Immune Globulins (immunoglobulin) (Intravenous)

Transcription

1 Immune Glbulins (immunglbulin) (Intravenus) Last Review Date: 09/05/2018 Date f Origin: 07/20/2010 Dcument Number: MODA-0071 Dates Reviewed: 09/2010, 12/2010, 02/2011, 03/2011, 06/2011, 09/2011, 10/2011, 12/2011, 03/2012, 06/2012, 09/2012, 12/2012, 03/2013, 05/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 06/2015, 09/2015, 12/2015, 03/2016, 06/2016, 09/2016, 12/2016, 03/2017, 06/2017, 09/2017, 12/2017, 03/2018, 06/2018, 09/2018 I. Length f Authrizatin Initial and renewal authrizatin perids vary by specific cvered indicatin. Unless therwise specified, the initial authrizatin will be prvided fr 6 mnths and may be renewed. II. Dsing Limits A. Quantity Limit (max daily dse) [Pharmacy Benefit]: # f vials Drug Vial size in IgG grams One time nly per 28 days Bivigam Carimune NF Flebgamma 10% DIF Flebgamma 5% DIF Gamunex-C Gammagard Liquid Gammagard S/D Gammaked Gammaplex LOAD MAINTENANCE , , 10, , 5, , 2.5, 5, 10, , 2.5, 5, 10, , 2.5, 5, , 5, Mda Health Plan, Inc. Medical Necessity Criteria Page 1/23

2 Octagam 10% Octagam 5% Privigen 2, 5, , 2.5, 5, , 10, Panzyga 1, 2.5, 5, 10, B. Max Units (per dse and ver time) [Medical Benefit]: Indicatin Billable Units Per # days (unless therwise specified) PID CIDP Lad: Maintenance: Immune thrmbcytpenia/itp FAIT Kawasaki s Disease (Pediatric Patients nly) dse nly Multifcal Mtr Neurpathy CLL/MM HIV (Pediatric Patients nly) Guillain-Barre (fr ne cycle nly) Myasthenia Gravis Aut-immune blistering diseases Bne Marrw r Stem Cell Transplant Dermatmysitis/Plymysitis Cmplicatins f transplanted slid rgan (kidney, liver, lung, heart and pancreas transplants) Stiff Persn Txic shck syndrme (fr ne cycle nly) NAIT 16 2 dses nly Management f Immune Checkpint Inhibitr Related Txicity (fr ne cycle nly) III. Initial Apprval Criteria Site f care specialty infusin prgram requirements are met (refer t Mda Site f Care Plicy). Cverage is prvided in the fllwing cnditins: Baseline values fr BUN and serum creatinine btained within 30 days f request; AND Primary immundeficiency (PID)/Wisktt - Aldrich syndrme Such as: x-linked agammaglbulinemia, cmmn variable immundeficiency, transient hypgammaglbulinemia f infancy, IgG subclass deficiency with r withut IgA deficiency, antibdy deficiency with near nrmal immunglbulin levels) and cmbined deficiencies (severe Mda Health Plan, Inc. Medical Necessity Criteria Page 2/23

3 cmbined immundeficiencies, ataxia-telangiectasia, x-linked lymphprliferative syndrme) [list nt all inclusive] Patient s IgG level is < 200 mg/dl OR bth f the fllwing Patient has a histry f multiple hard t treat infectins as indicated by at least ne f the fllwing: Fur r mre ear infectins within 1 year Tw r mre serius sinus infectins within 1 year Tw r mre mnths f antibitics with little effect Tw r mre pneumnias within 1 year Recurrent r deep skin abscesses Need fr intravenus antibitics t clear infectins Tw r mre deep-seated infectins including septicemia; AND The patient has a deficiency in prducing antibdies in respnse t vaccinatin; AND Titers were drawn befre challenging with vaccinatin; AND Titers were drawn between 4 and 8 weeks f vaccinatin Immune thrmbcytpenia/idipathic thrmbcytpenia purpura (ITP) Fr acute disease state: T manage acute bleeding due t severe thrmbcytpenia (platelet cunts less than 30 X 10 9 /L); OR T increase platelet cunts prir t invasive surgical prcedures such as splenectmy. (Platelets less than 100 X 10 9 /L); OR Patient has severe thrmbcytpenia (platelet cunts less than 20 X 10 9 /L) and is cnsidered t be at risk fr intracerebral hemrrhage Nte: Authrizatin is valid fr 1 mnth nly and cannt be renewed Chrnic Immune Thrmbcytpenia (CIT): The patient is at increased risk fr bleeding as indicated by a platelet cunt less than 30 X 10 9 /L; AND Histry f failure, cntraindicatin, r intlerance t crticsterids; AND Duratin f illness > 6 mnths; AND Patient age 2 years Chrnic Inflammatry Demyelinating Plyneurpathy (CIDP) Patient s disease curse is prgressive r relapsing and remitting fr 2 mnths r lnger; AND Patient has abnrmal r absent deep tendn reflexes in upper r lwer limbs; AND Electrdiagnstic testing indicating demyelinatin: Partial mtr cnductin blck in at least tw mtr nerves r in 1 nerve plus ne ther demyelinatin criterin listed here in at least 1 ther nerve; OR Distal CMAP duratin increase in at least 1 nerve plus ne ther demyelinatin criterin listed here in at least 1 ther nerve; OR Abnrmal tempral dispersin cnductin must be present in at least 2 mtr nerves; OR Reduced cnductin velcity in at least 2 mtr nerves; OR Prlnged distal mtr latency in at least 2 mtr nerves; OR Mda Health Plan, Inc. Medical Necessity Criteria Page 3/23

4 Absent F wave in at least tw mtr nerves plus ne ther demyelinatin criterin listed here in at least 1 ther nerve; OR Prlnged F wave latency in at least 2 mtr nerves; AND Cerebrspinal fluid analysis indicates the fllwing: CSF white cell cunt f <10 cells/mm 3 ; AND CSF prtein is elevated; AND Patient is refractry r intlerant t crticsterids (e.g., prednislne, prednisne, etc.) given in therapeutic dses ver at least three mnths; AND Baseline in strength/weakness has been dcumented using an bjective clinical measuring tl (e.g., INCAT, Medical Research Cuncil (MRC) muscle strength, 6-MWT, Rankin, Mdified Rankin, etc.) Nte: Initial authrizatin is valid fr 3 mnths Guillain-Barre Syndrme (Acute inflammatry plyneurpathy) Patient s disease is severe (i.e., patient requires assistance t ambulate); AND Onset f symptms are recent (i.e., less than 1 mnth); AND Apprval will be granted fr a maximum f 2 runds f therapy within 6 weeks f nset Nte: Authrizatin is valid fr 2 mnths nly and cannt be renewed Multifcal Mtr Neurpathy Patient has multi-fcal weakness; AND Partial cnductin blck r abnrmal tempral dispersin cnductin must be present in at least 2 nerves; AND Baseline in strength/weakness has been dcumented using an bjective clinical measuring tl (e.g., INCAT, Medical Research Cuncil (MRC) muscle strength, 6-MWT, Rankin, Mdified Rankin, etc.) Nte: Initial authrizatin is valid fr 1 curse (1 mnth) HIV infected children: Bacterial cntrl r preventin Patient age des nt exceed 13 years f age; AND Patient s IgG level is less than 400 mg/dl Myasthenia Gravis Patient has an acute exacerbatin resulting in impending myasthenic crisis (i.e., respiratry cmprmise, acute respiratry failure, and/r bulbar cmprmise); AND Patient is failing n cnventinal immunsuppressant therapy alne (e.g., crticsterids, azathiprine, cyclsprine, mycphenlate, methtrexate, tacrlimus, cyclphsphamide, etc.); AND Patient will be n cmbinatin therapy with crticsterids r ther immunsuppressant (e.g., azathiprine, mycphenlate, cyclsprine, methtrexate, tacrlimus, cyclphsphamide, etc.) Nte: Authrizatin is valid fr 1 curse (1 mnth) nly and cannt be renewed Mda Health Plan, Inc. Medical Necessity Criteria Page 4/23

5 Dermatmysitis/Plymysitis Patient has severe active disease; AND Patient has prximal weakness in all upper and/r lwer limbs; AND Diagnsis has been cnfirmed by muscle bipsy; AND Patient has failed a trial f crticsterids (i.e., prednisne); AND Patient has failed a trial f an immunsuppressant (e.g., methtrexate, azathiprine, etc.); AND Must be used as part f cmbinatin therapy with ther agents; AND Patient has a dcumented baseline n physical exam Nte: Initial authrizatin is valid fr 3 mnths Cmplicatins f transplanted slid rgan (kidney, liver, lung, heart, pancreas) and bne marrw transplant Cverage is prvided fr ne r mre f the fllwing (list nt all-inclusive): Suppressin f panel reactive anti-human leukcyte antigen (HLA) antibdies prir t transplantatin Treatment f antibdy-mediated rejectin f slid rgan transplantatin Preventin r treatment f viral infectins (e.g., cytmegalvirus, Parv B-19 virus, and Plyma BK virus) Stiff-Persn Syndrme Patient has anti-glutamic acid decarbxylase (GAD) antibdies; AND Patient has failed at least 2 f the fllwing treatments: benzdiazepines, baclfen, gabapentin, valprate, tiagabine, r levetiracetam; AND Patient has a dcumented baseline n physical exam Allgeneic Bne Marrw r Stem Cell Transplant Used fr preventin f acute Graft-Versus-Hst-Disease (agvhd) r infectin; AND Patient s BMT was allgeneic; AND Patient s transplant was less than 100 days ag; AND Patient s IgG level is less than 400 mg/dl Nte: Initial authrizatin is valid fr 3 mnths Kawasaki s disease (Pediatric) Nte: Authrizatin is valid fr 1 curse (1 mnth) nly and cannt be renewed Fetal allimmune thrmbcytpenia (FAIT) Patient has a histry f ne r mre f the fllwing: Previus FAIT pregnancy Family histry f the disease Mda Health Plan, Inc. Medical Necessity Criteria Page 5/23

6 Screening reveals platelet allantibdies Nte: Authrizatin is valid thrugh the delivery date nly and cannt be renewed Nenatal Allimmune Thrmbcytpenia Nte: Authrizatin is valid fr 1 curse (1 mnth) nly and cannt be renewed Aut-immune Muccutaneus Blistering Diseases Patient has been diagnsed with ne f the fllwing: Pemphigus vulgaris Pemphigus fliaceus Bullus Pemphigid Mucus Membrane Pemphigid (a.k.a. Cicatricial Pemphigid) Epidermlysis bullsa aquisita Pemphigus gestatinis (Herpes gestatinis) Linear IgA dermatsis; AND Patient has severe disease that is extensive and debilitating; AND Diagnsis has been cnfirmed by bipsy; AND Patient s disease is prgressive; AND Disease is refractry t a trial f cnventinal therapy with crticsterids and cncurrent immunsuppressive treatment (e.g., azathiprine, cyclphsphamide, mycphenlate mfetil, etc.); AND Patient has a dcumented baseline n physical exam Acquired Immune Deficiency secndary t Chrnic lymphcytic leukemia r Multiple Myelma Patient s IgG level is <200 mg/dl OR bth f the fllwing Patient has a histry f multiple hard t treat infectins as indicated by at least ne f the fllwing: Fur r mre ear infectins within 1 year Tw r mre serius sinus infectins within 1 year Tw r mre mnths f antibitics with little effect Tw r mre pneumnias within 1 year Recurrent r deep skin abscesses Need fr intravenus antibitics t clear infectins Tw r mre deep-seated infectins including septicemia; AND The patient has a deficiency in prducing antibdies in respnse t vaccinatin; AND Titers were drawn befre challenging with vaccinatin; AND Titers were drawn between 4 and 8 weeks f vaccinatin Nte: ther secndary immundeficiencies resulting in hypgammaglbulinemia and/r B-cell aplasia will be evaluated n a case-by-case basis Txic Shck Syndrme Nte: Authrizatin is valid fr 1 curse (1 mnth) nly and cannt be renewed Mda Health Plan, Inc. Medical Necessity Criteria Page 6/23

7 Management f Immune-Checkpint-Inhibitr Related Txicity Patient has been receiving therapy with an immune checkpint inhibitr (e.g. nivlumab, pembrlizumab, atezlizumab, avelumab, durvalumab, etc.); AND Patient has ne f the fllwing txicities related t their immuntherapy: Myasthenia gravis refractry t high-dse crticsterids Severe transverse myelitis Mderate r severe Guillain-Barre Syndrme r peripheral neurpathy txicity used in cmbinatin with pulse-dse methylprednislne Severe pneumnitis refractry t methylprednislne after 48 hurs f therapy Encephalitis used in cmbinatin with pulse-dse methylprednislne FDA Apprved Indicatin(s), Cmpendia/Literature Supprted Indicatin(s) IV. Renewal Criteria Cverage can be renewed based upn the fllwing criteria: Nte: unless therwise specified, renewal authrizatins are prvided fr 1 year Patient cntinues t meet criteria identified in sectin III; AND Absence f unacceptable txicity frm the drug. Examples f unacceptable txicity include the fllwing: acute kidney injury, thrmbsis, hemlysis, hypersensitivity, pulmnary adverse reactins, vlume verlad, etc.; AND BUN and serum creatinine have been btained within the last 6 mnths and the cncentratin and rate f infusin have been adjusted accrdingly; AND Patient meets the disease-specific criteria belw: Primary Immundeficiency (PID) Disease respnse as evidenced by ne r mre f the fllwing: Decrease in the frequency f infectin Decrease in the severity f infectin Chrnic Immune Thrmbcytpenia/ITP Disease respnse as indicated by the achievement and maintenance f a platelet cunt f at least 50 X 10 9 /L as necessary t reduce the risk fr bleeding Chrnic Inflammatry Demyelinating Plyneurpathy Renewals will be authrized fr patients that have demnstrated a clinical respnse t therapy based n an bjective clinical measuring tl (e.g., INCAT, Medical Research Cuncil (MRC) muscle strength, 6-MWT, Rankin, Mdified Rankin, etc.) Multifcal Mtr Neurpathy Mda Health Plan, Inc. Medical Necessity Criteria Page 7/23

8 Renewals will be authrized fr patients that have demnstrated a clinical respnse t therapy based n an bjective clinical measuring tl (e.g., INCAT, Medical Research Cuncil (MRC) muscle strength, 6-MWT, Rankin, Mdified Rankin, etc.) HIV infected children: Bacterial cntrl r preventin Disease respnse as evidenced by ne r mre f the fllwing: Decrease in the frequency f infectin Decrease in the severity f infectin; AND Patient cntinues t be at an increased risk f infectin necessitating cntinued therapy Dermatmysitis/Plymysitis Patient had an imprvement frm baseline n physical exam Nte: Renewal authrizatins are prvided fr 6 mnths Cmplicatins f transplanted slid rgan (kidney, liver, lung, heart, pancreas) and bne marrw transplant Disease respnse as evidenced by ne r mre f the fllwing: Decrease in the frequency f infectin Decrease in the severity f infectin; AND Patient cntinues t be at an increased risk f infectin necessitating cntinued therapy Stiff Persn Syndrme Dcumented imprvement frm baseline n physical exam Allgeneic Bne Marrw r Stem Cell Transplant Patient s IgG is less than 400 mg/dl; AND Therapy des nt exceed 360 days pst-allgeneic bne marrw transplantatin Nte: Renewal authrizatin is prvided fr up 360 days pst-allgeneic bne marrw transplantatin nly Aut-Immune Muccutaneus Blistering Diseases Dcumented imprvement frm baseline n physical exam Nte: Renewal authrizatins are prvided fr 6 mnths Acquired Immune Deficiency secndary t Chrnic Lymphcytic Leukemia r Multiple Myelma Disease respnse as evidenced by ne r mre f the fllwing: Decrease in the frequency f infectin Decrease in the severity f infectin; AND Patient cntinues t be at an increased risk f infectin necessitating cntinued therapy Management f Immune Checkpint Inhibitr related Txicity May nt be renewed. Mda Health Plan, Inc. Medical Necessity Criteria Page 8/23

9 Nte: Renewal authrizatins are prvided fr 6 mnths Dsing Recmmendatins: Patient s dse shuld be reduced t the lwest necessary t maintain benefit fr their cnditin Patients wh have tlerated dse reductin and cntinue t shw sustained imprvement shuld have had a trial f treatment discntinuatin; with the fllwing exceptins: PID wuld be excluded frm a trial f discntinuatin HIV-infected children shuld shw satisfactry cntrl f the underlying disease [e.g., undetectable viral lad, CD4 cunts elevated abve 200 r >15% (ages 9 mnths 5 years) n antiretrviral therapy, etc.] Slid rgan transplant, CLL, and MM patients shuld nt be at an increased risk f infectin V. Dsage/Administratin Dsing shuld be calculated using adjusted bdy weight if ne r mre f the fllwing criteria are met: Patient s bdy mass index (BMI) is 30 kg/m 2 r mre; OR Patient s actual bdy weight is 20% higher than his r her ideal bdy weight (IBW) Use the fllwing dsing frmulas t calculate the adjusted bdy weight (rund dse t nearest 5 gram increment in adult patients): Dsing frmulas BMI = 703 x (weight in punds/height in inches 2 ) IBW (kg) fr males = 50 + [2.3 (height in inches 60)] IBW (kg) fr females = [2.3 x (height in inches 60)] Adjusted bdy weight = IBW (actual bdy weight IBW) This infrmatin is nt meant t replace clinical decisin making when initiating r mdifying medicatin therapy and shuld nly be used as a guide. Patient-specific variables shuld be taken int accunt. Indicatin Dse PID CIDP 200 t 800 mg/kg every 21 t 28 days 2 g/kg divided ver 2-5 days initially, then 1 g/kg administered in 1-2 infusins every 21 days ITP 2 g/kg divided ver 5 days r 1 g/kg nce daily fr 2 cnsecutive days in a 28-day cycle FAIT Kawasaki s Disease (Pediatric Patients) 1 g/kg/week until delivery 1 g/kg t 2 g/kg x 1 curse Mda Health Plan, Inc. Medical Necessity Criteria Page 9/23

10 Indicatin Multifcal Mtr Neurpathy CLL/MM Pediatric HIV Guillain-Barre Dse Up t 2 g/kg divided ver 5 days in a 28-day cycle 400 mg/kg every 3 t 4 weeks 400 mg/kg every 2 t 4 weeks 2 g/kg divided ver 5 days x 1 curse Myasthenia Gravis 1-2 g/kg divided as either 0.5 g/kg daily x 2 days r 0.4 g/kg daily x 5 days x 1 curse Aut-immune blistering diseases Dermatmysitis/Plymysitis Up t 2 g/kg divided ver 5 days in a 28-day cycle 2 g/kg divided ver 2 t 5 days in a 28-day cycle Bne Marrw r Stem Cell Transplant 500 mg/kg nce weekly x 90 days, then 500 mg/kg every 3 t 4 weeks fr up t 360 days pst-transplant Cmplicatins f transplanted slid rgan: (kidney, liver, lung, heart, pancreas) transplant Stiff Persn Txic shck syndrme Nenatal Allimmune Thrmbcytpenia Management f Immune Checkpint Inhibitr Related Txicity 2 g/kg divided ver 5 days in a 28-day cycle 2 g/kg divided ver 5 days in a 28-day cycle 2 g/kg divided ver 5 days x 1 curse 1 g/kg x 1 dse, may be repeated nce if needed 2 g/kg divided ver 5 days x 1 curse *Dsing fr IVIG is highly variable depending n numerus patient specific factrs, indicatin(s), and the specific prduct selected. Fr specific dsing regimens refer t current prescribing literature. VI. Billing Cde/Availability Infrmatin Jcde & NDC: Drug Manufacturer J-Cde 1 Billable Unit Equivalent IgG (grams) per SDV NDC Bivigam Bitest Pharmaceuticals J mg XX XX Carimune NF CSL Behring AG J mg XX XX Flebgamma 10% DIF 5, 10, XX Institut Grifls, J mg S.A. Flebgamma 5% DIF 2.5, 5, 10, XX Gamunex-C Grifls Therapeutics J mg 1, 2.5, 5, 10, 20, XX Gammagard Liquid Baxalta J mg 1, 2.5, 5, 10, 20, XX XX Mda Health Plan, Inc. Medical Necessity Criteria Page 10/23

11 Gammagard S/D Less IGA Baxalta J mg XX Gammaked Grifls Therapeutics J mg 1, 2.5, 5, 10, XX Gammaplex 5% 5, 10, 20 Bi Prducts J mg Labratry Gammaplex 10% 5, 10, XX XX Octagam 10% 2, 5, 10, XX Octapharma USA J mg Inc Octagam 5% 1, 2.5, 5, 10, XX XX Privigen CSL Behring LLC J mg XX XX XX Panzyga Octapharma USA Inc J mg 1, 2.5, 5, 10, 20, XX Injectin, immune glbulin, intravenus, nn-lyphilized (e.g., liquid), nt therwise specified N/A J mg N/A N/A VII. References 1. Bivigam [package insert]. Bca Ratn, FL; Bitest Pharmaceuticals; June Accessed May Carimune NF [package insert]. Berne, Switzerland; CSL Behring AG; Nvember Accessed May Flebgamma 10% DIF [package insert]. Barcelna, Spain; Institut Grifls, S.A.; July Accessed May Flebgamma 5% DIF [package insert]. Barcelna, Spain; Institut Grifls, S.A.; August Accessed May Gammagard Liquid [package insert]. Westlake Village, CA; Baxalta US Inc.; June Accessed May Gammagard S/D Less IgA [package insert]. Westlake Village, CA; Baxalta US Inc.; September Accessed May Gamunex -C [package insert]. Research Triangle, NC; Grifls Therapeutics, Inc.; March Accessed May Gammaked [package insert]. Research Triangle, NC; Grifls Therapeutics, Inc; September Accessed May Gammaplex 5% [package insert]. Durham, NC; Bi Prducts Labratry Ltd.; December Accessed May Mda Health Plan, Inc. Medical Necessity Criteria Page 11/23

12 10. Gammaplex 10% [package insert]. Durham, NC; Bi Prducts Labratry Ltd.; December Accessed May Octagam 5% [package insert]. Hbken, NJ; Octapharma USA Inc; Octber Accessed May Octagam 10% [package insert]. Hbken, NJ; Octapharma USA Inc; April Accessed May Privigen [package insert]. Berne, Switzerland; CSL Behring LLC; September Accessed May Panzyga [package insert]. Hbken, NJ; Octapharma USA Inc; Nvember Accessed August Skeie GO, Apstlski S, Evli A, et al. Guidelines fr the treatment f autimmune neurmuscular transmissin disrders. Eur J Neurl. 2010;17(7): Van den Bergh PY, Hadden RD, Buche P, et al. Eurpean Federatin f Neurlgical Scieties/Peripheral Nerve Sciety guideline n management f chrnic inflammatry demyelinating plyradiculneurpathy: reprt f a jint task frce f the Eurpean Federatin f Neurlgical Scieties [trunc]. Eur J Neurl 2010 Mar;17(3): Patwa HS, Chaudhry V, Katzberg H, et al. Evidence-based guideline: intravenus immunglbulin in the treatment f neurmuscular disrders: reprt f the Therapeutics and Technlgy Assessment Subcmmittee f the American Academy f Neurlgy. Neurlgy Mar 27;78(13): French CIDP Study Grup. Recmmendatins n diagnstic strategies fr chrnic inflammatry demyelinating plyradiculneurpathy. J Neurl Neursurg Psychiatry 2008; 79: Dnfri PD, Berger A, Brannagan TH, et al. Cnsensus statement: The use f intravenus immunglbulin in the treatment f neurmuscular cnditins reprt f the AANEM ad hc cmmittee. Muscle Nerve. 2009;40: Feasby T, Banwell B, Benstead T, et al. Guidelines n the use f intravenus immune glbulin fr neurlgic cnditins. Transfus Med Rev. 2007;21(2 suppl 1):S Gajds P, Tranchant C, Clair B, et al; Myasthenia Gravis Clinical Study Grup. Treatment f myasthenia gravis exacerbatin with intravenus immunglbulin: a randmized duble-blind clinical trial. Arch Neurl. 2005;62(11): Elvaara I, et al. EFNS guidelines fr the use f intravenus immunglbulin in treatment f neurlgical diseases: EFNS task frce n the use f intravenus immunglbulin in treatment f neurlgical diseases. Eurpean Jurnal f Neurlgy 2008;15(9): Jint Task Frce f the EFNS and the PNS. Eurpean Federatin f Neurlgical Scieties/Peripheral Nerve Sciety guideline n management f multifcal mtr neurpathy. Reprt f a jint task frce f the Eurpean Federatin f Neurlgical Scieties and the Peripheral Nerve Sciety--first revisin. J Peripher Nerv Syst Dec;15(4): di: /j x. 24. Hahn AF, Bltn CF, Pillay N, et al. Plasma exchange therapy in chrnic inflammatry demyelinating plyneurpathy. A duble-blind, sham cntrlled, crss-ver study. Brain 1996;119: The Natinal Institute f Child Health and Human Develpments Intravenus Immunglbulin Study Grup. Intravenus immune glbulin fr the preventin f bacterial infectins in children with symptmatic human immundeficiency virus infectin. N Engl J Med Jul 11;325(2): Mda Health Plan, Inc. Medical Necessity Criteria Page 12/23

13 26. Silberry GK, Abzug MJ, Nachman, S, et al. Guidelines fr the Preventin and Treatment f Opprtunistic Infectins in HIV-Expsed and HIV-Infected Children: Recmmendatins frm the Natinal Institutes f Health, Centers fr Disease Cntrl and Preventin, the HIV Medicine Assciatin f the Infectius Diseases Sciety f America, the Pediatric Infectius Diseases Sciety, and the American Academy f Pediatrics. J Pediatric Infect Dis Sc Nv; 32 Suppl 2: i-kk Wlfe GI, Barhn RJ, Fster BM, et al; Myasthenia Gravis-IVIG Study Grup. Randmized, cntrlled trial f intravenus immunglbulin in myasthenia gravis. Muscle Nerve. 2002;26(4): Hughes RA, Wijdicks EF, Barhn R, et al; Quality Standards Subcmmittee f the American Academy f Neurlgy. Practice parameter: immuntherapy fr Guillain-Barré syndrme: reprt f the Quality Standards Subcmmittee f the American Academy f Neurlgy. Neurlgy. 2003;61(6): Hughes RA, Swan AV, Raphael JC, Annane D, van Kningsveld R, van Drn PA. Immuntherapy fr Guillain-Barré syndrme: a systematic review. Brain. 2007;130(pt 9): Bussel, JB et al. Antenatal management f allimmune thrmbcytpenia with Intravenus Immunglbulin: A randmized trial f lw dse sterid t intravenus immunglbulin. Am J Obstet Gynecl 1996; Ratk TA, Burnett DA, The Univ Hspital Cnsrtium Expert Panel fr the Off-label Use f Plyvalent Intravenusly Administered Immunglbulin Preparatins, et al. Recmmendatins fr the ff-label use f intravenusly administered immunglbulin preparatins. JAMA 1995; 273: Ahmed AR, Spigelman Z, Cavacine LA et al. Treatment f pemphigus vulgaris with rituximab and intravenus immune glbulin. N Eng J Med 2006; American Academy f Pediatrics Subcmmittee n Hyperbilirubinemia. Management f hyperbilirubinemia in the newbrn infant 35 r mre weeks f gestatin. Pediatrics 2004; 114: Gttstein R, Cke R. Systematic Review f intravenus immunglbulin in haemlytic disease f the newbrn. Arch Dis Child Fetal Nenatal Ed 2003; 88:F Andersn D, Ali K, Blanchette V, et al. Guidelines n the use f intravenus immune glbulin fr hematlgic cnditins. Transfus Med Rev. 2007;21(2 Suppl 1):S Orange J, Hssny E, Weiler C, et al. Use f intravenus immunglbulin in human disease: A review f evidence by members f the Primary Immundeficiency Cmmittee f the American Academy f Allergy, Asthma and Immunlgy. J Allergy Clin Immunl 2006;117(4 Suppl): S Stasi R, Evangelista ML, Stipa E, et al. Idipathic thrmbcytpenic purpura: current cncepts in pathphysilgy and management. Thrmbsis and Haemstasis 2008;99(1): Amagai M, Ikeda S, Shimizu H, et al. A randmized, duble-blind trial f intravenus immunglbulin fr pemphigus. J Am Acad Dermatl 2009; 60: Ahmed AR. Intravenus immunglbulin therapy in the treatment f patients with pemphigus vulgaris unrespnsive t cnventinal immunsuppressive treatment. J Am Acad Dermatl 2001; 45: Hughes R, Bensa S, Willisn H, Van den Bergh P, Cmi G, Illa I, Nbile-Orazi E, van Drn P, Dalakas M, Bjar M, Swan A; Inflammatry Neurpathy Cause and Treatment (INCAT) Grup. Randmized cntrlled trial f intravenus immunglbulin versus ral prednislne Mda Health Plan, Inc. Medical Necessity Criteria Page 13/23

14 in chrnic inflammatry demyelinating plyradiculneurpathy. Ann Neurl Aug;50(2): Zinman L, Ng E, Bril V. IV immunglbulin in patients with myasthenia gravis: a randmized cntrlled trial. Neurlgy Mar 13;68(11): Kski CL, Baumgarten M, Magder LS, et al. Derivatin and validatin f diagnstic criteria fr chrnic inflammatry demyelinating plyneurpathy. Jurnal f the Neurlgical Sciences 2009; 277: Sullivan KM, Strek J, Kpecky KJ, et al. A cntrlled trial f lng-term administratin f intravenus immunglbulin t prevent late infectin and chrnic graft-vs.-hst disease after marrw transplantatin: clinical utcme and effect n subsequent immune recvery. Bil Bld Marrw Transplant 1996;2: Alejandria MM, Lansang MA, Dans LF, Mantaring JB. Intravenus immunglbulin fr treating sepsis and septic shck. Cchrane Database Syst Rev 2002;CD American Cllege f Obstetricians and Gyneclgists (ACOG), Cmmittee n Practice Bulletins -- Obstetrics. Thrmbcytpenia in pregnancy. ACOG Practice Pattern N. 6. Washingtn, DC: ACOG; September Centers fr Disease Cntrl and Preventin. Guidelines fr preventing pprtunistic infectins amng hematpietic stem cell transplant recipients: recmmendatins f CDC, the Infectius Disease Sciety f America, and the American Sciety f Bld and Marrw Transplantatin. MMWR 2000;49(N. RR-10): Emersn GG, Herndn CN, Sreih AG. Thrmbtic cmplicatins after intravenus immunglbulin therapy in tw patients. Pharmactherapy. 2002;22: Department f Health (Lndn). Clinical Guidelines fr Immunglbulin Use: Update t Secnd Editin. August, Prvan, Drew, et al. "Clinical guidelines fr immunglbulin use." Department f Health Publicatin, Lndn (2008). 50. Sussman J, Farrugia ME, Maddisn P, et al. Myasthenia gravis: Assciatin f British Neurlgists management guidelines. Pract Neurl 2015; 15: Sanders DB, Wlfe GI, Benatar M, et al. Internatinal cnsensus guidance fr management f myasthenia gravis-executive Summary. Neurlgy Jul 26; 87(4): Orange JS, Ballw M, Stiehm, et al. Use and interpretatin f diagnstic vaccinatin in primary immundeficiency: A wrking grup reprt f the Basic and Clinical Immunlgy Interest Sectin f the American Academy f Allergy, Asthma & Immunlgy. J Allergy Clin Immunl Vl 130 (3). 53. Neunert C, Lim W, Crwther M, et al. The American Sciety f Hematlgy 2011 Evidencebased practice guidelines fr immune thrmbcytpenia. Bld April 2011; Vl 117 (16). 54. Jeffrey Mdell Fundatin Medical Advisry Bard, Warning Signs f Primary Immundeficiency. Jeffrey Mdell Fundatin, New Yrk, NY. 55. Bnilla FA, Khan DA, Ballas ZK, et al. Practice Parameter fr the diagnsis and management f primary immundeficiency. J Allergy Clin Immunl 2015 Nv;136(5): e Kuitwaard K, de Gelder J, Ti-Gillen AP, et al. Pharmackinetics f intravenus immunglbulin and utcme in Guillain-Barré syndrme. Ann Neurl. 2009;66(5): Shehata N, Palda VA, Meyer RM, et al: The use f immunglbulin therapy fr patients underging slid rgan transplantatin: an evidence-based practice guideline. Transfus Med Rev 2010; 24 Suppl 1:S7-S27. Mda Health Plan, Inc. Medical Necessity Criteria Page 14/23

15 58. Jrdan SC, Tyan D, Stablein D, et al: Evaluatin f intravenus immunglbulin as an agent t lwer allsensitizatin and imprve transplantatin in highly sensitized adult patients with end-stage renal disease: reprt f the NIH IG02 trial. J Am Sc Nephrl 2004; 15(12): Yuan XP, Wang CX, Ga W, et al: Kidney transplant in highly sensitized patients after desensitizatin with plasmapheresis and lw-dse intravenus immunglbulin. Exp Clin Transplant 2010; 8(2): Jrdan SC, Quartel AW, Czer LSC, et al: Psttransplant therapy using high-dse human immunglbulin (intravenus gamma glbulin) t cntrl acute humral rejectin in renal and cardiac allgraft recipients and ptential mechanism f actin. Transplantatin 1998; 66(6): Sullivan KM, Kpecky KJ, Jcm J, et al: Immunmdulatry and antimicrbial efficacy f intravenus immunglbulin in bne marrw transplantatin. N Engl J Med 1990; 323: Bhatti AB, Gazali ZA. Recent Advances and Review n Treatment f Stiff Persn Syndrme in Adults and Pediatric Patients. Cureus Dec 22;7(12):e Tanimt K, Nakan K, Kan S, et al. Classificatin criteria fr plymysitis and dermatmysitis. J Rheumatl Apr;22(4): Kyriakides T, Angelini C, Schaefer J, et al. EFNS guidelines n the diagnstic apprach t pauci- r asymptmatic hyperckemia. Eur J Neurl Jun 1;17(6): Feliciani C, Jly P, Jnkman MF, et al. Management f bullus pemphigid: the Eurpean Dermatlgy Frum cnsensus in cllabratin with the Eurpean Academy f Dermatlgy and Venerelgy. Br J Dermatl Apr;172(4): Hertl M, Jedlickva H, Karpati S, et al. Pemphigus. S2 Guideline fr diagnsis and treatment- -guided by the Eurpean Dermatlgy Frum (EDF) in cperatin with the Eurpean Academy f Dermatlgy and Venerelgy (EADV). J Eur Acad Dermatl Venerel Mar;29(3): Harman KE, Albert S, Black MM; British Assciatin f Dermatlgists. Guidelines fr the management f pemphigus vulgaris. Br J Dermatl Nv;149(5): Perez EE, Orange JS, Bnilla F, et al. Update n the use f immunglbulin in human disease: A review f evidence. J Allergy Clin Immunl Mar;139(3S):S1-S Dantal J. Intravenus Immunglbulins: In-Depth Review f Excipients and Acute Kidney Injury Risk. Am J Nephrl 2013;38: Rajabally YA et al. Validity f diagnstic criteria fr chrnic inflammatry demyelinating plyneurpathy: A multicentre Eurpean study. J Neurl Neursurg Psychiatry 2009 Dec; 80: First Cast Service Optins, Inc. Lcal Cverage Determinatin (LCD): Intravenus Immune Glbulin (L34007). Centers fr Medicare & Medicaid Services, Inc. Updated n 4/13/2018 with effective date 4/12/2018. Accessed May Nridian Administrative Services, LLC. Lcal Cverage Determinatin (LCD): Immune Glbulin Intravenus (IVIg) (L34074; L34314). Centers fr Medicare & Medicaid Services, Inc. Updated n 12/13/2017 with effective date 07/7/2017. Accessed May Nvitas Slutins, Inc. Lcal Cverage Determinatin (LCD): Intravenus Immune Glbulin (IVIG) (L35093). Centers fr Medicare & Medicaid Services, Inc. Updated n 3/2/2018 with effective date 3/8/2018. Accessed May Mda Health Plan, Inc. Medical Necessity Criteria Page 15/23

16 74. Wiscnsin Physicians Service Insurance Crpratin. Lcal Cverage Determinatin (LCD): Immune Glbulins (L34771). Centers fr Medicare & Medicaid Services, Inc. Updated n 12/19/2017 with effective date 1/1/2018. Accessed May CGS, Administratrs, LLC. Lcal Cverage Determinatin (LCD): Intravenus Immune Glbulin (L35891). Centers fr Medicare & Medicaid Services, Inc. Updated n 3/28/2018 with effective date 3/1/2018. Accessed May Palmett GBA. Lcal Cverage Determinatin (LCD): Intravenus Immunglbulin (IVIG) (L34580). Centers fr Medicare & Medicaid Services, Inc. Updated n 12/7/2017 with effective date 2/26/2018. Accessed May Natinal Cverage Determinatin (NCD) fr Intravenus Immune Glbulin fr the Treatment f Autimmune Muccutaneus Blistering Diseases (250.3). Centers fr Medicare and Medicaid Services, Inc. Updated n 12/01/2015 with effective date 10/1/2015. Accessed January Natinal Gvernment Services, Inc. Lcal Cverage Article fr Intravenus Immune Glbulin (IVIG) - Related t LCD L33394 (A52446). Centers fr Medicare & Medicaid Services, Inc. Updated n 9/22/2017 with effective date 10/7/2017. Accessed May Nridian Healthcare Slutins, LLC. Lcal Cverage Article fr Intravenus Immune Glbulin (IVIG)-NCD Related t LCD L34314, L34074 (A54641, A54643). Centers fr Medicare & Medicaid Services, Inc. Updated n 1/18/2017 with effective date 11/7/2015. Accessed May Nridian Healthcare Slutins, LLC. Lcal Cverage Article: Cverage f Intravenus Immune Glbulin fr Treatment f Primary Immune Deficiency Diseases in the Hme Medicare Benefit Plicy Manual, Chapter 15, (A54660, A54662). Centers fr Medicare & Medicaid Services, Inc. Updated 4/2/2018 with effective date 4/12/2018. Accessed May Referenced with permissin frm the NCCN Drugs & Bilgics Cmpendium (NCCN Cmpendium ) Management f Immuntherapy-Related Txicities, Versin 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 Pstw, MA. Managing Immune Checkpint-Blcking Antibdy Side Effects. American Sciety f Clinical Onclgy Educatin Bk. 2015; Williams TJ, Benavides DR, Patrice KA. Assciatin f Autimmune Encephalitis with cmbined immune checkpint inhibitr treatment fr metastatic cancer. JAMA Neurl :)8(73;2016di: /jamaneurl Appendix 1 Cvered Diagnsis Cdes ICD-10 ICD-10 Descriptin A48.3 Txic shck syndrme B20 Human immundeficiency virus (HIV) disease B25.0 Cytmegalviral pneumnitis B25.1 Cytmegalviral hepatitis B25.2 Cytmegalviral pancreatitis Mda Health Plan, Inc. Medical Necessity Criteria Page 16/23

17 ICD-10 ICD-10 Descriptin B25.8 Other cytmegalviral diseases B25.9 Cytmegalviral disease, unspecified C91.10 Chrnic lymphcytic leukemia f B-cell type nt having achieved remissin C91.11 Chrnic lymphcytic leukemia f B-cell type in remissin C91.12 Chrnic lymphcytic leukemia f B-cell type in relapse C90.00 Multiple Myelma nt having achieved remissin C90.01 Multiple Myelma in remissin C90.02 Multiple Myelma in relapse C90.10 Plasma cell leukemia nt having achieved remissin C90.11 Plasma cell leukemia in remissin C90.12 Plasma cell leukemia in relapse D69.3 Immune thrmbcytpenic purpura D69.41 Evans syndrme D69.42 Cngenital and hereditary thrmbcytpenic purpura D69.49 Other primary thrmbcytpenia D69.59 Other secndary thrmbcytpenia D80.0 Hereditary hypgammaglbulinemia D80.1 Nnfamilial hypgammaglbulinemia D80.3 Selective deficiency f immunglbulin G [IgG] subclasses D80.5 Immundeficiency with increased immunglbulin M [IgM] D80.7 Transient hypgammaglbulinemia f infancy D81.0 Severe cmbined immundeficiency [SCID] with reticular dysgenesis D81.1 Severe cmbined immundeficiency [SCID] with lw T- and B-cell numbers D81.2 Severe cmbined immundeficiency [SCID] with lw r nrmal B-cell numbers D81.6 Majr histcmpatibility cmplex class I deficiency D81.7 Majr histcmpatibility cmplex class II deficiency D81.89 Other cmbined immundeficiencies D81.9 Cmbined immundeficiency, unspecified D82.0 Wisktt-Aldrich syndrme D82.1 DiGerge's syndrme D83.0 Cmmn variable immundeficiency with predminant abnrmalities f B-cell numbers and functin D83.2 Cmmn variable immundeficiency with autantibdies t B- r T-cells D83.8 Other cmmn variable immundeficiencies D83.9 Cmmn variable immundeficiency, unspecified D Acute graft-versus-hst disease D Acute n chrnic graft-versus-hst disease Mda Health Plan, Inc. Medical Necessity Criteria Page 17/23

18 ICD-10 ICD-10 Descriptin G03.8 Meningitis due t ther specified causes G03.9 Meningitis, unspecified G04.81 Other encephalitis and encephalmyelitis G04.89 Other myelitis G04.90 Encephalitis and encephalmyelitis, unspecified G04.91 Myelitis, unspecified G25.82 Stiff-man syndrme G56.80 Other specified mnneurpathies f unspecified upper limb G56.81 Other specified mnneurpathies f right upper limb G56.82 Other specified mnneurpathies f left upper limb G56.83 Other specified mnneurpathies f bilateral upper limbs G56.90 Unspecified mnneurpathy f unspecified upper limb G56.91 Unspecified mnneurpathy f right upper limb G56.92 Unspecified mnneurpathy f left upper limb G56.93 Unspecified mnneurpathy f bilateral upper limbs G57.80 Other specified mnneurpathies f unspecified lwer limb G57.81 Other specified mnneurpathies f right lwer limb G57.82 Other specified mnneurpathies f left lwer limb G57.83 Other specified mnneurpathies f bilateral lwer limbs G57.90 Unspecified mnneurpathy f unspecified lwer limb G57.91 Unspecified mnneurpathy f right lwer limb G57.92 Unspecified mnneurpathy f left lwer limb G57.93 Unspecified mnneurpathy f bilateral lwer limbs G61.0 Guillain-Barre syndrme G61.1 Serum neurpathy G61.81* Chrnic inflammatry demyelinating plyneuritis G61.82 Multifcal mtr neurpathy G61.89 Other inflammatry plyneurpathies G61.9 Inflammatry plyneurpathy, unspecified G62.89 Other specified plyneurpathies G70.00 Myasthenia gravis withut (acute) exacerbatin G70.01 Myasthenia gravis with (acute) exacerbatin G90.09 Other idipathic peripheral autnmic neurpathy J70.2 Acute drug-induced interstitial lung disrders J70.4 Drug-induced interstitial lung disrders, unspecified L10.0 Pemphigus vulgaris L10.2 Pemphigus fliaceus Mda Health Plan, Inc. Medical Necessity Criteria Page 18/23

19 ICD-10 ICD-10 Descriptin L12.0 Bullus pemphigid L12.1 Cicatricial pemphigid L12.30 Acquired epidermlysis bullsa, unspecified L12.31 Epidermlysis bullsa due t drug L12.35 Other acquired epidermlysis bullsa L12.5 Other acquired epidermlysis bullsa L13.8 Other specified bullus disrders M30.3 Muccutaneus lymph nde syndrme [Kawasaki] M33.00 Juvenile dermatmysitis, rgan invlvement unspecified M33.01 Juvenile dermatmysitis with respiratry invlvement M33.02 Juvenile dermatmysitis with mypathy M33.03 Juvenile dermatmysitis withut mypathy M33.09 Juvenile dermatmysitis with ther rgan invlvement M33.10 Other dermatmysitis, rgan invlvement unspecified M33.11 Other dermatmysitis with respiratry invlvement M33.12 Other dermatmysitis with mypathy M33.13 Other dermatmysitis withut mypathy M33.19 Other dermatmysitis with ther rgan invlvement M33.20 Plymysitis, rgan invlvement unspecified M33.21 Plymysitis with respiratry invlvement M33.22 Plymysitis with mypathy M33.29 Plymysitis with ther rgan invlvement M33.90 Dermatplymysitis, unspecified, rgan invlvement unspecified M33.91 Dermatplymysitis, unspecified with respiratry invlvement M33.92 Dermatplymysitis, unspecified with mypathy M33.93 Dermatplymysitis, unspecified withut mypathy M33.99 Dermatplymysitis, unspecified with ther rgan invlvement M36.0 Dermat(ply)mysitis in neplastic disease O26.40 Herpes gestatinis, unspecified trimester O26.41 Herpes gestatinis, first trimester O26.42 Herpes gestatinis, secnd trimester O26.43 Herpes gestatinis, third trimester P61.0 Transient nenatal thrmbcytpenia T86.00 Unspecified cmplicatin f bne marrw transplant T86.01 Bne marrw transplant rejectin T86.02 Bne marrw transplant failure Mda Health Plan, Inc. Medical Necessity Criteria Page 19/23

20 ICD-10 ICD-10 Descriptin T86.03 Bne marrw transplant infectin T86.09 Other cmplicatins f bne marrw transplant T86.10 Unspecified cmplicatin f kidney transplant T86.11 Kidney transplant rejectin T86.12 Kidney transplant failure T86.13 Kidney transplant infectin T86.19 Other cmplicatin f kidney transplant T86.20 Unspecified cmplicatin f heart transplant T86.21 Heart transplant rejectin T86.22 Heart transplant failure T86.23 Heart transplant infectin T Cardiac allgraft vasculpathy T Other cmplicatins f heart transplant T86.30 Unspecified cmplicatin f heart-lung transplant T86.31 Heart-lung transplant rejectin T86.32 Heart-lung transplant failure T86.33 Heart-lung transplant infectin T86.39 Other cmplicatins f heart-lung transplant T86.40 Unspecified cmplicatin f liver transplant T86.41 Liver transplant rejectin T86.42 Liver transplant failure T86.43 Liver transplant infectin T86.49 Other cmplicatins f liver transplant T Lung transplant rejectin T Lung transplant failure T Lung transplant infectin T Other cmplicatins f lung transplant T Unspecified cmplicatin f lung transplant T Other transplanted tissue rejectin T Other transplanted tissue failure T Other transplanted tissue infectin T Other cmplicatins f ther transplanted tissue T Unspecified cmplicatin f ther transplanted tissue Z48.21 Encunter fr aftercare fllwing heart transplant Z48.22 Encunter fr aftercare fllwing kidney transplant Z48.23 Encunter fr aftercare fllwing liver transplant Mda Health Plan, Inc. Medical Necessity Criteria Page 20/23

21 ICD-10 ICD-10 Descriptin Z48.24 Encunter fr aftercare fllwing lung transplant Z Encunter fr aftercare fllwing heart-lung transplant Z Encunter fr aftercare fllwing bne marrw transplant Z94.0 Kidney transplant status Z94.1 Heart transplant status Z94.2 Lung transplant status Z94.3 Heart and lungs transplant status Z94.4 Liver transplant status Z94.81 Bne marrw transplant status Z94.83 Pancreas transplant status Z94.84 Stem cells transplant status *G61.81 is nt payable when assciated with diabetes mellitus, dysprteinemias, renal failure, r malnutritin 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): Jurisdictin(s): N NCD/LCD/Article Dcument (s): L34007 Jurisdictin(s): F NCD/LCD/Article Dcument (s): L34074 Jurisdictin(s): L; H NCD/LCD/Article Dcument (s): L35093 Jurisdictin(s): E NCD/LCD/Article Dcument (s): L Mda Health Plan, Inc. Medical Necessity Criteria Page 21/23

22 Jurisdictin(s): 5, 8 NCD/LCD/Article Dcument (s): L34771 Jurisdictin(s): J, M NCD/LCD/Article Dcument (s): L34580 Jurisdictin(s): ALL NCD/LCD/Article Dcument (s): Jurisdictin(s): 15 NCD/LCD/Article Dcument (s): L35891 Jurisdictin(s): E NCD/LCD/Article Dcument (s): A54641, A54643 Jurisdictin(s): E NCD/LCD/Article Dcument (s): A54660, A54662 Jurisdictin(s): 6, K NCD/LCD/Article Dcument (s): 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 Crpratin (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 Crpratin (WPS) N (9) FL, PR, VI First Cast Service Optins, Inc. Mda Health Plan, Inc. Medical Necessity Criteria Page 22/23

23 Medicare Part B Administrative Cntractr (MAC) Jurisdictins Jurisdictin Applicable State/US Territry Cntractr 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) Nvitas Slutins, Inc. K (13 & 14) NY, CT, MA, RI, VT, ME, NH Natinal Gvernment Services, Inc. (NGS) 15 KY, OH CGS Administratrs, LLC Mda Health Plan, Inc. Medical Necessity Criteria Page 23/23