S.Amdt. 2871

SA 2871. Mr. BROWN (for himself and Mrs. Hutchison) submitted an
amendment intended to be proposed to amendment SA 2786 proposed by Mr.
Reid (for himself, Mr. Baucus, Mr. Dodd, and Mr. Harkin) to the bill
H.R. 3590, to amend the Internal Revenue Code of 1986 to modify the
first-time homebuyers credit in the case of members of the Armed Forces
and certain other Federal employees, and for other purposes; which was
ordered to lie on the table; as follows:

On page 97, between lines 6 and 7, insert the following:

``SEC. 2710. COVERAGE FOR INDIVIDUALS PARTICIPATING IN
APPROVED CLINICAL TRIALS.

``(a) Coverage.--
``(1) In general.--If a group health plan or a health
insurance issuer offering group or individual health
insurance coverage provides coverage to a qualified
individual, then such 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; and
``(C) may not discriminate against the individual on the
basis of the individual's participation in such trial.
``(2) Routine patient costs.--
``(A) Inclusion.--For purposes of paragraph (1)(B), subject
to subparagraph (B), routine patient costs include all items
and services consistent with the coverage provided in the
plan (or coverage) that is typically covered for a qualified
individual who is not enrolled in a clinical trial.
``(B) Exclusion.--For purposes of paragraph (1)(B), routine
patient costs does not include--
``(i) the investigational item, device, or service, itself;
``(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; or
``(iii) a service that is clearly inconsistent with widely
accepted and established standards of care for a particular
diagnosis.
``(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.
``(4) Use of out-of-network.--Notwithstanding paragraph
(3), paragraph (1) shall apply to a qualified individual
participating in an approved clinical trial that is conducted
outside the State in which the qualified individual resides.
``(b) Qualified Individual Defined.--For purposes of
subsection (a), the term `qualified individual' means an
individual who is a participant or beneficiary in a health
plan or with coverage described in subsection (a)(1) and who
meets the following conditions:
``(1) The individual is eligible to participate in an
approved clinical trial according to the trial protocol with
respect to treatment of cancer or other life-threatening
disease or condition.
``(2) Either--
``(A) the referring health care professional is a
participating health care provider 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) Limitations on Coverage.--This section shall not be
construed to require a

[[Page S12345]]

group health plan, or a health insurance issuer offering
group or individual health insurance coverage, to provide
benefits for routine patient care services provided outside
of the plan's (or coverage's) health care provider network
unless out-of-network benefits are otherwise provided under
the plan (or coverage).
``(d) Approved Clinical Trial Defined.--
``(1) In general.--In this section, the term `approved
clinical trial' means a clinical trial (including a phase I,
phase II, phase III, or phase IV trial) that is conducted in
relation to the treatment of cancer or other life-threatening
disease or condition and is described in any of the following
subparagraphs:
``(A) The study or investigation is approved or funded
(which may include funding through in-kind contributions) by
one or more of the following:
``(i) The National Institutes of Health.
``(ii) The Centers for Disease Control and Prevention.
``(iii) The Agency for Health Care Research and Quality.
``(iv) The Centers for Medicare & Medicaid Services.
``(v) A cooperative group or center of any of the entities
described in clauses (i) through (iv) or the Department of
Defense or the Department of Veterans Affairs.
``(vi) A qualified non-governmental research entity
identified in the guidelines issued by the National
Institutes of Health for center support grants.
``(vii) 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) The study or investigation is conducted in accordance
with the requirements for investigational new drugs or
investigational devices under the Federal Food, Drug, and
Cosmetic Act.
``(C) The study or investigation is a clinical trial of a
drug or device that is exempt from the requirements described
under subparagraph (B).
``(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) Life-Threatening Condition Defined.--In this section,
the term `life-threatening condition' means any disease or
condition from which the likelihood of death is probable
unless the course of the disease or condition is interrupted.
``(f) Construction.--Nothing in this section shall be
construed to limit a plan's or issuer's coverage with respect
to clinical trials.
``(g) Application to FEHBP.--Notwithstanding any provision
of chapter 89 of title 5, United States Code, this section
shall apply to health plans offered under the program under
such chapter.
``(h) Preemption.--Notwithstanding any other provision of
this Act, nothing in this section shall preempt State laws
that require a clinical trials policy for State regulated
health insurance plans that is in addition to the policy
required under this section.''.
______