Medical Policy                                                                                                                                                                       

Policy Num:       M5.001.014
Policy Name:     Immune Globulin
Policy ID:          [M5.001.014] [Ac / MA / M+ / P+]  [L34007]

Last Review:       May 10, 2024
Next Review:      May 20, 2025
 

Medicare Policies: 

LCD 34007

Immune Globulin

Summary

Immune globulin (also referred to as gamma globulin or immunoglobulin) is a therapeutic compound prepared from pools of plasma obtained from several thousand healthy blood donors that contains antibodies to a wide spectrum of antigens. Immune globulin has been utilized for immune deficiencies identified in individuals with inherited or acquired immunodeficiencies and is used for its capacity in combating infection as a replacement therapy and for its anti-inflammatory and immunomodulating effects. The appropriate use of immune globulin can decrease morbidity and mortality and improve quality of life.^1,2
 

OBJECTIVE

The focus of this policy is the United States (U.S.) Food and Drug Administration (FDA) approved indications and the off-label indications for immune globulin where the evidence supports such use. Immune globulin products are not generic drugs and products are not interchangeable. A specific product needs to be matched to patient characteristics to ensure patient safety and a change of product should occur only with the active participation of the prescribing provider.³

The overall coverage of drugs is addressed in the CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Sections 50.4.1 and 50.4.2 and includes coverage for FDA-approved drugs and unlabeled use of a drug.

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY

Immune globulin products will be considered medically reasonable and necessary when administered for treatment of FDA-labeled indications (https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/immune-globulins⁴).

Off-label indications for intravenous immune globulin (IVIG) products will be considered medically reasonable and necessary in the following situations:

1. Multiple myeloma for recurrent infections with hypogammaglobulinemia and subprotective antibody levels following immunization against diphtheria, tetanus or pneumococcal infection^1,3,5-7
2. Following treatment of lymphoma utilizing B-cell depleting therapies for recurrent infections with hypogammaglobulinemia and subprotective antibody levels following immunization against diphtheria, tetanus or pneumococcal infection³
3. Recipients of hematopoietic stem cell transplants with severe combined immunodeficiency (SCID) or other primary immunodeficiencies who are functionally agammaglobulinemic because of weak B-cell engraftment³
4. Recipients of allogeneic hematopoietic stem cell transplantation with chronic graft versus host disease (GVHD), recurring bacterial infections, and subprotective antibody levels following immunization against diphtheria, tetanus or pneumococcal infection³
5. Human Leukocyte Antigen (HLA) and ABO desensitization protocols for the prevention of acute humoral rejection in renal transplantation³
6. The treatment of antibody mediated solid organ transplant rejection in combination with rituximab and plasma exchange (PE)^3,8
7. Treatment of hypogammaglobulinemia in solid organ transplants³
8. Autoimmune hemolytic anemia (AIHA) when other treatment approaches have failed^9-10
9. Systemic capillary leak syndrome (SCLS)^11-13
10. Guillain-Barré syndrome (GBS) in adults^1,3,14-15
11. Moderate to severe myasthenia gravis (MG)^2-3,10,15-18
12. Lambert-Eaton myasthenic syndrome (LEMS) in individuals who fail to respond or do not tolerate other treatments³
13. Relapsing-remitting multiple sclerosis (MS)^3,19-22
14. Neuromyelitis optica (Devic syndrome) in individuals with severe relapses not responding to corticosteroids and who are not candidates for PE³
15. Stiff-person syndrome (also referred to as stiff-man syndrome)^2-3
16. Treatment of autoimmune encephalitis, once infection is ruled out, as an alternative in patients who fail to respond or do not tolerate other treatments^23-27
17. Treatment of Susac syndrome in combination with high-dose intravenous corticosteroids²⁸
18. Severe forms of polymyositis resistant to treatment with glucocorticosteroids and immunosuppressants^29-30
19. Severe forms of inclusion body myositis with dysphagia and individuals are otherwise treatment-resistant^3,29-33
20. Immune mediated necrotizing myopathy resistant to treatment with glucocorticosteroids and immunosuppressants^29-30
21. Overlap syndrome with myositis including anti-synthetase syndrome resistant to treatment with glucocorticosteroids and immunosuppressants^29-30
22. Severe systemic lupus erythematosus (SLE) in individuals who fail to respond or do not tolerate other treatments^10,30
23. Biopsy-proven autoimmune mucocutaneous blistering diseases in individuals who fail to respond or do not tolerate other treatments and individuals with rapidly progressive disease requiring a faster response than conventional therapy (i.e., pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid and epidermolysis bullosa acquisita)^3,30,34-39
24. Toxic epidermal necrolysis (TEN)^3,30
25. Stevens-Johnson syndrome^3,30
26. Severe scleromyxedema^3,30,40-41
27. Thyroid eye disease, also referred to as Graves’ disease in patients who have failed treatment with teprotumumab or have contraindications to the use of teprotumumab^3,42-45

Limitations

The following are considered not medically reasonable and necessary:

1. The off-label use of subcutaneous immune globulin
2. The off-label use of intravenous immune globulin not listed above in the covered indications

AND

Immune globulin for the following:

3. Routine use in the immediate peri-transplantation period for the prevention of infection or GVHD following marrow or peripheral blood allogeneic transplantation^3,46
4. Acute GVHD with hematopoietic stem cell transplantation in the immediate post-transplantation phase³
5. Hematopoietic stem cell transplantation in the immediate post-transplantation phase with a history of sinusoidal obstructive syndrome^3,46
6. Cord blood stem cell transplantation for children or adults³
7. Polyneuropathy associated with IgM monoclonal gammopathy¹⁰
8. Idiopathic neuropathies¹⁰
9. Brachial plexopathy¹⁰
10. Adrenoleukodystrophy¹⁰
11. Amyotrophic lateral sclerosis¹⁰
12. Critical illness polyneuropathy¹⁰
13. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes)¹⁰

BENEFIT APPLICATION

REGULATORY STATUS

LCD L34007 Immune Globulin

IOM Citations:

• CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
  • Chapter 1, Section 30 Drugs and Biologicals
  • Chapter 15, Section 50 Drugs and Biologicals and Section 60 Services and Supplies
• CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual,
  • Chapter 1, Part 4, Section 250.3 Intravenous Immune Globulin for the Treatment of Autoimmune Mucocutaneous Blistering Diseases
• CMS IOM Publication 100-04, Medicare Claims Processing Manual,
  • Chapter 17, Section 40 Discarded Drugs and Biologicals, Section 80.6 Intravenous Immune Globulin and Section 90.2 Drugs, Biologicals, and Radiopharmaceuticals
• CMS IOM Publication 100-08, Medicare Program Integrity Manual,
  • Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

• Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.
• Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment may be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
• Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

SUPPLEMENTAL INFORMATION

This Billing and Coding Article provides billing and coding guidance for Local Coverage Determination (LCD) L34007 (Immune Globulin). Please refer to the LCD for reasonable and necessary requirements.

Coding Guidance

Notice: It is not appropriate to bill Medicare for services that are not covered (as described by the entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.

The use of the JA and JB modifiers is required for drugs which have one HCPCS Level II (J or Q) code but multiple routes of administration. Drugs that fall under this category must be billed with the JA modifier for the intravenous infusion of the drug or billed with the JB modifier for the subcutaneous injection of the drug.

HCPCS codes J1561 and J1569 must be billed with either modifier JA for the intravenous formulation or modifier JB for the subcutaneous formulation.

Not Otherwise Classified (NOC) Drug Billing

Office/Clinic

Providers submit NOC codes (e.g., J1599) in the 2400/SV101-2 data element in the 5010 professional claim transaction (837P). When billing an NOC code, providers are required to provide a description in the 2400/SV101-7 data element. The 5010 TR3 Implementation Guide instructs: "Use SV101-7 to describe non-specific procedure codes." (Do not use the 2400 NTE segment to describe non-specific procedure codes with 5010). The SV101-7 data element allows for 80 bytes (i.e., characters, including spaces) of information.

In order for the A/B MAC to correctly reimburse NOC drugs and biologicals, providers must indicate the following in the 2400/SV101-7 data element, or Item 19 of the CMS 1500 form:

• The name of the drug,
• The total dosage (plus strength of dosage, if appropriate), and
• The method of administration.

Important: List one unit of service in the 2400/SV1-04 data element or in item 24G of the CMS 1500 form. Do not quantity-bill NOC drugs and biologicals even if multiple units are provided. Medicare determines the proper payment of NOC drugs and biologicals by the narrative information, not the number of units billed.

Claims for NOC drugs and biologicals will reject as unprocessable if any of the information listed above is missing, or if the NOC code is billed with more than one unit of service. (Note: The remittance notice will include remark code M123, "Missing/incomplete/invalid name, strength, or dosage of the drug furnished," even if the rejection is due to the number of units billed).

Ambulatory Surgical Centers (ASCs) and Hospital Outpatient Departments

HCPCS code C9399, Unclassified drug or biological, should be used for new drugs and biologicals that are approved by the United States (U.S.) Food and Drug Administration (FDA) on or after January 1, 2004, for which a specific HCPCS code has not been assigned.

Drug Wastage

When billing for Part B drugs and biologicals (except those provided under a competitive acquisition program [CAP]), the use of the JW modifier to identify unused drugs or biologicals from single use vials or single use packages that are appropriately discarded is required. The discarded amount shall be billed on a separate claim line using the JW modifier. Providers are required to document the discarded drug or biological in the patient’s medical record.

Any amount wasted must be clearly documented in the medical record and should include the date and time, amount of medication wasted, and the reason for the wastage.

The use of the JZ modifier (attesting that there were no discarded amounts) is required on claims to report there are no discarded amounts of unused drugs or biologicals from single use vials or single use packages.

Claims for drugs separately payable under Medicare Part B from single-dose containers are required to report either the JW or JZ modifier, to identify any discarded amounts or to attest that there are no discarded amounts, respectively.

• The JW and JZ modifier policy does not apply for drugs that are not separately payable, such as packaged OPPS or ASC drugs, or drugs administered in the FQHC or RHC setting.
• The JW and JZ modifiers do not apply to drugs assigned status indicator N (Items and Services Packaged into APC Rates) under the OPPS. Similarly, the JW and JZ modifiers do not apply to drugs assigned payment indicator “N1” (ASC).

Documentation Requirements

• 1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
  2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
  3. The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
  4. The medical record documentation must support the medical necessity of the services as stated in the LCD.
  5. The information contained in the medical record should include all relevant diagnostic laboratory studies, prior history of bleeding, infection, disease progression, prior medical/surgical therapies, vaccination response, and any other information essential in establishing that the patient meets the coverage indications as set forth in the NCD and LCD.
  6. An accurate weight in kilograms should be documented prior to the infusion since the dosage is based on mg/kg/dosage.

Practice Guidelines and Position Statements

N/A

Medicare Coverage

Medicare LCD 34007

This policy supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for immune globulin services. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this policy. Neither Medicare payment policy rules nor this policy replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for immune globulin services and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.
 

References

1. Perez EE. Immunoglobulin Use in Immune Deficiency and Autoimmune Disease States. Am J Manag Care.2019;25:S92-S97.
2. Lünemann JD, Quast I, Dalakas MC. Efficacy of Intravenous Immunoglobulin in Neurological Diseases. Neurotherapeutics. 2016;13:34-46. doi:10.1007/s13311-015-0391-5.
3. Perez EE, Orange JS, Bonilla F, et al. Update on the use of immunoglobulin in human disease: A review of evidence. J Allergy Clin Immunol. 2017;139:S1-S46. doi:10.1016/j.jaci.2016.09.023.
4. U.S. Food & Drug Administration. Immune Globulins, Immune Globulin Intravenous (Human). https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/immune-globulins. Updated July 1, 2020. Accessed November 24, 2020.
5. Raanani P, Gafter-Gvili A, Paul M, Ben-Bassat I, Leibovici L, Shpilberg O. Immunoglobulin prophylaxis in hematopoietic stem cell transplantation: systematic review and meta-analysis. J Clin Oncol. 2009;27(5):770-81. doi:10.1200/JCO.2008.16.8450.
6. Blimark C, Holmberg E, Mellqvist UH, et al. Multiple myeloma and infections: a population-based study on 9253 multiple myeloma patients. Haematologica. 2015;100(1):107-13. doi:10.3324/haematol.2014.107714.
7. Khalafallah A, Maiwald M, Cox A, et al. Effect of immunoglobulin therapy on the rate of infections in multiple myeloma patients undergoing autologous stem cell transplantation or treated with immunomodulatory agents. Mediterr J Hematol Infect Dis. 2010;2(1):e2010005. doi:10.4084/MJHID.2010.005.
8. Thurman JM, Panzer SE, Le Quintrec M. The role of complement in antibody mediated transplant rejection. Mol Immunol. 2019;112:240-246. doi:10.1016/j.molimm.2019.06.002.
9. Zanella A, Barcellini W. Treatment of autoimmune hemolytic anemias. Haematologica. 2014;99(10):1547-1554.
10. Perez EE, Orange JS, Bonilla F, et al. Update on the use of immunoglobulin in human disease: A review of evidence. J Allergy Clin Immunol. 2016; 139(3):S1-46. http://dx.doi.org/10.1016/j.jaci.2016.09.023. Accessed October 6, 2020.
11. Eo TS, Chun KJ, Hong SJ, et al. Clinical Presentation, Management, and Prognostic Factors of Idiopathic Systemic Capillary Leak Syndrome: A Systematic Review. J Allergy Clin Immunol Pract. 2018;6(2):609-618. doi:10.1016/j.jaip.2017.07.021.
12. Druey KM, Parikh SM. Idiopathic Systemic Capillary Leak Syndrome (Clarkson disease). J Allergy Clin Immunol. 2017;140(3):663-670. doi:10.1016/j.jaci.2016.10.042.
13. Xie Z, Chan E, Long LM, Nelson C, Druey KM. High dose intravenous immunoglobulin therapy of the Systemic Capillary Leak Syndrome (Clarkson disease). Am J Med. 2015;128(1):91-95. doi:10.1016/j.amjmed.2014.08.015.
14. Hughes RAC, Swan AV, van Doorn PA. Intravenous immunoglobulin for Guillain-Barré syndrome. Cochrane Database of Systematic Reviews. 2014, Issue 9. Art. No.: CD002063. doi:10.1002/14651858.CD002063.pub6.
15. Patwa HS, Chaudhry V, Katzberg H, Rae-Grant AD, So YT. Evidence-based guideline: intravenous immunoglobulin in the treatment of neuromuscular disorders: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2012;78(13):1009-15. doi:10.1212/WNL.0b013e31824de293.
16. Gajdos P, Chevret S, Toyka KV. Intravenous immunoglobulin for myasthenia gravis. Cochrane Database of Systematic Reviews. 2012, Issue 12. Art. No.: CD002277. doi:10.1002/14651858.CD002277.pub4.
17. Sanders DB, Wolfe GI, Benatar M, et al. International consensus guidance for management of myasthenia gravis: Executive summary. Neurology. 2016;87(4):419-25. doi:10.1212/WNL.0000000000002790.
18. Wang S, Breskovska I, Gandhy S, Punga AR, Guptill JT, Kaminski HJ. Advances in autoimmune myasthenia gravis management. Expert Rev Neurother. 2018;18(7):573-588. doi:10.1080/14737175.2018.1491310.
19. Costello J, Njue A, Lyall M, et al. Efficacy, safety, and quality-of-life of treatments for acute relapses of multiple sclerosis: results from a literature review of randomized controlled trials. Degener Neurol Neuromuscul Dis. 2019;9:55-78. doi:10.2147/DNND.S208815.
20. Ruggieri S, Tortorella C, Gasperini C. Pharmacology and clinical efficacy of dimethyl fumarate (BG-12) for treatment of relapsing-remitting multiple sclerosis. Ther Clin Risk Manag. 2014;10:229-39. doi:10.2147/TCRM.S53285.
21. Berkovich R. Treatment of acute relapses in multiple sclerosis. Neurotherapeutics. 2013;10(1):97-105. doi:10.1007/s13311-012-0160-7.
22. Saguil A, Kane S, Farnell E. Multiple sclerosis: a primary care perspective. Am Fam Physician. 2014;90(9):644-52.
23. Abboud H, Probasco JC, Irani S, et al. Autoimmune encephalitis: proposed best practice recommendations for diagnosis and acute management. J Neurol Neurosurg Psychiatry. 2021;92(7):757-768. doi:10.1136/jnnp-2020-325300.
24. Uy CE, Binks S, Irani SR. Autoimmune encephalitis: clinical spectrum and management. Pract Neurol. 2021;21(5):412-423. doi:10.1136/practneurol-2020-002567.
25. Dalmau J, Graus F. Antibody-Mediated Encephalitis. NEJM. 2018;378:840-51. doi:10.1056/NEJMra1708712.
26. Azizi S, Vadlamuri DL, Cannizzaro LA. Treatment of Anti-GAD65 Autoimmune Encephalitis With Methylprednisolone. Ochsner J. 2021;21(3):312-315. doi:10.31486/toj.20.0096.
27. Sharma A, Dubey D, Sawhney A, Janga K. GAD65 Positive Autoimmune Limbic Encephalitis: A Case Report and Review of Literature. J Clin Med Res. 2012;4(6):424-428. doi:10.4021/jocmr1080w.
28. Pereira S, Vieira B, Maio T, Moreira J, Sampaio F. Susac's Syndrome: An Updated Review. Neuroophthalmology. 2020;44(6):355-360. doi:10.1080/01658107.2020.1748062.
29. Schmidt, J. Current Classification and Management of Inflammatory Myopathies. J Neuromuscul Dis. 2018;109-129. doi:10.3233/JND-180308.
30. Enk AH, Hadaschik EN, Eming R, et al. European Guidelines (S1) on the use of high-dose intravenous immunoglobulin in dermatology. J Eur Acad Dermatol Venereol. 2016;30(10):1657-1669. doi:10.1111/jdv.13725.
31. Machado P, Brady S, Hanna MG. Update in inclusion body myositis. Curr Opin Rheumatol. 2013;25:763-771. doi:10.1097/01.bor.0000434671.77891.9a.
32. Naddaf, E, Barohn RJ, Dimachkie MM. Inclusion Body Myositis: Update on Pathogenesis and Treatment. Neurotherapeutics. 2018;15:995-1005. https://doi.org/10.1007/s13311-018-0658-8. Accessed October 4, 2020.
33. Barsotti S, Lundberg IE. Current Treatment for Myositis. Curr Treat Options in Rheum. 2018;4:299-315. doi:10.1007/s40674-018-0106-2.
34. Czernik A. Intravenous immunoglobulin G in the treatment of autoimmune bullous disease. Clin Exp Immunol. 2014;178 Suppl 1(Suppl 1):118-9. doi:10.1111/cei.12535.
35. Kasperkiewicz M, Ellebrecht CT, Takahashi H, et al. Pemphigus. Nat Rev Dis Primers. 2017;3:17026. doi:10.1038/nrdp.2017.26.
36. Maruta CW, Miyamoto D, Aoki V, Carvalho RGR, Cunha BM, Santi CG. Paraneoplastic pemphigus: a clinical, laboratorial, and therapeutic overview. An Bras Dermatol. 2019;94(4):388-98. doi:http://dx.doi.org/10.1590/abd1806-4841.20199165. Accessed October 2, 2020.
37. Porro AM, Filho GH, Santi CG. Consensus on the treatment of autoimmune bullous dermatoses: pemphigus vulgaris and pemphigus foliaceus–Brazilian Society of Dermatology. An Bras Dermatol. 2019;94(2 Suppl 1):S20-32. doi:http://dx.doi.org/10.1590/abd1806-4841.2019940206. Accessed December 1, 2020.
38. Schmidt E, Zillikens D. The diagnosis and treatment of autoimmune blistering skin diseases. Dtsch Arztebl Int. 2011;108(23): 399–405. doi:10.3238/arztebl.2011.0399.
39. Santi CG, Gripp AC, Roselino AM, et al. Consensus on the treatment of autoimmune bullous dermatoses: bullous pemphigoid, mucous membrane pemphigoid and epidermolysis bullosa acquisita – Brazilian Society of Dermatology. An Bras Dermatol. 2019;94(2 Suppl 1):33-47. doi:http://dx.doi.org/10.1590/abd1806-4841.2019940207. Accessed November 29, 2020.
40. Hoffmann JHO, Enk AH. High-Dose Intravenous Immunoglobulin in Skin Autoimmune Disease. Front Immunol. 2019;10:1090. doi:10.3389/fimmu.2019.01090.
41. Knobler R, Moinzadeh P, Hunzelmann N, et al. European dermatology forum S1-guideline on the diagnosis and treatment of sclerosing diseases of the skin, Part 2: Scleromyxedema, scleredema and nephrogenic systemic fibrosis. J Eur Acad Dermatol Venereol. 2017;31(10):1581-1594. doi:10.1111/jdv.14466.
42. U.S. Food & Drug Administration. FDA Label, Tepezza (teprotumumab-trbw). https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761143s014lbl.pdf. Updated October 2021. Accessed May 17, 2022.
43. Douglas RS, Kahaly GJ, Patel A, et al. Teprotumumab for the Treatment of Active Thyroid Eye Disease. N Engl J Med. 2020;382:341-52. doi:10.1056/NEJMoa1910434.
44. Douglas RS, Kahaly GJ, Ugradar S, et al. Teprotumumab Efficacy, Safety, and Durability in Longer-Duration Thyroid Eye Disease and Re-treatment: OPTIC-X Study. Ophthalmology. 2022;129(4):438-449. doi:10.1016/j.ophtha.2021.10.017.
45. Winn BJ, Kersten RC. Teprotumumab: Interpreting the Clinical Trials in the Context of Thyroid Eye Disease Pathogenesis and Current Therapies. Ophthalmology. 2021;128(11):1627-1651. doi:10.1016/j.ophtha.2021.04.024.
46. Bhella S, Majhail NS, Betcher J, et al. Choosing Wisely BMT: American Society for Blood and Marrow Transplantation and Canadian Blood and Marrow Transplant Group's List of 5 Tests and Treatments to Question in Blood and Marrow Transplantation. Biol Blood Marrow Transplant. 2018;24(5):909-913. doi:10.1016/j.bbmt.2018.01.017.
47. Ueda M, Berger M, Gale RP, Lazarus HM. Immunoglobulin therapy in hematologic neoplasms and after hematopoietic cell transplantation. Blood Rev. 2018;32(2):106-115. doi:10.1016/j.blre.2017.09.003.
48. Aluri J, Desai M, Gupta M, et al. Clinical, Immunological, and Molecular Findings in 57 Patients With Severe Combined Immunodeficiency (SCID) From India. Front Immunol. 2019;10:23. doi:10.3389/fimmu.2019.00023.
49. Pai SY, Logan BR, Griffith LM, et al. Transplantation outcomes for severe combined immunodeficiency, 2000-2009. N Engl J Med. 2014;371(5):434-46. doi:10.1056/NEJMoa1401177.
50. Ghafoor A, Joseph SM. Making a Diagnosis of Common Variable Immunodeficiency: A Review. Cureus. 2020;12(1):e6711. doi:10.7759/cureus.6711.
51. Bonilla FA, Khan DA, Ballas ZK, et al. Joint Task Force on Practice Parameters, representing the American Academy of Allergy, Asthma & Immunology; the American College of Allergy, Asthma & Immunology; and the Joint Council of Allergy, Asthma & Immunology. Practice parameter for the diagnosis and management of primary immunodeficiency. J Allergy Clin Immunol. 2015;136(5):1186-205.e1-78. doi:10.1016/j.jaci.2015.04.049.
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53. Huang LC, Myer L, Jaspan HB. The role of polyclonal intravenous immunoglobulin in treating HIV-infected children with severe bacterial infections: A retrospective cohort study. BMC Infectious Diseases. 2008;8:127. doi:10.1186/1471-2334-8-127.
54. Agarwal S, Agrawal DK. Kawasaki Disease: Etiopathogenesis and Novel Treatment Strategies. Expert Rev Clin Immunol. 2017;13(3): 247–258. doi:10.1080/1744666X.2017.1232165.
55. Samson M, Fraser W, Lebowitz D. Treatments for Primary Immune Thrombocytopenia: A Review. Cureus. 2019;11(10): e5849. doi:10.7759/cureus.5849.
56. Bunschoten C, Jacobs BC, Van den Bergh PYK, Cornblath DR, van Doorn PA. Progress in diagnosis and treatment of chronic inflammatory demyelinating polyradiculoneuropathy. Lancet Neurol. 2019;18(8):784-794. doi:10.1016/S1474-4422(19)30144-9.
57. Oaklander AL, Lunn MP, Hughes RA, van Schaik IN, Frost C, Chalk CH. Treatments for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP): an overview of systematic reviews. Cochrane Database Syst Rev. 2017;1(1):CD010369. doi:10.1002/14651858.
58. Ryan M, Ryan SJ. Chronic inflammatory demyelinating polyneuropathy: considerations for diagnosis, management, and population health. Am J Manag Care. 2018;24(17 Suppl):S371-S379.
59. Umapathi T, Hughes RAC, Nobile-Orazio E, Léger JM. Immunosuppressant and immunomodulatory treatments for multifocal motor neuropathy. Cochrane Database of Systematic Reviews. 2015, Issue 3. Art. No.: CD003217. doi:10.1002/14651858.CD003217.pub5.
60. Lawson VH, Arnold WD. Multifocal motor neuropathy: a review of pathogenesis, diagnosis, and treatment. Neuropsychiatr Dis Treat. 2014;10:567-76. doi:10.2147/NDT.S39592.
61. Kaveri SV, Maddur, MS, Hegde P, Lacroix-Desmazes S, Bayry J. Intravenous immunoglobulins in immunodeficiencies: more than mere replacement therapy. Clin Exp Immunol. 2011;164(Suppl 2):2-5. doi:10.1111/j.1365-2249.2011.04387.x.

Codes

Applicable Modifiers

Policy History