Medicare Reimbursement in Clinical Trials for “Standard of Care” in Flux

It may no longer be possible to take for granted that Medicare will pay for standard of care treatment in the clinical trial setting. "Standard of care" services are generally understood to be those services that would be furnished even if the individual receiving those services were not a subject in a clinical trial. Since standard of care services are thus medically necessary independent of the study, most professionals involved in clinical trials would not hesitate to seek payment for those services from subjects' insurers, including Medicare. Yet, surprising to many, Medicare's policy regarding standard of care services is in a state of flux. In recent unofficial statements, staff from the Centers for Medicare and Medicaid Services (CMS) purportedly "clarified" that standard of care services furnished to clinical trial participants are not payable under Medicare. These statements set off a massive response from the industry, which was taken aback by CMS's clarification. As a result, CMS has given further thought to its policy and has now proposed standards allowing for reimbursement for standard of care services furnished in a clinical trial setting under certain limited circumstances. If finalized substantially as is, these standards could significantly increase the regulatory burdens, and the legal exposure, associated with seeking Medicare reimbursement for medically appropriate care when the patient happens to be in a clinical trial. All parties involved in clinical trials should carefully consider CMS's proposal and decide whether the submission of comments is appropriate.

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