The Alliance of Specialty Medicine and the Premier healthcare alliance have each sent comment letters expressing general support for a proposed rule on new regulations for reporting payments to medical researchers, but both also noted concerns with certain requirements and suggested changes that would lessen administrative burdens and clarify requirements.
The proposed requirements are included in a section of the Patient Protection and Affordable Care Act known as the
Physician Payments Sunshine Act, which calls for the CMS to annually publish online the payments and “transfers of value” made to physicians and teaching hospitals by GPOs and drug, device, biologic and medical supply manufacturers.
“This proposed rule will strengthen transparency in the medical profession and uphold the standards that professional medical societies have in place to govern interaction between physicians and the pharmaceutical, biologics, and device industries,” the
Alliance of Specialty Medicine, a coalition of 11 national specialty groups (PDF)representing more than 100,000 doctors, said in its letter.
It was also noted in the letter, however, that proposed rules on financing for continuing medical education and direct-to-patient educational materials would be burdensome, “close to impossible” to accurately report and could result in physicians “unknowingly being labeled as having a conflict with a manufacturer(s) for which they did not seek, accept, nor directly benefit from.”
In his comment letter to the CMS,
Blair Childs, Premier vice president for public affairs, wrote that “greater transparency of the financial relationships between physicians and the industry is needed” and that Premier “fully supports” the CMS proposal to include physician-owned distributors in defining the term “applicable group purchasing organization.”
“The proposal to include physician-owned distributors along with applicable GPOs should curb undue influence of these entities through requisite transparency of the relationships of the physicians involved and the healthcare services and products they prescribe,” Childs wrote.
A comment letter
had also been submitted by the Association of Clinical Research Organizations in which the proposed reporting requirements were criticized as burdensome and it was predicted they would yield “confusing information.”
Though it was inserted into the healthcare reform law, whose support was split down party lines, the Sunshine Act had bipartisan roots and was co-sponsored by Sen. Chuck Grassley (R-Iowa) and Sen. Herb Kohl (D-Wis.).