Are Clinical Trial Expenses ‘Necessary’? Medicare Seeks Clarity

Researchers might still face uncertainty over which clinical trial costs they can bill Medicare for despite the agency’s efforts to clarify its coverage standard for medical breakthroughs.

Payment Terms: A proposed CMS rule defines the “reasonable and necessary” standard that breakthrough medical devices must meet to get Medicare coverage. The same standard and interpretation—which provides that qualifying treatments must be safe and effective, appropriate for Medicare patients, and as beneficial as other approved alternatives—would apply to Medicare’s clinical trial policy.

Still Lacking Detail? The proposed definition would make it easier for FDA-approved drugs and devices to satisfy the “reasonable and ...