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Kristie Gurley advises pharmaceutical and biotechnology companies on marketing authorization and market access issues, including with respect to product development, product approval and launch, pricing and reimbursement activities, advertising and promotion, payer communications, value-based contracting, and related areas. Kristie routinely advises on regulatory compliance and enforcement risk, commercial transactions, and administrative and legislative policy opportunities.

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 created a pathway to provide

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 aimed at drug pricing. However,