Overview
Paul Radensky, MD, advises manufacturers at every stage of product development, including the design and monitoring of clinical trials, positioning and applying for Food and Drug Administration (FDA) approval, maintaining regulatory compliance, and obtaining coverage, coding and payment for new technologies by Medicare, Medicaid and other third-party payors. He serves as a principal of McDermott+Consulting LLC.
Paul also advises clinical laboratories on Clinical Laboratory Improvement Amendments (CLIA) and state licensure compliance as well as evolving policies on FDA regulation of laboratory-developed tests. He is a recognized authority on the full range of legal, regulatory and reimbursement issues pertaining to pharmaceutical, biotechnology, medical device, and clinical laboratory development and marketing.
Among recent engagements, Paul currently serves as Washington, DC, representative for several coalitions as well as individual companies that are developers of and stakeholders interested in various diagnostic technologies, including advanced laboratory diagnostics, diabetes testing supplies and drug testing systems. He is also policy and reimbursement counsel to global specialty pharmaceutical wound product, diagnostics imaging and pharmaceutical manufacturers.
Paul’s background as a clinical researcher and medical practitioner informs his practical and scientific understanding of product manufacturers and clinical laboratories. He is board certified in internal medicine.
Results
- Obtained a favorable Office of Inspector General (from the Department of Health & Human Services (HHS)) advisory opinion on subsidies provided in the setting of a clinical trial
- Obtained a new non-proprietary name for an established biological product, which, as a result, set the non-proprietary name stem on the entire family of biologicals
- Obtained four favorable Medicare national coverage determinations, including the first-ever parallel review
- Gained approval of two Coverage with Evidence Development (CED) protocols
- Obtained approval of multiple Local Coverage Determinations (LCDs)
Recognitions
- Chambers USA, Healthcare: Pharmaceutical/Medical Products Regulatory, 2018, 2021-2024
- Best Lawyers in America, Biotechnology and Life Sciences Practice, 2008-2019 and 2021-2025
- Thomson Reuters, Stand-out Lawyer – independently rated lawyers, 2023-2024
- LMG Life Sciences, Hall of Fame Inductee, 2021
- The Legal 500 United States, 2019
- LMG Life Sciences, Life Science Star 2015 to 2016, 2018
Community
- Alpha Omega Alpha Honor Medical Society
- American College of Physicians
Credentials
Education
Harvard Law School, JD, magna cum laude, 1988
University of Pennsylvania, MD, 1979
Princeton University, AB, cum laude, 1975
Admissions
District of Columbia
Florida
