I 
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 con-
cerned 
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 Representa-
tives 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’’. 
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SEC. 2. MEDICARE COVERAGE OF CERTAIN COSTS ASSOCI-
ATED 
WITH 
FDA-APPROVED 
CLINICAL 
TRIALS. 
(a) IN GENERAL.—Section 1862(m) of the Social Se-
curity 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 insert-
ing ‘‘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 cat-
egory B clinical trials, routine’’; 
(C) in subparagraph (A), as added by sub-
paragraph (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 investiga-
tion.’’; and 
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(3) by adding at the end the following new 
paragraphs: 
‘‘(3) CATEGORY B CLINICAL TRIAL.—For pur-
poses of paragraph (1), a ‘category B clinical trial’ 
means a trial of a medical device if— 
‘‘(A) the trial is of a nonexperiemental/in-
vestigational (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), respec-
tively, as the case may be, if the trial is conducted 
under the investigational use exemption under sec-
tion 520(g) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360j(g)).’’. 
(b) CONFORMING AMENDMENT.—Paragraph (3) of 
section 731(b) of the Medicare Prescription Drug, Im-
provement, and Modernization Act of 2003 (42 U.S.C. 
1395y note) is repealed. 
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(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. 
Æ 
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