The Centers for Medicare and Medicaid Services (CMS) released an interim final rule modifying the regulations relating to Part D Drugs. The rule is published in today’s Federal Register, and comments are due to the agency by March 17, 2009.
The interim final rule outlines CMS’s process for identifying those categories and classes of Part D Drugs that meet the two-pronged test relating to clinical importance, enacted as part of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). Part D Plan formularies must include all Part D Drugs within such protected categories and classes (Protected Classes) unless CMS adopts an exception.
CMS’s process for identifying such Protected Classes of drugs includes the following stages:
Identification of those categories and classes in which multiple drugs within the category or class are typically used to treat a specific disorder, and comparison with a CMS-developed analysis (based on PDE data) of beneficiary drug utilization
Review of such analysis by an expert panel of physicians and pharmacists, and issuance of recommendations for Protected Classes
Rulemaking, including notice and a comment period, for finalizing the Protected Classes as well as any applicable exceptions
Although the regulatory provisions codifying the process take effect today, CMS indicates adoption of Protected Classes (and related exceptions) will apply to CY 2011 and beyond. For CY 2010 Part D Plan formularies, the agency maintains its policy requiring coverage of the six classes of clinical concern.
The interim final rule also adopts a revised definition of Part D Drugs, incorporating by reference uses for medically accepted indications, as required by MIPPA. For covered Part D Drugs used in anticancer chemotherapeutic regimens, the term “medically accepted indication” has the same meaning as under Medicare Part B. For covered Part D Drugs not used for anticancer chemotherapeutic regimen, the term “medically accepted indication” has the same meaning as under the Medicaid Program.