LCD/NCD Portal
Automated World Health
NCD20.5
EXTRACORPOREAL IMMUNOADSORPTION (ECI) USING PROTEIN A COLUMNS
Effective Date of this Version
1/1/2001
Benefit Category
• Outpatient Hospital Services Incident to a Physician's Service
• Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.
Item/Service Description
• Extracorporeal immunoadsorption (ECI), using Protein A columns, has been developed for the purpose of selectively removing circulating immune complexes (CIC) and immunoglobulins (IgG) from patients in whom these substances are associated with their diseases.
• The technique involves pumping the patient's anticoagulated venous blood through a cell separator from which 1-3 liters of plasma are collected and perfused over adsorbent columns, after which the plasma rejoins the separated, unprocessed cells and is retransfused to the patient.
Indications and Limitations of Coverage
• For claims with dates of service on or after January 1, 2001, Medicare covers the use of Protein A columns for the treatment of ITP.
• In addition, Medicare will cover Protein A columns for the treatment of rheumatoid arthritis (RA) under the following conditions:
o Patient has severe RA. Patient disease is active, having >5 swollen joints, >20 tender joints, and morning stiffness >60 minutes.
o Patient has failed an adequate course of a minimum of 3 Disease Modifying Anti-Rheumatic Drugs (DMARDs). Failure does not include intolerance.
• Other uses of these columns are currently considered to be investigational and, therefore, not reasonable and necessary under the Medicare law. (See §1862(a)(1)(A) of the Act.)
Claims Processing Instructions
• TN 1811 (Medicare Intermediary Manual)
• TN 1679 (Medicare Carriers Manual)
Coverage Transmittal Link
• http://www.cms.gov/transmittals/downloads/R127CIM.pdf
National Coverage Analyses (NCAs)
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.
• Original consideration for Extracorporeal Immunoadsorption Using Protein A Columns for Rheumatoid Arthritis (CAG-00057N)