Improved Patient Access to Clinical Studies Act of 1997

Summary: Improved Patient Access to Clinical Studies Act of 1997 - Amends the Employee Retirement Income Security Act of 1974 and the Public Health Service Act to prohibit a group health plan and a health insurance issuer offering coverage in connection with a group health plan from denying, limiting, or imposing additional conditions on coverage if:  (1) the enrollee is participating in an approved clinical study; (2) the items and services are furnished according to the study's design or to treat conditions resulting from study participation; and (3) the items and services would otherwise be covered.  Amends the Public Health Service Act to apply that prohibition to coverage offered by an issuer in the individual market.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Improved Patient Access to Clinical 
Studies Act of 1997''.

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

    (a) Amendments to ERISA.--Subpart B of part 7 of subtitle B of 
title I of the Employee Retirement Income Security Act of 1974 (as 
added by section 603(a) of the Newborns' and Mothers' Health Protection 
Act of 1996 and amended by section 702(a) of the Mental Health Parity 
Act of 1996) is amended by adding at the end the following new section:

``SEC. 713. 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 they 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 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 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, efficacious, or having any other 
        characteristic of a treatment which must be demonstrated in 
        order for the treatment to be medically necessary or 
        appropriate.''.
    (b) Amendments to PHSA.--
            (1) Group market.--Subpart 2 of part A of title XXVII of 
        the Public Health Service Act (as added by section 604(a) of 
        the Newborns' and Mothers' Health Protection Act of 1996 and 
        amended by section 703(a) of the Mental Health Parity Act of 
        1996) is amended by adding at the end the following new 
        section:

``SEC. 2706. 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 they 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 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 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, efficacious, or having any other 
        characteristic of a treatment which must be demonstrated in 
        order for the treatment to be medically necessary or 
        appropriate.''.
            (2) Individual market.--Subpart 3 of part B of title XXVII 
        of the Public Health Service Act (as added by section 605(a) of 
        the Newborn's and Mother's Health Protection Act of 1996) is 
        amended by adding at the end the following new section:

``SEC. 2752. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED 
              CLINICAL STUDIES.

    ``The provisions of section 2706 shall apply to health insurance 
coverage offered by a health insurance issuer in the individual market 
in the same manner as they 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.''.

SEC. 3. EFFECTIVE DATE.

    The amendment made by this Act shall apply--
            (1) with respect to group health plans for plan years 
        beginning on or after January 1, 1998; 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, 1998.