S 2999
110th CONGRESS
2d Session
S. 2999
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 clinical trials.
IN THE SENATE OF THE UNITED STATES
May 8, 2008
Mr. BROWN (for himself, Mr. SPECTER, and Mr. WHITEHOUSE) introduced
the following bill; which was read twice and referred to the Committee
on Health, Education, Labor, and Pensions
A BILL
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 clinical trials.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the `Access to Cancer Clinical Trials Act of
2008'.
SEC. 2. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CANCER
CLINICAL TRIALS.
(1) PUBLIC HEALTH SERVICE ACT AMENDMENTS- 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.
`(1) IN GENERAL- If a group health plan (or a health insurance issuer
offering health insurance coverage in connection with the plan) provides
coverage to a qualified individual (as defined in subsection (b)),
the plan or issuer--
`(A) may not deny the individual participation in the clinical trial
referred to in subsection (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 individual on the basis of
the individual's participation in such trial.
`(2) EXCLUSION OF CERTAIN COSTS-
`(A) IN GENERAL- For purposes of paragraph (1)(B), subject to subparagraph
(B), routine 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 provided solely to satisfy data
collection and analysis needs and that are not used in the direct
clinical management of the patient.
`(B) INCLUSIONS- Such routine patient costs include costs for items
or services that are typically provided absent a clinical trial.
`(3) USE OF IN-NETWORK PROVIDERS- If one or more participating providers
is participating in a clinical trial, nothing in paragraph (1) shall
be construed 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 purposes 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 conditions:
`(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 protocol with respect to treatment of
such illness.
`(A) the referring physician is a participating health care professional
and has concluded 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 provides medical and scientific
information establishing that the individual's participation in
such trial would be appropriate based upon the individual meeting
the conditions described in paragraph (1).
`(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 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 payment 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 subparagraphs:
`(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) CMS- The Centers for Medicare & Medicaid Services.
`(v) COOPERATIVE CENTER- A cooperative group or center of any
of the entities described in clauses (i) through (iv) or the Departments
of Defense or Veterans Affairs.
`(vi) CENTER SUPPORT GRANTEES- A qualified non-governmental research
entity identified in the guidelines issued by the National Institutes
of Health for center 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 Defense.
`(III) The Department of Energy.
`(B) FDA DRUG TRIAL UNDER IND- The study or investigation is conducted
under an investigational 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 application.
`(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 highest scientific standards
by qualified individuals who have no interest in the outcome of
the review.
`(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 Retirement 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.
`(1) IN GENERAL- If a group health plan (or a health insurance issuer
offering health insurance coverage in connection with the plan) provides
coverage to a qualified individual (as defined in subsection (b)),
the plan or issuer--
`(A) may not deny the individual participation in the clinical trial
referred to in subsection (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 individual on the basis of
the individual's participation in such trial.
`(2) EXCLUSION OF CERTAIN COSTS-
`(A) IN GENERAL- For purposes of paragraph (1)(B), subject to subparagraph
(B), routine 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 provided 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
items or services that are typically provided absent a clinical
trial.
`(3) USE OF IN-NETWORK PROVIDERS- If one or more participating providers
is participating in a clinical trial, nothing in paragraph (1) shall
be construed 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 purposes 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 conditions:
`(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 protocol with respect to treatment of
such illness.
`(A) the referring physician is a participating health care professional
and has concluded 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 provides medical and scientific
information establishing that the individual's participation in
such trial would be appropriate based upon the individual meeting
the conditions described in paragraph (1).
`(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 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 payment 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 subparagraphs:
`(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) CMS- The Centers for Medicare & Medicaid Services.
`(v) COOPERATIVE CENTER- A cooperative group or center of any
of the entities described in clauses (i) through (iv) or the Departments
of Defense or Veterans Affairs.
`(vi) CENTER SUPPORT GRANTEES- A qualified non-governmental research
entity identified in the guidelines issued by the National Institutes
of Health for center 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 Defense.
`(III) The Department of Energy.
`(B) FDA DRUG TRIAL UNDER IND- The study or investigation is conducted
under an investigational 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 application.
`(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 highest scientific standards
by qualified individuals who have no interest in the outcome of
the review.
`(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 AMENDMENTS-
(A) IN GENERAL- Subchapter B of chapter 100 of the Internal Revenue
Code of 1986 is amended--
(i) in the table of sections, by inserting after the item relating
to section 9812 the following new item:
`Sec. 9813. Coverage for individuals participating in approved cancer
clinical trials.';
(ii) by inserting after section 9812 the following:
`SEC. 9813. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CANCER
CLINICAL TRIALS.
`(1) IN GENERAL- If a group health plan provides coverage to a qualified
individual (as defined in subsection (b)), the plan--
`(A) may not deny the individual participation in the clinical trial
referred to in subsection (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 individual on the basis of
the individual's participation in such trial.
`(2) EXCLUSION OF CERTAIN COSTS-
`(A) IN GENERAL- For purposes of paragraph (1)(B), subject to subparagraph
(B), routine 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 provided 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
items or services that are typically provided absent a clinical
trial.
`(3) USE OF IN-NETWORK PROVIDERS- If one or more participating providers
is participating in a clinical trial, nothing in paragraph (1) shall
be construed as preventing a plan 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 purposes 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 conditions:
`(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 protocol with respect to treatment of
such illness.
`(A) the referring physician is a participating health care professional
and has concluded 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 provides medical and scientific
information establishing that the individual's participation in
such trial would be appropriate based upon the individual meeting
the conditions described in paragraph (1).
`(1) IN GENERAL- Under this section a group health plan shall provide
for payment for routine patient 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 payment 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 subparagraphs:
`(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) CMS- The Centers for Medicare & Medicaid Services.
`(v) COOPERATIVE CENTER- A cooperative group or center of any
of the entities described in clauses (i) through (iv) or the Departments
of Defense or Veterans Affairs.
`(vi) CENTER SUPPORT GRANTEES- A qualified non-governmental research
entity identified in the guidelines issued by the National Institutes
of Health for center 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 Defense.
`(III) The Department of Energy.
`(B) FDA DRUG TRIAL UNDER IND- The study or investigation is conducted
under an investigational 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 application.
`(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 highest scientific standards
by qualified individuals who have no interest in the outcome of
the review.
`(e) Construction- Nothing in this section shall be construed to limit
a plan's coverage with respect to clinical trials.'.
(B) CONFORMING AMENDMENT- Section 4980D(d)(1) of such Code is amended
by striking `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 (relating to other requirements)
as subpart 2; and
(2) by adding at the end of subpart 2 the following 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.'.
(1) GROUP HEALTH PLANS AND GROUP HEALTH INSURANCE COVERAGE- Subject
to paragraph (3), the amendments made by subsection (a) apply with
respect to group health plans for plan years beginning on or after
January 1, 2009.
(2) INDIVIDUAL HEALTH INSURANCE COVERAGE- The amendment made by subsection
(b) applies with respect to health insurance coverage offered, 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 one or more collective bargaining agreements
between employee representatives and one or more employers ratified
before the date of the enactment of this Act, the amendments made
by 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 terminates (determined without regard to any
extension thereof agreed to after the date of the enactment of this
Act), or
For purposes of subparagraph (A), any plan amendment 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 Secretary 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 matter over which two or more such Secretaries
have responsibility 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.
(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 individuals with serious and life threatening diseases
other than cancer.
(2) REPORT TO CONGRESS- Not later than January 1, 2012, such Secretary
shall submit a report 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.
END
