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Sam Bernstein

Samuel C. Bernstein Partner

Chicago T +1 312 849 8222 F fax +1 312 698 4571
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Sam focuses his practice on representing life sciences companies and healthcare providers and suppliers, including medical device and pharmaceutical manufacturers, hospitals, physician practices, laboratories, IDTFs, dialysis facilities, and ambulatory surgery centers, regarding a wide range of regulatory, compliance, commercial, transactional, and corporate matters.

Sam regularly provides guidance to medical device and other life sciences companies and other healthcare providers and suppliers regarding compliance and regulatory matters, including establishing and updating compliance programs, addressing the development and use of artificial intelligence, developing compliant sales models and value-based arrangements, addressing marketing, off-label promotion, MDR, and other FDA-regulated matters, complying with the Physician Payments Sunshine Act and similar State laws, negotiating clinical trial agreements and purchase agreements, and addressing compliance and privacy-related matters.

Over the past 15 years, he has helped life sciences companies and healthcare providers and suppliers navigate fraud and abuse issues, including in connection with governmental investigations, and served as a key resource for compliance and legal departments.

Sam also assists healthcare providers and suppliers with compliance, commercial, transactional, and corporate governance matters, including addressing fraud and abuse concerns under anti-kickback laws, the Stark Law, and the False Claims Act, responding to governmental investigations, appealing overpayment determinations with Medicare, Medicaid, and commercial payors, challenging the termination of Medicare billing privileges and other adverse Medicare enrollment decisions, addressing AI, HIPAA, and data privacy issues, negotiating payor, supplier, electronic health record system, and other commercial agreements, and advising on corporate restructuring, transactions, and conflicts matters.

Sam has significant experience in value-based care and frequently assists healthcare providers and suppliers, including IPAs, health systems, ACOs, and physician practices develop, structure, and negotiate compliant value-based care models, including outcomes-based, risk-based, capitated, and other models.

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
  • Assisted medical device company with the development of an AI-based tool, including addressing related privacy issues.
  • Assisted healthcare providers and suppliers with adopting an AI governance framework, including developing policies and procedures and addressing related compliance risks.
  • Successfully resolved Medicare billing privileges deactivations through Administrative Law Judge appeals for multiple providers and suppliers.
  • Advised healthcare providers and suppliers regarding anti-kickback concerns related to joint ventures and pilot programs.
  • Counseled healthcare providers and suppliers regarding physician compensation concerns under the Stark law.
  • Advised medical device manufacturer regarding off-label concerns, including the need to pursue a 510(k) in light of product changes.
  • Assisted a large physician practice with a corporate restructuring and updating their compliance program.
  • 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 and healthcare providers and suppliers.
  • 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.

Events

Insights

  • Named to “Illinois Rising Stars,” Healthcare, Super Lawyers, Thomson Reuters, 2020

Spotlight

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