I
107TH CONGRESS
1ST SESSION
H. R. 967
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
MARCH 8, 2001
Ms. PRYCE of Ohio (for herself, Mrs. MALONEY of New York, Mrs. MYRICK,
and Mr. BENTSEN) introduced the following bill; which was referred to
the Committee on Energy and Commerce, and in addition to the Commit-
tees on Education and the Workforce, and Ways and Means, for a period
to be subsequently determined by the Speaker, in each case for consider-
ation 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 2001’’.
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 fol-
lowing if the conditions described in para-
graph (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-
tity identified in the guidelines issued by
the National Institutes of Health for cen-
ter support grants.
‘‘(vii) DOD; VA; DOE.—Any of the fol-
lowing if the conditions described in para-
graph (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 fol-
lowing if the conditions described in para-
graph (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, 2002.
(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, 2002.
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, 2005, 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