RETIRED - Coverage Reminder - Insulin Pump Qualification: Beta Cell Autoantibody Testing


Content Provided on this page contains outdated information and instruction and should not be considered current. Noridian is providing this archived information for research purposes only. This archived article contains previously issued instructions that have since been updated or are no longer applicable for Medicare billing purposes.

Original Effective Date: 11/05/2009
Revision Effective Date: 11/01/2013

The Centers for Medicare & Medical Services (CMS) national coverage determination for infusion pumps (Internet-only Manual, Pub. 100-03, Chapter 1, Part 4, Section 280.14) and the External Infusion Pump local coverage determination (LCD) contain coverage criteria for continuous subcutaneous insulin infusions using an external insulin pump. Criterion B requires a positive beta cell autoantibody test. Recently the DME MACs have received questions about which tests are acceptable to meet the beta cell autoantibody coverage requirement.

There are a number of antibody tests available that are related to pancreatic cells and insulin. The following tests were recently reviewed to evaluate whether they would be acceptable in meeting the policy requirement:

  • Insulin Autoantibodies (IAA)
  • Islet Cell Cytoplasmic Autoantibodies
  • Glutamic Acid Decarboxylase Auto Antibodies (GADA)
  • GAD65 Autoantibodies
  • ICA512 Autoantibodies
  • Insulinoma-Associated-2 Autoantibodies (IA-2A)

After review, it has been determined that only Islet Cell Cytoplasmic Autoantibodies (ICA) would be acceptable to meet the beta cell autoantibody test requirement described in the External Infusion Pump LCD. The other listed tests would not be acceptable alternatives to justify reimbursement of an external insulin pump by Medicare.

Refer to the External Infusion Pumps LCD for additional information about coverage, coding and documentation of external insulin pumps and continuous subcutaneous insulin infusions.

Publication History

Date of Change Description
11/05/09 Originally Published
11/01/13 Revised
02/25/21 Retired. Refer to the LCD and LCD-related Policy Article for guidance.


Last Updated Dec 10 , 2023