Bass, Berry & Sims attorneys Clint Hermes and Dawn Perez-Slavinski examined a new proposal from the Centers for Medicare & Medicaid Services (CMS) defining a standard for what is “reasonable and necessary” for items and services reimbursed under Medicare. Foremost, the authors question how the “‘safe and effective’ standard that would be newly-enshrined in Medicare regulations fits with the same standard used by the Food and Drug Administration for products it regulates.”

Clint and Dawn also question how certain items, such as laboratory-developed tests, that are outside of FDA regulation will be handled under the new proposal. “It’s unclear how these products would be treated under CMS’s proposed ‘safe and effective’ requirement, much less what ‘safe and effective’ may mean in the context of services that are not subject to FDA’s jurisdiction at all.”

The authors expect more guidance from CMS as these and other questions remain. “Without CMS’s express proposal to incorporate the FDA’s standard, and given the agency’s stated intention of broadening—rather than limiting—its existing coverage standards, it seems unlikely that the agency would require FDA approval as a threshold for obtaining Medicare coverage.”

The full article, “Will Medicare’s Proposed Coverage Standard Align With FDA?” was published by Bloomberg Law on September 24 and is available online.