---
kind: "section"
citation: "42 U.S.C. § 300gg–8"
title: "42"
title_heading: "The Public Health and Welfare"
number: "300gg–8"
heading: "Coverage for individuals participating in approved clinical trials"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/300gg-8"
units:
  - "Chapter 6A — Public Health Service"
  - "Subchapter XXV — Requirements Relating to Health Insurance Coverage"
  - "Part A — Individual and Group Market Reforms"
  - "Subpart I — General Reform"
---

# §300gg–8. Coverage for individuals participating in approved clinical trials

- (a) **Coverage—**
  - (1) **In general—** If a [group health plan](/usc/42/300bb–8.md?p=1) or a [health insurance issuer](/usc/42/300gg–91.md?p=b-2) offering group or [individual health insurance coverage](/usc/42/300gg–91.md?p=b-5) 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-2);
    - (B) subject to [subsection (c)](#c), may not deny (or limit or impose additional conditions on) the coverage of routine patient costs for items and [services](/usc/42/201.md?p=a) 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) **Routine patient costs—**
    - (A) **Inclusion—** For purposes of [paragraph (1)(B)](#a-1-B), subject to [subparagraph (B)](#a-2-B), routine patient costs include all items and [services](/usc/42/201.md?p=a) 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)](#a-1-B), routine patient costs does not include—
      - (i) the investigational item, device, or [service](/usc/42/201.md?p=a), itself;
      - (ii) items and [services](/usc/42/201.md?p=a) 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](/usc/42/201.md?p=a) 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](/usc/42/299b–21.md?p=8) is participating in a clinical trial, nothing in [paragraph (1)](#a-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](/usc/42/299b–21.md?p=8) if the [provider](/usc/42/299b–21.md?p=8) will accept the individual as a [participant](/usc/42/300gg–91.md?p=d-11) in the trial.
  - (4) **Use of out-of-network—** Notwithstanding [paragraph (3)](#a-3), [paragraph (1)](#a-1) shall apply to a qualified individual participating in an approved clinical trial that is conducted outside the [State](/usc/42/201.md?p=f) in which the qualified individual resides.
- (b) **Qualified individual defined—** For purposes of [subsection (a)](#a), the term “qualified individual” means an individual who is a [participant](/usc/42/300gg–91.md?p=d-11) or [beneficiary](/usc/42/300gg–91.md?p=d-2) in a health plan or with coverage described in [subsection (a)(1)](#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](/usc/42/11851.md?p=11) of cancer or other life-threatening disease or condition.
  - (2) Either—
    - (A) the referring health care professional is a participating [health care provider](/usc/42/300aa–33.md?p=1) 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)](#b-1); or
    - (B) the [participant](/usc/42/300gg–91.md?p=d-11) or [beneficiary](/usc/42/300gg–91.md?p=d-2) 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)](#b-1).
- (c) **Limitations on coverage—** This section shall not be construed to require a [group health plan](/usc/42/300bb–8.md?p=1), or a [health insurance issuer](/usc/42/300gg–91.md?p=b-2) offering group or [individual health insurance coverage](/usc/42/300gg–91.md?p=b-5), to provide benefits for routine patient [care services](/usc/42/300z–1.md?p=a-7) provided outside of the plan’s (or coverage’s) [health care provider](/usc/42/300aa–33.md?p=1) 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](/usc/42/11851.md?p=11) 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:
      - (i) The National Institutes of Health.
      - (ii) The Centers for Disease Control and Prevention.
      - (iii) The [Agency](/usc/42/8262.md?p=1) for Health Care Research and Quality.
      - (iv) The Centers for Medicare & Medicaid [Services](/usc/42/201.md?p=a).
      - (v) cooperative[^1] group or center of any of the entities described in clauses [(i)](#d-1-A-i) through [(iv)](#d-1-A-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)](#d-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 under an investigational new [drug](/usc/42/11851.md?p=4) application reviewed by the Food and [Drug](/usc/42/11851.md?p=4) Administration.
    - (C) The study or investigation is a [drug](/usc/42/11851.md?p=4) trial that is exempt from having such an investigational new [drug](/usc/42/11851.md?p=4) 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](/usc/42/201.md?p=c) 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](/usc/5/chptIII/sptG/ch89.md) of title 5, this section shall apply to health plans offered under the [program](/usc/42/274l–1.md?p=4) under such chapter.
- (h) **Preemption—** Notwithstanding any other provision of this chapter, nothing in this section shall preempt [State](/usc/42/201.md?p=f) laws that require a clinical trials policy for [State](/usc/42/201.md?p=f) regulated health insurance plans that is in addition to the policy required under this section.

## Footnotes

[^1]: So in original. Probably should be preceded by “A”.

## Source credit

(July 1, 1944, ch. 373, title XXVII, § 2709, as added Pub. L. 111–148, title X, § 10103(c), Mar. 23, 2010, 124 Stat. 892.)

## Notes

### Editorial Notes

### Codification

Another section 2709 of act July 1, 1944, is classified to section 300gg–9 of this title.

### Prior Provisions

A prior section 2709 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238h of this title.