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
With Proposal to Cap Drug Price Increases, Massachusetts Once Again Takes Center Stage in the Drug Pricing Debate
April 22, 2022 | Blog | By Xavier Hardy
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.
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.
Connecticut Proposal to Cap Drug Price Increases Could Portend a Shift in the Drug Pricing Debate
March 17, 2022 | Blog | By Xavier Hardy
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.
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
CMS Proposes Changes to Medicare Advantage Regulations: Network Adequacy, Beneficiary Access, MLR Reporting, and MOOP
January 19, 2022 | Blog | By Bridgette Keller, Xavier Hardy
Trump Administration Releases Series of Executive Orders on Drug Pricing
July 27, 2020 | Blog | By Xavier Hardy, Daryl Berke
A Review of the Affordable Care Act at 10 Years, Part 4: Alternative Payment and Delivery Models
April 10, 2020 | Blog | By Xavier Hardy
A Review of the Affordable Care Act at 10 Years, Part 3: Market Reforms and Risk Adjustment
April 9, 2020 | Blog | By Xavier Hardy
A Review of the Affordable Care Act at 10 Years, Part 2: Medicaid Expansion
April 8, 2020 | Blog | By Xavier Hardy
A Review of the Affordable Care Act at 10 Years, Part 1: The Individual Mandate
April 7, 2020 | Blog | By Xavier Hardy
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