Finally, CMS Issues Sunshine Act Proposed Rule and Resets Compliance Deadlines

Dec. 15, 2011 – The Centers for Medicare & Medicaid Services (CMS) issued its long-awaited Proposed Rule for implementing the Physician Payments Sunshine Act yesterday, just a day before the Senate Special Committee on Aging was slated to hold a hearing about the need for the “timely release of regulations” and the impact on industry and consumers of CMS missing its Oct. 1, 2011, regulation deadline.

“It’s high time the affected communities got to see the proposed rules,” remarked Coalition Executive Director John Kamp. “Obviously, CMS listened to concerns of the Coalition and others in developing this proposal and provided more reasonable deadlines for comment and compliance.”

The statutory deadlines had been an important sticking point for industry and others. Until today, industry was expected to begin data collection starting Jan. 1, 2012, and report it on March 31, 2013. Under yesterday’s notice, data collection will not begin until after final regulations are issued. Data submission is slated to occur on the original date of March 31, 2013, but CMS is proposing that only a partial year’s data will need to be reported.

As the details of the national Sunshine Act rule emerge and when the resulting data eventually are released, stakeholders must play a role in how they are interpreted, according to Kamp. “Our most important job is ensuring that our clients, healthcare providers and patients get past the headlines, understand the underlying issues and move forward,” he added.

“It’s time for politicians and the press to stop the finger pointing and get us all refocused on patient care,” he said, because “collaboration among medical providers, researchers, industry and government is key to patient care. It must be encouraged.”

For additional background on what the industry must do to fully prepare for the new rules see the feature story Kamp wrote on the Sunshine Act in Communiqué this fall (“Don’t Get Burnt”:

Among other comments, Kamp notes in the piece that although transparency is important, the value of communications between industry and medical professionals must be managed carefully. He recommends several

steps need to be taken to help patients, policymakers and the press better understand the data when published. “Doctors with strong industry ties are better informed,” Kamp stated, adding that these relationships should be considered “a credential, not a cause for concern.”

Meanwhile, today’s hearing has now been postponed as the Act’s developers, Sen. Herb Kohl (D. Wis.) and Sen. Charles Grassley (R-Iowa), take time to review the proposed rule, which is slated to be published in the Dec. 19 Federal Register.

“The Sunshine Act guidance is a welcome, if late, step toward ensuring that the financial links between physicians and the drug, biologics and medical device industries are transparent,” Kohl said in a statement postponing the hearing to early 2012. “As we move forward, it’s vital that stakeholders have a voice in this process to ensure transparency and accountability in our health care system.”

Both Kohl and Grassley sent a letter to CMS Administrator Donald Berwick expressing their “severe disappointment” that the agency missed the Oct. 1 deadline to issue regulations as mandated by the Affordable Care Act.

“The completion of the guidance is good news,” Grassley said. “It came after a lot of follow-up from Sen. Kohl and me to find out the status and to press for results from CMS. It shows Congress has a responsibility not just to make the laws but also to see that they’re carried out as intended. Companies need this guidance to do their part.”

CMS will be accepting comments on the Sunshine Act Proposed Rule until Feb. 17, 2012. To view a comprehensive summary of the proposed rule, go to: