Medicare Reimbursement for “Standard of Care” in Flux

Medicare has proposed new rules as to when reimbursement is available for standard of care treatment furnished to clinical research subjects. “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 clinical trial, most professionals involved in clinical trials usually seek payment for those services from Medicare and other insurers. Currently, 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. Yet, in response to a number of comments received from the industry, CMS has given further thought to its policy, leading to new proposed standards under which reimbursement for these services would be allowed. 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 patients happen to be in clinical trials. All parties involved in clinical trials should carefully consider CMS’s proposal and decide whether the submission of comments is appropriate.

For the full story, please view the PDF.