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`Medicare Part B Drug
`Average SalesPrice
`2021 ASP Drug Pricing Files
`2020 ASP Drug Pricing Files
`2019 ASP Drug Pricing Files
`2078 ASP Dmg Pricing Files
`2017 ASP Drug Pricing Files
`2016 ASP Dnig Pricing Files
`2015 ASP Drug Pricing Files
`2044 ASP Drug Pricing Files
`2013 ASP Dog Pricing Files
`2012 ASP Drug Pricing Files
`2011 ASP Drug Pricing Files
`2010 ASP Doig Pricing Files.
`2009 ASP Drug Pricing Files
`2003 ASP Drug Pricing Files.
`2007 ASP Drug Pricing Files.
`2006 ASP Dmg Pricing Files
`2005 ASP Drug Pricing Files
`Medicare Part B Drugs Regulations
`COVID-19 Vaccines and Monoclonal
`Antibodies
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`Medicare Part B Drug Average Sales Price
`Manufacturer reporting of Average Sales Price (ASP) data
`Section 401 of the Consolidated Appropriations Act (CAA), 2021 amended section 1847A of the Social Security Act (the Act) to add
`new section 1847A(f)(2) of the Act, which requires manufacturers without a Medicaid drug rebate agreementto report average sales
`price (ASP)information to CMS for calendar quarters beginning on January 1, 2022, for drugs or biologicals payable under Medicare
`Part B and described in sections 1842(0)(1)(C), (E), or (G) or 1881(b\(14)(B) of the Act, including items, services, supplies, and
`products that are payable under Part B as a drug orbiological. This is discussed in further detail in the Physician Fee Schedule 2022
`Final Rule.
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`Such manufacturers should first report ASP data to CMS for calendar quarters beginning on January 1, 2022. As stated in 42 CFR §
`414.304 (which is based on statutory language). the “manufacturer's average sales price must be calculated by the manufacturer
`every calendar quarter and submitted to CMS within 30 days of the close of the quarter.” Therefore, manufacturersfirst reporting
`ASP data to CMS in accordance with provisions in section 401 of the CAA, 2021 should do so nolater than April 30, 2022 (within 30
`days of the close ofthe first quarter of 2022) for the July 2022 ASP Drug Pricing File.
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`For instructions regarding ASP reporting, please see the Medicare Part B Drug ASP User Manual, Tips for Successful ASP
`submission, and visit hitps.//portal.cms.gov to register for the online portal system. Other helpfullinks are available below.
`MEN Model
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`The MFN Model has been announced. More information is available on the MFN webpage (seerelatedlinks section below).
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`HCPCS Codes for Which ASP Reporting Is Done in Units of Measure Other Than an NDC
`A list of drugs that must be reportedin units other than NDCs is posted in the Downloads section. More informationis available in
`the 2012 physician fee schedule final rule (76 FR 73296-8, November 28, 2011).
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`Medicare Contractor Reporting Template for Medicare Part B Drugs- (Located in the "Downloads"
`section below)
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`As indicated in CR 4140, dated February 15, 2006, Medicare contractors shall use the Medicare Contractor Reporting Template for
`SeasonalInfluenzaVaccinesPricing Part B drugs to report information on all Medicare Part B drugs not paid on a cost or prospective payment basis when paymentlimits
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`are notlisted in the quarterly drug pricing files, or in the OPPS Pricer. Contractors shall also use the template to report pricing
`Blood Clotting Factor Furnishing Fee
`information for the NOC drugbilling codes. This information must be sent to CMS on a monthly basis to e-mail address:
`secj03aspdata@cms hhs.gov.
`Part B Biosimilar Biological Product
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`Mylan v. Regeneron, IPR2021-00881
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` U.S. Pat. 9,254,338, Exhibit 2173
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`Exhibit 2173
`Page 01 of 01
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