LCD: Centers for Medicare & Medicaid Services

Please note: If you are printing this document and it is truncated on the right margin, please try printing landscape.

Contractor Information

Contractor Name ^{back to top}
CIGNA Government Services
Contractor Number ^{back to top}
18003
Contractor Type ^{back to top}
DME MAC

LCD Information

LCD ID Number ^{back to top}
L27259

LCD Title ^{back to top}
Intravenous Immune Globulin

Contractor's Determination Number ^{back to top}
IVIG

AMA CPT / ADA CDT Copyright Statement ^{back to top}
CPT codes, descriptions and other data only are copyright 2009 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.

CMS National Coverage Policy ^{back to top}


Primary Geographic Jurisdiction ^{back to top}
Alabama Arkansas Colorado Florida Georgia Louisiana Mississippi North Carolina New Mexico Oklahoma Puerto Rico South Carolina Tennessee Texas Virginia Virgin Islands West Virginia

Oversight Region ^{back to top}
Region IV

DME Region LCD Covers ^{back to top}
Jurisdiction C

Original Determination Effective Date ^{back to top}
For services performed on or after 04/01/2008

Original Determination Ending Date ^{back to top}


Revision Effective Date ^{back to top}
For services performed on or after 01/01/2009

Revision Ending Date ^{back to top}


Indications and Limitations of Coverage and/or Medical Necessity ^{back to top}
For any item to be covered by Medicare, it must: 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. For the items addressed in this medical policy, the criteria for “reasonable and necessary” is defined by the following indications and limitations of coverage and/or medical necessity. For an item to be covered by Medicare a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary. The statutory coverage criteria for intravenous immune globulin (IVIG) addressed in this policy is specified in the related Policy Article (PA). If the IVIG is administered using an infusion pump, the infusion pump and related administration supplies are denied as not medically necessary because they do not meet the coverage criteria specified in the External Infusion Pumps Local Coverage Determination (LCD). If the coverage criteria for IVIG specified in the related PA are not met and the IVIG is administered with an infusion pump, the IVIG will be denied as not medically necessary (because the pump is denied as not medically necessary). Drugs may be covered only if dispensed and billed to Medicare by the entity that actually dispenses the drug to the Medicare beneficiary, and that entity must be permitted under all applicable federal, state, and local laws and regulations to dispense drugs. Only entities licensed in the state where they are physically located may bill for IVIG. Claims submitted by entities not licensed to dispense drugs will be denied for as not medical necessity. Refer to the External Infusion Pumps LCD for information concerning coverage of subcutaneous immune globulin.

Coding Information

Bill Type Codes: ^{back to top}

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.

Revenue Codes: ^{back to top}

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.

CPT/HCPCS Codes ^{back to top}

HCPCS MODIFIERS:

EY - No physician or other licensed health care provider order for this item or service

HCPCS CODES:

A4223	INFUSION SUPPLIES NOT USED WITH EXTERNAL INFUSION PUMP, PER CASSETTE OR BAG (LIST DRUGS SEPARATELY)
J1459	INJECTION, IMMUNE GLOBULIN (PRIVIGEN), INTRAVENOUS, NON-LYOPHILIZED (E.G. LIQUID), 500 MG
J1561	INJECTION, IMMUNE GLOBULIN, (GAMUNEX), INTRAVENOUS, NON-LYOPHILIZED (E.G. LIQUID), 500 MG
J1566	INJECTION, IMMUNE GLOBULIN, INTRAVENOUS, LYOPHILIZED (E.G. POWDER), NOT OTHERWISE SPECIFIED, 500 MG
J1568	INJECTION, IMMUNE GLOBULIN, (OCTAGAM), INTRAVENOUS, NON-LYOPHILIZED (E.G. LIQUID), 500 MG
J1569	INJECTION, IMMUNE GLOBULIN, (GAMMAGARD LIQUID), INTRAVENOUS, NON-LYOPHILIZED, (E.G. LIQUID), 500 MG
J1572	INJECTION, IMMUNE GLOBULIN, (FLEBOGAMMA/FLEBOGAMMA DIF), INTRAVENOUS, NON-LYOPHILIZED (E.G. LIQUID), 500 MG
J1573	INJECTION, HEPATITIS B IMMUNE GLOBULIN (HEPAGAM B), INTRAVENOUS, 0.5 ML
J2791	INJECTION, RHO(D) IMMUNE GLOBULIN (HUMAN), (RHOPHYLAC), INTRAMUSCULAR OR INTRAVENOUS, 100 IU

ICD-9 Codes that Support Medical Necessity ^{back to top}

Not specified.
For ICD-9 codes relating to statutory coverage, see Policy Article

XX000 Not Applicable

Diagnoses that Support Medical Necessity ^{back to top}

ICD-9 Codes that DO NOT Support Medical Necessity ^{back to top}

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation ^{back to top}

Diagnoses that DO NOT Support Medical Necessity ^{back to top}

General Information

Documentation Requirements ^{back to top}

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the patient's medical records will reflect the need for the care provided. The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.

The supplier must enter an ICD-9 diagnosis code corresponding to the patient's diagnosis on each claim.

When Not Otherwise Classified (NOC) drug code J1566 is billed for miscellaneous immunoglobulin drugs, the claim must be accompanied by a clear statement detailing the drug provided and the amount dispensed.

Refer to the Supplier Manual for more information on documentation requirements.

Appendices ^{back to top}

Utilization Guidelines ^{back to top}

Refer to Indications and Limitations of coverage and/or Medical necessity

Sources of Information and Basis for Decision ^{back to top}

Medicare IOM 100-02 Benefit Policy Manual Chapter 15 Section 50.6

Advisory Committee Meeting Notes ^{back to top}

Start Date of Comment Period ^{back to top}

End Date of Comment Period ^{back to top}

Start Date of Notice Period ^{back to top}

03/20/2008

Revision History Number ^{back to top}

001

Revision History Explanation ^{back to top}

Revision Effective Date: 01/01/2009
HCPCS CODES:
Added J1459.
Changed code descriptor for J1572.
Deleted Q4097

11/09/2008 - The description for CPT/HCPCS code J1572 was changed in group 1

Reason for Change ^{back to top}

Last Reviewed On Date ^{back to top}

Medicare Coverage Database

LCD for Intravenous Immune Globulin (L27259)