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Coverage criteria policies

Immune Globulin Therapy

These services may or may not be covered by all HealthPartners plans. Please see your plan documents for your own coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Immune globulin requires prior authorization from Pharmacy Administration. The setting of drug administration will be reviewed as part of the prior authorization.

Note:

For all inquiries, transfer to the Medical Injectable Line (ext 26135).

Coverage

Immune globulin therapy is generally covered when medically necessary and per your plan documents.

Immune globulin is considered medically necessary for members when all of the following criteria are met:

  1. The member has one of the diagnoses listed below under “covered diagnoses”; and,
  2. For commercial products only (does not apply to Medicare or Minnesota Health Care Programs products), medication administration must occur at a clinic office or home-infusion setting unless medical necessity is met based on the criteria below, supported by medical documentation:
    1. The patient has experienced a severe or life-threatening reaction with previous infusions of the same or similar products; or,
    2. The patient has a medical condition that renders him or her unstable, exceptionally complex, immunocompromised or otherwise high-risk such that continued oversight in the current facility is required; or,
    3. There are no alternative settings available to the patient as a result of both of the following:
      1. The patient is unable to use home-infusion services as documented by the physician, social worker, or infusion provider; and,
      2. The patient is unable to access alternative settings due to unreasonable distance [>30 miles] or other extenuating circumstances.

Initial approvals will be for up to twelve months.

Annual reauthorizations will require medical chart documentation that the patient has been seen within the past 12 months and that markers of disease are improved by therapy.

Covered Diagnoses:

Immunologic diagnoses
  1. Primary immunodeficiencies including:
    1. B-cell deficiencies including: common variable immune deficiency, X-linked immunodeficiency, and Hyper-IgM syndromes
    2. Severe combined immunodeficiencies (SCID)
    3. Wiskott-Aldrich syndrome
    4. Congenital agammaglobulinemia
  2. Secondary immunodeficiencies including:
    1. Acquired hypogammagloulin conditions including B-cell chronic lymphocytic leukemia and multiple myeloma
    2. Prevention of acute graft versus host disease (GVHD) after transplantation
    3. Prevention of infection in transplant recipients (e.g., solid organ, stem cell, bone marrow)
Neurologic diagnoses
  1. Chronic inflammatory demyelination polyneuritis (CIDP)
  2. Myasthenia gravis
  3. Lambert-Eaton myasthenic syndrome
  4. Guillian-Barre syndrome
  5. Multifocal motor neuropathy
Other diagnoses
  1. Acute and chronic immune-medicated (idiopathic) thrombocytopenia purpura (ITP)
  2. HIV-associate thrombocytopenia
  3. Kawasaki disease when used in combination with aspirin
  4. Dermatomyositis and polymyositis when first-line oral agents have failed or are contraindicated
  5. Pemphigus when corticosteroids have failed or are contraindicated

Use of immune globulin for all other diagnoses requires review for medical necessity.

Definitions

Immune globulin therapy provides antibodies against a wide variety of bacterial and viral antigens. It is prepared from human blood plasma.

Setting: The type of physical site where the drug is provided. Settings include inpatient hospital, outpatient hospital, clinic office, or home-infusion.

  • Outpatient Hospital sites have physicians and practitioners on-site and are the appropriate site to manage unstable patients and patients experiencing certain moderate to severe adverse events. Hospital settings are typically the highest-cost, most-intensive, and are the highest level settings.
  • Clinic offices are lower level settings which are not outpatient hospital settings that can manage some unstable patients and patients experiencing adverse events. Physicians may or may not be readily available.
  • Home-infusion is a lower level setting, and is performed by a licensed nurse supported by a licensed pharmacy who have expertise in administering complex medications in a patient’s home. Home infusion providers regularly manage mild to moderate adverse events, and are prepared to manage severe adverse events if needed.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

Code

Description

Preparation

NDC Codes

90283

Immune Globulin (IgIV) human, for intravenous use (Code price is per 500 mg) for CPT billing requirements only

Bivigam

59730650301
59730650201

Carimune NF

44206041812
44206041706

Flebogamma DIF

61953000400

61953000401
61953000402
61953000403

61953000404
61953000405

61953000406

61953000407

61953000408

61953000409
61953000501
61953000502
61953000503

61953000504

61953000505

61953000506

Gammagard

00944270002
00944270003
00944270004
00944270005
00944270006
00944270007

Gammagard S/D

00944265804

00944265603

Gammaked

76125090001
76125090010
76125090025
76125090020
76125090050

Gammaplex

64208823501

64208823502

64208823503

64208823505

64208823506

64208823507

64208823402
64208823403

64208823404

64208823406

64208823407

64208823408

Gamunex-C

13533080012

13533080013

13533080015

13533080016
13533080020

13533080021

13533080024

13533080025

13530080040

13533080041
13533080071

13533080072

Octagam

68209084301

68209084302

68209084303

68209084304

67467084301

67467084302

67467084303

67467084304

67467084305

68982084001

68982084002

68982084003

68982084004

68982085001

68982085002

68982085003

68982085004

68982084005

Privigen

44206043710
44206043820

44206043940
44206043605

90284

Immune Globulin (SCIg), human, for use in subcutaneous infusions, 100 mg, each for CPT billing requirements only

Gammagard

00944270002

00944270003

00944270004

00944270005

00944270006

00944270007

Gammagard S/D

00944265804

00944262603

Gammaked

76125090001
76125090010
76125090025
76125090020
76125090050

Gamunex-C

13533080012

13533080013

13533080015

13533080016
13533080020

13533080021

13533080024

13533080025

13530080040

13533080041
13533080071

13533080072

Hizentra

44206045101
44206045202
44206045404

44206045510

   

Cuvitru

00944285001

00944285002

00944285003

00944285004

00944285005

00944285006

00944285007

00944285008

J1459

Injection, immune globulin (Privigen), intravenous, non-lyophilized (e.g., liquid), 500mg

Privigen

44206043710
44206043820
44206043605

44206043940

J1460

Injection, gamma globulin, intramuscular, 1 cc

Gamastan S/D

13533063504
13533063512
13533063513
13533063540

J1556

Injection, immune globulin (Bivigam), 500 mg

Bivigam

59730650301
59730650201

J1557

Injection, immune globulin, (Gammaplex), intravenous, non-lyophilized (e.g., liquid), 500 mg

Gammaplex

64208823501

64208823502

64208823503

64208823505

64208823506

64208823507

64208823402

64208823403

64208823404

64208823407

64208823406

64208823408

J1559

Injection, immune globulin (Hizentra), 100 mg

Hizentra

44206045101
44206045202
44206045404

44206045510

J1560

Injection, gamma globulin, intramuscular, 10 cc

Gamastan S/D

13533063504
13533063512
13533063513
13533063540

J1561

Injection, immune globulin, (Gamunex-C/Gammaked), intravenous, non-lyophilized (e.g., liquid), 500 mg

Gamunex-C

13533080012

13533080013

13533080015

13533080016
13533080020

13533080021

13533080024

13533080025

13530080040

13533080041
13533080071

13533080072

Gammaked

76125090001
76125090010
76125090025
76125090020
76125090050

J1566

Injection, immune globulin, intravenous, lyophilized (e.g., powder), not otherwise specified, 500 mg

Carimune NF

44206041812
44206041706

Gammagard S/D

00944265804

00944265603

J1568

Injection, immune globulin, (Octagam), intravenous, non-lyophilized (e.g., liquid), 500 mg

Octagam

68209084301

68209084302

68209084303

68209084304

67467084301

67467084302

67467084303

67467084304

67467084305

68982084001

68982084002

68982084003

68982084004

68982085001

68982085002

68982085003

68982085004

68982084005

J1569

Injection, immune globulin, (Gammagard), intravenous, non-lyophilized, (e.g., liquid), 500 mg

Gammagard

00944270002
00944270005
00944270003
00944270006
00944270007
00944270004

J1572

Injection, Immune globulin, (Flebogamma DIF), intravenous, non-lyophilized (e.g., liquid), 500 mg

Flebogamma DIF

61953000400

61953000401
61953000402
61953000403

61953000404
61953000405

61953000406

61953000407

61953000408

61953000409
61953000501
61953000502
61953000503

61953000504

61953000505

61953000506

J1575

Injection, immune globulin/hyaluronidase, (Hyqvia), 100mg immune globulin

Hyqvia

00944251202

00944251002

00944251302

00944251402

00944251102

J1599

Injection, immune globulin, intravenous, non-lyophilized (e.g., liquid), not otherwise specified, 500 mg

   

J1555

Injection, immune globulin (Cuvitru)

Cuvitru

00944285001

00944285002

00944285003

00944285004

00944285005

00944285006

00944285007

00944285008

J7799

Not otherwise classified (NOC) drugs other than inhalation drugs, administered through durable medical equipment (DME)

   

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

Available upon request.

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Policy activity

  • 11/14/2011 - Date of origin
  • 01/01/2018 - Effective date
Review date
  • 04/2017
Revision date
  • 01/01/2018

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