,,ii #aaith ,,congress #b;d ,session ,s4 #eega ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,september #bh1 #bjbf,mrs4 ,blackburn 7for herself1 ,mr4 ,schiff1 ,mr4 ,lankford1 and ,mr4 ,budd7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend title ,,xi of the ,social ,security ,act to alter when biosimilar biological products are eligible for price negotiations under the ,medicare program4 #a4 ,short title ,this ,act may be cited as the ,biosimilars ,access and ,affordability ,act4 #b4 ,change of when biosimilars are eligible for price negotiations 7a7 ,in general ,section #aaib of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;f-#a7 is amended-- 7#a7 in subsection 7c7-- 7,a7 in paragraph 7#a71 in the matter preceding subparagraph 7,a71 by striking such year and each subsequent year beginning before the first year that begins at least #i months and inserting the year of the selected drug publication date for such initial price applicability year and each subsequent year1 except that a drug or biological product shall no longer be a selected drug beginning on the first day of the year that begins2 and 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,b71 by striking or during the negotiation period with respect to such initial price applicability year and inserting the first day of such initial price applicability year2 and 7ii7 in the flush text following subparagraph 7,b7-- 7,i7 by striking and shall continue to and inserting if such negotiation period has not yet ended1 shall not have its maximum fair price or the explanation of such maximum fair price published under section #aaie7;a7 if such publication has not yet occurred1 and shall2 7,,ii7 by inserting solely before with respect to the number2 and 7,,iii7 by inserting 1 but no maximum fair price shall apply for such initial price applicability year in accordance with paragraph 7#a7 before the period at the end2 7#b7 in subsection 7f7-- 7,a7 in paragraph 7#a7-- 7i7 in subparagraph 7,a71 by striking an extended monopoly drug 7as defined in section #aaid7;c77#d72 7ii7 in subparagraph 7,b7-- 7,i7 in the heading1 by striking ,request required and inserting ,procedures2 7,,ii7 by redesignating clauses 7i7 and 7ii7 as clauses 7ii7 and 7iii7 respectively2 7,,iii7 by inserting before clause 7ii7 7as so redesignated7 the following3 7i7 ,automatic delay 7,i7 ,in general ,the ,secretary shall apply1 with respect to a biological product described in subparagraph 7,a71 the rules described in subparagraph 7,a7 of paragraph 7#b7 7subject to subparagraphs 7,b7 and 7,c7 of such paragraph7 if1 prior to the selected drug publication date for the list published under subsection 7a7 with respect to the initial price applicability year for which the biological product may have been included as a selected drug on such list but for paragraph 7#b77;,a7-- 7aa7 the manufacturer of a biosimilar biological product for which such biological product will be the reference product has publicly disclosed in a press release or other communication1 or the ,secretary determines from information from any other source-- 7,,aa7 that such manufacturer's application for licensure under section #cea7k7 of the ,public ,health ,service ,act for the biosimilar biological product was accepted for review or approved by the ,food and ,drug ,administration2 or 7,,bb7 that such manufacturer's clinical study or studies of the biosimilar biological product as described in section #cea7k77#b77;,a77i77,i77cc7 of the ,public ,health ,service ,act were initiated and remain ongoing1 are complete1 or that no such study or studies are necessary2 and 7bb7 subject to subclause 7,,ii71 based on information submitted to the ,secretary by any person or obtained by the ,secretary from any other source1 the ,secretary determines that the manufacturer of the biosimilar biological product expects that such product will be marketed before the date that is #b years after the selected drug publication date with respect to such initial price applicability year4 7,,ii7 ,requirements 7aa7 ,in general ,before making the determination described in subclause 7,,ii77bb71 the ,secretary shall-- 7,,aa7 inform the manufacturer of the biosimilar biological product of the information on which the ,secretary intends to rely in making such determination2 and 7,,bb7 require that such manufacturer confirms in writing1 under penalty of perjury1 the accuracy of such information or corrects any such inaccurate information1 including its expected marketing date4 7bb7 ,clarification ,the existence of pending or prospective patent litigation over a biosimilar biological product shall not preclude application of the rules described in subparagraph 7,a7 of paragraph 7#b7 7subject to paragraphs 7,b7 and 7,c7 of such paragraph74 2 7,,iv7 in clause 7ii7 7as so redesignated7-- 7aa7 by striking subclause 7,,ii72 7bb7 by striking ,in general and all that follows through unless and inserting ,delay upon request4-- ,the ,secretary shall provide for a delay under paragraph 7#b77;,a7 if2 and 7cc7 by striking subparagraph 7#b77;,a7 or2 and inserting paragraph 7#b77;,a71 provided that a determination of high likelihood is made under paragraph 7#c742 and 7,v7 in clause 7iii7 7as so redesignated7-- 7aa7 in the heading1 by inserting for a delay upon request after documents2 7bb7 in subclause 7,i71 in the matter before item 7aa71 by striking clause 7i7 and inserting clause 7ii72 7cc7 in subclause 7,i77bb71 by inserting to the extent available1 before all agreements2 and 7dd7 in subclause 7,,iii77bb7-- 7,,aa7 by inserting the anticipated launch date before capital investment2 and 7,,bb7 by striking year 7or the #b years1 as applicable7 and inserting applicable period2 and 7iii7 in subparagraph 7,c77i71 by striking paragraph 7#b77;,d77iv7 and inserting paragraph 7#b77;,c77iii72 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,a7-- 7,i7 in the heading1 by striking #a year and inserting #b years2 7,,ii7 by inserting or paragraph 7#a77;,b77i7 applies after under paragraph 7#c72 and 7,,iii7 by striking #a year and inserting #b years2 7ii7 by striking subparagraph 7,b7 and inserting the following3 7,b7 ,if not licensed and marketed during the delay ,if1 during the time period between the selected drug publication date on which the biological product would have been included on the list as a selected drug pursuant to subsection 7a7 but for subparagraph 7,a71 and the selected drug publication date with respect to the initial price applicability year that is #b years after the initial price applicability year for which such biological product would have been included as a selected drug on such list1 the ,secretary determines that such biological product is not the reference product for a biosimilar biological product that has been licensed and marketed under section #cea7k7 of the ,public ,health ,service ,act-- 7i7 the ,secretary shall include the biological product as a selected drug on the list published under subsection 7a7 with respect to the initial price applicability year that is #b years after the initial price applicability year for which such biological product would have been included as a selected drug on such list but for subparagraph 7,a72 and 7ii7 if such biosimilar biological product has not been licensed and marketed under section #cea7k7 of the ,public ,health ,service ,act on or before the date that is #b years after the selected drug publication date on which the biological product would have been included on the list as a selected drug pursuant to subsection 7a7 but for subparagraph 7,a71 the manufacturer of such biological product shall pay a rebate under paragraph 7#d7 with respect to the years for which such manufacturer would have provided access to a maximum fair price for such biological product but for subparagraph 7,a74 2 7iii7 by striking subparagraph 7,c72 7iv7 by redesignating subparagraph 7,d7 as subparagraph 7,c72 and 7v7 in subparagraph 7,c7 7as so redesignated7-- 7,i7 by striking clauses 7ii7 and 7iii72 7,,ii7 by redesignating clause 7iv7 as clause 7ii72 and 7,,iii7 in clause 7ii77,,ii7 7as so redesignated71 by striking paragraph 7#a77;,b77ii77,i77bb7 and inserting paragraph 7#a77;,b77iii77,i77bb72 7,c7 by striking paragraph 7#c7 and inserting the following3 7#c7 ,high likelihood 7,a7 ,in general ,subject to subparagraph 7,b71 for purposes of this subsection1 there is a high likelihood described in paragraph 7#a7 or paragraph 7#b71 as applicable1 if the ,secretary determines that information submitted to the ,secretary by any person or obtained by the ,secretary from any other source provides clear and convincing evidence that such biosimilar biological product will1 within the time period specified under paragraph 7#a77;,a7 be marketed4 7,b7 ,determination requirements ,before determining whether there is a high likelihood described in paragraph 7#a7 or paragraph 7#b71 the ,secretary shall inform the manufacturer of the biosimilar biological product of the information on which the ,secretary intends to rely in making such determination and shall require that such manufacturer confirms in writing1 under penalty of perjury1 the accuracy of such information or correct any such inaccurate information4 7,c7 ,clarification ,the existence of pending or prospective patent litigation regarding the biosimilar biological product shall not preclude a finding of high likelihood under this paragraph4 2 and 7,d7 in paragraph 7#d7-- 7i7 in subparagraph 7,a71 by striking subparagraphs 7,b77ii77,,ii7 and 7,c77ii7 of paragraph 7#b7 and inserting paragraph 7#b77;,b77ii72 and 7ii7 in subparagraph 7,b7-- 7,i7 in clause 7i71 by striking subclause 7,i7 and inserting the following3 7,i7 #ge percent of the amount by which the average manufacturer price1 as reported by the manufacturer of such covered part ,d drug under section #aibg 7or1 if not reported by such manufacturer under section #aibg1 as reported by such manufacturer to the ,secretary pursuant to the agreement under section #aaic7;a77 for such biological product1 with respect to each of the calendar quarters of the price applicability period that would have applied but for this subsection2 exceeds-- 7aa7 for the initial price applicability year that would have applied but for a delay under paragraph 7#b77;,a71 the maximum fair price negotiated under section #aaid for such biological product under such agreement2 or 7bb7 for the second year of such delay1 such maximum fair price1 increased as described in section #aaie7;b77#a77;,a72 and 2 and 7,,ii7 in clause 7ii71 by striking subclause 7,i7 and inserting the following3 7,i7 #hj percent of the amount by which the payment amount for such biological product under section #ahdg;,a7b71 with respect to each of the calendar quarters of the price applicability period that would have applied but for this subsection2 exceeds-- 7aa7 for the initial price applicability year that would have applied but for a delay under paragraph 7#b77;,a71 the maximum fair price negotiated under section #aaid for such biological product under such agreement2 or 7bb7 for the second year of such delay1 such maximum fair price1 increased as described in section #aaie7;b77#a77;,a72 and 2 and 7#c7 by adding at the end the following new subsection3 7g7 ,definition of marketed ,in this section1 the term marketed means1 with respect to a drug or biological product 7including a biosimilar biological product7 introduced or delivered for introduction into interstate commerce4 4 7b7 ,conforming and technical amendments ,such ,act is amended-- 7#a7 in section #aaib7;b77#c7 7#db ,u4,s4,c4 #acbj;f-#a7;b77#c77-- 7,a7 by striking subparagraphs 7,b77ii77,i7 and 7,c77i7 of subsection 7f77#b7 and inserting subsection 7f77#b77;,b77i72 and 7,b7 by striking described in such subparagraphs and inserting described in such subsection2 and 7#b7 in section #aaih7b7 7#db ,u4,s4,c4 #acbj;f-#g7b771 by striking #aaib7;f71 and inserting #aaib7;f74 7c7 ,effective date ,the amendments made by this section shall apply with respect to initial price applicability years beginning with initial price applicability year #bjbf4