I 
108TH CONGRESS 
1ST SESSION H. R. 2021
To amend the Public Health Service Act, the Employee Retirement Income 
Security Act of 1974, and the Internal Revenue Code of 1986 to require 
group and individual health insurance coverage and group health plans 
to provide coverage for individuals participating in approved cancer clin-
ical trials. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 7, 2003
Ms. PRYCE of Ohio (for herself, Mrs. MYRICK, Mrs. CAPPS, and Mr. ISRAEL) 
introduced the following bill; which was referred to the Committee on En-
ergy and Commerce, and in addition to the Committees on Education and 
the Workforce, and Ways and Means, for a period to be subsequently de-
termined 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 Re-
tirement Income Security Act of 1974, and the Internal 
Revenue Code of 1986 to require group and individual 
health insurance coverage and group health plans to 
provide coverage for individuals participating in approved 
cancer clinical trials.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Access to Cancer Clin-
ical Trials Act of 2003’’. 
SEC. 2. COVERAGE FOR INDIVIDUALS PARTICIPATING IN 
APPROVED CANCER CLINICAL TRIALS. 
(a) GROUP HEALTH PLANS.—
(1) PUBLIC
HEALTH
SERVICE
ACT
AMEND-
MENTS.—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. COVERAGE FOR INDIVIDUALS PARTICIPATING 
IN APPROVED CANCER CLINICAL TRIALS. 
‘‘(a) COVERAGE.—
‘‘(1) IN GENERAL.—If a group health plan (or 
a health insurance issuer offering health insurance 
coverage in connection with the plan) provides cov-
erage to a qualified individual (as defined in sub-
section (b)), the plan or issuer—
‘‘(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 or issuer from requiring 
that a qualified individual participate in the trial 
through such a participating provider if the provider 
will accept 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 (or health insurance issuer offering 
health insurance coverage in connection with the 
plan) shall provide for payment for routine patient 
costs described in subsection (a)(2) but is not re-
quired 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 or issuer’s coverage with 
respect to clinical trials.’’. 
(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. COVERAGE FOR INDIVIDUALS PARTICIPATING IN 
APPROVED CANCER CLINICAL TRIALS. 
‘‘(a) COVERAGE.—
‘‘(1) IN GENERAL.—If a group health plan (or 
a health insurance issuer offering health insurance 
coverage in connection with the plan) provides cov-
erage to a qualified individual (as defined in sub-
section (b)), the plan or issuer—
‘‘(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 or issuer from requiring 
that a qualified individual participate in the trial 
through such a participating provider if the provider 
will accept 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 (or health insurance issuer offering 
health insurance coverage in connection with the 
plan) shall provide for payment for routine patient 
costs described in subsection (a)(2) but is not re-
quired 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-