tity identified in the guidelines issued by 
the National Institutes of Health for cen-
ter support grants. 
‘‘(vii) DOD; VA; DOE.—Any of the 
following if the conditions described in 
paragraph (2) are met: 
‘‘(I) The Department of Veterans 
Affairs. 
‘‘(II) The Department of De-
fense. 
‘‘(III) The Department of En-
ergy. 
‘‘(B) FDA DRUG TRIAL UNDER IND.—The 
study or investigation is conducted under an in-
vestigational new drug application reviewed by 
the Food and Drug Administration. 
‘‘(C) EXEMPT DRUG TRIAL.—The study or 
investigation is a drug trial that is exempt from 
having such an investigational new drug appli-
cation. 
‘‘(2) CONDITIONS
FOR
DEPARTMENTS.—The 
conditions described in this paragraph, for a study 
or investigation conducted by a Department, are 
that the study or investigation has been reviewed
and approved through a system of peer review that 
the Secretary determines—
‘‘(A) to be comparable to the system of 
peer review of studies and investigations used 
by the National Institutes of Health, and 
‘‘(B) assures unbiased review of the high-
est scientific standards by qualified individuals 
who have no interest in the outcome of the re-
view. 
‘‘(e) CONSTRUCTION.—Nothing in this section shall 
be construed to limit a plan’s or issuer’s coverage with 
respect to clinical trials.’’. 
(B) Section 732(a) of such Act (29 U.S.C. 
1191a(a)) is amended by striking ‘‘section 711’’ and 
inserting ‘‘sections 711 and 714’’. 
(C) 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. Coverage for individuals participating in approved cancer clinical 
trials.’’.
(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. Coverage for individuals participating in approved 
cancer clinical trials.’’; and
(ii) by inserting after section 9812 the 
following: 
‘‘SEC. 9813. COVERAGE FOR INDIVIDUALS PARTICIPATING 
IN APPROVED CANCER CLINICAL TRIALS. 
‘‘(a) COVERAGE.—
‘‘(1) IN GENERAL.—If a group health plan pro-
vides coverage to a qualified individual (as defined in 
subsection (b)), the plan—
‘‘(A) may not deny the individual partici-
pation in the clinical trial referred to in sub-
section (b)(2); 
‘‘(B) subject to subsection (c), may not 
deny (or limit or impose additional conditions 
on) the coverage of routine patient costs for 
items and services furnished in connection with 
participation in the trial; and 
‘‘(C) may not discriminate against the in-
dividual on the basis of the individual’s partici-
pation in such trial. 
‘‘(2) EXCLUSION OF CERTAIN COSTS.—
‘‘(A) IN GENERAL.—For purposes of para-
graph (1)(B), subject to subparagraph (B), rou-
tine patient costs include all items and services 
provided in the clinical trial that are otherwise 
generally available to the qualified individual, 
except—
‘‘(i) in the cases of drugs and devices, 
the investigational item or service, itself; or 
‘‘(ii) items and services that are pro-
vided solely to satisfy data collection and 
analysis needs and that are not used in the 
direct clinical management of the patient. 
‘‘(B) EXCLUSION.—Such routine patient 
costs do include costs for the following: 
‘‘(i) CONVENTIONAL CARE.—Items or 
services that are typically provided absent 
a clinical trial. 
‘‘(ii) ADMINISTRATIVE ITEMS.—Items 
or services required solely for the provision 
of the investigational item or service (such 
as the administration of a noncovered 
chemotherapeutic agent), the clinically ap-
propriate monitoring of the effects of the 
item or service, or the prevention of com-
plications.
‘‘(iii) REASONABLE
AND
NECESSARY 
CARE.—Items or services needed for rea-
sonable and necessary care arising from 
the provision of an investigational item or 
service, including the diagnosis or treat-
ment of complications. 
‘‘(3) USE OF IN-NETWORK PROVIDERS.—If one 
or more participating providers is participating in a 
clinical trial, nothing in paragraph (1) shall be con-
strued as preventing a plan from requiring that a 
qualified individual participate in the trial through 
such a participating provider if the provider will ac-
cept the individual as a participant in the trial. 
‘‘(b) QUALIFIED INDIVIDUAL DEFINED.—For pur-
poses of subsection (a), the term ‘qualified individual’ 
means an individual who is a participant or beneficiary 
in a group health plan and who meets the following condi-
tions: 
‘‘(1)(A) The individual has been diagnosed with 
cancer. 
‘‘(B) The individual is eligible to participate in 
an approved clinical trial according to the trial pro-
tocol with respect to treatment of such illness. 
‘‘(2) Either—
‘‘(A) the referring physician is a partici-
pating health care professional and has con-
cluded that the individual’s participation in 
such trial would be appropriate based upon the 
individual meeting the conditions described in 
paragraph (1); or 
‘‘(B) the participant or beneficiary pro-
vides medical and scientific information estab-
lishing that the individual’s participation in 
such trial would be appropriate based upon the 
individual meeting the conditions described in 
paragraph (1). 
‘‘(c) PAYMENT.—
‘‘(1) IN GENERAL.—Under this section a group 
health plan shall provide for payment for routine pa-
tient costs described in subsection (a)(2) but is not 
required to pay for costs of items and services that 
are customarily provided by the research sponsors 
free of charge for individuals participating in the 
trial. 
‘‘(2) PAYMENT RATE.—In the case of covered 
items and services provided by—
‘‘(A) a participating provider, the payment 
rate shall be at the agreed upon rate, or
‘‘(B) a nonparticipating provider, the pay-
ment rate shall be at the rate the plan would 
normally pay for comparable items and services 
under subparagraph (A). 
‘‘(d) APPROVED CLINICAL TRIAL DEFINED.—
‘‘(1) IN GENERAL.—In this section, the term 
‘approved clinical trial’ means a clinical research 
study or clinical investigation that relates to the 
treatment of cancer (including related symptoms) 
and is described in any of the following subpara-
graphs: 
‘‘(A) FEDERALLY FUNDED TRIALS.—The 
study or investigation is approved or funded 
(which may include funding through in-kind 
contributions) by one or more of the following: 
‘‘(i) NIH.—The National Institutes of 
Health. 
‘‘(ii) CDC.—The Centers for Disease 
Control and Prevention. 
‘‘(iii) AHRQ.—The Agency for Health 
Care Research and Quality. 
‘‘(iv) HCFA.—The Health Care Fi-
nancing Administration. 
‘‘(v) COOPERATIVE CENTER.—A coop-
erative group or center of any of the enti-
ties described in clauses (i) through (iv) or 
the Departments of Defense or Veterans 
Affairs. 
‘‘(vi) CENTER SUPPORT GRANTEES.—
A qualified non-governmental research en-
tity identified in the guidelines issued by 
the National Institutes of Health for cen-
ter support grants. 
‘‘(vii) DOD; VA; DOE.—Any of the 
following if the conditions described in 
paragraph (2) are met: 
‘‘(I) The Department of Veterans 
Affairs. 
‘‘(II) The Department of De-
fense. 
‘‘(III) The Department of En-
ergy. 
‘‘(B) FDA DRUG TRIAL UNDER IND.—The 
study or investigation is conducted under an in-
vestigational new drug application reviewed by 
the Food and Drug Administration. 
‘‘(C) EXEMPT DRUG TRIAL.—The study or 
investigation is a drug trial that is exempt from 
having such an investigational new drug appli-
cation.
‘‘(2) CONDITIONS
FOR
DEPARTMENTS.—The 
conditions described in this paragraph, for a study 
or investigation conducted by a Department, are 
that the study or investigation has been reviewed 
and approved through a system of peer review that 
the Secretary determines—
‘‘(A) to be comparable to the system of 
peer review of studies and investigations used 
by the National Institutes of Health, and 
‘‘(B) assures unbiased review of the high-
est scientific standards by qualified individuals 
who have no interest in the outcome of the re-
view. 
‘‘(e) CONSTRUCTION.—Nothing in this section shall 
be construed to limit a plan’s coverage with respect to clin-
ical trials.’’. 
(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.—Part B of 
title XXVII of the Public Health Service Act is amended—
(1) by redesignating the first subpart 3 (relat-
ing to other requirements) as subpart 2; and
(2) by adding at the end of subpart 2 the fol-
lowing new section: 
‘‘SEC. 2753. COVERAGE FOR INDIVIDUALS PARTICIPATING 
IN APPROVED CANCER CLINICAL TRIALS. 
‘‘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 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.’’. 
(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, 2004. 
(2) INDIVIDUAL
HEALTH
INSURANCE
COV-
ERAGE.—The amendment made by subsection (b) 
applies 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, 2004. 
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. 
(e) STUDY AND REPORT.—
(1) STUDY.—The Secretary of Health and 
Human Services, jointly with the Secretaries of 
Labor and the Treasury, shall study the impact on 
group health plans and health insurance issuers of 
requiring group health plans and health insurance 
coverage to cover routine patient care costs for indi-
viduals with serious and life threatening diseases 
other than cancer. 
(2) REPORT
TO
CONGRESS.—Not later than 
January 1, 2007, such Secretary shall submit a re-
port to Congress that contains an assessment of—
(A) any incremental cost to group health 
plans and health insurance issuers resulting 
from the provisions of this section; and 
(B) a projection of expenditures of such 
plans and issuers if coverage of routine patient 
care costs in an approved clinical trial program
were extended to individuals entitled to benefits 
under such plans or health insurance coverage 
who have a diagnosis other than cancer.
Æ