Immunization Information Systems (IIS) code set updates

Having trouble viewing this email? View it as a Web page. You are subscribed to one or more CDC code sets email subscription services. This message serves to inform you that information has recently been updated and is now available. Links to all of the code sets can be found on the Code Sets web page. UPDATES: Previously, NDC 58160-0964-12 (Rabavert by GlaxoSmithKline) was mapped to CVX 18 (rabies, intramuscular injection), however this CVX has been retired. The correct mapping is to CVX 176 (Rabies – IM fibroblast culture). A new Unit of Use NDC has been introduced for Rabavert produced by GlaxoSmithKline. This new code is linked to the existing Unit of Sale NDC for Rabavert. New carton and vial NDCs have been introduced for Hiberix by GlaxoSmithKline. The Hiberix product consists of a “kit” which contains 2 “cartons” each containing 10 “vials” (one carton has 10 vials of lyophilized powder while the other carton has 10 vials of diluent). Mappings exist from the “kit” (as a Unit of Sale) to “carton” (as a Unit of Use) and from the “carton” (as a Unit of Sale) to “vial” (as a Unit of Use). A CVX code is mapped to a vaccine group when the vaccine may be used to meet the ACIP goals for protection against the vaccine group disease. CVX codes 177 (PCV10) and 186 (Influenza, injectable, Madin Darby Canine Kidney, quadrivalent) have been mapped to vaccine groups 152 (PneumoPCV) and 88 (Flu) respectively. The AMA has updated the name of several influenza related CPT codes. The CPT Description for codes 90655, 90656, 90657, 90658, 90685, 90686, 90687 & 90688 have been updated to reflect the newest text. Mappings using these CPT have not changed, only the description of the CPT code has changed. The CDC has reached over 1.4 million subscribers. Thank you for your support. Update Subscriber Preferences or Unsubscribe | Learn about CDC Updates Questions or problems? Please contact support.

What’s New at CBER Update

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• User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act
  Updated: 7/28/2017

CDC ACIP: Meetings Update

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CDC News: Immunization MMWRs Update

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What’s New at CBER Update

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• BK170045: PCS 300 Plasma Collection System
  Posted: 7/27/2017
• BK170033: Duploject, Duo Set and Duo Set A
  Posted: 7/27/2017
• BK170030: Bone Marrow Collection Kit with Flexible Pre-Filter and Inline Filters and Bone Marrow Collection Stand
  Posted: 7/27/2017
• Influenza Virus Vaccine for the 2017-2018 Season
  Updated: 7/27/2017

CDC’s Immunization Works! Newsletter

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What’s New at CBER Update

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• CBER-Regulated Products: Current Shortages
  Posted: 7/24/2017; Yellow Fever Vaccine Update

Announcing the HPV Vaccine is Cancer Prevention Champion Award

Immunization Information Systems (IIS) code set updates

Having trouble viewing this email? View it as a Web page. You are subscribed to one of CDC’s email subscription services: VIS 2D Barcode Lookup Table CVX – VIS Mapping Table VIS to Current URL Table The CVX-VIS Table has been updated to remove the mapping of the rotavirus vaccines (rotavirus, monovalent and rotavirus, pentavalent) to the Multi Pediatric Vaccines VIS. The Multi Pediatric Vaccines VIS does not cover the rotavirus vaccines. The CDC has reached over 1.4 million subscribers. Thank you for your support. Update Subscriber Preferences or Unsubscribe | Learn about CDC Updates Questions or problems? Please contact support.

Vaccine Information Statements Update

Having trouble viewing this email? View it as a Web page. You are subscribed to CDC’s Vaccine Information Statements (VIS) email subscription service. Reminder: The current influenza VIS, dated 8/7/15, is still valid for the 2017-18 influenza season. It will remain valid through upcoming flu seasons unless there are significant changes to CDC’s recommendations, in which case subscribers will be notified of any change. The CDC has reached over 1.4 million subscribers. Thank you for your support. Update Subscriber Preferences or Unsubscribe | Learn about CDC Updates Questions or problems? Please contact support.

Notification of upcoming changes to CPT mappings

Having trouble viewing this email? View it as a Web page. You are subscribed to one or more CDC code sets email subscription services. This message serves to inform you that information has recently been updated and is now available. Links to all of the code sets can be found on the Code Sets web page. UPDATES: The CDC maintains a mapping of CPT codes to CVX codes to assist system who receive CPT codes to translate the CPT code into a vaccine product via the CVX code. The goal of the table is to support mapping of CPT codes to CVX codes. It is not intended to support mapping from CVX to CPT nor to be a definitive source for CPT codes. It has been brought to our attention that the current CPT to CVX mapping table contains several instances where a single CPT code is mapped to multiple CVX codes. This duplicate mapping prevents a system from unambiguously translating a CPT code into vaccine product. For this reason, going forward, the CDC will ensure that each CPT code is mapped to only a single CVX code. In cases where multiple relevant CVX codes exist for a single CPT code, the CPT code will be mapped to the “unspecified formulation” CVX code. For example, CPT code 90734 (Meningococcal conjugate vaccine, serogroups A, C, Y and W-135 (tetravalent), for intramuscular use) is currently mapped to both CVX codes 114 (Meningococcal MCV4P) and 136 (Meningococcal MCV4O). Going forward the CPT code will be mapped to the more generic CVX code 147 (Meningococcal MCV4, unspecified formulation). The following mappings are expected to be updated: CPT code 90734 (Meningococcal conjugate vaccine, serogroups A, C, Y and W-135 (tetravalent), for intramuscular use) will be updated to map to CVX code 147 from CVX codes 114 & 136. CPT code 90675 (Rabies vaccine, for intramuscular use) will be updated to map to CVX code 90 from CVX codes 18, 175 & 176. CPT code 90700 (Diphtheria, tetanus toxoids, and acellular pertussis vaccine (DTaP), for use in individuals younger than seven years, for intramuscular use) will be updated to map to CVX code 107 from CVX codes 20 & 106. CPT code 90714 (Tetanus and diphtheria toxoids (Td) adsorbed, preservative free, for use in individuals seven years or older, for intramuscular use) will be updated to map to CVX code 139 from CVX codes 09 & 113. CPT code 90714 historically was also used with the Typhoid vaccine. This is no longer the case, so the mapping of CPT code 90714 to CVX code 91 will also be removed. Please contact Craig Newman (yuo9@cdc.gov) if you have any questions about this transition. The CDC has reached over 1.4 million subscribers. Thank you for your support. Update Subscriber Preferences or Unsubscribe | Learn about CDC Updates Questions or problems? Please contact support.

What’s New at CBER Update

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• BK170067: Galileo Neo Automated Blood Bank System
  Posted: 7/21/2017
• Public Meeting on Patient-Focused Drug Development for Hereditary Angioedema
  Posted: 7/21/2017

What’s New at CBER Update

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• Influenza Virus Vaccine for the 2017-2018 Season
  Updated: 7/20/2017

CDC ACIP: Meetings Update

Having trouble viewing this email? View it as a Web page. You are subscribed to either CDC’s ACIP Home Page or ACIP Meeting Page email subscription service. This email serves to inform you that the June ACIP meeting presentation slides are now available. The CDC has reached over 1.4 million subscribers. Thank you for your support. Update Subscriber Preferences or Unsubscribe | Learn about CDC Updates Questions or problems? Please contact support.

CDC News: Immunization MMWRs Update

Having trouble viewing this email? View it as a Web page. You are subscribed to CDC News: Immunization-related MMWRs email subscription service. This message serves to inform you that one or more MMWRs have recently been added to the MMWR page and are now available. The CDC has reached over 1.4 million subscribers. Thank you for your support. Update Subscriber Preferences or Unsubscribe | Learn about CDC Updates Questions or problems? Please contact support.

CDC Hepatitis B Coordinators List Update

Having trouble viewing this email? View it as a Web page. You are subscribed to CDC’s Immunizations’ Hepatitis B Coordinators email subscription service. This email serves to inform you that the contact information for the state of Texas has been updated and is now available. The CDC has reached over 1.4 million subscribers. Thank you for your support. Update Subscriber Preferences or Unsubscribe | Learn about CDC Updates Questions or problems? Please contact support.

What’s New at CBER Update

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• Recall of MENVEO [Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine] Solution for intramuscular injection
  Posted: 7/18/2017
• Clinical Investigator Status (Biologics)
  Posted: 7/18/2017; Updated through: 6/30/2017

What’s New at CBER Update

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• July 14, 2017 Approval Letter – Afluria and Afluria Quadrivalent (PDF – 32KB)
  Posted: 7/17/2017
• Complete List of Currently Approved NDA and ANDA Application Submissions (PDF – 17KB)
  Posted: 7/17/2017; Updated as of 7/17/2017
• Complete List of Currently Approved Premarket Approvals (PMAs) (PDF – 16KB)
  Posted: 7/17/2017; Updated as of 7/7/2017
• Complete List of Substantially Equivalent 510(k) Device Applications (PDF – 263KB)
  Posted: 7/17/2017; Updated as of 7/7/2017
• Complete List of Licensed Products and Establishments
  Posted: 7/17/2017; Updated as of 6/30/2017

Immunization Information Systems (IIS) code set updates

Having trouble viewing this email? View it as a Web page. You are subscribed to one or more CDC code sets email subscription services. This message serves to inform you that information has recently been updated and is now available. Links to all of the code sets can be found on the Code Sets web page. UPDATES: The CPT to CVX table has been updated to reflect the addition of a new unspecified oral poliovirus CVX code. The CDC has reached over 1.4 million subscribers. Thank you for your support. Update Subscriber Preferences or Unsubscribe | Learn about CDC Updates Questions or problems? Please contact support.

What’s New at CBER Update

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• July 7, 2017 Approval Letter – Fluarix Quadrivalent (PDF – 33KB)
  Posted: 7/14/2017

CDC Hepatitis B Coordinators List Update

Having trouble viewing this email? View it as a Web page. You are subscribed to CDC’s Immunizations’ Hepatitis B Coordinators email subscription service. This email serves to inform you that the contact information for the state of Alabama has been updated and is now available. The CDC has reached over 1.4 million subscribers. Thank you for your support. Update Subscriber Preferences or Unsubscribe | Learn about CDC Updates Questions or problems? Please contact support.

What’s New at CBER Update

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• Summary Basis for Regulatory Action – ALBAclone Anti-Fyb (Human/Murine Monoclonal) (PDF – 119KB)
  Posted: 7/13/2017
• July 7, 2017 Approval Letter – FluLaval Quadrivalent (PDF – 33KB)
  Posted: 7/13/2017
• BK170059 – Trima Accel Automated Blood Collection System
  Posted: 7/13/2017
• June 20, 2017 Summary Basis for Regulatory Action Template – ORTHO Sera (PDF – 278KB)
  Posted: 7/13/2017

CDC News: Immunization MMWRs Update

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What’s New at CBER Update

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• July 7, 2017 Approval Letter – Fluvirin (PDF – 32KB)
  Posted: 7/11/2017
• June 22, 2017 Summary Basis for Regulatory Action – HAEGARDA (PDF – 608KB)
  Posted: 7/11/2017
• July 7, 2017 Approval Letter – Flucelvax Quadrivalent (PDF – 31KB)
  Posted: 7/11/2017
• July 7, 2017 Approval Letter – FLUAD (PDF – 24KB)
  Posted: 7/11/2017
• July 7, 2017 Approval Letter – Fluzone (PDF – 31KB)
  Posted: 7/11/2017
• July 7, 2017 Approval Letter – Flublok and Flublok Quadrivalent (PDF – 32KB)
  Posted: 7/11/2017

CDC Vaccine Information Statements Update

Having trouble viewing this email? View it as a Web page. You are subscribed to CDC’s Vaccine Information Statements (VIS) email subscription service. This message serves to notify you that a vaccine information statement for the new Cholera vaccine has recently been created and is now available. The CDC has reached over 1.3 million subscribers. Thank you for your support. Update Subscriber Preferences or Unsubscribe | Learn about CDC Updates Questions or problems? Please contact support.