HbA1c

LCD Information Document Information Source LCD ID N/A LCD ID L33431 Original ICD-9 LCD ID Not Applicable LCD Title HbA1c Proposed LCD in Comment Period N/A Source Proposed LCD N/A Original Effective Date For services performed on or after 10/01/2015 Revision Effective Date For services performed on or after 09/18/2025 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date N/A Notice Period End Date N/A CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. CPT is a registered trademark of the American Medical Association. 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Issue Issue Description This LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations and/or Medical Necessity. Issue - Explanation of Change Between Proposed LCD and Final LCD CMS National Coverage Policy Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 3, §190.21 Glycated Hemoglobin/Glycated Protein Coverage Indications, Limitations, and/or Medical Necessity Hemoglobin A1c (HbA1c) refers to the major component of hemoglobin A1.Performance of the HbA1c test at least 2 times a year in patients who are meeting treatment goals and who have stable glycemic control is supported by the American Diabetes Association Standards of Medical Care in Diabetes - 2016 (ADA Standards).1 For beneficiaries with stable glycemic control (defined as 2 consecutive HbA1c results meeting the treatment goals) performing the HbA1c test at least 2 times a year may be considered reasonable and necessary. The ADA framework for considering treatment goals recognizes that “patient characteristics/health status” are important factors when considering glycemic goals.2 Beneficiaries eligible for the Medicare home health benefit, for example, often have multiple coexisting chronic illnesses that would support a higher target goal for the HbA1c (e.g., < 8.5%), in order to avoid adverse events (e.g., hypoglycemia-related emergency department visits and acute inpatient hospitalization). Palmetto GBA will allow 1 additional HbA1c test every 3 months for a total of 8 tests per year in patients with uncontrolled blood glucose levels. Additional tests beyond that frequency may be reimbursed on appeal with appropriate documentation of medical necessity.HbA1c may be inaccurate in certain situations including anemia, transfusions, hemoglobinopathies and conditions of rapid red cell turnover. Other tests to assess diabetes, including glucose, glycated protein, or fructosamine levels, may be used and are described in the Lab National Coverage Determination 190.21 (NCD for Glycated Hemoglobin / Glycated Protein). This NCD lists the ICD-10 codes for HbA1c for frequencies up to once every 3 months. Summary of Evidence N/A Analysis of Evidence (Rationale for Determination) N/A

Hemoglobin A1c (HbA1c) refers to the major component of hemoglobin A1. Performance of the HbA1c test at least 2 times a year in patients who are meeting treatment goals and who have stable glycemic control is supported by the American Diabetes Association Standards of Medical Care in Diabetes - 2016 (ADA Standards). 1 For beneficiaries with stable glycemic control (defined as 2 consecutive HbA1c results meeting the treatment goals) performing the HbA1c test at least 2 times a year may be considered reasonable and necessary. The ADA framework for considering treatment goals recognizes that “patient characteristics/health status” are important factors when considering glycemic goals. 2 Beneficiaries eligible for the Medicare home health benefit, for example, often have multiple coexisting chronic illnesses that would support a higher target goal for the HbA1c (e.g., Palmetto GBA will allow 1 additional HbA1c test every 3 months for a total of 8 tests per year in patients with uncontrolled blood glucose levels. Additional tests beyond that frequency may be reimbursed on appeal with appropriate documentation of medical necessity. HbA1c may be inaccurate in certain situations including anemia, transfusions, hemoglobinopathies and conditions of rapid red cell turnover. Other tests to assess diabetes, including glucose, glycated protein, or fructosamine levels, may be used and are described in the Lab National Coverage Determination 190.21 (NCD for Glycated Hemoglobin / Glycated Protein). This NCD lists the ICD-10 codes for HbA1c for frequencies up to once every 3 months.