Texas Prior Authorization Program Clinical Edit Criteria. H.P. Acthar

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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) References: clinical publications and sources relevant to this clinical edit Note: Click the hyperlink to navigate directly to that section. Revision Notes N/A, initial publication November 24, 2014 Copyright 2014 Health Information Designs, LLC 1

Drugs Requiring Prior Authorization Label Name GCN ACTHAR H.P. GEL 80U/ML VIAL 26016 November 24, 2014 Copyright 2014 Health Information Designs, LLC 2

Clinical Edit Criteria Logic 1. Is the client < 2 years of age? [] Yes Go to #2 [] No Go to #3 2. Does the client have a diagnosis of infantile spasms in the last 730 days? [] Yes Go to #6 [] No Deny 3. Does the client have a diagnosis of multiple sclerosis, psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, systemic dermatomyositis, severe erythema multiforme, Stevens-Johnson Syndrome, serum sickness, keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation or sarcoidosis in the last 730 days? [] Yes Go to #4 [] No Deny 4. Does the client have 1 claim for a corticosteroid in the last 60 days? [] Yes Go to #6 [] No Go to #5 5. Does the client have a documented contraindication or intolerance to corticosteroid therapy? [manual] [] Yes Go to #6 [] No Deny 6. Does the client have a diagnosis of scleroderma, osteoporosis, systemic fungal infection, ocular herpes simplex, peptic ulcer and/or heart failure in the last 365 days? [] Yes Deny [] No Approve (30 days) November 24, 2014 Copyright 2014 Health Information Designs, LLC 3

Clinical Edit Criteria Logic Diagram Step 1 Is the client < 2 years of age? Yes Step 2 Does the client have a diagnosis of infantile spasms in the last 730 days? No Deny Request No Step 3 Deny Request No Does the client have a listed diagnosis in the last 730 days? Yes Yes Step 4 Does the client have 1 claim for a corticosteroid in the last 60 days? Yes Step 6 Does the client have a condition that is contraindicated with therapy in the last 365 days? Yes Deny Request No Yes No Step 5 Does the client have a documented contraindication or intolerance to corticosteroid therapy? [manual] Approve Request (30 days) No Deny Request November 24, 2014 Copyright 2014 Health Information Designs, LLC 4

Clinical Edit Criteria Supporting Tables Step 2 (diagnosis of infantile spasms) Look back timeframe: 730 days ICD-9 Code Description 345.6 INFANTILE SPASMS 345.60 INFANTILE SPASMS, WITHOUT MENTION OF INTRACTABLE EPILEPSY 345.61 INFANTILE SPASMS, WITH INTRACTABLE EPILEPSY ICD-10 Code Description G40.82 EPILEPTIC SPASMS G40.821 EPILEPTIC SPASMS, NOT INTRACTABLE, WITH STATUS EPILEPTICUS G40.822 EPILEPTIC SPASMS, NOT INTRACTABLE, WITHOUT STATUS EPILEPTICUS Step 3 (history of indicated diagnosis) Look back timeframe: 730 days ICD-9 Code Description 340 MULTIPLE SCLEROSIS 696.0 PSORIATIC ARTHROPATHY 714.0 RHEUMATOID ARTHRITIS 714.3 JUVENILE CHRONIC POLYARTHRITIS 720.0 ANKYLOSING SPONDYLITIS 710.0 SYSTEMIC LUPUS ERYTHEMATOSUS 710.3 DERMATOMYOSITIS 695.1 ERYTHEMA MULTIFORME 395.13 STEVENS-JOHNSON SYNDROME 395.14 STEVENS-JOHNSON SYNDROME-TOXIC EPIDERMAL NECROLYSIS OVERLAP SYNDROME 999.5 OTHER SERUM REACTION NOT ELSEWHERE CLASSIFIED 370 KERATITIS 364.0 ACUTE AND SUBACUTE IRIDOCYCLITIS 364.1 CHRONIC IRIDOCYCLITIS 364.2 CERTAIN TYPES OF IRIDOCYCLITIS November 24, 2014 Copyright 2014 Health Information Designs, LLC 5

Step 3 (history of indicated diagnosis) Look back timeframe: 730 days 364.3 UNSPECIFIED IRIDOCYCLITIS 377.3 OPTIC NEURITIS 363.20 CHORIORETINITIS, UNSPECIFIED 135 SARCOIDOSIS ICD-10 G35 Description MULTIPLE SCLEROSIS L40.5 ARTHROPATHIC PSORIASIS M06.8 OTHER SPECIFIED RHEUMATOID ARTHRITIS M06.9 RHEUMATOID ARTHRITIS, UNSPECIFIED M08.0 UNSPECIFIED JUVENILE RHEUMATOID ARTHRITIS M08.2 JUVENILE RHEUMATOID ARTHRITIS WITH SYSTEMIC ONSET M08.3 JUVENILE RHEUMATOID POLYARTHRITIS (SERONEGATIVE) M08.4 PAUCIARTICULAR JUVENILE RHEUMATOID ARTHRITIS M45 ANKYLOSING SPONDYLITIS M45.0 ANKYLOSING SPONDYLITIS OF MULTIPLE SITES IN SPINE M45.1 ANKYLOSING SPONDYLITIS OF OCCIPITO-ATLANTO-AXIAL REGION M45.2 ANKYLOSING SPONDYLITIS OF CERVICAL REGION M45.3 ANKYLOSING SPONDYLITIS OF CERVICOTHORACIC REGION M45.4 ANKYLOSING SPONDYLITIS OF THORACIC REGION M45.5 ANKYLOSING SPONDYLITIS OF THORACOLUMBAR REGION M45.6 ANKYLOSING SPONDYLITIS LUMBAR REGION M45.7 ANKYLOSING SPONDYLITIS OF LUMBOSACRAL REGION M45.8 ANKYLOSING SPONDYLITIS SACRAL AND SACROCOCCYGEAL REGION M45.9 ANKYLOSING SPONDYLITIS OF UNSPECIFIED SITES IN SPINE M32 SYSTEMIC LUPUS ERYTHEMATOSUS M32.1 SYSTEMIC LUPUS ERYTHEMATOSUS WITH ORGAN OR SYSTEM INVOLVEMENT M32.8 OTHER FORMS OF SYSTEMIC LUPUS ERYTHEMATOSIS M32.9 SYSTEMIC LUPUS ERYTHEMATOSUS, UNSPECIFIED M33 DERMATOPOLYMYOSITIS M33.0 JUVENILE DERMATOPOLYMYOSITIS M33.1 OTHER DERMATOPOLYMYOSITIS M33.2 POLYMYOSITIS M33.9 DERMATOPOLYMYOSITIS, UNSPECIFIED L51 ERYTHEMA MULTIFORME L51.0 NONBULLOUS ERYTHEMA MULTIFORME L51.1 STEVENS-JOHNSON SYNDROME L51.2 TOXIC EPIDERMAL NECROLYSIS (LYELL) November 24, 2014 Copyright 2014 Health Information Designs, LLC 6

Step 3 (history of indicated diagnosis) Look back timeframe: 730 days L51.3 STEVENS-JOHNSON SYNDROME TOXIC EPIDERMAL NECROLYSIS OVERLAP SYNDROME L51.8 OTHER ERYTHEMA MULTIFORME L51.9 ERYTHEMA MULTIFORME, UNSPECIFIED T80.6 OTHER SERUM REACTIONS H16 KERATITIS H20 IRIDOCYCLITIS H46 OPTIC NEURITIS H46.0 OPTIC PAPILLITIS H46.1 RETROBULBAR NEURITIS H46.2 NUTRITIONAL OPTIC NEUROPATHY H46.3 TOXIC OPTIC NEUROPATHY H46.8 OTHER OPTIC NEURITIS H46.9 UNSPECIFIED OPTIC NEURITIS H30 CHORIORETINAL INFLAMMATION D86 SARCOIDOSIS Step 4 (history of corticosteroid therapy) Look back timeframe: 60 days GCN Label Name 27241 DEXAMETHASONE 0.25 MG TABLET 27422 DEXAMETHASONE 0.5 MG TABLET 27400 DEXAMETHASONE 0.5 MG/5 ML ELX 27411 DEXAMETHASONE 0.5 MG/5 ML LIQ 27425 DEXAMETHASONE 0.75 MG TABLET 41691 DEXAMETHASONE 0.75 MG TABLET 27424 DEXAMETHASONE 1 MG TABLET 27427 DEXAMETHASONE 1.5 MG TABLET 27426 DEXAMETHASONE 2 MG TABLET 27428 DEXAMETHASONE 4 MG TABLET 27429 DEXAMETHASONE 6 MG TABLET 26783 HYDROCORTISONE 5 MG TABLET 26781 HYDROCORTISONE 10 MG TABLET 26782 HYDROCORTISONE 20 MG TABLET 27056 METHYLPREDNISOLONE 4 MG TABLET November 24, 2014 Copyright 2014 Health Information Designs, LLC 7

Step 4 (history of corticosteroid therapy) Look back timeframe: 60 days GCN Label Name 27058 METHYLPREDNISOLONE 8 MG TABLET 27051 METHYLPREDNISOLONE 16 MG TABLET 27055 METHYLPREDNISOLONE 32 MG TABLET 37499 METHYLPREDNISOLONE 4 MG DOSEPACK 27171 PREDNISONE 1 MG TABLET 38364 PREDNISONE 10 MG TAB DOSE PACK 27172 PREDNISONE 10 MG TABLET 27173 PREDNISONE 2.5 MG TABLET 27174 PREDNISONE 20 MG TABLET 38363 PREDNISONE 5 MG TABLET 27176 PREDNISONE 5 MG TABLET 27160 PREDNISONE 5 MG/5 ML SOLUTION 27177 PREDNISONE 50 MG TABLET Step 6 (history of congenital infection) Look back timeframe: 60 days ICD-9 Code Description 771.1 CONGENITAL CYTOMEGALOVIRUS INFECTION 771.0 CONGENITAL RUBELLA 771 OTHER CONGENITAL INFECTIONS SPECIFIC TO THE PERINATAL PERIOD 090 CONGENITAL SYPHILIS ICD-10 Code Description P35 CONGENITAL VIRAL DISEASES P35.0 CONGENITAL RUBELLA SYNDROME P35.1 CONGENITAL CYTOMEGALOVIRUS INFECTION P35.2 CONGENITAL HERPESVIRAL [HERPES SIMPLEX] INFECTION P35.3 CONGENITAL VIRAL HEPATITIS P35.8 OTHER CONGENITAL VIRAL DISEASES P35.9 CONGENITAL VIRAL DISEASE, UNSPECIFIED P37.1 CONGENITAL TOXOPLASMOSIS A50 CONGENITAL SYPHILIS November 24, 2014 Copyright 2014 Health Information Designs, LLC 8

Clinical Edit Criteria Supporting Tables Step 7 (diagnosis of scleroderma, osteoporosis, systemic fungal infection, ocular herpes simplex, peptic ulcer and/or heart failure) Look back timeframe: 365 days ICD-9 Code Description 701.0 CIRCUMSCRIBED SCLERODERMA 733.0 OSTEOPOROSIS 114 COCCIDIOIDOMYCOSIS 115 HISTOPLASMOSIS 116 BLASTOMYCOTIC INFECTION 117 OTHER MYCOSES 054.4 HERPES SIMPLEX WITH OPHTHALMIC COMPLICATIONS 533 PEPTIC ULCER SITE UNSPECIFIED 533.0 ACUTE PEPTIC ULCER OF UNSPECIFIED SITE WITH HEMORRHAGE 533.1 ACUTE PEPTIC ULCER OF UNSPECIFIED SITE WITH PERFORATION 533.2 ACUTE PEPTIC ULCER OF UNSPECIFIED SITE WITH HEMORRHAGE AND PERFORATION 533.3 ACUTE PEPTIC ULCER OF UNSPECIFIED SITE WITHOUT MENTION OF HEMORRHAGE AND PERFORATION 533.4 CHRONIC OR UNSPECIFIED PEPTIC ULCER OF UNSPECIFIED SITE WITH HEMORRHAGE 533.5 CHRONIC OR UNSPECIFIED PEPTIC ULCER OF UNSPECIFIED SITE WITH PERFORATION 533.6 CHRONIC OR UNSPECIFIED PEPTIC ULCER OF UNSPECIFIED SITE WITH HEMORRHAGE AND PERFORMATION 533.7 CHRONIC PEPTIC ULCER OF UNSPECIFIED SITE WITHOUT MENTION OF HEMORRHAGE OR PERFORMATION 533.9 PEPTIC ULCER OF UNSPECIFIED SITE UNSPECIFIED AS ACUTE OR CHRONIC WITHOUT MENTION OF HEMORRHAGE OR PERFORATION 428 HEART FAILURE 428.0 LEFT HEART FAILURE 428.1 LEFT HEART FAILURE 428.2 SYSTOLIC HEART FAILURE 428.20 SYSTOLIC HEART FAILURE, UNSPECIFIED 428.21 ACUTE SYSTOLIC HEART FAILURE 428.22 CHRONIC SYSTOLIC HEART FAILURE 428.23 ACUTE ON CHRONIC SYSTOLIC HEART FAILURE November 24, 2014 Copyright 2014 Health Information Designs, LLC 9

Step 7 (diagnosis of scleroderma, osteoporosis, systemic fungal infection, ocular herpes simplex, peptic ulcer and/or heart failure) Look back timeframe: 365 days 428.3 DIASTOLIC HEART FAILURE 428.30 DIASTOLIC HEART FAILURE, UNSPECIFIED 428.31 ACUTE DIASTOLIC HEART FAILURE 428.32 CHRONIC DIASTOLIC HEART FAILURE 428.33 ACUTE ON CHRONIC DIASTOLIC HEART FAILURE 428.4 COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE 428.40 COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, UNSPECIFIED 428.41 ACUTE COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE 428.42 CHRONIC COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE 428.43 ACUTE ON CHRONIC COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE 428.9 HEART FAILURE, UNSPECIFIED ICD-10 Code Description L94.0 LOCALIZED SCLERODERMA [MORPHEA] L94.1 LINEAR SCLERODERMA M80 M81 B38 B39 B40 B41 B42 B44 B45 B46 B48 B49 OSTEOPOROSIS WITH CURRENT PATHOLOGICAL FRACTURE OSTEOPOROSIS WITHOUT CURRENT PATHOLOGICAL FRACTURE COCCIDIOIDOMYCOSIS HISTOPLASMOSIS BLASTOMYCOSIS PARACOCCIDIOIDOMYCOSIS SPOROTRICHOSIS ASPERGILLOSIS CRYTOCOCCOSIS ZYGOMYCOSIS OTHER MYCOSES, NOT ELSEWHERE CLASSIFIED UNSPECIFIED MYCOSES B00.5 HEREPESVIRAL OCULAR DISEASE K27 PEPTIC ULCER, SITE UNSPECIFIED K27.0 ACUTE PEPTIC ULCER, SITE UNSPECIFIED, WITH HEMORRHAGE K27.1 ACUTE PEPTIC ULCER, SITE UNSPECIFIED, WITH PERFORATION K27.2 ACUTE PEPTIC ULCER, SITE UNSPECIFIED, WITH BOTH HEMORRHAGE AND PERFORATION K27.3 ACUTE PEPTIC ULCER, SITE UNSPECIFIED, WITHOUT HEMORRHAGE OR PERFORATION K27.4 CHRONIC OR UNSPECIFIED PEPTIC ULCER, SITE UNSPECIFIED, WITH HEMORRHAGE November 24, 2014 Copyright 2014 Health Information Designs, LLC 10

Step 7 (diagnosis of scleroderma, osteoporosis, systemic fungal infection, ocular herpes simplex, peptic ulcer and/or heart failure) Look back timeframe: 365 days K27.5 CHRONIC OR UNSPECIFIED PEPTIC ULCER, SITE UNSPECIFIED, WITH PERFORATION K27.6 CHRONIC OR UNSPECIFIED PEPTIC ULCER, SITE UNSPECIFIED, WITH BOTH HEMORRHAGE AND PERFORATION K27.7 CHRONIC OR UNSPECIFIED PEPTIC ULCER, SITE UNSPECIFIED, WITHOUT HEMORRHAGE OR PERFORATION K27.9 PEPTIC ULCER, SITE UNSPECIFIED, UNSPECIFIED AS ACUTE OR CHRONIC, WITHOUT HEMORRHAGE OR PERFORATION I50 HEART FAILURE I50.1 LEFT VENTRICULAR FAILURE I50.2 SYSTOLIC (CONGESTIVE) HEART FAILURE I50.20 UNSPECIFIED SYSTOLIC (CONGESTIVE) HEART FAILURE I50.21 ACUTE SYSTOLIC (CONGESTIVE) HEART FAILURE I50.22 CHRONIC SYSTOLIC (CONGESTIVE) HEART FAILURE I50.23 ACUTE ON CHRONIC SYSTOLIC (CONGESTIVE) HEART FAILURE I50.3 DIASTOLIC (CONGESTIVE) HEART FAILURE I50.30 UNSPECIFIED DIASTOLIC (CONGESTIVE) HEART FAILURE I50.31 ACUTE DIASTOLIC (CONGESTIVE) HEART FAILURE I50.32 CHRONIC DIASTOLIC (CONGESTIVE) HEART FAILURE I50.33 ACUTE ON CHRONIC DIASTOLIC (CONGESTIVE) HEART FAILURE I50.4 COMBINED SYSTOLIC (CONGESTIVE) AND DIASTOLIC (CONGESTIVE) HEART FAILURE I50.40 UNSPECIFIED COMBINED SYSTOLIC (CONGESTIVE) AND DIASTOLIC (CONGESTIVE) HEART FAILURE I50.41 ACUTE COMBINED SYSTOLIC (CONGESTIVE) AND DIASTOLIC (CONGESTIVE) HEART FAILURE I50.42 CHRONIC COMBINED SYSTOLIC (CONGESTIVE) AND DIASTOLIC (CONGESTIVE) HEART FAILURE I50.43 ACUTE ON CHRONIC COMBINED SYSTOLIC (CONGESTIVE) AND DIASTOLIC (CONGESTIVE) HEART FAILURE I50.9 HEART FAILURE, UNSPECIFIED November 24, 2014 Copyright 2014 Health Information Designs, LLC 11

Clinical Edit Criteria References 1. Clinical Pharmacology [online database]. Tampa, FL: Elsevier / Gold Standard, Inc. 2014. Available at http://www.clinicalpharmacology.com. Accessed on July 3, 2014. 2. Micromedex [online database]. Available at www.micromedexsolutions.com. Accessed on July 3, 2014. 3. 2014 ICD-9-CM Diagnosis Codes, Volume 1. 2013. Available at http://www.icd9data.com/. Accessed on July 3, 2014. 4. 2014 ICD-10-CM Diagnosis Codes, Volume 1. 2013. Available at http://www.icd10data.com/. Accessed on July 3, 2014. 5. Gel Prescribing Information. Questcor Pharmaceuticals, Inc. September 2012. 6. Go CY, Mackay MT, Weiss SK, et al. Evidence-based guideline update: medical treatment of infantile spasms: report of the Guideline Development Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2012 Jun 12;78(24):1974-80. November 24, 2014 Copyright 2014 Health Information Designs, LLC 12

Publication History 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 November 24, 2014 Copyright 2014 Health Information Designs, LLC 13