,,ii #aagth ,,congress #b;d ,session ,s4 #djaa ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,april #f1 #bjbb,mr4 ,warnock introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend title ,,xviii of the ,social ,security ,act to provide for a cap on beneficiary liability under part ,d of the ,medicare program1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,capping ,drug ,costs for ,seniors ,act of #bjbb4 #b4 ,medicare part ,d benefit redesign 7a7 ,benefit structure redesign ,section #ahfj;,d-#b7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a71 in the matter preceding clause 7i71 by inserting for a year preceding #bjbe and for costs above the annual deductible specified in paragraph 7#a7 and up to the annual out-of-pocket threshold specified in paragraph 7#d77;,b7 for #bjbe and each subsequent year after paragraph 7#c72 7,b7 in subparagraph 7,c7-- 7i7 in clause 7i71 in the matter preceding subclause 7,i71 by inserting for a year preceding #bjbe1 after paragraph 7#d712 and 7ii7 in clause 7ii77,,iii71 by striking #bjbj and each subsequent year and inserting each of years #bjbj through #bjbd1 2 and 7,c7 in subparagraph 7,d7-- 7i7 in clause 7i7-- 7,i7 in the matter preceding subclause 7,i71 by inserting for a year preceding #bjbe1 after paragraph 7#d712 and 7,,ii7 in subclause 7,i77bb71 by striking a year after #bjah and inserting each of years #bjah through #bjbd2 and 7ii7 in clause 7ii77,v71 by striking #bjai and each subsequent year and inserting each of years #bjai through #bjbd2 7#b7 in paragraph 7#c77;,a7-- 7,a7 in the matter preceding clause 7i71 by inserting for a year preceding #bjbe1 after and 7#d712 and 7,b7 in clause 7ii71 by striking for a subsequent year and inserting for each of years #bjjg through #bjbd2 and 7#c7 in paragraph 7#d7-- 7,a7 in subparagraph 7,a7-- 7i7 in clause 7i7-- 7,i7 by redesignating subclauses 7,i7 and 7,,ii7 as items 7aa7 and 7bb71 respectively1 and moving the margin of each such redesignated item #b ems to the right2 7,,ii7 in the matter preceding item 7aa71 as redesignated by subclause 7,i71 by striking is equal to the greater of-- and inserting 8is equal to-- 7,i7 for a year preceding #bjbe1 the greater of-- 2 7,,iii7 by striking the period at the end of item 7bb71 as redesignated by subclause 7,i71 and inserting 2 and2 and 7,,iv7 by adding at the end the following3 7,,ii7 for #bjbe and each succeeding year1 #j4 2 and 7ii7 in clause 7ii7-- 7,i7 by striking clause 7i77,i7 and inserting clause 7i77,i77aa72 and 7,,ii7 by adding at the end the following new sentence3 ,the ,secretary shall continue to calculate the dollar amounts specified in clause 7i77,i77aa71 including with the adjustment under this clause1 after #bjbd for purposes of section #ahfj;,d-#ad7;a77#a77;,d77iii742 7,b7 in subparagraph 7,b7-- 7i7 in clause 7i7-- 7,i7 in subclause 7,v71 by striking or at the end2 7,,ii7 in subclause 7,,vi7-- 7aa7 by striking for a subsequent year and inserting for each of years #bjba through #bjbd2 and 7bb7 by striking the period at the end and inserting a semicolon2 and 7,,iii7 by adding at the end the following new subclauses3 7,,vii7 for #bjbe1 is equal to #b1jjj2 or 7,,viii7 for a subsequent year1 is equal to the amount specified in this subparagraph for the previous year1 increased by the annual percentage increase described in paragraph 7#f7 for the year involved4 2 and 7ii7 in clause 7ii71 by striking clause 7i77,,ii7 and inserting clause 7i72 7,c7 in subparagraph 7,c77i71 by striking and for amounts and inserting and1 for a year preceding #bjbe1 for amounts2 and 7,d7 in subparagraph 7,e71 by striking ,in applying and inserting ,for each of years #bjaa through #bjbd1 in applying4 7b7 ,reinsurance payment amount ,section #ahfj;,d-#ae7;b77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;b77#a77 is amended-- 7#a7 by striking equal to #hj percent and inserting 8equal to-- 7,a7 for a year preceding #bjbe1 #hj percent 2 7#b7 in subparagraph 7,a71 as added by subparagraph 7,a71 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following new subparagraph3 7,b7 for #bjbe and each subsequent year1 the sum of-- 7i7 with respect to applicable drugs 7as defined in section #ahfj;,d-#ad;,b7g77#b771 an amount equal to #bj percent of such allowable reinsurance costs attributable to that portion of gross covered prescription drug costs as specified in paragraph 7#c7 incurred in the coverage year after such individual has incurred costs that exceed the annual out-of-pocket threshold specified in section #ahfj;,d-#b7;b77#d77;,b72 and 7ii7 with respect to covered part ,d drugs that are not applicable drugs 7as so defined71 an amount equal to #dj percent of such allowable reinsurance costs attributable to that portion of gross covered prescription drug costs as specified in paragraph 7#c7 incurred in the coverage year after such individual has incurred costs that exceed the annual out-of-pocket threshold specified in section #ahfj;,d-#b7;b77#d77;,b74 4 7c7 ,manufacturer discount program 7#a7 ,in general ,part ,d of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq47 is amended by inserting after section #ahfj;,d-#ad;,a the following new section3 #ahfj;,d-#ad;,b4 ,manufacturer discount program 7a7 ,establishment ,the ,secretary shall establish a manufacturer discount program 7in this section referred to as the program74 ,under the program1 the ,secretary shall enter into agreements described in subsection 7b7 with manufacturers and provide for the performance of the duties described in subsection 7c74 7b7 ,terms of agreement 7#a7 ,in general 7,a7 ,agreement ,an agreement under this section shall require the manufacturer to provide1 in accordance with this section1 access to discounted prices for applicable drugs of the manufacturer that are dispensed to applicable beneficiaries on or after ,january #a1 #bjbe4 7,b7 ,clarification ,nothing in this section shall be construed as affecting-- 7i7 the application of a coinsurance of #be percent of the negotiated price1 as applied under paragraph 7#b77;,a7 of section #ahfj;,d-#b7;b71 for costs described in such paragraph2 or 7ii7 the application of the copayment amount described in paragraph 7#d77;,a7 of such section1 with respect to costs described in such paragraph4 7,c7 ,timing of agreement 7i7 ,special rule for #bjbe ,in order for an agreement with a manufacturer to be in effect under this section with respect to the period beginning on ,january #a1 #bjbe1 and ending on ,december #ca1 #bjbe1 the manufacturer shall enter into such agreement not later than ,march #a1 #bjbd4 7ii7 #bjbf and subsequent years ,in order for an agreement with a manufacturer to be in effect under this section with respect to plan year #bjbf or a subsequent plan year1 the manufacturer shall enter into such agreement 7or such agreement shall be renewed under paragraph 7#d77;,a77 not later than a calendar quarter or semi-annual deadline established by the ,secretary4 7#b7 ,provision of appropriate data ,each manufacturer with an agreement in effect under this section shall collect and have available appropriate data1 as determined by the ,secretary1 to ensure that it can demonstrate to the ,secretary compliance with the requirements under the program4 7#c7 ,compliance with requirements for administration of program ,each manufacturer with an agreement in effect under this section shall comply with requirements imposed by the ,secretary for purposes of administering the program1 including any determination under subparagraph 7,a7 of subsection 7c77#a7 or procedures established under such subsection 7c77#a74 7#d7 ,length of agreement 7,a7 ,in general ,an agreement under this section shall be effective for an initial period of not less than #ab months and shall be automatically renewed for a period of not less than #a year unless terminated under subparagraph 7,b74 7,b7 ,termination 7i7 ,by the ,secretary ,the ,secretary may provide for termination of an agreement under this section for a knowing and willful violation of the requirements of the agreement or other good cause shown4 ,such termination shall not be effective earlier than #cj days after the date of notice to the manufacturer of such termination4 ,the ,secretary shall provide1 upon request1 a manufacturer with a hearing concerning such a termination1 and such hearing shall take place prior to the effective date of the termination with sufficient time for such effective date to be repealed if the ,secretary determines appropriate4 7ii7 ,by a manufacturer ,a manufacturer may terminate an agreement under this section for any reason4 ,any such termination shall be effective1 with respect to a plan year-- 7,i7 if the termination occurs before ,january #ca of a plan year1 as of the day after the end of the plan year2 and 7,,ii7 if the termination occurs on or after ,january #ca of a plan year1 as of the day after the end of the succeeding plan year4 7iii7 ,effectiveness of termination ,any termination under this subparagraph shall not affect discounts for applicable drugs of the manufacturer that are due under the agreement before the effective date of its termination4 7c7 ,duties described ,the duties described in this subsection are the following3 7#a7 ,administration of program ,administering the program1 including-- 7,a7 the determination of the amount of the discounted price of an applicable drug of a manufacturer2 7,b7 the establishment of procedures to ensure that1 not later than the applicable number of calendar days after the dispensing of an applicable drug by a pharmacy or mail order service1 the pharmacy or mail order service is reimbursed for an amount equal to the difference between-- 7i7 the negotiated price of the applicable drug2 and 7ii7 the discounted price of the applicable drug2 7,c7 the establishment of procedures to ensure that the discounted price for an applicable drug under this section is applied before any coverage or financial assistance under other health benefit plans or programs that provide coverage or financial assistance for the purchase or provision of prescription drug coverage on behalf of applicable beneficiaries as the ,secretary may specify2 and 7,d7 providing a reasonable dispute resolution mechanism to resolve disagreements between manufacturers and applicable beneficiaries4 7#b7 ,monitoring compliance ,the ,secretary shall monitor compliance by a manufacturer with the terms of an agreement under this section4 7#c7 ,collection of data from prescription drug plans and ,,ma-,,pd plans ,the ,secretary may collect appropriate data from prescription drug plans and ,,ma-,,pd plans in a timeframe that allows for discounted prices to be provided for applicable drugs under this section4 7d7 ,administration 7#a7 ,in general ,subject to paragraph 7#b71 the ,secretary shall provide for the implementation of this section1 including the performance of the duties described in subsection 7c74 7#b7 ,limitation ,in providing for the implementation of this section1 the ,secretary shall not receive or distribute any funds of a manufacturer under the program4 7#c7 ,implementation ,the ,secretary may implement the program under this section by program instruction or otherwise4 7#d7 ,administration ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to the program under this section4 7e7 ,enforcement 7#a7 ,audits ,each manufacturer with an agreement in effect under this section shall be subject to periodic audit by the ,secretary4 7#b7 ,civil money penalty 7,a7 ,in general ,the ,secretary may impose a civil money penalty on a manufacturer that fails to provide discounts for applicable drugs of the manufacturer dispensed to applicable beneficiaries in accordance with such agreement for each such failure in an amount the ,secretary determines is equal to the sum of-- 7i7 the amount that the manufacturer would have paid with respect to such discounts under the agreement1 which will then be used to pay the discounts which the manufacturer had failed to provide2 and 7ii7 #be percent of such amount4 7,b7 ,application ,the provisions of section #aabh;,a 7other than subsections 7a7 and 7b77 shall apply to a civil money penalty under this paragraph in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a7a74 7f7 ,clarification regarding availability of other covered part ,d drugs ,nothing in this section shall prevent an applicable beneficiary from purchasing a covered part ,d drug that is not an applicable drug 7including a generic drug or a drug that is not on the formulary of the prescription drug plan or ,,ma-,,pd plan that the applicable beneficiary is enrolled in74 7g7 ,definitions ,in this section3 7#a7 ,applicable beneficiary ,the term applicable beneficiary means an individual who1 on the date of dispensing a covered part ,d drug-- 7,a7 is enrolled in a prescription drug plan or an ,,ma-,,pd plan2 7,b7 is not enrolled in a qualified retiree prescription drug plan2 and 7,c7 has incurred costs1 as determined in accordance with section #ahfj;,d-#b7;b77#d77;,c71 for covered part ,d drugs in the year that exceed the annual deductible for such year1 as specified in section #ahfj;,d-#b7;b77#a74 7#b7 ,applicable drug ,the term applicable drug1 with respect to an applicable beneficiary1 means a covered part ,d drug-- 7,a7 approved under a new drug application under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or1 in the case of a biologic product1 licensed under section #cea of the ,public ,health ,service ,act2 and 7,b7 7i7 if the ,,pdp sponsor of the prescription drug plan or the ,,ma organization offering the ,,ma-,,pd plan uses a formulary1 which is on the formulary of the prescription drug plan or ,,ma-,,pd plan that the applicable beneficiary is enrolled in2 7ii7 if the ,,pdp sponsor of the prescription drug plan or the ,,ma organization offering the ,,ma-,,pd plan does not use a formulary1 for which benefits are available under the prescription drug plan or ,,ma-,,pd plan that the applicable beneficiary is enrolled in2 or 7iii7 is provided through an exception or appeal4 7#c7 ,applicable number of calendar days ,the term applicable number of calendar days means-- 7,a7 with respect to claims for reimbursement submitted electronically1 #ad days2 and 7,b7 with respect to claims for reimbursement submitted otherwise1 #cj days4 7#d7 ,discounted price 7,a7 ,in general ,the term discounted price means1 with respect to an applicable drug of a manufacturer dispensed during a year to an applicable beneficiary-- 7i7 who has not incurred costs1 as determined in accordance with section #ahfj;,d-#b7;b77#d77;,c71 for covered part ,d drugs in the year that are equal to or exceed the annual out-of-pocket threshold specified in section #ahfj;,d-#b7;b77#d77;,b77i7 for the year1 #ij percent of the negotiated price of such drug2 and 7ii7 who has incurred such costs1 as so determined1 in the year that are equal to or exceed such threshold for the year1 #hj percent of the negotiated price of such drug4 7,b7 ,clarification ,nothing in this section shall be construed as affecting the responsibility of an applicable beneficiary for payment of a dispensing fee for an applicable drug4 7,c7 ,special case for certain claims 7i7 ,claims spanning deductible ,in the case where the entire amount of the negotiated price of an individual claim for an applicable drug with respect to an applicable beneficiary does not fall above the annual deductible specified in section #ahfj;,d-#b7;b77#a7 for the year1 the manufacturer of the applicable drug shall provide the discounted price under this section on only the portion of the negotiated price of the applicable drug that falls above such annual deductible4 7ii7 ,claims spanning out-of-pocket threshold ,in the case where the entire amount of the negotiated price of an individual claim for an applicable drug with respect to an applicable beneficiary does not fall entirely below or entirely above the annual out-of-pocket threshold specified in section #ahfj;,d-#b7;b77#d77;,b77i7 for the year1 the manufacturer of the applicable drug shall provide the discounted price-- 7,i7 in accordance with subparagraph 7,a77i7 on the portion of the negotiated price of the applicable drug that falls below such threshold2 and 7,,ii7 in accordance with subparagraph 7,a77ii7 on the portion of such price of such drug that falls at or above such threshold4 7#e7 ,manufacturer ,the term manufacturer means any entity which is engaged in the production1 preparation1 propagation1 compounding1 conversion1 or processing of prescription drug products1 either directly or indirectly by extraction from substances of natural origin1 or independently by means of chemical synthesis1 or by a combination of extraction and chemical synthesis4 ,such term does not include a wholesale distributor of drugs or a retail pharmacy licensed under ,state law4 7#f7 ,negotiated price ,the term negotiated price has the meaning given such term for purposes of section #ahfj;,d-#b7;d77#a77;,b71 except that such negotiated price shall not include any dispensing fee for the applicable drug4 7#g7 ,qualified retiree prescription drug plan ,the term qualified retiree prescription drug plan has the meaning given such term in section #ahfj;,d-#bb7;a77#b74 4 7#b7 ,sunset of ,medicare coverage gap discount program ,section #ahfj;,d-#ad;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #acie-aad;a7 is amended-- 7,a7 in subsection 7a71 in the first sentence1 by striking ,the ,secretary and inserting ,subject to subsection 7h71 the ,secretary2 and 7,b7 by adding at the end the following new subsection3 7h7 ,sunset of program 7#a7 ,in general ,the program shall not apply with respect to applicable drugs dispensed on or after ,january #a1 #bjbe1 and1 subject to paragraph 7#b71 agreements under this section shall be terminated as of such date4 7#b7 ,continued application for applicable drugs dispensed prior to sunset ,the provisions of this section 7including all responsibilities and duties7 shall continue to apply after ,january #a1 #bjbe1 with respect to applicable drugs dispensed prior to such date4 4 7#c7 ,inclusion of actuarial value of manufacturer discounts in bids ,section #ahfj;,d-#aa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7 is amended-- 7,a7 in subsection 7b77#b77;,c77iii7-- 7i7 by striking assumptions regarding the reinsurance an inserting 8assumptions regarding-- 7,i7 the reinsurance 2 and 7ii7 by adding at the end the following3 7,,ii7 for #bjbe and each subsequent year1 the manufacturer discounts provided under section #ahfj;,d-#ad;,b subtracted from the actuarial value to produce such bid2 and 2 and 7,b7 in subsection 7c77#a77;,c7-- 7i7 by striking an actuarial valuation of the reinsurance and inserting 8an actuarial valuation of-- 7i7 the reinsurance 2 7ii7 in clause 7i71 as inserted by clause 7i7 of this subparagraph1 by adding and at the end2 and 7iii7 by adding at the end the following3 7ii7 for #bjbe and each subsequent year1 the manufacturer discounts provided under section #ahfj;,d-#ad;,b2 4 7d7 ,conforming amendments 7#a7 ,section #ahfj;,d-#b of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7 is amended-- 7,a7 in subsection 7a77#b77;,a77i77,i71 by striking 1 or an increase in the initial and inserting or1 for a year preceding #bjbe1 an increase in the initial2 7,b7 in subsection 7c77#a77;,c7-- 7i7 in the subparagraph heading1 by striking at initial coverage limit2 and 7ii7 by inserting for a year preceding #bjbe or the annual out-of-pocket threshold specified in subsection 7b77#d77;,b7 for the year for #bjbe and each subsequent year after subsection 7b77#c7 for the year each place it appears2 and 7,c7 in subsection 7d77#a77;,a71 by striking or an initial and inserting or1 for a year preceding #bjbe1 an initial4 7#b7 ,section #ahfj;,d-#d7;a77#d77;,b77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;a77#d77;,b77i77 is amended by striking the initial and inserting for a year preceding #bjbe1 the initial4 7#c7 ,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,c71 by striking ,the continuation and inserting ,for a year preceding #bjbe1 the continuation2 7ii7 in subparagraph 7,d77iii71 by striking #ahfj;,d-#b7;b77#d77;,a77i77,i7 and inserting #ahfj;,d-#b7;b77#d77;,a77i77,i77aa72 and 7iii7 in subparagraph 7,e71 by striking ,the elimination and inserting ,for a year preceding #bjbe1 the elimination2 and 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,c71 by striking ,the continuation and inserting ,for a year preceding #bjbe1 the continuation2 and 7ii7 in subparagraph 7,e71 by striking #ahfj;,d-#b7;b77#d77;,a77i77,i7 and inserting #ahfj;,d-#b7;b77#d77;,a77i77,i77aa7 7for a year preceding #bjbe74 7#d7 ,section #ahfj;,d-#ba7;d77#g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aca7;d77#g77 is amended by striking section #ahfj;,d-#b7;b77#d77;,b77i7 and inserting section #ahfj;,d-#b7;b77#d77;,c77i74 7#e7 ,section #ahfj;,d-#bb7;a77#b77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#acb7;a77#b77;,a77 is amended-- 7,a7 by striking the value of any discount and inserting the following3 the value of-- 7i7 for years prior to #bjbe1 any discount 2 7,b7 in clause 7i71 as inserted by subparagraph 7,a7 of this paragraph1 by striking the period at the end and inserting 2 and2 and 7,c7 by adding at the end the following new clause3 7ii7 for #bjbe and each subsequent year1 any discount provided pursuant to section #ahfj;,d-#ad;,b4 4 7#f7 ,section #ahfj;,d-#da7;a77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aea7;a77#f77 is amended-- 7,a7 by inserting for a year before #bjbe after #ahfj;,d-#b7;b77#c72 and 7,b7 by inserting for such year before the period4 7#g7 ,section #ahfj;,d-#dc of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aec7 is amended-- 7,a7 in subsection 7a7-- 7i7 by striking paragraph 7#a7 and inserting the following3 7#a7 participate in-- 7,a7 for #bjaa through #bjbd1 the ,medicare coverage gap discount program under section #ahfj;,d-#ad;,a2 and 7,b7 for #bjbe and each subsequent year1 the manufacturer discount program under section #ahfj;,d-#ad;,b2 2 7ii7 by striking paragraph 7#b7 and inserting the following3 7#b7 have entered into and have in effect-- 7,a7 for #bjaa through #bjbd1 an agreement described in subsection 7b7 of section #ahfj;,d-#ad;,a with the ,secretary2 and 7,b7 for #bjbe and each subsequent year1 an agreement described in subsection 7b7 of section #ahfj;,d-#ad;,b with the ,secretary2 and 2 and 7iii7 in paragraph 7#c71 by striking such section and inserting section #ahfj;,d-#ad;,a2 and 7,b7 by striking subsection 7b7 and inserting the following3 7b7 ,effective date ,paragraphs 7#a77;,a71 7#b77;,a71 and 7#c7 of subsection 7a7 shall apply to covered part ,d drugs dispensed under this part on or after ,january #a1 #bjaa1 and before ,january #a1 #bjbe1 and paragraphs 7#a77;,b7 and 7#b77;,b7 of such subsection shall apply to covered part ,d drugs dispensed under this part on or after ,january #a1 #bjbe4 4 7#h7 ,section #aibg of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7 is amended-- 7,a7 in subsection 7c77#a77;,c77i77,,vi71 by inserting before the period at the end the following3 or under the manufacturer discount program under section #ahfj;,d-#ad;,b2 and 7,b7 in subsection 7k77#a77;,b77i77,v71 by inserting before the period at the end the following3 or under section #ahfj;,d-#ad;,b4 7e7 ,effective date ,the amendments made by this section shall apply with respect to plan year #bjbe and subsequent plan years4