Three of the largest trade groups representing medical device and drug companies—Pharmaceutical Research and Manufacturers of America, Biotechnology Industry Organization and the Advanced Medical Technology Association—last week sent a letter (PDF) to the CMS, pushing for more clarity around the rollout of the database. At stake is whether the database will include sufficient—or any—explanation of what a payment made to a healthcare provider means.
Manufacturers make payments to providers for a number of reasons, such as funding for research and clinical trials or payments for promotional work or speaking services. Manufacturers had the option to provide a payment explanation in a text box when submitting information for the database. But it's unclear how the CMS plans to use that information.
“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,” the groups said in the Sept. 18 letter.
Why the concern? Industry has long been dependent on healthcare providers to get new products adopted, prescribed and utilized. Both manufacturers and providers stress the value of these relationships to educate doctors and improve patient care through the adoption of new and potentially more innovative technologies, but some studies have pointed out that payments can inappropriately incentivize physicians to use certain products that may be more costly or less effective.
That's not the only concern about the law. A little known exclusion made by the CMS during the rulemaking process is also up in the air. In July the CMS proposed doing away with an exemption for continuing medical education. The exemption would have meant that drug and device firms would not have to disclose payments made through accredited continuing medical education organizations to physicians. At this time, the payments are still exempt.
The proposal has created “massive confusion on the part of the doctors” and could mean “tremendous costs on commercial supporters and CME providers,” said Andrew Rosenberg, senior adviser for the CME Coalition.
That proposal prompted Reps. Dr. Michael Burgess (R-Texas) and Allyson Schwartz (D-Pa.) to introduce a bill this week that would exempt CME payments. It would also exempt the value of medical texts. The bill is not expected to pass before the congressional session ends.
The scope of that provision and the wide range of sectors affected by the law make it likely that more changes may be ahead for the Sunshine Act. Allan Coukell, senior director for drugs and medical devices for the Pew Charitable Trusts, an advocate of the Sunshine Act, said it's somewhat “natural for a project of the size” to undergo some of the issues that have cropped up.
Despite delays and reports of inaccuracies and lack of usability in the database, Coukell expects the site to be live on Tuesday. That alone, he said, “is an important milestone in the implementation of this law.”
Follow Jaimy Lee on Twitter: @MHjlee