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Samuel C. Bernstein Partner

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Chicago T +1 312 849 8222 F fax +1 312 698 4571
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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.

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