Federal spending on the Medicare program for people with high drug costs has dramatically increased over the past five years, which is largely due to the soaring costs of expensive specialty medications, according to a January 2017 report from the Department of Health and Human Services. As the Wall Street Journal has noted, federal payments for Medicare Part D catastrophic coverage, which pays 80% of drug costs after a beneficiary has spent a certain amount annually, surpassed $33 billion in 2015, more than triple the amount paid in 2010. Most of this rise is due to increased spending on drugs that cost $1,000 or more a month, several of which came on the market in the last few years.

These high cost specialty drugs impact a range of stakeholders form payers, pharma, physicians, patients, and policymakers, and present complex legal issues ranging from Fraud & Abuse to compliance with FDA Marketing & Communications.

This course, presented by Rujul Desai, Vice President of Avalere Health, is designed to help attendees understand the unique dynamics of the specialty drug market in order to better advise clients on the legal, regulatory, and policy risks in today’s evolving healthcare landscape.

Learning Objectives: 

1. Understand the impact of high cost specialty drugs on overall healthcare spending trends

2. Outline the market access and distribution process for specialty drugs

3. Review recent attempts to address some of the cost pressure through innovative contracting

4. Identify key areas of legal risk for various stakeholders associated with the unique dynamics of the specialty drug marketplace

5. Discuss recent enforcement trends focusing on the specialty drug market