Physicians, industry continue to wait for Sunshine Act rules

Washington Senators from both major parties sharply criticized the Centers for Medicare & Medicaid Services for the continued delay in regulations on publicizing the financial ties between physicians and pharmaceutical, medical device and biologics companies during a Sept. 12 hearing.

The Senate Special Committee on Aging convened a roundtable discussion on the long-awaited implementation of the Sunshine Act, a bipartisan component to the 2010 health system reform law. Senators took the opportunity to voice their frustration with the agency tasked with running a program that is designed to allow public searches of databases to find information about individual physicians’ financial relationships.

CMS published a proposed rule for the Sunshine Act on Dec. 14, 2011, more than two months after the rule was supposed to be finalized. The overdue rule now should be ready following a review and comment period during the past nine months, said Sen. Charles Grassley (R, Iowa). However, the regulation still is in a state of flux. The rule is rumored to be awaiting final approval by the White House Office of Management and Budget, and probably will not be finalized until after Election Day, Grassley said.

“Our efforts to engage with CMS on the implementation of the Sunshine Act have been met with resistance and silence — just [as if] Congress passing a law doesn’t make any difference in this town,” he said.

The delay is unacceptable, agreed Senate Special Committee on Aging Chair Herb Kohl (D, Wis.). The public has the right to know about payments and gifts from the health care industry to doctors, and the law is not overly burdensome, because several drug manufacturers already release such information through disclosures on their own websites, he said.

CMS received more than 300 comments on the proposed rule. The agency has continued to assess the requirements for the program to ensure that it can accurately and effectively collect and publish the data, said Niall Brennan, director of the CMS policy and data analysis group.

“While there were a lot of comments, some [issues] were certainly commented on more often than others: continuing education, the treatment of indirect research payments, and the process for resolving disputes between physicians and manufacturers,” Brennan said.

The agency has announced that it will not require manufacturers to begin collecting disclosure data before Jan. 1, 2013. Brennan said during the hearing that manufacturers probably will be required to begin data collection later in 2013.

The American Medical Association supports the effort to increase transparency but wants physicians to be able to review their information and lodge a challenge before publication if they find any of it erroneous. The final regulations should ensure that the process will provide necessary insight on physician-industry relationships without being burdensome for those involved, said AMA President Jeremy A. Lazarus, MD.

“It is important to note, however, that while not all transfers are subject to reporting under the Sunshine Act, the AMA provides ethical guidance that covers all transfers, including indirect ones,” Dr. Lazarus said.