[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3958 Introduced in House (IH)]







104th CONGRESS
  2d Session
                                H. R. 3958

 To permit individuals to continue coverage under Federal health care 
 programs of services while participating in approved clinical studies 
   and to require the Secretary of Health and Human Services to make 
           publicly available information on clinical trials.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             August 2, 1996

 Mrs. Johnson of Connecticut introduced the following bill; which was 
     referred to the Committee on Commerce, and in addition to the 
Committees on Ways and Means, National Security, Veterans' Affairs, and 
   Government Reform and Oversight, 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 permit individuals to continue coverage under Federal health care 
 programs of services while participating in approved clinical studies 
   and to require the Secretary of Health and Human Services to make 
           publicly available information on 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 ``Federal Coverage for Clinical Trials 
Act of 1996''.

SEC. 2. COVERAGE UNDER CERTAIN FEDERAL HEALTH CARE PROGRAMS FOR 
              INDIVIDUALS PARTICIPATING IN APPROVED CLINICAL STUDIES.

    (a) Permitting Participation in Approved Clinical Studies.--A 
Federal health care program may not deny (or limit or impose additional 
conditions on) coverage of items and services furnished to an enrollee 
if--
            (1) the enrollee is participating in an approved clinical 
        study,
            (2) the items and services are furnished according to the 
        design of the study or to treat conditions resulting from 
        participation in the study, and
            (3) the items and services would otherwise be covered under 
        the program except for the fact that they are provided in 
        connection with participation in such a study.
Such a program may not discriminate against an enrollee on the basis of 
the enrollee's participation in such a study.
    (b) Construction.--Nothing in subsection (a) shall be construed as 
requiring a Federal health care program to provide for payment for 
items and services normally paid for as part of an approved clinical 
study, such as the experimental therapy or drug itself.
    (c) Approved Clinical Study Defined.--In this Act, the term 
``approved clinical study'' means--
            (1) a research study approved by the Secretary of Health 
        and Human Services, the Director of the National Institutes of 
        Health, the Commissioner of the Food and Drug Administration, 
        the Secretary of Veterans Affairs, the Secretary of Defense, or 
        a qualified nongovernmental research entity (as defined in 
        guidelines of the National Institute of Health), or
            (2) a peer-reviewed and approved research program, as 
        defined by the Secretary of Health and Human Services, 
        conducted for the primary purpose of determining whether or not 
        a treatment is safe, efficacious, or having any other 
        characteristic of a treatment which must be demonstrated in 
        order for the treatment to be medically necessary or 
        appropriate.
    (d) Federal Health Care Program Defined.--In this section, the term 
``Federal health care program'' means the following:
            (1) Medicare.--The medicare program under title XVIII of 
        the Social Security Act.
            (2) FEHBP.--Health benefits plans offered under the Federal 
        Employees Health Benefit Plan under chapter 89 of title 5, 
        United States Code.
            (3) VA health care.--The veterans health care program under 
        chapter 17 of title 38, United States Code.
            (4) DOD-related programs.--The Civilian Health and Medical 
        Program of the Uniformed Services (CHAMPUS), as defined in 
        section 1072(4) of title 10, United States Code.
    (e) Coverage Under Medicaid Program.--Nothing in title XIX of the 
Social Security Act shall be construed as preventing a State from 
receiving Federal financial participation with respect to medical 
assistance for which coverage is otherwise required to be provided by a 
Federal health care program under this section.

SEC. 3. MAKING PUBLICLY AVAILABLE INFORMATION ON RESULTS OF APPROVED 
              CLINICAL STUDIES.

    The Secretary of Health and Human Services shall make available to 
the public information about clinical investigations and results 
obtained from approved clinical studies (as defined in section 2(c)).
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