Press release




The Centers for Medicare & Medicaid Services (CMS) today announced an interim final rule that makes sure beneficiaries with conditions such as epilepsy, mental illness, and depression will not be discouraged from enrolling in any Part D plan, nor experience any interruptions in their drug therapy. The public comment period for this rule closes on March 17, 2009.


“The steps we are taking today reinforce CMS’ current formulary policy and ensure that Medicare beneficiaries with epilepsy, mental illness, certain cancers, HIV/AIDS, and other conditions will have access, without interruption, to the drugs they need,” said CMS Acting Administrator Kerry Weems.


In June 2005,  CMS directed that Part D formularies include all or substantially all drugs in the following six drug classes:  Antidepressant; Antipsychotic; Anticonvulsant; Immunosuppressant (to prevent rejection of organ transplants); Antiretroviral (for the treatment of infection by retroviruses, primarily human immunodeficiency virus (HIV); and Antineoplastic (only those chemotherapy drugs that are generally are not covered under Medicare Part B).


The interim final rule notifies Part D plans that they must continue to provide coverage of these drugs in 2010, consistent with the policy already in place.  As a result, enrollees who are already taking drugs from these six classes will not be discouraged from continuing their current treatment due to drug utilization management techniques, such as step therapy, that is, requiring enrollees to begin with a lower cost drug), quantity limitations, and/or prior authorization.


The rule also codifies in regulation a provision of the Medicare Improvements for Patients and Providers Act (MIPPA) with respect to the identification and coverage of protected drug categories and classes under the Part D program.  To identify appropriate drug categories and classes, CMS is beginning an extensive examination of widely used drug treatment guidelines, analyzing Part D data, and planning for a secondary validation review with input from an expert panel of physicians and pharmacists.


Because extensive analysis is needed to identify which protected categories and classes are appropriate, CMS has determined that the timing for Part D formulary submissions for 2010 (which will occur in April 2009) will preclude it from making such identification for the 2010 contract year.  Accordingly, as indicated above, the rule states that CMS will continue its existing six classes of protected drugs for 2010 under its existing, pre-MIPPA, administrative authority.


For contract years 2011 and beyond, CMS plans to consider whether any modifications are necessary to the existing six classes currently protected, whether under CMS’s existing administrative authority or under MIPPA.  Should CMS decide that modifications are necessary, CMS will propose these modifications through a rulemaking process that provides for meaningful public comment.  Similarly, any associated exceptions to those categories and classes will be addressed through rulemaking.


“CMS will conduct a transparent and comprehensive analysis in deciding whether to revise or broaden its list of protected classes of drugs,” said Weems. 


Reflecting a MIPPA provision, the interim final rule also requires Part D sponsors to use the same definition for a “medically accepted indication” for anti-cancer drugs as used for Medicare Part B, effective Jan. 1, 2009.  As a result, Part D sponsors will use Part B compendia and potentially consider peer reviewed medical literature when necessary and appropriate.


The regulation is on display today at the Federal Register will be available at  Click on View the Regular Filing Documents. 


The regulation will be published on Jan. 16, 2009, and may be viewed that day and thereafter at  Click “Go” next to where 2009 appears in the year selection box for “Back Issues (HTML Only).”


Comments on the interim final rule are due by 5:00 p.m. Eastern time on March 17, 2009.