,,ii #aagth ,,congress #ast ,session ,s4 #abhg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,april #ba1 #bjba,mr4 ,durbin 7for himself and ,mr4 ,portman7 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 require manufacturers of certain single-dose vial drugs payable under part ,b of the ,medicare program to provide refunds with respect to amounts of such drugs discarded1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,recovering ,excessive ,funds for ,unused and ,needless ,drugs ,act of #bjba or the ,,refund ,act of #bjba4 #b4 ,requiring manufacturers of certain single-dose container or single-use package drugs payable under part ,b of the ,medicare program to provide refunds with respect to discarded amounts of such drugs ,section #ahdg;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #acie-c;a71 as amended by section #dje of division ,,cc of the ,consolidated ,appropriations ,act1 #bjba1 is amended-- 7#a7 by redesignating subsection 7h7 as subsection 7i72 and 7#b7 inserting after subsection 7g7 the following3 7h7 ,refund for certain discarded single-,dose container or single-,use package drugs 7#a7 ,secretarial provision of information 7,a7 ,in general ,for each calendar quarter beginning on or after ,january #a1 #bjbb1 the ,secretary shall1 with respect to a refundable single-dose container or single-use package drug 7as defined in paragraph 7#h771 report to each manufacturer 7as defined in subsection 7c77#f77;,a77 of such refundable single-dose container or single-use package drug the following for the calendar quarter3 7i7 ,subject to subparagraph 7,c71 information on the total number of units of the billing and payment code of such drug1 if any1 that were discarded during such quarter1 as determined using a mechanism such as the ,,jw modifier used as of the date of enactment of this subsection 7or any such successor modifier that includes such data as determined appropriate by the ,secretary74 7ii7 ,the refund amount that the manufacturer is liable for pursuant to paragraph 7#c74 7,b7 ,determination of discarded amounts ,for purposes of subparagraph 7,a77i71 with respect to a refundable single-dose container or single-use package drug furnished during a quarter1 the amount of such drug that was discarded shall be determined based on the amount of such drug that was unused and discarded for each drug on the date of service4 7,c7 ,exclusion of units of packaged drugs ,the total number of units of the billing and payment code of a refundable single-dose container or single-use package drug of a manufacturer furnished during a calendar quarter for purposes of subparagraph 7,a77i7 shall not include such units that are packaged into the payment amount for an item or service and are not separately payable4 7#b7 ,manufacturer requirement ,for each calendar quarter beginning on or after ,january #a1 #bjbb1 the manufacturer of a refundable single-dose container or single-use package drug shall1 for such drug1 provide to the ,secretary a refund that is equal to the amount specified in paragraph 7#c7 for such drug for such quarter4 7#c7 ,refund amount 7,a7 ,in general ,the amount of the refund specified in this paragraph is1 with respect to a refundable single-dose container or single-use package drug of a manufacturer assigned to a billing and payment code for a calendar quarter beginning on or after ,january #a1 #bjbb1 an amount equal to #ij percent 7or1 in the case of a refundable single-dose container or single-use package drug described in subclause 7,i7 or 7,,ii7 of subparagraph 7,b77ii71 the percent determined for such drug under subparagraph 7,b77i77 of the product of-- 7i7 the total number of units of the billing and payment code for such drug that were discarded during such quarter 7as determined under paragraph 7#a772 and 7ii7 7,i7 in the case of a refundable single-dose container or single-use package drug that is a single source drug or biological1 the amount determined for such drug under subsection 7b77#d72 or 7,,ii7 in the case of a refundable single-dose container or single-use package drug that is a biosimilar biological product1 the average sales price determined under subsection 7b77#h77;,a74 7,b7 ,treatment of drugs that require filtration or other unique circumstances 7i7 ,in general ,the ,secretary1 through notice and comment rulemaking-- 7,i7 in the case of a refundable single-dose container or single-use package drug described in subclause 7,i7 of clause 7ii71 shall adjust the percentage otherwise applicable for purposes of determining the refund amount with respect to such drug under subparagraph 7,a7 as determined appropriate by the ,secretary2 and 7,,ii7 in the case of a refundable single-dose container or single-use package drug described in subclause 7,,ii7 of clause 7ii71 may adjust the percentage otherwise applicable for purposes of determining the refund amount with respect to such drug under subparagraph 7,a7 as determined appropriate by the ,secretary4 7ii7 ,drug described ,for purposes of clause 7i71 a refundable single-dose container or single-use package drug described in this clause is either of the following3 7,i7 ,a refundable single-dose container or single-use package drug for which preparation instructions required and approved by the ,commissioner of the ,food and ,drug ,administration include filtration during the drug preparation process1 prior to dilution and administration1 and require that any unused portion of such drug after the filtration process be discarded after the completion of such filtration process4 7,,ii7 ,any other refundable single-dose container or single-use package drug that has unique circumstances involving similar loss of product4 7#d7 ,frequency ,amounts required to be refunded pursuant to paragraph 7#b7 shall be paid in regular intervals 7as determined appropriate by the ,secretary74 7#e7 ,refund deposits ,amounts paid as refunds pursuant to paragraph 7#b7 shall be deposited into the ,federal ,supplementary ,medical ,insurance ,trust ,fund established under section #ahda4 7#f7 ,enforcement 7,a7 ,audits 7i7 ,manufacturer audits ,each manufacturer of a refundable single-dose container or single-use package drug that is required to provide a refund under this subsection shall be subject to periodic audit with respect to such drug and such refunds by the ,secretary4 7ii7 ,provider audits ,the ,secretary shall conduct periodic audits of claims submitted under this part with respect to refundable single-dose container or single-use package drugs in accordance with the authority under section #ahcc7;e7 to ensure compliance with the requirements applicable under this subsection4 7,b7 ,civil money penalty 7i7 ,in general ,the ,secretary shall impose a civil money penalty on a manufacturer of a refundable single-dose container or single-use package drug who has failed to comply with the requirement under paragraph 7#b7 for such drug for a calendar quarter in an amount equal to the sum of-- 7,i7 the amount that the manufacturer would have paid under such paragraph with respect to such drug for such quarter2 and 7,,ii7 #be percent of such amount4 7ii7 ,application ,the provisions of section #aabh;,a 7other than subsections 7a7 and 7b77 shall apply to a civil money penalty under this subparagraph in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a7a74 7#g7 ,implementation ,the ,secretary shall implement this subsection through notice and comment rulemaking4 7#h7 ,definition of refundable single-dose container or single-use package drug 7,a7 ,in general ,except as provided in subparagraph 7,b71 in this subsection1 the term refundable single-dose container or single-use package drug means a single source drug or biological 7as defined in section #ahdg;,a7c77#f77;,d77 or a biosimilar biological product 7as defined in section #ahdg;,a7c77#f77;,h77 for which payment is established under this part and that is furnished from a single-dose container or single-use package4 7,b7 ,exclusions ,the term refundable single-dose container or single-use package drug does not include a drug or biological that is either a radiopharmaceutical or an imaging agent4 7#i7 ,report to ,congress 7,a7 ,in general ,not later than #c years after the date of enactment of this subsection1 the ,office of the ,inspector ,general of the ,department of ,health and ,human ,services1 in consultation with the ,centers for ,medicare ,medicaid ,services and the ,food and ,drug ,administration1 shall submit to the ,committee on ,energy and ,commerce and the ,committee on ,ways and ,means of the ,house of ,representatives and the ,committee on ,finance of the ,senate1 a report on any impact this subsection is demonstrated to have on-- 7i7 the licensure1 market entry1 market retention1 or marketing of biosimilar biological products2 and 7ii7 vial size changes1 label adjustments1 or technological developments4 7,b7 ,updates ,at the direction of the ,committees referred to in subparagraph 7,a71 the ,office of the ,inspector ,general of the ,department of ,health and ,human ,services1 in consultation with the ,centers for ,medicare ,medicaid ,services and the ,food and ,drug ,administration1 shall periodically update the report under such subparagraph4 4