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