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Additionally, in section IV.A.4.e.(1)(e) of this proposed rule, there are two quality-related RFIs

If your doctor has prescribed this medication, read the Patient Information Leaflet if provided by your pharmacist before you start using this product and each time you get a refill

CMS believes that severe supply chain disruptions generally take time to resolve and for purposes of this proposed rule, CMS proposes in 427.402(a) to codify the policy established in section 50.12 of the revised Medicare Part B Drug Inflation Rebate Guidance whereby a determination that a severe supply chain disruption has occurred would be deemed to disrupt the supply chain for the quarter in which the event occurred and the three subsequent calendar quarters

2020;6:mgen000485