The Sunshine Act’s Impact on MSLs Interactions with KOLs


A recent survey conducted by the MSL Society and the Rutgers Institute for Pharmaceutical Industry Fellowships reveals key insights into how MSLs view their role in this new Sunshine Act environment.

As the industry prepares for the implementation of the new Physician Payment Sunshine Act (PPSA), which was passed under the Patient Protection and Affordable Care Act in 2010, the final regulations were published by the Centers for Medicare and Medicaid Services (CMS) in the Federal Register on February 1, 2013. The new rule requires manufacturers of drugs, devices, biologics and medical supplies covered by Medicare, Medicaid or the Children’s Health Insurance Program to report certain payments or other transfers of value made to physicians and teaching hospitals.

Over the last few years there has been a lot of discussion regarding how the new regulation will impact Medical Science Liaisons (MSLs) engagement with Key Opinion Leaders (KOLs) and other healthcare providers. To shed light on this question, the MSL Society recently partnered with the Rutgers Institute for Pharmaceutical Industry Fellowships to design and conduct a survey of current MSLs in the U.S. This survey collected responses from 167 MSLs, representing a variety of companies and therapeutic areas, who provided insights into how MSLs view these regulations and the impact they may have in the field.

According to the survey, most companies are already preparing for the new regulations. In fact, 73% of MSLs surveyed indicated that their companies have already implemented a standardized reporting system for tracking payment requirements to physicians and academic institutes. Even for those that do not have a formal tracking system in place, 11% of respondents indicated that their companies currently have plans to develop a tracking system. In addition, 50% of the MSLs surveyed reported that their company is also offering a formal training program on the new regulations.

The survey also provided insights into how MSLs perceive the level of awareness of these regulations by physicians. Although most MSLs reported that they believed physicians are aware of the general provisions, the level of awareness varied widely. However, MSLs also noted that the physicians with the most comprehensive understanding of the regulations are concerned about how general information may give the public the wrong perception of the relationship between physicians and pharmaceutical companies.

Although the majority of MSLs from the survey do not believe the act will have a negative impact on their relationship with physicians, some did express concerns that the regulations could reduce the frequency and quality of their interactions. Interestingly, a small percentage of MSLs indicated that the new regulations could actually increase the number and quality of interactions. However, most MSLs do agree that the regulations will likely negatively impact sales as access to physicians becomes increasingly restricted.

In addition to the Sunshine Act in the U.S., there are a number of global regulatory changes that will be implemented over the next several years that will result in increased scrutiny between physicians and the pharmaceutical industry. Clearly these regulations will have an effect on how pharmaceutical companies engage with physicians and other healthcare providers. However, the Sunshine Act and other regulatory changes are unlikely to have a negative impact on the relationship that MSLs have with physicians. In fact, MSLs may actually increase the number and quality of interactions they have with physicians as a result of these new regulations.

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