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National Coverage Determination (NCD)

Intravenous Immune Globulin for the Treatment of Autoimmune Mucocutaneous Blistering Diseases

250.3

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Tracking Information

Publication Number
100-3
Manual Section Number
250.3
Manual Section Title
Intravenous Immune Globulin for the Treatment of Autoimmune Mucocutaneous Blistering Diseases
Version Number
1
Effective Date of this Version
10/01/2002
Ending Effective Date of this Version
Implementation Date
10/01/2002
Implementation QR Modifier Date

Description Information

Benefit Category
Drugs and Biologicals


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

Intravenous immune globulin (IVIg) is a blood product prepared from the pooled plasma of donors. It has been used to treat a variety of autoimmune diseases, including mucocutaneous blistering diseases. It has fewer side effects than steroids or immunosuppressive agents.
Indications and Limitations of Coverage

Effective October 1, 2002, IVIg is covered for the treatment of biopsy-proven (1) Pemphigus Vulgaris, (2) Pemphigus Foliaceus, (3) Bullous Pemphigoid, (4) Mucous Membrane Pemphigoid (a.k.a., Cicatricial Pemphigoid), and (5) Epidermolysis Bullosa Acquisita for the following patient subpopulations:

  • Patients who have failed conventional therapy. Medicare Administrative Contractors (MACs) have the discretion to define what constitutes failure of conventional therapy;
  • Patients in whom conventional therapy is otherwise contraindicated. Contractors have the discretion to define what constitutes contraindications to conventional therapy; or
  • Patients with rapidly progressive disease in whom a clinical response could not be affected quickly enough using conventional agents. In such situations IVIg therapy would be given along with conventional treatment(s) and the IVIg would be used only until the conventional therapy could take effect.

In addition, IVIg for the treatment of autoimmune mucocutaneous blistering diseases must be used only for short-term therapy and not as a maintenance therapy. Contractors have the discretion to decide what constitutes short-term therapy.
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
155
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R155CIM.pdf
Revision History

03/2025 - The purpose of this Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations (NCDs). No policy is being changed as a result of these updates. (TN 13097) (CR13939)

01/2024 - Transmittal 12350 issued November 03, 2023, is being rescinded and replaced by Transmittal 12440 dated January 3, 2024, to make changes to NCD 90.2, Next Generation Sequencing, spreadsheet to align with revisions being made to CR 13278. All other information remains the same. (TN 12440) (CR13391)

11/2023 - The purpose of this Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations (NCDs). No policy is being changed as a result of these updates.(TN 12350) (CR13391)

10/2023 - The purpose of this Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations (NCDs). No policy is being changed as a result of these updates. (TN 12319) (CR13391)

12/2015 - This change request (CR) is the 3rd maintenance update of ICD-10 conversions/updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, & CR9087. Some are the result of revisions required to other NCD-related CRs released separately that included ICD-10 coding. Implementation date: 01/04/2016 Effective date: 10/1/2015. (TN 1580 ) (CR9252)

08/2015 - This change request (CR) is the 3rd maintenance update of ICD-10 conversions/updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, & CR9087. Some are the result of revisions required to other NCD-related CRs released separately that included ICD-10 coding.
These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 01/04/2016 Effective date: 10/1/2015. (TN 1537) (CR 9252)

05/2014 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 10/06/2014 Effective date: 10/1/2015. (TN 1388) (TN 1388) (CR 8691)

09/2012 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy.Implementation date: 01/07/2013 Effective date: 10/1/2015. (TN 1122) (TN 1122) (CR 7818)

05/2002 - Provided limited coverage for use of IVIg for treatment of biopsy-proven (1) Pemphigus Vulgaris, (2) Pemphigus Foliaceus, (3) Bullous Pemphigoid, (4) Mucous Membrane Pemphigoid (a.k.a., Cicatricial Pemphigoid), and (5) Epidermolysis Bullosa Acquisita. Effective and implementation dates 10/01/2002. (TN 155) (CR 2149)
Other

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Intravenous Immune Globulin for the Treatment of Autoimmune Mucocutaneous Blistering Diseases 1 10/01/2002 - N/A You are here
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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