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MEDICARE PART D EXCLUDED DRUGS LIST 2021 updated January 2021Reason: 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 coveragedetermination. 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 coveragedetermination 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 indicationsReasonLabel Name12-PANEL POC KIT TOXICOLO1ST BASE CRE1ST MEDX-PTC PAD LIDOCAIN3ML GLAS SYR KIT NA HEPAR5ML GLAS SYR KIT NA HEPAR7T GUMMY ES CHW 500MGA.A.G.C KIT CRE TERODERMABANEU-SL SUBACACIA EXTRA SOL 1:20ACCUCAINE INJ 1%ACD FORMULA SOL AACESO AG PAD 4"X4"ACREMONIUM SOL 20000PNUACTCT FLEX 3 PAD 4"X4"ACTHRELINJ 100MCGACTI ANTIMIC PAD 2"X2"ACTI ANTIMIC PAD 4"X4"ACTICOAT 7 PAD 2"X2"ACTICOAT 7 PAD 4"X5"ACTICOAT ABS PAD 4"X5"ACTICOAT MOI PAD 2"X2"ACTICOAT MOI PAD 4"X4"ACTICOAT MOI PAD 4"X8"ACTICOAT SUR PAD 4"X10"ACTICOAT SUR PAD 4"X8"ACTICOAT SUR PAD 4X13.75"ACTICOAT SUR PAD 4X4-3/4"ACTIVASE INJ 50MGACTIVEKIT INJECT LACTIVE INJEC INJ DLACTIVE INJEC INJ M-1ACTIVE INJEC KIT BLM-1ACTIVE INJEC KIT BMACTIVE INJEC KIT DACTIVE INJEC KIT DLMACTIVE INJEC KIT KET-LACTIVE INJEC KIT KETMARCACTIVE INJEC KIT KL-3ACTIVE INJEC KIT KMACTIVE INJEC KIT LM-2ACTIVE INJEC KIT LM-DEP-1ACTIVE INJEC KIT LM-DEP-2ACTIVE MEDIC KIT SPECIMENACTIVE-PAC/ MIS GABA 300ACTIVE-PREP CRE KIT IDiagnostic AgentBulk IngredientUnapproved DrugDiagnostic AgentDiagnostic AgentUnapproved DrugNot properly listed with FDAVitamin/MineralNon-standardized allergenicLISTBlood ComponentSurgical Supply/MedicalNon-standardized allergenicNot properly listed with FDADiagnostic AgentNot properly listed with FDANot properly listed with FDANot properly listed with FDANot properly listed with FDANot properly listed with FDASurgical Supply/MedicalSurgical Supply/MedicalSurgical Supply/MedicalSurgical Supply/MedicalSurgical Supply/MedicalSurgical Supply/MedicalSurgical Supply/MedicalLISTBulk IngredientBulk IngredientBulk IngredientBulk IngredientBulk IngredientBulk IngredientBulk IngredientBulk IngredientBulk IngredientBulk IngredientBulk IngredientBulk IngredientBulk IngredientNot properly listed with FDADiagnostic AgentLISTBulk Ingredient
MEDICARE PART D EXCLUDED DRUGS LIST 2021 updated January 2021Reason: 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 coveragedetermination. 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 coveragedetermination 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 indicationsReasonLabel NameACTIVE-PREP CRE KIT IIACTIVE-PREP CRE KIT IIIACTIVE-PREP CRE KIT IVACTIVE-PREP CRE KIT VACTIVITE TABACUICYNSOLACUNOLTAB 600MGADASHAADAP/BEN/NIA GELADAP/BENZ/ GEL CLINDAMYADAPTADERM CREADC/FLUORIDE DRO 0.5MGADDYITAB 100MGADENOSINE INJ 3MG/MLADENOSINE INJ 6MG/2MLADENOSINE INJ 90/30MLADIPEX-P CAP 37.5MGADIPEX-P TAB 37.5MGADRENAL C TAB FORMULAADREVIEW INJADV ALLERGY KIT COLLECTIADVANCED MIS AM/PMADVANCED BAS CRE PLUSADVATEINJ 1000UNITADVATEINJ 1500UNITADVATEINJ 2000UNITADVATEINJ 250UNITADVATEINJ 3000UNITADVATEINJ 4000UNITADVATEINJ 500UNITADYNOVATE INJ 1000UNITADYNOVATE INJ 1500UNITADYNOVATE INJ 2000UNITADYNOVATE INJ 250UNITADYNOVATE INJ 3000UNITADYNOVATE INJ 500UNITADYNOVATE INJ 750UNITADYPHREN KITADYPHREN AMP KIT 1MG/MLADYPHREN II KITAFLURIAINJ 2018-19AFLURIAINJ PF 18-19AFLURIA QUAD INJ 2018-19AFLURIA QUAD INJ 2019-20AFLURIA QUAD INJ 2020-21Bulk IngredientBulk IngredientBulk IngredientBulk IngredientVitamin/MineralNot properly listed with FDAUnapproved DrugNot properly listed with FDAUnapproved DrugUnapproved DrugNot properly listed with FDAVitamin/MineralSexual Dysfunction AgentDiagnostic AgentDiagnostic AgentDiagnostic AgentAnorexic, Anti-obestiy AgentAnorexic, Anti-obestiy AgentVitamin/MineralDiagnostic AgentNot properly listed with FDAVitamin/MineralNot properly listed with FDABlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentLISTUnapproved DrugUnapproved DrugInfluenza VaccineInfluenza VaccineInfluenza VaccineInfluenza VaccineInfluenza Vaccine
MEDICARE PART D EXCLUDED DRUGS LIST 2021 updated January 2021Reason: 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 coveragedetermination. 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 coveragedetermination 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 indicationsLabel NameAFLURIA QUAD INJ PF 18-19AFSTYLAKIT 1000UNITAFSTYLAKIT 1500UNITAFSTYLAKIT 2000UNITAFSTYLAKIT 2500UNITAFSTYLAKIT 250UNITAFSTYLAKIT 3000UNITAFSTYLAKIT 500UNITAGONEAZE KIT 2.5-2.5%AIF #2 DRUG CRE PREP KITAIF #3 DRUG CRE PREP KITAIRAVITE TABAK-FLUOR INJ 10% OPAK-FLUOR INJ 25% OPALA-QUIN CRE 3-0.5%ALBA-DERM CREALBUKED 25 INJ 25%ALBUKED 5 INJ 5%ALBUMIN HUM INJ 25%ALBUMIN HUM INJ 5%ALBUMINAR-25 INJ 25%ALBUMINAR-5 INJ 5%ALBUMINEX SOL 25%ALBUMINEX SOL 5%ALBUMIN-ZLB INJALBUMIN-ZLB SOL 25%ALBURXINJ 5%ALBUTEIN INJ 25%ALBUTEIN INJ 5%ALCOHOLINJ 98%ALCOHOL BASE GELALCORTIN A GEL 1-2-1%ALDER EXTRAC SOL 1:20ALEVAMAX CREALEVICYN GELALEVICYN SOL DERMALALEVICYN SG GEL ANTIPRURALGESISTABALKERANTAB 2MGALLEVYN AG MIS 6-3/4"ALLEVYN AG MIS 9"X9"SACALLEVYN AG PAD 2"X2"ALLEVYN AG PAD 3"X3"ALLEVYN AG PAD 4"X4"ALLEVYN AG PAD 5"X5"ReasonInfluenza VaccineBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentLISTNot properly listed with FDANot properly listed with FDAVitamin/MineralDiagnostic AgentDiagnostic AgentDESIUnapproved DrugBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentUnapproved DrugNot properly listed with FDADESINon-standardized allergenicNot properly listed with FDANot properly listed with FDANot properly listed with FDANot properly listed with FDADietary SupplementOral drug for cancer; infusion available under Part BSurgical Supply/MedicalSurgical Supply/MedicalSurgical Supply/MedicalNot properly listed with FDASurgical Supply/MedicalNot properly listed with FDA
MEDICARE PART D EXCLUDED DRUGS LIST 2021 updated January 2021Reason: 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 coveragedetermination. 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 coveragedetermination 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 indicationsReasonLabel NameALLEVYN AG PAD 6"X6"ALLEVYN AG PAD 7"X7"ALLEVYN AG PAD 8"X8ALLEVYN GENT PAD 4"X4ALLEVYN GENT PAD 8"X8"ALMONDINJ EXTRACTALOQUINGEL 1.25-1%ALPAWASH OINALPHA-LIPOIC SOL ACIDALPHANATE INJ VWF/HUMALPHANATE INJ VWF/HUMALPHANATE INJ VWF/HUMALPHANATE INJ VWF/HUMALPHANATE INJ VWF/HUMALPHANINE SD INJ 1000UNITALPHANINE SD INJ 1500UNITALPHANINE SD INJ 500UNITALPROLIX INJ 1000UNITALPROLIX INJ 2000UNITALPROLIX INJ 250UNITALPROLIX INJ 3000UNITALPROLIX INJ 4000UNITALPROLIX INJ 500UNITALPROSTADIL INJ 500MCGALTADERM CRE BASEALTAFLUOR SOL 0.25-0.4ALTAFLUOR-BE SOL 0.25-0.4ALTERNARIA SOL EXTRACTALZAIR NASAL SPR 800MGAMD FOAM PAD 4"X4"AMERICAN INJ SYCAMOREAMERICAN SOL BEECHAMERICAN SOL COCKROACAMERICAN ELM SOLAMIDATEINJ 2MG/MLAMINO PM RMS CAPAMINOAC ACID SOL 1.5% IRRAMINOAMCAP RMSAMINOBEZ POT POWAMINORELIEF CAP RMSAMITRIPTYLIN CREAMITRIPTYLIN KIT 2%AMLODIPINE SUS 1MG/MLAMMONIA N 13 INJAMORPH WOUND GEL DRESSINGSurgical Supply/MedicalNot properly listed with FDASurgical Supply/MedicalNot properly listed with FDANot properly listed with FDADiagnostic AgentDESINot properly listed with FDAUnapproved DrugBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentErectile DysfunctionNot properly listed with FDADiagnostic AgentDiagnostic AgentNon-standardized allergenicDeviceNot properly listed with FDANon-standardized allergenicNon-standardized allergenicNon-standardized allergenicNon-standardized allergenicGeneral AnestheticNot properly listed with FDANot properly listed with FDANot properly listed with FDADESINot properly listed with FDANot properly listed with FDABulk IngredientLISTDiagnostic AgentNot properly listed with FDA
MEDICARE PART D EXCLUDED DRUGS LIST 2021 updated January 2021Reason: 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 coveragedetermination. 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 coveragedetermination 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 indicationsReasonLabel NameAMVISCINJ 12MG/MLAMVISC PLUS INJ 16MG/MLAMYTAL SOD INJ 500MGAMYVIDINJANA-LEXKITANALPRAM HC CRE 2.5-1%ANALPRAM-HC CRE 1-1%ANALPRAM-HC LOT 2.5%ANALPRM SNGL CRE HC 2.5-1ANASCORP INJANASPAZTAB 0.125MGANASTIALOT 2.75%ANAVIPINJANECTINE INJ 200/10MLANECTINE INJ 20MG/MLANESTHESIA KIT S/I-40ANESTHESIA KIT S/I-40AANESTHESIA KIT S/I-40HANESTHESIA KIT S/I-60ANHYDROUS CRE BASEANHYDROUS OIN BASEANIMI-3CAPANIMI-3CAPANIMI-3CAP VIT DANODYNE LPT KIT 2.5-2.5%ANTICOAG CIT SOL DEX SOLANTICOAGULNT INJ SOD CITRANTIPRURITIC GELANTIVENIN KIT LAT MACTANTIVENIN NA INJ CORAL SNANUCORT-HC SUP 25MGANUSOL-HC SUP 25MGAPLISOLINJ 5/0.1MLAPOTHEDERM CREAPOTHESAR CRE PLUSAPOTHESAR CRE TRANSDERAPOTHESAR 2 CREAPOTHESIL CREAPP SLIM RMS CAPAPPLEINJ EXTRACTAPPTRIMCAPAPPTRIM-D CAPAPP-TRIM-D CAPAPRIZIO PAK KITAPRIZIO PAK KIT IIDeviceDeviceUnapproved DrugDiagnostic AgentUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugLISTUnapproved DrugNot properly listed with FDAAntiveninLISTLISTGeneral AnestheticGeneral AnestheticGeneral AnestheticGeneral AnestheticNot properly listed with FDANot properly listed with STUnapproved DrugUnapproved DrugNot properly listed with FDALISTLISTDESIDESIDiagnostic AgentNot properly listed with FDANot properly listed with FDANot properly listed with FDANot properly listed with FDANot properly listed with FDANot properly listed with FDADiagnostic AgentAnorexic, Anti-obestiy AgentAnorexic, Anti-obestiy AgentAnorexic, Anti-obestiy AgentLISTLIST
MEDICARE PART D EXCLUDED DRUGS LIST 2021 updated January 2021Reason: 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 coveragedetermination. 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 coveragedetermination 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 indicationsReasonLabel NameAP-ZELTABAQUASOL A INJ 50000/MLAQUORALSPRARIDAGELARIDOLKITARIZONAINJ CYPRESSARMOUR THYRO TAB 120MGARMOUR THYRO TAB 15MGARMOUR THYRO TAB 180MGARMOUR THYRO TAB 240MGARMOUR THYRO TAB 300MGARMOUR THYRO TAB 30MGARMOUR THYRO TAB 60MGARMOUR THYRO TAB 90MGARNICATIN FLOWERARNICA LG LIQARTICADENT INJ DENTALARTICADENT INJ DENTALARZOL SILVER MIS NITR APPASCLERAINJ 0.5%ASCLERAINJ 1%ASCORSOL 25000MGASCORBIC ACD INJ 500MG/MLASCORBIC ACI SOL 500MG/MLASILNASAL CAP RMSASPERGILLUS INJ 1:10ASPERGILLUS INJ 1:20ASPERGILLUS INJ SOLN 1:20ASTAMED MYO CAPASTEROGEL 4%ASTRINGYN SOL 259MG/GMATABEX EC TAB 29-1MGATABEX OB TAB 29-1MGATENOLOL SUS 1GM/MLATOPADERM CREATOPAVOEMUATOPICLAIR CREATORVA/COQ10 PAK 20-100MGATRACURIUM INJ 10MG/MLATRACURIUM INJ 10MG/MLATRACURIUM INJ 50MG/5MLATRAPROGEL HYDROGELATRAPRO CP KITATRAPRO DERM SPRATREVISCREVitamin/MineralVitamin/MineralNot properly listed with FDASurgical Supply/MedicalDiagnostic AgentNon-standardized allergenicUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugLISTLISTUnapproved ed DrugNot properly listed with FDANon-standardized allergenicDiagnostic AgentNon-standardized allergenicNot properly listed with FDANot properly listed with FDANot properly listed with l Supply/MedicalDeviceNot properly listed with FDALISTLISTLISTDeviceNot properly listed with FDANot properly listed with FDANot properly listed with FDA
MEDICARE PART D EXCLUDED DRUGS LIST 2021 updated January 2021Reason: 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 coveragedetermination. 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 coveragedetermination 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 indicationsReasonLabel NameATROPINE SUL INJ 1.2/3MLATROPINE SUL OIN 1% OPAUREOBASIDIU INJ 1:10AUREOBASIDIU INJ 1:20AUREOBASIDIU SOL 1:20AUSTRALIAN SOL PINE EXTAUXIPROCRE VANISHINAVAGECRE 0.1%AVAILNEX CHW 750MGAVARAER 9.5-5%AVARPAD 9.5-5%AVAR CLEANSE EMU 10-5%AVAR LSAER 10-2%AVAR LSLIQ 10-2%AVAR LSPAD 10-2%AVAR-E EMOLL CRE 10-5%AVAR-E GREEN CRE 10-5%AVAR-E LS CRE 10-2%AVEIDAOXIA GELAVENOVASOL 0.01%AVIDOXY DK KITAVO CREAM EMUAVOCADOINJ EXTRACTAXIFOLCAP C ACID CRE NIACINAMAZENASE PAK MIS 137-50AZESCHEW CHW 13-1MGAZESCOTAB 13-1MGAZUPHEN MB CAP 120MGB-12 COMP KIT 1000MCGB12 COMPLNCE KIT INJ KITB6 FOLIC ACD CAPBACLOFEN CREBACLOFEN CRE 1%BACLOFEN CRE 2%BACMINTABBACTER WATER INJ BENZ ALCBACTER WATER INJ PARABENSBAHIASOL EXTRACTBAL SALT SOL OPBAL-CARE MIS DHAUnapproved DrugUnapproved DrugNon-standardized allergenicDiagnostic AgentNon-standardized allergenicNon-standardized allergenicNot properly listed with FDACosmeticNot properly listed with FDAUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugNot properly listed with FDANot properly listed with FDANot properly listed with FDASurgical Supply/MedicalDiagnostic AgentNot properly listed with FDAMedical FoodDiagnostic AgentSurgical Supply/MedicalDietary SupplementUnapproved DrugNot properly listed with FDAVitamin/MineralVitamin/MineralUnapproved ot properly listed with FDABulk IngredientBulk IngredientVitamin/MineralUnapproved DrugUnapproved DrugNon-standardized allergenicLISTVitamin/Mineral
MEDICARE PART D EXCLUDED DRUGS LIST 2021 updated January 2021Reason: 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 coveragedetermination. 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 coveragedetermination 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 indicationsReasonLabel NameBALD CYPRESS INJ 1:20BALSAM PERU OIN CASTORBANANAINJ EXTRACTBARIUMPOW SULFATEBASADROX GELBASECRE LIPOSOMEBASE W301 CREBAYBERRY WAX SOL MYR EXTRBCAAINJ (AMINO ACID INJ SOLN)BCAAINJ (AMINO ACID IV SOLN)B-COMPLEX INJB-COMPLEX INJ 100B-COMPLEX INJ HYDRXCBBD POSIFLUSH INJ 0.9%BEAU RXGELBEE VENOM INJ 1300MCGBEE VENOM INJ 550MCGBEEF EXTRACT INJ 1:10BELLA ALK/PB TAB 16.2MGBELLA/OPIUM SUP 16.2-30BELLA/OPIUM SUP 16.2-60BELVIQTAB 10MGBELVIQ XR TAB 20MGBENEFIXINJ 1000UNITBENEFIXINJ 2000UNITBENEFIXINJ 250UNITBENEFIXINJ 3000UNITBENEFIXINJ 500UNITBENSAL HP OINBENZ PER FOR LOT HC 7.5-1BENZ PER- HC LOT 5-0.5%BENZ PEROXID GEL 6.5%BENZ/CLIN/ GEL NIACINBENZ/CLIN/NI GELBENZ/CLIND/ GEL NIA/TRETBENZ/CLIND/ GEL NIA/TRETBENZ/CLINDA/ GEL NIA/TRETBENZ/LIDO/TE OIN 20-10-10BENZAC AC LIQ 5% WASHBENZALKONIUM SOL 50%BENZALKONIUM SOL NFBENZEFOAM AER 5.3%BENZEFOAM AER 9.8%BENZEPRO AER 5.2%BENZEPRO AER 5.3%Non-standardized allergenicDeviceDiagnostic AgentDiagnostic AgentSurgical Supply/MedicalBulk IngredientNot properly listed with FDANon-standardized allergenicUnapproved DrugUnapproved ot properly listed with FDANot properly listed with FDANon-standardized allergenicNon-standardized allergenicDiagnostic AgentUnapproved DrugUnapproved DrugUnapproved DrugAnorexic, Anti-obestiy AgentAnorexic, Anti-obestiy AgentBlood ComponentBlood ComponentBlood ComponentBlood ComponentBlood ComponentUnapproved DrugNot properly listed with FDANot properly listed with FDANot properly listed with FDAUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugNot properly listed with FDAUnapproved DrugUnapproved DrugNot properly listed with FDAUnapproved Drug
MEDICARE PART D EXCLUDED DRUGS LIST 2021 updated January 2021Reason: 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 coveragedetermination. 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 coveragedetermination 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 indicationsReasonLabel NameBENZEPRO AER 9.7%BENZEPRO LIQ 6.8%BENZEPRO LIQ CREAMYBENZEPRO MIS 5.8%BENZEPRO MIS 6%BENZEPRO SC AER 9.8%BENZODOX 30 MISBENZODOX 60 MISBENZOINTIN NFBENZOIN CMPD TINBENZONATATE CAP 100MGBENZONATATE CAP 150MGBENZONATATE CAP 200MGBENZOYL PER AER 9.8%BENZOYL PERO GEL 8%BENZOYL PERX LIQ 6.9%BENZPHETAMIN TAB 50MGBENZPHETMINE TAB 25MGBERMUDASOL GRASSBERMUDA GRAS SOL 10000BAUBESERKIT 0.05%BETA 1 KIT KIT 30MG/5MLBETALIDO KITBETALOAN SUI INJ 3-3MG/MLBETAMETH SOD INJ 12MG/2MLBETAMETH SOD INJ 6MG/MLBETAMETHASON SOL MINOXIDIBETTERMILK PAK GLYTACTIBETTERMILK15 POW GLYTACTNBEVACIZUMAB INJ 2.5/.1MLBEVACIZUMAB INJ 2.75MGBEVACIZUMAB INJ 3.25/.13BEVACIZUMAB INJ 3.75/.15BEVACIZUMAB INJ 3.75MGBHI URI- TAB CONTROLBIAFINEEMUBI-EST 50:50 CREBI-EST 50:50 MICRO CREBIEST/PROGES CREBIIFENAC MIS 1000 KITBIIFENAC 500 MIS KITBIMATOPROST SOL 0.03%BI-MIXINJ 150-5MGBINAXNOW KIT COVID-19BIO GLOTES 1MG OPNot properly listed with FDANot properly listed with FDAUnapproved DrugNot properly listed with FDAUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugCough/ColdCough/ColdCough/ColdUnapproved DrugNot properly listed with FDANot properly listed with FDAAnorexic, Anti-obestiy AgentAnorexic, Anti-obestiy AgentNon-standardized allergenicLISTLISTLISTLISTLISTUnapproved DrugUnapproved DrugUnapproved DrugNot properly listed with FDANot properly listed with FDANot properly listed with FDAUnapproved DrugNot properly listed with FDANot properly listed with FDAUnapproved DrugUnapproved DrugSurgical Supply/MedicalNot properly listed with FDANot properly listed with FDABulk IngredientLISTLISTCosmeticErectile DysfunctionDiagnostic AgentDiagnostic Agent
MEDICARE PART D EXCLUDED DRUGS LIST 2021 updated January 2021Reason: 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 coveragedetermination. 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 coveragedetermination 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 indicationsReasonLabel NameBIOCELTABBIOGRD ISLND PAD 4"X10"BIOGRD ISLND PAD 4"X14"BIOGRD ISLND PAD 4"X5"BIOLONINJ 10MG/MLBIONECTAER 0.2%BIONECTCRE 0.2%BIONECTGEL 0.2%BIOPEPTIDE CRE BASEBIO-STATIN POWBLACK WALNUT SOL POLL EXTBLACK WILLOW INJ 1:20BLANCHECRE 4%BOCASALPOWBONE MARROW KIT BIOPSYBORIC ACID GRABOTOX COSMET INJ 100UNITBOTOX COSMET INJ 50UNITBOTRYTIS CIN INJ 1:20BOTRYTIS EXT SOL 20000PNUBOTRYTIS EXT SOL 43000PNUBOX ELDER INJ EXT 1:20BP 10-1EMUBP CLEANSING EMU 10-4%BP FOAMAER 5.3%BP FOAMAER 9.8%BP VIT 3 CAPBP WASHLIQ 2.5%BP WASHLIQ 7%BPCOOINB-PLEXTABB-PLEX PLUS TABBPMTAB 6MGBPM PSEUDO TAB 6-45MGBPM-PSE-DM SYP 2-30-10BPOGEL 4%BPOGEL 8%BRAVELLE INJ 75UNITBRAVURACRE ALL-IN-OBREVITAL SOD INJ 2.5GMBREVITAL SOD INJ 500MGBROM/PSE/DM SYPBROM/PSE/DM SYP 2/30/10BROM/PSE/DM SYP 2/30/10BROMESOL 1:20Vitamin/MineralNot properly listed with FDANot properly listed with FDANot properly listed with FDANot properly listed with FDASurgical Supply/MedicalSurgical Supply/MedicalSurgical Supply/MedicalNot properly listed with FDANot properly listed with FDANon-standardized allergenicNon-standardized allergenicCosmeticNot properly listed with FDANot properly listed with FDABulk IngredientCosmeticCosmeticDiagnostic AgentNon-standardized allergenicNon-standardized allergenicNon-standardized allergenicUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugVitamin/MineralUnapproved DrugUnapproved DrugNot properly listed with FDAVitamin/MineralVitamin/MineralUnapproved DrugUnapproved DrugLISTUnapproved DrugUnapproved DrugFertility AgentNot properly listed with FDAGeneral AnestheticGeneral AnestheticCough/ColdLISTLISTNon-standardized allergenic
MEDICARE PART D EXCLUDED DRUGS LIST 2021 updated January 2021Reason: 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 coveragedetermination. 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 coveragedetermination 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 indicationsLabel NameBROMFED DM SYPBSP 0820 KITBSSSOL OPBSS PLUS SOL OPBT INJECTION KIT 40-0.5%BUPIV/NACL INJ 0.0625%BUPIVAC HCL INJ 0.125%BUPIVAC/NACL INJBUPIVAC/NACL INJ 0.25-0.9BUPIVAC/NACL SOL 0.25-0.9BUPIVACA/D5W INJ /SPINALBUPIVACAINE INJ 312.5/10BUPIVACAINE INJ SPINALBUPIVACAINE/ INJ EPI 0.25BUPIVACAINE/ INJ EPI 0.25BUPIVACAINE/ INJ EPI 0.5%BUPIVACAINE/ INJ EPI 0.5%BUPIVILOG KITCA ALGINATE MIS 12" ROPECA ALGINATE PAD 2"X2"CA ALGINATE PAD 4"X4"CA ALGINATE PAD 4"X8"CADIRAMD KITCAFFEINE/SOD INJ BENZOATECALCIFOL WAFCALCIPOTRIEN SOL CLOBETASCALCIUM-FA WAF PLUS DCALI PEPPER INJ TREECALMINJCAM PRO COMP BAR GLYTACTICAMINO PRO LIQ PKUCANDIDAINJ ALBICANSCANDIDASOL ALBICANSCANDIDA ALBI INJ 1:20CANDIDA ALBI SOL 100MG/MLCANDININJCANTALOUPE INJ EXTRACTCAPECITABINE TAB 150MGCAPECITABINE TAB 500MGCAPHOSOL SOLCAPSFENAC PAKCAPSINAC PAKCAPSULE 0 CAP CLR DRCAPSULE CONI CAP -SN #000CAPSULE CONI CAP -SNAP #0ReasonCough/ColdLISTLISTLISTUnapproved DrugNot properly listed with FDAUnapproved DrugNot properly listed with FDANot properly listed with FDANot properly listed with FDALISTUnapproved DrugLISTLISTLISTLISTLISTLISTUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugVitamin/MineralUnapproved DrugVitamin/MineralNon-standardized allergenicUnapproved DrugNot properly listed with FDANot properly listed with FDADiagnostic AgentNon-standardized allergenicNon-standardized allergenicNon-standardized allergenicDiagnostic AgentDiagnostic AgentCovered under Part B; oral drug only indicated for cancerCovered under Part B; oral drug only indicated for cancerDeviceLISTLISTUnapproved DrugUnapproved DrugUnapproved Drug
MEDICARE PART D EXCLUDED DRUGS LIST 2021 updated January 2021Reason: 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 coveragedetermination. 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 coveragedetermination 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 indicationsReasonLabel NameCAPSULE CONI CAP -SNAP #0CAPSULE CONI CAP -SNAP #1CAPSULE CONI CAP -SNAP #1CAPSULE CONI CAP -SNAP #2CAPSULE CONI CAP -SNAP #3CAPSULE CONI CAP -SNAP #3CAPSULE CONI CAP -SNAP #4CAPSULE CONI CAP -SNAP#00CAPSULE EZFT CAP #0CAPSULE EZFT CAP #00CARBOGEL GEL 940CARBOHOL GEL 940CARBOMER GEL AQUEOUSCARBOMER GEL HYDROALCCARDIOPL IND SOL 4:1CARDIOPL IND SOL 8:1CARDIOPL IND SOL LOW DEX8CARDIOPL IND SOL NON-EN 8CARDIOPL IND SOL PLASMA 4CARDIOPL IND SOL PLS/TROMCARDIOPL MN SOL 8:1CARDIOPL MN SOL PLS/TROMCARDIOPL REP SOL 4:1CARDIOPLE MN SOL LOW TROMCARDIOPLEGI SOL DEL NIDOCARDIOPLEGIA SOL MAIN 4:1CARDIOPLEGIC SOLCARDIOTEK-RX TABCARDIOVID CAP PLUSCARRASYN GEL DRESSINGCARTICEL IMPCASCARAEXT SAGRADACASEININJ EXTRACTCAT HAIR SOL EXTRACTCAT HAIR EXT SOL 10000BAUCAT HAIR EXT SOL 5000BAUCATHFLO ACTI INJ 2MGCATTLE EPITH SOL 1:20CAVAREST GEL 1.1%CAVERJECT INJ 20MCGCAVERJECT INJ 40MCGCAVERJECT KIT 20MCGCAVERJECT IM KIT 10MCGCAYADPRCEDAR ELM INJ 1:20Unapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugUnapproved DrugNot properly listed with FDANot properly listed with FDABulk IngredientBulk IngredientBulk IngredientBulk IngredientNot properly listed with FDANot properly listed with FDANot properly listed with FDANot properly listed with FDANot properly listed with FDANot properly listed with FDANot properly listed with FDANot properly listed with FDANot properly listed with FDANot properly listed with FDANot properly listed with FDANot properly listed with FDALISTVitamin/MineralVitamin/MineralNot properly listed with FDALISTUnapproved DrugDiagnostic AgentNon-standardized allergenicLISTLISTLISTNon-standardized allergenicUnapproved DrugErectile DysfunctionErectile DysfunctionErectile DysfunctionErectile DysfunctionNot properly listed with FDANon-standardized allergenic
MEDICARE PART D EXCLUDED DRUGS LIST 2021 updated January 2021Reason: 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 coveragedetermination. 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 coveragedetermination 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 indicationsLabel NameCEFTRI-IM KITCEFTRISOL KIT PLUSCEFUROXIME INJ 3MGCELA BASE CRECELACYNGELCEM-UREA SOL 45%
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021. Reason: LIST . ANALPRM SNGL CRE HC 2.5-1 Unapproved Drug ANASCORP INJ LIST ANASPAZ TAB 0.125MG Unapproved Drug ANASTIA LOT 2.75% Not properly listed with FDA ANAVIP INJ Antivenin ANECTINE INJ 200/10ML LIST ANECTINE INJ 20MG/ML LIST .
