DISARM Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 4100 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 HOUSE OF REPRESENTATIVES JULY 30, 2019 Mr. DANNY K. DAVIS of Illinois (for himself, Mr. MARCHANT, Ms. SEWELL of Alabama, Mr. MARSHALL, Mr. HOLDING, Mr. MICHAEL F. DOYLE of Pennsylvania, and Mrs. WALORSKI) introduced the following bill; which was referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provi- sions as fall within the jurisdiction of the committee concerned 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 VerDate Sep 11 2014 00:14 Aug 15, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4100.IH H4100 pamtmann on DSKBFK8HB2PROD with BILLS 2 •HR 4100 IH SEC. 2. ENCOURAGING THE DEVELOPMENT AND USE OF 1 DISARM ANTIMICROBIAL DRUGS. 2 (a) ADDITIONAL PAYMENT FOR DISARM ANTI- 3 MICROBIAL DRUGS UNDER MEDICARE.— 4 (1) IN GENERAL.—Section 1886(d)(5) of the 5 Social Security Act (42 U.S.C. 1395ww(d)(5)) is 6 amended by adding at the end the following new 7 subparagraph: 8 ‘‘(M)(i)(I) Effective for discharges beginning on or 9 after October 1, 2020, or such sooner date as specified 10 by the Secretary, subject to subclause (II), the Secretary 11 shall, after notice and opportunity for public comment (in 12 the publications required by subsection (e)(5) for a fiscal 13 year or otherwise), provide for an additional payment 14 under a mechanism (separate from the mechanism estab- 15 lished under subparagraph (K)), with respect to such dis- 16 charges involving any DISARM antimicrobial drug, in an 17 amount equal to— 18 ‘‘(aa) the amount payable under section 1847A 19 for such drug during the calendar quarter in which 20 the discharge occurred; or 21 ‘‘(bb) if no amount for such drug is determined 22 under section 1847A, an amount to be determined 23 by the Secretary in a manner similar to the manner 24 in which payment amounts are determined under 25 section 1847A based on information submitted by 26 VerDate Sep 11 2014 00:14 Aug 15, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4100.IH H4100 pamtmann on DSKBFK8HB2PROD with BILLS 3 •HR 4100 IH the manufacturer or sponsor of such drug (as re- 1 quired under clause (v)). 2 ‘‘(II) In determining the amount payable under sec- 3 tion 1847A for purposes of items (aa) and (bb) of sub- 4 clause (I), subparagraphs (A) and (B) of subsection (b)(1) 5 of such section shall be applied by substituting ‘102 per- 6 cent’ for ‘106 percent’ each place it appears and para- 7 graph (8)(B) of such section shall be applied by sub- 8 stituting ‘2 percent’ for ‘6 percent’. 9 ‘‘(ii) For purposes of this subparagraph, a DISARM 10 antimicrobial drug is— 11 ‘‘(I) a drug— 12 ‘‘(aa) that— 13 ‘‘(AA) is approved by the Food and 14 Drug Administration; 15 ‘‘(BB) is designated by the Food and 16 Drug Administration as a qualified infec- 17 tious disease product under subsection (d) 18 of section 505E of the Federal Food, 19 Drug, and Cosmetic Act; and 20 ‘‘(CC) has received an extension of its 21 exclusivity period pursuant to subsection 22 (a) of such section; and 23 VerDate Sep 11 2014 00:14 Aug 15, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4100.IH H4100 pamtmann on DSKBFK8HB2PROD with BILLS 4 •HR 4100 IH ‘‘(bb) that has been designated by the Sec- 1 retary pursuant to the process established 2 under clause (iv)(I)(bb); or 3 ‘‘(II) an antibacterial or antifungal biological 4 product— 5 ‘‘(aa) that is licensed for use, or an anti- 6 bacterial or antifungal biological product for 7 which an indication is first licensed for use, by 8 the Food and Drug Administration on or after 9 June 5, 2014, under section 351(a) of the Pub- 10 lic Health Service Act for human use to treat 11 serious or life-threatening infections, as deter- 12 mined by the Food and Drug Administration, 13 including those caused by, or likely to be caused 14 by— 15 ‘‘(AA) an antibacterial or antifungal 16 resistant pathogen, including novel or 17 emerging infectious pathogens; or 18 ‘‘(BB) a qualifying pathogen (as de- 19 fined under section 505E(f) of the Federal 20 Food, Drug, and Cosmetic Act); and 21 ‘‘(bb) has been designated by the Secretary 22 pursuant to the process established under 23 clause (iv)(I)(bb). 24 VerDate Sep 11 2014 00:14 Aug 15, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4100.IH H4100 pamtmann on DSKBFK8HB2PROD with BILLS 5 •HR 4100 IH ‘‘(iii) The mechanism established pursuant to clause 1 (i) shall provide that the additional payment under clause 2 (i) shall— 3 ‘‘(I) with respect to a discharge, only be made 4 to a subsection (d) hospital that, as determined by 5 the Secretary— 6 ‘‘(aa) is participating in the National 7 Healthcare Safety Network Antimicrobial Use 8 and Resistance Module of the Centers for Dis- 9 ease Control and Prevention; and 10 ‘‘(bb) has an antimicrobial stewardship 11 program that aligns with the Core Elements of 12 Hospital Antibiotic Stewardship Programs of 13 the Centers for Disease Control and Prevention 14 or the Antimicrobial Stewardship Standard set 15 by the Joint Commission; and 16 ‘‘(II) apply to discharges occurring on or after 17 October 1 of the year in which the drug or biological 18 product is designated by the Secretary as a DIS- 19 ARM antimicrobial drug. 20 For purposes of this clause, in the case of a similar report- 21 ing program described in item (aa), a subsection (d) hos- 22 pital shall be treated as participating in such a program 23 if the entity maintaining such program identifies to the 24 Secretary such hospital as so participating. 25 VerDate Sep 11 2014 00:14 Aug 15, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4100.IH H4100 pamtmann on DSKBFK8HB2PROD with BILLS 6 •HR 4100 IH ‘‘(iv)(I) The mechanism established pursuant to 1 clause (i) shall provide for a process for— 2 ‘‘(aa) a manufacturer or sponsor of a drug or 3 biological product to request the Secretary to des- 4 ignate the drug or biological product as a DISARM 5 antimicrobial drug; and 6 ‘‘(bb) the designation (and removal of such des- 7 ignation) by the Secretary of drugs and biological 8 products as DISARM antimicrobial drugs. 9 ‘‘(II) A designation of a drug or biological product 10 as a DISARM antimicrobial drug may be revoked by the 11 Secretary if the Secretary determines that— 12 ‘‘(aa) the drug or biological product no longer 13 meets the requirements for a DISARM antimicrobial 14 drug under clause (ii); 15 ‘‘(bb) the request for such designation con- 16 tained an untrue statement of material fact; or 17 ‘‘(cc) clinical or other information that was not 18 available to the Secretary at the time such designa- 19 tion was made shows that— 20 ‘‘(AA) such drug or biological product is 21 unsafe for use or not shown to be safe for use 22 for individuals who are entitled to benefits 23 under part A; or 24 VerDate Sep 11 2014 00:14 Aug 15, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4100.IH H4100 pamtmann on DSKBFK8HB2PROD with BILLS 7 •HR 4100 IH ‘‘(BB) an alternative to such drug or bio- 1 logical product is an advance that substantially 2 improves the diagnosis or treatment of such in- 3 dividuals. 4 ‘‘(III) Not later than October 1, 2020, the Secretary 5 shall publish in the Federal Register a list of the DISARM 6 antimicrobial drugs designated under this subparagraph 7 pursuant to the process established under subclause 8 (I)(bb). The Secretary shall annually update such list. 9 ‘‘(v)(I) For purposes of determining additional pay- 10 ment amounts under clause (i), a manufacturer or sponsor 11 of a drug or biological product that submits a request de- 12 scribed in clause (iv)(I)(aa) shall submit to the Secretary 13 information described in section 1927(b)(3)(A)(iii). 14 ‘‘(II) The penalties for failure to provide timely infor- 15 mation under clause (i) of subparagraph (C) section 16 1927(b)(3) and for providing false information under 17 clause (ii) of such subparagraph shall apply to manufac- 18 turers and sponsors of a drug or biological product under 19 this section with respect to information under subclause 20 (I) in the same manner as such penalties apply to manu- 21 facturers under such clauses with respect to information 22 under subparagraph (A) of such section. 23 ‘‘(vi)(I) The mechanism established pursuant to 24 clause (i) shall provide that— 25 VerDate Sep 11 2014 00:14 Aug 15, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H4100.IH H4100 pamtmann on DSKBFK8HB2PROD with BILLS 8 •HR 4100 IH ‘‘(aa) except as provided in item (bb), no addi- 1 tional payment shall be made under this subpara- 2 graph for discharges involving a DISARM anti- 3 microbial drug if any additional payments have been 4 made for discharges involving such drug as a new 5 medical service or technology under subparagraph 6 (K); 7 ‘‘(bb) additional payments may be made under 8 this subparagraph for discharges involving a DIS- 9 ARM antimicrobial drug if any additional payments 10 have been made for discharges occurring prior to the 11 date of enactment of this subparagraph involving 12 such drug as a new medical service or technology 13 under subparagraph (K); and 14 ‘‘(cc) no additional payment shall be made 15 under subparagraph (K) for discharges involving a 16 DISARM antimicrobial drug as a new medical serv- 17 ice or technology if any additional payments for dis- 18 charges involving such drug have been made under 19 this subparagraph.’’. 20 (2) CONFORMING AMENDMENT.—Section 21 1886(d)(5)(K)(ii)(III) of the Social Security Act (42 22 U.S.C. 1395ww(d)(5)(K)(ii)(III)) is amended by 23 striking ‘‘provide’’ and inserting ‘‘subject to sub- 24 paragraph (M)(vii), provide’’. 25 VerDate Sep 11 2014 00:14 Aug 15, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H4100.IH H4100 pamtmann on DSKBFK8HB2PROD with BILLS 9 •HR 4100 IH (b) STUDY AND REPORTS ON REMOVING BARRIERS 1 TO THE DEVELOPMENT OF DISARM ANTIMICROBIAL 2 DRUGS.— 3 (1) STUDY.—The Comptroller General of the 4 United States (in this subsection referred to as the 5 ‘‘Comptroller General’’) shall, in consultation with 6 the Director of the National Institutes of Health, 7 the Commissioner of Food and Drugs, the Adminis- 8 trator of the Centers for Medicare & Medicaid Serv- 9 ices, and the Director of the Centers for Disease 10 Control and Prevention, conduct a study to— 11 (A) identify and examine the barriers that 12 prevent the development of DISARM anti- 13 microbial drugs (as defined in section 14 1886(d)(5)(M)(ii) of the Social Security Act, as 15 added by subsection (a)); and 16 (B) develop recommendations for actions 17 to be taken in order to overcome any barriers 18 identified under subparagraph (A). 19 (2) REPORTS.— 20 (A) INTERIM REPORT.—Not later than 3 21 years after the date of the enactment of this 22 Act, the Comptroller General shall submit to 23 Congress an interim report containing the pre- 24 liminary results of the study conducted under 25 VerDate Sep 11 2014 00:14 Aug 15, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H4100.IH H4100 pamtmann on DSKBFK8HB2PROD with BILLS 10 •HR 4100 IH paragraph (1), together with recommendations 1 for such legislation and administrative action as 2 the Comptroller General determines appro- 3 priate. 4 (B) FINAL REPORT.—Not later than 5 5 years after the date of the enactment of this 6 Act, the Comptroller General shall submit to 7 Congress a report containing the results of the 8 study conducted under paragraph (1), together 9 with recommendations for such legislation and 10 administrative action as the Comptroller Gen- 11 eral determines appropriate. 12 Æ VerDate Sep 11 2014 00:14 Aug 15, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6301 E:\BILLS\H4100.IH H4100 pamtmann on DSKBFK8HB2PROD with BILLS