The Patient Protection and
Affordable Care Act added the following section of the federal Public Health
COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CLINICAL TRIALS.
(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)
(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.
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.
For purposes of paragraph (1) (B), routine patient costs does not include--
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.
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
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.
(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
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
on Coverage- This section shall not be construed to require a 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).
Clinical Trial Defined-
(1) IN GENERAL-
In this section, the term `approved clinical trial` means a phase I, phase II,
phase III, or phase IV clinical trial that is conducted in relation to the
prevention, detection, or treatment of cancer or other life-threatening disease
or condition and is described in any of the following subparagraphs:
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) 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.
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:
Department of Veterans Affairs.
Department of Defense.
Department of Energy.
(B) The study or
investigation is conducted under an investigational new drug application
reviewed by the Food and Drug Administration.
(C) The study or
investigation is a drug trial that is exempt from having such an investigational
new drug application.
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
(A) To be
comparable to the system of peer review of studies and investigations used by
the National Institutes of Health, and
unbiased review of the highest scientific standards by qualified individuals who
have no interest in the outcome of the review.
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.
Nothing in this section shall be construed to limit a plan`s or issuer`s
coverage with respect to clinical trials.
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
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