Michael Lampert provides strategic, regulatory, and transactional advice to clients including health systems, colleges, universities, schools of medicine and academic medical centers, medical device and pharmaceutical companies, investors, physician practices, laboratories, and emerging providers. Recently, Michael has provided critical guidance to clients on a variety of legal and regulatory issues associated with the COVID-19 pandemic, including advising on practices and policies related to COVID-19 in view of public health guidance, and helping clients navigate evolving developments in state and federal guidelines.
Michael has extensive familiarity with fraud and abuse laws, in both an advisory and enforcement context, conflicts of interest standards, and other regulation such as Medicare reimbursement rules, requirements of the LCME and other accreditation bodies, the Food, Drug & Cosmetic Act, and HIPAA. Michael also advises in mergers, acquisitions, restructurings, affiliations, and financings in both the for-profit and nonprofit context. In addition, Michael guides clients in rigorous compliance program assessment and development projects against the backdrop of, and as a component of, investigations arising from allegations of significant noncompliance.
- Academic Medicine – Advised a university in a strategic assessment and redesign of the relationship between its school of medicine and affiliated health system.
- Hospital Operations and Transactions – Provided ongoing regulatory and transactional advice to a multi-state hospital system. Matters include hospital and physician practice acquisitions; ambulatory care management arrangements; development of accountable care organization and other structures for participating in innovative reimbursement models; hospital-physician relationships; internal compliance investigations; and representation in front of federal oversight and enforcement agencies.
- Compliance – Counseled a major Midwestern university in investigation of allegations of research misconduct and grant noncompliance, and assessment of related systems of compliance and oversight.
- Enforcement – Represented medical device manufacturers in investigations involving the Department of Justice, the HHS Office of Inspector General, and other agencies, with allegations involving the Anti-Kickback Statute and the Food, Drug & Cosmetic Act, and resolutions ranging from no-action decisions to formal settlements and negotiation of a Corporate Integrity Agreement.
- Conflicts of Interest – Worked with a teaching hospital in conducting an internal review of its individual and institutional conflicts of interest policies; an assessment of relationships with affiliated spin-off development companies; and development of conflict management plans.
- Incentive Compensation – Advised a hospital in development of a new incentive compensation system for currently employed and newly recruited physicians across varying specialties.
- Privacy – Counseled an emerging, consumer-focused and web-based health informatics provider in structural and operational HIPAA compliance.
- International – Advised an academic medical center in the structuring and development of international teaching and clinical programs across three continents.
- Pro Bono – Assisted a pro bono client in its organization of a charitable health care network in several Latin American countries and at the Vatican.