MICHAEL M. GABA is a shareholder at Polsinelli PC where he provides strategic FDA regulatory, Medicare policy, and federal relations counsel to an array of companies developing a variety of products in the life sciences space, whether traditional medical devices, digital health-based products, biotechnologies, biologic-device combinations, or pharmaceuticals. His primary goal is to bring companies to market and then help them remain there in the most efficient and effective manner possible. Working as an extension of each company’s legal and business teams, Michael draws on more than 25 years of experience to navigate the FDA pre-market regulatory pathways, counsel companies on FDA post-market compliance matters, and resolve Medicare coverage, coding, and reimbursement disputes with the Centers for Medicare and Medicaid Services. By using his FDA and CMS experience during the product development phase, Michael is able to help maximize companies’ opportunities to be appropriately compensated in the proper treatment venues, whether a physician’s office, hospital outpatient or inpatient departments, ambulatory surgical centers or home care. During the COVID-19 pandemic, Michael continues to provide strategic FDA counsel to many medical device and diagnostic companies, including several first-time entrants to the medical device space, assisting them in obtaining emergency use authorizations from the FDA, and advising them on how to comply with FDA’s pandemic-focused enforcement discretion policies. There are times when federally-regulated life science companies and the patients they serve would benefit from changes to public policy, Michael works with members of Congress and Executive Branch officials to develop, enact and implement these policy changes.
