```

[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 512 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 512

   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

                            January 22, 2015

Mr. Roskam (for himself and Mr. Danny K. Davis of Illinois) 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 provisions 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 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 2015'' and as the 
``DISARM Act of 2015''.

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, 2015, the Secretary shall, after 
                notice and opportunity for public comment (in the 
                publications required by subsection (e)(5) for a fiscal 
                year or otherwise), recognize the costs of DISARM 
                antimicrobial drugs under the payment system 
                established under this subparagraph.
                    ``(ii) Pursuant to clause (i), the Secretary shall 
                provide for additional payment to be made under this 
                subsection with respect to discharges involving DISARM 
                antimicrobial drugs in the amount provided for under 
                section 1847A for drugs and biological products that 
                are described in section 1842(o)(1)(C).
                    ``(iii) For purposes of this subparagraph, the term 
                `DISARM antimicrobial drug' means a product that is 
                approved or licensed for use, or a product for which an 
                indication is first approved or licensed for use, by 
                the Food and Drug Administration on or after January 1, 
                2015, and--
                            ``(I)(aa) is intended to treat an infection 
                        caused by, or likely to be caused by, a 
                        qualifying pathogen (as defined under section 
                        505E(f) of the Federal Food, Drug, and Cosmetic 
                        Act); or
                            ``(bb) meets the definition of a qualified 
                        infectious disease product under section 
                        505E(g) of the Federal Food, Drug, and Cosmetic 
                        Act;
                            ``(II) is intended to treat an infection 
                        for which there is an unmet medical need as 
                        determined by the Food and Drug Administration;
                            ``(III) is intended to treat an infection 
                        that is associated with high rates of mortality 
                        or significant patient morbidity, as determined 
                        by the Secretary, in consultation with the 
                        Director of the Centers for Disease Control and 
                        Prevention and the infectious disease 
                        professional community; and
                            ``(IV) is used in facilities that, to the 
                        extent available to such facilities, as 
                        determined by the Secretary, participate in--
                                    ``(aa) the National Healthcare 
                                Safety Network of the Centers for 
                                Disease Control and Prevention; or
                                    ``(bb) a similar reporting program 
                                relating to antimicrobial drugs, as 
                                specified by the Secretary.
                    ``(iv)(I) The manufacturer or sponsor of a drug may 
                request the Secretary to designate a drug as a DISARM 
                antimicrobial drug at any time before or after the 
                submission of an application under section 505(b) of 
                the Federal Food, Drug, and Cosmetic Act or section 
                351(a) of the Public Health Service Act for such drug. 
                Pursuant to the previous sentence, the Secretary shall, 
                not later than 60 days after the submission of such a 
                request, determine whether the drug will be considered 
                a DISARM antimicrobial drug in the case that it is 
                approved or licensed for use, or is first approved or 
                licensed for an indication.
                    ``(II) Except as provided in subclause (III), a 
                designation under this clause shall not be withdrawn 
                for any reason.
                    ``(III) The Secretary may revoke a designation of a 
                drug as a DISARM antimicrobial drug product if the 
                Secretary finds that the request for such designation 
                contained an untrue statement of material fact.
                    ``(v) Not later than October 1, 2016, the Secretary 
                shall first publish in the Federal Register a list of 
                the DISARM antimicrobial drugs.
                    ``(vi) The Secretary shall make a proportional 
                adjustment in the standardized amount determined under 
                paragraph (3) to assure that the provisions of this 
                subparagraph do not result in aggregate payments under 
                this subsection that are greater or less than those 
                that would otherwise be made under such subsection for 
                a fiscal year.''.
            (2) Relationship to ntap payments.--Section 1886(d)(5) of 
        the Social Security Act (42 U.S.C. 1395ww(d)(5)), as amended by 
        paragraph (1), is further amended in subparagraph (K)--
                    (A) in clause (i), by inserting ``that are not 
                DISARM antimicrobial drugs (as defined in subparagraph 
                (M)(iii))'' after ``new medical services and 
                technologies''; and
                    (B) in clause (ii)(I), by inserting ``if the 
                service or technology is not a DISARM antimicrobial 
                drug and'' after ``a new medical service or 
                technology''.
    (b) Study and Report on Removing Barriers to Development of DISARM 
Antimicrobial Drugs.--
            (1) Study.--The Comptroller General of the United States 
        shall, in consultation with the Director of the National 
        Institutes of Health, the Commissioner of Food and Drugs, 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)(iii) 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) Report.--Not later than 1 year after the date of the 
        enactment of this Act, the Comptroller General shall submit to 
        Congress a report on the study conducted under paragraph (1).
                                 <all>
```