The Medicare program announced it would not reevaluate for the 2010 calendar year the 2 psychiatric drug categories protected under Part D "all or substantially all." Seniors who need antidepressants and antipsychotics will still be able to get "all or substantially all" of the chemically distinct drugs offered in those 2 categories.
Congress passed a law last summer that instructed Medicare to reevaluate the 6 protected Part D categories—of which 2 are antidepres- sants and antipsychotics.
The Medicare Improvements for Patients and Providers Act (MIPPA) requires the Centers for Medicare and Medicaid Services (CMS) to ensure that all 6 categories meet 2 standards. If they fail to do so, they would be dropped from their protected status in 2010. The CMS can also use the 2 standards to designate new protected drug categories. The MIPPA requires the CMS to identify protected categories or classes of drugs in which "access to multiple drugs within a category or class" is needed and in which "major or life-threatening clinical consequences" may arise if access is restricted.
An interim final rule that the CMS published on January 16 (just days before the Obama administration took office) held that there was too little time to make changes by 2010. Psychiatric patients in Part D plans will therefore continue to have access to all antidepressants and antipsychotics in 2009 and 2010—and perhaps beyond—depending on how long the CMS analysis takes. The FDA defines chemically distinct drugs as therapeutic equivalents identified as such in the FDA's Orange Book.
Psychiatric groups had hoped the 2 new standards would allow additional psychopharmacological categories to be added to antidepressants and antipsychotics as protected.
That may, in fact, turn out to be the case. In its Federal Register notice, the CMS indicated that the 2 standards "will likely expand access to drugs for certain classes or categories and provide greater inclusion of manufacturers' drugs associated with those classes or categories