Samuel C. Bernstein Partner

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.

Experience

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

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

Member, American Health Lawyers Association, 2011-present

  • Illinois
Back to top