What is the process for revising the Model Guidelines?
A. USP drug information specialists continually monitor the biomedical and pharmaceutical literature for Food and Drug Administration (FDA) approval of new covered Part D drugs and changes in therapeutic uses of covered Part D drugs. These changes are reported to the relevant Information Expert Committees who then make recommendations to the MGEC. With input from the Information Expert Committees, Advisory Forums, and other interested parties, the MGEC proposes revisions to the Model Guidelines and Formulary Key Drug Types (FKDTs). These draft revisions will be published for the express purpose of soliciting public comment. They will be posted annually on the USP Web site. The MGEC will utilize these comments to finalize the guidelines and FKDTs before submitting them to CMS.
