- 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 M. Cleary 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.
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.
Public Service and Affiliations