The Sunshine Act was introduced as part of the Affordable Care Act (ACA) in 2010. It was designed to clarify financial relationships between businesses in the healthcare industry (such as pharmaceutical and medical device manufacturers) and doctors. Under the Sunshine Act, manufacturers of drugs, medical devices, or other life sciences items in the US must report payments or valuable items given to doctors or to teaching hospitals. The Centers for Medicare and Medicaid Services (CMS) is in charge of implementing the Sunshine Act.
Reports on this data are released to the public as "an opportunity for the public to learn about the relationships among health care providers, and pharmaceutical and device companies," according to CMS Administrator Marilyn Tavenner. Items in the reports include things like consulting fees, travel reimbursements, research grants, and gifts.
What Is Required of Pharmaceutical Sales Reps Under the Sunshine Act?
Pharmaceutical sales training should now include information about what is required of pharmaceutical sales representatives and their organizations under the Sunshine Act. Pharmaceutical manufacturers are required to track and report annually to the CMS about "transfers of value" including payments made to physicians and teaching hospitals, and pharmaceutical sales reps are essential to this process being done properly.
Since there are sometimes subtle differences between what does and does not have to be reported, pharmaceutical sales training should address which items must be reported, and which do not. For example, items that do not have to be reported include samples not intended to be sold, educational materials benefiting patients directly, in-kind items for charity care, and "de minimus" payments, which include things like snacks, occasional tickets to entertainment events, flowers, fruit, or holiday gifts.
Supervision of Data Collection
Supervision of data collection should also be included in pharmaceutical sales training under the provisions of the Sunshine Act. Data must be collected in the proper format, and contracts or information collection systems should be reviewed to ensure accuracy of data collected. Since pharmaceutical sales reps are on the front lines of many of these transfers, their training should include an action plan for compliance with the Sunshine Act.
Development of Training Programs
The pharmaceutical sales training having to do with the Sunshine Act should explain the Act's legal framework and clearly identify the company's obligations for data collection under the Act. Sources of data may include expense reports, contracts for consulting, research, honoraria, etc., and details from programs such as physician speaker programs. Since sales representatives will be primary collectors of data on gifts, entertainment, food, etc., they must understand exactly what does and does not have to be reported.
Some companies may elect, as part of their pharmaceutical sales training programs, to include information on reaching out proactively to physicians about new requirements under the Sunshine Act. Ensuring that physicians know what must be reported, and the possible impact reporting could have on them can be essential to maintaining good professional and commercial relationships between pharmaceutical companies and physicians. Keeping the lines of communication open could, for example, prevent the scenario of a company reporting a payment to the CMS that is later disputed by the physician.
With implementation of the Sunshine Act, pharmaceutical sales training should include information on accurate and appropriate data collection, the legal framework of the Act, and advice on reaching out to doctors concerning reporting requirements. Customized corporate learning for pharmaceutical sales reps has always been essential to the success of pharmaceutical companies, and is even more so with new requirements under the ACA. As a leading provider of pharmaceutical sales training, CLD is ready to assist pharmaceutical companies in developing and implementing training's new and evolving demands. CLD creates proven training scenarios in custom training packages designed to keep pharmaceutical sales reps productive and in compliance with all regulations that apply to their work.