Plan Design & Coverage Issues:
Coverage for Clinical Trial Participants
Coverage for Participants in Clinical Trials
The Affordable Care Act (ACA) contains requirements relating to health coverage for clinical trial participants. ACA’s clinical trial rules apply to non-grandfathered group health plans and insurers, and are effective for plan years beginning on or after January 1, 2014.
Effective in 2014, non-grandfathered group health plans and insurance policies may not terminate coverage because an individual participates in an approved clinical trial or deny coverage for routine care that they would otherwise provide just because an individual is enrolled in a clinical trial.
Specifically, group health plans may not:
- Deny a qualified individual the right to participate in an approved clinical trial;
- Deny, limit or impose additional conditions on coverage of routine patient costs for items and services furnished in connection with the approved clinical trial; or
- Discriminate against a qualified individual based on participation in an approved clinical trial.
Routine patient costs include items and services typically provided under the plan for a participant who is not enrolled in a clinical trial. They do not include: (a) the investigational item, device or service itself; (b) items and services not included in the direct clinical management of the patient, but instead provided in connection with data collection and analysis; or (c) a service clearly not consistent with widely accepted and established standards of care for the particular diagnosis.
Qualified Individuals
A qualified individual is a group health plan participant or beneficiary who is eligible, according to the trial protocol, to participate in an approved clinical trial for the treatment of cancer or other life-threatening condition and either:
- The referring health care professional is a participating provider and has concluded that the individual’s participation in the clinical trial would be appropriate; or
- The individual provides medical and scientific information establishing that his or her participation in the clinical trial would be appropriate.
- A life-threatening condition is a disease or condition that is likely to result in death unless it is interrupted.
Approved Clinical Trial
An approved clinical trial is a phase I, phase II, phase III or phase IV clinical trial that is:
- Conducted in connection with the prevention, detection or treatment of cancer or other life-threatening condition and is federally funded;
- Conducted in connection with an investigational new drug application reviewed by the FDA; or
- Exempt from investigational new drug application requirements.
Implementation
ACA’s coverage mandate for individuals participating in clinical trials is effective for plan years beginning on or after January 1, 2014. In a set of ACA FAQs issued on April 29, 2013, the Departments of Labor, Health and Human Services and the Treasury (Departments) noted that they do not expect to issue regulations on ACA’s clinical trial mandate before it becomes effective. Until guidance is issued, group health plans and health insurance issuers are expected to implement the requirements of ACA’s clinical trial mandate using a good faith, reasonable
