Sunshine Act May Be Cloudy for Docs

The Sunshine Act requiring device companies to publicly report payments to physicians kicks in this fall.

Based on a recent Yale University study, physicians better pay attention to what companies are reporting in payments because they can expect to find some big discrepancies between what device manufacturers are reporting to the government and what they are self-reporting.

Jonathan Grauer, M.D., and his colleagues analyzed payments to physicians that were made in 2010 (pre-Sunshine) by Medtronic, Inc. and DePuy Spine Inc. and posted on the company web sites. They compared these payments with the monetary conflict-of-interest disclosures made by physicians who were participants at the 2011 annual meeting of the North American Spine Society (NASS).

The results?

Based on NASS disclosures, 52.4% of NASS participants affiliated with Medtronic had their disclosures inaccurately reflected on the Medtronic web site. Based on Medtronic payment postings, 45.7% of NASS participants listed on Medtronic’s webpage had discrepancies in their NASS disclosures. Those who received payments under $100, 000 were more likely to have discrepancies in their disclosures than those who received payments over $100, 000.

Based on DePuy Spine payment postings, 30% of NASS participants listed on DePuy Spine’s site had discrepancies in their NASS disclosures.

Medtronic and DePuy Spine were disclosed by 12.1% and 8.75% of NASS participants, respectively.

“It goes wrong in both directions, ” said Grauer, an orthopedist in a March 8, 2014 story in the Star Tribune. “My concern is that people will look at it as trying to hide things. But it’s not. It’s largely a documentation issue.”

For example, Grauer said a company that makes spinal implants reported providing him a meal at a dinner that he knows he did not attend.

The Centers for Medicare and Medicaid Services (CMS) lets physicians check data between the time companies submit it and the time the government publishes it. During a 45-day window providers may dispute numbers and negotiate privately with companies to make changes. If the two sides fail to agree, however, the numbers submitted by industry go public with a notation that the amount remains contested.

Most health care providers are not aware of that, reportedly said Anita Griner, who manages Sunshine Act disclosures for CMS. “The fact that they disputed [data] does not inhibit it from being posted on the public website, ” she explained. That is because manufacturers, not doctors, guarantee the accuracy of data and face penalties if they violate the law.

However, according to the Tribune story, Griner said CMS is “encouraging physicians to ask [companies] for pre-submission review and we are also encouraging manufacturers to offer pre-submission review so the data gets cleaned up even before we get it.”

Griner says CMS won’t penalize companies “for submitting a correction. It is no indication that they were derelict in their reporting. Corrections are encouraged.”

But the accuracy of the data that goes public September 30, 2014 will be evolving. “There will be some bumps along the way, no doubt, ” said David Dvorak, CEO of Zimmer Holdings Inc. “Those challenges are going to be driven by the newness of the legislation and clarity and understanding of what it requires in certain circumstances.”

The discrepancies are “concerning given the passage of the [Sunshine Act] as well as the increased public visibility of potential discrepancies. More uniform practices will certainly be necessary, ” concluded the Yale study.