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National Coverage Determination (NCD) for Intravenous Immune Globulin for the Treatment of Autoimmune Mucocutaneous Blistering Diseases (250.3)

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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

10/1/2002

Implementation Date

10/1/2002



Benefit Category
Drugs and Biologicals
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. Contractors 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.


Transmittal Number

155

Coverage Transmittal Link

http://www.cms.gov/transmittals/downloads/R155CIM.pdf

Revision History

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)


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.

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