Skip to main content

Xavier G. Hardy

Associate

[email protected]

+1.202.434.7314

Share:

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

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. 
Read more
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? 
Read more
Two weeks ago marked the tenth anniversary of the enactment of the Affordable Care Act (ACA).  Given the ongoing COVID-19 pandemic, which Mintz has been closely monitoring, it is understandable why the anniversary has largely flown under the radar.  However, now is as good a time as any to reflect on all the controversy that has surrounded the law over the last decade, as well as how much the law has accomplished. While far from comprehensive, our upcoming blog series will review some of the impacts the law has had on the U.S. healthcare system, in particular focusing on the legal issues and debates that have surrounded the law.  Mintz has previously covered many of these items, and links to our prior coverage is included throughout.
Read more
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.  
Read more
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.
Read more
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.
Read more
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.
Read more
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. 
Read more
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. 
Read more
Read less

News & Press

News Thumbnail
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 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.
News Thumbnail
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.
Press Release Thumbnail
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.
Read less

Events & Speaking

Involvement

  • Member, American Health Lawyers Association
Read less