Physician Payments Sunshine Act regulatory guidance released in the USA


On 14 December, Senate Special Committee on Aging chairman Herb Kohl (D-Wis) announced that the Centers for Medicare and Medicaid Services (CMS) has issued proposed regulatory guidance for implementing the Physician Payments Sunshine Act, prompting the postponement of a Thursday hearing on the new law.

Kohl and Chuck Grassley (R-Iowa) developed the Physician Payments Sunshine Act, which was signed into law as Section 6002 of the Patient Protection and Affordable Care Act. The law requires public disclosure of the financial relationships between physicians and the pharmaceutical, medical device and biologics industries. The law also required the Department of Health and Human Services (HHS) to establish reporting procedures for applicable manufacturers to submit information, as well as procedures for making that information available to the public, by 1 October 2011. CMS issued that guidance on 14 December.

“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. “As we move forward, it is vital that stakeholders have a voice in this process to ensure transparency and accountability in our health care system.”

“The completion of the guidance is good news,” Grassley said. “It came after a lot of follow-up from senator 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 laws but also to see that they are carried out as intended. Companies need this guidance to do their part.”

Kohl and Grassley have been pushing for the timely release of regulatory guidance for more than a year. In November 2010, Grassley and Kohl urged HHS secretary Kathleen Sebelius to implement the Sunshine Act with adequate time for time for comment and review. And, on 3 October 2011, Kohl and Grassley urged CMS to issue guidance and sought an explanation for having missed the 1 October 2011 deadline.

Kohl and Grassley plan to review the newly issued guidance to see if it fulfills all of their goals in developing the law. Kohl plans to reschedule the hearing early next year.