Regulatory Guidance from Aprel Buonpane
The main components of the new US healthcare reform legislation will continue to be subjects for debate in the coming months and years, but tucked in among all of the changes for Medicare beneficiaries, coverage for pre-existing conditions, and the effects on small business owners lies a provision that most laypeople would not even notice. This provision, however, has the attention of US drug and device manufacturers and cannot be ignored.
The Physician Payment Sunshine Provision, also known as the Sunshine Act, requires that these companies publicly report gifts and payments made to physicians and other entities such as teaching hospitals. The intention of the provision is to address the public’s perception that biopharmaceutical companies use payments to influence a physician’s prescription-writing habits and to improve transparency as to what actually does exchange hands, in the form of services and remuneration for those services, and why. Drug and device manufacturers must begin capturing this data in January 2012 and must make their first report on these activities to the Department of Health and Human Services by March 2013. This provision has far-reaching implications for how the medical meetings and event industry will conduct its business in service of the healthcare community for years to come.
The new law requires that every dollar spent on physicians and health care providers (HCPs) be captured, documented and eventually reported. It goes beyond cash payments, even including every type of cash-valued benefit such as travel, entertainment, meals, lodging, and honoraria. These benefits all make up important meeting components for investigators and thought leaders in the medical community. Failure to report these expenditures will be punishable by expensive fines that will apply to corporations, individuals and even the meeting planners working with the industry. Thus, it is quite important that meeting and event planners are up to speed with these new regulations and able to provide assistance to the client with their compliance needs through the capture and documentation phases of the meeting lifecycle. In addition to the new US legislation, there is a worldwide phenomenon of increasing regulation set around medical meetings and HCPs as well.
You can learn more about the Physician Payment Sunshine Provision by visiting: http://www.prescriptionproject.org/sunshine_act
This week’s guest blogger, Aprel Buonpane, manages business development activities for TMP Meeting Services, a Raleigh, NC company that plans and executes meetings and events for companies in a variety of industries. One of TMP’s specialty practices areas is the planning and execution of investigator meetings and medical advisory board meetings for the biopharmaceutical industry. The company is offering a free webinar on March 2, 2011 to offer guidance on compliance issues surrounding these meetings in lieu of the impending enforcement of the Sunshine Act. To register for the webinar, please follow this link.