Samuel Bernstein

McGuireWoods LLP

Samuel C. Bernstein 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.

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
  • Counseled medical device manufacturer regarding FDA Mandatory Medical Device Reporting Requirements
  • Advised a durable medical equipment supplier regarding compliance with Medicare supplier standards.
  • 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.
  • Represented a private equity firm in providing a $75 million dollar senior secured credit facility to a multistate physician practice.

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

Cost

Rate : $$$$

What types of cases Attorney Samuel Bernstein & McGuireWoods LLP can handle?
McGuireWoods LLP can handle cases related to laws concerning Corporate, Real Estate, Contracts, Health Care, Mergers & Acquisitions, Venture capital. We manually verify each attorney’s practice areas before approving their profiles and reviews on our website.
Where is McGuireWoods LLP located?
McGuireWoods LLP is located at 77 W Wacker Dr #4100, Chicago, IL 60601, USA. You can reach out to McGuireWoods LLP using their phone line 312.849.8222. You can also check their website mcguirewoods.com or email them at [email protected].
How much would it cost to hire McGuireWoods LLP?
Samuel Bernstein lawyer charges are specific to each case. However, they work with contingency fees and its ranges from $$ to $$$. They also provide free consultation [and no obligation quotes] if you are interested to hire.
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McGuireWoods LLP
West Wacker Drive 77
Chicago 60601 IL US
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Broadway 42
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