The Physician Payment Sunshine Act Final Rule

On February 1, 2013 the Centers for Medicare & Medicaid Services (CMS) released the final regulations to implement the Physician Payment Sunshine Act—Section 6002 of the Affordable Care Act and will be published in the Federal Register on February 8, 2013. The Physician Payment Sunshine Act is designed to expose financial relationships between doctors and industry and requires physicians and teaching hospitals to annually report gifts and payments they receive from medical device and pharmaceutical manufacturers. Manufacturers must begin collecting the required data by August 1, 2013 and report the data to CMS by March 31, 2014. “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, M.D. CMS deputy administrator for Program Integrity. “Disclosure of these relationships allows patients to have more informed discussions with their doctors."

The final regulations to implement the Physician Payment Sunshine Act were supposed to be published in October 2011. Unfortunately, these regulations are 15 months overdue. Originally, the manufacturers were supposed to start collecting the payment data in January 2012 and report the relationships to CMS by Mar. 31, 2013. But CMS later pushed back the data collection date. Many groups have been urging CMS to publish the final rule. The uncertainty created by the delay in publishing the final rule has now given way to praise in some quarters. "This rule allows a long-delayed transparency measure to take effect," Allan Coukell, director of medical programs at The Pew Charitable Trusts, said in a statement. "Public reporting of the financial relationships between doctors and drug or medical device companies will protect patients and help restore trust in our healthcare system. We applaud the Centers for Medicare and Medicaid Services for issuing the Sunshine regulation, which will now allow manufacturers to comply with their reporting obligations under the law."

After hearing over 350 comments with respect to the continuing medical education (CME) industry, CMS has exempted payments or other transfers of value provided as compensation for speaking at a continuing education if certain conditions are met—which are consistent with the ACCME’s accreditation standards and standards for commercial support. "This decision recognizes the adequacy of current protections against inappropriate bias in CME, and acknowledges CME’s special role in educating physicians and improving patient outcomes." said the CME Coalition. "Further, by limiting CME support payments from the reporting rules required of direct physician payments, CMS has made it clear that pharmaceutical companies, medical device manufacturers, and other commercial supporters should not be discouraged from underwriting accredited CME activities."

The American Medical Association (AMA) was a bit more cautious in their praise. In a statement AMA President Jeremy Lazarus, MD. said: "The AMA will carefully review the new Physician Payment Sunshine Act rule. Physicians’ relationships with the pharmaceutical industry should be transparent and focused on benefits to patients. Our feedback during this rulemaking process was aimed at ensuring the new registry will provide a meaningful picture of physician-industry interactions and give physicians an easy way to correct any inaccuracies. As the rule is implemented, we will work to make sure physicians have up-to-date information about the new reporting process."

Payment categories will include consulting fees, honoraria, gifts, food, entertainment, and travel, among others. Stakeholders are required to report their payments if they are covered by any federal health program. So far ProPublica's Dollars for Docs tool has been the only freely available source for the public to search and analyze the payments made since 2009 by a dozen drug companies. ProPublica gathered the information from the companies' websites into one searchable, sortable database.

The Pharmaceutical Research and Manufacturers of America (PhRMA) said in a statement, "PhRMA remains committed to the principles of the Sunshine Act and continues to believe that careful implementation is essential to ensuring that Sunshine fulfills its objective of usable, transparent, and understandable sharing of information." And the Medical Imaging & Technology Alliance (MITA) issued a statement saying: "We appreciate that CMS has given device manufacturers 180 days after publication to implement the final regulations, so that our members have sufficient time to successfully implement the law."

Senator Chuck Grassley (R-Iowa), co-author of the original legislation, has been repeatedly urging for the regulations to be completed. Now, after the regulations have finally been published he said that "disclosure brings about accountability, and accountability will strengthen the credibility of medical research, the marketing of ideas and, ultimately, the practice of medicine."

"I will stay vigilant about how this law is implemented, especially after the delays seen already," Grassley added.