Coding Analysis for Labs (CAL) Tracking Sheet

Glycated Hemoglobin/Glycated Protein (Addition of CPT Code 83037, Hemoglobin; glycosylated [A1c] by device cleared by FDA for home use)

CAG-00373N

Issue

CMS received an external request to add CPT code 83037—Hemoglobin; glycosylated (A1c) by device cleared by FDA for home use—as a HCPCS code encompassed under the national coverage determination (NCD) on glycated hemoglobin/glycated protein testing at section 190.21 of the Medicare National Coverage Determination Manual (NCDM).  

Section 190.21 of the NCDM states that glycated hemoglobin testing is used “to assess long-term glucose control in diabetes.”  The NCDM includes alternate names for this testing which include, “glycated or glycosylated hemoglobin or Hgb, hemoglobin glycated or glycosylated protein, and fructosamine.”

We believe that the CPT code 83037—Hemoglobin; glycosylated (A1c) by device cleared by FDA for home use—may flow from this narrative description of the tests for which the policy contained section 190.21 of the NCDM applies.

We seek public comments on the request to add code 83037 to the list of HCPCS codes applicable to the glycated hemoglobin NCD.

Benefit Category

Diagnostic Laboratory Tests

Requestor Information

Requestor Name Requestor Letter
Michael Allen View Letter
Metrika, Inc. N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
01/26/2007
Expected CAL Completion Date
04/26/2007
Public Comment Period
01/26/2007 - 02/25/2007
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
04/02/2007

Contacts

Lead Analysts
Maria Ciccanti
Kelly Anderson
Lead Medical Officers
Jim Rollins, MD, MSHA, PhD

Medicare Benefit Category Determination Date

Actions Taken

January 26, 2007

CMS accepts a request to add CPT code 83037 as a HCPCS code encompassed under the glycated hemoglobin national coverage determination.

The 30-day public comment period begins with this date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the test under consideration.

April 2, 2007

CMS posts the decision.