In follow-up to the release of the final regulations implementing the federal Physician Payment Sunshine (Sunshine) provisions, the Centers for Medicare & Medicaid Services (CMS) has provided stakeholders with the opportunity to comment on certain aspects of the Sunshine final rule that were not raised in the proposed rule. 

As addressed in our Health Alert, the Sunshine statute, codified at 42 U.S.C. § 1320a-7h, requires manufacturers of covered drugs, devices, biologicals, and medical supplies to disclose annually all payments and other transfers of value that they make to physicians and teaching hospitals (covered recipients), with certain exceptions. The rule also requires reporting by manufacturers and group purchasing organizations (GPOs) of ownership interests held by physicians and their immediate family members.

In its solicitation, CMS has invited comment on the estimated burden of complying with the final rule as well as “any other aspect of this collection of information,” including:

  • the necessity and utility of the proposed information collection for the proper performance of the agency’s functions;
  • the accuracy of the estimated burden;
  • ways to enhance the quality, utility, and clarity of the information to be collected; and
  • the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

In addition, CMS has posted three draft reporting templates on its website: a non-research payment template, a research payment template, and a physician ownership interest template. These draft templates are also open for comment.

Comments are due by April 9, 2013.