Today, the Centers for Medicare and Medicaid Services (CMS) released the final rule to implement the federal Physician Payment Sunshine Act (commonly known as the Sunshine Act). The Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, and medical supplies to track and publicly report payments and other transfers of value that they make to physicians and teaching hospitals. The statute also requires requires applicable manufacturers and group purchasing organizations (GPOs) to report ownership or investment interests held by physicians and their immediate family members. The rule will be published in the Federal Register on Friday, February 8.
The final rule announces that applicable manufacturers will be required to begin tracking reportable payments on August 1, 2013, and must submit their first disclosure reports to CMS by March 31, 2014.
The final rule also addresses a number of important outstanding issues with respect to implementation of the statute’s payment reporting requirements. In particular, the rule addresses:
- the definition of what manufacturers are covered under the law;
- how manufacturers should report payments related to research;
- whether and how manufacturers should report payments provided indirectly to a covered recipient through a third party;
- the scope of the statute’s exclusion of certain payments and transfers of value from the reporting obligation;
- submission, review, dispute, and correction of manufacturers’ disclosure reports;
- the format and content of the public website on which the reports will be posted; and
- the scope of the federal statute’s preemption of similar state laws.
We are developing a client alert with additional analysis of the key provisions of the final rule, which will be available on our website, http://www.hoganlovells.com, in the coming week.