Overview
With deep experience in the life sciences industry, Michael W. Ryan advises manufacturers, healthcare providers, drug and technology developers, and investors on the legal, regulatory and reimbursement issues that arise during the development and commercialization of medical devices, clinical laboratory testing services, biological products and drugs. He guides life sciences companies and laboratories by evaluating and implementing strategies to optimize coding, coverage and payment for novel technologies. Michael also helps innovative companies identify and navigate applicable FDA regulatory requirements for new technologies, particularly in vitro diagnostics and digital health products. In particular, he regularly advises clients on the FDA’s evolving requirements for laboratory developed tests (LDTs) and digital health products, such as clinical decision support (CDS) software.
Throughout the life cycle of US Food and Drug Administration (FDA)-regulated medical devices, drugs and biological products, Michael provides clients, including global device companies, pharmaceutical companies and diagnostic test developers, with sound guidance on compliance issues. He is experienced in the review of promotional and marketing materials for FDA-regulated medical products.
Michael 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
- Advised medical device manufacturers, clinical laboratories, and investors on evolving FDA regulatory paradigm for personalized medicine products.
- Engaged Center for Devices and Radiological Health leadership on issues related to proposed FDA oversight of laboratory developed tests (LDTs).
- Consulted with clinical laboratories to draft substantive comments on documents outlining the FDA proposed oversight of LDTs.
- Advised entities who successfully sought and obtained Emergency Use Authorizations from FDA to offer or perform COVID-19 diagnostic tests.
- Obtained a favorable Medicare National Coverage Determination (NCD) 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).
- Earned product-specific HCPCS codes for biopharmaceutical products.
- Obtained favorable payment rates from Medicare for diagnostic services paid under the Clinical Laboratory Fee Schedule.
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
