Actemra (tocilizumab) (Intravenous)

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1 Actemra (tcilizumab) (Intravenus) Last Review Date: 06/01/2018 Date f Origin: 09/21/2010 Dcument Number: MODA-0002 Dates Reviewed: 12/2010, 03/2011, 05/2011, 06/2011, 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 09/2012, 11/2012, 12/2012, 03/2013, 06/2013, 09/2013, 11/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 5/2015, 9/2015, 12/0215, 03/2016, 06/2016, 09/2016, 12/2016, 03/2017, 05/2017, 09/2017, 12/2017, 03/2018, 06/2018 I. Length f Authrizatin Cverage will be prvided as fllws: Castleman s Disease: 4 mnths and may be renewed Cytkine Release Syndrme: 4 dses nly and may nt be renewed Immune Checkpint Inhibitr related arthritis: 1 dse and may nt be renewed All ther indicatins: 6 mnths and may be renewed. II. Dsing Limits A. Quantity Limit (max daily dse) [Pharmacy Benefit]: Actemra 80 mg/4 ml vial: 1 vial per 14 days Actemra 200 mg/10 ml vial: 1 vial per 14 days Actemra 400 mg/20 ml vial: 2 vials per 14 days B. Max Units (per dse and ver time) [Medical Benefit]: Diagnsis Billable Units Interval (days) Rheumatid Arthritis & Plyarticular Juvenile Idipathic Arthritis Systemic Juvenile Idipathic Arthritis & Castleman s Disease (NHL) Cytkine Release Syndrme (CRS) curse f therapy nly Immune Checkpint Inhibitr related arthritis curse f therapy nly III. Initial Apprval Criteria Site f care specialty infusin prgram requirements are met (refer t Mda Site f Care Plicy). Self-administered injectable medicatins are nt cvered when supplied in a prvider s ffice, clinic r facility. Cverage is prvided in the fllwing cnditins: Mda Health Plan, Inc. Medical Necessity Criteria Page 1/18

2 Patient has been evaluated and screened fr the presence f latent TB infectin prir t initiating treatment; AND Patient des nt have an active infectin, including clinically imprtant lcalized infectins; AND Must nt be administered cncurrently with live vaccines; AND Patient is nt n cncurrent treatment with anther TNF-inhibitr, bilgic respnse mdifier r ther nn-bilgic agent (i.e., apremilast); AND Rheumatid Arthritis Patient is 18 years r lder; AND Physician has assessed baseline disease severity utilizing an bjective measure/tl; AND Dcumented mderate t severe active disease; AND Patient has had at least a 3 mnth trial and failed previus therapy with ONE ral disease mdifying anti-rheumatic agent (DMARD) such as methtrexate, azathiprine, auranfin, hydrxychlrquine, penicillamine, sulfasalazine, leflunmide ; AND May be used alne r in cmbinatin with methtrexate; AND Patient must try and have an inadequate respnse, cntraindicatin, r intlerance t at least a three (3) mnth trial f Enbrel AND Humira; OR Patient is cntinuing treatment Juvenile Idipathic Arthritis (JIA) Patient is 2 years r lder ; AND Patient has active systemic (SJIA) r plyarticular (PJIA) disease; AND Physician has assessed baseline disease severity utilizing an bjective measure/tl; AND Patient has had at least a 1-mnth trial and failure (unless cntraindicated r intlerant) f previus therapy with either ral nn-steridal anti-inflammatry drugs (NSAIDs) OR a systemic gluccrticid (prednisne, methylprednislne, etc.); AND May be used alne r in cmbinatin with methtrexate; AND (Nte: The fllwing applies t plyarticular (PJIA) disease nly) Patient must try and have an inadequate respnse, cntraindicatin, r intlerance t at least a three (3) mnth trial f Enbrel AND Humira; OR Patient is cntinuing treatment Castleman s Disease (NHL) Used as a single agent; AND Patient has unicentric disease; AND Patient is human immundeficiency virus (HIV)-negative and human herpesvirus-8 (HHV-8)-negative; AND Used as secnd-line therapy fr relapsed r refractry disease; OR Patient has multicentric disease; AND Mda Health Plan, Inc. Medical Necessity Criteria Page 2/18

3 Used as subsequent therapy fr relapsed, refractry, r prgressive disease Cytkine Release Syndrme (CRS) Patient is 2 years r lder; AND Patient has received r will be receiving chimeric antigen receptr (CAR) T cell therapy; AND Tcilizumab is being rdered t have n-hand, prir t the administratin f CAR-T therapy, if needed fr the treatment f CRS; OR Patient has a cnfirmed diagnsis f CAR-T therapy induced severe r life-threatening CRS Management f Immune Checkpint Inhibitr related Inflammatry Arthritis Patient has been receiving therapy with an immune checkpint inhibitr (e.g. nivlumab, pembrlizumab, atezlizumab, avelumab, durvalumab, etc.); AND Patient has inflammatry arthritis related t their immuntherapy; AND Dcumented severe disease; AND Patient s cnditin is refractry t crticsterids and anti-inflammatry agents FDA Apprved Indicatin(s); Cmpendia Recmmended Indicatin(s) IV. Renewal Criteria Cverage can be renewed based upn the fllwing criteria: Patient cntinues t meet criteria identified in sectin III; AND Absence f unacceptable txicity frm the drug. Examples f unacceptable txicity include the fllwing: neutrpenia (abslute neutrphil cunt (ANC) belw 1000 per mm 3 ), thrmbcytpenia (platelet cunt belw 100,000 per mm 3 ), hepattxicity (ALT r AST abve 3-5 times the upper limit f nrmal), gastrintestinal perfratin, severe hypersensitivity reactins, etc.; AND Patient is receiving nging mnitring fr presence f TB r ther active infectins; AND (Onclgy Indicatins) Castleman s Disease (NHL) Tumr respnse with stabilizatin f disease r decrease in size f tumr r tumr spread (Nn-Onclgy Indicatins) Rheumatid arthritis (RA) Disease respnse as indicated by imprvement in signs and symptms cmpared t baseline such as the number f tender and swllen jint cunts and/r an imprvement n a disease activity scring tl [e.g. an imprvement n a cmpsite scring index such as Disease Activity Scre-28 (DAS28) f 1.2 pints r mre r a 20% imprvement n the American Cllege f Rheumatlgy-20 (ACR20) criteria] Juvenile Idipathic Arthritis (SJIA/PJIA) Disease respnse as indicated by imprvement in signs and symptms cmpared t baseline such as the number f tender and swllen jint cunts and/r an imprvement n a disease Mda Health Plan, Inc. Medical Necessity Criteria Page 3/18

4 activity scring tl [e.g. an imprvement n a cmpsite scring index such as Juvenile Arthritis Disease Activity Scre (JADAS) r the American Cllege f Rheumatlgy (ACR) Pediatric (ACR-Pedi 30) f at least 30% imprvement frm baseline in three f six variables]. Cytkine Release Syndrme May nt be renewed Management f Immune Checkpint Inhibitr related Inflammatry Arthritis May nt be renewed V. Dsage/Administratin Dses exceeding 800 mg per infusin are nt recmmended Indicatin Adult Rheumatid Arthritis Plyarticular Juvenile Idipathic Arthritis Systemic Juvenile Idipathic Arthritis Castleman s Disease (NHL) Cytkine Release Syndrme (CRS) Immune- Checkpint Inhibitr related inflammatry arthritis 4 mg/kg IV every 4 weeks Dse May increase t 8 mg/kg every 4 weeks based n clinical respnse Weight 30 kg 8 mg/kg IV every 4 weeks Weight < 30 kg 10 mg/kg IV every 4 weeks Weight 30 kg 8 mg/kg IV every 2 weeks Weight < 30 kg 12 mg/kg IV every 2 weeks 8 mg/kg IV every 2 weeks fr 16 weeks (8 dses) Weight 30 kg 8 mg/kg IV every 8 hurs, if needed, up t a maximum f 4 ttal dses* Weight < 30 kg 12 mg/kg IV every 8 hurs, if needed, up t a maximum f 4 ttal dses* *If n clinical imprvement in the signs and symptms f CRS ccurs after the first dse, up t 3 additinal dses may be administered. The interval between cnsecutive dses shuld be at least 8 hurs. May be used with r withut crticsterids. 4 mg/kg IV nce VI. Billing Cde/Availability Infrmatin Jcde: J3262 Injectin, tcilizumab, 1 mg; 1 billable unit = 1 mg NDC: Actemra 80 mg/ 4 ml vial: xx Mda Health Plan, Inc. Medical Necessity Criteria Page 4/18

5 Actemra 200 mg/10 ml vial: xx Actemra 400 mg/20 ml vial: xx VII. References 1. Actemra [package insert]. Suth San Francisc, CA; Genentech, Inc; March Accessed May Referenced with permissin frm the NCCN Drugs & Bilgics Cmpendium (NCCN Cmpendium ) tcilizumab. Natinal Cmprehensive Cancer Netwrk, The NCCN Cmpendium is a derivative wrk f the NCCN Guidelines. NATIONAL COMPREHENSIVE CANCER NETWORK, NCCN, and NCCN GUIDELINES are trademarks wned by the Natinal Cmprehensive Cancer Netwrk, Inc. T view the mst recent and cmplete versin f the Cmpendium, g nline t NCCN.rg. Accessed May Singh JA, Saag KG, Bridges SL Jr, et al American Cllege f Rheumatlgy Guideline fr the Treatment f Rheumatid Arthritis. Arthritis Care Res (Hbken) Nv 6. di: /acr Beukelman T, Patkar NM, Saag KG, et al American Cllege f Rheumatlgy recmmendatins fr the treatment f juvenile idipathic arthritis: initiatin and safety mnitring f therapeutic agents fr the treatment f arthritis and systemic features. Arthritis Care Res (Hbken) Apr;63(4): Ringld S, Weiss PF, Beukelman T, et al update f the 2011 American Cllege f Rheumatlgy recmmendatins fr the treatment f juvenile idipathic arthritis: recmmendatins fr the medical therapy f children with systemic juvenile idipathic arthritis and tuberculsis screening amng children receiving bilgic medicatins. Arthritis Rheum Oct;65(10): DeWitt EM, Kimura Y, Beukelman T, et al. Cnsensus treatment plans fr new-nset systemic juvenile idipathic arthritis. Arthritis Care Res (Hbken) Jul;64(7): Nishimt N, Kanakura Y, Azasa K, et al. Humanized anti-interleukin-6 receptr antibdy treatment f multicentric Castleman disease. Bld 2005;106: Smlen JS, Landewé R, Bijlsma J, et al. EULAR recmmendatins fr the management f rheumatid arthritis with synthetic and bilgical disease-mdifying antirheumatic drugs: 2016 update. Ann Rheum Dis Mar 6. pii: annrheumdis Fraser JA, Weyand CM, Newman NJ, Biusse V. The treatment f giant cell arteritis. Rev Neurl Dis Summer;5(3): Dasgupta B, Brg FA, Hassan N, et al. BSR and BHPR guidelines fr the management f giant cell arteritis. Rheumatlgy (Oxfrd) Aug;49(8): Natinal Institute fr Health and Care Excellence. NICE Rheumatid Arthritis in Adults: Management. Published 25 February Clinical Guideline [CG79] Natinal Institute fr Health and Care Excellence. NICE Adalimumab, etanercept, infliximab, rituximab and abatacept fr the treatment f rheumatid arthritis after failure f a TNF inhibitr. Published 10 Octber Clinical Guideline [TA195]. Mda Health Plan, Inc. Medical Necessity Criteria Page 5/18

6 tnf-inhibitr-pdf Ward MM, Guthri LC, Alba MI. Rheumatid Arthritis Respnse Criteria And Patient- Reprted Imprvement in Arthritis Activity: Is an ACR20 Respnse Meaningful t Patients. Arthritis Rheumatl Sep; 66(9): di: /art Ringld S, Bittner R, Neggi T, et al. Perfrmance f rheumatid arthritis disease activity measures and juvenile arthritis disease activity scres in plyarticular-curse juvenile idipathic arthritis: Analysis f their ability t classify the American Cllege f Rheumatlgy pediatric measures f respnse and the preliminary criteria fr flare and inactive disease. Arthritis Care Res (Hbken) Aug;62(8): Cnslar A, Giancane G, Schiappapietra B, et al. Clinical utcme measures in juvenile idipathic arthritis. Pediatric Rheumatlgy 18 April : Strud C, Hedge A, Cherry C, et al. Tciluzumab fr the management f immune mediated adverse events secndary t PD-1 blckage. Jurnal f Onclgy Pharmacy Practice December. Appendix 1 Cvered Diagnsis Cdes ICD-10 C82.00 Fllicular lymphma grade I, unspecified site C82.01 Fllicular lymphma grade I, lymph ndes f head, face and neck C82.02 Fllicular lymphma, grade I, intrathracic lymph ndes C82.03 Fllicular lymphma grade I, intra-abdminal lymph ndes C82.04 Fllicular lymphma grade I, lymph ndes f axilla and upper limb C82.05 Fllicular lymphma grade I, lymph ndes f inguinal reginal and lwer limb C82.06 Fllicular lymphma grade I, intrapelvic lymph ndes C82.07 Fllicular lymphma grade I, spleen C82.08 Fllicular lymphma grade I, lymph ndes f multiple sites C82.09 Fllicular lymphma grade I, extrandal and slid rgan sites C82.10 Fllicular lymphma grade II, unspecified site C82.11 Fllicular lymphma grade II, lymph ndes f head, face and neck C82.12 Fllicular lymphma, grade II, intrathracic lymph ndes C82.13 Fllicular lymphma grade II, intra-abdminal lymph ndes C82.14 Fllicular lymphma grade II, lymph ndes f axilla and upper limb C82.15 Fllicular lymphma grade II, lymph ndes f inguinal regin and lwer limb C82.16 Fllicular lymphma grade II, intrapelvic lymph ndes C82.17 Fllicular lymphma grade II, spleen C82.18 Fllicular lymphma grade II, lymph ndes f multiple sites C82.19 Fllicular lymphma grade II, extrandal and slid rgan sites C82.20 Fllicular lymphma grade III, unspecified, unspecified site C82.21 Fllicular lymphma grade III, unspecified, lymph ndes f head, face and neck Mda Health Plan, Inc. Medical Necessity Criteria Page 6/18

7 C82.22 Fllicular lymphma, grade III, unspecified, intrathracic lymph ndes C82.23 Fllicular lymphma grade III, unspecified, intra-abdminal lymph ndes C82.24 Fllicular lymphma grade III, unspecified, lymph ndes f axilla and upper limb C82.25 Fllicular lymphma grade III, unspecified, lymph ndes f inguinal regin and lwer limb C82.26 Fllicular lymphma grade III, unspecified, intrapelvic lymph ndes C82.27 Fllicular lymphma grade III, unspecified, spleen C82.28 Fllicular lymphma grade III, unspecified, lymph ndes f multiple sites C82.29 Fllicular lymphma grade III, unspecified, extrandal and slid rgan sites C82.30 Fllicular lymphma grade IIIa, unspecified site C82.31 Fllicular lymphma grade IIIa, lymph ndes f head, face and neck C82.32 Fllicular lymphma, grade IIIa, intrathracic lymph ndes C82.33 Fllicular lymphma grade IIIa, intra-abdminal lymph ndes C82.34 Fllicular lymphma grade IIIa, lymph ndes f axilla and upper limb C82.35 Fllicular lymphma grade IIIa, lymph ndes f inguinal regin and lwer limb C82.36 Fllicular lymphma grade IIIa, intrapelvic lymph ndes C82.37 Fllicular lymphma grade IIIa, spleen C82.38 Fllicular lymphma grade IIIa, lymph ndes f multiple sites C82.39 Fllicular lymphma grade IIIa, extrandal and slid rgan sites C82.40 Fllicular lymphma grade IIIb, unspecified site C82.41 Fllicular lymphma grade IIIb, lymph ndes f head, face and neck C82.42 Fllicular lymphma, grade IIIb, intrathracic lymph ndes C82.43 Fllicular lymphma grade IIIb, intra-abdminal lymph ndes C82.44 Fllicular lymphma grade IIIb, lymph ndes f axilla and upper limb C82.45 Fllicular lymphma grade IIIb, lymph ndes f inguinal regin and lwer limb C82.46 Fllicular lymphma grade IIIb, intrapelvic lymph ndes C82.47 Fllicular lymphma grade IIIb, spleen C82.48 Fllicular lymphma grade IIIb, lymph ndes f multiple sites C82.49 Fllicular lymphma grade IIIb, extrandal and slid rgan sites C82.50 Diffuse fllicle center lymphma, unspecified site C82.51 Diffuse fllicle center lymphma, lymph ndes f head, face and neck C82.52 Diffuse fllicle center lymphma, intrathracic lymph ndes C82.53 Diffuse fllicle center lymphma, intra-abdminal lymph ndes C82.54 Diffuse fllicle center lymphma, lymph ndes f axilla and upper limb C82.55 Diffuse fllicle center lymphma, lymph ndes f inguinal regin and lwer limb C82.56 Diffuse fllicle center lymphma, intrapelvic lymph ndes C82.57 Diffuse fllicle center lymphma, spleen C82.58 Diffuse fllicle center lymphma, lymph ndes f multiple sites C82.59 Diffuse fllicle center lymphma, extrandal and slid rgan sites C82.60 Cutaneus fllicle center lymphma, unspecified site C82.61 Cutaneus fllicle center lymphma, lymph ndes f head, face and neck Mda Health Plan, Inc. Medical Necessity Criteria Page 7/18

8 C82.62 Cutaneus fllicle center lymphma, intrathracic lymph ndes C82.63 Cutaneus fllicle center lymphma, intra-abdminal lymph ndes C82.64 Cutaneus fllicle center lymphma, lymph ndes f axilla and upper limb C82.65 Cutaneus fllicle center lymphma, lymph ndes f inguinal regin and lwer limb C82.66 Cutaneus fllicle center lymphma, intrapelvic lymph ndes C82.67 Cutaneus fllicle center lymphma, spleen C82.68 Cutaneus fllicle center lymphma, lymph ndes f multiple sites C82.69 Cutaneus fllicle center lymphma, extrandal and slid rgan sites C82.80 Other types f fllicular lymphma, unspecified site C82.81 Other types f fllicular lymphma, lymph ndes f head, face and neck C82.82 Other types f fllicular lymphma, intrathracic lymph ndes C82.83 Other types f fllicular lymphma, intra-abdminal lymph ndes C82.84 Other types f fllicular lymphma, lymph ndes f axilla and upper limb C82.85 Other types f fllicular lymphma, lymph ndes f inguinal regin and lwer limb C82.86 Other types f fllicular lymphma, intrapelvic lymph ndes C82.87 Other types f fllicular lymphma, spleen C82.88 Other types f fllicular lymphma, lymph ndes f multiple sites C82.89 Other types f fllicular lymphma, extrandal and slid rgan sites C82.90 Fllicular lymphma, unspecified, unspecified site C82.91 Fllicular lymphma, unspecified, lymph ndes f head, face and neck C82.92 Fllicular lymphma, unspecified, intrathracic lymph ndes C82.93 Fllicular lymphma, unspecified, intra-abdminal lymph ndes C82.94 Fllicular lymphma, unspecified, lymph ndes f axilla and upper limb C82.95 Fllicular lymphma, unspecified lymph ndes f inguinal regin and lwer limb C82.96 Fllicular lymphma, unspecified, intrapelvic lymph ndes C82.97 Fllicular lymphma, unspecified, spleen C82.98 Fllicular lymphma, unspecified, lymph ndes f multiple sites C82.99 Fllicular lymphma, unspecified, extrandal and slid rgan sites C83.00 Small cell B-cell lymphma, unspecified site C83.01 Small cell B-cell lymphma, lymph ndes f head, face and neck C83.02 Small cell B-cell lymphma, intrathracic lymph ndes C83.03 Small cell B-cell lymphma, intra-abdminal lymph ndes C83.04 Small cell B-cell lymphma, lymph ndes f axilla and upper limb C83.05 Small cell B-cell lymphma, lymph ndes f inguinal regin and lwer limb C83.06 Small cell B-cell lymphma, intrapelvic lymph ndes C83.07 Small cell B-cell lymphma, spleen C83.08 Small cell B-cell lymphma, lymph ndes f multiple sites C83.09 Small cell B-cell lymphma, extrandal and slid rgan sites C83.30 Diffuse large B-cell lymphma unspecified site C83.31 Diffuse large B-cell lymphma, lymph ndes f head, face, and neck Mda Health Plan, Inc. Medical Necessity Criteria Page 8/18

9 C83.32 Diffuse large B-cell lymphma intrathracic lymph ndes C83.33 Diffuse large B-cell lymphma intra-abdminal lymph ndes C83.34 Diffuse large B-cell lymphma lymph ndes f axilla and upper limb C83.35 Diffuse large B-cell lymphma, lymph ndes f inguinal regin and lwer limb C83.36 Diffuse large B-cell lymphma intrapelvic lymph ndes C83.37 Diffuse large B-cell lymphma, spleen C83.38 Diffuse large B-cell lymphma lymph ndes f multiple sites C83.39 Diffuse large B-cell lymphma extrandal and slid rgan sites C91.00 Acute lymphblastic leukemia nt having achieved remissin C91.01 Acute lymphblastic leukemia, in remissin C91.02 Acute lymphblastic leukemia, in relapse D36.0 Benign neplasm f lymph ndes D47.Z2 Castleman disease M05.10 Rheumatid lung disease with rheumatid arthritis f unspecified site M Rheumatid lung disease with rheumatid arthritis f right shulder M Rheumatid lung disease with rheumatid arthritis f left shulder M Rheumatid lung disease with rheumatid arthritis f unspecified shulder M Rheumatid lung disease with rheumatid arthritis f right elbw M Rheumatid lung disease with rheumatid arthritis f left elbw M Rheumatid lung disease with rheumatid arthritis f unspecified elbw M Rheumatid lung disease with rheumatid arthritis f right wrist M Rheumatid lung disease with rheumatid arthritis f left wrist M Rheumatid lung disease with rheumatid arthritis f unspecified wrist M Rheumatid lung disease with rheumatid arthritis f right hand M Rheumatid lung disease with rheumatid arthritis f left hand M Rheumatid lung disease with rheumatid arthritis f unspecified hand M Rheumatid lung disease with rheumatid arthritis f right hip M Rheumatid lung disease with rheumatid arthritis f left hip M Rheumatid lung disease with rheumatid arthritis f unspecified hip M Rheumatid lung disease with rheumatid arthritis f right knee M Rheumatid lung disease with rheumatid arthritis f left knee M Rheumatid lung disease with rheumatid arthritis f unspecified knee M Rheumatid lung disease with rheumatid arthritis f right ankle and ft M Rheumatid lung disease with rheumatid arthritis f left ankle and ft M Rheumatid lung disease with rheumatid arthritis f unspecified ankle and ft M05.19 Rheumatid lung disease with rheumatid arthritis f multiple sites M05.20 Rheumatid vasculitis with rheumatid arthritis f unspecified site M Rheumatid vasculitis with rheumatid arthritis f right shulder M Rheumatid vasculitis with rheumatid arthritis f left shulder M Rheumatid vasculitis with rheumatid arthritis f unspecified shulder Mda Health Plan, Inc. Medical Necessity Criteria Page 9/18

10 M Rheumatid vasculitis with rheumatid arthritis f right elbw M Rheumatid vasculitis with rheumatid arthritis f left elbw M Rheumatid vasculitis with rheumatid arthritis f unspecified elbw M Rheumatid vasculitis with rheumatid arthritis f right wrist M Rheumatid vasculitis with rheumatid arthritis f left wrist M Rheumatid vasculitis with rheumatid arthritis f unspecified wrist M Rheumatid vasculitis with rheumatid arthritis f right hand M Rheumatid vasculitis with rheumatid arthritis f left hand M Rheumatid vasculitis with rheumatid arthritis f unspecified hand M Rheumatid vasculitis with rheumatid arthritis f right hip M Rheumatid vasculitis with rheumatid arthritis f left hip M Rheumatid vasculitis with rheumatid arthritis f unspecified hip M Rheumatid vasculitis with rheumatid arthritis f right knee M Rheumatid vasculitis with rheumatid arthritis f left knee M Rheumatid vasculitis with rheumatid arthritis f unspecified knee M Rheumatid vasculitis with rheumatid arthritis f right ankle and ft M Rheumatid vasculitis with rheumatid arthritis f left ankle and ft M Rheumatid vasculitis with rheumatid arthritis f unspecified ankle and ft M05.29 Rheumatid vasculitis with rheumatid arthritis f multiple sites M05.30 Rheumatid heart disease with rheumatid arthritis f unspecified site M Rheumatid heart disease with rheumatid arthritis f right shulder M Rheumatid heart disease with rheumatid arthritis f left shulder M Rheumatid heart disease with rheumatid arthritis f unspecified shulder M Rheumatid heart disease with rheumatid arthritis f right elbw M Rheumatid heart disease with rheumatid arthritis f left elbw M Rheumatid heart disease with rheumatid arthritis f unspecified elbw M Rheumatid heart disease with rheumatid arthritis f right wrist M Rheumatid heart disease with rheumatid arthritis f left wrist M Rheumatid heart disease with rheumatid arthritis f unspecified wrist M Rheumatid heart disease with rheumatid arthritis f right hand M Rheumatid heart disease with rheumatid arthritis f left hand M Rheumatid heart disease with rheumatid arthritis f unspecified hand M Rheumatid heart disease with rheumatid arthritis f right hip M Rheumatid heart disease with rheumatid arthritis f left hip M Rheumatid heart disease with rheumatid arthritis f unspecified hip M Rheumatid heart disease with rheumatid arthritis f right knee M Rheumatid heart disease with rheumatid arthritis f left knee M Rheumatid heart disease with rheumatid arthritis f unspecified knee M Rheumatid heart disease with rheumatid arthritis f right ankle and ft M Rheumatid heart disease with rheumatid arthritis f left ankle and ft Mda Health Plan, Inc. Medical Necessity Criteria Page 10/18

11 M Rheumatid heart disease with rheumatid arthritis f unspecified ankle and ft M05.39 Rheumatid heart disease with rheumatid arthritis f multiple sites M05.40 Rheumatid mypathy with rheumatid arthritis f unspecified site M Rheumatid mypathy with rheumatid arthritis f right shulder M Rheumatid mypathy with rheumatid arthritis f left shulder M Rheumatid mypathy with rheumatid arthritis f unspecified shulder M Rheumatid mypathy with rheumatid arthritis f right elbw M Rheumatid mypathy with rheumatid arthritis f left elbw M Rheumatid mypathy with rheumatid arthritis f unspecified elbw M Rheumatid mypathy with rheumatid arthritis f right wrist M Rheumatid mypathy with rheumatid arthritis f left wrist M Rheumatid mypathy with rheumatid arthritis f unspecified wrist M Rheumatid mypathy with rheumatid arthritis f right hand M Rheumatid mypathy with rheumatid arthritis f left hand M Rheumatid mypathy with rheumatid arthritis f unspecified hand M Rheumatid mypathy with rheumatid arthritis f right hip M Rheumatid mypathy with rheumatid arthritis f left hip M Rheumatid mypathy with rheumatid arthritis f unspecified hip M Rheumatid mypathy with rheumatid arthritis f right knee M Rheumatid mypathy with rheumatid arthritis f left knee M Rheumatid mypathy with rheumatid arthritis f unspecified knee M Rheumatid mypathy with rheumatid arthritis f right ankle and ft M Rheumatid mypathy with rheumatid arthritis f left ankle and ft M Rheumatid mypathy with rheumatid arthritis f unspecified ankle and ft M05.49 Rheumatid mypathy with rheumatid arthritis f multiple sites M05.50 Rheumatid mypathy with rheumatid arthritis f unspecified sites M Rheumatid plyneurpathy with rheumatid arthritis f right shulder M Rheumatid plyneurpathy with rheumatid arthritis f left shulder M Rheumatid plyneurpathy with rheumatid arthritis f unspecified shulder M Rheumatid plyneurpathy with rheumatid arthritis f right elbw M Rheumatid plyneurpathy with rheumatid arthritis f left elbw M Rheumatid plyneurpathy with rheumatid arthritis f unspecified elbw M Rheumatid plyneurpathy with rheumatid arthritis f right wrist M Rheumatid plyneurpathy with rheumatid arthritis f left wrist M Rheumatid plyneurpathy with rheumatid arthritis f unspecified wrist M Rheumatid plyneurpathy with rheumatid arthritis f right hand M Rheumatid plyneurpathy with rheumatid arthritis f left hand M Rheumatid plyneurpathy with rheumatid arthritis f unspecified hand M Rheumatid plyneurpathy with rheumatid arthritis f right hip M Rheumatid plyneurpathy with rheumatid arthritis f left hip Mda Health Plan, Inc. Medical Necessity Criteria Page 11/18

12 M Rheumatid plyneurpathy with rheumatid arthritis f unspecified hip M Rheumatid plyneurpathy with rheumatid arthritis f right knee M Rheumatid plyneurpathy with rheumatid arthritis f left knee M Rheumatid plyneurpathy with rheumatid arthritis f unspecified knee M Rheumatid plyneurpathy with rheumatid arthritis f right ankle and ft M Rheumatid plyneurpathy with rheumatid arthritis f left ankle and ft M Rheumatid plyneurpathy with rheumatid arthritis f unspecified ankle and ft M05.59 Rheumatid plyneurpathy with rheumatid arthritis f multiple sites M05.60 Rheumatid arthritis f unspecified site with invlvement f ther rgans and systems M Rheumatid arthritis f right shulder with invlvement f ther rgans and systems M Rheumatid arthritis f left shulder with invlvement f ther rgans and systems M Rheumatid arthritis f unspecified shulder with invlvement f ther rgans and systems M Rheumatid arthritis f right elbw with invlvement f ther rgans and systems M Rheumatid arthritis f left elbw with invlvement f ther rgans and systems M Rheumatid arthritis f unspecified elbw with invlvement f ther rgans and systems M Rheumatid arthritis f right wrist with invlvement f ther rgans and systems M Rheumatid arthritis f left wrist with invlvement f ther rgans and systems M Rheumatid arthritis f unspecified wrist with invlvement f ther rgans and systems M Rheumatid arthritis f right hand with invlvement f ther rgans and systems M Rheumatid arthritis f left hand with invlvement f ther rgans and systems M Rheumatid arthritis f unspecified hand with invlvement f ther rgans and systems M Rheumatid arthritis f right hip with invlvement f ther rgans and systems M Rheumatid arthritis f left hip with invlvement f ther rgans and systems M Rheumatid arthritis f unspecified hip with invlvement f ther rgans and systems M Rheumatid arthritis f right knee with invlvement f ther rgans and systems M Rheumatid arthritis f left knee with invlvement f ther rgans and systems M Rheumatid arthritis f unspecified knee with invlvement f ther rgans and systems M Rheumatid arthritis f right ankle and ft with invlvement f ther rgans and systems M Rheumatid arthritis f left ankle and ft with invlvement f ther rgans and systems M Rheumatid arthritis f unspecified ankle and ft with invlvement f ther rgans and systems M05.69 Rheumatid arthritis f multiple sites with invlvement f ther rgans and systems M05.70 Rheumatid arthritis with rheumatid factr f unspecified site withut rgan r systems M Rheumatid arthritis with rheumatid factr f right shulder withut rgan r systems M Rheumatid arthritis with rheumatid factr f left shulder withut rgan r systems invlvement M Rheumatid arthritis with rheumatid factr f unspecified shulder withut rgan r systems M Rheumatid arthritis with rheumatid factr f right elbw withut rgan r systems invlvement M Rheumatid arthritis with rheumatid factr f left elbw withut rgan r systems invlvement M Rheumatid arthritis with rheumatid factr f unspecified elbw withut rgan r systems M Rheumatid arthritis with rheumatid factr f right wrist withut rgan r systems invlvement M Rheumatid arthritis with rheumatid factr f left wrist withut rgan r systems invlvement Mda Health Plan, Inc. Medical Necessity Criteria Page 12/18

13 M Rheumatid arthritis with rheumatid factr f unspecified wrist withut rgan r systems M Rheumatid arthritis with rheumatid factr f right hand withut rgan r systems invlvement M Rheumatid arthritis with rheumatid factr f left hand withut rgan r systems invlvement M Rheumatid arthritis with rheumatid factr f unspecified hand withut rgan r systems M Rheumatid arthritis with rheumatid factr f right hip withut rgan r systems invlvement M Rheumatid arthritis with rheumatid factr f left hip withut rgan r systems invlvement M Rheumatid arthritis with rheumatid factr f unspecified hip withut rgan r systems M Rheumatid arthritis with rheumatid factr f right knee withut rgan r systems invlvement M Rheumatid arthritis with rheumatid factr f left knee withut rgan r systems invlvement M Rheumatid arthritis with rheumatid factr f unspecified knee withut rgan r systems M Rheumatid arthritis with rheumatid factr f right ankle and ft withut rgan r systems M Rheumatid arthritis with rheumatid factr f left ankle and ft withut rgan r systems M Rheumatid arthritis with rheumatid factr f unspecified ankle and wrist withut rgan r M05.79 Rheumatid arthritis with rheumatid factr f multiple sites withut rgan r systems M05.80 Other rheumatid arthritis with rheumatid factr f unspecified site M Other rheumatid arthritis with rheumatid factr f right shulder M Other rheumatid arthritis with rheumatid factr f left shulder M Other rheumatid arthritis with rheumatid factr f unspecified shulder M Other rheumatid arthritis with rheumatid factr f right elbw M Other rheumatid arthritis with rheumatid factr f left elbw M Other rheumatid arthritis with rheumatid factr f unspecified elbw M Other rheumatid arthritis with rheumatid factr f right wrist M Other rheumatid arthritis with rheumatid factr f left wrist M Other rheumatid arthritis with rheumatid factr f unspecified wrist M Other rheumatid arthritis with rheumatid factr f right hand M Other rheumatid arthritis with rheumatid factr f left hand M Other rheumatid arthritis with rheumatid factr f unspecified hand M Other rheumatid arthritis with rheumatid factr f right hip M Other rheumatid arthritis with rheumatid factr f left hip M Other rheumatid arthritis with rheumatid factr f unspecified hip M Other rheumatid arthritis with rheumatid factr f right knee M Other rheumatid arthritis with rheumatid factr f left knee M Other rheumatid arthritis with rheumatid factr f unspecified knee M Other rheumatid arthritis with rheumatid factr f right ankle and ft M Other rheumatid arthritis with rheumatid factr f left ankle and ft M Other rheumatid arthritis with rheumatid factr f unspecified ankle and ft M05.89 Other rheumatid arthritis with rheumatid factr f multiple sites M05.9 Rheumatid arthritis with rheumatid factr, unspecified M06.00 Rheumatid arthritis withut rheumatid factr, unspecified site M Rheumatid arthritis withut rheumatid factr, unspecified shulder Mda Health Plan, Inc. Medical Necessity Criteria Page 13/18

14 M Rheumatid arthritis withut rheumatid factr, right elbw M Rheumatid arthritis withut rheumatid factr, left elbw M Rheumatid arthritis withut rheumatid factr, unspecified elbw M Rheumatid arthritis withut rheumatid factr, right wrist M Rheumatid arthritis withut rheumatid factr, left wrist M Rheumatid arthritis withut rheumatid factr, unspecified wrist M Rheumatid arthritis withut rheumatid factr, right hand M Rheumatid arthritis withut rheumatid factr, left hand M Rheumatid arthritis withut rheumatid factr, unspecified hand M Rheumatid arthritis withut rheumatid factr, right hip M Rheumatid arthritis withut rheumatid factr, left hip M Rheumatid arthritis withut rheumatid factr, unspecified hip M Rheumatid arthritis withut rheumatid factr, right knee M Rheumatid arthritis withut rheumatid factr, left knee M Rheumatid arthritis withut rheumatid factr, unspecified knee M Rheumatid arthritis withut rheumatid factr, right ankle and ft M Rheumatid arthritis withut rheumatid factr, left ankle and ft M Rheumatid arthritis withut rheumatid factr, unspecified ankle and ft M06.4 Inflammatry plyarthrpathy M06.08 Rheumatid arthritis withut rheumatid factr, vertebrae M06.09 Rheumatid arthritis withut rheumatid factr, multiple sites M06.80 Other specified rheumatid arthritis, unspecified site M Other specified rheumatid arthritis, right shulder M Other specified rheumatid arthritis, left shulder M Other specified rheumatid arthritis, unspecified shulder M Other specified rheumatid arthritis, right elbw M Other specified rheumatid arthritis, left elbw M Other specified rheumatid arthritis, unspecified elbw M Other specified rheumatid arthritis, right wrist M Other specified rheumatid arthritis, left wrist M Other specified rheumatid arthritis, unspecified wrist M Other specified rheumatid arthritis, right hand M Other specified rheumatid arthritis, left hand M Other specified rheumatid arthritis, unspecified hand M Other specified rheumatid arthritis, right hip M Other specified rheumatid arthritis, left hip M Other specified rheumatid arthritis, unspecified hip M Other specified rheumatid arthritis, right knee M Other specified rheumatid arthritis, left knee M Other specified rheumatid arthritis, unspecified knee Mda Health Plan, Inc. Medical Necessity Criteria Page 14/18

15 M Other specified rheumatid arthritis, right ankle and ft M Other specified rheumatid arthritis, left ankle and ft M Other specified rheumatid arthritis, unspecified ankle and ft M06.88 Other specified rheumatid arthritis, vertebrae M06.89 Other specified rheumatid arthritis, multiple sites M06.9 Rheumatid arthritis, unspecified M08.00 Unspecified juvenile rheumatid arthritis f unspecified site M Unspecified juvenile rheumatid arthritis, right shulder M Unspecified juvenile rheumatid arthritis, left shulder M Unspecified juvenile rheumatid arthritis, unspecified shulder M Unspecified juvenile rheumatid arthritis, right elbw M Unspecified juvenile rheumatid arthritis, left elbw M Unspecified juvenile rheumatid arthritis, unspecified elbw M Unspecified juvenile rheumatid arthritis, right wrist M Unspecified juvenile rheumatid arthritis, left wrist M Unspecified juvenile rheumatid arthritis, unspecified wrist M Unspecified juvenile rheumatid arthritis, right hand M Unspecified juvenile rheumatid arthritis, left hand M Unspecified juvenile rheumatid arthritis, unspecified hand M Unspecified juvenile rheumatid arthritis, right hip M Unspecified juvenile rheumatid arthritis, left hip M Unspecified juvenile rheumatid arthritis, unspecified hip M Unspecified juvenile rheumatid arthritis, right knee M Unspecified juvenile rheumatid arthritis, left knee M Unspecified juvenile rheumatid arthritis, unspecified knee M Unspecified juvenile rheumatid arthritis, right ankle and ft M Unspecified juvenile rheumatid arthritis, left ankle and ft M Unspecified juvenile rheumatid arthritis, unspecified ankle and ft M08.08 Unspecified juvenile rheumatid arthritis, vertebrae M08.09 Unspecified juvenile rheumatid arthritis, multiple sites M08.20 Juvenile rheumatid arthritis with systemic nset, unspecified site M Juvenile rheumatid arthritis with systemic nset, right shulder M Juvenile rheumatid arthritis with systemic nset, left shulder M Juvenile rheumatid arthritis with systemic nset, unspecified shulder M Juvenile rheumatid arthritis with systemic nset, right elbw M Juvenile rheumatid arthritis with systemic nset, left elbw M Juvenile rheumatid arthritis with systemic nset, unspecified elbw M Juvenile rheumatid arthritis with systemic nset, right wrist M Juvenile rheumatid arthritis with systemic nset, left wrist M Juvenile rheumatid arthritis with systemic nset, unspecified wrist Mda Health Plan, Inc. Medical Necessity Criteria Page 15/18

16 M Juvenile rheumatid arthritis with systemic nset, right hand M Juvenile rheumatid arthritis with systemic nset, left hand M Juvenile rheumatid arthritis with systemic nset, unspecified hand M Juvenile rheumatid arthritis with systemic nset, right hip M Juvenile rheumatid arthritis with systemic nset, left hip M Juvenile rheumatid arthritis with systemic nset, unspecified hip M Juvenile rheumatid arthritis with systemic nset, right knee M Juvenile rheumatid arthritis with systemic nset, left knee M Juvenile rheumatid arthritis with systemic nset, unspecified knee M Juvenile rheumatid arthritis with systemic nset, right ankle and ft M Juvenile rheumatid arthritis with systemic nset, left ankle and ft M Juvenile rheumatid arthritis with systemic nset, unspecified ankle and ft M08.28 Juvenile rheumatid arthritis with systemic nset, vertebrae M08.29 Juvenile rheumatid arthritis with systemic nset, multiple sites M08.3 Juvenile rheumatid plyarthritis (sernegative) M08.40 Pauciarticular juvenile rheumatid arthritis, unspecified site M Pauciarticular juvenile rheumatid arthritis, right shulder M Pauciarticular juvenile rheumatid arthritis, left shulder M Pauciarticular juvenile rheumatid arthritis, unspecified shulder M Pauciarticular juvenile rheumatid arthritis, right elbw M Pauciarticular juvenile rheumatid arthritis, left elbw M Pauciarticular juvenile rheumatid arthritis, unspecified elbw M Pauciarticular juvenile rheumatid arthritis, right wrist M Pauciarticular juvenile rheumatid arthritis, left wrist M Pauciarticular juvenile rheumatid arthritis, unspecified wrist M Pauciarticular juvenile rheumatid arthritis, right hand M Pauciarticular juvenile rheumatid arthritis, left hand M Pauciarticular juvenile rheumatid arthritis, unspecified hand M Pauciarticular juvenile rheumatid arthritis, right hip M Pauciarticular juvenile rheumatid arthritis, left hip M Pauciarticular juvenile rheumatid arthritis, unspecified hip M Pauciarticular juvenile rheumatid arthritis, right knee M Pauciarticular juvenile rheumatid arthritis, left knee M Pauciarticular juvenile rheumatid arthritis, unspecified knee M Pauciarticular juvenile rheumatid arthritis, right ankle and ft M Pauciarticular juvenile rheumatid arthritis, left ankle and ft M Pauciarticular juvenile rheumatid arthritis, unspecified ankle and ft M08.48 Pauciarticular juvenile rheumatid arthritis, vertebrae M08.80 Other juvenile arthritis, unspecified site M Other juvenile arthritis, right shulder Mda Health Plan, Inc. Medical Necessity Criteria Page 16/18

17 M Other juvenile arthritis, left shulder M Other juvenile arthritis, unspecified shulder M Other juvenile arthritis, right elbw M Other juvenile arthritis, left elbw M Other juvenile arthritis, unspecified elbw M Other juvenile arthritis, right wrist M Other juvenile arthritis, left wrist M Other juvenile arthritis, unspecified wrist M Other juvenile arthritis, right hand M Other juvenile arthritis, left hand M Other juvenile arthritis, unspecified hand M Other juvenile arthritis, right hip M Other juvenile arthritis, left hip M Other juvenile arthritis, unspecified hip M Other juvenile arthritis, right knee M Other juvenile arthritis, left knee M Other juvenile arthritis, unspecified knee M Other juvenile arthritis, right ankle and ft M Other juvenile arthritis, left ankle and ft M Other juvenile arthritis, unspecified ankle and ft M08.88 Other juvenile arthritis, ther specified site M08.89 Other juvenile arthritis, multiple sites M08.90 Juvenile arthritis, unspecified, unspecified site M Juvenile arthritis, unspecified, right shulder M Juvenile arthritis, unspecified, left shulder M Juvenile arthritis, unspecified, unspecified shulder M Juvenile arthritis, unspecified, right elbw M Juvenile arthritis, unspecified, left elbw M Juvenile arthritis, unspecified, unspecified elbw M Juvenile arthritis, unspecified, right wrist M Juvenile arthritis, unspecified, left wrist M Juvenile arthritis, unspecified, unspecified wrist M Juvenile arthritis, unspecified, right hand M Juvenile arthritis, unspecified, left hand M Juvenile arthritis, unspecified, unspecified hand M Juvenile arthritis, unspecified, right hip M Juvenile arthritis, unspecified, left hip M Juvenile arthritis, unspecified, unspecified hip M Juvenile arthritis, unspecified, right knee M Juvenile arthritis, unspecified, left knee Mda Health Plan, Inc. Medical Necessity Criteria Page 17/18

18 M Juvenile arthritis, unspecified, unspecified knee M Juvenile arthritis, unspecified, right ankle and ft M Juvenile arthritis, unspecified, left ankle and ft M Juvenile arthritis, unspecified, unspecified ankle and ft M08.98 Juvenile arthritis, unspecified, vertebrae M08.99 Juvenile arthritis, unspecified, multiple sites R59.0 Lcalized enlarged lymph ndes R59.1 Generalized enlarged lymph ndes R59.9 Enlarged lymph ndes, unspecified Z85.72 Persnal histry f nn-hdgkin lymphmas Appendix 2 Centers fr Medicare and Medicaid Services (CMS) Medicare cverage fr utpatient (Part B) drugs is utlined in the Medicare Benefit Plicy Manual (Pub ), Chapter 15, 50 Drugs and Bilgicals. In additin, Natinal Cverage Determinatin (NCD) and Lcal Cverage Determinatins (LCDs) may exist and cmpliance with these plicies is required where applicable. They can be fund at: Additinal indicatins may be cvered at the discretin f the health plan. Medicare Part B Cvered Diagnsis Cdes (applicable t existing NCD/LCD): N/A Medicare Part B Administrative Cntractr (MAC) Jurisdictins Jurisdictin Applicable State/US Territry Cntractr E (1) CA, HI, NV, AS, GU, CNMI Nridian Healthcare Slutins, LLC F (2 & 3) AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ Nridian Healthcare Slutins, LLC 5 KS, NE, IA, MO Wiscnsin Physicians Service Insurance Crp (WPS) 6 MN, WI, IL Natinal Gvernment Services, Inc. (NGS) H (4 & 7) LA, AR, MS, TX, OK, CO, NM Nvitas Slutins, Inc. 8 MI, IN Wiscnsin Physicians Service Insurance Crp (WPS) N (9) FL, PR, VI First Cast Service Optins, Inc. J (10) TN, GA, AL Palmett GBA, LLC M (11) NC, SC, WV, VA (excluding belw) Palmett GBA, LLC L (12) DE, MD, PA, NJ, DC (includes Arlingtn & Fairfax cunties and the city f Alexandria in VA) K (13 & 14) NY, CT, MA, RI, VT, ME, NH Nvitas Slutins, Inc. Natinal Gvernment Services, Inc. (NGS) 15 KY, OH CGS Administratrs, LLC Mda Health Plan, Inc. Medical Necessity Criteria Page 18/18