Michael B. Lampert

Partner

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.

Experience

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.

Presentations

Publications

Co-author, “OIG finds physician-owned medical device innovator not a suspect 'POD',” Westlaw Today (May 24, 2022)

Quoted, “OIG: Some Physician-Owned Distributors May Pose Lower Fraud Risk,” Medtech Insight (May 3, 2022)

Quoted, “OIG clarifies anti-kickback rules for MD inventors with start-up equity” Technology Transfer Tactics (May 2022)

Co-author, “How To Determine Eligibility for HHS Emergency Funds,” Law360 (April 24, 2020)

Co-author, “The New Gov’t Policies Easing Deployment of Health Workers,” Law360 (April 14, 2020)

Co-author, “Should Health Orgs Join CMS' Direct Contracting Program?,” Law360 (February 5, 2020)

Quoted, “DOJ Offers Guidance on Compliance Programs,” Hospital Peer Review (September 1, 2019)

Co-author, “What’s New For CMS Bundled Payments Program,” Law360 (June 3, 2019)

Co-author, “The Return on Investment of Healthcare Compliance,” Bio-IT World (May 15, 2019)

Co-author, “BPCI Advanced: Key considerations for prospective model participants,” Milliman Inc. White Paper (April 9, 2019)

Quoted, “Evolution of Healthcare Industry Poses New and Ongoing Compliance Risks in 2019,” Healthcare Risk Management (March 1, 2019)

Co-author, “HHS is Embracing a Broader Vision of Health Care,” Law360 (February 21, 2019)

Co-author, “A Look Inside CMS' New Medicare Shared Savings Program,” Law360 (January 14, 2019)

Co-author, “INSIGHT: Kickbacks or Common Sense Business? Hurdles for Value-Based Care,” Bloomberg Law’s Health Law and Business (December 10, 2018)

Co-author, “New CMS Rules Reinforce Trend Away From Traditional Care,” Law360 (November 29, 2018)

Quoted, “Shifting Medicare Model Could Set Fraud Traps for Providers,” Bloomberg Law’s Health Law & Business (October 25, 2018)

Co-author, “INSIGHT: Overhauling the Medicare Shared Savings Program for Accountable Care Organizations,” Bloomberg Law’s Health Law & Business (September 11, 2018)

Co-author, “Overhauling the Medicare Shared Savings Program for Accountable Care Organizations,” Bloomberg Law’s Health Law & Business (September 11, 2018)

Co-author, “Medicare Shared Savings Program May Get a Makeover,” Law360 (August 27, 2018)

Co-author, “Agency Guidance Limits May Shift Health Care Enforcement,” Law360 (February 9, 2018)

Co-author, “What To Know About CMS' New Bundled Payment Model,” Law360 (February 5, 2018)

Co-author, “Health Care Mergers and Acquisitions: The Transactional Perspective,” Bloomberg BNA Health Law & Business Series Portfolio 2100 (2nd edition) (2017)

Co-author, “Representing Hospitals and Health Systems Handbook,” American Health Lawyers Association (2016)

Co-author, “Modifying CMS Medicare And Medicaid Incentive Programs,” Law360 (July 2, 2014)

Co-author, “Unknowing company executives held responsible for FDCA violations,” Inside Counsel (August 7, 2013)

Co-author, “OIG's Alert Has Broad Implications With A Hint Of Warning,” Law360 (April 22, 2013)

“Opportunities for U.S. Academic Medical Centers in the Persian Gulf,” American Health Lawyers Association Member Briefing, Doing Business in the Global Healthcare Sector

Nancy Forbes and Michael Lampert, “Business Opportunities in China for the American Healthcare Sector,” American Health Lawyers Association

Presentations

Presenter, “Three CIA Provisions that Will Enhance Your Compliance Program,” HCCA 2019 Compliance Institute (April 7, 2019)

Speaker, “The New AdvaMed Code,” Ropes & Gray Webinar (February 14, 2019)

Presenter, “Alternative Payment Models and Related Regulatory Issues: Stark Law, Anti-Kickback Statute, Gainsharing, PIP, MLR,” Strafford (December 5, 2018)

Presenter, “Considerations for US Healthcare Providers Seeking to Do Business in China,” U.S. Cooperative for International Patient Programs (November 29, 2018)

Moderator, “A Global Reach: Considering International Affiliations,” Consero Healthcare General Counsel Forum (October 29, 2018)

Speaker, “Tips and Tricks for Managing the Unique Elements of Health Care Transactions,” Bloomberg BNA Webinar (October 5, 2016)

Speaker, “Money and Data in Risk-Bearing Provider Networks: Fraud and Abuse, Privacy, and How to Have Your Cake and Eat it Too,” Healthcare Law & Compliance Institute (March 2016)

Michael Lampert, Thomas O’Neill and Wes Porter, “Corporate Integrity Agreements: Lessons Learned from Implementation, for Companies with and without a CIA,” AHLA Fraud and Compliance Forum (September 27, 2015)

Speaker, “Stark Law: Issues with Academic Medical Center and School of Medicine Relationships” University HealthSystem Consortium Legal and Compliance Council Annual Meeting (May 2015)

“Corporate Integrity Agreements: Lessons Learned from Implementation, for Companies with and without a CIA” Michael Lampert and Jeffrey Kahn, “AMCs Go Global: How Can It Happen and What Does It Mean?,” American Health Lawyers Association Program, Legal Issues Affecting Academic Medical Centers and other Teaching Institutions

Panelist, “CLE - Medicare Hot Topics: Payment, Audit, and Enforcement,” Boston Bar Association (September 16, 2014)

Michael Lampert, “Compliance Trends & Strategies: Trends in Enforcement & Resolution,” Medical Device Manufacturers Association Annual Medical Technology Executive Forum

Michael Lampert and Christopher McDermott, “Conflicts of Interest in Research: Issues Presented by the 2010 PHS Proposed Rule,” American Health Lawyers Association Program, Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions