DISARM Act of 2019

II 116TH CONGRESS 1ST SESSION S. 1712 To amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. IN THE SENATE OF THE UNITED STATES JUNE 4, 2019 Mr. ISAKSON (for himself and Mr. CASEY) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. 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 ‘‘Developing an Innova- 4 tive Strategy for Antimicrobial Resistant Microorganisms 5 Act of 2019’’ and as the ‘‘DISARM Act of 2019’’. 6 SEC. 2. ENCOURAGING THE DEVELOPMENT AND USE OF 7 DISARM ANTIMICROBIAL DRUGS. 8 (a) ADDITIONAL PAYMENT FOR DISARM ANTI- 9 MICROBIAL DRUGS UNDER MEDICARE.— 10 VerDate Sep 11 2014 04:54 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1712.IS S1712 pamtmann on DSKBFK8HB2PROD with BILLS 2 •S 1712 IS (1) IN GENERAL.—Section 1886(d)(5) of the 1 Social Security Act (42 U.S.C. 1395ww(d)(5)) is 2 amended by adding at the end the following new 3 subparagraph: 4 ‘‘(M)(i)(I) Effective for discharges beginning on or 5 after October 1, 2020, subject to subclause (II), the Sec- 6 retary shall, after notice and opportunity for public com- 7 ment (in the publications required by subsection (e)(5) for 8 a fiscal year or otherwise), provide for an additional pay- 9 ment under a mechanism (separate from the mechanism 10 established under subparagraph (K)), with respect to such 11 discharges involving any DISARM antimicrobial drug, in 12 an amount equal to— 13 ‘‘(aa) the amount payable under section 1847A 14 for such drug during the calendar quarter in which 15 the discharge occurred; or 16 ‘‘(bb) if no amount for such drug is determined 17 under section 1847A, an amount to be determined 18 by the Secretary in a manner similar to the manner 19 in which payment amounts are determined under 20 section 1847A based on information submitted by 21 the manufacturer or sponsor of such drug (as re- 22 quired under clause (v)). 23 ‘‘(II) In determining the amount payable under sec- 24 tion 1847A for purposes of items (aa) and (bb) of sub- 25 VerDate Sep 11 2014 04:54 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1712.IS S1712 pamtmann on DSKBFK8HB2PROD with BILLS 3 •S 1712 IS clause (I), subparagraphs (A) and (B) of subsection (b)(1) 1 of such section shall be applied by substituting ‘102 per- 2 cent’ for ‘106 percent’ each place it appears and para- 3 graph (8)(B) of such section shall be applied by sub- 4 stituting ‘2 percent’ for ‘6 percent’. 5 ‘‘(ii) For purposes of this subparagraph, a DISARM 6 antimicrobial drug is— 7 ‘‘(I) a drug— 8 ‘‘(aa) that— 9 ‘‘(AA) is approved by the Food and 10 Drug Administration; 11 ‘‘(BB) is designated by the Food and 12 Drug Administration as a qualified infec- 13 tious disease product under subsection (d) 14 of section 505E of the Federal Food, 15 Drug, and Cosmetic Act; and 16 ‘‘(CC) has received an extension of its 17 exclusivity period pursuant to subsection 18 (a) of such section; and 19 ‘‘(bb) that has been designated by the Sec- 20 retary pursuant to the process established 21 under clause (iv)(I)(bb); or 22 ‘‘(II) an antibacterial or antifungal biological 23 product— 24 VerDate Sep 11 2014 04:54 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1712.IS S1712 pamtmann on DSKBFK8HB2PROD with BILLS 4 •S 1712 IS ‘‘(aa) that is licensed for use, or an anti- 1 bacterial or antifungal biological product for 2 which an indication is first licensed for use, by 3 the Food and Drug Administration on or after 4 June 5, 2014, under section 351(a) of the Pub- 5 lic Health Service Act for human use to treat 6 serious or life-threatening infections, as deter- 7 mined by the Food and Drug Administration, 8 including those caused by, or likely to be caused 9 by— 10 ‘‘(AA) an antibacterial or antifungal 11 resistant pathogen, including novel or 12 emerging infectious pathogens; or 13 ‘‘(BB) a qualifying pathogen (as de- 14 fined under section 505E(f) of the Federal 15 Food, Drug, and Cosmetic Act); and 16 ‘‘(bb) has been designated by the Secretary 17 pursuant to the process established under 18 clause (iv)(I)(bb). 19 ‘‘(iii) The mechanism established pursuant to clause 20 (i) shall provide that the additional payment under clause 21 (i) shall— 22 ‘‘(I) with respect to a discharge, only be made 23 to a subsection (d) hospital that, as determined by 24 the Secretary— 25 VerDate Sep 11 2014 04:54 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1712.IS S1712 pamtmann on DSKBFK8HB2PROD with BILLS 5 •S 1712 IS ‘‘(aa) is participating in the National 1 Healthcare Safety Network Antimicrobial Use 2 and Resistance Module of the Centers for Dis- 3 ease Control and Prevention or a similar report- 4 ing program, as specified by the Secretary, re- 5 lating to antimicrobial drugs; and 6 ‘‘(bb) has an antimicrobial stewardship 7 program that aligns with the Core Elements of 8 Hospital Antibiotic Stewardship Programs of 9 the Centers for Disease Control and Prevention 10 or the Antimicrobial Stewardship Standard set 11 by the Joint Commission; and 12 ‘‘(II) apply to discharges occurring on or after 13 October 1 of the year in which the drug or biological 14 product is designated by the Secretary as a DIS- 15 ARM antimicrobial drug. 16 ‘‘(iv)(I) The mechanism established pursuant to 17 clause (i) shall provide for a process for— 18 ‘‘(aa) a manufacturer or sponsor of a drug or 19 biological product to request the Secretary to des- 20 ignate the drug or biological product as a DISARM 21 antimicrobial drug; and 22 ‘‘(bb) the designation by the Secretary of drugs 23 and biological products as DISARM antimicrobial 24 drugs. 25 VerDate Sep 11 2014 04:54 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1712.IS S1712 pamtmann on DSKBFK8HB2PROD with BILLS 6 •S 1712 IS ‘‘(II) A designation of a drug or biological product 1 as a DISARM antimicrobial drug may be revoked by the 2 Secretary if the Secretary determines that— 3 ‘‘(aa) the drug or biological product no longer 4 meets the requirements for a DISARM antimicrobial 5 drug under clause (ii); 6 ‘‘(bb) the request for such designation con- 7 tained an untrue statement of material fact; or 8 ‘‘(cc) clinical or other information that was not 9 available to the Secretary at the time such designa- 10 tion was made shows that— 11 ‘‘(AA) such drug or biological product is 12 unsafe for use or not shown to be safe for use 13 for individuals who are entitled to benefits 14 under part A; or 15 ‘‘(BB) an alternative to such drug or bio- 16 logical product is an advance that substantially 17 improves the diagnosis or treatment of such in- 18 dividuals. 19 ‘‘(III) Not later than October 1, 2020, and annually 20 thereafter, the Secretary shall publish in the Federal Reg- 21 ister a list of the DISARM antimicrobial drugs designated 22 under this subparagraph pursuant to the process estab- 23 lished under clause (iv)(I)(bb). 24 VerDate Sep 11 2014 04:54 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1712.IS S1712 pamtmann on DSKBFK8HB2PROD with BILLS 7 •S 1712 IS ‘‘(v)(I) For purposes of determining additional pay- 1 ment amounts under clause (i), a manufacturer or sponsor 2 of a drug or biological product that submits a request de- 3 scribed in clause (iv)(I)(aa) shall submit to the Secretary 4 information described in section 1927(b)(3)(A)(iii). 5 ‘‘(II) The penalties for failure to provide timely infor- 6 mation under clause (i) of subparagraph (C) under section 7 1927(b)(3) and for providing false information under 8 clause (ii) of such subparagraph shall apply to manufac- 9 turers and sponsors of a drug or biological product under 10 this section with respect to information under subclause 11 (I) in the same manner as such penalties apply to manu- 12 facturers under such clauses with respect to information 13 under subparagraph (A) of such section. 14 ‘‘(vi)(I) The mechanism established pursuant to 15 clause (i) shall provide that— 16 ‘‘(aa) except as provided in item (bb), no addi- 17 tional payment shall be made under this subpara- 18 graph for discharges involving a DISARM anti- 19 microbial drug if any additional payments have been 20 made for discharges involving such drug as a new 21 medical service or technology under subparagraph 22 (K); 23 ‘‘(bb) additional payments may be made under 24 this subparagraph for discharges involving a DIS- 25 VerDate Sep 11 2014 04:54 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1712.IS S1712 pamtmann on DSKBFK8HB2PROD with BILLS 8 •S 1712 IS ARM antimicrobial drug if any additional payments 1 have been made for discharges occurring prior to the 2 date of enactment of this subparagraph involving 3 such drug as a new medical service or technology 4 under subparagraph (K); and 5 ‘‘(cc) no additional payment shall be made 6 under subparagraph (K) for discharges involving a 7 DISARM antimicrobial drug as a new medical serv- 8 ice or technology if any additional payments for dis- 9 charges involving such drug have been made under 10 this subparagraph.’’. 11 (2) CONFORMING AMENDMENT.—Section 12 1886(d)(5)(K)(ii)(III) of the Social Security Act (42 13 U.S.C. 1395ww(d)(5)(K)(ii)(III)) is amended by 14 striking ‘‘provide’’ and inserting ‘‘subject to sub- 15 paragraph (M)(vii), provide’’. 16 (b) STUDY AND REPORTS ON REMOVING BARRIERS 17 TO THE DEVELOPMENT OF DISARM ANTIMICROBIAL 18 DRUGS.— 19 (1) STUDY.—The Comptroller General of the 20 United States (in this subsection referred to as the 21 ‘‘Comptroller General’’) shall, in consultation with 22 the Director of the National Institutes of Health, 23 the Commissioner of Food and Drugs, the Adminis- 24 trator of the Centers for Medicare & Medicaid Serv- 25 VerDate Sep 11 2014 04:54 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1712.IS S1712 pamtmann on DSKBFK8HB2PROD with BILLS 9 •S 1712 IS ices, and the Director of the Centers for Disease 1 Control and Prevention, conduct a study to— 2 (A) identify and examine the barriers that 3 prevent the development of DISARM anti- 4 microbial drugs (as defined in section 5 1886(d)(5)(M)(ii) of the Social Security Act, as 6 added by subsection (a)); and 7 (B) develop recommendations for actions 8 to be taken in order to overcome any barriers 9 identified under subparagraph (A). 10 (2) REPORTS.— 11 (A) INTERIM REPORT.—Not later than 3 12 years after the date of the enactment of this 13 Act, the Comptroller General shall submit to 14 Congress an interim report containing the pre- 15 liminary results of the study conducted under 16 paragraph (1), together with recommendations 17 for such legislation and administrative action as 18 the Comptroller General determines appro- 19 priate. 20 (B) FINAL REPORT.—Not later than 5 21 years after the date of the enactment of this 22 Act, the Comptroller General shall submit to 23 Congress a report containing the results of the 24 study conducted under paragraph (1), together 25 VerDate Sep 11 2014 04:54 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1712.IS S1712 pamtmann on DSKBFK8HB2PROD with BILLS 10 •S 1712 IS with recommendations for such legislation and 1 administrative action as the Comptroller Gen- 2 eral determines appropriate. 3 Æ VerDate Sep 11 2014 04:54 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6301 E:\BILLS\S1712.IS S1712 pamtmann on DSKBFK8HB2PROD with BILLS