FDA and Healthcare

Dr. Paul Rudolf has significant experience in both Medicare and FDA legal, regulatory and policy issues, particularly those relating to counterfeit drugs and radiofrequency identification technology as applied to pharmaceuticals and medical devices. He also is widely recognized for his experience with coverage, coding, and reimbursement issues for hospital and physician payment systems under the Medicare payment systems.

Dr. Rudolf practiced medicine for more than 15 years and taught at George Washington University before becoming a Medicare Carrier Medical director. He subsequently joined the Centers for Medicare and Medicaid Services where he led policy development for the physician fee schedule and the hospital outpatient prospective payment system, and became recognized for his in-depth experience with coding and reimbursement for Medicare. Dr. Rudolf left the Centers for Medicare and Medicaid Services to join the FDA where he was a senior advisor for medical and health policy in the Office of the Commissioner. At the FDA, he led policy development for counterfeit drugs and radiofrequency identification technology and worked on issues related to follow-on biologics and pediatric medical devices. After leaving government, Dr. Rudolf worked for Avalere Health LLC, where he consulted for a variety of clients including pharmaceutical manufacturers, medical device manufacturers, healthcare technology manufacturers and physician trade organizations.

Dr. Rudolf has served in a number of elected and appointed positions in organized medicine including service on the Board of Trustees of the Medical Society of the District of Columbia and as chairman of the young physician’s section of the American Medical Association. Dr. Rudolf has received numerous awards for leadership and performance from the Administrator of CMS and the Commissioner of the FDA.