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 ID: 129218
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Slide1
Medicare Part D
How CMS uses the FDA NSDE File
Craig Miner
Rph
, JD
October 28, 2013Slide2
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 SharingSlide3
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
CMSSlide4
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 FDASlide5
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
BSlide6
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 EditingSlide7
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
FinderSlide8
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
Slide9
Contact Information
Craig Miner
410-786-7937
Craig.miner@cms.hhs.gov