National Coverage Determination (NCD)

Extracorporeal Immunoadsorption (ECI) Using Protein A Columns

20.5

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Tracking Information

Publication Number
100-3
Manual Section Number
20.5
Manual Section Title
Extracorporeal Immunoadsorption (ECI) Using Protein A Columns
Version Number
1
Effective Date of this Version
01/01/2001
Ending Effective Date of this Version
01/01/2021
Implementation Date
01/01/2001

Description Information

Benefit Category
Outpatient Hospital Services Incident to a Physician's Service


Please 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 Information

Transmittal Number
127
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)

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)

05/2014 - 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)

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)

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)

02/2018 - This Change Request (CR) constitutes a maintenance update of International Code of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 2033) (CR10473)

02/2018 - Transmittal 2033, dated February 16, 2018, is being rescinded and replaced by Transmittal 2039, dated, February 28, 2018 to correct instructions in business requirement 7, NCD210.3, Colorectal Cancer Screening, and its accompanying spreadsheet. All other information remains the same. (TN 2039) (CR10473)

10/2020 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, longstanding NCD process. (TN 10432) (CR12027)

12/2020 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, longstanding NCD process. (TN 10515) (CR12027)

01/2021 - Transmittal 10515, dated December 10, 2020, is being rescinded and replaced by Transmittal 10566, dated, January 14, 2021 to remove FISS Reason Codes (RCs) 59041, 59042, 59209, and 59210 from the spreadsheet for NCD 160.18. All other information remains the same. (TN 10566) (CR12027)

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.

Additional Information

Other Versions
Title Version Effective Between
Extracorporeal Immunoadsorption (ECI) Using Protein A Columns 2 01/01/2021 - 01/01/2021 View
Extracorporeal Immunoadsorption (ECI) Using Protein A Columns 1 01/01/2001 - 01/01/2021 You are here