[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4187 Introduced in House (IH)]

113th CONGRESS
  2d Session
                                H. R. 4187

   To amend title XVIII of the Social Security Act to encourage the 
development and use of new antimicrobial drugs, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 11, 2014

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 new 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 2014'' and as the 
``DISARM Act of 2014''.

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

    (a) Additional Payment for New 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, 
2014, 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 new antimicrobial drugs 
under the payment system established under this subsection.
    ``(ii) Pursuant to clause (i), the Secretary shall provide for 
additional payment to be made under this subsection with respect to 
discharges involving new antimicrobial drugs in the amount provided for 
under section 1847A for drugs and biologicals that are described in 
section 1842(o)(1)(C).
    ``(iii) For purposes of this subparagraph, the term `new 
antimicrobial drug' means a product that is approved for use, or a 
product for which an indication is first approved for use, by the 
Federal Food and Drug Administration on or after January 1, 2014, and 
that--
            ``(I) is indicated 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 (21 
        U.S.C. 355f(f))) for which there is an unmet medical need and 
        which 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
            ``(II) is used in facilities that participate in the 
        Antimicrobial Use and Resistance Module of the National 
        Healthcare Safety Network of the Centers for Disease Control 
        and Prevention (or, in the case that such Module is not 
        available, is used in facilities that participate in such 
        successor or similar reporting module or program relating to 
        antimicrobials as the Secretary shall specify to the extent 
        available to such facilities, as determined by the Secretary).
    ``(iv) Not later than July 1, 2014, the Secretary shall first 
publish in the Federal Register a list of the new antimicrobial 
drugs.''.
            (2) Budget neutrality.--Section 1886(d)(3)(C) of the Social 
        Security Act (42 U.S.C. 1395ww(d)(3)(C)) is amended by adding 
        at the end the following new clause:
            ``(iii) Maintaining budget neutrality for certain 
        antimicrobial drugs.--For discharges occurring in a fiscal year 
        beginning with fiscal year 2015, the Secretary shall further 
        reduce each of the average standardized amounts in an amount 
        equal to the amount of the net additional expenditures, if any, 
        in such fiscal year resulting from the application of paragraph 
        (5)(M).''.
    (b) Study and Report on Removing Barriers to Development of New 
Antimicrobial Drugs.--
            (1) Study.--The Comptroller General of the United States 
        shall, in consultation with the Director of the United States 
        Patent and Trademark Office, 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 new antimicrobial drugs, as defined 
                in section 1886(d)(5)(M)(iii) of the Social Security 
                Act (42 U.S.C. 1395ww(d)(5)(M)(iii)); and
                    (B) develop recommendations for actions to be taken 
                in order to overcome any barriers identified under 
                subparagraph (A).
            (2) Report.--Not later than one 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).
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