendments made by this section during the period beginning on ,january #a1 #bjbg1 and ending on ,september #cj1 #bjcf4 7#b7 ,program instruction ,the ,secretary of ,health and ,human ,services shall implement the provisions of1 and the amendments made by1 this section for #bjbg and #bjbh by program instruction4 ,,vi ,lowering the cost of care #fja4 ,strengthening hospital price transparency ,title ,,xxvii of the ,public ,health ,service ,act is amended by inserting after section #bgah 7#db ,u4,s4,c4 #cjj;gg-#ah7 the following3 #bgah;,a4 ,provider price transparency 7a7 ,definitions ,in this section3 7#a7 ,applicable imaging service provider ,the term applicable imaging provider means a provider of services or supplier who furnishes any imaging services to patients1 including an independent diagnostic testing facility1 an outpatient diagnostic facility1 and any other imaging center designated by the ,secretary1 except that such term does not include an imaging service provider with respect to which standard charges for specified imaging service provider services furnished by such service provider are made available by a hospital pursuant to subsection 7b7 or specified ambulatory surgical center pursuant to subsection 7e74 7#b7 ,applicable laboratory ,the term applicable laboratory means a laboratory as such term is defined in section #dic4b1 of title #db1 ,code of ,federal ,regulations 7or a successor regulation71 except that such term does not include a laboratory with respect to which standard charges for specified clinical diagnostic laboratory tests furnished by such laboratory are made available by a hospital pursuant to subsection 7b7 or specified ambulatory surgical center pursuant to subsection 7e74 7#c7 ,discounted cash price 7,a7 ,in general ,the term discounted cash price means the minimum charge expressed as a dollar amount1 subject to subparagraph 7,b71 that the applicable service provider subject to this section accepts from an individual who pays cash1 or cash equivalent1 for a furnished item or service1 without regard to health insurance coverage1 as payment in full4 7,b7 ,exclusions ,for purposes of subparagraph 7,a71 the minimum charge described in such subparagraph1 with respect to a furnished item or service1 as applicable1 shall be calculated without taking into account any financial assistance1 including assistance attributable to charity care 7in the case of a hospital1 as such term is used for purposes of hospital cost reporting under title ,,xviii of the ,social ,security ,act71 or third-party assistance for such item or service4 7#d7 ,extraordinary collection actions ,the term extraordinary collection action has the meaning given such term for purposes of section #eja7r7 of the ,internal ,revenue ,code of #aihf4 7#e7 ,gross charge ,the term gross charge means the charge for an individual item or service that is reflected on a hospital's chargemaster or similar list of prices facilitated by any other provider1 as defined by the ,secretary1 absent any discounts4 7#f7 ,hospital ,the term hospital means an institution in any ,state in which ,state or applicable local law provides for the licensing of hospitals1 that is licensed as a hospital pursuant to such law or is approved1 by the agency of such ,state or locality responsible for licensing hospitals1 as meeting the standards established for such licensing4 ,for purposes of this paragraph1 the term ,state includes each of the several ,states1 the ,district of ,columbia1 ,puerto ,rico1 the ,virgin ,islands1 ,guam1 ,american ,samoa1 and the ,northern ,mariana ,islands4 7#g7 ,payer-specific negotiated charge ,the term payer-specific negotiated charge means the charge that a hospital has negotiated with a third-party payer for an item or service4 7#h7 ,shoppable service ,the term shoppable service means a service that can be scheduled by a healthcare consumer in advance4 ,such services are routinely provided in non-urgent situations that do not require immediate action or attention to the patient1 thus allowing patients to price shop and schedule a service at a time that is convenient for them4 7#i7 ,specified ambulatory surgical center ,the term specified ambulatory surgical center means any distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization and in which the expected duration of services would not exceed #bd hours following an admission1 except that such term does not include a surgical center with respect to which standard charges for specified ambulatory surgical center services furnished by such surgical center are made available by a hospital pursuant to subsection 7b74 7#aj7 ,specified clinical diagnostic laboratory test ,the term specified clinical diagnostic laboratory test means any clinical diagnostic laboratory test or service that is provided by the applicable laboratory1 excluding advanced diagnostic laboratory tests 7as defined in section #ahcd;,a7d77#e7 of the ,social ,security ,act74 7#aa7 ,specified imaging service ,the term specified imaging service has the meaning given to the term radiology and certain other imaging services for purposes of section #daa4cea of title #db1 ,code of ,federal ,regulations 7or successor regulations74 7#ab7 ,third party payer ,the term third party payer means an entity that is1 by statute1 contract1 or agreement1 legally responsible for payment of a claim for a health care item or service4 7b7 ,hospital price transparency 7#a7 ,in general ,beginning ,january #a of the year that begins on or after the date that is #a year after the date of enactment of the ,health ,,care ,act of #bjbf1 each hospital shall1 in accordance with a method and format established by the ,secretary under paragraph 7#c71 on a quarterly basis 7if there have been any changes to the standard charges described in subparagraph 7#b77 compile and make publicly available on an internet website 7without subscription and free of charge7-- 7,a7 all of the hospital's standard charges for each item and service furnished by such hospital in a machine-readable format 7or a successor technology specified by the ,secretary72 7,b7 all of the hospital's standard charges in a consumer-friendly format 7as specified by the ,secretary71 that includes-- 7i7 as many of the ,centers for ,medicare ,medicaid ,services-specified shoppable services that are furnished by the hospital1 and as many additional hospital-selected shoppable services 7or all such additional services1 if such hospital furnishes fewer than #cjj shoppable services7 as may be necessary for a combined total of at least #cjj shoppable services through the ,january #a described in this subparagraph1 after which the hospital shall include all shoppable services that the hospital furnishes2 and 7ii7 with respect to each ,centers for ,medicare ,medicaid ,services-specified shoppable service that is not furnished by the hospital1 an indication that such service is not so furnished2 and 7,c7 the name and business address for each person or entity that1 with respect to the hospital-- 7i7 has an ownership or investment interest2 7ii7 has a controlling interest2 7iii7 is a management services organization2 or 7iv7 is a significant equity investor4 7#b7 ,standard charges defined ,for purposes of paragraph 7#a71 the term standard charges means the following3 7,a7 ,a plain language description of each item and service1 accompanied by any applicable billing codes1 including modifiers1 using commonly recognized billing code sets1 including-- 7i7 the ,diagnosis ,related ,group2 7ii7 the ,healthcare ,common ,procedure ,coding ,system code2 7iii7 the ,national ,drug ,code2 and 7iv7 other applicable identifiers as determined by the ,secretary 7or successor code sets74 7,b7 ,the gross charge1 expressed as a dollar amount1 for each such item or service1 when provided in1 as applicable1 the inpatient setting and outpatient department setting4 7,c7 ,the discounted cash price4 7,d7 ,the payer-specific negotiated charges1 expressed as a dollar amount and clearly associated with the name of the applicable third-party payer and name of each plan1 that apply to each such item or service when provided in1 as applicable1 the inpatient setting and outpatient department setting4 ,if the charges are based on an algorithm1 percentage of another amount1 or other formula or criteria1 the hospital shall also disclose such algorithm1 percentage1 formula1 or criteria as set forth in its contract and any other information necessary to determine the negotiated charge as a dollar amount4 7,e7 ,the de-identified maximum and minimum negotiated charges for each such item or service1 expressed as a non-zero dollar amount4 7,f7 ,the amount of any facility fee1 as defined by the ,secretary1 or add-on charges that will be part of the final payment amount1 in addition to any information that might help the patient understand when a facility fee or add-on charge may apply and how to avoid such charges4 7,g7 ,any other additional information the ,secretary may require for the purpose of improving the accuracy of1 or enabling consumers to easily understand and compare1 standard charges for an item or service1 except information that is duplicative of any other reporting requirement under this subsection4 ,in the case of standard charges for an item or service included as part of a bundled1 per diem1 episodic1 or other similar arrangement1 the information described in this subparagraph shall be made available as determined appropriate by the ,secretary4 7#c7 ,uniform method and format ,the ,secretary shall establish a standard1 uniform method and format for hospitals to use in compiling and making public information described in paragraph 7#a74 ,such method and format shall-- 7,a7 include a machine-readable format 7or successor technology specified by the ,secretary7 containing the information described in paragraph 7#b7 for all items and services furnished by each hospital2 7,b7 meet such standards as determined appropriate by the ,secretary in order to ensure the accessibility and usability of such charges2 and 7,c7 be updated as determined appropriate by the ,secretary1 in consultation with stakeholders4 7#d7 ,no deemed compliance ,hospitals may offer a price estimator tool1 but the availability of such a price estimator tool shall not be considered to deem compliance with or otherwise vitiate the requirements of paragraph 7#a77;,b7 or any other requirements of this subsection4 7#e7 ,monitoring compliance ,the ,secretary shall1 in consultation with the ,inspector ,general of the ,department of ,health and ,human ,services1 establish a process to monitor compliance with this subsection4 ,such process shall ensure that each hospital's compliance with this subsection is reviewed not less frequently than once every year4 7#f7 ,attestation ,a senior official from each hospital 7the ,chief ,executive ,officer1 ,chief ,financial ,officer1 or an official of equivalent seniority7 shall attest to the accuracy and completeness of the disclosures1 and any other attestations as required by the ,secretary1 made in accordance with the hospital price transparency requirements based on criteria established by the ,secretary4 7#g7 ,enforcement 7,a7 ,in general ,in the case of a hospital that fails to comply with the requirements of this subsection1 not later than #cj days after the date on which the ,secretary determines such failure exists1 the ,secretary shall notify such hospital of such determination1 which shall include a request for a corrective action plan if applicable to comply with such requirements4 7,b7 ,civil monetary penalty 7i7 ,in general ,in addition to any other enforcement actions or penalties that may apply under another provision of law1 a hospital that has received a request for a corrective action plan under subparagraph 7,a7 and fails to comply with the requirements of this subsection by the date that is #ij days after such request is made shall be subject to a civil monetary penalty of an amount specified by the ,secretary for each day 7beginning on the day the hospital was first out of compliance1 as determined by the ,secretary7 during which such failure was ongoing4 ,such amount shall not exceed-- 7,i7 in the case of a specified hospital with #cj or fewer beds1 #cjj per day 7or1 in the case of such a hospital that has been noncompliant with such requirements for a #a-year period or longer1 beginning with the first day following such #a-year period1 #djj per day72 7,,ii7 in the case of a specified hospital with more than #cj beds but fewer than #aja beds1 #ab4ej per bed per day 7or1 in the case of such a hospital that has been noncompliant with such requirements for a #a-year period or longer1 beginning with the first day following such #a-year period1 #ae per bed per day72 7,,iii7 in the case of a specified hospital with more than #ajj beds but fewer than #bja beds1 #ag4ej per bed per day 7or1 in the case of such a hospital that has been noncompliant with such requirements for a #a-year period or longer1 beginning with the first day following such #a-year period1 #bj per bed per day72 7,,iv7 in the case of a specified hospital with more than #bjj beds but fewer than #eja beds1 #bj per bed per day 7or1 in the case of such a hospital that has been noncompliant with such requirements for a #a-year period or longer1 beginning with the first day following such #a-year period1 #be per bed per day72 and 7,v7 in the case of a specified hospital with more than #ejj beds1 #be per bed per day 7or1 in the case of such a hospital that has been noncompliant with such requirements for a #a-year period or longer1 beginning with the first day following such #a-year period1 #ce per bed per day74 7ii7 ,increase authority ,in applying this subparagraph with respect to hospitals that fail to comply in #bjbh or a subsequent year1 the ,secretary may through notice and comment rulemaking increase-- 7,i7 the limitation on the per day amount of any penalty applicable to a hospital under clause 7i77,i72 7,,ii7 the limitations on the per bed per day amount of any penalty applicable under any of subclauses 7,,ii7 through 7,v7 of clause 7i72 and 7,,iii7 the limitation on the increase of any penalty applied under clause 7iii7 pursuant to the amounts specified in subclause 7,,ii7 of such clause4 7iii7 ,persistent noncompliance 7,i7 ,in general ,in the case of a hospital that the ,secretary has determined to be noncompliant with the provisions of this subsection two or more times during a #a-year period 7as determined by the ,secretary71 the ,secretary may increase any penalty otherwise applicable under this subparagraph by the amount specified in subclause 7,,ii7 with respect to such hospital and may require such hospital to complete such additional corrective actions plans as the ,secretary may specify4 7,,ii7 ,specified amount ,for purposes of subclause 7,i71 the amount specified in this subclause is1 with respect to a hospital-- 7aa7 with more than #cj beds but fewer than #aja beds1 an amount that is not less than #ejj1jjj and not more than #a1jjj1jjj2 7bb7 with more than #ajj beds but fewer than #cja beds1 an amount that is greater than #a1jjj1jjj and not more than #b1jjj1jjj2 7cc7 with more than #cjj beds but fewer than #eja beds1 an amount that is greater than #b1jjj1jjj and not more than #d1jjj1jjj2 and 7dd7 with more than #ejj beds1 an amount that is not less than #e1jjj1jjj and not more than #aj1jjj1jjj4 7iv7 ,provision of technical assistance ,the ,secretary may1 to the extent practicable1 provide technical assistance relating to compliance with the provisions of this section to hospitals requesting such assistance4 7v7 ,application of certain provisions ,the provisions of section #aabh;,a of the ,social ,security ,act 7other than subsections 7a7 and 7b7 of such section7 shall apply to a civil monetary penalty imposed under this subparagraph in the same manner as such provisions apply to a civil monetary penalty imposed under subsection 7a7 of such section4 7,c7 ,no authority to waive or reduce penalty ,the ,secretary shall not grant or extend any waiver1 delay1 tolling1 or other mitigation of a civil monetary penalty for failing to comply with the requirements of this subsection except where the ,secretary determines that imposing the maximum civil monetary penalty1 including penalties for persistent noncompliance1 will disrupt hospital operations in a manner that impacts patient care4 ,the ,secretary may request documentation in such form and manner as the ,secretary may require in order to evaluate impact on hospital operations4 7,d7 ,prohibition on extraordinary collection ,in addition to civil monetary penalties applicable under subparagraph 7,b7 and any other enforcement actions or penalties that may apply under any other provision of law1 for a hospital that has received a request for a corrective action plan under subparagraph 7,a7 and fails to comply with the requirements of this subsection by the date that is #ij days after such request1 that hospital or any other person or entity collecting on behalf of the hospital shall-- 7i7 not take any extraordinary collection actions against any patient or patient guarantor for debt incurred by any patient on the date or dates of service when the hospital was not in compliance with the requirements of this subsection2 7ii7 cease any extraordinary collection actions that have begun against any patient or patient guarantor for debt incurred by any patient on the date or dates of service when the hospital was not in compliance with the requirements of this subsection2 and 7iii7 not take any extraordinary collection actions against any patient or patient guarantor for debt incurred by any patient on the date or dates of service when the hospital was not in compliance with the requirements of this subsection after the hospital comes back into compliance with the requirements of this subsection4 7#h7 ,rulemaking 7,a7 ,in general ,the ,secretary shall implement this subsection through notice and comment rulemaking in accordance with section #eec of title #e1 ,united ,states ,code4 7,b7 ,ownership information ,in promulgating regulations under this paragraph1 the ,secretary shall define the individuals and organizations that must be disclosed under paragraph 7#a77;,c7 in a manner that harmonizes disclosure requirements with requirements established under section #aabd of the ,social ,security ,act and prioritizes the disclosure of individuals and organizations whose ownership or management relationship with a hospital impacts operational1 financial1 or clinical decision making for such hospital4 4 #fjb4 ,clinical diagnostic laboratory price transparency ,section #bgah;,a of the ,public ,health ,service ,act1 as added by section #fja1 is amended by adding at the end the following3 7c7 ,clinical diagnostic laboratory price transparency 7#a7 ,in general ,beginning ,january #a of the year that begins on or after the date that is #a year after the date of enactment of the ,health ,,care ,act of #bjbf1 an applicable laboratory shall1 on a quarterly basis 7if there have been any changes to the standard charges described in paragraph 7#b77 compile and make publicly available on an internet website 7without subscription and free of charge7-- 7,a7 the standard charges described in paragraph 7#b7 with respect to each specified clinical diagnostic laboratory test that such laboratory so furnishes2 and 7,b7 the name and business address for each person or entity that1 with respect to the laboratory-- 7i7 has an ownership or investment interest2 7ii7 has a controlling interest2 7iii7 is a management services organization2 or 7iv7 is a significant equity investor4 7#b7 ,standard charges defined ,for purposes of paragraph 7#a71 the term standard charges means1 with respect to an applicable laboratory and a specified clinical diagnostic laboratory test1 the following3 7,a7 ,a plain language description of each item or service1 accompanied by any applicable billing codes 7including modifiers that materially change the price for insurers or providers1 and that materially change out-of-pocket costs for consumers7 using commonly recognized billing code sets1 including-- 7i7 the ,healthcare ,common ,procedure ,coding ,system code2 7ii7 the ,national ,drug ,code2 or 7iii7 other applicable identifier as determined by the ,secretary 7or successor code sets74 7,b7 ,the gross charge expressed as a dollar amount1 for each such test4 7,c7 ,the discounted cash price4 7,d7 ,the payer-specific negotiated charges1 expressed as a dollar amount and clearly associated with the name of the applicable third-party payer and name of each plan1 that apply to each such test4 ,if the charges are based on an algorithm1 percentage of another amount1 or other formula or criteria1 the applicable laboratory also shall disclose such algorithm1 percentage1 formula1 or criteria as set forth in its contract and any other information necessary to determine the negotiated charge as a dollar amount4 7,e7 ,the de-identified maximum and minimum negotiated charges for each such item or service1 expressed as a non-zero dollar amount4 7,f7 ,any other additional information the ,secretary may require for the purpose of improving the accuracy of1 or enabling consumers to easily understand and compare1 standard charges for an item or service1 except information that is duplicative of any other reporting requirement under this section4 ,in the case of standard charges for an item or service included as part of a bundled1 per diem1 episodic1 or other similar arrangement1 the information described in this subparagraph shall be made available as determined appropriate by the ,secretary4 7#c7 ,uniform method and format ,the ,secretary shall establish a standard1 uniform method and format for applicable laboratories to use in compiling and making public information pursuant to paragraph 7#a74 ,such method and format shall-- 7,a7 include a machine-readable format 7or a successor technology specified by the ,secretary7 containing the information described in paragraph 7#b7 for all specified clinical diagnostic laboratory tests furnished by each laboratory and the ownership information described in paragraph 7#a77;,b72 7,b7 meet such standards as determined appropriate by the ,secretary in order to ensure the accessibility and usability of such information2 and 7,c7 be updated as determined appropriate by the ,secretary1 in consultation with stakeholders4 7#d7 ,monitoring compliance ,the ,secretary shall1 in consultation with the ,inspector ,general of the ,department of ,health and ,human ,services1 establish a process to monitor compliance with this subsection4 ,such process shall ensure that each applicable laboratory's compliance with this subsection is reviewed not less frequently than once every year4 7#e7 ,inclusion of ancillary services ,any charge for a specified clinical diagnostic laboratory test furnished by an applicable laboratory made publicly available in accordance with paragraph 7#a7 shall include the charge for any ancillary item or service 7such as specimen collection services1 specimen transport1 centrifugation1 aliquoting1 labeling1 requisition processing1 and standard result reporting services7 that would customarily and routinely be furnished by such laboratory as part of such test1 as specified by the ,secretary4 7#f7 ,attestation ,a senior official from each clinical diagnostic laboratory 7the ,chief ,executive ,officer1 ,chief ,financial ,officer1 or an official of equivalent seniority7 shall attest to the accuracy and completeness of the disclosures1 and any other attestations as required by the ,secretary1 made in accordance with the clinical laboratory price transparency requirements based on criteria established by the ,secretary4 7#g7 ,enforcement 7,a7 ,in general ,in the case of an applicable laboratory that fails to comply with the requirements of this subsection-- 7i7 the ,secretary shall notify such laboratory of such failure not later than #cj days after the date on which the ,secretary determines such failure exists2 and 7ii7 upon request of the ,secretary1 such laboratory shall submit to the ,secretary1 not later than #de days after the date of such request1 a corrective action plan to comply with such requirements4 7,b7 ,civil monetary penalty 7i7 ,in general ,an applicable laboratory that has received a notification under subparagraph 7,a77i7 and fails to comply with the requirements of this subsection by the date that is #ij days after such notification 7or1 in the case of an applicable laboratory that has submitted a corrective action plan described in subparagraph 7,a77ii7 in response to a request so described1 by the date that is #ij days after such submission7 shall be subject to a civil monetary penalty of an amount specified by the ,secretary for each day 7beginning with the day on which the ,secretary first determined that such laboratory was not complying with such requirements7 during which such failure is ongoing 7not to exceed #cjj per day74 7ii7 ,increase authority ,in applying this subparagraph with respect to an applicable laboratory that fails to comply with the requirements of this subsection in #bjbh or a subsequent year1 the ,secretary may through notice and comment rulemaking increase the limitation on the per day amount of any penalty applicable to an applicable laboratory under clause 7i74 7iii7 ,application of certain provisions ,the provisions of section #aabh;,a of the ,social ,security ,act 7other than subsections 7a7 and 7b7 of such section7 shall apply to a civil monetary penalty imposed under this subparagraph in the same manner as such provisions apply to a civil monetary penalty imposed under subsection 7a7 of such section4 7iv7 ,no authority to waive or reduce penalty ,the ,secretary shall not grant or extend any waiver1 delay1 tolling1 or other mitigation of a civil monetary penalty for failing to comply with the requirements of this subsection except where the ,secretary determines that imposing the maximum civil monetary penalty will disrupt applicable laboratory operations in a manner that impacts patient care4 ,the ,secretary may request documentation in such form and manner as the ,secretary may require in order to evaluate impact on applicable laboratory operations4 7#h7 ,provision of technical assistance ,the ,secretary shall1 to the extent practicable1 provide technical assistance relating to compliance with the provisions of this subsection to applicable laboratories requesting such assistance4 7#i7 ,rulemaking 7,a7 ,in general ,the ,secretary shall implement this subsection through notice and comment rulemaking in accordance with section #eec of title #e1 ,united ,states ,code4 7,b7 ,ownership information ,in promulgating regulations under this paragraph1 the ,secretary shall define the individuals and organizations that must be disclosed under paragraph 7#a77;,b7 in a manner that harmonizes disclosure requirements with requirements established under section #aabd of the ,social ,security ,act and prioritizes the disclosure of individuals and organizations whose ownership or management relationship with a laboratory impacts operational1 financial1 or clinical decision making for such laboratory4 4 #fjc4 ,imaging services price transparency ,section #bgah;,a of the ,public ,health ,service ,act1 as amended by section #fjb1 is further amended by adding at the end the following3 7d7 ,imaging services price transparency 7#a7 ,in general ,beginning ,january #a of the year that begins on or after the date that is #a year after the date of enactment of the ,health ,,care ,act of #bjbf1 each applicable imaging service provider shall1 on a quarterly basis 7if there have been any changes to the standard charges described in paragraph 7#b77 compile and make publicly available on an internet website 7without subscription and free of charge7-- 7,a7 the standard charges described in paragraph 7#b7 with respect to each such specified imaging service provided by such provider2 and 7,b7 the name and business address for each person or entity that1 with respect to the imaging services provider-- 7i7 has an ownership or investment interest2 7ii7 has a controlling interest2 7iii7 is a management services organization2 or 7iv7 is a significant equity investor4 7#b7 ,standard charges defined ,for purposes of paragraph 7#a71 the term standard charges1 with respect to an applicable imaging service provider and a specified imaging service1 means the following3 7,a7 ,a plain language description of each item or service1 accompanied by any applicable billing codes 7including modifiers that materially change the price for insurers or providers1 and that materially change out-of-pocket costs for consumers7 using commonly recognized billing code sets1 including-- 7i7 the ,healthcare ,common ,procedure ,coding ,system code2 7ii7 the ,national ,drug ,code2 or 7iii7 other applicable identifier as determined by the ,secretary 7or successor code sets74 7,b7 ,the gross charge expressed as a dollar amount1 for each such item or service4 7,c7 ,the discounted cash price4 7,d7 ,the payer-specific negotiated charges1 expressed as a dollar amount and clearly associated with the name of the applicable third-party payer and name of each plan1 that apply to each such service4 ,if the charges are based on an algorithm1 percentage of another amount1 or other formula or criteria1 the provider or supplier also shall disclose such algorithm1 percentage1 formula1 or criteria as set forth in its contract and any other information necessary to determine the negotiated charge as a dollar amount4 7,e7 ,the de-identified maximum and minimum negotiated charges for each such item or service1 expressed as a non-zero dollar amount4 7,f7 ,any other additional information the ,secretary may require for the purpose of improving the accuracy of1 or enabling consumers to easily understand and compare1 standard charges and prices for an item or service1 except information that is duplicative of any other reporting requirement under this subsection4 ,in the case of standard charges for an item or service included as part of a bundled1 per diem1 episodic1 or other similar arrangement1 the information described in this subparagraph shall be made available as determined appropriate by the ,secretary4 7#c7 ,uniform method and format ,the ,secretary shall establish a standard1 uniform method and format for applicable imaging service providers to use in making public information described in paragraph 7#a74 ,any such method and format shall-- 7,a7 include a machine-readable format 7as specified by the ,secretary7 containing the information described in paragraph 7#b7 for all specified imaging services furnished by each applicable imaging service provider and ownership information described in paragraph 7#a77;,b72 7,b7 meet such standards as determined appropriate by the ,secretary in order to ensure the accessibility and usability of such information2 and 7,c7 be updated as determined appropriate by the ,secretary1 in consultation with stakeholders4 7#d7 ,monitoring compliance ,the ,secretary shall1 in consultation with the ,inspector ,general of the ,department of ,health and ,human ,services1 establish a process to monitor compliance with this subsection4 7#e7 ,attestation ,a senior official from each specified imaging service provider 7the ,chief ,executive ,officer1 ,chief ,financial ,officer1 or an official of equivalent seniority7 shall attest to the accuracy and completeness of the disclosures1 and any other attestations as required by the ,secretary1 made in accordance with the imaging service provider price transparency requirements based on criteria established by the ,secretary4 7#f7 ,enforcement 7,a7 ,in general ,in the case of a specified imaging service provider that fails to comply with the requirements of this subsection-- 7i7 the ,secretary shall notify such imaging service provider of such failure not later than #cj days after the date on which the ,secretary determines such failure exists2 and 7ii7 upon request of the ,secretary1 such imaging service provider shall submit to the ,secretary1 not later than #de days after the date of such request1 a corrective action plan to comply with such requirements4 7,b7 ,civil monetary penalty 7i7 ,in general ,a specified imaging service provider that has received a notification under subparagraph 7,a77i7 and fails to comply with the requirements of this subsection by the date that is #ij days after such notification 7or1 in the case of a specified imaging service provider that has submitted a corrective action plan described in subparagraph 7,a77ii7 in response to a request so described1 by the date that is #ij days after such submission7 shall be subject to a civil monetary penalty of an amount specified by the ,secretary for each day 7beginning with the day on which the ,secretary first determined that such imaging service provider was not complying with such requirements7 during which such failure is ongoing 7not to exceed #cjj per day74 7ii7 ,increase authority ,in applying this subparagraph with respect to a specified imaging service provider that fails to comply with the requirements of this subsection in #bjbh or a subsequent year1 the ,secretary may through notice and comment rulemaking increase the limitation on the per day amount of any penalty applicable to a specified imaging service provider under clause 7i74 7iii7 ,application of certain provisions ,the provisions of section #aabh;,a of the ,social ,security ,act 7other than subsections 7a7 and 7b7 of such section7 shall apply to a civil monetary penalty imposed under this subparagraph in the same manner as such provisions apply to a civil monetary penalty imposed under subsection 7a7 of such section4 7iv7 ,no authority to waive or reduce penalty ,the ,secretary shall not grant or extend any waiver1 delay1 tolling1 or other mitigation of a civil monetary penalty for failing to comply with the requirements of this subsection except where the ,secretary determines that imposing the maximum civil monetary penalty will disrupt specified imaging service provider operations in a manner that impacts patient care4 ,the ,secretary may request documentation in such form and manner as the ,secretary may require in order to evaluate impact on specified imaging service provider operations4 7#g7 ,provision of technical assistance ,the ,secretary shall1 to the extent practicable1 provide technical assistance relating to compliance with the provisions of this subsection to providers of services and suppliers requesting such assistance4 7#h7 ,rulemaking 7,a7 ,in general ,the ,secretary shall implement this subsection through notice and comment rulemaking in accordance with section #eec of title #e1 ,united ,states ,code4 7,b7 ,ownership information ,in promulgating regulations under this paragraph1 the ,secretary shall define the individuals and organizations that must be disclosed under paragraph 7#a77;,b7 in a manner that harmonizes disclosure requirements with requirements established under section #aabd of the ,social ,security ,act and prioritizes the disclosure of individuals and organizations whose ownership or management relationship with an imaging service provider impacts operational1 financial1 or clinical decision making for such imaging service provider4 4 #fjd4 ,ambulatory surgical center price transparency ,section #bgah;,a of the ,public ,health ,service ,act1 as amended by section #fjc1 is further amended by adding at the end the following3 7e7 ,ambulatory surgical center price transparency 7#a7 ,in general ,beginning ,january #a of the year that begins on or after the date that is #a year after the date of enactment of the ,health ,,care ,act of #bjbf1 each specified ambulatory surgical center shall1 on a quarterly basis 7if there have been any changes to the standard charges described in paragraph 7#b771 compile and make publicly available on an internet website 7without subscription and free of charge7-- 7,a7 the standard charges described in paragraph 7#b7 with respect to each specified service furnished by such surgical center2 and 7,b7 the name and business address for each person or entity that1 with respect to the ambulatory surgical center-- 7i7 has an ownership or investment interest2 7ii7 has a controlling interest2 7iii7 is a management services organization2 or 7iv7 is a significant equity investor4 7#b7 ,standard charges defined ,for purposes of paragraph 7#a71 the term standard charges with respect to standard charges and prices made public by a specified ambulatory surgical center means the following3 7,a7 ,a plain language description of each item or service1 accompanied by any applicable billing codes 7including modifiers that materially change the price for insurers or providers1 and that materially change out-of-pocket costs for consumers7 using commonly recognized billing code sets1 including-- 7i7 the ,healthcare ,common ,procedure ,coding ,system code2 7ii7 the ,national ,drug ,code2 or 7iii7 other applicable identifier as determined by the ,secretary 7or successor code sets74 7,b7 ,the gross charge1 expressed as a dollar amount1 for each such item or service4 7,c7 ,the discounted cash price4 7,d7 ,the payer-specific negotiated charges1 expressed as a dollar amount and clearly associated with the name of the applicable third party payer and name of each plan1 that apply to each such item or service4 ,if the charges are based on an algorithm1 percentage of another amount1 or other formula or criteria1 the ambulatory surgical center also shall disclose such algorithm1 percentage1 formula1 or criteria as set forth in its contract and any other information necessary to determine the negotiated charge as a dollar amount4 7,e7 ,the de-identified maximum and minimum negotiated charges for each such item or service1 expressed as a non-zero dollar amount4 7,f7 ,any other additional information the ,secretary may require for the purpose of improving the accuracy of1 or enabling consumers to easily understand and compare1 standard charges and prices for an item or service4 ,in the case of standard charges for an item or service included as part of a bundled1 per diem1 episodic1 or other similar arrangement1 the information described in this subparagraph shall be made available as determined appropriate by the ,secretary4 7#c7 ,uniform method and format ,the ,secretary shall establish a standard1 uniform method and format for specified ambulatory surgical centers to use in compiling and making public information pursuant to paragraph 7#a74 ,such method and format shall-- 7,a7 include a machine-readable format 7or a successor technology specified by the ,secretary7 containing the information described in paragraph 7#b7 for all specified services furnished by each ambulatory surgical center and for the ownership information described in paragraph 7#a77;,b72 7,b7 meet such standards as determined appropriate by the ,secretary in order to ensure the accessibility and usability of such charges2 and 7,c7 be updated as determined appropriate by the ,secretary1 in consultation with stakeholders4 7#d7 ,monitoring compliance ,the ,secretary shall1 in consultation with the ,inspector ,general of the ,department of ,health and ,human ,services1 establish a process to monitor compliance with this subsection4 ,such process shall ensure that each specified ambulatory surgical center's compliance with this subsection is reviewed not less frequently than once every year4 7#e7 ,attestation ,a senior official from each specified ambulatory surgical center 7the ,chief ,executive ,officer1 ,chief ,financial ,officer1 or an official of equivalent seniority7 shall attest to the accuracy and completeness of the disclosures1 and any other attestations as required by the ,secretary1 made in accordance with the ambulatory center price transparency requirements based on criteria established by the ,secretary4 7#f7 ,enforcement 7,a7 ,in general ,in the case of a specified ambulatory surgical center that fails to comply with the requirements of this subsection-- 7i7 the ,secretary shall notify such ambulatory surgical center of such failure not later than #cj days after the date on which the ,secretary determines such failure exists2 and 7ii7 upon request of the ,secretary1 such ambulatory surgical center shall submit to the ,secretary1 not later than #de days after the date of such request1 a corrective action plan to comply with such requirements4 7,b7 ,civil monetary penalty 7i7 ,in general ,a specified ambulatory surgical center that has received a notification under subparagraph 7,a77i7 and fails to comply with the requirements of this subsection by the date that is #ij days after such notification 7or1 in the case of a specified ambulatory surgical center that has submitted a corrective action plan described in subparagraph 7,a77ii7 in response to a request so described1 by the date that is #ij days after such submission7 shall be subject to a civil monetary penalty of an amount specified by the ,secretary for each day 7beginning with the day on which the ,secretary first determined that such ambulatory surgical center was not complying with such requirements7 during which such failure is ongoing 7not to exceed #cjj per day74 7ii7 ,increase authority ,in applying this subparagraph with respect to a specified ambulatory surgical center that fails to comply with the requirements of this subsection in #bjbh or a subsequent year1 the ,secretary may through notice and comment rulemaking increase the limitation on the per day amount of any penalty applicable to a specified ambulatory surgical center under clause 7i74 7iii7 ,application of certain provisions ,the provisions of section #aabh;,a of the ,social ,security ,act 7other than subsections 7a7 and 7b7 of such section7 shall apply to a civil monetary penalty imposed under this subparagraph in the same manner as such provisions apply to a civil monetary penalty imposed under subsection 7a7 of such section4 7iv7 ,no authority to waive or reduce penalty ,the ,secretary shall not grant or extend any waiver1 delay1 tolling1 or other mitigation of a civil monetary penalty for failing to comply with the requirements of this subsection except where the ,secretary determines that imposing the maximum civil monetary penalty will disrupt specified ambulatory surgical center operations in a manner that impacts patient care4 ,the ,secretary may request documentation in such form and manner as the ,secretary may require in order to evaluate impact on specified ambulatory surgical center operations4 7#g7 ,provision of technical assistance ,the ,secretary shall1 to the extent practicable1 provide technical assistance relating to compliance with the provisions of this subsection to specified ambulatory surgical centers requesting such assistance4 7#h7 ,rulemaking 7,a7 ,in general ,the ,secretary shall implement this subsection through notice and comment rulemaking in accordance with section #eec of title #e1 ,united ,states ,code4 7,b7 ,ownership information ,in promulgating regulations under this paragraph1 the ,secretary shall define the individuals and organizations that must be disclosed under paragraph 7#a77;,b7 in a manner that harmonizes disclosure requirements with requirements established under section #aabd of the ,social ,security ,act and prioritizes the disclosure of individuals and organizations whose ownership or management relationship with an ambulatory surgical center impacts operational1 financial1 or clinical decision making for such ambulatory surgical center4 7f7 ,continued applicability of ,state law ,the provisions of this section shall not supersede any provision of ,state law that establishes1 implements1 or continues in effect any requirement or prohibition related to health care price transparency1 except to the extent that such requirement or prohibition prevents the application of a requirement or prohibition of this section4 4 #fje4 ,strengthening health coverage transparency requirements 7a7 ,transparency in coverage ,section #bgae;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ae;a7 is amended-- 7#a7 by striking ,a ,group health and inserting the following3 7a7 ,in general ,a group health 2 and 7#b7 by adding at the end the following3 7b7 ,additional transparency requirements 7#a7 ,specified information required 7,a7 ,in general ,a group health plan or health insurance issuer offering coverage in the individual or group market shall provide to each participant1 beneficiary1 or enrollee1 at the time of enrollment in the plan or coverage1 the information described in subparagraph 7,b74 7,b7 ,information required ,for purposes of subparagraph 7,a71 the information specified in this subparagraph is1 with respect to benefits available under the plan or coverage for an item or service furnished by a health care provider1 the following 7or other information as determined appropriate by the ,secretary73 7i7 ,if such provider is an in-network provider with respect to such item or service1 the in-network rate 7as defined in paragraph 7#e77 for such item or service4 7ii7 ,if such provider is not described in clause 7i71 the out-of-network allowed amount 7as such term is defined for purposes of section #adg4baj7;a77#b77xvii7 of title #de1 ,code of ,federal ,regulations7 for such item or service that the plan or coverage will pay without regard to the amount in clause 7iii74 7iii7 ,the amount of cost-sharing liability 7including deductibles1 copayments1 and coinsurance7 that the individual will incur for such item or service based on the information available to the plan or coverage at the time the request is made 7which1 in the case such item or service is to be furnished by a provider described in clause 7ii71 shall be calculated using the maximum amount described in such clause74 7iv7 ,the accumulated amounts with respect to any deductible or out-of-pocket maximum under the plan or coverage reflected in the plan's or coverage's records at the time the request is made 7broken down1 in the case separate deductibles or maximums apply to separate individuals enrolled in the plan or coverage1 by such separate deductibles or maximums1 in addition to any cumulative deductible or maximum74 7v7 ,in the case such plan or coverage imposes any frequency or volume limitations with respect to such item or service 7excluding medical necessity determinations71 the amount that such individual has accrued towards such limitation with respect to such item or service reflected in the plan's or coverage's records at the time the request is made4 7vi7 ,information about any utilization management requirements1 such as prior authorization1 concurrent review1 step therapy1 fail first1 or similar requirements applicable to coverage of such item or service under such plan or coverage1 including information regarding utilization management practices and determinations1 including aggregate information related to approval and denial rates1 associated timelines1 and appeals1 as determined appropriate by the ,secretary4 7,c7 ,self-service tool ,for purposes of subparagraph 7,a71 a self-service tool established by a health plan meets the requirements of this subparagraph if such tool-- 7i7 is based on an internet website2 7ii7 provides for real-time responses to requests described in such subparagraph2 7iii7 is updated in a manner such that the information is accurate based on the information available to the plan or coverage at the time the request is made2 7iv7 allows such a request to be made for information with respect to an item or service furnished by-- 7,i7 a specific provider that is an in-network provider with respect to such item or service2 or 7,,ii7 all providers that are in-network providers with respect to such plan or coverage and such item or service2 7v7 provides that such a request may be made for information with respect to an item or service through use of-- 7,i7 the billing code for such item or service2 or 7,,ii7 through use of a descriptive term for such item or service2 and 7vi7 is made available in plain language1 without subscription or other fee4 7,d7 ,nonduplication ,a group health plan or health insurance issuers shall be deemed to be in compliance with this paragraph if such plan or issuer has a tool in place under section #bgii;,a-#d4 7#b7 ,rate and payment information 7,a7 ,in general ,beginning ,january #a of the year that begins on or after the date that is #a year after the date of enactment of the ,health ,,care ,act of #bjbf1 and every quarter thereafter 7if there have been any changes to the rate and payment information described in subparagraphs 7,b7 and 7,c71 each group health plan or health insurance issuer offering coverage in the group or individual market shall make available to the public1 the rate and payment information described in subparagraph 7,b7 in accordance with subparagraph 7,c774 7,b7 ,rate and payment information described ,for purposes of subparagraph 7,a71 the rate and payment information described in this subparagraph is1 with respect to a plan or coverage1 the following3 7i7 ,with respect to each item or service for which benefits are available under such plan or coverage1 excluding those included in clause 7ii71 identified by ,,cpt1 ,,hcpcs1 ,,drg1 or other applicable nationally recognized identifier1 including any applicable code modifiers1 and accompanied by a plain language description of the item or service1 the in-network rate 7expressed as a dollar amount or percentage of charges1 unless otherwise specified by the ,secretary71 including the individual and total amounts for any bundled rates1 in effect as of the date of the submission of such information with each provider 7identified by national provider identifier7 that is an in-network provider with respect to such item or service1 other than such a rate in effect with a provider that an issuer has determined based on factors determined by the ,secretary 7such as medical specialty7 that it is unlikely that the provider would be reimbursed for the item or service4 7ii7 ,with respect to each drug and biologic 7identified by ,national ,drug ,code1 ,j-code1 or other commonly recognized billing code used for drugs7 for which benefits are available under such plan or coverage1 the in-network rate 7expressed as a dollar amount or percentage of charges1 unless otherwise specified by the ,secretary7 in effect as of the first day of the quarter in which such information is made public with each pharmacy or other prescription drug dispenser that is an in-network pharmacy or other prescription drug dispenser with respect to such drug4 7iii7 ,with respect to each item or service for which benefits are available under such plan or coverage 7expressed as a dollar amount71 identified by ,,cpt1 ,,drg1 ,,hcpcs1 or other applicable nationally recognized identifier1 including any applicable code modifiers1 and accompanied by a brief description of the item or service1 the amount billed or charged by the provider1 and the amount allowed by the plan or coverage1 for each such item or service furnished during a representative lookback window established by the ,secretary by each provider that was an out-of-network provider with respect to such item or service1 broken down by each such provider 7identified by national provider identifier71 other than items and services with respect to which not fewer than #aa claims for such item or service were submitted to such plan during such period4 7,c7 ,manner of submission ,rate and payment information required to be submitted and made available under this paragraph shall be so submitted and so made available as follows3 7i7 ,information shall be contained in at least #c separate machine-readable files corresponding to the information described in each of clauses 7i7 through 7iii7 of subparagraph 7,b7 that meet such requirements as specified by the ,secretary through rulemaking1 in consultation with the ,secretaries of ,labor and the ,treasury1 to apply comparable requirements to group health plans and health insurance coverage and to entities providing benefit management or other third-party administration services on a contractual basis with a group health plan or coverage4 7ii7 ,requirements specified by the ,secretary through rulemaking 7or subregulatory guidance7 shall ensure the following3 7,i7 ,such files are made available in a widely available format that allows for information contained in such files to be compared across plans and coverage and are freely accessible to individuals at no cost and without the need to establish a user account or provide other credentials4 7,,ii7 ,each such file includes each of the following data elements3 7aa7 ,a numerical identifier for the group health plan or health insurance issuer 7such as a ,health ,insurance ,oversight ,system identifier74 7bb7 ,a plain-language description of the item or service 7including1 for drugs1 the proprietary and nonproprietary name assigned74 7cc7 ,the billing code1 including any applicable modifiers1 associated with such item or service1 including the ,healthcare ,common ,procedure ,coding ,system code1 diagnosis-related group1 national drug code1 or other commonly recognized code set4 7dd7 ,the place of service code4 7ee7 ,the ,national ,provider ,identifier and provider ,tax ,identification ,number4 7iii7 ,the rate and payment information disclosed under clauses 7i7 through 7iii7 of subparagraph 7,b7 shall be separately delineated for each item or service1 regardless of whether such item or service is reimbursed as a part of a bundle1 episode1 or other grouping of items and services4 7iv7 ,an officer or executive of competent authority shall attest to the accuracy and completeness of information submitted and made available under this subparagraph4 ,in the case of a plan or coverage that relies on a third-party administrator or other service provider to compile the information submitted and made available under this subparagraph1 such plan or coverage may satisfy the requirement under this clause by obtaining such an attestation from the third-party administrator or other service provider4 ,such attestation shall be subject to enforcement under paragraph 7#f74 7#c7 ,ownership information ,beginning ,january #a of the year that begins on or after the date that is #a year after the date of enactment of the ,health ,,care ,act of #bjbf1 and every quarter thereafter 7if there have been any changes in the required information71 each group health plan or health insurance issuer offering coverage in the individual or group market shall submit to the ,secretary1 the applicable ,state authority1 and make available to the public1 the name and business address of each person or entity that1 with respect to such plan or coverage-- 7,a7 has an ownership or investment interest2 7,b7 has a controlling interest2 7,c7 is a management services organization2 or 7,d7 is a significant equity investor4 7#d7 ,enforcement 7,a7 ,in general ,each year1 the ,secretary shall audit the machine-readable files required by paragraph 7#b77;,b7 posted by not fewer than #ej group health plans or health insurance issuers for compliance with format and accessibility standards4 7,b7 ,notification and request for corrective action ,in the case of a group health plan or health insurance issuer that fails to comply with the requirements of this paragraph1 not later than #cj days after the date on which the ,secretary determines such failure exists1 the ,secretary shall submit to such plan or issuer a notification of such determination1 which shall include a request for a corrective action plan to comply with such requirements4 7,c7 ,civil monetary penalty ,a plan or issuer that has received a request for a corrective action plan under subparagraph 7,b7 and fails to comply with the requirements of this paragraph by the date that is #cj days after such request is made shall be subject to a civil monetary penalty of an amount specified by the ,secretary for each day 7beginning with the day on which such health plan or health insurance issuer was failing to comply with such paragraph7 during which such failure was ongoing4 ,such amount shall not exceed #cjj per participant1 beneficiary1 or covered individual per day or #aj1jjj1jjj1 whichever is lesser4 7#e7 ,definitions ,in this subsection3 7,a7 ,in-network provider ,the term in-network provider has the meaning given such term in section #ed4ihae-bgae;,a#a7;a77#b77xii7 of title #bf1 ,code of ,federal ,regulations4 7,b7 ,in-network rate ,the term in-network rate means1 with respect to a health plan and an item or service furnished by a provider that is a participating provider with respect to such plan and item or service1 the contracted rate in effect between such plan and such provider for such item or service4 ,if the rate is based on an algorithm1 percentage of another amount1 or other formula or criteria1 the health plan also shall disclose such algorithm1 percentage1 formula1 or criteria as set forth in its contract and any other terms1 schedules1 exhibits1 data1 or other information referenced in any such contract as shall be required to determine and disclose the negotiated rate4 7#f7 ,rulemaking 7,a7 ,in general ,the ,secretary shall implement this subsection through notice and comment rulemaking in accordance with section #eec of title #e1 ,united ,states ,code4 ,the ,secretary may implement the manner of submission of data described in paragraph 7#b77;,c7 through subregulatory guidance4 7,b7 ,regulations ,regulations promulgated pursuant to this subsection shall provide the following3 7i7 ,the ,secretary shall annually audit the machine-readable files required by paragraph 7#b77;,b7 posted by not fewer than #ej group health plans or health insurance issuers for compliance with format and accessibility standards4 7ii7 ,the ,secretary of ,labor shall annually audit the machine-readable files required by paragraph 7#b77;,b7 posted by not fewer than #bej group health plans or service providers furnishing third-party administrator services to a group health plan for compliance with format and accessibility standards4 7iii7 ,the ,secretary of ,health and ,human ,services1 in conjunction with the ,secretary of ,labor and the ,secretary of the ,treasury1 shall annually issue a report to ,congress that includes findings1 conclusions1 and enforcement actions taken based on audits of the machine-readable files4 ,such report shall be provided no later than ,july #a following the calendar year during which the audits were completed4 ,the ,secretary of ,health and ,human ,services shall make such report to ,congress accessible to the public4 4 7b7 ,effective date 7#a7 ,in general ,the amendments made by subsections 7a7 and 7b7 shall apply beginning ,january #a of the year that begins on or after the date that is #a year after the date of enactment of the ,health ,,care ,act of #bjbf4 7#b7 ,continued applicability of rules for previous years ,nothing in the amendments made by this section may be construed as affecting the applicability of the rule entitled ,transparency in ,coverage published by the ,department of the ,treasury1 the ,department of ,labor1 and the ,department of ,health and ,human ,services on ,november #ab1 #bjbj 7#he ,fed4 ,reg4 #gbaeh71 or amendments made to such rule that are applicable before the date of enactment of the ,health ,,care ,act of #bjbf4 #fjf4 ,increasing group health plan access to health data 7a7 ,group health plan access to information 7#a7 ,in general ,section #bgii;,a-#i of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aai7 is amended by adding at the end the following3 7#a7 ,group ,health ,plan ,access to ,information 7,a7 ,in general ,no contract or arrangement for services1 and no extension or renewal of such contract or arrangement1 between a group health plan that is offered by a specified large employer or that is a specified large plan 7as such terms are defined in subparagraph 7,f77 and a health care provider 7which for purposes of this subparagraph1 includes a health care facility71 network or association of providers1 service provider offering access to a network of providers1 third-party administrator1 health insurance issuer offering group or individual health insurance coverage1 or pharmacy benefit manager1 or any entity acting as an intermediary between the group health plan and the health care provider1 network association of providers1 service provider offering access to a network or association of providers 7including a licensed health insurance issuer or third-party administrator71 or pharmacy benefit manager 7collectively referred to in this subsection as ,covered ,service ,providers71 is reasonable within the meaning of this subsection unless such contract or arrangement-- 7i7 allows the responsible plan fiduciary 7as that term is defined in section #djh7;b77#b77;,b77ii77,i77ee77 access to all claims and encounter information or data1 and any documentation supporting claim payments1 including1 but not limited to1 medical records and policy documents1 or information or data described in subsection 7a77#a77;,b7 to-- 7,i7 comply with applicable law2 and 7,,ii7 determine the accuracy or reasonableness of claims payment2 and 7ii7 does not-- 7,i7 unreasonably limit or delay access1 as determined by the ,secretary but in any event not longer than #ae days1 after a request for access by a plan fiduciary to such information or data2 7,,ii7 limit the volume of claims and encounter information or data that the group health plan1 the plan sponsor1 the plan administrator1 or a business associate of such plan may access during an audit or pursuant to any request for such information or data2 7,,iii7 limit the disclosure of pricing terms for value-based payment arrangements or capitated payment arrangements1 including-- 7aa7 payment calculations and formulas2 7bb7 quality measures2 7cc7 contract terms2 7dd7 payment amounts2 7ee7 measurement periods for all incentives2 and 7ff7 other payment methodologies used by an entity1 including a health care provider 7including a health care facility71 network or association of providers1 service provider offering access to a network of providers1 third-party administrator1 or pharmacy benefit manager2 7,,iv7 limit the disclosure of overpayments and overpayment recovery terms2 7,v7 limit the right of the group health plan1 the plan sponsor1 or the plan administrator of such plan to select an auditor or define audit scope or frequency2 7,,vi7 otherwise limit or unduly delay the group health plan1 the plan sponsor1 the plan administrator1 or a business associate of such plan from accessing claims and encounter information or data2 7,,vii7 limit the disclosure of fees charged to the group health plan related to plan administration and claims processing1 including renegotiation fees1 access fees1 repricing fees1 or enhanced review fees2 7,,viii7 limit the right of the group health plan1 the plan sponsor1 or the plan administrator to request action on any suspect claim payments2 7,,ix7 limit public disclosure of de-identified or aggregate information2 7,x7 limit the disclosure of1 with respect to a provider that files claims under such plan1 whether a ,covered ,service ,provider-- 7aa7 has an ownership or investment interest2 7bb7 has a controlling interest2 7cc7 is a management services organization2 or 7dd7 is a significant equity investor2 or 7,,xi7 limit the disclosure of the name and address of each person or entity that1 with respect to the health plan service provider-- 7aa7 has an ownership or investment interest2 7bb7 has a controlling interest2 or 7cc7 is a significant equity investor4 7,b7 ,manner of providing information or data 7i7 ,in general ,a ,covered ,service ,provider shall provide information or data under this subsection in a manner consistent with the privacy regulations promulgated under section #acdjb7;a7 of the ,health ,information ,technology for ,economic and ,clinical ,health ,act 7#db ,u4,s4,c4 #agicb7;a77 and consistent with the privacy regulations promulgated under the ,health ,insurance ,portability and ,accountability ,act of #aiif in part #afj and subparts ,a and ,e of part #afd of title #de1 ,code of ,federal ,regulations 7or successor regulations7 7referred to in this paragraph as the ,,hipaa privacy regulations7 and shall restrict the use and disclosure of such information according to such privacy regulations and such ,,hipaa privacy regulations4 ,a ,covered ,service ,provider shall not be required to disclose information or data under this subsection that could reasonably identify a participant or beneficiary through individually identifiable health information 7as such term is defined under ,,hipaa privacy regulations74 7ii7 ,additional requirements ,in carrying out this subsection1 a ,covered ,service ,provider shall comply with section #afd4ejd7;f7 of title #de1 ,code of ,federal ,regulations 7or a successor regulation74 7iii7 ,rule of construction 7,i7 ,in general ,nothing in this subsection shall be construed to modify the requirements for the creation1 receipt1 maintenance1 or transmission of protected health information under the ,,hipaa privacy regulations4 7,,ii7 ,civil rights laws ,nothing in this subsection shall be construed to affect the application of any ,federal or ,state privacy or civil rights law1 including the ,,hipaa privacy regulations1 the ,genetic ,information ,nondiscrimination ,act of #bjjh 7,public ,law #aaj-bcc7 7including the amendments made by such ,act71 the ,americans with ,disabilities ,act of #aiij 7#db ,u4,s4,c4 #abaja et seq471 section #ejd of the ,rehabilitation ,act of #aigc 7#bi ,u4,s4,c4 #gid71 section #aeeg of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahaaf71 title ,,vi of the ,civil ,rights ,act of #aifd 7#db ,u4,s4,c4 #bjjj;d71 and title ,,vii of the ,civil ,rights ,act of #aifd 7#db ,u4,s4,c4 #bjjj;e74 7iv7 ,written notice ,each plan year1 a ,covered ,service ,provider shall provide to each participant or beneficiary written notice informing the participant or beneficiary of the requirement that ,covered ,service ,providers respond to requests to submit information or data under paragraph 7#a71 as applicable1 which may include incorporating such notification in plan documents provided to the participant or beneficiary1 or providing individual notification4 7v7 ,clarification regarding public disclosure of information ,nothing in this subsection shall prevent a ,covered ,service ,provider from placing reasonable restrictions on the public disclosure of the information or data described in paragraph 7#a71 except that such ,provider may not restrict disclosure of such report to the ,department of ,health and ,human ,services1 the ,department of ,labor1 or the ,department of the ,treasury4 7vi7 ,limitation ,this paragraph shall not be construed to abridge or limit the disclosure requirements under this subsection or to impose additional privacy or security requirements on ,covered ,service ,providers or plan sponsors4 7,c7 ,limitation on disclosure ,a group health plan receiving information or data under this subsection may disclose such information only in a manner that is consistent with ,,hipaa and the privacy and security regulations promulgated thereunder1 regardless of their direct or indirect applicability to the plan or any entities that could be or are business associates4 ,a group health plan 7and any business associate or other entity acting on behalf of such plan7 may use such information or data only for purposes of plan administration and may not sell1 license1 or otherwise commercially exploit such information or data or provide such information or data to any third party that may take such action4 7,d7 ,requirements of information ,information made available under this subsection shall conform to the following standards3 7i7 ,all claims from a healthcare provider shall be made to the group health plan in accordance with transaction standards adopted by regulation under ,,hipaa1 as follows3 7,i7 ,institutional1 professional1 and dental claims shall be in ,,asc ,x#ab,n #hcg;,d format or any subsequent standard as established by the ,secretary4 7,,ii7 ,pharmacy claims shall be in the ,national ,council for ,prescription ,drug ,programs 7,,ncpdp7 format or any subsequent standard as established by the ,secretary4 7,,iii7 ,the files shall be unmodified copies of the files sent from the provider1 or1 upon request1 delivered in a machine readable format4 ,in the event that paper claims are sent by the provider1 they shall be converted to the appropriate standard electronic format4 ,files shall be accessible to the plan at no cost to the group health plan4 7ii7 ,all claim payment 7or ,,eft1 electronic funds transfer7 and electronic remittance advice 7,,era7 notices sent by a ,covered ,service ,provider shall be made available to the group health plan as ,,asc ,x#ab,n #hce files 7or any other format as identified by the ,secretary7 in accordance with standards adopted by regulation under ,,hipaa4 ,the files shall be unmodified copies of the files sent by the ,covered ,service ,provider to the healthcare provider4 ,files shall be accessible at no cost to the group health plan4 7iii7 ,the contractual terms containing payment calculations and formulas1 pricing methodologies1 and other information used to determine the dollar value of reimbursement1 in a format as specified by the ,secretary4 7iv7 ,all non-claim costs shall be itemized and made available to the group health plan as requested through a web-based portal1 through an application program interface 7,,api71 through a downloadable ,comma-,separated ,value 7,,csv7 file1 and1 as appropriate1 through other downloadable machine-readable file types4 7,e7 ,implementation ,the ,secretary shall implement this subsection through notice and comment rulemaking in accordance with section #eec of title #e1 ,united ,states ,code4 7,f7 ,definitions 7i7 ,in general ,the provisions of sections #djh and #daj of the ,employee ,retirement ,income ,security ,act of #aigd shall apply with respect to terms used under this subsection4 7ii7 ,specified large employer ,in this subsection1 the term specified large employer means1 in connection with a group health plan 7including group health insurance coverage offered in connection with such a plan7 established or maintained by a single employer1 with respect to a calendar year or a plan year1 as applicable1 an employer who employed an average of at least #ej employees on business days during the preceding calendar year or plan year and who employs at least #a employee on the first day of the calendar year or plan year4 7iii7 ,specified large plan ,in this subsection1 the term specified large plan means a group health plan 7including group health insurance coverage offered in connection with such a plan7 established or maintained by a plan sponsor described in clause 7ii7 or 7iii7 of section #c7af77;,b7 of the ,employee ,retirement ,income ,security ,act of #aigd that had an average of at least #ej participants on business days during the preceding calendar year or plan year1 as applicable4 4 7#b7 ,civil enforcement 7,a7 ,civil enforcement ,subsection 7c7 of section #ejb of such ,act 7#bi ,u4,s4,c4 #aacb7 is amended by adding at the end the following new paragraph3 7#ac7 7,a7 ,in the case of an agreement between a group health plan 7as defined in section #gcc7;a771 the plan sponsor of such plan 7as defined in section #c7af77;,b771 or the plan administrator of such plan 7as defined in section #c7af77;,a77 and a health care provider 7which1 for purposes of this paragraph1 includes a health care facility71 network or association of providers1 service provider offering access to a network or association of providers1 third-party administrator1 or pharmacy benefit manager1 that violates the provisions of section #gbd7;b71 the ,secretary may assess a civil penalty against such provider1 network or association1 service provider offering access to a network or association of providers1 third-party administrator1 pharmacy benefit manager1 or other service provider in the amount of up to #aj1jjj for each day during which such violation continues4 ,such penalty shall be in addition to other penalties as may be prescribed by law4 7,b7 ,nothing in subparagraph 7,a7 shall be construed to permit the ,secretary to regulate health care providers acting in their capacity as medical organizations furnishing items and services to patients4 4 7,b7 ,existing provisions void ,section #daj of such ,act 7#bi ,u4,s4,c4 #aaaj7 is amended by adding at the end the following3 7c7 ,any provision in an agreement or instrument shall be void as against public policy if such provision-- 7#a7 unduly delays or limits a group health plan 7as defined in section #gcc7;a771 the plan sponsor of such plan 7as defined in section #c7af77;,b771 or the plan administrator of such plan 7as defined in section #c7af77;,a77 from accessing the claims and encounter information or data described in section #gbd7;b77#a77;,b72 or 7#b7 violates the requirements of section #djh7;b77#b77;,c74 4 7,c7 ,technical amendments ,section #djh7;b77#b77;,b7 of such ,act 7#bi ,u4,s4,c4 #aajh7;b77#b77 is amended-- 7i7 in clause 7i71 by striking this clause and inserting this paragraph2 and 7ii7 by adding at the end the following3 7xi7 ,a contract or arrangement shall not be reasonable under this subparagraph if it fails to comply with section #gbd7;b74 4 7b7 ,updated attestation for price and quality information ,section #bgii;,a-#i7;a77#d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aai7;a77#d77 is amended to read as follows3 7#d7 ,attestation 7,a7 ,in general ,subject to subparagraph 7,c71 a group health plan or health insurance issuer offering group health insurance coverage shall annually submit to the ,secretary an attestation that such plan or issuer of such coverage is in compliance with the requirements of this subsection4 ,such attestation shall also include a statement verifying that-- 7i7 the information or data described under subparagraphs 7,a7 and 7,b7 of paragraph 7#a7 is available upon request and provided to the group health plan1 the plan sponsor1 the plan administrator1 or the business associate of such plan1 or the issuer1 as applicable1 in a timely manner2 and 7ii7 there are no terms in the agreement under such paragraph 7#a7 that directly or indirectly restrict or unduly delay a group health plan1 the plan sponsor1 the plan administrator1 a business associate of such plan1 or the issuer from auditing1 reviewing1 or otherwise accessing such information4 7,b7 ,limitation on submission ,a group health plan or issuer offering group health insurance coverage may not enter into an agreement with a third-party administrator or other service provider to submit the attestation required under subparagraph 7,a74 7,c7 ,exception ,in the case of a group health plan or health insurance issuer offering group health insurance coverage that is unable to obtain the information or data needed to submit the attestation required under subparagraph 7,a71 such plan or issuer may submit a written statement in lieu of such attestation that includes-- 7i7 an explanation of why such plan or issuer was unsuccessful in obtaining such information or data1 including whether such plan1 the plan sponsor1 or the plan administrator or issuer was limited or prevented from auditing1 reviewing1 or otherwise accessing such information or data2 7ii7 a description of the efforts made by the group health plan1 the plan sponsor1 or the plan administrator to remove any gag clause provisions from the agreement under paragraph 7#a72 and 7iii7 a description of any response by the third-party administrator or other service provider with respect to efforts to comply with the attestation requirement under subparagraph 7,a71 including the name of the third-party administrator or other service provider4 4 7c7 ,effective date ,the amendments made by subsections 7a7 and 7b7 shall apply with respect to a plan beginning with the first plan year that begins on or after the date that is #a year after the date of enactment of this ,act4 #fjg4 ,oversight of administrative service providers 7a7 ,,phsa amendment ,part ,d of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aaa et seq471 as amended by section #djd1 is amended by adding at the end the following3 #bgii;,a-#ae4 ,oversight of administrative service providers 7a7 ,in general ,for plan years beginning on or after ,january #a of the year that begins on or after the date that is #a year after the date of enactment of the ,health ,,care ,act of #bjbf1 no agreement between a group health plan that is offered by a specified large employer or that is a specified large plan 7as such terms are defined in section #bgii;,a-#aa7;f77 or a health insurance issuer offering individual or group health coverage 7that makes an election subject to subsection 7b77#e77 and a health insurance issuer that is operating as a third-party administrator1 a health care provider1 network or association of providers1 third-party administrator1 service provider offering access to a network of providers1 pharmacy benefit managers1 or any other third party 7each referred to in this section as a health plan service provider7 is permissible if such agreement limits 7or delays beyond the applicable reporting period described in subsection 7b77#a77 the disclosure of information to such group health plans and health insurance issuers in a manner that prevents any health plan service provider from providing the information described in subsection 7b74 7b7 ,required disclosures 7#a7 ,contents and frequency ,with respect to plan years beginning on or after the date that is #a year after the date of enactment of this section1 not less frequently than quarterly1 a health plan service provider shall provide to the group health or the health insurance issuer offering individual or group health insurance coverage the following information at no cost to the plan or issuer3 7,a7 ,the information described in section #bgii;,a-#i7;a77#a77;,b7 7#db ,u4,s4,c4 #cjj;gg-#aai7;a77#a77;,b774 7,b7 ,any contractual and subcontractual calculation methodologies1 pricing or fee schedules1 or other formulae used to determine reimbursement amounts to providers and subcontractors1 including methodologies1 schedules1 fee structures1 and any applied adjustments or modifiers1 with such information provided in a manner sufficiently detailed to enable the group health plan or issuer to accurately assess1 verify1 and ensure compliance with the terms of any contractual and subcontractual agreement governing the reimbursement amounts4 7,c7 ,the total amount received or expected to be received by the health plan service provider or its subcontractors in provider or supplier rebates1 fees1 alternative discounts1 and all other remuneration including amounts held in escrow or variance accounts that has been paid or is to be paid for claims incurred and administrative services including data sales or network payments4 7,d7 ,the total amount paid or expected to be paid by the health plan service provider to its subcontractors in rebates1 fees1 contractual arrangements1 and all other remuneration for administrative and other services4 7,e7 ,all payment data1 calculation methodologies1 and reconciliation information related to alternative compensation arrangements1 including accountable care organizations1 value-based programs1 shared savings programs1 incentive compensation1 bundled payments1 capitation arrangements1 performance payments1 and any other reimbursement or payment models1 where the group health plan paid fees1 incurred obligations1 or made payments in connection with the group health plan or issuer related to such arrangements4 7,f7 ,whether1 with respect to a provider that files claims under such plan or coverage1 the health plan service provider-- 7i7 has an ownership or investment interest2 7ii7 has a controlling interest2 7iii7 is a management services organization2 or 7iv7 is a significant equity investor4 7,g7 ,the name and business address for each person or entity that1 with respect to the health plan service provider-- 7i7 has an ownership or investment interest2 7ii7 has a controlling interest2 or 7iii7 is a significant equity investor4 7#b7 ,manner of providing information or data 7,a7 ,in general ,a health plan service provider shall provide information or data under paragraph 7#a7 in a manner consistent with the privacy regulations promulgated under section #acdjb7;a7 of the ,health ,information ,technology for ,economic and ,clinical ,health ,act 7#db ,u4,s4,c4 #agicb7;a77 and consistent with the privacy regulations promulgated under the ,health ,insurance ,portability and ,accountability ,act of #aiif in part #afj and subparts ,a and ,e of part #afd of title #de1 ,code of ,federal ,regulations 7or successor regulations7 7referred to in this paragraph as the ,,hipaa privacy regulations7 and shall restrict the use and disclosure of such information according to such privacy regulations and such ,,hipaa privacy regulations4 7,b7 ,additional requirements ,in carrying out this subsection1 a health plan service provider shall comply with section #afd4ejd7;f7 of title #de1 ,code of ,federal ,regulations 7or a successor regulation74 7,c7 ,rule of construction 7i7 ,in general ,nothing in this subsection shall be construed to modify the requirements for the creation1 receipt1 maintenance1 or transmission of protected health information under the ,,hipaa privacy regulations4 7ii7 ,civil rights laws ,nothing in this subsection shall be construed to affect the application of any ,federal or ,state privacy or civil rights law1 including the ,,hipaa privacy regulations1 the ,genetic ,information ,nondiscrimination ,act of #bjjh 7,public ,law #aaj-bcc7 7including the amendments made by such ,act71 the ,americans with ,disabilities ,act of #aiij 7#db ,u4,s4,c4 #abaja et seq471 section #ejd of the ,rehabilitation ,act of #aigc 7#bi ,u4,s4,c4 #gid71 section #aeeg of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahaaf71 title ,,vi of the ,civil ,rights ,act of #aifd 7#db ,u4,s4,c4 #bjjj;d71 and title ,,vii of the ,civil ,rights ,act of #aifd 7#db ,u4,s4,c4 #bjjj;e74 7,d7 ,written notice ,each plan year1 a health plan service provider shall provide to each participant or beneficiary written notice informing the participant or beneficiary of the requirement for health plan service providers to submit information or data under paragraph 7#a71 as applicable1 which may include incorporating such notification in plan documents provided to the participant or beneficiary1 or providing individual notification4 7,e7 ,clarification regarding public disclosure of information ,nothing in this subsection shall prevent a health plan service provider from placing reasonable restrictions on the public disclosure of the information or data described in paragraph 7#a71 except that such provider may not restrict disclosures under subsection 7b77#a7 to the ,department of ,health and ,human ,services1 the ,department of ,labor1 or the ,department of the ,treasury4 7,f7 ,limitation ,this paragraph shall not be construed to abridge or limit the disclosure requirements under this subsection or to impose additional privacy or security requirements on health plan service providers or plan sponsors4 7#c7 ,disclosure and redisclosure 7,a7 ,in general ,a group health plan or health insurance issuer offering individual or group coverage receiving information under paragraph 7#a7 may disclose such information only-- 7i7 to the entity from which the information was received or to that entity's business associates as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or successor regulations72 or 7ii7 as permitted by the ,,hipaa ,privacy ,rule 7#de ,,cfr part #afj and subparts ,a and ,e of part #afd74 7,b7 ,availability of information ,to the extent the information required by this subsection is made available to the health insurance issuer offering group health insurance coverage1 the health insurance issuer shall make such information available1 at the same time1 in the same format1 and at no cost1 to the group health plan4 7,c7 ,limitation on use of information ,a group health plan or health insurance issuer 7and any business associate or other entity acting on behalf of such plan7 may use information or data under this paragraph only for purposes of plan administration and may not sell1 license1 or otherwise commercially exploit such information or data or provide such information or data to any third party that may take such action4 7,d7 ,rule of construction ,nothing in this section shall be construed to prevent a group health plan1 a health insurance issuer1 or a health plan service provider providing services with respect to such a plan1 from placing reasonable restrictions on the public disclosure of the information described in paragraph 7#a71 except that such plan or entity may not restrict disclosure of such information to the ,department of ,health and ,human ,services1 the ,department of ,labor1 the ,department of the ,treasury1 or the ,comptroller ,general of the ,united ,states4 7,e7 ,failure to provide ,the obligation to provide information pursuant to this subsection shall exist notwithstanding the presence of any formal data-sharing agreement between the parties4 ,failure to provide the required information as specified shall constitute a violation of this ,act and the ,secretary shall initiate enforcement action under section #bgbc7;b7 7#db ,u4,s4,c4 #cjj;gg-#bb7;b77 within #ij days of becoming aware of a violation of this section1 except that nothing in this section shall be construed to limit the ,secretary's existing authority under this ,act4 7#d7 ,data format standards ,all data and information provided pursuant to this subsection shall comply with the following standards3 7,a7 ,all claims from a healthcare provider shall be made to the group health plan in accordance with standards adopted under ,,hipaa as described in subpart ,k of part #afb of title #de1 ,code of ,federal ,regulations1 as follows3 7i7 ,institutional1 professional1 and dental claims and adjustments to these claims shall be provided to the group health plan or health insurance issuer in the ,,asc ,x#ab,n #hcg format4 7ii7 ,prescription drug claims shall be in the ,national ,council for ,prescription ,drug ,programs 7,,ncpdp7 format4 7iii7 ,the files shall be unmodified copies of the files sent from the provider4 ,in the event that paper claims are sent by the provider1 they shall be converted to the appropriate standard electronic format4 ,such data shall be provided at no cost to the group health plan4 7,b7 ,all claim payment 7or ,,eft1 electronic funds transfer7 and electronic remittance advice 7,,era7 information sent by a health plan service provider shall be provided to the group health plan or health insurance issuer in the ,,asc ,x#ab,n #hce format1 in accordance with standards and operating rules adopted under ,,hipaa at subpart ,p of part #afb of title #de1 ,code of ,federal ,regulations1 unmodified from the form in which it was transmitted to the healthcare provider4 ,such information shall be provided at no cost to the group health plan4 7,c7 ,the ,secretary may modify the standards set forth in this paragraph as necessary to align with any changes adopted by the ,secretary pursuant to the authority provided under section #aagc of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d-#b74 7#e7 ,opt-in for health insurance coverage ,in the case of a health insurance issuer offering coverage in the individual or group market1 such issuer may1 on an annual basis1 for plan years beginning on or after the effective date of this section1 elect to require a health plan service provider to submit to such issuer a report that includes all of the information described in paragraph 7#a74 7c7 ,prohibited contractual provisions ,any provision in an agreement that unduly delays or limits a group health plan or issuer's access to information described in this section or that restricts the format or timing of the provision of such information in a manner that is inconsistent with the requirements of this section shall be prohibited and1 if a group health plan or issuer enters into such agreement1 shall be deemed void as against public policy4 7d7 ,regulations ,the ,secretary shall implement this section through notice and comment rulemaking in accordance with section #eec of title #e1 ,united ,states ,code4 4 7b7 ,penalty ,section #bgbc7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#bb7;b77 is amended by adding at the end the following3 7#d7 ,enforcement authority relating to health plan service providers ,notwithstanding any provisions to the contrary1 the ,secretary may assess a penalty against a health plan service provider1 as defined in section #bgii;,a-#ae7;a71 of #ajj1jjj per day for each violation of such section1 pursuant to substantially similar processes and procedures as those set forth in section #bgbc7;b77#b77;,d7 through 7,g74 4 7c7 ,,erisa amendments 7#a7 ,in general ,section #ejb7;c7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aacb7;c77 is amended by adding at the end the following new paragraph3 7#ad7 ,the ,secretary may assess a civil penalty against any person of #ajj1jjj per day for each violation by any person of section #bgii;,a-#ae of the ,public ,health ,service ,act4 4 7#b7 ,technical amendment ,paragraph 7#f7 of section #ejb7;a7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aacb7;a77 is amended by striking or 7#i7 and inserting 7#i71 7#ac71 or 7#ad74 #fjh4 ,state preemption only in event of conflict ,the provisions of section #bgah;,a of the ,public ,health ,service ,act 7as added and amended by this ,act7 shall not be construed to supersede any provision of ,state law which establishes1 implements1 or continues in effect any requirement or prohibition related to health care price transparency1 including for hospitals1 clinical diagnostic laboratories1 provider of specified imaging services1 and ambulatory surgical centers 7as such terms are defined in section #bgah;,a7a7 of the ,public ,health ,service ,act71 except to the extent that such requirement or prohibition prevents the application of a requirement or prohibition of such sections 7or such amendments74 ,nothing in this section shall be construed to affect group health plans established under the ,employee ,retirement ,income ,security ,act of #aigd1 or alter the application of section #ead of such ,act 7#bi ,u4,s4,c4 #aadd74 #fji4 ,requirement for explanation of benefits 7a7 ,advanced explanation of benefits ,section #bgii;,a-#a7;f7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aaa7;f77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 by striking subparagraph 7,c7 and inserting the following3 7,c7 ,a good faith estimate of the amount the plan or coverage is responsible for paying for items and services included in the estimate described in subparagraph 7,b71 including a plain language description of each item or service and all applicable billing codes for each item or service1 including modifiers1 using standard and commonly recognized billing code sets that are clearly identified4 2 and 7,b7 by adding at the end the following3 7,i7 ,a notification that the recipient may be held harmless1 in certain circumstances1 if the information in the advanced explanation of benefits does not match the amount the recipient is billed4 2 and 7#b7 by adding at the end the following3 7#c7 ,hold harmless 7,a7 ,in general ,for plan years beginning on or after the date that is #a year after the date on which the ,secretary implements this section1 a participant1 beneficiary1 or enrollee shall be held harmless for any amount that is substantially in excess 7as defined by the ,secretary in a manner consistent with the process described in section #bgii;,b-#g7 of the estimate generated by the advanced explanation of benefits4 7,b7 ,no patient responsibility for excess charges ,a group health plan or a health insurance issuer in the group or individual market shall not hold a participant1 beneficiary1 or enrollee responsible for excess charges described in this paragraph if such excess is the result of coverage or payment determinations that differ from projections made in the advanced explanation of benefits at the time such explanation was generated4 7,c7 ,substantial excess ,a participant1 beneficiary1 or enrollee shall not be held harmless for excess amounts if such amounts reflect the cost of medically necessary items or services furnished based on unforeseen circumstances that could not have reasonably been anticipated by the provider or facility at the time the good faith estimate was generated or by the plan or issuer at the time the advanced explanation of benefits was generated4 4 7b7 ,good faith estimates ,section #bgii;,b-#f of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#acf7 is amended-- 7#a7 by striking ,each health care and inserting the following3 7a7 ,in general ,each health care 2 and 7#b7 by adding at the end the following3 7b7 ,hold harmless 7#a7 ,in general ,for plan years beginning on or after the date that is #a year after the date on which the ,secretary implements section #bgii;,a-#a7;f71 if an individual enrolled in a group health plan or health insurance coverage 7and seeks to have a claim for an item or service submitted to such plan or coverage7 is responsible for any amount that is substantially in excess 7as defined by the ,secretary in a manner consistent the process described in section #bgii;,b-#g7 of the estimate generated in the advanced explanation of benefits described in section #bgii;,a-#a7;f7 because the final charges for items and services were substantially in excess of the good faith estimate provided to the plan or coverage under this section1 a provider shall not bill the patient for amounts substantially in excess of the advanced explanation of benefits4 7#b7 ,substantial excess ,an individual seeking to have a claim for an item or service covered by a group health plan or health insurance coverage shall not be held harmless for excess amounts if such amounts reflect the cost of medically necessary items or services furnished based on unforeseen circumstances that could not have reasonably been anticipated by the provider or facility at the time the good faith estimate was generated or by the plan or issuer at the time the advanced explanation of benefits was generated4 4 7c7 ,explanation of benefits ,section #bgii;,a-#a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aaa7 is amended by adding at the end the following3 7g7 ,explanation of benefits 7#a7 ,in general ,for plan years beginning on ,january #a of the year that begins on or after the date that is #a year after the date of enactment of the ,health ,,care ,act of #bjbf1 each group health plan1 or a health insurance issuer offering group or individual health insurance coverage shall1 within #de days of receiving the information necessary to decide a claim for payment 7as defined by the ,secretary7 for an item or service under the plan or coverage for which liability under the plan or coverage has been determined1 provide to the participant1 beneficiary1 or enrollee 7through mail or electronic means1 as requested by the participant1 beneficiary1 or enrollee7 a notification 7in clear and understandable language and utilizing substantially the same format as the advanced explanation of benefits required by subsection 7f7 to enable comparison when an advanced explanation of benefits is provided7 including the following3 7,a7 ,whether or not the provider or facility is a participating provider or a participating facility with respect to the plan or coverage with respect to the furnishing of such item or service4 7,b7 ,an itemized explanation of benefits that includes the following3 7i7 ,a plain language description of each item or service4 7ii7 ,all applicable billing codes for each item or service1 including modifiers1 using standard and commonly recognized billing code sets that are clearly identified4 7iii7 ,the amount the plan or coverage is responsible for paying for each item or service4 7iv7 ,the amount of any cost-sharing for which the participant1 beneficiary1 or enrollee is responsible for each item or service 7as of the date of such notification74 7v7 ,the amount that the participant1 beneficiary1 or enrollee has incurred toward meeting the limit of the financial responsibility 7including with respect to deductibles and out-of-pocket maximums7 under the plan or coverage 7as of the date of such notification74 7vi7 ,the type of site of each item or service1 including office1 facility1 or emergency room4 7vii7 ,if applicable1 a description of any discrepancies that exist between the services outlined in a patient's advanced explanation of benefits and the explanation of benefits4 7viii7 ,the amount of any facility fee or other patient charges that were added to the final payment amount1 together with a plain language explanation of the fee1 if applicable4 7,c7 ,if the provider or facility is a participating provider or facility with respect to the plan or coverage with respect to the furnishing of such item or service1 the contracted rate under such plan or coverage for such item or service4 7,d7 ,the charges submitted by the provider or facility for each item or service4 7,e7 ,information pertaining to plan type1 as defined the ,secretary4 7#b7 ,format ,if applicable1 the notification described in paragraph 7#a7 may be provided in conjunction with1 or as part of1 a notice of a claim determination or other communication required by section #bgai7;a7 7#db ,u4,s4,c4 #cjj;gg-#ai7;a771 or regulations thereunder4 7h7 ,regulations ,the ,secretary shall implement this section through notice and comment rulemaking in accordance with section #eec of title #e1 ,united ,states ,code4 4 #faj4 ,transparency in billing 7a7 ,in general ,part ,e of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aca et seq47 is amended by adding at the end the following3 #bgii;,b-#aj4 ,patient access to complete billing information 7a7 ,requirements 7#a7 ,notice of right of access to itemized bills2 ,in general ,a health care provider or health care facility that requests payment from an individual for providing a health care item or service to the patient shall include with such request a written notice of the individual's right to request an itemized bill as part of the individual's designated record set under section #afd4ebd of title #de1 ,code of ,federal ,regulations 7or a successor regulation74 7#b7 ,required information ,a notice under paragraph 7#a7 shall provide-- 7,a7 a phone number and internet website where an individual can make a request for access to their itemized bill2 7,b7 information about the availability of language-assistance services for individuals with limited ,english proficiency 7,,lep72 and 7,c7 information about the health care provider's or health care facility's charity care policies and instructions on how to apply for charity care4 7#c7 ,collections actions 7,a7 ,in general ,a health care provider or health care facility shall not bill or take any collections actions against an individual-- 7i7 for any provided health care item or service unless the health care provider or health care facility has complied with paragraph 7#a7 or section #acdje7;e77#d7 of the ,,hitech ,act2 or 7ii7 with respect to any items or services for which the amount appearing on an itemized bill described above in paragraph 7#a7 exceeds the amount disclosed pursuant to ,federal health care price transparency regulations1 including part #ahj of title #de1 ,code of ,federal ,regulations1 or provided in a good faith estimate that complies with section #bgii;,b-#f of this ,act and section #adi4faj of title #de1 ,code of ,federal ,regulations1 or another good faith estimate provided by a health care entity covered under this section but not otherwise covered under such section #bgii;,b-#f1 unless the provider or facility documents that the additional items or services were medically necessary due to unforeseen complications or a patient-initiated change1 and could not reasonably have been anticipated4 7,b7 ,provider requirement ,if a provider fails to provide a documentation as required under subparagraph 7,a77ii7 in the case of items or services1 the good faith estimate described in such subparagraph with respect to such items or services shall be binding4 7b7 ,failure ,to comply 7#a7 ,penalties ,the ,secretary shall impose penalties on any health care provider or health care facility that fails to comply with the requirements of this section in an amount not to exceed #aj1jjj for each instance of failure to comply4 7#b7 ,presumption in favor of individual ,if a health care provider or health care facility fails to comply with the requirements of this section1 the presumption shall be that charges were substantially in excess of the good faith estimate1 as set forth in section #bgii;,b-#f1 for the purpose of any patient-provider dispute1 including in accordance with section #bgii;,b-#g and regulations promulgated thereunder4 7c7 ,regulations ,the ,secretary shall implement this section through notice and comment rulemaking in accordance with section #eec of title #e1 ,united ,states ,code4 4 7b7 ,standards for accessing itemized bills ,section #acdje7;e7 of the ,,hitech ,act 7#db ,u4,s4,c4 #agice7;e77 is amended-- 7#a7 in paragraph 7#b71 by striking and at the end2 7#b7 in paragraph 7#c71 by striking the period and inserting 2 and2 and 7#c7 by adding at the end1 the following3 7#d7 if the individual makes a request only for an itemized copy of a bill for services provided1 the covered entity or business associate shall-- 7,a7 make such protected health information available within #cj days of such request2 7,b7 not impose any fee for providing such individual a copy of their information2 and 7,c7 include in such itemized bill1 a plain language description of each distinct health care item or service1 all applicable billing codes for each distinct item or service1 including modifiers1 using standard and commonly recognized billing code sets1 the price and billed amount1 if different1 of each distinct item or service4 4 #faa4 ,technical amendments 7a7 ,,erisa ,section #gae7;a77#a7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aahe;d7a77#a77 is amended by inserting and parts ,d and ,e of title ,,xxvii of the ,public ,health ,service ,act 7as amended by title ,,vi the ,health ,,care ,act of #bjbf7 after ,affordable ,care ,act74 7b7 ,internal ,revenue ,code ,section #ihae7;a77#a7 of the ,internal ,revenue ,code of #aihf is amended by inserting and parts ,d and ,e of title ,,xxvii of the ,public ,health ,service ,act 7as amended by title ,,vi of the ,health ,,care ,act of #bjbf7 after ,affordable ,care ,act74 #fab4 ,implementation and enforcement funding 7a7 ,appropriation for ,secretary of ,labor ,there are authorized to be appropriated1 such sums as may be necessary for fiscal year #bjbg1 and each subsequent fiscal year1 to enable the ,secretary of ,labor to carry out this ,act and the amendments made by this ,act1 including enforcement activities4 7b7 ,appropriation for the ,secretary of ,health and ,human ,services ,there are authorized to be appropriated1 such sums as may be necessary for fiscal year #bjbg1 and each subsequent fiscal year1 to enable the ,secretary of ,health and ,human ,services to carry out the amendments made by this ,act1 including implementation and enforcement activities4 ,,vii ,reforming ,p,b,ms and ,protecting ,pharmacies #gja4 ,ensuring accurate payments to pharmacies under ,medicaid 7a7 ,in general ,section #aibg7;f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f77 is amended-- 7#a7 in paragraph 7#a77;,a7-- 7,a7 by redesignating clause 7ii7 as clause 7iii72 and 7,b7 by striking and after the semicolon at the end of clause 7i7 and all that precedes it through 7#a7 and inserting the following3 7#a7 ,determining pharmacy actual acquisition costs ,the ,secretary shall conduct a survey of retail community pharmacy drug prices and applicable non-retail pharmacy drug prices to determine national average drug acquisition cost benchmarks 7as such term is defined by the ,secretary7 as follows3 7,a7 ,use of vendor ,the ,secretary may contract services for-- 7i7 with respect to retail community pharmacies1 the determination of retail survey prices of the national average drug acquisition cost for covered outpatient drugs that represent a nationwide average of consumer purchase prices for such drugs1 net of all discounts1 rebates1 and other price concessions 7to the extent any information with respect to such discounts1 rebates1 and other price concessions is available7 based on a monthly survey of such pharmacies2 7ii7 with respect to applicable non-retail pharmacies-- 7,i7 the determination of survey prices1 separate from the survey prices described in clause 7i71 of the non-retail national average drug acquisition cost for covered outpatient drugs that represent a nationwide average of consumer purchase prices for such drugs1 net of all discounts1 rebates1 and other price concessions 7to the extent any information with respect to such discounts1 rebates1 and other price concessions is available7 based on a monthly survey of such pharmacies2 and 7,,ii7 at the discretion of the ,secretary1 for each type of applicable non-retail pharmacy1 the determination of survey prices1 separate from the survey prices described in clause 7i7 or subclause 7,i7 of this clause1 of the national average drug acquisition cost for such type of pharmacy for covered outpatient drugs that represent a nationwide average of consumer purchase prices for such drugs1 net of all discounts1 rebates1 and other price concessions 7to the extent any information with respect to such discounts1 rebates1 and other price concessions is available7 based on a monthly survey of such pharmacies2 and 2 7#b7 in subparagraph 7,b7 of paragraph 7#a71 by striking subparagraph 7,a77ii7 and inserting subparagraph 7,a77iii72 7#c7 in subparagraph 7,d7 of paragraph 7#a71 by striking clauses 7ii7 and 7iii7 and inserting the following3 7ii7 ,the vendor must update the ,secretary no less often than monthly on the survey prices for covered outpatient drugs4 7iii7 ,the vendor must differentiate1 in collecting and reporting survey data1 for all cost information collected1 whether a pharmacy is a retail community pharmacy or an applicable non-retail pharmacy1 including whether such pharmacy is an affiliate 7as defined in subsection 7k77#ac771 and1 in the case of an applicable non-retail pharmacy1 which type of applicable non-retail pharmacy it is using the relevant pharmacy type indicators included in the guidance required by subsection 7d77#b7 of section #gja of the ,health ,,care ,act of #bjbf4 2 7#d7 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 or applicable non-retail pharmacy in the ,state that receives any payment1 reimbursement1 administrative fee1 discount1 rebate1 or other price concession related to the dispensing of covered outpatient drugs to individuals receiving benefits under this title1 regardless of whether such payment1 reimbursement1 administrative fee1 discount1 rebate1 or other price concession is received from the ,state or a managed care entity or other specified entity 7as such terms are defined in section #aijc7m77#i77;,d77 directly or from a pharmacy benefit manager or another entity that has a contract with the ,state or a managed care entity or other specified entity 7as so defined71 shall respond to surveys conducted under this paragraph4 7,g7 ,survey information ,information on national drug acquisition prices obtained under this paragraph shall be made publicly available in a form and manner to be determined by the ,secretary and shall include at least the following3 7i7 ,the monthly response rate to the survey including a list of pharmacies not in compliance with subparagraph 7,f74 7ii7 ,the sampling methodology and number of pharmacies sampled monthly4 7iii7 ,information on price concessions to pharmacies1 including discounts1 rebates1 and other price concessions1 to the extent that such information may be publicly released and has been collected by the ,secretary as part of the survey4 7,h7 ,penalties 7i7 ,in general ,subject to clauses 7ii71 7iii71 and 7iv71 the ,secretary shall enforce the provisions of this paragraph with respect to a pharmacy through the establishment of civil money penalties applicable to a retail community pharmacy or an applicable non-retail pharmacy4 7ii7 ,basis for penalties ,the ,secretary shall impose a civil money penalty established under this subparagraph on a retail community pharmacy or applicable non-retail pharmacy if-- 7,i7 the retail pharmacy or applicable non-retail pharmacy refuses or otherwise fails to respond to a request for information about prices in connection with a survey under this subsection2 7,,ii7 knowingly provides false information in response to such a survey2 or 7,,iii7 otherwise fails to comply with the requirements established under this paragraph4 7iii7 ,parameters for penalties 7,i7 ,in general ,a civil money penalty established under this subparagraph may be assessed with respect to each violation1 and with respect to each non-compliant retail community pharmacy 7including a pharmacy that is part of a chain7 or non-compliant applicable non-retail pharmacy 7including a pharmacy that is part of a chain71 in an amount not to exceed #ajj1jjj for each such violation4 7,,ii7 ,considerations ,in determining the amount of a civil money penalty imposed under this subparagraph1 the ,secretary may consider the size1 business structure1 and type of pharmacy involved1 as well as the type of violation and other relevant factors1 as determined appropriate by the ,secretary4 7iv7 ,rule of application ,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 civil money penalty or proceeding under section #aabh;,a7a74 7,i7 ,limitation on use of applicable non-retail pharmacy pricing information ,no ,state shall use pricing information reported by applicable non-retail pharmacies under subparagraph 7,a77ii7 to develop or inform payment methodologies for retail community pharmacies4 2 7#e7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a71 by inserting 1 including payment rates and methodologies for determining ingredient cost reimbursement under managed care entities or other specified entities 7as such terms are defined in section #aijc7m77#i77;,d771 after under this title2 and 7,b7 in subparagraph 7,b71 by inserting and the basis for such dispensing fees before the semicolon2 7#f7 by redesignating paragraph 7#d7 as paragraph 7#e72 7#g7 by inserting after paragraph 7#c7 the following new paragraph3 7#d7 ,oversight 7,a7 ,in general ,the ,inspector ,general of the ,department of ,health and ,human ,services shall conduct periodic studies of the survey data reported under this subsection1 as appropriate1 including with respect to substantial variations in acquisition costs or other applicable costs1 as well as with respect to how internal transfer prices and related party transactions may influence the costs reported by pharmacies that are affiliates 7as defined in subsection 7k77#ac77 or are owned by1 controlled by1 or related under a common ownership structure with a wholesaler1 distributor1 or other entity that acquires covered outpatient drugs relative to costs reported by pharmacies not affiliated with such entities4 ,the ,inspector ,general shall provide periodic updates to ,congress on the results of such studies1 as appropriate1 in a manner that does not disclose trade secrets or other proprietary information4 7,b7 ,appropriation ,there is appropriated to the ,inspector ,general of the ,department of ,health and ,human ,services1 out of any money in the ,treasury not otherwise appropriated1 #e1jjj1jjj for fiscal year #bjbg1 to remain available until expended1 to carry out this paragraph4 2 and 7#h7 in paragraph 7#e71 as so redesignated-- 7,a7 by inserting 1 and #i1jjj1jjj for fiscal year #bjbg and each fiscal year thereafter1 after #bjaj2 and 7,b7 by inserting ,funds appropriated under this paragraph for fiscal year #bjbg and any subsequent fiscal year shall remain available until expended4 after the period4 7b7 ,definitions ,section #aibg7k7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by striking ,in the section and inserting ,in this section2 and 7#b7 by adding at the end the following new paragraphs3 7#ab7 ,applicable non-retail pharmacy ,the term applicable non-retail pharmacy means a pharmacy that is licensed as a pharmacy by the ,state and that is not a retail community pharmacy1 including a pharmacy that dispenses prescription medications to patients primarily through mail and specialty pharmacies4 ,such term does not include nursing home pharmacies1 long-term care facility pharmacies1 hospital pharmacies1 clinics1 charitable or not-for-profit pharmacies1 government pharmacies1 or low dispensing pharmacies 7as defined by the ,secretary74 7#ac7 ,affiliate ,the term affiliate means any entity that is owned by1 controlled by1 or related under a common ownership structure with a pharmacy benefit manager or a managed care entity or other specified entity 7as such terms are defined in section #aijc7m77#i77;,d774 4 7c7 ,effective date 7#a7 ,in general ,subject to paragraph 7#b71 the amendments made by this section shall take effect on the first day of the first quarter that begins on or after the date that is #f months after the date of enactment of this ,act4 7#b7 ,delayed application to applicable non-retail pharmacies ,the pharmacy survey requirements established by the amendments to section #aibg7;f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f77 made by this section shall apply to retail community pharmacies beginning on the effective date described in paragraph 7#a71 but shall not apply to applicable non-retail pharmacies until the first day of the first quarter that begins on or after the date that is #ah months after the date of enactment of this ,act4 7d7 ,identification of applicable non-,retail pharmacies 7#a7 ,in general ,not later than ,january #a1 #bjbh1 the ,secretary of ,health and ,human ,services shall1 in consultation with stakeholders as appropriate1 publish guidance specifying pharmacies that meet the definition of applicable non-retail pharmacies 7as such term is defined in subsection 7k77#ab7 of section #aibg of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h71 as added by subsection 7b771 and that will be subject to the survey requirements under subsection 7f77#a7 of such section1 as amended by subsection 7a74 7#b7 ,inclusion of pharmacy type indicators ,the guidance published under paragraph 7#a7 shall include pharmacy type indicators to distinguish between different types of applicable non-retail pharmacies1 such as pharmacies that dispense prescriptions primarily through the mail and pharmacies that dispense prescriptions that require special handling or distribution4 ,an applicable non-retail pharmacy may be identified through multiple pharmacy type indicators4 7e7 ,implementation 7#a7 ,in general ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services may implement the amendments made by this section by program instruction or otherwise4 7#b7 ,nonapplication of ,administrative ,procedure ,act ,implementation of the amendments made by this section shall be exempt from the requirements of section #eec of title #e1 ,united ,states ,code4 7f7 ,nonapplication of paperwork reduction act ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to any data collection undertaken by the ,secretary of ,health and ,human ,services under section #aibg7;f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f771 as amended by this section4 #gjb4 ,preventing the use of abusive spread pricing in ,medicaid 7a7 ,in general ,section #aibg of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7 is amended-- 7#a7 in subsection 7e71 by adding at the end the following new paragraph3 7#f7 ,transparent prescription drug pass-through pricing required 7,a7 ,in general ,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;,d7 and collectively referred to in this paragraph as the entity7 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 transparent prescription drug pass-through pricing model under which-- 7i7 any payment made by the entity or the ,,pbm 7as applicable7 for such a drug-- 7,i7 is limited to-- 7aa7 ingredient cost2 and 7bb7 a professional dispensing fee that is not less than the professional dispensing fee that the ,state would pay if the ,state were making the payment directly in accordance with the ,state plan2 7,,ii7 is passed through in its entirety 7except as reduced under ,federal or ,state laws and regulations in response to instances of waste1 fraud1 or abuse7 by the entity or ,,pbm to the pharmacy or provider that dispenses the drug2 and 7,,iii7 is made in a manner that is consistent with sections #ddg4ejb1 #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 ,,pbm1 except that any payment by the entity or the ,,pbm for the ingredient cost of such drug purchased by a covered entity 7as defined in subsection 7a77#e77;,b77 may exceed the actual acquisition cost 7as defined in #ddg4ejb of title #db1 ,code of ,federal ,regulations1 or any successor regulation7 for such drug if-- 7aa7 such drug was subject to an agreement under section #cdj;,b of the ,public ,health ,service ,act2 7bb7 such payment for the ingredient cost of such drug does not exceed the maximum payment that would have been made by the entity or the ,,pbm for the ingredient cost of such drug if such drug had not been purchased by such covered entity2 and 7cc7 such covered entity reports to the ,secretary 7in a form and manner specified by the ,secretary71 on an annual basis and with respect to payments for the ingredient costs of such drugs so purchased by such covered entity that are in excess of the actual acquisition costs for such drugs1 the aggregate amount of such excess2 7ii7 payment to the entity or the ,,pbm 7as applicable7 for administrative services performed by the entity or ,,pbm is limited to an administrative fee that reflects the fair market value 7as defined by the ,secretary7 of such services2 7iii7 the entity or the ,,pbm 7as applicable7 makes available to the ,state1 and the ,secretary upon request in a form and manner specified by the ,secretary1 all costs and payments related to covered outpatient drugs and accompanying administrative services 7as described in clause 7ii77 incurred1 received1 or made by the entity or the ,,pbm1 broken down 7as specified by the ,secretary71 to the extent such costs and payments are attributable to an individual covered outpatient drug1 by each such drug1 including any ingredient costs1 professional dispensing fees1 administrative fees 7as described in clause 7ii771 post-sale and post-invoice fees1 discounts1 or related adjustments such as direct and indirect remuneration fees1 and any and all other remuneration1 as defined by the ,secretary2 and 7iv7 any form of spread pricing whereby any amount charged or claimed by the entity or the ,,pbm 7as applicable7 that exceeds the amount paid to the pharmacies or providers on behalf of the ,state or entity1 including any post-sale or post-invoice fees1 discounts1 or related adjustments such as direct and indirect remuneration fees or assessments1 as defined by the ,secretary 7after allowing for an administrative fee as described in clause 7ii771 is not allowable for purposes of claiming ,federal matching payments under this title4 7,b7 ,publication of information ,the ,secretary shall publish1 not less frequently than on an annual basis and in a manner that does not disclose the identity of a particular covered entity or organization1 information received by the ,secretary pursuant to subparagraph 7,a77iii77,,iii7 that is broken out by ,state and by each of the following categories of covered entity within each such ,state3 7i7 ,covered entities described in subparagraph 7,a7 of section #cdj;,b7a77#d7 of the ,public ,health ,service ,act4 7ii7 ,covered entities described in subparagraphs 7,b7 through 7,k7 of such section4 7iii7 ,covered entities described in subparagraph 7,l7 of such section4 7iv7 ,covered entities described in subparagraph 7,m7 of such section4 7v7 ,covered entities described in subparagraph 7,n7 of such section4 7vi7 ,covered entities described in subparagraph 7,o7 of such section4 2 and 7#b7 in subsection 7k71 as amended by section #gja7;b71 by adding at the end the following new paragraph3 7#ad7 ,pharmacy benefit manager ,the term pharmacy benefit manager means any person or entity that1 either directly or through an intermediary1 acts as a price negotiator or group purchaser on behalf of a ,state1 managed care entity 7as defined in section #aijc7m77#i77;,d771 or other specified entity 7as so defined71 or manages the prescription drug benefits provided by a ,state1 managed care entity1 or other specified entity1 including the processing and payment of claims for prescription drugs1 the performance of drug utilization review1 the processing of drug prior authorization requests1 the managing of appeals or grievances related to the prescription drug benefits1 contracting with pharmacies1 controlling the cost of covered outpatient drugs1 or the provision of services related thereto4 ,such term includes any person or entity that acts as a price negotiator 7with regard to payment amounts to pharmacies and providers for a covered outpatient drug or the net cost of the drug7 or group purchaser on behalf of a ,state1 managed care entity1 or other specified entity or that carries out #a or more of the other activities described in the preceding sentence1 irrespective of whether such person or entity calls itself a pharmacy benefit manager4 4 7b7 ,conforming amendments ,section #aijc7m7 of such ,act 7#db ,u4,s4,c4 #acif;b7m77 is amended-- 7#a7 in paragraph 7#b77;,a77xiii7-- 7,a7 by striking and 7,,iii7 and inserting 7,,iii72 7,b7 by inserting before the period at the end the following3 1 and 7,,iv7 if the contract includes provisions making the entity responsible for coverage of covered outpatient drugs1 the entity shall comply with the requirements of section #aibg7;e77#f72 and 7,c7 by moving the margin #b ems to the left2 and 7#b7 by adding at the end the following new paragraph3 7#aj7 ,no payment shall be made under this title to a ,state with respect to expenditures incurred by the ,state for payment for services provided by an other specified entity 7as defined in paragraph 7#i77;,d77iii77 unless such services are provided in accordance with a contract between the ,state and such entity which satisfies the requirements of paragraph 7#b77;,a77xiii74 4 7c7 ,effective date ,the amendments made by this section shall apply to contracts between ,states and managed care entities1 other specified entities1 or pharmacy benefit managers that have an effective date beginning on or after the date that is #ah months after the date of enactment of this ,act4 7d7 ,implementation 7#a7 ,in general ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services may implement the amendments made by this section by program instruction or otherwise4 7#b7 ,nonapplication of administrative procedure act ,implementation of the amendments made by this section shall be exempt from the requirements of section #eec of title #e1 ,united ,states ,code4 7e7 ,nonapplication of paperwork reduction act ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to any data collection undertaken by the ,secretary of ,health and ,human ,services under section #aibg7;e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;e771 as amended by this section4