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