Kristie Gurley advises clients on complex drug pricing, reimbursement, and compliance issues affecting the market access landscape for innovative drug products.

Kristie brings unique insight from her recent experience serving in the Office of the General Counsel of the U.S. Department of Health and Human Services (HHS), where she supported the Centers for Medicare & Medicaid Services (CMS) on drug pricing issues, including implementation of Medicare provisions in the Inflation Reduction Act (IRA) and government price reporting. In this role, Kristie served as a lead attorney on the IRA Medicare Drug Price Negotiation Program, including with respect to policy development, operations, and participating in the first cycle of negotiations. She also supported the Medicare Prescription Drug Inflation Rebate Program and additional IRA implementation efforts, Medicaid Drug Rebate Program (MDRP) rulemaking and guidance, and the Center for Medicare & Medicaid Innovation’s (CMMI) development and launch of a drug pricing model for cell and gene therapies.

Kristie’s practice involves strategic, policy, and regulatory advice supporting market access for innovative drug and biological products. Kristie advises on federal health care program coverage and reimbursement, Medicaid price reporting, agency engagement, payer contracting and formulary access, value-based contracting, and other issues under federal and state drug pricing regimes. In addition to regulatory counseling, Kristie advises on commercial transactions, litigation opportunities, compliance and enforcement risk, and policy advocacy. Kristie leads the firm’s drug pricing practice, including “Most-Favored-Nation” engagement and strategic planning, as well as IRA negotiations and engagement.