Regulatory, Legal Uncertainties are Barriers to Value-Based Agreements

2017-07-14T07:26:10-06:00November 4th, 2016|Viewpoints|

Alison Sexton Ward, Mark Linthicum, Michelle Drozd, Alison Silverstein, and Joe Vandigo identify key legal and regulatory barriers in the creation of value-based contracts for drugs in their recent addition to the IVI-sponsored Health Affairs blog series. Based on two-part, in-depth interviews with a group of five stakeholders regarding their experience with value-based agreements, the authors identify three key legal concerns that frequently undermine efforts to create value-based agreements: federal anti-kickback statute, Medicare and Medicaid pricing rules, and FDA regulations regarding manufacturer communications. Notably, the authors found that it is uncertainty around the legal consequences of the agreements — and not clear conflicts with the law — that frequently stops progress on value-based agreements.

“There is some information available for the few value-based agreements that have been implemented, but it is very difficult to find information about the many agreements that never make it off of the drawing board,” noted Linthicum, who is IVI’s Director of Scientific Communications. “We wanted to learn from the people involved in these negotiations about the specific obstacles that make it difficult to implement the agreements.”

Read the full article here.

About the Health Affairs/IVI Featured Blog Series: Drugs and Medical Innovation — In partnership with Health Affairs, IVI is proud to sponsor the “Drugs and Medical Innovation” blog series. On an ongoing basis, articles in this series will explore topics such as value-based reimbursement, drug policy and pricing, balancing short-term access against long-term rates of innovation, and other relevant issues. Our goal is to create an open forum for sharing ideas and debating issues in these areas, extending the discussion to a broader audience.