NOTE: Should you have landed here as a result of a search engine (or other) link, be advised that these files contain material that is copyrighted by the American Medical Association. You are forbidden to download the files unless you read, agree to, and abide by the provisions of the copyright statement. Read the copyright statement now and you will be linked back to here.

Contractor's Policy Number

96-05-R8

Contractor's Name

CareFirst of Maryland Inc., Medicare Part A

Contractor Number

00190

Contractor Type

Fiscal Intermediary

LMRP Title

Intravenous Immune Globulin

AMA CPT Copyright Statement

CPT codes, descriptions, and other data only are copyright 1999 American Medical Association (or such publication of CPT). All rights reserved. Applicable FARS/DFARS clauses apply.

CMS National Coverage Policy

• Establishment of national policy supersedes all previous contractor policy statements, including Local Medical Policy coverage guidelines
• Title XVIII of the Social Security Act, section 1862 (a) (7). This section excludes routine physical examinations.
• Title XVIII of the Social Security Act, section 1862 (a) (1) (A). This section allows coverage and payment for only those services that are considered to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Primary Geographic Jurisdiction

Maryland

Washington, DC

Secondary Geographic Jurisdiction

Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, Washington state, and Wyoming

CMS Region

Region III

CMS Consortium

Northeast

Original Policy Effective Date

10/12/1996

Original Policy Ending Date

Revision Effective Date

09/01/2004

Revision Ending Date

LMRP Description

Intravenous immune globulin (IVIG) is a sterile solution of plasma proteins containing IgG antibodies from pooled human plasma. It is used to increase circulating immunoglobulins for a variety of therapeutic effects, including anti-viral and anti-bacterial activity, as well as modulating immune function.

Indications and Limitations of Coverage and/or Medical Necessity

Intravenous immune globulin may be used as an adjunct to anti-infective therapies, such as in the following conditions:

• Primary immunodeficiencies such as x-linked agammaglobulinemia
• Acquired immunodeficiency syndrome and acquired immunodeficiency syndrome-related complex
• Chronic lymphocytic leukemia

Intravenous immune globulin may be used as an immune modulator in conditions such as the following:

• Immune, secondary, or idiopathic thrombocytopenic purpura
• Kawasaki syndrome (acute febrile mucocutaneous lymph node syndrome)
• Myasthenia gravis

Physicians should only prescribe IVIG for patients with immunodeficiency and low antibody levels, or with other well-established indications as described within this policy.

CPT/HCPCS Section & Benefit Category

Injections/Drugs

Medical

Type of Bill Code

11X, 13X, 21X, 23X, 71X, 74X, 75X, 83X, 85X

Revenue Codes

250, 636

CPT/HCPCS Codes

The AMA and CMS require the use of short descriptors for policies published on the Web. Refer to the CPT book for the long descriptor of the following codes:

J0850	Inj. Cytomegalovirus IG
J1563	IV Immune globulin
J1564	Immune globulin 10 mg
J2788	Rho(D) h immune globulin, mini, 50 mcg
J2790	Rho(D) h immune globulin, full dose, 300 mcg
J2792	Rho(D) immune globulin h, sd

Not Otherwise Classified (NOC)

NA

ICD-9 Codes that Support Medical Necessity

ICD-9-CM code listings may cover a range and include truncated codes. It is the provider’s responsibility to avoid truncated codes by selecting a code(s) carried out to the highest level of specificity and selected from the ICD-9-CM book appropriate to the year in which the claim is submitted.

It is not enough to link the procedure code to a correct, payable ICD-9-CM code. The diagnosis or clinical suspicion must be present for the procedure to be paid.

Medicare is establishing the following limited coverage for J0850:

078.5	Cytomegaloviral disease
V42.0	Organ or tissue replaced by transplant, kidney
V42.1	Organ or tissue replaced by transplant, heart
V42.2	Organ or tissue replaced by transplant, heart valve
V42.3	Organ or tissue replaced by transplant, skin
V42.4	Organ or tissue replaced by transplant, bone
V42.5	Organ or tissue replaced by transplant, cornea
V42.6	Organ or tissue replaced by transplant, lung
V42.7	Organ or tissue replaced by transplant, liver
V42.81	Other specified organ or tissue, bone marrow
V42.82	Other specified organ or tissue, peripheral stem cells
V42.83	Other specified organ or tissue, pancreas
V42.84	Other specified organ or tissue, intestines
V42.89	Other specified organ or tissue, other

Medicare is establishing the following limited coverage for J1563 and 1564:

042	Human immunodeficiency virus [HIV] disease
203.00	Multiple Myeloma, without mention of remission
203.01	Multiple Myeloma, in remission
204.10	Chronic Lymphoid Leukemia, without mention of remission
204.11	Chronic Lymphoid Leukemia, in remission
273.0	Polyclonal hypergammaglobulinemia
273.3	Macroglobulinemia
279.00	Hypogammaglobulinemia, unspecified
279.04	Congenital hypogammaglobulinemia
279.05	Immunodeficiency with increased IgM
279.06	Common variable immunodeficiency
279.09	Deficiency of humoral immunity, other
279.12	Wiskott-Aldrich syndrome
279.2	Combined immunity deficiency
287.3	Primary thrombocytopenia
287.4	Secondary thrombocytopenia
340	Multiple sclerosis
341.0	Neuromyelitis optica
341.1	Schilder’s disease
341.8	Other demyelinating diseases of central nervous system
341.9	Demyelinating disease of central nervous system, unspecified
356.4	Idiopathic progressive polyneuropathy
357.0	Acute infective polyneuritis
357.81	Chronic inflammatory demyelinating polyneuritis
357.82	Critical illness polyneuropathy
357.89	Other inflammatory and toxic neuropathy
358.00	Myasthenia gravis without (acute) exacerbation
358.01	Myasthenia gravis with (acute) exacerbation
403.01	Hypertensive renal disease, malignant, with renal failure
403.11	Hypertensive renal disease, benign, with renal failure
403.91	Hypertensive renal disease, unspecified, with renal failure
446.1	Acute febrile mucocutaneous lymph node syndrome
585	Chronic renal failure
586	Renal failure, unspecified
588.8	Other specified disorders resulting from impaired renal function
588.81	Secondary hyperparathyroidism (or renal origin)
588.89	Other specified disorders resulting from impaired renal function
588.9	Unspecified disorder resulting from impaired renal function
656.10	Rhesus isoimmunization, unspecified as to episode of care or not applicable
656.11	Rhesus isoimmunization, delivered, with or without mention of antepartum condition
656.13	Rhesus isoimmunization, antepartum condition or complication
694.4	Bullous dermatoses; pemphigus
694.5	Bullous dermatoses; pemphigoid
694.60	Benign mucous membrane pemphigoid; without mention of ocular involvement
694.61	Benign mucous membrane pemphigoid with ocular involvement
694.8	Other specified bullous dermatoses
710.3	Dermatomyositis
710.4	Polymyositis
714.30	Polyarticular juvenile rheumatoid arthritis, chronic or unspecified
714.31	Polyarticular juvenile rheumatoid arthritis, acute
996.81	Complications of transplanted organ, kidney
996.85	Complications of transplanted organ, bone marrow
V42.0	Organ or tissue replaced by transplant, kidney
V42.81	Organ or tissue replaced by transplant, other specified organ or tissue, bone marrow
V42.82	Organ or tissue replaced by transplant, other specified organ or tissue, peripheral stem cells

Medicare is establishing the following limited coverage for J2788, J2790, and J2792:

656.10	Rhesus isoimmunization, unspecified as to episode of care or not applicable
656.11	Rhesus isoimmunization, delivered, with or without mention of antepartum condition
656.13	Rhesus isoimmunization, antepartum condition or complication

Diagnoses that Support Medical Necessity

As listed in the “ICD-9 Codes that Support Medical Necessity” section of this policy.

ICD-9 Codes that DO NOT Support Medical Necessity

Any diagnosis codes not listed in the “ICD-9 Codes that Support Medical Necessity” section of this policy.

Diagnoses that DO NOT Support Medical Necessity

Conditions not listed in the “ICD-9 Codes that Support Medical Necessity” section of this policy.

Reasons for Denial

• The medical record does not document that the service described by the HCPCS code was provided.
• The service was provided for an indication not listed in the “ICD-9 Codes that Support Medical Necessity” section of this policy.
• The service does not follow the guidelines of this policy.
• The documentation in the medical record does not support the medical necessity of providing this service.

Non-covered ICD-9 Codes

Any diagnosis codes not listed in the “ICD-9 Codes that Support Medical Necessity” section of this policy

Non-covered Diagnoses

Conditions not listed in the “ICD-9 Codes that Support Medical Necessity” section of this policy.

Coding Guidelines

• Diagnosis (diagnoses) must be present on the submitted claim, and be coded to the highest level of specificity to accurately represent the patient’s condition
• The service(s) should be reported using the appropriate HCPCS code(s)
• Refer to the Correct Coding Initiative for “bundling” information

Documentation Requirements

• Documentation supporting the medical necessity for this procedure should be legible, maintained in the patient’s medical record, and available to Medicare upon request.
• Appropriate HCPCS codes should be used when reporting this service.
• An appropriate diagnosis code should be submitted on the claim. The patient’s medical record should indicate the signs/symptoms supporting the diagnosis, as well as functional impairments.

Utilization Guidelines

NA

Other Comments

NA

Sources of Information and Basis for Decision

TrailBlazer Health Enterprises, Inc.

Medical Policy Committee, CareFirst, Inc.

Advisory Committee Notes

This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups.

Start Date of Comment Period

NA

End Date of Comment Period

NA

Start Date of Notice Period

NA

Revision History

Number	Date	Changes
96-05-R8	09/01/2004	Added 3 HCPCS codes, J0850, J2788, and J2790 and deleted
		ICD -9 code 284.8. Expanded 588.8 to include new codes
		588.81 and 588.89. Divided ICD-9 codes into 3 sections.
96-05-R7	10/01/2003	Annual update of ICD-9 codes for FY 2004. Delete root codes
		341, 422, and 358.0. Expand to include 341.0, 341.1,
		341.8, 341.9, 358.00, 358.01, 714.30 and 714.31.
		(PM AB 03-091, CR 2763) Corrected revision number and codes
		erroneously omitted.
96-05R6	04/09/2003	ICD-9 code expanded from 203.0 to include 203.00 and 203.01.
96-05-R5	01/01/2003	Annual update of CPT/HCPCS codes. Deleted J1561, added J1564.
		CPT descriptors changed to short descriptors.
96-05-R4	11/14/2002	Policy updated with criteria and ICD-9 codes 694.4, 694.5, 694.6,
		694.60, 694.61, 694.8 per AB 02-060, CR 2149,
		effective 10/01/2002.
96-05-R3	10/01/2002	Annual update of ICD-9 codes for 2003. See bulletin on website for
		specifics.
96-05-R2	05/01/2002	Revised "Description," "Indications and Limitations of Coverage and/or
		Medical Necessity," "CPT/HCPCS Codes," "ICD-9 Codes that
		Support Medical Necessity," "Reasons for Denial," "Coding
		Guidelines,” and "Documentation Requirements" sections, and
		changed to HTML format.
96-05-R1	08/10/01	Expanded the policy with ICD-9 codes for existing and new
		indications. Added HCPCS code J1563, per HCPCS
		Level II Codes. Placed in new format.

THIS BULLETIN SHOULD BE SHARED WITH ALL HEALTH CARE PRACTITIONERS AND MANAGERIAL MEMBERS OF THE PROVIDER/SUPPLIER STAFF. BULLETINS ISSUED AFTER OCTOBER 1, 1999 ARE AVAILABLE FROM OUR WEBSITE AT www.marylandmedicare.com

Italicized and/or quoted material is excerpted from the American Medical Association Current Procedural Terminology CPT codes, descriptions and other data only are copyrighted 1999 American Medical Association (or such other publication of CPT). All rights reserved. Applicable FARS/DFARS apply.