-
Label Name Reason
12-PANEL POC KIT TOXICOLO Diagnostic Agent1ST BASE CRE Bulk
Ingredient2-FUCCOSYLLA PAK LACTO-N Medical FoodA.A.G.C KIT CRE
TERODERM Not properly listed with FDAABANEU-SL SUB
Vitamin/MineralABLAVAR INJ 244MG/ML Diagnostic AgentACACIA EXTRA
SOL 1:20 Non-standardized allergenicACCUCAINE INJ 1% LISTACD
FORMULA SOL A Blood ComponentACLARO EMU CosmeticACREMONIUM SOL
20000PNU Non-standardized allergenicACTCT FLEX 3 PAD 4"X4" Not
properly listed with FDAACTHREL INJ 100MCG Diagnostic AgentACTI
ANTIMIC PAD 2"X2" Not properly listed with FDAACTI ANTIMIC PAD
4"X4" Not properly listed with FDAACTICOAT 7 PAD 2"X2" Not properly
listed with FDAACTICOAT 7 PAD 4"X5" Not properly listed with
FDAACTICOAT ABS PAD 4"X5" Not properly listed with FDAACTICOAT MOI
PAD 2"X2" Surgical Supply/MedicalACTICOAT MOI PAD 4"X4" Surgical
Supply/MedicalACTICOAT MOI PAD 4"X8" Surgical
Supply/MedicalACTICOAT SUR PAD 4"X10" Surgical
Supply/MedicalACTICOAT SUR PAD 4"X8" Surgical
Supply/MedicalACTICOAT SUR PAD 4X13.75" Surgical
Supply/MedicalACTICOAT SUR PAD 4X4-3/4" Surgical
Supply/MedicalACTIVASE INJ 50MG LISTACTIVE INJEC INJ DL Bulk
IngredientACTIVE INJEC INJ M-1 Bulk IngredientACTIVE INJEC KIT
BLM-1 Bulk IngredientACTIVE INJEC KIT BM Bulk IngredientACTIVE
INJEC KIT D Bulk IngredientACTIVE INJEC KIT DLM Bulk
IngredientACTIVE INJEC KIT KET-L Bulk IngredientACTIVE INJEC KIT
KETMARC Bulk IngredientACTIVE INJEC KIT KL-3 Bulk IngredientACTIVE
INJEC KIT KM Bulk IngredientACTIVE INJEC KIT LM-2 Bulk
IngredientACTIVE INJEC KIT LM-DEP-1 Bulk IngredientACTIVE KIT
INJECT L Bulk IngredientACTIVE MEDIC KIT SPECIMEN Diagnostic
AgentACTIVE OB CAP Vitamin/MineralACTIVE-PAC/ MIS GABA 300
LISTACTIVE-PREP CRE KIT I Bulk IngredientACTIVE-PREP CRE KIT II
Bulk IngredientACTIVE-PREP CRE KIT III Bulk Ingredient
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
ACTIVE-PREP CRE KIT IV Bulk IngredientACTIVE-PREP CRE KIT V Bulk
IngredientACUICYN LIQ Not properly listed with FDAACUNOL TAB 600MG
Unapproved DrugADA SHA Not properly listed with FDAADAPTADERM CRE
Not properly listed with FDAADAZIN CRE Unapproved DrugADDYI TAB
100MG Sexual Dysfunction AgentADENOSCAN INJ 3MG/ML Diagnostic
AgentADENOSINE INJ 3MG/ML Diagnostic AgentADIPEX-P CAP 37.5MG
Anorexic, Anti-obestiy AgentADIPEX-P TAB 37.5MG Anorexic,
Anti-obestiy AgentADRENAL C TAB FORMULA Vitamin/MineralADREVIEW INJ
Diagnostic AgentADV ALLERGY KIT COLLECTI Not properly listed with
FDAADVANCED MIS AM/PM Vitamin/MineralADVANCED BAS CRE PLUS Not
properly listed with FDAADVANCED DNA KIT COLLECTI Diagnostic
AgentADVATE INJ 1000UNIT Blood ComponentADVATE INJ 1500UNIT Blood
ComponentADVATE INJ 2000UNIT Blood ComponentADVATE INJ 250UNIT
Blood ComponentADVATE INJ 3000UNIT Blood ComponentADVATE INJ
4000UNIT Blood ComponentADVATE INJ 500UNIT Blood ComponentADYNOVATE
INJ 1000UNIT Blood ComponentADYNOVATE INJ 1500UNIT Blood
ComponentADYNOVATE INJ 2000UNIT Blood ComponentADYNOVATE INJ
250UNIT Blood ComponentADYNOVATE INJ 3000UNIT Blood
ComponentADYNOVATE INJ 500UNIT Blood ComponentADYNOVATE INJ 750UNIT
Blood ComponentADYPHREN KIT LISTADYPHREN AMP KIT 1MG/ML Unapproved
DrugADYPHREN II KIT Unapproved DrugAFLURIA INJ 2014-15 Influenza
VaccineAFLURIA INJ 2015-16 Influenza VaccineAFLURIA INJ 2016-17
Influenza VaccineAFLURIA INJ PF 14-15 Influenza VaccineAFLURIA INJ
PF 15-16 Influenza VaccineAFLURIA INJ PF 16-17 Influenza
VaccineAFLURIA QUAD INJ PF 16-17 Influenza VaccineAFSTYLA KIT
1000UNIT Blood ComponentAFSTYLA KIT 1500UNIT Blood ComponentAFSTYLA
KIT 2000UNIT Blood Component
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
AFSTYLA KIT 2500UNIT Blood ComponentAFSTYLA KIT 250UNIT Blood
ComponentAFSTYLA KIT 3000UNIT Blood ComponentAFSTYLA KIT 500UNIT
Blood ComponentAGONEAZE KIT 2.5-2.5% LISTAIF #2 DRUG CRE PREP KIT
Not properly listed with FDAAIF #3 DRUG CRE PREP KIT Not properly
listed with FDAAIRAVITE TAB Vitamin/MineralAK-FLUOR INJ 10% OP
Diagnostic AgentAK-FLUOR INJ 25% OP Diagnostic AgentALA-QUIN CRE
3-0.5% DESIALBA-DERM CRE Unapproved DrugALBUKED 25 INJ 25% Blood
ComponentALBUKED 5 INJ 5% Blood ComponentALBUMIN HUM INJ 25% Blood
ComponentALBUMIN HUM INJ 5% Blood ComponentALBUMIN-ZLB INJ Blood
ComponentALBUMIN-ZLB SOL 25% Blood ComponentALBUMINAR-25 INJ 25%
Blood ComponentALBUMINAR-5 INJ 5% Blood ComponentALBURX INJ 5%
Blood ComponentALBUTEIN INJ 25% Blood ComponentALBUTEIN INJ 5%
Blood ComponentALCOHOL INJ 98% Unapproved DrugALCOHOL BASE GEL Not
properly listed with FDAALCORTIN A GEL DESIALCORTIN A GEL 1-2-1%
DESIALDER EXTRAC SOL 1:20 Non-standardized allergenicALEVICYN GEL
Not properly listed with FDAALEVICYN KIT PLUS Not properly listed
with FDAALEVICYN SOL DERMAL Not properly listed with FDAALEVICYN SG
LIQ ANTIPRUR Not properly listed with FDAALKERAN TAB 2MG Oral drug
for cancer; infusion available under Part BALLEVYN AG PAD 2"X2" Not
properly listed with FDAALLEVYN AG PAD 2"X2" Surgical
Supply/MedicalALLEVYN AG PAD 3"X3" Not properly listed with
FDAALLEVYN AG PAD 4"X4" Not properly listed with FDAALLEVYN AG PAD
4"X4" Surgical Supply/MedicalALLEVYN AG PAD 5"X5" Not properly
listed with FDAALLEVYN AG PAD 6"X6" Not properly listed with
FDAALLEVYN AG PAD 6"X6" Surgical Supply/MedicalALLEVYN AG PAD
6-3/4" Not properly listed with FDAALLEVYN AG PAD 7"X7" Not
properly listed with FDAALLEVYN AG PAD 8"X8 Surgical
Supply/MedicalALLEVYN AG PAD 8"X8" Not properly listed with FDA
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
ALLEVYN AG PAD 9"X9"SAC Not properly listed with FDAALLEVYN GENT
PAD 4"X4 Not properly listed with FDAALLEVYN GENT PAD 8"X8" Not
properly listed with FDAALLO-PAX CRE 5-5% Unapproved DrugALMOND INJ
EXTRACT Diagnostic AgentALOQUIN GEL 1.25-1% DESIALPAWASH OIN Not
properly listed with FDAALPHANATE INJ VWF/HUM Blood
ComponentALPHANATE INJ VWF/HUM Blood ComponentALPHANATE INJ VWF/HUM
Blood ComponentALPHANATE INJ VWF/HUM Blood ComponentALPHANATE INJ
VWF/HUM Blood ComponentALPHANINE SD INJ 1000UNIT Blood
ComponentALPHANINE SD INJ 1500UNIT Blood ComponentALPHANINE SD INJ
500UNIT Blood ComponentALPHAQUIN HP CRE 4% CosmeticALPROLIX INJ
1000UNIT Blood ComponentALPROLIX INJ 2000UNIT Blood
ComponentALPROLIX INJ 250UNIT Blood ComponentALPROLIX INJ 3000UNIT
Blood ComponentALPROLIX INJ 4000UNIT Blood ComponentALPROLIX INJ
500UNIT Blood ComponentALPROSTADIL INJ 500MCG Erectile
DysfunctionALTACAINE SOL 0.5% OP Unapproved DrugALTADERM CRE BASE
Not properly listed with FDAALTAFLUOR SOL 0.25-0.4 Diagnostic
AgentALTERNARIA SOL EXTRACT Non-standardized allergenicALUVEA CRE
39% Unapproved DrugAMERICAN INJ SYCAMORE Non-standardized
allergenicAMERICAN SOL BEECH Non-standardized allergenicAMERICAN
SOL COCKROAC Non-standardized allergenicAMERICAN ELM SOL
Non-standardized allergenicAMIDATE INJ 2MG/ML General
AnestheticAMINO PM RMS CAP Not properly listed with FDAAMINOAC ACID
SOL 1.5% IRR Not properly listed with FDAAMINOAM CAP RMS Not
properly listed with FDAAMINOBEZ POT POW DESIAMINORELIEF CAP RMS
Not properly listed with FDAAMITRIPTYLIN CRE Not properly listed
with FDAAMITRIPTYLIN KIT 2% Bulk IngredientAMLODIPINE SUS 1MG/ML
LISTAMORPH WOUND GEL DRESSING Not properly listed with FDAAMVISC
INJ 12MG/ML DeviceAMVISC PLUS INJ 16MG/ML DeviceAMYTAL SOD INJ
500MG Unapproved Drug
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
AMYVID INJ Diagnostic AgentANA-LEX KIT Unapproved DrugANALPRAM
KIT ADVANCED Unapproved DrugANALPRAM E KIT DESIANALPRAM HC CRE
2.5-1% Unapproved DrugANALPRAM-HC CRE 1-1% Unapproved
DrugANALPRAM-HC CRE 1-2.5% DESIANALPRAM-HC CRE SINGLES Unapproved
DrugANALPRAM-HC CRE SINGLES DESIANALPRAM-HC LOT 2.5% Unapproved
DrugANALPRM SNGL CRE HC 2.5-1 Unapproved DrugANASCORP INJ
LISTANASEPT SPR Not properly listed with FDAANASPAZ TAB 0.125MG
Unapproved DrugANASTIA LOT 2.75% Not properly listed with
FDAANECTINE INJ 20MG/ML LISTANESTHESIA KIT S/I-60 General
AnestheticANHYDROUS CRE BASE Not properly listed with FDAANHYDROUS
OIN BASE Not properly listed with FDAANIMI-3 CAP
Vitamin/MineralANIMI-3 CAP Vitamin/MineralANIMI-3 CAP VIT D
Vitamin/MineralANODYNE LPT KIT 2.5-2.5% LISTANODYNZ MIS 0.0375-5
Unapproved DrugANTICOAG CIT SOL DEX SOL Unapproved DrugANTICOAG CPD
SOL Blood ComponentANTIPRURITIC GEL Not properly listed with
FDAANTIPY/BENZO SOL OTIC Unapproved DrugANTIPY/BENZO SOL OTIC
Unapproved DrugANTIVENIN KIT LAT MACT LISTANTIVENIN MI INJ
LISTANTIVENIN NA INJ CORAL SN LISTANUCORT-HC SUP 25MG DESIANUSOL-HC
SUP 25MG DESIAP-ZEL TAB Vitamin/MineralAPLISOL INJ 5/0.1ML
Diagnostic AgentAPOTHEDERM CRE Not properly listed with
FDAAPOTHESAR CRE PLUS Not properly listed with FDAAPOTHESAR CRE
TRANSDER Not properly listed with FDAAPOTHESAR 2 CRE Not properly
listed with FDAAPOTHESIL CRE Not properly listed with FDAAPP SLIM
RMS CAP Not properly listed with FDAAPP-TRIM-D CAP Anorexic,
Anti-obestiy AgentAPPLE INJ EXTRACT Diagnostic AgentAPPTRIM CAP
Anorexic, Anti-obestiy Agent
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
APPTRIM-D CAP Anorexic, Anti-obestiy AgentAQUASOL A INJ 50000/ML
Vitamin/MineralAQUORAL AER DeviceAQUORAL SPR Not properly listed
with FDAARGENTUM-D20 INJ Not properly listed with FDAARIDA GEL
Surgical Supply/MedicalARIZONA INJ CYPRESS Non-standardized
allergenicARMOUR THYRO TAB 120MG Unapproved DrugARMOUR THYRO TAB
15MG Unapproved DrugARMOUR THYRO TAB 180MG Unapproved DrugARMOUR
THYRO TAB 240MG Unapproved DrugARMOUR THYRO TAB 300MG Unapproved
DrugARMOUR THYRO TAB 30MG Unapproved DrugARMOUR THYRO TAB 60MG
Unapproved DrugARMOUR THYRO TAB 90MG Unapproved DrugARNICA LG LIQ
Unapproved DrugARNICA TIN FLOWER Unapproved DrugARTICADENT INJ
DENTAL LISTARTICADENT INJ DENTAL LISTARZE-JECT-A KIT LISTARZOL
SILVER MIS NITR APP Unapproved DrugASCLERA INJ 0.5% LISTASCLERA INJ
1% LISTASCORBIC ACD INJ 500MG/ML Vitamin/MineralASILNASAL CAP RMS
Not properly listed with FDAASPERGILLUS INJ 1:500 Diagnostic
AgentASPERGILLUS SOL 1:20 Non-standardized allergenicASPERGILLUS
SOL FUMIGATI Non-standardized allergenicASTAMED MYO CAP Not
properly listed with FDAASTERO GEL 4% Not properly listed with
FDAASTRINGYN SOL 259MG/GM Not properly listed with FDAATABEX EC TAB
Vitamin/MineralATENDIA PAD 4-3% Unapproved DrugATENOLOL SUS 1GM/ML
LISTATOPICLAIR CRE DeviceATORVA/COQ10 PAK 20-100MG Not properly
listed with FDAATRACURIUM INJ 10MG/ML LISTATRACURIUM INJ 10MG/ML
LISTATRACURIUM INJ 50MG/5ML LISTATRAPRO GEL HYDROGEL DeviceATRAPRO
CP KIT Not properly listed with FDAATRAPRO DERM SPR Not properly
listed with FDAATROPINE SUL OIN 1% OP Unapproved DrugAUREOBASIDIU
INJ 1:10 Non-standardized allergenicAUREOBASIDIU SOL 1:20
Non-standardized allergenic
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
AURSTAT KIT HYDROGEL DeviceAURSTAT ANTI GEL -ITCH DeviceAURUM
LIQ 12X Unapproved DrugAUSTRALIAN SOL PINE EXT Non-standardized
allergenicAUXIPRO CRE EMOLLIEN Not properly listed with FDAAUXIPRO
CRE VANISHIN Not properly listed with FDAAV-PHOS 250 TAB NEUTRAL
Dietary SupplementAV-VITE FB TAB 2.5-25-1 Vitamin/MineralAV-VITE FB
TAB 2.5-25-2 Vitamin/MineralAVAGE CRE 0.1% CosmeticAVAILNEX CHW
750MG Not properly listed with FDAAVAR AER 9.5-5% Unapproved
DrugAVAR PAD 9.5-5% Unapproved DrugAVAR CLEANSE EMU 10-5%
Unapproved DrugAVAR LS AER 10-2% Unapproved DrugAVAR LS LIQ 10-2%
Unapproved DrugAVAR LS PAD 10-2% Unapproved DrugAVAR-E EMOLL CRE
10-5% Unapproved DrugAVAR-E GREEN CRE 10-5% Unapproved DrugAVAR-E
LS CRE 10-2% Unapproved DrugAVENOVA SOL 0.01% Not properly listed
with FDAAVENOVA SOL NEUTROX Not properly listed with FDAAVIDOXY DK
KIT Not properly listed with FDAAVO CREAM EMU Surgical
Supply/MedicalAVOCADO INJ EXTRACT Diagnostic AgentAXONA POW Medical
FoodAZENASE PAK MIS 137-50 Not properly listed with FDAAZUPHEN MB
CAP 120MG Unapproved DrugB-12 COMP KIT 1000MCG Vitamin/MineralB-12
KIT 1000MCG Vitamin/MineralB-COMPLEX INJ 100 Vitamin/MineralB-DONNA
TAB 16.2MG Unapproved DrugB-PLEX TAB Vitamin/MineralB-PLEX PLUS TAB
Vitamin/MineralB-SERENE PAD Dietary SupplementB12 COMPLNCE KIT INJ
KIT Vitamin/MineralB3/AZEL/TURM TAB FA/B6/ZN Vitamin/MineralB6
FOLIC ACD CAP Vitamin/MineralBACLOFEN CRE Not properly listed with
FDABACLOFEN CRE 1% Bulk IngredientBACLOFEN CRE 2% Bulk
IngredientBACMIN TAB Vitamin/MineralBACTER WATER INJ BENZ ALC
Unapproved DrugBACTER WATER INJ PARABENS Unapproved DrugBAHIA SOL
EXTRACT Non-standardized allergenic
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
BAL SALT SOL OP LISTBAL-CARE MIS DHA Vitamin/MineralBALANCED SAL
SOL OP LISTBALD CYPRESS INJ 1:20 Non-standardized allergenicBANANA
INJ EXTRACT Diagnostic AgentBARIUM POW SULFATE Diagnostic AgentBASE
CRE LIPOSOME Bulk IngredientBASE FOR CRE SCARS Not properly listed
with FDABASE W301 CRE Not properly listed with FDABAYBERRY WAX SOL
MYR EXTR Non-standardized allergenicBD POSIFLUSH INJ 0.9% Not
properly listed with FDABEAU RX GEL Not properly listed with
FDABEBULIN INJ 200-1200 Blood ComponentBEE VENOM INJ 1300MCG
Non-standardized allergenicBEE VENOM INJ 550MCG Non-standardized
allergenicBEEF EXTRACT INJ 1:10 Diagnostic AgentBELLA ALK/PB TAB
16.2MG Unapproved DrugBELLA/OPIUM SUP 16.2-30 Unapproved
DrugBELLA/OPIUM SUP 16.2-60 Unapproved DrugBELVIQ TAB 10MG
Anorexic, Anti-obestiy AgentBELVIQ XR TAB 20MG Anorexic,
Anti-obestiy AgentBENEFIX INJ 1000UNIT Blood ComponentBENEFIX INJ
2000UNIT Blood ComponentBENEFIX INJ 250UNIT Blood ComponentBENEFIX
INJ 3000UNIT Blood ComponentBENEFIX INJ 500UNIT Blood
ComponentBENSAL HP OIN Unapproved DrugBENZAC AC LIQ 5% WASH
Unapproved DrugBENZALKONIUM SOL 50% Unapproved DrugBENZEFOAM AER
5.3% Unapproved DrugBENZEFOAM AER 9.8% Unapproved DrugBENZEPRO AER
5.3% Unapproved DrugBENZEPRO LIQ CREAMY Unapproved DrugBENZEPRO MIS
6% Unapproved DrugBENZEPRO SC AER 9.8% Unapproved DrugBENZIQ GEL
5.25% Unapproved DrugBENZIQ LS GEL 2.75% Unapproved DrugBENZIQ WASH
LIQ 5.25% Unapproved DrugBENZODOX 30 MIS Unapproved DrugBENZODOX 60
MIS Unapproved DrugBENZOIN TIN NF Unapproved DrugBENZOIN CMPD TIN
Unapproved DrugBENZONATATE CAP 100MG Cough/ColdBENZONATATE CAP
150MG Cough/ColdBENZONATATE CAP 200MG Cough/Cold
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
BENZOYL PER AER 5.3% Unapproved DrugBENZOYL PER AER 9.8%
Unapproved DrugBENZOYL PERO AER 9.8% Unapproved DrugBENZPHETAMIN
TAB 50MG Anorexic, Anti-obestiy AgentBENZPHETMINE TAB 25MG
Anorexic, Anti-obestiy AgentBERMUDA SOL GRASS Non-standardized
allergenicBETA 1 KIT KIT 30MG/5ML LISTBETALIDO KIT LISTBETALOAN SUI
INJ 3-3MG/ML LISTBETTERMILK PAK GLYTACTI Not properly listed with
FDABETTERMILK15 POW GLYTACTN Not properly listed with FDABHI URI-
TAB CONTROL Unapproved DrugBIAFINE EMU Surgical
Supply/MedicalBIEST/PROGES CRE Bulk IngredientBIMATOPROST SOL 0.03%
CosmeticBIO GLO TES 1MG OP Diagnostic AgentBIO-STATIN POW Not
properly listed with FDABIOCEL TAB Vitamin/MineralBIONECT AER 0.2%
Surgical Supply/MedicalBIONECT CRE 0.2% Surgical
Supply/MedicalBIONECT GEL 0.2% Surgical Supply/MedicalBIOPEPTIDE
CRE BASE Not properly listed with FDABIOPSY TRAY KIT MARROW Not
properly listed with FDABIOTUSS LIQ Cough/ColdBIOTUSS LIQ PEDIATRC
Cough/ColdBL INJECTION KIT Unapproved DrugBLACK WALNUT SOL POLL EXT
Non-standardized allergenicBLACK WILLOW INJ 1:20 Non-standardized
allergenicBLANCHE CRE 4% CosmeticBONE MARROW KIT BIOPSY Not
properly listed with FDABONTRIL PDM TAB 35MG Anorexic, Anti-obestiy
AgentBORIC ACID GRA Bulk IngredientBOTOX COSMET INJ 100UNIT
CosmeticBOTOX COSMET INJ 50UNIT CosmeticBOTRYTIS EXT SOL 20000PNU
Non-standardized allergenicBOX ELDER INJ EXT 1:20 Non-standardized
allergenicBP 10-1 EMU Unapproved DrugBP CLEANSING EMU 10-4%
Unapproved DrugBP FOAM AER 5.3% Unapproved DrugBP FOAM AER 9.8%
Unapproved DrugBP FOAMING LIQ WASH 10% Not properly listed with
FDABP FOLINATAL TAB PLUS B Vitamin/MineralBP MULTINATL CHW PLUS
Vitamin/MineralBP MULTINATL TAB PLUS Vitamin/MineralBP VIT 3 CAP
Vitamin/Mineral
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
BP VIT 3 CAP PLUS Vitamin/MineralBP WASH LIQ 2.5% Unapproved
DrugBP WASH LIQ 7% Unapproved DrugBPM TAB 6MG Unapproved DrugBPM
PSEUDO TAB 6-45MG Unapproved DrugBPO CLOTHS MIS 3% Unapproved
DrugBPO CLOTHS MIS 6% Unapproved DrugBPO CLOTHS MIS 9% Unapproved
DrugBRAVELLE INJ 75UNIT Fertility AgentBREVITAL SOD INJ 2.5GM
General AnestheticBREVITAL SOD INJ 500MG General
AnestheticBROM/PSE/DM SYP Cough/ColdBROME SOL 1:20 Non-standardized
allergenicBROMFED DM SYP Cough/ColdBROMPHENIRAM CHW 12MG Unapproved
DrugBSS SOL OP LISTBSS PLUS SOL OP LISTBT INJECTION KIT 40-0.5%
Unapproved DrugBUMINATE INJ 25% Blood ComponentBUMINATE INJ 5%
Blood ComponentBUPIVACA/D5W INJ /SPINAL LISTBUPIVACAINE INJ SPINAL
LISTBUPIVACAINE/ INJ EPI 0.25 LISTBUPIVACAINE/ INJ EPI 0.25
LISTBUPIVACAINE/ INJ EPI 0.5% LISTBUPIVACAINE/ INJ EPI 0.5%
LISTBUPIVILOG KIT LISTBXN MOUTHWSH SUS Unapproved DrugC-NATE DHA
CAP 28-1-200 Vitamin/MineralCA ALGINATE MIS 12" ROPE Unapproved
DrugCA ALGINATE PAD 2"X2" Unapproved DrugCA ALGINATE PAD 4"X4"
Unapproved DrugCA ALGINATE PAD 4"X8" Unapproved DrugCADIRAMD KIT
Unapproved DrugCAFFEINE/SOD INJ BENZOATE Unapproved DrugCALCIFOL
WAF Vitamin/MineralCALCIUM PNV CAP Vitamin/MineralCALCIUM-FA WAF
PLUS D Vitamin/MineralCALI PEPPER INJ TREE Non-standardized
allergenicCAM PRO COMP BAR GLYTACTI Not properly listed with
FDACAMINO PRO LIQ 15PE Not properly listed with FDACAMINO PRO LIQ
PKU Not properly listed with FDACAMINO PRO LIQ RESTORE Not properly
listed with FDACAMINO PRO PAK SWIRL Not properly listed with
FDACAMINO PRO POW BETTRMLK Not properly listed with FDA
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
CAMPHOMEX SPR Unapproved DrugCANDIDA ALBI INJ 1:20
Non-standardized allergenicCANDIDA INJ ALBICANS Diagnostic
AgentCANDIN INJ Diagnostic AgentCANDIDA SOL ALBICANS
Non-standardized allergenicCANTALOUPE INJ EXTRACT Diagnostic
AgentCAPXIB KIT LISTCAPECITABINE TAB 150MG Covered under Part B;
oral drug only indicated for cancerCAPECITABINE TAB 500MG Covered
under Part B; oral drug only indicated for cancerCAPHOSOL SOL
DeviceCAPSULE #0 CAP VEGGIE Unapproved DrugCAPSULE #1 CAP DRCAPS
Unapproved DrugCAPSULE 0 CAP CLR DR Unapproved DrugCAPSULE CONI CAP
-SN #000 Unapproved DrugCAPSULE CONI CAP -SNAP #0 Unapproved
DrugCAPSULE CONI CAP -SNAP #0 Unapproved DrugCAPSULE CONI CAP -SNAP
#1 Unapproved DrugCAPSULE CONI CAP -SNAP #1 Unapproved DrugCAPSULE
CONI CAP -SNAP #2 Unapproved DrugCAPSULE CONI CAP -SNAP #3
Unapproved DrugCAPSULE CONI CAP -SNAP #3 Unapproved DrugCAPSULE
CONI CAP -SNAP #4 Unapproved DrugCAPSULE CONI CAP -SNAP#00
Unapproved DrugCAPSULE LOCK CAP #0 CLEAR Unapproved DrugCAPSULE
LOCK CAP #00 CLR Unapproved DrugCAPSULE LOCK CAP #1 CLEAR
Unapproved DrugCAPSULE LOCK CAP #3 CLEAR Unapproved DrugCAPTRACIN
PAD .0375-5% Unapproved DrugCARB-O-PHILC CRE /40 Not properly
listed with FDACARB-O-PHILC GEL 40% Unapproved DrugCARBAPHEN 12 LIQ
Cough/ColdCARBAPHEN 12 SUS PED Cough/ColdCARBOGEL GEL 940 Bulk
IngredientCARBOHOL GEL 940 Bulk IngredientCARBOMER GEL AQUEOUS Bulk
IngredientCARBOMER GEL HYDROALC Bulk IngredientCARDIOPLEGIC SOL
LISTCARDIOTEK-RX TAB Vitamin/MineralCARDIOVID CAP PLUS
Vitamin/MineralCARRASYN GEL DRESSING Not properly listed with
FDACARTICEL IMP LISTCASCARA EXT SAGRADA Unapproved DrugCASEIN INJ
EXTRACT Diagnostic AgentCAT HAIR INJ EXTRACT Non-standardized
allergenicCAT HAIR SOL EXTRACT Non-standardized allergenic
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
CATHFLO ACTI INJ VASE LISTCATTLE EPITH SOL 1:20 Non-standardized
allergenicCAVAREST GEL 1.1% Unapproved DrugCAVERJECT INJ 20MCG
Erectile DysfunctionCAVERJECT INJ 40MCG Erectile
DysfunctionCAVERJECT KIT 10MCG Erectile DysfunctionCAVERJECT KIT
20MCG Erectile DysfunctionCAVIRINSE SOL 0.2% Unapproved DrugCAYA
DPR Not properly listed with FDACEDAR ELM INJ 1:20 Non-standardized
allergenicCEFAZOLIN INJ 300GM Bulk IngredientCELA BASE CRE Bulk
IngredientCELACYN GEL Not properly listed with FDACELACYN KIT Not
properly listed with FDACEM-UREA SOL 45% Unapproved DrugCENFOL TAB
Vitamin/MineralCENOVIA CRE CosmeticCENTANY AT KIT 2% LISTCERACADE
EMU Not properly listed with FDACERAMAX CRE Not properly listed
with FDACEREFOLIN TAB Vitamin/MineralCEREFOLIN TAB NAC
Vitamin/MineralCEREFOLIN TAB NAC Vitamin/MineralCERETEC INJ
Diagnostic AgentCERISA WASH EMU 10-1% Unapproved DrugCEROVEL GEL
40% Unapproved DrugCEROVEL LOT 40% Unapproved DrugCERVICAL MIS
SPECIMEN Diagnostic AgentCETACAINE AER DESICETROTIDE KIT 0.25MG
Fertility AgentCHELIDONIUM LIQ COMPOUND Unapproved DrugCHERRY SYP
Bulk IngredientCHICKEN MEAT INJ EXTRACT Diagnostic AgentCHIRHOSTIM
SOL 16MCG Diagnostic AgentCHLORHEX GLU SOL 20% Bulk IngredientCHO
MAG TRIS LIQ 500/5ML Unapproved DrugCHOLETEC INJ Diagnostic
AgentCHROMIUM CL INJ 4MCG/ML Not properly listed with FDACHRYSADERM
CRE DAY Not properly listed with FDACHRYSADERM CRE NIGHT Not
properly listed with FDA
CIALIS TAB 10MG Erectile Dysfunction
CIALIS TAB 2.5MG* (Coverable for Benign Prostatic Hyperplasia
(BPH) diagnosis only.) Erectile Dysfunction [only coverable for
diagnosis of Benign Prostatic Hyperplasia (BPH)]
CIALIS TAB 20MG Erectile Dysfunction
CIALIS TAB 5MG* (Coverable for Benign Prostatic Hyperplasia
(BPH) diagnosis only.) Erectile Dysfunction [only coverable for
diagnosis of Benign Prostatic Hyperplasia (BPH)]CICLODAN CRE KIT
0.77% LIST
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
CIDALEAZE CRE 3% Not properly listed with FDACIFEREX CAP
Unapproved DrugCIFRAZOL CAP 1-3775 Unapproved DrugCISATRACURIU INJ
10MG/ML LISTCISATRACURIU INJ 2MG/ML Not properly listed with
FDACITRANATAL CAP HARMONY Vitamin/MineralCITRANATAL CAP HARMONY
Vitamin/MineralCITRANATAL CAP HARMONY Vitamin/MineralCITRANATAL MIS
90 DHA Vitamin/MineralCITRANATAL MIS B-CALM
Vitamin/MineralCITRANATAL PAK ASSURE Vitamin/MineralCITRANATAL PAK
DHA Vitamin/MineralCITRANATAL TAB RX Vitamin/MineralCITRUS POW
BERGAMOT Not properly listed with FDACLADOSPORIUM INJ CLADOSPO
Non-standardized allergenicCLADOSPORIUM SOL 1:20 Non-standardized
allergenicCLADOSPORIUM SOL 20000PNU Non-standardized
allergenicCLARIFOAM EF AER 10-5% Unapproved DrugCLARYS CRE
CosmeticCLEARPLEX X GEL 10% Unapproved DrugCLIN SINGLE KIT USE
LISTCLINDAP-T CRE Unapproved DrugCLINOIN CRE Not properly listed
with FDACLINPRO 5000 PST 1.1% Unapproved DrugCLODAN KIT 0.05%
LISTCLOMIPHENE TAB 50MG Fertility AgentCNL8 NAIL KIT LISTCO-BALAMIN
CAP Dietary SupplementCO-NATAL FA TAB 29-1MG
Vitamin/MineralCO-VERATROL CAP Unapproved DrugCOAGADEX INJ 250UNIT
Blood ComponentCOAGADEX INJ 500UNIT Blood ComponentCOAL TAR SOL 20%
Not properly listed with FDACOCAINE HCL SOL 4% Unapproved
DrugCOCKLEBUR EX SOL 1:20 Non-standardized allergenicCOCOA BEAN INJ
EXTRACT Diagnostic AgentCOD LIVER OIL Vitamin/MineralCODAR AR LIQ
2-8/5ML OTC ProductCOLLIGINIX MIS OTC ProductCOLCIGEL GEL
Unapproved DrugCOLLODION LIQ FLEXIBLE Not properly listed with
FDACOMPLETE NAT PAK DHA Vitamin/MineralCOMPLETENATE CHW
Vitamin/MineralCONCENTRATE CRE Not properly listed with FDACONCEPT
DHA CAP Vitamin/Mineral
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
CONCEPT OB CAP Vitamin/MineralCONRAY INJ 60% Diagnostic
AgentCONRAY 30 INJ 30% Diagnostic AgentCONRAY 43 INJ 43% Diagnostic
AgentCONTR ALLRGY KIT PREMD PK Unapproved DrugCONTRAVE TAB 8-90MG
Anorexic, Anti-obestiy AgentCONTROLRX CRE 1.1% Unapproved
DrugCONVENIENCE PAK Not properly listed with FDACOPASIL GEL Not
properly listed with FDACORIFACT KIT Blood ComponentCORN POLLEN SOL
1:20 Non-standardized allergenicCORTANE-B DRO AQ OTIC DESICORTANE-B
DRO OTIC DESICORTANE-B LOT DESICORTIC-ND DRO DESICORTROSYN INJ
0.25MG Diagnostic AgentCORVITA TAB Vitamin/MineralCORVITE TAB
Vitamin/MineralCORVITE FREE TAB Vitamin/MineralCOSYNTROPIN INJ
0.25MG Diagnostic AgentCOSYNTROPIN INJ 0.25MG Diagnostic
AgentCOVARYX TAB 1.25-2.5 Unapproved DrugCOVARYX HS TAB DESICPB WC
LIQ Cough/ColdCRAB EXTRACT INJ 1:10 Diagnostic AgentCREAM BASE CRE
Not properly listed with FDACROFAB INJ Not properly listed with
FDACURITY AMD MIS 1"X3' Not properly listed with FDACURITY AMD MIS
1/2"X3' Not properly listed with FDACURITY AMD MIS 1/4"X3' Not
properly listed with FDACURITY HYPER MIS 1/2"X15' Not properly
listed with FDACURITY IODO MIS STRIP Not properly listed with
FDACURITY NACL PAD 6"X6-3/4 Not properly listed with FDACURVULARIA
INJ 20000PNU Non-standardized allergenicCUSHING SYND KIT DIAG
Diagnostic AgentCUTIS PLUS CRE Bulk IngredientCYANOCOBALAM INJ
1000MCG Vitamin/MineralCYCLO/GABA PAK 10/300 LISTCYCLOBENZAPR CRE
20MG/GM Bulk IngredientCYCLOBENZAPR CRE 5% KIT Bulk
IngredientCYCLOBENZAPR PAK PAX Unapproved DrugCYCLOPHENE CRE
RAPIDPAQ Unapproved DrugCYFOLEX CAP Vitamin/MineralCYOTIC DRO
DESICYSTO-CONRAY INJ II 17.2% Diagnostic Agent
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
CYSTOGRAFIN INJ 30% Diagnostic AgentCYSTOGRAFIN- INJ DILUTE
Diagnostic AgentCYSVIEW INJ 100MG Diagnostic AgentCYTRA K GRA
CRYSTALS Unapproved DrugD-CARE 100X KIT LISTD-CARE BLOOD TES
GLUCOSE Diagnostic AgentD-CARE DM2 KIT 500MG LISTD-XYLOSE POW
Diagnostic AgentDATSCAN SOL Diagnostic AgentDEBACTEROL SOL 30-50%
DeviceDECON-A ELX 2-5MG/5M Unapproved DrugDECON-G DRO 2-1-40MG
DESIDEFINITY SUS 1.1MG/ML Diagnostic AgentDELFLEX-LC/ SOL 1.5% DEX
Dialysis covered by ESRD bundled paymentDELFLEX-LC/ SOL 2.5% DEX
Dialysis covered by ESRD bundled paymentDELFLEX-LC/ SOL 4.25 DEX
Dialysis covered by ESRD bundled paymentDELFLEX-SM/ SOL 1.5% DEX
Dialysis covered by ESRD bundled paymentDELFLEX-SM/ SOL 2.5% DEX
Dialysis covered by ESRD bundled paymentDELIVRA CRE SR Not properly
listed with FDADENTA 5000 CRE PLUS Unapproved DrugDENTA 5000 CRE
PLUS 2PK Unapproved DrugDENTAGEL GEL 1.1% Unapproved DrugDEPLIN 15
CAP Medical FoodDEPLIN 7.5 CAP Medical FoodDEPRIZINE SUS 22.4/ML
Unapproved DrugDEPRIZINE SUS RAPIDPAQ Unapproved DrugDERMA SERUM
CRE FREEDOM Not properly listed with FDADERMA SILKRX KIT SDS PAK
Unapproved DrugDERMA SILKRX PAK ANODYNEX LISTDERMA SILKRX PAK
DICLOPAK LISTDERMACINRX KIT 4-2-5% LISTDERMACINRX KIT ANALGESI
LISTDERMACINRX KIT COMBOPAK LISTDERMACINRX KIT PHARMAPA
LISTDERMACINRX KIT PRIZOPAK LISTDERMACINRX KIT SILAPAK
LISTDERMACINRX PAK Not properly listed with FDADERMACINRX PAK
CINLONE LISTDERMACINRX PAK DPN PAK LISTDERMACINRX PAK DUOPATCH Not
properly listed with FDADERMACINRX PAK INFLAMMA LISTDERMACINRX PAK
LEXITRAL Not properly listed with FDADERMACINRX PAK PHN
LISTDERMACINRX PAK THERAZOL LISTDERMACINRX PAK ZRM LIST
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
DERMACINRX SOL BASE LISTDERMANIC TAB Unapproved DrugDERMAPAK PAK
PLUS Unapproved DrugDERMASORB AF KIT 3-0.5% DESIDERMASORB HC KIT 2%
Not properly listed with FDADERMASORB TA KIT 0.1% Not properly
listed with FDADERMASORB XM KIT 39% Not properly listed with
FDADERMATODORON LIQ Unapproved DrugDERMAWERX KIT SURGICAL
LISTDERMAWERX PAK SDS LISTDERMAZENE CRE 1% DESIDERMAZONE MIS
LISTDERMAZYL PAK 5% LISTDEXERYL CRE Not properly listed with
FDADEXLIDO KIT LISTDEXLIDO-M KIT LISTDIAB GEL Not properly listed
with FDADIAB F.D.G. GEL Not properly listed with FDADIABETIC CAP
VITAMIN Unapproved DrugDIAGNOSTIC KIT Diagnostic AgentDIALYVITE TAB
Vitamin/MineralDIALYVITE TAB 3000 Vitamin/MineralDIALYVITE TAB 5000
Vitamin/MineralDIALYVITE TAB SUPREM D Vitamin/MineralDIALYVITE/ TAB
ZINC Vitamin/MineralDIANEAL SOL LOW CALC Dialysis covered by ESRD
bundled paymentDIANEAL SOL LOW CALC Dialysis covered by ESRD
bundled paymentDIANEAL SOL LOW CALC Dialysis covered by ESRD
bundled paymentDIANEAL PD-2 SOL 1.5% DEX Dialysis covered by ESRD
bundled paymentDIANEAL PD-2 SOL 2.5% DEX Dialysis covered by ESRD
bundled paymentDIANEAL PD-2 SOL 4.25%DEX Dialysis covered by ESRD
bundled paymentDIAZEPAM INJ 10MG/2ML DeviceDICLO GEL PAK 1%
LISTDICLOFENAC CRE SODIUM Unapproved DrugDICLOFEX DC MIS Not
properly listed with FDADICLOTRAL PAK LISTDICLOZOR MIS 1%
LISTDICOPANOL SUS 5MG/ML Unapproved DrugDICOPANOL SUS RAPIDPAQ
Unapproved DrugDIETHYLPROP TAB 25MG Anorexic, Anti-obestiy
AgentDIETHYLPROP TAB 75MG ER Anorexic, Anti-obestiy AgentDIFIL-G
FORT LIQ 100-100 Unapproved DrugDIGESTODORON LIQ Unapproved
DrugDIPENTOCAINE CRE 5-5-2% Unapproved DrugDIPRIVAN INJ General
Anesthetic
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
DIPRIVAN INJ 100MG/ML General AnestheticDIPRIVAN INJ 200/20ML
General AnestheticDIPRIVAN INJ 500/50ML General
AnestheticDIPYRIDAMOLE INJ 5MG/ML Diagnostic AgentDISALCID TAB
500MG Unapproved DrugDISALCID TAB 750MG Unapproved DrugDISCUS LIQ
COMPOSIT Unapproved DrugDIUSCREEN ME KIT COLLECTI Diagnostic
AgentDIVISTA CAP Vitamin/MineralDMT SUIK KIT 10MG/ML LISTDNA
COLLECT KIT Diagnostic AgentDNA COLLECT KIT MEDICATE Diagnostic
AgentDOG SOL EPITHELI Non-standardized allergenicDOG EPITHELI SOL
1:20 Non-standardized allergenicDOG FENNEL SOL 1:20
Non-standardized allergenicDOLOTRANZ KIT LISTDONNATAL ELX
DESIDONNATAL ELX GRAPE Unapproved DrugDONNATAL ELX MINT Unapproved
DrugDONNATAL TAB DESIDONNATAL TAB 16.2MG DESIDOTAREM INJ 10MMOL
Diagnostic AgentDOTAREM INJ 50MMOL Diagnostic AgentDOTAREM INJ
5MMOL Diagnostic AgentDOTAREM INJ 7.5MMOL Diagnostic AgentDOTHELLE
DHA CAP Vitamin/MineralDOUBLEDEX KIT LISTDOUBLE PM SOL Not properly
listed with FDADRAX IMAGE KIT DTPA Diagnostic AgentDRCAPS CLEAR CAP
SIZE 0 Unapproved DrugDRCAPS CLEAR CAP SIZE 00 Unapproved
DrugDRCAPS CLEAR CAP SIZE 1 Unapproved DrugDRECHSLERA SOL 1:10
Non-standardized allergenicDRECHSLERA SOL 1:20 Non-standardized
allergenicDRISDOL CAP 50000UNT Vitamin/MineralDRITHO-CREME CRE HP
1% Unapproved DrugDRYSOL SOL 20% Unapproved DrugDS PREP PAK PAK
1%-0.13% Unapproved DrugDSG PAK PAK Unapproved DrugDST PLUS PAK KIT
LISTDUET DHA MIS BALANCED Vitamin/MineralDUET DHA MIS BALANCED
Vitamin/MineralDUET DHA MIS BALANCED Vitamin/MineralDUET DHA MIS
BALANCED Vitamin/MineralDUET DHA 400 MIS 25-1-400
Vitamin/Mineral
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
DUET DHA 400 MIS 25-1-400 Vitamin/MineralDUODOTE INJ
LISTDURACHOL CAP 1-3775IU Unapproved DrugDURAFIBER PAD 4X4-3/4"
Surgical Supply/MedicalDURAFIBER AG PAD 2"X2" Surgical
Supply/MedicalDURAFIBER AG PAD 3/4X18" Surgical
Supply/MedicalDURAFIBER AG PAD 4"X4" Surgical
Supply/MedicalDURAFIBER AG PAD 4X4-3/4" Surgical
Supply/MedicalDURAFIBER AG PAD 6"X6" Surgical
Supply/MedicalDURAFIBER AG PAD 8X11.75" Surgical
Supply/MedicalDURAXIN CAP Unapproved DrugDYNAMIC KIT Diagnostic
AgentDYNAMIC PLUS KIT PAK Diagnostic AgentDYURAL-40 KIT
LISTDYURAL-80 KIT LISTDYURAL-L KIT LISTDYURAL-LM KIT LISTE-Z-CAT
DRY PAK Diagnostic AgentE-Z-DISK TAB 700MG Diagnostic AgentE-Z-DOSE
ENE Diagnostic AgentE-Z-HD SUS 98% Diagnostic AgentE-Z-PAQUE SUS
60% Diagnostic AgentE-Z-PAQUE SUS 96% Diagnostic AgentE-Z-PASTE CRE
60% Diagnostic AgentEASTERN SOL COTTONWO LISTEASYGEL GEL 0.4%
Unapproved DrugEASYGEL GEL 0.4%CHRY Unapproved DrugEASYGEL GEL
0.4%CITR Unapproved DrugEASYGEL GEL 0.4%MINT Unapproved DrugEC-RX
ESTRAD CRE 0.4% Not properly listed with FDAEC-RX ESTRAD CRE 0.6%
Not properly listed with FDAEC-RX PROGES CRE 10% Not properly
listed with FDAEC-RX PROGES CRE 20% Not properly listed with
FDAEC-RX TESTOS CRE 0.2% Not properly listed with FDAEC-RX TESTOS
CRE 0.4% Not properly listed with FDAEC-RX TESTOS CRE 10% Not
properly listed with FDAEC-RX TESTOS CRE 20% Not properly listed
with FDAECZEMOL TAB Unapproved DrugED-SPAZ TAB 0.125MG Unapproved
DrugEDEX KIT 10MCG Erectile DysfunctionEDEX KIT 20MCG Erectile
DysfunctionEDEX KIT 40MCG Erectile DysfunctionEEMT TAB 1.25-2.5
DESIEEMT HS TAB DESIEFFER-K TAB 10MEQ Unapproved Drug
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
EFFER-K TAB 20MEQ Unapproved DrugEFFER-K TAB 25MEQ EF Unapproved
DrugEGG WHITE INJ EXTRACT Diagnostic AgentEHA LOT 4% Unapproved
DrugELENZAPATCH DIS 4-1% Unapproved DrugELETONE CRE Not properly
listed with FDAELETONE CRE TWINPACK Not properly listed with
FDAELFOLATE TAB 15MG Vitamin/MineralELFOLATE TAB 7.5MG
Vitamin/MineralELFOLATE TAB PLUS Vitamin/MineralELIGEN B12 TAB
1000-100 Not properly listed with FDAELITE-OB TAB
Vitamin/MineralELLZIA PAK PAK 0.1%/5% LISTELOCTATE INJ 1000UNIT
Blood ComponentELOCTATE INJ 1500UNIT Blood ComponentELOCTATE INJ
2000UNIT Blood ComponentELOCTATE INJ 250UNIT Blood
ComponentELOCTATE INJ 3000UNIT Blood ComponentELOCTATE INJ 4000UNIT
Blood ComponentELOCTATE INJ 500UNIT Blood ComponentELOCTATE INJ
5000UNIT Blood ComponentELOCTATE INJ 6000UNIT Blood
ComponentELOCTATE INJ 750UNIT Blood ComponentEMOLIVAN CRE Not
properly listed with FDAEMOLLIENT CRE Not properly listed with
FDAEMPRICAINE KIT 2.5-2.5% LISTEMPTY CAPSUL CAP SIZE 0 Unapproved
DrugEMPTY CAPSUL CAP SIZE 00 Unapproved DrugEMPTY CAPSUL CAP SIZE 1
Unapproved DrugEMPTY CAPSUL CAP SIZE 1 Unapproved DrugEMPTY CAPSUL
CAP SIZE 2 Unapproved DrugEMPTY CAPSUL CAP SIZE 3 Unapproved
DrugEMPTY CAPSUL CAP SIZE 4 Unapproved DrugEMPTY CAPSUL CAP SIZE 5
Unapproved DrugEMPTY CAPSUL CAP SIZE 7 Unapproved DrugEMULSION SB
EMU Not properly listed with FDAEMVOREN CRE Bulk IngredientENBRACE
HR CAP Vitamin/MineralENDOMETRIN SUP 100MG Fertility AgentENGLISH
SOL PLANTAIN Non-standardized allergenicENGYSTOL INJ Unapproved
DrugENLYTE CAP Unapproved DrugENOVARX CRE 2.5% Not properly listed
with FDAENTERAGAM POW 5GM Not properly listed with FDAENTERO VU SUS
24% Diagnostic Agent
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
ENTTY EMU SPRAY Not properly listed with FDAEOVIST INJ
Diagnostic AgentEPHEDRINE SU INJ 50MG/ML Unapproved DrugEPICERAM
EMU LISTEPICOCCUM EX SOL 1:10 Non-standardized allergenicEPICOCCUM
INJ 1:20 Non-standardized allergenicEPIFOAM AER 1% Unapproved
DrugEPINPHEPHRIN KIT SNAP-V Not properly listed with FDAEPIQUIN
MICR CRE 4% CosmeticEPISNAP KIT LISTEPY KIT LISTEPY II KIT
Unapproved DrugERECAID KIT CLASSIC Erectile DysfunctionERECAID KIT
ESTEEM Erectile DysfunctionERGOCAL CAP 2500UNIT
Vitamin/MineralERYSIDORON LIQ #1 Unapproved DrugERYSIDORON TAB #2
Unapproved DrugESCAVITE CHW Vitamin/MineralESCAVITE D CHW
Vitamin/MineralESCAVITE LQ DRO 0.25-6MG Vitamin/MineralESPUMIL AER
Bulk IngredientESSENTRA MIS 9X9" Not properly listed with FDAEST
ESTROGEN TAB MTEST DESIEST ESTROGEN TAB MTEST HS DESIESTROG/MTEST
TAB 1.25-2.5 DESIETHYL CHLOR AER FINE PIN Not properly listed with
FDAETHYL CHLOR AER FN STRM Not properly listed with FDAETHYL CHLOR
AER MED JET Not properly listed with FDAETHYL CHLOR AER MED STRM
Not properly listed with FDAETHYL CHLOR AER MIST Not properly
listed with FDAETHYL CHLOR AER SPRAY Not properly listed with
FDAETOMIDATE INJ 20/10ML General AnestheticETOMIDATE INJ 2MG/ML
General AnestheticETOMIDATE INJ 40/20ML General AnestheticETOPOSIDE
CAP 50MG Oral drug for cancer; infusion available under Part
BEVICEL KIT 2ML Not properly listed with FDAEVICEL KIT 5ML Not
properly listed with FDAEXACTUSS LIQ Cough/ColdEXODERM LOT 25-1%
Unapproved DrugEXOTIC-HC DRO OTIC DESIEXTARDOL CRE Bulk
IngredientEXTRA-VIRT CAP PLUS DHA Vitamin/MineralEXTRANEAL SOL
Dialysis covered by ESRD bundled paymentEXYDERM PAD Not properly
listed with FDAEZ FLU SHOT INJ 2015-16 Influenza Vaccine
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
EZ FLU SHOT INJ PF 14-15 Influenza VaccineEZ FLU SHOT KIT
2015-16 Influenza VaccineEZ FLU SHOT KIT 2016-17 Influenza
VaccineFA-B6-B12 TAB Vitamin/MineralFABB TAB 2.2-25-1
Vitamin/MineralFAGRON LS CRE PLUS Not properly listed with
FDAFALESSA KIT Unapproved DrugFALESSA TAB 1MG Not properly listed
with FDAFANATREX SUS 25MG/ML Unapproved DrugFBL KIT CRE 15-4-5%
Bulk IngredientFEIBA INJ Blood ComponentFEIBA NF INJ Blood
ComponentFEM PH GEL Not properly listed with FDAFEMCAP MIS 22MM
DeviceFEMCAP MIS 26MM DeviceFEMCAP MIS 30MM DeviceFENTANYL CIT INJ
0.05MG/1 General AnestheticFENTANYL CIT INJ 1000MCG General
AnestheticFENTANYL CIT INJ 100/2ML General AnestheticFENTANYL CIT
INJ 100MCG General AnestheticFENTANYL CIT INJ 2500MCG General
AnestheticFENTANYL CIT INJ 250MCG General AnestheticFENTANYL CIT
INJ 500MCG General AnestheticFERAHEME INJ 510/17ML LISTFEROCON CAP
Vitamin/MineralFEROTRINSIC CAP Vitamin/MineralFERRIC GLUCO INJ
12.5/ML Vitamin/MineralFERRIC GLUCO INJ 12.5MG/M
Vitamin/MineralFERRLECIT INJ 12.5MG/M Vitamin/MineralFERRO-PLEX TAB
Vitamin/MineralFERROTRIN CAP Vitamin/MineralFIBERSOUR HN LIQ Not
properly listed with FDAFINASTERIDE TAB 1MG CosmeticFIRE ANT EXT
INJ 1:20 Non-standardized allergenicFIRE ANT INJ 1:10
Non-standardized allergenicFIRST DUKES SUS MOUTHWSH Unapproved
DrugFIRST-BACLOF SUS 1 Not properly listed with FDAFIRST-BACLOF SUS
5 KIT Not properly listed with FDAFIRST-MARYS SUS MOUTHWSH
Unapproved DrugFIRST-METRON SUS 100MG/ML Not properly listed with
FDAFIRST-METRON SUS 50MG/ML Not properly listed with
FDAFIRST-MOUTHW SUS BLM Unapproved DrugFIRST-OMEPRA SUS 2MG/ML Bulk
IngredientFIRST-TESTOS CRE MC 2% Unapproved DrugFIRST-TESTOS OIN 2%
Unapproved Drug
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
FITALITE CRE BASE Not properly listed with FDAFLAVOR BLEND SUS
Unapproved DrugFLAVOR PLUS LIQ Unapproved DrugFLAVOR SWEET SYP
Unapproved DrugFLAVOR SWEET SYP S/F Not properly listed with
FDAFLEXBUMIN INJ 25% Blood ComponentFLEXBUMIN INJ 5% Blood
ComponentFLEXEPAX MIS LISTFLEXIN PAD .0375-5% OTC ProductFLEXIZOL
PAK COMBIPAK Not properly listed with FDAFLORIVA CHW 0.25MG
Vitamin/MineralFLORIVA CHW 0.5MG Vitamin/MineralFLORIVA CHW 1MG
Vitamin/MineralFLORIVA DRO 0.25MG Unapproved DrugFLORIVA DRO PLUS
Vitamin/MineralFLOWTUSS SOL 2.5-200 Cough/ColdFLUAD INJ 2016-17
Influenza VaccineFLUARIX QUAD INJ 2014-15 Influenza VaccineFLUARIX
QUAD INJ 2015-16 Influenza VaccineFLUARIX QUAD INJ 2016-17
Influenza VaccineFLUBLOK SOL 2014-15 Influenza VaccineFLUBLOK SOL
2015-16 Influenza VaccineFLUBLOK SOL 2016-17 Influenza
VaccineFLUCAINE SOL 0.25-0.5 Diagnostic AgentFLUCELVAX INJ 2015-16
Influenza VaccineFLUCLVX QUAD INJ 2016-17 Influenza VaccineFLULAVAL
INJ 2014-15 Influenza VaccineFLULAVAL QUA INJ 2014-15 Influenza
VaccineFLULAVAL QUA INJ 2014-15 Influenza VaccineFLULAVAL QUA INJ
2015-16 Influenza VaccineFLULAVAL QUA INJ 2016-17 Influenza
VaccineFLUMIST QUAD SUS 2014-15 Influenza VaccineFLUMIST QUAD SUS
2015-16 Influenza VaccineFLUMIST QUAD SUS 2016-17 Influenza
VaccineFLUOR-A-DAY CHW 0.25MG F Unapproved DrugFLUOR-A-DAY CHW
0.5MG F Unapproved DrugFLUOR-A-DAY CHW 1MG F Unapproved
DrugFLUOR-A-DAY DRO 0.125MG Unapproved DrugFLUOR-I-STRI TES 1MG OP
Diagnostic AgentFLUORABON DRO Unapproved DrugFLUORAC CRE 5-1%
Unapproved DrugFLUORE-BENOX SOL 0.25-0.4 Diagnostic
AgentFLUORESCEIN/ SOL PROPARAC Diagnostic AgentFLUORESCITE INJ 10%
OP Diagnostic AgentFLUORID SENS PST 1.1-5% Not properly listed with
FDA
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
FLUORIDE CHW 0.25MG F Unapproved DrugFLUORIDE CHW 0.5MG F
Unapproved DrugFLUORIDE CHW 1MG F Unapproved DrugFLUORIDEX CON DLY
REN Not properly listed with FDAFLUORIDEX GEL 1.1% Unapproved
DrugFLUORIDEX GEL SENSITIV Unapproved DrugFLUORIDEX GEL WHITENIN
Unapproved DrugFLUORIDEX DD PST SENSITIV Unapproved DrugFLUORIDEX
PST 1.1% Unapproved DrugFLUORITAB CHW 0.25MG F Unapproved
DrugFLUORITAB CHW 0.5MG F Unapproved DrugFLUORITAB CHW 1MG F
Unapproved DrugFLUORITAB CHW 2.2MG Unapproved DrugFLUORITAB DRO
0.125MG Unapproved DrugFLURA-DROPS DRO 0.125MG Unapproved
DrugFLURA-DROPS DRO 0.25MG F Unapproved DrugFLURA-SAFE SOL
Diagnostic AgentFLUROX SOL OP Diagnostic AgentFLUSH SYRING INJ 0.9%
Not properly listed with FDAFLUVIRIN INJ 2015-16 Influenza
VaccineFLUVIRIN INJ 2016-17 Influenza VaccineFLUZONE HD INJ PF
15-16 Influenza VaccineFLUZONE HD INJ PF 16-17 Influenza
VaccineFLUZONE QUAD INJ 15-16 Influenza VaccineFLUZONE QUAD INJ
2015-16 Influenza VaccineFLUZONE QUAD INJ 2016-17 Influenza
VaccineFLUZONE SPLT INJ 2015-16 Influenza VaccineFOAMIL LIQ Not
properly listed with FDAFOCALGIN 90 MIS DHA Vitamin/MineralFOCALGIN
CA MIS Vitamin/MineralFOLBEE TAB Vitamin/MineralFOLBEE PLUS TAB
Vitamin/MineralFOLBEE PLUS TAB CZ Vitamin/MineralFOLBIC TAB
Vitamin/MineralFOLBIC RF TAB Vitamin/MineralFOLCAL DHA CAP
Vitamin/MineralFOLCAPS CAP OMEGA 3 Vitamin/MineralFOLENE CAP
Unapproved DrugFOLET DHA PAK Vitamin/MineralFOLET ONE CAP 38-1-225
Vitamin/MineralFOLGARD OS TAB Vitamin/MineralFOLGARD RX TAB
Vitamin/MineralFOLIC ACID INJ 5MG/ML Vitamin/MineralFOLIC ACID TAB
1MG Vitamin/MineralFOLIC ACID TAB 1000MCG Vitamin/Mineral
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
FOLIVANE-F CAP Vitamin/MineralFOLIVANE-OB CAP
Vitamin/MineralFOLIXAPURE TAB 1-5000 Vitamin/MineralFOLLISTIM AQ
INJ 300UNIT Fertility AgentFOLLISTIM AQ INJ 600UNIT Fertility
AgentFOLLISTIM AQ INJ 75UNIT Fertility AgentFOLLISTIM AQ INJ
900UNIT Fertility AgentFOLPLEX 2.2 TAB Vitamin/MineralFOLTANX TAB
Vitamin/MineralFOLTANX RF CAP Vitamin/MineralFOLTRATE TAB
Vitamin/MineralFOLTRIN CAP Vitamin/MineralFOLTX TAB
Vitamin/MineralFOLTX TAB Vitamin/MineralFOOD COLOR LIQ BLUE Not
properly listed with FDAFORANE SOL General AnestheticFORMA-RAY SOL
20% Unapproved DrugFORMADON SOL Unapproved DrugFORMALDEHYDE SOL 10%
Unapproved DrugFORMALDEHYDE SOL 37% Unapproved DrugFORTAVIT CAP
Vitamin/MineralFOSTEUM CAP Medical FoodFOSTEUM PLUS CAP Medical
FoodFOVEX CAP Medical FoodFP DERM CRE Not properly listed with
FDAFP ENHANCING CRE Not properly listed with FDAFP NATURAL CRE Not
properly listed with FDAFP PLUS CRE Not properly listed with FDAFP
SUPREME CRE Not properly listed with FDAFP ULTRA CRE Not properly
listed with FDAFREEDOM CRE DERMA-D Not properly listed with
FDAFREEDOM CRE DERMA-N Not properly listed with FDAFREEDOM CRE
ULTRAPEN Not properly listed with FDAFREEDOM GEL ALCOHOL Not
properly listed with FDAFREEDOM HRT CRE ULTRA Not properly listed
with FDAFROTEK CRE 10% Not properly listed with FDAFRST-HYDRCRT GEL
10% Not properly listed with FDAFUL-GLO TES 0.6MG OP Diagnostic
AgentFUL-GLO TES 1MG OP Diagnostic AgentFUSARIUM EXT SOL 1:20
Non-standardized allergenicFUSARIUM INJ 1:10 Non-standardized
allergenicFUSION PAK SPRINKLE Vitamin/MineralGABADONE CAP Medical
FoodGADAVIST INJ 1MMOL/ML Diagnostic AgentGALAXTRA POW Not properly
listed with FDA
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
GALZIN CAP 25MG Vitamin/MineralGALZIN CAP 50MG
Vitamin/MineralGANIRELIX AC INJ Fertility AgentGAPEAUM CRE BUDIBAC
Bulk IngredientGASTROGRAFIN SOL 66-10% Diagnostic AgentGEBAUERS SPR
AER /STRETCH Not properly listed with FDAGEL-KAM CON 0.63%
Unapproved DrugGELATIN EMPT CAP #0 Unapproved DrugGELATIN EMPT CAP
LOCKING Unapproved DrugGELCLAIR GEL DeviceGELFILM MIS OP Not
properly listed with FDAGELFOAM-JMI KIT POWDER Not properly listed
with FDAGELFOAM-JMI KIT SPONGE Not properly listed with FDAGENADUR
KIT Not properly listed with FDAGENADUR LIQ Not properly listed
with FDAGERMAN INJ COCKROAC Non-standardized allergenicGIALAX KIT
LISTGILPHEX TR TAB 10-388MG Unapproved DrugGILTUSS LIQ
Cough/ColdGILTUSS PED LIQ Cough/ColdGILTUSS TR TAB
Cough/ColdGILTUSS TR TAB Cough/ColdGLOFIL-125 INJ 0.1% Diagnostic
AgentGLONOIN DRO HOMACCOR Unapproved DrugGLUCAGEN INJ 1MG
Diagnostic AgentGLUCAGON INJ 1MG Diagnostic AgentGLYCINE SOL 1.5%
IRR Not properly listed with FDAGLYGEST PAK Medical FoodGLYTAC
COMPL BAR 10PE Not properly listed with FDAGLYTACTIN LIQ RES/LITE
Not properly listed with FDAGLYTACTIN LIQ RESTORE Not properly
listed with FDAGLYTACTIN LIQ RTD 10 Not properly listed with
FDAGLYTACTIN LIQ RTD 15 Not properly listed with FDAGLYTACTIN POW
BLD 10PE Not properly listed with FDAGLYTACTIN POW RESTOR 5 Not
properly listed with FDAGLYTACTIN POW RESTOR10 Not properly listed
with FDAGOLDENROD SOL 1:20 Non-standardized allergenicGONAL-F INJ
1050UNIT Fertility AgentGONAL-F INJ 450UNIT Fertility AgentGONAL-F
RFF INJ 300/0.5 Fertility AgentGONAL-F RFF INJ 450/0.75 Fertility
AgentGONAL-F RFF INJ 75UNIT Fertility AgentGONAL-F RFF INJ 900/1.5
Fertility AgentGORDONS UREA OIN 40% Unapproved DrugGRANULEX AER
DESI
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
GREEN GLO MIS 1.5MG Diagnostic AgentGRX HICORT SUP 25MG
DESIHACKBERRY EX SOL 1:20 Non-standardized allergenicHC PRAMOXINE
CRE 1-1% Unapproved DrugHC PRAMOXINE CRE 2.5-1% DESIHEALON INJ
10MG/ML DeviceHEALON GV INJ 14MG/ML DeviceHEALON5 INJ 23MG/ML
DeviceHELIXATE FS INJ 1000UNIT Blood ComponentHELIXATE FS INJ
2000UNIT Blood ComponentHELIXATE FS INJ 250UNIT Blood
ComponentHELIXATE FS INJ 3000UNIT Blood ComponentHELIXATE FS INJ
500UNIT Blood ComponentHEMATINIC/FA TAB Vitamin/MineralHEMATRON-AF
TAB Vitamin/MineralHEMENATAL OB MIS + DHA Vitamin/MineralHEMENATAL
OB TAB 28-6-1MG Vitamin/MineralHEMMOREX-HC SUP 25MG Unapproved
DrugHEMMOREX-HC SUP 30MG Unapproved DrugHEMOCYTE-F TAB
Vitamin/MineralHEMOFIL M INJ 1000UNIT Blood ComponentHEMOFIL M INJ
1700UNIT Blood ComponentHEMOFIL M INJ 250UNIT Blood
ComponentHEMOFIL M INJ 500UNIT Blood ComponentHEMOFIL M SOL Blood
ComponentHEMOFIL M SOL 801-1500 Blood ComponentHEPAGAM B INJ
Hepatitis B VaccineHEPARIN LOCK INJ 100/ML Not properly listed with
FDAHEPARIN LOCK INJ 10UNT/ML Not properly listed with FDAHEPARIN
LOCK INJ 1UNIT/ML Not properly listed with FDAHEPARIN LOCK KIT
100/ML Not properly listed with FDAHEPARIN LOCK KIT 10UNT/ML Not
properly listed with FDAHEPATOLITE KIT 99M Diagnostic AgentHEXABRIX
INJ Diagnostic AgentHISTATROL INJ 0.275/ML Diagnostic
AgentHISTATROL INJ 2.75/ML Diagnostic AgentHOMACTIN AA LIQ PLUS Not
properly listed with FDAHOMATROPAIRE SOL 5% OP Unapproved
DrugHOMATROPINE SOL 5% OP Unapproved DrugHOME PAP KIT Diagnostic
AgentHONEY BEE INJ 1000MCG Non-standardized allergenicHONEY BEE INJ
1100MCG Non-standardized allergenicHONEY BEE INJ 120MCG
Non-standardized allergenicHONEY BEE KIT 100MCG Non-standardized
allergenicHORMEL ALLERGY ANTIGEN Not properly listed with FDA
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
HORNET VENOM INJ 1300MCG Non-standardized allergenicHORNET VENOM
INJ 550MCG Non-standardized allergenicHORSE EPITHE INJ 1:10
Non-standardized allergenicHORSE EPITHE INJ 1:20 Non-standardized
allergenicHPR AER LISTHPR PLUS AER LISTHPR PLUS CRE LISTHPR PLUS
KIT DeviceHPR PLUS MB KIT HYDROGEL LISTHSA DILUENT SOL STERILE Not
properly listed with FDAHUMATE-P SOL 2400UNIT Blood
ComponentHUMATE-P SOL 250-600 Blood ComponentHUMATE-P SOL 500-1200
Blood ComponentHURRISEAL SOL Not properly listed with FDAHYALGAN
INJ 20MG/2ML Surgical Supply/MedicalHYALUCIL-0.5 CRE 2-0.5% Not
properly listed with FDAHYALUCIL-4 CRE 2-4% Not properly listed
with FDAHYALURONATE GEL 0.2% Unapproved DrugHYCAMTIN CAP 0.25MG
Oral drug for cancer; infusion available under Part BHYCAMTIN CAP
1MG Oral drug for cancer; infusion available under Part BHYCOFENIX
SOL Cough/ColdHYD POL/CPM SUS 10-8/5ML Cough/ColdHYDR/CPM/PSE LIQ
5-4-60MG Cough/ColdHYDRFRA BLUE PAD RDY 2.5" Not properly listed
with FDAHYDRFRA BLUE PAD RDY 4X5" Not properly listed with
FDAHYDRFRA BLUE PAD RDY 8X8" Not properly listed with FDAHYDRFRA
MRF PAD 2"X2.75" Not properly listed with FDAHYDRO 35 AER
Unapproved DrugHYDRO 40 AER FOAM Unapproved DrugHYDRO/CHLOR/ LIQ
5-4-60MG Cough/ColdHYDROC/HOMAT TAB 5-1.5MG Cough/ColdHYDROCOD/HOM
SYP 5-1.5/5 Cough/ColdHYDROCORT CRE IODOQUIN DESIHYDROCORT AC SUP
25MG DESIHYDROCORT AC SUP 30MG DESIHYDROCORT/ CRE IODOQUIN
DESIHYDROCORT/ KIT PRAMOXIN DESIHYDROFERA PAD 4"X4" Not properly
listed with FDAHYDROFERA PAD BLUE 2X2 Not properly listed with
FDAHYDROFERA PAD BLUE 4X4 Not properly listed with FDAHYDROFERA PAD
BLUE 6X6 Not properly listed with FDAHYDROFERA PAD BLUE 9MM Not
properly listed with FDAHYDROFERA PAD MRF 2.5" Not properly listed
with FDAHYDROFERA PAD MRF4"X4" Not properly listed with FDAHYDROFRA
MRF PAD 2-1/4X8" Not properly listed with FDA
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
HYDROGEL GEL Not properly listed with FDAHYDROGEL DRE PAD 2"X3"
Surgical Supply/MedicalHYDROGEL DRE PAD 4"X5" Surgical
Supply/MedicalHYDROGEN PER SOL 30% Not properly listed with
FDAHYDROMET SYP 5-1.5/5 Cough/ColdHYDROMORPHON SUP 3MG Not properly
listed with FDAHYDROQUINONE CRE 4% CosmeticHYDROQUINONE CRE 4% TR
CosmeticHYDROXOCOBAL INJ 1000MCG Not properly listed with FDAHYGEL
GEL 2.5% Surgical Supply/MedicalHYLAFEM SUP Unapproved
DrugHYLATOPIC AER PLUS DeviceHYLATOPIC CRE PLUS DeviceHYLATOPIC LOT
PLUS Not properly listed with FDAHYLENEX INJ 150 UNIT LISTHYLIRA
GEL 0.2% DeviceHYLIRA LOT 0.1% DeviceHYMENOPTRA KIT VENOM PR
Diagnostic AgentHYOLEV MB TAB 81MG Unapproved DrugHYOPHEN TAB
Unapproved DrugHYOSCYAMINE DRO 0.125/ML Unapproved DrugHYOSCYAMINE
ELX 0.125/5 Unapproved DrugHYOSCYAMINE SUB 0.125MG Unapproved
DrugHYOSCYAMINE TAB 0.125MG Unapproved DrugHYOSCYAMINE TAB 0.125MG
Unapproved DrugHYOSCYAMINE TAB 0.375 ER Unapproved DrugHYOSCYAMINE
TAB 0.375 SR Unapproved DrugHYOSYNE DRO 0.125/ML Unapproved
DrugHYOSYNE ELX 0.125/5 Unapproved DrugHYPER-SAL NEB 7% Not
properly listed with FDAHYPERHEP B INJ S/D Hepatitis B
VaccineHYPERSAL NEB 3.5% Not properly listed with FDAHYPERSAL NEB
7% Not properly listed with FDAHYPERTENSA CAP Medical FoodHYSKON
SOL Diagnostic AgentIBU/MINREX PAK Not properly listed with
FDAIBUPROFEN CRE 10% Bulk IngredientIC GREEN INJ 25MG Diagnostic
AgentIDELVION SOL 1000UNIT Blood ComponentIDELVION SOL 2000UNIT
Blood ComponentIDELVION SOL 250UNIT Blood ComponentIDELVION SOL
500UNIT Blood ComponentINATAL ADV TAB Vitamin/MineralINATAL GT TAB
Vitamin/MineralINATAL ULTRA TAB Vitamin/Mineral
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
INDICLOR INJ Diagnostic AgentINDIGO CARMI INJ 8MG/ML Diagnostic
AgentINDIOMIN MB CAP 120MG Unapproved DrugINDIUM IN111 INJ DTPA
Diagnostic AgentINDIUM IN111 INJ OXYQUINO Diagnostic
AgentINDOCYANINE INJ 25MG Diagnostic AgentINFANATE CAP BALANCE
Vitamin/MineralINFANATE CAP PLUS Vitamin/MineralINFED INJ 50MG/ML
Vitamin/MineralINFLAMMA-K KIT Not properly listed with
FDAINFLAMMACIN MIS 75-0.025 LISTINFLAMMATION PAK REDUCTIO
LISTINFUVITE INJ Vitamin/MineralINFUVITE INJ ADULT
Vitamin/MineralINFUVITE INJ PEDIATRI Vitamin/MineralINJECTAFER INJ
750/15ML Not properly listed with FDAINNOPRAX-5 CRE Unapproved
DrugINOVA KIT 4% Not properly listed with FDAINTEGRA F CAP
Vitamin/MineralINTERARTICUL KIT JOINT LISTINTRAROSA SUP 6.5MG
Sexual Dysfunction AgentINULIN INJ 100MG/ML Diagnostic AgentIODINE
SOL STRONG Not properly listed with FDAIODINE TIN 2% Not properly
listed with FDAIODOFLEX PAD PAD Surgical Supply/MedicalIODOPEN INJ
100MCG Unapproved DrugIODOSORB GEL Not properly listed with
FDAIODOSORB GEL 0.9% Not properly listed with FDAISCAR MALI INJ
5MG/ML Not properly listed with FDAISOFLURANE SOL General
AnestheticISOMETH/APAP CAP DICHLOR DESIISOMETH/CAFF TAB /APAP
DESIISOMETH/CAFF TAB /APAP DESIISOP ALCOHOL SOL 70% Not properly
listed with FDAISOPROPANOL SOL 70% LISTISOSULFAN INJ BLUE 1%
Diagnostic AgentISOVACTIN AA LIQ PLUS Not properly listed with
FDAISOVUE-200 INJ 41% Diagnostic AgentISOVUE-250 INJ 51% Diagnostic
AgentISOVUE-250 INJ 51%MLTPK Diagnostic AgentISOVUE-300 INJ 61%
Diagnostic AgentISOVUE-300 INJ 61%MLTPK Diagnostic AgentISOVUE-370
INJ 76% Diagnostic AgentISOVUE-370 INJ 76%MLTPK Diagnostic
AgentISOVUE-M 200 INJ 41% Diagnostic Agent
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
ISOVUE-M 300 INJ 61% Diagnostic AgentISOXSUPRINE TAB 10MG
DESIISOXSUPRINE TAB HCL 20MG DESIIV INFUSION KIT CPI LISTIXINITY
INJ 1000UNIT Blood ComponentIXINITY INJ 1500UNIT Blood
ComponentIXINITY INJ 2000UNIT Blood ComponentIXINITY INJ 250UNIT
Blood ComponentIXINITY INJ 3000UNIT Blood ComponentIXINITY INJ
500UNIT Blood ComponentJNT/TUNNEL/ KIT TRIGGER LISTJOHNSON SOL
GRASS Non-standardized allergenicJTT PHYSICNS KIT LISTJUNE GRASS
SOL POLLEN Non-standardized allergenicK CITRATE SOL CITR ACD
Unapproved DrugK-EFFERVESCE TAB 25MEQ EF Unapproved DrugK-PHOS TAB
Unapproved DrugK-PHOS TAB NEUTRAL Unapproved DrugK-PHOS TAB NO 2
Unapproved DrugK-PRIME TAB 25MEQ EF Unapproved DrugK-VESCENT TAB
25MEQ EF Unapproved DrugK.B.G.L IN CRE TERODERM Bulk IngredientK/NA
CITRATE SOL CITR ACD Unapproved DrugKAPOK SOL 1:20 Non-standardized
allergenicKARIDIUM DRO 0.125MG Unapproved DrugKARIGEL GEL 0.5%
Unapproved DrugKARIGEL-N GEL 1.1% Unapproved DrugKCENTRA KIT
1000UNIT Blood ComponentKCENTRA KIT 500UNIT Blood ComponentKEDBUMIN
INJ 25% Blood ComponentKERAGEL GEL WOUND DeviceKERAGELT GEL
DeviceKERALAC CRE 47% Unapproved DrugKERALYT GEL 6% Unapproved
DrugKERALYT KIT SCALP 6% Unapproved DrugKERAMATRIX PAD 10X10CM
DeviceKERAMATRIX PAD 5X5CM DeviceKERLIX AMD MIS BANDAGE Not
properly listed with FDAKETALAR INJ 100MG/ML General
AnestheticKETALAR INJ 10MG/ML General AnestheticKETALAR INJ 50MG/ML
General AnestheticKETAMIN/NACL INJ 50/5ML General
AnestheticKETAMIN/NACL SOL 100/10ML General AnestheticKETAMIN/NACL
SOL 20MG/2ML General AnestheticKETAMINE HCL INJ 100/2ML General
Anesthetic
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
KETAMINE HCL SOL 50MG/ML General AnestheticKETAMINE INJ 100MG/ML
General AnestheticKETAMINE INJ 10MG/ML General AnestheticKETAMINE
INJ 50MG/ML General AnestheticKETODAN KIT 2% LISTKETOPHENE CRE
RAPIDPAQ Unapproved DrugKETOPROFEN CRE 5% KIT Not properly listed
with FDAKETOROCAINE KIT -L LISTKETOROCAINE KIT -LM LISTKETOROLAC
GEL 2% Not properly listed with FDAKETOVIE LIQ CHOCOLAT Not
properly listed with FDAKETOVIE LIQ PEPTIDE Not properly listed
with FDAKETOVIE LIQ VANILLA Not properly listed with FDAKINEVAC INJ
5MCG Diagnostic AgentKLOR-CON/25 POW 25MEQ Unapproved
DrugKLOR-CON/EF TAB 25MEQ FR Unapproved DrugKOATE-DVI INJ 1000UNIT
Blood ComponentKOATE-DVI INJ 250UNIT Blood ComponentKOATE-DVI INJ
500UNIT Blood ComponentKOATE INJ 1000UNIT Blood ComponentKOATE INJ
250UNIT Blood ComponentKOATE INJ 500 UNIT Blood ComponentKOCHIA
EXTRA INJ 1:20 Non-standardized allergenicKOGENATE FS INJ 1000/BS
Blood ComponentKOGENATE FS INJ 1000UNIT Blood ComponentKOGENATE FS
INJ 2000/BS Blood ComponentKOGENATE FS INJ 2000UNIT Blood
ComponentKOGENATE FS INJ 250/BS Blood ComponentKOGENATE FS INJ
250UNIT Blood ComponentKOGENATE FS INJ 3000/BS Blood
ComponentKOGENATE FS INJ 3000UNIT Blood ComponentKOGENATE FS INJ
500/BS Blood ComponentKOGENATE FS INJ 500UNIT Blood ComponentKOSHR
PRENAT TAB 30-1MG Vitamin/MineralKOVALTRY INJ 1000UNIT Blood
ComponentKOVALTRY INJ 2000UNIT Blood ComponentKOVALTRY INJ 250UNIT
Blood ComponentKOVALTRY INJ 3000UNIT Blood ComponentKOVALTRY INJ
500UNIT Blood ComponentKRISGEL 100 GEL Not properly listed with
FDAKYBELLA INJ CosmeticL-METHYL- TAB B6-B12
Vitamin/MineralL-METHYL-MC TAB Vitamin/MineralL-METHYL-MC TAB NAC
Unapproved DrugL-METHYLFOLA CAP FORM 15 Not properly listed with
FDA
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
L-METHYLFOLA CAP FORM 7.5 Not properly listed with
FDAL-METHYLFOLA CAP FORTE Not properly listed with FDAL-METHYLFOLA
CAP FORTE 15 Not properly listed with FDAL-METHYLFOLA TAB 15MG
Medical FoodL-METHYLFOLA TAB 7.5MG Medical FoodLACTIC ACID CRE /VIT
E Unapproved DrugLACTIC ACID CRE E Unapproved DrugLACTIC ACID LOT
10% Unapproved DrugLAMBS SOL QUARTERS Non-standardized
allergenicLANOLIN OIN Unapproved DrugLANOLIN ANHY OIN Not properly
listed with FDALANSOPRAZOLE SUS 3MG/ML Bulk IngredientLATISSE SOL
0.03% CosmeticLATRIX SUS 50% Unapproved DrugLATRIX XM EMU 45%
Unapproved DrugLAVARE WOUND GEL WASH Not properly listed with
FDALDO PLUS GEL 4% LISTLECITHIN GEL Not properly listed with
FDALECITHIN GRA Not properly listed with FDALENSCALE INJ 1:20
Non-standardized allergenicLETS KIT Unapproved DrugLEVA SET KIT
LISTLEVA SET KIT 2.5-2.5% LISTLEVATIO PAD 0.3-5% Unapproved
DrugLEVBID TAB 0.375 ER Unapproved DrugLEVITRA TAB 10MG Erectile
DysfunctionLEVITRA TAB 2.5MG Erectile DysfunctionLEVITRA TAB 20MG
Erectile DysfunctionLEVITRA TAB 5MG Erectile
DysfunctionLEVOMEFOLATE CAP /ALGAL Unapproved DrugLEVOMEFOLATE CAP
/ALGAL Unapproved DrugLEVOMEFOLATE CAP DHA Vitamin/MineralLEVOPHED
INJ 1MG/ML Not properly listed with FDALEVSIN INJ 0.5MG/ML
Unapproved DrugLEVSIN TAB 0.125MG Unapproved DrugLEVSIN/SL SUB
0.125MG Unapproved DrugLEXISCAN INJ 0.4MG Diagnostic AgentLEXIXRYL
PAK 1.5% LISTLEXUSS 210 LIQ 2-10/5ML Unapproved DrugLIDAZONE CRE
Unapproved DrugLIDENZA PAD 4-1% Unapproved DrugLIDO BDK KIT Not
properly listed with FDALIDO-HYDRO GEL 2.8-0.55 Unapproved
DrugLIDO-K LOT 3% Not properly listed with FDALIDO-PRILO KIT
2.5-2.5% LIST
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
LIDO-RX 4.1 CRE 4-0.1% Unapproved DrugLIDO/DEXTROS INJ 5-7.5%
Not properly listed with FDALIDO/EPI INJ 0.5% Not properly listed
with FDALIDO/EPI INJ 1.5% Not properly listed with FDALIDO/EPI INJ
2% Not properly listed with FDALIDO/EPI INJ 2% Not properly listed
with FDALIDO/EPI 1%- INJ 1:100000 Not properly listed with
FDALIDO/PRILOCN KIT 2.5-2.5% Not properly listed with FDALIDOCAINE
CRE 10% Bulk IngredientLIDOCAINE CRE 3% Unapproved DrugLIDOCAINE
CRE 5% Bulk IngredientLIDOCAINE LOT 3% Unapproved DrugLIDOCAINE/HC
CRE 3%-0.5% Unapproved DrugLIDOCAINE/HC KIT 2-2% Unapproved
DrugLIDOCAINE/HC KIT 3%-0.5% Unapproved DrugLIDOCAINE/HC KIT 3%-1%
Unapproved DrugLIDOCAINE/HC KIT 3-2.5% Unapproved DrugLIDOCIN GEL
3% Unapproved DrugLIDODEXTRAPI PAD 4-1% Unapproved DrugLIDOLOG KIT
LISTLIDOPAC KIT 5% Not properly listed with FDALIDOPIN CRE 3%
Unapproved DrugLIDOPIN CRE 3.25% Unapproved DrugLIDOPRIL KIT
2.5-2.5% LISTLIDOPRIL XR KIT 2.5-2.5% LISTLIDOPROFEN CRE 5-5-2%
Bulk IngredientLIDORX GEL 3% Not properly listed with FDALIDOTHOL
PAD 4.5-5% Unapproved DrugLIDOTRAL CRE 3.88% Unapproved
DrugLIDOTRANS 5 KIT 5% LISTLIDOTREX GEL 2% Not properly listed with
FDALIDOVEX CRE 3.75% Unapproved DrugLIDOVIN CRE 3.95% Unapproved
DrugLIDOVIR OIN 4-4% Bulk IngredientLIDOXIB KIT LISTLIDOZOL CRE
3.75% Unapproved DrugLIDTOPIC MAX CRE 10% Not properly listed with
FDALIMBREL CAP 250MG Medical FoodLIMBREL CAP 500MG Medical
FoodLIMBREL250 CAP 250-50MG Medical FoodLIMBREL500 CAP 500-50MG
Medical FoodLIPICHOL 540 CAP Not properly listed with FDALIPO CREAM
CRE BASE Not properly listed with FDALIPOFOAM RX AER Not properly
listed with FDALIPOPEN ABSO CRE ENHANCNG Not properly listed with
FDA
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL
indications
LIPOPEN CRE Not properly listed with FDALIPOPEN CRE ANHYDRO Not
properly listed with FDALIPOPEN CRE PLUS Not properly listed with
FDALIPOPEN CRE ULTRA Not properly listed with FDALIPOPEN ULTR CRE
BASE Not properly listed with FDALIPOSOMAL CRE HEAVY Not properly
listed with FDALIPOSOMAL CRE REGULAR Not properly listed with
FDALIPOZYME CRE Not properly listed with FDALIPROZONEPAK KIT
2.5-2.5% LISTLISSAMINE GR TES 1.5MG Diagnostic AgentLISTER-V CAP
Not properly listed with FDALIVIXIL PAK KIT 2.5-2.5%
LISTLMTHF/B6/B12 TAB Vitamin/MineralLOMAIRA TAB 8MG Anorexic,
Anti-obesity AgentLOPROX KIT 0.77% LISTLORENZA PAD 4-1% Unapproved
DrugLORVATUS KIT PHARMAPA LISTLOUTREX CRE LISTLOZI-FLUR LOZ 1MG F
Unapproved DrugLP LITE PAK KIT 2.5-2.5% Unapproved DrugLT INJECTION
KIT LISTLUDENT CHW 0.25MG F Unapproved DrugLUDENT CHW 0.5MG F
Unapproved DrugLUDENT CHW 1MG F Unapproved DrugLUGOLS SOL STRONG
Unapproved DrugLUKAID GLA EMU 1GM/ML Unapproved DrugLUMASON INJ
60.7-25 Diagnostic AgentLURIDE DRO 0.5MG/ML Unapproved DrugLUSTRA
CRE 4% CosmeticLUSTRA-AF CRE 4% CosmeticLUSTRA-ULTRA CRE 4%
CosmeticLUXAMEND CRE Not properly listed with FDALYMPHOMYSOT INJ X
Not properly listed with FDALYSIPLEX TAB PLUS Vitamin/MineralM-VIT
TAB 27-1MG Vitamin/MineralM.V.I PEDIAT INJ Vitamin/MineralM.V.I-12
W/O INJ VIT K Vitamin/MineralM.V.I. ADULT INJ
Vitamin/MineralMACNATAL CN CAP DHA Vitamin/MineralMACUTEK TAB Not
properly listed with FDAMACUVEX CAP Unapproved DrugMACUZIN CAP
Unapproved DrugMAGNEBIND TAB 400 Vitamin/MineralMAGNEVIST INJ 46.9%
Diagnostic AgentMANGANESE SU INJ 0.1MG/ML Unapproved Drug
-
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2017_updated July 2017
Reason: LIST = multiple reasons it's excluded; "not covered
under Part D law"
Reason: Not properly listed with FDA = CMS considers it best
practice for Part D sponsors to consider the proper listing of a
drug product with the FDA as a prerequisite for making a Part D
drug coverage determination. The
FDA is unable to provide regulatory status determinations
through their regular processes if a drug product is not properly
listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming
that a prescription drug product national drug code (NDC) is
properly listed