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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

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States and manufacturers clash over 340B contract pharmacy laws as litigation mounts and courts weigh in on the future of pharmacy access protections.

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Senate HELP Committee releases 340B report urging transparency, oversight, and reforms amid uncertainty over future federal legislative action.

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Federal courts continue to uphold the Medicare Drug Price Negotiation Program, with multiple rulings emphasizing the voluntary nature of manufacturer participation. Key legal challenges from AstraZeneca, Boehringer Ingelheim, PhRMA, and others face setbacks as the government remains undefeated.

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HRSA launches 340B rebate pilot tied to Medicare drug negotiations, signaling major program shifts amid legal rulings and stakeholder concerns.

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President Trump issues executive orders and letters to curb drug costs, promote MFN pricing, and reform Medicare’s Negotiation Program.

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CMS proposes OPPS payment cuts and a drug cost survey, signaling major 340B reimbursement shifts and renewed scrutiny of hospital payment rates.

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The PBM Policy and Legislative Update — Spring 2025 edition builds upon prior issues and summarizes activity from January through March (2025) that affects the PBM industry. It highlights federal activities, state activities, and other noteworthy events and trends affecting the PBM industry.

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A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the IRA’s Drug Negotiation Program.

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On April 15, 2025, President Trump issued an Executive Order instructing federal agencies to implement a variety of drug pricing reforms. The Executive Order addresses drug pricing from several different angles, including pharmacy benefit manager (“PBM”) competition and transparency, Medicare and Medicaid drug pricing, international importation, and drug manufacturer competition (the “Executive Order”).

The Executive Order, which is the first significant action taken by the current Administration to address drug prices, echoes initiatives and policy statements announced during the first Trump Administration. However, most of the drug pricing reforms announced during the first Administration were never fully implemented. It is unclear how many of the proposals in this Executive Order will ultimately be implemented, but it does provide the clearest outline yet of the Administration’s policy priorities regarding drug prices.

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Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its 2025 Marketplace Integrity and Affordability Proposed Rule (Proposed Rule), proposing a number of enrollment and eligibility policies impacting both Federal and State Exchanges. While CMS frames these policies as necessary to combat fraud and abuse, the impact will be a reduction in enrollment in the ACA Marketplace – with the Proposed Rule estimating that between 750,000 and 2 million fewer individuals enroll in health insurance plans on the Exchanges in 2026. 

This blog outlines the major provisions of the Proposed Rule, followed by a discussion of their potential impact on plans participating in the ACA Marketplace.

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News & Press

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173 Mintz attorneys across 53 practice areas have been recognized by Best Lawyers® in the 2026 edition of The Best Lawyers in America©. Five Mintz attorneys received 2026 “Lawyer of the Year” awards, and 61 firm attorneys were included in the 2026 edition of Best Lawyers: Ones to Watch.

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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

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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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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Health regulatory diligence has the ability to make or break a deal. Listen to hear about our team’s firsthand experience in the importance of conducting health regulatory diligence and best practices in preparing for a sell-side transaction.

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2021 was a busy year for Mintz ’s Health Law team, as they helped clients navigate complex health care transactions.
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Events & Speaking

Recognition & Awards

  • Best Lawyers in America: Ones to Watch - Health Care Law (2026)

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Involvement

  • Member, American Health Lawyers Association
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