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Xavier G. Hardy


[email protected]



Xavier’s practice includes a variety of health care regulatory compliance, fraud and abuse, and reimbursement 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.

Xavier 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.

He also routinely advises clients on a wide variety of federal and state health care regulatory issues, including fraud and abuse, licensure and scope of practice rules, telehealth, certificate of need applications, and genetic privacy. He has a particular focus on regulatory and compliance matters for health plans participating in Medicare Advantage, Medicare Part D, and Medicaid Managed Care programs.  He also has experience with accountable care organization compliance and contracting.

On behalf of health care providers, Xavier handles licensure and regulatory filings, particularly in the context of transactions. 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.

Prior to joining Mintz, Xavier was an associate in the Washington, DC office of a national law firm. In that role, he advised clients on legal and regulatory issues around health care reimbursement involving Medicare, Medicaid, and other third-party payors. He also counseled clients on federal and state health care fraud and abuse laws, including the Stark Law and the anti-kickback statute.

While he was 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.


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Court Strikes Down HHS Rule on Copay Accumulators: Implications for Health Plans and PBMs

October 9, 2023 | Blog | By Theresa Carnegie, Xavier Hardy, David Gilboa

In a significant development with far-reaching implications for health plans and pharmacy benefit managers (“PBMs”), Justice John D. Bates of the U.S. District Court for the District of Columbia has recently struck down a federal rule that allowed health plans to use copay accumulator programs to exclude drug manufacturer copay assistance from a patient’s out-of-pocket costs. This ruling has significant implications for the way health plans and PBMs operate and interact with patients and copay assistance programs.
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Mintz IRA Update — Inaugural Edition

September 20, 2023 | Blog | By Theresa Carnegie, Tara E. Dwyer, Mitchell Clough, Xavier Hardy, Stephnie John, Bridgette Keller, Lauren Moldawer, Pat Ouellette, Hassan Shaikh

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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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California Legislative Update Part II: Upcoming Changes for Health Facilities

December 20, 2022 | Blog | By Lara Compton, Xavier Hardy

Governor Gavin Newsom signed 997 bills into law in 2022, including a substantial number relating to health care. In Part II of our legislative update, this blog post summarizes many of the laws relevant to health facilities, a number of which will go into effect January 1, 2023.
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MintzRx Newsletter — Your Prescription for the Pharmaceutical Supply Chain

October 3, 2022 | Article | By Theresa Carnegie, Tara E. Dwyer, Xavier Hardy, Stephnie John, Bridgette Keller, Lauren Moldawer, Pat Ouellette, Hassan Shaikh

MintzRx is a regular newsletter providing you with everything you need to know to stay abreast of the legal, regulatory, and industry developments across the pharmaceutical supply chain.
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On March 17, the same day we wrote about proposed legislation in Connecticut to cap drug price increases, Governor Charlie Baker of Massachusetts included a similar proposal in his proposed budget.  Similar to the Connecticut legislation, the Massachusetts bill (S. 2774) would penalize manufacturers for increasing the price of any medication above its reference price, adjusted for inflation using the Consumer Price Index, plus 2%.  Manufacturers that exceed this threshold would have to pay a penalty equal to 80% of the amount above the excessive price increase threshold – meaning the manufacturer would essentially only collect 20% of the revenue for a drug above the price cap.  Like the Connecticut bill, the reference price is based on a drug’s Wholesale Acquisition Cost (WAC), which is essentially the list price set by manufacturers for a prescription drug before any negotiations or discounting. This article addresses the implications if S.2774 were to become law. 
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Health Law Diagnosed — Transactions Part 2: The Role of Health Regulatory Diligence and How to Prepare for a Sell-Side Transaction

March 24, 2022 | Podcast | By Tara E. Dwyer, Xavier Hardy, Bridgette Keller, Lauren Moldawer, Cassandra Paolillo, Kate Stewart

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On March 15, 2022, a drug pricing bill proposed by Connecticut Governor Ned Lamont’s (S.B. 13) was referred to the state legislature’s nonpartisan legal counsel responsible for drafting and processing official legislation. The proposed legislation, which would cap increases on pharmaceutical drugs to the rate of inflation plus 2%, is notable because it represents a relatively aggressive approach to addressing high drug prices. The legislation would also establish a program to authorize the importation of Canadian pharmaceuticals into the state.
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Health Law Diagnosed — Transactions Part 1: Regulatory Trends in Recent Health Care Transactions

March 3, 2022 | Podcast | By Xavier Hardy, Bridgette Keller, Lauren Moldawer, Cassandra Paolillo, Kate Stewart

2021 was a busy year for Mintz ’s Health Law team, as they helped clients navigate complex health care transactions.
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Continuing our series analyzing the recently proposed Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs rules (Proposed Rule), this post focuses on a few items that are specific to Medicare Advantage (MA) Plans. Here, we discuss CMS’ proposals to (1) require initial and expanded services area applicants to submit their proposed contracted networks during the application process, (2) clarify that beneficiary access requirements during disasters and emergencies apply when there is a “disruption in access to health care,” (3) return to medical loss ratio (MLR) reporting requirements from 2014 – 2017, and (4) an adjustment to how the maximum out-of-pocket (MOOP) limit is calculated for dually-eligible beneficiaries.
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News & Press

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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


  • Member, American Health Lawyers Association
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