,,ii ,calendar ,no4 #chi #aagth ,,congress #b;d ,session ,h4 ,r4 #fhcc ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,april #d 7legislative day1 ,march #ca71 #bjbb,received ,may #bd1 #bjbb ,read the first time ,may #be1 #bjbb,read the second time and placed on the calendar ,,an ,,act ,to amend title ,,xxvii of the ,public ,health ,service ,act1 the ,internal ,revenue ,code of #aihf1 and the ,employee ,retirement ,income ,security ,act of #aigd to establish requirements with respect to cost-sharing for certain insulin products1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,affordable ,insulin ,now ,act4 #b4 ,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 seq47 is amended by adding at the end the following new section3 #bgii;,a-#aa4 ,requirements with respect to cost-sharing for certain insulin products 7a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbc1 a group health plan or health insurance issuer offering group or individual health insurance coverage shall provide coverage of selected insulin products and1 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 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 ,,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 ,requirements with respect to cost-sharing for certain insulin products 7a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbc1 a group health plan shall provide coverage of selected insulin products and1 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 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 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 #aihf is amended by adding at the end the following new item3 ,sec4 #ihbf4 ,requirements with respect to cost-sharing for certain insulin products4 4 7c7 ,,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 following3 #gbf4 ,requirements with respect to cost-sharing for certain insulin products 7a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbc1 a group health plan or health insurance issuer offering group health insurance coverage shall provide coverage of selected insulin products and1 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 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 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 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 #gbe the following3 ,sec4 #gbf4 ,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-#aa7;b7 of the ,public ,health ,service ,act7 from the application of any deductible pursuant to section #bgii;,a-#aa7;a77#a7 of such ,act1 section #gbf7;a77#a7 of the ,employee ,retirement ,income ,security ,act of #aigd1 or section #ihbf7;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 following3 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-#aa of the ,public ,health ,service ,act1 before an enrolled individual has incurred1 during a plan year1 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-#aa7;b7 of the ,public ,health ,service ,act2 and 7ii7 the requirements of section #bgii;,a-#aa 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 7f7 ,implementation ,the ,secretary of ,health and ,human ,services1 the ,secretary of ,labor1 and the ,secretary of the ,treasury may implement the provisions of1 including the amendments made by1 this section through sub-regulatory guidance1 program instruction1 or otherwise4 #c4 ,appropriate cost-sharing for certain insulin products under ,medicare part ,d 7a7 ,in general ,section #ahfj;,d-#b of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7 is amended-- 7#a7 in subsection 7b7-- 7,a7 in paragraph 7#a77;,a71 by striking ,the coverage and inserting ,subject to paragraph 7#h71 the coverage2 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,a71 by striking and 7,d7 and inserting and 7,d7 and paragraph 7#h72 7ii7 in subparagraph 7,b71 by striking and 7,d7 and inserting and 7,d7 and paragraph 7#h72 7iii7 in subparagraph 7,c77i71 by striking paragraph 7#d7 and inserting paragraphs 7#d7 and 7#h72 and 7iv7 in subparagraph 7,d77i71 by striking paragraph 7#d7 and inserting paragraphs 7#d7 and 7#h72 7,c7 in paragraph 7#c77;,a71 by striking and 7#d7 and inserting 7#d71 and 7#h72 7,d7 in paragraph 7#d77;,a77i71 by striking ,the coverage and inserting ,subject to paragraph 7#h71 the coverage2 and 7,e7 by adding at the end the following new paragraph3 7#h7 ,treatment of cost-sharing for certain insulin products 7,a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbc1 with respect to an individual1 the following shall apply with respect to any insulin product 7as defined in subparagraph 7,b77 that is covered under the prescription drug plan or ,,ma-,,pd plan in which the individual is enrolled3 7i7 ,no application of deductible ,the deductible under paragraph 7#a7 shall not apply with respect to such insulin product4 7ii7 ,application of cost-sharing 7,i7 ,in general ,the coverage provides benefits for such insulin product1 regardless of whether an individual has reached the initial coverage limit under paragraph 7#c7 or the out-of-pocket threshold under paragraph 7#d71 with cost-sharing for a one-month supply that is equal to the applicable copayment amount4 7,,ii7 ,applicable copayment amount ,for purposes of this clause1 the term applicable copayment amount means1 with respect to an insulin product under a prescription drug plan or an ,,ma-,,pd plan1 an amount that is not more than #ce4 7,b7 ,insulin product ,for purposes of this paragraph1 the term insulin product means a covered part ,d drug that is an insulin product that is approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed under section #cea of the ,public ,health ,service ,act and marketed pursuant to such approval or licensure1 including any insulin product that has been deemed to be licensed under section #cea of the ,public ,health ,service ,act pursuant to section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji and marketed pursuant to such section4 2 and 7#b7 in subsection 7c71 by adding at the end the following new paragraph3 7#d7 ,treatment of cost-sharing for insulin products ,the coverage is provided in accordance with subsection 7b77#h74 4 7b7 ,conforming amendments to cost-,sharing for low-,income individuals ,section #ahfj;,d-#ad7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,d77iii71 by adding at the end the following new sentence3 ,for plan year #bjbc and subsequent plan years1 the copayment amount applicable under the preceding sentence for a one-month supply of an insulin product 7as defined in subparagraph 7,b7 of section #ahfj;,d-#b7;b77#h77 dispensed to the individual may not exceed the applicable copayment amount 7as defined in subparagraph 7,a77ii77,,ii7 of such section7 for the product under the prescription drug plan or ,,ma-,,pd plan in which the individual is enrolled42 and 7,b7 in subparagraph 7,e71 by inserting the following before the period at the end or under section #ahfj;,d-#b7;b77#h7 in the case of an insulin product 7as defined in subparagraph 7,b7 of such section72 and 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,b71 by adding at the end the following new sentence3 ,for plan year #bjbc and subsequent plan years1 the annual deductible applicable under such section1 including as reduced under the preceding sentence1 shall not apply with respect to an insulin product 7as defined in subparagraph 7,b7 of section #ahfj;,d-#b7;b77#h77 dispensed to the individual42 7,b7 in subparagraph 7,d71 by adding at the end the following new sentence3 ,for plan year #bjbc and subsequent plan years1 the amount of the coinsurance applicable under the preceding sentence for a one-month supply of an insulin product 7as defined in subparagraph 7,b7 of section #ahfj;,d-#b7;b77#h77 dispensed to the individual may not exceed the applicable copayment amount 7as defined in subparagraph 7,a77ii77,,ii7 of such section7 for the product under the prescription drug plan or ,,ma-,,pd plan in which the individual is enrolled42 and 7,c7 in subparagraph 7,e71 by adding at the end the following new sentence3 ,for plan year #bjbc and subsequent plan years1 the amount of the copayment or coinsurance applicable under the preceding sentence for a one-month supply of an insulin product 7as defined in subparagraph 7,b7 of section #ahfj;,d-#b7;b77#h77 dispensed to the individual may not exceed the applicable copayment amount 7as defined in subparagraph 7,a77ii77,,ii7 of such section7 for the product under the prescription drug plan or ,,ma-,,pd plan in which the individual is enrolled4 7c7 ,implementation ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services shall implement this section for plan years #bjbc and #bjbd by program instruction or otherwise4 #d4 ,one year-extension on moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates ,section #ijjjf of the ,infrastructure ,investment and ,jobs ,act 7,p4,l4 #aag-eh7 is amended by striking ,january #a1 #bjbf and inserting ,january #a1 #bjbg4 #e4 ,medicare ,improvement ,fund ,section #ahih7;b77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;iii7b77#a771 as amended by section #cac of division ,p of the ,consolidated ,appropriations ,act1 #bjbb1 is amended by striking #e1jjj1jjj and inserting #i1jdf1ejj1jjj4 ,passed the ,house of ,representatives ,march #ca1 #bjbb4;,cheryl ,l4 ,johnson1,clerk4 ,may #be1 #bjbb,read the second time and placed on the calendar