Will Drug, Device and Biologics Manufacturers be Penalized for Not Reporting Payments Under the Proposed CMS Rule?

• By: Staff Editor
• Date: December 20, 2011

Yes – but only payments above $10 made to covered recipients (i.e., physicians or teaching hospitals) have to be reported by manufacturers under the proposed rule, part of the enforcement requirements included in the Physician Payment Sunshine Act of 2010. This rule has been drafted by the Centers for Medicine and Medicaid Services (CMS), which has been tasked by the government to enforce the Act’s requirements.

For failing to report, manufacturers will be subject to a civil monetary penalty of not less than $1,000, but not more than $10,000, for each payment or other transfer of value or ownership or investment interest not reported.

For knowingly failing to report, manufacturers will be subject to a civil monetary penalty of not less than $10,000, but not more than $100,000, for each payment or other transfer of value or ownership or investment interest not reported.

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