Comment on FR Doc # 2012-03228

Regarding the Notice of Modification, we ask that clarification be provided in relation to the types of material modifcations that would require a 60 day notification, specifically related to a health plan's prescription drug benefit. Prescription drug benefits could potentially change on a daily basis as new FDA approved drugs are released to the market, specifically new brands or newly approved generic formulations of a brand drug. In these instances where formularies are updated daily based on new FDA approvals, would these changes be defined as "material modifications" and would they be subject to the 60 day notification requirement? In addition, a health plan may base the level of cost sharing for brand-name prescription drugs on the classification of the drugs under the plan as having or not having generic alternatives. The classification of a drug that had no generic alternative changes because a generic alternative becomes available and is added to the formulary, with a resulting increase in the cost-sharing level for the brand-name drug. Does this increase meet the definiton of a "material modifciation" and would this increase be subject to the 60 day notifcation requirement?