CMS Updates NGS Coverage Policy Under NCD 372: What Billing Teams Need to Know for 2026
The Centers for Medicare & Medicaid Services has modified its National Coverage Determination for Next Generation Sequencing (NGS) diagnostic laboratory tests under NCD 372, with an effective date of March 12, 2026. This policy governs Medicare coverage of NGS testing for both somatic (acquired) and germline (inherited) cancer—and the coverage criteria are highly specific, with strict patient eligibility requirements that directly affect whether a claim gets paid or denied. If your practice or lab bills NGS testing to Medicare, your team needs to understand exactly where the coverage lines are drawn.
| Field | Detail |
|---|---|
| Payer | CMS (Centers for Medicare & Medicaid Services) |
| Policy | Next Generation Sequencing (NGS) |
| Policy Code | NCD 372 (372-v2) |
| Change Type | Modified |
| Effective Date | 2026-03-12 |
| Impact Level | High |
| Specialties Affected | Oncology, Hematology/Oncology, Gynecologic Oncology, Breast Surgery, Clinical Laboratory, Pathology, Genetic Counseling |
| Key Action | Audit NGS ordering workflows and documentation to confirm all patient eligibility criteria—cancer stage, prior test history, and FDA approval status—are captured before the claim is submitted. |
What NCD 372 Covers: CMS NGS Coverage Requirements by Cancer Type
NCD 372 establishes national coverage for NGS diagnostic laboratory tests under two distinct clinical pathways: somatic (acquired) cancer and germline (inherited) cancer. These are not interchangeable—each pathway has its own eligibility criteria, and a claim that meets somatic criteria does not automatically satisfy germline requirements, or vice versa.
The policy falls under the Medicare benefit categories of Diagnostic Laboratory Tests, Diagnostic Services in Outpatient Hospital, and Diagnostic Tests (other). Coverage in all cases requires that the test be performed in a CLIA-certified laboratory and ordered by a treating physician—not a consulting physician or a patient-initiated order.
CMS NGS Coverage Criteria for Somatic (Acquired) Cancer
For somatic cancer, Medicare coverage under NCD 372 has been effective for services on or after March 16, 2018. To qualify, the patient must meet all three of the following conditions:
| # | Covered Indication |
|---|---|
| 1 | The patient has either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer |
| 2 | The patient has not been previously tested with the same NGS test for the same cancer genetic content |
| 3 | The patient has decided to seek further cancer treatment—for example, therapeutic chemotherapy |
The test itself must also meet three separate requirements:
| # | Covered Indication |
|---|---|
| 1 | FDA approval or clearance as a companion in vitro diagnostic |
| 2 | An FDA-approved or cleared indication for use in that patient's specific cancer type |
| 3 | Results delivered to the treating physician using a report template that specifies treatment options |
Every one of these criteria must be satisfied. A test that has FDA approval but lacks a specific indication for the patient's cancer type is non-covered under this NCD. Similarly, a patient who meets the cancer-stage threshold but has previously received the same NGS test for the same genetic content is explicitly excluded.
CMS NGS Coverage Criteria for Germline (Inherited) Cancer
Germline coverage under NCD 372 is more narrowly defined. Effective for services on or after January 27, 2020, Medicare covers germline NGS testing when the patient meets all four of these conditions:
- The patient has ovarian or breast cancer
- There is a clinical indication for germline testing for hereditary breast or ovarian cancer (HBOC)
- The patient has a documented risk factor for germline breast or ovarian cancer
- The patient has not been previously tested with the same germline NGS test for the same germline genetic content
The test must have FDA approval or clearance (companion diagnostic designation is not required for germline), and results must be provided to the treating physician via a report template that specifies treatment options.
Note that germline coverage is currently limited to breast and ovarian cancer—not all hereditary cancer syndromes. Patients with hereditary colorectal cancer, Lynch syndrome, or other germline indications are not covered under the national determination and would fall to MAC-level discretion.
What Is Non-Covered Under NCD 372
CMS has explicitly designated non-coverage for somatic NGS testing when a patient does not meet the criteria in section B.1 of the NCD. This is not a gray area—it is a nationally non-covered indication, effective March 16, 2018.
Practically speaking, this means claims for somatic NGS on patients with early-stage cancer (stage I or II without recurrence), patients who have already received the same test for the same genetic content, or patients who are not pursuing further treatment will be denied at the national level. No MAC discretion applies in those scenarios.
For NGS applications outside of somatic and germline cancer—including RNA sequencing and protein analysis—MACs retain discretion to determine coverage independently. Billing teams working in multiple MAC jurisdictions should verify local coverage determinations (LCDs) in addition to this NCD.
MAC Discretionary Coverage: Advanced Cancer Without FDA-Approved Tests
There is an important middle tier worth flagging. For patients with advanced cancer who do not have access to an FDA-approved NGS companion diagnostic for their specific cancer type, MACs may—at their discretion—determine coverage when the test is performed in a CLIA-certified lab and ordered by a treating physician. The full MAC criteria were not included in the truncated policy summary, but billing teams should verify their specific MAC's LCD for this pathway before assuming coverage.
This MAC-level discretion is particularly relevant for rare cancers and tumor types where FDA-approved companion diagnostics may not yet exist.
| 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 |
Affected Codes
The NCD 372 (372-v2) policy document does not list specific CPT or HCPCS codes within the covered data provided. Billing teams should reference their MAC's applicable LCD and associated Billing and Coding Articles to identify the specific procedure codes—such as those in the 81000 series for molecular pathology—that align with these coverage criteria. Do not assume code-level coverage without verifying against current LCD guidance in your jurisdiction.
Related ICD-10 Diagnosis Codes: The policy document does not enumerate specific ICD-10-CM codes. Diagnosis coding should reflect the patient's confirmed cancer type, stage, and recurrence status to support medical necessity documentation aligned with the criteria above.
What Your Billing Team Should Do
| # | Action Item |
|---|---|
| 1 | Audit your NGS prior-authorization and documentation workflow immediately. Before March 12, 2026, confirm that your intake process captures all required data points: cancer stage, recurrence/relapse/refractory status, prior NGS test history for the same genetic content, patient intent to pursue treatment, FDA approval status of the specific test, and treating physician order. Missing any one of these will result in a denial. |
| 2 | Build a "prior test" check into your ordering system. The prohibition on retesting with the same NGS test for the same cancer genetic content is a hard exclusion—both for somatic and germline pathways. If your EHR or LIS does not flag prior NGS results at the time of a new order, implement a manual review step now to prevent duplicate-test denials. |
| 3 | Verify FDA companion diagnostic status for every somatic NGS test before billing. The somatic coverage pathway requires FDA approval or clearance as a companion in vitro diagnostic with an indication specific to the patient's cancer. Maintain an internal reference list of FDA-approved NGS companion diagnostics and update it quarterly as approvals change. |
| 4 | For germline testing, confirm breast or ovarian cancer diagnosis and documented HBOC risk factors in the medical record. CMS auditors will look for clinical indication and risk factor documentation—not just a physician order. Make sure the ordering physician's notes explicitly support both criteria before the claim goes out. |
| 5 | Check your MAC's LCD for advanced cancer cases without FDA-approved tests. If you serve patients with rare tumors or cancer types lacking FDA-cleared NGS companion diagnostics, contact your MAC or review current LCDs to determine whether local discretionary coverage applies and what additional documentation is required. |
| 6 | Train genetic counselors and oncology schedulers on coverage boundaries. The difference between covered germline indications (breast and ovarian cancer) and non-covered hereditary cancer syndromes (e.g., Lynch syndrome) is a frequent source of patient and staff confusion. A brief training update before the effective date will reduce avoidable prior-authorization requests and denial volume. |
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