[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3582 Introduced in House (IH)]







104th CONGRESS
  2d Session
                                H. R. 3582

  To permit individuals to continue health plan coverage of services 
           while participating in approved clinical studies.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              June 5, 1996

  Mrs. Lowey introduced the following bill; which was referred to the 
                         Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
  To permit individuals to continue health plan coverage of services 
           while participating in approved clinical studies.

    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 ``Improved Patient Access to Clinical 
Studies Act of 1996''.

SEC. 2. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CLINICAL 
              STUDIES.

    (a) Permitting Participation in Approved Clinical Studies.--A 
health plan 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 plan except for the fact that they are provided in 
        connection with participation in such a study.
A health plan 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 health plan to provide for payment for items and services 
normally paid for as part of an approved clinical study.
    (c) Approved Clinical Study Defined.--In this section, 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.
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