Kevin J. Malone

"My work in government gave me a ground-level view of how policy actually plays out for health plans and providers. I bring that perspective to every matter I handle." —Kevin J. Malone

Health plans, provider organizations, and government agencies navigating the complex and shifting requirements that govern managed care turn to Kevin Malone for practical, business-minded regulatory counsel shaped by years spent inside the federal agencies that write and enforce those rules.

Kevin is a Member of the Firm in Epstein Becker Green’s Health Care and Life Sciences practice and a Strategic Advisor with the firm’s consulting affiliate, EBG Advisors. His clients range from start-ups and regional health plans to trade associations, state and local governments, and some of the largest health care companies.

In his managed care work, Kevin brings particular depth to issues involving Medicare Advantage, Medicaid managed care, special needs plans, and the Program of All-Inclusive Care for the Elderly (PACE). A substantial part of his practice focuses on delivery systems for Medicare-Medicaid dual-eligible beneficiaries, the federal Mental Health Parity and Addiction Equity Act (MHPAEA), and value-based payment arrangements. He also advises health systems and policy organizations on the regulatory and payer-interface issues that arise under medical aid in dying (MAiD) laws.

Prior to joining Epstein Becker Green in 2016, Kevin spent six years in health care financing policy roles at the U.S. Department of Health and Human Services (HHS). He led the Substance Abuse and Mental Health Services Administration’s (SAMHSA’s) federal implementation of MHPAEA and, most recently, developed Medicare-Medicaid demonstration models for dual-eligible beneficiaries at the Centers for Medicare & Medicaid Services’ (CMS’s) Federal Coordinated Health Care Office.

Before entering the federal government, Kevin served as a Peace Corps volunteer in Zambia, working in community agricultural development. He later coordinated a national domestic violence prevention program in Zambia before conducting research on community health and social services programs in Washington, DC.

Kevin developed URAC’s Mental Health Parity Accreditation Program, the nation’s first third-party commercial accreditation assessing insurers’ capacity to comply with federal parity law, as well as the industry’s first enterprise software solution for parity compliance. He continues to serve as an accreditation reviewer for the program. He also teaches Managed Care Law and Policy as an adjunct professor at The George Washington University Law School.

What Kevin Delivers for Clients

• A Clearer Path Through Regulatory Approval: Kevin’s experience inside HHS and CMS gives clients practical insight into how regulatory review processes work. He helps clients anticipate agency concerns, sequence submissions, and respond effectively to requests, keeping complex applications and approvals moving forward.
• Clarity When the Rules Are Still Evolving: When health policy evolves faster than the law, clients often must make decisions before the regulatory landscape is settled. Kevin draws on his experience as a regulator, policy advisor, and outside counsel to help clients assess risk and develop practical approaches in novel and rapidly evolving areas.
• Confidence Under Audit and Investigation: Federal and state audits and investigations can demand quick decisions while putting significant pressure on day-to-day operations. Kevin helps managed care organizations and provider entities understand their exposure, respond strategically, and navigate government scrutiny while minimizing operational disruption.
• Continuity from the Inside: Some clients need more than outside counsel; they need an advisor who can step into the organization and understand its operations as well as its legal exposure. Kevin’s experience in seconded and acting general counsel roles enables him to provide continuity of judgment during leadership transitions, periods of rapid growth, and other times of change.
• Regulatory Support Through the Deal Cycle: Regulatory issues can create uncertainty at any stage of a managed care or value-based transaction. Kevin helps investors and health care companies identify and address those issues before closing and provides ongoing regulatory counsel as businesses integrate, grow, and evolve.

Embedded General Counsel Roles

• Serves as seconded deputy general counsel for a regional health plan, with responsibility for managed care and government program matters.
• Serves as acting general counsel for a national laboratory network benefit management and technology company.

Managed Care Entities—Medicare Advantage, Medicaid, and PACE

• Represents the full range of fully insured and self-funded managed care entities, including health maintenance organizations, third-party administrators, pharmacy benefit managers, and other specialty benefit management entities, with particular emphasis on Medicare Advantage special needs plans, fully integrated dual-eligible special needs plans (FIDE-SNPs), Medicaid managed care organizations, and PACE organizations. Kevin’s work encompasses:
• Advising on formation, state licensure, capitalization, solvency, and buy- and sell-side transactions; CMS Medicare Advantage organization applications and approvals; Medicaid procurement support; and the PACE federal and state application process
• Counseling on operational matters, including benefit design and filing, actuarial and medical loss ratio reporting, related-party transactions, co-branding and marketing arrangements, agent and broker compliance, utilization management (such as AI and algorithmic vendor tools), care management and Model of Care development, appeals and grievance operations, and special investigations unit operations
• Negotiating network provider contracting and resolving related disputes, including template structuring, value-based payment program development and operation, and mediation of related settlement disputes
• Preparing for and responding to federal and state audits
• Advising on government relations and policy advocacy
• Developing MHPAEA compliance programs and operations and defending parity investigations

Behavioral Health Specialty Societies

• Advises multiple behavioral health medical specialty societies on licensing and commercializing medical necessity criteria, including intellectual property structuring and compliance with parity requirements.

Accountable Care Organizations and Value-Based Enterprises

• Represents Medicare Shared Savings Program (MSSP) accountable care organizations, ACO REACH entities, LEAD Model ACOs, and high-needs ACOs. Kevin’s work encompasses:
• Advising on formation, capitalization, and corporate governance, including compliance program design
• Structuring risk transfer arrangements and participant and preferred provider agreements, such as synthetic preferred provider arrangements for MSSP ACOs
• Negotiating non-provider vendor contracting
• Structuring value-based enterprises and conducting Anti-Kickback Statute and Stark Law safe harbor analysis for value-based and shared-savings arrangements
• Implementing care management programs
• Conducting regulatory-status due diligence in connection with corporate transactions, covering LEAD, MSSP, and ACO REACH participation history and onboarding timelines

Health Systems and Provider Organizations

• Represents hospitals, health systems, physician practices, telehealth companies, management services organizations, and other risk-bearing provider entities. Kevin’s work encompasses:
• Advising on practice formation and structuring management services organizations for value-based primary care models, including corporate-practice-of-medicine compliance in states with heightened restrictions.
• Advising on market access and growth strategy, including supplemental benefit design and risk-sharing strategy.
• Counseling on licensure, network development, and corporate-practice-of-medicine compliance for behavioral health providers, telehealth companies, and multistate provider groups.
• Negotiating value-based contracts and regulatory disputes with major national payors.

Government and Policy Counseling

• Advises states and trade associations on the design and implementation of Medicaid delivery systems for Medicare-Medicaid dual-eligible beneficiaries.

Transactions and Investments

• Provides strategic counseling and transactional support to private equity and venture capital investors in the managed care, behavioral health, and long-term care industries.

Medical Aid in Dying

• Advises on MAiD law and practice, including successfully defending the constitutionality of New Mexico’s MAiD law in coordination with the state Attorney General’s Office and developing the clinical, operational, and compliance framework for a physician practice delivering MAiD care.

• The Best Lawyers in America^©: “Ones to Watch” in Health Care Law (2022 to 2027)
• The Legal 500 United States, Healthcare: Health Insurers (2023 to 2024)
• Washington, DC, Rising Stars, Health Care (2022 to 2025)

Education

• The George Washington University Law School (J.D.)
• Washington University in St. Louis (B.A.)