The Department of Health & Human Services (HHS) and Centers for Medicare & Medicaid Services proposed new rules in October 2019 that have the potential to impact the Life Sciences industry and the relationships companies have with Healthcare Professionals (HCPs) and Healthcare Organizations (HCOs).
Among other things, the proposed changes would modify the personal services safe harbor provisions of the Anti-Kickback Statute (AKS) as well as create some new safe harbor protections. According to the HHS, these modifications would roll back barriers that currently inhibit improvements in patient care coordination and allow pharmaceutical and medical device manufacturers to participate more fully in the patient continuum of care, while still providing robust safeguards to defend against the potential for fraud and abuse.
With the proposed rule modification to the personal services safe harbor provision, pharmaceutical and medical device manufacturers no longer must predetermine a level of aggregate compensation in advance of initiating a relationship. They also would no longer be compelled to predetermine exact schedules, length and charge for such intervals — current stipulations that can effectively function as barriers inhibiting more flexible models of HCP education and patient care delivery. For example, agreements between manufacturers and HCPs for as-needed consulting or speaking services would be more likely to meet the revised personal services safe harbor, provided that compensation is fair market value and the other requirements are met. This simplification would free manufacturers from a layer of burdensome and cost-inefficient administrative requirements.
HHS has established a public comment period to gather feedback on its proposed changes to the AKS and Stark Law; this comment period ended December 31, 2019. These are important developments for pharmaceutical and medical device manufacturers, and this evolution of regulatory protocol in the age of value-based healthcare should be watched closely by all industry stakeholders.
IQVIA assists companies in meeting the safe harbors of the AKS including the calculation of FMV. We welcome the opportunity to further discuss these changes. For more information, please email firstname.lastname@example.org or visit our webpage.