On May 12, 2025, President Trump issued an Executive Order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” and an accompanying “Fact Sheet: President Donald J. Trump Announces Actions to Put American Patients First by Lowering Drug Prices and Stopping Foreign Free-riding on American Pharmaceutical Innovation
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Kristie Gurley
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.
CMS Proposal Would Impact Coverage of Innovative Digital Health Technologies
On September 15, 2021, CMS published a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” Final Rule (“MCIT/RN Rule”), which was published on January 14, 2021 and was set to take effect on December 15, 2021. The MCIT/RN Rule would have…
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Trump Administration Releases, Revokes, and Reissues “Most-Favored-Nation” Executive Order
The Trump Administration has released the much-anticipated executive order entitled “Lowering Drug Prices by Putting America First” (commonly referred to as the “Most-Favored-Nation” or “MFN” executive order). President Trump initially had announced the MFN executive order during his July 24, 2020 press conference highlighting four separate executive orders…
Continue Reading Trump Administration Releases, Revokes, and Reissues “Most-Favored-Nation” Executive Order