42 U.S. Code § 300gg–8 - Coverage for individuals participating in approved clinical trials
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(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 for items and services furnished in connection with participation in the trial; and
(2) Routine patient costs
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—
(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
(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 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.
(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
(c) Limitations 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).
(d) Approved 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:
(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:
(v) 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.
(B) The study or investigation is conducted under an investigational new drug application reviewed by the Food and Drug Administration.
(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
(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.
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 other provision of this chapter, 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..
 So in original. Probably should be preceded by “A”.
Source(July 1, 1944, ch. 373, title XXVII, § 2709, as added Pub. L. 111–148, title X, § 10103(c),Mar. 23, 2010, 124 Stat. 892.)
Another section 2709 of act July 1, 1944, is classified to section 300gg–9 of this title.
A prior section 2709 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238h of this title.
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