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 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. December 10, 2018 Copyright 2018 Health Information Designs, LLC 1
Revision tes Added GCN for imiquimod cream 3.75% pump to Drugs Requiring PA, page 8 December 10, 2018 Copyright 2018 Health Information Designs, LLC 2
Drugs Requiring Prior Authorization Drugs Requiring Prior Authorization Label Name GCN ALDARA 5% CREAM 54201 IMIQUIMOD 5% CREAM PACKET 54201 December 10, 2018 Copyright 2018 Health Information Designs, LLC 3
Clinical Criteria Logic 1. Does the client have a diagnosis of genital or perianal warts in the last 60 days? [ ] (Go to #2) [ ] (Go to #3) 2. Is the client greater than or equal to ( ) 12 years of age? [ ] (Approve 112 days) [ ] (Deny) 3. Is the client greater than or equal to ( ) 18 years of age? [ ] (Go to #4) [ ] (Deny) 4. Does the client have a diagnosis of actinic keratosis or basal cell carcinoma in the last 60 days? [ ] (Approve - 112 days) [ ] (Deny) December 10, 2018 Copyright 2018 Health Information Designs, LLC 4
Clinical Criteria Logic Diagram Step 1 Step 2 Does the client have a diagnosis of genital or perianal warts in the last 60 days? Is the client 12 years of age? Approve (112 days) Deny Request Step 3 Step 4 Is the client 18 years of age? Does the client have a diagnosis of actinic keratosis or basal cell carcinoma in the last 60 days? Approve (112 days) Deny Request Deny Request December 10, 2018 Copyright 2018 Health Information Designs, LLC 5
Clinical Criteria Supporting Tables ICD-10 Code A630 Step 1 (diagnosis of genital or perianal warts) Required diagnosis: 1 Look back timeframe: 60 days Description ANOGENITAL (VENEREAL) WARTS Step 4 (diagnosis of actinic keratosis or basal cell carcinoma) Required diagnosis: 1 Look back timeframe: 60 days ICD-10 C4400 C4401 C4409 C44101 C44111 C44191 C44201 C44211 C44291 C44300 C44301 C44309 C44310 C44311 C44319 C44390 C44391 C44399 Description UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF LIP BASAL CELL CARCINOMA OF SKIN OF LIP OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF LIP UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF UNSPECIFIED EYELID, INCLUDING CANTHUS BASAL CELL CARCINOMA OF SKIN OF UNSPECIFIED EYELID, INCLUDING CANTHUS OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF UNSPECIFIED EYELID, INCLUDING CANTHUS UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF UNSPECIFIED EAR AND EXTERNAL AURICULAR CANAL BASAL CELL CARCINOMA OF SKIN OF UNSPECIFIED EAR AND EXTERNAL AURICULAR CANAL OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF UNSPECIFIED 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 OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF UNSPECIFIED PART OF FACE OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF NOSE OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF OTHER PARTS OF FACE December 10, 2018 Copyright 2018 Health Information Designs, LLC 6
C4440 C4441 C4449 C44500 C44501 C44509 C44510 C44511 C44519 C44590 C44591 C44599 C44601 C44611 C44691 C44701 C44711 C44791 C4480 C4481 C4489 C4490 C4491 C4499 L570 Step 4 (diagnosis of actinic keratosis or basal cell carcinoma) Required diagnosis: 1 Look back timeframe: 60 days UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF SCALP AND NECK BASAL CELL CARCINOMA OF KIN 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 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 BASAL CELL CARCINOMA OF SKIN OF UNSPECIFIED UPPER LIMB, INCLUDING SHOULDER OTHER SPECIFIED MALIGNANT NEOPLASM OF UNSPECIFIED UPPER LIMB, INCLUDING SHOULDER UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF UNSPECIFIED LOWER LIMB, INCLUDING HIP BASAL CELL CARCINOMA OF SKIN OF UNSPECIFIED LOWER LIMB, INCLUDING HIP OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF UNSPECIFIED LOWER LIMB, INCLUDING HIP UNSPECIFIED MALIGNANT NEOPLASM OF OVERLAPPING SITES OF SKIN BASAL 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 OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN, UNSPECIFIED ACTINIC KERATOSIS December 10, 2018 Copyright 2018 Health Information Designs, LLC 7
Drugs Requiring Prior Authorization Drugs Requiring Prior Authorization Label Name GCN ZYCLARA 3.75% CREAM 28216 IMIQUIMOD CREAM 3.75% PUMP 31436 December 10, 2018 Copyright 2018 Health Information Designs, LLC 8
Clinical Criteria Logic 1. Does the client have a diagnosis of genital or perianal warts in the last 60 days? [ ] (Go to #2) [ ] (Go to #3) 2. Is the client greater than or equal to ( ) 12 years of age? [ ] (Approve - 56 days) [ ] (Deny) 3. Is the client greater than or equal to ( ) 18 years of age? [ ] (Go to #4) [ ] (Deny) 4. Does the client have a diagnosis of actinic keratosis in the last 60 days? [ ] (Approve 56 days) [ ] (Deny) December 10, 2018 Copyright 2018 Health Information Designs, LLC 9
Clinical Criteria Logic Diagram Step 1 Step 2 Does the client have a diagnosis of genital or perianal warts in the last 60 days? Is the client 12 years of age? Approve (56 days) Deny Request Step 3 Step 4 Is the client 18 years of age? Does the client have a diagnosis of actinic keratosis in the last 60 days? Approve (56 days) Deny Request Deny Request December 10, 2018 Copyright 2018 Health Information Designs, LLC 10
Clinical Criteria Supporting Table ICD-10 Code L570 Step 2 (diagnosis of actinic keratosis) Required diagnosis: 1 Look back timeframe: 60 days Description ACTINIC KERATOSIS December 10, 2018 Copyright 2018 Health Information Designs, LLC 11
Clinical Criteria References 1. Aldara [package insert]. Bristol, TN: Graceway Pharmaceuticals, LLC. October 2010. 2. Clinical Pharmacology [online database]. Tampa, FL: Elsevier/Gold Standard, Inc.; 2017. Available at www.clinicalpharmacology.com. Accessed on April 13, 2017. 3. Micromedex [online database]. Available at www.micromedexsolutions.com. Accessed on April 13, 2017. 4. 2015 ICD-9-CM Diagnosis Codes. 2015. Available at www.icd9data.com. Accessed on April 3, 2015. 5. 2015 ICD-10-CM Diagnosis Codes. 2015. Available at www.icd10data.com. Accessed on April 3, 2015. 6. American Medical Association data files. 2015 ICD-9-CM Diagnosis Codes. Available at www.commerce.ama-assn.org. 7. American Medical Association data files. 2015 ICD-10-CM Diagnosis Codes. Available at www.commerce.ama-assn.org. 8. Zyclara Prescribing Information. Bridgewater, NJ. Valeant Pharmaceuticals rth America LLC. September 2016. December 10, 2018 Copyright 2018 Health Information Designs, LLC 12
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 04/11/2012 Initial publication and posting to website 4/3/2015 Updated to include ICD-10s 05/08/2017 Annual review by staff Updated criteria logic to show approval duration of 112 days, page 4 Updated logic diagram, page 5 Removed ICD-9 codes from Table 1 and 4, pages 6-8 Updated criteria logic to show approval duration of 56 days and updated age requirements, page 9 Updated logic diagram, page 10 Removed ICD-9 codes from Table 2, page 11 Updated references, page 12 05/18/2018 Updated Table 1, page 6 12/10/2018 Added GCN for imiquimod cream 3.75% pump to Drugs Requiring PA, page 8 December 10, 2018 Copyright 2018 Health Information Designs, LLC 13