Clinical Trials – Medical Policy Article

Medicare covers routine costs of qualifying clinical trials, including many federally funded and FDA IND (or IND-exempt) trials, provided the trial evaluates services within a Medicare benefit category and meets design and ethical standards. Routine costs include items and services that would be provided absent the trial and medically necessary monitoring and complication care, while investigational items, eligibility-only tests, data-collection-only services, sponsor-provided free items, excess testing beyond ordinary care, and statutorily non-covered items remain excluded unless specific exceptions apply.

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

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