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.
Paul Rudolf has extensive experience in representing clinical labs on the following matters:
- Development and implementation of compliance policies related to the OIG compliance guidance, CLIA requirements, Stark law, antikickback statute (e.g., financial relationships with potential referral sources, leases, provision of phlebotomist services), and other healthcare issues
- In connections with responding to subpoenas and government investigations
- Responses to deficiencies identified during an inspection (e.g., issued on Form 2567) by Federal, state, or accredited inspectors
- Responding to notice of sanctions and appeals of sanctions
- Medicare enrollment
- Regulatory issues related to closing a CLIA lab
- Advising laboratories on issues related to proficiency testing, reporting non-validated CLIA tests, and reporting of investigational/experimental test results
- Obtaining CPT codes for laboratory tests including developing a coding strategy (taking into account PAMA reporting and payment requirements), drafting CPT applications, and representing labs before the CPT editorial panel
- Obtaining Medicare reimbursement for clinical lab tests
- Obtaining Medicare coverage via local or national coverage determinations
- Compliance with PAMA reporting requirements
- Medicare audits
- Disputes with commercial payers and Medicare Advantage programs
- Strategic advice regarding the regulatory environment for laboratory developed tests, FDA regulated in-vitro diagnostic tests and how that affects coverage, coding, and reimbursement
- Due diligence on potential investments in, and acquisition of, clinical laboratories
- JD, The George Washington University Law School, 1993
- MD, University of Florida, 1982, Alpha Omega Alpha
- BA, Yale College, 1978
- District of Columbia
- Senior Advisor for Medical and Health Policy, Office of the Commissioner, US Food and Drug Administration
- Medical Officer, US Centers for Medicare & Medicaid Services