Medicare Part D How CMS uses the FDA

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 2

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 3

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 4

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 5

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 6

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 7

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 8

Contact Information Craig Miner 410 -786 -7937 Craig. miner@cms. hhs. gov 9