[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 1712 Introduced in Senate (IS)]

<DOC>






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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Developing an Innovative Strategy 
for Antimicrobial Resistant Microorganisms Act of 2019'' and as the 
``DISARM Act of 2019''.

SEC. 2. ENCOURAGING THE DEVELOPMENT AND USE OF DISARM ANTIMICROBIAL 
              DRUGS.

    (a) Additional Payment for DISARM Antimicrobial Drugs Under 
Medicare.--
            (1) In general.--Section 1886(d)(5) of the Social Security 
        Act (42 U.S.C. 1395ww(d)(5)) is amended by adding at the end 
        the following new subparagraph:
    ``(M)(i)(I) Effective for discharges beginning on or after October 
1, 2020, subject to subclause (II), the Secretary shall, after notice 
and opportunity for public comment (in the publications required by 
subsection (e)(5) for a fiscal year or otherwise), provide for an 
additional payment under a mechanism (separate from the mechanism 
established under subparagraph (K)), with respect to such discharges 
involving any DISARM antimicrobial drug, in an amount equal to--
            ``(aa) the amount payable under section 1847A for such drug 
        during the calendar quarter in which the discharge occurred; or
            ``(bb) if no amount for such drug is determined under 
        section 1847A, an amount to be determined by the Secretary in a 
        manner similar to the manner in which payment amounts are 
        determined under section 1847A based on information submitted 
        by the manufacturer or sponsor of such drug (as required under 
        clause (v)).
    ``(II) In determining the amount payable under section 1847A for 
purposes of items (aa) and (bb) of subclause (I), subparagraphs (A) and 
(B) of subsection (b)(1) of such section shall be applied by 
substituting `102 percent' for `106 percent' each place it appears and 
paragraph (8)(B) of such section shall be applied by substituting `2 
percent' for `6 percent'.
    ``(ii) For purposes of this subparagraph, a DISARM antimicrobial 
drug is--
            ``(I) a drug--
                    ``(aa) that--
                            ``(AA) is approved by the Food and Drug 
                        Administration;
                            ``(BB) is designated by the Food and Drug 
                        Administration as a qualified infectious 
                        disease product under subsection (d) of section 
                        505E of the Federal Food, Drug, and Cosmetic 
                        Act; and
                            ``(CC) has received an extension of its 
                        exclusivity period pursuant to subsection (a) 
                        of such section; and
                    ``(bb) that has been designated by the Secretary 
                pursuant to the process established under clause 
                (iv)(I)(bb); or
            ``(II) an antibacterial or antifungal biological product--
                    ``(aa) that is licensed for use, or an 
                antibacterial or antifungal biological product for 
                which an indication is first licensed for use, by the 
                Food and Drug Administration on or after June 5, 2014, 
                under section 351(a) of the Public Health Service Act 
                for human use to treat serious or life-threatening 
                infections, as determined by the Food and Drug 
                Administration, including those caused by, or likely to 
                be caused by--
                            ``(AA) an antibacterial or antifungal 
                        resistant pathogen, including novel or emerging 
                        infectious pathogens; or
                            ``(BB) a qualifying pathogen (as defined 
                        under section 505E(f) of the Federal Food, 
                        Drug, and Cosmetic Act); and
                    ``(bb) has been designated by the Secretary 
                pursuant to the process established under clause 
                (iv)(I)(bb).
    ``(iii) The mechanism established pursuant to clause (i) shall 
provide that the additional payment under clause (i) shall--
            ``(I) with respect to a discharge, only be made to a 
        subsection (d) hospital that, as determined by the Secretary--
                    ``(aa) is participating in the National Healthcare 
                Safety Network Antimicrobial Use and Resistance Module 
                of the Centers for Disease Control and Prevention or a 
                similar reporting program, as specified by the 
                Secretary, relating to antimicrobial drugs; and
                    ``(bb) has an antimicrobial stewardship program 
                that aligns with the Core Elements of Hospital 
                Antibiotic Stewardship Programs of the Centers for 
                Disease Control and Prevention or the Antimicrobial 
                Stewardship Standard set by the Joint Commission; and
            ``(II) apply to discharges occurring on or after October 1 
        of the year in which the drug or biological product is 
        designated by the Secretary as a DISARM antimicrobial drug.
    ``(iv)(I) The mechanism established pursuant to clause (i) shall 
provide for a process for--
            ``(aa) a manufacturer or sponsor of a drug or biological 
        product to request the Secretary to designate the drug or 
        biological product as a DISARM antimicrobial drug; and
            ``(bb) the designation by the Secretary of drugs and 
        biological products as DISARM antimicrobial drugs.
    ``(II) A designation of a drug or biological product as a DISARM 
antimicrobial drug may be revoked by the Secretary if the Secretary 
determines that--
            ``(aa) the drug or biological product no longer meets the 
        requirements for a DISARM antimicrobial drug under clause (ii);
            ``(bb) the request for such designation contained an untrue 
        statement of material fact; or
            ``(cc) clinical or other information that was not available 
        to the Secretary at the time such designation was made shows 
        that--
                    ``(AA) such drug or biological product is unsafe 
                for use or not shown to be safe for use for individuals 
                who are entitled to benefits under part A; or
                    ``(BB) an alternative to such drug or biological 
                product is an advance that substantially improves the 
                diagnosis or treatment of such individuals.
    ``(III) Not later than October 1, 2020, and annually thereafter, 
the Secretary shall publish in the Federal Register a list of the 
DISARM antimicrobial drugs designated under this subparagraph pursuant 
to the process established under clause (iv)(I)(bb).
    ``(v)(I) For purposes of determining additional payment amounts 
under clause (i), a manufacturer or sponsor of a drug or biological 
product that submits a request described in clause (iv)(I)(aa) shall 
submit to the Secretary information described in section 
1927(b)(3)(A)(iii).
    ``(II) The penalties for failure to provide timely information 
under clause (i) of subparagraph (C) under section 1927(b)(3) and for 
providing false information under clause (ii) of such subparagraph 
shall apply to manufacturers and sponsors of a drug or biological 
product under this section with respect to information under subclause 
(I) in the same manner as such penalties apply to manufacturers under 
such clauses with respect to information under subparagraph (A) of such 
section.
    ``(vi)(I) The mechanism established pursuant to clause (i) shall 
provide that--
            ``(aa) except as provided in item (bb), no additional 
        payment shall be made under this subparagraph for discharges 
        involving a DISARM antimicrobial drug if any additional 
        payments have been made for discharges involving such drug as a 
        new medical service or technology under subparagraph (K);
            ``(bb) additional payments may be made under this 
        subparagraph for discharges involving a DISARM antimicrobial 
        drug if any additional payments have been made for discharges 
        occurring prior to the date of enactment of this subparagraph 
        involving such drug as a new medical service or technology 
        under subparagraph (K); and
            ``(cc) no additional payment shall be made under 
        subparagraph (K) for discharges involving a DISARM 
        antimicrobial drug as a new medical service or technology if 
        any additional payments for discharges involving such drug have 
        been made under this subparagraph.''.
            (2) Conforming amendment.--Section 1886(d)(5)(K)(ii)(III) 
        of the Social Security Act (42 U.S.C. 1395ww(d)(5)(K)(ii)(III)) 
        is amended by striking ``provide'' and inserting ``subject to 
        subparagraph (M)(vii), provide''.
    (b) Study and Reports on Removing Barriers to the Development of 
DISARM Antimicrobial Drugs.--
            (1) Study.--The Comptroller General of the United States 
        (in this subsection referred to as the ``Comptroller General'') 
        shall, in consultation with the Director of the National 
        Institutes of Health, the Commissioner of Food and Drugs, the 
        Administrator of the Centers for Medicare & Medicaid Services, 
        and the Director of the Centers for Disease Control and 
        Prevention, conduct a study to--
                    (A) identify and examine the barriers that prevent 
                the development of DISARM antimicrobial drugs (as 
                defined in section 1886(d)(5)(M)(ii) of the Social 
                Security Act, as added by subsection (a)); and
                    (B) develop recommendations for actions to be taken 
                in order to overcome any barriers identified under 
                subparagraph (A).
            (2) Reports.--
                    (A) Interim report.--Not later than 3 years after 
                the date of the enactment of this Act, the Comptroller 
                General shall submit to Congress an interim report 
                containing the preliminary results of the study 
                conducted under paragraph (1), together with 
                recommendations for such legislation and administrative 
                action as the Comptroller General determines 
                appropriate.
                    (B) Final report.--Not later than 5 years after the 
                date of the enactment of this Act, the Comptroller 
                General shall submit to Congress a report containing 
                the results of the study conducted under paragraph (1), 
                together with recommendations for such legislation and 
                administrative action as the Comptroller General 
                determines appropriate.
                                 <all>