Clinical Trials – Medical Policy Article

Medicare covers routine costs of qualifying clinical trials, including conventional care, clinically appropriate monitoring, prevention and treatment of complications, and certain services required to provide investigational interventions, but not the investigational item itself unless available outside the trial. Trials automatically qualified include those funded or supported by NIH, CDC, AHRQ, CMS, DOD, or VA, trials under FDA-reviewed INDs, and specified IND-exempt drug trials; other trials must meet Medicare-benefit, therapeutic-intent, enrollment, and scientific-quality requirements. Coverage exclusions include items for eligibility screening, data-collection-only services, sponsor-provided free items, excess testing beyond ordinary care, statutorily non-covered items (unless required to treat complications), and any items non-covered by applicable NCDs or local coverage determinations.

"Clinical trials funded by NIH, CDC, AHRQ, CMS, DOD, or VA are automatically qualified for Medicare coverage of routine costs."