medicare part d how cms uses the fda nsde file craig miner rph, jd october 28, 2013
TRANSCRIPT
Medicare Part DMedicare Part D
How CMS uses the FDA NSDE File
Craig Miner Rph, JDOctober 28, 2013
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Medicare Part DMedicare Part D
• Prescription Drug Benefit Administered by Private Plans that contract with CMS
• Plans are paid PMPM premiums determined through a competitive bidding process [CMS and Beneficiary]
-CMS does NOT pay claims directly
• Plan payments are not entirely capitated -Reinsurance payments—CMS pays 80% of claim cost for beneficiaries that exceed the catastrophic threshold-Risk Sharing
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Part D ClaimsPart D Claims
• Part D plans adjudicate pharmacy claims for Part D drugs
• Plans report their Part D claims to CMS—reports referred to as prescription drug events (PDEs)
• PDEs must pass CMS edits to be accepted by CMS
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Part D DrugsPart D Drugs
• FDA approved RX Drugs (NDA, ANDA and BLA)
• Possibly some older drugs that have not been subject to a “new drug” determination by FDA
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Part D ExclusionsPart D Exclusions
– Excluded Classes• RX Vitamins (except prenatal vitamins)• Drugs used for weight loss or gain• Cosmetic Drugs• Cough/Cold Drugs• ED Drugs
–Drugs covered under Medicare Part A or B
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FDA NSDE FileFDA NSDE File
• NSDE—Comprehensive NDC SPL Data Elements File (http://labels.fda.gov )
• Data Elements include:– NDC (11 digit)– Marketing Category (NDA, BLA, ANDA, Unapproved)– Application Number– Marketing Start and End dates
• NSDE is CMS’ Authoritative source of NDC information for Medicare Part D Formulary Reference File and PDE Editing
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Part D Formulary Reference File
Part D Formulary Reference File
• Pick-list of Part D drugs used by Part D plans to specify their formulary drugs
• Drugs are listed by RXNORM code but must be represented by at least one NDC on NSDE File
• Only drugs on FRF are displayed on Medicare Plan Finder
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PDEs and NSDE FilePDEs and NSDE File
• All PDEs--CMS only accepts PDEs with NDCs listed on NSDE file with “date of service” prior to any “marketing end date”
• Coverage Gap Discount Program—CMS only accepts PDEs with NDCs representing NDA or BLA approved drugs that are covered by a Coverage Gap Discount Program Agreement
