Served as Deputy General Counsel at HHS and Chief Legal Officer for CMS.
Provides strategic advice and counsel to the full range of health care and life sciences participants—including hospitals, academic medical centers, cancer centers, health IT companies, and pharmaceutical and device manufacturers—on health care policy, regulatory and enforcement matters.

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

Medicare and Medicaid Regulations

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.

Legislative and Regulatory Advocacy

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.

Assisted clients in advocacy efforts before HHS, CMS, the Food and Drug Administration (FDA) and other federal agencies and departments relating to implementation of the ACA, HITECH Act and MACRA.

Fraud and Abuse/Compliance

Counseled clients on state and federal fraud and abuse laws, including the Stark Law, Anti-Kickback Statute, FCA and Physician Payment Sunshine Act (PPSA).
Assisted clients in designing and implementing compliance programs and responding to government investigations.
Represented clients in federal court in lawsuits arising under the FCA and Anti-Kickback Statute.
Assisted clients in all aspects of litigation, including discovery, depositions, witness preparation, pre-trial preparation, trial and post-trial briefing.

Information Privacy

Counseled health care entities on issues arising under state and federal privacy, security and data breach notification laws and regulations, including HIPAA, the HITECH Act and the FTC Red Flags Rule.

"She's terrific, she's one of my go-to lawyers in DC."

Chambers USA, 2022

Education
J.D., The Catholic University of America Columbus School of Law, magna cum laude, 2006
B.A., Colgate University, 2002

Clerkships
U.S.D.C., Eastern District of Virginia

Bar Admissions
District of Columbia

Recognitions

Chambers USA, Healthcare, 2022-2024.
The National Law Journal, Health Care/Life Science Trailblazer, 2021.
Super Lawyers, Rising Star, Washington, D.C., 2015-2016.

Affiliations and Public Service

Deputy General Counsel at HHS and Chief Legal Officer for CMS, 2017 to 2020.
Member, American Health Lawyers Association.

Speeches and Publications

Speaker, “HHS in the First 100 Days: A Look at How Policy Priorities Have (and Haven't) Shifted from Trump to Biden?," Webinar, American Health Law Association, September 15, 2021.
“Supreme Discord: Will SCOTUS Upend Healthcare in 2021?” MedPage Today Webinar, January 14, 2021.
“Interoperability & Information Blocking: What Providers Need to Know,” Akin Webinar, October 1, 2020.
“The Stark Proposed Rule: Exploring the New FMV, Commercial Reasonableness, and Volume or Value Guidance,” American Health Lawyers Association Webinar, November 12, 2019.
“Health Law in the Trump Administration: Regulatory Reform and Future Priorities,” American Health Lawyers Association Annual Meeting, June 25, 2019.
“Current Topics in Medicaid,” State Bar of Georgia Health Law Section Lunch Program, March 9, 2018.
“An Update on the Future of Healthcare,” American Bar Association Health Law Section and Chicago Medical Society Physicians Legal Issues Conference, June 9, 2017.
“MACRA, MIPS & You – What’s Next?: Policy Perspectives,” Statewide Continuing Medical Education Program hosted by the Nevada State Medical Association, January 10, 2017.
“Forecasting the 2017 Health Care Agenda: An Election Day Breakdown of What’s in Store for Health Sector Stakeholders,” Akin CLE Program, November 8, 2016.
“What Does Performance Under Medicare’s Value-Based Modifier (VM) Program Suggest Concerning Physician Performance Under MACRA: A Conversation With Kelly Cleary,” The Healthcare Policy Podcast, July 20, 2016.
“Overview of Physician Payment System Reforms in the Medicare Access and CHIP Reauthorization Act of 2015,” The Health Collaborative, June 18, 2015.
“Paying for Value: An Olympic Challenge,” Wisconsin Collaborative for Healthcare Quality Annual Assembly, March 8, 2016.