,,ii #aafth ,,congress #ast ,session ,s4 #bjea ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #bh 7legislative day1 ,june #bg71 #bjai,mr4 ,menendez 7for himself and ,mr4 ,young7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend ,,xviii of the ,social ,security ,act to require certain manufacturers to report drug pricing information with respect to drugs under the ,medicare program4 #a4 ,short title ,this ,act may be cited as the ,strengthening ,average ,sales ,price ,reporting ,act of #bjai4 #b4 ,requiring certain manufacturers to report drug pricing information with respect to drugs under the ,medicare program 7a7 ,in general ,section #ahdg;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is amended-- 7#a7 in subsection 7b7-- 7,a7 in paragraph 7#b77;,a71 by inserting or subsection 7f77#b71 as applicable before the period at the end2 7,b7 in paragraph 7#c71 in the matter preceding subparagraph 7,a71 by inserting or subsection 7f77#b71 as applicable1 before determined by2 and 7,c7 in paragraph 7#f77;,a71 in the matter preceding clause 7i71 by inserting or subsection 7f77#b71 as applicable1 before determined by2 and 7#b7 in subsection 7f7-- 7,a7 by striking ,for requirements and inserting the following3 7#a7 ,in general ,for requirements 2 and 7,b7 by adding at the end the following new paragraph3 7#b7 ,manufacturers without a rebate agreement under title ,,xix 7,a7 ,in general ,in the case of a manufacturer of an applicable drug or biological that does not have a rebate agreement in effect under section #aibg1 for calendar quarters beginning on or after ,january #a1 #bjbj1 such manufacturer shall report to the ,secretary the information described in subsection 7b77#c77;,a77iii7 of such section #aibg with respect to such applicable drug or biological in a time and manner specified by the ,secretary4 7,b7 ,definition of applicable drug or biological ,in this paragraph1 the term applicable drug or biological means-- 7i7 a drug or biological described in-- 7,i7 subparagraph 7,c71 7,e71 or 7,g7 of section #ahdb7o77#a72 or 7,,ii7 clause 7ii7 or 7iii7 of section #ahha7;b77#ad77;,b72 and 7ii7 an item for which payment is established under this section4 7,c7 ,audit ,information reported under subparagraph 7,a7 is subject to audit by the ,inspector ,general of the ,department of ,health and ,human ,services4 7,d7 ,verification ,the ,secretary may survey wholesalers and manufacturers that directly distribute an applicable drug or biological1 when necessary1 to verify manufacturer prices and manufacturer's average sales prices 7including wholesale acquisition cost7 if required to make payment reported under subparagraph 7,a74 ,the ,secretary may impose a civil monetary penalty in an amount not to exceed #ajj1jjj on a wholesaler1 manufacturer1 or direct seller1 if the wholesaler1 manufacturer1 or direct seller of such a drug refuses a request for information about charges or prices by the ,secretary in connection with a survey under this subparagraph or knowingly provides false information4 ,the provisions of section #aabh;,a 7other than subsections 7a7 7with respect to amounts of penalties or additional assessments7 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,e7 ,confidentiality ,notwithstanding any other provision of law1 information disclosed by manufacturers or wholesalers under this paragraph 7other than the wholesale acquisition cost for purposes of carrying out this section7 is confidential and shall not be disclosed by the ,secretary in a form which discloses the identity of a specific manufacturer or wholesaler or prices charged for an applicable drug or biological by such manufacturer or wholesaler1 except-- 7i7 as the ,secretary determines to be necessary to carry out this section 7including the determination and implementation of the payment amount71 or to carry out section #ahdg;,b2 7ii7 to permit the ,comptroller ,general to review the information provided2 and 7iii7 to permit the ,director of the ,congressional ,budget ,office to review the information provided4 4 7b7 ,enforcement ,section #ahdg;,a such ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is further amended-- 7#a7 in subsection 7d77#d7-- 7,a7 in subparagraph 7,a71 by striking ,in general and inserting ,misrepresentation2 7,b7 in subparagraph 7,b71 by striking subparagraph 7,b7 and inserting subparagraph 7,a71 7,b71 or 7,c72 7,c7 by redesignating subparagraph 7,b7 as subparagraph 7,d72 and 7,d7 by inserting after subparagraph 7,a7 the following new subparagraphs3 7,b7 ,failure to provide timely information ,if the ,secretary determines that a manufacturer described in subsection 7f77#b7 has failed to report on information described in section #aibg7;b77#c77;,a77iii7 with respect to an applicable drug or biological in accordance with such subsection1 the ,secretary shall apply a civil money penalty in an amount of #aj1jjj for each day the manufacturer has failed to report such information and such amount shall be paid to the ,treasury4 7,c7 ,false information ,any manufacturer required to submit information under subsection 7f77#b7 that knowingly provides false information is subject to a civil money penalty in an amount not to exceed #ajj1jjj for each item of false information4 ,such civil money penalties are in addition to other penalties as may be prescribed by law4 2 and 7#b7 in subsection 7c77#f77;,a71 by striking the period at the end and inserting 1 except that1 for purposes of subsection 7f77#b71 the ,secretary may1 if the ,secretary determines appropriate1 exclude repackagers of an applicable drug or biological from such term44 7c7 ,report ,not later than ,january #a1 #bjba1 the ,inspector ,general of the ,department of ,health and ,human ,services shall assess and submit to ,congress a report on the accuracy of average sales price information submitted by manufacturers under section #ahdg;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a74 ,such report shall include any recommendations on how to improve the accuracy of such information4