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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 December 31, 2019, the Tenth Circuit Court of Appeals upheld the Department of Health & Human Services’ Affordable Care Act (ACA) risk adjustment methodology in New Mexico Health Connections v. HHS, No. 18-2186 (10th Cir. 2019), reversing a federal district court's 2018 decision that certain aspects of the administration and risk management formulas used by the Department of Health & Human Services (HHS) were arbitrary and capricious.  It was a fitting end to a decade so defined by health care and, in particular, legal and political challenges to the ACA.  However, whether or not the decision marks the end of serious challenges to the ACA’s risk adjustment program remains unclear.  
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The Department of Justice (DOJ) recently announced that it has agreed to a $21.36 million settlement with compounding pharmacy Diabetic Care Rx LLC d/b/a Patient Care America (PCA), private equity firm Riordan, Lewis & Haden Inc. (RLH), and two PCA executives to resolve a pending False Claims Act (FCA) case. As discussed in a previous post regarding DOJ's decision to intervene, this case is notable because a private equity firm does not typically find itself subject to FCA action, and it is reported to be the first case against a private equity firm in which DOJ has chosen to intervene.
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CMS Proposes Changes to Medicare Advantage Program for CY 2020

February 6, 2019 | Blog | By Xavier Hardy, Bridgette Keller

CMS recently proposed several important changes for the Medicare Advantage (MA) program that relate to payment, benefit design, and new actions to combat the opioid crisis. Here, we take a look at the proposed changes to risk adjustment payments, supplemental benefits, and a value-based insurance design model; all working toward CMS’s goal of maximizing coverage and competition. In a prior post we discussed CMS’s Part D Payment Modernization Model and stay tuned for our upcoming discussion of CMS’s next steps to combat opioid misuse.
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New Mexico Court Affirms Ruling in ACA Risk Adjustment Case

November 6, 2018 | Blog | By Xavier Hardy

On October 19, 2018, a New Mexico district judge rejected a request from HHS to reconsider a February decision that had briefly led to the suspension of the ACA’s risk adjustment program.  In February, District Judge James Browning ruled that HHS’s use of statewide average premium to calculate risk adjustment payments, and the fact that the program was administered as budget-neutral, were arbitrary and capricious.
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ACA plans scored a major victory last week when a federal court held that health plans participating on the ACA exchanges are entitled to unpaid cost sharing reduction (CSR) payments from the federal government. 
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On Wednesday, August 8, CMS filed a proposed rule clearing the way for the federal government to continue making payments under the ACA’s risk adjustment program for the benefit year 2018. 
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Appeals Court Rejects Insurers Risk Corridors Claims

June 14, 2018 | Blog | By Xavier Hardy

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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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.

Press Release Thumbnail Mintz
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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