I
106TH CONGRESS
1ST SESSION
H. R. 3110
To amend the Public Health Service Act, the Employee Retirement Income
Security Act of 1974, and the Internal Revenue Code of 1986 to provide
coverage for individuals participating in approved cancer clinical trials.
IN THE HOUSE OF REPRESENTATIVES
OCTOBER 19, 1999
Mr. SALMON (for himself, Mr. KOLBE, and Mr. SHADEGG) introduced the fol-
lowing bill; which was referred to the Committee on Commerce, and in
addition to the Committees on Ways and Means, and Education and the
Workforce, for a period to be subsequently determined by the Speaker,
in each case for consideration of such provisions as fall within the juris-
diction 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 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 ‘‘Dr. Sydney E. Salmon
Access to Cancer Clinical Trials Act of 1999’’.
SEC. 2. COVERAGE FOR INDIVIDUALS PARTICIPATING IN
APPROVED CANCER CLINICAL TRIALS.
(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. 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 subsections (b), (c), and
(d) may not deny (or limit or impose additional
conditions on) the coverage of routine patient
costs for items and services furnished in con-
nection with participation in the trial; and
‘‘(C) may not discriminate against the in-
dividual on the basis of the participant’s or
beneficiaries participation in such trial.
‘‘(2) EXCLUSION OF CERTAIN COSTS.—For pur-
poses of paragraph (1)(B), routine patient costs do
not include the cost of the tests or measurements
conducted primarily for the purpose of the clinical
trial involved.
‘‘(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.
‘‘(C) The individual’s participation in the trial
offers meaningful potential for significant clinical
benefit for the individual.
‘‘(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
reasonably expected to be paid for by the sponsors
of an approved clinical trial.
‘‘(2) ROUTINE PATIENT CARE COSTS.—
‘‘(A) IN GENERAL.—For purposes of this
Act, ‘routine patient care costs’ shall include
the costs associated with the provision of items
and services that—
‘‘(i) would otherwise be covered under
the group health plan if such items and
services were not provided in connection
with an approved clinical trial program;
and
‘‘(ii) are furnished according to the
protocol of an approved clinical trial pro-
gram.
‘‘(B) EXCLUSION.—For purposes of this
Act, ‘routine patient care costs’ shall not in-
clude the costs associated with the provision
of—
‘‘(i) an investigational drug or device,
unless the Secretary has authorized the
manufacturer of such drug or device to
charge for such drug or device; or
‘‘(ii) any item or service supplied
without charge by the sponsor of the ap-
proved clinical trial program.
‘‘(3) 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 or services
under subparagraph (A).
‘‘(d) APPROVED CLINICAL TRIAL DEFINED.—
‘‘(1) IN GENERAL.—In this section, the term
‘approved clinical trial’ means a cancer clinical re-
search study or cancer clinical investigation ap-
proved by an Institutional Review Board.
‘‘(e) CONSTRUCTION.—Nothing in this section shall
be construed to limit a plan’s coverage with respect to clin-
ical trials.
‘‘(f) PLAN SATISFACTION
OF CERTAIN REQUIRE-
MENTS; RESPONSIBILITIES OF FIDUCIARIES.—
‘‘(1) IN GENERAL.—For purposes of this sec-
tion, insofar as a group health plan provides benefits
in the form of health insurance coverage through a
health insurance issuer, the plan shall be treated as
meeting the requirements of this section with respect
to such benefits and not be considered as failing to
meet such requirements because of a failure of the
issuer to meet such requirements so long as the plan
sponsor or its representatives did not cause such
failure by the issuer.
‘‘(J) patient satisfaction and preference of
sites of service.
‘‘(2) REPORT TO CONGRESS.—Not later than
January 1, 2005, the Secretary shall submit a re-
port to Congress that contains—
‘‘(A) an assessment of any incremental
cost to group health plans resulting from the
provisions of this section;
‘‘(B) a projection of expenditures to such
plans resulting from this section;
‘‘(C) an assessment of any impact on pre-
miums resulting from this section; and
‘‘(D) recommendations regarding action on
other diseases.’’.
(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 subsections (b), (c), and
(d) may not deny (or limit or impose additional
conditions on) the coverage of routine patient
costs for items and services furnished in con-
nection with participation in the trial; and
‘‘(C) may not discriminate against the in-
dividual on the basis of the participant’s or
beneficiaries participation in such trial.
‘‘(2) EXCLUSION OF CERTAIN COSTS.—For pur-
poses of paragraph (1)(B), routine patient costs do
not include the cost of the tests or measurements
conducted primarily for the purpose of the clinical
trial involved.
‘‘(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.
‘‘(C) The individual’s participation in the trial
offers meaningful potential for significant clinical
benefit for the individual.
‘‘(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
reasonably expected to be paid for by the sponsors
of an approved clinical trial.
‘‘(2) ROUTINE PATIENT CARE COSTS.—
‘‘(A) IN GENERAL.—For purposes of this
Act, ‘routine patient care costs’ shall include
the costs associated with the provision of items
and services that—
‘‘(i) would otherwise be covered under
the group health plan if such items and
services were not provided in connection
with an approved clinical trial program;
and
‘‘(ii) are furnished according to the
protocol of an approved clinical trial pro-
gram.
‘‘(B) EXCLUSION.—For purposes of this
Act, ‘routine patient care costs’ shall not in-
clude the costs associated with the provision
of—
‘‘(i) an investigational drug or device,
unless the Secretary has authorized the
manufacturer of such drug or device to
charge for such drug or device; or
‘‘(ii) any item or service supplied
without charge by the sponsor of the ap-
proved clinical trial program.
‘‘(3) 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 or services
under subparagraph (A).
‘‘(d) APPROVED CLINICAL TRIAL DEFINED.—
‘‘(1) IN GENERAL.—In this section, the term
‘approved clinical trial’ means a cancer clinical re-
search study or cancer clinical investigation ap-
proved by an Institutional Review Board.
‘‘(e) CONSTRUCTION.—Nothing in this section shall
be construed to limit a plan’s coverage with respect to clin-
ical trials.
‘‘(f) PLAN SATISFACTION
OF CERTAIN REQUIRE-
MENTS; RESPONSIBILITIES OF FIDUCIARIES.—
‘‘(1) IN GENERAL.—For purposes of this sec-
tion, insofar as a group health plan provides benefits
in the form of health insurance coverage through a
health insurance issuer, the plan shall be treated as
meeting the requirements of this section with respect
to such benefits and not be considered as failing to
meet such requirements because of a failure of the
issuer to meet such requirements so long as the plan
sponsor or its representatives did not cause such
failure by the issuer.
‘‘(2) CONSTRUCTION.—Nothing in this section
shall be construed to affect or modify the respon-
sibilities of the fiduciaries of a group health plan
under part 4 of subtitle B.
‘‘(g) STUDY AND REPORT.—
‘‘(1) STUDY.—The Secretary shall analyze can-
cer clinical research and its cost implications for
managed care, including differentiation in—
‘‘(A) the cost of patient care in trials
versus standard care;
‘‘(B) the cost effectiveness achieved in dif-
ferent sites of service;
‘‘(C) research outcomes;
‘‘(D) volume of research subjects available
in different sites of service;
‘‘(E) access to research sites and clinical
trials by cancer patients;
‘‘(F) patient cost sharing or copyament
costs realized in different sites of service;
‘‘(G) health outcomes experienced in dif-
ferent sites of service;
‘‘(H) long term health care services and
costs experienced in different sites of service;
‘‘(I) morbidity and mortality experienced
in different sites of service; and
‘‘(J) patient satisfaction and preference of
sites of service.
‘‘(2) REPORT TO CONGRESS.—Not later than
January 1, 2005, the Secretary shall submit a re-
port to Congress that contains—
‘‘(A) an assessment of any incremental
cost to group health plans resulting from the
provisions of this section;
‘‘(B) a projection of expenditures to such
plans resulting from this section;
‘‘(C) an assessment of any impact on pre-
miums resulting from this section; and
‘‘(D) recommendations regarding action on
other diseases.’’.
(B) CLERICAL AMENDMENT.—The table of con-
tents in section 1 of the Employee Retirement In-
come Security Act of 1974 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 or issuer—
‘‘(A) may not deny the individual partici-
pation in the clinical trial referred to in sub-
section (b)(2);
‘‘(B) subject to subsections (b), (c), and
(d) may not deny (or limit or impose additional
conditions on) the coverage of routine patient
costs for items and services furnished in con-
nection with participation in the trial; and
‘‘(C) may not discriminate against the in-
dividual on the basis of the participant’s or
beneficiaries participation in such trial.
‘‘(2) EXCLUSION OF CERTAIN COSTS.—For pur-
poses of paragraph (1)(B), routine patient costs do
not include the cost of the tests or measurements
conducted primarily for the purpose of the clinical
trial involved.
‘‘(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.
‘‘(C) The individual’s participation in the trial
offers meaningful potential for significant clinical
benefit for the individual.
‘‘(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 reasonably expected to be paid for by the spon-
sors of an approved clinical trial.
‘‘(2) ROUTINE PATIENT CARE COSTS.—
‘‘(A) IN GENERAL.—For purposes of this
Act, ‘routine patient care costs’ shall include
the costs associated with the provision of items
and services that—
‘‘(i) would otherwise be covered under
the group health plan if such items and
services were not provided in connection
with an approved clinical trial program;
and
‘‘(ii) are furnished according to the
protocol of an approved clinical trial pro-
gram.
‘‘(B) EXCLUSION.—For purposes of this
Act, ‘routine patient care costs’ shall not in-
clude the costs associated with the provision
of—
‘‘(i) an investigational drug or device,
unless the Secretary has authorized the
manufacturer of such drug or device to
charge for such drug or device; or
‘‘(ii) any item or service supplied
without charge by the sponsor of the ap-
proved clinical trial program.
‘‘(3) 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 or services
under subparagraph (A).
‘‘(d) APPROVED CLINICAL TRIAL DEFINED.—
‘‘(1) IN GENERAL.—In this section, the term
‘approved clinical trial’ means a cancer clinical re-
search study or cancer clinical investigation ap-
proved by an Institutional Review Board.
‘‘(e) CONSTRUCTION.—Nothing in this section shall
be construed to limit a plan’s coverage with respect to clin-
ical trials.
‘‘(f) PLAN SATISFACTION
OF CERTAIN REQUIRE-
MENTS; RESPONSIBILITIES OF FIDUCIARIES.—
‘‘(1) IN GENERAL.—For purposes of this sec-
tion, insofar as a group health plan provides benefits
in the form of health insurance coverage through a
health insurance issuer, the plan shall be treated as
meeting the requirements of this section with respect
to such benefits and not be considered as failing to
meet such requirements because of a failure of the
issuer to meet such requirements so long as the plan
sponsor or its representatives did not cause such
failure by the issuer.
‘‘(2) CONSTRUCTION.—Nothing in this section
shall be construed to affect or modify the respon-
sibilities of the fiduciaries of a group health plan
under part 4 of subtitle B.
‘‘(g) STUDY AND REPORT.—
‘‘(1) STUDY.—The Secretary shall analyze can-
cer clinical research and its cost implications for
managed care, including differentiation in—
‘‘(A) the cost of patient care in trials
versus standard care;
‘‘(B) the cost effectiveness achieved in dif-
ferent sites of service;
‘‘(C) research outcomes;
‘‘(D) volume of research subjects available
in different sites of service;
‘‘(E) access to research sites and clinical
trials by cancer patients;
‘‘(F) patient cost sharing or copyament
costs realized in different sites of service;
‘‘(G) health outcomes experienced in dif-
ferent sites of service;
‘‘(H) long term health care services and
costs experienced in different sites of service;
‘‘(I) morbidity and mortality experienced
in different sites of service; and
‘‘(J) patient satisfaction and preference of
sites of service.
‘‘(2) REPORT TO CONGRESS.—Not later than
January 1, 2005, the Secretary shall submit a re-
port to Congress that contains—
‘‘(A) an assessment of any incremental
cost to group health plans resulting from the
provisions of this section;
‘‘(B) a projection of expenditures to such
plans resulting from this section;
‘‘(C) an assessment of any impact on pre-
miums resulting from this section; and
‘‘(D) recommendations regarding action on
other diseases.’’.
(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. STANDARD RELATING PATIENT FREEDOM OF
CHOICE.
‘‘(a) IN
GENERAL.—The provisions of section
2707(a) 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 cov-
erage offered by a health insurance issuer in connection
with a group health plan in the small or large group mar-
ket.
‘‘(b) NOTICE.—A health insurance issuer under this
part shall comply with the notice requirement under sec-
tion 714(b) 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 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, 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