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
PBM Policy and Legislative Update — Fall 2024
November 22, 2024| Blog|
Unpacking Johnson & Johnson’s Lawsuit Over 340B Rebate Model
November 19, 2024| Blog|
CMS 2026 IRA Price Negotiations Results Likely to Create Upstream and Downstream Effects
August 20, 2024| Blog|
PBM Policy and Legislative Update — Summer 2024
July 31, 2024| Blog|
Mintz IRA Update — Third Edition: Q2 2024
July 15, 2024| Blog|
The Uncertain Landscape of Medicare Agent/Broker Compensation Rules
July 11, 2024 | Blog | By Tara E. Dwyer, Xavier Hardy, Madison Castle
In the Proposed Medicare Advantage and Part D Rules for 2025, the Centers for Medicare & Medicaid Services (CMS) proposed significant changes to how Medicare Advantage organizations (MAOs) are allowed to contract with and compensate entities that provide agent/broker and enrollment services. The proposed rules were heavily disfavored by entities that provide such services, but were not widely commented on by MAOs or Part D sponsors (PDP Sponsors), which are the entities to which the rules actually apply.
PBM Policy and Legislative Update — Winter 2024
May 2, 2024| Blog|
Safeguarding Reproductive Rights
February 23, 2024 | Article
Lawyers for Good Government, in partnership with the American College of Obstetricians and Gynecologists, initiated a vital project known as The Policy Resource Hub in 2022.
News & Press
HHS Pushes Back on Accumulator Ruling, Prompting Wait-and-See Situation
December 21, 2023
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.
Mintz Advises Kindred Healthcare in Sale to LifePoint Health, Launching ScionHealth
December 23, 2021
Mintz Advises Kindred at Home in $5.7 Billion Sale to Humana
August 23, 2021
Monopsony Issues in the Post-ACA World: How the Affordable Care Act May Impact Monopsony Analyses in the Review of Health Insurance Mergers
October 1, 2016
Events & Speaking
Involvement
- Member, American Health Lawyers Association