Overview
Michael (Mike) Ryan advises manufacturers, healthcare providers, and investors on the legal, regulatory, and reimbursement/market access issues that arise during the development and commercialization of medical devices, clinical laboratory testing services, biological products, and drugs. He helps clinical laboratories and life sciences companies maintain regulatory compliance and evaluate, develop, and implement strategies to optimize coding, coverage, and payment for novel technologies.
Additionally, Mike helps innovative companies identify and navigate applicable Food and Drug Administration (FDA) regulatory requirements for new technologies, particularly in vitro diagnostics and digital health products. He regularly advises clients on the FDA’s evolving requirements for laboratory developed tests (LDTs) and reviews promotional and marketing materials for FDA-regulated medical products.
Mike also counsels clinical laboratories on state and federal compliance issues, including those under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), state laboratory licensure laws, and billing and reimbursement rules.
Results
- Obtained multiple favorable Medicare National Coverage Determinations (NCDs), including under FDA/CMS parallel review.
- Earned approval of a Coverage with Evidence Development (CED) protocol from CMS.
- Obtained multiple favorable Medicare local coverage determinations (LCDs).
- Obtained favorable payment rates from Medicare for services paid under the Clinical Laboratory Fee Schedule and Physician Fee Schedule.
- Earned product-specific Healthcare Common Procedure Coding System (HCPCS) codes and transitional pass-through status for biopharmaceutical products.
- Engaged Center for Devices and Radiological Health leadership on issues related to proposed FDA oversight of LDTs, including continuation of enforcement discretion for certain clinical laboratory services.
Recognitions
- Thomson Reuters, Stand-out Lawyer – independently rated lawyers, 2024
Community
- American Health Lawyers Association
- Food and Drug Law Institute
Credentials
Education
Wake Forest University School of Law, JD, magna cum laude, 2008
University of Maryland, BS, summa cum laude, 2003
Admissions
District of Columbia
Maryland
