Overview
Jeff Weinstein helps life sciences and healthcare clients navigate complex regulatory landscapes, achieve best practice compliance, manage investigations and respond to government enforcement. His preventive law mindset enables him to help clients steer clear of legal minefields and find the enterprise-transforming opportunities that the dynamic and ever-changing operating environment can offer legally astute managers.
Specifically, Jeff advises manufacturers and distributors of Food and Drug Administration (FDA)-regulated products on achieving market access, overcoming competitive challenges and reducing enforcement risk at every stage of the product life cycle. He has extensive background in counseling medical device, pharmaceutical and biologics manufacturers, software and equipment vendors, and physician practice management (PPM) companies on regulatory due diligence in transactions and representing them in contract negotiation.
He also advises on the legal risks that federal, state and local laws, regulations, licensing, coverage and payor requirements present for life sciences and healthcare operations. Beyond counseling his clients to uphold government and industry standards, Jeff advises them on using law as a source of strategic advantage to achieve their commercial goals and organizational missions.
Jeff’s practice is informed by more than a decade of distinguished service at the US Department of Health and Human Services Office of Inspector General (HHS-OIG), the lead agency responsible for policing fraud, waste and abuse in federal healthcare programs. At HHS-OIG, Jeff interpreted and helped implement sections of the Affordable Care Act and the Medicare Access and CHIP Reauthorization Act of 2015. He also worked on other important laws and policies and drafted official guidance that continues to affect life sciences and healthcare enterprises. Prior to joining McDermott, Jeff also spent years in private practice representing life sciences and healthcare clients at other firms.
Jeff has published extensively on life sciences and healthcare regulatory issues and is a volunteer and mentor at the American Health Law Association.
Results
- Performed regulatory due diligence and developed healthcare contracts for practice acquisitions by multistate specialty PPMs*
- Audited leading regenerative medicine wound care manufacturer sales operations and contracting processes for safeguards under the Anti-Kickback Statute and other federal fraud and abuse law*
- Negotiated contracts with major US academic medical centers on behalf of pioneering blood and platelet supply vendor*
- Audited physician training programs and other provider interactions at innovative manufacturer of medical devices for stroke treatment*
- Advised medical and consumer product manufacturers on whether product recalls or regulatory notifications were warranted based on product performance in the field*
- Advised leading nonprofit in regulatory matters relating to an experimental psychotherapeutic drug product application*
- Drafted HHS-OIG advisory opinions, preambles and other guidance documents implementing and explaining federal healthcare fraud and abuse laws*
*matter handled prior to joining McDermott
Recognitions
- OIG-HHS, Inspector General’s Award for Advancing Excellence and Innovation, 2016; Inspector General’s Exceptional Achievement Award, 2016; Inspector General’s Cooperative Achievement Award, 2011
- Council of the Inspectors General for Integrity and Efficiency Award for Excellence, 2011
Community
- American Health Law Association, Member
Credentials
Education
University of Michigan Law School, JD, 1993
Massachusetts Institute of Technology, MS, 1990
Williams College, BA, 1987
Admissions
District of Columbia
