Topical Immunomodulators

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1 Texas Prior Authorization Program Clinical Criteria Drug/Drug Class Topical Immunomodulators Clinical Criteria Information Included in this Document Topical Immunomodulators Elidel and Protopic 0.03% 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 Topical Immunomodulators Protopic 0.1% 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 te: Click the hyperlink to navigate directly to that section.

2 Topical Immunomodulators Eucrisa 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 te: Click the hyperlink to navigate directly to that section. Revision tes Updated Table 4, page 9 removed ICD-9/10s for diaper rash/dermatitis Added criteria for Eucrisa Added GCN for Eucrisa to Drugs Requiring PA, page 34 Added criteria logic for Eucrisa, page 35 Added logic diagram for Eucrisa, page 36 Added supporting tables for Eucrisa, page 37 Updated references, page 38

3 Topical Immunomodulators Elidel and Protopic 0.03% Drugs Requiring Prior Authorization Drugs Requiring Prior Authorization Label Name GCN ELIDEL 1% CREAM PROTOPIC 0.03% OINTMENT TACROLIMUS 0.03% OINTMENT May 31, 2017 Copyright Health Information Designs, LLC 3

4 Topical Immunomodulators Elidel and Protopic 0.03% Clinical Criteria Logic 1. Is the client less than (<) 2 years of age? [ ] (Deny) [ ] (Go to #2) 2. Does the client have a claim for a topical steroid in the last 730 days? [ ] (Go to #4) [ ] (Go to #3) 3. Does the client have a claim for pimecrolimus or tacrolimus in the last 90 days? [ ] (Go to #4) [ ] (Deny) 4. Does the client have a diagnosis of atopic dermatitis in the last 730 days? [ ] (Go to #5) [ ] (Deny) 5. Does the client have a diagnosis of HIV or immune system disorder in the last 730 days? [ ] (Deny) [ ] (Go to #6) 6. Does the client have a history of HIV drugs or immunosuppressants in the last 730 days? [ ] (Deny) [ ] (Go to #7) 7. Does the client have a history of antineoplastic agents in the last 730 days? [ ] (Deny) [ ] (Go to #8) 8. Does the client have a diagnosis of a skin absorption disorder or a skin malignancy in the last 730 days? [ ] (Deny) [ ] (Go to #9) 9. Does the client have claims history of prior pimecrolimus or tacrolimus use for less than or equal to ( ) 180 days in the last 200 days? [ ] (Approve 180 days) [ ] (Deny) May 31, 2017 Copyright Health Information Designs, LLC 4

5 Topical Immunomodulators Elidel and Protopic 0.03% Clinical Criteria Logic Diagram Step 1 Is the client < 2 years of age? Deny Request Step 2 Step 4 Does the client have a claim for a topical steroid in the last 730 days? Does the client have a diagnosis of atopic dermatitis in the last 730 days? Deny Request Step 3 Step 5 Step 6 Does the client have a claim for pimecrolimus or tacrolimus in the last 90 days? Does the client have a diagnosis of HIV or immune system disorder in the last 730 days? Does the client have a history of HIV drugs or immunosuppressants in the last 730 days? Deny Request Deny Request Deny Request Step 7 Does the client have a history of antineoplastic agents in the last 730 days? Deny Request Step 9 Step 8 Deny Request Does the client have claims history of prior pimecrolimus or tacrolimus use for 180 days in the last 200 days? Does the client have a diagnosis of a skin absorption disorder or a skin malignancy in the last 730 days? Deny Request Approve Request (180 days) May 31, 2017 Copyright Health Information Designs, LLC 5

6 Topical Immunomodulators Elidel and Protopic 0.03% Clinical Criteria Supporting Tables Step 2 (history of a topical steroid) Label Name GCN ALCLOMETASONE DIPRO 0.05% CRM ALCLOMETASONE DIPR 0.05% OINT AMCINONIDE 0.1% CREAM AMCINONIDE 0.1% LOTION AMCINONIDE 0.1% OINTMENT APEXICON 0.05% OINTMENT APEXICON E 0.05% CREAM BETAMETHASONE DP 0.05% CRM BETAMETHASONE DP 0.05% LOT BETAMETHASONE DP 0.05% OINT BETAMETHASONE DP AUG 0.05% CRM BETAMETHASONE DP AUG 0.05% GEL BETAMETHASONE DP AUG 0.05% LOT BETAMETHASONE DP AUG 0.05% OIN BETAMETHASONE VA 0.1% CREAM BETAMETHASONE VA 0.1% LOTION BETAMETHASONE VALER 0.1% OINTM BETA-VAL 0.1% LOTION CLOBETASOL 0.05% CREAM CLOBETASOL 0.05% GEL CLOBETASOL 0.05% OINTMENT CLOBETASOL 0.05% SOLUTION CLOBETASOL EMOLLIENT 0.05% CRM CLOBETASOL PROP 0.05% FOAM CLOBEX 0.05% SPRAY CLOBEX 0.05% TOPICAL LOTION CLODERM 0.1% CREAM CORDRAN 4 MCG/SQ CM TAPE CORMAX 0.05% SOLUTION CORTISPORIN OINTMENT May 31, 2017 Copyright Health Information Designs, LLC 6

7 Step 2 (history of a topical steroid) Label Name GCN CUTIVATE 0.05% LOTION DERMA-SMOOTHE-FS BODY OIL DERMA-SMOOTHE-FS SCALP OIL DERMATOP 0.1% CREAM DERMATOP 0.1% OINTMENT DESONIDE 0.05% CREAM DESONIDE 0.05% LOTION DESONIDE 0.05% OINTMENT DESOXIMETASONE 0.05% CREAM DESOXIMETASONE 0.25% CREAM DESOXIMETASONE 0.05% GEL DESOXIMETASONE 0.25% OINTMENT DIFLORASONE 0.05% CREAM DIFLORASONE 0.05% OINTMENT DIPROLENE 0.05% LOTION DIPROLENE 0.05% OINTMENT DIPROLENE AF 0.05% CREAM ELOCON 0.1% CREAM ELOCON 0.1% LOTION ELOCON 0.1% OINTMENT FLUOCINOLONE 0.01% CREAM FLUOCINOLONE 0.025% CREAM FLUOCINONIDE 0.05% CREAM FLUOCINONIDE 0.05% GEL FLUOCINOLONE 0.025% OINT FLUOCINONIDE 0.05% OINTMENT FLUOCINOLONE 0.01% SOLUTION FLUOCINONIDE 0.05% SOLUTION FLUOCINONIDE-E 0.05% CREAM FLUOCINONIDE-EMOL 0.05% CREAM FLUTICASONE PROP 0.05% CREAM FLUTICASONE PROP 0.005% OINT HALOBETASOL PROP 0.05% CREAM HALOBETASOL PROP 0.05% OINTMNT HALOG 0.1% CREAM HALOG 0.1% OINTMENT May 31, 2017 Copyright Health Information Designs, LLC 7

8 Step 2 (history of a topical steroid) Label Name GCN HYDRO SKIN 1% LOTION HYDROCORTISONE 0.5% CREAM HYDROCORTISONE 1% CREAM HYDROCORTISONE 1% CREAM HYDROCORTISONE 2.5% CREAM HYDROCORTISONE 1% LOTION HYDROCORTISONE 2.5% LOTION HYDROCORTISONE 0.5% OINTMENT HYDROCORTISONE 1% OINTMENT HYDROCORTISONE 2.5% OINTMENT HYDROCORTISONE 0.1% SOLN HYDROCORTISONE ACETATE 2% GEL HYDROCORTISONE BUTY 0.1% CREAM HYDROCORTISONE BUTYR 0.1% OINT HYDROCORTISONE VAL 0.2% CREAM HYDROCORTISONE VAL 0.2% OINTMT ITCH-X HC 1% LOTION LOKARA 0.05% LOTION MEDI-CORTISONE 1% CREAM MOMETASONE FUROATE 0.1% CREAM MOMETASONE FUROATE 0.1% OINT MOMETASONE FUROATE 0.1% SOLN NUZON GEL OLUX 0.05% FOAM OLUX-E 0.05% FOAM PREDNICARBATE 0.1% CREAM PREDNICARBATE 0.1% OINTMENT TOPICORT 0.05% GEL TOPICORT 0.25% CREAM TOPICORT 0.25% OINTMENT TOPICORT LP 0.05% CREAM TRIAMCINOLONE 0.025% CREAM TRIAMCINOLONE 0.1% CREAM TRIAMCINOLONE 0.5% CREAM TRIAMCINOLONE 0.025% LOTION TRIAMCINOLONE 0.1% LOTION May 31, 2017 Copyright Health Information Designs, LLC 8

9 Step 2 (history of a topical steroid) Label Name GCN TRIAMCINOLONE 0.025% OINT TRIAMCINOLONE 0.1% OINTMENT TRIAMCINOLONE 0.5% OINTMENT TRIANEX 0.05% OINTMENT ULTRAVATE 0.05% CREAM VANOS 0.1% CREAM VERDESO 0.05% FOAM WESTCORT 0.2% OINTMENT Step 3 (claim for pimecrolimus or tacrolimus) Look back timeframe: 90 days Label Name GCN ELIDEL 1% CREAM PROTOPIC 0.03% OINTMENT PROTOPIC 0.1% OINTMENT TACROLIMUS 0.03% OINTMENT TACROLIMUS 0.1% OINTMENT Step 4 (diagnosis of atopic dermatitis) Required diagnosis: 1 ICD-9 Code Description 691 ATOPIC DERMATITIS AND RELATED CONDITIONS 6918 OTHER ATOPIC DERMATITIS ICD-10 Code Description L200 L2081 L2082 L2084 L2089 L209 BESNIER'S PRURIGO ATOPIC NEURODERMATITIS FLEXURAL ECZEMA INTRINSIC (ALLERGIC) ECZEMA OTHER ATOPIC DERMATITIS ATOPIC DERMATITIS, UNSPECIFIED May 31, 2017 Copyright Health Information Designs, LLC 9

10 Step 5 (diagnosis of HIV or immune system disorder) Required diagnosis: 1 ICD-9 Code Description 042 HUMAN IMMUNO VIRUS DIS 279 DISORDERS INVOLVING THE IMMUNE MECHANISM 2790 DEFICIENCY OF HUMORAL IMMUNITY HYPOGAMMAGLOBULINEM NOS SELECTIVE IGA IMMUNODEF SELECTIVE IGM IMMUNODEF SELECTIVE IG DEFIC NEC CONG HYPOGAMMAGLOBULINEM IMMUNODEFIC W HYPER-IGM COMMON VARIABL IMMUNODEF HUMORAL IMMUNITY DEF NEC 2791 DEFICIENCY OF CELL-MEDIATED IMMUNITY IMMUNDEF T-CELL DEF NOS DIGEORGE S SYNDROME WISKOTT-ALDRICH SYNDROME NEZELOF S SYNDROME DEFIC CELL IMMUNITY NOS 2792 COMBINED IMMUNITY DEFIC 2793 IMMUNITY DEFICIENCY NOS 2794 AUTOIMMUNE DISEASE NEC 2795 GRAFT-VERSUS-HOST DISEASE GRAFT-VERSUS-HOST DISEASE, UNSPECIFIED ACUTE GRAFT-VERSUS-HOST DISEASE CHRONIC GRAFT-VERSUS-HOST DISEASE ACUTE ON CHRONIC GRAFT-VERSUS-HOST DISEASE 2798 IMMUNE MECHANISM DIS NEC 2799 IMMUNE MECHANISM DIS NOS ICD-10 Code Description B20 HUMAN IMMUNODEFICIENCY VIRUS [HIV] DISEASE D800 HEREDITARY HYPOGAMMAGLOBULINEMIA D801 NONFAMILIAL HYPOGAMMAGLOBULINEMIA D802 SELECTIVE DEFICIENCY OF IMMUNOGLOBULIN A [IGA] D803 SELECTIVE DEFICIENCY OF IMMUNOGLOBULIN G [IGG] SUBCLASSES D804 SELECTIVE DEFICIENCY OF IMMUNOGLOBULIN M [IGM] D805 IMMUNODEFICIENCY WITH INCREASED IMMUNOGLOBULIN M [IGM] May 31, 2017 Copyright Health Information Designs, LLC 10

11 D806 D807 D808 D809 D810 Step 5 (diagnosis of HIV or immune system disorder) Required diagnosis: 1 ANTIBODY DEFICIENCY WITH NEAR-NORMAL IMMUNOGLOBULINS OR WITH HYPERIMMUNOGLOBULINEMIA TRANSIENT HYPOGAMMAGLOBULINEMIA OF INFANCY OTHER IMMUNODEFICIENCIES WITH PREDOMINANTLY ANTIBODY DEFECTS IMMUNODEFICIENCY WITH PREDOMINANTLY ANTIBODY DEFECTS, UNSPECIFIED SEVERE COMBINED IMMUNODEFICIENCY [SCID] WITH RETICULAR DYSGENESIS D811 SEVERE COMBINED IMMUNODEFICIENCY [SCID] WITH LOW T- AND B- CELL NUMBERS D812 D814 D816 D817 D8189 D819 D820 D821 D822 D823 D824 D828 D829 D830 D831 SEVERE COMBINED IMMUNODEFICIENCY [SCID] WITH LOW OR NORMAL B-CELL NUMBERS NEZELOF'S SYNDROME MAJOR HISTOCOMPATIBILITY COMPLEX CLASS I DEFICIENCY MAJOR HISTOCOMPATIBILITY COMPLEX CLASS II DEFICIENCY OTHER COMBINED IMMUNODEFICIENCIES COMBINED IMMUNODEFICIENCY, UNSPECIFIED WISKOTT-ALDRICH SYNDROME DI GEORGE'S SYNDROME IMMUNODEFICIENCY WITH SHORT-LIMBED STATURE IMMUNODEFICIENCY FOLLOWING HEREDITARY DEFECTIVE RESPONSE TO EPSTEIN-BARR VIRUS HYPERIMMUNOGLOBULIN E [IGE] SYNDROME IMMUNODEFICIENCY ASSOCIATED WITH OTHER SPECIFIED MAJOR DEFECTS IMMUNODEFICIENCY ASSOCIATED WITH MAJOR DEFECT, UNSPECIFIED COMMON VARIABLE IMMUNODEFICIENCY WITH PREDOMINANT ABNORMALITIES OF B-CELL NUMBERS AND FUNCTION COMMON VARIABLE IMMUNODEFICIENCY WITH PREDOMINANT IMMUNOREGULATORY T-CELL DISORDERS D832 COMMON VARIABLE IMMUNODEFICIENCY WITH AUTOANTIBODIES TO B- OR T-CELLS D838 D839 D840 D841 D848 D849 D893 D89810 OTHER COMMON VARIABLE IMMUNODEFICIENCIES COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED LYMPHOCYTE FUNCTION ANTIGEN-1 [LFA-1] DEFECT DEFECTS IN THE COMPLEMENT SYSTEM OTHER SPECIFIED IMMUNODEFICIENCIES IMMUNODEFICIENCY, UNSPECIFIED IMMUNE RECONSTITUTION SYNDROME ACUTE GRAFT-VERSUS-HOST DISEASE May 31, 2017 Copyright Health Information Designs, LLC 11

12 D89811 D89812 D89813 D8989 D899 Step 5 (diagnosis of HIV or immune system disorder) Required diagnosis: 1 CHRONIC GRAFT-VERSUS-HOST DISEASE ACUTE ON CHRONIC GRAFT-VERSUS-HOST DISEASE GRAFT-VERSUS-HOST DISEASE, UNSPECIFIED OTHER SPECIFIED DISORDERS INVOLVING THE IMMUNE MECHANISM, NOT ELSEWHERE CLASSIFIED DISORDER INVOLVING THE IMMUNE MECHANISM, UNSPECIFIED Step 6 (history of HIV drugs or immunosuppressants) Label Name GCN ABACAVIR 300 MG TABLET ABACAVIR-LAMIVUDINE-ZIDOV TAB AFINITOR 10 MG TABLET AFINITOR 2.5 MG TABLET AFINITOR 5 MG TABLET AFINITOR 7.5 MG TABLET AFINITOR DISPERZ 2 MG TABLET AFINITOR DISPERZ 3 MG TABLET AFINITOR DISPERZ 5 MG TABLET APTIVUS 250 MG CAPSULE ASTAGRAF XL 0.5 MG CAPSULE ASTAGRAF XL 1 MG CAPSULE ASTAGRAF XL 5 MG CAPSULE ATRIPLA TABLET AZATHIOPRINE 50 MG TABLET CELLCEPT 200 MG/ML ORAL SUSP CELLCEPT 250 MG CAPSULE CELLCEPT 500 MG TABLET COMBIVIR TABLET COMPLERA TABLET CRIXIVAN 200 MG CAPSULE CRIXIVAN 400 MG CAPSULE CYCLOSPORINE 100 MG CAPSULE CYCLOSPORINE 100 MG/ML SOLN CYCLOSPORINE 25 MG CAPSULE May 31, 2017 Copyright Health Information Designs, LLC 12

13 Step 6 (history of HIV drugs or immunosuppressants) Label Name GCN CYCLOSPORINE 50 MG SOFTGEL CYCLOSPORINE MODIFIED 100 MG CYCLOSPORINE MODIFIED 25 MG DIDANOSINE DR 125 MG CAPSULE DIDANOSINE DR 200 MG CAPSULE DIDANOSINE DR 250 MG CAPSULE DIDANOSINE DR 400 MG CAPSULE EDURANT 25 MG TABLET EMTRIVA 200 MG CAPSULE ENVARSUS XR 0.75 MG TABLET ENVARSUS XR 1 MG TABLET ENVARSUS XR 4 MG TABLET EPIVIR 10 MG/ML ORAL SOLN EPIVIR 150 MG TABLET EPIVIR 300 MG TABLET EPZICOM TABLET EVOTAZ MG TABLET FUZEON 90 MG VIAL GENGRAF 100 MG CAPSULE GENGRAF 100 MG/ML SOLUTION GENGRAF 25 MG CAPSULE GENVOYA TABLET IMURAN 50 MG TABLET INTELENCE 100 MG TABLET INTELENCE 200 MG TABLET INTELENCE 25 MG TABLET INVIRASE 200 MG CAPSULE INVIRASE 500 MG TABLET ISENTRESS 100 MG POWDER PACKET ISENTRESS 100 MG TABLET CHEW ISENTRESS 25 MG TABLET CHEW ISENTRESS 400 MG TABLET KALETRA MG TABLET KALETRA MG TABLET KALETRA /5 ML ORAL SOLU LAMIVUDINE 100 MG TABLET May 31, 2017 Copyright Health Information Designs, LLC 13

14 Step 6 (history of HIV drugs or immunosuppressants) Label Name GCN LAMIVUDINE 10MG/ML ORAL SOLUTION LAMIVUDINE 150 MG TABLET LAMIVUDINE 300 MG TABLET LAMIVUDINE-ZIDOVUDINE TABLET LEXIVA 50 MG/ML SUSPENSION LEXIVA 700 MG TABLET MYCOPHENOLATE 250 MG CAPSULE MYCOPHENOLATE 500 MG TABLET MYCOPHENOLIC ACID DR 180 MG TAB MYCOPHENOLIC ACID DR 360 MG TAB MYFORTIC 180 MG TABLET MYFORTIC 360 MG TABLET NEORAL 100 MG GELATN CAPSULE NEORAL 100 MG/ML SOLUTION NEORAL 25 MG GELATIN CAPSULE NEVIRAPINE 200 MG TABLET NEVIRAPINE 50 MG/5 ML SUSP NEVIRAPINE ER 400 MG TABLET NORVIR 100 MG SOFTGEL CAP NORVIR 100 MG TABLET NORVIR 80 MG/ML SOLUTION PREZCOBIX MG TABLET PREZISTA 100 MG/ML SUSPENSION PREZISTA 150 MG TABLET PREZISTA 600 MG TABLET PREZISTA 75 MG TABLET PREZISTA 800 MG TABLET PROGRAF 0.5 MG CAPSULE PROGRAF 1 MG CAPSULE PROGRAF 5 MG CAPSULE RAPAMUNE 0.5MG TABLET RAPAMUNE 1 MG TABLET RAPAMUNE 1 MG/ML ORAL SOLN RAPAMUNE 2 MG TABLET RESCRIPTOR 100 MG TABLET RESCRIPTOR 200 MG TABLET May 31, 2017 Copyright Health Information Designs, LLC 14

15 Step 6 (history of HIV drugs or immunosuppressants) Label Name GCN RETROVIR 10 MG/ML SYRUP RETROVIR 10 MG/ML VIAL RETROVIR 100 MG CAPSULE REYATAZ 150 MG CAPSULE REYATAZ 200 MG CAPSULE REYATAZ 300 MG CAPSULE REYATAZ 50 MG POWDER PACKET SANDIMMUNE 100 MG CAPSULE SANDIMMUNE 100 MG/ML SOLN SANDIMMUNE 25 MG CAPSULE SELZENTRY 150 MG TABLET SELZENTRY 300 MG TABLET SIROLIMUS 0.5 MG TABLET SIROLIMUS 1 MG TABLET SIROLIMUS 2 MG TABLET STAVUDINE 15 MG CAPSULE STAVUDINE 20 MG CAPSULE STAVUDINE 30 MG CAPSULE STAVUDINE 40 MG CAPSULE STRIBILD TABLET SUSTIVA 200 MG CAPSULE SUSTIVA 50 MG CAPSULE SUSTIVA 600 MG TABLET TACROLIMUS 0.5 MG CAPSULE TACROLIMUS 1 MG CAPSULE TACROLIMUS 5 MG CAPSULE TIVICAY 50 MG TABLET TRIUMEQ TABLET TRIZIVIR TABLET TRUVADA 200 MG-300 MG TABLET VIDEX 2 GM PEDIATRIC SOLN VIDEX 4 GM PEDIATRIC SOLN VIDEX EC 125 MG CAPSULE VIDEX EC 200 MG CAPSULE VIDEX EC 250 MG CAPSULE VIDEX EC 400 MG CAPSULE May 31, 2017 Copyright Health Information Designs, LLC 15

16 Step 6 (history of HIV drugs or immunosuppressants) Label Name GCN VIRACEPT 250 MG TABLET VIRACEPT 625 MG TABLET VIRAMUNE 200 MG TABLET VIRAMUNE 50 MG/5 ML SUSP VIRAMUNE XR 100 MG TABLET VIRAMUNE XR 400 MG TABLET VIREAD 150 MG TABLET VIREAD 200 MG TABLET VIREAD 300 MG TABLET VIREAD POWDER VITEKTA 150 MG TABLET VITEKTA 85 MG TABLET ZERIT 1 MG/ML SOLUTION ZERIT 15 MG CAPSULE ZERIT 20 MG CAPSULE ZERIT 30 MG CAPSULE ZERIT 40 MG CAPSULE ZIAGEN 20 MG/ML SOLUTION ZIAGEN 300 MG TABLET ZIDOVUDINE 100 MG CAPSULE ZIDOVUDINE 300 MG TABLET ZIDOVUDINE 50 MG/5 ML SYRUP ZORTRESS 0.25 MG TABLET ZORTRESS 0.5 MG TABLET ZORTRESS 0.75 MG TABLET Step 7 (history of antineoplastic agents) Label Name GCN ALKERAN 2 MG TABLET ANASTROZOLE 1 MG TABLET ARIMIDEX 1 MG TABLET AROMASIN 25 MG TABLET May 31, 2017 Copyright Health Information Designs, LLC 16

17 Step 7 (history of antineoplastic agents) Label Name GCN AVODART 0.5 MG SOFTGEL AZACITIDINE 100 MG VIAL BICALUTAMIDE 50 MG TABLET BICNU 100 MG VIAL BOSULIF 100 MG TABLET BOSULIF 500 MG TABLET CAPECITABINE 150 MG TABLET CAPECITABINE 500 MG TABLET CAPRELSA 100 MG TABLET CAPRELSA 300 MG TABLET CASODEX 50 MG TABLET COMETRIQ 100 MG DAILY-DOSE PK COMETRIQ 140 MG DAILY-DOSE PK COMETRIQ 60 MG DAILY-DOSE PK COSMEGEN 0.5 MG VIAL CYCLOPHOSPHAMIDE 25 MG CAPSULE CYCLOPHOSPHAMIDE 50 MG CAPSULE CYTARABINE 100 MG/ML VIAL CYTARABINE 1000 MG/50 ML VIAL CYTARABINE 20 MG/ML VIAL CYTARABINE 20 MG/ML VIAL CYTARABINE 20 MG/ML VIAL DROXIA 200 MG CAPSULE DROXIA 300 MG CAPSULE DROXIA 400 MG CAPSULE DUTASTERIDE 0.5 MG CAPSULE EMCYT 140 MG CAPSULE ERIVEDGE 150 MG CAPSULE ETOPOSIDE 1,000 MG/50 ML VIAL ETOPOSIDE 100 MG/5 ML VIAL ETOPOSIDE 50 MG CAPSULE ETOPOSIDE 500 MG/25 ML VIAL EVISTA 60 MG TABLET EXEMESTANE 25 MG TABLET FARESTON 60 MG TABLET FARYDAK 10 MG CAPSULE May 31, 2017 Copyright Health Information Designs, LLC 17

18 Step 7 (history of antineoplastic agents) Label Name GCN FARYDAK 15 MG CAPSULE FARYDAK 20 MG CAPSULE FEMARA 2.5 MG TABLET FINASTERIDE 5 MG TABLET FLUOROURACIL 1,000 MG/20 ML FLUOROURACIL 2.5 GM/50 ML VIAL FLUOROURACIL 5 GM/100 ML VIAL FLUOROURACIL 500 MG/10 ML VIAL FLUTAMIDE 125 MG CAPSULE GLEEVEC 100 MG TABLET GLEEVEC 400 MG TABLET GLEOSTINE 10 MG CAPSULE GLEOSTINE 100 MG CAPSULE GLEOSTINE 40 MG CAPSULE HEXALEN 50 MG CAPSULE HYCAMTIN 0.25 MG CAPSULE HYCAMTIN 1 MG CAPSULE HYDROXYUREA 500 MG CAPSULE IBRANCE 100 MG CAPSULE IBRANCE 125 MG CAPSULE IBRANCE 75 MG CAPSULE ICLUSIG 15 MG TABLET ICLUSIG 45 MG TABLET IMBRUVICA 140 MG CAPSULE INLYTA 1 MG TABLET INLYTA 5 MG TABLET IRESSA 250 MG TABLET LENVIMA 10 MG DAILY DOSE LENVIMA 14 MG DAILY DOSE LENVIMA 20 MG DAILY DOSE LENVIMA 24 MG DAILY DOSE LETROZOLE 2.5 MG TABLET LEUKERAN 2 MG TABLET LYSODREN 500 MG TABLET MATULANE 50 MG CAPSULE MEGACE 40 MG/ML ORAL SUSP May 31, 2017 Copyright Health Information Designs, LLC 18

19 Step 7 (history of antineoplastic agents) Label Name GCN MEGACE ES 625 MG/5 ML SUSP MEGESTROL 20 MG TABLET MEGESTROL 40 MG TABLET MEGESTROL ACET 40 MG/ML SUSP MEKINIST 0.5 MG TABLET MEKINIST 2 MG TABLET MERCAPTOPURINE 50 MG TABLET METHOTREXATE 2.5 MG TABLET METHOTREXATE 25 MG/ML VIAL METHOTREXATE 25 MG/ML VIAL MITOMYCIN 20 MG VIAL MITOMYCIN 5 MG VIAL MITOXANTRONE 20 MG/10 ML VIAL MITOXANTRONE 25 MG/12.5 ML VL MITOXANTRONE 30 MG/15 ML VIAL MYLERAN 2 MG TABLET NEXAVAR 200 MG TABLET NILANDRON 150 MG TABLET ONCASPAR 750 UNIT/ML VIAL PROSCAR 5 MG TABLET PURIXAN 20 MG/ML ORAL SUSPENSION RALOXIFENE HCL 60 MG TABLET RHEUMATREX 2.5 MG TABLET SOLTAMOX 10 MG/5 ML SOLN SPRYCEL 100 MG TABLET SPRYCEL 140 MG TABLET SPRYCEL 20 MG TABLET SPRYCEL 50 MG TABLET SPRYCEL 70 MG TABLET SPRYCEL 80 MG TABLET SUTENT 12.5 MG CAPSULE SUTENT 25 MG CAPSULE SUTENT 37.5 MG CAPSULE SUTENT 50 MG CAPSULE SYNRIBO 3.5 MG/ML VIAL TABLOID 40 MG TABLET May 31, 2017 Copyright Health Information Designs, LLC 19

20 Step 7 (history of antineoplastic agents) Label Name GCN TAMOXIFEN 10 MG TABLET TAMOXIFEN 20 MG TABLET TARCEVA 100 MG TABLET TARCEVA 150 MG TABLET TARCEVA 25 MG TABLET TARGRETIN 75 MG SOFTGEL TASIGNA 150 MG CAPSULE TASIGNA 200 MG CAPSULE TEMODAR 100 MG CAPSULE TEMODAR 140 MG CAPSULE TEMODAR 180 MG CAPSULE TEMODAR 20 MG CAPSULE TEMODAR 250 MG CAPSULE TEMOZOLOMIDE 100 MG CAPSULE TEMOZOLOMIDE 140 MG CAPSULE TEMOZOLOMIDE 180 MG CAPSULE TEMOZOLOMIDE 20 MG CAPSULE TEMOZOLOMIDE 250 MG CAPSULE TEMOZOLOMIDE 5 MG CAPSULE TENIPOSIDE 50 MG/5 ML AMPULE TREXALL 10 MG TABLET TREXALL 15 MG TABLET TREXALL 5 MG TABLET TREXALL 7.5 MG TABLET TYKERB 250 MG TABLET VINBLASTINE 1 MG/ML VIAL VINCRISTINE 1 MG/ML VIAL VINCRISTINE 2 MG/2 ML VIAL VOTRIENT 200 MG TABLET XALKORI 200 MG CAPSULE XALKORI 250 MG CAPSULE XELODA 150 MG TABLET XELODA 500 MG TABLET XTANDI 40 MG CAPSULE ZELBORAF 240 MG TABLET ZOLINZA 100 MG CAPSULE May 31, 2017 Copyright Health Information Designs, LLC 20

21 Step 7 (history of antineoplastic agents) Label Name GCN ZYDELIG 100 MG TABLET ZYDELIG 150 MG TABLET ZYKADIA 150 MG CAPSULE ZYTIGA 250 MG TABLET ICD-9 Code Step 8 (diagnosis of skin absorption disorder or skin malignancy) Description Required diagnosis: MALIGNANT MELANOMA OF SKIN OF LIP 1721 MALIGNANT MELANOMA OF SKIN OF EYELID, INCLUDING CANTHUS MALIGNANT MELANOMA OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL MALIGNANT MELANOMA OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE 1724 MALIGNANT MELANOMA OF SKIN OF SCALP AND NECK 1725 MALIGNANT MELANOMA OF SKIN OF TRUNK, EXCEPT SCROTUM 1726 MALIGNANT MELANOMA OF SKIN OF UPPER LIMB, INCLUDING SHOULDER 1727 MALIGNANT MELANOMA OF SKIN OF LOWER LIMB, INCLUDING HIP 1728 MALIGNANT MELANOMA OF OTHER SPECIFIED SITES OF SKIN 1729 MELANOMA OF SKIN, SITE UNSPECIFIED 1760 KAPOSI'S SARCOMA, SKIN UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF LIP BASAL CELL CARCINOMA OF SKIN OF LIP SQUAMOUS CELL CARCINOMA OF SKIN OF LIP OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF LIP UNSPECIFIED MALIGNANT NEOPLASM OF EYELID, INCLUDING CANTHUS BASAL CELL CARCINOMA OF EYELID, INCLUDING CANTHUS SQUAMOUS CELL CARCINOMA OF EYELID, INCLUDING CANTHUS OTHER SPECIFIED MALIGNANT NEOPLASM OF EYELID, INCLUDING CANTHUS UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL BASAL CELL CARCINOMA OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL May 31, 2017 Copyright Health Information Designs, LLC 21

22 Step 8 (diagnosis of skin absorption disorder or skin malignancy) Required diagnosis: 1 SQUAMOUS CELL CARCINOMA OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE BASAL CELL CARCINOMA OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE SQUAMOUS CELL CARCINOMA OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE UNSPECIFIED MALIGNANT NEOPLASM OF SCALP AND SKIN OF NECK BASAL CELL CARCINOMA OF SCALP AND SKIN OF NECK SQUAMOUS CELL CARCINOMA OF SCALP AND SKIN OF NECK OTHER SPECIFIED MALIGNANT NEOPLASM OF SCALP AND SKIN OF NECK UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF TRUNK, EXCEPT SCROTUM BASAL CELL CARCINOMA OF SKIN OF TRUNK, EXCEPT SCROTUM SQUAMOUS CELL CARCINOMA OF SKIN OF TRUNK, EXCEPT SCROTUM OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF TRUNK, EXCEPT SCROTUM UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF UPPER LIMB, INCLUDING SHOULDER BASAL CELL CARCINOMA OF SKIN OF UPPER LIMB, INCLUDING SHOULDER SQUAMOUS CELL CARCINOMA OF SKIN OF UPPER LIMB, INCLUDING SHOULDER OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF UPPER LIMB, INCLUDING SHOULDER UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF LOWER LIMB, INCLUDING HIP BASAL CELL CARCINOMA OF SKIN OF LOWER LIMB, INCLUDING HIP SQUAMOUS CELL CARCINOMA OF SKIN OF LOWER LIMB, INCLUDING HIP OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF LOWER LIMB, INCLUDING HIP UNSPECIFIED MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF SKIN BASAL CELL CARCINOMA OF OTHER SPECIFIED SITES OF SKIN SQUAMOUS CELL CARCINOMA OF OTHER SPECIFIED SITES OF SKIN OTHER SPECIFIED MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF SKIN May 31, 2017 Copyright Health Information Designs, LLC 22

23 Step 8 (diagnosis of skin absorption disorder or skin malignancy) Required diagnosis: UNSPECIFIED MALIGNANT NEOPLASM OF SKIN, SITE UNSPECIFIED BASAL CELL CARCINOMA OF SKIN, SITE UNSPECIFIED SQUAMOUS CELL CARCINOMA OF SKIN, SITE UNSPECIFIED OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN, SITE UNSPECIFIED PERIPHERAL T CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK PERIPHERAL T CELL LYMPHOMA, INTRATHORACIC LYMPH NODES PERIPHERAL T CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB PERIPHERAL T CELL LYMPHOMA, INTRAPELVIC LYMPH NODES PERIPHERAL T CELL LYMPHOMA, SPLEEN PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES 7571 ICHTHYOSIS CONGENITA ICD-10 Code C430 C4310 C4311 C4312 C4320 C4321 C4322 C4330 C4331 C4339 C434 C4351 C4352 C4359 C4360 C4361 C4362 Description MALIGNANT MELANOMA OF LIP MALIGNANT MELANOMA OF UNSPECIFIED EYELID, INCLUDING CANTHUS MALIGNANT MELANOMA OF RIGHT EYELID, INCLUDING CANTHUS MALIGNANT MELANOMA OF LEFT EYELID, INCLUDING CANTHUS MALIGNANT MELANOMA OF UNSPECIFIED EAR AND EXTERNAL AURICULAR CANAL MALIGNANT MELANOMA OF RIGHT EAR AND EXTERNAL AURICULAR CANAL MALIGNANT MELANOMA OF LEFT EAR AND EXTERNAL AURICULAR CANAL MALIGNANT MELANOMA OF UNSPECIFIED PART OF FACE MALIGNANT MELANOMA OF NOSE MALIGNANT MELANOMA OF OTHER PARTS OF FACE MALIGNANT MELANOMA OF SCALP AND NECK MALIGNANT MELANOMA OF ANAL SKIN MALIGNANT MELANOMA OF SKIN OF BREAST MALIGNANT MELANOMA OF OTHER PART OF TRUNK MALIGNANT MELANOMA OF UNSPECIFIED UPPER LIMB, INCLUDING SHOULDER MALIGNANT MELANOMA OF RIGHT UPPER LIMB, INCLUDING SHOULDER MALIGNANT MELANOMA OF LEFT UPPER LIMB, INCLUDING SHOULDER May 31, 2017 Copyright Health Information Designs, LLC 23

24 C4370 C4371 C4372 C438 C439 C4400 C4401 C4402 C4409 C44101 C44102 C44109 C44111 C44112 C44119 C44121 C44122 C44129 C44191 C44192 C44199 C44201 C44202 C44209 C44211 C44212 Step 8 (diagnosis of skin absorption disorder or skin malignancy) Required diagnosis: 1 MALIGNANT MELANOMA OF UNSPECIFIED LOWER LIMB, INCLUDING HIP MALIGNANT MELANOMA OF RIGHT LOWER LIMB, INCLUDING HIP MALIGNANT MELANOMA OF LEFT LOWER LIMB, INCLUDING HIP MALIGNANT MELANOMA OF OVERLAPPING SITES OF SKIN MALIGNANT MELANOMA OF SKIN, UNSPECIFIED UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF LIP BASAL CELL CARCINOMA OF SKIN OF LIP SQUAMOUS CELL CARCINOMA OF SKIN OF LIP OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF LIP UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF UNSPECIFIED EYELID, INCLUDING CANTHUS UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF RIGHT EYELID, INCLUDING CANTHUS UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF LEFT EYELID, INCLUDING CANTHUS BASAL CELL CARCINOMA OF SKIN OF UNSPECIFIED EYELID, INCLUDING CANTHUS BASAL CELL CARCINOMA OF SKIN OF RIGHT EYELID, INCLUDING CANTHUS BASAL CELL CARCINOMA OF SKIN OF LEFT EYELID, INCLUDING CANTHUS SQUAMOUS CELL CARCINOMA OF SKIN OF UNSPECIFIED EYELID, INCLUDING CANTHUS SQUAMOUS CELL CARCINOMA OF SKIN OF RIGHT EYELID, INCLUDING CANTHUS SQUAMOUS CELL CARCINOMA OF SKIN OF LEFT EYELID, INCLUDING CANTHUS OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF UNSPECIFIED EYELID, INCLUDING CANTHUS OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF RIGHT EYELID, INCLUDING CANTHUS OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF LEFT EYELID, INCLUDING CANTHUS UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF UNSPECIFIED EAR AND EXTERNAL AURICULAR CANAL UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF RIGHT EAR AND EXTERNAL AURICULAR CANAL UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF LEFT EAR AND EXTERNAL AURICULAR CANAL BASAL CELL CARCINOMA OF SKIN OF UNSPECIFIED EAR AND EXTERNAL AURICULAR CANAL BASAL CELL CARCINOMA OF SKIN OF RIGHT EAR AND EXTERNAL AURICULAR CANAL May 31, 2017 Copyright Health Information Designs, LLC 24

25 C44219 C44221 C44222 C44229 C44291 C44292 C44299 C44300 C44301 C44309 C44310 C44311 C44319 C44320 C44321 C44329 C44390 C44391 C44399 C4440 C4441 C4442 C4449 C44500 C44501 C44509 C44510 C44511 C44519 Step 8 (diagnosis of skin absorption disorder or skin malignancy) Required diagnosis: 1 BASAL CELL CARCINOMA OF SKIN OF LEFT EAR AND EXTERNAL AURICULAR CANAL SQUAMOUS CELL CARCINOMA OF SKIN OF UNSPECIFIED EAR AND EXTERNAL AURICULAR CANAL SQUAMOUS CELL CARCINOMA OF SKIN OF RIGHT EAR AND EXTERNAL AURICULAR CANAL SQUAMOUS CELL CARCINOMA OF SKIN OF LEFT EAR AND EXTERNAL AURICULAR CANAL OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF UNSPECIFIED EAR AND EXTERNAL AURICULAR CANAL OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF RIGHT EAR AND EXTERNAL AURICULAR CANAL OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF LEFT EAR AND EXTERNAL AURICULAR CANAL UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF UNSPECIFIED PART OF FACE UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF NOSE UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF OTHER PARTS OF FACE BASAL CELL CARCINOMA OF SKIN OF UNSPECIFIED PARTS OF FACE BASAL CELL CARCINOMA OF SKIN OF NOSE BASAL CELL CARCINOMA OF SKIN OF OTHER PARTS OF FACE SQUAMOUS CELL CARCINOMA OF SKIN OF UNSPECIFIED PARTS OF FACE SQUAMOUS CELL CARCINOMA OF SKIN OF NOSE SQUAMOUS CELL CARCINOMA OF SKIN OF OTHER PARTS OF FACE OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF UNSPECIFIED PARTS OF FACE OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF NOSE OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF OTHER PARTS OF FACE UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF SCALP AND NECK BASAL CELL CARCINOMA OF SKIN OF SCALP AND NECK SQUAMOUS CELL CARCINOMA OF SKIN OF SCALP AND NECK OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF SCALP AND NECK UNSPECIFIED MALIGNANT NEOPLASM OF ANAL SKIN UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF BREAST UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF OTHER PART OF TRUNK BASAL CELL CARCINOMA OF ANAL SKIN BASAL CELL CARCINOMA OF SKIN OF BREAST BASAL CELL CARCINOMA OF SKIN OF OTHER PART OF TRUNK May 31, 2017 Copyright Health Information Designs, LLC 25

26 C44520 C44521 C44529 C44590 C44591 C44599 C44601 C44602 C44609 C44611 C44612 C44619 C44621 C44622 C44629 C44691 C44692 C44699 C44701 C44702 C44709 C44711 C44712 C44719 Step 8 (diagnosis of skin absorption disorder or skin malignancy) Required diagnosis: 1 SQUAMOUS CELL CARCINOMA OF ANAL SKIN SQUAMOUS CELL CARCINOMA OF SKIN OF BREAST SQUAMOUS CELL CARCINOMA OF SKIN OF OTHER PART OF TRUNK OTHER SPECIFIED MALIGNANT NEOPLASM OF ANAL SKIN OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF BREAST OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF OTHER PART OF TRUNK UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF UNSPECIFIED UPPER LIMB, INCLUDING SHOULDER UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF RIGHT UPPER LIMB, INCLUDING SHOULDER UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF LEFT UPPER LIMB, INCLUDING SHOULDER BASAL CELL CARCINOMA OF SKIN OF UNSPECIFIED UPPER LIMB, INCLUDING SHOULDER BASAL CELL CARCINOMA OF SKIN OF RIGHT UPPER LIMB, INCLUDING SHOULDER BASAL CELL CARCINOMA OF SKIN OF LEFT UPPER LIMB, INCLUDING SHOULDER SQUAMOUS CELL CARCINOMA OF SKIN OF UNSPECIFIED UPPER LIMB, INCLUDING SHOULDER SQUAMOUS CELL CARCINOMA OF SKIN OF RIGHT UPPER LIMB, INCLUDING SHOULDER SQUAMOUS CELL CARCINOMA OF SKIN OF LEFT UPPER LIMB, INCLUDING SHOULDER OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF UNSPECIFIED UPPER LIMB, INCLUDING SHOULDER OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF RIGHT UPPER LIMB, INCLUDING SHOULDER OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF LEFT UPPER LIMB, INCLUDING SHOULDER UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF UNSPECIFIED LOWER LIMB, INCLUDING HIP UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF RIGHT LOWER LIMB, INCLUDING HIP UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF LEFT LOWER LIMB, INCLUDING HIP BASAL CELL CARCINOMA OF SKIN OF UNSPECIFIED LOWER LIMB, INCLUDING HIP BASAL CELL CARCINOMA OF SKIN OF RIGHT LOWER LIMB, INCLUDING HIP BASAL CELL CARCINOMA OF SKIN OF LEFT LOWER LIMB, INCLUDING HIP May 31, 2017 Copyright Health Information Designs, LLC 26

27 C44721 C44722 C44729 C44791 C44792 C44799 C4480 C4481 C4482 C4489 C4490 C4491 C4492 C4499 C460 C8440 C8441 C8442 C8443 C8444 C8445 C8446 C8447 C8448 C8449 D030 D0310 D0311 D0312 D0320 Step 8 (diagnosis of skin absorption disorder or skin malignancy) Required diagnosis: 1 SQUAMOUS CELL CARCINOMA OF SKIN OF UNSPECIFIED LOWER LIMB, INCLUDING HIP SQUAMOUS CELL CARCINOMA OF SKIN OF RIGHT LOWER LIMB, INCLUDING HIP SQUAMOUS CELL CARCINOMA OF SKIN OF LEFT LOWER LIMB, INCLUDING HIP OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF UNSPECIFIED LOWER LIMB, INCLUDING HIP OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF RIGHT LOWER LIMB, INCLUDING HIP OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF LEFT LOWER LIMB, INCLUDING HIP UNSPECIFIED MALIGNANT NEOPLASM OF OVERLAPPING SITES OF SKIN BASAL CELL CARCINOMA OF OVERLAPPING SITES OF SKIN SQUAMOUS CELL CARCINOMA OF OVERLAPPING SITES OF SKIN OTHER SPECIFIED MALIGNANT NEOPLASM OF OVERLAPPING SITES OF SKIN UNSPECIFIED MALIGNANT NEOPLASM OF SKIN, UNSPECIFIED BASAL CELL CARCINOMA OF SKIN, UNSPECIFIED SQUAMOUS CELL CARCINOMA OF SKIN, UNSPECIFIED OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN, UNSPECIFIED KAPOSI'S SARCOMA OF SKIN PERIPHERAL T-CELL LYMPHOMA, UNSPECIFIED SITE PERIPHERAL T-CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK PERIPHERAL T-CELL LYMPHOMA, INTRATHORACIC LYMPH NODES PERIPHERAL T-CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES PERIPHERAL T-CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB PERIPHERAL T-CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB PERIPHERAL T-CELL LYMPHOMA, INTRAPELVIC LYMPH NODES PERIPHERAL T-CELL LYMPHOMA, SPLEEN PERIPHERAL T-CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES PERIPHERAL T-CELL LYMPHOMA, EXTRANODAL AND SOLID ORGAN SITES MELANOMA IN SITU OF LIP MELANOMA IN SITU OF UNSPECIFIED EYELID, INCLUDING CANTHUS MELANOMA IN SITU OF RIGHT EYELID, INCLUDING CANTHUS MELANOMA IN SITU OF LEFT EYELID, INCLUDING CANTHUS MELANOMA IN SITU OF UNSPECIFIED EAR AND EXTERNAL AURICULAR CANAL May 31, 2017 Copyright Health Information Designs, LLC 27

28 D0321 D0322 D0330 D0339 D034 D0351 D0352 D0359 D0360 D0361 D0362 D0370 D0371 D0372 D038 D039 Q802 Q803 Q808 Q809 Step 8 (diagnosis of skin absorption disorder or skin malignancy) Required diagnosis: 1 MELANOMA IN SITU OF RIGHT EAR AND EXTERNAL AURICULAR CANAL MELANOMA IN SITU OF LEFT EAR AND EXTERNAL AURICULAR CANAL MELANOMA IN SITU OF UNSPECIFIED PART OF FACE MELANOMA IN SITU OF OTHER PARTS OF FACE MELANOMA IN SITU OF SCALP AND NECK MELANOMA IN SITU OF ANAL SKIN MELANOMA IN SITU OF BREAST (SKIN) (SOFT TISSUE) MELANOMA IN SITU OF OTHER PART OF TRUNK MELANOMA IN SITU OF UNSPECIFIED UPPER LIMB, INCLUDING SHOULDER MELANOMA IN SITU OF RIGHT UPPER LIMB, INCLUDING SHOULDER MELANOMA IN SITU OF LEFT UPPER LIMB, INCLUDING SHOULDER MELANOMA IN SITU OF UNSPECIFIED LOWER LIMB, INCLUDING HIP MELANOMA IN SITU OF RIGHT LOWER LIMB, INCLUDING HIP MELANOMA IN SITU OF LEFT LOWER LIMB, INCLUDING HIP MELANOMA IN SITU OF OTHER SITES MELANOMA IN SITU, UNSPECIFIED LAMELLAR ICHTHYOSIS CONGENITAL BULLOUS ICHTHYOSIFORM ERYTHRODERMA OTHER CONGENITAL ICHTHYOSIS CONGENITAL ICHTHYOSIS, UNSPECIFIED Step 9 (history of prior pimecrolimus/tacrolimus use for 180 days) Look back timeframe: 200 days For the list of pimecrolimus/tacrolimus prescriptions that pertain to this step, see the Pimecrolimus/Tacrolimus Drugs table in this Supporting Tables section. te: Click the hyperlink to navigate directly to the table. May 31, 2017 Copyright Health Information Designs, LLC 28

29 Texas Prior Authorization Program Clinical Criteria Protopic 0.1% Topical Immunomodulators Protopic 0.1% Drugs Requiring Prior Authorization Drugs Requiring Prior Authorization Label Name GCN PROTOPIC 0.1% OINTMENT TACROLIMUS 0.1% OINTMENT May 31, 2017 Copyright Health Information Designs, LLC 29

30 Texas Prior Authorization Program Clinical Criteria Protopic 0.1% Topical Immunomodulators Protopic 0.1% Clinical Criteria Logic 1. Is the client less than (<) 16 years of age? [ ] (Deny) [ ] (Go to #2) 2. Does the client have a claim for a topical steroid in the last 730 days? [ ] (Go to #4) [ ] (Go to #3) 3. Does the client have a claim for pimecrolimus or tacrolimus in the last 90 days? [ ] (Go to #4) [ ] (Deny) 4. Does the client have a diagnosis of atopic dermatitis in the last 730 days? [ ] (Go to #5) [ ] (Deny) 5. Has the client had a diagnosis of HIV or immune system disorder in the last 730 days? [ ] (Deny) [ ] (Go to #6) 6. Does the client have a history of HIV drugs or immunosuppressants in the last 730 days? [ ] (Deny) [ ] (Go to #7) 7. Does the client have a history of antineoplastic agents in the last 730 days? [ ] (Deny) [ ] (Go to #8) 8. Does the client have a diagnosis of a skin absorption disorder or a skin malignancy in the last 730 days? [ ] (Deny) [ ] (Go to #9) 9. Does the client have claims history of prior pimecrolimus or tacrolimus use for less than or equal to ( ) 180 days in the last 200 days? [ ] (Approve 180 days) [ ] (Deny) May 31, 2017 Copyright Health Information Designs, LLC 30

31 Texas Prior Authorization Program Clinical Criteria Protopic 0.1% Topical Immunomodulators Protopic 0.1% Clinical Criteria Logic Diagram Step 1 Is the client < 16 years of age? Deny Request Step 2 Step 4 Does the client have a claim for a topical steroid in the last 730 days? Does the client have a diagnosis of atopic dermatitis in the last 730 days? Deny Request Step 3 Step 5 Step 6 Does the client have a claim for pimecrolimus or tacrolimus in the last 90 days? Does the client have a diagnosis of HIV or immune system disorder in the last 730 days? Does the client have a history of HIV drugs or immunosuppressants in the last 730 days? Deny Request Deny Request Deny Request Step 7 Does the client have a history of antineoplastic agents in the last 730 days? Deny Request Step 9 Step 8 Deny Request Does the client have claims history of prior pimecrolimus or tacrolimus use for 180 days in the last 200 days? Does the client have a diagnosis of a skin absorption disorder or a skin malignancy in the last 730 days? Deny Request Approve Request (180 days) May 31, 2017 Copyright Health Information Designs, LLC 31

32 Texas Prior Authorization Program Clinical Criteria Protopic 0.1% Topical Immunomodulators Protopic 0.1% Clinical Criteria Supporting Tables Step 2 (history of a topical steroid) For the list of topical steroid agents that pertain to this step, see the Topical Steroid table in the previous Supporting Tables section. te: Click the hyperlink to navigate directly to the table. Step 3 (claim for pimecrolimus or tacrolimus) Look back timeframe: 90 days For the list of pimecrolimus/tacrolimus agents that pertain to this step, see the Pimecrolimus/Tacrolimus Drugs table in the previous Supporting Tables section. te: Click the hyperlink to navigate directly to the table. Step 4 (diagnosis of atopic dermatitis) Required diagnosis: 1 For the list of atopic dermatitis diagnoses that pertain to this step, see the Atopic Dermatitis Diagnoses table in the previous Supporting Tables section. te: Click the hyperlink to navigate directly to the table. Step 5 (diagnosis of HIV or immune system disorder) Required diagnosis: 1 For the list of HIV and immune system disorder diagnoses that pertain to this step, see the HIV and Immune System Disorder Diagnoses table in the previous Supporting Tables section. te: Click the hyperlink to navigate directly to the table. May 31, 2017 Copyright Health Information Designs, LLC 32

33 Texas Prior Authorization Program Clinical Criteria Protopic 0.1% Step 6 (history of HIV drugs or immunosuppressants) For the list of HIV drugs and immunosuppressants that pertain to this step, see the HIV Drugs and Immunosuppressants table in the previous Supporting Tables section. te: Click the hyperlink to navigate directly to the table. Step 7 (history of an antineoplastic agent) For the list of antineoplastic agents that pertain to this step, see the Antineoplastic Agents table in the previous Supporting Tables section. te: Click the hyperlink to navigate directly to the table. Step 8 (diagnosis of skin absorption disorder or skin malignancy) For the list of diagnoses that pertain to this step, see the Skin Absorption Disorder or Skin Malignancy table in the previous Supporting Tables section. te: Click the hyperlink to navigate directly to the table. Step 9 (history of pimecrolimus or tacrolimus use 180 days) Look back timeframe: 200 days For the list of pimecrolimus/tacrolimus agents that pertain to this step, see the Pimecrolimus/Tacrolimus Drugs table in the previous Supporting Tables section. te: Click the hyperlink to navigate directly to the table. May 31, 2017 Copyright Health Information Designs, LLC 33

34 Texas Prior Authorization Program Clinical Criteria Eucrisa Topical Immunomodulators Eucrisa Drugs Requiring Prior Authorization Drugs Requiring Prior Authorization Label Name GCN EUCRISA 2% OINTMENT May 31, 2017 Copyright Health Information Designs, LLC 34

35 Texas Prior Authorization Program Clinical Criteria Eucrisa Topical Immunomodulators Eucrisa Clinical Criteria Logic 1. Is the client less than (<) 2 years of age? [ ] (Deny) [ ] (Go to #2) 2. Does the client have a diagnosis of atopic dermatitis in the last 730 days? [ ] (Go to #3) [ ] (Deny) 3. Does the client have a claim for a topical steroid in the last 730 days? [ ] (Approve 180 days) [ ] (Deny) May 31, 2017 Copyright Health Information Designs, LLC 35

36 Texas Prior Authorization Program Clinical Criteria Eucrisa Topical Immunomodulators Eucrisa Clinical Criteria Logic Diagram Step 1 Is the client < 2 years of age? Deny Request Step 2 Step 3 Does the client have a diagnosis of atopic dermatitis in the last 730 days? Does the client have a claim for a topical steroid in the last 730 days? Approve Request (180 days) Deny Request Deny Request May 31, 2017 Copyright Health Information Designs, LLC 36

37 Texas Prior Authorization Program Clinical Criteria Eucrisa Topical Immunomodulators Eucrisa Clinical Criteria Supporting Tables Step 2 (diagnosis of atopic dermatitis) Required diagnosis: 1 For the list of atopic dermatitis diagnoses that pertain to this step, see the Atopic Dermatitis Diagnoses table in the previous Supporting Tables section. te: Click the hyperlink to navigate directly to the table. Step 3 (history of a topical steroid) For the list of topical steroid agents that pertain to this step, see the Topical Steroid table in the previous Supporting Tables section. te: Click the hyperlink to navigate directly to the table. May 31, 2017 Copyright Health Information Designs, LLC 37

38 Texas Prior Authorization Program Clinical Criteria Topical Immunomodulators Topical Immunomodulators Clinical Criteria References 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 4. American Medical Association data files ICD-10-CM Diagnosis Codes. Available at 5. Clinical Pharmacology [online database]. Tampa, FL: Elsevier/Gold Standard, Inc.; Available at Accessed on April 13, Micromedex [online database]. Available at Accessed on April 13, Elidel Prescribing Information. Bridgewater, NJ. Valeant Pharmaceuticals rth America LLC. August Protopic Prescribing Information. rthbrook, IL. Astellas Pharma US, Inc. vember Eucrisa Prescribing Information. Palo Alto, CA. Anacor Pharmaceuticals. December Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis. J Am Acad Dermatology Jul;71(1): Wahn U, Bos JD, Goodfield M, Caputo R, Papp K, Manjra A, et al. Efficacy and safety of pimecrolimus cream in the long-term management of atopic dermatitis in children. Pediatrics 2002;110:e2. 12.Kapp A, Papp K, Bingham A, Folster-Holst R, Ortonne JP, Potter PC, et al. Longtermmanagement of atopic dermatitis in infants with topical pimecrolimus, a nonsteroid anti-inflammatory drug. J Allergy Clin Immunol 2002;110: Thaci D, Chambers C, Sidhu M, Dorsch B, Ehlken B, Fuchs S. Twice-weekly treatment with tacrolimus 0.03% ointment in children with atopic dermatitis: clinical efficacy and economic impact over 12 months. J Eur Acad Dermatol Venereol 2010;24: May 31, 2017 Copyright Health Information Designs, LLC 38

39 Texas Prior Authorization Program Clinical Criteria Topical Immunomodulators 14. Koo JY, Fleischer AB Jr, Abramovits W, Pariser DM, McCall CO, Horn TD, et al. Tacrolimus ointment is safe and effective in the treatment of atopic dermatitis: results in 8000 patients. J Am Acad Dermatol 2005;53(Suppl):S May 31, 2017 Copyright Health Information Designs, LLC 39

40 Texas Prior Authorization Program Clinical Criteria Topical Immunomodulators Publication History The Publication History records the publication iterations and revisions to this document. tes for the most current revision are also provided in the Revision tes on the first page of this document. Publication Date tes 01/31/2011 Initial publication and posting to website 04/10/2012 Added a new section to specify the drugs requiring prior authorization for each form of topical immunomodulators Revised age check (step 1) in criteria logic and logic diagram for Elidel and Protopic 0.03% from less than 3 (<3) to less than or equal to () 2 years of age In the Clinical Edit Supporting Tables section for Elidel and Protopic 0.03%, revised tables to specify the drug names and GCNs pertinent to steps 2, 4, 5, 7, 8, 9, and 10 of the logic diagram In the Clinical Edit Supporting Tables section for Elidel and Protopic 0.03%, revised tables to specify the diagnosis codes pertinent to steps 3 and 6 of the logic diagram In the Clinical Edit Supporting Tables section for Protopic 0.1%, revised tables to specify the diagnosis codes pertinent to steps 2 and 5 of the logic diagram In the Clinical Edit Supporting Tables section for Protopic 0.1%, revised tables to specify the drug names and GCNs pertinent to steps 3, 4, 6, 7, 8, and 9 of the logic diagram 4/24/2014 In the Clinical Edit Criteria Logic section for Elidel and Protopic 0.03%, revised question #10 decision steps to if yes, approve and if no, deny. In the Clinical Edit Criteria Logic section for Protopic 0.1%, revised question #9 decision steps to if yes, approve and if no, deny. 04/03/2015 Updated to include ICD-10s 10/05/2016 Updated Step 1, page 4. If less than 2 years of age, deny Updated Step 9, page 4. Checks for less than or equal to 180 days therapy in the last 200 days. Approval will be for 180 days Updated Clinical Edit Diagram, page 5 Updated Table 2, page 6. Removed GCN Updated Table 6, page 12. Added GCNs for the following: Afinitor, Astagraf, Envarsus, Evotaz, Fuzeon, Genvoya, Intelence, Isentress, Prezista, Rapamune, Reyataz, Stribild, Tivicay, Triumeq, Viramune and Zortress Updated Table 7, page 16. Added GCNs for the following: Azacitidine, BiCNU, Bosulif, Caprelsa, Cometriq, May 31, 2017 Copyright Health Information Designs, LLC 40

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