CMS Stresses Doctors' Rights to Challenge Data Collected Under Sunshine Act

By Michael Bologna  

CHICAGO--Centers for Medicare & Medicaid Services policymakers rolling out the Physician Payments Sunshine Act June 17 attempted to soothe physicians' fears over potentially false or misleading reports pointing to dubious financial relationships with medical device and pharmaceutical manufacturers.

Anita Griner, CMS’s deputy director for the Data Sharing & Partnership Group, said data accuracy is the agency's top priority as it implements the Sunshine Act, created under Section 6002 of the Affordable Care Act. In line with that goal, Griner said CMS is creating a range of educational tools to orient stakeholders toward their compliance responsibilities.

Speaking to physicians attending the American Medical Association's House of Delegates meeting here, Griner also emphasized that medical professionals have the right to challenge data coming to CMS under the sunshine requirements if they think the information is false or misleading. She called on physicians to play an active role in the data accuracy process. Her comments were in response to concerns from several physicians that media outlets and consumer groups would attempt to “sensationalize’’ financial data published through the sunshine process.

“Data accuracy is the number one goal of our program,’’ Griner said. “We want the data put on the public website to be complete and accurate. We do not want it to be disputed. We do not want it to be inaccurate. We do not want to perpetuate any false information about a physician or teaching hospital. So data accuracy is key. And that will come from you tracking your own transfers and checking the website before it goes public.’’

Beginning Aug. 1, manufacturers of pharmaceuticals, medical devices, and biologicals will commence complying with the sunshine law's National Physician Payment Transparency Program, which CMS is calling OPEN PAYMENTS. The program requires companies to track items of value provided to physicians and teaching hospitals and submit annual reports on such activities. The data will be published annually as a strategy for preventing inappropriate influences on research, education, and clinical decisionmaking.

Data to Be Reported

Dr. Shantanu Agrawal, director of CMS’s Data Sharing & Partnership Group, said three specific types of data must be reported to CMS:

• Covered manufacturers must report payments or other transfers of value (TOVs) made to physicians and teaching hospitals.

• Covered manufacturers and applicable group purchasing organizations (GPOs) must report certain ownership or investment interests held by physicians or their immediate family members.

• GPOs must report payments or other TOVs made to physician owners or investors if they held ownership or an investment interest at any point during a particular reporting year.

Griner said physicians do not have specific reporting requirements under the program. At the same time, she said physicians will have the right to check the information being supplied by manufacturers and GPOs and challenge inaccuracies prior to publication. Specifically, physicians will have 45 days to access the consolidated reports through an online portal. Disputed information then will undergo a resolution process.

Griner said CMS is creating several tools that will permit physicians to monitor the process, track transactions, and contest data inaccuracies. She pointed to fact pages and reporting explanations on the OPEN PAYMENTS website. Griner said CMS is also in the process of developing a free smart phone application that syncs with the reporting activities of the manufacturers.

Data Accuracy Paramount

AMA's outgoing president, Dr. Jeremy A. Lazarus, said the association supports efforts that provide the public with additional transparency over financial relationships between the medical profession and players in the health industry. At the same time, Lazarus said data accuracy is paramount.

“We want the law implemented appropriately and physician rights to challenge false or misleading reports protected,’’ Lazarus said in his June 15 address before the House of Delegates.

He noted that AMA has launched a Sunshine Act resource page to educate physicians on the law's requirements. He added that AMA will host online modules and webinars to provide physicians with further assistance.