Access to Cancer Clinical Trials Act of 2006 - Amends the Public Health Service Act, the Employee Retirement Income Security Act of 1974 (ERISA), and the Internal Revenue Code to prohibit a group health plan or a health insurance issuer offering health insurance coverage in connection with such a plan from: (1) denying an eligible participant or beneficiary participation in clinical trials related to the treatment of cancer that are federally funded or conducted under an investigational new drug application reviewed by the Food and Drug Administration (FDA); (2) denying (or limiting or imposing additional conditions on) the coverage of routine patient costs for items and services furnished in connection with such participation; or (3) discriminating against an individual on the basis of such participation. Includes as routine patient costs all items and services provided in the clinical trial that are otherwise generally available to a qualified individual, with certain exceptions.
Applies such prohibitions to coverage offered in the individual market.
Requires the Secretary of Health and Human Services to study the impact on group health plans and health insurance issuers of requiring them to cover routine patient care costs for individuals with serious and life threatening diseases other than cancer.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6247 Introduced in House (IH)]
109th CONGRESS
2d Session
H. R. 6247
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 HOUSE OF REPRESENTATIVES
September 28, 2006
Ms. Pryce of Ohio (for herself and Mrs. Myrick) introduced the
following bill; which was referred to the Committee on Energy and
Commerce, and in addition to the Committees on Education and the
Workforce and Ways and Means, for a period to be subsequently
determined 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 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 2006''.
SEC. 2. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CANCER
CLINICAL TRIALS.
(a) Group Health Plans.--
(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.
``(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 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 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
appropriate monitoring of the effects of the
item or service, or the prevention of
complications.
``(iii) Reasonable and necessary care.--
Items or services needed for reasonable and
necessary care arising from the provision of an
investigational item or service, including the
diagnosis or treatment 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 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.
``(2) Either--
``(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).
``(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
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.
``(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 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 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
appropriate monitoring of the effects of the
item or service, or the prevention of
complications.
``(iii) Reasonable and necessary care.--
Items or services needed for reasonable and
necessary care arising from the provision of an
investigational item or service, including the
diagnosis or treatment 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 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.
``(2) Either--
``(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).
``(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
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''; 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 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 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
appropriate monitoring of the effects of the
item or service, or the prevention of
complications.
``(iii) Reasonable and necessary care.--
Items or services needed for reasonable and
necessary care arising from the provision of an
investigational item or service, including the
diagnosis or treatment 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 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.
``(2) Either--
``(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).
``(c) Payment.--
``(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.''.
(c) Effective Dates.--
(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, 2007.
(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 1 or more collective
bargaining agreements between employee representatives and 1 or
more employers 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 terminates
(determined without regard to any extension thereof
agreed to after the date of enactment of this Act), or
(B) January 1, 2007.
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.
(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 individuals
with serious and life threatening diseases other than cancer.
(2) Report to congress.--Not later than January 1, 2010,
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.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and the Workforce, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and the Workforce, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and the Workforce, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and the Workforce, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Employer-Employee Relations.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line