With regard to the Sunshine Act, the pharmaceutical, biotechnology, and medical device industry are presently concerned with a number of issues:
1) How will the Sunshine Act weigh on reporting indirect payments to physicians?
The CMS allows manufacturers to send payments to physicians through third-party agents if and only if they remain unaware of the identities of said physicians. Otherwise, the CMS is concerned that manufacturers might adjust their financial relationships to take advantage of an indirect model for sending payments. In addition, CMS will require third-party agents to track payment information on behalf of manufacturers, which can then be reported by either the third-party or the manufacturer, but not both.
2) How will companies develop and execute aggregate spend plans?
Manufacturers will need to be highly confident in the quality and accuracy of their master databases, including verifying the accuracy of their physician information (including license numbers), removing duplicate records, and improving the usability of their database systems. In addition, manufacturers will need to designate someone within their organization to validate and communicate these payments to physicians, as well as to handle reporting disputes.
3) How will the Sunshine Act affect physician learning and research?
Dr. Henry Black, a clinical professor in the Department of Medicine at NYU Langone Medical Center, views the Sunshine Act as an “abomination.” Of most concern is that the Sunshine Act requires documentation of gifts and dinners alongside grants that sponsor new research, and may have a chilling effect on the state of clinical research in America. Thus, the Act may prompt a decrease of medical innovation in the United States, shifting the tremendously expensive burden of novel drug and device development to an already overburdened public health system.
4) How educated and prepared are physicians on the new guidelines?
The American Medical Association has developed an online resource for physicians to help educate themselves on the reporting process outlined by the Sunshine Act. This resource will include, as it becomes publicly available, a physician portal through CMS that will allow physicians to access reporting information, as well as an informational chart that characterizes the differences between federal and state Sunshine Laws.
5) How can companies maintain relationships with physicians?
The relationships between manufacturers and physicians are essential for both scientific innovation and clinical research. However, relationships between the two are subject to more scrutiny now than ever before, from the CMS and state oversight laws, as well as hospitals and academic institutions. At present, the onus is on physicians to understand the reporting and transparency rules, but manufacturers can help by creating systems that are as simple and painless as possible.