MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

1ST BASE CRE Bulk Ingredient2-FUCCOSYLLA PAK LACTO-N Medical FoodABANEU-SL SUB Vitamin/MineralABLAVAR INJ 244MG/ML Diagnostic AgentACACIA EXTRA SOL 1:20 Non-standardized allergenicACCUCAINE INJ 1% LISTACD FORMULA SOL A Blood ComponentACD-A SOL Blood ComponentACLARO PD EMU 4% 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 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 IngredientACTIVE-PREP CRE KIT IV Bulk IngredientACTIVE-PREP CRE KIT V Bulk Ingredient

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

ACUICYN LIQ Not properly listed with FDAACUNOL TAB 600MG Unapproved DrugADAPTADERM 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 2000UNIT Blood ComponentADYNOVATE INJ 250UNIT Blood ComponentADYNOVATE INJ 500UNIT Blood ComponentAERO OTIC HC SOL DESIAFLURIA INJ 2012-13 Influenza VaccineAFLURIA INJ 2013-14 Influenza VaccineAFLURIA INJ 2014-15 Influenza VaccineAFLURIA INJ 2015-16 Influenza VaccineAFLURIA INJ PF 12-13 Influenza VaccineAFLURIA INJ PF 13-14 Influenza VaccineAFLURIA INJ PF 14-15 Influenza VaccineAFLURIA INJ PF 15-16 Influenza VaccineAFSTYLA KIT 1000UNIT Blood ComponentAFSTYLA KIT 2000UNIT Blood ComponentAFSTYLA KIT 250UNIT Blood ComponentAFSTYLA KIT 3000UNIT Blood ComponentAFSTYLA KIT 500UNIT Blood ComponentAIF #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 Agent

Reason

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

ALA-QUIN CRE 3-0.5% DESIALBA-DERM CRE Unapproved DrugALBAFORT INJ Vitamin/MineralALBATUSSIN CAP DESIALBATUSSIN LIQ NN DESIALBUKED 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 FDAALCOHOL GEL 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 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 FDAALLEVYN 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 DrugALODOX KIT 20MG Unapproved DrugALOQUIN GEL 1.25-1% DESIALPAWASH OIN Not properly listed with FDA

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

ALPHANATE 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 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 COCKROAC Non-standardized allergenicAMERICAN ELM SOL Non-standardized allergenicAMIDATE INJ 2MG/ML General AnestheticAMINOAC ACID SOL 1.5% IRR Not properly listed with FDAAMINOBEZ POT POW DESIAMINOHIPPURA INJ 20% Diagnostic AgentAMITRIPTYLIN CRE Not properly listed with FDAAMITRIPTYLIN KIT 2% Bulk IngredientAMORPH WOUND GEL DRESSING Not properly listed with FDAAMVISC INJ 12MG/ML DeviceAMVISC PLUS INJ 16MG/ML DeviceAMYTAL SOD INJ 500MG Unapproved DrugAMYVID 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 LIST

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

ANASEPT SPR Not properly listed with FDAANASPAZ TAB 0.125MG Unapproved DrugANECTINE INJ 20MG/ML LISTANHYDROUS 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/MineralANODYNERX PAD Unapproved DrugANODYNZ MIS 0.0375-5 Unapproved DrugANTICOAG CIT SOL DEX SOL Unapproved DrugANTICOAG CPD SOL Blood ComponentANTIPY/BENZO SOL OTIC Unapproved DrugANTIPY/BENZO SOL OTIC Unapproved DrugANTIVENIN KIT LAT MACT LISTANTIVENIN MI INJ 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 TRANSDER 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 AgentAPPBUTAMONE PAK Unapproved DrugAPPTRIM CAP Anorexic, Anti-obestiy AgentAPPTRIM LIFE CAP BARIATRC Anorexic, Anti-obestiy AgentAPPTRIM LIFE CAP OBESITY Anorexic, Anti-obestiy AgentAPPTRIM-D CAP Anorexic, Anti-obestiy AgentAQUASOL A INJ 50000/ML Vitamin/MineralAQUORAL AER DeviceARIDA GEL Surgical Supply/MedicalARIDOL KIT Diagnostic AgentARIZONA 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 TIN FLOWER Unapproved DrugARTICADENT INJ DENTAL LIST

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

ARTICADENT INJ DENTAL LISTARZOL SILVER MIS NITR APP Unapproved DrugASCLERA INJ 0.5% LISTASCLERA INJ 1% LISTASCORBIC ACD INJ 500MG/ML Vitamin/MineralASPERGILLUS INJ 1:500 Diagnostic AgentASPERGILLUS SOL 1:20 Non-standardized allergenicASPERGILLUS SOL FUMIGATI Non-standardized allergenicASTRINGYN SOL 259MG/GM Not properly listed with FDAATABEX EC TAB Vitamin/MineralATENDIA PAD 4-3% Unapproved DrugATOPICLAIR 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 FDAATROPEN INJ 0.25MG DeviceATROPEN INJ 0.5MG DeviceATROPEN INJ 1MG DeviceATROPEN INJ 2MG DeviceATROPINE SUL OIN 1% OP Unapproved DrugAUREOBASIDIU INJ 1:10 Non-standardized allergenicAUREOBASIDIU SOL 1:20 Non-standardized allergenicAURODEX SOL OTIC Unapproved DrugAURSTAT 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 FDAAVALIN-RX PAD 4-1% Unapproved DrugAVAR 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 Drug

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

AVAR-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/MedicalAXONA 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/MineralB12/LMTHF/B6 TAB 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 allergenicBAL SALT SOL OP LISTBAL-CARE MIS DHA Vitamin/MineralBALANCED SAL SOL OP LISTBALD CYPRESS INJ 1:20 Non-standardized allergenicBARIUM 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 allergenicBELLA/OPIUM SUP 16.2-30 Unapproved DrugBELLA/OPIUM SUP 16.2-60 Unapproved DrugBELVIQ TAB 10MG Anorexic, Anti-obestiy Agent

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

BENEFIX 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 DrugBENZAC W 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/ColdBENZOYL 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 LISTBETA INJECT KIT LISTBETALIDO KIT 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 IngredientBIO 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/Medical

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

BIONECT SPR 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/MineralBP 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 GEL 4% Unapproved DrugBPO GEL 8% 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 200MG General AnestheticBREVITAL SOD INJ 500MG General AnestheticBROM/PSE/DM SYP Cough/ColdBROMFED DM SYP Cough/ColdBROMPHENIRAM CHW 12MG Unapproved DrugBSS SOL OP LISTBSS PLUS SOL OP LISTBT INJECTION KIT 40-0.5% Unapproved Drug

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

BUMINATE INJ 25% Blood ComponentBUMINATE INJ 5% Blood ComponentBUPIVACAINE 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 DrugCA-DTPA SOL 1000MG Not properly listed with FDACAFFEINE/SOD INJ BENZOATE Unapproved DrugCALCIFOL WAF Vitamin/MineralCALCIUM PNV CAP Vitamin/MineralCALCIUM-FA WAF PLUS D Vitamin/MineralCALI PEPPER INJ TREE Non-standardized allergenicCAMINO PRO LIQ 15PE Not properly listed with FDACAMPHOMEX SPR Unapproved DrugCANDIDA ALBI INJ 1:20 Non-standardized allergenicCANDIDA INJ ALBICANS Diagnostic AgentCANDIN INJ Diagnostic AgentCANDIDA SOL ALBICANS Non-standardized allergenicCAPXIB 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 DeviceCAPS LOCK #0 CAP CLR/WHT Unapproved DrugCAPS LOCK #1 CAP CLR/WHT Unapproved DrugCAPS LOCK #3 CAP CLR/WHT Unapproved DrugCAPSULE #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 Drug

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

CAPSULE 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 #1 OPAQ 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 DrugCAT HAIR INJ EXTRACT Non-standardized allergenicCAT HAIR SOL EXTRACT Non-standardized allergenicCATHFLO ACTI INJ VASE LISTCATTLE EPITH SOL 1:20 Non-standardized allergenicCAVAN-EC SOD MIS DHA Vitamin/MineralCAVAREST 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 FDACEFAZOLIN INJ 300GM Bulk IngredientCEFUROXIME INJ 225GM Bulk IngredientCEFUROXIME INJ 75GM 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 FDA

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

CEREFOLIN 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 DrugCETACAINE AER DESICETROTIDE KIT 0.25MG Fertility AgentCHELIDONIUM LIQ COMPOUND Unapproved DrugCHERRY SYP Bulk IngredientCHIRHOSTIM SOL 16MCG Diagnostic AgentCHLORD/CLIDI CAP 5-2.5MG DESICHLORHEX GLU SOL 20% Bulk IngredientCHLORTHALID TAB 100MG DESICHO MAG TRIS LIQ 500/5ML Unapproved DrugCHO MAG TRIS TAB 1000MG Unapproved DrugCHOLETEC INJ Diagnostic AgentCHOLOGRAFIN INJ 52% 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 DysfunctionCIALIS TAB 2.5MG* (Coverable for Benign Prostatic Hyperplasia (BPH) diagnosis only with quantity

limit of 1 tablet daily.) Erectile Dysfunction [only coverable for diagnosis of Benign Prostatic Hyperplasia (BPH)]

CIALIS TAB 20MG Erectile DysfunctionCIALIS TAB 5MG* (Coverable for Benign Prostatic Hyperplasia (BPH) diagnosis only with quantity limit

of 1 tablet daily.) Erectile Dysfunction [only coverable for diagnosis of Benign Prostatic Hyperplasia (BPH)]CICLODAN CRE KIT 0.77% LISTCICLOPIROX KIT 8% Unapproved DrugCIDALEAZE CRE 3% Not properly listed with FDACIFEREX CAP 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/MineralCITRIC ACID/ SOL SOD CITR Unapproved DrugCITRUS POW BERGAMOT Not properly listed with FDACLADOSPORIUM INJ CLADOSPO Non-standardized allergenic

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

CLADOSPORIUM SOL 1:20 Non-standardized allergenicCLADOSPORIUM SOL 20000PNU Non-standardized allergenicCLARIFOAM EF AER 10-5% Unapproved DrugCLARIS WASH EMU 10-4% Unapproved DrugCLARYS CRE CosmeticCLEARPLEX X GEL 10% Unapproved DrugCLIN SINGLE KIT USE LISTCLIN-LIDO KIT 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 FDACOCKLEBUR EX SOL 1:20 Non-standardized allergenicCOD LIVER OIL Vitamin/MineralCODAR AR LIQ 2-8/5ML OTC ProductCOLLIGINIX MIS OTC ProductCOLCIGEL GEL Unapproved DrugCOLLODION LIQ FLEXIBLE Not properly listed with FDACOMFORT EZ PAD 2-4-1% Unapproved DrugCOMFORT EZ PAD 20-4-1% Unapproved DrugCOMPLETE NAT PAK DHA Vitamin/MineralCOMPLETENATE CHW Vitamin/MineralCONCENTRATE CRE Not properly listed with FDACONCEPT DHA CAP Vitamin/MineralCONCEPT OB CAP Vitamin/MineralCONRAY INJ 60% Diagnostic AgentCONRAY 30 INJ 30% Diagnostic AgentCONRAY 43 INJ 43% Diagnostic AgentCONTRAVE 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 ComponentCORTANE-B DRO AQ OTIC DESICORTANE-B DRO OTIC DESICORTANE-B LOT DESICORTIC-ND DRO DESI

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

CORTROSYN 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/ColdCREAM BASE CRE Not properly listed with FDACRNATAL PAK Vitamin/MineralCROFAB 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 allergenicCUTIS PLUS CRE Bulk IngredientCYANOCOBALAM INJ 1000MCG Vitamin/MineralCYCLOBENZAPR CRE 20MG/GM Bulk IngredientCYCLOBENZAPR CRE 5% KIT Bulk IngredientCYCLOBENZAPR PAK PAX Unapproved DrugCYOTIC DRO DESICYSTO-CONRAY INJ II 17.2% Diagnostic AgentCYSTOGRAFIN INJ 30% Diagnostic AgentCYSTOGRAFIN- INJ DILUTE Diagnostic AgentCYSVIEW INJ 100MG Diagnostic AgentCYTRA K GRA CRYSTALS Unapproved DrugCYTRA-2 SOL Unapproved DrugCYTRA-3 SYP Unapproved DrugCYTRA-K SOL Unapproved DrugD-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-LM SOL 1.5% DEX Dialysis covered by ESRD bundled paymentDELFLEX-LM SOL 2.5% DEX Dialysis covered by ESRD bundled paymentDELFLEX-LM/ SOL 4.25 DEX Dialysis covered by ESRD bundled payment

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

DELFLEX-SM/ SOL 1.5% DEX Dialysis covered by ESRD bundled paymentDELFLEX-SM/ SOL 2.5% DEX Dialysis covered by ESRD bundled paymentDELFLEX-SM/ SOL 4.25 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 DrugDERMA SERUM CRE FREEDOM Not properly listed with FDADERMA SILKRX KIT SDS PAK Unapproved DrugDERMA SILKRX PAK ANODYNEX LISTDERMA SILKRX PAK DICLOPAK LISTDERMACINRX KIT ANALGESI LISTDERMACINRX KIT COMBOPAK LISTDERMACINRX KIT PHARMAPA LISTDERMACINRX KIT PRIZOPAK LISTDERMACINRX KIT SILAPAK LISTDERMACINRX PAK Not properly listed with FDADERMACINRX PAK DUOPATCH Not properly listed with FDADERMACINRX PAK INFLAMMA LISTDERMACINRX PAK LEXITRAL Not properly listed with FDADERMACINRX PAK PHN LISTDERMACINRX PAK ZRM LISTDERMACINRX 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 LISTDEXFERRUM INJ 50MG/ML Vitamin/MineralDEXLIDO 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/Mineral

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

DIALYVITE 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 paymentDIATX ZN TAB Vitamin/MineralDIAZEPAM INJ 10MG/2ML DeviceDICLOFEX DC MIS Not properly listed with FDADICLOTRAL PAK LISTDICOPANOL SUS 5MG/ML Unapproved DrugDIDREX TAB 50MG Anorexic, Anti-obestiy AgentDIETHYLPROP 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 AnestheticDIPRIVAN 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/MineralDM/CPM/PE DRO Cough/ColdDMSA KIT Diagnostic AgentDNA 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 allergenicDONNATAL ELX DESIDONNATAL ELX GRAPE Unapproved DrugDONNATAL ELX MINT Unapproved DrugDONNATAL TAB DESIDONNATAL TAB 16.2MG DESIDONNATAL TAB EXTENTAB DESIDOTAREM INJ 10MMOL Diagnostic Agent

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

DOTAREM INJ 50MMOL Diagnostic AgentDOTAREM INJ 5MMOL Diagnostic AgentDOTAREM INJ 7.5MMOL Diagnostic AgentDOTHELLE DHA CAP Vitamin/MineralDOUBLEDEX KIT LISTDPI CLASSIC CRE AEB Not properly listed with FDADPI LS PLUS CRE Not properly listed with FDADPI LS ULTRA CRE Not properly listed with FDADPI NATURAL CRE BASE Not properly listed with FDADPI NATURAL CRE LOTION Not properly listed with FDADPI SUPREME CRE BASE 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 DrugDUET 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/MineralDUET DHA 400 MIS 25-1-400 Vitamin/MineralDUET DHA 430 MIS 25-1-430 Vitamin/MineralDUET DHA 430 MIS 25-1-430 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 AgentDYSPORT INJ 300UNIT CosmeticDYURAL-40 KIT LISTDYURAL-80 KIT LIST

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

DYURAL-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 DrugECZEMOL TAB Unapproved DrugED CYTE F TAB Vitamin/MineralED-FLEX CAP 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 DrugEFFER-K TAB 20MEQ Unapproved DrugEFFER-K TAB 25MEQ EF Unapproved DrugELEDERM-D CRE DPI Not properly listed with FDAELEDERM-N CRE DPI Not properly listed with FDAELENZAPATCH 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/MineralELOCTATE INJ 1000UNIT Blood ComponentELOCTATE INJ 1500UNIT Blood ComponentELOCTATE INJ 2000UNIT Blood ComponentELOCTATE INJ 250UNIT Blood ComponentELOCTATE INJ 3000UNIT Blood ComponentELOCTATE INJ 500UNIT Blood ComponentELOCTATE INJ 750UNIT Blood ComponentEMOLLIENT CRE Not properly listed with FDAEMPTY CAPSUL CAP SIZE 0 Unapproved Drug

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

EMPTY 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 allergenicENLYTE CAP Unapproved DrugENTERAGAM POW 5GM Not properly listed with FDAENTERO VU SUS 24% Diagnostic AgentENTTY 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 DrugEPIQUIN MICR CRE 4% CosmeticEPISNAP KIT LISTERECAID KIT CLASSIC Erectile DysfunctionERECAID KIT ESTEEM Erectile DysfunctionERGOCALCIFER CAP 50000UNT 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 Anesthetic

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

ETOMIDATE 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 2014-15 Influenza VaccineEZ FLU SHOT INJ 2015-16 Influenza VaccineEZ FLU SHOT INJ PF 13-14 Influenza VaccineEZ FLU SHOT INJ PF 14-15 Influenza VaccineEZ FLU SHOT KIT 2015-16 Influenza VaccineFA-B6-B12 TAB Vitamin/MineralFABB TAB Vitamin/MineralFAGRON LS CRE PLUS Not properly listed with FDAFAGRON LS CRE ULTRA Not properly listed with FDAFALESSA 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 100MCG General AnestheticFENTANYL CIT INJ 2500MCG General AnestheticFENTANYL CIT INJ 250MCG General AnestheticFENTANYL CIT INJ 500MCG General AnestheticFENTANYL INJ CITRATE 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/Mineral

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

FIBERSOUR 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-MARYS SUS MOUTHWSH Unapproved DrugFIRST-MOUTHW SUS BLM Unapproved DrugFIRST-OMEPRA SUS 2MG/ML Bulk IngredientFIRST-TESTOS CRE MC 2% Unapproved DrugFIRST-TESTOS OIN 2% Unapproved DrugFITALITE CRE BASE Not properly listed with FDAFLAVOR BLEND SUS Unapproved DrugFLAVOR PLUS LIQ Unapproved DrugFLAVOR SWEET LIQ S/F Unapproved DrugFLAVOR SWEET SYP Unapproved DrugFLEXBUMIN 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/ColdFLUARIX PF INJ 2013-14 Influenza VaccineFLUARIX PF INJ 2014-15 Influenza VaccineFLUARIX QUAD INJ 2013-14 Influenza VaccineFLUARIX QUAD INJ 2014-15 Influenza VaccineFLUARIX QUAD INJ 2015-16 Influenza VaccineFLUBLOK SOL 2013-14 Influenza VaccineFLUBLOK SOL 2014-15 Influenza VaccineFLUBLOK SOL 2015-16 Influenza VaccineFLUCAINE SOL 0.25-0.5 Diagnostic AgentFLUCELVAX INJ 2014-15 Influenza VaccineFLUCELVAX INJ 2015-16 Influenza VaccineFLULAVAL INJ 2013-14 Influenza VaccineFLULAVAL INJ 2014-15 Influenza VaccineFLULAVAL QUA INJ 2013-14 Influenza VaccineFLULAVAL QUA INJ 2014-15 Influenza VaccineFLULAVAL QUA INJ 2014-15 Influenza VaccineFLULAVAL QUA INJ 2015-16 Influenza VaccineFLUMIST QUAD SUS 2014-15 Influenza VaccineFLUMIST QUAD SUS 2015-16 Influenza Vaccine

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

FLUOR-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 DrugFLUORACAINE SOL OP Diagnostic AgentFLUORE-BENOX SOL 0.25-0.4 Diagnostic AgentFLUORESCEIN/ SOL PROPARAC Diagnostic AgentFLUORESCITE INJ 10% OP Diagnostic AgentFLUORIDE CHW 0.25MG F Unapproved DrugFLUORIDE CHW 0.5MG F Unapproved DrugFLUORIDE CHW 1MG F Unapproved DrugFLUORIDEX GEL 1.1% Unapproved DrugFLUORIDEX GEL SENSITIV Unapproved DrugFLUORIDEX GEL WHITENIN Unapproved DrugFLUORIDEX DD PST SENSITIV 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 2014-15 Influenza VaccineFLUVIRIN INJ 2015-16 Influenza VaccineFLUVIRIN PF INJ 2014-15 Influenza VaccineFLUZONE INJ INTRADRM Influenza VaccineFLUZONE INJ PF 14-15 Influenza VaccineFLUZONE HD INJ PF 14-15 Influenza VaccineFLUZONE HD INJ PF 15-16 Influenza VaccineFLUZONE QUAD INJ 14-15 Influenza VaccineFLUZONE QUAD INJ 15-16 Influenza VaccineFLUZONE QUAD INJ 2015-16 Influenza VaccineFLUZONE SPLT INJ 2014-15 Influenza VaccineFLUZONE SPLT INJ 2015-16 Influenza VaccineFOCALGIN 90 MIS DHA Vitamin/MineralFOCALGIN CA MIS Vitamin/MineralFOCALGIN-B TAB Vitamin/MineralFOLBEE TAB Vitamin/MineralFOLBEE AR TAB Vitamin/Mineral

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

FOLBEE PLUS TAB Vitamin/MineralFOLBEE PLUS TAB CZ Vitamin/MineralFOLBIC TAB Vitamin/MineralFOLBIC RF TAB Vitamin/MineralFOLCAL DHA CAP Vitamin/MineralFOLCAPS CAP OMEGA 3 Vitamin/MineralFOLET 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/MineralFOLIVANE-F CAP Vitamin/MineralFOLIVANE-OB CAP Vitamin/MineralFOLIVANE-PRX CAP DHA NF Vitamin/MineralFOLIXAPURE TAB 1-5000 Vitamin/MineralFOLLISTIM AQ INJ 150UNIT Fertility AgentFOLLISTIM 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 FDA

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

FREEDOM 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 FDAFRST-HYDRCRT GEL 10% Not properly listed with FDAFUL-GLO TES 0.6MG OP Diagnostic AgentFUL-GLO TES 1MG OP Diagnostic AgentFUSARIUM EXT SOL 1:20FUSARIUM INJ 1:10 Non-standardized allergenicFUSION PAK SPRINKLE Vitamin/MineralGABADONE CAP Medical FoodGABAVALE-5 PAK Unapproved DrugGABAZOLAMINE PAK Unapproved DrugGABAZOLAMINE PAK 0.5MG Unapproved DrugGABAZOLPIDEM PAK 5MG Unapproved DrugGABITIDINE PAK 150MG Unapproved DrugGABOXETINE PAK Unapproved DrugGADAVIST INJ 1MMOL/ML Diagnostic AgentGALAXTRA POW Not properly listed with FDAGALZIN CAP 25MG Vitamin/MineralGALZIN CAP 50MG Vitamin/MineralGANIRELIX AC INJ Fertility AgentGAPEAUM CRE BUDIBAC Bulk IngredientGASTRINEX NF CAP Unapproved DrugGASTROGRAFIN 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 FDAGENADUR KIT Not properly listed with FDAGENADUR LIQ Not properly listed with FDAGERMAN INJ COCKROAC Non-standardized allergenicGESTICARE PAK DHA Vitamin/MineralGILPHEX TR TAB 10-388MG Unapproved DrugGILTUSS LIQ Cough/ColdGILTUSS LIQ PED-C 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 Agent

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

GLUCAGON INJ 1MG Diagnostic AgentGLYCINE SOL 1.5% IRR Not properly listed with FDAGLYTACTIN LIQ RTD 10 Not properly listed with FDAGLYTACTIN LIQ RTD 15 Not properly listed with FDAGONAL-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 DrugGRAFCO SILVR MIS NIT APPL Unapproved DrugGRANULEX AER DESIGREEN GLO MIS 1.5MG Diagnostic AgentGRX HICORT SUP 25MG DESIHACKBERRY EX SOL 1:20 Non-standardized allergenicHC AC/ALOE GEL 2% Unapproved DrugHC PRAMOXINE CRE 1-1% Unapproved DrugHC PRAMOXINE CRE 2.5-1% DESIHC/LIDOCAINE KIT 2-2% Not properly listed with FDAHEALON 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 220-400 Blood ComponentHEMOFIL M INJ 250UNIT Blood ComponentHEMOFIL M INJ 401-800 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 FDA

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

HEPARIN LOCK INJ 10UNT/ML Not properly listed with FDAHEPARIN LOCK INJ 1UNIT/ML Not properly listed with FDAHEPARIN LOCK INJ 2UNIT/ML Not properly listed with FDAHEPARIN LOCK KIT 100/ML Not properly listed with FDAHEPARIN LOCK KIT 10UNT/ML Not properly listed with FDAHEXABRIX 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 DrugHONEY BEE INJ 1000MCG Non-standardized allergenicHONEY BEE KIT 100MCG Non-standardized allergenicHORMEL ALLERGY ANTIGEN Not properly listed with FDAHORNET 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 ComponentHUMCO BASE CRE PAIN MGM Unapproved DrugHURRISEAL SOL Not properly listed with FDAHYALGAN INJ 20MG/2ML Surgical Supply/MedicalHYALUCIL-0.5 CRE Not properly listed with FDAHYALUCIL-4 CRE 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/Cold

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

HYDROC/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 FDAHYDROGEL 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/MedicalHYLATOPIC AER DeviceHYLATOPIC AER PLUS DeviceHYLATOPIC CRE PLUS DeviceHYLENEX INJ 150 UNIT LISTHYLIRA GEL 0.2% DeviceHYLIRA LOT 0.1% DeviceHYOLEV MB TAB 81MG Unapproved DrugHYOMAX-SL SUB 0.125MG 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 FDAHYPERCARE SOL 20% Not properly listed with FDA

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

HYPERHEP 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 ComponentIMPLANON IMP 68MG Not properly listed with FDAINATAL ADV TAB Vitamin/MineralINATAL GT TAB Vitamin/MineralINATAL ULTRA TAB Vitamin/MineralINDICLOR 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 LISTINULIN 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 DrugISCAR MALI INJ 5MG/ML Not properly listed with FDAISO CARBACHO SOL 1.5% OP Unapproved DrugISO CARBACHO SOL 3% OP Unapproved DrugISO HOMATROP SOL 2% OP Unapproved Drug

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

ISO HOMATROP SOL 5% OP Unapproved DrugISOFLURANE 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 AgentISOVUE-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 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 DrugK10-LIDO KIT LISTK2K PAIN REL PAD 4-4% Unapproved DrugK40-LIDO KIT LISTKARIDIUM DRO 0.125MG Unapproved DrugKARIGEL GEL 0.5% Unapproved DrugKARIGEL-N GEL 1.1% Unapproved DrugKCENTRA KIT 1000UNIT Blood ComponentKCENTRA KIT 500UNIT Blood Component

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

KEDBUMIN INJ 25% Blood ComponentKERAFOAM AER 30% Unapproved DrugKERAFOAM 42 AER 42% Unapproved DrugKERALAC CRE 47% Unapproved DrugKERALYT GEL 6% Unapproved DrugKERALYT KIT SCALP 6% Unapproved DrugKERLIX AMD MIS BANDAGE Not properly listed with FDAKETALAR INJ 100MG/ML General AnestheticKETALAR INJ 10MG/ML General AnestheticKETALAR INJ 50MG/ML General AnestheticKETAMINE HCL SOL 10MG/ML General AnestheticKETAMINE HCL SOL 50MG/ML General AnestheticKETAMINE INJ 100MG/ML General AnestheticKETAMINE INJ 10MG/ML General AnestheticKETAMINE INJ 50MG/ML General AnestheticKETAMINE HCL INJ SOD CL General AnestheticKETAMINE SOL 10MG/ML General AnestheticKETODAN KIT 2% LISTKETOROCAINE 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/25 POW 25MEQ Unapproved DrugKLOR-CON/EF TAB 25MEQ EF Unapproved DrugKLOR-CON/EF TAB 25MEQ FR Unapproved DrugKOATE-DVI INJ 1000UNIT Blood ComponentKOATE-DVI INJ 250UNIT Blood ComponentKOATE-DVI INJ 500UNIT 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 ComponentKOVALTRY INJ 1000UNIT Blood ComponentKOVALTRY INJ 2000UNIT Blood Component

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

KOVALTRY INJ 250UNIT Blood ComponentKOVALTRY INJ 3000UNIT Blood ComponentKOVALTRY INJ 500UNIT Blood ComponentKRISGEL 100 GEL Not properly listed with FDAL-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 FDAL-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 ANHY OIN Not properly listed with FDALANSOPRAZOLE SUS 3MG/ML Bulk IngredientLATISSE SOL 0.03% CosmeticLATRIX 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 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 AgentLEXUSS 210 LIQ 2-10/5ML Unapproved DrugLIBRAX CAP 5-2.5MG LISTLIDAZONE CRE Unapproved DrugLIDENZA PAD 4-1% Unapproved DrugLIDO-HYDRO GEL 2.8-0.55 Unapproved Drug

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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-K LOT 3% Not properly listed with FDALIDO-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 INJ 4% LISTLIDOCAINE 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 LISTLIDOPIN CRE 3% Unapproved DrugLIDOPIN CRE 3.25% Unapproved DrugLIDOPROFEN CRE 5-5-2% Bulk IngredientLIDORX GEL 3% Not properly listed with FDALIDOTHOL PAD 4.5-5% Unapproved DrugLIDOTRAL CRE 3.88% Unapproved DrugLIDOVEX CRE 3.75% Unapproved DrugLIDOVIN CRE 3.95% Unapproved DrugLIDOVIR OIN 4-4% Bulk IngredientLIDOXIB KIT LISTLIDOZOL CRE 3.75% Unapproved DrugLIMBREL 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 FDALIPOBASE CRE HEAVY Not properly listed with FDALIPOBASE CRE REGULAR Not properly listed with FDALIPOFOAM RX AER Not properly listed with FDALIPOPEN CRE Not properly listed with FDALIPOPEN CRE ANHYDRO Not properly listed with FDALIPOPEN CRE PLUS Not properly listed with FDA

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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 ULTRA Not properly listed with FDALIPOZYME CRE Not properly listed with FDALISSAMINE GR TES 1.5MG Diagnostic AgentLISTER-V CAP Not properly listed with FDALIVIXIL PAK KIT 2.5-2.5% LISTLMTHF/B6/B12 TAB Vitamin/MineralLORENZA 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 DrugLUKAID GLA EMU 1GM/ML Unapproved DrugLUMASON INJ 60.7-25 Diagnostic AgentLURIDE CHW 0.25MG F Unapproved DrugLURIDE CHW 0.5MG F Unapproved DrugLURIDE CHW 1MG F Unapproved DrugLURIDE DRO 0.5MG/ML Unapproved DrugLUSTRA CRE 4% CosmeticLUSTRA-AF CRE 4% CosmeticLUSTRA-ULTRA CRE 4% CosmeticLUXAMEND CRE Not properly listed with FDALYSIPLEX TAB PLUS Vitamin/MineralLYTENSOPRIL MIS -90 KIT Unapproved DrugLYTENSOPRIL PAK KIT Unapproved DrugM-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/MineralMAC PATCH PAD .0375-5% Not properly listed with FDAMACNATAL CN CAP DHA Vitamin/MineralMACUGEN INJ LISTMACUTEK 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 DrugMARBETA-25 KIT LISTMARBETA-L KIT LISTMARCAINE INJ SPINAL Not properly listed with FDAMARCAINE/EPI INJ 0.25% LIST

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

MARCAINE/EPI INJ 0.25% Not properly listed with FDAMARCAINE/EPI INJ 0.5% LISTMARCAINE/EPI INJ 0.5% Not properly listed with FDAMARDEX-25 KIT LISTMARLIDO KIT LISTMARLIDO-25 KIT LISTMARNATAL-F CAP Vitamin/MineralMARSH ELDER INJ 1:20 Non-standardized allergenicMB HYDROGEL KIT Unapproved DrugMD-76 R INJ Diagnostic AgentMD-GASTROVIE SOL 66-10% Diagnostic AgentME/NAPHOS/MB TAB HYO 1 Unapproved DrugMEADOW FESCU INJ 100000BA Non-standardized allergenicMEDACTIV TAB Anorexic, Anti-obesity AgentMEDCATED DNA KIT COLLECT Diagnostic AgentMEDI-10 CAP Unapproved DrugMEDI-DERM/L- CRE RX Unapproved DrugMEDI-PATCH PAD RX Not properly listed with FDAMEDIDERM CRE Not properly listed with FDAMEDIHOL BASE GEL Not properly listed with FDAMEDIHONEY PAD 2"X2" Not properly listed with FDAMEDIHONEY PAD 3/4"X12" Not properly listed with FDAMEDIHONEY PAD 4"X5" Not properly listed with FDAMEDROX-RX OIN OTC ProductMEGA-C/A PLU INJ 500MG/ML Unapproved DrugMEGRIX MIS Unapproved DrugMELALEUCA INJ 1:20 Non-standardized allergenicMELPAQUE HP CRE 4% CosmeticMELQUIN 3 SOL 3% CosmeticMELQUIN HP CRE 4% CosmeticMENOPUR INJ 75UNIT Fertility AgentMENTHOCIN PAD LIDOCAIN Unapproved DrugMENTHOLIX SPR 4-1% Unapproved DrugMEPER/PROMET CAP 50-25MG Unapproved DrugMEPHYTON TAB 5MG Vitamin/MineralMESQUITE SOL EXTRACT Non-standardized allergenicMETAFOLBIC TAB Vitamin/MineralMETAFOLBIC TAB PLUS Vitamin/MineralMETAFOLBIC TAB PLUS RF Vitamin/MineralMETANX CAP Vitamin/MineralMETHAVER CAP Unapproved DrugMETHAZEL CAP Unapproved DrugMETHENAM MAN TAB 1000MG Unapproved DrugMETHENAM MAN TAB 1GM Unapproved DrugMETHENAM MAN TAB 500MG Unapproved Drug

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

METHOHEXITAL INJ 100/10ML General AnestheticMETHOHEXITAL SOL 10MG/ML General AnestheticMETHYL SALIC LIQ Not properly listed with FDAMETHYLFOL/CA TAB ME-CBL Vitamin/MineralMETHYLFOL/ME CAP CBL/P5P Vitamin/MineralMETOPIRONE CAP 250MG Diagnostic AgentMG SO4/D5W INJ 20MG/ML Not properly listed with FDAMICROCYN GEL Not properly listed with FDAMICROCYN GEL SKIN/WOU Not properly listed with FDAMICROCYN LIQ Not properly listed with FDAMIDAZOLAM INJ 10/10ML General AnestheticMIDAZOLAM INJ 10MG/2ML General AnestheticMIDAZOLAM INJ 25MG/5ML General AnestheticMIDAZOLAM INJ 2MG/2ML General AnestheticMIDAZOLAM INJ 50MG/10 General AnestheticMIDAZOLAM INJ 5MG/5ML General AnestheticMIDAZOLAM INJ 5MG/ML General AnestheticMIDAZOLAM INJ 5MG/ML General AnestheticMIDAZOLAM INJ 5MG/ML General AnestheticMIDAZOLAM SOL HCL General AnestheticMIDAZOLAM SYP 2MG/ML General AnestheticMIFEPREX TAB 200MG Not properly listed with FDAMIGRAGESIC CAP IDA DESIMIGRALAM CAP DESIMIGRANOW PAK LISTMIGRYL MIS 0.0375-5 Unapproved DrugMITE SOL EXTRACT Non-standardized allergenicMITE SOL EXTRACT Non-standardized allergenicMIXED ASPERG SOL 20000PNU Non-standardized allergenicMIXED SOL FEATHERS Non-standardized allergenicMIXED SOL RAGWEED Non-standardized allergenicMIXED VESPID INJ 1650MCG Non-standardized allergenicMIXED VESPID INJ 3900MCG Non-standardized allergenicMIXED VESPID KIT 3000MCG Non-standardized allergenicMIXED VESPID KIT 300MCG Non-standardized allergenicMLK F1 KIT LISTMLK F2 KIT LISTMLK F3 KIT LISTMLK F4 KIT LISTMLP A-1 KIT LISTMONOCLATE-P INJ 1000UNIT Blood ComponentMONOCLATE-P INJ 1500UNIT Blood ComponentMONOCLATE-P INJ 250UNIT Blood ComponentMONONINE INJ 1000UNIT Blood ComponentMONONINE INJ 500UNIT Blood Component

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

MONSELS FERR SOL SUBSULF Unapproved DrugMORPHINE SUL SUP 10MG Not properly listed with FDAMORPHINE SUL SUP 20MG Not properly listed with FDAMORPHINE SUL SUP 30MG Not properly listed with FDAMORPHINE SUL SUP 5MG Not properly listed with FDAMOSQUITO INJ 1:100 Non-standardized allergenicMOUNTAIN SOL CEDAR Non-standardized allergenicMOUSE EPITHE INJ 1:20 Non-standardized allergenicMOUTH WASH LIQ GP Not properly listed with FDAMOUTHWASH LIQ AF Not properly listed with FDAMOUTHWASH LIQ OM Not properly listed with FDAMUCOR EXT INJ 1:10 Non-standardized allergenicMUCOR EXT INJ 1:20 Non-standardized allergenicMUGWORT SOL EXTRACT Non-standardized allergenicMULT-VIT/FL CHW 0.5MG Vitamin/MineralMULTI-DRUG KIT DIUSCREE Diagnostic AgentMULTI- KIT SPECIALT LISTMULTI-VIT/FE DRO /FL 0.25 Vitamin/MineralMULTI-VIT/FL DRO /FE 0.25 Vitamin/MineralMULTI-VIT/FL DRO 0.25MG Vitamin/MineralMULTI-VIT/FL DRO 0.5MG/ML Vitamin/MineralMULTIHANCE SOL Diagnostic AgentMULTITRACE-4 INJ Unapproved DrugMULTITRACE-4 INJ CONC Unapproved DrugMULTITRACE-4 INJ NEONATAL Unapproved DrugMULTITRACE-4 INJ PED Unapproved DrugMULTIUSE CRE BASE Not properly listed with FDAMULTIVIT/FL CHW 0.25MG Vitamin/MineralMULTIVIT/FL CHW 0.5MG Vitamin/MineralMULTIVIT/FL CHW 1MG Vitamin/MineralMUSE SUP 1000MCG Erectile DysfunctionMUSE SUP 125MCG Erectile DysfunctionMUSE SUP 250MCG Erectile DysfunctionMUSE SUP 500MCG Erectile DysfunctionMVC-FLUORIDE CHW 0.25MG Vitamin/MineralMVC-FLUORIDE CHW 0.5MG Vitamin/MineralMVC-FLUORIDE CHW 1MG Vitamin/MineralMYDRAL SOL 0.5% OP Diagnostic AgentMYDRAL SOL 1% OP Diagnostic AgentMYDRIACYL SOL 1% OP Diagnostic AgentMYKIDZ IRON SUS FL Vitamin/MineralMYLERAN TAB 2MG LISTMYNATAL CAP Vitamin/MineralMYNATAL TAB Vitamin/MineralMYNATAL TAB ADVANCE Vitamin/Mineral

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

MYNATAL PLUS TAB Vitamin/MineralMYNATAL-Z TAB Vitamin/MineralMYNATE 90 TAB PLUS Vitamin/MineralMYNEPHROCAPS CAP Vitamin/MineralMYOVIEW KIT 30ML Diagnostic AgentN-ACETYL-L- CAP CYSTEINE Not properly listed with FDANA HYDROXIDE SOL 10% Unapproved DrugNABI-HB INJ Hepatitis B VaccineNACL/BACT INJ 0.9%BENZ LISTNAFRINSE CHW 1MG F Unapproved DrugNAFRINSE DRO 0.125MG Unapproved DrugNAFRINSE SOL DAILY Unapproved DrugNAFRINSE DLY SOL /NEUTRAL Unapproved DrugNAFRINSE WK SOL 0.2% Unapproved DrugNAPROPAK PAK LISTNAPROPAK PAK COOL LISTNAPROPAX MIS LISTNAPROXEN CRE Bulk IngredientNAPROXEN CRE 10% Bulk IngredientNAPROXENPAX MIS Unapproved DrugNASCOBAL SPR 500MCG Vitamin/MineralNATACHEW CHW Vitamin/MineralNATACREAM CRE Not properly listed with FDANATALVIRT MIS 90 DHA Vitamin/MineralNATALVIRT CA PAK Vitamin/MineralNATALVIT TAB 75-1MG Vitamin/MineralNATELLE ONE CAP Vitamin/MineralNATURAL CRE Not properly listed with FDANATURE THROI TAB 162.5MG Unapproved DrugNATURE-THROI TAB 113.75MG Unapproved DrugNATURE-THROI TAB 130MG Unapproved DrugNATURE-THROI TAB 146.25MG Unapproved DrugNATURE-THROI TAB 16.25MG Unapproved DrugNATURE-THROI TAB 195MG Unapproved DrugNATURE-THROI TAB 260MG Unapproved DrugNATURE-THROI TAB 32.5MG Unapproved DrugNATURE-THROI TAB 325MG Unapproved DrugNATURE-THROI TAB 48.75MG Unapproved DrugNATURE-THROI TAB 65MG Unapproved DrugNATURE-THROI TAB 81.25MG Unapproved DrugNATURE-THROI TAB 97.5MG Unapproved DrugNAZIREX CRE Unapproved DrugNEBUSAL NEB 3% DeviceNEBUSAL NEB 6% DeviceNEEVO DHA CAP 27-1.13 Vitamin/Mineral

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

NEO-SYNALAR KIT LISTNEOSALUS AER DeviceNEOSALUS CRE DeviceNEOSALUS LOT DeviceNEOSALUS CP CRE DeviceNEOTUSS PLUS LIQ Cough/ColdNEPHPLEX RX TAB Vitamin/MineralNEPHRO-VITE TAB RX Vitamin/MineralNEPHROCAPS CAP Vitamin/MineralNEPHROCAPS TAB QT Vitamin/MineralNEPHRONEX TAB 1MG Vitamin/MineralNESTABS TAB Vitamin/MineralNESTABS ABC MIS Vitamin/MineralNESTABS DHA PAK Vitamin/MineralNEUAC KIT 1.2-5% LISTNEUREPA CAP Not properly listed with FDANEURIN-SL SUB Vitamin/MineralNEUTRAGARD GEL 1.1% Unapproved DrugNEUTRASAL POW Not properly listed with FDANEUVAXIN PAD 0.0375-5 Unapproved DrugNEWGEN TAB 32-1MG Vitamin/MineralNEXA PLUS CAP Vitamin/MineralNEXAVIR INJ Unapproved DrugNEXPLANON IMP 68MG Not properly listed with FDANIACIN POW USP/NF Not properly listed with FDANICADAN TAB Vitamin/MineralNICAZEL TAB Vitamin/MineralNICAZEL TAB FORTE Vitamin/MineralNICAZELDOXY KIT 30 Vitamin/MineralNICAZELDOXY KIT 60 Vitamin/MineralNICOMIDE TAB Vitamin/MineralNICOMIDE TAB Vitamin/MineralNIMBEX INJ 10MG/ML LISTNIMBEX INJ 2MG/ML LISTNIMBEX INJ 2MG/ML LISTNITROPRESS INJ 25MG/ML LISTNIVA-FOL TAB Vitamin/MineralNIVA-PLUS TAB Vitamin/MineralNIVATOPIC CRE PLUS LISTNOCLOT-50 SOL ACD-A Not properly listed with FDANODOLOR CAP DESINOREPINEPHR INJ 1MG/ML Not properly listed with FDANORMAL SALIN INJ 0.9% Not properly listed with FDANORML SALINE INJ FLUSH Not properly listed with FDANORML SALINE INJ IV FLUSH Not properly listed with FDA

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

NORTUSS-DE DRO Cough/ColdNORTUSS-EX LIQ 200-20/5 Cough/ColdNOURISH LIQ Not properly listed with FDANOURIVAN CRE ANTIOX Not properly listed with FDANOVACORT GEL DESINOVOCLAIR CRE Bulk IngredientNOVOEIGHT INJ 1000UNIT Blood ComponentNOVOEIGHT INJ 1500UNIT Blood ComponentNOVOEIGHT INJ 2000UNIT Blood ComponentNOVOEIGHT INJ 250UNIT Blood ComponentNOVOEIGHT INJ 3000UNIT Blood ComponentNOVOEIGHT INJ 500UNIT Blood ComponentNOVOSEVEN RT INJ 1MG Blood ComponentNOVOSEVEN RT INJ 2MG Blood ComponentNOVOSEVEN RT INJ 5MG Blood ComponentNOVOSEVEN RT INJ 8MG Blood ComponentNOXI-K CRE Not properly listed with FDANOXIFINE EMU Surgical Supply/MedicalNOXIFOL-D TAB Not properly listed with FDANOXIPAK PAK Not properly listed with FDANP #2 DRUG CRE PREP KIT Not properly listed with FDANP THYROID TAB 30MG Unapproved DrugNP THYROID TAB 60MG Unapproved DrugNP THYROID TAB 90MG Unapproved DrugNUFOL TAB Vitamin/MineralNULEV TAB 0.125MG Unapproved DrugNUMOISYN LIQ Unapproved DrugNUMOISYN LOZ Unapproved DrugNUOX GEL 6-3% Unapproved DrugNUQUIN HP CRE 4% CosmeticNUQUIN HP GEL 4% CosmeticNUTRICAP TAB Vitamin/MineralNUTRIFAC ZX TAB Vitamin/MineralNUTRIVIT LIQ 800-15-1 Vitamin/MineralNUVAIL SOL 16% DeviceNUVYA CRE Unapproved DrugNUWIQ INJ 1000UNIT Blood ComponentNUWIQ INJ 2000UNIT Blood ComponentNUWIQ INJ 250UNIT Blood ComponentNUWIQ INJ 500UNIT Blood ComponentNUWIQ KIT 1000UNIT Blood ComponentNUWIQ KIT 2000UNIT Blood ComponentNUWIQ KIT 250UNIT Blood ComponentNUWIQ KIT 500UNIT Blood ComponentNUZON GEL 2% Unapproved Drug

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

NYATA KIT LISTNYSTATIN POW Unapproved DrugO-CAL TAB PRENATAL Vitamin/MineralO-CAL FA TAB Vitamin/MineralOB COMPLETE CAP 400 Vitamin/MineralOB COMPLETE CAP ONE Vitamin/MineralOB COMPLETE CAP GOLD Vitamin/MineralOB COMPLETE CAP PETITE Vitamin/MineralOB COMPLETE CHW Vitamin/MineralOB COMPLETE TAB Vitamin/MineralOB COMPLETE TAB PREMIER Vitamin/MineralOB COMPLETE/ CAP DHA Vitamin/MineralOBIZUR INJ 500 UNIT Blood ComponentOBREDON SOL 2.5-200 Cough/ColdOBSTETRIX PAK DHA Vitamin/MineralOBSTETRIX EC TAB Vitamin/MineralOCTAPLAS INJ GROUP A Blood ComponentOCTAPLAS INJ GROUP AB Blood ComponentOCTAPLAS INJ GROUP B Blood ComponentOCTAPLAS INJ GROUP O Blood ComponentOCTREOSCAN KIT Diagnostic AgentOCUVEL CAP 0.5MG Vitamin/MineralOLIVE TREE INJ 1:20 Non-standardized allergenicOLLIZAC POW Medical FoodOMEGA-3/D-3 KIT WELLNESS LISTOMEPRAZOLE + SUS SYRSPEND Not properly listed with FDAOMNIFLEX DPR DeviceOMNIPAQUE INJ 140MG/ML Diagnostic AgentOMNIPAQUE INJ 180MG/ML Diagnostic AgentOMNIPAQUE INJ 240MG/ML Diagnostic AgentOMNIPAQUE INJ 300MG/ML Diagnostic AgentOMNIPAQUE INJ 350MG/ML Diagnostic AgentOMNISCAN INJ /NACL Diagnostic AgentOMNISCAN INJ 287MG/ML Diagnostic AgentOMNISCAN INJ 287MG/ML Diagnostic AgentOPIUM TIN 1% Unapproved DrugOPTASE GEL DESIOPTIMARK INJ 330.9MG Diagnostic AgentOPTIRAY 160 INJ 34% Diagnostic AgentOPTIRAY 240 INJ 51% Diagnostic AgentOPTIRAY 300 INJ 64% Diagnostic AgentOPTIRAY 320 INJ 68% Diagnostic AgentOPTIRAY 350 INJ 74% Diagnostic AgentOPTISON INJ Diagnostic AgentORA-BLEND SUS Not properly listed with FDA

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

ORA-BLEND SF SUS Not properly listed with FDAORA-PLUS LIQ Not properly listed with FDAORA-SWEET SYP Not properly listed with FDAORA-SWEET SF SYP Not properly listed with FDAORACIT SOL Unapproved DrugORAFATE PST 10% Not properly listed with FDAORAL MIX LIQ SUSPENDI Unapproved DrugORAL MIX SF LIQ Unapproved DrugORAL SUSPEND LIQ Unapproved DrugORAL SYRUP LIQ FLAVORED Unapproved DrugORAL SYRUP LIQ SF Unapproved DrugORCHARD GRAS INJ 100000BA Non-standardized allergenicORTHO COIL DPR KIT 100 DeviceORTHO COIL DPR KIT 105 DeviceORTHO COIL DPR KIT 50 DeviceORTHO D CAP 1-3775IU Unapproved DrugORTHO FLAT DPR KIT 55 DeviceORTHO FLAT DPR KIT 60 DeviceORTHO FLAT DPR KIT 65 DeviceORTHO FLAT DPR KIT 70 DeviceORTHO FLAT DPR KIT 75 DeviceORTHO FLAT DPR KIT 80 DeviceORTHO FLAT DPR KIT 85 DeviceORTHO FLAT DPR KIT 90 DeviceORTHO FLAT DPR KIT 95 DeviceORTHO-CS 250 INJ 250MG/ML Vitamin/MineralOSCIMIN SUB 0.125MG Unapproved DrugOSCIMIN TAB 0.125MG Unapproved DrugOSCIMIN TAB 0.125MG Unapproved DrugOSCIMIN SR TAB 0.375MG Unapproved DrugOSCION CLNSR LOT 6% Unapproved DrugOSPHENA TAB 60MG Sexual DysfunctionOTIC CARE DRO Unapproved DrugOTICIN DRO 1-0.1% Unapproved DrugOTICIN HC DRO DESIOTO-END 10 SOL DESIOTOMAX-HC DRO DESIOTOZIN DRO Unapproved DrugOVACE PLUS AER 9.8% Unapproved DrugOVACE PLUS CRE 10% Unapproved DrugOVACE PLUS GEL 10% WASH Unapproved DrugOVACE PLUS LIQ 10% WASH Unapproved DrugOVACE PLUS LOT 9.8% Unapproved DrugOVACE PLUS SHA 10% Unapproved DrugOVACE WASH LIQ 10% Unapproved Drug

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

OVIDREL INJ Fertility AgentOXYTOCIN INJ 10UNT/ML LISTP-SILOXAN DS CRE Not properly listed with FDAPAIN EASE AER MD STRM Not properly listed with FDAPAIN EASE AER MIST Not properly listed with FDAPAIN RELIEF PAD PATCH Unapproved DrugPAIN RELIEF PAD PATCH Unapproved DrugPAIRE OB MIS Vitamin/MineralPANATUSS DXP LIQ Cough/ColdPANCURONIUM INJ 1MG/ML Not properly listed with FDAPANCURONIUM INJ 2MG/ML Not properly listed with FDAPANHEMATIN INJ 313MG Blood ComponentPAPAVER-PHEN SOL ALPROSTI Erectile DysfunctionPAPAVER-PHEN SOL ALRPOS Erectile DysfunctionPAPAVERINE INJ 30MG/ML Unapproved DrugPAPAVERINE SOL 30MG/ML Unapproved DrugPAPAVERINE SOL ALPROSTA Erectile DysfunctionPAPAVERINE SOL PHENTOLA Erectile DysfunctionPAPAVERINE- SOL ALPROSTA Erectile DysfunctionPARACENTESIS KIT TRAY 8FR Not properly listed with FDAPAREGORIC TIN 2MG/5ML Unapproved DrugPAREMYD SOL 1-0.25% Diagnostic AgentPCCA ALADERM CRE BASE Not properly listed with FDAPCCA COBASE OIN #1 Not properly listed with FDAPCCA COSMETI CRE HRT BASE Not properly listed with FDAPCCA CUSTOM CRE LIPO-MAX Not properly listed with FDAPCCA LIPODER CRE BASE Not properly listed with FDAPCCA LIPOSOM CRE DRY Not properly listed with FDAPCCA LIPOSOM CRE NORMAL Not properly listed with FDAPCCA LIPOSOM CRE OILY Not properly listed with FDAPCCA LIPOSOM CRE SENSITIV Not properly listed with FDAPCCA MVC CRE BASE Not properly listed with FDAPCCA SWEET SYP -SF Not properly listed with FDAPCCA SYRUP SYP VEHICLE Not properly listed with FDAPCCA VANISH CRE BASE Not properly listed with FDAPCCA VANISHI CRE LIGHT Not properly listed with FDAPCCA VANPEN CRE BASE Not properly listed with FDAPCCA-PLUS SUS Not properly listed with FDAPCP 100 KIT LISTPE/GUAIFENES DRO 1.5-20MG Cough/ColdPECAN POLLEN SOL EXTRACT Non-standardized allergenicPEDIADERM AF KIT COMPLETE LISTPEDIADERM HC KIT LISTPEDIADERM TA KIT LISTPEDIPAK PAK Unapproved Drug

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

PEDIPIROX-4 KIT NAIL Not properly listed with FDAPENCREAM CRE Not properly listed with FDAPENDERM CRE Not properly listed with FDAPENICILLIUM INJ 1:20 Non-standardized allergenicPENICILLIUM INJ NOTATUM Non-standardized allergenicPENTAPHENE CRE Bulk IngredientPERCURA CAP Not properly listed with FDAPERENNIAL INJ RYE GRAS Non-standardized allergenicPERLANE INJ 20MG/ML CosmeticPERLANE-L GEL 40MG/2ML CosmeticPERLANE-L INJ 20MG/ML CosmeticPERMAVAN PAD Unapproved DrugPETROLATUM OIN WHITE Not properly listed with FDAPH 12 STERIL SOL FLOLAN Not properly listed with FDAPHARM CH TSX PAD 2-4-1% Not properly listed with FDAPHARMABASE CRE COSMETIC Not properly listed with FDAPHARMABASE CRE HEAVY Not properly listed with FDAPHENACTIN AA LIQ PLUS Not properly listed with FDAPHENAZO TAB 200MG Unapproved DrugPHENAZOPYRID TAB 100MG Unapproved DrugPHENAZOPYRID TAB 200MG Unapproved DrugPHENDIMETRAZ CAP 105MG ER Anorexic, Anti-obesity AgentPHENDIMETRAZ TAB 35MG Anorexic, Anti-obesity AgentPHENOHYTRO TAB Unapproved DrugPHENTERMINE CAP 15MG Anorexic, Anti-obesity AgentPHENTERMINE CAP 30MG Anorexic, Anti-obesity AgentPHENTERMINE CAP 37.5MG Anorexic, Anti-obesity AgentPHENTERMINE TAB 37.5MG Anorexic, Anti-obesity AgentPHENTOLAMINE SOL ALPROSTA Erectile DysfunctionPHOMA EXTRAC INJ 20000PNU Non-standardized allergenicPHOS-FLUR GEL 1.1% Unapproved DrugPHOSPHA 250 TAB NEUTRAL Unapproved DrugPHOSPHASAL TAB Unapproved DrugPHYS EZ USE KIT M-PRED LISTPHYTOBASE CRE Bulk IngredientPHYTONADIONE INJ 1MG/0.5 Vitamin/MineralPICO WOUND KIT THER SYS Not properly listed with FDAPINNACAINE DRO 20% OTIC Unapproved DrugPITOCIN INJ 10UNT/ML LISTPITRESSIN INJ 20UNT/ML Unapproved DrugPKU EASY TAB MICROTAB Not properly listed with FDAPLACEBO #00 CAP Unapproved DrugPLASBUMIN-25 INJ 25% Blood ComponentPLASBUMIN-5 INJ 5% Blood ComponentPLEGISOL SOL Not properly listed with FDA

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

PLEXION CRE 9.8-4.8% Unapproved DrugPLEXION LIQ 9.8-4.8% Unapproved DrugPLEXION LOT 9.8-4.8% Unapproved DrugPLEXION CLTH PAD 9.8-4.8% Unapproved DrugPLO GEL MEDIFLO Not properly listed with FDAPLO MEDIFLO KIT KIT Not properly listed with FDAPLO TRANSDER CRE Not properly listed with FDAPLO20 BASE GEL Not properly listed with FDAPNEUMODORON LIQ Unapproved DrugPNEUMOVAX 23 INJ 25/0.5 Pneumococcal VaccinePNV FE FUM TAB DOC/FA Vitamin/MineralPNV FOLIC AC TAB + IRON Vitamin/MineralPNV OB+DHA PAK Vitamin/MineralPNV PRENATAL TAB PLUS Vitamin/MineralPNV TABS TAB 29-1MG Vitamin/MineralPNV-DHA CAP Vitamin/MineralPNV-DHA CAP DOCUSATE Vitamin/MineralPNV-OMEGA CAP Vitamin/MineralPNV-SELECT TAB Vitamin/MineralPNV-TOTAL CAP Vitamin/MineralPNV-VP-U CAP 106.5-1 Vitamin/MineralPODIAPN CAP Vitamin/MineralPODOCON SOL 25% Unapproved DrugPOLIBAR SUS 100% Diagnostic AgentPOLIBAR ACB KIT 96% Diagnostic AgentPOLIBAR PLUS SUS 105% Diagnostic AgentPOLY-VI-FLOR CHW 0.25MG Vitamin/MineralPOLY-VI-FLOR CHW 0.5MG Vitamin/MineralPOLY-VI-FLOR CHW 1MG Vitamin/MineralPOLY-VI-FLOR CHW W/IRON Vitamin/MineralPOLY-VI-FLOR MIS FS Vitamin/MineralPOLY-VI-FLOR MIS FS 0.25 Vitamin/MineralPOLY-VI-FLOR MIS FS 0.5MG Vitamin/MineralPOLY-VI-FLOR SUS /IRON Vitamin/MineralPOLY-VI-FLOR SUS 0.25/ML Vitamin/MineralPOLYPEG OIN BASE Not properly listed with FDAPOT CHLORIDE TAB 25MEQ EF Unapproved DrugPOT CITRATE- PAK CIT ACID Unapproved DrugPOT HYDROXID SOL 5% Unapproved DrugPOT/CHLORIDE TAB 25MEQ EF Unapproved DrugPOTABA CAP 500MG DESIPOTASSIUM TAB 25MEQ EF Unapproved DrugPR BENZOYL LIQ 7% WASH Unapproved DrugPR CREAM KIT Unapproved DrugPR NATAL 400 PAK Vitamin/Mineral

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

PR NATAL 400 PAK EC Vitamin/MineralPR NATAL 430 PAK Vitamin/MineralPR NATAL 430 PAK EC Vitamin/MineralPRACASIL TM- CRE PLUS Not properly listed with FDAPRALIDOXIME INJ 600/2ML Not properly listed with FDAPRAMCORT CRE 1-1% Unapproved DrugPRAMLYTE PAK Unapproved DrugPRAMOSONE CRE 1% Unapproved DrugPRAMOSONE CRE 1-1% LISTPRAMOSONE CRE 1-2.5% DESIPRAMOSONE OIN 1% DESIPRAMOSONE OIN 2.5% DESIPRAMOSONE E CRE 1-2.5% DESIPRAMOTIC DRO 1-0.1% Unapproved DrugPRAMOX GEL 1% Not properly listed with FDAPRASCION EMU Unapproved DrugPRASCION FC PAD 10-5% Unapproved DrugPRASCION RA CRE 10-5% Unapproved DrugPRASTERA KIT Unapproved DrugPRAZOLAMINE PAK Unapproved DrugPRE-FOLIC TAB 1-100MG Vitamin/MineralPRE-PEN INJ Diagnostic AgentPREFERA OB MIS + DHA Vitamin/MineralPREFERA OB TAB Vitamin/MineralPREFERAOB CAP ONE Vitamin/MineralPREFERAOB MIS +DHA Vitamin/MineralPREFOL-DHA CAP Vitamin/MineralPRENA1 CAP QUATREFO Vitamin/MineralPRENA1 CHW Vitamin/MineralPRENA1 PEARL CAP Vitamin/MineralPRENA1 PLUS MIS QUATREFO Vitamin/MineralPRENAISSANCE CAP Vitamin/MineralPRENAISSANCE CAP BALANCE Vitamin/MineralPRENAISSANCE CAP PLUS Vitamin/MineralPRENAISSANCE MIS HARMONY Vitamin/MineralPRENAISSANCE PAK 90 DHA Vitamin/MineralPRENAISSANCE PAK DHA Vitamin/MineralPRENAISSANCE PAK PROMISE Vitamin/MineralPRENAISSANCE TAB NEXT Vitamin/MineralPRENAISSANCE TAB NEXT-B Vitamin/MineralPRENAPLUS TAB Vitamin/MineralPRENAT PLUS TAB 27-1MG Vitamin/MineralPRENATA CHW 29-1MG Vitamin/MineralPRENATABS FA TAB Vitamin/MineralPRENATABS RX TAB Vitamin/Mineral

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

PRENATAL MIS COMPLEAT Vitamin/MineralPRENATAL TAB 27-1MG Vitamin/MineralPRENATAL TAB PLUS Vitamin/MineralPRENATAL 19 CHW 29-1MG Vitamin/MineralPRENATAL 19 CHW TAB Vitamin/MineralPRENATAL 19 TAB Vitamin/MineralPRENATAL 19 TAB 29-1MG Vitamin/MineralPRENATAL AD TAB Vitamin/MineralPRENATAL VIT TAB LOW IRON Vitamin/MineralPRENATAL+FE TAB 29-1MG Vitamin/MineralPRENATAL-U CAP 106.5-1 Vitamin/MineralPRENATE CAP ENHANCE Vitamin/MineralPRENATE CAP ESSENT Vitamin/MineralPRENATE CAP ESSENTIA Vitamin/MineralPRENATE CAP PIXIE Vitamin/MineralPRENATE CAP RESTORE Vitamin/MineralPRENATE CHW 0.6-0.4 Vitamin/MineralPRENATE TAB ELITE Vitamin/MineralPRENATE TAB ELITE Vitamin/MineralPRENATE AM TAB 1MG Vitamin/MineralPRENATE DHA CAP Vitamin/MineralPRENATE DHA CAP Vitamin/MineralPRENATE MINI CAP Vitamin/MineralPRENATE MINI CAP Vitamin/MineralPRENATE STAR TAB 20-1MG Vitamin/MineralPRENTIF MIS 22MM DevicePRENTIF MIS 25MM DevicePRENTIF MIS 28MM DevicePRENTIF MIS 31MM DevicePRENTIF MIS FITTING DevicePREPLUS TAB 27-1MG Vitamin/MineralPREQUE 10 TAB Vitamin/MineralPRESERA AER Not properly listed with FDAPRETAB TAB 29-1MG Vitamin/MineralPREVDNT 5000 PST 1.1% Unapproved DrugPREVIDENT CRE 5000 PLS Unapproved DrugPREVIDENT GEL 1.1% Unapproved DrugPREVIDENT GEL 1.1% BER Unapproved DrugPREVIDENT GEL 1.1% CHR Unapproved DrugPREVIDENT GEL 1.1% MIN Unapproved DrugPREVIDENT PST 5000 BST Unapproved DrugPREVIDENT PST 5000 SEN Unapproved DrugPREVIDENT SOL RINSE Unapproved DrugPREVIDOLRX PAK ANALGESI LISTPREVNAR 13 INJ Pneumococcal Vaccine

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

PRIVET EXT INJ 1:20 Non-standardized allergenicPRO DNA KIT KIT Diagnostic AgentPRO-C-DURE 1 KIT LISTPRO-C-DURE 2 KIT LISTPRO-C-DURE 3 KIT LISTPRO-C-DURE 4 KIT LISTPRO-C-DURE 5 KIT 40MG/ML LISTPRO-C-DURE 6 KIT 40MG/ML LISTPROBARIMIN CHW QT Anorexic, Anti-obesity AgentPROCORT CRE Unapproved DrugPROCTOCORT SUP 30MG DESIPROCTOFOAM AER HC 1% Unapproved DrugPRODRIN TAB DESIPRODRIN TAB DESIPROFERRIN- TAB FORTE Vitamin/MineralPROFILNINE INJ 1000UNIT Blood ComponentPROFILNINE INJ 1500UNIT Blood ComponentPROFILNINE INJ 500UNIT Blood ComponentPROGESTERONE CRE 10% KIT Bulk IngredientPROGESTERONE SUP VGS 100 Not properly listed with FDAPROGESTERONE SUP VGS 200 Not properly listed with FDAPROGESTERONE SUP VGS 25 Not properly listed with FDAPROGESTERONE SUP VGS 400 Not properly listed with FDAPROGESTERONE SUP VGS 50 Not properly listed with FDAPROHANCE INJ 279.3/ML Diagnostic AgentPROMACTIN AA SUS PLUS Not properly listed with FDAPROMETH VC/ SYP CODEINE Cough/ColdPROMETH/COD SYP 6.25-10 Cough/ColdPROMETH/PE/ SYP CODEINE Cough/ColdPROMETHAZINE SYP DM Cough/ColdPROMISEB CRE Unapproved DrugPROMISEB KIT COMPLETE Unapproved DrugPROPECIA TAB 1MG CosmeticPROPOFOL INJ General AnestheticPROPOFOL INJ 10MG/ML General AnestheticPROPOFOL INJ 200/20ML General AnestheticPROPOFOL INJ 500/50ML General AnestheticPROPOVEN INJ General AnestheticPROPOVEN INJ 200/20ML General AnestheticPROPOVEN INJ 500/50ML General AnestheticPROPYLENE GL SOL Bulk IngredientPROSTASCINT KIT Diagnostic AgentPROSTIN VR INJ 500MCG Not properly listed with FDAPROTECT PLUS CAP Vitamin/MineralPROTEOLIN TAB Not properly listed with FDA

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

PROTHELIAL PST 10% Not properly listed with FDAPROVENGE INJ LISTPROVENZA PAD 4-1% Unapproved DrugPROVIDA DHA CAP Vitamin/MineralPROVIDA OB CAP Vitamin/MineralPROVISC INJ 1% DevicePROVOCHOLINE SOL 100MG Diagnostic AgentPROZENA PAD 4% Not properly listed with FDAPRUCLAIR CRE LISTPRUMYX CRE LISTPRUTECT EMU Surgical Supply/MedicalPRVDNT 5000 PST ENAML PR Unapproved DrugPSORIZIDE TAB FORTE Unapproved DrugPSORIZIDE TAB ULTRA Unapproved DrugPUDEND/LOCAL KIT 1% LIDO Not properly listed with FDAPULMONA CAP Medical FoodPULMOPHYLLIN PAK Unapproved DrugPULMOSAL NEB 7% DevicePURALOR CI TAB Unapproved DrugPUREFE OB CAP PLUS Vitamin/MineralPUREFOLIX TAB 1-5000 Unapproved DrugPURIFIED LIQ WATER OTC ProductPYRIDIUM TAB 100MG Unapproved DrugPYRIDIUM TAB 200MG Unapproved DrugPYRIDOXINE INJ 100MG/ML Vitamin/MineralQROXIN PAD Unapproved DrugQSYMIA CAP 11.25-69 Anorexic, Anti-obesity AgentQSYMIA CAP 15-92MG Anorexic, Anti-obesity AgentQSYMIA CAP 3.75-23 Anorexic, Anti-obesity AgentQSYMIA CAP 7.5-46MG Anorexic, Anti-obesity AgentQUEEN PALM SOL EXTRACT Non-standardized allergenicQUELICIN INJ -1000 LISTQUELICIN INJ 20MG/ML LISTQUFLORA PED CHW 0.25MG Vitamin/MineralQUFLORA PED CHW 0.5MG Vitamin/MineralQUFLORA PED CHW 1MG Vitamin/MineralQUFLORA PED DRO 0.25MG Vitamin/MineralQUFLORA PED DRO 0.5MG/ML Vitamin/MineralR-GENE 10 INJ 10% Diagnostic AgentR-NATAL OB CAP 20-1-320 Vitamin/MineralRABBIT EPITH INJ 1:20 Non-standardized allergenicRABBIT INJ EPITHELI Non-standardized allergenicRADIAGEL GEL Not properly listed with FDARADIAPLEXRX GEL Not properly listed with FDARAPID GEL RX GEL Unapproved Drug

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

RAPPORT RLS KIT Erectile DysfunctionRAPPORT VTD KIT Erectile DysfunctionRASPBERRY SYP Bulk IngredientREA LO 39 CRE 39% Unapproved DrugREA LO 40 CRE 40% Unapproved DrugREA LO 40 LOT 40% Unapproved DrugREADI-CAT 2 SUS 2.1% Diagnostic AgentREADI-CAT 2 SUS BANANA Diagnostic AgentREADI-CAT 2 SUS BERRY Diagnostic AgentREADI-CAT 2 SUS MOCHACCI Diagnostic AgentREADYSHARP- KIT P40 LISTREADYSHARP- KIT P80 LISTREADYSHARP-A KIT 1%/0.5% LISTREADYSHARP-K KIT LISTRECEDO GEL Not properly listed with FDARECIPHEXAMIN DIS 4-1% Unapproved DrugRECOMBINATE INJ Blood ComponentRECOMBINATE INJ Blood ComponentRECOMBINATE INJ 220-400 Blood ComponentRECOMBINATE INJ 401-800 Blood ComponentRECOMBINATE INJ 801-1240 Blood ComponentRECTACORT-HC SUP 25MG DESIRED BIRCH SOL EXTRACT Non-standardized allergenicRED CEDAR SOL EXTRACT Non-standardized allergenicRED MAPLE INJ 1:20 Non-standardized allergenicRED MULBERRY INJ 1:20 Non-standardized allergenicRED TOP GRAS INJ 100000BA Non-standardized allergenicRED YEAST POW RICE Not properly listed with FDAREDICHEW RX CHW Vitamin/MineralREFISSA CRE 0.05% CosmeticREGIMEX TAB 25MG Anorexic, Anti-obesity AgentRELADOR PAK KIT 2.5-2.5% LISTRELADOR PAK KIT PLUS LISTRELAGARD GEL Unapproved DrugRELEEVIA PAD .0375-5% Unapproved DrugRELEEVIA MC PAD .0375-5% Unapproved DrugRELEEVIA ML PAD 4-1% Unapproved DrugRELNATE DHA CAP Vitamin/MineralRELYYKS PAD Unapproved DrugRELYYT DIS 0.025-5% Not properly listed with FDAREMATEX CRE Unapproved DrugREMAXAZON PAD Unapproved DrugREMERGENT HQ CRE 4% CosmeticREMEVEN CRE 50% Unapproved DrugRENA-VITE RX TAB Vitamin/Mineral

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

RENAL CAP SOFTGEL Vitamin/MineralRENATABS MIS IRON Vitamin/MineralRENATABS TAB Vitamin/MineralRENO CAP Vitamin/MineralRENOVA CRE 0.02% CosmeticRENOVA PUMP CRE 0.02% CosmeticRENOVO PAD 0.0375-5 Unapproved DrugRENOVO LIDO5 CRE Unapproved DrugRENUU PAD 2-5-30% Unapproved DrugRENUU NL PAD 2-30% Unapproved DrugREQ 49+ TAB Vitamin/MineralRESCON-JR TAB Unapproved DrugRESCON-MX TAB Unapproved DrugRESECTISOL SOL 5% Diagnostic AgentRESPA-BR TAB 11MG Unapproved DrugRESTIZAN GEL Not properly listed with FDARESTORA RX CAP 60-1.25 Not properly listed with FDARESTORA SPRI PAK 15-0.25 LISTRESTORE SILV PAD 2"X2" Not properly listed with FDARESTORE SILV PAD 4"X4" Not properly listed with FDARESTORE SILV PAD 4"X4.75" Not properly listed with FDARESTORE SILV PAD 4"X5" Not properly listed with FDARESTORE SILV PAD 6"X8" Not properly listed with FDARESTYLANE INJ 20MG/ML CosmeticRESTYLANE-L INJ 10/0.5ML CosmeticRESTYLANE-L INJ 20MG/ML CosmeticRESTYLANE-L INJ 40MG/2ML CosmeticREVESTA CAP 1MG-5750 Not properly listed with FDAREZIRA SOL 60-5/5ML Cough/ColdREZYST IM CHW Not properly listed with FDAREZYST SB CHW 250MG Not properly listed with FDARGH PIGWEED SOL EXTRACT Non-standardized allergenicRHEUMADORON LIQ 102A Unapproved DrugRHEUMATE CAP Medical FoodRHIZOPUS INJ 1:10 Non-standardized allergenicRIASTAP SOL 1GM Blood ComponentRIAX AER 5.5% OTC ProductRIAX AER 9.5% OTC ProductRIXUBIS INJ 1000UNIT Blood ComponentRIXUBIS INJ 2000UNIT Blood ComponentRIXUBIS INJ 250 UNIT Blood ComponentRIXUBIS INJ 3000UNIT Blood ComponentRIXUBIS INJ 500UNIT Blood ComponentROCURONIUM INJ 100MG/10 LISTROCURONIUM INJ 10MG/ML LIST

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

ROCURONIUM INJ 10MG/ML LISTROCURONIUM INJ 50MG/5ML LISTROSADAN KIT 0.75% LISTROSADAN KIT 0.75% LISTROSANIL EMU CLEANSER Unapproved DrugROSANIL KIT Unapproved DrugROSE GLO TES 1.5MG Diagnostic AgentROSULA LIQ 10-4.5% Unapproved DrugROSULA PAD 10-5% Unapproved DrugRULAVITE DHA CAP Vitamin/MineralRUSS THISTLE SOL EXTRACT Non-standardized allergenicRX-SPECIMEN KIT COLLECTI Diagnostic AgentRYNODERM CRE 37.5% Not properly listed with FDASACCHARIN POW SODIUM Bulk IngredientSACCHAROMYCE INJ CEREVISI Non-standardized allergenicSAGEBRUSH SOL EXTRACT Non-standardized allergenicSALACYN CRE 6% Unapproved DrugSALACYN LOT 6% Unapproved DrugSALEX SHA 6% Unapproved DrugSALEX CREAM KIT 6% Unapproved DrugSALEX LOTION KIT 6% Unapproved DrugSALICYLIC AER 6% Unapproved DrugSALICYLIC AC CRE 6% Unapproved DrugSALICYLIC AC GEL 6% Unapproved DrugSALICYLIC AC KIT 6% Unapproved DrugSALICYLIC AC KIT 6% CREAM Unapproved DrugSALICYLIC AC KIT 6% LOTN Unapproved DrugSALICYLIC AC LIQ 26% Unapproved DrugSALICYLIC AC LIQ 27.5% Unapproved DrugSALICYLIC AC LOT 6% Unapproved DrugSALICYLIC AC SHA 6% Unapproved DrugSALICYLIC AC SOL 28.5% Unapproved DrugSALINE FLUSH INJ 0.9% Not properly listed with FDASALINE FLUSH INJ ZR 0.9% Not properly listed with FDASALINE/PHENO SOL LISTSALIVAMAX POW LISTSALIVATE RX POW Not properly listed with FDASALSALATE TAB 500MG Unapproved DrugSALSALATE TAB 750MG Unapproved DrugSALT DURABLE CRE Not properly listed with FDASALT STABLE CRE Not properly listed with FDASALT STABLE CRE LS ADV Not properly listed with FDASALVAX AER 6% Unapproved DrugSALVAX DUO KIT PLUS Unapproved DrugSANADERMRX KIT SKIN REP LIST

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

SANARE CRE ADVANCED Not properly listed with FDASANARE SCAR CRE THERAPY Not properly listed with FDASARAPIN INJ Not properly listed with FDASASH KIT 100/ML Not properly listed with FDASASH KIT 10UNT/ML Not properly listed with FDASAXENDA INJ 6MG/ML Anorexic, Anti-obesity AgentSCAR PATCH PAD Unapproved DrugSCAR PATCH PAD Unapproved DrugSCAR PATCH PAD PREMIUM Unapproved DrugSCLEROSOL AER INTRAPLE LISTSE 10-5 SS CRE 10-5% Unapproved DrugSE BPO WASH LIQ 7% Unapproved DrugSE-NATAL 19 CHW Vitamin/MineralSE-NATAL 19 TAB Vitamin/MineralSE-TAN DHA CAP Vitamin/MineralSEB-PREV LIQ WASH Unapproved DrugSECREFLO INJ 16MCG Diagnostic AgentSEDANARE CRE Not properly listed with FDASELECT-OB CHW Vitamin/MineralSELECT-OB CHW Vitamin/MineralSELECT-OB+ PAK DHA Vitamin/MineralSELENIUM SUL SHA 2.25% Unapproved DrugSELRX SHA 2.3% Unapproved DrugSENSORCAINE INJ -MPF/EPI LISTSENSORCAINE INJ -MPF/EPI LISTSENSORCAINE INJ -MPF/EPI LISTSENSORCAINE INJ MPF SPIN LISTSENSORCAINE/ INJ EPI 0.25 LISTSENSORCAINE/ INJ EPI 0.5% LISTSENTRA AM CAP Medical FoodSENTRA PM CAP Medical FoodSENTRADINE PAK Unapproved DrugSENTRAFLOX PAK AM-10 Unapproved DrugSENTRALOPRAM PAK AM-10 Unapproved DrugSENTRAMODAFI PAK AM-100 Unapproved DrugSENTRAVIL PM PAK -25 Unapproved DrugSENTRAZOLAM PAK AM 0.25 Unapproved DrugSENTRAZOLPID PAK PM-5 Unapproved DrugSENTROXATINE PAK Unapproved DrugSEROPHENE TAB 50MG Fertility AgentSEVOFLURANE SOL General AnestheticSF GEL 1.1% Unapproved DrugSF 5000 PLUS CRE 1.1% Unapproved DrugSHAGBARK HCK SOL EXTRACT Non-standardized allergenicSHEEP SORREL INJ 1:20 Non-standardized allergenic

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

SHELLGEL SOL DeviceSHOHLS SOL MODIFIED Unapproved DrugSHORT RAGWEE INJ 1:20 Non-standardized allergenicSIDEROL TAB Vitamin/MineralSILAZONE PAK PHARMAPA LISTSILAZONE-II PAK LISTSILMANIX CRE Unapproved DrugSILOSOME CRE TRANSDER Not properly listed with FDASILPROTEX CRE PLUS Not properly listed with FDASILVASORB GEL Not properly listed with FDASILVERA PAIN PAD RELIEF Unapproved DrugSILVRSTAT GEL DRESSING Surgical Supply/MedicalSIMPLE SYP Bulk IngredientSINELEE PAD 0.0375-5 Unapproved DrugSINELEE PAD 0.05-5% Unapproved DrugSINOGRAFIN INJ Diagnostic AgentSKIN BLEACH CRE 4% CosmeticSKIN BLEACH CRE SUNSCREE CosmeticSKYY DERM CRE Not properly listed with FDASMARTRX PAK GABA LISTSMARTRX PAK GABA-V LISTSOD CHLORIDE INJ 0.9% LISTSOD CHLORIDE INJ 0.9% LISTSOD CHLORIDE INJ 0.9%BACT LISTSOD CHLORIDE INJ 23.4% LISTSOD CHLORIDE INJ 4MEQ/ML LISTSOD CITRATE SOL CITR ACD Unapproved DrugSOD FLUORIDE CHW 0.25MG F Unapproved DrugSOD FLUORIDE CHW 0.5MG F Unapproved DrugSOD FLUORIDE CHW 1.1MG Unapproved DrugSOD FLUORIDE CHW 1MG F Unapproved DrugSOD FLUORIDE CHW 2.2MG Unapproved DrugSOD FLUORIDE DRO 0.5MG/ML Unapproved DrugSOD FLUORIDE SOL 0.2% Unapproved DrugSOD FLUORIDE SOL 0.2%MINT Unapproved DrugSOD FLUORIDE TAB 0.5MG F Unapproved DrugSOD FLUORIDE TAB 1MG F Unapproved DrugSOD NITRITE INJ 30MG/ML LISTSOD SACCHARI GRA Not properly listed with FDASOD SUL/SULF AER 10-5% Unapproved DrugSOD SUL/SULF CRE 10-2% Unapproved DrugSOD SUL/SULF CRE 10-5% Unapproved DrugSOD SUL/SULF CRE 9.8-4.8% Unapproved DrugSOD SUL/SULF EMU 10-5% Unapproved DrugSOD SUL/SULF EMU 10-5% Unapproved Drug

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

SOD SUL/SULF GEL 10-5% Unapproved DrugSOD SUL/SULF KIT Unapproved DrugSOD SUL/SULF LIQ 10-2% Unapproved DrugSOD SUL/SULF LIQ 9-4.5% Unapproved DrugSOD SUL/SULF LIQ 9.8-4.8% Unapproved DrugSOD SUL/SULF LIQ WASH Unapproved DrugSOD SUL/SULF LOT 10-5% Unapproved DrugSOD SUL/SULF LOT 9.8-4.8% Unapproved DrugSOD SUL/SULF PAD 10-4% Unapproved DrugSOD SUL/SULF PAD 10-5% Unapproved DrugSOD SUL/SULF SUS 10-5% Unapproved DrugSOD SUL/SULF SUS 8-4% Unapproved DrugSOD SULFACET GEL 10% Unapproved DrugSOD SULFACET SHA 10% Unapproved DrugSOD THIOSULF INJ 10% Unapproved DrugSOD THIOSULF INJ 25% Unapproved DrugSODIUM POW BICARBON Bulk IngredientSODIUM CHLOR NEB 10% Unapproved DrugSODIUM CHLOR NEB 3% Unapproved DrugSODIUM CHLOR NEB 7% Unapproved DrugSODIUM SULFA LIQ 10% WASH Unapproved DrugSOJOURN SOL General AnestheticSOLAICE PAD Unapproved DrugSOLMARA PAD 4-5% Unapproved DrugSOLUPAK PAK Not properly listed with FDASONAFINE EMU Surgical Supply/MedicalSOOTHEE PAD Unapproved DrugSORBITOL SOL 3% IRR LISTSORBITOL SOL 3.3% IRR LISTSORBITOL-MAN SOL LISTSORREL/DOCK INJ EXTRACT Non-standardized allergenicSPECIMEN KIT COLLECTI Diagnostic AgentSPECTRAGEL GEL Not properly listed with FDASPEEDGEL RX GEL Unapproved DrugSPHERUSOL INJ Diagnostic AgentSPINAL/EPIDU KIT CL CATH Not properly listed with FDASPINAL/EPIDU KIT OPN CATH Not properly listed with FDASS 10-2 SOL 10-2% Not properly listed with FDASSKI SOL 1GM/ML Vitamin/MineralSSS CRE 10%-5% Unapproved DrugSSS 10-5 AER 10-5% Unapproved DrugSTAN FLUORID CON 0.63% Unapproved DrugSTAXYN TAB 10MG Erectile DysfunctionSTEMPHYLIUM SOL 20000PNU Non-standardized allergenicSTENDRA TAB 100MG Erectile Dysfunction

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

STENDRA TAB 200MG Erectile DysfunctionSTENDRA TAB 50MG Erectile DysfunctionSTERA BASE CRE Not properly listed with FDASTERIL TALC SUS 5GM LISTSTERIL WATER INJ LISTSTERIL WATER INJ LISTSTERILE DILU SOL EPOPROS LISTSTERILE DILU SOL FLOLAN LISTSTERYMINE GEL Unapproved DrugSTRAZEPAM PAK Unapproved DrugSTROVITE FOR SYP Vitamin/MineralSTROVITE FOR TAB Vitamin/MineralSTROVITE ONE TAB Vitamin/MineralSUBLIMAZE INJ 1000MCG General AnestheticSUBLIMAZE INJ 100MCG General AnestheticSUBLIMAZE INJ 250MCG General AnestheticSUCCINYLCHOL SOL 20MG/ML Not properly listed with FDASUFENTA INJ 50MCG/ML General AnestheticSUFENTA INJ 50MCG/ML General AnestheticSUFENTA INJ 50MCG/ML General AnestheticSUFENTANIL INJ 100/2ML General AnestheticSUFENTANIL INJ 250/5ML General AnestheticSUFENTANIL INJ 50MCG/ML General AnestheticSUL SOD/SULF LIQ 10-2% Unapproved DrugSUL SOD/SULF PAD 10-4% Unapproved DrugSULF/SUNSCRN KIT 9-4.5% Unapproved DrugSULFACLEANSE SUS 8-4% Unapproved DrugSULFOAM SHA 2% Unapproved DrugSULFZIX CAP Medical FoodSULFZIX POW Medical FoodSUMACHIP PAK Unapproved DrugSUMADAN KIT Unapproved DrugSUMADAN WASH LIQ 9-4.5% Unapproved DrugSUMADAN XLT KIT 9-4.5% Unapproved DrugSUMAXIN PAD 10-4% Unapproved DrugSUMAXIN CP KIT Unapproved DrugSUMAXIN TS SUS 8-4% Unapproved DrugSUMAXIN WASH LIQ 9-4% Unapproved DrugSUPERVITE LIQ Vitamin/MineralSUPERVITE EC TAB Vitamin/MineralSUPPORT LIQ Vitamin/MineralSUPPORT-500 CAP Vitamin/MineralSUPRACIL CRE Bulk IngredientSUPRANE INH General AnestheticSUPRANE SOL General Anesthetic

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

SUPREME CRE Not properly listed with FDASUPRENZA TAB 15MG Anorexic, Anti-obesity AgentSUPRENZA TAB 30MG Anorexic, Anti-obesity AgentSUPRENZA TAB 37.5MG Anorexic, Anti-obesity AgentSURE RESULT KIT O3D3 SYS LISTSURE RESULT KIT TAC PAK LISTSURE RESULT MIS DSS PACK LISTSUSPENSION SUS VEHICLE Not properly listed with FDASUTTAR-2 SYP Cough/ColdSUTTAR-SF SYP Cough/ColdSWABFLUSH INJ 0.9% Not properly listed with FDASWEET GUM INJ 1:20 Non-standardized allergenicSWEET VERNAL INJ GRASS PO Non-standardized allergenicSYMAX DUOTAB TAB Unapproved DrugSYMAX FASTAB TAB 0.125MG Unapproved DrugSYMAX-SL SUB 0.125MG Unapproved DrugSYMAX-SR TAB 0.375MG Unapproved DrugSYNAGEX CAP 1.25MG Vitamin/MineralSYNALAR KIT 0.025% LISTSYNALAR KIT 0.025% LISTSYNAPRYN SUS 10MG/ML Unapproved DrugSYNATEK CAP Vitamin/MineralSYNVEXIA PAD 4-1% Unapproved DrugSYNVEXIA TC CRE 4-1% Unapproved DrugSYNVISC INJ 8MG/ML Surgical Supply/MedicalSYNVISC ONE INJ 8MG/ML Surgical Supply/MedicalSYRPALTA SYP Not properly listed with FDASYRPALTA SYP CLEAR Not properly listed with FDASYRSPEND SF LIQ Bulk IngredientSYRUP SYP VEHICLE Not properly listed with FDASYRUP SF SYP VEHICLE Not properly listed with FDAT.R.U.E. TES Diagnostic AgentTABRADOL SUS 1MG/ML Unapproved DrugTAGITOL V SUS 40% Diagnostic AgentTANDEM F CAP Vitamin/MineralTARON GRA CRYSTALS Unapproved DrugTARON-BC MIS Vitamin/MineralTARON-C DHA CAP Vitamin/MineralTARON-PREX CAP Vitamin/MineralTBC AER DESITDC MAX CRE Not properly listed with FDATDM SOLUTION SOL Not properly listed with FDATEGADERM AG PAD 2"X2" Not properly listed with FDATEGADERM AG PAD 4"X5" Not properly listed with FDATEGADERM AG PAD 4"X8" Not properly listed with FDA

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

TEGADERM AG PAD 8"X8" Not properly listed with FDATEMODAR CAP 100MG Oral drug for cancer; infusion available under Part BTEMODAR CAP 140MG Oral drug for cancer; infusion available under Part BTEMODAR CAP 180MG Oral drug for cancer; infusion available under Part BTEMODAR CAP 20MG Oral drug for cancer; infusion available under Part BTEMODAR CAP 250MG Oral drug for cancer; infusion available under Part BTEMODAR CAP 5MG Oral drug for cancer; infusion available under Part BTEMOZOLOMIDE CAP 100MG Oral drug for cancer; infusion available under Part BTEMOZOLOMIDE CAP 140MG Oral drug for cancer; infusion available under Part BTEMOZOLOMIDE CAP 180MG Oral drug for cancer; infusion available under Part BTEMOZOLOMIDE CAP 20MG Oral drug for cancer; infusion available under Part BTEMOZOLOMIDE CAP 250MG Oral drug for cancer; infusion available under Part BTEMOZOLOMIDE CAP 5MG Oral drug for cancer; infusion available under Part BTERODERM CRE Not properly listed with FDATERRELL SOL General AnestheticTERSI FOAM AER 2.25% LISTTESSALON PER CAP 100MG Cough/ColdTESTONE CIK KIT 200MG/ML LISTTETCAINE SOL 0.5% OP Unapproved DrugTETRACAINE INJ 1% Unapproved DrugTETRACAINE SOL 0.5% OP Unapproved DrugTETRAMEX SPR 2-1-3% Unapproved DrugTETRAVISC SOL 0.5% OP Unapproved DrugTETRAVISC SOL FORTE Unapproved DrugTETRIX CRE Not properly listed with FDATETRIX KIT Unapproved DrugTEXAVITE LQ LIQ Vitamin/MineralTGQ 15DM/5PE SYP H/2CPM Cough/ColdTGQ 30/ SYP 150/15 Cough/ColdTGQ 30/PSE/3 SYP BRM/15DM Cough/ColdTGQ 50PSE/3 SYP BRM/30DM Cough/ColdTHALAMUS SUB COMPOSIT Unapproved DrugTHALLOUS INJ TL 201 Diagnostic AgentTHALLOUS CL INJ TL 201 Diagnostic AgentTHERA-FLUR-N DRO 1.1% Unapproved DrugTHERABENZAPR PAK -60 Unapproved DrugTHERABENZAPR PAK -90 Unapproved DrugTHERABENZAPR PAK -90-5 Unapproved DrugTHERACODEINE PAK -300 Unapproved DrugTHERACODOPHN PAK -325 Unapproved DrugTHERAFELDAMI PAK Unapproved DrugTHERAHONEY GEL Not properly listed with FDATHERAMINE CAP Medical FoodTHERAMINE POW PLUS Medical FoodTHERAPENTIN PAK -60 Unapproved Drug

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

THERAPENTIN PAK -90 Unapproved DrugTHERAPROFEN PAK -60 Unapproved DrugTHERAPROFEN PAK -90 Unapproved DrugTHERAPROFEN PAK 800MG Unapproved DrugTHERAPROXEN PAK -60 Unapproved DrugTHERAPROXEN PAK -90 Unapproved DrugTHERAPROXEN PAK 500MG Unapproved DrugTHERATRAMADO PAK -60 Unapproved DrugTHERATRAMADO PAK -90 Unapproved DrugTHIAMINE HCL INJ 100MG/ML Vitamin/MineralTHRIVITE 19 TAB Vitamin/MineralTHRIVITE RX TAB 29-1MG Vitamin/MineralTHROMBIN KIT 5000UNIT Blood ComponentTHROMBIN-JMI KIT 20000UNT Blood ComponentTHROMBIN-JMI KIT 5000UNIT Blood ComponentTHROMBIN-JMI SOL 20000UNT Blood ComponentTHROMBIN-JMI SOL 5000UNIT Blood ComponentTHYROGEN INJ 1.1MG Diagnostic AgentTICANASE PAK 50-2.7 LISTTIGHTENING CRE BASE Not properly listed with FDATIMOTHY SOL GRASS Non-standardized allergenicTIMOTHY GRAS INJ 10000BAU Non-standardized allergenicTISSEEL KIT Blood ComponentTISSEEL VH KIT 2ML Blood ComponentTL FOLATE TAB Vitamin/MineralTL G-FOL OS TAB Vitamin/MineralTL GARD RX TAB Vitamin/MineralTL HYDROQUIN CRE 4% CosmeticTL ICON CAP Vitamin/MineralTL TRISEB CRE DeviceTL-CARE DHA CAP 27-1-500 Vitamin/MineralTL-FLUORIVIT CHW Vitamin/MineralTL-HEM 150 TAB Vitamin/MineralTL-ICARE CAP Medical FoodTL-SELECT CAP Vitamin/MineralTL-SELECT CAP DHA Vitamin/MineralTOXICOL SALV KIT COLLECT Diagnostic AgentTOZAL CAP Medical FoodTRACE ELEM 4 INJ PED Unapproved DrugTRAMADOL CRE 5% Bulk IngredientTRAMADOL CRE 8% KIT Bulk IngredientTRANS-PEN CRE Not properly listed with FDATRANSDERMAL CRE PAIN BAS Not properly listed with FDATRANZGEL GEL Unapproved DrugTRAZAMINE PAK 50MG Unapproved Drug

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

TREPADICLOFE PAK 25MG Not properly listed with FDATREPADONE CAP Unapproved DrugTREPOXICAM PAK 7.5MG Unapproved DrugTRETINOIN EM CRE 0.05% CosmeticTRETTEN INJ Blood ComponentTRI-CHLOR LIQ 80% Unapproved DrugTRI-LUMA CRE CosmeticTRI-SILA KIT 0.1-5% LISTTRI-TABS DHA MIS Vitamin/MineralTRI-VI-FLOR SUS 0.25/ML Vitamin/MineralTRI-VI-FLOR SUS 0.5MG/ML Vitamin/MineralTRI-VI-FLORO SUS 0.25/ML Vitamin/MineralTRI-VI-FLORO SUS 0.5MG/ML Vitamin/MineralTRI-VIT/FE DRO /FL 0.25 Vitamin/MineralTRI-VIT/FL DRO 0.25MG Vitamin/MineralTRI-VIT/FL DRO 0.5MG Vitamin/MineralTRI-VIT/FLUO DRO 0.25MG Vitamin/MineralTRI-VIT/FLUO DRO 0.5MG Vitamin/MineralTRI-VITA/FL DRO 0.25MG Vitamin/MineralTRIADVANCE TAB Vitamin/MineralTRIAMSIL PAK COMBIPAK Not properly listed with FDATRIAMSIL PAK MULTIPAK Not properly listed with FDATRICARE PAK PRENATAL Vitamin/MineralTRICARE TAB PRENATAL Vitamin/MineralTRICARE PRE CAP 27-1-500 Vitamin/MineralTRICHOPHYTON INJ 1:200 Diagnostic AgentTRICHOPHYTON INJ 1:500 Diagnostic AgentTRICHOPHYTON SOL 20000PNU Non-standardized allergenicTRICITRASOL CON LISTTRICITRATES SOL Unapproved DrugTRICON CAP Vitamin/MineralTRIDERMA CRE FORTE Bulk IngredientTRIFERIC SOL Not properly listed with FDATRINATAL GT TAB Vitamin/MineralTRINATAL RX TAB 1 Vitamin/MineralTRINATE TAB Vitamin/MineralTRIPHROCAPS CAP Vitamin/MineralTRISEON CRE Bulk IngredientTRISTART DHA CAP Vitamin/MineralTRIVEEN-DUO PAK DHA Vitamin/MineralTRIVEEN-PRX CAP RNF Vitamin/MineralTROPAZONE CRE Not properly listed with FDATROPAZONE LOT Not properly listed with FDATROPICAMIDE SOL 0.5% OP Diagnostic AgentTROPICAMIDE SOL 1% OP Diagnostic Agent

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

TRYPTOPHAN CAP 500MG Unapproved DrugTUBERSOL INJ 5/0.1ML Diagnostic AgentTUSNEL CAP DESITUSSICAPS CAP 10-8MG Cough/ColdTUSSICAPS CAP 5-4MG Cough/ColdTUSSIGON TAB 5-1.5MG Cough/ColdTUSSIONEX SUS 10-8/5ML Cough/ColdTUZISTRA XR SUS Cough/ColdTYLACTIN LIQ REST 10 Not properly listed with FDATYLACTIN LIQ RTD 15 Not properly listed with FDAUDAMIN SP TAB Vitamin/MineralULTANE SOL General AnestheticULTIMATECARE CAP ONE Vitamin/MineralULTIMATECARE CAP ONE NF Vitamin/MineralULTRA TABS TAB Vitamin/MineralULTRABAG/ SOL DIANEAL Dialysis covered by ESRD bundled paymentULTRABAG/ SOL DIANEAL Dialysis covered by ESRD bundled paymentULTRABAG/PD2 SOL DIANEAL Dialysis covered by ESRD bundled paymentULTRABAG/PD2 SOL DIANEAL Dialysis covered by ESRD bundled paymentULTRABAG/PD2 SOL DIANEAL Dialysis covered by ESRD bundled paymentULTRADERM CRE Not properly listed with FDAULTRASAL-ER SOL 28.5% Unapproved DrugULTRAVATE X KIT 0.05-10% LISTULTRAVATE X KIT 0.05-10% LISTULTRAVIST INJ 150MG/ML Diagnostic AgentULTRAVIST INJ 240MG/ML Diagnostic AgentULTRAVIST INJ 300MG/ML Diagnostic AgentULTRAVIST INJ 370MG/ML Diagnostic AgentUMECTA EMU Unapproved DrugUMECTA SUS 40% Unapproved DrugUMECTA MOUSS AER 40% Unapproved DrugUMECTA NAIL SUS FILM Unapproved DrugUMECTA PD EMU 40-0.3% Unapproved DrugUMECTA PD SUS 40-0.3% Unapproved DrugUNIVERSAL GEL WATER Not properly listed with FDAUR N-C TAB Unapproved DrugURAMAXIN AER 20% Unapproved DrugURAMAXIN CRE 45% Unapproved DrugURAMAXIN GEL 45% Unapproved DrugURAMAXIN LOT 45% Unapproved DrugURAMAXIN GT GEL 45% Unapproved DrugURAMAXIN GT KIT 45% Unapproved DrugURAMIT MB CAP 118MG Unapproved DrugURE-K CRE 50% Unapproved DrugUREA CRE 39% Unapproved Drug

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

UREA CRE 40% Unapproved DrugUREA CRE 45% Unapproved DrugUREA CRE 47% Unapproved DrugUREA CRE 50% Unapproved DrugUREA EMU 50% Unapproved DrugUREA GEL 40% Unapproved DrugUREA LOT 40% Unapproved DrugUREA LOT 45% Unapproved DrugUREA 40% SUS NAIL Unapproved DrugUREA HYDRATI AER 35% Unapproved DrugUREA NAIL GEL 45% Unapproved DrugUREA NAIL KIT Unapproved DrugUREA NAIL MIS 50% Unapproved DrugUREA TOPICAL SUS 40% Unapproved DrugUREA-C40 LOT 40% Unapproved DrugURELLE TAB Unapproved DrugURETRON D/S TAB Unapproved DrugURETRON D/S TAB Unapproved DrugUREVAZ CRE 44% Unapproved DrugURI-CONTROL TAB RX Unapproved DrugURIBEL CAP 118MG Unapproved DrugURIMAR-T TAB Unapproved DrugURIN D/S TAB Unapproved DrugURINX MEDIC KIT SPECIMEN Diagnostic AgentURO-BLUE TAB 81.6MG Unapproved DrugURO-L TAB 81MG Unapproved DrugURO-MP CAP 118MG Unapproved DrugUROAV-81 TAB Unapproved DrugUROAV-B CAP Unapproved DrugUROGESIC- TAB BLUE Unapproved DrugUROLET MB TAB Unapproved DrugUROPHEN MB TAB 81.6MG Unapproved DrugUROSEX TAB Vitamin/MineralURYL TAB Unapproved DrugUSTELL CAP Unapproved DrugUTA CAP 120MG Unapproved DrugUTA CAP 120MG Unapproved DrugUTICAP CAP Unapproved DrugUTIRA-C TAB Unapproved DrugUTOPIC CRE 41% Unapproved DrugUTRONA-C TAB Unapproved DrugV-C FORTE CAP Vitamin/MineralVACUSTIM KIT BLACK LISTVALIDERM CRE Unapproved DrugVANCOMYCIN SUS +SYRSPEN Not properly listed with FDA

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

VANCOMYCN 25 SOL 25MG/ML Unapproved DrugVANCOMYCN 50 SOL 50MG/ML Unapproved DrugVANIQA CRE 13.9% CosmeticVANISH-PEN CRE Not properly listed with FDAVANISHING CRE Not properly listed with FDAVANISHING CRE BOTANCAL Not properly listed with FDAVARIBAR PST PUDDING Diagnostic AgentVARIBAR HONE SUS 40% Diagnostic AgentVARIBAR NECT SUS 40% Diagnostic AgentVARIBAR THIN SUS HONEY Diagnostic AgentVARIBAR THIN SUS LIQUID Diagnostic AgentVARITHENA AER 10MG/ML LISTVARIZIG INJ 125UNIT Blood ComponentVASCAZEN CAP 1GM Not properly listed with FDAVASCUDERM GEL HYDROGEL DeviceVASCUDERM KIT STASIS Not properly listed with FDAVASCULERA TAB Medical FoodVASOLEX OIN DESIVASOPRESSIN INJ 10/0.5ML Unapproved DrugVASOPRESSIN INJ 20UNT/ML Unapproved DrugVAYACOG CAP Not properly listed with FDAVAYARIN CAP Not properly listed with FDAVAYAROL CAP Not properly listed with FDAVECURONIUM INJ 10MG LISTVECURONIUM INJ 20MG LISTVEG CAPSULE CAP #0 WHITE Unapproved DrugVEG CAPSULE CAP #00 WHIT Unapproved DrugVEG CAPSULE CAP #1 GREEN Unapproved DrugVEG CAPSULE CAP #1 WHITE Unapproved DrugVEG CAPSULE CAP #2 WHITE Unapproved DrugVEG CAPSULE CAP #3 WHITE Unapproved DrugVEG CAPSULE CAP #4 WHITE Unapproved DrugVELMA PAD 16-4-2% Unapproved DrugVELTRIX CRE 4-1% Unapproved DrugVEMAVITE- CAP PRX 2 Vitamin/MineralVENA-BAL MIS DHA Vitamin/MineralVENATAL-FA TAB Vitamin/MineralVENELEX OIN DeviceVENIPUNCTURE KIT CPI LISTVENOFER INJ 20MG/ML Vitamin/MineralVENOMIL KIT HONEYBEE Non-standardized allergenicVENOMIL KIT HONEYBEE Non-standardized allergenicVENOMIL KIT WASP Non-standardized allergenicVENOMIL KIT WASP Non-standardized allergenicVENOMIL KIT WHT HORN Non-standardized allergenic

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

VENOMIL KIT WHT HORN Non-standardized allergenicVENOMIL KIT YEL HORN Non-standardized allergenicVENOMIL KIT YEL HORN Non-standardized allergenicVENOMIL KIT YEL JACK Non-standardized allergenicVENOMIL KIT YEL JACK Non-standardized allergenicVENOMIL MIX INJ VESPID Non-standardized allergenicVERRUNEX CRE Unapproved DrugVERSAFREE SYP Not properly listed with FDAVERSAPLUS SYP Not properly listed with FDAVERSAPRO CRE Bulk IngredientVERSATILE CRE BASE Bulk IngredientVERSATILE CRE RICH BSE Bulk IngredientVERTIGOHEEL SUB Unapproved DrugVEXA PAD 2-4-30% Unapproved DrugVIAGRA TAB 100MG Erectile DysfunctionVIAGRA TAB 25MG Erectile DysfunctionVIAGRA TAB 50MG Erectile DysfunctionVIASPAN SOL Not properly listed with FDAVIC-FORTE CAP Vitamin/MineralVILACTIN AA LIQ PLUS Not properly listed with FDAVINACAL B MIS Vitamin/MineralVINATE AZ EX TAB Vitamin/MineralVINATE C TAB Vitamin/MineralVINATE CAL TAB Vitamin/MineralVINATE CARE CHW Vitamin/MineralVINATE DHA CAP 27-1.13 Vitamin/MineralVINATE IC CAP Vitamin/MineralVINATE II TAB Vitamin/MineralVINATE M TAB Vitamin/MineralVINATE ONE TAB Vitamin/MineralVIRASAL LIQ 27.5% Unapproved DrugVIRGINIA INJ LIVE OAK Non-standardized allergenicVIRILEX CAP Medical FoodVIRT NATE TAB Vitamin/MineralVIRT NATE TAB 28-1MG Vitamin/MineralVIRT-ADVANCE TAB 90-1MG Vitamin/MineralVIRT-C DHA CAP Vitamin/MineralVIRT-CAPS CAP Vitamin/MineralVIRT-CARE CAP ONE Vitamin/MineralVIRT-GARD TAB 2.2-25-1 Vitamin/MineralVIRT-NATE CAP DHA Vitamin/MineralVIRT-PHOS TAB 250 NEUT Vitamin/MineralVIRT-PN TAB Vitamin/MineralVIRT-PN DHA CAP Vitamin/MineralVIRT-PN PLUS CAP Vitamin/Mineral

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

VIRT-SELECT CAP Vitamin/MineralVIRT-VITE TAB Vitamin/MineralVIRT-VITE TAB FORTE Vitamin/MineralVIRT-VITE TAB PLUS Vitamin/MineralVIRT-VITE GT TAB 90-1MG Vitamin/MineralVIRTI-SULF CRE 10-5% Unapproved DrugVIRTPREX CAP Vitamin/MineralVIRTRATE-2 SOL Vitamin/MineralVIRTRATE-2 SOL 500-334 Vitamin/MineralVIRTRATE-3 SOL Vitamin/MineralVIRTRATE-K SOL Vitamin/MineralVIRTRATE-K SOL 1100-334 Vitamin/MineralVISBIOME PAK Not properly listed with FDAVISIPAQUE INJ 270MG/ML Diagnostic AgentVISIPAQUE INJ 320MG/ML Diagnostic AgentVIT A/C/D/FL DRO 0.25MG Vitamin/MineralVIT B-COMPLX INJ 100 Vitamin/MineralVITA S FORTE TAB Vitamin/MineralVITA-MIN CAP Vitamin/MineralVITA-PREN TAB Vitamin/MineralVITA-RESPA TAB Vitamin/MineralVITACEL TAB Vitamin/MineralVITAFOL CAP ULTRA Vitamin/MineralVITAFOL CHW GUMMIES Vitamin/MineralVITAFOL TAB Vitamin/MineralVITAFOL FE+ CAP Vitamin/MineralVITAFOL-NANO TAB Vitamin/MineralVITAFOL-OB PAK +DHA Vitamin/MineralVITAFOL-OB TAB 65-1MG Vitamin/MineralVITAFOL-ONE CAP Vitamin/MineralVITAJECT INJ Vitamin/MineralVITAL-D RX TAB Vitamin/MineralVITAMAX PED DRO Vitamin/MineralVITAMEDMD CAP ONE RX Vitamin/MineralVITAMEDMD MIS PLUS RX Vitamin/MineralVITAMIN C INJ 222MG/ML Vitamin/MineralVITAMIN D CAP 50000UNT Vitamin/MineralVITAMIN K1 INJ 10MG/ML Vitamin/MineralVITAMIN K1 INJ 1MG/0.5 Vitamin/MineralVITAPEARL CAP Vitamin/MineralVITAROCA PLU TAB Vitamin/MineralVITATRUE MIS Vitamin/MineralVITUZ SOL 5-4MG Cough/ColdVIVA DHA CAP Vitamin/MineralVIZAMYL INJ Diagnostic Agent

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

VOL-CARE RX TAB Vitamin/MineralVOL-NATE TAB Vitamin/MineralVOL-PLUS TAB Vitamin/MineralVOL-TAB RX TAB Vitamin/MineralVOLUMEN SUS 0.1% Diagnostic AgentVOLUMEX INJ 25/ML Diagnostic AgentVOPAC CRE 10-2% Unapproved DrugVOPAC GB CRE 5-2-5% Not properly listed with FDAVOPAC KT CRE 5-5-2% Not properly listed with FDAVOPAC MDS KIT 1.5% LISTVP CH ULTRA CAP Vitamin/MineralVP-CH PLUS CAP Vitamin/MineralVP-CH-PNV CAP Vitamin/MineralVP-GGR-B6 TAB PRENATAL Vitamin/MineralVP-GSTN CAP Medical FoodVP-HEME OB MIS + DHA Vitamin/MineralVP-HEME OB TAB Vitamin/MineralVP-HEME ONE CAP Vitamin/MineralVP-HEME-OB TAB 28-6-1MG Vitamin/MineralVP-PNV-DHA CAP Vitamin/MineralVP-PRECIP CAP Dietary SupplementVP-VITE RX TAB Vitamin/MineralVP-ZEL TAB Vitamin/MineralVSL#3 DS PAK Medical FoodVYTONE CRE 1-1.9% DESIWASP VENOM INJ 1000MCG Non-standardized allergenicWASP VENOM INJ 1300MCG Non-standardized allergenicWASP VENOM INJ 550MCG Non-standardized allergenicWASP VENOM KIT 100MCG Non-standardized allergenicWATER BASE GEL Not properly listed with FDAWELLMIND TAB VERTIGO Unapproved DrugWESTERN JUNI SOL 1:20 Non-standardized allergenicWESTHROID TAB 113.75MG Unapproved DrugWESTHROID TAB 130MG Unapproved DrugWESTHROID TAB 146.25MG Unapproved DrugWESTHROID TAB 16.25MG Unapproved DrugWESTHROID TAB 162.50MG Unapproved DrugWESTHROID TAB 195MG Unapproved DrugWESTHROID TAB 260MG Unapproved DrugWESTHROID TAB 32.5MG Unapproved DrugWESTHROID TAB 325MG Unapproved DrugWESTHROID TAB 48.75MG Unapproved DrugWESTHROID TAB 65MG Unapproved DrugWESTHROID TAB 81.25MG Unapproved DrugWESTHROID TAB 97.5MG Unapproved Drug

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

WHEAT GERM OIL Not properly listed with FDAWHITE ASH INJ EXTRACT Non-standardized allergenicWHITE BIRCH INJ 1:20 Non-standardized allergenicWHITE HORNET KIT 100MCG Non-standardized allergenicWHITE HORNET SOL 1000MCG Non-standardized allergenicWHITE OAK SOL Non-standardized allergenicWHITE PINE INJ 1:20 Non-standardized allergenicWHYTEDERM KIT SURGIPAK LISTWHYTEDERM KIT TRILASIL LISTWHYTEDERM TD KIT PAK LISTWIDE-SEAL DPR KIT 60 DeviceWIDE-SEAL DPR KIT 65 DeviceWIDE-SEAL DPR KIT 70 DeviceWIDE-SEAL DPR KIT 75 DeviceWIDE-SEAL DPR KIT 80 DeviceWIDE-SEAL DPR KIT 85 DeviceWIDE-SEAL DPR KIT 90 DeviceWIDE-SEAL DPR KIT 95 DeviceWILATE INJ Blood ComponentWOUND CARE PAD 2" X 2" OTC ProductWOUND CARE PAD 4" X 4" OTC ProductWOUND CARE PAD 4" X 5" OTC ProductWP THYROID TAB 113.75MG Unapproved DrugWP THYROID TAB 130MG Unapproved DrugWP THYROID TAB 16.25MG Unapproved DrugWP THYROID TAB 32.5MG Unapproved DrugWP THYROID TAB 48.75MG Unapproved DrugWP THYROID TAB 65MG Unapproved DrugWP THYROID TAB 81.25MG Unapproved DrugWP THYROID TAB 97.5MG Unapproved DrugX-VIATE CRE 40% Unapproved DrugX-VIATE GEL 40% Unapproved DrugX-VIATE LOT 40% Unapproved DrugXAQUIL XR TAB 30MG Not properly listed with FDAXELITRAL PAK LISTXELODA TAB 150MG Covered under Part B; oral drug only indicated for cancerXELODA TAB 500MG Covered under Part B; oral drug only indicated for cancerXEMATOP CRE BASE Not properly listed with FDAXENADERM OIN DESIXENICAL CAP 120MG Anorexic, Anti-obesity AgentXERAC-AC SOL 6.25% OTC ProductXEROFORM OIL MIS 1"X8" Not properly listed with FDAXEROFORM OIL PAD 2"X2" Not properly listed with FDAXEROFORM PET MIS OVERWRAP Not properly listed with FDAXEROFORM PET MIS ROLL Not properly listed with FDA

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

XEROFORM PET PAD 1"X8" Not properly listed with FDAXEROFORM PET PAD 2"X2" Not properly listed with FDAXEROFORM PET PAD 4"X4" Not properly listed with FDAXEROFORM PET PAD 5"X9" Not properly listed with FDAXEROFRM GAUZ MIS 1"X8" Not properly listed with FDAXEROFRM GAUZ MIS 5"X9" Not properly listed with FDAXEROFRM GAUZ PAD 5"X9" Not properly listed with FDAXEROFRM PETR PAD 2"X2" Not properly listed with FDAXEROFRM PETR PAD 4"X4" Not properly listed with FDAXEROFRM ROLL MIS 4"X9" Not properly listed with FDAXEROFRM ROLL MIS 4"X9' Not properly listed with FDAXIZFLUS CAP Unapproved DrugXIZFLUS POW Unapproved DrugXROFORM PET MIS OVERWRAP Not properly listed with FDAXRYLIX PAK LISTXYLO-MPF/EPI INJ 1% LISTXYLO-MPF/EPI INJ 1.5% LISTXYLO-MPF/EPI INJ 2% LISTXYLO/EPI INJ 0.5% LISTXYLO/EPI INJ 2% LISTXYLO/EPI 1%- INJ 1:100000 LISTXYLOCAINE INJ -MPF 4% LISTXYLOCAINE INJ DENT 2% LISTXYNTHA INJ 1000UNIT Blood ComponentXYNTHA INJ 2000UNIT Blood ComponentXYNTHA INJ 250UNIT Blood ComponentXYNTHA INJ 500UNIT Blood ComponentXYNTHA SOLOF INJ 1000UNIT Blood ComponentXYNTHA SOLOF INJ 2000UNIT Blood ComponentXYNTHA SOLOF INJ 3000UNIT Blood ComponentXYNTHA SOLOF INJ 500UNIT Blood ComponentXYNTHA SOLOF KIT 250UNIT Blood ComponentXYPHEX MIS OTC ProductXYZBAC TAB Vitamin/MineralYELLOW DOCK INJ 1:20 Non-standardized allergenicYELLOW HORN INJ 550MCG Non-standardized allergenicYELLOW HORNT KIT 100MCG Non-standardized allergenicYELLOW HORNT SOL 1000MCG Non-standardized allergenicYELLOW JACK INJ 1300MCG Non-standardized allergenicYELLOW JACK INJ 550MCG Non-standardized allergenicYELLOW JACKT KIT 100MCG Non-standardized allergenicYELLOW JACKT SOL 1000MCG Non-standardized allergenicYODOXIN TAB 650MG Not properly listed with FDAZACLIR LOT 8% Unapproved DrugZANABIN GEL HYDROGEL Not properly listed with FDA

Label Name Reason

MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016

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

ZATEAN-CH CAP Vitamin/MineralZATEAN-PN CAP DHA Vitamin/MineralZATEAN-PN CAP PLUS Vitamin/MineralZATEAN-PN TAB Vitamin/MineralZAVARA CAP 1MG-5750 Unapproved DrugZEMURON INJ 10MG/ML LISTZEMURON INJ 10MG/ML LISTZENCIA LIQ 9-4% Unapproved DrugZERUVIA PAD 4-1% Unapproved DrugZINC SULFATE INJ 1MG/ML Unapproved DrugZINC TRACE INJ 1MG/ML LISTZITHRANOL SHA 1% Unapproved DrugZITHRANOL-RR CRE 1.2% Unapproved DrugZN-DTPA SOL 1000MG Not properly listed with FDAZOE SCRIPTS CRE IDEALBAS Not properly listed with FDAZONATUSS CAP 150MG Cough/ColdZUTRIPRO LIQ 60-4-5MG Cough/ColdZYVODOL CRE Unapproved Drug