Under the Medicare Coverage Gap Discount Program, which takes effect January 1, 2011, Medicare beneficiaries in the Part D coverage gap (sometimes called the “donut hole”) will have access to manufacturer discounts equal to 50% of the negotiated price of applicable drugs (that is, prescription drugs approved or licensed under new drug applications or biologic license applications). In order to participate, manufacturers must sign an agreement with CMS to provide the discount on all of its applicable drugs. CMS has posted a complete list of applicable drug labeler codes for the 2011 calendar year (as of October 1, 2010). Beginning January 1, 2011; applicable Part D drugs may be covered under Part D only if they are marketed under labeler codes specified on the CMS list. While CMS does not anticipate many changes to this list during 2011, CMS notes that a manufacturer could add new labeler codes that currently are not marketed or currently are marketed by another manufacturer; in such case, CMS will promptly notify Part D sponsors.