​

Last Review Date: 01/06/2025

Date of Origin: 01/01/2012

Dates Reviewed: 06/2012, 02/2013, 04/2014, 09/2014, 07/2015, 07/2016, 09/2016, 12/2016, 03/2017, 06/2017, 09/2017, 12/2017, 03/2018, 06/2018, 10/2018, 10/2019, 10/2020, 12/2020, 01/2021, 05/2021, 08/2021, 10/2022, 10/2023, 03/2024, 04/2024, 10/2024, 01/2025

1. Length of Authorization

• Initial: 6 months for moderate to severe persistent asthma, chronic spontaneous urticaria (CSU), IgE-mediated food allergy, and chronic rhinosinusitis with nasal polyps (CRSwNP); 12 months for all other indications
• Renewal: 12 months for all indications

2. Dosing Limits

    Max Units (per dose and over time) [HCPCS Unit]:

Moderate to Severe Persistent Asthma

• 75 billable units every 14 days

CRSwNP and IgE-Mediated Food Allergy

• 120 billable units every 14 days

All other indications

• 60 billable units every 28 days

3. Initial Approval Criteria

Target Agent(s) will be approved when ALL of the following are met:

1. ONE of the following
   1. The requested agent is eligible for continuation of therapy AND ONE of the following:

1. The patient has been treated with the requested agent (starting on samples is not approvable) OR
2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
3. BOTH of the following:
   1. ONE of the following:
      1. The patient has a diagnosis of moderate to severe persistent asthma AND ALL of the following:
         1. ONE of the following:
            1. The patient is 6 to less than 12 years of age AND BOTH of the following:
               1. The patient's pretreatment IgE level is 30 IU/mL to 1300 IU/mL AND
               2. The patient’s weight is 20 kg to 150 kg OR
            2. The patient is 12 years of age or over AND BOTH of the following:
               1. The patient's pretreatment IgE level is 30 IU/mL to 700 IU/mL AND
               2. The patient’s weight is 30 kg to 150 kg AND
         2. Allergic asthma has been confirmed by a positive skin test or in vitro reactivity test to a perennial aeroallergen AND
         3. The patient has a history of uncontrolled asthma while on asthma control therapy as demonstrated by ONE of the following:
            1. Frequent severe asthma exacerbations requiring two or more courses of systemic corticosteroids (steroid burst) within the past 12 months OR
            2. Serious asthma exacerbations requiring hospitalization, mechanical ventilation, or visit to the emergency room or urgent care within the past 12 months OR
            3. Controlled asthma that worsens when the doses of inhaled and/or systemic corticosteroids are tapered OR
            4. The patient has baseline (prior to therapy with the requested agent) Forced Expiratory Volume (FEV1) that is less than 80% of predicted OR
      2. The patient has a diagnosis of chronic spontaneous urticaria (CSU) (otherwise known as chronic idiopathic urticaria [CIU]) AND ALL of the following:
         1. The patient has had over 6 weeks of hives and itching AND
         2. If the patient is currently treated with medications known to cause or worsen urticaria, then ONE of the following:
            1. The prescriber has reduced the dose or discontinued any medications known to cause or worsen urticaria (e.g., NSAIDs) OR
            2. There is support that a reduced dose or discontinuation of any medication(s) known to cause or worsen urticaria is NOT appropriate AND
         3. ONE of the following:
            1. The patient has tried and had an inadequate response to the FDA labeled maximum dose of a second-generation H-1 antihistamine (e.g., cetirizine, levocetirizine, fexofenadine, loratadine, desloratadine) after at least a 2-week duration of therapy AND ONE of the following:
               1. The patient has tried and had an inadequate response to a dose titrated up to 4 times the FDA labeled maximum dose of a second-generation H-1 antihistamine OR
               2. There is support that the patient cannot be treated with a dose titrated up to 4 times the FDA labeled maximum dose of a second-generation H-1 antihistamine OR
            2. The patient has an intolerance or hypersensitivity to therapy with a second-generation H-1 antihistamine OR
            3. The patient has an FDA labeled contraindication to ALL second-generation H-1 antihistamines OR
      3. The patient has a diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) AND ALL of the following:
         1. BOTH of the following:
            1. The patient's pretreatment IgE level is 30 IU/mL to 1500 IU/mL AND
            2. The patient’s weight is 30 kg to 150 kg AND
         2. The patient has at least TWO of the following symptoms consistent with chronic rhinosinusitis (CRS): 
            1. Nasal discharge (rhinorrhea or post-nasal drainage) 
            2. Nasal obstruction or congestion
            3. Loss or decreased sense of smell (hyposmia)
            4. Facial pressure or pain AND

1. The patient has had symptoms consistent with chronic rhinosinusitis (CRS) for at least 12 consecutive weeks AND
2. The patient’s diagnosis was confirmed by ONE of the following:
   1. Anterior rhinoscopy or endoscopy OR
   2. Computed tomography (CT) of the sinuses AND
3. ONE of the following:
   1. The patient has tried and had an inadequate response to ONE intranasal corticosteroid therapy (e.g., fluticasone nasal spray, mometasone nasal spray, Sinuva) after at least a 4-week duration of therapy OR
   2. The patient has an intolerance or hypersensitivity to ONE intranasal corticosteroid therapy (e.g., fluticasone nasal spray, mometasone nasal spray, Sinuva) OR
   3. The patient has an FDA labeled contraindication to ALL intranasal corticosteroids OR
4. The patient has a diagnosis of IgE-mediated food allergy AND ALL of the following:
   1. BOTH of the following:
      1. The patient’s pretreatment IgE level is 30 IU/mL to 1850 IU/mL AND
      2. The patient’s weight is 10 kg to 150 kg AND
   2. The patient has a confirmed IgE-mediated food allergy confirmed by an allergy diagnostic test (e.g., skin prick test, serum specific IgE test, oral food challenge) AND
   3. The requested agent will NOT be used for the emergency treatment of allergic reactions, including anaphylaxis OR
5. The patient has another FDA labeled indication for the requested agent AND
6. If the patient has an FDA labeled indication, then ONE of the following:
   1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
   2. There is support for using the requested agent for the patient’s age for the requested indication OR
7. The patient has another indication that is supported in compendia for the requested agent AND
8. If the patient has a diagnosis of moderate to severe persistent asthma, then ALL of the following:
   1. ONE of the following:
      1. The patient is NOT currently treated with the requested agent AND is currently treated with a maximally tolerated inhaled corticosteroid for at least 3 months AND has been adherent for 90 days within the past 120 days OR
      2. The patient is currently treated with the requested agent AND ONE of the following:
         1. The patient is currently treated with an inhaled corticosteroid for at least 3 months that is adequately dosed to control symptoms AND has been adherent for 90 days within the past 120 days OR
         2. The patient is currently treated with a maximally tolerated inhaled corticosteroid for at least 3 months AND has been adherent for 90 days within the past 120 days OR
      3. The patient has an intolerance or hypersensitivity to therapy with an inhaled corticosteroid OR
      4. The patient has an FDA labeled contraindication to ALL inhaled corticosteroids AND
   2. ONE of the following:
      1. The patient is currently treated for at least 3 months AND has been adherent for 90 days within the past 120 days with ONE of the following:
         1. A long-acting beta-2 agonist (LABA) OR
         2. A long-acting muscarinic antagonist (LAMA) OR
         3. A Leukotriene receptor antagonist (LTRA) OR
         4. Theophylline OR
      2. The patient has an intolerance or hypersensitivity to therapy with a long-acting beta-2 agonist (LABA), a long-acting muscarinic antagonist (LAMA), a leukotriene receptor antagonist (LTRA), or theophylline OR
      3. The patient has an FDA labeled contraindication to ALL long-acting beta-2 agonists (LABA) AND long-acting muscarinic antagonists (LAMA) AND
   3. The patient will continue asthma control therapy (e.g., ICS, ICS/LABA, LTRA, LAMA, theophylline) in combination with the requested agent AND
   4. The requested dose is based on the patient’s pretreatment serum IgE level and body weight as defined in FDA labeling AND does NOT exceed 375 mg every 2 weeks AND
9. If the patient has a diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP), then ALL of the following:
   1. The patient is currently treated with standard nasal polyp maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids [e.g., fluticasone nasal spray, mometasone nasal spray, Sinuva]) AND
   2. The patient will continue standard nasal polyp maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids [e.g., fluticasone nasal spray, mometasone nasal spray, Sinuva]) in combination with the requested agent AND
   3. The requested dose is based on the patient’s pretreatment serum IgE level and body weight as defined in FDA labeling AND does NOT exceed 600 mg every 2 weeks AND
10. If the patient has a diagnosis of chronic spontaneous urticaria (CSU) (otherwise known as chronic idiopathic urticaria [CIU]), the requested dose is within FDA labeled dosing for the requested indication AND does NOT exceed 300 mg every 4 weeks AND
11. If the patient has a diagnosis of IgE-mediated food allergy, then ALL of the following:
    1. The patient will avoid known food allergens while treated with the requested agent AND
    2. The patient has epinephrine on hand for emergency treatment AND
    3. The requested dose is based on the patient’s pretreatment serum IgE level and body weight as defined in FDA labeling AND does NOT exceed 600 mg every 2 weeks AND
12. If the patient has another FDA labeled indication for the requested agent, the requested quantity (dose) is within FDA labeled dosing for the requested indication AND
13. If the patient has another indication that is supported in compendia for the requested agent, the requested quantity (dose) is supported in compendia for the requested indication AND
14. If the request is for Xolair vial, then ONE of the following:
    1. The patient has tried a self-administered Xolair product (reference table above) OR
    2. The patient has NOT yet received 3 doses of Xolair in the healthcare setting OR
    3. There is support that self-administration is NOT appropriate for the patient based on careful assessment of risk for anaphylaxis and mitigation strategies AND
15. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist, otolaryngologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
16. ONE of the following (Please refer to “Agents NOT to be used Concomitantly” table): 
    1. The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR
    2. The patient will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following:
       1. The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent AND
       2. There is support for the use of combination therapy (submitted copy of clinical trials, phase III studies, or guidelines required) AND
17. The patient does NOT have any FDA labeled contraindications to the requested agent

Compendia Allowed: AHFS, DrugDex 1 or 2a level of evidence, or NCCN 1 or 2a recommended use

4. Renewal Criteria

Target Agent(s) will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested agent through the plan’s Medical Drug Review process [Note: patients not previously approved for the requested agent will require initial evaluation review] AND
2. ONE of the following:
   1. The patient has a diagnosis of moderate to severe persistent asthma AND ALL of the following:
      1. The patient has had improvements or stabilization with the requested agent from baseline (prior to therapy with the requested agent) as indicated by ONE of the following:
         1. Increase in percent predicted Forced Expiratory Volume (FEV1) OR
         2. Decrease in the dose of inhaled corticosteroid required to control the patient’s asthma OR
         3. Decrease in need for treatment with systemic corticosteroids due to exacerbations of asthma OR
         4. Decrease in the number of hospitalizations, need for mechanical ventilation, or visits to the emergency room or urgent care due to exacerbations of asthma AND
      2. The patient is currently treated within the past 90 days and is compliant with asthma control therapy (e.g., inhaled corticosteroids [ICS], ICS/long-acting beta-2 agonist [ICS/LABA], leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonist [LAMA], theophylline) AND
      3. The requested dose is based on the patient’s pretreatment serum IgE level and body weight as defined in FDA labeling AND does NOT exceed 375 mg every 2 weeks OR
   2. The patient has a diagnosis of chronic spontaneous urticaria (CSU) (otherwise known as chronic idiopathic urticaria [CIU]) AND BOTH of the following:
      1. The patient has had clinical benefit with the requested agent AND
      2. The requested dose is within FDA labeled dosing for the requested indication AND does NOT exceed 300 mg every 4 weeks OR
   3. The patient has a diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) AND ALL of the following:
      1. The patient has had clinical benefit with the requested agent AND
      2. The patient will continue standard nasal polyp maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids [e.g., fluticasone nasal spray, mometasone nasal spray, Sinuva]) in combination with the requested agent AND
      3. The requested dose is based on the patient’s pretreatment serum IgE level and body weight as defined in FDA labeling AND does NOT exceed 600 mg every 2 weeks OR
   4. The patient has a diagnosis of IgE-mediated food allergy AND ALL of the following:
      1. The patient will avoid known food allergens while treated with the requested agent AND
      2. The patient has epinephrine on hand for emergency treatment AND
      3. The requested dose is based on the patient’s pretreatment serum IgE level and body weight as defined in FDA labeling AND does NOT exceed 600 mg every 2 weeks OR
   5. The patient has a diagnosis other than moderate to severe persistent asthma, CSU/CIU, CRSwNP, or IgE-mediated food allergy AND BOTH of the following:
      1. The patient has had clinical benefit with the requested agent AND
      2. The requested quantity (dose) is within FDA labeled dosing (or supported in compendia) for the requested indication AND
3. If the request is for Xolair vial, then ONE of the following:
   1. The patient has tried a self-administered Xolair product (reference table above) OR
   2. The patient has NOT yet received 3 doses of Xolair in the healthcare setting OR
   3. There is support that self-administration is NOT appropriate for the patient based on careful assessment of risk for anaphylaxis and mitigation strategies AND
4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist, otolaryngologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
5. ONE of the following (Please refer to “Agents NOT to be used Concomitantly” table): 
   1. The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR
   2. The patient will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following:
      1. The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent AND
      2. There is support for the use of combination therapy (submitted copy of clinical trials, phase III studies, or guidelines required) AND
6. The patient does NOT have any FDA labeled contraindications to the requested agent

Compendia Allowed: AHFS, DrugDex 1 or 2a level of evidence, or NCCN 1 or 2a recommended use

5. Dosage/Administration

6. Billing Code/Availability Information

HCPCS Code:

• J2357 – Injection, omalizumab, 5 mg; 1 billable unit = 5 mg

NDC:

• Xolair 75 mg single-dose prefilled syringe or autoinjector: 50242-0214-xx
• Xolair 150 mg single-dose prefilled syringe or autoinjector: 50242-0215-xx
• Xolair 150 mg single-dose vial powder for injection: 50242-0040-xx
• Xolair 300 mg single-dose prefilled syringe or autoinjector: 50242-0227-xx

7. References

1. Xolair [package insert]. South San Francisco, CA; Genentech, Inc.; February 2024. Accessed August 2024.
2. National Asthma Education and Prevention Program (NAEPP). Guidelines for the diagnosis and management of asthma. Expert Panel Report 3. Bethesda, MD: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI); August 2007.
3. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2022 Update. Available from: https://ginasthma.org/wp-content/uploads/2022/07/GINA-Main-Report-2022-FINAL-22-07-01-WMS.pdf. Accessed September 2023.
4. Baiardini I, Braido F, Bindslev-Jensen C, et al. Recommendations for assessing patient-reported outcomes and health-related quality of life in patients with urticaria: a GA (2) LEN taskforce position paper. Allergy. 2011 Jul;66(7):840-4. doi: 10.1111/j.1398-9995.2011.02580.x. Epub 2011 Mar 9.
5. Zuberbier T, Aberer W, Asero R, et al. EAACI/GA²LEN/EDF/WAO guideline for the Definition, Classification, Diagnosis and Management of Urticaria. The 2017 Revision and Update. Allergy. 2018 Jan 15. doi: 10.1111/all.13397.
6. Maurer M, Rosén K, Hsieh HJ, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med. 2013 Mar 7;368(10):924-35. doi: 10.1056/NEJMoa1215372. Epub 2013 Feb 24.
7. Siles RI, Hsieh FH. Allergy blood testing: A practical guide for clinicians. Cleve Clin J Med. 2011 Sep;78(9):585-92. doi: 10.3949/ccjm.78a.11023.
8. Bernstein JA, Lang DM, Khan DA, et al. The diagnosis and management of acute and chronic urticaria: 2014 update. J Allergy Clin Immunol. 2014 May;133(5):1270-7.
9. Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium^®) Omalizumab. National Comprehensive Cancer Network, 2024. 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 August 2024.
10. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Management of Immunotherapy-Related Toxicities 1.2024. National Comprehensive Cancer Network, 2024. 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 August 2024.
11. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Systemic Mastocytosis Version 3.2024. National Comprehensive Cancer Network, 2024. 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 August 2024.
12. Carter MC, Robyn JA, Bressler PB, Walker JC, Shapiro GG, Metcalfe DD. Omalizumab for the treatment of unprovoked anaphylaxis in patients with systemic mastocytosis. J Allergy Clin Immunol. 2007;119(6):1550-1551.
13. Slapnicar C, Trinkaus M, Hicks L, Vadas P. Efficacy of Omalizumab in Indolent Systemic Mastocytosis. Case Rep Hematol. 2019;2019:3787586. Published 2019 Sep 16.
14. Jendoubi, F, Gaudenzio, N, Gallini, A, et al. Omalizumab in the treatment of adult patients with mastocytosis: A systematic review. Clin Exp Allergy. 2020; 50: 654– 661.
15. Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol. 2001;108(2):184-190.
16. Solèr M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Respir J. 2001;18(2):254-261.
17. Lanier B, Bridges T, Kulus M, et al. Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma. J Allergy Clin Immunol. 2009;124(6):1210-1216.
18. Milgrom H, Berger W, Nayak A, et al. Treatment of childhood asthma with anti-immunoglobulin E antibody (omalizumab). Pediatrics. 2001;108(2):E36.
19. Saini SS, Bindslev-Jensen C, Maurer M, et al. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study. J Invest Dermatol. 2015;135(1):67-75.
20. Holguin F, Cardet JC, Chung KF, et al. Management of severe asthma: a European

Respiratory Society/American Thoracic Society guideline. Eur Respir J 2020; 55: 1900588 [https://doi.org/10.1183/13993003.00588-2019].

21. Gevaert P, Omachi TA, Corren J, et al. Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials. J Allergy Clin Immunol. 2020 Sep;146(3):595-605. doi: 10.1016/j.jaci.2020.05.032. Epub 2020 Jun 7.
22. Fokkens WJ, Lund V, Bachert C, et al. EUFOREA consensus on biologics for CRSwNP with or without asthma. Allergy. 2019;74(12):2312–2319. doi:10.1111/all.13875.
23. Gandhi NA, Bennett BL, Graham NMH, et al. Targeting key proximal drivers of type 2 inflammation in disease. Nat Rev Drug Discov. 2016;15(1):35-50.
24. ASCIA Chronic Spontaneous Urticaria (CSU) Position Paper and Treatment Guidelines; updated July 2020. Available at: https://www.allergy.org.au/hp/papers/chronic-spontaneous-urticaria-csu-guidelines.
25. National Asthma Education and Prevention Program (NAEPP). 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. Bethesda, MD: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI); December 2020.
26. Fokkens WJ, Viskens AS, Backer V, et. al. EPOS/EUFOREA update on indication and evaluation of Biologics in Chronic Rhinosinusitis with Nasal Polyps 2023. Rhinology 2023; 61:194.
27. Rank MA, Chu DK, Bognanni A, et al. The Joint Task Force on Practice Parameters GRADE guidelines for the medical management of chronic rhinosinusitis with nasal polyposis. J Allergy Clin Immunol 2023; 151:386.
28. Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2022 Mar;77(3):734-766. doi: 10.1111/all.15090. Epub 2021 Oct 20.
29. Global Initiative for Asthma (GINA) Report: Global Strategy for Asthma Management and Prevention. 2023 Update. Available from: http://www.ginasthma.org/2023-gina-main-report. Accessed September 2023.
30. Wood RA, Chinthrajah RS, Rudman Spergel AK, et al; OUtMATCH study team. Protocol design and synopsis: Omalizumab as Monotherapy and as Adjunct Therapy to Multiallergen OIT in Children and Adults with Food Allergy (OUtMATCH). J Allergy Clin Immunol Glob. 2022 Jul 21;1(4):225-232. doi: 10.1016/j.jacig.2022.05.006. PMID: 37779534; PMCID: PMC10509974.
31. Muraro A, de Silva D, Halken S, et al. GA2LEN Food Allergy Guideline Group; GALEN Food Allergy Guideline Group. Managing food allergy: GA2LEN guideline 2022. World Allergy Organ J. 2022 Sep 7;15(9):100687. doi: 10.1016/j.waojou.2022.100687. PMID: 36119657; PMCID: PMC9467869.
32. Santos AF, Riggioni C, Agache I, et al. EAACI guidelines on the diagnosis of IgE-mediated food allergy. Allergy. 2023 Dec;78(12):3057-3076. doi: 10.1111/all.15902. Epub 2023 Oct 10. PMID: 37815205.
33. National Government Services, Inc. Local Coverage Article: Billing and Coding: Omalizumab (A52448). Centers for Medicare & Medicare Services. Updated on 03/04/2022 with effective dates 03/10/2022. Accessed August 2024.

Appendix 1 – Covered Diagnosis Codes

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

The preceding information is intended for non-Medicare coverage determinations. 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 Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.