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

2. 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

3. 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

4. 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

5. 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

6. FDA NSDE File
NSDE—Comprehensive NDC SPL Data Elements File ( )
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

7. 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

8. 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

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