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 concerned 

A BILL 

To amend title XVIII of the Social Security Act to ensure 

Medicare coverage of certain costs associated with FDAapproved clinical trials. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Removing Barriers to 

5 Clinical Research Act of 2016’’. 


srobinson on DSK5SPTVN1PROD with BILLS
2 

•HR 4714 IH

1 SEC. 2. MEDICARE COVERAGE OF CERTAIN COSTS ASSOCI2 ATED WITH FDA-APPROVED CLINICAL 

3 TRIALS. 

4 (a) IN GENERAL.—Section 1862(m) of the Social Se5 curity Act (42 U.S.C. 13957(m)) is amended— 

6 (1) in the subsection heading— 

7 (A) by striking ‘‘ROUTINE’’ and inserting 

8 ‘‘CERTAIN’’; and 

9 (B) by striking ‘‘CATEGORY A’’ and insert10 ing ‘‘MEDICAL’’; 

11 (2) in paragraph (1)— 

12 (A) by striking ‘‘category A’’ and inserting 

13 ‘‘category A or category B’’; and 

14 (B) by striking ‘‘payment for coverage of 

15 routine’’ and inserting the following: ‘‘payment 

16 for coverage of— 

17 ‘‘(A) in the case of category A and cat18 egory B clinical trials, routine’’; 

19 (C) in subparagraph (A), as added by sub20 paragraph (B) of this subsection, by striking 

21 the period at the end and inserting ‘‘; or’’; and 

22 (D) by adding at the end the following new 

23 subparagraph: 

24 ‘‘(B) in the case of category B clinical 

25 trials, the costs of the devices under investiga26 tion.’’; and 


srobinson on DSK5SPTVN1PROD with BILLS
3 

•HR 4714 IH

1 (3) by adding at the end the following new 

2 paragraphs: 

3 ‘‘(3) CATEGORY B CLINICAL TRIAL.—For pur4 poses of paragraph (1), a ‘category B clinical trial’ 

5 means a trial of a medical device if— 

6 ‘‘(A) the trial is of a nonexperiemental/in7 vestigational (category B) medical device (as 

8 defined in regulations under section 405.201(b) 

9 of title 42, Code of Federal Regulations (as in 

10 effect as of January 1, 2015)); and 

11 ‘‘(B) the trial meets criteria established by 

12 the Secretary to ensure that the trial conforms 

13 to appropriate scientific and ethical standards. 

14 ‘‘(4) AUTOMATIC QUALIFICATION OF CERTAIN

15 TRIALS.—A trial of a medical device shall be deemed 

16 to be meet the definition of a category A or category 

17 B clinical trial under paragraph (2) or (3), respec18 tively, as the case may be, if the trial is conducted 

19 under the investigational use exemption under sec20 tion 520(g) of the Federal Food, Drug, and Cos21 metic Act (21 U.S.C. 360j(g)).’’. 

22 (b) CONFORMING AMENDMENT.—Paragraph (3) of 

23 section 731(b) of the Medicare Prescription Drug, Im24 provement, and Modernization Act of 2003 (42 U.S.C. 

25 1395y note) is repealed. 


srobinson on DSK5SPTVN1PROD with BILLS
4 

•HR 4714 IH

1 (c) EFFECTIVE DATE.—The amendments made by 

2 this section shall apply to costs incurred on or after the 

3 date that is 90 days after the date of the enactment of 

4 this Act. 

Æ 


srobinson on DSK5SPTVN1PROD with BILLS