SEC. 2. CONTINUING COVERAGE FOR INDIVIDUALS PAR-
TICIPATING IN APPROVED CLINICAL STUD-
IES.
(a) GROUP HEALTH PLANS.—
(1) PUBLIC
HEALTH
SERVICE
ACT
AMEND-
MENTS.—(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 addi-
tional conditions on) coverage of items and services
furnished to a participant or beneficiary if—
‘‘(A) the participant or beneficiary is par-
ticipating 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 other-
wise 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 clin-
ical 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 Sec-
retary of Health and Human Services, the Director
of the National Institutes of Health, the Commis-
sioner of the Food and Drug Administration, the
Secretary of Veterans Affairs, the Secretary of De-
fense, 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 appro-
priate.’’.
(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 Re-
tirement Income Security Act of 1974 is amended by
adding at the end the following new section:
‘‘SEC. 714. CONTINUING COVERAGE FOR INDIVIDUALS PAR-
TICIPATING IN APPROVED CLINICAL STUD-
IES.
‘‘(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 addi-
tional conditions on) coverage of items and services
furnished to a participant or beneficiary if—
‘‘(A) the participant or beneficiary is par-
ticipating 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 other-
wise 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 clin-
ical study.
‘‘(c) NOTICE UNDER GROUP HEALTH PLAN.—The
imposition of the requirement of this section shall be treat-
ed as a material modification in the terms of the plan de-
scribed in section 102(a)(1), for purposes of assuring no-
tice 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 Sec-
retary of Health and Human Services, the Director
of the National Institutes of Health, the Commis-
sioner of the Food and Drug Administration, the
Secretary of Veterans Affairs, the Secretary of De-
fense, 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 appro-
priate.’’.
(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
AMEND-
MENTS.—
(A) IN GENERAL.—Subchapter B of chap-
ter 100 of the Internal Revenue Code of 1986
is amended—
(i) in the table of sections, by insert-
ing 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 addi-
tional conditions on) coverage of items and services
furnished to a participant or beneficiary if—
‘‘(A) the participant or beneficiary is par-
ticipating 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 other-
wise 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 pro-
vide 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 Sec-
retary of Health and Human Services, the Director
of the National Institutes of Health, the Commis-
sioner of the Food and Drug Administration, the
Secretary of Veterans Affairs, the Secretary of De-
fense, 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 appro-
priate.’’.
(B) CONFORMING
AMENDMENT.—Section
4980D(d)(1) of such Code is amended by strik-
ing ‘‘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 amend-
ed by inserting after section 2752 the following new sec-
tion:
‘‘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 indi-
vidual 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 sec-
tion 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 para-
graph (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
COV-
ERAGE.—The amendments made by subsection (b)
apply with respect to health insurance coverage of-
fered, 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 be-
tween employee representatives and 1 or more em-
ployers 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 ter-
minates (determined without regard to any ex-
tension thereof agreed to after the date of en-
actment of this Act), or
(B) January 1, 2000.
For purposes of subparagraph (A), any plan amend-
ment 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 Sec-
retary 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 mat-
ter over which two or more such Secretaries have re-
sponsibility 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.
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