Guide
Does Medicare or insurance cover clinical trial costs?
In most cases, yes, for your routine care. Medicare, most private health plans and Medicaid must cover the routine costs of care in qualifying clinical trials. The study itself usually pays for the experimental treatment and any tests done only for research.
Who pays for what
| Cost | Usually paid by |
|---|---|
| The experimental medicine, device or treatment | The study sponsor |
| Tests and visits done only to collect research data | The study sponsor |
| Routine care you'd get anyway, such as doctor visits, lab tests and scans | Your Medicare, Medicaid or health plan |
| Treatment for complications from taking part | Your Medicare, Medicaid or health plan |
Medicare
Medicare covers routine costs in qualifying clinical trials, in both the treatment group and the comparison group. That includes care to monitor the treatment and to treat complications. It doesn't cover the experimental item itself (unless Medicare would cover it anyway), tests used only for research, or anything the sponsor provides free. Trials funded by the NIH, CDC, VA or Department of Defense, and trials of medicines under FDA review, generally qualify.
Private health insurance
Under the Affordable Care Act, most private health plans must cover routine patient costs for people in approved Phase 1 to Phase 4 trials for cancer or another life-threatening disease. Plans can't stop you from joining or drop your coverage because you take part. Your plan may require you to use in-network providers.
Medicaid
Since January 2022, state Medicaid programs must cover routine patient costs for people in qualifying trials for serious or life-threatening conditions. Coverage decisions must be made within 72 hours.
Before you join, ask
- Which costs will the study pay for?
- Will my insurance be billed for anything, and what will I owe?
- Is the study site in my plan's network?
- Who can help me check coverage before I start?
Most study sites have a coordinator who can check your coverage with you.
See studies recruiting near you →
Sources
- National Coverage Determination 310.1: Routine costs in clinical trials — Centers for Medicare & Medicaid Services
- 42 U.S.C. § 300gg-8: Coverage for individuals participating in approved clinical trials — U.S. Code (Office of the Law Revision Counsel)
- State Medicaid Director Letter SMD #21-005: Medicaid coverage of routine patient costs in qualifying clinical trials — Centers for Medicare & Medicaid Services