Highmark Medicare Services

00363

Fiscal Intermediary

L780

Use of Intravenous Immune Globulin (IVIG) in Neurological and Musculoskeletal Disorders

04-010

CPT codes, descriptions and other data only are copyright 2007 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Pennsylvania

Region III

For services performed on or after 02/02/1998

For services performed on or after 11/19/2004

04/11/2005

Intravenous Immune Globulin (IVIG) is a sterile solution of immunoglobulins prepared from pooled human plasma for intravenous infusion. The solution contains no less than 90% immunoglobulin, which contains a broad range of antibodies that act against bacterial and viral antigens. All IgG subclasses are represented, also included are trace amounts of IgA and IgM.

This LCD will address uses of pooled, broad spectrum intravenous immunoglobulin. This LCD will not address the use(s) of narrow spectrum intravenous immunoglobulins prepared to work in very specific circumstances (e.g., CMV immunoglobulin); as opposed to IVIG which has a broad spectrum of effect.

GENERAL INDICATIONS AND LIMITATIONS FOR COVERED NEUROLOGICAL AND MUSCULOSKELETAL DISORDERS

When using IVIG to treat neurological disorders, the diagnosis of the disorder must be unequivocal. There must be clinical evidence, including biopsy (muscle-nerve) data when necessary, to support the diagnosis. Other clinical data which may contribute to the diagnosis include quantitative clinical examinations, electrophysiological motor-sensory nerve conductions (EMG), CSF studies, and other ancillary tests (e.g., serum immunoprotein). Clear diagnostic criteria exist for making a diagnosis in the neurological disorders considered eligible for coverage under this LCD. The reason for choosing IVIG as a treatment is expected to be stated clearly in the medical records.

Once treatment is initiated, the patient's progress is expected to be meticulously documented in the medical record. If there is initial improvement by the second course of treatment, and continued treatment is necessary, then objective clinical assessment to monitor the progress is required. Objective monitoring may use any accepted clinical method such as the MRC scale, Rankin score,ADL scores,and/or objective findings on physical exam. For Multiple Sclerosis, documentation of the number of relapses may be used. Changes in these measures, and the relationship of the change to IVIG use, are expected to be clearly documented. Subjective improvement alone is insufficient to continue IVIG.

Clinical monitoring takes clear precedence over laboratory monitoring. If clinical improvement is evident, then laboratory monitoring solely to guide IVIG therapy is not necessary.

There must be an attempt made to wean the dosage when improvement has occurred. There must be an attempt to stop the IVIG infusion if improvement is sustained with dosage reduction. If withholding or decreasing IVIG therapy is inappropriate for the purpose of assessing response to therapy, then the record is expected to include documentation discussing why therapy cannot be withheld or decreased. If improvement does not occur with IVIG, then infusion should not continue.

At present, IVIG is indicated as described in this policy for use in the following neurological and musculoskeletal disorders:

-Guillain-Barre Syndrome,

-Myasthenia Gravis Syndrome,

-Chronic Inflammatory Demyelinating Polyneuropathy (CIDP),

-Multiple Sclerosis,

-Dermatomyositis and Polymyositis (PM),

-Multifocal Motor Neuropathy (MMN), and

-Lambert-Eaton Syndrome.

THE FOLLOWING DETAILED INFORMATION IS IN ADDITION TO THE GENERAL INDICATIONS AND LIMITATIONS DISCUSSED ABOVE.

A. Guillain-Barre Syndrome

IVIG is indicated when:

1. The patient has unequivocal acute or chronic Guillain-Barre Syndrome; and

2. The patient has impaired function measured by a standard clinical scale and/or objective findings on physical exam at the time of initial therapy.

B. Myasthenia Gravis Syndrome

IVIG is indicated when:

1. The patient has unequivocal Myasthenia Gravis Syndrome;

2. The patient has severely impaired function measured by a standard clinical scale and/or objective findings on physical exam at the time of initial therapy; and

3. The patient is refractory to other standard therapies (e.g., cholinesterase inhibitors, corticosteroids, azathioprine) given in therapeutic doses over at least three (3) months; or is intolerant of/has a contraindication to those standard therapies.

C. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

IVIG is indicated when:

1. The patient has unequivocal CIDP;

2. The patient has impaired function measured by a standard clinical scale and/or objective findings on physical exam at the time of initial therapy.

D. Multiple Sclerosis

IVIG is indicated when:

1. The patient has unequivocal Multiple Sclerosis;

2. The patient has impaired function measured by a standard clinical scale and/or objective findings on physical exam at the time of initial therapy; and

3. The patient is refractory to other standard therapies (e.g., interferons) given in therapeutic doses over at least three (3) months; or is intolerant of/has a contraindication to those standard therapies.

E. Inflammatory Myopathies

IVIG is indicated when:

1. The patient has unequivocal Dermatomyositis or Polymyositis;

2. The patient has impaired function measured by a standard clinical scale and/or objective findings on physical exam at the time of initial therapy; and

3. The patient is refractory to corticosteroids given in therapeutic doses over at least four (4) months; or is intolerant of/has a contraindication to corticosteroids.

LIMITATIONS

The use of IVIG is not indicated at present for the following disorders: epilepsy, Amyotrophic Lateral Sclerosis (ALS), inclusion body myositis, undiagnosed neuropathy or weakness, and malignancies with no causal link to coexisting neurological dysfunctions.

Outpatient Hospital Services

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

Italicized and/or quoted material is excerpted from the American Medical Association,Current Procedural Terminology (CPT) codes.

Note: HCPCS code J1564 will have a description change effective January 1, 2005. For services prior to January 1, 2005, the description for J1564 is as follows: J1564 injection, immune globulin, 10 mg

Note:

It is the providers responsibility to select codes carried out to the highest level of specificity and selected from the ICD-9-CM code book appropriate to the year in which the service is rendered for the claim (s) submitted.

N/A

Conditions that are not listed in the "ICD-9-CM Codes that Support Medical Necessity" section of this policy.

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N/A

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04-010

11/10/2004