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Xavier G. Hardy

Associate

[email protected]

+1.202.434.7314

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Xavier advises clients on complex health care regulatory compliance issues, guiding them through transactions and business arrangements in the health care and life sciences industries. He represents industry stakeholders and investors, helping them navigate regulatory challenges.

He has a particular focus on regulatory and compliance issues related to commercial health plans and managed care.  He regularly advises health plans and other payor-side organizations (including PBMs, other benefit managers, care management organizations, and marketing agencies) participating or involved in Medicare Advantage, Part D, and Medicaid Managed Care on program compliance. He has experience advising clients on regulatory issues related to TRICARE and the Federal Employee Health Benefits Program. He also regularly advises health plans and other payor-side organizations on federal regulatory compliance issues imposed by the Affordable Care Act, the Consolidated Appropriations Act, the Mental Health Parity and Addiction Equity Act, the Inflation Reduction Act, and the Employee Retirement Income Security Act of 1974, and has extensive experience is advising clients on complex issues related to copay accumulators, copay maximizers, and alternative funding programs; utilization management and prior authorization; the 340B program; and risk adjustment and medical loss ratio.  He also has experience with accountable care organization compliance and contracting and has advised risk-based providers and organizations on compliance with state insurance requirements.  

Xavier also provides regulatory counsel to private equity firms and other investors in mergers and acquisitions involving a variety of targets, including health systems and other health care providers, pharmacies, health insurance plans and pharmacy benefit managers, accountable care organizations, laboratories, health care technology companies, and risk adjustment vendors.

On behalf of health care providers and suppliers (including health care facilities and agencies, physician and other provider groups, and veterinary practices), Xavier has extensive experience advising clients on compliance with corporate practice of medicine and fee splitting prohibitions and state and federal licensure and regulatory filing requirements, and reimbursement-related issues. He also routinely advises these and other health care industry clients on legislative and regulatory trends, including on issues such as drug pricing and risk adjustment.

While in law school, Xavier served as an intern in the US Department of Health and Human Services’ Office of Inspector General and Vermont Legal Aid’s Office of the Health Care Advocate. He also worked as a senior research assistant at The George Washington University Milliken Institute School of Public Health, where he contributed to projects around health care regulatory issues.

viewpoints

In early January, Idaho Governor Butch Otter signed an executive order (EO) directing the state’s Department of Insurance (DOI) to “seek creative options” to expand “access” to health insurance coverage for Idahoans.
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The Department of Justice (DOJ) recently intervened in a False Claims Act (FCA) case that raises a variety of interesting allegations, including payment of kickbacks by a compounding pharmacy to contracted marketing companies in the form of percentage-based compensation, to TRICARE beneficiaries in the form of co-payment waivers, and to physicians who submitted prescriptions without seeing patients.
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Mintz’s Antitrust & Federal Regulatory Practice recently published a Health Care Antitrust Alert on the DOJ Antitrust Division’s announced settlement with Henry Ford Allegiance Health (“Allegiance”).
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News & Press

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MMIT quoted a recent article written by Mintz attorneys Theresa Carnegie, Xavier Hardy, and David Gilboa in a story discussing the US district court ruling that overturned a federal rule allowing health plans to exclude copayment assistance from members’ out-of-pocket costs. The article notes the Department of Health and Human Services’ current stance of refraining from immediate action.

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Mintz served as health regulatory legal advisor to Kindred Healthcare in the recently completed sale of Kindred Healthcare to LifePoint Health, a national network of hospitals, post-acute service providers, and outpatient centers. As a result of the successful transaction, ScionHealth, a new healthcare system focused on high-quality acute and post-acute hospital solutions, was launched on December 23rd.
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Mintz Member Thomas Crane and Associate Xavier Hardy co-authored a Bloomberg Law Insights article discussing the COVID-19 pandemic’s impact on the Affordable Care Act (ACA), specifically the staggering unemployment numbers’ emphasis on the ACA’s measures to increase coverage.
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Mintz is advising a consortium of investors led by TPG Capital and Welsh, Carson, Anderson & Stowe in their acquisition of Curo Health Services, one of the nation’s leading hospice providers. The definitive agreement was announced on April 23, 2018. The deal is valued at approximately $1.4 billion.
Xavier Hardy, an Associate in Mintz's Health Law practice, authored this American Bar Association Antitrust Health Care Chronicle article on what impact the Affordable Care Act may have on monopsony analyses in health insurance mergers reviews.
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podcasts

Health Law Diagnosed – New Year's Gratitude

February 3, 2025 | Podcast | By Bridgette Keller, Alison H. Peters, Samantha Kingsbury, Theresa Carnegie, Joanne Hawana, Abdie Santiago, Stephnie John, Pamela Polevoy, Karen Lovitch, Jean D. Mancheno, Deborah Daccord, Rachel A. Alexander, Jane Haviland, David Gilboa, Kathryn Edgerton, Hassan Shaikh, Madison Castle, Laurence Freedman, Priyanka Amirneni, Samantha Hawkins, Tara E. Dwyer, Rachel Yount, Sophia Temis, Xavier Hardy

Host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead. Hear from a dynamic group of Members, Of Counsel, and Associates as they share their perspectives on what’s coming up over the horizon.

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As the Mintz Health Law team welcomes the beginning of 2024, many of its members take a moment to reflect on the exciting growth of the Health Law Practice, opportunities to partner with clients on complex legal issues, and the celebration of numerous milestones.

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Mintz Health Law: What We Are Grateful For

January 11, 2023 | Podcast | By Bridgette Keller

Bridgette Keller speaks with the Mintz Health Law team about what they are grateful for as they look back on a year of client service, mentorship, and working together as a team.

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Events & Speaking

Involvement

  • Member, American Health Lawyers Association
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