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Health Care

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Areas of Focus

Pillsbury’s Health Law team combines extensive industry knowledge, legal and regulatory experience, and litigation skill to provide comprehensive service to those in the health care sector.

Pillsbury advises health care providers of all types and sizes, including hospitals, health systems and medical groups, as well as enterprises that serve and support them, third-party payors, medical device and pharmaceutical manufacturers, mobile health and technology developers, and data analytics companies. Our health care lawyers possess a keen understanding of the industry and health policy gained from working in hospitals, health care think tanks and government agencies, and from decades representing industry clients. Backed by the resources of a full-service, global law firm, we can meet all of our clients’ needs, providing strategic business advice, transactional counsel, regulatory guidance and litigation support.

From corporate, employment and outsourcing to privacy and security implications of big data to tax guidance and public policy advocacy, Pillsbury’s world-class team of lawyers has the necessary experience and skill in each area impacting our health care industry clients. We are especially known for handling mergers, acquisitions and joint ventures, privacy/data breach, Anti-Kickback and Stark Law-related allegations, and managed care payment matters. With offices throughout the U.S. and in key business centers worldwide, we offer seamless service across offices and disciplines to achieve the best results for our clients, wherever they operate.

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Our work includes advising on and litigating disputes involving:

  • The Affordable Care Act
  • Advertising and consumer protection
  • Fraud and abuse, Anti-Kickback Statute and Stark Law physician self-referrals
  • Antitrust
  • Associations and trade groups
  • Capital finance
  • Corporate issues, including corporate governance
  • Communications/public relations
  • Cybersecurity, privacy, security and data breach
  • Emerging growth
  • Labor, employment, employee benefits, executive compensation and union relations
  • Federal health care program reimbursement
  • Fund formation, investment and lending
  • Government investigations and enforcement defense
  • Government and legislative relations
  • Health care regulation, licensing and credentialing
  • Health system integration
  • Information technology procurement and outsourcing
  • Insolvency and restructuring
  • Insurance coverage and risk management
  • Intellectual property protection, defense and prosecution
  • Internal investigations
  • Joint ventures, mergers, acquisitions and dispositions
  • Managed care contracting and payment
  • Real estate and facility development
  • Tax and tax exemption

Representative Experience

  • Advised health systems, hospitals and health care providers regarding federal health care program fraud-and-abuse legal compliance, disclosures and self-reporting of potential misconduct to DOJ, OIG and CMS.
  • Assisted health systems in HRSA 340B drug discount program compliance reviews, HRSA audits, developing correction plans and implementing manufacturer underpayment settlements.
  • Represented an academic medical center in joint venturing neonatal and pediatric services with five community hospital systems.

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  • Federal Health Care Program Fraud-and-Abuse Compliance, Investigations and Defense
    • Represented a national ancillary services provider regarding qui tam allegations under the False Claims Act and Anti-Kickback Statute related to its contractual arrangements with providers.
    • Represented numerous providers with respect to overpayment considerations when faced with regulatory noncompliance allegations.
    • Represented health systems, hospitals, hospices, and other providers and suppliers in fraud and abuse investigations, including qui tam and federal and state government-initiated civil False Claims Act investigations and prosecutions.
    • Represented a life sciences company and its founder/CEO in criminal and civil investigations into allegations of fraudulent lab testing results, as well as environmental and workplace safety issues.
    • Provided counsel to a pharmaceutical manufacturer in an off-label promotion investigation.
    • Represented a leading respiratory care provider in DOJ FCA action alleging it submitted fraudulent bills, deliberately manipulating and falsifying pulse oximetry tests in order to provide Medicare-covered oxygen to nonqualifying patients.
  • Health Care Regulatory Compliance
    • Counseled numerous health systems, hospitals and health care providers on current and historical financial relationships with referring providers.
    • Offered guidance regarding Medicare provider-based and under-arrangements requirements.
    • Advised health care providers and suppliers regarding development and implementation of compliance programs and provided employee training regarding federal and state regulatory compliance.
    • Provided counsel on federal and state home health regulatory compliance.
    • Assisted in licensing, certification and accreditation compliance for a national behavioral health care provider.
    • Analyzed FDA, FTC, HHS and other implications for mHealth developers.
    • Advised health systems and hospitals on the development and implementation of telehealth and mobile health programs.
  • Privacy and Security
    • Defended academic medical center against various privacy violation claims, including California Confidentiality of Medical Information Act violations. Case involved information disclosure to the patient’s insurer.
    • Represented hospitals, laboratories, physicians’ practice groups and group health plans in data breach reporting and Office for Civil Rights investigations.
    • Advised covered entities and business associates on HIPAA privacy and security compliance, including development and implementation of policies, procedures and compliance programs.
    • Advised multiple employer-sponsored health plans regarding management of a major data breach by health insurer acting as their third-party administrator and legal implications for the employer plans.
    • Defended major hospital in class action lawsuits arising from a hospital vendor’s unauthorized disclosure of patient health information and advised on litigation with a general liability insurer for class action litigation coverage.
    • Successfully prosecuted coverage claims for a national managed care organization under cyber and professional liability insurance policies for data security breach lawsuits. Involved more than a million patients potentially seeking billions in damages.
  • Joint Ventures, Mergers and Acquisitions, Clinical Integrations and Other Business Combinations
    • Represented NTT DATA, Inc. with the acquisition of 100 percent of the membership interests in Cognosante Consulting LLC, a leader in health information technology solutions and services for federal and state health agencies, from Cognosante Holdings LLC.
    • Served as lead counsel in RFP process resulting in successful divestiture of community health system.
    • Represented numerous physician organizations in sale of practices and subsequent professional services arrangements.
    • Served as lead counsel in a regional urgent care center rollup.
    • Provided counsel in a major academic pediatric medical center’s acquisition of 120 pediatric practices.
    • Represented a health plan in $2 billion sale and contract-back of claims administration and beneficiary management functions.
    • Prosecuted highly publicized dispute and sought agreement invalidation for a local hospital district with private hospital corporation regarding hospital lease and purchase option that involved closing emergency room serving thousands of residents.
    • Successfully defended and achieved resolution of a stockholder’s challenge of the merger between IDEC Pharmaceuticals and Biogen.
  • Technology
    • Assisted in the formation of California Joint Replacement Registry.
    • Represented association of Medicare providers in development of member-focused analytics.
    • Served as Connecting for Health’s lead counsel in development of Model Contract Health Information Exchange and for development of California Office of Health Information Integrity’s Model Modular Participants Agreement.
  • Antitrust and Competition
    • Represented a university research center in an unfair competition and patent infringement case involving the infringement of patented technology used to test canine DNA for genetic disorders.
    • Represented a Virginia-based hospital in a challenge by a physician alleging antitrust and other violations related to termination and revocation of hospital privileges.
    • Served as lead counsel defending a large specialty benefit management company against specialty radiology provider’s challenge involving allegations of price fixing, boycott, tying and monopolization under the Sherman Act.
    • Defended a leading radiotherapy company that distributes medical equipment used for cancer treatment in claims brought by an aftermarket service rival (retained two years after the antitrust counterclaims were filed).
    • Represented a leading health care services provider in a lawsuit alleging the defendants disseminated false and misleading advertising and related unlawful conduct in an effort to promote their competing services.
    • Represented a pharmacy benefits manager in consolidated class action proceedings brought by putative class of pharmacies alleging violations of California state statutes and California’s Unfair Competition Law.
    • Represented a national professional society of physicians and a national services company in prosecuting antitrust group boycott and monopolization claims concerning allergy care.
    • Represented North Shore Health System in acquiring Long Island Jewish Medical Center. DOJ challenged the proposed combination. Won the judge’s denial of DOJ’s injunction request. Combination challenge case was dismissed and transaction was finalized.
  • Insolvency & Restructuring
    • Served as debtors’ counsel in bankruptcy of a national acute care hospitals and nursing facilities company.
    • Served as debtors’ counsel in bankruptcy of owner/operator of a clinical laboratories company.
    • Provided restructuring advice to a state facilities finance and construction authority.
    • Advised a nonprofit hospital system regarding restructuring options after its failed sale to for-profit system.
    • Represented Saint Vincent’s Catholic Medical Centers as a reorganized debtor and served as chapter 11 counsel.
    • Represented Daughters of Charity Health System and its local health ministries regarding novel recapitalization program requiring California’s Attorney General approval. Described as largest and most complex nonprofit transaction in California history.
    • Represented Foundation Health Systems in the Delaware chapter 11 bankruptcy cases involving FPA Medical Management Inc. and its 64 affiliates.
  • Payment and Managed Care Contracting
    • Assisted with managed care contracting for providers with Anthem, Aetna, large health insurer, Blue Shield of California, Kaiser Foundation Health Plan, Humana, Cigna and many others.
    • Represented a leading mental health provider in challenging application of Medicare as secondary payor rule.
    • Represented a major academic pediatric medical center in disproportionate share settlement with the state of California.
    • Represented providers in Provider Reimbursement Review Board proceedings.
    • Advised health care providers and suppliers regarding federal, state and commercial payor billing, coding and coverage matters.
    • Represented one of the largest providers of rehabilitation services in litigation filed against 27 health care facilities that have not paid for services rendered by our client.
  • Insurance Coverage Disputes
    • Represented New York University and NYU Langone Medical Center on their more than $1.4 billion property damage and business interruption insurance claims against FM Global arising from Superstorm Sandy.
    • Defended a supplier of respiratory equipment company in a payments-related litigation brought by United Healthcare.
    • Successfully defended numerous health care providers in their response to a national health insurance company seeking over $50 million in recoupment demands. The demands were ultimately dropped in their entirety.
  • Intellectual Property
    • Represented pharmaceutical companies Immunex Corporation and Amgen Inc. in challenging Axel patents regarding co-transformation of mammalian cells to produce proteins of interest.
    • Pursued action for Invitae Corporation to have declared invalid genetic testing patents asserted by Myriad Genetics in a multidistrict litigation in Utah. Following extensive litigation, Myriad abandoned its patents enforcement efforts.
    • Achieved favorable arbitration panel ruling for University of Kansas following years of litigation in a case involving inventorship credit on National Institutes of Health-owned patents covering cancer drug formulations.

Practice Area Highlights

  • Ranked 5th for most active in Pharma & Biotech sector in Pitchbook’s Venture Capital League Tables for Q2 2021.
  • Team members ranked nationally by Chambers USA – Healthcare Transactional and for Healthcare – California; team members and the California Health Care practice are ranked by U.S. News – Best Law Firms; and team members are recognized by their peers in The Legal 500 U.S.
  • Pillsbury lawyers are active members and leaders in industry organizations including the American Health Lawyers Association, Health Care Compliance Association, Health Information Management Systems Society and the American Telemedicine Association.

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  • Ranked 6th for most active in health care devices and supplies in Pitchbook’s Venture Capital League Tables for Q3 2018.

Resources

Brochure

Health Law Practice

Factsheet

Health Care Litigation

Factsheet

Health Care Antitrust & Competition

Factsheet

Technology Contracting in the Health Care Industry

Factsheet

Higher Education and Academic Medical Centers

Factsheet

Health Care Insolvency & Restructuring

Factsheet

Cybersecurity in the Health Care Sector

Factsheet

Intellectual Property in the Health Care Sector

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