Average Manufacturer definition

Average Manufacturer s Price (AMP)” means the average price that manufacturers sell medication to wholesalers and retail pharmacies, as further clarified in 42 CFR 447;
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Examples of Average Manufacturer in a sentence

  • The 340B ceiling price for a covered outpatient drug is equal to the Average Manufacturer Price (AMP) from the preceding calendar quarter for the smallest unit of measure minus the Unit Rebate Amount (URA) and will be calculated using six decimal places.

  • The Medicaid Drug Rebate Program and Average Manufacturer PricesFor Federal payment to be available for covered outpatient drugs provided under Medicaid, sections 1927(a)(1) and (b)(1) of the Act mandate that drug manufacturers enter into rebate agreements with the Secretary and pay quarterly rebates to State Medicaid agencies.

  • The 340B ceiling price is based on quarterly pricing data reported to the Centers for Medicare & Medicaid Services (CMS) and is calculated by subtracting the Unit Rebate Amount (URA) from the Average Manufacturer Price (AMP).

  • See Marci Anderson, Senior Auditor, VA Office of Inspector General, VHCA § 603: Calculating the Non-Federal Average Manufacturer Price (Non-FAMP) and the Federal Ceiling Price, Presentation at ACI’s “Big Four” Rx Pricing Boot Camp, slide 58 (May 21, 2013) (presentation on file).

  • In its ruling, the Grand Chamber concluded that Turkey had violated the men’s rights, under Article 34 of the ECHR, to petition the European Court of Human Rights, by failing to comply with the interim measures.

  • Average Manufacturer Price (AMP): The AMP per unit per product code for the period covered, based on sales.

  • Section 6001(c)(3) of the DRA requires the Secretary to clarify the requirements for and the manner in which AMPs are determined by promulgating a regulation no later than July 1, 2007, taking into consideration the OIG’s recommendations.OIG Recommendations on AMPIn accordance with 6001(c)(3) of the DRA, the OIG issued its report, ‘‘Determining Average Manufacturer Prices for Prescription Drugs under the Deficit Reduction Act of 2005,’’ (A–06– 06–00063), in May 2006.

  • Under section 1847A(d) of the Act, CMS also has the authority to substitute an Average Manufacturer Price (AMP) or Widely Available Market Price (WAMP)-based payment amount for the ASP-based payment amount when the ASP exceeds the AMP or WAMP by a threshold amount.

  • Such functions include the calculation and reporting of Average Sales Price, Average Wholesale Price, Wholesale Acquisition Cost, Wholesale List Price, Direct Price, Average Manufacturer price, Best Price, the 340B Program ceiling price and all other information reported or used in connection with Federal healthcare programs for Government Reimbursed Products.

  • The complaint alleges that the defendants should have treated certain credits from distributors as retroactive price increases and included such increases in calculating Average Manufacturer Prices (AMP).

Related to Average Manufacturer

  • Engine Manufacturer means CFM International, Inc.

  • Satellite Manufacturer means, with respect to any Satellite, the prime contractor and manufacturer of such Satellite.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Original component manufacturer means an organization that designs and/or engineers a part and is entitled to any intellectual property rights to that part.

  • Original manufacturer means the original component manufacturer, the original equipment manufacturer, or the contract manufacturer.

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.

  • Manufacturer means the person or body who is responsible to the approval authority for all aspects of the type approval process and for ensuring conformity of production. It is not essential that the person or body is directly involved in all stage of the construction of the vehicle, system, component or separate technical unit which is the subject of the approval process.

  • City-based manufacturer means a person who: (i) holds any appropriate city license; (ii) is subject to applicable city taxes; and (iii) owns, operates, or leases a manufacturing facility within the city.

  • Third Party Manufacturer means (i) a Third Party whose primary business is contract manufacturing, or (ii) a Third Party who has a contractual arrangement with Licensee or with a sublicensee of Licensee that includes manufacturing of Client Product and/or Drug Product by such Third Party for Licensee or such sublicensee.

  • Successor manufacturer means a manufacturer that acquires, succeeds to, or assumes any part of the business of another manufacturer as the result of any of the following:

  • Original equipment manufacturer means a company that manufactures products that it has designed from purchased components and sells those products under the company's brand name.

  • Motor vehicle manufacturer means any of the following:

  • Participating manufacturer means that term as defined in the master settlement agreement.

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

  • Modular building manufacturer means a person or corporation who owns or operates a

  • Analytical x-ray equipment means equipment used for x-ray diffraction or fluorescence analysis.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Fully Burdened Manufacturing Cost means, with respect to any Licensed Product supplied by or on behalf of NVCR to Zai hereunder if such Licensed Product (or any precursor or intermediate thereof) is manufactured by a Third Party manufacturer [***].

  • API means American Petroleum Institute.

  • Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.

  • Authorized aftermarket manufacturer means an organization that fabricates a part under a contract with, or with the express written authority of, the original component manufacturer based on the original component manufacturer’s designs, formulas and/or specifications.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.