Physician Payment Sunshine Act: Final Rule
Taken from AOA CME E-Newsletter
On Friday, Feb. 1, the Centers for Medicare and Medicaid Services (CMS) released its “Final Rule” implementing the Physician Payment Sunshine Act. The Final Rule is 286 pages and was published in the Federal Register on Friday, Feb. 8.
The Sunshine Act includes several exceptions from the disclosure requirements, including, for example, payments to a physician or a teaching hospital in amounts under $10 (amount increases annually based on Consumer Price Index) so long as annual aggregate payments do not exceed $100; educational materials and samples used by patients; discounts and rebates; and payments for speaking at accredited or certified CME programs. While the definition of “applicable manufacturer” is broad under the Final Rule, hospitals, hospital-based pharmacies and labs that manufacture products solely for internal use or for patients do not qualify as “applicable manufacturers” for purposes of the Sunshine Act.
The Final Rule also sets forth several important upcoming dates. Manufacturers and GPOs must begin to collect data on Aug. 1, 2013. They must track data between Aug. 1, 2013 and Dec. 31, 2013 and report this data to CMS by March 31, 2014. Data will be submitted via an electronic system to be published by CMS at a later date.
The Final Rule includes several penalties for non-compliance with the Sunshine Act. Applicable manufacturers and GPOs that fail to report as required by the Final Rule can be subject to a civil monetary penalty (CMP) of up to $150,000 annually, and intentional failures to report carry much stricter penalties, up to $1,000,000. CMS has also reserved the right to review compliance by applicable manufacturers and GPOs, and these entities are now required to maintain records and documents for at least five (5) years from the date of publication of the reportable event.
For more information about the Sunshine Act and the Final Rule, CMS has distributed a fact sheet.
