May 23, 2008
By C. Brooks Newman*
In response to a request from the Centers for Medicare and Medicaid Services (CMS), the United States Pharmacopeia (USP) announced on May 20, 2008, it will no longer revise the Medicare Model Guidelines on an annual basis. Instead, "based on the success and stabilization of recent versions of the Model Guidelines, the Centers for Medicare and Medicaid Services (CMS) and USP have agreed to move from an annual timeline for revision to a three-year cycle."
The MMA designates USP to develop the Medicare Model Guidelines and to revise the Guidelines from time to time to reflect changes in therapeutic uses of covered Part D drugs and additions of new covered Part D drugs. Plans that design to conform to the categories and classes in the Model Guidelines may not be found "likely to substantially discourage enrollment" by certain Medicare beneficiaries. (MMA, Section 1860D-11(e)(2)(D)(i) and (ii)).
USP's press release states that CMS will use the current Medicare Model Guidelines Version 4.0, without changes, through plan year 2011. In 2010, USP intends to begin work on Version 5.0, which will be utilized during the Part D formulary review process for plan year 2012. Version 4.0 and related information are available on USP's Web site.
We would like to thank C. Brooks Newman, Esquire (Humana Inc., Louisville, KY) for writing this email alert.