Kristen PollockMcDonald

Partner

Atlanta + 1.404.581.8498

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Kristen McDonald defends providers in False Claims Act litigation brought by federal and state agencies and qui tam whistleblowers. Her civil fraud experience involves billing, coding, medical necessity, eligibility, physician compensation, and potential liability under the Stark Law and Anti-Kickback Statute. Kristen defends providers in government extrapolated audits, and she conducts internal investigations including assistance with repayments and self-disclosures. Additionally, she conducts internal investigations associated with HIPAA/HITECH concerns and defends providers in OCR (Office of Civil Rights) investigations. Kristen also represents organ transplant programs under review by the Organ Procurement & Transplantation Network (OPTN) and its Membership & Professional Standards Committee (MPSC).

In addition, she has extensive experience conducting health care due diligence reviews for mergers, acquisitions, investments, and banking matters, focusing on fraud and abuse and other regulatory and compliance concerns. Kristen routinely advises health care and life science companies and related investors on fraud and abuse analyses, telemedicine services and reimbursement, HCP (health care professionals) arrangements, conditions of payment, and compliance program effectiveness reviews.

Kristen has represented hospitals/health systems; hospice, home health, skilled nursing, and other post-acute care providers; life science companies including pharmaceutical, medical device, and biologics manufacturers and distributors; telehealth companies; AI companies; diagnostic imaging; ambulance suppliers; DME (durable medical equipment) suppliers; financial institutions; and private equity investors.

Kristen is a member of the American Health Law Association and served as chair of AHLA's Health Care Liability and Litigation Practice Group.

Kristen has written and spoken extensively on health care issues, including telemedicine, cybersecurity, program integrity audits, government recoveries, risks in post-acute care, and strategies for diligence.

Experience

  • Reneo Pharmaceuticals announces reverse merger with OnKureJones Day represented Reneo Pharmaceuticals, Inc. (NASDAQ: RPHM) in an all-stock reverse merger between Reneo and OnKure, Inc., a privately-held, clinical-stage biopharmaceutical company valued at $170 million that is focused on the development of novel precision medicines in oncology.
  • Accelmed Partners acquires Bioventus Advanced Rehabilitation businessJones Day is advising Accelmed Partners in its acquisition of Bioventus Inc.'s Advanced Rehabilitation business.
  • Guardian Pharmacy Services completes $128.8 million IPO and pre-IPO corporate reorganizationJones Day represented Guardian Pharmacy Services, Inc., a leading long-term care pharmacy services company, in connection with its $128.8 million initial public offering (“IPO”) and pre-IPO corporate reorganization.
  • STERIS sells dental segment to an affiliate of Peak Rock CapitalJones Day advised STERIS Plc in the $787.5 million sale of Dental segment to Peak Rock Capital, a leading middle-market private investment firm.
  • Swander Pace Capital sells Functional Formularies to DanoneJones Day advised Swander Pace Capital in the sale of Functional Formularies, a leading provider of organic, whole food, shelf-stable feeding tube formulas, to Danone.
  • Leading financial services company provides incremental syndicated senior secured credit facilities to finance merger of two national hospice companiesJones Day represented a leading financial services company, as left lead arranger and administrative agent, in connection with an incremental syndicated senior secured credit facilities to finance the merger of two national hospice companies.
  • MEDHOST sells company to N. Harris Computer CorporationJones Day advised MEDHOST, Inc., a leading electronic health record solution provider, in its sale of the company to N. Harris Computer Corporation, a wholly-owned subsidiary of Constellation Software, Inc.
  • Leading financial services company provides $600 million syndicated senior secured credit facility to national skilled nursing facilities companyJones Day represented a leading financial services company, as left lead arranger and administrative agent, in connection with a $600 million syndicated senior secured revolving credit facility provided to a national skilled nursing facilities company.
  • Leading financial services company provides $380 million syndicated senior secured credit facility to global supplier of technologies for security, healthcare, and other industrial end-marketsJones Day represented a leading financial services company, as left lead arranger and administrative agent, in connection with a $380 million syndicated senior secured credit facility, consisting of a $340 million term loan and a $40 million revolving credit facility, provided to a leading global supplier of advanced imaging, power, and motion control technologies for security, healthcare, and other industrial end-markets.
  • restor3d acquires Conformis, Inc.Jones Day advised restor3d, Inc., a leading personalized 3D-printed orthopedic company, on its acquisition of Conformis, Inc. (NASDAQ: CFMS), a leading medical technology company focused on orthopedic patient care.
  • Norwest Equity Partners acquires Nationwide Organ Recovery Transport Alliance, LLCJones Day represented Norwest Equity Partners on its acquisition and financing of Nationwide Organ Recovery Transport Alliance, LLC, a provider of air and ground organ recovery transportation services.
  • ONCAP sells medical division to BiomericsJones Day advised ONCAP in the sale by portfolio company Precision Concepts International of its medical division to Biomerics, a portfolio company of Wasatch Equity Partners.
  • Astellas acquires Iveric bioJones Day advised Astellas Pharma Inc. in the $5.9 billion cash acquisition of Iveric bio, Inc., a science-driven biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs.
  • Cardinal Health merges its Outcomes™ business into Transaction Data SystemsJones Day advised Cardinal Health, Inc. (NYSE: CAH) in connection with the combination of its Outcomes™ business to Transaction Data Systems, a portfolio company of BlackRock Long Term Private Capital and GTCR, in exchange for a minority stake in the combined entity.
  • Leading financial services company provides $425 million syndicated senior secured credit facility to healthcare companyJones Day represented a leading financial services company, as left lead arranger and administrative agent, in connection with a $425 million syndicated senior secured credit facility, consisting of a $275 million term loan and a $150 million revolving credit facility, provided to a healthcare company.
  • Organon makes strategic investment in Claria MedicalJones Day advised Organon in the strategic investment in Claria Medical, Inc. a privately-held company developing an investigational medical device being studied for use during minimally invasive laparoscopic hysterectomy.
  • Riverside portfolio company acquires Jupiter Life Science Consulting (Jupiter)Jones Day advised The Riverside Company in connection with the acquisition and financing by portfolio company Red Nucleus of Jupiter Life Science Consulting (Jupiter), a leading provider of commercial and market access strategies for global pharma, biotech, and medical device companies with its primary focus in rare disease, hematology/oncology, metabolic, and neurology therapeutic areas.
  • Riverside portfolio company acquires RockpointeJones Day represented The Riverside Company in connection with the acquisition by portfolio company Clinical Education Alliance (CEA) of Rockpointe, Inc., a premier healthcare education company providing accredited continuing education activities and related training for healthcare professionals.
  • Cardinal Health acquires the Bendcare CPO-GPO entity and makes a minority investment in the Bendcare MSOJones Day advised Cardinal Health, Inc. in the acquisition of the Bendcare group purchasing organization (CPO-GPO) entity and a minority investment in the Bendcare management services organization (MSO).
  • City of Hope acquires Cancer Treatment Centers of AmericaJones Day advised City of Hope, a world-renowned, National Cancer Institute (NCI)-designated comprehensive cancer research and treatment organization, in connection with its acquisition of Cancer Treatment Centers of America, a network of oncology hospitals and outpatient care centers across the United States.
    • View All

    NOVEMBER 2024 Alert

    New York Imposes Stringent Cybersecurity and Cyber Incident Reporting Obligations on Hospitals

    August 2024 Commentary

    Eighth Circuit Holds Penalties in Non-Intervened FCA Case Violate Excessive Fines Clause

    July 2024 Alert

    U.S. District Court Invalidates HHS Guidance Overreading HIPAA's Application to Online Technologies

    July 2024 Alert

    FTC's Final Health Breach Notification Rule: Expanded Scope, New Obligations, and Modified Reporting Requirements

    June 2024 White Paper

    2023 False Claims Act Enforcement in Health Care and Life Sciences, Part III

    April 2024 White Paper

    2023 False Claims Act Enforcement in Health Care and Life Sciences, Part II

    April 2024 Commentary

    Second Circuit Reinforces Anti-Kickback Statute's Demanding Willfulness Standard

    APRIL 2024 Alert

    New State Health Privacy Laws—Moving Beyond HIPAA and Recasting Consumer Health Data Rights?

    March 2024 White Paper

    2023 False Claims Act Enforcement in Health Care and Life Sciences, Part I

    FEBRUARY 2024 Alert

    DOJ Announces Record-Breaking Year for False Claims Act Settlements and Judgments
    View All

    Additional Publications

    • October 20, 2015
      AseraCare Update: Jury Finds Majority of Sampled Claims False, AseraCare Seeks JMOL Following Phase One of Bifurcated Trial, American Health Lawyers Association Practice Group, Email Alert
    • August 28, 2015
      Fifth Circuit Requires Pharmacies to Arbitrate Claims Against Non-Signatories to Arbitration Agreement, American Health Lawyers Association Practice Group Email Alert
    • December 27, 2013
      Another Record Year for Government Recoveries under the False Claims Act, American Health Lawyers Association Practice Group, Email Alert
    • October 2013
      What Hospitals Need to Know About ZPIC Audits, Healthcare Financial Management Association
    • November 2012
      What do you do when a ZPIC comes knocking? Compliance Today, Health Care Compliance Association
    • August 29, 2012
      Beware of the Minefield - The New Survey and Enforcement Landscape for Home Health Agencies, The American Health Lawyers Association's Healthcare Liability and Litigation Health Briefs
    • February 1, 2012
      The Various Weapons in the ZPIC Arsenal, The American Health Lawyers Association's LTC-SIR Advisor
    • December 22, 2011
      Why the Anti-Kickback Statute May Be the Tip of the Iceberg When It Comes to Questionable Vendor Arrangements, The American Health Lawyers Association's LTC-SIR Advisor
    • May 2011
      Nursing Homes May Find Some Solace Amid the Storm of New Regulations Governing the Assessment of CMPs, American Health Lawyers Association's Healthcare Liability and Litigation Practice Group, May 2011 Health Briefs e-Newsletter
    • June 21, 2010
      Has a Trap Been Set? - What Risks Lie Ahead for Nursing Homes Compelled to Disclose Organizational Information under the Patient Protection and Affordable Care Act, American Health Lawyers Association's Healthcare Liability & Litigation Health Briefs
    • February 17, 2010
      New Guidance on the Indicia of Reliability Standard: What Now Faces Potential Relators in False Claims Act Litigation, American Health Lawyers Association's Healthcare Liability & Litigation Health Briefs

    Additional Speaking Engagements

    • April 21, 2020
      Part 2: Opportunities and Risks for Telehealth under HIPAA and State Privacy Responses to the COVID-19 Pandemic,” American Telemedicine Association , COVID-19 Response Webinar Series
    • April 14, 2020
      Part 1: Opportunities and Risks for Telehealth under HIPAA and State Privacy Responses to the COVID-19 Pandemic,” American Telemedicine Association , COVID-19 Response Webinar Series
    • April 15, 2019
      The Evolving Landscape of Telehealth: Politics, Policy, Operations and Oversight, American Telemedicine Association
    • February 24, 2015
      Long Term Care and the Law: Why Long Term Care Providers are Finding New Uses for ADR: Best Practices for an Evolving Landscape, American Health Lawyers Association
    • February 19, 2015
      Due Diligence Reviews in Healthcare Transactions, Jones Day's CLE Academy
    • December 17, 2013
      Advocating Effectively in Health Care Arbitrations, American Health Lawyers Association
    • November 2011
      Beware of the ZPIC - Tips and Tactics from the Trenches, American Health Lawyers Association
    • Fall 2009
      Federal and state efforts to improve patient safety and reduce medical errors, Patient Safety and Never Events

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