Local Coverage Article

Intravenous Immune Globulin - Policy Article

A52509

Expand All | Collapse All

Contractor Information

Article Information

General Information

Article ID
A52509
Original ICD-9 Article ID
A46761
A47336
A47173
A47177
Article Title
Intravenous Immune Globulin - Policy Article
Article Type
Article
Original Effective Date
10/01/2015
Revision Effective Date
01/01/2020
Revision Ending Date
N/A
Retirement Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2020 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2020 American Dental Association. All rights reserved.

Copyright © 2013 - 2021, the American Hospital Association, Chicago, Illinois. Reproduced by CMS with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB-04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312-893-6816. Making copies or utilizing the content of the UB-04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB-04 Manual and/or codes and descriptions; and/or making any commercial use of UB-04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. To license the electronic data file of UB-04 Data Specifications, contact Tim Carlson at (312) 893-6816. You may also contact us at ub04@aha.org.

Article Guidance

Article Text

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES

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. Information provided in this policy article relates to determinations other than those based on Social Security Act §1862(a)(1)(A) provisions (i.e. “reasonable and necessary”).

Intravenous immune globulin used for the treatment of primary immunodeficiency is covered under the Intravenous Immune Globulin benefit. (IOM 100-2, Ch. 15, §50.6) In order for a beneficiary’s equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.

Intravenous immune globulin (IVIG) is covered if all of the following criteria are met:

  1. It is an approved pooled plasma derivative for the treatment of primary immune deficiency disease; and
  2. The patient has a diagnosis of primary immune deficiency disease (See Diagnosis Codes that Support Medical Necessity section below); and
  3. The IVIG is administered in the home; and
  4. The treating practitioner has determined that administration of the IVIG in the patient’s home is medically appropriate.

If all of the criteria are not met and the IVIG is not administered with an infusion pump, the IVIG will be denied as noncovered - no benefit category.

If the criteria are not met and the IVIG is administered with an infusion pump, refer to the Intravenous Immune Globulin LCD.

Coverage under the IVIG benefit is limited to the IVIG itself, not to related supplies and services. If the IVIG is not administered with an infusion pump, related supplies will be denied as noncovered – no benefit category.

Codes J1573 and J2791 are non-covered. They are not indicated for the treatment of primary immune deficiency disease (#2 above).

Refer to the External Infusion Pumps LCD for information concerning coverage of subcutaneous immune globulin.

 

REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)

Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The link will be located here once it is available.

Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.

If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.


POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

In addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.

Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.

The supplier must enter a diagnosis code corresponding to the patient's diagnosis on each claim.


MODIFIERS

JW MODIFER

Effective for claims with dates of service on or after January 1, 2017, the JW modifier must be used when billing for discarded drugs and biologicals.

Multi-use vials are not subject to payment for discarded amounts of drug or biologicals.

Because of the HCPCS code descriptors and the associated UOS for DMEPOS items, the DME MACs expect rare use of the JW modifier on claims.

There are two scenarios that can occur:

Scenario 1
When the HCPCS code Unit of Service (UOS) is less than the drug quantity contained in the single use vial or single dose package, the following applies:

  • The quantity administered is billed on one claim line without the JW modifier; and
  • The quantity discarded is billed on a separate claim line with the JW modifier.

In this scenario, the JW modifier must be billed on a separate line to provide payment for the amount of discarded drug or biological. For example:

  • A single use vial is labeled to contain 100 mg of a drug.
  • The drug's HCPCS code UOS is 1 UOS = 1 mg.
  • 95 mg of the 100 mg in the vial are administered to the beneficiary.
  • 5 mg remaining in the vial are discarded.
  • The 95 mg dose is billed on one claim line as 95 UOS.
  • The discarded 5 mg is billed as 5 UOS on a separate claim line with the JW modifier.
  • Both claim line items would be processed for payment.

Scenario 2
When the HCPCS code UOS is equal to or greater than the total of the actual dose and the amount discarded, use of the JW modifier is not permitted. If the quantity of drug administered is less that a full UOS, the billed UOS is rounded to the appropriate UOS. For example:

  • A single use vial is labeled to contain 100 mg of a drug.
  • The drug's HCPCS code UOS is 1 UOS = 100 mg.
  • 70 mg of the 100 mg in the vial are administered to the beneficiary.
  • 30 mg remaining in the vial are discarded.
  • The 70 mg dose is billed correctly by rounding up to one UOS (representing the entire 100 mg vial) on a single line item.
  • The single line item of 1 UOS would be processed for payment of the combined total 100 mg of administered and discarded drug.
  • The discarded 30 mg must not be billed as another 1 UOS on a separate line item with the JW modifier. Billing an additional 1 UOS for the discarded drug with the JW modifier is incorrect billing and will result in an overpayment.

Effective for claims with dates of service on or after January 1, 2017, suppliers must add a JW modifier to codes for infusion drugs, only if all of the criteria in the “Coverage Indications, Limitations and/or Medical Necessity” section of the related policy have been met.


CODING GUIDELINES

If the IVIG is not administered through an infusion pump and if supplies are billed, code A4223 (INFUSION SUPPLIES NOT USED WITH EXTERNAL INFUSION PUMP, PER CASSETTE OR BAG (LIST DRUGS SEPARATELY) must be used for the supplies.

If the IVIG is administered through an infusion pump refer to the External Infusion Pump LCD and Policy Article for additional information.

Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) contractor for guidance on the correct coding of these items.

 

Coding Information

CPT/HCPCS Codes

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph

The presence of an ICD-10 code listed in this section is not sufficient by itself to assure coverage. Refer to the Non-Medical Necessity Coverage and Payment Rules section for other coverage criteria and payment information.

Group 1 Codes
CodeDescription
D80.0 Hereditary hypogammaglobulinemia
D80.2 Selective deficiency of immunoglobulin A [IgA]
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
D81.5 Purine nucleoside phosphorylase [PNP] deficiency
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
G11.3 Cerebellar ataxia with defective DNA repair

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

All codes not listed in the previous section.

Group 1 Codes

N/A

Additional ICD-10 Information

N/A

Bill Type Codes

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 article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

N/A

Revenue Codes

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 article, 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 article should be assumed to apply equally to all Revenue Codes.

N/A

Revision History Information

Revision History DateRevision History NumberRevision History Explanation
01/01/2020 R6

Revision Effective Date: 01/01/2020
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Revised: “physician” to “practitioner”
REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 Fed. Reg Vol 217):
Added: Section and related information based on Final Rule 1713
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Revised: Section header “ICD-10 Codes that are Covered” updated to “ICD-10 Codes that Support Medical Necessity”
ICD-10 CODES THAT DO NOT SUPPORT MEDICAL NECESSITY:
Revised: Section header “ICD-10 Codes that are Not Covered” updated to “ICD-10 Codes that DO NOT Support Medical Necessity”

02/06/2020: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

08/13/2019 R5

Revision Effective Date: 08/13/2019
ICD-10 CODES THAT ARE COVERED:
Added: Codes D80.2, D80.3, D80.4, D80.6, D80.7, D81.5, D82.1, D82.4, D83.1 and G11.3 per update to Medicare Benefit Policy Manual, Chapter 15, section 50.6

07/25/2019: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

01/01/2017 R4

02/21/2019: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This is an article and not a local coverage determination.

01/01/2017 R3 Revision History Effective Date: 01/01/2017
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: Modifier requirements
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements Language Article
07/01/2016 R2 Effective July 1, 2016 oversight for DME MAC Articles is the responsibility of CGS Administrators, LLC 18003 and 17013 and Noridian Healthcare Solutions, LLC 19003 and 16013. No other changes have been made to the Articles.
10/01/2015 R1 Revision Effective Date: 10/01/2015
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Removed: Diagnosis codes from this section
Added: Reference to diagnosis codes section

Associated Documents

Related National Coverage Documents
N/A
Statutory Requirements URLs
N/A
Rules and Regulations URLs
N/A
CMS Manual Explanations URLs
N/A
Other URLs
N/A
Public Versions
Updated On Effective Dates Status
01/30/2020 01/01/2020 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

N/A