On April 12, 2012, HHS issued final regulations addressing changes to the Medicare Part D program (Part D), a federal program that subsidizes the cost of prescription drugs for Medicare beneficiaries. Subject to certain exceptions, the regulations are effective on June 1, 2012. Among other things, the final regulations:

The ACA included changes intended to simplify Part D procedures and expand beneficiary protections. For example, under amendments to Part D made by the ACA, the Part D coverage gap for Medicare beneficiaries (known as the "donut hole") will be phased out under a program called the Coverage Gap Discount Program (Discount Program). The Discount Program provides for manufacturer discounts at the point-of-sale for Medicare beneficiaries who receive drugs within the coverage gap. The regulations consolidate most of the existing Discount Program requirements, which HHS previously issued in other guidance and program instructions.

The regulations include changes reflecting HHS' experience to date in administering Part D and will be of interest to sponsors of Part D prescription drug plans. In addition, some group health plans must coordinate with Part D prescription drug plans, among other reasons, to determine which coverage pays first and to disclose to Part D individuals whether the group health plan coverage is creditable.