Opdivo (nivolumab) (Intravenous)

Transcription

1 Opdiv (nivlumab) (Intravenus) Last Review Date: 1/03/2018 Date f Origin: 01/06/2015 Dcument Number: IC-0226 Dates Reviewed: 03/2015, 07/2015, 10/2015, 11/2015, 02/2016, 05/2016, 08/2016, 10/2016, 11/2016, 02/2017, 05/2017, 08/2017, 10/2017, 01/2018 I. Length f Authrizatin Cverage will be prvided fr six mnths and may be renewed. Adjuvant use in the treatment f melanma patients can be authrized up t a maximum f 12 mnths f therapy. II. Dsing Limits A. Quantity Limit (max daily dse) [Pharmacy Benefit]: Opdiv 40 mg/4 ml single-use vial: 2 vials per 14 days Opdiv 100 mg/10 ml single-use vial: 4 vials per 14 days B. Max Units (per dse and ver time) [Medical Benefit]: Indicatin Billable Units (BU) Per unit time (days) Classical Hdgkin Lymphma, SCCHN, Merkel Cell, & SCLC (as a single agent) 340 BU 14 days Melanma (in cmbinatin with Initial: 140 BU 21 days x 4 dses ipilimumab) Fllwed by: 240 BU 14 days Melanma (as a single agent), NSCLC, RCC, MSI-H/dMMR CRC, HCC & 240 BU 14 days Urthelial Carcinma SCLC (in cmbinatin with ipilimumab) Initial: 340 BU 21 days x 4 dses Fllwed by: 340 BU 14 days MPM (as a single agent r in cmbinatin with ipilimumab) 340 BU 14 days CNS Metastases (in cmbinatin with Initial: 140 BU 21 days x 4 dses ipilimumab) Fllwed by: 340 BU 14 days III. Initial Apprval Criteria Cverage is prvided fr the fllwing cnditins: Patient must be 18 years f age r lder (unless therwise specified); AND Patient has nt received previus therapy with a prgrammed death (PD-1/PD-L1)-directed therapy (e.g., avelumab, pembrlizumab, atezlizumab, durvalumab, etc.) unless therwise specified; AND Mda Health Plan, Inc. Medical Necessity Criteria Page 1/13

2 Melanma Patient s disease is unresectable r metastatic; AND Used as a single agent; OR Used in cmbinatin with ipilimumab; OR Used as adjuvant treatment as a single agent; AND Patient has lymph nde invlvement r metastatic disease and has undergne cmplete resectin Hepatcellular Carcinma (HCC) Patient prgressed n r was intlerant t srafenib; AND Patient has a labratry cnfirmed diagnsis f hepatcellular carcinma; AND Patient has Child-Pugh Class A r B7 disease Nn-Small Cell Lung Cancer (NSCLC) Must be used as a single agent; AND Used as subsequent therapy in patients with metastatic disease; AND Disease has prgressed during r fllwing cyttxic therapy; AND Patients with genmic tumr aberratins must have prgressed fllwing systemic therapy fr thse aberratins (e.g., EGFR, ALK, etc.) Renal Cell Carcinma (RCC) Must be used as a single agent; AND Patient has advanced disease and has failed prir anti-angigenic therapy; OR Patient has relapsed r stage IV disease; AND Used as subsequent therapy fr predminant clear cell histlgy; OR Used fr nn-clear cell histlgy Hdgkin Lymphma (HL) Must be used as a single agent; AND Patient has refractry r relapsed disease and was previusly treated with brentuximab vedtin; OR Used after relapse r prgressin; AND Patient had an autlgus hematpietic stem cell transplantatin (HSCT) and psttransplantatin brentuximab vedtin; OR Patient has received 3 r mre lines f systemic therapy that includes autlgus HSCT Squamus Cell Carcinma f the Head and Neck (SCCHN) Patient has unresectable, recurrent, r metastatic disease; AND Patient has prgressed n r after platinum-based therapy; AND Must be used as a single agent Urthelial Carcinma Must be used as a single agent; AND Mda Health Plan, Inc. Medical Necessity Criteria Page 2/13

3 Must be used as subsequent systemic therapy; AND Patient has ne f the fllwing: Lcally advanced r metastatic disease; OR Disease recurrence pst-cystectmy ; OR Recurrent r metastatic Primary Carcinma f the Urethra ; OR Metastatic Urthelial Carcinma f the Prstate ; OR Metastatic Upper GU Tract Tumrs Small Cell Lung Cancer (SCLC) Must be used as subsequent systemic therapy; AND Patient has an ECOG perfrmance status f 0-2; AND Must be used as ne f the fllwing; A single agent; OR In cmbinatin with ipilimumab; AND Patient must have ne f the fllwing: Primary prgressive disease; OR Relapsed within 6 mnths fllwing cmplete respnse, partial respnse, r stable disease fllwing initial treatment Micrsatellite Instability-High (MSI-H)/Mismatch Repair Deficient (dmmr) Clrectal Cancer Patient must be at least 12 years ld; AND Used as a single agent; AND Patient s disease must be micrsatellite instability-high (MSI-H) r mismatch repair deficient (dmmr); AND Patient has metastatic disease that has prgressed fllwing treatment with a flurpyrimidine, xaliplatin, and irintecan ; OR Patient has unresectable advanced r metastatic disease; AND Used as initial therapy fr patients wh are nt candidates fr intensive therapy r wh failed adjuvant treatment with FOLFOX (flururacil, leucvrin and xaliplatin) r CapeOX (capecitabine-xaliplatin) in the previus 12 mnths ; OR Subsequent therapy fllwing previus xaliplatin, irintecan and/r flurpyrimidine based therapy Malignant Pleural Mesthelima Used as subsequent therapy; AND Used as a single agent; OR Used in cmbinatin with ipilimumab Merkel Cell Carcinma Used as a single agent; AND Patient has metastatic disease Central Nervus System Cancer Mda Health Plan, Inc. Medical Necessity Criteria Page 3/13

4 Used fr recurrent disease fr brain metastases; AND Nivlumab is active against the primary melanma tumr; AND Used in cmbinatin with ipilimumab FDA Apprved Indicatin(s); Cmpendia recmmended indicatin(s) IV. Renewal Criteria Authrizatins can be renewed based n the fllwing criteria: Patient cntinues t meet the criteria identified in sectin III; AND Absence f unacceptable txicity frm the drug. Examples f unacceptable txicity include the fllwing: severe infusin reactins, cmplicatins f allgeneic HSCT, severe immunemediated adverse reactins such as pneumnitis, clitis, hepatitis, endcrinpathies, nephritis/renal dysfunctin, rash, encephalitis, etc.; AND Tumr respnse with stabilizatin f disease r decrease in size f tumr r tumr spread; AND Fr the fllwing indicatin (s), the patient has nt exceeded a maximum f twelve (12) mnths f therapy: Adjuvant treatment f melanma in patients with lymph nde invlvement r metastatic disease with cmplete resectin Retreatment fr Melanma (metastatic r unresectable disease) Patient has perfrmance status 0-2; AND Used as re-inductin therapy in patients wh experienced disease cntrl, but subsequently disease prgressin/relapse > 3 mnths after treatment discntinuatin; OR Used as subsequent therapy in cmbinatin with ipilimumab in patients wh experience disease prgressin after initial mntherapy with an immune checkpint-inhibitr V. Dsage/Administratin Indicatin Classical Hdgkin Lymphma, SCCHN, and Merkel Cell Melanma Dse 3 mg/kg every 2 weeks Single agent: 240 mg every 2 weeks Adjuvant single-agent treatment: 240 mg every 2 weeks until disease recurrence r unacceptable txicity fr up t 1 year In cmbinatin with ipilimumab: 1 mg/kg, fllwed by ipilimumab n the same day, every 3 weeks fr 4 dses, then 240 mg every 2 weeks NSCLC, RCC, MSI-H/dMMR CRC, 240 mg every 2 weeks, until disease prgressin r HCC and Urthelial Carcinma SCLC unacceptable txicity. Single agent: 3 mg/kg every 2 weeks In cmbinatin with ipilimumab: Mda Health Plan, Inc. Medical Necessity Criteria Page 4/13

5 Malignant Pleural Mesthelima (MPM) 1 mg/kg t 3 mg/kg, fllwed by ipilimumab n the same day, every 3 weeks fr 4 dses, then 3 mg/kg every 2 weeks Single agent: 3 mg/kg every 2 weeks In cmbinatin with ipilimumab: 3 mg/kg every 2 weeks, fllwed by ipilimumab 1mg/kg every 6 weeks, until disease prgressin r unacceptable txicity CNS Metastases 1 mg/kg, fllwed by ipilimumab n the same day, every 3 weeks fr 4 dses, then 3 mg/kg every 2 weeks VI. Billing Cde/Availability Infrmatin Jcde: J Injectin, nivlumab, 1 mg; 1 billable unit = 1 mg NDC: Opdiv 40 mg/4 ml single-use vial: xx Opdiv 100 mg/10 ml single-use vial: xx VII. References 1. Opdiv [package insert]. Princetn, NJ; Bristl-Myers Squibb Cmpany; December Accessed December Referenced with permissin frm the NCCN Drugs & Bilgics Cmpendium (NCCN Cmpendium ) nivlumab. 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 December Scherpereel A, Mazieres J, Greillier L, et al. Secnd- r third-line nivlumab (Niv) versus niv plus ipilimumab (Ipi) in malignant pleural mesthelima (MPM) patients: Results f the IFCT-1501 MAPS2 randmized phase II trial. [Abstract]. J Clin Oncl 2017;35: Abstract LBA Walck FM, Scheier BY, Harms PW, et al. Metastatic Merkel cell carcinma respnse t nivlumab. J Immunther Cancer Nv 15;4: Tawbi HA-H, Frsyth PAJ, Algazi AP, et al. Efficacy and safety f nivlumab (NIVO) plus ipilimumab (IPI) in patients with melanma (MEL) metastatic t the brain: Results f the phase II study CheckMate 204. J Clin Oncl 2017;35(15_suppl):abstr Natinal Gvernment Services, Inc. Lcal Cverage Article: Nivlumab (Opdiv ) Related t LCD L33394 (A54862). Centers fr Medicare & Medicaid Services, Inc. Updated n 7/21/2017 with effective date 7/7/2017. Accessed September Mda Health Plan, Inc. Medical Necessity Criteria Page 5/13

6 Appendix 1 Cvered Diagnsis Cdes ICD-10 ICD-10 Descriptin C00.0 Malignant neplasm f external upper lip C00.1 Malignant neplasm f external lwer lip C00.2 Malignant neplasm f external lip, unspecified C00.3 Malignant neplasm f upper lip, inner aspect C00.4 Malignant neplasm f lwer lip, inner aspect C00.5 Malignant neplasm f lip, unspecified, inner aspect C00.6 Malignant neplasm f cmmissure f lip, unspecified C00.8 Malignant neplasm f verlapping sites f lip C01 Malignant neplasm f base f tngue C02.0 Malignant neplasm f drsal surface f tngue C02.1 Malignant neplasm f brder f tngue C02.2 Malignant neplasm f ventral surface f tngue C02.3 Malignant neplasm f anterir tw-thirds f tngue, part unspecified C02.4 Malignant neplasm f lingual tnsil C02.8 Malignant neplasm f verlapping sites f tngue C02.9 Malignant neplasm f tngue, unspecified C03.0 Malignant neplasm f upper gum C03.1 Malignant neplasm f lwer gum C03.9 Malignant neplasm f gum, unspecified C04.0 Malignant neplasm f anterir flr f muth C04.1 Malignant neplasm f lateral flr f muth C04.8 Malignant neplasm f verlapping sites f flr f muth C04.9 Malignant neplasm f flr f muth, unspecified C05.0 Malignant neplasm f hard palate C05.1 Malignant neplasm f sft palate C06.0 Malignant neplasm f cheek mucsa C06.2 Malignant neplasm f retrmlar area C06.80 Malignant neplasm f verlapping sites f unspecified parts f muth C06.89 Malignant neplasm f verlapping sites f ther parts f muth C06.9 Malignant neplasm f muth, unspecified C09.0 Malignant neplasm f tnsillar fssa C09.1 Malignant neplasm f tnsillar pillar (anterir) (psterir) C09.8 Malignant neplasm f verlapping sites f tnsil C09.9 Malignant neplasm f tnsil, unspecified C10.3 Malignant neplasm f psterir wall f rpharynx Mda Health Plan, Inc. Medical Necessity Criteria Page 6/13

7 C11.0 Malignant neplasm f superir wall f naspharynx C11.1 Malignant neplasm f psterir wall f naspharynx C11.2 Malignant neplasm f lateral wall f naspharynx C11.3 Malignant neplasm f anterir wall f naspharynx C11.8 Malignant neplasm f verlapping sites f naspharynx C11.9 Malignant neplasm f naspharynx, unspecified C12 Malignant neplasm f pyrifrm sinus C13.0 Malignant neplasm f pstcricid regin C13.1 Malignant neplasm f aryepiglttic fld, hyppharyngeal aspect C13.2 Malignant neplasm f psterir wall f hyppharynx C13.8 Malignant neplasm f verlapping sites f hyppharynx C13.9 Malignant neplasm f hyppharynx, unspecified C14.0 Malignant neplasm f pharynx, unspecified C14.2 Malignant neplasm f Waldeyer's ring C14.8 Malignant neplasm f verlapping sites f lip, ral cavity and pharynx C17.0 Malignant neplasm f dudenum C17.1 Malignant neplasm f jejunum C17.2 Malignant neplasm f ileum C17.8 Malignant neplasm f verlapping sites f small intestine C17.9 Malignant neplasm f small intestine, unspecified C18.0 Malignant neplasm f cecum C18.1 Malignant neplasm f appendix C18.2 Malignant neplasm f ascending cln C18.3 Malignant neplasm f hepatic flexure C18.4 Malignant neplasm f transverse cln C18.5 Malignant neplasm f splenic flexure C18.6 Malignant neplasm f descending cln C18.7 Malignant neplasm f sigmid cln C18.8 Malignant neplasm f verlapping sites f cln C18.9 Malignant neplasm f cln, unspecified C19 Malignant neplasm f rectsigmid junctin C20 Malignant neplasm f rectum C21.8 Malignant neplasm f verlapping sites f rectum, anus and anal canal C22.0 Liver cell carcinma C22.9 Malignant neplasm f liver, nt specified as primary r secndary C31.0 Malignant neplasm f maxillary sinus C31.1 Malignant neplasm f ethmidal sinus Mda Health Plan, Inc. Medical Necessity Criteria Page 7/13

8 C32.0 Malignant neplasm f glttis C32.1 Malignant neplasm f supraglttis C32.2 Malignant neplasm f subglttis C32.3 Malignant neplasm f laryngeal cartilage C32.8 Malignant neplasm f verlapping sites f larynx C32.9 Malignant neplasm f larynx, unspecified C33 Malignant neplasm f trachea C34.00 Malignant neplasm f unspecified main brnchus C34.01 Malignant neplasm f right main brnchus C34.02 Malignant neplasm f left main brnchus C34.10 Malignant neplasm f upper lbe, unspecified brnchus r lung C34.11 Malignant neplasm f upper lbe, right brnchus r lung C34.12 Malignant neplasm f upper lbe, left brnchus r lung C34.2 Malignant neplasm f middle lbe, brnchus r lung C34.30 Malignant neplasm f lwer lbe, unspecified brnchus r lung C34.31 Malignant neplasm f lwer lbe, right brnchus r lung C34.32 Malignant neplasm f lwer lbe, left brnchus r lung C34.80 Malignant neplasm f verlapping sites f unspecified brnchus and lung C34.81 Malignant neplasm f verlapping sites f right brnchus and lung C34.82 Malignant neplasm f verlapping sites f left brnchus and lung C34.90 Malignant neplasm f unspecified part f unspecified brnchus r lung C34.91 Malignant neplasm f unspecified part f right brnchus r lung C34.92 Malignant neplasm f unspecified part f left brnchus r lung C38.4 Malignant neplasm f pleura C43.0 Malignant melanma f lip C43.10 Malignant melanma f unspecified eyelid, including canthus C43.11 Malignant melanma f right eyelid, including canthus C43.12 Malignant melanma f left eyelid, including canthus C43.20 Malignant melanma f unspecified ear and external auricular canal C43.21 Malignant melanma f right ear and external auricular canal C43.22 Malignant melanma f left ear and external auricular canal C43.30 Malignant melanma f unspecified part f face C43.31 Malignant melanma f nse C43.39 Malignant melanma f ther parts f face C43.4 Malignant melanma f scalp and neck C43.51 Malignant melanma f anal skin C43.52 Malignant melanma f skin f breast Mda Health Plan, Inc. Medical Necessity Criteria Page 8/13

9 C43.59 Malignant melanma f ther part f trunk C43.60 Malignant melanma f unspecified upper limb, including shulder C43.61 Malignant melanma f right upper limb, including shulder C43.62 Malignant melanma f left upper limb, including shulder C43.70 Malignant melanma f unspecified lwer limb, including hip C43.71 Malignant melanma f right lwer limb, including hip C43.72 Malignant melanma f left lwer limb, including hip C43.8 Malignant melanma f verlapping sites f skin C43.9 Malignant melanma f skin, unspecified C44.00 Unspecified malignant neplasm f skin f lip C44.02 Squamus cell carcinma f skin f lip C44.09 Other specified malignant neplasm f skin f lip C45.0 Mesthelima f pleura C4A.0 Merkel cell carcinma f lip C4A.10 C4A.11 C4A.12 C4A.20 C4A.21 C4A.22 C4A.30 C4A.31 C4A.39 C4A.4 C4A.51 C4A.52 C4A.59 C4A.60 C4A.61 C4A.62 C4A.70 C4A.71 C4A.72 C4A.8 C4A.9 C61 Merkel cell carcinma f eyelid, including canthus Merkel cell carcinma f right eyelid, including canthus Merkel cell carcinma f left eyelid, including canthus Merkel cell carcinma f unspecified ear and external auricular canal Merkel cell carcinma f right ear and external auricular canal Merkel cell carcinma f left ear and external auricular canal Merkel cell carcinma f unspecified part f face Merkel cell carcinma f nse Merkel cell carcinma f ther parts f face Merkel cell carcinma f scalp and neck Merkel cell carcinma f anal skin Merkel cell carcinma f skin f breast Merkel cell carcinma f ther part f trunk Merkel cell carcinma f unspecified upper limb, including shulder Merkel cell carcinma f right upper limb, including shulder Merkel cell carcinma f left upper limb, including shulder Merkel cell carcinma f unspecified lwer limb, including hip Merkel cell carcinma f right lwer limb, including hip Merkel cell carcinma f left lwer limb, including hip Merkel cell carcinma f verlapping sites Merkel cell carcinma, unspecified Malignant neplasm f prstate C64.1 Malignant neplasm f right kidney, except renal pelvis C64.2 Malignant neplasm f left kidney, except renal pelvis C64.9 Malignant neplasm f unspecified kidney, except renal pelvis Mda Health Plan, Inc. Medical Necessity Criteria Page 9/13

10 C65.1 Malignant neplasm f right renal pelvis C65.2 Malignant neplasm f left renal pelvis C65.9 Malignant neplasm f unspecified renal pelvis C66.1 Malignant neplasm f right ureter C66.2 Malignant neplasm f left ureter C66.9 Malignant neplasm f unspecified ureter C67.0 Malignant neplasm f trigne f bladder C67.1 Malignant neplasm f dme f bladder C67.2 Malignant neplasm f lateral wall f bladder C67.3 Malignant neplasm f anterir wall f bladder C67.4 Malignant neplasm f psterir wall f bladder C67.5 Malignant neplasm f bladder neck C67.6 Malignant neplasm f ureteric rifice C67.7 Malignant neplasm f urachus C67.8 Malignant neplasm f verlapping sites f bladder C67.9 Malignant neplasm f bladder, unspecified C68.0 Malignant neplasm f urethra C69.30 Malignant neplasm f unspecified chrid C69.31 Malignant neplasm f right chrid C69.32 Malignant neplasm f left chrid C69.40 Malignant neplasm f unspecified ciliary bdy C69.41 Malignant neplasm f right ciliary bdy C69.42 Malignant neplasm f left ciliary bdy C69.90 Malignant neplasm f unspecified site f unspecified eye C69.91 Malignant neplasm f unspecified site f right eye C69.92 Malignant neplasm f unspecified site f left eye C76.0 Malignant neplasm f head, face and neck C77.0 Secndary and unspecified malignant neplasm f lymph ndes f head, face and neck C78.00 Secndary malignant neplasm f unspecified lung C78.01 Secndary malignant neplasm f right lung C78.02 Secndary malignant neplasm f left lung C78.6 Secndary malignant neplasm f retrperitneum and peritneum C78.7 Secndary malignant neplasm f liver and intrahepatic bile duct C78.89 Secndary malignant neplasm f ther digestive rgans C79.31 Secndary malignant neplasm f brain C79.51 Secndary malignant neplasm f bne C79.52 Secndary malignant neplasm f bne marrw Mda Health Plan, Inc. Medical Necessity Criteria Page 10/13

11 C7B.1 Secndary Merkel cell carcinma C80.0 Disseminated malignant neplasm, unspecified C80.1 Malignant (primary) neplasm, unspecified C81.10 Ndular sclersis Hdgkin lymphma, unspecified site C81.11 Ndular sclersis Hdgkin lymphma, lymph ndes f head, face, and neck C81.12 Ndular sclersis Hdgkin lymphma, intrathracic lymph ndes C81.13 Ndular sclersis Hdgkin lymphma, intra-abdminal lymph ndes C81.14 Ndular sclersis Hdgkin lymphma, lymph ndes f axilla and upper limb C81.15 Ndular sclersis Hdgkin lymphma, lymph ndes f inguinal regin and lwer limb C81.16 Ndular sclersis Hdgkin lymphma, intrapelvic lymph ndes C81.17 Ndular sclersis Hdgkin lymphma, spleen C81.18 Ndular sclersis Hdgkin lymphma, lymph ndes f multiple sites C81.19 Ndular sclersis Hdgkin lymphma, extrandal and slid rgan sites C81.20 Mixed cellularity Hdgkin lymphma, unspecified site C81.21 Mixed cellularity Hdgkin lymphma, lymph ndes f head, face, and neck C81.22 Mixed cellularity Hdgkin lymphma, intrathracic lymph ndes C81.23 Mixed cellularity Hdgkin lymphma, intra-abdminal lymph ndes C81.24 Mixed cellularity Hdgkin lymphma, lymph ndes f axilla and upper limb C81.25 Mixed cellularity Hdgkin lymphma, lymph ndes f inguinal regin and lwer limb C81.26 Mixed cellularity Hdgkin lymphma, intrapelvic lymph ndes C81.27 Mixed cellularity Hdgkin lymphma, spleen C81.28 Mixed cellularity Hdgkin lymphma, lymph ndes f multiple sites C81.29 Mixed cellularity Hdgkin lymphma, extrandal and slid rgan sites C81.30 Lymphcyte depleted Hdgkin lymphma, unspecified site C81.31 Lymphcyte depleted Hdgkin lymphma, lymph ndes f head, face, and neck C81.32 Lymphcyte depleted Hdgkin lymphma, intrathracic lymph ndes C81.33 Lymphcyte depleted Hdgkin lymphma, intra-abdminal lymph ndes C81.34 Lymphcyte depleted Hdgkin lymphma, lymph ndes f axilla and upper limb C81.35 Lymphcyte depleted Hdgkin lymphma, lymph ndes f inguinal regin and lwer limb C81.36 Lymphcyte depleted Hdgkin lymphma, intrapelvic lymph ndes C81.37 Lymphcyte depleted Hdgkin lymphma, spleen C81.38 Lymphcyte depleted Hdgkin lymphma, lymph ndes f multiple sites C81.39 Lymphcyte depleted Hdgkin lymphma, extrandal and slid rgan sites C81.40 Lymphcyte-rich Hdgkin lymphma, unspecified site C81.41 Lymphcyte-rich Hdgkin lymphma, lymph ndes f head, face, and neck C81.42 Lymphcyte-rich Hdgkin lymphma, intrathracic lymph ndes C81.43 Lymphcyte-rich Hdgkin lymphma, intra-abdminal lymph ndes Mda Health Plan, Inc. Medical Necessity Criteria Page 11/13

12 C81.44 Lymphcyte-rich Hdgkin lymphma, lymph ndes f axilla and upper limb C81.45 Lymphcyte-rich Hdgkin lymphma, lymph ndes f inguinal regin and lwer limb C81.46 Lymphcyte-rich Hdgkin lymphma, intrapelvic lymph ndes C81.47 Lymphcyte-rich Hdgkin lymphma, spleen C81.48 Lymphcyte-rich Hdgkin lymphma, lymph ndes f multiple sites C81.49 Lymphcyte-rich Hdgkin lymphma, extrandal and slid rgan sites C81.70 Other Hdgkin lymphma unspecified site C81.71 Other Hdgkin lymphma lymph ndes f head, face, and neck C81.72 Other Hdgkin lymphma intrathracic lymph ndes C81.73 Other Hdgkin lymphma intra-abdminal lymph ndes C81.74 Other Hdgkin lymphma lymph ndes f axilla and upper limb C81.75 Other Hdgkin lymphma lymph ndes f inguinal regin and lwer limb C81.76 Other Hdgkin lymphma intrapelvic lymph ndes C81.77 Other Hdgkin lymphma spleen C81.78 Other Hdgkin lymphma lymph ndes f multiple sites C81.79 Other Hdgkin lymphma extrandal and slid rgan sites C81.90 Hdgkin lymphma, unspecified site C81.91 Hdgkin lymphma, unspecified lymph ndes f head, face, and neck C81.92 Hdgkin lymphma, unspecified intrathracic lymph ndes C81.93 Hdgkin lymphma, unspecified intra-abdminal lymph ndes C81.94 Hdgkin lymphma, unspecified lymph ndes f axilla and upper limb C81.95 Hdgkin lymphma, unspecified lymph ndes f inguinal regin and lwer limb C81.96 Hdgkin lymphma, unspecified intrapelvic lymph ndes C81.97 Hdgkin lymphma, unspecified spleen C81.98 Hdgkin lymphma, unspecified lymph ndes f multiple sites C81.99 Hdgkin lymphma, unspecified extrandal and slid rgan sites D09.0 Carcinma in situ f bladder D37.01 Neplasm f uncertain behavir f lip D37.02 Neplasm f uncertain behavir f tngue D37.05 Neplasm f uncertain behavir f pharynx D37.09 Neplasm f uncertain behavir f ther specified sites f the ral cavity D38.0 Neplasm f uncertain behavir f larynx D38.5 Neplasm f uncertain behavir f ther respiratry rgans D38.6 Neplasm f uncertain behavir f respiratry rgan, unspecified Z Persnal histry f ther malignant neplasm f large intestine Z Persnal histry f ther malignant neplasm f brnchus and lung Z85.21 Persnal histry f malignant neplasm f larynx Mda Health Plan, Inc. Medical Necessity Criteria Page 12/13

13 Z85.22 Persnal histry f malignant neplasm f nasal cavities, middle ear, and accessry sinuses Z85.51 Persnal histry f malignant neplasm f bladder Z Persnal histry f ther malignant neplasm f kidney Z85.59 Persnal histry f malignant neplasm f ther urinary tract rgan Z85.71 Persnal histry f Hdgkin lymphma Z Persnal histry f malignant neplasm f tngue Z Persnal histry f malignant neplasm f ther sites f lip, ral cavity and pharynx Z Persnal histry f malignant neplasm f unspecified site f lip, ral cavity and pharynx Z Persnal histry f malignant melanma f skin Z Persnal histry f Merkel cell carcinma 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): 6, K NCD/LCD 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 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 Cahaba Gvernment Benefit Administratrs, 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 13/13