42 U.S.C. § 300gg–8 — Coverage for individuals participating in approved clinical trials

(a) Coverage (1) In general: If a group health plan, or an insurer offering group or individual coverage, covers a "qualified individual" (defined in (b)), the plan or insurer (A) can't deny that person the chance to take part in the clinical trial described in (b)(2); (B) subject to (c), can't deny, limit, or add conditions on covering the routine patient costs of items and services connected to taking part in the trial; and (C) can't discriminate against the person because of their participation in the trial. (2) Routine patient costs (A) Inclusion: Subject to (B), "routine patient costs" include everything the plan or coverage normally covers for a qualified individual not enrolled in a clinical trial. (B) Exclusion: "Routine patient costs" do not include (i) the investigational item, device, or service itself; (ii) items or services provided only to satisfy data collection and analysis needs, that aren't used in the patient's direct clinical care; or (iii) a service clearly inconsistent with widely accepted, established standards of care for that diagnosis. (3) Use of in-network providers: If a participating provider is taking part in a clinical trial, nothing in paragraph (1) stops the plan or insurer from requiring the qualified individual to join the trial through that provider, as long as the provider will accept the person as a participant. (4) Use of out-of-network: Despite paragraph (3), paragraph (1) still applies to a qualified individual taking part in an approved clinical trial conducted outside the state where they live. (b) Qualified individual defined: A "qualified individual" is someone who is a participant or beneficiary in a plan or coverage described in (a)(1) and who meets both: (1) they're eligible under the trial's protocol to be treated for cancer or another life-threatening disease or condition; and (2) either (A) a participating health care provider who is their referring provider has concluded, based on meeting condition (1), that joining the trial would be appropriate, or (B) the participant or beneficiary supplies medical and scientific information showing that joining the trial would be appropriate based on meeting condition (1). (c) Limitations on coverage: This section doesn't require a group health plan or insurer to cover routine patient care services given outside the plan's or coverage's provider network, unless out-of-network benefits are otherwise offered under the plan or coverage. (d) Approved clinical trial defined (1) In general: An "approved clinical trial" is a phase I, II, III, or IV clinical trial conducted to study preventing, detecting, or treating cancer or another life-threatening disease or condition, that is (A) federally funded or approved — by the National Institutes of Health, the Centers for Disease Control and Prevention, the Agency for Health Care Research and Quality, the Centers for Medicare & Medicaid Services, a cooperative group or center connected to any of those (or to the Department of Defense or Department of Veterans Affairs), a qualified nongovernmental research entity recognized in NIH center-support grant guidelines, or — if the (2) conditions are met — the Department of Veterans Affairs, the Department of Defense, or the Department of Energy; (B) conducted under an investigational new drug application reviewed by the FDA; or (C) a drug trial that's exempt from needing that kind of application. (2) Conditions for departments: For a study run by the VA, DOD, or Department of Energy to qualify under (1)(A)(vii), it must have been reviewed and approved through peer review that the Secretary decides (A) is comparable to the National Institutes of Health's own system of peer review, and (B) ensures unbiased review, using the highest scientific standards, by qualified people with no stake in the outcome. (e) Life-threatening condition defined: A "life-threatening condition" is any disease or condition where death is likely unless the course of the disease or condition is interrupted. (f) Construction: Nothing in this section limits a plan's or insurer's coverage of clinical trials beyond what this section requires. (g) Application to FEHBP: Despite anything in chapter 89 of title 5, this section applies to health plans offered under the Federal Employees Health Benefits Program established by that chapter. (h) Preemption: Despite any other provision of this chapter, this section doesn't preempt state laws that require a clinical-trials coverage policy for state-regulated health insurance plans, on top of what this section requires.