Healthcare Regulation After Loper Bright and Corner Post: Agency Implications, Litigation Challenges, Client Impact

Mr. Grimm maintains a national practice guiding and advising health care providers and investment firms through the complex regulatory, transactional, and government enforcement challenges in the health care industry. He focuses his practice in the areas of mergers and acquisitions; strategic and compliance planning; fraud and abuse; Medicare reimbursement; health information privacy and security; and telehealth. Mr. Grimm represents a wide range of clients including health systems, investment funds, group practices, clinical laboratories, specialty providers, and medical device manufacturers. He previously served as a former CEO of multiple acute-care hospitals throughout the United States, and remains active in health care administration as a Fellow of the American College of Healthcare Executives (FACHE), the premier certification in health care management. This unique background enables Douglas to provide legal counsel with a practical, pragmatic perspective gained from years of experience as a health care executive and attorney.

Drawing on more than a decade of litigation experience with the U.S. Department of Health and Human Services Office of the General Counsel for the Centers for Medicare & Medicaid Services Division, Mr. Tsui assists healthcare clients seeking to develop comprehensive and durable approaches to the Medicare regulatory environments. His extensive background as lead agency counsel and his track record of success before both administrative and federal courts nationwide provides a unique optic to support the critical legal and business challenges his clients confront. A trusted advocate for healthcare providers and payers alike, Mr. Tsui also assists clients in the medical device, biopharmaceutical, and other emerging healthcare technology industries bring their products to market with confidence.

Mr. Maida counsels healthcare and life sciences clients on government investigations, regulatory compliance and compliance program development. Having served as a government official, he has extensive experience in healthcare fraud and abuse and compliance issues, including the federal and state Anti-Kickback and Stark Laws and Medicare and Medicaid coverage and payment rules. Mr. Maida represents clients in False Claims Act (FCA) qui tam matters, government audits, civil monetary penalty and exclusion investigations, and CMS suspension, and revocation actions, negotiating and implementing corporate integrity agreements, and making government self-disclosures. He also draws on his background in government investigations to assist clients in evaluating, developing and implementing corporate compliance programs. Mr. Maida previously served as deputy chief of the Administrative and Civil Remedies Branch of the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG), where he represented the agency on investigating FCA and civil monetary penalty cases, negotiating and monitoring corporate integrity agreements, and defending exclusion appeals. While serving at HHS, he was a principal author of the OIG’s current Self-Disclosure Protocol.