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Coverage criteria policies

Immune globulin therapy – Minnesota Health Care Programs

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific 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

Prior authorization is required for Immune globulin therapy from HealthPartners Pharmacy Administration for any diagnosis not listed under “Covered Diagnoses” below.

No prior authorization is required when the drug is given for a covered diagnosis.

Coverage

Immune globulin therapy is generally covered subject to the indications listed below when all of the following criteria are met, and per your plan documents.

  1. The member has one of the diagnoses listed below under “covered diagnoses”; and,
  2. The prescribed regimen is within the FDA-approved dosing regimen.

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

Non-Covered Diagnoses:

Use of immune globulin for all other diagnoses not listed above requires review for medical necessity.

For diagnoses requiring prior authorization, approved authorizations will be provided for up to 12 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.

Definitions

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

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

90281

Immune Globulin (Ig), human, for intramuscular use (Code Price is per 2 mL)

Gamastan S/D

54569582800

13533063504
13533063512
13533063513
13533063540

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

44206043892

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

J1555

Injection, immune globulin Cuvitru, 100mg

Cuvitru

00944285001

00944285002

00944285003

00944285004

00944285005

00944285006

00944285007

00944285008

J1459

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

Privigen

44206043710
44206043820

44206043892
44206043605

44206043940

J1460

Injection, gamma globulin, intramuscular, 1 cc

Gamastan S/D

13533063504
13533063512
13533063513
13533063540

13533528000

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

54569582800

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

 

No NDCs currently crosswalked to this code

ICD-10-CM Codes
The following diagnosis codes do not require prior authorization. All other diagnosis codes require review.

ICD10

Description

B20

Human immunodeficiency virus [HIV] disease

C91

Acute lymphoblastic leukemia [ALL]

C91.10

Chronic lymphocytic leukemia of B-cell type not having achieved remission

C91.11

Chronic lymphocytic leukemia of B-cell type in remission

C91.12

Chronic lymphocytic leukemia of B-cell type in relapse

C92

Acute myeloid leukemia

C92

Chronic myeloid leukemia

D47.2

Monoclonal gammopathy

D47.9

Neoplasm of uncertain behavior of lymphoid, hematopoietic and related tissue, unspecified

D69.3

Immune thrombocytopenic purpura

D69.51

Posttransfusion purpura

D69.59

Other secondary thrombocytopenia

D80.0

Hereditary hypogammaglobulinemia

D80.1

Nonfamilial hypogammaglobulinemia

D80.3

Selective deficiency of immunoglobulin G [IgG] subclasses

D80.4

Selective deficiency of immunoglobulin M [IgM]

D80.5

Immunodeficiency with increased immunoglobulin M [IgM]

D80.6

Antibody deficiency with near-normal immunoglobulins or with hyperimmunoglobulinemia

D80.7

Transient hypogammaglobulinemia of infancy

D81.0

Severe combined immunodeficiency [SCID] with reticular dysgenesis

D81.1

Severe combined immunodeficiency [SCID] with low T- and B-cell numbers

D81.2

Severe combined immunodeficiency [SCID] with low or normal B-cell numbers

D81.6

Major histocompatibility complex class I deficiency

D81.7

Major histocompatibility complex class II deficiency

D81.89

Other combined immunodeficiencies

D81.9

Combined immunodeficiency, unspecified

D82.0

Wiskott-Aldrich syndrome

D82.1

Di George's syndrome

D82.4

Hyperimmunoglobulin E [IgE] syndrome

D83.0

Common variable immunodeficiency with predominant abnormalities of B-cell numbers and function

D83.1

Common variable immunodeficiency with predominant immunoregulatory T-cell disorders

D83.2

Common variable immunodeficiency with autoantibodies to B- or T-cells

D83.8

Other common variable immunodeficiencies

D83.9

Common variable immunodeficiency, unspecified

D84.8

Other specified immunodeficiencies

D89.2

Hypergammaglobulinemia, unspecified

D89.9

Disorder involving the immune mechanism, unspecified

D89.810

Acute graft-versus-host disease

D89.812

Acute on chronic graft-versus-host disease

D89.82

Autoimmune lymphoproliferative syndrome [ALPS]

G61.0

Guillain-Barré syndrome

G61.81

Chronic inflammatory demyelinating polyneuritis

G65.0

Sequelae of Guillain-Barré syndrome

G70.01

Myasthenia gravis with (acute) exacerbation

G70.80

Lambert-Eaton syndrome, unspecified

G70.81

Lambert-Eaton syndrome in disease classified elsewhere

G73.1

Lambert-Eaton syndrome in neoplastic disease

P61.0

Transient neonatal thrombocytopenia

T86.00

Unspecified complication of bone marrow transplant

T86.01

Bone marrow transplant rejection

T86.02

Bone marrow transplant failure

T86.03

Bone marrow transplant infection

T86.09

Other complications of bone marrow transplant

T86.10

Unspecified complication of kidney transplant

T86.11

Kidney transplant rejection

T86.12

Kidney transplant failure

T86.13

Kidney transplant infection

T86.19

Other complication of kidney transplant

Z48.290

Encounter for aftercare following bone marrow transplant

Z94.81

Bone marrow transplant status

Z94.84

Stem cells transplant status

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References

Available upon request.

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.

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Policy activity

  • 01/01/2017 - Date of origin
  • 05/07/2018 - Effective date
Review date
  • 05/2018
Revision date
  • 05/07/2018

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