Texas Prior Authorization Program Clinical Edit Criteria

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1 Texas Prior Authorization Program Clinical Edit Criteria Drug/Drug Class Clinical Edit Information Included in this Document 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. Revision Notes Review and update CYP3A4 inducer/inhibitor tables February 26, 2016 Copyright 2016 Health Information Designs, LLC 1

2 Drugs Requiring Prior Authorization Drugs Requiring Prior Authorization Label Name RANEXA ER 500 MG TABLET RANEXA ER 1,000 MG TABLET February 26, 2016 Copyright 2016 Health Information Designs, LLC 2

3 Clinical Edit Criteria Logic 1. Does the client have a diagnosis of chronic angina in the past 730 days? [ ] Yes (Go to #2) [ ] No (Deny) 2. Has the client received greater than or equal to ( ) 30 days of therapy with a first-line agent in the past 365 days? [ ] Yes (Go to #4) [ ] No (Go to #3) 3. Does the client have a history of greater than or equal to ( ) 90 days of therapy with ranolazine in the past 120 days? [ ] Yes (Go to #4) [ ] No (Deny) 4. Does the client have a diagnosis of clinically-significant hepatic impairment in the past 365 days? [ ] Yes (Deny) [ ] No (Go to step #5) 5. Does the client have a history of a drug that is contraindicated with ranolazine in the past 30 days? [ ] Yes (Deny) [ ] No (Approve 365 days) February 26, 2016 Copyright 2016 Health Information Designs, LLC 3

4 Clinical Edit Criteria Logic Diagram Step 1 Step 2 Step 4 Does the client have a diagnosis of chronic angina in the past 730 days? Yes Has the client received 30 days of therapy with a first-line agent in the past 365 days? Yes Does the client have a history of clinically significant hepatic impairment in the past 365 days? Yes Deny Request No No Yes No Step 3 Step 5 Deny Request Does the client have a history of 90 days of therapy with ranolazine in the past 120 days? Does the client have a history of a drug that is contraindicated with ranolazine in the past 30 days? Yes Deny Request No No Deny Request Approve (365 days) February 26, 2016 Copyright 2016 Health Information Designs, LLC 4

5 Clinical Edit Criteria Supporting Tables ICD-9 Code 4130 ANGINA DECUBITUS 4131 PRINZMETAL ANGINA Step 1 (diagnosis of chronic angina) Required diagnosis: 1 Look back timeframe: 730 days 4139 ANGINA PECTORIS NEC/NOS ICD-10 Code I201 I208 I209 I25111 I25118 I25119 I25701 I25708 I25709 I25711 I25718 I25719 I25721 I25728 I25729 I25731 I25738 ANGINA PECTORIS WITH DOCUMENTED SPASM OTHER FORMS OF ANGINA PECTORIS ANGINA PECTORIS, UNSPECIFIED ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITH ANGINA PECTORIS WITH DOCUMENTED SPASM ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITH OTHER FORMS OF ANGINA PECTORIS ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITH UNSPECIFIED ANGINA PECTORIS ATHEROSCLEROSIS OF CORONARY ARTERY BYPASS GRAFT(S), UNSPECIFIED, WITH ANGINA PECTORIS WITH DOCUMENTED SPASM ATHEROSCLEROSIS OF CORONARY ARTERY BYPASS GRAFT(S), UNSPECIFIED, WITH OTHER FORMS OF ANGINA PECTORIS ATHEROSCLEROSIS OF CORONARY ARTERY BYPASS GRAFT(S), UNSPECIFIED, WITH UNSPECIFIED ANGINA PECTORIS ATHEROSCLEROSIS OF AUTOLOGOUS VEIN CORONARY ARTERY BYPASS GRAFT(S) WITH ANGINA PECTORIS WITH DOCUMENTED SPASM ATHEROSCLEROSIS OF AUTOLOGOUS VEIN CORONARY ARTERY BYPASS GRAFT(S) WITH OTHER FORMS OF ANGINA PECTORIS ATHEROSCLEROSIS OF AUTOLOGOUS VEIN CORONARY ARTERY BYPASS GRAFT(S) WITH UNSPECIFIED ANGINA PECTORIS ATHEROSCLEROSIS OF AUTOLOGOUS ARTERY CORONARY ARTERY BYPASS GRAFT(S) WITH ANGINA PECTORIS WITH DOCUMENTED SPASM ATHEROSCLEROSIS OF AUTOLOGOUS ARTERY CORONARY ARTERY BYPASS GRAFT(S) WITH OTHER FORMS OF ANGINA PECTORIS ATHEROSCLEROSIS OF AUTOLOGOUS ARTERY CORONARY ARTERY BYPASS GRAFT(S) WITH UNSPECIFIED ANGINA PECTORIS ATHEROSCLEROSIS OF NONAUTOLOGOUS BIOLOGICAL CORONARY ARTERY BYPASS GRAFT(S) WITH ANGINA PECTORIS WITH DOCUMENTED SPASM ATHEROSCLEROSIS OF NONAUTOLOGOUS BIOLOGICAL CORONARY ARTERY BYPASS GRAFT(S) WITH OTHER FORMS OF ANGINA PECTORIS February 26, 2016 Copyright 2016 Health Information Designs, LLC 5

6 I25739 I25751 I25758 I25759 I25761 I25768 I25769 I25791 I25798 I25799 Step 1 (diagnosis of chronic angina) Required diagnosis: 1 Look back timeframe: 730 days ATHEROSCLEROSIS OF NONAUTOLOGOUS BIOLOGICAL CORONARY ARTERY BYPASS GRAFT(S) WITH UNSPECIFIED ANGINA PECTORIS ATHEROSCLEROSIS OF NATIVE CORONARY ARTERY OF TRANSPLANTED HEART WITH ANGINA PECTORIS WITH DOCUMENTED SPASM ATHEROSCLEROSIS OF NATIVE CORONARY ARTERY OF TRANSPLANTED HEART WITH OTHER FORMS OF ANGINA PECTORIS ATHEROSCLEROSIS OF NATIVE CORONARY ARTERY OF TRANSPLANTED HEART WITH UNSPECIFIED ANGINA PECTORIS ATHEROSCLEROSIS OF BYPASS GRAFT OF CORONARY ARTERY OF TRANSPLANTED HEART WITH ANGINA PECTORIS WITH DOCUMENTED SPASM ATHEROSCLEROSIS OF BYPASS GRAFT OF CORONARY ARTERY OF TRANSPLANTED HEART WITH OTHER FORMS OF ANGINA PECTORIS ATHEROSCLEROSIS OF BYPASS GRAFT OF CORONARY ARTERY OF TRANSPLANTED HEART WITH UNSPECIFIED ANGINA PECTORIS ATHEROSCLEROSIS OF OTHER CORONARY ARTERY BYPASS GRAFT(S) WITH ANGINA PECTORIS WITH DOCUMENTED SPASM ATHEROSCLEROSIS OF OTHER CORONARY ARTERY BYPASS GRAFT(S) WITH OTHER FORMS OF ANGINA PECTORIS ATHEROSCLEROSIS OF OTHER CORONARY ARTERY BYPASS GRAFT(S) WITH UNSPECIFIED ANGINA PECTORIS Step 2 ( 30 days of therapy with first-line agent) Look back timeframe: 365 days ACEBUTOLOL 200 MG CAPSULE ACEBUTOLOL 400 MG CAPSULE ADALAT CC 30 MG TABLET ADALAT CC 60 MG TABLET ADALAT CC 90 MG TABLET AFEDITAB CR 30 MG TABLET AFEDITAB CR 60 MG TABLET AMLODIPINE BESYLATE 2.5 MG TAB AMLODIPINE BESYLATE 5 MG TAB AMLODIPINE BESYLATE 10 MG TAB AMLODIPINE-BENAZEPRIL AMLODIPINE-BENAZEPRIL 5-10 MG AMLODIPINE-BENAZEPRIL 5-20 MG AMLODIPINE-BENAZEPRIL 5-40 MG February 26, 2016 Copyright 2016 Health Information Designs, LLC 6

7 Step 2 ( 30 days of therapy with first-line agent) Look back timeframe: 365 days AMLODIPINE-BENAZEPRIL MG AMLODIPINE-BENAZEPRIL MG ATENOLOL 25 MG TABLET ATENOLOL 50 MG TABLET ATENOLOL 100 MG TABLET ATENOLOL-CHLORTHAL TB ATENOLOL-CHLORTHALIDONE AZOR 5-20 MG TABLET AZOR 5-40 MG TABLET AZOR MG TABLET AZOR MG TABLET BETAXOLOL 10 MG TABLET BETAXOLOL 20 MG TABLET BIDIL TABLET BISOPROLOL FUMARATE 5 MG TAB BISOPROLOL FUMARATE 10 MG TAB BISOPROLOL-HCTZ MG TB BISOPROLOL-HCTZ MG TAB BISOPROLOL-HCTZ MG TAB CADUET 10 MG-10 MG TABLET CADUET 10 MG-20 MG TABLET CADUET 10 MG-40 MG TABLET CADUET 10 MG-80 MG TABLET CADUET 5 MG-10 MG TABLET CADUET 5 MG-20 MG TABLET CADUET 5 MG-40 MG TABLET CADUET 5 MG-80 MG TABLET CORGARD 20 MG TABLET CORGARD 40 MG TABLET CORGARD 80 MG TABLET CORZIDE 40-5 TABLET CORZIDE 80-5 TABLET DILATRATE-SR 40 MG CAPSULE DYNACIRC CR 10 MG TABLET EXFORGE MG TABLET February 26, 2016 Copyright 2016 Health Information Designs, LLC 7

8 Step 2 ( 30 days of therapy with first-line agent) Look back timeframe: 365 days EXFORGE MG TABLET EXFORGE MG TABLET EXFORGE MG TABLET EXFORGE HCT MG TAB EXFORGE HCT MG TAB EXFORGE HCT MG TAB EXFORGE HCT MG TAB EXFORGE HCT MG TAB FELODIPINE ER 2.5 MG TABLET FELODIPINE ER 5 MG TABLET FELODIPINE ER 10 MG TABLET IMDUR ER 30 MG TABLET IMDUR ER 60 MG TABLET IMDUR ER 120 MG TABLET INDERAL LA 60 MG CAPSULE INDERAL LA 80 MG CAPSULE INDERAL LA 120 MG CAPSULE INDERAL LA 160 MG CAPSULE INNOPRAN XL 80 MG CAPSULE INNOPRAN XL 120 MG CAPSULE ISMO 20 MG TABLET ISORDIL 40 MG TABLET ISOSORBIDE DN 2.5 MG TAB SL ISOSORBIDE DN 5 MG TABLET ISOSORBIDE DN 5 MG TABLET SL ISOSORBIDE DN 10 MG TABLET ISOSORBIDE DN 20 MG TABLET ISOSORBIDE DN 30 MG TABLET ISOSORBIDE DN ER 40 MG TABLET ISOSORBIDE MN 10 MG TABLET ISOSORBIDE MN 20 MG TABLET ISOSORBIDE MN ER 30 MG TABLET ISOSORBIDE MN ER 60 MG TABLET ISOSORBIDE MN ER 120 MG TAB ISRADIPINE 2.5 MG CAPSULE February 26, 2016 Copyright 2016 Health Information Designs, LLC 8

9 Step 2 ( 30 days of therapy with first-line agent) Look back timeframe: 365 days ISRADIPINE 5 MG CAPSULE LEVATOL 20 MG TABLET LOPRESSOR 50 MG TABLET LOPRESSOR 100 MG TABLET LOTREL MG CAPSULE LOTREL 5-10 MG CAPSULE LOTREL 5-20 MG CAPSULE LOTREL 5-40 MG CAPSULE LOTREL MG CAPSULE LOTREL MG CAPSULE METOPROLOL SUCC ER 25 MG TAB METOPROLOL SUCC ER 50 MG TAB METOPROLOL SUCC ER 100 MG TAB METOPROLOL SUCC ER 200 MG TAB METOPROLOL TARTRATE 25 MG TAB METOPROLOL TARTRATE 50 MG TAB METOPROLOL TARTRATE 100 MG TAB METOPROLOL-HCTZ MG TAB METOPROLOL-HCTZ MG TAB METOPROLOL-HCTZ MG TAB MINITRAN 0.1 MG/HR PATCH MINITRAN 0.2 MG/HR PATCH MINITRAN 0.4 MG/HR PATCH MINITRAN 0.6 MG/HR PATCH MONOKET 10 MG TABLET MONOKET 20 MG TABLET NADOLOL 20 MG TABLET NADOLOL 40 MG TABLET NADOLOL 80 MG TABLET NADOLOL-BENDROFLU 40-5 MG TAB NADOLOL-BENDROFLU 80-5 MG TAB NICARDIPINE 20 MG CAPSULE NICARDIPINE 30 MG CAPSULE NIFEDIAC CC 30 MG TABLET NIFEDIAC CC 60 MG TABLET February 26, 2016 Copyright 2016 Health Information Designs, LLC 9

10 Step 2 ( 30 days of therapy with first-line agent) Look back timeframe: 365 days NIFEDIAC CC 90 MG TABLET NIFEDICAL XL 30 MG TABLET NIFEDICAL XL 60 MG TABLET NIFEDIPINE 10 MG CAPSULE NIFEDIPINE 20 MG CAPSULE NIFEDIPINE ER 30 MG TABLET NIFEDIPINE ER 30 MG TABLET NIFEDIPINE ER 60 MG TABLET NIFEDIPINE ER 60 MG TABLET NIFEDIPINE ER 90 MG TABLET NIFEDIPINE ER 90 MG TABLET NISOLDIPINE ER 8.5 MG TABLET NISOLDIPINE ER 17 MG TABLET NISOLDIPINE ER 25.5 MG TABLET NISOLDIPINE ER 34 MG TABLET NITRO-DUR 0.1 MG/HR PATCH NITRO-DUR 0.2 MG/HR PATCH NITRO-DUR 0.3 MG/HR PATCH NITRO-DUR 0.4 MG/HR PATCH NITRO-DUR 0.6 MG/HR PATCH NITRO-DUR 0.8 MG/HR PATCH NITROGLYCERIN 0.1 MG/HR PATCH NITROGLYCERIN 0.2 MG/HR PATCH NITROGLYCERIN 0.3 MG TAB SL NITROGLYCERIN 0.4 MG TABLET SL NITROGLYCERIN 0.4 MG/HR PATCH NITROGLYCERIN 0.6 MG TAB SL NITROGLYCERIN 0.6 MG/HR PATCH NITROGLYCERIN ER 2.5 MG CAP NITROGLYCERIN LINGUAL 0.4 MG NITROLINGUAL 0.4 MG SPRAY NITROQUICK 0.3 MG TABLET SL NITROQUICK 0.4 MG TABLET SL NITROQUICK 0.6 MG TABLET SL NITROSTAT 0.3 MG TABLET SL February 26, 2016 Copyright 2016 Health Information Designs, LLC 10

11 Step 2 ( 30 days of therapy with first-line agent) Look back timeframe: 365 days NITROSTAT 0.4 MG TABLET SL NITROSTAT 0.6 MG TABLET SL NORVASC 2.5 MG TABLET NORVASC 5 MG TABLET NORVASC 10 MG TABLET PINDOLOL 5 MG TABLET PINDOLOL 10 MG TABLET PROCARDIA 10 MG CAPSULE PROCARDIA XL 30 MG TABLET PROCARDIA XL 60 MG TABLET PROCARDIA XL 90 MG TABLET PROPRANOLOL 10 MG TABLET PROPRANOLOL 20 MG TABLET PROPRANOLOL 20 MG/5 ML SOLN PROPRANOLOL 40 MG TABLET PROPRANOLOL 40 MG/5 ML SOLN PROPRANOLOL 60 MG TABLET PROPRANOLOL 80 MG TABLET PROPRANOLOL ER 60 MG CAPSULE PROPRANOLOL ER 80 MG CAPSULE PROPRANOLOL ER 120 MG CAPSULE PROPRANOLOL ER 160 MG CAPSULE PROPRANOLOL-HCTZ MG TAB PROPRANOLOL-HCTZ MG TAB SECTRAL 200 MG CAPSULE SECTRAL 400 MG CAPSULE SULAR ER 8.5 MG TABLET SULAR ER 17 MG TABLET SULAR ER 25.5 MG TABLET SULAR ER 34 MG TABLET TEKAMLO 150 MG-5 MG TABLET TEKAMLO 150 MG-10 MG TABLET TEKAMLO 300 MG-5 MG TABLET TEKAMLO 300 MG-10 MG TABLET TENORETIC 50 TABLET February 26, 2016 Copyright 2016 Health Information Designs, LLC 11

12 Step 2 ( 30 days of therapy with first-line agent) Look back timeframe: 365 days TENORETIC 100 TABLET TENORMIN 25 MG TABLET TENORMIN 50 MG TABLET TENORMIN 100 MG TABLET TIMOLOL MALEATE 5 MG TABLET TIMOLOL MALEATE 10 MG TABLET TIMOLOL MALEATE 20 MG TABLET TOPROL XL 25 MG TABLET TOPROL XL 50 MG TABLET TOPROL XL 100 MG TABLET TOPROL XL 200 MG TABLET TRIBENZOR MG TABLET TRIBENZOR MG TABLET TRIBENZOR MG TABLET TRIBENZOR MG TABLET TRIBENZOR MG TABLET TWYNSTA 40-5 MG TABLET TWYNSTA MG TABLET TWYNSTA 80-5 MG TABLET TWYNSTA MG TABLET ZEBETA 5 MG TABLET ZEBETA 10 MG TABLET ZIAC MG TABLET ZIAC MG TABLET ZIAC MG TABLET Step 3 (history of greater than or equal to ( ) 90 days of therapy with ranolazine) Look back timeframe: 120 days For the list of drug names and s that pertain to this step, see the Drugs Requiring Prior Authorization table in the Supporting Tables section. Note: Click the hyperlink to navigate directly to the table. February 26, 2016 Copyright 2016 Health Information Designs, LLC 12

13 Step 4 (diagnosis of clinically-significant hepatic impairment) Required diagnosis: 1 Look back timeframe: 365 days ICD HEPATITIS A WITH COMA 0701 HEPATITIS A W/O COMA HPT B ACTE COMA WO DLTA HPT B ACTE COMA W DLTA HPT B CHRN COMA WO DLTA HPT B CHRN COMA W DLTA HPT B ACTE WO CM WO DLTA HPT B ACTE WO CM W DLTA HPT B CHRN WO CM WO DLTA HPT B CHRN WO CM W DLTA ACUTE HEPATITIS C WITH HEPATIC COMA HPT DLT WO B W HPT COMA HPT E W HEPAT COMA CHRNC HPT C W HEPAT COMA OTH VRL HEPAT W HPT COMA ACUTE HEPATITIS C WITHOUT MENTION OF HEPATIC COMA HPT DLT WO B WO HPT COMA HPT E WO HEPAT COMA CHRNC HPT C WO HPAT COMA OTH VRL HPAT WO HPT COMA 0706 VIRAL HEPAT NOS W COMA UNSPECIFIED VIRAL HEPATITIS C WITHOUT HEPATIC COMA UNSPECIFIED VIRAL HEPATITIS C WITH HEPATIC COMA 0709 VIRAL HEPAT NOS W/O COMA 5710 ALCOHOLIC FATTY LIVER 5711 AC ALCOHOLIC HEPATITIS 5712 ALCOHOL CIRRHOSIS LIVER 5713 ALCOHOL LIVER DAMAGE NOS CHRONIC HEPATITIS NOS CHR PERSISTENT HEPATITIS AUTOIMMUNE HEPATITIS CHRONIC HEPATITIS NEC 5715 CIRRHOSIS OF LIVER NOS 5716 BILIARY CIRRHOSIS 5718 CHRONIC LIVER DIS NEC February 26, 2016 Copyright 2016 Health Information Designs, LLC 13

14 Step 4 (diagnosis of clinically-significant hepatic impairment) Required diagnosis: 1 Look back timeframe: 365 days 5719 CHRONIC LIVER DIS NOS 5720 ABSCESS OF LIVER 5721 PORTAL PYEMIA 5722 HEPATIC ENCEPHALOPATHY 5723 PORTAL HYPERTENSION 5724 HEPATORENAL SYNDROME 5728 OTH SEQUELA, CHR LIV DIS 5730 CHR PASSIV CONGEST LIVER 5731 HEPATITIS IN VIRAL DIS 5732 HEPATITIS IN OTH INF DIS 5733 HEPATITIS NOS 5734 HEPATIC INFARCTION 5738 LIVER DISORDERS NEC 5739 LIVER DISORDER NOS ICD-10 Code B150 B159 B160 B161 B162 B169 B170 B1710 B1711 B172 B178 B179 B180 B181 B182 B188 B189 B190 B1910 B1911 B1920 HEPATITIS A WITH HEPATIC COMA HEPATITIS A WITHOUT HEPATIC COMA ACUTE HEPATITIS B WITH DELTA-AGENT WITH HEPATIC COMA ACUTE HEPATITIS B WITH DELTA-AGENT WITHOUT HEPATIC COMA ACUTE HEPATITIS B WITHOUT DELTA-AGENT WITH HEPATIC COMA ACUTE HEPATITIS B WITHOUT DELTA-AGENT AND WITHOUT HEPATIC COMA ACUTE DELTA-(SUPER) INFECTION OF HEPATITIS B CARRIER ACUTE HEPATITIS C WITHOUT HEPATIC COMA ACUTE HEPATITIS C WITH HEPATIC COMA ACUTE HEPATITIS E OTHER SPECIFIED ACUTE VIRAL HEPATITIS ACUTE VIRAL HEPATITIS, UNSPECIFIED CHRONIC VIRAL HEPATITIS B WITH DELTA-AGENT CHRONIC VIRAL HEPATITIS B WITHOUT DELTA-AGENT CHRONIC VIRAL HEPATITIS C OTHER CHRONIC VIRAL HEPATITIS CHRONIC VIRAL HEPATITIS, UNSPECIFIED UNSPECIFIED VIRAL HEPATITIS WITH HEPATIC COMA UNSPECIFIED VIRAL HEPATITIS B WITHOUT HEPATIC COMA UNSPECIFIED VIRAL HEPATITIS B WITH HEPATIC COMA UNSPECIFIED VIRAL HEPATITIS C WITHOUT HEPATIC COMA February 26, 2016 Copyright 2016 Health Information Designs, LLC 14

15 Step 4 (diagnosis of clinically-significant hepatic impairment) Required diagnosis: 1 Look back timeframe: 365 days B1921 B199 B251 K700 K7010 K7011 K702 K7030 K7031 K7040 K7041 K709 K710 K7110 K7111 K712 K713 K714 K7150 K7151 K716 K717 K718 K719 K7201 K7210 K7211 K7290 K7291 K730 K731 K732 K738 K739 K740 UNSPECIFIED VIRAL HEPATITIS C WITH HEPATIC COMA UNSPECIFIED VIRAL HEPATITIS WITHOUT HEPATIC COMA CYTOMEGALOVIRAL HEPATITIS ALCOHOLIC FATTY LIVER ALCOHOLIC HEPATITIS WITHOUT ASCITES ALCOHOLIC HEPATITIS WITH ASCITES ALCOHOLIC FIBROSIS AND SCLEROSIS OF LIVER ALCOHOLIC CIRRHOSIS OF LIVER WITHOUT ASCITES ALCOHOLIC CIRRHOSIS OF LIVER WITH ASCITES ALCOHOLIC HEPATIC FAILURE WITHOUT COMA ALCOHOLIC HEPATIC FAILURE WITH COMA ALCOHOLIC LIVER DISEASE, UNSPECIFIED TOXIC LIVER DISEASE WITH CHOLESTASIS TOXIC LIVER DISEASE WITH HEPATIC NECROSIS, WITHOUT COMA TOXIC LIVER DISEASE WITH HEPATIC NECROSIS, WITH COMA TOXIC LIVER DISEASE WITH ACUTE HEPATITIS TOXIC LIVER DISEASE WITH CHRONIC PERSISTENT HEPATITIS TOXIC LIVER DISEASE WITH CHRONIC LOBULAR HEPATITIS TOXIC LIVER DISEASE WITH CHRONIC ACTIVE HEPATITIS WITHOUT ASCITES TOXIC LIVER DISEASE WITH CHRONIC ACTIVE HEPATITIS WITH ASCITES TOXIC LIVER DISEASE WITH HEPATITIS, NOT ELSEWHERE CLASSIFIED TOXIC LIVER DISEASE WITH FIBROSIS AND CIRRHOSIS OF LIVER TOXIC LIVER DISEASE WITH OTHER DISORDERS OF LIVER TOXIC LIVER DISEASE, UNSPECIFIED ACUTE AND SUBACUTE HEPATIC FAILURE WITH COMA CHRONIC HEPATIC FAILURE WITHOUT COMA CHRONIC HEPATIC FAILURE WITH COMA HEPATIC FAILURE, UNSPECIFIED WITHOUT COMA HEPATIC FAILURE, UNSPECIFIED WITH COMA CHRONIC PERSISTENT HEPATITIS, NOT ELSEWHERE CLASSIFIED CHRONIC LOBULAR HEPATITIS, NOT ELSEWHERE CLASSIFIED CHRONIC ACTIVE HEPATITIS, NOT ELSEWHERE CLASSIFIED OTHER CHRONIC HEPATITIS, NOT ELSEWHERE CLASSIFIED CHRONIC HEPATITIS, UNSPECIFIED HEPATIC FIBROSIS February 26, 2016 Copyright 2016 Health Information Designs, LLC 15

16 Step 4 (diagnosis of clinically-significant hepatic impairment) Required diagnosis: 1 Look back timeframe: 365 days K741 K742 K743 K744 K745 K7460 K7469 K750 K751 K752 K753 K7581 K7589 K759 K760 K761 K763 K764 K765 K766 K767 K7689 K769 K77 HEPATIC SCLEROSIS HEPATIC FIBROSIS WITH HEPATIC SCLEROSIS PRIMARY BILIARY CIRRHOSIS SECONDARY BILIARY CIRRHOSIS BILIARY CIRRHOSIS, UNSPECIFIED UNSPECIFIED CIRRHOSIS OF LIVER OTHER CIRRHOSIS OF LIVER ABSCESS OF LIVER PHLEBITIS OF PORTAL VEIN NONSPECIFIC REACTIVE HEPATITIS GRANULOMATOUS HEPATITIS, NOT ELSEWHERE CLASSIFIED NONALCOHOLIC STEATOHEPATITIS (NASH) OTHER SPECIFIED INFLAMMATORY LIVER DISEASES INFLAMMATORY LIVER DISEASE, UNSPECIFIED FATTY (CHANGE OF) LIVER, NOT ELSEWHERE CLASSIFIED CHRONIC PASSIVE CONGESTION OF LIVER INFARCTION OF LIVER PELIOSIS HEPATIS HEPATIC VENO-OCCLUSIVE DISEASE PORTAL HYPERTENSION HEPATORENAL SYNDROME OTHER SPECIFIED DISEASES OF LIVER LIVER DISEASE, UNSPECIFIED LIVER DISORDERS IN DISEASES CLASSIFIED ELSEWHERE Step 5 (history of a drug that is contraindicated with ranolazine) Look back timeframe: 30 days BIAXIN 250 MG TABLET BIAXIN 250 MG/5 ML SUSPENSION BIAXIN 500 MG TABLET BUNAVAIL MG FILM BUNAVAIL MG FILM BUNAVAIL MG FILM CALAN 120 MG TABLET February 26, 2016 Copyright 2016 Health Information Designs, LLC 16

17 Step 5 (history of a drug that is contraindicated with ranolazine) Look back timeframe: 30 days CALAN 80 MG TABLET CALAN SR 120 MG CAPLET CALAN SR 180 MG CAPLET CALAN SR 240 MG CAPLET CARDIZEM 120 MG TABLET CARDIZEM 30 MG TABLET CARDIZEM 60 MG TABLET CARDIZEM CD 120 MG CAPSULE CARDIZEM CD 180 MG CAPSULE CARDIZEM CD 240 MG CAPSULE CARDIZEM CD 300 MG CAPSULE CARDIZEM CD 360 MG CAPSULE CARDIZEM LA 120 MG TABLET CARDIZEM LA 180 MG TABLET CARDIZEM LA 360 MG TABLET CARDIZEM LA 420 MG TABLET CARTIA XT 120MG CAPSULE CARTIA XT 180MG CAPSULE CARTIA XT 240MG CAPSULE CARTIA XT 300MG CAPSULE CLARITHROMYCIN 125 MG/5 ML SUS CLARITHROMYCIN 250 MG TABLET CLARITHROMYCIN 250 MG/5 ML SUS CLARITHROMYCIN 500 MG TABLET CLARITHROMYCIN ER 500 MG TAB CRIXIVAN 200 MG CAPSULE CRIXIVAN 400 MG CAPSULE DIFLUCAN 10 MG/ML SUSPENSION DIFLUCAN 100 MG TABLET DIFLUCAN 150 MG TABLET DIFLUCAN 200 MG TABLET DIFLUCAN 40 MG/ML SUSPENSION DIFLUCAN 50 MG TABLET DILTIAZEM 120 MG TABLET DILTIAZEM 12HR ER 120 MG CAP DILTIAZEM 12HR ER 60 MG CAP DILTIAZEM 12HR ER 90 MG CAP February 26, 2016 Copyright 2016 Health Information Designs, LLC 17

18 Step 5 (history of a drug that is contraindicated with ranolazine) Look back timeframe: 30 days DILTIAZEM 24HR ER 120 MG CAP DILTIAZEM 24HR ER 180 MG CAP DILTIAZEM 24HR ER 240 MG CAP DILTIAZEM 24HR ER 300 MG CAP DILTIAZEM 24HR ER 360 MG CAP DILTIAZEM 30 MG TABLET DILTIAZEM 60 MG TABLET DILTIAZEM 90 MG TABLET DILTIAZEM ER 120 MG CAPSULE DILTIAZEM ER 120 MG CAPSULE DILTIAZEM ER 180 MG CAPSULE DILTIAZEM ER 180 MG CAPSULE DILTIAZEM ER 240 MG CAPSULE DILTIAZEM HCL ER 240 MG CAP DILTIAZEM HCL ER 300 MG CAP DILTIAZEM HCL ER 360 MG CAP DILTIAZEM HCL ER 420 MG CAP E.E.S. 200 MG/5 ML GRANULES E.E.S. 400 FILMTAB EMEND 125MG CAPSULE EMEND 40MG CAPSULE EMEND 80MG CAPSULE EMEND TRIPACK ERYPED 200 MG/5 ML SUSPENSION ERYPED 400 MG/5 ML SUSPENSION ERY-TAB EC 250 MG TABLET ERY-TAB EC 333 MG TABLET ERY-TAB EC 500 MG TABLET ERYTHROCIN 250 MG FILMTAB ERYTHROCIN 500 MG ADDVNT VL ERYTHROCIN 500 MG VIAL ERYTHROMYCIN 250 MG FILMTAB ERYTHROMYCIN 500 MG FILMTAB ERYTHROMYCIN EC 250 MG CAP ERYTHROMYCIN ES 400 MG TAB EVOTAZ MG TABLET FLUCONAZOLE 10 MG/ML SUSP February 26, 2016 Copyright 2016 Health Information Designs, LLC 18

19 Step 5 (history of a drug that is contraindicated with ranolazine) Look back timeframe: 30 days FLUCONAZOLE 100 MG TABLET FLUCONAZOLE 150 MG TABLET FLUCONAZOLE 200 MG TABLET FLUCONAZOLE 40 MG/ML SUSP FLUCONAZOLE 50 MG TABLET FLUCONAZOLE-DEXT 200 MG/100 ML FLUCONAZOLE-NACL 200 MG/100 ML FLUCONAZOLE-NACL 400 MG/200 ML FLUCONAZOLE-NS 200 MG/100 ML GLEEVEC 100MG TABLET GLEEVEC 400MG TABLET INVIRASE 200 MG CAPSULE INVIRASE 500 MG TABLET ITRACONAZOLE 100 MG CAPSULE KALETRA MG TABLET KALETRA MG TABLET KALETRA /5 ML ORAL SOLU KETEK 300 MG TABLET KETEK 400 MG TABLET KETOCONAZOLE 200 MG TABLET LANSOPRAZOL-AMOXICIL-CLARITHRO LEXIVA 50MG/ML SUSPENSION LEXIVA 700MG TABLET MATZIM LA 180MG TABLET MATZIM LA 240MG TABLET MATZIM LA 300MG TABLET MATZIM LA 360MG TABLET MATZIM LA 420MG TABLET NEFAZODONE 100MG TABLET NEFAZODONE 150MG TABLET NEFAZODONE 200MG TABLET NEFAZODONE 250MG TABLET NEFAZODONE 50MG TABLET NORVIR 100 MG SOFTGEL CAP NORVIR 100 MG TABLET NORVIR 80 MG/ML SOLUTION NOXAFIL 40 MG/ML SUSPENSION February 26, 2016 Copyright 2016 Health Information Designs, LLC 19

20 Step 5 (history of a drug that is contraindicated with ranolazine) Look back timeframe: 30 days NOXAFIL DR 100 MG TABLET PCE 333 MG TABLET PCE 500 MG TABLET PREVPAC PATIENT PACK PREZCOBIX MG TABLET PREZISTA 100MG/ML SUSPENSION PREZISTA 150MG TABLET PREZISTA 600MG TABLET PREZISTA 75MG TABLET PREZISTA 800MG TABLET REYATAZ 150MG CAPSULE REYATAZ 200MG CAPSULE REYATAZ 300MG CAPSULE REYATAZ 50MG POWDER PACK SPORANOX 10 MG/ML SOLUTION SPORANOX 100 MG CAPSULE SUBOXONE 12 MG-3 MG SL FILM SUBOXONE 2 MG-0.5 MG SL FILM SUBOXONE 4 MG-1 MG SL FILM SUBOXONE 8 MG-2 MG SL FILM TAZTIA XT 120MG CAPSULE TAZTIA XT 180MG CAPSULE TAZTIA XT 240MG CAPSULE TAZTIA XT 300MG CAPSULE TAZTIA XT 360MG CAPSULE TIAZAC ER 120MG CAPSULE TIAZAC ER 180MG CAPSULE TIAZAC ER 240MG CAPSULE TIAZAC ER 300MG CAPSULE TIAZAC ER 360MG CAPSULE TIAZAC ER 420MG CAPSULE TRANDOLAPR-VERAPAM ER MG TRANDOLAPR-VERAPAM ER MG TRANDOLAPR-VERAPAM ER MG TRANDOLAPR-VERAPAM ER MG VERAPAMIL 120 MG TABLET VERAPAMIL 360 MG CAP PELLET February 26, 2016 Copyright 2016 Health Information Designs, LLC 20

21 Step 5 (history of a drug that is contraindicated with ranolazine) Look back timeframe: 30 days VERAPAMIL 40 MG TABLET VERAPAMIL 80 MG TABLET VERAPAMIL ER 120 MG CAPSULE VERAPAMIL ER 120 MG TABLET VERAPAMIL ER 180 MG CAPSULE VERAPAMIL ER 180 MG TABLET VERAPAMIL ER 240 MG CAPSULE VERAPAMIL ER 240 MG TABLET VERAPAMIL ER PM 100 MG CAPSULE VERAPAMIL ER PM 200 MG CAPSULE VERAPAMIL ER PM 300 MG CAPSULE VERELAN 120 MG CAP PELLET VERELAN 180 MG CAP PELLET VERELAN 240 MG CAP PELLET VERELAN 360 MG CAP PELLET VERELAN PM 100 MG CAP PELLET VERELAN PM 200 MG CAP PELLET VERELAN PM 300 MG CAP PELLET VFEND 200 MG TABLET VFEND 40 MG/ML SUSPENSION VFEND 50 MG TABLET VFEND IV 200 MG VIAL VICTRELIS 200 MG CAPSULE VIEKIRA PAK VIRACEPT 250 MG TABLET VIRACEPT 625 MG TABLET VORICONAZOLE 200 MG TABLET VORICONAZOLE 200 MG VIAL VORICONAZOLE 40 MG/ML SUSP VORICONAZOLE 50 MG TABLET February 26, 2016 Copyright 2016 Health Information Designs, LLC 21

22 Clinical Edit Criteria References 1. [package insert]. Foster City, CA: Gilead Sciences, Inc. December Available at Accessed on March 7, MICROMEDEX Health Services. DRUGDEX evaluations: drug evaluation. Available at: Accessed on February 28, Lexi-Comp Drug Information Handbook. drug evaluation. Available at: Accessed on February 28, ICD-9-CM Diagnosis Codes Available at Accessed on April 3, ICD-10-CM Diagnosis Codes Available at Accessed on April 3, American Medical Association data files ICD-9-CM Diagnosis Codes. Available at 7. American Medical Association data files ICD-10-CM Diagnosis Codes. Available at 8. Indiana University, Department of Medicine, Clinical Pharmacology Research Institute. P450 Interaction Table. Available at medicine.iupui.edu. Accessed on February 19, U.S. Food and Drug Administration (FDA). Drug Development and Drug Interactions: Table of Substrates, Inhibitors and Inducers. Available at Accessed on February 19, February 26, 2016 Copyright 2016 Health Information Designs, LLC 22

23 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 04/03/2012 Initial publication and posting to website 04/03/2015 Updated to include ICD-10s 02/26/2016 Review and update CYP inducer/inhibitor tables February 26, 2016 Copyright 2016 Health Information Designs, LLC 23

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