Samuel C. Bernstein

Associate

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Practices
Industries
Education
  • University of Illinois College of Law, JD, magna cum laude, Order of the Coif, 2008
  • University of Illinois at Urbana-Champaign, BS Physics, 2001
Admissions
  • Illinois
Affiliations

Member, American Health Lawyers Association, 2011-present

Sam focuses his practice on counseling healthcare and life sciences companies regarding regulatory, compliance, and corporate matters. The mainstay of his practice is providing guidance to clients regarding fraud and abuse laws, including anti-kickback laws, the Stark Law, Medicare coverage and reimbursement rules, and state healthcare laws and regulations. He regularly assists life sciences companies, healthcare providers, clinical laboratories, and other healthcare service providers in developing and implementing compliance programs, addressing regulatory issues, and responding to government investigations. He also frequently represents providers and suppliers in prepayment and post-payment audits by government contractors and commercial payors.

Sam regularly represents medical device companies in matters relating to sales and marketing compliance, healthcare provider relationships, overcoming impediments to market adoption, and various commercial matters. His experience includes facilitating the adoption of compliant discount and rebate sales models, developing and negotiating royalty and consulting arrangements, addressing intellectual property issues, counseling companies regarding FDA approval pathways, and negotiating clinical trial agreements.

Sam routinely provides guidance to laboratories on matters such as sales and marketing regulatory compliance, order documentation requirements, reference laboratory issues, and fraud and abuse compliance. Sam also frequently advises laboratories regarding joint ventures and other affiliations with healthcare providers.

In addition, Sam regularly provides regulatory advice regarding and manages transactional matters, including public and private offerings, mergers and acquisitions, and joint ventures. Sam formerly held Series 6, 63, and 26 securities licenses, was an Illinois licensed insurance producer and mortgage broker, and is an Illinois licensed real estate broker.

Sam is also a regular speaker at corporate seminars and industry conferences.

Samuel C Bernstein
vCard
T: +1 312 849 8222F: +1 312 698 457177 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

Negotiated royalty and consulting agreements for a medical device manufacturer

Developed discount and rebate programs for a medical device manufacturer

Resolved multi-million dollar commercial overpayment dispute for a laboratory

Conducted comprehensive compliance review of a clinical laboratory

Conducted comprehensive compliance reviews of dialysis chain providers

Advised a durable medical equipment supplier regarding compliance with Medicare supplier standards

Completed private placement for an early-stage medical device manufacturer

Advised specialty hospital chain regarding fraud and abuse compliance

Counseled providers and suppliers regarding satisfying Medicare conditions of payment, conditions of participation, conditions of coverage, and enrollment requirements

Represented physicians and other licensed professionals regarding complying with advertising and professional conduct restrictions

Facilitated $487 million dollar public offering for an insurance company

Represented a multistate physician practice in its $61.1 million dollar sale to a private equity firm

Represented a private equity firm in providing a $75 million dollar senior secured credit facility to a multistate physician practice

Represented a private equity firm in a $2.5 million dollar investment in a dental practice

Represented multiple nephrology practices in establishing dialysis facility joint ventures

Developed and negotiated residency affiliation agreements for a medical school with training sites and hospitals

Co-author, "Navigating the Newly Adopted Local Transportation Safe Harbor to the Federal Anti-Kickback Statute," Bender's Health Care Law Monthly, Vol. 2017; No. 5, May 2017
Co-author, "Key Legal Issues for Nephrology Practices: Structure and Governance," Renal Physicians Association News, May 2014
Co-Host and Moderator, "HCP Relationships and Current Enforcement Issues," 9th Annual Pharmaceutical and Medical Device Conference, November 16, 2017
Moderator, "Current Fraud and Abuse Enforcement Issues Faced by Providers," 15th Annual Business and Legal Issues in Dialysis and Nephrology Symposium, May 18, 2017
Moderator, "HCP Relationships and Current Enforcement Issues," 8th Annual Pharmaceutical and Medical Device Conference, November 10, 2016
Moderator, "Staying Ahead of the Government: Self-Regulation Strategies for Ensuring Fraud and Abuse Compliance," 14th Annual Business and Legal Issues in Dialysis and Nephrology Symposium, May 19, 2016
Panelist, "Uncovering Anti-Kickback Pitfalls in Your Medical Device Contracts, Training and Education in a Changing Regulatory and Enforcement Climate," American Conference Institute's 16th Advanced Forum on Fraud and Abuse in the Sales & Marketing of Medical Devices, American Conference Institute, March 8, 2016
Moderator, "Executive Roundtable - Medical Device Industry Update," 7th Annual Medical Device and Life Sciences Conference, November 19, 2015
Speaker, "Operating Profitably in a Climate of Scrutiny: Why Compliance is Good Business and How to Achieve it," 13th Annual Business and Legal Issues in Dialysis and Nephrology Symposium, April 14, 2015
Moderator, "HCP Relationships, Open Payments and Current Enforcement Issues," 6th Annual Medical Device and Life Sciences Conference, November 18, 2014
Speaker, "Structuring Your Medical Practice for Tomorrow While Effectively Addressing Today's Issues," 12th Annual Business and Legal Issues in Dialysis and Nephrology Symposium, May 15, 2014