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Xavier G. Hardy

Associate

[email protected]

+1.202.434.7314

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Xavier’s practice includes a variety of health care regulatory compliance issues in health care transactions and business arrangements. He represents clients that are involved in, or invest in, the health care and life sciences industries.

He has a particular focus on regulatory and compliance issues related to the Affordable Care Act and federal health care programs such as Medicare, Medicaid, and TRICARE.  He regularly advises health plans and other payor-side organizations participating in Medicare Advantage, Part D, and Medicaid Managed Care, and often advises health plans and related organizations 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 (including health care facilities and agencies, physician 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. 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

On Thursday June 14, 2018, the US Court of Appeals for the Federal Circuit ruled against two health plans seeking risk corridors payments from the federal government. Inside contains more detailed information on the program.
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Many provisions of the Affordable Care Act (“ACA”) have been the subject of litigation over the last decade, with several high-profile Supreme Court cases including: NFIB v. Sebelius, King v. Burwell, and Burwell v. Hobby Lobby. One of the more overlooked topics of litigation has been the ACA’s “Risk Corridors” program.
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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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Events & Speaking

Involvement

  • Member, American Health Lawyers Association
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