National Coverage Analysis (NCA) Tracking Sheet

Intravenous Immune Globulin for Autoimmune Mucocutaneous Blistering Diseases



Intravenous Immune Globulin (IVIG) is an antibody produced by healthy immune systems to kill viruses, bacteria, fungi, and parasites. It is derived from donated human plasma. IVIG was approved by the FDA in 1981. FDA has approved six indications for IVIG, but not for the treatment of autoimmune mucocutaneous blistering diseases.

Benefit Category

Drugs and Biologicals

Requestor Information

Requestor Name Requestor Letter
Dr. A. Razzaque Ahmed N/A

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
11/28/2001 - 12/28/2001
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released


Lead Analysts
Jackie Sheridan-Moore
Lead Medical Officers
Ron Dei Cas, MD
Michael Londner, MD

Medicare Benefit Category Determination Date

Actions Taken

July 20, 2001

Requestor contacted CMS to discuss formal application process.

August 29, 2001

CMS met with requestor.

September 26, 2001

CMS sent comments on draft request to requestor.

October 23, 2001

CMS received formal request.

October 29, 2001

Formal request accepted.

January 22, 2002

CMS issues decision memorandum indicating intent to cover IVIg for 5 autoimmune mucocutaneous blistering diseases under specified conditions.

May 2002

Claims processing instructions issued and NCD updated.