,i #aaith ,,congress #ast ,session ,h4 ,r4 #faff ,,in ,,the ,,house ,,of ,,representatives ,november #bj1 #bjbe,mr4 ,pallone 7for himself1 ,mr4 ,neal1 and ,mr4 ,scott of ,virginia7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committees on ,ways and ,means1 and ,education and ,workforce1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to expand the drug price negotiation program under title ,,xi of the ,social ,security ,act and repeal certain changes to the program made by ,public ,law #aai-ba1 to apply prescription drug inflation rebates under the ,medicare program to drugs furnished in the commercial market1 and to establish out-of-pocket limits on expenditures for prescription drugs under private health insurance4 #a4 ,short title ,this ,act may be cited as the ,lowering ,drug ,costs for ,american ,families ,act4 ,i ,drug price negotiation program #aja4 ,expanding the drug price negotiation program 7a7 ,increasing the number of drugs subject to negotiation ,section #aaib7;a77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;f-#a7;a77#d77 is amended by striking #bj each place it appears and inserting #ej in each such place4 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 ,secretary and the ,secretary of ,labor and the ,secretary of the ,treasury1 as applicable1 shall make public a list of each group health plan and each health insurance issuer offering group or individual health insurance coverage1 with respect to which coverage is provided under such plan or coverage for such drug1 that has elected under subsection 7a7 not to participate under the program with respect to such period and drug4 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-#aa4 ,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 #gbf4 ,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 section #gaa and inserting sections #gaa and #gbf4 7,c7 ,clerical amendment ,the table of contents in section #a of such ,act is amended by inserting after the item relating to section #gbe the following new item3 ,sec4 #gbf4 ,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 #ihbf4 ,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 other than with respect to section #ihbf1 before any group health plan4 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 #ihbf4 ,drug ,price ,negotiation ,program and application of maximum fair prices4 4 #ajb4 ,requiring consideration of average international market price under drug price negotiation program 7a7 ,in general ,section #aaid7;e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;f-#c7;e77 is amended by adding at the end the following new paragraph3 7#c7 ,average international market price 7,a7 ,in general ,the average price 7which shall be the net average price1 if practicable1 and volume-weighted1 if practicable7 for a unit 7as defined in subparagraph 7,c77 of such drug for sales of such drug 7calculated across different dosage forms and strengths of the drug and not based on the specific formulation or package size or package type71 as computed 7as of the date of publication of such drug as a selected drug under section #aaib7;a77 in all countries described in clause 7ii7 of subparagraph 7,b7 that are applicable countries 7as described in clause 7i7 of such subparagraph7 with respect to such drug4 7,b7 ,applicable countries 7i7 ,in general ,for purposes of subparagraph 7,a71 a country described in clause 7ii7 is an applicable country described in this clause with respect to a drug if there is available an average price for any unit for the drug for sales of such drug in such country4 7ii7 ,countries described ,for purposes of this paragraph1 the following are countries described in this clause3 7,i7 ,australia4 7,,ii7 ,canada4 7,,iii7 ,france4 7,,iv7 ,germany4 7,v7 ,japan4 7,,vi7 ,the ,united ,kingdom4 7,c7 ,unit defined ,for purposes of this paragraph1 term unit means1 with respect to a drug1 the lowest identifiable quantity 7such as a capsule or tablet1 milligram of molecules1 or grams7 of the drug that is dispensed4 4 7b7 ,effective date ,the amendment made by subsection 7a7 shall apply with respect to negotiations under the ,drug ,price ,negotiation ,program under part ,e of title ,,xi of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;f et seq47 for initial price applicability years beginning on or after ,january #a1 #bjbh1 and renegotiations under such program for years beginning on or after such date4 #ajc4 ,repealing certain changes to the drug price negotiation program made by ,public ,law #aai-ba ,section #gabjc 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 repealed1 and the provisions of law amended by such section are hereby restored as if such section had not been enacted into law4 ,,ii ,prescription drug inflation rebates #bja4 ,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;,b7 for each ,national ,drug ,code of such drug during the calendar quarter that is two 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 #bjbf1 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 ,,iii ,out-of-pocket limits for prescription drugs #cja4 ,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 seq471 as amended by section #aja1 is further 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 #bjbg4 2 and 7#b7 in part ,d1 by adding at the end the following new section3 #bgii;,a-#ab4 ,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 #bjbg1 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 #bjbh 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 #bjbg 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 #bjbg1 #b1jjj2 and 7ii7 for plan years beginning in #bjbh 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 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 #bjbg 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 #aja1 is further amended by adding at the end the following new section3 #gbg4 ,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 #bjbg1 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 #bjbh 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 #bjbg 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 #bjbg1 #b1jjj2 and 7ii7 for plan years beginning in #bjbh 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 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 #bjbg 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 7#b7 ,clerical amendment ,the table of contents in section #a of such ,act is amended by inserting after the item relating to section #gbf 7as inserted by section #aja7 the following new item3 ,sec4 #gbg4 ,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 #aja1 is further amended by adding at the end the following new section3 #ihbg4 ,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 #bjbg1 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 #bjbh 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 #bjbg 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 #bjbg1 #b1jjj2 and 7ii7 for plan years beginning in #bjbh 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 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 #bjbg 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 #aja1 is further amended by adding at the end the following new item3 ,sec4 #ihbg4 ,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 #bjbg1 in effect under section #bgii;,a-#ab7;b77#a77;,a77 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 #bjbg1 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-#ab7;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 #bjbg1 the applicable out-of-pocket limit under section #bgii;,a-#ab7;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 #bjbg4 #cjb4 ,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 sections #aja and #cja1 is further amended by adding at the end the following new section3 #bgii;,a-#ac4 ,requirements with respect to cost-sharing for certain insulin products 7a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbg1 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 section1 including any insulin product that has been deemed to be licensed under section #cea7;a7 pursuant to section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji 7,public ,law #aaa-adh7 and continues to be marketed pursuant to such licensure4 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 sections #aja and #cja1 is further amended by adding at the end the following new section3 #gbh4 ,requirements with respect to cost-sharing for certain insulin products 7a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbg1 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 section1 including any insulin product that has been deemed to be licensed under section #cea7;a7 of such ,act pursuant to section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji 7,public ,law #aaa-adh7 and continues to be marketed pursuant to such licensure4 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 #gbg 7as inserted by section #cja7 the following new item3 ,sec4 #gbh4 ,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 sections #aja and #cja1 is further amended by adding at the end the following new section3 #ihbh4 ,requirements with respect to cost-sharing for certain insulin products 7a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbg1 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 section1 including any insulin product that has been deemed to be licensed under section #cea7;a7 of such ,act pursuant to section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji 7,public ,law #aaa-adh7 and continues to be marketed pursuant to such licensure4 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 sections #aja and #cja1 is further amended by adding at the end the following new item3 ,sec4 #ihbh4 ,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-#ac7;b7 of the ,public ,health ,service ,act7 from the application of any deductible pursuant to section #bgii;,a-#ac7;a77#a7 of such ,act1 section #gbh7;a77#a7 of the ,employee ,retirement ,income ,security ,act of #aigd1 or section #ihbh7;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-#ac 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-#ac7;b7 of the ,public ,health ,service ,act2 and 7ii7 the requirements of section #bgii;,a-#ac 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