Texas Prior Authorization Program Clinical Edit Criteria

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Texas Prior Authorization Program Clinical Edit Criteria Drug/Drug Class Thiazolidinediones Clinical Edit Information Included in this Document Thiazolidinediones Drugs requiring prior authorization: the list of drugs requiring prior authorization for this clinical edit Prior authorization criteria logic: a description of how the prior authorization request will be evaluated against the clinical edit criteria rules Logic diagram: a visual depiction of the clinical edit criteria logic Supporting tables: a collection of information associated with the steps within the criteria (diagnosis codes, procedure codes, and therapy codes); provided when applicable References: clinical publications and sources relevant to this clinical edit Thiazolidinediones Rosiglitazone Drugs requiring prior authorization: the list of drugs requiring prior authorization for this clinical edit Prior authorization criteria logic: a description of how the prior authorization request will be evaluated against the clinical edit criteria rules Logic diagram: a visual depiction of the clinical edit criteria logic Supporting tables: a collection of information associated with the steps within the criteria (diagnosis codes, procedure codes, and therapy codes); provided when applicable References: clinical publications and sources relevant to this clinical edit Note: Click the hyperlink to navigate directly to that section. February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 1

Revision Notes Annual review by staff Removed ICD-9 codes Updated pioglitazone-containing agents, criteria logic and logic diagram, pages 3-6 Updated Table 2, pages 6-7 Updated Table 4, pages 11-12 Updated Table 6, pages 22-23 February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 2

Thiazolidinediones Drugs Requiring Prior Authorization Table 1 Drugs Requiring Prior Authorization for Criteria Steps 1-4 (Thiazolidinediones and Metformin) Label Name GCN ACTOPLUS MET 15 MG-500 MG TAB 25444 ACTOPLUS MET XR 15-1,000 MG TB 28620 ACTOPLUS MET XR 30-1,000 MG TB 28622 PIOGLITAZONE-METFORMIN 15-500 25444 PIOGLITAZONE-METFORMIN 15-850 25445 Table 2 Drugs Requiring Prior Authorization for Criteria Steps 1-5 (Thiazolidinediones, plain and other Thiazolidinedione combinations) Label Name GCN ACTOS 15 MG TABLET 92991 ACTOS 30 MG TABLET 93001 ACTOS 45 MG TABLET 93011 ALOGLIPTIN-PIOGLIT 12.5-15 34080 ALOGLIPTIN-PIOGLIT 12.5-30 34083 ALOGLIPTIN-PIOGLIT 12.5-45 34084 ALOGLIPTIN-PIOGLIT 25-15 34077 ALOGLIPTIN-PIOGLIT 25-30 34078 ALOGLIPTIN-PIOGLIT 25-45 34079 DUETACT 30-2 MG TABLET 97181 DUETACT 30-4 MG TABLET 97180 OSENI 12.5-15 MG TABLET 34080 OSENI 12.5-30 MG TABLET 34083 OSENI 12.5-45 MG TABLET 34084 OSENI 25-15 MG TABLET 34077 OSENI 25-30 MG TABLET 34078 OSENI 25-45 MG TABLET 34079 PIOGLITAZONE HCL 15 MG TABLET 92991 PIOGLITAZONE HCL 30 MG TABLET 93001 February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 3

Table 2 Drugs Requiring Prior Authorization for Criteria Steps 1-5 (Thiazolidinediones, plain and other Thiazolidinedione combinations) Label Name GCN PIOGLITAZONE HCL 45 MG TABLET 93011 PIOGLITAZONE-GLIMEPIRIDE 30-2 97181 PIOGLITAZONE-GLIMEPIRIDE 30-4 97180 February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 4

Thiazolidinediones Clinical Edit Criteria Logic 1. Does the client have a diagnosis of heart failure in the last 365 days? [ ] Yes (Go to # 2) [ ] No (Go to #3) 2. Does the client have a history of 2 heart failure drugs for 30 days in the last 90 days? [ ] Yes (Deny) [ ] No (Go to #3) 3. Does the client have a diagnosis of type II diabetes in the last 730 days? [ ] Yes (Go to #4) [ ] No (Deny) 4. Does the client have a history of a metformin-containing agent for 30 days in the last 730 days? [ ] Yes (Approve 365 days) [ ] If No, and drug is in Table 1 (Deny) [ ] If No, and drug is in Table 2 (Go to #5) 5. Does the client have a diagnosis of renal failure in the last 730 days? [ ] Yes (Approve 365 days) [ ] No (Deny) February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 5

Thiazolidinediones Clinical Edit Criteria Logic Diagram Step 1 Step 2 Does the client have a diagnosis of heart failure in the last 365 days? Yes Does the client have a history of 2 heart failure drugs for 30 days in the last 90 days? Yes Deny Request No No Step 3 Does the client have a diagnosis of type 2 diabetes in the last 730 days? No Deny Request Yes Step 4 Does the client have a history of a metformincontaining agent for 30 days in the last 730 days? Yes Approve Request (365 days) No, and drug is in Table 2 No, and drug is in Table 1 Step 5 Does the client have a diagnosis of renal failure in the last 730 days? No Deny Request Yes Approve Request (365 days) February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 6

Thiazolidinediones Clinical Edit Criteria Supporting Tables ICD-10 Code I501 I5020 I5021 I5022 I5023 I5030 I5031 I5032 I5033 I5040 I5041 I5042 I5043 I509 Description Step 1 (diagnosis of heart failure) Required diagnosis: 1 Look back timeframe: 365 days LEFT VENTRICULAR FAILURE UNSPECIFIED SYSTOLIC (CONGESTIVE) HEART FAILURE ACUTE SYSTOLIC (CONGESTIVE) HEART FAILURE CHRONIC SYSTOLIC (CONGESTIVE) HEART FAILURE ACUTE ON CHRONIC SYSTOLIC (CONGESTIVE) HEART FAILURE UNSPECIFIED DIASTOLIC (CONGESTIVE) HEART FAILURE ACUTE DIASTOLIC (CONGESTIVE) HEART FAILURE CHRONIC DIASTOLIC (CONGESTIVE) HEART FAILURE ACUTE ON CHRONIC DIASTOLIC (CONGESTIVE) HEART FAILURE UNSPECIFIED COMBINED SYSTOLIC (CONGESTIVE) AND DIASTOLIC (CONGESTIVE) HEART FAILURE ACUTE COMBINED SYSTOLIC (CONGESTIVE) AND DIASTOLIC (CONGESTIVE) HEART FAILURE CHRONIC COMBINED SYSTOLIC (CONGESTIVE) AND DIASTOLIC (CONGESTIVE) HEART FAILURE ACUTE ON CHRONIC COMBINED SYSTOLIC (CONGESTIVE) AND DIASTOLIC (CONGESTIVE) HEART FAILURE HEART FAILURE, UNSPECIFIED Step 2 (history of 2 heart failure drugs) Required quantity: 2 Look back timeframe: 90 days Label Name GCN BIDIL TABLET 24925 BUMETANIDE 0.5 MG TABLET 35020 BUMETANIDE 1 MG TABLET 35021 BUMETANIDE 2 MG TABLET 35022 CORLANOR 5 MG TABLET 26238 CORLANOR 7.5 MG TABLET 26239 DIGOXIN 50 MCG/ML SOLUTION 00120 DIGOXIN 125 MCG TABLET 00132 February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 7

Step 2 (history of 2 heart failure drugs) Required quantity: 2 Look back timeframe: 90 days Label Name GCN DIGOXIN 250 MCG TABLET 00133 ENTRESTO 24-26 MG TABLET 39046 ENTRESTO 49-51 MG TABLET 39047 ENTRESTO 97-103 MG TABLET 39048 EPLERENONE 25 MG TABLET 91883 EPLERENONE 50 MG TABLET 91884 ETHACRYNIC ACID 25 MG TABLET 34910 FUROSEMIDE 10 MG/ML SOLUTION 34950 FUROSEMIDE 40 MG/5 ML SOLN 34951 FUROSEMIDE 20 MG TABLET 34961 FUROSEMIDE 40 MG TABLET 34962 FUROSEMIDE 80 MG TABLET 34963 FUROSEMIDE 10 MG/ML VIAL 34940 INSPRA 25 MG TABLET 91883 INSPRA 50 MG TABLET 91884 LANOXIN 125 MCG TABLET 00132 TORSEMIDE 5 MG TABLET 21130 TORSEMIDE 10 MG TABLET 21131 TORSEMIDE 20 MG TABLET 21132 TORSEMIDE 100 MG TABLET 21133 ICD-10 Code E1100 E1101 E1121 E1122 E1129 E11311 E11319 Description Step 3 (diagnosis of type II diabetes) Required diagnosis: 1 TYPE 2 DIABETES MELLITUS WITH HYPEROSMOLARITY WITHOUT NONKETOTIC HYPERGLYCEMIC-HYPEROSMOLAR COMA (NKHHC) TYPE 2 DIABETES MELLITUS WITH HYPEROSMOLARITY WITH COMA TYPE 2 DIABETES MELLITUS WITH DIABETIC NEPHROPATHY TYPE 2 DIABETES MELLITUS WITH DIABETIC CHRONIC KIDNEY DISEASE TYPE 2 DIABETES MELLITUS WITH OTHER DIABETIC KIDNEY COMPLICATION TYPE 2 DIABETES MELLITUS WITH UNSPECIFIED DIABETIC RETINOPATHY WITH MACULAR EDEMA TYPE 2 DIABETES MELLITUS WITH UNSPECIFIED DIABETIC RETINOPATHY WITHOUT MACULAR EDEMA February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 8

ICD-10 Code E11321 E11329 E11331 E11339 E11341 E11349 E11351 E11359 E1136 E1139 E1140 E1141 E1142 E1143 E1144 E1149 E1151 E1152 E1159 E11610 E11618 E11620 E11621 E11622 E11628 E11630 Description Step 3 (diagnosis of type II diabetes) Required diagnosis: 1 TYPE 2 DIABETES MELLITUS WITH MILD NONPROLIFERATIVE DIABETIC RETINOPATHY WITH MACULAR EDEMA TYPE 2 DIABETES MELLITUS WITH MILD NONPROLIFERATIVE DIABETIC RETINOPATHY WITHOUT MACULAR EDEMA TYPE 2 DIABETES MELLITUS WITH MODERATE NONPROLIFERATIVE DIABETIC RETINOPATHY WITH MACULAR EDEMA TYPE 2 DIABETES MELLITUS WITH MODERATE NONPROLIFERATIVE DIABETIC RETINOPATHY WITHOUT MACULAR EDEMA TYPE 2 DIABETES MELLITUS WITH SEVERE NONPROLIFERATIVE DIABETIC RETINOPATHY WITH MACULAR EDEMA TYPE 2 DIABETES MELLITUS WITH SEVERE NONPROLIFERATIVE DIABETIC RETINOPATHY WITHOUT MACULAR EDEMA TYPE 2 DIABETES MELLITUS WITH PROLIFERATIVE DIABETIC RETINOPATHY WITH MACULAR EDEMA TYPE 2 DIABETES MELLITUS WITH PROLIFERATIVE DIABETIC RETINOPATHY WITHOUT MACULAR EDEMA TYPE 2 DIABETES MELLITUS WITH DIABETIC CATARACT TYPE 2 DIABETES MELLITUS WITH OTHER DIABETIC OPHTHALMIC COMPLICATION TYPE 2 DIABETES MELLITUS WITH DIABETIC NEUROPATHY, UNSPECIFIED TYPE 2 DIABETES MELLITUS WITH DIABETIC MONONEUROPATHY TYPE 2 DIABETES MELLITUS WITH DIABETIC POLYNEUROPATHY TYPE 2 DIABETES MELLITUS WITH DIABETIC AUTONOMIC (POLY)NEUROPATHY TYPE 2 DIABETES MELLITUS WITH DIABETIC AMYOTROPHY TYPE 2 DIABETES MELLITUS WITH OTHER DIABETIC NEUROLOGICAL COMPLICATION TYPE 2 DIABETES MELLITUS WITH DIABETIC PERIPHERAL ANGIOPATHY WITHOUT GANGRENE TYPE 2 DIABETES MELLITUS WITH DIABETIC PERIPHERAL ANGIOPATHY WITH GANGRENE TYPE 2 DIABETES MELLITUS WITH OTHER CIRCULATORY COMPLICATIONS TYPE 2 DIABETES MELLITUS WITH DIABETIC NEUROPATHIC ARTHROPATHY TYPE 2 DIABETES MELLITUS WITH OTHER DIABETIC ARTHROPATHY TYPE 2 DIABETES MELLITUS WITH DIABETIC DERMATITIS TYPE 2 DIABETES MELLITUS WITH FOOT ULCER TYPE 2 DIABETES MELLITUS WITH OTHER SKIN ULCER TYPE 2 DIABETES MELLITUS WITH OTHER SKIN COMPLICATIONS TYPE 2 DIABETES MELLITUS WITH PERIODONTAL DISEASE February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 9

ICD-10 Code E11638 E11641 E11649 E1165 E1169 E118 E119 E1300 E1301 E1310 E1311 E1321 E1322 E1329 E13311 E13319 E13321 E13329 E13331 E13339 E13341 E13349 E13351 E13359 Description Step 3 (diagnosis of type II diabetes) Required diagnosis: 1 TYPE 2 DIABETES MELLITUS WITH OTHER ORAL COMPLICATIONS TYPE 2 DIABETES MELLITUS WITH HYPOGLYCEMIA WITH COMA TYPE 2 DIABETES MELLITUS WITH HYPOGLYCEMIA WITHOUT COMA TYPE 2 DIABETES MELLITUS WITH HYPERGLYCEMIA TYPE 2 DIABETES MELLITUS WITH OTHER SPECIFIED COMPLICATION TYPE 2 DIABETES MELLITUS WITH UNSPECIFIED COMPLICATIONS TYPE 2 DIABETES MELLITUS WITHOUT COMPLICATIONS OTHER SPECIFIED DIABETES MELLITUS WITH HYPEROSMOLARITY WITHOUT NONKETOTIC HYPERGLYCEMIC-HYPEROSMOLAR COMA (NKHHC) OTHER SPECIFIED DIABETES MELLITUS WITH HYPEROSMOLARITY WITH COMA OTHER SPECIFIED DIABETES MELLITUS WITH KETOACIDOSIS WITHOUT COMA OTHER SPECIFIED DIABETES MELLITUS WITH KETOACIDOSIS WITH COMA OTHER SPECIFIED DIABETES MELLITUS WITH DIABETIC NEPHROPATHY OTHER SPECIFIED DIABETES MELLITUS WITH DIABETIC CHRONIC KIDNEY DISEASE OTHER SPECIFIED DIABETES MELLITUS WITH OTHER DIABETIC KIDNEY COMPLICATION OTHER SPECIFIED DIABETES MELLITUS WITH UNSPECIFIED DIABETIC RETINOPATHY WITH MACULAR EDEMA OTHER SPECIFIED DIABETES MELLITUS WITH UNSPECIFIED DIABETIC RETINOPATHY WITHOUT MACULAR EDEMA OTHER SPECIFIED DIABETES MELLITUS WITH MILD NONPROLIFERATIVE DIABETIC RETINOPATHY WITH MACULAR EDEMA OTHER SPECIFIED DIABETES MELLITUS WITH MILD NONPROLIFERATIVE DIABETIC RETINOPATHY WITHOUT MACULAR EDEMA OTHER SPECIFIED DIABETES MELLITUS WITH MODERATE NONPROLIFERATIVE DIABETIC RETINOPATHY WITH MACULAR EDEMA OTHER SPECIFIED DIABETES MELLITUS WITH MODERATE NONPROLIFERATIVE DIABETIC RETINOPATHY WITHOUT MACULAR EDEMA OTHER SPECIFIED DIABETES MELLITUS WITH SEVERE NONPROLIFERATIVE DIABETIC RETINOPATHY WITH MACULAR EDEMA OTHER SPECIFIED DIABETES MELLITUS WITH SEVERE NONPROLIFERATIVE DIABETIC RETINOPATHY WITHOUT MACULAR EDEMA OTHER SPECIFIED DIABETES MELLITUS WITH PROLIFERATIVE DIABETIC RETINOPATHY WITH MACULAR EDEMA OTHER SPECIFIED DIABETES MELLITUS WITH PROLIFERATIVE DIABETIC RETINOPATHY WITHOUT MACULAR EDEMA February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 10

ICD-10 Code E1336 E1339 E1340 E1341 E1342 E1343 E1344 E1349 E1351 E1352 E1359 E13610 E13618 E13620 E13621 E13622 E13628 E13630 E13638 E13641 E13649 E1365 E1369 E138 E139 Description Step 3 (diagnosis of type II diabetes) Required diagnosis: 1 OTHER SPECIFIED DIABETES MELLITUS WITH DIABETIC CATARACT OTHER SPECIFIED DIABETES MELLITUS WITH OTHER DIABETIC OPHTHALMIC COMPLICATION OTHER SPECIFIED DIABETES MELLITUS WITH DIABETIC NEUROPATHY, UNSPECIFIED OTHER SPECIFIED DIABETES MELLITUS WITH DIABETIC MONONEUROPATHY OTHER SPECIFIED DIABETES MELLITUS WITH DIABETIC POLYNEUROPATHY OTHER SPECIFIED DIABETES MELLITUS WITH DIABETIC AUTONOMIC (POLY)NEUROPATHY OTHER SPECIFIED DIABETES MELLITUS WITH DIABETIC AMYOTROPHY OTHER SPECIFIED DIABETES MELLITUS WITH OTHER DIABETIC NEUROLOGICAL COMPLICATION OTHER SPECIFIED DIABETES MELLITUS WITH DIABETIC PERIPHERAL ANGIOPATHY WITHOUT GANGRENE OTHER SPECIFIED DIABETES MELLITUS WITH DIABETIC PERIPHERAL ANGIOPATHY WITH GANGRENE OTHER SPECIFIED DIABETES MELLITUS WITH OTHER CIRCULATORY COMPLICATIONS OTHER SPECIFIED DIABETES MELLITUS WITH DIABETIC NEUROPATHIC ARTHROPATHY OTHER SPECIFIED DIABETES MELLITUS WITH OTHER DIABETIC ARTHROPATHY OTHER SPECIFIED DIABETES MELLITUS WITH DIABETIC DERMATITIS OTHER SPECIFIED DIABETES MELLITUS WITH FOOT ULCER OTHER SPECIFIED DIABETES MELLITUS WITH OTHER SKIN ULCER OTHER SPECIFIED DIABETES MELLITUS WITH OTHER SKIN COMPLICATIONS OTHER SPECIFIED DIABETES MELLITUS WITH PERIODONTAL DISEASE OTHER SPECIFIED DIABETES MELLITUS WITH OTHER ORAL COMPLICATIONS OTHER SPECIFIED DIABETES MELLITUS WITH HYPOGLYCEMIA WITH COMA OTHER SPECIFIED DIABETES MELLITUS WITH HYPOGLYCEMIA WITHOUT COMA OTHER SPECIFIED DIABETES MELLITUS WITH HYPERGLYCEMIA OTHER SPECIFIED DIABETES MELLITUS WITH OTHER SPECIFIED COMPLICATION OTHER SPECIFIED DIABETES MELLITUS WITH UNSPECIFIED COMPLICATIONS OTHER SPECIFIED DIABETES MELLITUS WITHOUT COMPLICATIONS February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 11

Step 4 (history of a metformin-containing agent) Required quantity: 1 Label Name GCN ACTOPLUS MET 15 MG-500 MG TAB 25444 ACTOPLUS MET XR 15-1,000 MG TB 28620 ACTOPLUS MET XR 30-1,000 MG TB 28622 ALOGLIPTIN-METFORMIN 12.5-1000 34088 ALOGLIPTIN-METFORMIN 12.5-500 34087 FORTAMET ER 1,000 MG TABLET 21831 FORTAMET ER 500 MG TABLET 21832 GLIPIZIDE-METFORMIN 2.5-250 MG 18366 GLIPIZIDE-METFORMIN 2.5-500 MG 18367 GLIPIZIDE-METFORMIN 5-500 MG 18368 GLUCOPHAGE 1,000 MG TABLET 10857 GLUCOPHAGE 500 MG TABLET 10810 GLUCOPHAGE 850 MG TABLET 10811 GLUCOPHAGE XR 500 MG TAB 89863 GLUCOPHAGE XR 750 MG TAB 19578 GLUCOVANCE 2.5-500 MG TABLET 92889 GLUCOVANCE 5-500 MG TABLET 89879 GLUMETZA ER 1,000 MG TABLET 97067 GLUMETZA ER 500 MG TABLET 97061 GLYBURIDE-METFORMIN 2.5-500 MG 92889 GLYBURIDE-METFORMIN 5-500 MG 89879 GLYBURID-METFORMIN 1.25-250 MG 89878 INVOKAMET 150-1000 MG TABLET 36859 INVOKAMET 150-500 MG TABLET 36953 INVOKAMET 50-1000 MG TABLET 36857 INVOKAMET 50-500 MG TABLET 36954 INVOKAMET XR 150-1000 MG TABLET 42315 INVOKAMET XR 150-500 MG TABLET 42314 INVOKAMET XR 50-1000 MG TABLET 42313 INVOKAMET XR 50-500 MG TABLET 42312 JANUMET 50-1,000 MG TABLET 98307 JANUMET 50-500 MG TABLET 98306 JANUMET XR 100-1000 MG TABLET 31348 JANUMET XR 50-1000 MG TABLET 31340 February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 12

Step 4 (history of a metformin-containing agent) Required quantity: 1 Label Name GCN JANUMET XR 50-500 MG TABLET 31339 JENTADUETO 2.5-1000 MG TAB 31317 JENTADUETO 2.5-500 MG TAB 31315 JENTADUETO 2.5-850 MG TAB 31316 JENTADUETO XR 2.5-1000 MG TAB 41637 JENTADUETO XR 5-1000 MG TAB 41639 KAZANO 12.5-1000 MG TABLET 34088 KAZANO 12.5-500 MG TABLET 34087 KOMBIGLYZE XR 2.5-1000 MG TAB 29225 KOMBIGLYZE XR 5-1000 MG TAB 29224 KOMBIGLYZE XR 5-500 MG TAB 29118 METFORMIN HCL 1,000 MG TABLET 10857 METFORMIN HCL 500 MG TABLET 10810 METFORMIN HCL 850 MG TABLET 10811 METFORMIN HCL ER 1,000 MG TAB 21831 METFORMIN HCL ER 500 MG TABLET 21832 METFORMIN HCL ER 500 MG TABLET 89863 METFORMIN HCL ER 750 MG TABLET 19578 PIOGLITAZONE-METFORMIN 15-500 25444 PIOGLITAZONE-METFORMIN 15-850 25445 REPAGLINIDE-METFORMIN 1-500 MG 16084 REPAGLINIDE-METFORMIN 2-500 MG 16085 RIOMET 500 MG/5 ML SOLUTION 20808 SYNJARDY 12.5-1000 MG TABLET 38932 SYNJARDY 12.5-500 MG TABLET 39378 SYNJARDY 5-1000 MG TABLET 38929 XIGDUO XR 10-1000 MG TABLET 37344 XIGDUO XR 10-500 MG TABLET 37342 XIGDUO XR 5-1000 MG TABLET 37343 XIGDUO XR 5-500 MG TABLET 37339 February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 13

ICD-10 Code B520 E0821 E0822 E0829 E0921 E0922 E0929 M3214 M3215 M3504 N000 N001 N002 N003 N004 N005 N006 N007 N008 N009 N010 N011 N012 N013 Description Step 5 (diagnosis of renal failure) Required diagnosis: 1 PLASMODIUM MALARIAE MALARIA WITH NEPHROPATHY DIABETES MELLITUS DUE TO UNDERLYING CONDITION WITH DIABETIC NEPHROPATHY DIABETES MELLITUS DUE TO UNDERLYING CONDITION WITH DIABETIC CHRONIC KIDNEY DISEASE DIABETES MELLITUS DUE TO UNDERLYING CONDITION WITH OTHER DIABETIC KIDNEY COMPLICATION DRUG OR CHEMICAL INDUCED DIABETES MELLITUS WITH DIABETIC NEPHROPATHY DRUG OR CHEMICAL INDUCED DIABETES MELLITUS WITH DIABETIC CHRONIC KIDNEY DISEASE DRUG OR CHEMICAL INDUCED DIABETES MELLITUS WITH OTHER DIABETIC KIDNEY COMPLICATION GLOMERULAR DISEASE IN SYSTEMIC LUPUS ERYTHEMATOSUS TUBULO-INTERSTITIAL NEPHROPATHY IN SYSTEMIC LUPUS ERYTHEMATOSUS SICCA SYNDROME WITH TUBULO-INTERSTITIAL NEPHROPATHY ACUTE NEPHRITIC SYNDROME WITH MINOR GLOMERULAR ABNORMALITY ACUTE NEPHRITIC SYNDROME WITH FOCAL AND SEGMENTAL GLOMERULAR LESIONS ACUTE NEPHRITIC SYNDROME WITH DIFFUSE MEMBRANOUS ACUTE NEPHRITIC SYNDROME WITH DIFFUSE MESANGIAL PROLIFERATIVE ACUTE NEPHRITIC SYNDROME WITH DIFFUSE ENDOCAPILLARY PROLIFERATIVE ACUTE NEPHRITIC SYNDROME WITH DIFFUSE MESANGIOCAPILLARY ACUTE NEPHRITIC SYNDROME WITH DENSE DEPOSIT DISEASE ACUTE NEPHRITIC SYNDROME WITH DIFFUSE CRESCENTIC ACUTE NEPHRITIC SYNDROME WITH OTHER MORPHOLOGIC CHANGES ACUTE NEPHRITIC SYNDROME WITH UNSPECIFIED MORPHOLOGIC CHANGES RAPIDLY PROGRESSIVE NEPHRITIC SYNDROME WITH MINOR GLOMERULAR ABNORMALITY RAPIDLY PROGRESSIVE NEPHRITIC SYNDROME WITH FOCAL AND SEGMENTAL GLOMERULAR LESIONS RAPIDLY PROGRESSIVE NEPHRITIC SYNDROME WITH DIFFUSE MEMBRANOUS RAPIDLY PROGRESSIVE NEPHRITIC SYNDROME WITH DIFFUSE MESANGIAL PROLIFERATIVE February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 14

ICD-10 Code N014 N015 N016 N017 N018 N019 N020 N021 N022 N023 N024 N025 N026 N027 N028 N029 N030 N031 N032 N033 N034 N035 Description Step 5 (diagnosis of renal failure) Required diagnosis: 1 RAPIDLY PROGRESSIVE NEPHRITIC SYNDROME WITH DIFFUSE ENDOCAPILLARY PROLIFERATIVE RAPIDLY PROGRESSIVE NEPHRITIC SYNDROME WITH DIFFUSE MESANGIOCAPILLARY RAPIDLY PROGRESSIVE NEPHRITIC SYNDROME WITH DENSE DEPOSIT DISEASE RAPIDLY PROGRESSIVE NEPHRITIC SYNDROME WITH DIFFUSE CRESCENTIC RAPIDLY PROGRESSIVE NEPHRITIC SYNDROME WITH OTHER MORPHOLOGIC CHANGES RAPIDLY PROGRESSIVE NEPHRITIC SYNDROME WITH UNSPECIFIED MORPHOLOGIC CHANGES RECURRENT AND PERSISTENT HEMATURIA WITH MINOR GLOMERULAR ABNORMALITY RECURRENT AND PERSISTENT HEMATURIA WITH FOCAL AND SEGMENTAL GLOMERULAR LESIONS RECURRENT AND PERSISTENT HEMATURIA WITH DIFFUSE MEMBRANOUS RECURRENT AND PERSISTENT HEMATURIA WITH DIFFUSE MESANGIAL PROLIFERATIVE RECURRENT AND PERSISTENT HEMATURIA WITH DIFFUSE ENDOCAPILLARY PROLIFERATIVE RECURRENT AND PERSISTENT HEMATURIA WITH DIFFUSE MESANGIOCAPILLARY RECURRENT AND PERSISTENT HEMATURIA WITH DENSE DEPOSIT DISEASE RECURRENT AND PERSISTENT HEMATURIA WITH DIFFUSE CRESCENTIC RECURRENT AND PERSISTENT HEMATURIA WITH OTHER MORPHOLOGIC CHANGES RECURRENT AND PERSISTENT HEMATURIA WITH UNSPECIFIED MORPHOLOGIC CHANGES CHRONIC NEPHRITIC SYNDROME WITH MINOR GLOMERULAR ABNORMALITY CHRONIC NEPHRITIC SYNDROME WITH FOCAL AND SEGMENTAL GLOMERULAR LESIONS CHRONIC NEPHRITIC SYNDROME WITH DIFFUSE MEMBRANOUS CHRONIC NEPHRITIC SYNDROME WITH DIFFUSE MESANGIAL PROLIFERATIVE CHRONIC NEPHRITIC SYNDROME WITH DIFFUSE ENDOCAPILLARY PROLIFERATIVE CHRONIC NEPHRITIC SYNDROME WITH DIFFUSE MESANGIOCAPILLARY February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 15

ICD-10 Code N036 N037 N038 N039 N040 N041 N042 N043 N044 N045 N046 N047 N048 N049 N050 N051 N052 N053 N054 N055 N056 N057 N058 N059 N060 Description Step 5 (diagnosis of renal failure) Required diagnosis: 1 CHRONIC NEPHRITIC SYNDROME WITH DENSE DEPOSIT DISEASE CHRONIC NEPHRITIC SYNDROME WITH DIFFUSE CRESCENTIC CHRONIC NEPHRITIC SYNDROME WITH OTHER MORPHOLOGIC CHANGES CHRONIC NEPHRITIC SYNDROME WITH UNSPECIFIED MORPHOLOGIC CHANGES NEPHROTIC SYNDROME WITH MINOR GLOMERULAR ABNORMALITY NEPHROTIC SYNDROME WITH FOCAL AND SEGMENTAL GLOMERULAR LESIONS NEPHROTIC SYNDROME WITH DIFFUSE MEMBRANOUS NEPHROTIC SYNDROME WITH DIFFUSE MESANGIAL PROLIFERATIVE NEPHROTIC SYNDROME WITH DIFFUSE ENDOCAPILLARY PROLIFERATIVE NEPHROTIC SYNDROME WITH DIFFUSE MESANGIOCAPILLARY NEPHROTIC SYNDROME WITH DENSE DEPOSIT DISEASE NEPHROTIC SYNDROME WITH DIFFUSE CRESCENTIC NEPHROTIC SYNDROME WITH OTHER MORPHOLOGIC CHANGES NEPHROTIC SYNDROME WITH UNSPECIFIED MORPHOLOGIC CHANGES UNSPECIFIED NEPHRITIC SYNDROME WITH MINOR GLOMERULAR ABNORMALITY UNSPECIFIED NEPHRITIC SYNDROME WITH FOCAL AND SEGMENTAL GLOMERULAR LESIONS UNSPECIFIED NEPHRITIC SYNDROME WITH DIFFUSE MEMBRANOUS UNSPECIFIED NEPHRITIC SYNDROME WITH DIFFUSE MESANGIAL PROLIFERATIVE UNSPECIFIED NEPHRITIC SYNDROME WITH DIFFUSE ENDOCAPILLARY PROLIFERATIVE UNSPECIFIED NEPHRITIC SYNDROME WITH DIFFUSE MESANGIOCAPILLARY UNSPECIFIED NEPHRITIC SYNDROME WITH DENSE DEPOSIT DISEASE UNSPECIFIED NEPHRITIC SYNDROME WITH DIFFUSE CRESCENTIC UNSPECIFIED NEPHRITIC SYNDROME WITH OTHER MORPHOLOGIC CHANGES UNSPECIFIED NEPHRITIC SYNDROME WITH UNSPECIFIED MORPHOLOGIC CHANGES ISOLATED PROTEINURIA WITH MINOR GLOMERULAR ABNORMALITY February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 16

ICD-10 Code N061 N062 N063 N064 N065 N066 N067 N068 N069 N070 N071 N072 N073 N074 N075 N076 N077 N078 N079 N08 N140 N141 N142 N143 Description Step 5 (diagnosis of renal failure) Required diagnosis: 1 ISOLATED PROTEINURIA WITH FOCAL AND SEGMENTAL GLOMERULAR LESIONS ISOLATED PROTEINURIA WITH DIFFUSE MEMBRANOUS ISOLATED PROTEINURIA WITH DIFFUSE MESANGIAL PROLIFERATIVE ISOLATED PROTEINURIA WITH DIFFUSE ENDOCAPILLARY PROLIFERATIVE ISOLATED PROTEINURIA WITH DIFFUSE MESANGIOCAPILLARY ISOLATED PROTEINURIA WITH DENSE DEPOSIT DISEASE ISOLATED PROTEINURIA WITH DIFFUSE CRESCENTIC ISOLATED PROTEINURIA WITH OTHER MORPHOLOGIC LESION ISOLATED PROTEINURIA WITH UNSPECIFIED MORPHOLOGIC LESION HEREDITARY NEPHROPATHY, NOT ELSEWHERE CLASSIFIED WITH MINOR GLOMERULAR ABNORMALITY HEREDITARY NEPHROPATHY, NOT ELSEWHERE CLASSIFIED WITH FOCAL AND SEGMENTAL GLOMERULAR LESIONS HEREDITARY NEPHROPATHY, NOT ELSEWHERE CLASSIFIED WITH DIFFUSE MEMBRANOUS HEREDITARY NEPHROPATHY, NOT ELSEWHERE CLASSIFIED WITH DIFFUSE MESANGIAL PROLIFERATIVE HEREDITARY NEPHROPATHY, NOT ELSEWHERE CLASSIFIED WITH DIFFUSE ENDOCAPILLARY PROLIFERATIVE HEREDITARY NEPHROPATHY, NOT ELSEWHERE CLASSIFIED WITH DIFFUSE MESANGIOCAPILLARY HEREDITARY NEPHROPATHY, NOT ELSEWHERE CLASSIFIED WITH DENSE DEPOSIT DISEASE HEREDITARY NEPHROPATHY, NOT ELSEWHERE CLASSIFIED WITH DIFFUSE CRESCENTIC HEREDITARY NEPHROPATHY, NOT ELSEWHERE CLASSIFIED WITH OTHER MORPHOLOGIC LESIONS HEREDITARY NEPHROPATHY, NOT ELSEWHERE CLASSIFIED WITH UNSPECIFIED MORPHOLOGIC LESIONS GLOMERULAR DISORDERS IN DISEASES CLASSIFIED ELSEWHERE ANALGESIC NEPHROPATHY NEPHROPATHY INDUCED BY OTHER DRUGS, MEDICAMENTS AND BIOLOGICAL SUBSTANCES NEPHROPATHY INDUCED BY UNSPECIFIED DRUG, MEDICAMENT OR BIOLOGICAL SUBSTANCE NEPHROPATHY INDUCED BY HEAVY METALS February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 17

ICD-10 Code N144 N150 N158 N159 N16 N170 N171 N172 N178 N179 Description Step 5 (diagnosis of renal failure) Required diagnosis: 1 TOXIC NEPHROPATHY, NOT ELSEWHERE CLASSIFIED BALKAN NEPHROPATHY OTHER SPECIFIED RENAL TUBULO-INTERSTITIAL DISEASES RENAL TUBULO-INTERSTITIAL DISEASE, UNSPECIFIED RENAL TUBULO-INTERSTITIAL DISORDERS IN DISEASES CLASSIFIED ELSEWHERE ACUTE KIDNEY FAILURE WITH TUBULAR NECROSIS ACUTE KIDNEY FAILURE WITH ACUTE CORTICAL NECROSIS ACUTE KIDNEY FAILURE WITH MEDULLARY NECROSIS OTHER ACUTE KIDNEY FAILURE ACUTE KIDNEY FAILURE, UNSPECIFIED N181 CHRONIC KIDNEY DISEASE, STAGE 1 N182 N183 N184 CHRONIC KIDNEY DISEASE, STAGE 2 (MILD) CHRONIC KIDNEY DISEASE, STAGE 3 (MODERATE) CHRONIC KIDNEY DISEASE, STAGE 4 (SEVERE) N185 CHRONIC KIDNEY DISEASE, STAGE 5 N186 N189 N19 N250 N251 N2581 N259 N261 N269 END STAGE RENAL DISEASE CHRONIC KIDNEY DISEASE, UNSPECIFIED UNSPECIFIED KIDNEY FAILURE RENAL OSTEODYSTROPHY NEPHROGENIC DIABETES INSIPIDUS SECONDARY HYPERPARATHYROIDISM OF RENAL ORIGIN DISORDER RESULTING FROM IMPAIRED RENAL TUBULAR FUNCTION, UNSPECIFIED ATROPHY OF KIDNEY (TERMINAL) RENAL SCLEROSIS, UNSPECIFIED February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 18

Rosiglitazone Thiazolidinediones Rosiglitazone Drugs Requiring Prior Authorization Drugs Requiring Prior Authorization Label Name GCN AVANDIA 2 MG TABLET 93193 AVANDIA 4 MG TABLET 93203 AVANDIA 8 MG TABLET 93363 February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 19

Rosiglitazone Thiazolidinediones Rosiglitazone Clinical Edit Criteria Logic 1. Does the client have a diagnosis of heart failure in the last 365 days? [ ] Yes (Go to # 2) [ ] No (Go to #3) 2. Does the client have a history of 2 heart failure drugs for 30 days in the last 90 days? [ ] Yes (Deny) [ ] No (Go to #3) 3. Does the client have a diagnosis of type II diabetes in the last 730 days? [ ] Yes (Go to #4) [ ] No (Deny) 4. Does the client have a history of a metformin-containing agent for 30 days in the last 730 days? [ ] Yes (Go to #6) [ ] No (Go to #5) 5. Does the client have a diagnosis of renal failure in the last 730 days? [ ] Yes (Go to #6) [ ] No (Deny) 6. Does the client have a history of insulin therapy in the last 30 days? [ ] Yes (Deny) [ ] No (Approve 365 days) February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 20

Rosiglitazone Thiazolidinediones Rosiglitazone Clinical Edit Criteria Logic Diagram Step 1 Step 2 Does the client have a diagnosis of heart failure in the last 365 days? Yes Does the client have a history of 2 heart failure drugs for 30 days in the last 90 days? Yes Deny Request No No Step 3 Deny Request No Does the client have a diagnosis of type II diabetes in the last 730 days? Yes Step 4 Does the client have a history of a metformincontaining agent for 30 days in the last 730 days? Yes Step 6 No Step 5 Yes Does the client have a history of insulin therapy in the last 30 days? No Approve Request (365 days) Does the client have a diagnosis of renal failure in the last 730 days? Yes No Deny Request Deny Request February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 21

Rosiglitazone Thiazolidinediones Rosiglitazone Clinical Edit Criteria Supporting Tables Step 1 (diagnosis of heart failure) Required diagnosis: 1 Look back timeframe: 365 days For the list of diagnosis codes that pertain to this step, see the Heart Failure Diagnosis Codes table in the previous Supporting Tables section. Note: Click the hyperlink to navigate directly to the table. Step 2 (history of 2 heart failure drugs) Required quantity: 2 Look back timeframe: 90 days For the list of drug names and GCNs that pertain to this step, see the Heart Failure Drugs table in the previous Supporting Tables section. Note: Click the hyperlink to navigate directly to the table. Step 3 (diagnosis of type II diabetes) Required diagnosis: 1 For the list of diagnosis codes that pertain to this step, see the Diabetes Type II Diagnosis Codes table in the previous Supporting Tables section. Note: Click the hyperlink to navigate directly to the table. Step 4 (history of a metformin-containing agent) Required quantity: 1 For the list of drug names and GCNs that pertain to this step, see the Metformin- Containing Agents table in the previous Supporting Tables section. Note: Click the hyperlink to navigate directly to the table. February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 22

Rosiglitazone Step 5 (diagnosis of renal failure) Required diagnosis: 1 For the list of diagnosis codes that pertain to this step, see the Renal Failure Diagnosis Codes table in the previous Supporting Tables section. Note: Click the hyperlink to navigate directly to the table. Step 6 (history of an insulin agent) Required quantity: 1 Look back timeframe: 30 days Label Name GCN AFREZZA 30-4 UNIT / 60-8 UNIT 37623 AFREZZA 4 UNIT / 8 UNIT / 12 UNIT 42833 AFREZZA 4 UNIT CARTRIDGE 37619 AFREZZA 60-4 UNIT / 30-8 UNIT 37622 AFREZZA 60-8 UNIT / 30-12 UNIT 38923 AFREZZA 90-4 UNIT / 90-8 UNIT 37624 APIDRA 100 UNITS/ML VIAL 25936 APIDRA SOLOSTAR 100 UNITS/ML 26508 BASAGLAR 100 UNIT/ML KWIKPEN 98637 HUMALOG 100 UNITS/ML CARTRIDGE 05678 HUMALOG 100 UNITS/ML KWIKPEN 96719 HUMALOG 100 UNITS/ML VIAL 05679 HUMALOG 200 UNITS/ML KWIKPEN 33798 HUMALOG MIX 50-50 KWIKPEN 50461 HUMALOG MIX 50-50 VIAL 97507 HUMALOG MIX 75-25 KWIKPEN 93717 HUMALOG MIX 75-25 VIAL 22681 HUMULIN 70-30 KWIKPEN 24486 HUMULIN 70-30 VIAL 50001 HUMULIN N 100 UNITS/ML KWIKPEN 18488 HUMULIN N 100 UNITS/ML VIAL 11660 HUMULIN R 100 UNITS/ML VIAL 11642 HUMULIN R 500 UNITS/ML KWIKPEN 40542 HUMULIN R 500 UNITS/ML VIAL 09633 LANTUS 100 UNITS/ML VIAL 13072 LANTUS SOLOSTAR 100 UNITS/ML 98637 LEVEMIR 100 UNITS/ML VIAL 25305 February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 23

Rosiglitazone Step 6 (history of an insulin agent) Required quantity: 1 Look back timeframe: 30 days Label Name GCN LEVEMIR FLEXPEN 100 UNITS/ML 22836 NOVOLIN 70-30 100 UNIT/ML VIAL 50001 NOVOLIN N 100 UNITS/ML VIAL 11660 NOVOLIN R 100 UNITS/ML VIAL 11642 NOVOLOG 100 UNIT/ML CARTRIDGE 92886 NOVOLOG 100 UNIT/ML VIAL 92326 NOVOLOG FLEXPEN SYRINGE 92336 NOVOLOG MIX 70-30 FLEXPEN SYRN 17075 NOVOLOG MIX 70-30 VIAL 19057 SOLIQUA 100 UNIT-33MCG/ML PEN 42676 TOUJEO SOLOSTAR 300 UNITS/ML 37988 TRESIBA FLEXTOUCH 100 UNITS/ML 35836 TRESIBA FLEXTOUCH 200 UNITS/ML 35837 XULTOPHY 100 UNIT-3.6 MG/ML PEN 38348 February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 24

Thiazolidinediones Thiazolidinediones Clinical Edit Criteria References 1. 2015 ICD-9-CM Diagnosis Codes. 2015. Available at www.icd9data.com. Accessed on April 3, 2015. 2. 2015 ICD-10-CM Diagnosis Codes. 2015. Available at www.icd10data.com. Accessed on April 3, 2015. 3. American Medical Association data files. 2015 ICD-9-CM Diagnosis Codes. Available at www.commerce.ama-assn.org. 4. American Medical Association data files. 2015 ICD-10-CM Diagnosis Codes. Available at www.commerce.ama-assn.org. 5. Clinical Pharmacology [online database]. Tampa, FL: Elsevier/Gold Standard, Inc.; 2016. Available at www.clinicalpharmacology.com. Accessed on October 6, 2017. 6. Micromedex [online database]. Available at www.micromedexsolutions.com. Accessed on October 6, 2017. 7. Actos Prescribing Information. Deerfield, IL. Takeda Pharmaceuticals America, Inc. December 2016. 8. Avandia Prescribing Information. Research Triangle Park, NC. GlaxoSmithKline. September 2016. 9. American Diabetes Association. Standards of Medical Care in Diabetes-2017. Diabetes Care. January 2017;40(1):S1-S135. 10.Garber AJ, Abrahamson MJ, Barzilay JI, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm 2017 Executive Summary. Endocr Pract. 2017 Feb;23(2):207-38. February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 25

Thiazolidinediones Publication History The Publication History records the publication iterations and revisions to this document. Notes for the most current revision are also provided in the Revision Notes on the first page of this document. Publication Date Notes 01/31/2011 Initial publication and posting to website 03/06/2012 Added a new section to specify the drugs requiring prior authorization for and Rosiglitazone In the "Clinical Edit Supporting Tables" section for, added a table to specify the drug names and GCNs pertinent to step 2 of the logic diagram In each Clinical Edit Supporting Tables section, revised tables to specify the diagnosis codes pertinent to steps 1, 3, and 5 of the logic diagrams In the Clinical Edit Supporting Tables section for, revised tables to specify the drug names and GCNs pertinent to step 4 of the logic diagram In the Clinical Edit Supporting Tables section for Rosiglitazone, revised tables to specify the drug names and GCNs pertinent to steps 2, 4, and 6 of the logic diagram 04/03/2015 Updated to include ICD-10s 02/08/2018 Annual review by staff Removed ICD-9 codes Updated pioglitazone-containing agents, criteria logic and logic diagram, pages 3-6 Updated Table 2, pages 6-7 Updated Table 4, pages 11-12 Updated Table 6, pages 22-23 February 8, 2018 Copyright 2011-2018 Health Information Designs, LLC 26