SUPPLIES Act of 2020

I 116TH CONGRESS 2D SESSION H. R. 8139 To amend title XIX of the Social Security Act to remove direct sales of drugs near expiration during the COVID–19 emergency from the calcula- tion of certain pricing metrics under the Medicaid program. IN THE HOUSE OF REPRESENTATIVES SEPTEMBER 1, 2020 Mr. BILIRAKIS (for himself and Mr. SOTO) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend title XIX of the Social Security Act to remove direct sales of drugs near expiration during the COVID– 19 emergency from the calculation of certain pricing metrics under the Medicaid program. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Surplus Utilization of 4 Pharmaceutical Products Leveraged In Emergency Sce- 5 narios Act of 2020’’ or the ‘‘SUPPLIES Act of 2020’’. 6 VerDate Sep 11 2014 17:00 Sep 05, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H8139.IH H8139 pbinns on DSKJLVW7X2PROD with BILLS 2 •HR 8139 IH SEC. 2. REMOVING DIRECT SALES OF DRUGS NEAR EXPIRA- 1 TION DURING THE COVID–19 EMERGENCY 2 FROM THE CALCULATION OF CERTAIN PRIC- 3 ING METRICS UNDER THE MEDICAID PRO- 4 GRAM. 5 (a) IN GENERAL.—Section 1927 of the Social Secu- 6 rity Act (42 U.S.C. 1396r–8) is amended— 7 (1) in subsection (c)(1)(C)— 8 (A) in clause (i)— 9 (i) in subclause (V), by striking ‘‘and’’ 10 at the end; 11 (ii) in subclause (VI), by striking the 12 period and inserting ‘‘; and’’; and 13 (iii) by adding at the end the fol- 14 lowing new subclause: 15 ‘‘(VII) any prices charged with 16 respect to the direct sale by a manu- 17 facturer of a short-dated drug (as de- 18 fined in clause (iv)) during the period 19 beginning on the first day of the 20 emergency period described in section 21 1135(g)(1)(B) and ending on the date 22 that is 6 months after the last day of 23 such emergency period.’’; and 24 (B) by adding at the end the following new 25 clause: 26 VerDate Sep 11 2014 17:00 Sep 05, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H8139.IH H8139 pbinns on DSKJLVW7X2PROD with BILLS 3 •HR 8139 IH ‘‘(iv) SHORT-DATED DRUG DE- 1 FINED.— 2 ‘‘(I) IN GENERAL.—For purposes 3 of clause (i)(VII), the term ‘short- 4 dated drug’ means, in the case of a 5 drug with an applicable shelf life (as 6 defined in subclause (II))— 7 ‘‘(aa) of 1 year or greater, a 8 drug expiring (as determined by 9 the labeled expiration date) not 10 later than 1 year after the date 11 of sale of such drug; and 12 ‘‘(bb) of less than 1 year, a 13 drug expiring (as determined by 14 the labeled expiration date) not 15 later than the end of the period 16 beginning on the date of sale of 17 such drug and ending on the date 18 that is the number of days of the 19 applicable shelf life of such drug 20 after such date of sale. 21 ‘‘(II) APPLICABLE SHELF 22 LIFE.—The term ‘applicable shelf life’ 23 means, with respect to a drug, 50 per- 24 cent of the number of days occurring 25 VerDate Sep 11 2014 17:00 Sep 05, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H8139.IH H8139 pbinns on DSKJLVW7X2PROD with BILLS 4 •HR 8139 IH during the period beginning on the 1 date such drug is manufactured and 2 ending on the date such drug expires 3 (as determined by the labeled expira- 4 tion date), rounded to the nearest 5 whole day.’’; and 6 (2) in subsection (k)(1)(B)— 7 (A) in subclause (IV), by striking ‘‘and’’ at 8 the end; 9 (B) in subclause (V), by striking the period 10 and inserting ‘‘; and’’; and 11 (C) by adding at the end the following new 12 subclause: 13 ‘‘(VI) any prices described in 14 subsection (c)(1)(C)(i)(VII).’’. 15 (b) OUTREACH TO MANUFACTURERS.—The Sec- 16 retary of Health and Human Services shall notify drug 17 manufacturers of the amendments made by subsection (a) 18 through an electronic communication through MLN Con- 19 nects or such other method as determined appropriate by 20 the Secretary. 21 Æ VerDate Sep 11 2014 17:00 Sep 05, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\H8139.IH H8139 pbinns on DSKJLVW7X2PROD with BILLS