LCD L33431

Coverage Guidance

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

Indications and Limitations of Coverage

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 &ldquo;patient characteristics/health status&rdquo; 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

N/A

Associated Information

Documentation Requirements

When the documentation does not meet the criteria for the service rendered or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary.

Utilization Guidelines

A. Up to 1 additional test per 3 month period for Diabetes Mellitus out of control.

B. Up to 1 monthly test for pregnant Type I diabetic patients.

Bibliography

American Diabetes Association. Older Adults. Diabetes Care. 2016;39(Supp 1):S81-S85.

American Diabetes Association. Prevention or Delay of Type 2 Diabetes. Diabetes Care. 2016;39(Supp 1):S36-S38.

American Diabetes Association. Standards of medical care in diabetes-2013. Diabetes Care. 2013;36(Supp 1):S11-S66.

Goldstein DE, Little RR, Lorenz RA, et al. Tests of glycemia in diabetes. Diabetes Care. 2004;27(7):1761-1773.

Sacks DB, Arnold M, Bakris GL, et al. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clinical Chemistry. 2011;57(6):e1-e47.

Wisconsin diabetes mellitus essential care guidelines 2012. Wisconsin Diabetes Prevention and Control Program. 2012.