,,ii #aagth ,,congress #b;d ,session ,s4 #cgjj ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,february #ag1 #bjbb ,mr4 ,warnock 7for himself1 ,mr4 ,schumer1 ,mr4 ,durbin1 ,mr4 ,wyden1 ,mr4 ,bennet1 ,mr4 ,blumenthal1 ,ms4 ,baldwin1 ,mr4 ,kelly1 ,ms4 ,stabenow1 ,mr4 ,reed1 ,mr4 ,van ,hollen1 ,ms4 ,hirono1 ,ms4 ,klobuchar1 ,mr4 ,murphy1 ,ms4 ,hassan1 ,mrs4 ,shaheen1 ,mr4 ,booker1 ,mr4 ,king1 ,ms4 ,smith1 and ,mr4 ,padilla7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to provide for appropriate cost-sharing for insulin products covered under ,medicare part ,d and private health plans4 #a4 ,short title ,this ,act may be cited as the ,affordable ,insulin ,now ,act4 #b4 ,appropriate cost-sharing for insulin products covered under ,medicare part ,d and private health plans 7a7 ,medicare part ,d 7#a7 ,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-- 7i7 in paragraph 7#a77;,a71 in the matter preceding clause 7i71 by striking ,the coverage and inserting ,subject to paragraph 7#h71 the coverage2 7ii7 in paragraph 7#b7-- 7,i7 in subparagraph 7,a71 in the matter preceding clause 7i71 by striking and 7,d7 and inserting and 7,d7 and paragraph 7#h72 7,,ii7 in subparagraph 7,c77i71 in the matter preceding subclause 7,i71 by striking paragraph 7#d7 and inserting paragraphs 7#d7 and 7#h72 and 7,,iii7 in subparagraph 7,d77i71 in the matter preceding subclause 7,i71 by striking paragraph 7#d7 and inserting paragraphs 7#d7 and 7#h72 7iii7 in paragraph 7#c77;,a71 in the matter preceding clause 7i71 by striking and 7#d7 and inserting 7#d71 and 7#h72 7iv7 in paragraph 7#d77;,a77i71 in the matter preceding subclause 7,i71 by striking ,the coverage and inserting ,subject to paragraph 7#h71 the coverage2 and 7v7 by adding at the end the following new paragraph3 7#h7 ,treatment of cost-sharing for covered insulin products 7,a7 ,in general ,for the portion of plan year #bjbb beginning on ,october #a1 #bjbb1 and ending on ,december #ca1 #bjbb1 and for plan year #bjbc and subsequent plan years1 the following rules shall apply with respect to cost-sharing for a month's supply of any covered insulin product 7as defined in subparagraph 7,b77 that is covered under the prescription drug plan or ,,ma-,,pd plan3 7i7 ,no application of deductible ,the deductible under paragraph 7#a7 shall not apply with respect to any such covered insulin product4 7ii7 ,maximum cost-sharing 7,i7 ,in general ,the coverage shall provide benefits for such any covered insulin product1 regardless of whether an individual has reached the initial coverage limit under paragraph 7#c7 or the annual out-of-pocket threshold under paragraph 7#d71 with cost-sharing for a month's supply that does not exceed the maximum cost-sharing amount4 7,,ii7 ,maximum cost-sharing amount ,for purposes of subclause 7,i71 the term maximum cost-sharing amount means1 with respect to a covered insulin product under a prescription drug plan or an ,,ma-,,pd plan dispensed-- 7aa7 on or after ,october #a1 #bjbb1 and before ,january #a1 #bjbd1 #ce2 and 7bb7 during plan year #bjbd or subsequent plan year1 the lesser of-- 7,,aa7 #ce2 or 7,,bb7 an amount equal to #be percent of the negotiated price of the covered insulin product under the prescription drug plan or ,,ma-,,pd plan4 7,b7 ,covered insulin product ,for purposes of this paragraph1 the term covered 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 continues to be marketed1 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 continues to be marketed4 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 7#b7 ,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-- 7i7 in subparagraph 7,d77iii71 by adding at the end the following new sentence3 ,for the portion of plan year #bjbb beginning on ,october #a1 #bjbb1 and ending on ,december #ca1 #bjbb1 and for plan year #bjbc and subsequent plan years1 the copayment amount applicable under the preceding sentence to a month's supply of a covered insulin product 7as described in section #ahfj;,d-#b7;b77#h77 dispensed to the individual may not exceed the applicable copayment or coinsurance amount for the product under the prescription drug plan or ,,ma-,,pd plan in which the individual is enrolled42 and 7ii7 in subparagraph 7,e71 by inserting the following before the period at the end3 or under section #ahfj;,d-#b7;b77#h7 in the case of a covered insulin product 7as described in such section72 and 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,d71 by adding at the end the following new sentence3 ,for the portion of plan year #bjbb beginning on ,october #a1 #bjbb1 and ending on ,december #ca1 #bjbb1 and for plan year #bjbc and subsequent plan years1 the amount of the coinsurance applicable under the preceding sentence to a month's supply of a covered insulin product 7as described in section #ahfj;,d-#b7;b77#h77 dispensed to the individual may not exceed the applicable copayment or coinsurance amount for the product under the prescription drug plan or ,,ma-,,pd plan in which the individual is enrolled42 and 7ii7 in subparagraph 7,e71 by adding at the end the following new sentence3 ,for the portion of plan year #bjbb beginning on ,october #a1 #bjbb1 and ending on ,december #ca1 #bjbb1 and for plan year #bjbc and subsequent plan years1 the amount of the copayment or coinsurance applicable under the preceding sentence to a month's supply of a covered insulin product 7as described in section #ahfj;,d-#b7;b77#h77 dispensed to the individual may not exceed the applicable copayment or coinsurance amount for the product under the prescription drug plan or ,,ma-,,pd plan in which the individual is enrolled44 7#c7 ,implementation ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services may implement the provisions of1 including the amendments made by1 this subsection for plan years #bjbb1 #bjbc1 and #bjbd by program instruction or otherwise4 7#d7 ,funding ,in addition to amounts otherwise available1 there is appropriated to the ,centers for ,medicare ,medicaid ,services1 out of any money in the ,treasury not otherwise appropriated1 #a1ejj1jjj for fiscal year #bjbb1 to remain available until expended1 to carry out the provisions of1 including the amendments made by1 this subsection4 7b7 ,private health plans 7#a7 ,in general ,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 following3 #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 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 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 ,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 7#c7 ,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 the 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 7#d7 ,,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 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 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 7#e7 ,internal ,revenue ,code 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 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 such ,code is amended by adding at the end the following new item3 ,sec4 #ihbf4 ,requirements with respect to cost-sharing for certain insulin products4 4 7#f7 ,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 subsection through sub-regulatory guidance1 program instruction or otherwise4