Michael B. Lampert
Michael Lampert provides strategic, regulatory, and transactional advice to health care clients, including hospitals, universities, schools of medicine, medical device and pharmaceutical companies, investors, physician practices, laboratories, and emerging providers. He has extensive familiarity with fraud and abuse laws, in both an advisory and enforcement context, 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.
- Academic Medicine – Advising a university in a strategic assessment of the relationship between its school of medicine and affiliated health system, and in potential transformative transactions with other schools of medicine in the region.
- Hospital Operations and Transactions – Providing 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.
- Enforcement – Representing 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.
- Incentive Compensation – Advising a hospital in development of a new incentive compensation system for currently employed and newly recruited physicians across varying specialties.
- Conflicts of Interest – Working 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.
- Privacy – Counseling an emerging, consumer-focused and web-based health informatics provider in structural and operational HIPAA compliance.
- International – Advising an academic medical center in the structuring and development of international teaching and clinical programs across three continents.
- Pro Bono – Assisting a pro bono client in its organization of a charitable health care network in several Latin American countries and at the Vatican.
- Co-author, “A Look Inside CMS' New Medicare Shared Savings Program,” Law360 (January 14, 2019)
- Co-author, “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
- 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