Instance of overcharging Sample Clauses
Instance of overcharging. An instance of overcharging is any order for a covered outpatient drug, by NDC, which results in a covered entity paying more than the ceiling price, as defined in § 10.10, for that covered outpatient drug.
(1) Each order for an NDC will constitute a single instance, regardless of the number of units of each NDC ordered. This includes any order placed directly with a manufacturer or through a wholesaler, authorized distributor, or agent.
(2) Manufacturers have an obligation to ensure that the 340B discount is provided through distribution arrangements made by the manufacturer.
(3) An instance of overcharging is considered at the NDC level and may not be offset by other discounts provided on any other NDC or discounts provided on the same NDC on other transactions, orders, or purchases.
(4) An instance of overcharging may occur at the time of initial purchase or when subsequent ceiling price recalculations due to pricing data submitted to CMS result in a covered entity paying more than the ceiling price due to failure or refusal to refund or credit a covered entity.
(5) A manufacturer’s failure to provide the 340B ceiling price is not considered an instance of overcharging when a covered entity did not initially identify the purchase to the manufacturer as 340B-eligible at the time of purchase. Covered entity orders of non-340B priced drugs will not subsequently be considered an instance of overcharging unless the manufacturer’s refusal to sell or make drugs available at the 340B price resulted in the covered entity purchasing at the non-340B price. [FR Doc. 2015–14648 Filed 6–16–15; 8:45 am] AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of Proposed Rulemaking (NPRM), request for comments. SUMMARY: FMCSA proposes to amend the Federal Motor Carrier Safety Regulations (FMCSRs) by requiring United States-domiciled (U.S.- domiciled) motor carriers engaged in interstate commerce to use only commercial motor vehicles (CMV) that display a certification label affixed by the vehicle manufacturer or a U.S. Department of Transportation (DOT) Registered Importer, indicating that the vehicle satisfied all applicable Federal Motor Vehicle Safety Standards (FMVSS) in effect at the time of manufacture. If the certification label is missing, the motor carrier must obtain, and a driver upon demand present, a letter issued by the vehicle manufacturer stating that the vehicle met all applicable FMVSS in effect at the time of manufacture. DATE...
Instance of overcharging. An in- stance of overcharging is any order for a covered outpatient drug, by NDC, which results in a covered entity pay- ing more than the ceiling price, as de- fined in § 10.10, for that covered out- patient drug.
(1) Each order for an NDC will con- stitute a single instance, regardless of the number of units of each NDC or- dered. This includes any order placed directly with a manufacturer or through a wholesaler, authorized dis- tributor, or agent.
(2) Manufacturers have an obligation to ensure that the 340B discount is pro- vided through distribution arrange- ments made by the manufacturer.
(3) An instance of overcharging is considered at the NDC level and may not be offset by other discounts pro- vided on any other NDC or discounts provided on the same NDC on other transactions, orders, or purchases.
(4) An instance of overcharging may occur at the time of initial purchase or when subsequent ceiling price recal- culations due to pricing data submitted to CMS or new drug price estimations as defined in § 10.10(c) result in a cov- ered entity paying more than the ceil- ing price due to failure or refusal to re- fund or credit a covered entity.