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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 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

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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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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Trump Administration Releases Series of Executive Orders on Drug Pricing

July 27, 2020 | Blog | By Xavier Hardy, Daryl Berke

The Trump Administration issued a series of Executive Orders (“EOs” or “Orders”) Friday afternoon related to drug pricing.  Several of the EOs seek to restart stalled or withdrawn policy initiatives previously announced by the Administration.  Brief summaries of the EOs are below, and we will provide more detailed analysis this week.
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Today's post is the last in our series on the 10-year anniversary of the Affordable Care Act (ACA). While the Congress that passed the ACA recognized that health care delivery reform was necessary, the law included few mechanisms to address the deeper problems in this area. In this post, we will look at the changes that were made and what may lie ahead. 
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This post is the third installment in our blog series looking back the Affordable Care Act (ACA) and the 10 years since it was passed. We will cover the ACA's market reforms, including the establishment of essential health benefits, as well as risk adjustment and other programs designed to mitigate some of the financial risk that insurance companies would face as a result of a potential influx of individuals with pre-existing conditions into the marketplaces. 
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This post is the second installment in our blog series looking back on the 10-year anniversary of the Affordable Care Act (ACA) and will cover Medicaid expansion under the ACA. Medicaid is joint federal-state program that provides health insurance coverage to people with low incomes.  State participation in the program is voluntary, although all states currently participate.  The program has historically provided states with a significant amount of flexibility and autonomy in how it is administered.  However, in exchange for federal matching funds, states are required to comply with federal Medicaid laws and guidance. 
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This post is the first installment in our blog series looking back on the 10-year anniversary of the Affordable Care Act (ACA).  The most controversial of the ACA's reforms has been the individual mandate, which requires that individuals maintain health care coverage that meets certain standards (known as “minimum essential coverage”) or pay a penalty in the form of a tax.  Even as the law was winding itself through the legislative process, the individual mandate received a fair amount of attention outside the typical industry specific publications that cover the minutia of health care reform.  While  there were some critics of the individual mandate who, even prior to enactment, specifically argued the individual mandate was unconstitutional, most of the coverage dealt with a more basic underlying question: was it appropriate for the government to mandate that everyone pay for health insurance? 
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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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