(Last Revised 10/04/18)

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1 Department Of Pharmacy (Medicaid, Child Health Plus, Medicare Part B, Qualified Health Plan, Essentials Plan, Enriched Health () Medications Requiring Authorization under Medical Benefit Fax request to (718) (Last Revised 10/04/18) It is the policy of Affinity Health Plan to require prior authorization for medical claims for the all drugs listed within this document when administered in an office or clinic setting. Some devices and supplies will also require prior authorization if listed. In addition, all drugs requested by nonparticipating providers shall require prior authorization i.e. Specialty Pharmacies. All drugs that are self-administered are covered as part of the Pharmacy Benefit. Prior authorization will be required in order to be covered as a Medical Benefit. Any drug that does not have an supported by FDA or Compendia requires authorization. Acceptable Compendia are Micromedex DrugDex and NCCN (National Comprehensive Cancer Network). Items Covered Benefit for Preferred Vendor Contact Information Medicaid/ Phone: Fax: Limits calories/day Enteral formula Enriched Health CVS Caremark Phone: Fax: Medicare Phone: Fax: Phone: Fax: Enteral supplies All lines of business Coram Phone: Fax: Insulin pump/supplies, Continuous Glucose Monitoring All lines of business Better Living Now Phone Fax: insulinpump@betterlivingnow.com Durable Medical Equipment (D), Supplies, Orthodontics, and Prosthetics* All lines of business Reliacare Alliance, IPA Phone: Fax : *Review the quantities in the Fee Schedule Excel document for a list of Medicaid covered supplies/d with quantity limits at

2 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health Unclassified Meds 1 per NDC package size Miscellaneous Codes ENDOCRINE Lupron Depot Lupron Depot- Ped Lupron Depot Eligard Leuprolide Leuprolide Supprelin LA Histrelin Implant C9399 J3490 J3590 J7199 J7599 J7799 J8498 J8499 J8597 J8999 J9999 J mg Central Precocious Puberty (CPP) Uterine leiomyomata with anemia Breast Cancer (BC) Endometriosis Gender Dysphoria (GD) J mg Ovarian Cancer Prostate Cancer Gender Dysphoria (GD) J mg Central Precocious Puberty Clinical documentation to support FDA or Compendia CPP: GnRH test, bone age assessment, imaging of the brain, age. Liomyomata: Laboratory confirmation of anemia BC: hormone receptor (+) GD: Tanner Stage 2 of puberty in adolescents Note: no authorization needed for prostate CA GD: Tanner Stage 2 of puberty in adolescents GnRH test, bone age assessment, imaging of the brain, age. Not to be used if drug specific code exists Delaying puberty for short stature In vitro fertilization Preserve ovarian function during chemotherapy Premenstrual syndrome Age < 2 Delaying puberty for short stature 2

3 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health Makena Hydroxyprogesterone Caproate (Makena) Other HPC Not Specified Hydroxyprogesterone Caproate J mg Asymptomatic women with singleton pregnancy at high risk for preterm birth J mg Asymptomatic women with singleton pregnancy at high risk for preterm birth Current weeks gestation and estimated delivery date History of spontaneous singleton preterm birth Note: no prior authorization required when obtaining compounded agent from Alere; however Prior Authorization required from Alere for nurse home administration Singletons without prior spontaneous preterm birth Short cervix Multiple gestation Symptomatic preterm labor Premature rupture of membranes (PROM) Other abnormal uterine and vaginal bleeding Patients less than 16 years of age safety and effectiveness in pediatric patients have not been established HETOLOGICS Soliris Eculizumab J mg Paroxysmal Nocturnal Hemoglobinuria Atypical Hemolytic Uremic Syndrome Confirmed Dx through laboratory test Shiga toxin E. Coli related to hemolytic uremic syndrome 3

4 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health Coagadex Human Factor X Vonvendi Recombinant von Willebrand factor Corifact Human Factor XIII Tretten Recombinant Factor XIII A Sub-unit J7175 IU Factor X deficiency Factor X deficiency: o Age 12 years old o For on demand treatment of bleeding for mild Factor X deficiency o Prolonged aptt, PT, and mild Factor X deficiency confirmed through laboratory evaluation J7179 IU Von Willebrand Disease (VWD) For mild-moderate VWD, with documentation that DDAVP is known to have an insufficient response or a documented clinical reason for not using DDAVP J7180 IU Factor XIII deficiency Factor XIII deficiency: o For routine prophylactic treatment of Factor XIII deficiency o FXIII deficiency confirmed through laboratory evaluation J7181 IU Factor XIII deficiency Factor XIII deficiency: o For routine prophylactic treatment of Factor XIII A subunit deficiency o FXIII deficiency confirmed through (STEC-HUS). Congenital Factor XIII B- subunit deficiency 4

5 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health laboratory evaluation Novoeight Recombinant Factor VIII J7182 IU Hemophilia A Confirmed diagnosis with laboratory test Wilate VWF complex Xyntha Alphanate Factor VIII (antihemophilic factor, recombinant) Antihemophilic factor VIII/VWF complex Humate P VWF complex J7183 IU VWD For mild-moderate VWD, with documentation that DDAVP is known to have an insufficient response or a documented clinical reason for not using DDAVP J7185 IU Hemophilia A Confirmed diagnosis with laboratory test J7186 IU Hemophilia A Acquired Factor VIII deficiency VWD surgical bleeding non responsive to DDAVP VWD J7187 IU Hemophilia A VWD VWD: o For mild-moderate VWD, with documentation that DDAVP is known to have an insufficient response or a documented clinical reason for not using DDAVP Hemophilia A o Confirmed severity of diagnosis with laboratory tests o Absence of or low inhibitor titers Von Willebrand Disease (VWD) Von Willebrand Disease (VWD) Severe VWD (Type 3) undergoing major surgery Prophylaxis of spontaneous bleeding episodes in 5

6 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health Obizur NovoSeven RT Hemofil Koate-DVI Recombinant Factor VIII Factor VII (antihemophillic factor, recombinant) Factor VIII (antihemophilic o Mild disease, documentation that DDAVP is known to have an insufficient response or a documented clinical reason for not using DDAVP VWD: o For mild-moderate VWD, with documentation that DDAVP is known to have an insufficient response or a documented clinical reason for not using DDAVP J7188 IU Acquired Hemophilia 18 years old Absence of inhibitors confirmed with laboratory diagnosis J mcg Hemophilia A with inhibitors Hemophilia B with inhibitors Acquired Hemophilia Congenital Factor VII deficiency Glanzmann s thrombasthenia refractory to transfusions Confirmed diagnosis with laboratory test Hemophilia A and B presence of inhibitors confirmed with laboratory diagnosis J7190 IU Hemophilia A Confirmed diagnosis with laboratory test VWD 6

7 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health Monoclate-P factor, human) Advate Helixate FS Kogenate FS Factor VIII (antihemophilic factor, recombinant) J7192 IU Hemophilia A Confirmed diagnosis with laboratory test Von Willebrand Disease (VWD) AlphaNine SD Mononine Bebulin VH Profilnine BeneFIX Ixinity Thrombate III Feiba NF Feliba VH Factor IX (antihemophilic factor, purified, nonrecombinant) Factor IX, complex Factor IX (antihemophilic factor, recombinant) Human Antithrombin III Anti-inhibitor J7193 IU Hemophilia B Confirmed diagnosis with laboratory test J7194 IU Hemophilia B Confirmed diagnosis with laboratory test Bebulin VH: Documentation of no allergy to heparin or history of heparin induced thrombocytopenia Profilnine SD: Documentation of no evidence of DIC nor fibrinolysis J7195 IU Hemophilia B Confirmed diagnosis with laboratory test J7197 IU Antithrombin deficiency J7198 IU Hemophilia A with inhibitors Confirmed diagnosis with laboratory tests Confirmed diagnosis with laboratory tests Von Willebrand Disease (VWD) Factor VII deficiency Ixinity: < 12 years of age 7

8 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health Afstyla Recombinant Factor VIII Hemophilia B with inhibitors Hemophilia A and B presence of inhibitors confirmed with laboratory diagnosis No evidence of DIC, acute thrombosis or embolism J7199 Hemophilia A Confirmed diagnosis with laboratory test Coagulation factor deficiencies in the absence of inhibitors to factor VIII or factor IX Rixubis Recombinant Factor IX J7200 IU Hemophilia B Confirmed diagnosis with laboratory test Von Willebrand Disease (VWD) Alprolix Recombinant Factor IX, Fc fusion protein J7201 IU Hemophilia B Confirmed diagnosis with laboratory test Induction of Immune tolerance in patients with Hemophilia B Idelvion Recombinant Factor IX, albumin fusion J7202 IU Hemophilia B Confirmed diagnosis with laboratory test Induction of Immune tolerance in patients with Hemophilia B 8

9 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health protein Eloctate Recombinant Factor VIII, Fc fusion protein J7205 IU Hemophilia A Confirmed diagnosis with laboratory test Induction of Immune tolerance in patients with Hemophilia B Adynovate Recombinant, PEGylated Factor VIII J7207 IU Hemophilia A Confirmed diagnosis with laboratory test Von Willebrand Disease (VWD) Nuwiq Recombinant Factor VIII J7209 IU Hemophilia A Confirmed diagnosis with laboratory test Von Willebrand Disease (VWD) Afstyla Recombinant Factor VIII J7210 IU Hemophilia A Confirmed diagnosis with laboratory test Kovaltry Recombinant Factor VIII J7211 IU Hemophilia A Confirmed diagnosis with laboratory test Epogen Procrit Epoetin alpha Epoetin alpha J0885 J units 1000 units Anemia, CKD nondialysis Anemia, chemotherapy induced, non-myeloid cancer Current Hgb Iron studies (excluding MDS) & evidence of adequate iron intake SQ route is Pharmacy benefit and requires authorization from Caremark 9

10 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health Anemia, zidouvidine or ribavirin ADR Surgical procedure, transfusion of blood product, allogeneic; prophylaxis Anemia, CHF Anemia, radiation Anemia during puerperium Aranesp Darbepoetin alfa J mcg Anemia, CKD nondialysis Anemia, chemotherapy induced, non-myeloid cancer Current Hgb Iron studies (excluding MDS) & evidence of adequate iron intake Anemia, dialysis SQ route is Pharmacy benefit and requires authorization from Caremark Neupogen Neulasta Filgrastim Pegfilgrastim J1442 J mcg 6 mg Febrile neutropenia, in non-myeloid cancer Neutropenia prophylaxis ANC Chemotherapy regimen is intermediate-high risk of neutropenia Patient risk factors Harvesting of peripheral blood stem cells, prior to autologous stem-cell transplantation Leukine Sargramostim J mcg Allogeneic bone marrow transplantation, Myeloid reconstitution CBC w/differential Renal function LFT 10

11 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health in HLA-matched related donors Autologous bone marrow transplant, Myeloid reconstitution following transplant in patients with non- Hodgkin's lymphoma, Hodgkin's disease, and acute lymphoblastic lymphoma Bone marrow transplant, Delay or failure of myeloid engraftment Febrile neutropenia, In acute myelogenous leukemia following induction chemotherapy; Prophylaxis Harvesting of peripheral blood stem cells Peripheral blood stem cell graft, Autologous, myeloid reconstitution following transplant in patients mobilized with granulocyte macrophage colony 11

12 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health Mozobil Plerixafor stimulating factor J mg Combination with granulocyte-colony stimulating factor (G- CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non- Hodgkin s lymphoma and multiple myeloma Cr at baseline CBC w/differential Neumega Oprelvekin J mg Prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy Platelet count <20,000/mcL Diagnosis of nonmyeloid cancer CBC and platelets Absence of atrial arrhythmias or fluid retention IMMUNOLOGIC Cytogam Cytomegalovirus Immune Globulin Intravenous (Human) J ml Prophylaxis of Cytomegalovirus (CMV) disease associated with transplantation of kidney, lung, liver, pancreas and heart Clinical documentation of transplant and donor s CMV status 12

13 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health Bivigam Immune Globulin Privigen J mg GamaSTAN J ml Gammaplex Hizentra J1557 J mg 100 mg Gammaked J mg Gamunex J mg Gammagard J mg Primary Immune Deficiency: J1566 J mg Octagam J mg Carimune J mg Cuvitru J mg Flebogamma J mg Congenital Agammaglobulinemia Hypogammaglobuline mia Kawasaki Solid Organ Transplant Secondary Immunodeficiency Chronic Lymphocytic Leukemia with Hypogammaglobuline mia (CLL) B cell CLL Bone Marrow Transplant Hematology: Idiopathic Thrombocytopenia Purpura (ITP) Fetal/Neonatal Alloimmune Thrombocytopenia Acquired red cell aplasia due to parvovirus Neurological Conditions: Chronic Inflammatory Demyelinating Polyneuropathy (CIPD) Inflammatory Chart notes detailing patient history IgG Subclass levels levels should be while patient is free from infection Serum antibody titers to pneumococcus, tetanus, and/or diphtheria Details of recurrent infections Re-Authorizations trough IgG levels; documenting patient response to Ig. Date of transplant, detailed patient history Laboratory results: CBC Serum ESR Serum C-reactive protein Serum LFTs Total IgG levels Hematology: Laboratory values used to confirm diagnosis Neurology: Fibromyalgia Lyme Disease Pediatric Epilepsy Neuropathy Encephalopathy Sicca Syndrome Uveitis 13

14 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health Kymriah Tisagenlecleucel Q infusion bag (up to 250 million car-positive viable T cells) Myopathies (Polymyositis, Dermatomyositis) Guillain-Barre Syndrome Myasthenia Gravis exacerbation Multifocal Motor Neuropathy Relapsing/Remitting Multiple Sclerosis Lambert-Eaton Syndrome Treatment of patients 25 years of age and younger with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Testing used to confirm diagnosis (examples: EMG, Nerve Conduction Study (NCS), muscle biopsy, MRI, CSF protein, Anti-Mag antibodies, Anti-GD1a, Anti-GD1b) Documentation of standard treatment tried/failed/contraindicate Multifocal Motor Neuropathy Anti-GM 1 antibody results Diagnosis confirmed with laboratory tests History of refractory disease/relapses Documentation of CD19 tumor expression and Philadelphia chromosome karyotype analysis Documentation of previous treatments s Repeat treatment Burkitt s lymphoma/leuk emia Treatment with any prior gene therapy product Documentation of Karnofsky/Lansky score Active hepatitis B, C, or any uncontrolled infection Grade 2 to 4 14

15 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health Graft versus Host Disease (GVHD) TABOLIC Aldurazyme Laronidase J mg Hurler and Hurler- Scheie forms of Mucopolysaccharidosis, Type I and Scheie form with moderate to severe symptoms Cerezyme Imiglucerase J units Type 1 Gaucher VPRIV Velaglucerase alfa J units Elelyso Taliglucerase alpfa J units Elaprase Idursulfase Fabrazyme Agalsidase beta disease in pediatric and adults with one or more of the following: anemia, thrombocytopenia, bone disease, hepatomegaly, or splenomegaly J mg Hunter syndrome or (mucopolysaccharidosi s II) Enzyme assay showing deficiency of L-iduronidase Enzyme assay demonstrating deficiency of beta glucosidase enzyme activity or by DNA testing > 1 disease complications Enzyme assay shown deficiency of iduronate- 2-sulfate enzyme activity or by DNA testing J mg Fabry's disease Assay shown deficiency of alpha galactosidase enzyme activity or DNA testing Symptoms description Use in combination with other chemotherapy agents Combined use with Zevesca 15

16 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health Myozyme Alglucosidase alfa Lumizyme Alglucosidase alfa Naglazyme Galsulfase Vimizim Elosulfase alpfa J mg Pompe disease, infantile onset J mg 8 years of age or older with late-onset (noninfantile) Pompe disease (GAA deficiency) who do not have evidence of cardiac hypertrophy J mg Mucopolysaccharidosis type VI (Maroteaux- Lamy syndrome) J mg Mucopolysaccharidosis type IVA (Morquio A syndrome) Enzyme test demonstrate reduce GAA enzyme activity or DNA testing for mutation in the GAA gene Enzyme test demonstrate reduce GAA enzyme activity or DNA testing for mutation in the GAA gene Assay shown deficiency of N-acetylgalactosamine-4- sulfatase enzyme activity or by DNA testing Assay shown deficiency of N-acetylgalactosamine-6- sulfatase enzyme activity or by DNA testing Aralast Glassia NEUROLOGIC Botox Alpha1-proteinase inhibitor Onabotulinumtoxin A J0256 J mg 10 mg Alpha-1-antitrypsin deficiency J unit Primary axillary hyperhidrosis in adults Chronic migraine prophylaxis Overactive bladder Neurogenic bladder Pretreatment serum Alpha 1-antitrysin (AAT) levels Post-bronchodilation FEV1 % of predicted Trial of topical agents Trial of at least 3 classes of migraine prophylaxis meds for at least 2 month duration for each agent Failure/intolerance to other drugs Cosmetics uses Diabetic neuropathic pain Spasticity related to stroke (except Botox) 16

17 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health Blepharospasm (>12 years old) Neurologic workup with previous treatments Writer s cramp Motor tics Strabismus ( 12 years old) Anal fissure Cervical Dystonia (>16 years old) Hemifacial Spasm Excessive salivation from other neurologic disorder Botox ONLY: Upper and Lower extremity spasticity in adults including related to stroke Spasticity related to Cerebral Palsy Achalasia Sialorrhea, Parkinson s Laryngeal dystonia Myobloc Rimabotulinumtoxin Xeomin Incobotulinumtoxin A J units Cervical Dystonia Neurologic workup with previous treatments J unit Blepharospasm Cervical Dystonia Neurologic workup with previous treatments 17

18 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health Dysport Abobotulinumtoxin J units Blepharospasm Cervical Dystonia Upper extremity spasticity in adults Lower extremity spasticity in pediatric patients related to Cerebral Palsy ( 2 to 17 years old) Novantrone Mitoxantrone J mg Relapsing forms of Multiple Sclerosis Tysabri Natalizumab J mg Relapsing forms of Multiple Sclerosis Crohn s disease moderate-severe Neurologic workup with previous treatments Baseline or current cardiac function & LVEF CBC with Diff Hepatic function Lifetime cumulative dose Note: no authorization needed for Acute myeloid leukemia or prostate cancer. Anti-John Cunningham Virus (JCV) antibody negative MS: Insufficient response to other biologics & MRI scan Crohn's Disease: Prior treatment use 18

19 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health OPHTHALMIC Avastin Bevacizumab C mg Facilities Only J mg Diabetic macular edema Diabetic retinopathy with macular edema Retinal vascular occlusion Wet age related macular degeneration Classic subfoveal choroidal neovascularization due to AMD Retinopathy of prematurity Glaucoma associated with vascular eye disorders Confirmed diagnosis through optical coherence tomography Visual acuity Informed consent for compounded formulation Macular edema Clinically significant with central involvement/vision loss Note: no authorization needed for cancer s when supported by FDA or Compendia Dry age related macular degeneration Proliferative diabetic retinopathy without macular edema EXCT Lucentis Pathologic myopia with subfoveal choroidal neovascularization 19

20 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health Eylea Aflibercept J0178 1mg Diabetic macular edema Diabetic retinopathy with macular edema Confirmed diagnosis through optical coherence tomography Visual acuity Combination therapy with intravitreal pharmacotherapy Lucentis Ranibizumab Macugen Pegaptanib Retinal vascular occlusion Wet age related macular degeneration J mg Diabetic macular edema Diabetic retinopathy with or without macular edema Retinal vascular occlusion Wet age related macular degeneration J mg Diabetic macular edema Diabetic retinopathy with macular edema Macular edema Clinically significant with central involvement/vision loss Confirmed diagnosis through optical coherence tomography Visual acuity Macular edema Clinically significant with central involvement/vision loss Confirmed diagnosis through optical coherence tomography Visual acuity Dry age related macular degeneration Proliferative diabetic retinopathy without macular edema Visudyne Verteporfin Wet age related macular degeneration J mg Wet age related macular degeneration Macular edema Clinically significant with central involvement/vision loss Confirmed diagnosis through optical Combination therapy with intravitreal 20

21 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health Classic subfoveal choroidal neovascularization due to AMD Pathologic myopia with subfoveal choroidal neovascularization coherence tomography Visual acuity Documentation to support that lesion compromises 50% of entire lesion & treatment spot 6.4 mm diameter pharmacotherapy Luxturna voretigene neparvovec-rzyl RESPIRATORY Synagis Palivizumab Histoplasmosis retinitis J mg Vision loss due to biallelic RPE65 variant-associated retinal dystrophy mg Seasonal usage: November March Prevention of lower respiratory tract disease in infants at high risk for Age 12 months of age Genetic testing to detect mutations in the RPE65 gene Documentation to support the presence of sufficient viable retinal cells by optical coherence tomography and/or ophthalmoscopy Clinical chart notes: outlining when the procedure(s) will be done and the treatment history for the affected eye(s) Gestational age Weight Risk factors s not listed above Second trial of the medication Hypersensitivity Age > 12 months 21

22 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health RSV: Chronic Lung Disease Premature Infant Healthy infants born > 29 wks/0 days gestation Congenital Abnormality of airway/neuro-muscular Condition Cinryze C1 esterase inhibitor (human) Hemodynamically unstable chronic heart disease J units Prophylaxis for Hereditary angioedema (HAE) for patients 12 years old Previous medication trials Confirmed diagnosis of HAE by laboratory testing Age 12 years of age Non- FDA s Emergency CABG Haegarda C1 esterase inhibitor (human) C units Prophylaxis for Hereditary angioedema (HAE) for patients 12 years old Clinical documentation with history of moderate or severe attacks Previous medication trials Confirmed diagnosis of HAE by laboratory testing Age 12 years of age Non- FDA s Emergency CABG Ruconest C1 esterase inhibitor (recombinant) J units Treatment of Acute attacks of HAE Clinical documentation with history of moderate or severe attacks Confirmed diagnosis of HAE by laboratory testing 22

23 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health Age 13 years of age Berinert C1 esterase inhibitor (human) Firazyr Icatibant Kalbitor Ecallantide Xolair Omalizumab J units Treatment of Acute attacks of HAE J mg Treatment of Acute attacks of HAE J mg Treatment of Acute attacks of HAE J mg Asthma: Moderate to severe persistent asthma & a positive skin test reactive to perennial allergen & Clinical documentation with history of moderate or severe attacks Confirmed diagnosis of HAE by laboratory testing Age 5 years of age Clinical documentation with history of moderate or severe attacks Confirmed diagnosis of HAE by laboratory testing Age 18 years of age Clinical documentation with history of moderate or severe attacks Confirmed diagnosis of HAE by laboratory testing Age 12 years of age Clinical documentation with history of moderate or severe attacks Asthma: Age > 6 years old Weight 150 kg Documented medication history, recent hospitalizations, Acute asthma exacerbations Allergy to peanuts Allergic rhinitis 23

24 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health inadequately controlled by corticosteroids Urticaria: Moderate to severe urticaria unresponsive to 2 months of antihistamines, corticosteroids or leukotriene receptor antagonists symptoms Serum IgE levels Urticaria Age 12 years old Documented medication history Documented Consultation with pulmonologist, immunologist, or allergist prophylaxis Latex Allergy label Fasenra Benralizumab Nucala Mepolizumab J per NDC package size Add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype J mg Add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype Eosinophilic Granulomatosis with Polyangiitis in adult Age > 12 y/o Baseline blood eosinophil count Clinicals including but not limited to: medication history, current therapy, and/or treatments, number of exacerbations Age > 12 y/o Baseline blood eosinophil count Clinicals including but not limited to: medication history, current therapy, and/or treatments, number of exacerbations Treatment of other eosinophilic conditions Acute bronchospasm or status asthmaticus Acute bronchospasm or status asthmaticus 24

25 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health Rheumatologic patients Euflexxa Gel-One Hyalgan Orthovisc Supartz Monovisc Synvisc GelSyn-3 Hyaluronate sodium Prolia Denosumab J7323 J7326 J7321 J7324 J7321 J7327 J7325 J mg/2ml Per dose 20mg/2ml 30mg/2ml 25mg/2.5ml Per dose 1mg 0.1 mg Treatment of pain in Osteoarthritis (OA) of the knee is no longer considered a covered benefit for Medicaid. J mg Treatment of postmenopausal women with osteoporosis at high risk of fracture Treatment to increase bone mass in men with osteoporosis at high risk for fracture Radiographic studies to support diagnosis Pharmacological treatment history including use of intraarticular steroids History of weight loss and rehab therapy Duration & response to trial of oral bisphosphonate Bone mineral density pretreatment T-score Fracture risk factors Serum calcium OA knee Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer Oral exam Pregnancy status Treatment to increase bone bass in women at high risk for fracture 25

26 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health receiving adjuvant aromatase inhibitor therapy for breast cancer Xgeva Denosumab J mg Prevention of skeletalrelated events in patients with multiple myeloma and in patients with bone metastases from solid tumors Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable Documentation of bone metastases Confirmation of the diagnosis Duration & response to trial of oral bisphosphonate Reclast Zoledronic acid Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy J mg Treatment and prevention of postmenopausal osteoporosis Treatment to increase bone mass in men with osteoporosis Duration & response to trial of oral bisphosphonate Bone mineral density pretreatment T-score Fracture risk factors Treatment and Renal function 26

27 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health prevention of glucocorticoid-induced osteoporosis Serum calcium, magnesium, phosphate Treatment of Paget s disease Zometa Zoledronic acid Forteo Teriparatide J mg Prevention of skeletalrelated events in patients with multiple myeloma with documented bone metastases Treatment for hypercalcemia of malignancy J mcg Treatment of postmenopausal women with osteoporosis at high risk for fracture Treatment to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture Confirmation of the diagnosis Documentation of bone metastases Note: Zometa has the same J code as Reclast. Zometa does not require authorization when used for Hypercalcemia of malignancy Duration & response to trial of oral bisphosphonate Bone mineral density pretreatment T-score Fracture risk factors Paget s disease of bone Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at 27

28 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health high risk for fracture Actemra Simponi Aria Tocilizumab Golimumab J3262 J mg 1 mg Rheumatoid Arthritis IV route Screened for latent TB History of past treatment regimens SQ route is Pharmacy benefit and requires authorization from Caremark Orencia Abatacept J mg Rheumatoid Arthritis (IV route ONLY) Adult Psoriatic Arthritis (IV route ONLY) Remicade Infliximab J mg Crohn s disease Ulcerative colitis Rheumatoid Arthritis Severe plaque psoriasis Psoriatic arthritis Screened for latent TB History of past treatment regimens Screened for latent TB History of past treatment regimens s SQ route is Pharmacy benefit and requires authorization from Caremark s 28

29 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health Musculoskeletal Spinraza Nusinersen Exondys 51 Eteplirsen J mg Spinal muscular atrophy J mg Duchenne Muscular Dystrophy Documentation confirming diagnosis Genetic testing Baseline and continued motor function exams Coagulation studies (ex. platelet count, prothrombin time, aptt) Quantitative spot urine protein test Documentation confirming diagnosis Genetic testing s Treatment of Spinal Muscular Atrophy, Type IV Doses higher than FDA dosing s Supplies Insulin Pump & Supplies External ambulatory infusion pump, insulin Disposable insulin delivery system E0784 A unit Type 1 or Type 2 diabetes AND the patient has completed a comprehensive diabetes education program and has been on multiple injections of insulin with frequent selfadjustments for at least 6 months OR C-peptide Evidence of member motivation & pump training Glucose monitoring log Insulin frequency Gestational diabetes AND has the patient 29

30 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health Continuous Glucose Monitoring Systems (CGM) Sensor Transmitter Receiver Monitor A9276 A9277 A9278 K0553 K0554 completed a comprehensive diabetes education program. 1 unit Type I diabetes without adequate control despite frequent self-monitoring of blood glucose levels Clinical documentation of diagnosis Inadequate glycemic control despite frequent self- monitoring Under the care of an endocrinologist Insulin frequency devices Replacement of loss/stolen devices Replacement of device within manufacturer warrantee period Type II DM Continuous Glucose Monitoring Systems (CGM) Sensor Transmitter Receiver Monitor A9276 A9277 A9278 K0553 K unit Diabetes without adequate control despite frequent self-monitoring of blood glucose levels Clinical documentation of diagnosis Inadequate glycemic control despite frequent self- monitoring Frequent insulin administration or on an insulin infusion pump Consistent follow-up with Provider to evaluate diabetes control Pregnancy/ Gestational DM devices Replacement of loss/stolen devices Replacement of device within manufacturer warrantee period Pregnancy/Gest ational DM 30

31 Key for Line of Business (LOB): Medicaid Child Health Plus Medicare Essentials Plan Enriched Health MISCELLANEOUS Caverject Alprostadil J mcg Diagnosis of Erectile Dysfunction (ED) Muse Alprostadil urethral J mcg suppository Pavacot Papaverine J mg Complete physical examination. Treatment of ED Registered Sex Offender Oraverse Solesta Phentolamine mesylate Dextranomer/ hyaluronic acid copolymer implant, anal canal Provenge Sipuleucel-T J mg L ml Fecal incontinence History of trial of pharmacologic & nonpharmacologic therapies Q dose Malignant neoplasm of prostate Cleveland clinic Florida Incontinence Score (CCFIS) & history of fecal incontinence. History pharmacologic & non-pharmacologic therapies ECOG Status (Eastern Cooperative Oncology Group) CRPC value TNM Cancer staging Life expectancy is estimated to be greater than 6 months Male infertility Urinary incontinence Vesicoureteral reflux 31

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