Centers for Medicare & Medicaid Services

Content Section

Publication Number

100-3

Manual Section Number

20.5

Version Number

Effective Date of this Version

1/1/2001

Implementation Date

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:

Patient has severe RA. Patient disease is active, having >5 swollen joints, >20 tender joints, and morning stiffness >60 minutes.
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.)

Transmittal Number

127

Transmittal Link

http://www.cms.hhs.gov/transmittals/downloads/R127CIM.pdf

Revision History

04/1991 - Covered use of protein A columns. Effective date 05/06/1991. (TN 46)

10/2000 - Covered for patients with severe active rheumatoid arthritis. Effective and implementation dates 01/01/2001. (TN 127) (CR 1005)

Claims Processing Instructions

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.