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 healthcare regulatory compliance, general corporate representation of healthcare providers and suppliers, contract negotiation, and transactional matters. The mainstay of his practice is providing guidance to medical device companies regarding FDA approval pathways, fraud and abuse issues, off-label promotion, adverse event reporting, negotiating clinical trial agreements, negotiating and structuring discount and rebate agreements, developing and implementing compliance programs, and other regulatory and compliance matters.  His experience includes developing and negotiating royalty and consulting arrangements, addressing intellectual property issues, and handling a variety of commercial matters for device companies.

Sam also represents a wide range of healthcare providers and suppliers in regulatory matters relating to 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 healthcare providers and suppliers in responding to government investigations, addressing compliance concerns, and responding to and appealing prepayment and post-payment audits by government contractors and commercial payors.

In addition, 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.

Sam also 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 industry conferences and corporate seminars.

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

Advised medical device manufacturer regarding off-label concerns, including the need to pursue a 510(k) in light of alleged safety and efficacy issues

Advised digital health company regarding FDA device exemptions under the 21st Century Cures Act

Negotiated industry-sponsored and investigator-initiated trial agreements for device companies

Assisted pharmaceutical company with obtaining HCPCS code for a drug

Counseled medical device manufacturer regarding FDA Mandatory Medical Device Reporting Requirements

Developed code of conduct and compliance policies for mid-size medical device manufacturer

Negotiated royalty and consulting agreements for a medical device manufacturer

Developed discount and rebate programs for medical device manufacturers

Provided compliance advice regarding outcomes-based (and value-added) sales models

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

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

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
Speaker, "Legal Perspectives," 3rd Annual Life Science Compliance Training Conference, Q1 Productions, June 6-7, 2018
Moderator, "Current Fraud and Abuse Enforcement Issues," 16th Annual Business and Legal Issues in Dialysis and Nephrology Symposium, May 17, 2018
Moderator, "Issues & Trends in Medical Device and Life Sciences Investments," 15th Annual Healthcare and Life Sciences Private Equity and Finance Conference, February 22, 2018
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