Next Generation Sequencing (NGS) — NCD 372 | CMS Coverage Update

TL;DR: The Centers for Medicare & Medicaid Services modified NCD 372 governing Next Generation Sequencing (NGS) coverage, with an updated policy effective February 7, 2026. Here's what billing teams need to know before submitting claims.

CMS NGS coverage policy under NCD 372 Medicare sets national coverage rules for NGS diagnostic lab tests used in cancer care. This modification clarifies the criteria for somatic (acquired) and germline (inherited) cancer testing — and the distinctions matter enormously for medical necessity documentation and claim denial risk. The policy does not list specific CPT or HCPCS codes, so your code mapping depends on your lab's test lineup and FDA clearance status.

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Quick-Reference Table

Field	Detail Copy
Payer	CMS (Centers for Medicare & Medicaid Services)
Policy	Next Generation Sequencing (NGS) — NCD 372
Policy Code	NCD 372
Change Type	Modified
Effective Date	February 7, 2026
Impact Level	High
Specialties Affected	Oncology, Clinical Laboratory, Pathology, Genetic Counseling, Hematology/Oncology
Key Action	Audit documentation for all NGS claims to confirm FDA clearance, CLIA certification, treating physician orders, and patient eligibility criteria before submitting

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CMS Next Generation Sequencing Coverage Criteria and Medical Necessity Requirements 2026

NCD 372 is the National Coverage Determination governing Medicare coverage of NGS as a diagnostic laboratory test for cancer. It covers two distinct patient populations — somatic cancer and germline cancer — and each has its own medical necessity criteria. Get one criterion wrong and you're looking at a denied claim with limited appeal options.

Somatic (Acquired) Cancer Coverage

Coverage for somatic cancer has been in place since March 16, 2018. The CMS NGS coverage policy requires all of the following to be true before a claim is covered nationally.

The patient must have recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer. That's a defined list — early-stage cancer does not qualify under the national coverage determination. The patient also must not have been previously tested with the same NGS test for the same cancer genetic content. Repeat testing with the same test is non-covered.

The patient must also have decided to seek further cancer treatment — specifically, therapeutic chemotherapy or equivalent. A patient in hospice who is not pursuing active treatment does not meet this criterion.

On the test side, the NGS diagnostic lab test must carry FDA approval or clearance as a companion in vitro diagnostic. It must also have an FDA-approved or cleared indication for use in that patient's specific cancer type. And the results must be delivered to the treating physician using a report template that specifies treatment options. That last requirement is not optional — it's part of the coverage standard.

Germline (Inherited) Cancer Coverage

Germline coverage has been in place since January 27, 2020. Under this coverage policy, the patient must have ovarian or breast cancer specifically. This is a narrower population than somatic coverage. The patient must also have a clinical indication for germline testing for hereditary breast or ovarian cancer, plus a documented risk factor for hereditary breast or ovarian cancer.

Like somatic coverage, prior testing is a disqualifier. If the patient has already had the same germline NGS test for the same germline genetic content, the test is not covered again.

The test itself must have FDA approval or clearance. Results must go to the treating physician through a report template specifying treatment options — same documentation standard as somatic.

MAC-Level Coverage and Local Coverage Determinations

Here's where it gets complicated. CMS gives Medicare Administrative Contractors (MAC) authority to make local coverage determinations for NGS used in RNA sequencing and protein analysis. Those uses fall outside the national coverage determination entirely.

MACs can also cover NGS for advanced cancer patients outside the strict somatic criteria above — but only when the test is CLIA-certified, ordered by a treating physician, and meets specific patient conditions. Check your MAC's local coverage determination if your patients fall outside the national indications. What's covered in one MAC jurisdiction may not be covered in another.

If you're billing for NGS billing purposes across multiple MAC jurisdictions, build that LCD check into your pre-submission workflow now.

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CMS Next Generation Sequencing Exclusions and Non-Covered Indications

The national non-coverage rule for somatic cancer is straightforward: if a patient doesn't meet every criterion in section B.1 of NCD 372, the test is nationally non-covered. There's no partial credit here.

The most common disqualifiers are cancer stage (not stage III/IV, metastatic, or meeting the recurrence criteria), prior testing with the same test, and patients who are not pursuing further treatment. Any one of these alone triggers non-coverage.

For germline testing, non-coverage applies to cancer types other than breast or ovarian. If a patient has colorectal cancer and needs germline testing, national coverage under NCD 372 does not apply. Your MAC may have a local coverage determination, but you need to verify that separately before submitting.

NGS for RNA sequencing and protein analysis is not nationally covered under NCD 372 at all. CMS explicitly leaves that to MAC discretion. Do not submit those claims under national coverage — route them through your MAC's LCD process.

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Coverage Indications at a Glance

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CMS Next Generation Sequencing Billing Guidelines and Action Items 2026

The February 7, 2026 effective date means this modified policy is active now. Don't wait on these steps.

Copy Action Items

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CPT, HCPCS, and ICD-10 Codes for Next Generation Sequencing Under NCD 372

The policy data for NCD 372 does not list specific CPT, HCPCS, or ICD-10 codes. CMS did not include a code table in this version of the coverage policy.

This is actually a known issue with NGS billing. The NGS testing space evolves faster than code assignment, and multiple CPT codes can apply depending on test type, cancer type, and the number of genes analyzed. Your specific code selection depends on the test performed, the lab billing the claim, and the FDA clearance status of the test.

What to Do Without an Assigned Code List

Work directly with your CLIA-certified lab to identify the correct CPT codes for each NGS test they perform. The lab is the billing entity for the technical component in most cases, but if your practice bills the professional interpretation, code selection still matters on your end.

Cross-reference your code set against your MAC's local coverage determination for any advanced cancer or RNA sequencing use cases. MACs sometimes publish code lists in their LCDs even when CMS does not include them in the NCD.

If you're unsure whether a specific NGS test and its associated CPT code falls under NCD 372 or a local coverage determination, that's a question for your MAC's provider outreach line or your billing consultant — not something to guess on a claim.

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