,,ii #aafth ,,congress #ast ,session ,s4 #baii ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #bb1 #bjai ,mrs4 ,shaheen 7for herself1 ,ms4 ,collins1 ,mr4 ,carper1 and ,mr4 ,cramer7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to provide patient protections with respect to the cost of insulin4 #a4 ,short title ,this ,act may be cited as the ,insulin ,price ,reduction ,act4 #b4 ,insulin price protections 7a7 ,in general ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq47 is amended by adding at the end the following3 #bgbi;,a4 ,insulin price protections 7a7 ,contracting requirements 7#a7 ,in general 7,a7 ,requirement ,except as provided in subparagraph 7,b71 a group health plan or a health insurance issuer offering group or individual health insurance coverage shall not1 and shall ensure that any entity that provides pharmacy benefits management services under a contract with any such health plan or health insurance coverage does not1 directly or indirectly1 receive from a manufacturer of certified insulin a rebate1 reduction in price1 or other remuneration with respect to such insulin received by an enrollee in the plan or coverage and covered by the plan or coverage4 7,b7 ,exception ,the requirement under subparagraph 7,a7 shall not apply to-- 7i7 any such reduction in price that is reflected at the point of sale to the enrollee2 or 7ii7 any remuneration that is a flat fee-based service fee that a manufacturer of such insulin pays to a pharmacy benefit manager for services rendered to the manufacturer that relate to arrangements by the pharmacy benefit manager to provide pharmacy benefit management services to a health plan or health insurance issuer1 if certain conditions established by the ,secretary are met1 including requirements that the fees are transparent to the health plan or health insurance issuer4 7#b7 ,applicability ,the restriction under paragraph 7#a7 shall apply with respect to insulin described in paragraph 7#a71 for which the manufacturer has certified the list price in accordance with section #e7;b7 of the ,insulin ,price ,reduction ,act with respect to-- 7,a7 any plan year in which the list price for insulin is certified under section #e7;b77#b77;,a7 of the ,insulin ,price ,reduction ,act2 and 7,b7 each subsequent plan year during which the manufacturer limits any increase in the list price to the price that gave rise to the restriction under paragraph 7#a71 adjusted by not more than the price change in the medical care component of the consumer price index for all urban consumers 7,u4,s4 city average71 as certified under section #e7;b77#b77;,b7 of the ,insulin ,price ,reduction ,act4 7b7 ,deductible limitation ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall not apply any deductible amount that otherwise is applicable to prescription drugs with respect to coverage of certified insulin under such plan or coverage1 during the period described in subsection 7a77#b74 7c7 ,hold harmless ,in the first #b plan years during which paragraph 7#a7 applies with respect to an insulin certified under section #e7;b7 of the ,insulin ,price ,reduction ,act1 a group health plan or a health insurance issuer offering group or individual health insurance coverage shall not1 and shall ensure that any entity that provides pharmacy benefits management services under a contract with such health plan or health insurance coverage does not-- 7#a7 remove such insulin from the formulary applicable to the plan or coverage2 7#b7 impose higher cost-sharing with respect to such insulin than the cost-sharing that applied with respect to the insulin in the year in which the list price reduction certification was provided under section #e7;b77#b77;,a7 of the ,insulin ,price ,reduction ,act2 7#c7 impose any prior authorization requirements for coverage of such insulin that were not applied during the year in which the list price reduction certification was provided under such section #e7;b77#b77;,a72 or 7#d7 establish a step therapy requirement for such insulin that was not applied during the year in which the list price reduction certification was provided under such section #e7;b77#b77;,a74 7d7 ,definitions ,in this section-- 7#a7 the term certified insulin means1 with respect to a year1 insulin that has been certified under section #e7;b7 of the ,insulin ,price ,reduction ,act for the year2 7#b7 the term insulin means any insulin product approved by the ,food and ,drug ,administration to improve glycemic control in patients with diabetes mellitus2 7#c7 the term list price has the meaning given the term wholesale acquisition cost in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act2 and 7#d7 the term rebate means any discount1 price concession1 or fee1 other than the fee described in section 7a77#a77;,b71 the terms of which are fixed at the time of the sale and disclosed1 but which is not received at the time of the sale4 4 7b7 ,conforming amendment ,paragraph 7#b7 of section #bbc7;d7 of the ,internal ,revenue ,code of #aihf is amended by redesignating subparagraph 7,d7 as subparagraph 7,e7 and by inserting after subparagraph 7,c7 the following new subparagraph3 7,d7 ,safe harbor for absence of deductible for insulin ,a plan shall not fail to be treated as a high deductible health plan by reason of exempting insulin from any deductible pursuant to section #bgbi;,a7b7 of the ,public ,health ,service ,act during the period described in section #bgbi;,a7a77#b7 of such ,act4 4 7c7 ,effective date ,the amendments made by subsections 7a7 and 7b7 shall take effect with respect to plan years beginning on or after ,january #a1 #bjbb4 #c4 ,insulin price protections under ,medicare part ,d ,section #ahfj;,d-#d of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7 is amended-- 7#a7 by redesignating the subsection 7m7 as added by section #fjfc7;c7 of the ,,support for ,patients and ,communities ,act 7,public ,law #aae-bga7 as subsection 7n72 and 7#b7 by adding at the end the following new subsection3 7o7 ,limitation on rebates1 price reductions1 or other remuneration for certified insulin 7#a7 ,limitation 7,a7 ,in general ,subject to subparagraphs 7,b7 and 7,c71 for plan year #bjbb and subsequent plan years1 a ,,pdp sponsor and a ,medicare ,advantage organization shall ensure that each prescription drug plan or ,,ma-,,pd plan offered by the sponsor or organization1 and any entity that provides pharmacy benefits management services under a contract with the prescription drug plan or ,,ma-,,pd plan offered by the sponsor or organization1 does not1 directly or indirectly1 receive from a manufacturer of certified insulin a rebate1 reduction in price1 or other remuneration with respect to certified insulin that is covered by the plan4 7,b7 ,exception ,the requirement under subparagraph 7,a7 shall not apply to-- 7i7 any such reduction in price that is reflected at the point of sale to the beneficiary2 or 7ii7 any remuneration that is a flat fee-based service fee that a manufacturer of such certified insulin pays to a pharmacy benefit manager for services rendered to the manufacturer that relate to arrangements by the pharmacy benefit manager to provide pharmacy benefit management services to a prescription drug plan or ,,ma-,,pd plan1 if certain conditions established by the ,secretary are met1 including requirements that the fees are transparent to the prescription drug plan or ,,ma-,,pd plan4 7,c7 ,hold harmless for first #b years that an insulin is certified ,in the first #b plan years during which paragraph 7#b7 applies with respect to a certified insulin1 a ,,pdp sponsor and a ,medicare ,advantage organization shall not1 and shall ensure that any entity that provides pharmacy benefits management services under a contract with such sponsor or organization does not-- 7i7 remove such insulin from the formulary applicable to the prescription drug plan or ,,ma-,,pd plan2 7ii7 impose higher cost-sharing with respect to such insulin than the cost-sharing that applied with respect to the certified insulin in the year in which the list price reduction certification was provided under section #e7;b77#b77;,a7 of the ,insulin ,price ,reduction ,act2 7iii7 impose any prior authorization requirements for coverage of the certified insulin that were not applied during the year in which the list price reduction certification was provided under such section #e7;b77#b77;,a72 or 7iv7 establish a step therapy requirement for the certified insulin that was not applied during the year in which the list price reduction certification was provided under such section #e7;b77#b77;,a74 7#b7 ,definitions ,in this section3 7,a7 ,certified insulin ,the term certified insulin means1 with respect to a year1 insulin that has been certified under section #e7;b7 of the ,insulin ,price ,reduction ,act for the year4 7,b7 ,insulin ,the term insulin means any insulin product approved by the ,food and ,drug ,administration to improve glycemic control in patients with diabetes mellitus4 7,c7 ,list price ,the term list price has the meaning given the term wholesale acquisition cost in section #ahdg;,a7c77#f77;,b74 7,d7 ,rebate ,the term rebate means any discount1 price concession1 or fee1 other than the fee described in paragraph 7#a77;,b71 the terms of which are fixed at the time of the sale and disclosed1 but which is not received at the time of the sale4 4 #d4 ,applicability of pre-list price reduction ,,amp to ,medicaid minimum rebate amounts ,section #aibg7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77 is amended-- 7#a7 in paragraph 7#a77;,a71 in the matter preceding clause 7i71 by inserting and paragraph 7#e7 after paragraph 7#b72 7#b7 in paragraph 7#c77;,a71 in the matter preceding clause 7i71 by inserting and paragraph 7#e7 after subparagraph 7,c72 and 7#c7 by adding at the end the following new paragraph3 7#e7 ,special rule for determining minimum basic rebates for insulin 7,a7 ,in general ,in determining the amount of the rebate specified in this subsection for a dosage form and strength of a covered outpatient drug described in subparagraph 7,b7 for any rebate period occurring after ,april #cj1 #bjbj1 paragraph 7#a77;,a77ii77,,ii7 or paragraph 7#c77;,a77i7 7as applicable7 shall be applied by substituting-- 7i7 the pre-reduction average manufacturer price 7as defined in subparagraph 7,c77 for the dosage form and strength of the drug for the rebate period2 for 7ii7 the average manufacturer price for the dosage form and strength of the drug for the rebate period4 7,b7 ,drugs described ,a covered outpatient drug is described in this subparagraph for a rebate period if the drug is insulin for which1 throughout such rebate period1 the manufacturer has certified the list price for each dosage form and strength of such drug in accordance with section #e7;b7 of the ,insulin ,price ,reduction ,act4 7,c7 ,pre-reduction average manufacturer price ,for purposes of this paragraph1 the term pre-reduction average manufacturer price means1 with respect to each dosage form and strength of a covered outpatient drug described in subparagraph 7,b7 and a rebate period-- 7i7 the average manufacturer price for such drug for the calendar quarter beginning ,july #a1 #bjai2 increased by 7ii7 the percentage by which the consumer price index for all urban consumers 7,united ,states city average7 for the month before the month in which the rebate period begins exceeds such index for ,september #bjai4 4 #e4 ,list price data submissions 7a7 ,initial submission 7#a7 ,in general ,not later than ,april #cj1 #bjbj1 any manufacturer of insulin wishing to receive certification under this section shall submit to the ,secretary-- 7,a7 data on the list price of any insulin manufactured by the manufacturer during the period beginning on ,january #a1 #bjjj 7or the first date on which such manufacturer begins manufacturing such insulin71 through the list price applicable at the time of the report2 and 7,b7 a certification that such data is accurate4 7#b7 ,later submissions ,any manufacturer of insulin that does not submit the information described in paragraph 7#a7 by the date described in such paragraph may later submit the information described in subparagraphs 7,a7 and 7,b7 of paragraph 7#a7 to the ,secretary4 ,such a manufacturer who submits such information pursuant to this paragraph is eligible to certify its list price for the applicable insulin under subsection 7b77#b77;,a77ii7 with respect to the first plan year that begins at least #ae months after the date of submission under this paragraph4 7b7 ,annual price certification 7#a7 ,in general ,any manufacturer of insulin who submits information in accordance with subsection 7a7 is eligible for certification under this subsection4 7#b7 ,requirements 7,a7 ,first certification 7i7 ,initial eligibility for certification ,a manufacturer of insulin who submits information under subsection 7a77#a7 is considered certified under this subsection for plan year #bjbb if such manufacturer1 not later than ,september #cj1 #bjbj1 submits to the ,secretary a certification that the manufacturer reduced its list price for insulin to an amount that is no greater than the list price for the same insulin that applied as of ,july #a1 #bjjf4 7ii7 ,later certification ,a manufacturer of insulin that submitted information under subsection 7a77#b7 not later than ,september #cj of the calendar year that is #b years prior to the applicable plan year1 is considered certified under this subsection for the applicable plan year if such manufacturer submits to the ,secretary a certification1 not later than ,september #cj of such calendar year1 that the manufacturer reduced its list price for insulin to the amount that is no greater than the list price for the same insulin that applied as of ,july #a1 #bjjf1 increased by not more than the rate by which the medical care component of the consumer price index for all urban consumers 7,u4,s4 city average7 increased between ,september #cj1 #bjbj1 and the date on which the certification is submitted4 7,b7 ,subsequent certification ,for plan year #bjbc and each plan year thereafter1 a manufacturer of insulin who previously submitted a certification under clause 7i7 or 7ii7 of subparagraph 7,a7 is considered certified under this subsection for the applicable plan year if such manufacturer submits1 not later than ,september #cj of the calendar year that is #b years prior to the applicable plan year1 a certification that the manufacturer did not increase the list price for insulin previously certified under clause 7i7 or 7ii7 of subparagraph 7,a71 by more than the rate by which the medical care component of the consumer price index for all urban consumers 7,u4,s4 city average7 increased since the initial certification under such clause 7i7 or 7ii74 7#c7 ,special rule for certain insulin 7,a7 ,in general ,in the case of a manufacturer of insulin that did not manufacture a particular insulin in #bjjf1 such manufacturer may be certified under this subsection with respect to such insulin by submitting information under paragraph 7#b77;,a7 certifying that the list price of such insulin is no greater than the weighted average list price1 in #bjjf1 of1 as applicable-- 7i7 7,i7 all short-acting insulins2 7,,ii7 all rapid-acting insulins2 or 7,,iii7 all long-acting insulins2 or 7ii7 such other insulin categories1 as the ,secretary determines appropriate4 7,b7 ,increase ,the weighted averages under subparagraph 7,a7 shall be increased in accordance with paragraph 7#b77;,a77ii71 as applicable4 7#d7 ,application to authorized generic insulin ,in the case of an insulin that is classified as an authorized generic drug1 as defined in section #eje7t77#c7 of the ,federal ,food1 ,drug and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7t77#c771 the manufacturer of such insulin may be certified under this section by submitting information under paragraph 7#a77;,a7 certifying that the list price of such authorized generic insulin is no greater than the list price1 as of ,july #a1 #bjjf1 of the listed drug insulin product upon which the authorized generic drug was based under section #eje7t7 of the ,federal ,food1 ,drug and ,cosmetic ,act4 ,the certification pursuant to this paragraph applies only to the authorized generic drug insulin1 and does not apply with respect to the applicable listed drug insulin4 7c7 ,audits and penalties ,the ,inspector ,general of the ,department of ,health and ,human ,services may audit the financial records and other relevant records of any manufacturer submitting data under subsections 7a7 and 7b71 and any manufacturer or officer1 director1 agent1 or managing employee of such manufacturer that knowingly submits false or incomplete data shall be subject to a civil penalty for each insulin for which false or incomplete data are submitted in an amount not to exceed the greater of-- 7#a7 an amount equal to #b times the total amount of rebates paid by the manufacturer to ,state ,medicaid plans for the insulin for rebate periods occurring in calendar year #bjah under section #aibg of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h72 or 7#b7 an alternative amount to be determined by the ,secretary4 7d7 ,definitions ,in this section-- 7#a7 the term insulin means any insulin product approved by the ,food and ,drug ,administration to improve glycemic control in patients with diabetes mellitus2 7#b7 the term list price has the meaning given the term wholesale acquisition cost in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b772 and 7#c7 the term ,secretary means the ,secretary of ,health and ,human ,services4