Kristie Gurley

Partner, Washington at Covington & Burling LLP

Speaker

Kristie Gurley advises life sciences clients on complex pricing, reimbursement, and market access issues. 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 the Inflation Reduction Act (IRA). 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 the first cycle of negotiations. She also supported the Medicare Prescription Drug Inflation Rebate Program and additional IRA implementation efforts, Medicaid Drug Rebate Program rulemaking and agency determinations, and the Center for Medicare & Medicaid Innovation’s development and launch of a model for cell and gene therapies.

Kristie’s practice involves strategic, policy, and regulatory advice supporting market access for drug and biological products. Kristie provides advice related to 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 strategic commercial transactions, litigation opportunities, compliance and enforcement risk, and policy advocacy.