Sheva Sanders, Tricia Kaufman Detail Prior Authorization Program Considerations for Compliance Today

In the News

Partners Sheva Sanders and Tricia Kaufman recently published an article for Compliance Today discussing key compliance considerations for manufacturer prior authorization programs.

Life sciences companies often operate prior authorization assistance programs directed at establishing and obtaining coverage for their therapies. Recent enforcement activity underscores that these programs can present compliance challenges. In this article, Sheva and Tricia detail how these programs can be structured in a manner that avoids common compliance pitfalls, including guarding against the possibility of fraudulent misrepresentation, and assuring demonstrable compliance with the anti-kickback statute. They stress that manufacturers have a "legitimate self-interest in running prior authorization support programs to establish and assure continuing and competitive third-party payer coverage for their products" and that each program is unique and should be reviewed on a case-by-case basis.

Sheva and Tricia advise health care, managed care, medical device, pharmaceutical, life sciences, and pharmacy benefit management clients on complex state and federal regulatory issues, including FDA, fraud and abuse, privacy, compliance, reimbursement and transactional matters.


Related Capabilities

Media Contact

Elle Moxley
Media Relations Manager

Abigail Schoenrade
Communications Specialist

Subscribe to Stinson's
News & Insights
Jump to Page

We use cookies on our website to improve functionality and performance, analyze website traffic and enable social media features. For more information, please see our Cookie Policy.