[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 3787 Introduced in Senate (IS)]

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115th CONGRESS
  2d Session
                                S. 3787

   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

                           December 19, 2018

 Mr. Hatch (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 2018'' and as the 
``DISARM Act of 2018''.

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) Effective for discharges beginning on or 
                after October 1, 2021, 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--
                            ``(I) the amount payable under section 
                        1847A for such drug during the calendar quarter 
                        in which the discharge occurred; or
                            ``(II) 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) 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, 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
                            ``(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, 2021, 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) 
                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.
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