,,ii #aafth ,,congress #ast ,session ,s4 #bhag ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,november #g1 #bjai,mr4 ,merkley 7for himself and ,mr4 ,durbin7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to require the ,secretary of ,health and ,human ,services to establish an annual reference price for insulin products for purposes of ,federal health programs1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,end ,price ,gouging for ,insulin ,act4 #b4 ,reference price for insulin products 7a7 ,reference price ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 in accordance with subsection 7b71 shall establish an annual reference price for insulin products4 ,notwithstanding any other provision of law1 including section #ahfj;,d-#aa7;i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;i771 with respect to enrollees or beneficiaries in any of the ,federal health programs described in subsection 7c71 the wholesale acquisition cost for insulin products1 including the cost-sharing amount1 shall not exceed the reference price for the applicable year4 7b7 ,criteria 7#a7 ,in general ,not later than #f months after the date of enactment of this ,act and every #f months thereafter1 the ,secretary shall establish the reference price for insulin products-- 7,a7 by determining the median wholesale acquisition cost or the commensurate list price in the reference countries for insulin products among the reference countries in which such products are available1 if insulin product pricing information is available for at least three of such countries2 or 7,b7 in the case that insulin product pricing information or dosage equivalents are not available for at least three of the reference countries1 by determining an appropriate price based on-- 7i7 the clinical and therapeutic effect and value of the product2 7ii7 patient access to the product2 7iii7 the costs associated with manufacturing1 marketing1 researching1 and developing the product2 7iv7 total revenues1 net profit1 and executive compensation associated with the manufacturer of the product2 and 7v7 other factors1 as the ,secretary determines appropriate4 7#b7 ,reference countries ,for purposes of paragraph 7#a71 the reference countries are ,japan1 ,germany1 the ,united ,kingdom1 ,france1 ,italy1 ,canada1 ,australia1 ,spain1 the ,netherlands1 ,switzerland1 and ,sweden4 7c7 ,federal health programs ,the reference price established under subsection 7a7 shall apply with respect to covered insulin products under-- 7#a7 the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq472 7#b7 a ,state ,medicaid plan under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq472 7#c7 the ,state ,children's ,health ,insurance ,program under title ,,xxi of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;aa et seq472 7#d7 the ,,tricare program under chapter #ee of title #aj1 ,united ,states ,code2 7#e7 hospital care and medical services furnished by the ,department of ,veterans ,affairs under chapters #ag and #ah of title #ch1 ,united ,states ,code2 7#f7 the ,federal ,employees ,health ,benefits ,program established under chapter #hi of title #e1 ,united ,states ,code2 and 7#g7 any health program1 service1 function1 activity1 or facility funded1 in whole or part1 under the ,indian ,health ,care ,improvement ,act 7#be ,u4,s4,c4 #afja et seq471 including through direct or contract care provided under such ,act or through a contract or compact under the ,indian ,self-,determination and ,education ,assistance ,act 7#be ,u4,s4,c4 #ecjd et seq474 7d7 ,applicability to other purchasers of insulin products ,notwithstanding any other provision of law1 an insulin product manufacturer shall offer such product at the reference price to all individuals1 including individuals who are not insured and individuals who are covered under a group health plan or group or individual health insurance coverage4 7e7 ,civil penalty ,the ,secretary shall enforce this section by imposing a civil penalty upon any insulin product manufacturer who does not comply with the requirements of subsection 7a71 for each year in which the violation occurs1 in an amount equal to #aj times the difference between-- 7#a7 the total amount received by the manufacturer for sales of insulin products under the ,federal health programs under subsection 7c7 for the year2 less 7#b7 the total amount the manufacturer would have received for sales of insulin products under such programs for the year if the manufacturer had complied with subsection 7a74 7f7 ,use of amounts collected ,each year1 the ,secretary of the ,treasury shall allocate the amount collected under subsection 7e7 for the previous year as follows3 7#a7 ,half of such amount shall be deposited in the ,federal ,hospital ,insurance ,trust ,fund and the ,federal ,supplementary ,medical ,insurance ,trust ,fund 7including the ,medicare ,prescription ,drug ,account within such ,trust ,fund7 in such proportion as the ,secretary of ,health and ,human ,services determines appropriate4 7#b7 ,half of such amount shall be transferred to the ,national ,institutes of ,health1 for purposes of carrying out drug research and development4 7g7 ,applicability to brand and generic insulin products ,the reference price established under subsection 7a7 shall apply to insulin products approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74