Removing Barriers to Clinical Research Act of 2016

Bill: 114-hr-4714
Sponsor: full_name: Rep. Young, Todd [R-IN-9]
Introduced: 2016-03-03
Policy area: Health
Subjects: Health technology, devices, supplies

Medicare
Latest action: action_date: 2016-03-09
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2016-03-03
action_desc: Introduced in House
text: <p><strong>Removing Barriers to Clinical Research Act of 2016</strong></p> <p>This bill amends title XVIII (Medicare) of the Social Security Act to expand Medicare coverage of costs associated with clinical trials. Under current law, Medicare covers routine costs of care furnished to a beneficiary enrolled in a category A (experimental) clinical trial of a medical device intended for use in the diagnosis, monitoring, or treatment of an immediately life-threatening disease or condition. The bill requires Medicare to also cover,&nbsp;with respect to&nbsp;a beneficiary enrolled in a category B (non-experimental) clinical trial, routine costs of care as well as the cost of the device under investigation. </p> <p>A trial of a medical device shall, for purposes of Medicare coverage,&nbsp;be deemed to meet the definition of a category A or category B clinical trial, as the case may be, if the trial is conducted under the Federal Food, Drug, and Cosmetic Act's investigational use exemption.</p>

tv_txt: I 114th CONGRESS 2d Session H. R. 4714 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.

1. Short title This Act may be cited as the Removing Barriers to Clinical Research Act of 2016 . 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.