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[DOCID: f:s257is.txt]






107th CONGRESS
  1st Session
                                 S. 257

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            February 6, 2001

   Ms. Snowe introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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 2001''.

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

    (a) Amendments to ERISA.--
            (1) In general.--Subpart B of part 7 of subtitle B of title 
        I of the Employee Retirement Income Security Act of 1974 (29 
        U.S.C. 1185 et seq.) is amended by adding at the end the 
        following:

``SEC. 714. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CLINICAL 
              STUDIES.

    ``(a) Permitting Participation in Approved Clinical Studies.--A 
group health plan, and a health insurance issuer offering health 
insurance coverage in connection with a group health plan, may not deny 
(or limit or impose additional conditions on) the 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 the items and services 
        are provided in connection with participation in such a study.
Such a plan or issuer 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 group health plan, or a health insurance issuer offering 
health insurance coverage in connection with a group 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 Food and Drugs, the Secretary of 
        Veterans Affairs, the Secretary of Defense, or a qualified 
        nongovernmental research entity (as defined in guidelines of 
        the National Institutes 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, is efficacious, or has any other 
        characteristic of a treatment that must be demonstrated in 
        order for the treatment to be medically necessary or 
        appropriate.''.
            (2) Table of contents.--The table of contents in section 1 
        of the Employee Retirement Income Security Act of 1974 (29 
        U.S.C. prec. 1001) is amended by inserting after the item 
relating to section 713 the following:

``Sec. 714. Coverage for individuals participating in approved clinical 
                            studies.''.
    (b) Amendments to PHSA.--
            (1) Group market.--Subpart 2 of part A of title XXVII of 
        the Public Health Service Act (29 U.S.C. 300gg-4 et seq.) is 
        amended by adding at the end the following:

``SEC. 2707. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED 
              CLINICAL STUDIES.

    ``(a) Permitting Participation in Approved Clinical Studies.--A 
group health plan, and a health insurance issuer offering health 
insurance coverage in connection with a group health plan, may not deny 
(or limit or impose additional conditions on) the 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 the items and services 
        are provided in connection with participation in such a study.
Such a plan or issuer 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 group health plan, or a health insurance issuer offering 
health insurance coverage in connection with a group 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 Food and Drugs, the Secretary of 
        Veterans Affairs, the Secretary of Defense, or a qualified 
        nongovernmental research entity (as defined in guidelines of 
        the National Institutes 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, is efficacious, or has any other 
        characteristic of a treatment that must be demonstrated in 
        order for the treatment to be medically necessary or 
        appropriate.''.
            (2) Individual market.--The first subpart 3 of part B of 
        title XXVII of the Public Health Service Act (29 U.S.C. 300gg-
        51 et seq.) is amended--
            (1) by adding at the end the following:

``SEC. 2753. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED 
              CLINICAL STUDIES.

    ``The provisions of section 2707 shall apply to health insurance 
coverage offered by a health insurance issuer in the individual market 
in the same manner as the provisions apply to health insurance coverage 
offered by a health insurance issuer in connection with a group health 
plan in the small or large group market.''; and
            (2) by redesignating such subpart 3 as subpart 2.

SEC. 3. EFFECTIVE DATE.

    The amendments made by this Act shall apply--
            (1) with respect to group health plans for plan years 
        beginning on or after January 1, 2002; and
            (2) with respect to health insurance coverage offered, 
        sold, issued, renewed, in effect, or operated in the individual 
        market on or after January 1, 2002.
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