Texas Prior Authorization Program Clinical Criteria

Transcription

1 Texas Prior Authorization Program Clinical Criteria Drug/Drug Class Clinical Criteria Information Included in this Document Drugs requiring prior authorization: the list of drugs requiring prior authorization for this clinical criteria Prior authorization criteria logic: a description of how the prior authorization request will be evaluated against the clinical criteria rules Logic diagram: a visual depiction of the clinical 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 criteria Note: Click the hyperlink to navigate directly to that section. Revision Notes Annual review by staff Updated Table 2, page 6 Updated Table 5, page 16 Updated references, pages November 20, 2017 Copyright 2017 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 November 20, 2017 Copyright 2017 Health Information Designs, LLC 2

3 Clinical 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) November 20, 2017 Copyright 2017 Health Information Designs, LLC 3

4 Clinical 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) November 20, 2017 Copyright 2017 Health Information Designs, LLC 4

5 Clinical 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 November 20, 2017 Copyright 2017 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 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 10 MG TAB AMLODIPINE BESYLATE 2.5 MG TAB AMLODIPINE BESYLATE 5 MG TAB AMLODIPINE-ATORVAST MG AMLODIPINE-ATORVAST MG AMLODIPINE-ATORVAST MG AMLODIPINE-ATORVAST MG AMLODIPINE-ATORVAST MG AMLODIPINE-ATORVAST MG November 20, 2017 Copyright 2017 Health Information Designs, LLC 6

7 Step 2 ( 30 days of therapy with first-line agent) Look back timeframe: 365 days AMLODIPINE-ATORVAST MG AMLODIPINE-ATORVAST 5-10 MG AMLODIPINE-ATORVAST 5-20 MG AMLODIPINE-ATORVAST 5-40 MG AMLODIPINE-ATORVAST 5-80 MG ATENOLOL 100 MG TABLET ATENOLOL 25 MG TABLET ATENOLOL 50 MG TABLET ATENOLOL-CHLORTHAL TB ATENOLOL-CHLORTHALIDONE 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 CALAN 120 MG TABLET CALAN 80 MG TABLET CALAN SR 120 MG CAPLET CALAN SR 180 MG CAPLET CALAN SR 240 MG CAPLET CARDIZEM 120 MG TABLET 2363 CARDIZEM 30 MG TABLET 2360 CARDIZEM 60 MG TABLET 2361 CARDIZEM CD 120 MG CAPSULE 2326 CARDIZEM CD 180 MG CAPSULE 2323 CARDIZEM CD 240 MG CAPSULE 2324 CARDIZEM CD 300 MG CAPSULE 2325 CARDIZEM CD 360 MG CAPSULE 7460 CARDIZEM LA 180 MG TABLET CARDIZEM LA 360 MG TABLET CARTIA XT 120 MG CAPSULE 2326 CARTIA XT 180 MG CAPSULE 2323 November 20, 2017 Copyright 2017 Health Information Designs, LLC 7

8 Step 2 ( 30 days of therapy with first-line agent) Look back timeframe: 365 days CARTIA XT 240 MG CAPSULE 2324 CARTIA XT 300 MG CAPSULE 2325 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 DILT XR 120 MG CAPSULE DILT XR 180 MG CAPSULE DILT XR 240 MG CAPSULE DILTIAZEM 120 MG TABLET DILTIAZEM 12HR ER 120 MG CAP DILTIAZEM 12HR ER 60 MG CAP DILTIAZEM 12HR ER 90 MG CAP 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 HEMANGEOL 4.28 MG/ML ORAL SOLN INDERAL LA 120 MG CAPSULE INDERAL LA 160 MG CAPSULE November 20, 2017 Copyright 2017 Health Information Designs, LLC 8

9 Step 2 ( 30 days of therapy with first-line agent) Look back timeframe: 365 days INDERAL LA 60 MG CAPSULE INDERAL LA 80 MG CAPSULE INNOPRAN XL 120 MG CAPSULE INNOPRAN XL 80 MG CAPSULE ISOSORBIDE DN 10 MG TABLET ISOSORBIDE DN 20 MG TABLET ISOSORBIDE DN 30 MG TABLET ISOSORBIDE DN 5 MG TABLET ISOSORBIDE DN ER 40 MG TABLET ISOSORBIDE MN 10 MG TABLET ISOSORBIDE MN 20 MG TABLET ISOSORBIDE MN ER 120 MG TAB ISOSORBIDE MN ER 30 MG TABLET ISOSORBIDE MN ER 60 MG TABLET MATZIM LA 180 MG TABLET MATZIM LA 240 MG TABLET MATZIM LA 300 MG TABLET MATZIM LA 360 MG TABLET MATZIM LA 420 MG TABLET METOPROLOL SUCC ER 100 MG TAB METOPROLOL SUCC ER 200 MG TAB METOPROLOL SUCC ER 25 MG TAB METOPROLOL SUCC ER 50 MG TAB METOPROLOL TARTRATE 100 MG TAB METOPROLOL TARTRATE 25 MG TAB METOPROLOL TARTRATE 50 MG TAB METOPROLOL-HCTZ MG TAB METOPROLOL-HCTZ MG TAB METOPROLOL-HCTZ MG TAB 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 November 20, 2017 Copyright 2017 Health Information Designs, LLC 9

10 Step 2 ( 30 days of therapy with first-line agent) Look back timeframe: 365 days NICARDIPINE 30 MG CAPSULE 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 NITRO-BID 2% OINTMENT 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 0.4 MG/HR PATCH NITROGLYCERIN 0.6 MG/HR PATCH NITROGLYCERIN ER 2.5 MG CAP NITROGLYCERIN LINGUAL 0.4 MG NITROLINGUAL 0.4 MG SPRAY NITROMIST 400 MCG SPRAY NITROSTAT 0.3 MG TABLET SL NITROSTAT 0.4 MG TABLET SL NITROSTAT 0.6 MG TABLET SL NORVASC 10 MG TABLET NORVASC 2.5 MG TABLET NORVASC 5 MG TABLET NYMALIZE 60 MG/20 ML SOLUTION PROCARDIA 10 MG CAPSULE PROCARDIA XL 30 MG TABLET November 20, 2017 Copyright 2017 Health Information Designs, LLC 10

11 Step 2 ( 30 days of therapy with first-line agent) Look back timeframe: 365 days 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 120 MG CAPSULE PROPRANOLOL ER 160 MG CAPSULE PROPRANOLOL ER 60 MG CAPSULE PROPRANOLOL ER 80 MG CAPSULE PROPRANOLOL-HCTZ MG TAB PROPRANOLOL-HCTZ MG TAB TAZTIA XT 120 MG CAPSULE TAZTIA XT 180 MG CAPSULE TAZTIA XT 240 MG CAPSULE TAZTIA XT 300 MG CAPSULE TAZTIA XT 360 MG CAPSULE TENORETIC 100 TABLET TENORETIC 50 TABLET TENORMIN 100 MG TABLET TENORMIN 25 MG TABLET TENORMIN 50 MG TABLET TIAZAC ER 120 MG CAPSULE TIAZAC ER 180 MG CAPSULE TIAZAC ER 240 MG CAPSULE TIAZAC ER 300 MG CAPSULE TIAZAC ER 360 MG CAPSULE TIAZAC ER 420 MG CAPSULE TOPROL XL 100 MG TABLET TOPROL XL 200 MG TABLET TOPROL XL 25 MG TABLET TOPROL XL 50 MG TABLET November 20, 2017 Copyright 2017 Health Information Designs, LLC 11

12 Step 2 ( 30 days of therapy with first-line agent) Look back timeframe: 365 days VERAPAMIL 120 MG TABLET VERAPAMIL 360 MG CAP PELLET 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 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. Step 4 (diagnosis of clinically-significant hepatic impairment) Required diagnosis: 1 Look back timeframe: 365 days ICD HEPATITIS A WITH COMA November 20, 2017 Copyright 2017 Health Information Designs, LLC 12

13 Step 4 (diagnosis of clinically-significant hepatic impairment) Required diagnosis: 1 Look back timeframe: 365 days 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 5719 CHRONIC LIVER DIS NOS 5720 ABSCESS OF LIVER November 20, 2017 Copyright 2017 Health Information Designs, LLC 13

14 Step 4 (diagnosis of clinically-significant hepatic impairment) Required diagnosis: 1 Look back timeframe: 365 days 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 B1921 B199 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 UNSPECIFIED VIRAL HEPATITIS C WITH HEPATIC COMA UNSPECIFIED VIRAL HEPATITIS WITHOUT HEPATIC COMA November 20, 2017 Copyright 2017 Health Information Designs, LLC 14

15 Step 4 (diagnosis of clinically-significant hepatic impairment) Required diagnosis: 1 Look back timeframe: 365 days 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 K741 K742 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 HEPATIC SCLEROSIS HEPATIC FIBROSIS WITH HEPATIC SCLEROSIS November 20, 2017 Copyright 2017 Health Information Designs, LLC 15

16 Step 4 (diagnosis of clinically-significant hepatic impairment) Required diagnosis: 1 Look back timeframe: 365 days K743 K744 K745 K7460 K7469 K750 K751 K752 K753 K7581 K7589 K759 K760 K761 K763 K764 K765 K766 K767 K7689 K769 K77 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 CALAN 80 MG TABLET CALAN SR 120 MG CAPLET November 20, 2017 Copyright 2017 Health Information Designs, LLC 16

17 Step 5 (history of a drug that is contraindicated with ranolazine) Look back timeframe: 30 days 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 CARBAMAZEPINE 100 MG TAB CHEW CARBAMAZEPINE 100 MG/5 ML SUSP CARBAMAZEPINE 200 MG TABLET CARBAMAZEPINE ER 100 MG CAP CARBAMAZEPINE ER 200 MG CAP CARBAMAZEPINE ER 200 MG TABLET CARBAMAZEPINE ER 300 MG CAP CARBAMAZEPINE ER 400 MG TABLET CARBATROL ER 100 MG CAPSULE CARBATROL ER 200 MG CAPSULE CARBATROL ER 300 MG CAPSULE 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 November 20, 2017 Copyright 2017 Health Information Designs, LLC 17

18 Step 5 (history of a drug that is contraindicated with ranolazine) Look back timeframe: 30 days DIFLUCAN 100 MG TABLET DIFLUCAN 150 MG TABLET DIFLUCAN 200 MG TABLET DIFLUCAN 40 MG/ML SUSPENSION DIFLUCAN 50 MG TABLET DILANTIN 100 MG CAPSULE DILANTIN 125 MG/5 ML SUSP DILANTIN 30 MG CAPSULE DILANTIN 50 MG INFATAB DILTIAZEM 120 MG TABLET DILTIAZEM 12HR ER 120 MG CAP DILTIAZEM 12HR ER 60 MG CAP DILTIAZEM 12HR ER 90 MG CAP 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 EPITOL 200 MG TABLET November 20, 2017 Copyright 2017 Health Information Designs, LLC 18

19 Step 5 (history of a drug that is contraindicated with ranolazine) Look back timeframe: 30 days EQUETRO 100 MG CAPSULE EQUETRO 200 MG CAPSULE EQUETRO 300 MG CAPSULE 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 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 November 20, 2017 Copyright 2017 Health Information Designs, LLC 19

20 Step 5 (history of a drug that is contraindicated with ranolazine) Look back timeframe: 30 days 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 MYCOBUTIN 150MG CAPSULE 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 NOXAFIL DR 100 MG TABLET PCE 333 MG TABLET PCE 500 MG TABLET PHENOBARBITAL 100 MG TABLET PHENOBARBITAL 130 MG/ML VIAL PHENOBARBITAL 15 MG TABLET PHENOBARBITAL 16.2 MG TABLET PHENOBARBITAL 20 MG/5 ML ELIX PHENOBARBITAL 30 MG TABLET PHENOBARBITAL 32.4 MG TABLET PHENOBARBITAL 60 MG TABLET PHENOBARBITAL 64.8 MG TABLET PHENOBARBITAL 65 MG/ML VIAL PHENOBARBITAL 97.2 MG TABLET PHENYTEK 200 MG CAPSULE PHENYTEK 300 MG CAPSULE PHENYTOIN 125 MG/5 ML SUSP PHENYTOIN 50 MG TABLET CHEW PHENYTOIN 50 MG/ML VIAL November 20, 2017 Copyright 2017 Health Information Designs, LLC 20

21 Step 5 (history of a drug that is contraindicated with ranolazine) Look back timeframe: 30 days PHENYTOIN SOD EXT 100 MG CAP PHENYTOIN SOD EXT 200 MG CAP PHENYTOIN SOD EXT 300 MG CAP PREVPAC PATIENT PACK PREZCOBIX MG TABLET PREZISTA 100MG/ML SUSPENSION PREZISTA 150MG TABLET PREZISTA 600MG TABLET PREZISTA 75MG TABLET PREZISTA 800MG TABLET PRIFTIN 150MG TABLET REYATAZ 150MG CAPSULE REYATAZ 200MG CAPSULE REYATAZ 300MG CAPSULE REYATAZ 50MG POWDER PACK RIFABUTIN 150MG CAPSULE RIFADIN 150MG CAPSULE RIFADIN 300MG CAPSULE RIFAMATE CAPSULE RIFAMPIN 150MG CAPSULE RIFAMPIN 300MG CAPSULE RIFATER TABLET 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 TEGRETOL 100 MG/5 ML SUSP TEGRETOL 200 MG TABLET TEGRETOL XR 100 MG TABLET TEGRETOL XR 200 MG TABLET November 20, 2017 Copyright 2017 Health Information Designs, LLC 21

22 Step 5 (history of a drug that is contraindicated with ranolazine) Look back timeframe: 30 days TEGRETOL XR 400 MG TABLET 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 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 November 20, 2017 Copyright 2017 Health Information Designs, LLC 22

23 Step 5 (history of a drug that is contraindicated with ranolazine) Look back timeframe: 30 days 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 November 20, 2017 Copyright 2017 Health Information Designs, LLC 23

24 Clinical Criteria References 1. 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 5. American Medical Association data files ICD-10-CM Diagnosis Codes. Available at 6. 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, Clinical Pharmacology [online database]. Tampa, FL: Elsevier/Gold Standard, Inc.; Available at Accessed on July 1, Micromedex [online database]. Available at Accessed on July 1, Prescribing Information. Foster City, CA. Gilead Sciences, Inc. January Fihn SD, Gardin JM, Abrams J, et al ACCF/AHA/ACP/AATS, PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients with Stable Ischemic Heart Disease: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the American College of Physicians, American Association for Thoracic Surgery, Preventative Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions and Society of Thoracic Surgeons. Circulation. 2012;126:e354-e471. November 20, 2017 Copyright 2017 Health Information Designs, LLC 24

25 12.Gibbons RJ, Chatterjee K, Daley J, et al. ACC/AHA/ACP-ASIM Guidelines for the Management of Patients with Chronic Stable Angina: Executive Summary and Recommendations. A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Patients with Chronic Stable Angina). Circulation. 1999;99: November 20, 2017 Copyright 2017 Health Information Designs, LLC 25

26 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 11/20/2017 Annual review by staff Updated Table 2, page 6 Updated Table 5, page 16 Updated references, pages November 20, 2017 Copyright 2017 Health Information Designs, LLC 26