Little is known about the Sunshine Act site ahead of launch, AdvaMed says

With just a week to go before the expected release of pharma and med tech companies' payments to physicians under the Sunshine Act, stakeholders are still in the dark about what the website will look like, AdvaMed told FierceMedicalDevices.

The medical device industry association has long been lobbying the federal Center for Medicare & Medicaid Services to provide important contextual information about the financial disclosures so that they aren't automatically viewed as improper in some way, AdvaMed general counsel Andy Van Haute said in an interview.

"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," AdvaMed wrote in a Sept. 18 letter to CMS alongside fellow life science industry associations PhRMA and the Biotechnology Industry Organization.

Another concern is CMS' decision to withhold disclosure of one-third of the payments because some of the data was linked to the wrong physicians, although industry says they followed the guidelines. Van Haute said the association has received no assurances that any information about the withheld data will be provided, such as which company's information is complete and incomplete."There won't be any way to compare apples to apples," said AdvaMed spokeswoman Wanda Moebius during the interview.

"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 letter said.

The cosigned letter affirms that all three groups support the Sunshine Act, but they are also worried about protecting their industry's relationship with physicians. "As industry representatives, we believe it is important that collaboration with physicians and other health care providers continues and thrives. These interactions help encourage R&D as well as physician education and training, and benefit patients," the letter says.

Van Haute would like the website to include definitions of the various payment types and an explanation of their value. Some of the different forms of compensation include consulting fees, compensation for time and expertise, education and training, research grants and royalty fees, AdvaMed explained in an email.

"The types of interactions that device companies have with physicians are varied," Van Haute said.

Indeed, those outside the industry are often surprised to learn that it is common for company representatives to watch and advise doctors during a surgery. But AdvaMed and other stakeholders have no idea whether the reason for that interaction and other such complexities will be explained to website's users upon the website's supposed Sept. 30 launch.

- read the AdvaMed/Bio/PhRMA letter