docMedicare Part D Excluded Drug List
download 
Report Transcription
Medicare Part D Excluded Drug List
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 1ST BASE CRE 2-FUCCOSYLLA PAK LACTO-N ABANEU-SL SUB ABLAVAR INJ 244MG/ML ACACIA EXTRA SOL 1:20 ACCUCAINE INJ 1% ACD FORMULA SOL A ACD-A SOL ACLARO PD EMU 4% ACREMONIUM SOL 20000PNU ACTCT FLEX 3 PAD 4"X4" ACTHREL INJ 100MCG ACTI 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 50MG ACTIVE INJEC INJ DL ACTIVE INJEC INJ M-1 ACTIVE INJEC KIT BLM-1 ACTIVE INJEC KIT BM ACTIVE INJEC KIT D ACTIVE INJEC KIT DLM ACTIVE INJEC KIT KET-L ACTIVE INJEC KIT KETMARC ACTIVE INJEC KIT KL-3 ACTIVE INJEC KIT KM ACTIVE INJEC KIT LM-2 ACTIVE INJEC KIT LM-DEP-1 ACTIVE MEDIC KIT SPECIMEN ACTIVE OB CAP ACTIVE-PAC/ MIS GABA 300 ACTIVE-PREP CRE KIT I ACTIVE-PREP CRE KIT II ACTIVE-PREP CRE KIT III ACTIVE-PREP CRE KIT IV ACTIVE-PREP CRE KIT V Reason Bulk Ingredient Medical Food Vitamin/Mineral Diagnostic Agent Non-standardized allergenic LIST Blood Component Blood Component Cosmetic Non-standardized allergenic Not properly listed with FDA Diagnostic Agent Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Surgical Supply/Medical Surgical Supply/Medical Surgical Supply/Medical Surgical Supply/Medical Surgical Supply/Medical Surgical Supply/Medical Surgical Supply/Medical LIST Bulk Ingredient Bulk Ingredient Bulk Ingredient Bulk Ingredient Bulk Ingredient Bulk Ingredient Bulk Ingredient Bulk Ingredient Bulk Ingredient Bulk Ingredient Bulk Ingredient Bulk Ingredient Diagnostic Agent Vitamin/Mineral LIST Bulk Ingredient Bulk Ingredient Bulk Ingredient Bulk Ingredient 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 Reason Label Name ACUICYN LIQ ACUNOL TAB 600MG ADAPTADERM CRE ADAZIN CRE ADDYI TAB 100MG ADENOSCAN INJ 3MG/ML ADENOSINE INJ 3MG/ML ADIPEX-P CAP 37.5MG ADIPEX-P TAB 37.5MG ADRENAL C TAB FORMULA ADREVIEW INJ ADV ALLERGY KIT COLLECTI ADVANCED MIS AM/PM ADVANCED BAS CRE PLUS ADVANCED DNA KIT COLLECTI ADVATE INJ 1000UNIT ADVATE INJ 1500UNIT ADVATE INJ 2000UNIT ADVATE INJ 250UNIT ADVATE INJ 3000UNIT ADVATE INJ 4000UNIT ADVATE INJ 500UNIT ADYNOVATE INJ 1000UNIT ADYNOVATE INJ 2000UNIT ADYNOVATE INJ 250UNIT ADYNOVATE INJ 500UNIT AERO OTIC HC SOL AFLURIA INJ 2012-13 AFLURIA INJ 2013-14 AFLURIA INJ 2014-15 AFLURIA INJ 2015-16 AFLURIA INJ PF 12-13 AFLURIA INJ PF 13-14 AFLURIA INJ PF 14-15 AFLURIA INJ PF 15-16 AFSTYLA KIT 1000UNIT AFSTYLA KIT 2000UNIT AFSTYLA KIT 250UNIT AFSTYLA KIT 3000UNIT AFSTYLA KIT 500UNIT AIF #2 DRUG CRE PREP KIT AIF #3 DRUG CRE PREP KIT AIRAVITE TAB AK-FLUOR INJ 10% OP AK-FLUOR INJ 25% OP Not properly listed with FDA Unapproved Drug Not properly listed with FDA Unapproved Drug Sexual Dysfunction Agent Diagnostic Agent Diagnostic Agent Anorexic, Anti-obestiy Agent Anorexic, Anti-obestiy Agent Vitamin/Mineral Diagnostic Agent Not properly listed with FDA Vitamin/Mineral Not properly listed with FDA Diagnostic Agent Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component DESI Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Blood Component Blood Component Blood Component Blood Component Blood Component Not properly listed with FDA Not properly listed with FDA Vitamin/Mineral Diagnostic Agent Diagnostic Agent 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 ALA-QUIN CRE 3-0.5% ALBA-DERM CRE ALBAFORT INJ ALBATUSSIN CAP ALBATUSSIN LIQ NN ALBUKED 25 INJ 25% ALBUKED 5 INJ 5% ALBUMIN HUM INJ 25% ALBUMIN HUM INJ 5% ALBUMIN-ZLB INJ ALBUMIN-ZLB SOL 25% ALBUMINAR-25 INJ 25% ALBUMINAR-5 INJ 5% ALBURX INJ 5% ALBUTEIN INJ 25% ALBUTEIN INJ 5% ALCOHOL INJ 98% ALCOHOL BASE GEL ALCOHOL GEL GEL ALCORTIN A GEL ALCORTIN A GEL 1-2-1% ALDER EXTRAC SOL 1:20 ALEVICYN GEL ALEVICYN SOL DERMAL ALEVICYN SG LIQ ANTIPRUR ALKERAN TAB 2MG ALLEVYN AG PAD 2"X2" ALLEVYN AG PAD 2"X2" ALLEVYN AG PAD 3"X3" ALLEVYN AG PAD 4"X4" ALLEVYN AG PAD 4"X4" ALLEVYN AG PAD 5"X5" ALLEVYN AG PAD 6"X6" ALLEVYN AG PAD 6"X6" ALLEVYN AG PAD 6-3/4" ALLEVYN AG PAD 7"X7" ALLEVYN AG PAD 8"X8 ALLEVYN AG PAD 8"X8" ALLEVYN AG PAD 9"X9"SAC ALLEVYN GENT PAD 4"X4 ALLEVYN GENT PAD 8"X8" ALLO-PAX CRE 5-5% ALODOX KIT 20MG ALOQUIN GEL 1.25-1% ALPAWASH OIN Reason DESI Unapproved Drug Vitamin/Mineral DESI DESI Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Unapproved Drug Not properly listed with FDA Not properly listed with FDA DESI DESI Non-standardized allergenic Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Oral drug for cancer; infusion available under Part B Not properly listed with FDA Surgical Supply/Medical Not properly listed with FDA Not properly listed with FDA Surgical Supply/Medical Not properly listed with FDA Not properly listed with FDA Surgical Supply/Medical Not properly listed with FDA Not properly listed with FDA Surgical Supply/Medical Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Unapproved Drug Unapproved Drug DESI Not properly listed with FDA 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 ALPHANATE INJ VWF/HUM ALPHANATE INJ VWF/HUM ALPHANATE INJ VWF/HUM ALPHANATE INJ VWF/HUM ALPHANATE INJ VWF/HUM ALPHANINE SD INJ 1000UNIT ALPHANINE SD INJ 1500UNIT ALPHANINE SD INJ 500UNIT ALPHAQUIN HP CRE 4% ALPROLIX INJ 1000UNIT ALPROLIX INJ 2000UNIT ALPROLIX INJ 250UNIT ALPROLIX INJ 3000UNIT ALPROLIX INJ 500UNIT ALPROSTADIL INJ 500MCG ALTACAINE SOL 0.5% OP ALTADERM CRE BASE ALTAFLUOR SOL 0.25-0.4 ALTERNARIA SOL EXTRACT ALUVEA CRE 39% AMERICAN INJ SYCAMORE AMERICAN SOL COCKROAC AMERICAN ELM SOL AMIDATE INJ 2MG/ML AMINOAC ACID SOL 1.5% IRR AMINOBEZ POT POW AMINOHIPPURA INJ 20% AMITRIPTYLIN CRE AMITRIPTYLIN KIT 2% AMORPH WOUND GEL DRESSING AMVISC INJ 12MG/ML AMVISC PLUS INJ 16MG/ML AMYTAL SOD INJ 500MG AMYVID INJ ANA-LEX KIT ANALPRAM KIT ADVANCED ANALPRAM E KIT ANALPRAM HC CRE 2.5-1% ANALPRAM-HC CRE 1-1% ANALPRAM-HC CRE 1-2.5% ANALPRAM-HC CRE SINGLES ANALPRAM-HC CRE SINGLES ANALPRAM-HC LOT 2.5% ANALPRM SNGL CRE HC 2.5-1 ANASCORP INJ Reason Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Cosmetic Blood Component Blood Component Blood Component Blood Component Blood Component Erectile Dysfunction Unapproved Drug Not properly listed with FDA Diagnostic Agent Non-standardized allergenic Unapproved Drug Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic General Anesthetic Not properly listed with FDA DESI Diagnostic Agent Not properly listed with FDA Bulk Ingredient Not properly listed with FDA Device Device Unapproved Drug Diagnostic Agent Unapproved Drug Unapproved Drug DESI Unapproved Drug Unapproved Drug DESI Unapproved Drug DESI Unapproved Drug Unapproved Drug LIST 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 ANASEPT SPR ANASPAZ TAB 0.125MG ANECTINE INJ 20MG/ML ANHYDROUS CRE BASE ANHYDROUS OIN BASE ANIMI-3 CAP ANIMI-3 CAP ANIMI-3 CAP VIT D ANODYNERX PAD ANODYNZ MIS 0.0375-5 ANTICOAG CIT SOL DEX SOL ANTICOAG CPD SOL ANTIPY/BENZO SOL OTIC ANTIPY/BENZO SOL OTIC ANTIVENIN KIT LAT MACT ANTIVENIN MI INJ ANUCORT-HC SUP 25MG ANUSOL-HC SUP 25MG AP-ZEL TAB APLISOL INJ 5/0.1ML APOTHEDERM CRE APOTHESAR CRE TRANSDER APOTHESIL CRE APP SLIM RMS CAP APP-TRIM-D CAP APPBUTAMONE PAK APPTRIM CAP APPTRIM LIFE CAP BARIATRC APPTRIM LIFE CAP OBESITY APPTRIM-D CAP AQUASOL A INJ 50000/ML AQUORAL AER ARIDA GEL ARIDOL KIT ARIZONA INJ CYPRESS ARMOUR THYRO TAB 120MG ARMOUR THYRO TAB 15MG ARMOUR THYRO TAB 180MG ARMOUR THYRO TAB 240MG ARMOUR THYRO TAB 300MG ARMOUR THYRO TAB 30MG ARMOUR THYRO TAB 60MG ARMOUR THYRO TAB 90MG ARNICA TIN FLOWER ARTICADENT INJ DENTAL Reason Not properly listed with FDA Unapproved Drug LIST Not properly listed with FDA Not properly listed with FDA Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Unapproved Drug Unapproved Drug Unapproved Drug Blood Component Unapproved Drug Unapproved Drug LIST LIST DESI DESI Vitamin/Mineral Diagnostic Agent Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Anorexic, Anti-obestiy Agent Unapproved Drug Anorexic, Anti-obestiy Agent Anorexic, Anti-obestiy Agent Anorexic, Anti-obestiy Agent Anorexic, Anti-obestiy Agent Vitamin/Mineral Device Surgical Supply/Medical Diagnostic Agent Non-standardized allergenic Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug LIST 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 ARTICADENT INJ DENTAL ARZOL SILVER MIS NITR APP ASCLERA INJ 0.5% ASCLERA INJ 1% ASCORBIC ACD INJ 500MG/ML ASPERGILLUS INJ 1:500 ASPERGILLUS SOL 1:20 ASPERGILLUS SOL FUMIGATI ASTRINGYN SOL 259MG/GM ATABEX EC TAB ATENDIA PAD 4-3% ATOPICLAIR CRE ATORVA/COQ10 PAK 20-100MG ATRACURIUM INJ 10MG/ML ATRACURIUM INJ 10MG/ML ATRACURIUM INJ 50MG/5ML ATRAPRO GEL HYDROGEL ATRAPRO CP KIT ATRAPRO DERM SPR ATROPEN INJ 0.25MG ATROPEN INJ 0.5MG ATROPEN INJ 1MG ATROPEN INJ 2MG ATROPINE SUL OIN 1% OP AUREOBASIDIU INJ 1:10 AUREOBASIDIU SOL 1:20 AURODEX SOL OTIC AURSTAT KIT HYDROGEL AURSTAT ANTI GEL -ITCH AURUM LIQ 12X AUSTRALIAN SOL PINE EXT AUXIPRO CRE EMOLLIEN AUXIPRO CRE VANISHIN AV-PHOS 250 TAB NEUTRAL AV-VITE FB TAB 2.5-25-1 AV-VITE FB TAB 2.5-25-2 AVAGE CRE 0.1% AVAILNEX CHW 750MG AVALIN-RX PAD 4-1% AVAR AER 9.5-5% AVAR PAD 9.5-5% AVAR CLEANSE EMU 10-5% AVAR LS AER 10-2% AVAR LS LIQ 10-2% AVAR LS PAD 10-2% Reason LIST Unapproved Drug LIST LIST Vitamin/Mineral Diagnostic Agent Non-standardized allergenic Non-standardized allergenic Not properly listed with FDA Vitamin/Mineral Unapproved Drug Device Not properly listed with FDA LIST LIST LIST Device Not properly listed with FDA Not properly listed with FDA Device Device Device Device Unapproved Drug Non-standardized allergenic Non-standardized allergenic Unapproved Drug Device Device Unapproved Drug Non-standardized allergenic Not properly listed with FDA Not properly listed with FDA Dietary Supplement Vitamin/Mineral Vitamin/Mineral Cosmetic Not properly listed with FDA Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug 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 AVAR-E EMOLL CRE 10-5% AVAR-E GREEN CRE 10-5% AVAR-E LS CRE 10-2% AVENOVA SOL 0.01% AVENOVA SOL NEUTROX AVIDOXY DK KIT AVO CREAM EMU AXONA POW AZENASE PAK MIS 137-50 AZUPHEN MB CAP 120MG B-12 COMP KIT 1000MCG B-12 KIT 1000MCG B-COMPLEX INJ 100 B-DONNA TAB 16.2MG B-PLEX TAB B-PLEX PLUS TAB B-SERENE PAD B12 COMPLNCE KIT INJ KIT B12/LMTHF/B6 TAB B3/AZEL/TURM TAB FA/B6/ZN B6 FOLIC ACD CAP BACLOFEN CRE BACLOFEN CRE 1% BACLOFEN CRE 2% BACMIN TAB BACTER WATER INJ BENZ ALC BACTER WATER INJ PARABENS BAHIA SOL EXTRACT BAL SALT SOL OP BAL-CARE MIS DHA BALANCED SAL SOL OP BALD CYPRESS INJ 1:20 BARIUM POW SULFATE BASE CRE LIPOSOME BASE FOR CRE SCARS BASE W301 CRE BAYBERRY WAX SOL MYR EXTR BD POSIFLUSH INJ 0.9% BEAU RX GEL BEBULIN INJ 200-1200 BEE VENOM INJ 1300MCG BEE VENOM INJ 550MCG BELLA/OPIUM SUP 16.2-30 BELLA/OPIUM SUP 16.2-60 BELVIQ TAB 10MG Reason Unapproved Drug Unapproved Drug Unapproved Drug Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Surgical Supply/Medical Medical Food Not properly listed with FDA Unapproved Drug Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Unapproved Drug Vitamin/Mineral Vitamin/Mineral Dietary Supplement Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Not properly listed with FDA Bulk Ingredient Bulk Ingredient Vitamin/Mineral Unapproved Drug Unapproved Drug Non-standardized allergenic LIST Vitamin/Mineral LIST Non-standardized allergenic Diagnostic Agent Bulk Ingredient Not properly listed with FDA Not properly listed with FDA Non-standardized allergenic Not properly listed with FDA Not properly listed with FDA Blood Component Non-standardized allergenic Non-standardized allergenic Unapproved Drug Unapproved Drug Anorexic, Anti-obestiy Agent 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 BENEFIX INJ 1000UNIT BENEFIX INJ 2000UNIT BENEFIX INJ 250UNIT BENEFIX INJ 3000UNIT BENEFIX INJ 500UNIT BENSAL HP OIN BENZAC AC LIQ 5% WASH BENZAC W LIQ 5% WASH BENZALKONIUM SOL 50% BENZEFOAM AER 5.3% BENZEFOAM AER 9.8% BENZEPRO AER 5.3% BENZEPRO LIQ CREAMY BENZEPRO MIS 6% BENZEPRO SC AER 9.8% BENZIQ GEL 5.25% BENZIQ LS GEL 2.75% BENZIQ WASH LIQ 5.25% BENZODOX 30 MIS BENZODOX 60 MIS BENZOIN TIN NF BENZOIN CMPD TIN BENZONATATE CAP 100MG BENZONATATE CAP 150MG BENZONATATE CAP 200MG BENZOYL PER AER 5.3% BENZOYL PER AER 9.8% BENZOYL PERO AER 9.8% BENZPHETAMIN TAB 50MG BENZPHETMINE TAB 25MG BERMUDA SOL GRASS BETA 1 KIT KIT 30MG/5ML BETA INJECT KIT BETALIDO KIT BETTERMILK PAK GLYTACTI BETTERMILK15 POW GLYTACTN BHI URI- TAB CONTROL BIAFINE EMU BIEST/PROGES CRE BIO GLO TES 1MG OP BIO-STATIN POW BIOCEL TAB BIONECT AER 0.2% BIONECT CRE 0.2% BIONECT GEL 0.2% Reason Blood Component Blood Component Blood Component Blood Component Blood Component Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Cough/Cold Cough/Cold Cough/Cold Unapproved Drug Unapproved Drug Unapproved Drug Anorexic, Anti-obestiy Agent Anorexic, Anti-obestiy Agent Non-standardized allergenic LIST LIST LIST Not properly listed with FDA Not properly listed with FDA Unapproved Drug Surgical Supply/Medical Bulk Ingredient Diagnostic Agent Not properly listed with FDA Vitamin/Mineral Surgical Supply/Medical Surgical Supply/Medical Surgical Supply/Medical 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 BIONECT SPR 0.2% BIOPEPTIDE CRE BASE BIOPSY TRAY KIT MARROW BIOTUSS LIQ BIOTUSS LIQ PEDIATRC BL INJECTION KIT BLACK WALNUT SOL POLL EXT BLACK WILLOW INJ 1:20 BLANCHE CRE 4% BONE MARROW KIT BIOPSY BONTRIL PDM TAB 35MG BORIC ACID GRA BOTOX COSMET INJ 100UNIT BOTOX COSMET INJ 50UNIT BOTRYTIS EXT SOL 20000PNU BOX ELDER INJ EXT 1:20 BP 10-1 EMU BP CLEANSING EMU 10-4% BP FOAM AER 5.3% BP FOAM AER 9.8% BP FOAMING LIQ WASH 10% BP FOLINATAL TAB PLUS B BP MULTINATL CHW PLUS BP MULTINATL TAB PLUS BP VIT 3 CAP BP VIT 3 CAP PLUS BP WASH LIQ 2.5% BP WASH LIQ 7% BPM TAB 6MG BPM PSEUDO TAB 6-45MG BPO GEL 4% BPO GEL 8% BPO CLOTHS MIS 3% BPO CLOTHS MIS 6% BPO CLOTHS MIS 9% BRAVELLE INJ 75UNIT BREVITAL SOD INJ 2.5GM BREVITAL SOD INJ 200MG BREVITAL SOD INJ 500MG BROM/PSE/DM SYP BROMFED DM SYP BROMPHENIRAM CHW 12MG BSS SOL OP BSS PLUS SOL OP BT INJECTION KIT 40-0.5% Reason Surgical Supply/Medical Not properly listed with FDA Not properly listed with FDA Cough/Cold Cough/Cold Unapproved Drug Non-standardized allergenic Non-standardized allergenic Cosmetic Not properly listed with FDA Anorexic, Anti-obestiy Agent Bulk Ingredient Cosmetic Cosmetic Non-standardized allergenic Non-standardized allergenic Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Not properly listed with FDA Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Fertility Agent General Anesthetic General Anesthetic General Anesthetic Cough/Cold Cough/Cold Unapproved Drug LIST LIST Unapproved Drug 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 BUMINATE INJ 25% BUMINATE INJ 5% BUPIVACAINE INJ SPINAL BUPIVACAINE/ INJ EPI 0.25 BUPIVACAINE/ INJ EPI 0.25 BUPIVACAINE/ INJ EPI 0.5% BUPIVACAINE/ INJ EPI 0.5% BUPIVILOG KIT BXN MOUTHWSH SUS C-NATE DHA CAP 28-1-200 CA ALGINATE MIS 12" ROPE CA ALGINATE PAD 2"X2" CA ALGINATE PAD 4"X4" CA ALGINATE PAD 4"X8" CA-DTPA SOL 1000MG CAFFEINE/SOD INJ BENZOATE CALCIFOL WAF CALCIUM PNV CAP CALCIUM-FA WAF PLUS D CALI PEPPER INJ TREE CAMINO PRO LIQ 15PE CAMPHOMEX SPR CANDIDA ALBI INJ 1:20 CANDIDA INJ ALBICANS CANDIN INJ CANDIDA SOL ALBICANS CAPXIB KIT CAPECITABINE TAB 150MG CAPECITABINE TAB 500MG CAPHOSOL SOL CAPS LOCK #0 CAP CLR/WHT CAPS LOCK #1 CAP CLR/WHT CAPS LOCK #3 CAP CLR/WHT CAPSULE #0 CAP VEGGIE CAPSULE #1 CAP DRCAPS CAPSULE 0 CAP CLR DR CAPSULE CONI CAP -SN #000 CAPSULE CONI CAP -SNAP #0 CAPSULE CONI CAP -SNAP #0 CAPSULE CONI CAP -SNAP #1 CAPSULE CONI CAP -SNAP #1 CAPSULE CONI CAP -SNAP #2 CAPSULE CONI CAP -SNAP #3 CAPSULE CONI CAP -SNAP #3 CAPSULE CONI CAP -SNAP #4 Reason Blood Component Blood Component LIST LIST LIST LIST LIST LIST Unapproved Drug Vitamin/Mineral Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Not properly listed with FDA Unapproved Drug Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Non-standardized allergenic Not properly listed with FDA Unapproved Drug Non-standardized allergenic Diagnostic Agent Diagnostic Agent Non-standardized allergenic LIST Covered under Part B; oral drug only indicated for cancer Covered under Part B; oral drug only indicated for cancer Device Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug 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 CAPSULE CONI CAP -SNAP#00 CAPSULE LOCK CAP #0 CLEAR CAPSULE LOCK CAP #00 CLR CAPSULE LOCK CAP #1 CLEAR CAPSULE LOCK CAP #1 OPAQ CAPSULE LOCK CAP #3 CLEAR CAPTRACIN PAD .0375-5% CARB-O-PHILC CRE /40 CARB-O-PHILC GEL 40% CARBAPHEN 12 LIQ CARBAPHEN 12 SUS PED CARBOGEL GEL 940 CARBOHOL GEL 940 CARBOMER GEL AQUEOUS CARBOMER GEL HYDROALC CARDIOPLEGIC SOL CARDIOTEK-RX TAB CARDIOVID CAP PLUS CARRASYN GEL DRESSING CARTICEL IMP CASCARA EXT SAGRADA CAT HAIR INJ EXTRACT CAT HAIR SOL EXTRACT CATHFLO ACTI INJ VASE CATTLE EPITH SOL 1:20 CAVAN-EC SOD MIS DHA CAVAREST GEL 1.1% CAVERJECT INJ 20MCG CAVERJECT INJ 40MCG CAVERJECT KIT 10MCG CAVERJECT KIT 20MCG CAVIRINSE SOL 0.2% CAYA DPR CEFAZOLIN INJ 300GM CEFUROXIME INJ 225GM CEFUROXIME INJ 75GM CELA BASE CRE CELACYN GEL CELACYN KIT CEM-UREA SOL 45% CENFOL TAB CENOVIA CRE CENTANY AT KIT 2% CERACADE EMU CERAMAX CRE Reason Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Not properly listed with FDA Unapproved Drug Cough/Cold Cough/Cold Bulk Ingredient Bulk Ingredient Bulk Ingredient Bulk Ingredient LIST Vitamin/Mineral Vitamin/Mineral Not properly listed with FDA LIST Unapproved Drug Non-standardized allergenic Non-standardized allergenic LIST Non-standardized allergenic Vitamin/Mineral Unapproved Drug Erectile Dysfunction Erectile Dysfunction Erectile Dysfunction Erectile Dysfunction Unapproved Drug Not properly listed with FDA Bulk Ingredient Bulk Ingredient Bulk Ingredient Bulk Ingredient Not properly listed with FDA Not properly listed with FDA Unapproved Drug Vitamin/Mineral Cosmetic LIST Not properly listed with FDA Not properly listed with FDA 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 CEREFOLIN TAB CEREFOLIN TAB NAC CEREFOLIN TAB NAC CERETEC INJ CERISA WASH EMU 10-1% CEROVEL GEL 40% CEROVEL LOT 40% CETACAINE AER CETROTIDE KIT 0.25MG CHELIDONIUM LIQ COMPOUND CHERRY SYP CHIRHOSTIM SOL 16MCG CHLORD/CLIDI CAP 5-2.5MG CHLORHEX GLU SOL 20% CHLORTHALID TAB 100MG CHO MAG TRIS LIQ 500/5ML CHO MAG TRIS TAB 1000MG CHOLETEC INJ CHOLOGRAFIN INJ 52% CHROMIUM CL INJ 4MCG/ML CHRYSADERM CRE DAY CHRYSADERM CRE NIGHT CIALIS TAB 10MG CIALIS TAB 2.5MG* (Coverable for Benign Prostatic Hyperplasia (BPH) diagnosis only with quantity limit of 1 tablet daily.) CIALIS TAB 20MG CIALIS TAB 5MG* (Coverable for Benign Prostatic Hyperplasia (BPH) diagnosis only with quantity limit of 1 tablet daily.) CICLODAN CRE KIT 0.77% CICLOPIROX KIT 8% CIDALEAZE CRE 3% CIFEREX CAP CISATRACURIU INJ 10MG/ML CISATRACURIU INJ 2MG/ML CITRANATAL CAP HARMONY CITRANATAL CAP HARMONY CITRANATAL CAP HARMONY CITRANATAL MIS 90 DHA CITRANATAL MIS B-CALM CITRANATAL PAK ASSURE CITRANATAL PAK DHA CITRANATAL TAB RX CITRIC ACID/ SOL SOD CITR CITRUS POW BERGAMOT CLADOSPORIUM INJ CLADOSPO Reason Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Diagnostic Agent Unapproved Drug Unapproved Drug Unapproved Drug DESI Fertility Agent Unapproved Drug Bulk Ingredient Diagnostic Agent DESI Bulk Ingredient DESI Unapproved Drug Unapproved Drug Diagnostic Agent Diagnostic Agent Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Erectile Dysfunction Erectile Dysfunction [only coverable for diagnosis of Benign Prostatic Hyperplasia (BPH)] Erectile Dysfunction Erectile Dysfunction [only coverable for diagnosis of Benign Prostatic Hyperplasia (BPH)] LIST Unapproved Drug Not properly listed with FDA Unapproved Drug LIST Not properly listed with FDA Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Unapproved Drug Not properly listed with FDA Non-standardized allergenic 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 CLADOSPORIUM SOL 1:20 CLADOSPORIUM SOL 20000PNU CLARIFOAM EF AER 10-5% CLARIS WASH EMU 10-4% CLARYS CRE CLEARPLEX X GEL 10% CLIN SINGLE KIT USE CLIN-LIDO KIT CLINDAP-T CRE CLINOIN CRE CLINPRO 5000 PST 1.1% CLODAN KIT 0.05% CLOMIPHENE TAB 50MG CNL8 NAIL KIT CO-BALAMIN CAP CO-NATAL FA TAB 29-1MG CO-VERATROL CAP COAGADEX INJ 250UNIT COAGADEX INJ 500UNIT COAL TAR SOL 20% COCKLEBUR EX SOL 1:20 COD LIVER OIL CODAR AR LIQ 2-8/5ML COLLIGINIX MIS COLCIGEL GEL COLLODION LIQ FLEXIBLE COMFORT EZ PAD 2-4-1% COMFORT EZ PAD 20-4-1% COMPLETE NAT PAK DHA COMPLETENATE CHW CONCENTRATE CRE CONCEPT DHA CAP CONCEPT OB CAP CONRAY INJ 60% CONRAY 30 INJ 30% CONRAY 43 INJ 43% CONTRAVE TAB 8-90MG CONTROLRX CRE 1.1% CONVENIENCE PAK COPASIL GEL CORIFACT KIT CORTANE-B DRO AQ OTIC CORTANE-B DRO OTIC CORTANE-B LOT CORTIC-ND DRO Reason Non-standardized allergenic Non-standardized allergenic Unapproved Drug Unapproved Drug Cosmetic Unapproved Drug LIST LIST Unapproved Drug Not properly listed with FDA Unapproved Drug LIST Fertility Agent LIST Dietary Supplement Vitamin/Mineral Unapproved Drug Blood Component Blood Component Not properly listed with FDA Non-standardized allergenic Vitamin/Mineral OTC Product OTC Product Unapproved Drug Not properly listed with FDA Unapproved Drug Unapproved Drug Vitamin/Mineral Vitamin/Mineral Not properly listed with FDA Vitamin/Mineral Vitamin/Mineral Diagnostic Agent Diagnostic Agent Diagnostic Agent Anorexic, Anti-obestiy Agent Unapproved Drug Not properly listed with FDA Not properly listed with FDA Blood Component DESI DESI DESI DESI 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 CORTROSYN INJ 0.25MG CORVITA TAB CORVITE TAB CORVITE FREE TAB COSYNTROPIN INJ 0.25MG COSYNTROPIN INJ 0.25MG COVARYX TAB 1.25-2.5 COVARYX HS TAB CPB WC LIQ CREAM BASE CRE CRNATAL PAK CROFAB INJ CURITY AMD MIS 1"X3' CURITY AMD MIS 1/2"X3' CURITY AMD MIS 1/4"X3' CURITY HYPER MIS 1/2"X15' CURITY IODO MIS STRIP CURITY NACL PAD 6"X6-3/4 CURVULARIA INJ 20000PNU CUTIS PLUS CRE CYANOCOBALAM INJ 1000MCG CYCLOBENZAPR CRE 20MG/GM CYCLOBENZAPR CRE 5% KIT CYCLOBENZAPR PAK PAX CYOTIC DRO CYSTO-CONRAY INJ II 17.2% CYSTOGRAFIN INJ 30% CYSTOGRAFIN- INJ DILUTE CYSVIEW INJ 100MG CYTRA K GRA CRYSTALS CYTRA-2 SOL CYTRA-3 SYP CYTRA-K SOL D-XYLOSE POW DATSCAN SOL DEBACTEROL SOL 30-50% DECON-A ELX 2-5MG/5M DECON-G DRO 2-1-40MG DEFINITY SUS 1.1MG/ML DELFLEX-LC/ SOL 1.5% DEX DELFLEX-LC/ SOL 2.5% DEX DELFLEX-LC/ SOL 4.25 DEX DELFLEX-LM SOL 1.5% DEX DELFLEX-LM SOL 2.5% DEX DELFLEX-LM/ SOL 4.25 DEX Reason Diagnostic Agent Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Diagnostic Agent Diagnostic Agent Unapproved Drug DESI Cough/Cold Not properly listed with FDA Vitamin/Mineral Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Non-standardized allergenic Bulk Ingredient Vitamin/Mineral Bulk Ingredient Bulk Ingredient Unapproved Drug DESI Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Diagnostic Agent Diagnostic Agent Device Unapproved Drug DESI Diagnostic Agent Dialysis covered by ESRD bundled payment Dialysis covered by ESRD bundled payment Dialysis covered by ESRD bundled payment Dialysis covered by ESRD bundled payment Dialysis covered by ESRD bundled payment Dialysis covered by ESRD bundled payment 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 DELFLEX-SM/ SOL 1.5% DEX DELFLEX-SM/ SOL 2.5% DEX DELFLEX-SM/ SOL 4.25 DEX DELIVRA CRE SR DENTA 5000 CRE PLUS DENTA 5000 CRE PLUS 2PK DENTAGEL GEL 1.1% DEPLIN 15 CAP DEPLIN 7.5 CAP DEPRIZINE SUS 22.4/ML DERMA SERUM CRE FREEDOM DERMA SILKRX KIT SDS PAK DERMA SILKRX PAK ANODYNEX DERMA SILKRX PAK DICLOPAK DERMACINRX KIT ANALGESI DERMACINRX KIT COMBOPAK DERMACINRX KIT PHARMAPA DERMACINRX KIT PRIZOPAK DERMACINRX KIT SILAPAK DERMACINRX PAK DERMACINRX PAK DUOPATCH DERMACINRX PAK INFLAMMA DERMACINRX PAK LEXITRAL DERMACINRX PAK PHN DERMACINRX PAK ZRM DERMACINRX SOL BASE DERMANIC TAB DERMAPAK PAK PLUS DERMASORB AF KIT 3-0.5% DERMASORB HC KIT 2% DERMASORB TA KIT 0.1% DERMASORB XM KIT 39% DERMATODORON LIQ DERMAWERX KIT SURGICAL DERMAWERX PAK SDS DERMAZENE CRE 1% DERMAZONE MIS DEXFERRUM INJ 50MG/ML DEXLIDO KIT DEXLIDO-M KIT DIAB GEL DIAB F.D.G. GEL DIABETIC CAP VITAMIN DIAGNOSTIC KIT DIALYVITE TAB Reason Dialysis covered by ESRD bundled payment Dialysis covered by ESRD bundled payment Dialysis covered by ESRD bundled payment Not properly listed with FDA Unapproved Drug Unapproved Drug Unapproved Drug Medical Food Medical Food Unapproved Drug Not properly listed with FDA Unapproved Drug LIST LIST LIST LIST LIST LIST LIST Not properly listed with FDA Not properly listed with FDA LIST Not properly listed with FDA LIST LIST LIST Unapproved Drug Unapproved Drug DESI Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Unapproved Drug LIST LIST DESI LIST Vitamin/Mineral LIST LIST Not properly listed with FDA Not properly listed with FDA Unapproved Drug Diagnostic Agent Vitamin/Mineral 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 DIALYVITE TAB 3000 DIALYVITE TAB 5000 DIALYVITE TAB SUPREM D DIALYVITE/ TAB ZINC DIANEAL SOL LOW CALC DIANEAL SOL LOW CALC DIANEAL SOL LOW CALC DIANEAL PD-2 SOL 1.5% DEX DIANEAL PD-2 SOL 2.5% DEX DIANEAL PD-2 SOL 4.25%DEX DIATX ZN TAB DIAZEPAM INJ 10MG/2ML DICLOFEX DC MIS DICLOTRAL PAK DICOPANOL SUS 5MG/ML DIDREX TAB 50MG DIETHYLPROP TAB 25MG DIETHYLPROP TAB 75MG ER DIFIL-G FORT LIQ 100-100 DIGESTODORON LIQ DIPENTOCAINE CRE 5-5-2% DIPRIVAN INJ DIPRIVAN INJ 100MG/ML DIPRIVAN INJ 200/20ML DIPRIVAN INJ 500/50ML DIPYRIDAMOLE INJ 5MG/ML DISALCID TAB 500MG DISALCID TAB 750MG DISCUS LIQ COMPOSIT DIUSCREEN ME KIT COLLECTI DIVISTA CAP DM/CPM/PE DRO DMSA KIT DNA COLLECT KIT DNA COLLECT KIT MEDICATE DOG SOL EPITHELI DOG EPITHELI SOL 1:20 DOG FENNEL SOL 1:20 DONNATAL ELX DONNATAL ELX GRAPE DONNATAL ELX MINT DONNATAL TAB DONNATAL TAB 16.2MG DONNATAL TAB EXTENTAB DOTAREM INJ 10MMOL Reason Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Dialysis covered by ESRD bundled payment Dialysis covered by ESRD bundled payment Dialysis covered by ESRD bundled payment Dialysis covered by ESRD bundled payment Dialysis covered by ESRD bundled payment Dialysis covered by ESRD bundled payment Vitamin/Mineral Device Not properly listed with FDA LIST Unapproved Drug Anorexic, Anti-obestiy Agent Anorexic, Anti-obestiy Agent Anorexic, Anti-obestiy Agent Unapproved Drug Unapproved Drug Unapproved Drug General Anesthetic General Anesthetic General Anesthetic General Anesthetic Diagnostic Agent Unapproved Drug Unapproved Drug Unapproved Drug Diagnostic Agent Vitamin/Mineral Cough/Cold Diagnostic Agent Diagnostic Agent Diagnostic Agent Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic DESI Unapproved Drug Unapproved Drug DESI DESI DESI Diagnostic Agent 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 DOTAREM INJ 50MMOL DOTAREM INJ 5MMOL DOTAREM INJ 7.5MMOL DOTHELLE DHA CAP DOUBLEDEX KIT DPI CLASSIC CRE AEB DPI LS PLUS CRE DPI LS ULTRA CRE DPI NATURAL CRE BASE DPI NATURAL CRE LOTION DPI SUPREME CRE BASE DRAX IMAGE KIT DTPA DRCAPS CLEAR CAP SIZE 0 DRCAPS CLEAR CAP SIZE 00 DRCAPS CLEAR CAP SIZE 1 DRECHSLERA SOL 1:10 DRECHSLERA SOL 1:20 DRISDOL CAP 50000UNT DRITHO-CREME CRE HP 1% DRYSOL SOL 20% DS PREP PAK PAK 1%-0.13% DSG PAK PAK DUET DHA MIS BALANCED DUET DHA MIS BALANCED DUET DHA MIS BALANCED DUET DHA MIS BALANCED DUET DHA 400 MIS 25-1-400 DUET DHA 400 MIS 25-1-400 DUET DHA 430 MIS 25-1-430 DUET DHA 430 MIS 25-1-430 DUODOTE INJ DURACHOL CAP 1-3775IU DURAFIBER PAD 4X4-3/4" DURAFIBER AG PAD 2"X2" DURAFIBER AG PAD 3/4X18" DURAFIBER AG PAD 4"X4" DURAFIBER AG PAD 4X4-3/4" DURAFIBER AG PAD 6"X6" DURAFIBER AG PAD 8X11.75" DURAXIN CAP DYNAMIC KIT DYNAMIC PLUS KIT PAK DYSPORT INJ 300UNIT DYURAL-40 KIT DYURAL-80 KIT Reason Diagnostic Agent Diagnostic Agent Diagnostic Agent Vitamin/Mineral LIST Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Diagnostic Agent Unapproved Drug Unapproved Drug Unapproved Drug Non-standardized allergenic Non-standardized allergenic Vitamin/Mineral Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral LIST Unapproved Drug Surgical Supply/Medical Surgical Supply/Medical Surgical Supply/Medical Surgical Supply/Medical Surgical Supply/Medical Surgical Supply/Medical Surgical Supply/Medical Unapproved Drug Diagnostic Agent Diagnostic Agent Cosmetic LIST LIST 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 DYURAL-L KIT DYURAL-LM KIT E-Z-CAT DRY PAK E-Z-DISK TAB 700MG E-Z-DOSE ENE E-Z-HD SUS 98% E-Z-PAQUE SUS 60% E-Z-PAQUE SUS 96% E-Z-PASTE CRE 60% EASTERN SOL COTTONWO EASYGEL GEL 0.4% EASYGEL GEL 0.4%CHRY EASYGEL GEL 0.4%CITR EASYGEL GEL 0.4%MINT ECZEMOL TAB ED CYTE F TAB ED-FLEX CAP ED-SPAZ TAB 0.125MG EDEX KIT 10MCG EDEX KIT 20MCG EDEX KIT 40MCG EEMT TAB 1.25-2.5 EEMT HS TAB EFFER-K TAB 10MEQ EFFER-K TAB 20MEQ EFFER-K TAB 25MEQ EF ELEDERM-D CRE DPI ELEDERM-N CRE DPI ELENZAPATCH DIS 4-1% ELETONE CRE ELETONE CRE TWINPACK ELFOLATE TAB 15MG ELFOLATE TAB 7.5MG ELFOLATE TAB PLUS ELIGEN B12 TAB 1000-100 ELITE-OB TAB ELOCTATE INJ 1000UNIT ELOCTATE INJ 1500UNIT ELOCTATE INJ 2000UNIT ELOCTATE INJ 250UNIT ELOCTATE INJ 3000UNIT ELOCTATE INJ 500UNIT ELOCTATE INJ 750UNIT EMOLLIENT CRE EMPTY CAPSUL CAP SIZE 0 Reason LIST LIST Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent LIST Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Vitamin/Mineral Unapproved Drug Unapproved Drug Erectile Dysfunction Erectile Dysfunction Erectile Dysfunction DESI DESI Unapproved Drug Unapproved Drug Unapproved Drug Not properly listed with FDA Not properly listed with FDA Unapproved Drug Not properly listed with FDA Not properly listed with FDA Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Not properly listed with FDA Vitamin/Mineral Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Not properly listed with FDA Unapproved Drug 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 EMPTY CAPSUL CAP SIZE 00 EMPTY CAPSUL CAP SIZE 1 EMPTY CAPSUL CAP SIZE 1 EMPTY CAPSUL CAP SIZE 2 EMPTY CAPSUL CAP SIZE 3 EMPTY CAPSUL CAP SIZE 4 EMPTY CAPSUL CAP SIZE 5 EMPTY CAPSUL CAP SIZE 7 EMULSION SB EMU EMVOREN CRE ENBRACE HR CAP ENDOMETRIN SUP 100MG ENGLISH SOL PLANTAIN ENLYTE CAP ENTERAGAM POW 5GM ENTERO VU SUS 24% ENTTY EMU SPRAY EOVIST INJ EPHEDRINE SU INJ 50MG/ML EPICERAM EMU EPICOCCUM EX SOL 1:10 EPICOCCUM INJ 1:20 EPIFOAM AER 1% EPIQUIN MICR CRE 4% EPISNAP KIT ERECAID KIT CLASSIC ERECAID KIT ESTEEM ERGOCALCIFER CAP 50000UNT ERYSIDORON LIQ #1 ERYSIDORON TAB #2 ESCAVITE CHW ESCAVITE D CHW ESCAVITE LQ DRO 0.25-6MG ESPUMIL AER ESSENTRA MIS 9X9" EST ESTROGEN TAB MTEST EST ESTROGEN TAB MTEST HS ESTROG/MTEST TAB 1.25-2.5 ETHYL CHLOR AER FINE PIN ETHYL CHLOR AER FN STRM ETHYL CHLOR AER MED JET ETHYL CHLOR AER MED STRM ETHYL CHLOR AER MIST ETHYL CHLOR AER SPRAY ETOMIDATE INJ 20/10ML Reason Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Not properly listed with FDA Bulk Ingredient Vitamin/Mineral Fertility Agent Non-standardized allergenic Unapproved Drug Not properly listed with FDA Diagnostic Agent Not properly listed with FDA Diagnostic Agent Unapproved Drug LIST Non-standardized allergenic Non-standardized allergenic Unapproved Drug Cosmetic LIST Erectile Dysfunction Erectile Dysfunction Vitamin/Mineral Unapproved Drug Unapproved Drug Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Bulk Ingredient Not properly listed with FDA DESI DESI DESI Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA General Anesthetic 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 ETOMIDATE INJ 2MG/ML ETOMIDATE INJ 40/20ML ETOPOSIDE CAP 50MG EVICEL KIT 2ML EVICEL KIT 5ML EXACTUSS LIQ EXODERM LOT 25-1% EXOTIC-HC DRO OTIC EXTARDOL CRE EXTRA-VIRT CAP PLUS DHA EXTRANEAL SOL EXYDERM PAD EZ FLU SHOT INJ 2014-15 EZ FLU SHOT INJ 2015-16 EZ FLU SHOT INJ PF 13-14 EZ FLU SHOT INJ PF 14-15 EZ FLU SHOT KIT 2015-16 FA-B6-B12 TAB FABB TAB FAGRON LS CRE PLUS FAGRON LS CRE ULTRA FALESSA TAB 1MG FANATREX SUS 25MG/ML FBL KIT CRE 15-4-5% FEIBA INJ FEIBA NF INJ FEM PH GEL FEMCAP MIS 22MM FEMCAP MIS 26MM FEMCAP MIS 30MM FENTANYL CIT INJ 0.05MG/1 FENTANYL CIT INJ 1000MCG FENTANYL CIT INJ 100MCG FENTANYL CIT INJ 2500MCG FENTANYL CIT INJ 250MCG FENTANYL CIT INJ 500MCG FENTANYL INJ CITRATE FERAHEME INJ 510/17ML FEROCON CAP FEROTRINSIC CAP FERRIC GLUCO INJ 12.5/ML FERRIC GLUCO INJ 12.5MG/M FERRLECIT INJ 12.5MG/M FERRO-PLEX TAB FERROTRIN CAP Reason General Anesthetic General Anesthetic Oral drug for cancer; infusion available under Part B Not properly listed with FDA Not properly listed with FDA Cough/Cold Unapproved Drug DESI Bulk Ingredient Vitamin/Mineral Dialysis covered by ESRD bundled payment Not properly listed with FDA Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Vitamin/Mineral Vitamin/Mineral Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Unapproved Drug Bulk Ingredient Blood Component Blood Component Not properly listed with FDA Device Device Device General Anesthetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic LIST Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral 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 FIBERSOUR HN LIQ FINASTERIDE TAB 1MG FIRE ANT EXT INJ 1:20 FIRE ANT INJ 1:10 FIRST DUKES SUS MOUTHWSH FIRST-MARYS SUS MOUTHWSH FIRST-MOUTHW SUS BLM FIRST-OMEPRA SUS 2MG/ML FIRST-TESTOS CRE MC 2% FIRST-TESTOS OIN 2% FITALITE CRE BASE FLAVOR BLEND SUS FLAVOR PLUS LIQ FLAVOR SWEET LIQ S/F FLAVOR SWEET SYP FLEXBUMIN INJ 25% FLEXBUMIN INJ 5% FLEXEPAX MIS FLEXIN PAD .0375-5% FLEXIZOL PAK COMBIPAK FLORIVA CHW 0.25MG FLORIVA CHW 0.5MG FLORIVA CHW 1MG FLORIVA DRO 0.25MG FLORIVA DRO PLUS FLOWTUSS SOL 2.5-200 FLUARIX PF INJ 2013-14 FLUARIX PF INJ 2014-15 FLUARIX QUAD INJ 2013-14 FLUARIX QUAD INJ 2014-15 FLUARIX QUAD INJ 2015-16 FLUBLOK SOL 2013-14 FLUBLOK SOL 2014-15 FLUBLOK SOL 2015-16 FLUCAINE SOL 0.25-0.5 FLUCELVAX INJ 2014-15 FLUCELVAX INJ 2015-16 FLULAVAL INJ 2013-14 FLULAVAL INJ 2014-15 FLULAVAL QUA INJ 2013-14 FLULAVAL QUA INJ 2014-15 FLULAVAL QUA INJ 2014-15 FLULAVAL QUA INJ 2015-16 FLUMIST QUAD SUS 2014-15 FLUMIST QUAD SUS 2015-16 Reason Not properly listed with FDA Cosmetic Non-standardized allergenic Non-standardized allergenic Unapproved Drug Unapproved Drug Unapproved Drug Bulk Ingredient Unapproved Drug Unapproved Drug Not properly listed with FDA Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Blood Component Blood Component LIST OTC Product Not properly listed with FDA Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Unapproved Drug Vitamin/Mineral Cough/Cold Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Diagnostic Agent Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine 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 FLUOR-A-DAY CHW 0.25MG F FLUOR-A-DAY CHW 0.5MG F FLUOR-A-DAY CHW 1MG F FLUOR-A-DAY DRO 0.125MG FLUOR-I-STRI TES 1MG OP FLUORABON DRO FLUORAC CRE 5-1% FLUORACAINE SOL OP FLUORE-BENOX SOL 0.25-0.4 FLUORESCEIN/ SOL PROPARAC FLUORESCITE INJ 10% OP FLUORIDE CHW 0.25MG F FLUORIDE CHW 0.5MG F FLUORIDE CHW 1MG F FLUORIDEX GEL 1.1% FLUORIDEX GEL SENSITIV FLUORIDEX GEL WHITENIN FLUORIDEX DD PST SENSITIV FLUORITAB CHW 0.25MG F FLUORITAB CHW 0.5MG F FLUORITAB CHW 1MG F FLUORITAB CHW 2.2MG FLUORITAB DRO 0.125MG FLURA-DROPS DRO 0.125MG FLURA-DROPS DRO 0.25MG F FLURA-SAFE SOL FLUROX SOL OP FLUSH SYRING INJ 0.9% FLUVIRIN INJ 2014-15 FLUVIRIN INJ 2015-16 FLUVIRIN PF INJ 2014-15 FLUZONE INJ INTRADRM FLUZONE INJ PF 14-15 FLUZONE HD INJ PF 14-15 FLUZONE HD INJ PF 15-16 FLUZONE QUAD INJ 14-15 FLUZONE QUAD INJ 15-16 FLUZONE QUAD INJ 2015-16 FLUZONE SPLT INJ 2014-15 FLUZONE SPLT INJ 2015-16 FOCALGIN 90 MIS DHA FOCALGIN CA MIS FOCALGIN-B TAB FOLBEE TAB FOLBEE AR TAB Reason Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Diagnostic Agent Unapproved Drug Unapproved Drug Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Diagnostic Agent Diagnostic Agent Not properly listed with FDA Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Influenza Vaccine Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral 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 FOLBEE PLUS TAB FOLBEE PLUS TAB CZ FOLBIC TAB FOLBIC RF TAB FOLCAL DHA CAP FOLCAPS CAP OMEGA 3 FOLET DHA PAK FOLET ONE CAP 38-1-225 FOLGARD OS TAB FOLGARD RX TAB FOLIC ACID INJ 5MG/ML FOLIC ACID TAB 1MG FOLIC ACID TAB 1000MCG FOLIVANE-F CAP FOLIVANE-OB CAP FOLIVANE-PRX CAP DHA NF FOLIXAPURE TAB 1-5000 FOLLISTIM AQ INJ 150UNIT FOLLISTIM AQ INJ 300UNIT FOLLISTIM AQ INJ 600UNIT FOLLISTIM AQ INJ 75UNIT FOLLISTIM AQ INJ 900UNIT FOLPLEX 2.2 TAB FOLTANX TAB FOLTANX RF CAP FOLTRATE TAB FOLTRIN CAP FOLTX TAB FOLTX TAB FOOD COLOR LIQ BLUE FORANE SOL FORMA-RAY SOL 20% FORMADON SOL FORMALDEHYDE SOL 10% FORMALDEHYDE SOL 37% FORTAVIT CAP FOSTEUM CAP FOSTEUM PLUS CAP FOVEX CAP FP DERM CRE FP ENHANCING CRE FP NATURAL CRE FP PLUS CRE FP SUPREME CRE FP ULTRA CRE Reason Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Fertility Agent Fertility Agent Fertility Agent Fertility Agent Fertility Agent Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Not properly listed with FDA General Anesthetic Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Vitamin/Mineral Medical Food Medical Food Medical Food Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA 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 FREEDOM CRE DERMA-D FREEDOM CRE DERMA-N FREEDOM CRE ULTRAPEN FREEDOM GEL ALCOHOL FREEDOM HRT CRE ULTRA FRST-HYDRCRT GEL 10% FUL-GLO TES 0.6MG OP FUL-GLO TES 1MG OP FUSARIUM EXT SOL 1:20 FUSARIUM INJ 1:10 FUSION PAK SPRINKLE GABADONE CAP GABAVALE-5 PAK GABAZOLAMINE PAK GABAZOLAMINE PAK 0.5MG GABAZOLPIDEM PAK 5MG GABITIDINE PAK 150MG GABOXETINE PAK GADAVIST INJ 1MMOL/ML GALAXTRA POW GALZIN CAP 25MG GALZIN CAP 50MG GANIRELIX AC INJ GAPEAUM CRE BUDIBAC GASTRINEX NF CAP GASTROGRAFIN SOL 66-10% GEBAUERS SPR AER /STRETCH GEL-KAM CON 0.63% GELATIN EMPT CAP #0 GELATIN EMPT CAP LOCKING GELCLAIR GEL GELFILM MIS OP GENADUR KIT GENADUR LIQ GERMAN INJ COCKROAC GESTICARE PAK DHA GILPHEX TR TAB 10-388MG GILTUSS LIQ GILTUSS LIQ PED-C GILTUSS PED LIQ GILTUSS TR TAB GILTUSS TR TAB GLOFIL-125 INJ 0.1% GLONOIN DRO HOMACCOR GLUCAGEN INJ 1MG Reason Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Diagnostic Agent Diagnostic Agent Non-standardized allergenic Vitamin/Mineral Medical Food Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Diagnostic Agent Not properly listed with FDA Vitamin/Mineral Vitamin/Mineral Fertility Agent Bulk Ingredient Unapproved Drug Diagnostic Agent Not properly listed with FDA Unapproved Drug Unapproved Drug Unapproved Drug Device Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Non-standardized allergenic Vitamin/Mineral Unapproved Drug Cough/Cold Cough/Cold Cough/Cold Cough/Cold Cough/Cold Diagnostic Agent Unapproved Drug Diagnostic Agent 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 GLUCAGON INJ 1MG GLYCINE SOL 1.5% IRR GLYTACTIN LIQ RTD 10 GLYTACTIN LIQ RTD 15 GONAL-F INJ 1050UNIT GONAL-F INJ 450UNIT GONAL-F RFF INJ 300/0.5 GONAL-F RFF INJ 450/0.75 GONAL-F RFF INJ 75UNIT GONAL-F RFF INJ 900/1.5 GORDONS UREA OIN 40% GRAFCO SILVR MIS NIT APPL GRANULEX AER GREEN GLO MIS 1.5MG GRX HICORT SUP 25MG HACKBERRY EX SOL 1:20 HC AC/ALOE GEL 2% HC PRAMOXINE CRE 1-1% HC PRAMOXINE CRE 2.5-1% HC/LIDOCAINE KIT 2-2% HEALON INJ 10MG/ML HEALON GV INJ 14MG/ML HEALON5 INJ 23MG/ML HELIXATE FS INJ 1000UNIT HELIXATE FS INJ 2000UNIT HELIXATE FS INJ 250UNIT HELIXATE FS INJ 3000UNIT HELIXATE FS INJ 500UNIT HEMATINIC/FA TAB HEMATRON-AF TAB HEMENATAL OB MIS + DHA HEMENATAL OB TAB 28-6-1MG HEMMOREX-HC SUP 25MG HEMMOREX-HC SUP 30MG HEMOCYTE-F TAB HEMOFIL M INJ 1000UNIT HEMOFIL M INJ 1700UNIT HEMOFIL M INJ 220-400 HEMOFIL M INJ 250UNIT HEMOFIL M INJ 401-800 HEMOFIL M INJ 500UNIT HEMOFIL M SOL HEMOFIL M SOL 801-1500 HEPAGAM B INJ HEPARIN LOCK INJ 100/ML Reason Diagnostic Agent Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Fertility Agent Fertility Agent Fertility Agent Fertility Agent Fertility Agent Fertility Agent Unapproved Drug Unapproved Drug DESI Diagnostic Agent DESI Non-standardized allergenic Unapproved Drug Unapproved Drug DESI Not properly listed with FDA Device Device Device Blood Component Blood Component Blood Component Blood Component Blood Component Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Unapproved Drug Unapproved Drug Vitamin/Mineral Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Hepatitis B Vaccine Not properly listed with FDA 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 HEPARIN LOCK INJ 10UNT/ML HEPARIN LOCK INJ 1UNIT/ML HEPARIN LOCK INJ 2UNIT/ML HEPARIN LOCK KIT 100/ML HEPARIN LOCK KIT 10UNT/ML HEXABRIX INJ HISTATROL INJ 0.275/ML HISTATROL INJ 2.75/ML HOMACTIN AA LIQ PLUS HOMATROPAIRE SOL 5% OP HOMATROPINE SOL 5% OP HONEY BEE INJ 1000MCG HONEY BEE KIT 100MCG HORMEL ALLERGY ANTIGEN HORNET VENOM INJ 1300MCG HORNET VENOM INJ 550MCG HORSE EPITHE INJ 1:10 HORSE EPITHE INJ 1:20 HPR AER HPR PLUS AER HPR PLUS CRE HPR PLUS KIT HPR PLUS MB KIT HYDROGEL HSA DILUENT SOL STERILE HUMATE-P SOL 2400UNIT HUMATE-P SOL 250-600 HUMATE-P SOL 500-1200 HUMCO BASE CRE PAIN MGM HURRISEAL SOL HYALGAN INJ 20MG/2ML HYALUCIL-0.5 CRE HYALUCIL-4 CRE HYALURONATE GEL 0.2% HYCAMTIN CAP 0.25MG HYCAMTIN CAP 1MG HYCOFENIX SOL HYD POL/CPM SUS 10-8/5ML HYDR/CPM/PSE LIQ 5-4-60MG HYDRFRA BLUE PAD RDY 2.5" HYDRFRA BLUE PAD RDY 4X5" HYDRFRA BLUE PAD RDY 8X8" HYDRFRA MRF PAD 2"X2.75" HYDRO 35 AER HYDRO 40 AER FOAM HYDRO/CHLOR/ LIQ 5-4-60MG Reason Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Diagnostic Agent Diagnostic Agent Diagnostic Agent Not properly listed with FDA Unapproved Drug Unapproved Drug Non-standardized allergenic Non-standardized allergenic Not properly listed with FDA Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic LIST LIST LIST Device LIST Not properly listed with FDA Blood Component Blood Component Blood Component Unapproved Drug Not properly listed with FDA Surgical Supply/Medical Not properly listed with FDA Not properly listed with FDA Unapproved Drug Oral drug for cancer; infusion available under Part B Oral drug for cancer; infusion available under Part B Cough/Cold Cough/Cold Cough/Cold Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Unapproved Drug Unapproved Drug Cough/Cold 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 HYDROC/HOMAT TAB 5-1.5MG HYDROCOD/HOM SYP 5-1.5/5 HYDROCORT CRE IODOQUIN HYDROCORT AC SUP 25MG HYDROCORT AC SUP 30MG HYDROCORT/ CRE IODOQUIN HYDROCORT/ KIT PRAMOXIN HYDROFERA PAD 4"X4" HYDROFERA PAD BLUE 2X2 HYDROFERA PAD BLUE 4X4 HYDROFERA PAD BLUE 6X6 HYDROFERA PAD BLUE 9MM HYDROFERA PAD MRF 2.5" HYDROFERA PAD MRF4"X4" HYDROFRA MRF PAD 2-1/4X8" HYDROGEL GEL HYDROGEL DRE PAD 2"X3" HYDROGEL DRE PAD 4"X5" HYDROGEN PER SOL 30% HYDROMET SYP 5-1.5/5 HYDROMORPHON SUP 3MG HYDROQUINONE CRE 4% HYDROQUINONE CRE 4% TR HYDROXOCOBAL INJ 1000MCG HYGEL GEL 2.5% HYLATOPIC AER HYLATOPIC AER PLUS HYLATOPIC CRE PLUS HYLENEX INJ 150 UNIT HYLIRA GEL 0.2% HYLIRA LOT 0.1% HYOLEV MB TAB 81MG HYOMAX-SL SUB 0.125MG HYOPHEN TAB HYOSCYAMINE DRO 0.125/ML HYOSCYAMINE ELX 0.125/5 HYOSCYAMINE SUB 0.125MG HYOSCYAMINE TAB 0.125MG HYOSCYAMINE TAB 0.125MG HYOSCYAMINE TAB 0.375 ER HYOSCYAMINE TAB 0.375 SR HYOSYNE DRO 0.125/ML HYOSYNE ELX 0.125/5 HYPER-SAL NEB 7% HYPERCARE SOL 20% Reason Cough/Cold Cough/Cold DESI DESI DESI DESI DESI Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Surgical Supply/Medical Surgical Supply/Medical Not properly listed with FDA Cough/Cold Not properly listed with FDA Cosmetic Cosmetic Not properly listed with FDA Surgical Supply/Medical Device Device Device LIST Device Device Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Not properly listed with FDA Not properly listed with FDA 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 HYPERHEP B INJ S/D HYPERSAL NEB 3.5% HYPERSAL NEB 7% HYPERTENSA CAP HYSKON SOL IBU/MINREX PAK IBUPROFEN CRE 10% IC GREEN INJ 25MG IDELVION SOL 1000UNIT IDELVION SOL 2000UNIT IDELVION SOL 250UNIT IDELVION SOL 500UNIT IMPLANON IMP 68MG INATAL ADV TAB INATAL GT TAB INATAL ULTRA TAB INDICLOR INJ INDIGO CARMI INJ 8MG/ML INDIOMIN MB CAP 120MG INDIUM IN111 INJ DTPA INDIUM IN111 INJ OXYQUINO INDOCYANINE INJ 25MG INFANATE CAP BALANCE INFANATE CAP PLUS INFED INJ 50MG/ML INFLAMMA-K KIT INFLAMMACIN MIS 75-0.025 INFLAMMATION PAK REDUCTIO INFUVITE INJ INFUVITE INJ ADULT INFUVITE INJ PEDIATRI INJECTAFER INJ 750/15ML INNOPRAX-5 CRE INOVA KIT 4% INTEGRA F CAP INTERARTICUL KIT JOINT INULIN INJ 100MG/ML IODINE SOL STRONG IODINE TIN 2% IODOFLEX PAD PAD IODOPEN INJ 100MCG ISCAR MALI INJ 5MG/ML ISO CARBACHO SOL 1.5% OP ISO CARBACHO SOL 3% OP ISO HOMATROP SOL 2% OP Reason Hepatitis B Vaccine Not properly listed with FDA Not properly listed with FDA Medical Food Diagnostic Agent Not properly listed with FDA Bulk Ingredient Diagnostic Agent Blood Component Blood Component Blood Component Blood Component Not properly listed with FDA Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Diagnostic Agent Diagnostic Agent Unapproved Drug Diagnostic Agent Diagnostic Agent Diagnostic Agent Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Not properly listed with FDA LIST LIST Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Not properly listed with FDA Unapproved Drug Not properly listed with FDA Vitamin/Mineral LIST Diagnostic Agent Not properly listed with FDA Not properly listed with FDA Surgical Supply/Medical Unapproved Drug Not properly listed with FDA Unapproved Drug Unapproved Drug Unapproved Drug 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 ISO HOMATROP SOL 5% OP ISOFLURANE SOL ISOMETH/APAP CAP DICHLOR ISOMETH/CAFF TAB /APAP ISOMETH/CAFF TAB /APAP ISOP ALCOHOL SOL 70% ISOPROPANOL SOL 70% ISOSULFAN INJ BLUE 1% ISOVACTIN AA LIQ PLUS ISOVUE-200 INJ 41% ISOVUE-250 INJ 51% ISOVUE-250 INJ 51%MLTPK ISOVUE-300 INJ 61% ISOVUE-300 INJ 61%MLTPK ISOVUE-370 INJ 76% ISOVUE-370 INJ 76%MLTPK ISOVUE-M 200 INJ 41% ISOVUE-M 300 INJ 61% ISOXSUPRINE TAB 10MG ISOXSUPRINE TAB HCL 20MG IV INFUSION KIT CPI IXINITY INJ 1000UNIT IXINITY INJ 1500UNIT IXINITY INJ 500UNIT JNT/TUNNEL/ KIT TRIGGER JOHNSON SOL GRASS JTT PHYSICNS KIT JUNE GRASS SOL POLLEN K CITRATE SOL CITR ACD K-EFFERVESCE TAB 25MEQ EF K-PHOS TAB K-PHOS TAB NEUTRAL K-PHOS TAB NO 2 K-PRIME TAB 25MEQ EF K-VESCENT TAB 25MEQ EF K.B.G.L IN CRE TERODERM K/NA CITRATE SOL CITR ACD K10-LIDO KIT K2K PAIN REL PAD 4-4% K40-LIDO KIT KARIDIUM DRO 0.125MG KARIGEL GEL 0.5% KARIGEL-N GEL 1.1% KCENTRA KIT 1000UNIT KCENTRA KIT 500UNIT Reason Unapproved Drug General Anesthetic DESI DESI DESI Not properly listed with FDA LIST Diagnostic Agent Not properly listed with FDA Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent DESI DESI LIST Blood Component Blood Component Blood Component LIST Non-standardized allergenic LIST Non-standardized allergenic Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Bulk Ingredient Unapproved Drug LIST Unapproved Drug LIST Unapproved Drug Unapproved Drug Unapproved Drug Blood Component Blood Component 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 KEDBUMIN INJ 25% KERAFOAM AER 30% KERAFOAM 42 AER 42% KERALAC CRE 47% KERALYT GEL 6% KERALYT KIT SCALP 6% KERLIX AMD MIS BANDAGE KETALAR INJ 100MG/ML KETALAR INJ 10MG/ML KETALAR INJ 50MG/ML KETAMINE HCL SOL 10MG/ML KETAMINE HCL SOL 50MG/ML KETAMINE INJ 100MG/ML KETAMINE INJ 10MG/ML KETAMINE INJ 50MG/ML KETAMINE HCL INJ SOD CL KETAMINE SOL 10MG/ML KETODAN KIT 2% KETOROCAINE KIT -L KETOROCAINE KIT -LM KETOROLAC GEL 2% KETOVIE LIQ CHOCOLAT KETOVIE LIQ PEPTIDE KETOVIE LIQ VANILLA KINEVAC INJ 5MCG KLOR-CON-25 POW 25MEQ KLOR-CON/25 POW 25MEQ KLOR-CON/EF TAB 25MEQ EF KLOR-CON/EF TAB 25MEQ FR KOATE-DVI INJ 1000UNIT KOATE-DVI INJ 250UNIT KOATE-DVI INJ 500UNIT KOCHIA EXTRA INJ 1:20 KOGENATE FS INJ 1000/BS KOGENATE FS INJ 1000UNIT KOGENATE FS INJ 2000/BS KOGENATE FS INJ 2000UNIT KOGENATE FS INJ 250/BS KOGENATE FS INJ 250UNIT KOGENATE FS INJ 3000/BS KOGENATE FS INJ 3000UNIT KOGENATE FS INJ 500/BS KOGENATE FS INJ 500UNIT KOVALTRY INJ 1000UNIT KOVALTRY INJ 2000UNIT Reason Blood Component Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Not properly listed with FDA General Anesthetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic LIST LIST LIST Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Diagnostic Agent Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Blood Component Blood Component Blood Component Non-standardized allergenic Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component 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 KOVALTRY INJ 250UNIT KOVALTRY INJ 3000UNIT KOVALTRY INJ 500UNIT KRISGEL 100 GEL L-METHYL- TAB B6-B12 L-METHYL-MC TAB L-METHYL-MC TAB NAC L-METHYLFOLA CAP FORM 15 L-METHYLFOLA CAP FORM 7.5 L-METHYLFOLA CAP FORTE L-METHYLFOLA CAP FORTE 15 L-METHYLFOLA TAB 15MG L-METHYLFOLA TAB 7.5MG LACTIC ACID CRE /VIT E LACTIC ACID CRE E LACTIC ACID LOT 10% LAMBS SOL QUARTERS LANOLIN ANHY OIN LANSOPRAZOLE SUS 3MG/ML LATISSE SOL 0.03% LATRIX XM EMU 45% LAVARE WOUND GEL WASH LDO PLUS GEL 4% LECITHIN GEL LECITHIN GRA LENSCALE INJ 1:20 LETS KIT LEVBID TAB 0.375 ER LEVITRA TAB 10MG LEVITRA TAB 2.5MG LEVITRA TAB 20MG LEVITRA TAB 5MG LEVOMEFOLATE CAP /ALGAL LEVOMEFOLATE CAP /ALGAL LEVOMEFOLATE CAP DHA LEVOPHED INJ 1MG/ML LEVSIN INJ 0.5MG/ML LEVSIN TAB 0.125MG LEVSIN/SL SUB 0.125MG LEXISCAN INJ 0.4MG LEXUSS 210 LIQ 2-10/5ML LIBRAX CAP 5-2.5MG LIDAZONE CRE LIDENZA PAD 4-1% LIDO-HYDRO GEL 2.8-0.55 Reason Blood Component Blood Component Blood Component Not properly listed with FDA Vitamin/Mineral Vitamin/Mineral Unapproved Drug Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Medical Food Medical Food Unapproved Drug Unapproved Drug Unapproved Drug Non-standardized allergenic Not properly listed with FDA Bulk Ingredient Cosmetic Unapproved Drug Not properly listed with FDA LIST Not properly listed with FDA Not properly listed with FDA Non-standardized allergenic Unapproved Drug Unapproved Drug Erectile Dysfunction Erectile Dysfunction Erectile Dysfunction Erectile Dysfunction Unapproved Drug Unapproved Drug Vitamin/Mineral Not properly listed with FDA Unapproved Drug Unapproved Drug Unapproved Drug Diagnostic Agent Unapproved Drug LIST Unapproved Drug Unapproved Drug Unapproved Drug 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 LIDO-K LOT 3% LIDO-RX 4.1 CRE 4-0.1% LIDO/DEXTROS INJ 5-7.5% LIDO/EPI INJ 0.5% LIDO/EPI INJ 1.5% LIDO/EPI INJ 2% LIDO/EPI INJ 2% LIDO/EPI 1%- INJ 1:100000 LIDO/PRILOCN KIT 2.5-2.5% LIDOCAINE CRE 10% LIDOCAINE CRE 3% LIDOCAINE CRE 5% LIDOCAINE INJ 4% LIDOCAINE LOT 3% LIDOCAINE/HC CRE 3%-0.5% LIDOCAINE/HC KIT 2-2% LIDOCAINE/HC KIT 3%-0.5% LIDOCAINE/HC KIT 3%-1% LIDOCAINE/HC KIT 3-2.5% LIDOCIN GEL 3% LIDODEXTRAPI PAD 4-1% LIDOLOG KIT LIDOPIN CRE 3% LIDOPIN CRE 3.25% LIDOPROFEN CRE 5-5-2% LIDORX GEL 3% LIDOTHOL PAD 4.5-5% LIDOTRAL CRE 3.88% LIDOVEX CRE 3.75% LIDOVIN CRE 3.95% LIDOVIR OIN 4-4% LIDOXIB KIT LIDOZOL CRE 3.75% LIMBREL CAP 250MG LIMBREL CAP 500MG LIMBREL250 CAP 250-50MG LIMBREL500 CAP 500-50MG LIPICHOL 540 CAP LIPO CREAM CRE BASE LIPOBASE CRE HEAVY LIPOBASE CRE REGULAR LIPOFOAM RX AER LIPOPEN CRE LIPOPEN CRE ANHYDRO LIPOPEN CRE PLUS Reason Not properly listed with FDA Unapproved Drug Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Bulk Ingredient Unapproved Drug Bulk Ingredient LIST Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug LIST Unapproved Drug Unapproved Drug Bulk Ingredient Not properly listed with FDA Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Bulk Ingredient LIST Unapproved Drug Medical Food Medical Food Medical Food Medical Food Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA 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 LIPOPEN CRE ULTRA LIPOZYME CRE LISSAMINE GR TES 1.5MG LISTER-V CAP LIVIXIL PAK KIT 2.5-2.5% LMTHF/B6/B12 TAB LORENZA PAD 4-1% LORVATUS KIT PHARMAPA LOUTREX CRE LOZI-FLUR LOZ 1MG F LP LITE PAK KIT 2.5-2.5% LT INJECTION KIT LUDENT CHW 0.25MG F LUDENT CHW 0.5MG F LUDENT CHW 1MG F LUKAID GLA EMU 1GM/ML LUMASON INJ 60.7-25 LURIDE CHW 0.25MG F LURIDE CHW 0.5MG F LURIDE CHW 1MG F LURIDE DRO 0.5MG/ML LUSTRA CRE 4% LUSTRA-AF CRE 4% LUSTRA-ULTRA CRE 4% LUXAMEND CRE LYSIPLEX TAB PLUS LYTENSOPRIL MIS -90 KIT LYTENSOPRIL PAK KIT M-VIT TAB 27-1MG M.V.I PEDIAT INJ M.V.I-12 W/O INJ VIT K M.V.I. ADULT INJ MAC PATCH PAD .0375-5% MACNATAL CN CAP DHA MACUGEN INJ MACUTEK TAB MACUVEX CAP MACUZIN CAP MAGNEBIND TAB 400 MAGNEVIST INJ 46.9% MANGANESE SU INJ 0.1MG/ML MARBETA-25 KIT MARBETA-L KIT MARCAINE INJ SPINAL MARCAINE/EPI INJ 0.25% Reason Not properly listed with FDA Not properly listed with FDA Diagnostic Agent Not properly listed with FDA LIST Vitamin/Mineral Unapproved Drug LIST LIST Unapproved Drug Unapproved Drug LIST Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Diagnostic Agent Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Cosmetic Cosmetic Cosmetic Not properly listed with FDA Vitamin/Mineral Unapproved Drug Unapproved Drug Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Not properly listed with FDA Vitamin/Mineral LIST Not properly listed with FDA Unapproved Drug Unapproved Drug Vitamin/Mineral Diagnostic Agent Unapproved Drug LIST LIST Not properly listed with FDA LIST 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 MARCAINE/EPI INJ 0.25% MARCAINE/EPI INJ 0.5% MARCAINE/EPI INJ 0.5% MARDEX-25 KIT MARLIDO KIT MARLIDO-25 KIT MARNATAL-F CAP MARSH ELDER INJ 1:20 MB HYDROGEL KIT MD-76 R INJ MD-GASTROVIE SOL 66-10% ME/NAPHOS/MB TAB HYO 1 MEADOW FESCU INJ 100000BA MEDACTIV TAB MEDCATED DNA KIT COLLECT MEDI-10 CAP MEDI-DERM/L- CRE RX MEDI-PATCH PAD RX MEDIDERM CRE MEDIHOL BASE GEL MEDIHONEY PAD 2"X2" MEDIHONEY PAD 3/4"X12" MEDIHONEY PAD 4"X5" MEDROX-RX OIN MEGA-C/A PLU INJ 500MG/ML MEGRIX MIS MELALEUCA INJ 1:20 MELPAQUE HP CRE 4% MELQUIN 3 SOL 3% MELQUIN HP CRE 4% MENOPUR INJ 75UNIT MENTHOCIN PAD LIDOCAIN MENTHOLIX SPR 4-1% MEPER/PROMET CAP 50-25MG MEPHYTON TAB 5MG MESQUITE SOL EXTRACT METAFOLBIC TAB METAFOLBIC TAB PLUS METAFOLBIC TAB PLUS RF METANX CAP METHAVER CAP METHAZEL CAP METHENAM MAN TAB 1000MG METHENAM MAN TAB 1GM METHENAM MAN TAB 500MG Reason Not properly listed with FDA LIST Not properly listed with FDA LIST LIST LIST Vitamin/Mineral Non-standardized allergenic Unapproved Drug Diagnostic Agent Diagnostic Agent Unapproved Drug Non-standardized allergenic Anorexic, Anti-obesity Agent Diagnostic Agent Unapproved Drug Unapproved Drug Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA OTC Product Unapproved Drug Unapproved Drug Non-standardized allergenic Cosmetic Cosmetic Cosmetic Fertility Agent Unapproved Drug Unapproved Drug Unapproved Drug Vitamin/Mineral Non-standardized allergenic Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug 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 METHOHEXITAL INJ 100/10ML METHOHEXITAL SOL 10MG/ML METHYL SALIC LIQ METHYLFOL/CA TAB ME-CBL METHYLFOL/ME CAP CBL/P5P METOPIRONE CAP 250MG MG SO4/D5W INJ 20MG/ML MICROCYN GEL MICROCYN GEL SKIN/WOU MICROCYN LIQ MIDAZOLAM INJ 10/10ML MIDAZOLAM INJ 10MG/2ML MIDAZOLAM INJ 25MG/5ML MIDAZOLAM INJ 2MG/2ML MIDAZOLAM INJ 50MG/10 MIDAZOLAM INJ 5MG/5ML MIDAZOLAM INJ 5MG/ML MIDAZOLAM INJ 5MG/ML MIDAZOLAM INJ 5MG/ML MIDAZOLAM SOL HCL MIDAZOLAM SYP 2MG/ML MIFEPREX TAB 200MG MIGRAGESIC CAP IDA MIGRALAM CAP MIGRANOW PAK MIGRYL MIS 0.0375-5 MITE SOL EXTRACT MITE SOL EXTRACT MIXED ASPERG SOL 20000PNU MIXED SOL FEATHERS MIXED SOL RAGWEED MIXED VESPID INJ 1650MCG MIXED VESPID INJ 3900MCG MIXED VESPID KIT 3000MCG MIXED VESPID KIT 300MCG MLK F1 KIT MLK F2 KIT MLK F3 KIT MLK F4 KIT MLP A-1 KIT MONOCLATE-P INJ 1000UNIT MONOCLATE-P INJ 1500UNIT MONOCLATE-P INJ 250UNIT MONONINE INJ 1000UNIT MONONINE INJ 500UNIT Reason General Anesthetic General Anesthetic Not properly listed with FDA Vitamin/Mineral Vitamin/Mineral Diagnostic Agent Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA General Anesthetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic Not properly listed with FDA DESI DESI LIST Unapproved Drug Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic LIST LIST LIST LIST LIST Blood Component Blood Component Blood Component Blood Component Blood Component 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 MONSELS FERR SOL SUBSULF MORPHINE SUL SUP 10MG MORPHINE SUL SUP 20MG MORPHINE SUL SUP 30MG MORPHINE SUL SUP 5MG MOSQUITO INJ 1:100 MOUNTAIN SOL CEDAR MOUSE EPITHE INJ 1:20 MOUTH WASH LIQ GP MOUTHWASH LIQ AF MOUTHWASH LIQ OM MUCOR EXT INJ 1:10 MUCOR EXT INJ 1:20 MUGWORT SOL EXTRACT MULT-VIT/FL CHW 0.5MG MULTI-DRUG KIT DIUSCREE MULTIKIT SPECIALT MULTI-VIT/FE DRO /FL 0.25 MULTI-VIT/FL DRO /FE 0.25 MULTI-VIT/FL DRO 0.25MG MULTI-VIT/FL DRO 0.5MG/ML MULTIHANCE SOL MULTITRACE-4 INJ MULTITRACE-4 INJ CONC MULTITRACE-4 INJ NEONATAL MULTITRACE-4 INJ PED MULTIUSE CRE BASE MULTIVIT/FL CHW 0.25MG MULTIVIT/FL CHW 0.5MG MULTIVIT/FL CHW 1MG MUSE SUP 1000MCG MUSE SUP 125MCG MUSE SUP 250MCG MUSE SUP 500MCG MVC-FLUORIDE CHW 0.25MG MVC-FLUORIDE CHW 0.5MG MVC-FLUORIDE CHW 1MG MYDRAL SOL 0.5% OP MYDRAL SOL 1% OP MYDRIACYL SOL 1% OP MYKIDZ IRON SUS FL MYLERAN TAB 2MG MYNATAL CAP MYNATAL TAB MYNATAL TAB ADVANCE Reason Unapproved Drug Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Vitamin/Mineral Diagnostic Agent LIST Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Diagnostic Agent Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Not properly listed with FDA Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Erectile Dysfunction Erectile Dysfunction Erectile Dysfunction Erectile Dysfunction Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Diagnostic Agent Diagnostic Agent Diagnostic Agent Vitamin/Mineral LIST Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral 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 MYNATAL PLUS TAB MYNATAL-Z TAB MYNATE 90 TAB PLUS MYNEPHROCAPS CAP MYOVIEW KIT 30ML N-ACETYL-L- CAP CYSTEINE NA HYDROXIDE SOL 10% NABI-HB INJ NACL/BACT INJ 0.9%BENZ NAFRINSE CHW 1MG F NAFRINSE DRO 0.125MG NAFRINSE SOL DAILY NAFRINSE DLY SOL /NEUTRAL NAFRINSE WK SOL 0.2% NAPROPAK PAK NAPROPAK PAK COOL NAPROPAX MIS NAPROXEN CRE NAPROXEN CRE 10% NAPROXENPAX MIS NASCOBAL SPR 500MCG NATACHEW CHW NATACREAM CRE NATALVIRT MIS 90 DHA NATALVIRT CA PAK NATALVIT TAB 75-1MG NATELLE ONE CAP NATURAL CRE NATURE THROI TAB 162.5MG NATURE-THROI TAB 113.75MG NATURE-THROI TAB 130MG NATURE-THROI TAB 146.25MG NATURE-THROI TAB 16.25MG NATURE-THROI TAB 195MG NATURE-THROI TAB 260MG NATURE-THROI TAB 32.5MG NATURE-THROI TAB 325MG NATURE-THROI TAB 48.75MG NATURE-THROI TAB 65MG NATURE-THROI TAB 81.25MG NATURE-THROI TAB 97.5MG NAZIREX CRE NEBUSAL NEB 3% NEBUSAL NEB 6% NEEVO DHA CAP 27-1.13 Reason Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Diagnostic Agent Not properly listed with FDA Unapproved Drug Hepatitis B Vaccine LIST Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug LIST LIST LIST Bulk Ingredient Bulk Ingredient Unapproved Drug Vitamin/Mineral Vitamin/Mineral Not properly listed with FDA Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Not properly listed with FDA Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Device Device Vitamin/Mineral 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 NEO-SYNALAR KIT NEOSALUS AER NEOSALUS CRE NEOSALUS LOT NEOSALUS CP CRE NEOTUSS PLUS LIQ NEPHPLEX RX TAB NEPHRO-VITE TAB RX NEPHROCAPS CAP NEPHROCAPS TAB QT NEPHRONEX TAB 1MG NESTABS TAB NESTABS ABC MIS NESTABS DHA PAK NEUAC KIT 1.2-5% NEUREPA CAP NEURIN-SL SUB NEUTRAGARD GEL 1.1% NEUTRASAL POW NEUVAXIN PAD 0.0375-5 NEWGEN TAB 32-1MG NEXA PLUS CAP NEXAVIR INJ NEXPLANON IMP 68MG NIACIN POW USP/NF NICADAN TAB NICAZEL TAB NICAZEL TAB FORTE NICAZELDOXY KIT 30 NICAZELDOXY KIT 60 NICOMIDE TAB NICOMIDE TAB NIMBEX INJ 10MG/ML NIMBEX INJ 2MG/ML NIMBEX INJ 2MG/ML NITROPRESS INJ 25MG/ML NIVA-FOL TAB NIVA-PLUS TAB NIVATOPIC CRE PLUS NOCLOT-50 SOL ACD-A NODOLOR CAP NOREPINEPHR INJ 1MG/ML NORMAL SALIN INJ 0.9% NORML SALINE INJ FLUSH NORML SALINE INJ IV FLUSH Reason LIST Device Device Device Device Cough/Cold Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral LIST Not properly listed with FDA Vitamin/Mineral Unapproved Drug Not properly listed with FDA Unapproved Drug Vitamin/Mineral Vitamin/Mineral Unapproved Drug Not properly listed with FDA Not properly listed with FDA Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral LIST LIST LIST LIST Vitamin/Mineral Vitamin/Mineral LIST Not properly listed with FDA DESI Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA 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 NORTUSS-DE DRO NORTUSS-EX LIQ 200-20/5 NOURISH LIQ NOURIVAN CRE ANTIOX NOVACORT GEL NOVOCLAIR CRE NOVOEIGHT INJ 1000UNIT NOVOEIGHT INJ 1500UNIT NOVOEIGHT INJ 2000UNIT NOVOEIGHT INJ 250UNIT NOVOEIGHT INJ 3000UNIT NOVOEIGHT INJ 500UNIT NOVOSEVEN RT INJ 1MG NOVOSEVEN RT INJ 2MG NOVOSEVEN RT INJ 5MG NOVOSEVEN RT INJ 8MG NOXI-K CRE NOXIFINE EMU NOXIFOL-D TAB NOXIPAK PAK NP #2 DRUG CRE PREP KIT NP THYROID TAB 30MG NP THYROID TAB 60MG NP THYROID TAB 90MG NUFOL TAB NULEV TAB 0.125MG NUMOISYN LIQ NUMOISYN LOZ NUOX GEL 6-3% NUQUIN HP CRE 4% NUQUIN HP GEL 4% NUTRICAP TAB NUTRIFAC ZX TAB NUTRIVIT LIQ 800-15-1 NUVAIL SOL 16% NUVYA CRE NUWIQ INJ 1000UNIT NUWIQ INJ 2000UNIT NUWIQ INJ 250UNIT NUWIQ INJ 500UNIT NUWIQ KIT 1000UNIT NUWIQ KIT 2000UNIT NUWIQ KIT 250UNIT NUWIQ KIT 500UNIT NUZON GEL 2% Reason Cough/Cold Cough/Cold Not properly listed with FDA Not properly listed with FDA DESI Bulk Ingredient Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Not properly listed with FDA Surgical Supply/Medical Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Unapproved Drug Unapproved Drug Unapproved Drug Vitamin/Mineral Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Cosmetic Cosmetic Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Device Unapproved Drug Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Unapproved Drug 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 NYATA KIT NYSTATIN POW O-CAL TAB PRENATAL O-CAL FA TAB OB COMPLETE CAP 400 OB COMPLETE CAP ONE OB COMPLETE CAP GOLD OB COMPLETE CAP PETITE OB COMPLETE CHW OB COMPLETE TAB OB COMPLETE TAB PREMIER OB COMPLETE/ CAP DHA OBIZUR INJ 500 UNIT OBREDON SOL 2.5-200 OBSTETRIX PAK DHA OBSTETRIX EC TAB OCTAPLAS INJ GROUP A OCTAPLAS INJ GROUP AB OCTAPLAS INJ GROUP B OCTAPLAS INJ GROUP O OCTREOSCAN KIT OCUVEL CAP 0.5MG OLIVE TREE INJ 1:20 OLLIZAC POW OMEGA-3/D-3 KIT WELLNESS OMEPRAZOLE + SUS SYRSPEND OMNIFLEX DPR OMNIPAQUE INJ 140MG/ML OMNIPAQUE INJ 180MG/ML OMNIPAQUE INJ 240MG/ML OMNIPAQUE INJ 300MG/ML OMNIPAQUE INJ 350MG/ML OMNISCAN INJ /NACL OMNISCAN INJ 287MG/ML OMNISCAN INJ 287MG/ML OPIUM TIN 1% OPTASE GEL OPTIMARK INJ 330.9MG OPTIRAY 160 INJ 34% OPTIRAY 240 INJ 51% OPTIRAY 300 INJ 64% OPTIRAY 320 INJ 68% OPTIRAY 350 INJ 74% OPTISON INJ ORA-BLEND SUS Reason LIST Unapproved Drug Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Blood Component Cough/Cold Vitamin/Mineral Vitamin/Mineral Blood Component Blood Component Blood Component Blood Component Diagnostic Agent Vitamin/Mineral Non-standardized allergenic Medical Food LIST Not properly listed with FDA Device Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent Unapproved Drug DESI Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent Not properly listed with FDA 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 ORA-BLEND SF SUS ORA-PLUS LIQ ORA-SWEET SYP ORA-SWEET SF SYP ORACIT SOL ORAFATE PST 10% ORAL MIX LIQ SUSPENDI ORAL MIX SF LIQ ORAL SUSPEND LIQ ORAL SYRUP LIQ FLAVORED ORAL SYRUP LIQ SF ORCHARD GRAS INJ 100000BA ORTHO COIL DPR KIT 100 ORTHO COIL DPR KIT 105 ORTHO COIL DPR KIT 50 ORTHO D CAP 1-3775IU ORTHO FLAT DPR KIT 55 ORTHO FLAT DPR KIT 60 ORTHO FLAT DPR KIT 65 ORTHO FLAT DPR KIT 70 ORTHO FLAT DPR KIT 75 ORTHO FLAT DPR KIT 80 ORTHO FLAT DPR KIT 85 ORTHO FLAT DPR KIT 90 ORTHO FLAT DPR KIT 95 ORTHO-CS 250 INJ 250MG/ML OSCIMIN SUB 0.125MG OSCIMIN TAB 0.125MG OSCIMIN TAB 0.125MG OSCIMIN SR TAB 0.375MG OSCION CLNSR LOT 6% OSPHENA TAB 60MG OTIC CARE DRO OTICIN DRO 1-0.1% OTICIN HC DRO OTO-END 10 SOL OTOMAX-HC DRO OTOZIN DRO OVACE PLUS AER 9.8% OVACE PLUS CRE 10% OVACE PLUS GEL 10% WASH OVACE PLUS LIQ 10% WASH OVACE PLUS LOT 9.8% OVACE PLUS SHA 10% OVACE WASH LIQ 10% Reason Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Unapproved Drug Not properly listed with FDA Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Non-standardized allergenic Device Device Device Unapproved Drug Device Device Device Device Device Device Device Device Device Vitamin/Mineral Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Sexual Dysfunction Unapproved Drug Unapproved Drug DESI DESI DESI Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug 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 OVIDREL INJ OXYTOCIN INJ 10UNT/ML P-SILOXAN DS CRE PAIN EASE AER MD STRM PAIN EASE AER MIST PAIN RELIEF PAD PATCH PAIN RELIEF PAD PATCH PAIRE OB MIS PANATUSS DXP LIQ PANCURONIUM INJ 1MG/ML PANCURONIUM INJ 2MG/ML PANHEMATIN INJ 313MG PAPAVER-PHEN SOL ALPROSTI PAPAVER-PHEN SOL ALRPOS PAPAVERINE INJ 30MG/ML PAPAVERINE SOL 30MG/ML PAPAVERINE SOL ALPROSTA PAPAVERINE SOL PHENTOLA PAPAVERINE- SOL ALPROSTA PARACENTESIS KIT TRAY 8FR PAREGORIC TIN 2MG/5ML PAREMYD SOL 1-0.25% PCCA ALADERM CRE BASE PCCA COBASE OIN #1 PCCA COSMETI CRE HRT BASE PCCA CUSTOM CRE LIPO-MAX PCCA LIPODER CRE BASE PCCA LIPOSOM CRE DRY PCCA LIPOSOM CRE NORMAL PCCA LIPOSOM CRE OILY PCCA LIPOSOM CRE SENSITIV PCCA MVC CRE BASE PCCA SWEET SYP -SF PCCA SYRUP SYP VEHICLE PCCA VANISH CRE BASE PCCA VANISHI CRE LIGHT PCCA VANPEN CRE BASE PCCA-PLUS SUS PCP 100 KIT PE/GUAIFENES DRO 1.5-20MG PECAN POLLEN SOL EXTRACT PEDIADERM AF KIT COMPLETE PEDIADERM HC KIT PEDIADERM TA KIT PEDIPAK PAK Reason Fertility Agent LIST Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Unapproved Drug Unapproved Drug Vitamin/Mineral Cough/Cold Not properly listed with FDA Not properly listed with FDA Blood Component Erectile Dysfunction Erectile Dysfunction Unapproved Drug Unapproved Drug Erectile Dysfunction Erectile Dysfunction Erectile Dysfunction Not properly listed with FDA Unapproved Drug Diagnostic Agent Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA LIST Cough/Cold Non-standardized allergenic LIST LIST LIST Unapproved Drug 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 PEDIPIROX-4 KIT NAIL PENCREAM CRE PENDERM CRE PENICILLIUM INJ 1:20 PENICILLIUM INJ NOTATUM PENTAPHENE CRE PERCURA CAP PERENNIAL INJ RYE GRAS PERLANE INJ 20MG/ML PERLANE-L GEL 40MG/2ML PERLANE-L INJ 20MG/ML PERMAVAN PAD PETROLATUM OIN WHITE PH 12 STERIL SOL FLOLAN PHARM CH TSX PAD 2-4-1% PHARMABASE CRE COSMETIC PHARMABASE CRE HEAVY PHENACTIN AA LIQ PLUS PHENAZO TAB 200MG PHENAZOPYRID TAB 100MG PHENAZOPYRID TAB 200MG PHENDIMETRAZ CAP 105MG ER PHENDIMETRAZ TAB 35MG PHENOHYTRO TAB PHENTERMINE CAP 15MG PHENTERMINE CAP 30MG PHENTERMINE CAP 37.5MG PHENTERMINE TAB 37.5MG PHENTOLAMINE SOL ALPROSTA PHOMA EXTRAC INJ 20000PNU PHOS-FLUR GEL 1.1% PHOSPHA 250 TAB NEUTRAL PHOSPHASAL TAB PHYS EZ USE KIT M-PRED PHYTOBASE CRE PHYTONADIONE INJ 1MG/0.5 PICO WOUND KIT THER SYS PINNACAINE DRO 20% OTIC PITOCIN INJ 10UNT/ML PITRESSIN INJ 20UNT/ML PKU EASY TAB MICROTAB PLACEBO #00 CAP PLASBUMIN-25 INJ 25% PLASBUMIN-5 INJ 5% PLEGISOL SOL Reason Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Non-standardized allergenic Non-standardized allergenic Bulk Ingredient Not properly listed with FDA Non-standardized allergenic Cosmetic Cosmetic Cosmetic Unapproved Drug Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Unapproved Drug Unapproved Drug Unapproved Drug Anorexic, Anti-obesity Agent Anorexic, Anti-obesity Agent Unapproved Drug Anorexic, Anti-obesity Agent Anorexic, Anti-obesity Agent Anorexic, Anti-obesity Agent Anorexic, Anti-obesity Agent Erectile Dysfunction Non-standardized allergenic Unapproved Drug Unapproved Drug Unapproved Drug LIST Bulk Ingredient Vitamin/Mineral Not properly listed with FDA Unapproved Drug LIST Unapproved Drug Not properly listed with FDA Unapproved Drug Blood Component Blood Component Not properly listed with FDA 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 PLEXION CRE 9.8-4.8% PLEXION LIQ 9.8-4.8% PLEXION LOT 9.8-4.8% PLEXION CLTH PAD 9.8-4.8% PLO GEL MEDIFLO PLO MEDIFLO KIT KIT PLO TRANSDER CRE PLO20 BASE GEL PNEUMODORON LIQ PNEUMOVAX 23 INJ 25/0.5 PNV FE FUM TAB DOC/FA PNV FOLIC AC TAB + IRON PNV OB+DHA PAK PNV PRENATAL TAB PLUS PNV TABS TAB 29-1MG PNV-DHA CAP PNV-DHA CAP DOCUSATE PNV-OMEGA CAP PNV-SELECT TAB PNV-TOTAL CAP PNV-VP-U CAP 106.5-1 PODIAPN CAP PODOCON SOL 25% POLIBAR SUS 100% POLIBAR ACB KIT 96% POLIBAR PLUS SUS 105% POLY-VI-FLOR CHW 0.25MG POLY-VI-FLOR CHW 0.5MG POLY-VI-FLOR CHW 1MG POLY-VI-FLOR CHW W/IRON POLY-VI-FLOR MIS FS POLY-VI-FLOR MIS FS 0.25 POLY-VI-FLOR MIS FS 0.5MG POLY-VI-FLOR SUS /IRON POLY-VI-FLOR SUS 0.25/ML POLYPEG OIN BASE POT CHLORIDE TAB 25MEQ EF POT CITRATE- PAK CIT ACID POT HYDROXID SOL 5% POT/CHLORIDE TAB 25MEQ EF POTABA CAP 500MG POTASSIUM TAB 25MEQ EF PR BENZOYL LIQ 7% WASH PR CREAM KIT PR NATAL 400 PAK Reason Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Unapproved Drug Pneumococcal Vaccine Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Unapproved Drug Diagnostic Agent Diagnostic Agent Diagnostic Agent Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Not properly listed with FDA Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug DESI Unapproved Drug Unapproved Drug Unapproved Drug Vitamin/Mineral 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 PR NATAL 400 PAK EC PR NATAL 430 PAK PR NATAL 430 PAK EC PRACASIL TM- CRE PLUS PRALIDOXIME INJ 600/2ML PRAMCORT CRE 1-1% PRAMLYTE PAK PRAMOSONE CRE 1% PRAMOSONE CRE 1-1% PRAMOSONE CRE 1-2.5% PRAMOSONE OIN 1% PRAMOSONE OIN 2.5% PRAMOSONE E CRE 1-2.5% PRAMOTIC DRO 1-0.1% PRAMOX GEL 1% PRASCION EMU PRASCION FC PAD 10-5% PRASCION RA CRE 10-5% PRASTERA KIT PRAZOLAMINE PAK PRE-FOLIC TAB 1-100MG PRE-PEN INJ PREFERA OB MIS + DHA PREFERA OB TAB PREFERAOB CAP ONE PREFERAOB MIS +DHA PREFOL-DHA CAP PRENA1 CAP QUATREFO PRENA1 CHW PRENA1 PEARL CAP PRENA1 PLUS MIS QUATREFO PRENAISSANCE CAP PRENAISSANCE CAP BALANCE PRENAISSANCE CAP PLUS PRENAISSANCE MIS HARMONY PRENAISSANCE PAK 90 DHA PRENAISSANCE PAK DHA PRENAISSANCE PAK PROMISE PRENAISSANCE TAB NEXT PRENAISSANCE TAB NEXT-B PRENAPLUS TAB PRENAT PLUS TAB 27-1MG PRENATA CHW 29-1MG PRENATABS FA TAB PRENATABS RX TAB Reason Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Not properly listed with FDA Not properly listed with FDA Unapproved Drug Unapproved Drug Unapproved Drug LIST DESI DESI DESI DESI Unapproved Drug Not properly listed with FDA Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Vitamin/Mineral Diagnostic Agent Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral 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 PRENATAL MIS COMPLEAT PRENATAL TAB 27-1MG PRENATAL TAB PLUS PRENATAL 19 CHW 29-1MG PRENATAL 19 CHW TAB PRENATAL 19 TAB PRENATAL 19 TAB 29-1MG PRENATAL AD TAB PRENATAL VIT TAB LOW IRON PRENATAL+FE TAB 29-1MG PRENATAL-U CAP 106.5-1 PRENATE CAP ENHANCE PRENATE CAP ESSENT PRENATE CAP ESSENTIA PRENATE CAP PIXIE PRENATE CAP RESTORE PRENATE CHW 0.6-0.4 PRENATE TAB ELITE PRENATE TAB ELITE PRENATE AM TAB 1MG PRENATE DHA CAP PRENATE DHA CAP PRENATE MINI CAP PRENATE MINI CAP PRENATE STAR TAB 20-1MG PRENTIF MIS 22MM PRENTIF MIS 25MM PRENTIF MIS 28MM PRENTIF MIS 31MM PRENTIF MIS FITTING PREPLUS TAB 27-1MG PREQUE 10 TAB PRESERA AER PRETAB TAB 29-1MG PREVDNT 5000 PST 1.1% PREVIDENT CRE 5000 PLS PREVIDENT GEL 1.1% PREVIDENT GEL 1.1% BER PREVIDENT GEL 1.1% CHR PREVIDENT GEL 1.1% MIN PREVIDENT PST 5000 BST PREVIDENT PST 5000 SEN PREVIDENT SOL RINSE PREVIDOLRX PAK ANALGESI PREVNAR 13 INJ Reason Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Device Device Device Device Device Vitamin/Mineral Vitamin/Mineral Not properly listed with FDA Vitamin/Mineral Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug LIST Pneumococcal Vaccine 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 PRIVET EXT INJ 1:20 PRO DNA KIT KIT PRO-C-DURE 1 KIT PRO-C-DURE 2 KIT PRO-C-DURE 3 KIT PRO-C-DURE 4 KIT PRO-C-DURE 5 KIT 40MG/ML PRO-C-DURE 6 KIT 40MG/ML PROBARIMIN CHW QT PROCORT CRE PROCTOCORT SUP 30MG PROCTOFOAM AER HC 1% PRODRIN TAB PRODRIN TAB PROFERRIN- TAB FORTE PROFILNINE INJ 1000UNIT PROFILNINE INJ 1500UNIT PROFILNINE INJ 500UNIT PROGESTERONE CRE 10% KIT PROGESTERONE SUP VGS 100 PROGESTERONE SUP VGS 200 PROGESTERONE SUP VGS 25 PROGESTERONE SUP VGS 400 PROGESTERONE SUP VGS 50 PROHANCE INJ 279.3/ML PROMACTIN AA SUS PLUS PROMETH VC/ SYP CODEINE PROMETH/COD SYP 6.25-10 PROMETH/PE/ SYP CODEINE PROMETHAZINE SYP DM PROMISEB CRE PROMISEB KIT COMPLETE PROPECIA TAB 1MG PROPOFOL INJ PROPOFOL INJ 10MG/ML PROPOFOL INJ 200/20ML PROPOFOL INJ 500/50ML PROPOVEN INJ PROPOVEN INJ 200/20ML PROPOVEN INJ 500/50ML PROPYLENE GL SOL PROSTASCINT KIT PROSTIN VR INJ 500MCG PROTECT PLUS CAP PROTEOLIN TAB Reason Non-standardized allergenic Diagnostic Agent LIST LIST LIST LIST LIST LIST Anorexic, Anti-obesity Agent Unapproved Drug DESI Unapproved Drug DESI DESI Vitamin/Mineral Blood Component Blood Component Blood Component Bulk Ingredient Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Diagnostic Agent Not properly listed with FDA Cough/Cold Cough/Cold Cough/Cold Cough/Cold Unapproved Drug Unapproved Drug Cosmetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic Bulk Ingredient Diagnostic Agent Not properly listed with FDA Vitamin/Mineral Not properly listed with FDA 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 PROTHELIAL PST 10% PROVENGE INJ PROVENZA PAD 4-1% PROVIDA DHA CAP PROVIDA OB CAP PROVISC INJ 1% PROVOCHOLINE SOL 100MG PROZENA PAD 4% PRUCLAIR CRE PRUMYX CRE PRUTECT EMU PRVDNT 5000 PST ENAML PR PSORIZIDE TAB FORTE PSORIZIDE TAB ULTRA PUDEND/LOCAL KIT 1% LIDO PULMONA CAP PULMOPHYLLIN PAK PULMOSAL NEB 7% PURALOR CI TAB PUREFE OB CAP PLUS PUREFOLIX TAB 1-5000 PURIFIED LIQ WATER PYRIDIUM TAB 100MG PYRIDIUM TAB 200MG PYRIDOXINE INJ 100MG/ML QROXIN PAD QSYMIA CAP 11.25-69 QSYMIA CAP 15-92MG QSYMIA CAP 3.75-23 QSYMIA CAP 7.5-46MG QUEEN PALM SOL EXTRACT QUELICIN INJ -1000 QUELICIN INJ 20MG/ML QUFLORA PED CHW 0.25MG QUFLORA PED CHW 0.5MG QUFLORA PED CHW 1MG QUFLORA PED DRO 0.25MG QUFLORA PED DRO 0.5MG/ML R-GENE 10 INJ 10% R-NATAL OB CAP 20-1-320 RABBIT EPITH INJ 1:20 RABBIT INJ EPITHELI RADIAGEL GEL RADIAPLEXRX GEL RAPID GEL RX GEL Reason Not properly listed with FDA LIST Unapproved Drug Vitamin/Mineral Vitamin/Mineral Device Diagnostic Agent Not properly listed with FDA LIST LIST Surgical Supply/Medical Unapproved Drug Unapproved Drug Unapproved Drug Not properly listed with FDA Medical Food Unapproved Drug Device Unapproved Drug Vitamin/Mineral Unapproved Drug OTC Product Unapproved Drug Unapproved Drug Vitamin/Mineral Unapproved Drug Anorexic, Anti-obesity Agent Anorexic, Anti-obesity Agent Anorexic, Anti-obesity Agent Anorexic, Anti-obesity Agent Non-standardized allergenic LIST LIST Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Diagnostic Agent Vitamin/Mineral Non-standardized allergenic Non-standardized allergenic Not properly listed with FDA Not properly listed with FDA Unapproved Drug 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 RAPPORT RLS KIT RAPPORT VTD KIT RASPBERRY SYP REA LO 39 CRE 39% REA LO 40 CRE 40% REA LO 40 LOT 40% READI-CAT 2 SUS 2.1% READI-CAT 2 SUS BANANA READI-CAT 2 SUS BERRY READI-CAT 2 SUS MOCHACCI READYSHARP- KIT P40 READYSHARP- KIT P80 READYSHARP-A KIT 1%/0.5% READYSHARP-K KIT RECEDO GEL RECIPHEXAMIN DIS 4-1% RECOMBINATE INJ RECOMBINATE INJ RECOMBINATE INJ 220-400 RECOMBINATE INJ 401-800 RECOMBINATE INJ 801-1240 RECTACORT-HC SUP 25MG RED BIRCH SOL EXTRACT RED CEDAR SOL EXTRACT RED MAPLE INJ 1:20 RED MULBERRY INJ 1:20 RED TOP GRAS INJ 100000BA RED YEAST POW RICE REDICHEW RX CHW REFISSA CRE 0.05% REGIMEX TAB 25MG RELADOR PAK KIT 2.5-2.5% RELADOR PAK KIT PLUS RELAGARD GEL RELEEVIA PAD .0375-5% RELEEVIA MC PAD .0375-5% RELEEVIA ML PAD 4-1% RELNATE DHA CAP RELYYKS PAD RELYYT DIS 0.025-5% REMATEX CRE REMAXAZON PAD REMERGENT HQ CRE 4% REMEVEN CRE 50% RENA-VITE RX TAB Reason Erectile Dysfunction Erectile Dysfunction Bulk Ingredient Unapproved Drug Unapproved Drug Unapproved Drug Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent LIST LIST LIST LIST Not properly listed with FDA Unapproved Drug Blood Component Blood Component Blood Component Blood Component Blood Component DESI Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Not properly listed with FDA Vitamin/Mineral Cosmetic Anorexic, Anti-obesity Agent LIST LIST Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Vitamin/Mineral Unapproved Drug Not properly listed with FDA Unapproved Drug Unapproved Drug Cosmetic Unapproved Drug Vitamin/Mineral 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 RENAL CAP SOFTGEL RENATABS MIS IRON RENATABS TAB RENO CAP RENOVA CRE 0.02% RENOVA PUMP CRE 0.02% RENOVO PAD 0.0375-5 RENOVO LIDO5 CRE RENUU PAD 2-5-30% RENUU NL PAD 2-30% REQ 49+ TAB RESCON-JR TAB RESCON-MX TAB RESECTISOL SOL 5% RESPA-BR TAB 11MG RESTIZAN GEL RESTORA RX CAP 60-1.25 RESTORA SPRI PAK 15-0.25 RESTORE SILV PAD 2"X2" RESTORE SILV PAD 4"X4" RESTORE SILV PAD 4"X4.75" RESTORE SILV PAD 4"X5" RESTORE SILV PAD 6"X8" RESTYLANE INJ 20MG/ML RESTYLANE-L INJ 10/0.5ML RESTYLANE-L INJ 20MG/ML RESTYLANE-L INJ 40MG/2ML REVESTA CAP 1MG-5750 REZIRA SOL 60-5/5ML REZYST IM CHW REZYST SB CHW 250MG RGH PIGWEED SOL EXTRACT RHEUMADORON LIQ 102A RHEUMATE CAP RHIZOPUS INJ 1:10 RIASTAP SOL 1GM RIAX AER 5.5% RIAX AER 9.5% RIXUBIS INJ 1000UNIT RIXUBIS INJ 2000UNIT RIXUBIS INJ 250 UNIT RIXUBIS INJ 3000UNIT RIXUBIS INJ 500UNIT ROCURONIUM INJ 100MG/10 ROCURONIUM INJ 10MG/ML Reason Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Cosmetic Cosmetic Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Vitamin/Mineral Unapproved Drug Unapproved Drug Diagnostic Agent Unapproved Drug Not properly listed with FDA Not properly listed with FDA LIST Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Cosmetic Cosmetic Cosmetic Cosmetic Not properly listed with FDA Cough/Cold Not properly listed with FDA Not properly listed with FDA Non-standardized allergenic Unapproved Drug Medical Food Non-standardized allergenic Blood Component OTC Product OTC Product Blood Component Blood Component Blood Component Blood Component Blood Component LIST LIST 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 ROCURONIUM INJ 10MG/ML ROCURONIUM INJ 50MG/5ML ROSADAN KIT 0.75% ROSADAN KIT 0.75% ROSANIL EMU CLEANSER ROSANIL KIT ROSE GLO TES 1.5MG ROSULA LIQ 10-4.5% ROSULA PAD 10-5% RULAVITE DHA CAP RUSS THISTLE SOL EXTRACT RX-SPECIMEN KIT COLLECTI RYNODERM CRE 37.5% SACCHARIN POW SODIUM SACCHAROMYCE INJ CEREVISI SAGEBRUSH SOL EXTRACT SALACYN CRE 6% SALACYN LOT 6% SALEX SHA 6% SALEX CREAM KIT 6% SALEX LOTION KIT 6% SALICYLIC AER 6% SALICYLIC AC CRE 6% SALICYLIC AC GEL 6% SALICYLIC AC KIT 6% SALICYLIC AC KIT 6% CREAM SALICYLIC AC KIT 6% LOTN SALICYLIC AC LIQ 26% SALICYLIC AC LIQ 27.5% SALICYLIC AC LOT 6% SALICYLIC AC SHA 6% SALICYLIC AC SOL 28.5% SALINE FLUSH INJ 0.9% SALINE FLUSH INJ ZR 0.9% SALINE/PHENO SOL SALIVAMAX POW SALIVATE RX POW SALSALATE TAB 500MG SALSALATE TAB 750MG SALT DURABLE CRE SALT STABLE CRE SALT STABLE CRE LS ADV SALVAX AER 6% SALVAX DUO KIT PLUS SANADERMRX KIT SKIN REP Reason LIST LIST LIST LIST Unapproved Drug Unapproved Drug Diagnostic Agent Unapproved Drug Unapproved Drug Vitamin/Mineral Non-standardized allergenic Diagnostic Agent Not properly listed with FDA Bulk Ingredient Non-standardized allergenic Non-standardized allergenic Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Not properly listed with FDA Not properly listed with FDA LIST LIST Not properly listed with FDA Unapproved Drug Unapproved Drug Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Unapproved Drug Unapproved Drug LIST 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 SANARE CRE ADVANCED SANARE SCAR CRE THERAPY SARAPIN INJ SASH KIT 100/ML SASH KIT 10UNT/ML SAXENDA INJ 6MG/ML SCAR PATCH PAD SCAR PATCH PAD SCAR PATCH PAD PREMIUM SCLEROSOL AER INTRAPLE SE 10-5 SS CRE 10-5% SE BPO WASH LIQ 7% SE-NATAL 19 CHW SE-NATAL 19 TAB SE-TAN DHA CAP SEB-PREV LIQ WASH SECREFLO INJ 16MCG SEDANARE CRE SELECT-OB CHW SELECT-OB CHW SELECT-OB+ PAK DHA SELENIUM SUL SHA 2.25% SELRX SHA 2.3% SENSORCAINE INJ -MPF/EPI SENSORCAINE INJ -MPF/EPI SENSORCAINE INJ -MPF/EPI SENSORCAINE INJ MPF SPIN SENSORCAINE/ INJ EPI 0.25 SENSORCAINE/ INJ EPI 0.5% SENTRA AM CAP SENTRA PM CAP SENTRADINE PAK SENTRAFLOX PAK AM-10 SENTRALOPRAM PAK AM-10 SENTRAMODAFI PAK AM-100 SENTRAVIL PM PAK -25 SENTRAZOLAM PAK AM 0.25 SENTRAZOLPID PAK PM-5 SENTROXATINE PAK SEROPHENE TAB 50MG SEVOFLURANE SOL SF GEL 1.1% SF 5000 PLUS CRE 1.1% SHAGBARK HCK SOL EXTRACT SHEEP SORREL INJ 1:20 Reason Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Anorexic, Anti-obesity Agent Unapproved Drug Unapproved Drug Unapproved Drug LIST Unapproved Drug Unapproved Drug Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Unapproved Drug Diagnostic Agent Not properly listed with FDA Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Unapproved Drug Unapproved Drug LIST LIST LIST LIST LIST LIST Medical Food Medical Food Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Fertility Agent General Anesthetic Unapproved Drug Unapproved Drug Non-standardized allergenic Non-standardized allergenic 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 SHELLGEL SOL SHOHLS SOL MODIFIED SHORT RAGWEE INJ 1:20 SIDEROL TAB SILAZONE PAK PHARMAPA SILAZONE-II PAK SILMANIX CRE SILOSOME CRE TRANSDER SILPROTEX CRE PLUS SILVASORB GEL SILVERA PAIN PAD RELIEF SILVRSTAT GEL DRESSING SIMPLE SYP SINELEE PAD 0.0375-5 SINELEE PAD 0.05-5% SINOGRAFIN INJ SKIN BLEACH CRE 4% SKIN BLEACH CRE SUNSCREE SKYY DERM CRE SMARTRX PAK GABA SMARTRX PAK GABA-V SOD CHLORIDE INJ 0.9% SOD CHLORIDE INJ 0.9% SOD CHLORIDE INJ 0.9%BACT SOD CHLORIDE INJ 23.4% SOD CHLORIDE INJ 4MEQ/ML SOD CITRATE SOL CITR ACD SOD FLUORIDE CHW 0.25MG F SOD FLUORIDE CHW 0.5MG F SOD FLUORIDE CHW 1.1MG SOD FLUORIDE CHW 1MG F SOD FLUORIDE CHW 2.2MG SOD FLUORIDE DRO 0.5MG/ML SOD FLUORIDE SOL 0.2% SOD FLUORIDE SOL 0.2%MINT SOD FLUORIDE TAB 0.5MG F SOD FLUORIDE TAB 1MG F SOD NITRITE INJ 30MG/ML SOD SACCHARI GRA SOD SUL/SULF AER 10-5% SOD SUL/SULF CRE 10-2% SOD SUL/SULF CRE 10-5% SOD SUL/SULF CRE 9.8-4.8% SOD SUL/SULF EMU 10-5% SOD SUL/SULF EMU 10-5% Reason Device Unapproved Drug Non-standardized allergenic Vitamin/Mineral LIST LIST Unapproved Drug Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Unapproved Drug Surgical Supply/Medical Bulk Ingredient Unapproved Drug Unapproved Drug Diagnostic Agent Cosmetic Cosmetic Not properly listed with FDA LIST LIST LIST LIST LIST LIST LIST Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug LIST Not properly listed with FDA Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug 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 SOD SUL/SULF GEL 10-5% SOD SUL/SULF KIT SOD SUL/SULF LIQ 10-2% SOD SUL/SULF LIQ 9-4.5% SOD SUL/SULF LIQ 9.8-4.8% SOD SUL/SULF LIQ WASH SOD SUL/SULF LOT 10-5% SOD SUL/SULF LOT 9.8-4.8% SOD SUL/SULF PAD 10-4% SOD SUL/SULF PAD 10-5% SOD SUL/SULF SUS 10-5% SOD SUL/SULF SUS 8-4% SOD SULFACET GEL 10% SOD SULFACET SHA 10% SOD THIOSULF INJ 10% SOD THIOSULF INJ 25% SODIUM POW BICARBON SODIUM CHLOR NEB 10% SODIUM CHLOR NEB 3% SODIUM CHLOR NEB 7% SODIUM SULFA LIQ 10% WASH SOJOURN SOL SOLAICE PAD SOLMARA PAD 4-5% SOLUPAK PAK SONAFINE EMU SOOTHEE PAD SORBITOL SOL 3% IRR SORBITOL SOL 3.3% IRR SORBITOL-MAN SOL SORREL/DOCK INJ EXTRACT SPECIMEN KIT COLLECTI SPECTRAGEL GEL SPEEDGEL RX GEL SPHERUSOL INJ SPINAL/EPIDU KIT CL CATH SPINAL/EPIDU KIT OPN CATH SS 10-2 SOL 10-2% SSKI SOL 1GM/ML SSS CRE 10%-5% SSS 10-5 AER 10-5% STAN FLUORID CON 0.63% STAXYN TAB 10MG STEMPHYLIUM SOL 20000PNU STENDRA TAB 100MG Reason Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Bulk Ingredient Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug General Anesthetic Unapproved Drug Unapproved Drug Not properly listed with FDA Surgical Supply/Medical Unapproved Drug LIST LIST LIST Non-standardized allergenic Diagnostic Agent Not properly listed with FDA Unapproved Drug Diagnostic Agent Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Vitamin/Mineral Unapproved Drug Unapproved Drug Unapproved Drug Erectile Dysfunction Non-standardized allergenic Erectile Dysfunction 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 STENDRA TAB 200MG STENDRA TAB 50MG STERA BASE CRE STERIL TALC SUS 5GM STERIL WATER INJ STERIL WATER INJ STERILE DILU SOL EPOPROS STERILE DILU SOL FLOLAN STERYMINE GEL STRAZEPAM PAK STROVITE FOR SYP STROVITE FOR TAB STROVITE ONE TAB SUBLIMAZE INJ 1000MCG SUBLIMAZE INJ 100MCG SUBLIMAZE INJ 250MCG SUCCINYLCHOL SOL 20MG/ML SUFENTA INJ 50MCG/ML SUFENTA INJ 50MCG/ML SUFENTA INJ 50MCG/ML SUFENTANIL INJ 100/2ML SUFENTANIL INJ 250/5ML SUFENTANIL INJ 50MCG/ML SUL SOD/SULF LIQ 10-2% SUL SOD/SULF PAD 10-4% SULF/SUNSCRN KIT 9-4.5% SULFACLEANSE SUS 8-4% SULFOAM SHA 2% SULFZIX CAP SULFZIX POW SUMACHIP PAK SUMADAN KIT SUMADAN WASH LIQ 9-4.5% SUMADAN XLT KIT 9-4.5% SUMAXIN PAD 10-4% SUMAXIN CP KIT SUMAXIN TS SUS 8-4% SUMAXIN WASH LIQ 9-4% SUPERVITE LIQ SUPERVITE EC TAB SUPPORT LIQ SUPPORT-500 CAP SUPRACIL CRE SUPRANE INH SUPRANE SOL Reason Erectile Dysfunction Erectile Dysfunction Not properly listed with FDA LIST LIST LIST LIST LIST Unapproved Drug Unapproved Drug Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral General Anesthetic General Anesthetic General Anesthetic Not properly listed with FDA General Anesthetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic General Anesthetic Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Medical Food Medical Food Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Bulk Ingredient General Anesthetic General Anesthetic 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 SUPREME CRE SUPRENZA TAB 15MG SUPRENZA TAB 30MG SUPRENZA TAB 37.5MG SURE RESULT KIT O3D3 SYS SURE RESULT KIT TAC PAK SURE RESULT MIS DSS PACK SUSPENSION SUS VEHICLE SUTTAR-2 SYP SUTTAR-SF SYP SWABFLUSH INJ 0.9% SWEET GUM INJ 1:20 SWEET VERNAL INJ GRASS PO SYMAX DUOTAB TAB SYMAX FASTAB TAB 0.125MG SYMAX-SL SUB 0.125MG SYMAX-SR TAB 0.375MG SYNAGEX CAP 1.25MG SYNALAR KIT 0.025% SYNALAR KIT 0.025% SYNAPRYN SUS 10MG/ML SYNATEK CAP SYNVEXIA PAD 4-1% SYNVEXIA TC CRE 4-1% SYNVISC INJ 8MG/ML SYNVISC ONE INJ 8MG/ML SYRPALTA SYP SYRPALTA SYP CLEAR SYRSPEND SF LIQ SYRUP SYP VEHICLE SYRUP SF SYP VEHICLE T.R.U.E. TES TABRADOL SUS 1MG/ML TAGITOL V SUS 40% TANDEM F CAP TARON GRA CRYSTALS TARON-BC MIS TARON-C DHA CAP TARON-PREX CAP TBC AER TDC MAX CRE TDM SOLUTION SOL TEGADERM AG PAD 2"X2" TEGADERM AG PAD 4"X5" TEGADERM AG PAD 4"X8" Reason Not properly listed with FDA Anorexic, Anti-obesity Agent Anorexic, Anti-obesity Agent Anorexic, Anti-obesity Agent LIST LIST LIST Not properly listed with FDA Cough/Cold Cough/Cold Not properly listed with FDA Non-standardized allergenic Non-standardized allergenic Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Vitamin/Mineral LIST LIST Unapproved Drug Vitamin/Mineral Unapproved Drug Unapproved Drug Surgical Supply/Medical Surgical Supply/Medical Not properly listed with FDA Not properly listed with FDA Bulk Ingredient Not properly listed with FDA Not properly listed with FDA Diagnostic Agent Unapproved Drug Diagnostic Agent Vitamin/Mineral Unapproved Drug Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral DESI Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA 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 TEGADERM AG PAD 8"X8" TEMODAR CAP 100MG TEMODAR CAP 140MG TEMODAR CAP 180MG TEMODAR CAP 20MG TEMODAR CAP 250MG TEMODAR CAP 5MG TEMOZOLOMIDE CAP 100MG TEMOZOLOMIDE CAP 140MG TEMOZOLOMIDE CAP 180MG TEMOZOLOMIDE CAP 20MG TEMOZOLOMIDE CAP 250MG TEMOZOLOMIDE CAP 5MG TERODERM CRE TERRELL SOL TERSI FOAM AER 2.25% TESSALON PER CAP 100MG TESTONE CIK KIT 200MG/ML TETCAINE SOL 0.5% OP TETRACAINE INJ 1% TETRACAINE SOL 0.5% OP TETRAMEX SPR 2-1-3% TETRAVISC SOL 0.5% OP TETRAVISC SOL FORTE TETRIX CRE TETRIX KIT TEXAVITE LQ LIQ TGQ 15DM/5PE SYP H/2CPM TGQ 30/ SYP 150/15 TGQ 30/PSE/3 SYP BRM/15DM TGQ 50PSE/3 SYP BRM/30DM THALAMUS SUB COMPOSIT THALLOUS INJ TL 201 THALLOUS CL INJ TL 201 THERA-FLUR-N DRO 1.1% THERABENZAPR PAK -60 THERABENZAPR PAK -90 THERABENZAPR PAK -90-5 THERACODEINE PAK -300 THERACODOPHN PAK -325 THERAFELDAMI PAK THERAHONEY GEL THERAMINE CAP THERAMINE POW PLUS THERAPENTIN PAK -60 Reason Not properly listed with FDA Oral drug for cancer; infusion available under Part B Oral drug for cancer; infusion available under Part B Oral drug for cancer; infusion available under Part B Oral drug for cancer; infusion available under Part B Oral drug for cancer; infusion available under Part B Oral drug for cancer; infusion available under Part B Oral drug for cancer; infusion available under Part B Oral drug for cancer; infusion available under Part B Oral drug for cancer; infusion available under Part B Oral drug for cancer; infusion available under Part B Oral drug for cancer; infusion available under Part B Oral drug for cancer; infusion available under Part B Not properly listed with FDA General Anesthetic LIST Cough/Cold LIST Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Not properly listed with FDA Unapproved Drug Vitamin/Mineral Cough/Cold Cough/Cold Cough/Cold Cough/Cold Unapproved Drug Diagnostic Agent Diagnostic Agent Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Not properly listed with FDA Medical Food Medical Food Unapproved Drug 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 THERAPENTIN PAK -90 THERAPROFEN PAK -60 THERAPROFEN PAK -90 THERAPROFEN PAK 800MG THERAPROXEN PAK -60 THERAPROXEN PAK -90 THERAPROXEN PAK 500MG THERATRAMADO PAK -60 THERATRAMADO PAK -90 THIAMINE HCL INJ 100MG/ML THRIVITE 19 TAB THRIVITE RX TAB 29-1MG THROMBIN KIT 5000UNIT THROMBIN-JMI KIT 20000UNT THROMBIN-JMI KIT 5000UNIT THROMBIN-JMI SOL 20000UNT THROMBIN-JMI SOL 5000UNIT THYROGEN INJ 1.1MG TICANASE PAK 50-2.7 TIGHTENING CRE BASE TIMOTHY SOL GRASS TIMOTHY GRAS INJ 10000BAU TISSEEL KIT TISSEEL VH KIT 2ML TL FOLATE TAB TL G-FOL OS TAB TL GARD RX TAB TL HYDROQUIN CRE 4% TL ICON CAP TL TRISEB CRE TL-CARE DHA CAP 27-1-500 TL-FLUORIVIT CHW TL-HEM 150 TAB TL-ICARE CAP TL-SELECT CAP TL-SELECT CAP DHA TOXICOL SALV KIT COLLECT TOZAL CAP TRACE ELEM 4 INJ PED TRAMADOL CRE 5% TRAMADOL CRE 8% KIT TRANS-PEN CRE TRANSDERMAL CRE PAIN BAS TRANZGEL GEL TRAZAMINE PAK 50MG Reason Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Blood Component Blood Component Blood Component Blood Component Blood Component Diagnostic Agent LIST Not properly listed with FDA Non-standardized allergenic Non-standardized allergenic Blood Component Blood Component Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Cosmetic Vitamin/Mineral Device Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Medical Food Vitamin/Mineral Vitamin/Mineral Diagnostic Agent Medical Food Unapproved Drug Bulk Ingredient Bulk Ingredient Not properly listed with FDA Not properly listed with FDA Unapproved Drug Unapproved Drug 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 TREPADICLOFE PAK 25MG TREPADONE CAP TREPOXICAM PAK 7.5MG TRETINOIN EM CRE 0.05% TRETTEN INJ TRI-CHLOR LIQ 80% TRI-LUMA CRE TRI-SILA KIT 0.1-5% TRI-TABS DHA MIS TRI-VI-FLOR SUS 0.25/ML TRI-VI-FLOR SUS 0.5MG/ML TRI-VI-FLORO SUS 0.25/ML TRI-VI-FLORO SUS 0.5MG/ML TRI-VIT/FE DRO /FL 0.25 TRI-VIT/FL DRO 0.25MG TRI-VIT/FL DRO 0.5MG TRI-VIT/FLUO DRO 0.25MG TRI-VIT/FLUO DRO 0.5MG TRI-VITA/FL DRO 0.25MG TRIADVANCE TAB TRIAMSIL PAK COMBIPAK TRIAMSIL PAK MULTIPAK TRICARE PAK PRENATAL TRICARE TAB PRENATAL TRICARE PRE CAP 27-1-500 TRICHOPHYTON INJ 1:200 TRICHOPHYTON INJ 1:500 TRICHOPHYTON SOL 20000PNU TRICITRASOL CON TRICITRATES SOL TRICON CAP TRIDERMA CRE FORTE TRIFERIC SOL TRINATAL GT TAB TRINATAL RX TAB 1 TRINATE TAB TRIPHROCAPS CAP TRISEON CRE TRISTART DHA CAP TRIVEEN-DUO PAK DHA TRIVEEN-PRX CAP RNF TROPAZONE CRE TROPAZONE LOT TROPICAMIDE SOL 0.5% OP TROPICAMIDE SOL 1% OP Reason Not properly listed with FDA Unapproved Drug Unapproved Drug Cosmetic Blood Component Unapproved Drug Cosmetic LIST Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Not properly listed with FDA Not properly listed with FDA Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Diagnostic Agent Diagnostic Agent Non-standardized allergenic LIST Unapproved Drug Vitamin/Mineral Bulk Ingredient Not properly listed with FDA Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Bulk Ingredient Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Not properly listed with FDA Not properly listed with FDA Diagnostic Agent Diagnostic Agent 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 TRYPTOPHAN CAP 500MG TUBERSOL INJ 5/0.1ML TUSNEL CAP TUSSICAPS CAP 10-8MG TUSSICAPS CAP 5-4MG TUSSIGON TAB 5-1.5MG TUSSIONEX SUS 10-8/5ML TUZISTRA XR SUS TYLACTIN LIQ REST 10 TYLACTIN LIQ RTD 15 UDAMIN SP TAB ULTANE SOL ULTIMATECARE CAP ONE ULTIMATECARE CAP ONE NF ULTRA TABS TAB ULTRABAG/ SOL DIANEAL ULTRABAG/ SOL DIANEAL ULTRABAG/PD2 SOL DIANEAL ULTRABAG/PD2 SOL DIANEAL ULTRABAG/PD2 SOL DIANEAL ULTRADERM CRE ULTRASAL-ER SOL 28.5% ULTRAVATE X KIT 0.05-10% ULTRAVATE X KIT 0.05-10% ULTRAVIST INJ 150MG/ML ULTRAVIST INJ 240MG/ML ULTRAVIST INJ 300MG/ML ULTRAVIST INJ 370MG/ML UMECTA EMU UMECTA SUS 40% UMECTA MOUSS AER 40% UMECTA NAIL SUS FILM UMECTA PD EMU 40-0.3% UMECTA PD SUS 40-0.3% UNIVERSAL GEL WATER UR N-C TAB URAMAXIN AER 20% URAMAXIN CRE 45% URAMAXIN GEL 45% URAMAXIN LOT 45% URAMAXIN GT GEL 45% URAMAXIN GT KIT 45% URAMIT MB CAP 118MG URE-K CRE 50% UREA CRE 39% Reason Unapproved Drug Diagnostic Agent DESI Cough/Cold Cough/Cold Cough/Cold Cough/Cold Cough/Cold Not properly listed with FDA Not properly listed with FDA Vitamin/Mineral General Anesthetic Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Dialysis covered by ESRD bundled payment Dialysis covered by ESRD bundled payment Dialysis covered by ESRD bundled payment Dialysis covered by ESRD bundled payment Dialysis covered by ESRD bundled payment Not properly listed with FDA Unapproved Drug LIST LIST Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Not properly listed with FDA Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug 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 UREA CRE 40% UREA CRE 45% UREA CRE 47% UREA CRE 50% UREA EMU 50% UREA GEL 40% UREA LOT 40% UREA LOT 45% UREA 40% SUS NAIL UREA HYDRATI AER 35% UREA NAIL GEL 45% UREA NAIL KIT UREA NAIL MIS 50% UREA TOPICAL SUS 40% UREA-C40 LOT 40% URELLE TAB URETRON D/S TAB URETRON D/S TAB UREVAZ CRE 44% URI-CONTROL TAB RX URIBEL CAP 118MG URIMAR-T TAB URIN D/S TAB URINX MEDIC KIT SPECIMEN URO-BLUE TAB 81.6MG URO-L TAB 81MG URO-MP CAP 118MG UROAV-81 TAB UROAV-B CAP UROGESIC- TAB BLUE UROLET MB TAB UROPHEN MB TAB 81.6MG UROSEX TAB URYL TAB USTELL CAP UTA CAP 120MG UTA CAP 120MG UTICAP CAP UTIRA-C TAB UTOPIC CRE 41% UTRONA-C TAB V-C FORTE CAP VACUSTIM KIT BLACK VALIDERM CRE VANCOMYCIN SUS +SYRSPEN Reason Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Diagnostic Agent Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Vitamin/Mineral Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Vitamin/Mineral LIST Unapproved Drug Not properly listed with FDA 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 VANCOMYCN 25 SOL 25MG/ML VANCOMYCN 50 SOL 50MG/ML VANIQA CRE 13.9% VANISH-PEN CRE VANISHING CRE VANISHING CRE BOTANCAL VARIBAR PST PUDDING VARIBAR HONE SUS 40% VARIBAR NECT SUS 40% VARIBAR THIN SUS HONEY VARIBAR THIN SUS LIQUID VARITHENA AER 10MG/ML VARIZIG INJ 125UNIT VASCAZEN CAP 1GM VASCUDERM GEL HYDROGEL VASCUDERM KIT STASIS VASCULERA TAB VASOLEX OIN VASOPRESSIN INJ 10/0.5ML VASOPRESSIN INJ 20UNT/ML VAYACOG CAP VAYARIN CAP VAYAROL CAP VECURONIUM INJ 10MG VECURONIUM INJ 20MG VEG CAPSULE CAP #0 WHITE VEG CAPSULE CAP #00 WHIT VEG CAPSULE CAP #1 GREEN VEG CAPSULE CAP #1 WHITE VEG CAPSULE CAP #2 WHITE VEG CAPSULE CAP #3 WHITE VEG CAPSULE CAP #4 WHITE VELMA PAD 16-4-2% VELTRIX CRE 4-1% VEMAVITE- CAP PRX 2 VENA-BAL MIS DHA VENATAL-FA TAB VENELEX OIN VENIPUNCTURE KIT CPI VENOFER INJ 20MG/ML VENOMIL KIT HONEYBEE VENOMIL KIT HONEYBEE VENOMIL KIT WASP VENOMIL KIT WASP VENOMIL KIT WHT HORN Reason Unapproved Drug Unapproved Drug Cosmetic Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent Diagnostic Agent LIST Blood Component Not properly listed with FDA Device Not properly listed with FDA Medical Food DESI Unapproved Drug Unapproved Drug Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA LIST LIST Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Device LIST Vitamin/Mineral Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic 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 VENOMIL KIT WHT HORN VENOMIL KIT YEL HORN VENOMIL KIT YEL HORN VENOMIL KIT YEL JACK VENOMIL KIT YEL JACK VENOMIL MIX INJ VESPID VERRUNEX CRE VERSAFREE SYP VERSAPLUS SYP VERSAPRO CRE VERSATILE CRE BASE VERSATILE CRE RICH BSE VERTIGOHEEL SUB VEXA PAD 2-4-30% VIAGRA TAB 100MG VIAGRA TAB 25MG VIAGRA TAB 50MG VIASPAN SOL VIC-FORTE CAP VILACTIN AA LIQ PLUS VINACAL B MIS VINATE AZ EX TAB VINATE C TAB VINATE CAL TAB VINATE CARE CHW VINATE DHA CAP 27-1.13 VINATE IC CAP VINATE II TAB VINATE M TAB VINATE ONE TAB VIRASAL LIQ 27.5% VIRGINIA INJ LIVE OAK VIRILEX CAP VIRT NATE TAB VIRT NATE TAB 28-1MG VIRT-ADVANCE TAB 90-1MG VIRT-C DHA CAP VIRT-CAPS CAP VIRT-CARE CAP ONE VIRT-GARD TAB 2.2-25-1 VIRT-NATE CAP DHA VIRT-PHOS TAB 250 NEUT VIRT-PN TAB VIRT-PN DHA CAP VIRT-PN PLUS CAP Reason Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Unapproved Drug Not properly listed with FDA Not properly listed with FDA Bulk Ingredient Bulk Ingredient Bulk Ingredient Unapproved Drug Unapproved Drug Erectile Dysfunction Erectile Dysfunction Erectile Dysfunction Not properly listed with FDA Vitamin/Mineral Not properly listed with FDA Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Unapproved Drug Non-standardized allergenic Medical Food Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral 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 VIRT-SELECT CAP VIRT-VITE TAB VIRT-VITE TAB FORTE VIRT-VITE TAB PLUS VIRT-VITE GT TAB 90-1MG VIRTI-SULF CRE 10-5% VIRTPREX CAP VIRTRATE-2 SOL VIRTRATE-2 SOL 500-334 VIRTRATE-3 SOL VIRTRATE-K SOL VIRTRATE-K SOL 1100-334 VISBIOME PAK VISIPAQUE INJ 270MG/ML VISIPAQUE INJ 320MG/ML VIT A/C/D/FL DRO 0.25MG VIT B-COMPLX INJ 100 VITA S FORTE TAB VITA-MIN CAP VITA-PREN TAB VITA-RESPA TAB VITACEL TAB VITAFOL CAP ULTRA VITAFOL CHW GUMMIES VITAFOL TAB VITAFOL FE+ CAP VITAFOL-NANO TAB VITAFOL-OB PAK +DHA VITAFOL-OB TAB 65-1MG VITAFOL-ONE CAP VITAJECT INJ VITAL-D RX TAB VITAMAX PED DRO VITAMEDMD CAP ONE RX VITAMEDMD MIS PLUS RX VITAMIN C INJ 222MG/ML VITAMIN D CAP 50000UNT VITAMIN K1 INJ 10MG/ML VITAMIN K1 INJ 1MG/0.5 VITAPEARL CAP VITAROCA PLU TAB VITATRUE MIS VITUZ SOL 5-4MG VIVA DHA CAP VIZAMYL INJ Reason Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Unapproved Drug Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Not properly listed with FDA Diagnostic Agent Diagnostic Agent Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Cough/Cold Vitamin/Mineral Diagnostic Agent 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 VOL-CARE RX TAB VOL-NATE TAB VOL-PLUS TAB VOL-TAB RX TAB VOLUMEN SUS 0.1% VOLUMEX INJ 25/ML VOPAC CRE 10-2% VOPAC GB CRE 5-2-5% VOPAC KT CRE 5-5-2% VOPAC MDS KIT 1.5% VP CH ULTRA CAP VP-CH PLUS CAP VP-CH-PNV CAP VP-GGR-B6 TAB PRENATAL VP-GSTN CAP VP-HEME OB MIS + DHA VP-HEME OB TAB VP-HEME ONE CAP VP-HEME-OB TAB 28-6-1MG VP-PNV-DHA CAP VP-PRECIP CAP VP-VITE RX TAB VP-ZEL TAB VSL#3 DS PAK VYTONE CRE 1-1.9% WASP VENOM INJ 1000MCG WASP VENOM INJ 1300MCG WASP VENOM INJ 550MCG WASP VENOM KIT 100MCG WATER BASE GEL WELLMIND TAB VERTIGO WESTERN JUNI SOL 1:20 WESTHROID TAB 113.75MG WESTHROID TAB 130MG WESTHROID TAB 146.25MG WESTHROID TAB 16.25MG WESTHROID TAB 162.50MG WESTHROID TAB 195MG WESTHROID TAB 260MG WESTHROID TAB 32.5MG WESTHROID TAB 325MG WESTHROID TAB 48.75MG WESTHROID TAB 65MG WESTHROID TAB 81.25MG WESTHROID TAB 97.5MG Reason Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Diagnostic Agent Diagnostic Agent Unapproved Drug Not properly listed with FDA Not properly listed with FDA LIST Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Medical Food Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Dietary Supplement Vitamin/Mineral Vitamin/Mineral Medical Food DESI Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Not properly listed with FDA Unapproved Drug Non-standardized allergenic Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug 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 WHEAT GERM OIL WHITE ASH INJ EXTRACT WHITE BIRCH INJ 1:20 WHITE HORNET KIT 100MCG WHITE HORNET SOL 1000MCG WHITE OAK SOL WHITE PINE INJ 1:20 WHYTEDERM KIT SURGIPAK WHYTEDERM KIT TRILASIL WHYTEDERM TD KIT PAK WIDE-SEAL DPR KIT 60 WIDE-SEAL DPR KIT 65 WIDE-SEAL DPR KIT 70 WIDE-SEAL DPR KIT 75 WIDE-SEAL DPR KIT 80 WIDE-SEAL DPR KIT 85 WIDE-SEAL DPR KIT 90 WIDE-SEAL DPR KIT 95 WILATE INJ WOUND CARE PAD 2" X 2" WOUND CARE PAD 4" X 4" WOUND CARE PAD 4" X 5" WP THYROID TAB 113.75MG WP THYROID TAB 130MG WP THYROID TAB 16.25MG WP THYROID TAB 32.5MG WP THYROID TAB 48.75MG WP THYROID TAB 65MG WP THYROID TAB 81.25MG WP THYROID TAB 97.5MG X-VIATE CRE 40% X-VIATE GEL 40% X-VIATE LOT 40% XAQUIL XR TAB 30MG XELITRAL PAK XELODA TAB 150MG XELODA TAB 500MG XEMATOP CRE BASE XENADERM OIN XENICAL CAP 120MG XERAC-AC SOL 6.25% XEROFORM OIL MIS 1"X8" XEROFORM OIL PAD 2"X2" XEROFORM PET MIS OVERWRAP XEROFORM PET MIS ROLL Reason Not properly listed with FDA Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic LIST LIST LIST Device Device Device Device Device Device Device Device Blood Component OTC Product OTC Product OTC Product Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Unapproved Drug Not properly listed with FDA LIST Covered under Part B; oral drug only indicated for cancer Covered under Part B; oral drug only indicated for cancer Not properly listed with FDA DESI Anorexic, Anti-obesity Agent OTC Product Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA 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 XEROFORM PET PAD 1"X8" XEROFORM PET PAD 2"X2" XEROFORM PET PAD 4"X4" XEROFORM PET PAD 5"X9" XEROFRM GAUZ MIS 1"X8" XEROFRM GAUZ MIS 5"X9" XEROFRM GAUZ PAD 5"X9" XEROFRM PETR PAD 2"X2" XEROFRM PETR PAD 4"X4" XEROFRM ROLL MIS 4"X9" XEROFRM ROLL MIS 4"X9' XIZFLUS CAP XIZFLUS POW XROFORM PET MIS OVERWRAP XRYLIX PAK XYLO-MPF/EPI INJ 1% XYLO-MPF/EPI INJ 1.5% XYLO-MPF/EPI INJ 2% XYLO/EPI INJ 0.5% XYLO/EPI INJ 2% XYLO/EPI 1%- INJ 1:100000 XYLOCAINE INJ -MPF 4% XYLOCAINE INJ DENT 2% XYNTHA INJ 1000UNIT XYNTHA INJ 2000UNIT XYNTHA INJ 250UNIT XYNTHA INJ 500UNIT XYNTHA SOLOF INJ 1000UNIT XYNTHA SOLOF INJ 2000UNIT XYNTHA SOLOF INJ 3000UNIT XYNTHA SOLOF INJ 500UNIT XYNTHA SOLOF KIT 250UNIT XYPHEX MIS XYZBAC TAB YELLOW DOCK INJ 1:20 YELLOW HORN INJ 550MCG YELLOW HORNT KIT 100MCG YELLOW HORNT SOL 1000MCG YELLOW JACK INJ 1300MCG YELLOW JACK INJ 550MCG YELLOW JACKT KIT 100MCG YELLOW JACKT SOL 1000MCG YODOXIN TAB 650MG ZACLIR LOT 8% ZANABIN GEL HYDROGEL Reason Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Not properly listed with FDA Unapproved Drug Unapproved Drug Not properly listed with FDA LIST LIST LIST LIST LIST LIST LIST LIST LIST Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component Blood Component OTC Product Vitamin/Mineral Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Non-standardized allergenic Not properly listed with FDA Unapproved Drug Not properly listed with FDA 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 ZATEAN-CH CAP ZATEAN-PN CAP DHA ZATEAN-PN CAP PLUS ZATEAN-PN TAB ZAVARA CAP 1MG-5750 ZEMURON INJ 10MG/ML ZEMURON INJ 10MG/ML ZENCIA LIQ 9-4% ZERUVIA PAD 4-1% ZINC SULFATE INJ 1MG/ML ZINC TRACE INJ 1MG/ML ZITHRANOL SHA 1% ZITHRANOL-RR CRE 1.2% ZN-DTPA SOL 1000MG ZOE SCRIPTS CRE IDEALBAS ZONATUSS CAP 150MG ZUTRIPRO LIQ 60-4-5MG ZYVODOL CRE Reason Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Vitamin/Mineral Unapproved Drug LIST LIST Unapproved Drug Unapproved Drug Unapproved Drug LIST Unapproved Drug Unapproved Drug Not properly listed with FDA Not properly listed with FDA Cough/Cold Cough/Cold Unapproved Drug
Similar documents
celecoxib
Lista de Medicamentos - Blue Cross and Blue Shield of Illinois
Calcium carbonate con vitamin D (genérico);
Calcium citrate con vitamin D (genérico);
Ferrous gluconate (genérico); Ferrous sulfate (genérico);
Folic acid (genérico); multivitaminas (genérico);
mul...
2016 Drugs Requiring Prior Authorization List
ALPRAZOLAM ODT (NIRAVAM) 0.25 mg Lower Cost
ORALLY DISINTEGRATING TABLET
ALPRAZOLAM ODT (NIRAVAM) 0.5 mg
ORALLY DISINTEGRATING TABLET
