Medicare Part D

Medicare Part D

How CMS uses the FDA NSDE File

Craig Miner Rph, JDOctober 28, 2013

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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

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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

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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

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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

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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

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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 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

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Contact Information

Craig Miner410-786-7937

[email protected]