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Akin Gump
Kelly Cleary
Partner, Akin Gump
Washington, D.C., United States
About me
Address: Washington, D.C.: Robert S. Strauss Tower, 2001 K Street, N.W., Washington, DC 20006-1037
Areas of Focus: Regulatory; Cybersecurity, Privacy & Data Protection; Administrative & Regulatory Litigation; Inspector General Investigations
Biography:
Kelly represents clients on a diverse range of health care regulatory and policy matters, helping clients understand and navigate an increasingly complex and often changing regulatory code. As an advisor to health industry participants, she supports in-house legal and business teams in structuring complex transactions and other strategic initiatives in a manner that minimizes regulatory risk. She has particular experience in matters involving state and federal fraud and abuse laws, including the federal Stark Law and Anti-Kickback Statute and their state analogs, and the Patient Protection and Affordable Care Act (ACA) marketplace regulations. She also has successfully represented clients before administrative and judicial tribunals on matters relating to Medicare and Medicaid enrollment and reimbursement, as well as in lawsuits arising under the False Claims Act (FCA). In addition, Kelly advises clients on privacy, security and breach notification issues arising under state and federal laws.
Kelly rejoined Akin after serving for three years at the Department of Health and Human Services (HHS) as Deputy General Counsel and Chief Legal Officer for the Centers for Medicare & Medicaid Services (CMS). While at HHS, she served as the principal legal counselor and advisor to the CMS Administrator and HHS leadership on all matters relating to the administration of federal health care programs covering more than 130 million Americans. At CMS, Kelly formulated legal strategy to advance policy priorities and optimize success in high-stakes litigation. She also served as a liaison with the Department of Justice (DOJ) on pending and anticipated litigation, with the Office of the Inspector General (OIG) on program integrity matters and with the White House on high-priority initiatives.
As CMS’s head lawyer, Kelly played a lead role in the Department’s efforts to revamp health care fraud and abuse laws, with a goal of creating more space for collaboration and innovation among health care providers.
Kelly was also the lead legal advisor to the Office of the National Coordinator for Health Information Technology (ONC) during development and implementation of policies to promote interoperability of electronic health records and curb “information blocking” practices that keep individuals from readily being able to obtain their electronic health records.
Kelly began her legal career as a law clerk for the Honorable Claude M. Hilton in the U.S. District Court for the Eastern District of Virginia. She served as editor-in-chief of the Catholic University Law Review .
Representative Work:
- Navigated complex statutory and regulatory code on a wide variety of issues, such as Medicare and Medicaid participation, coverage and reimbursement.
- Advised on Medicare payment and delivery system reform, including the Medicare Access and CHIP Reauthorization Act (MACRA), the Center for Medicare and Medicaid Innovation programs, the Medicaid Managed Care regulatory overhaul and site-neutral payment provisions impacting off-campus hospital outpatient departments.
- Analyzed proposed legislation and regulations, and assisted clients in understanding and quantifying potential effects on business lines.
- Developed and implemented strategies to achieve client policy goals, including drafting legislative language on Medicare hospital and physician value-based payment programs, access to Medicare claims data for performance evaluation (the Qualified Entity program), use of protected health information for marketing and data breaches under the Health Insurance Portability and Accountability Act (HIPAA).
- Advised clients on major congressional health care initiatives, including the ACA of 2010; the Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted as part of the American Recovery and Reinvestment Act of 2009; and MACRA.
Credentials:
Education: J.D., The Catholic University of America Columbus School of Law, 2006 (magna cum laude); B.A., Colgate University, 2002
Bar Admissions: District of Columbia, 2008
Court Admissions: U.S.C.A., 4th Circuit, 2007; U.S.D.C., District of Columbia, 2022; U.S.D.C., Eastern District of Virginia, 2007
Clerkships: {"clerkship": {"template_keyword": "clerkship", "status": "active", "name": "U.S.D.C., Eastern District of Virginia", "parent_id": null, "id": 1013215, "frontend_active": true, "display_order": null, "globaldata_ancestor_fk": [1000003], "content_subsite_fk": 1, "open_graph": {}}}
Recognitions:
- Chambers USA, Healthcare, 2022-2026.
- The Legal 500 US, Healthcare: Life Sciences, 2025, "Next Generation Partner," 2025-2026.
- Washingtonian , Top Lawyer, Healthcare, 2024.
- The National Law Journal, Health Care/Life Science Trailblazer, 2021.
- Super Lawyers , Rising Star, Washington, D.C., 2015-2016.
Affiliations:
- Deputy General Counsel at HHS and Chief Legal Officer for CMS, 2017 to 2020.
- Member, American Health Lawyers Association.
Insights:
- Akin Advises Pharmakon Advisors on Debt Financing for ARCHIMED’s Up to $1.1 Billion Acquisition of Esperion Therapeutics (July 22, 2026): https://www.akingump.com/en/insights/press-releases/akin-advises-pharmakon-advisors-on-debt-financing-for-archimeds-up-to-dollar11-billion-acquisition-of-esperion-therapeutics
- CMS Rolls Out New ‘Make Hospital Food Healthier’ Pledge (July 16, 2026): https://www.akingump.com/en/insights/alerts/cms-rolls-out-new-make-hospital-food-healthier-pledge
- Akin Secures Top Rankings in The Legal 500 US 2026 (June 10, 2026): https://www.akingump.com/en/insights/awards-and-accolades/akin-secures-top-rankings-in-the-legal-500-us-2026
- Chambers USA 2026 Recognizes Akin Lawyers and Practices (June 4, 2026): https://www.akingump.com/en/insights/awards-and-accolades/chambers-usa-2026-recognizes-akin-lawyers-and-practices
- CMS ‘Crackdown on Fraud’ Continues with Nationwide Six-Month Moratoria on New Medicare Enrollments for Hospices and Home Health Agencies (May 15, 2026): https://www.akingump.com/en/insights/alerts/cms-crackdown-on-fraud-continues-with-nationwide-six-month-moratoria-on-new-medicare-enrollments-for-hospices-and-home-health-agencies
- From Guidance to the Galley: CMS Urges DGA‑Aligned Menus and Procurement Under Hospital CoPs (April 10, 2026): https://www.akingump.com/en/insights/alerts/from-guidance-to-the-galley-cms-urges-dgaaligned-menus-and-procurement-under-hospital-cops
- 2026 Perspectives in Private Equity: Health Care & Life Sciences (March 31, 2026): https://www.akingump.com/en/insights/articles/2026-perspectives-in-private-equity-health-care-and-life-sciences
- CMS Launches Five New Models at the End of 2025: Looks to Advance ACCESS, BALANCE, MAHA ELEVATE, GLOBE and GUARD in 2026 (January 7, 2026): https://www.akingump.com/en/insights/alerts/cms-launches-five-new-models-at-the-end-of-2025-looks-to-advance-access-balance-maha-elevate-globe-and-guard-in-2026
- BIOSECURE Act Becomes Law (December 19, 2025): https://www.akingump.com/en/insights/alerts/biosecure-act-becomes-law
- Artificial Intelligence in Clinical Decision-Making: Regulatory Roadmap and Reimbursement Strategies (December 11, 2025): https://www.akingump.com/en/insights/alerts/artificial-intelligence-in-clinical-decision-making-regulatory-roadmap-and-reimbursement-strategies
- Akin Secures Top Rankings in The Legal 500 US 2025 (June 12, 2025): https://www.akingump.com/en/insights/awards-and-accolades/akin-secures-top-rankings-in-the-legal-500-us-2025
- Chambers USA 2025 Recognizes Akin Lawyers and Practices (June 5, 2025): https://www.akingump.com/en/insights/awards-and-accolades/chambers-usa-2025-recognizes-akin-lawyers-and-practices