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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4714 Introduced in House (IH)]

<DOC>

114th CONGRESS
  2d Session
                                H. R. 4714

  To amend title XVIII of the Social Security Act to ensure Medicare 
coverage of certain costs associated with FDA-approved clinical trials.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             March 3, 2016

   Mr. Young of Indiana (for himself and Mr. Peters) 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 ensure Medicare 
coverage of certain costs associated with FDA-approved clinical trials.

    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 ``Removing Barriers to Clinical 
Research Act of 2016''.

SEC. 2. MEDICARE COVERAGE OF CERTAIN COSTS ASSOCIATED WITH FDA-APPROVED 
              CLINICAL TRIALS.

    (a) In General.--Section 1862(m) of the Social Security Act (42 
U.S.C. 13957(m)) is amended--
            (1) in the subsection heading--
                    (A) by striking ``Routine'' and inserting 
                ``Certain''; and
                    (B) by striking ``Category A'' and inserting 
                ``Medical'';
            (2) in paragraph (1)--
                    (A) by striking ``category A'' and inserting 
                ``category A or category B''; and
                    (B) by striking ``payment for coverage of routine'' 
                and inserting the following: ``payment for coverage 
                of--
                    ``(A) in the case of category A and category B 
                clinical trials, routine'';
                    (C) in subparagraph (A), as added by subparagraph 
                (B) of this subsection, by striking the period at the 
                end and inserting ``; or''; and
                    (D) by adding at the end the following new 
                subparagraph:
                    ``(B) in the case of category B clinical trials, 
                the costs of the devices under investigation.''; and
            (3) by adding at the end the following new paragraphs:
            ``(3) Category b clinical trial.--For purposes of paragraph 
        (1), a `category B clinical trial' means a trial of a medical 
        device if--
                    ``(A) the trial is of a nonexperiemental/
                investigational (category B) medical device (as defined 
                in regulations under section 405.201(b) of title 42, 
                Code of Federal Regulations (as in effect as of January 
                1, 2015)); and
                    ``(B) the trial meets criteria established by the 
                Secretary to ensure that the trial conforms to 
                appropriate scientific and ethical standards.
            ``(4) Automatic qualification of certain trials.--A trial 
        of a medical device shall be deemed to be meet the definition 
        of a category A or category B clinical trial under paragraph 
        (2) or (3), respectively, as the case may be, if the trial is 
        conducted under the investigational use exemption under section 
        520(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        360j(g)).''.
    (b) Conforming Amendment.--Paragraph (3) of section 731(b) of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003 
(42 U.S.C. 1395y note) is repealed.
    (c) Effective Date.--The amendments made by this section shall 
apply to costs incurred on or after the date that is 90 days after the 
date of the enactment of this Act.
                                 <all>
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