TL;DR: The Centers for Medicare & Medicaid Services modified NCD 100, its glycated hemoglobin/glycated protein coverage policy, effective March 7, 2026. Here's what changes for billing teams.
This update to NCD 100 in the CMS Medicare system affects how often you can bill glycated hemoglobin and glycated protein tests for diabetic patients — including tighter frequency limits for controlled patients, specific exceptions for pregnant women, and documentation requirements when testing exceeds four times per year. The policy does not list specific CPT or HCPCS codes. Your team will need to map your charge capture to the clinical criteria spelled out in the updated national coverage determination.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | CMS (Centers for Medicare & Medicaid Services) |
| Policy | Glycated Hemoglobin/Glycated Protein |
| Policy Code | NCD 100 |
| Change Type | Modified |
| Effective Date | March 7, 2026 |
| Impact Level | Medium — high volume test with specific frequency limits that drive claim denial risk |
| Specialties Affected | Endocrinology, primary care, internal medicine, OB/GYN (diabetic pregnancy), clinical laboratory |
| Key Action | Audit your billing frequency for glycated hemoglobin and glycated protein tests against the updated per-patient criteria before March 7, 2026 |
CMS Glycated Hemoglobin Coverage Criteria and Medical Necessity Requirements 2026
The CMS glycated hemoglobin/glycated protein coverage policy covers these tests as medically necessary for managing and controlling diabetes. CMS also recognizes medical necessity for assessing hyperglycemia, a history of hyperglycemia, and dangerous hypoglycemia.
The real issue here is frequency. CMS draws a hard line: for controlled diabetic patients, glycated hemoglobin testing is covered no more than once every three months. That's four times per year, max — unless you have documentation that justifies more.
When More Frequent Testing Is Covered
CMS allows testing every one to two months when a patient's diabetes regimen has changed to improve control. It's also allowed when intercurrent events — major surgery, glucocorticoid therapy — have disrupted a previously stable patient. In those cases, you need documentation that shows why the standard quarterly schedule wasn't appropriate.
For diabetic pregnant women, glycated protein (fructosamine) testing is covered monthly. That's a specific carve-out, and it applies to glycated protein — not glycated hemoglobin. The clinical reason is that glycated protein measures glycemic control over one to two weeks, making it the better tool for the rapid metabolic shifts of pregnancy.
Testing Beyond Four Times Per Year
Testing more than four times per year for uncontrolled type 1 or type 2 diabetes can be covered. But "uncontrolled" isn't self-evident on a claim. Your documentation must show the clinical basis for that frequency. CMS is explicit: medical necessity documentation must support any testing that exceeds the standard guidelines. Without it, you're looking at a claim denial.
Glycated Protein as an Alternative
Glycated protein — also called fructosamine — is covered as an alternative to glycated hemoglobin in specific situations. If a patient has hemolytic anemia or a hemoglobinopathy, standard glycated hemoglobin assays may produce unreliable results due to interference from elevated fetal hemoglobin or variant hemoglobin molecules. In those cases, glycated protein is the appropriate test and is covered.
When a glycated hemoglobin assay is run first and the lab identifies a possible analytical interference, the lab should inform the ordering physician. At that point, switching to glycated protein testing is clinically and coverage-justified.
CMS Glycated Hemoglobin Exclusions and Non-Covered Indications
CMS does not cover glycated hemoglobin testing more than once every three months for a controlled diabetic patient when the sole purpose is confirming stable metabolic control. There's no medical necessity basis for that frequency when the patient is on target.
Monthly glycated hemoglobin or glycated protein testing is not covered for the general diabetic population. The monthly frequency applies only to diabetic pregnant women, and only for glycated protein.
Testing without documentation to support medical necessity — especially when frequency exceeds four times per year — is not considered reasonable and necessary. If you can't show in the medical record why the patient needed more frequent testing, the reimbursement risk falls on your practice.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Glycated hemoglobin testing for controlled diabetic patients | Covered | Not specified by policy | Covered up to every 3 months (4x/year max) |
| Glycated hemoglobin testing for uncontrolled type 1 or type 2 diabetes | Covered | Not specified by policy | More than 4x/year allowed; medical necessity documentation required |
| Glycated hemoglobin testing every 1–2 months after regimen change | Covered | Not specified by policy | Document the specific regimen change or intercurrent event |
| Glycated hemoglobin testing every 1–2 months after major surgery or glucocorticoid therapy | Covered | Not specified by policy | Intercurrent event must be documented in the medical record |
| Glycated protein (fructosamine) monthly for diabetic pregnant women | Covered | Not specified by policy | Monthly covered; glycated hemoglobin monthly is not |
| Glycated protein as alternative in hemolytic anemia or hemoglobinopathy | Covered | Not specified by policy | Use when glycated hemoglobin assay shows analytical interference |
| Glycated hemoglobin testing more often than every 3 months for controlled patients | Not Covered | Not specified by policy | Exceeds frequency limits; claim denial risk |
| Glycated hemoglobin or protein testing monthly for general (non-pregnant) diabetic patients | Not Covered | Not specified by policy | Monthly frequency does not apply to the general diabetic population |
CMS Glycated Hemoglobin Billing Guidelines and Action Items 2026
| # | Action Item |
|---|---|
| 1 | Audit your current billing frequency per patient before March 7, 2026. Pull a report of all glycated hemoglobin and glycated protein claims over the past 12 months. Flag any patient with more than four tests per year and confirm each has medical necessity documentation in the chart. |
| 2 | Update your charge capture workflow to flag high-frequency orders. Build a check into your order entry or billing system that alerts your team when a glycated hemoglobin or glycated protein order would exceed the quarterly limit for a controlled patient. Stop the problem before the claim goes out. |
| 3 | Verify that pregnant diabetic patients are being billed for glycated protein, not glycated hemoglobin, when monthly testing is indicated. The monthly frequency carve-out applies specifically to glycated protein. If your providers are ordering glycated hemoglobin monthly for this population, that's a claim denial waiting to happen. |
| 4 | Review your documentation templates for intercurrent events and regimen changes. If a patient had major surgery or started glucocorticoid therapy, the medical record needs to explicitly connect those events to the decision to test more frequently. "Ordered per physician" doesn't cut it. The note should say why. |
| 5 | Train your ordering providers on the interference rule. When a lab flags analytical interference on a glycated hemoglobin assay — particularly in patients with hemolytic anemia or hemoglobinopathy — the ordering physician needs to know that switching to glycated protein is the covered path. The lab's notification should trigger a documented clinical decision, not just a reflexive reorder. |
| 6 | Know that prior authorization is not mentioned in this policy for routine testing. NCD 100 does not impose a prior authorization requirement for glycated hemoglobin or glycated protein testing. But your Medicare Administrative Contractor may have a local coverage determination that adds requirements. Check your MAC's LCD for any regional billing guidelines that layer on top of this national policy. |
| 7 | Talk to your compliance officer if your patient mix includes high proportions of uncontrolled diabetics. Testing more than four times per year is allowed for uncontrolled type 1 or type 2 diabetes — but "uncontrolled" has to be supportable in the chart. If your practice bills at high frequency for a significant portion of your diabetic population, get your compliance officer involved before the effective date to review documentation standards. |
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
CPT, HCPCS, and ICD-10 Codes for Glycated Hemoglobin/Glycated Protein Under NCD 100
A Note on Codes
NCD 100 does not specify any CPT, HCPCS, or ICD-10 codes. Code mapping for this policy must come from your applicable Medicare Administrative Contractor's local coverage determination or billing guidelines — not from the national policy itself.
Do not assign codes to this NCD without MAC validation. A mismatched code-to-policy mapping is a fast path to a claim denial — and potentially a reopened claim audit if the pattern repeats.
Check your MAC's LCD for the definitive code list that aligns with this coverage policy. If you're unsure which MAC jurisdiction applies to your practice, CMS publishes the full MAC contractor map at cms.gov.
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