CMS Defines Terms For Part D Protected Classes, Revises Multi-Step Review
CMS' latest take on policy for "protected classes" under Medicare Part D identifies three key issues that will shape how such classes are chosen in the future: defining terms used in the statutory language, a new approach to the agency's previously proposed multi-step process for evaluating classes, and options for public comment on the agency's choices
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Medicare Part D formulary requirements for the six "protected" classes will be maintained through 2011 and until the agency establishes otherwise through rulemaking, under a final rule slated for April 15 publication.
CMS is creating a multi-step process that will give outside experts and the public a role in adding or subtracting "protected" drug classes in Medicare Part D, as well as making exceptions to the rule that all drugs must be covered in a protected class
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011