[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2769 Introduced in House (IH)]







106th CONGRESS
  1st Session
                                H. R. 2769

To amend the Public Health Service Act, the Employee Retirement Income 
 Security Act of 1974, and the Internal Revenue Code of 1986 to permit 
individuals to continue health coverage of services while participating 
                     in approved clinical studies.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             August 5, 1999

  Mrs. Lowey introduced the following bill; which was referred to the 
 Committee on Commerce, and in addition to the Committees on Education 
and the Workforce, and Ways and Means, 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 the Public Health Service Act, the Employee Retirement Income 
 Security Act of 1974, and the Internal Revenue Code of 1986 to permit 
individuals to continue health 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 1999''.

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

    (a) Group Health Plans.--
            (1) Public health service act amendments.--(A) Subpart 2 of 
        part A of title XXVII of the Public Health Service Act is 
        amended by adding at the end the following new section:

``SEC. 2707. CONTINUING 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 group health 
insurance coverage--
            ``(1) may not deny (or limit or impose additional 
        conditions on) coverage of items and services furnished to a 
        participant or beneficiary if--
                    ``(A) the participant or beneficiary is 
                participating in an approved clinical study;
                    ``(B) the items and services are furnished 
                according to the design of the study or to treat 
                conditions resulting from participation in the study; 
                and
                    ``(C) 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; and
            ``(2) may not discriminate against a participant or 
        beneficiary on the basis of the participant's or beneficiary's 
        participation in such a study.
    ``(b) Construction.--Nothing in subsection (a) shall be construed 
as requiring a group health plan or health insurance issuer to provide 
for payment for items and services normally paid for as part of an 
approved clinical study.
    ``(c) Notice.--A group health plan under this part shall comply 
with the notice requirement under section 714(c) of the Employee 
Retirement Income Security Act of 1974 with respect to the requirements 
of this section as if such section applied to such plan.
    ``(d) 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.''.
            (B) Section 2723(c) of such Act (42 U.S.C. 300gg-23(c)) is 
        amended by striking ``section 2704'' and inserting ``sections 
        2704 and 2707''.
            (2) ERISA amendments.--(A) Subpart B of part 7 of subtitle 
        B of title I of the Employee Retirement Income Security Act of 
        1974 is amended by adding at the end the following new section:

``SEC. 714. CONTINUING 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 group health 
insurance coverage--
            ``(1) may not deny (or limit or impose additional 
        conditions on) coverage of items and services furnished to a 
        participant or beneficiary if--
                    ``(A) the participant or beneficiary is 
                participating in an approved clinical study;
                    ``(B) the items and services are furnished 
                according to the design of the study or to treat 
                conditions resulting from participation in the study; 
                and
                    ``(C) 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; and
            ``(2) may not discriminate against a participant or 
        beneficiary on the basis of the participant's or beneficiary's 
        participation in such a study.
    ``(b) Construction.--Nothing in subsection (a) shall be construed 
as requiring a group health plan or health insurance issuer to provide 
for payment for items and services normally paid for as part of an 
approved clinical study.
    ``(c) Notice Under Group Health Plan.--The imposition of the 
requirement of this section shall be treated as a material modification 
in the terms of the plan described in section 102(a)(1), for purposes 
of assuring notice of such requirements under the plan; except that the 
summary description required to be provided under the last sentence of 
section 104(b)(1) with respect to such modification shall be provided 
by not later than 60 days after the first day of the first plan year in 
which such requirement apply.''.
    ``(d) 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.''.
            (B) Section 731(c) of such Act (29 U.S.C. 1191(c)) is 
        amended by striking ``section 711'' and inserting ``sections 
        711 and 714''.
            (C) Section 732(a) of such Act (29 U.S.C. 1191a(a)) is 
        amended by striking ``section 711'' and inserting ``sections 
        711 and 714''.
            (D) The table of contents in section 1 of such Act is 
        amended by inserting after the item relating to section 713 the 
        following new item:

``Sec. 714. Continuing coverage for individuals participating in 
                            approved clinical studies.''.
            (3) Internal revenue code amendments.--
                    (A) In general.--Subchapter B of chapter 100 of the 
                Internal Revenue Code of 1986 is amended--
                            (i) in the table of sections, by inserting 
                        after the item relating to section 9812 the 
                        following new item:

                              ``Sec. 9813. Continuing coverage for 
                                        individuals participating in 
                                        approved clinical studies.''; 
                                        and
                            (ii) by inserting after section 9812 the 
                        following:

``SEC. 9813. CONTINUING COVERAGE FOR INDIVIDUALS PARTICIPATING IN 
              APPROVED CLINICAL STUDIES.

    ``(a) Permitting Participation in Approved Clinical Studies.--A 
group health plan--
            ``(1) may not deny (or limit or impose additional 
        conditions on) coverage of items and services furnished to a 
        participant or beneficiary if--
                    ``(A) the participant or beneficiary is 
                participating in an approved clinical study;
                    ``(B) the items and services are furnished 
                according to the design of the study or to treat 
                conditions resulting from participation in the study; 
                and
                    ``(C) 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; and
            ``(2) may not discriminate against a participant or 
        beneficiary on the basis of the participant's or beneficiary's 
        participation in such a study.
    ``(b) Construction.--Nothing in subsection (a) shall be construed 
as requiring 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 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.''.
                    (B) Conforming amendment.--Section 4980D(d)(1) of 
                such Code is amended by striking ``section 9811'' and 
                inserting ``sections 9811 and 9813''.
    (b) Individual Health Insurance.--(1) Part B of title XXVII of the 
Public Health Service Act is amended by inserting after section 2752 
the following new section:

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

    ``(a) In General.--The provisions of section 2707 (other than 
subsection (c)) 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.
    ``(b) Notice.--A health insurance issuer under this part shall 
comply with the notice requirement under section 714(c) of the Employee 
Retirement Income Security Act of 1974 with respect to the requirements 
referred to in subsection (a) as if such section applied to such issuer 
and such issuer were a group health plan.''.
    (2) Section 2762(b)(2) of such Act (42 U.S.C. 300gg-62(b)(2)) is 
amended by striking ``section 2751'' and inserting ``sections 2751 and 
2753''.
    (c) Effective Dates.--
            (1) Group health plans and group health insurance 
        coverage.--Subject to paragraph (3), the amendments made by 
        subsection (a) apply with respect to group health plans for 
        plan years beginning on or after January 1, 2000.
            (2) Individual health insurance coverage.--The amendments 
        made by subsection (b) apply with respect to health insurance 
        coverage offered, sold, issued, renewed, in effect, or operated 
        in the individual market on or after such date.
            (3) Collective bargaining exception.--In the case of a 
        group health plan maintained pursuant to 1 or more collective 
        bargaining agreements between employee representatives and 1 or 
        more employers ratified before the date of enactment of this 
        Act, the amendments made subsection (a) shall not apply to plan 
        years beginning before the later of--
                    (A) the date on which the last collective 
                bargaining agreements relating to the plan terminates 
                (determined without regard to any extension thereof 
                agreed to after the date of enactment of this Act), or
                    (B) January 1, 2000.
        For purposes of subparagraph (A), any plan amendment made 
        pursuant to a collective bargaining agreement relating to the 
        plan which amends the plan solely to conform to any requirement 
        added by subsection (a) shall not be treated as a termination 
        of such collective bargaining agreement.
    (d) Coordination of Administration.--The Secretary of Labor, the 
Secretary of the Treasury, and the Secretary of Health and Human 
Services shall ensure, through the execution of an interagency 
memorandum of understanding among such Secretaries, that--
            (1) regulations, rulings, and interpretations issued by 
        such Secretaries relating to the same matter over which two or 
        more such Secretaries have responsibility under the provisions 
        of this Act (and the amendments made thereby) are administered 
        so as to have the same effect at all times; and
            (2) coordination of policies relating to enforcing the same 
        requirements through such Secretaries in order to have a 
        coordinated enforcement strategy that avoids duplication of 
        enforcement efforts and assigns priorities in enforcement.
                                 <all>