vp-0148
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Yervoy™ (ipilimumab) (Intravenous)

Policy Number: VP-0148

Last Review Date: 04/01/2020

Date of Origin: 11/28/2011

Dates Reviewed: 12/2011, 03/2012, 06/2012, 09/2012, 12/2012, 05/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 08/2015, 10/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 01/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 08/2018, 12/2018, 03/2019, 06/2019, 09/2019, 12/2019, 03/2020, 04/2020

I. Length of Authorization

Small Cell Lung Cancer (SCLC)/Renal Cell Carcinoma (RCC)/ Cutaneous Melanoma (unresectable or metastatic)/Colorectal Cancer (CRC)/Small Bowel Adenocarcinoma/Hepatocellular Carcinoma (HCC) 

  • Coverage will be provided for 12 weeks (may be extended to 16 weeks if 4 doses were not administered within the 12 week time frame) and may not be renewed (unless the patient meets the provisions for metastatic or unresectable melanoma re-induction).  

Non-Small Cell Lung Cancer (NSCLC)

  • Coverage will be provided for 6 months and may not be renewed.

Cutaneous Melanoma (maintenance adjuvant therapy)

  • Coverage for adjuvant treatment will be provided for six months and may be renewed for up to 3 years of therapy total.

Malignant Pleural Mesothelioma (MPM)

  • Coverage will be provided for 6 months and may be renewed.

CNS metastases from Melanoma/Uveal Melanoma

  • Coverage will be provided for 12 weeks initially (may be extended to 16 weeks if 4 doses were not administered within the 12 week time frame). Coverage may be renewed in 6 month intervals thereafter.

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Yervoy 200 mg/40 mL injection:           
    • 5 vials per 84 days (initially up to 5 vials per 21 days x 4 doses)
  • Yervoy 50 mg/10 mL injection:
    • 3 vials per 84 days (initially up to 3 vials per 21 days x 4 doses)
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • Unresectable or metastatic Cutaneous Melanoma
    • 350 billable units per 21 days x 4 doses           
  • Adjuvant treatment of Cutaneous Melanoma
    • 1150 billable units per 21 days x 4 doses; then 1150 billable units per 84 days
  • Uveal Melanoma
    • Initial authorization: 1150 billable units per 21 days x 4 doses
    • Subsequent authorizations: 1150 billable units per 84 days
  • CNS metastases from Melanoma
    • Initial authorization: 1150 billable units per 21 days x 4 doses
    • Subsequent authorizations: 1150 billable units per 84 days
  • Colorectal Cancer (CRC)
    • 115 billable units per 21 days x 4 doses
  • Renal Cell Carcinoma (RCC)
    • 115 billable units per 21 days x 4 doses
  • Small Bowel Adenocarcinoma (SBA)
    • 115 billable units per 21 days x 4 doses
  • Malignant Pleural Mesothelioma
    • 115 billable units per 42 days
  • Small Cell Lung Cancer (SCLC)
    • 350 billable units per 21 days x 4 doses
  • Non-Small Cell Lung Cancer (NSCLC)
    • 115 billable units per 42 days x 4 doses
  • Hepatocellular Carcinoma (HCC)
    • 350 billable units per 21 days x 4 doses

III. Initial Approval Criteria

Coverage is provided in the following conditions:

  • Patient is 18 years or older, unless otherwise indicated; AND

Cutaneous Melanoma

  • Patient’s disease is unresectable or metastatic; AND
    • Used as first-line therapy in combination with nivolumab; OR
    • Used for disease previously treated with cytotoxic chemotherapy as a single agent in patients 12 years or older ; OR
    • Used as subsequent therapy after disease progression on prior therapy or after maximum clinical benefit from BRAF-targeted therapy; AND
      • Used as a single agent or in combination with nivolumab if checkpoint inhibitor immunotherapy was not previously used; OR
      • Used in combination with nivolumab for patients who progressed on single agent checkpoint inhibitor immunotherapy; OR
    • Used for retreatment of disease as re-induction as a single agent or in combination with nivolumab in patients who experienced disease control (i.e., complete or partial response or stable disease), but subsequently have disease progression/relapse > 3 months after treatment discontinuation; AND
      • Patient has completed initial induction (completion of 4 cycles within a 16 week period); OR
  • Used as initial therapy in combination with nivolumab for limited resectable disease with satellite/in-transit recurrence or metastases; OR
  • Used as single-agent for adjuvant therapy; AND
    • Patient has pathologic involvement of regional lymph nodes of more than 1 mm and has undergone complete resection including total lymphadenectomy ; OR
    • Patient has satellite/in-transit recurrence and has no evidence of disease (NED) after complete excision; OR
    • Patient has undergone therapeutic lymph node dissection (TLND) and/or complete resection of nodal recurrence and patient has previously received nivolumab or pembrolizumab ; OR
    • Patient has undergone complete resection of distant metastatic disease and patient has previously received nivolumab or pembrolizumab

Uveal Melanoma

  • Used as a single agent or in combination with nivolumab for distant metastatic disease

Renal Cell Carcinoma (RCC)

  • Used as initial therapy in combination with nivolumab; AND
    • Patient has advanced, relapsed, or stage IV disease with poor or intermediate risk; OR
    • Patient has relapsed or stage IV disease, predominantly clear cell histology, and favorable risk; OR
  • Used as subsequent therapy in combination with nivolumab ; AND
    • Patient has relapsed or stage IV disease; AND
    • Patient has predominantly clear cell histology

Small Cell Lung Cancer (SCLC)

  • Used as subsequent therapy in combination with nivolumab; AND
  • Patient has performance status of 0-2; AND
    • Used for relapse within 6 months of initial therapy following a complete or partial response or stable disease; AND
      • Patient did not relapse while on maintenance atezolizumab or durvalumab; OR
    • Used for primary progressive disease

Non-Small Cell Lung Cancer (NSCLC) ‡

  • Used in combination with nivolumab; AND
    • Used for recurrent, advanced or metastatic disease (excluding locoregional recurrence or symptomatic local disease without evidence of disseminated disease) or mediastinal lymph node recurrence with prior radiation therapy; AND
      • Used as first-line therapy for patients who are genomic tumor aberration (e.g., EGFR, ALK, ROS1, BRAF) negative and PD-L1 <1% in patients with a performance status (PS) of 0-1; OR
      • Used as first-line therapy for PD-L1 expression positive (≥1%) tumors that are genomic tumor aberration (e.g., EGFR, ALK, ROS1, BRAF) negative in patients with a PS of 0-2; OR
      • Used as first-line or subsequent therapy for patients with BRAF V600E-mutation positive or NTRK gene fusion positive tumors in patients with a PS of 0-1; OR
      • Used as subsequent therapy for patients who are genomic tumor aberration (e.g., EGFR, ALK, and ROS1) positive and received prior targeted therapies for those aberrations in patients with a PS of 0-1; OR
    • Used as first-line therapy for metastatic disease with a high tumor mutational burden (TMB)* (i.e., ≥10 mutations per megabase)

*TMB is an evolving biomarker that may be helpful in selecting patients for immunotherapy. There is no consensus on how to measure TMB.

Malignant Pleural Mesothelioma ‡

  • Used in combination with nivolumab as subsequent therapy

Central Nervous System (CNS) Cancers

  • Used for the treatment of brain metastases in patients with melanoma; AND
    • Used for recurrent disease as a single agent or in combination with nivolumab (regimen used must have been active against the primary tumor); AND
      • Patient has limited brain metastases; OR
      • Patient has extensive brain metastases with stable systemic disease or reasonable systemic treatment options; OR
    • Used for newly diagnosed limited brain metastases in combination with nivolumab in patients with small asymptomatic metastases AND with stable systemic disease or with reasonable treatment options

Colorectal Cancer †

  • Patient must be at least 12 years of age; AND
  • Used in combination with nivolumab; AND
  • Patient’s disease must be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); AND
    • Patient has unresectable, advanced, or metastatic disease that has progressed following a fluoropyrimidine-, oxaliplatin-, and/or irinotecan-based regimen; OR
    • Used as primary treatment for unresectable metastatic disease after previous adjuvant therapy with FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) within the past 12 months

Small Bowel Adenocarcinoma

  • Patient has advanced or metastatic disease that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR): AND
  • Used in combination with nivolumab in one of the following settings:
    • As subsequent therapy; OR
    • As initial therapy in patients with prior oxaliplatin exposure in the adjuvant setting or a contraindication

Hepatocellular Carcinoma (HCC) †

  • Patient locally advanced, unresectable, or metastatic disease; AND
  • Patient has a laboratory confirmed diagnosis of hepatocellular carcinoma; AND
  • Patient progressed on or was intolerant to sorafenib; AND
  • Patient has Child-Pugh Class A disease; AND
  • Used in combination with nivolumab

FDA approved indication(s); Compendia recommended indication

IV. Renewal Criteria

  • Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: immune-mediated reactions (e.g. enterocolitis/colitis, hepatitis, dermatitis, neuropathies, pneumonitis, nephritis/renal dysfunction, encephalitis, endocrinopathies like hypopituitarism, hypothyroidism, hypogonadism, or adrenal insufficiency, and ocular disease, etc.), severe infusion reactions, etc; AND

Cutaneous Melanoma Re-induction (metastatic or unresectable disease)

  • Refer to Section III for criteria (see Melanoma – Used for retreatment of disease as re-induction)

Cutaneous Melanoma Maintenance therapy (adjuvant treatment)

  • Tumor response/absence of recurrence; AND
  • Length of therapy has not exceeded 3 years

CNS metastases from melanoma

  • Initial renewal: Patient’s disease is clinically stable at week 24
  • Subsequent renewals: Tumor response/absence of recurrence

Malignant Pleural Mesothelioma

  • Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread

Non-Small Cell Lung Cancer (NSCLC)/Small Cell Lung Cancer (SCLC)/Renal Cell Carcinoma (RCC)/Colorectal Cancer (CRC)/Small Bowel Adenocarcinoma (SBA)/ Hepatocellular Carcinoma (HCC)

  • Coverage may not be renewed.

V. Dosage/Administration

Indication

Dose

Cutaneous Melanoma (unresectable or metastatic)

Administer 3 mg/kg every 3 weeks for a maximum of 4 doses

* all treatment must be administered within 16 weeks of the first dose

Cutaneous Melanoma (adjuvant)

Administer 10 mg/kg every 3 weeks for 4 doses, followed by 10 mg/kg every 12 weeks for up to 3 years

Uveal Melanoma

Single Agent

  • Initial:  3 mg/kg or 10mg/kg every 3 weeks for 4 doses
  • Subsequent: 10 mg/kg every 12 weeks

Combination Therapy (with nivolumab)

  • Initial: Ipilimumab 3 mg/kg and Nivolumab 1mg/kg every 3 weeks for 4 doses
  • Subsequent: Nivolumab 3 mg/kg every 2 weeks until disease progression or intolerance

CNS metastases from melanoma

Single Agent

  • Initial: 10 mg/kg every 3 weeks for 4 doses
  • Subsequent: 10 mg/kg every 12 weeks

Combination Therapy (with nivolumab)

  • Initial: Ipilimumab 3 mg/kg and Nivolumab 1mg/kg every 3 weeks for 4 doses
  • Subsequent: Nivolumab 3 mg/kg every 2 weeks until disease progression or intolerance

Small Cell Lung Cancer (SCLC)/ Hepatocellular Carcinoma (HCC)

Administer 3 mg/kg every 3 weeks for a total of 4 doses (given in combination with nivolumab followed by nivolumab monotherapy)

* all treatment must be administered within 16 weeks of the first dose

Non-Small Cell Lung Cancer (NSCLC)

Administer 1 mg/kg every 6 weeks for a total of 4 doses (given in combination with nivolumab followed by nivolumab monotherapy

Renal Cell Carcinoma (RCC), Colorectal Cancer (CRC), Small Bowel Adenocarcinoma (SBA)

Administer 1 mg/kg every 3 weeks for a total of 4 doses (given in combination with nivolumab followed by nivolumab monotherapy)

Malignant Pleural Mesothelioma

Administer 1 mg/kg every 6 weeks until progression or unacceptable toxicity, given in combination with nivolumab

VI. Billing Code/Availability Information

HCPCS code:

  • J9228 – Injection, ipilimumab, 1 mg: 1 billable unit = 1 mg

NDC(s):

  • Yervoy 200 mg/40 mL injection (single-use vial): 00003-2328-xx
  • Yervoy 50 mg/10 mL injection (single-use vial): 00003-2327-xx

VII. References

  1. Yervoy [package insert]. Princeton, NJ; Bristol Meyers Squib; March 2020. Accessed March 2020.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) ipilimumab. National Comprehensive Cancer Network, 2020. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed March 2020.
  3. Referenced with permission from the NCCN Clinical Practice Guidelines (NCCN Guidelines®) Small Cell Lung Cancer. National Comprehensive Cancer Network, Version 3.2020. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed February 2020.
  4. Referenced with permission from the NCCN Clinical Practice Guidelines (NCCN Guidelines®) Central Nervous System Cancers. National Comprehensive Cancer Network, Version 3.2019. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed February 2020.
  5. Referenced with permission from the NCCN Clinical Practice Guidelines (NCCN Guidelines®) Malignant Pleural Mesothelioma. National Comprehensive Cancer Network, Version 1.2020. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed February 2020.
  6. Hodi FS, O'Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010 Aug 19; 363(8):711-23.
  7. Wilgenhof S, Du Four S, Vandenbroucke F, et al. Single-center experience with ipilimumab in an expanded access program for patients with pretreated advanced melanoma. J Immunother. 2013 Apr; 36(3):215-22.
  8. Margolin K, Ernstoff MS, Hamid O, et al. Ipilimumab in patients with melanoma and brain metastases: an open-label, phase 2 trial. Lancet Oncol. 2012 May; 13(5):459-65.
  9. Antonia SJ, López-Martin JA, Bendell J, et al. Nivolumab alone and nivolumab plus ipilimumab in recurrent small-cell lung cancer (CheckMate 032): a multicentre, open-label, phase 1/2 trial. Lancet Oncol. 2016 Jul;17(7):883-895
  10. Tawbi HA, Forsyth PAJ, Algazi AP, et al.  Efficacy and safety of nivolumab (NIVO) plus ipilimumab (IPI) in patients with melanoma (MEL) metastatic to the brain: Results of the phase II study CheckMate 204.  Journal of Clinical Oncology 35, no. 15_suppl (May 2017) 9507-9507.
  11. Long GV, Atkinson V, Menzies AM, et al.  A randomized phase II study of nivolumab or nivolumab combined with ipilimumab in patients (pts) with melanoma brain metastases (mets): The Anti-PD1 Brain Collaboration (ABC).  Journal of Clinical Oncology 35, no. 15_suppl (May 2017) 9508-9508.
  12. Hellmann MD, Ciuleanu TE, Pluzanski A, et al. Nivolumab plus ipilimumab in lung cancer with a high tumor mutational burden. N Engl J Med 2018; 378:2093-2104.
  1. Fahrenbruch R, Kintzel P, Bott AM, et al. Dose Rounding of Biologic and Cytotoxic Anticancer Agents: A Position Statement of the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2018 Mar;14(3):e130-e136.
  2. Hematology/Oncology Pharmacy Association (2019). Intravenous Cancer Drug Waste Issue Brief. Retrieved from http://www.hoparx.org/images/hopa/advocacy/Issue-Briefs/Drug_Waste_2019.pdf
  3. Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016 Feb 29;352:i788.
  4. Referenced with permission from the NCCN Clinical Practice Guidelines (NCCN Guidelines®) Non-Small Cell Lung Cancer. National Comprehensive Cancer Network, Version 3.2020. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed February 2020.
  5. Eggermont AM, Chiarion-Sileni V, Grob JJ, et al. Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2015 May;16(5):522-30. doi: 10.1016/S1470-2045(15)70122-1. Epub 2015 Mar 31.
  6. Motzer RJ, Tannir NM, McDermott DF, et al. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018 Apr 5;378(14):1277-1290. doi: 10.1056/NEJMoa1712126. Epub 2018 Mar 21.
  7. Overman MJ, Lonardi S, Wong KYM, et al. Durable Clinical Benefit With Nivolumab Plus Ipilimumab in DNA Mismatch Repair-Deficient/Microsatellite Instability-High Metastatic Colorectal Cancer. J Clin Oncol. 2018 Mar 10;36(8):773-779. doi: 10.1200/JCO.2017.76.9901. Epub 2018 Jan 20.
  8. Piulats JM, Cruz-Merino LDL, Garcia MTC, et al. Phase II multicenter, single arm, open label study of nivolumab in combination with ipilimumab in untreated patients with metastatic uveal melanoma (GEM1402.NCT02626962). Annals of Oncology, Volume 29, Issue suppl_8, October 2018, mdy289.003, https://doi.org/10.1093/annonc/mdy289.003.
  9. Zimmer L, Vaubel J, Mohr P, et al. Phase II DeCOG-study of ipilimumab in pretreated and treatment-naïve patients with metastatic uveal melanoma. PLoS One. 2015 Mar 11;10(3):e0118564. doi: 10.1371/journal.pone.0118564. eCollection 2015.
  10. Danielli R, Ridolfi R, Chiarion-Sileni V, et al. Ipilimumab in pretreated patients with metastatic uveal melanoma: safety and clinical efficacy. Cancer Immunol Immunother. 2012 Jan;61(1):41-8. doi: 10.1007/s00262-011-1089-0. Epub 2011 Aug 11.
  11. Luke JJ1, Callahan MK, Postow MA, et al. Clinical activity of ipilimumab for metastatic uveal melanoma: a retrospective review of the Dana-Farber Cancer Institute, Massachusetts General Hospital, Memorial Sloan-Kettering Cancer Center, and University Hospital of Lausanne experience. Cancer. 2013 Oct 15;119(20):3687-95. doi: 10.1002/cncr.28282. Epub 2013 Aug 2.
  12. Hellmann MD, Paz-Ares L, Bernabe Caro R, et al. Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2019 Nov 21;381(21):2020-2031. doi: 10.1056/NEJMoa1910231. Epub 2019 Sep 28.
  13. Scherpereel A, Mazieres J, Greillier L, et al. Nivolumab or nivolumab plus ipilimumab in patients with relapsed malignant pleural mesothelioma (IFCT-1501 MAPS2): a multicentre, open-label, randomised, non-comparative, phase 2 trial. Lancet Oncol. 2019 Feb;20(2):239-253. doi: 10.1016/S1470-2045(18)30765-4. Epub 2019 Jan 16.
  14. Disselhorst MJ, Quispel-Janssen J, Lalezari F, et al. Ipilimumab and nivolumab in the treatment of recurrent malignant pleural mesothelioma (INITIATE): results of a prospective, single-arm, phase 2 trial. Lancet Respir Med. 2019 Mar;7(3):260-270. doi: 10.1016/S2213-2600(18)30420-X. Epub 2019 Jan 16.
  15. Long GV, Atkinson V, Lo S, et al. Combination nivolumab and ipilimumab or nivolumab alone in melanoma brain metastases: a multicentre randomised phase 2 study. Lancet Oncol. 2018 May;19(5):672-681. doi: 10.1016/S1470-2045(18)30139-6. Epub 2018 Mar 27.
  16. Margolin K, Ernstoff MS, Hamid O, et al. Ipilimumab in patients with melanoma and brain metastases: an open-label, phase 2 trial. Lancet Oncol. 2012 May;13(5):459-65. doi: 10.1016/S1470-2045(12)70090-6. Epub 2012 Mar 27.
  17. Referenced with permission from the NCCN Clinical Practice Guidelines (NCCN Guidelines®) Small Bowel Adenocarcinoma. National Comprehensive Cancer Network, Version 1.2020. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed February 2020.
  18. El-Khoueiry AB, Sangro B, Yau T, et al. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. Lancet. 2017 Jun 24;389(10088):2492-2502. doi: 10.1016/S0140-6736(17)31046-2. Epub 2017 Apr 20.
  19. CGS Administrators, LLC. Local Coverage Article (LCA): Billing and Coding: Ipilimumab (Yervoy)-J9228 (A57251).  Centers for Medicare & Medicaid Services, Inc. Updated on 09/18/2019 with effective date 09/26/2019. Accessed February 2020.
  20. Palmetto GBA. Local Coverage Article (LCA): Billing and Coding: Chemotherapy (A56141). Centers for Medicare & Medicaid Services, Inc. Updated on 10/29/2019 with effective date 11/07/2019. Accessed February 2020.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C17.0

Malignant neoplasm of duodenum

C17.1

Malignant neoplasm of jejunum

C17.2

Malignant neoplasm of ileum

C17.3

Meckel's diverticulum, malignant

C17.8

Malignant neoplasm of overlapping sites of small intestine

C17.9

Malignant neoplasm of small intestine, unspecified

C18.0

Malignant neoplasm of cecum

C18.1

Malignant neoplasm of appendix

C18.2

Malignant neoplasm of ascending colon

C18.3

Malignant neoplasm of hepatic flexure

C18.4

Malignant neoplasm of transverse colon

C18.5

Malignant neoplasm of splenic flexure

C18.6

Malignant neoplasm of descending colon

C18.7

Malignant neoplasm of sigmoid colon

C18.8

Malignant neoplasm of overlapping sites of colon

C18.9

Malignant neoplasm of colon, unspecified

C19

Malignant neoplasm of rectosigmoid junction

C20

Malignant neoplasm of rectum

C21.8

Malignant neoplasm of overlapping sites of rectum, anus and anal canal

C22.0

Liver cell carcinoma

C22.9

Malignant neoplasm of liver, not specified as primary or secondary

C33

Malignant neoplasm of trachea

C34.00

Malignant neoplasm of unspecified main bronchus

C34.01

Malignant neoplasm of right main bronchus

C34.02

Malignant neoplasm of left main bronchus

C34.10

Malignant neoplasm of upper lobe, unspecified bronchus or lung

C34.11

Malignant neoplasm of upper lobe, right bronchus or lung

C34.12

Malignant neoplasm of upper lobe, left bronchus or lung

C34.2

Malignant neoplasm of middle lobe, bronchus or lung

C34.30

Malignant neoplasm of lower lobe, unspecified bronchus or lung

C34.31

Malignant neoplasm of lower lobe, right bronchus or lung

C34.32

Malignant neoplasm of lower lobe, left bronchus or lung

C34.80

Malignant neoplasm of overlapping sites of unspecified bronchus and lung

C34.81

Malignant neoplasm of overlapping sites of right bronchus and lung

C34.82

Malignant neoplasm of overlapping sites of left bronchus and lung

C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

C38.4

Malignant neoplasm of pleura

C43.0

Malignant melanoma of lip

C43.10

Malignant melanoma of unspecified eyelid, including canthus

C43.11

Malignant melanoma of right eyelid, including canthus

C43.12

Malignant melanoma of left eyelid, including canthus

C43.20

Malignant melanoma of unspecified ear and external auricular canal

C43.21

Malignant melanoma of right ear and external auricular canal

C43.22

Malignant melanoma of left ear and external auricular canal

C43.30

Malignant melanoma of unspecified part of face

C43.31

Malignant melanoma of nose

C43.39

Malignant melanoma of other parts of face

C43.4

Malignant melanoma of scalp and neck

C43.51

Malignant melanoma of anal skin

C43.52

Malignant melanoma of skin of breast

C43.59

Malignant melanoma of other part of trunk

C43.60

Malignant melanoma of unspecified upper limb, including shoulder

C43.61

Malignant melanoma of right upper limb, including shoulder

C43.62

Malignant melanoma of left upper limb, including shoulder

C43.70

Malignant melanoma of unspecified lower limb, including hip

C43.71

Malignant melanoma of right lower limb, including hip

C43.72

Malignant melanoma of left lower limb, including hip

C43.8

Malignant melanoma of overlapping sites of skin

C43.9

Malignant melanoma of skin, unspecified

C45.0

Mesothelioma of pleura

C64.1

Malignant neoplasm of right kidney, except renal pelvis

C64.2

Malignant neoplasm of left kidney, except renal pelvis

C64.9

Malignant neoplasm of unspecified kidney, except renal pelvis

C65.1

Malignant neoplasm of right renal pelvis

C65.2

Malignant neoplasm of left renal pelvis

C65.9

Malignant neoplasm of unspecified renal pelvis

C69.30

Malignant neoplasm of unspecified choroid

C69.31

Malignant neoplasm of right choroid

C69.32

Malignant neoplasm of left choroid

C69.40

Malignant neoplasm of unspecified ciliary body

C69.41

Malignant neoplasm of right ciliary body

C69.42

Malignant neoplasm of left ciliary body

C69.60

Malignant neoplasm of unspecified orbit

C69.61

Malignant neoplasm of right orbit

C69.62

Malignant neoplasm of left orbit

C69.90

Malignant neoplasm of unspecified site of unspecified eye

C69.91

Malignant neoplasm of unspecified site of right eye

C69.92

Malignant neoplasm of unspecified site of left eye

C78.00

Secondary malignant neoplasm of unspecified lung

C78.01

Secondary malignant neoplasm of right lung

C78.02

Secondary malignant neoplasm of left lung

C78.6

Secondary malignant neoplasm of retroperitoneum and peritoneum

C78.7

Secondary malignant neoplasm of liver and intrahepatic bile duct

C79.31

Secondary malignant neoplasm of brain

C79.51

Secondary malignant neoplasm of bone

C79.52

Secondary malignant neoplasm of bone marrow

C7A.1

Malignant poorly differentiated neuroendocrine tumors

C80.0

Disseminated malignant neoplasm, unspecified

C80.1

Malignant (primary) neoplasm, unspecified

Z85.038

Personal history of other malignant neoplasm of large intestine

Z85.068

Personal history of other malignant neoplasm of small intestine

Z85.118

Personal history of other malignant neoplasm of bronchus and lung

Z85.528

Personal history of other malignant neoplasm of kidney

Z85.820

Personal history of malignant melanoma of skin

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Articles may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/Article):

Jurisdiction(s): 15

NCD/LCD/Article Document (s): A57251

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID= A57251&bc=gAAAAAAAAAAAAA

Jurisdiction(s): J&M

NCD/LCD/Article Document (s): A56141

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A56141&bc=gAAAAAAAAAAA

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC