Are OTC drugs covered by CMS’ proposed Physician Payment Sunshine rule?

• By: Staff Editor
• Date: December 21, 2011

No – Over-the-Counter or OTC drugs are not covered by the Centers for Medicine and Medicaid Services’ (CMS) newly proposed Physician Payment Sunshine rule.

According to the Act and proposed rule, the requirements apply to manufacturers of a “covered drug, device, biological, or medical supply."

A covered drug, device, biological or medical supply refers to any drug, biological product, device, or medical supply for which payment is "available" under Medicare, Medicaid, or CHIP.

Over-the-counter (OTC) drugs and biologicals are not covered by this rule.

Read an overview and summary of requirements of the proposed rule.