DISARM Act of 2015

Summary: Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2015 or the  DISARM Act of 2015  Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services to: (1) recognize the costs of DISARM antimicrobial drugs under the Medicare payment system for the inpatient services of subsection (d) hospitals, (2) provide for additional payment with respect to discharges involving such drugs, (3) publish in the Federal Register a list of the DISARM antimicrobial drugs, and (4) make a proportional adjustment in standardized payment amounts to assure that the requirements of this Act do not result in aggregate payments greater or less than those that would otherwise be made for a fiscal year. (Generally, a subsection [d] hospital is an acute care hospital, particularly one that receives payments under Medicare's inpatient prospective payment system [IPPS] when providing covered inpatient services to eligible beneficiaries.) Defines a &quot;DISARM antimicrobial drug&quot; as one approved or licensed by the Food and Drug Administration on or after January 1, 2015, which, among other things, is intended to treat an infection:  caused by, or likely to be caused by, a qualifying pathogen; associated with high rates of mortality or significant patient morbidity; and for which there is an unmet medical need.  Requires that the mechanism established by the Secretary to recognize the costs of new medical services and technologies that are not DISARM antimicrobial drugs under the Medicare payment system is applicable to new medical services or technology if the service or technology is not a DISARM antimicrobial drug.  Directs the Comptroller General to study the barriers that prevent the development of DISARM antimicrobial drugs and develop recommendations for actions to be taken in order to overcome those barriers.

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).