Big Pharma and Devices: Sunshine Act Not Ready

Implementation of the Sunshine Act through the CMS (Centers for Medicare and Medicaid Services) Open Payments program goes into effect on September 30, 2014.

The heads of Big Pharma, biotechnology and medical devices aren’t happy about that and want CMS to stop publishing physician payment information until industry has a chance to suggest and secure changes before going public.

On September 18, 2014, the heads of AdvaMed (Advanced Medical Technology Association), BIO (Biotechnology Industry Organization) and PhRMA (Pharmaceutical Research and Manufacturers of America), wrote CMS Administrator Marilynn Tavenner to complain that they have not had an opportunity to meet with CMS to assure that patients don’t get the impression that all payments to physicians are “suspect.”

No Opportunity to Review

“Unfortunately, with only less than two weeks before the public website is to go live, we have not been given an opportunity to review how CMS intends to present this crucial contextual information or to consult with CMS on its content. We are hopeful that this situation can be addressed before the first expected release of Sunshine data September 30.”

Specifically, the trade group bosses write that for implementation of the Sunshine Act to be successful and for the data to be meaningful to patients and the public, “the CMS Open Payments program public website must provide clear background information and context regarding such industry relationships. Such background ensures the reported data is helpful in patient decision-making. Further, providing context for reported payments and other transfers of value is critical to ensuring patients do not form mistaken impressions that all payments to physicians are suspect.”

Confused Submissions

In addition, they are concerned that CMS is going to withhold as much as one-third of the data that was submitted by industry. They say that based on reviews by their members of the removed data, it appears they all followed the rules. “It is not clear why this volume of data is being withheld. We are hopeful that this issue can be resolved expeditiously so that the data that is made available to the public is accurate, useful and complete.”

The launch of the Open Payments database was delayed when a Louisville, Kentucky, electrophysiologist named David E. Mann, M.D., complained that payments were being attributed to him even though they were made to another physician with the same name. In the process of reviewing that complaint, the agency found “intermingled data, ” where physicians were being linked to medical license numbers or national provider identification numbers that were not theirs.

The agency then said it was returning about one-third of submitted records to the manufacturers and [group purchasing organizations] because of intermingled data, and will include these records in the next reporting cycle. Those records won’t be posted until June 2015. CMS said there too many errors and might even level fines if further mistakes are made.

Changes Sought

The heads of the trade groups said they support and are committed to the goals of the Sunshine Act, but they want a chance to chime in and secure changes before it all goes public.

The sun is supposed to shine on physician payments on September 30, but the skies are not all clear yet.