CMS Regulation Addresses Protected Drug Categories and Classes

Some pharmaceutical manufacturers will be affected by a rule just issued by the Centers for Medicare & Medicaid Services (CMS) regarding how the Medicare program determines which drug categories and classes will receive favorable, "protected" status. If a drug is in one of these protected classes or categories, then Medicare Part D prescription drug plans must include in their formulary all of the drugs in that category or class. For manufacturers that have found it difficult to get favorable placement for one of their products on Part D plan formularies, CMS's conferral on that product of protected status could help ensure patient access to it.

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