Kristie Gurley

Partner at Covington & Burling

Speaker

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 Centers for Medicare & Medicaid Services (CMS) Division of the Office of the General Counsel, U.S. Department of Health and Human Services (HHS), where she advised on implementation and negotiation under the Inflation Reduction Act (IRA), Medicaid Drug Rebate Program guidance and rulemaking, and Center for Medicare & Medicaid Innovation (CMMI) drug pricing models.

Kristie’s practice involves strategic, policy, and regulatory advice supporting market access for innovative drug 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.