CMS Nonmatched NDC List Webinar

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CMS Non-matched NDC List Webinar

• Presented by
• The National Council for Prescription Drug
  Programs
• September 3, 2009

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Speakers

• Moderator Thomas R. Bizzaro, R.Ph.
• Vice President, Health Policy and Industry
  Relations, First DataBank
• Sandra Anderson, CMS Sandra.Anderson_at_cms.hhs.gov
  
• Tamara Bruce, CMS - Tamara.bruce_at_cms.hhs.gov
• John Coburn, FDA John.Coburn_at_fda.hhs.gov
• John Kilbourne M.D., NLM-RxNorm
  john.kilbourne_at_nih.hhs.gov
• Randy Levin, M.D., FDA Randy.Levin_at_fda.hhs.gov
• Craig Miner, R.Ph., J.D., CMS
  Craig.Miner_at_CMS.hhs.gov
• Kim Tran Simmons, R.Ph., J.D., FDA
• Kim-Chi.Simmons_at_fda.hhs.gov
• Lonnie Smith, FDA - Lonnie.Smith_at_fda.hhs.gov

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Objectives

• Understanding of CMS Non-matched NDC list
• Description of FDA Drug Listing Requirements
• Implications of the list
• Medicare Part D Plans
• Providers
• Manufacturers/Distributors
• Medicare Part D Participants

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CMS Non-matched NDC List

• NDCs that effectively will not be eligible for
  reimbursement under Medicare Part D Plans
• List compiled by matching NDCs available from the
  National Library of Medicine (NLM) with the FDA
  NDC Directory
• Effective January 1, 2010

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The FDA Drug Listing Requirement

• All drugs marketed in the United States are
  required to be properly listed with the FDA
• The Drug Listing regulations are not new and have
  been in force for many years

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FDAs Registration Drug Listing

• LAWS REGULATIONS
• Section 510 Federal Food Drug Cosmetic Act (21
  U.S.C. 360)
• http//www.fda.gov/RegulatoryInformation/Legislati
  on/FederalFoodDrugandCosmeticActFDCAct/FDCActChapt
  erVDrugsandDevices/ucm109201.htm
• 21 CFR 207
• http//www.access.gpo.gov/nara/cfr/waisidx_09/21cf
  r207_09.html
• REQUIREMENTS
• Summary of Registration and Listing Requirements
• http//www.fda.gov/Drugs/GuidanceComplianceRegulat
  oryInformation/DrugRegistrationandListing/ucm07975
  5.htm
• FDA Website Drug Registration and Listing System
  (DRLS)
• http//www.fda.gov/Drugs/GuidanceComplianceRegulat
  oryInformation/DrugRegistrationandListing/default.
  htm
• FDA Website Electronic Drug Registration and
  Listing Instructions
• http//www.fda.gov/Drugs/GuidanceComplianceRegulat
  oryInformation/DrugRegistrationandListing/ucm07880
  1.htm

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FDAs Registration Drug Listing

• REGISTRATION LISTING STATUS
• Drug Firm Annual Registration Status
• http//www.fda.gov/Drugs/GuidanceComplianceRegulat
  oryInformation/DrugRegistrationandListing/ucm07099
  8.htm
• FDA NDC Directory
• Background Information
• http//www.fda.gov/Drugs/InformationOnDrugs/ucm142
  438.htm
• Search the database
• http//www.accessdata.fda.gov/scripts/cder/ndc/def
  ault.cfm
• FOR MORE INFORMATION
• For questions or concerns about FDAs NDC
  Directory, FDAs drug listing procedures, or
  possible errors in the Non-Matched NDC List,
  please contact FDAs Drug Registration and
  Listing Team at [phone] or e-mail
  nonlisted_at_fda.hhs.gov.
• For questions or concerns about electronic drug
  listing submissions, please contact FDAs Drug
  Registration and Listing Team at [phone]
  or e-mail spl_at_fda.hhs.gov.

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CMS Non-matched NDC List

• The list does not indicate that drugs are
  approved or unapproved
• It is likely that new NDCs will NOT be added to
  the list during 2010
• CMS may update the list no more than twice in
  2010 (remove drugs that have become properly
  listed)
• Plans may reimburse for any appropriate drugs
  properly listed in the FDA NDC directory

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CMS Non-matched NDC List

• Pilot CMS Non-matched NDC list
• http//www.cms.hhs.gov/PrescriptionDrugCovContra/0
  3_RxContracting_FormularyGuidance.asp (click on
  the zipped file entitled Non-Matched National
  Drug Code (NDC) List)
• CMS will publish a final Non-matched NDC list in
  September for use beginning 1/1/2010

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CMS Non-matched NDC List

• For questions or concerns about
• FDAs NDC Directory
• FDAs drug listing procedures
• possible inaccuracies in the Non-Matched NDC
  List, contact FDAs Drug Registration and Listing
  Team at [phone] or e-mail
  nonlisted_at_fda.hhs.gov.
• For questions or concerns about PDE reject edits
  for NDCs listed on the Non-Matched NDC List,
  e-mail PartD_NDC_at_cms.hhs.gov

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Implications

• Manufacturers/Distributors
• Responsible for ensuring that all drugs marketed
  in the United States are properly listed
• Drugs on the non-matched list will not be
  eligible for reimbursement for Medicare Part D
  participants

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Implications

• Medicare Part D Plans
• Formularies should be reviewed to ensure that
  drugs are properly listed
• Participants access to care may be affected if
  Part D plans do not proactively address potential
  issues ahead of time
• Prescription Drug Events (PDE) for drugs that are
  removed from the CMS non-matched list will need
  resubmitted

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Implications

• Part D Pharmacy Providers
• Claims (PDE) for drugs on the CMS non-matched NDC
  list may be rejected
• Participants access to care may be affected if
  providers are not prepared ahead of time
• Multi-Source products rejected may be
  manufacturer/distributor specific

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CMS Non-matched NDC List

• Plan sponsors and pharmacy providers should
  review the FDA letter which accompanies the pilot
  Non-matched NDC list found at http//www.cms.hhs.g
  ov/PrescriptionDrugCovContra/03_RxContracting_Form
  ularyGuidance.asp
• (PDF document entitled FDACMSResponse_05.19.09)
  
• Initial CMS instructions for non-matched NDCs are
  in the 2010 Final Call Letter and can be found at
  http//www.cms.hhs.gov/PrescriptionDrugCovContra/
  beginning on page 58.

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Questions?