On February 1, 2013, the Centers for Medicare and Medicaid Services ("CMS") announced the release of the final regulations implementing the Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient Protection and Affordable Care Act, commonly referred to as the "Sunshine Act." The Sunshine Act requires applicable manufacturers of covered drugs, devices, biological products, and medical supplies to report annually certain information regarding payments and other transfers of value to physicians and teaching hospitals. An additional provision requires applicable manufacturers and group purchasing organizations ("GPOs") to report all ownership and investment interests held by physicians or members of their families. As set forth in the final regulations, applicable manufacturers and GPOs must begin data collection on August 1, 2013, and must file their first reports on March 31, 2014.
CMS recently published a notice in the Federal Register permitting interested parties to submit comments regarding the Sunshine Act. Specifically, CMS is collecting information related to the following requirements of the Sunshine Act:
- Registration: Applicable manufacturers and GPOs required to report payments and transfers of value must register with CMS within 90 days of the end of the calendar year for which a report is required;
- Attestation: Applicable manufacturers’ and GPOs’ reports must include a certification that the information reported is timely, accurate, and complete;
- Dispute Resolution: Applicable manufacturers, GPOs, and covered recipients will have the opportunity to review and submit corrections to payments and transfers of value reported to CMS;
- Submission of an assumptions document: Applicable manufacturers and GPOs may submit an assumptions document containing assumptions and methodologies used to produce the reports; and
- Record retention requirements.
To be assured consideration, comments and recommendations must be received no later September 20, 2013, either electronically to http://www.regulations.gov or by mail to the following address:
CMS Office of Strategic Operations and Regulatory Affairs
Division of Regulations Development
Attention: Document Identifier OMB Control Number CMS-10495
7500 Security Boulevard
Baltimore, Maryland 21244-1850
With Sunshine Act data collection to commence on August 1st, CMS continues to provide resources and guidance to the life sciences industry. In recent weeks, CMS developed and released a mobile app to assist physicians and applicable manufacturers and group purchasing organizations in tracking of payments and transfers of value. CMS also continues to issue informative responses Frequently Asked Questions on the Open Payments website. On August 8th, CMS will hold a conference call from 1:30 to 3:00 p.m. EDT titled, Open Payments – Policy Updates on Payments and the Physician Resource Toolkit. The Data Sharing & Partnership Group within the Center for Program Integrity will discuss topics including updates on program policy, focusing on Third Party Payment, Indirect Payments, and the Physician Resource Toolkit. It is anticipated that as a result of this request for comments, CMS will release additional guidance regarding Sunshine Act data capture and reporting requirements.