CMS releases much-anticipated Sunshine Act
The Centers for Medicare & Medicaid Services (CMS) has released its final rule seeking to increase public awareness of financial relationships between drug and device manufacturers and certain healthcare providers. Called the “National Physician Payment Transparency Program: Open Payments,” this is one of the steps in the Patient Protection and Affordable Care Act designed to create greater transparency in the healthcare market, according to the agency.
“You should know when your doctor has a financial relationship with the companies that manufacture or supply the medicines or medical devices you may need,” said Peter Budetti, MD, JD, CMS deputy administrator at the Center for Program Integrity. “Disclosure of these relationships allows patients to have more informed discussions with their doctors.”
The rule finalizes the provisions that require manufacturers of drugs, devices, biologicals and medical supplies covered by Medicare, Medicaid or the Children’s Health Insurance Program (CHIP) to report payments or other transfers of value they make to physicians and teaching hospitals to CMS. CMS will post the data to a public website. The final rule also requires manufacturers and group purchasing organizations (GPOs) to disclose to CMS physician ownership or investment interests.
"This increased transparency is intended to help reduce the potential for conflicts of interest that physicians or teaching hospitals could face as a result of their relationships with manufacturers," stated the CMS in a press release. "This new reporting will apply to applicable manufacturers and GPOs. These organizations, as well as the physicians and teaching hospitals, will have an opportunity to review and correct reported information prior to its publication."
To give applicable manufacturers and applicable GPOs sufficient time to prepare, data collection will begin on Aug. 1, 2013. Applicable manufacturers and applicable GPOs will report the data for August through December 2013 to CMS by March 31, 2014, and CMS will release the data on a public website by Sept. 30, 2014. CMS is developing an electronic system to facilitate the reporting process.
Chuck Grassley (R-Iowa), co-author of the 2010 Physician Payments Sunshine Act, said the release of the bill was "long overdue, long-delayed" in a statement on his website. “Disclosure brings about accountability, and accountability will strengthen the credibility of medical research, the marketing of ideas and, ultimately, the practice of medicine. The lack of transparency regarding payments made by the pharmaceutical and medical device community to physicians has created a culture that this law should begin to change substantially...CMS needs to make certain the reporting and disclosure are complete and clear,” added Grassley in his statement.
The final rule can be downloaded at the Federal Register.