Serra J. Schlanger
Serra Schlanger assists clients with FDA regulatory strategy, compliance matters, and enforcement issues. She advises clients on compliance with rules and regulations governing product advertising and promotion, corporate compliance matters, preparing regulatory submissions, and drafting regulatory policies and procedures. Ms. Schlanger counsels clients in the areas of federal and state health care fraud and abuse matters and defends clients in connection with government investigations, audits, qui tam actions, and other enforcement inquiries. She helps clients with contract matters and regulatory due diligence related to corporate transactional matters. Ms. Schlanger also advises clients on legal and regulatory issues associated with state licensure and CLIA certification.
Prior to joining the firm, Ms. Schlanger practiced in the health care and life sciences practice of a national law firm, where she provided regulatory and compliance counseling to a wide variety of health care providers, defended clients in government investigations, and advised clients on issues related to the Medicare and Medicaid programs.
Before beginning her legal career, Ms. Schlanger worked in clinical administration at Memorial Sloan-Kettering Cancer Center in New York City as a liaison between physicians, patients, researchers, and administrators.
Ms. Schlanger was a Leadership Scholar at the University of Maryland School of Law and graduated cum laude with a certification in Health Care Law. While attending law school, she was the Executive Editor of the Journal of Health Care Law & Policy and a member of the National Health Law Moot Court Team. As a law student, Ms. Schlanger interned at the U.S. Department of Health and Human Services, Office of the General Counsel, Public Health Division and the Office of the General Counsel at the University of Maryland Medical System.
American Bar Association
American Health Lawyers Association
Articles / Publications
• The Regulatory Landscape for Hospice and Home Health Providers Continues to Change,
January , 2015
• Hospitals’ Heavy Lifting: Understanding OSHA’s New Hospital Worker and Patient Safety Guidance,
May 1, 2014
• Putting Together the Pieces: Recent Proposals to Fill in the Genetic Testing Regulatory Puzzle,
• Filling in the Cracks: Improving the Regulation of Direct-to-Consumer Genetic Tests,
April 18, 2011
• HCCA 20th Annual Compliance Institute, Top Five Hospice Risk Areas: What You Need to Know and Do Now, April 18, 2016
• 2015 NAHC Annual Meeting, How to Mitigate Risk – Enforcement Trends in Home Health and Hospice, October 30, 2015
see more blog entries
• OIG Issues an Advisory Opinion on Providing Replacement Product,
August 28, 2017
• 21st Century Cures Act: Three Notable Health Care Provisions and a Reminder to Sign Up for HP&M’s Two Complimentary Webinars,
January 5, 2017
• HHS OIG’s Latest Work Plan: What to Look Out for in FY2017,
November 22, 2016
• DOJ Weighs in on Discount Safe Harbor,
October 13, 2016
• Another Blow to the Discount Safe Harbor in Massachusetts District Court,
September 29, 2016