How CMS uses the FDA NSDE File

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Presentation transcript:

How CMS uses the FDA NSDE File Medicare Part D How CMS uses the FDA NSDE File Craig Miner Rph, JD October 28, 2013

Medicare 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

Part 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

Part 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

Part 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

FDA 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

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

PDEs 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

Craig Miner 410-786-7937 Craig.miner@cms.hhs.gov Contact Information Craig Miner 410-786-7937 Craig.miner@cms.hhs.gov