Patient advocacy groups usually pool money from all sources of funding and then provide donations, grants or sponsorships to physicians, researchers and research institutes studying a particular disease or condition. Some patient organizations have been successful in funding clinical development of new treatments for their patient populations. The Cystic Fibrosis Foundation, for example, provided $75 million to Vertex Pharmaceuticals for research that led to the development of the drug Kalydeco, which received approval from the Food and Drug Administration in 2012.
Asking patient groups to develop a process that directly ties a manufacturer's funding to a specific physician is an “administrative burden,” said Nancy Hughes, a spokeswoman for the National Health Council. “Trying to identify specific dollars to specific physicians is very difficult.”
The groups are asking the CMS to grant an exclusion in cases where the manufacturer gives the patient advocacy organization full discretion in selecting recipients for funding.
The Sept. 30 deadline for the CMS to publish the first round of Sunshine Act data it has collected on its Open Payments website is rapidly approaching, and concern about the quality and accuracy of the collected data is rising.
While payment information has not yet been made public, physicians and representatives of teaching hospitals have had access to the database since July to review payments or other types of transfers of value reported by manufacturers. Some doctors reported that incorrect payment data was attributed to them. The CMS later announced that it will only release one-third of the data because of suspected inaccuracies.
The issues have prompted organizations ranging from the American Medical Association and the CME Coalition to request that the CMS delay the September publication deadline.
Follow Jaimy Lee on Twitter: @MHjlee