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We discuss and seek comment on the circumstances in which we would exercise our discretion to reopen a payment determination and issue a revised initial determination to account for the impact of identified improper payments on Shared Savings Program calculations (as described in section III.G.7.c.(2).(b) of this proposed rule)

For each applicable period, CMS will identify drugs and biologicals with average annual total costs under Part D for such applicable period, per individual who uses such drug or biological, that are below the applicable threshold in accordance with the steps described in this paragraph (b)

(Please note: For some products, the 8-digit sequence will include hyphens, e.g

Inform your doctor if you have a history of diabetes (a condition with high blood sugar levels), hypertension (high blood pressure), seizures (fits) or pre-existing kidney, liver, or heart problems before beginning treatment with this medicine