CMS Updates FDG PET Coverage Policy for Oncologic Conditions (NCD 331)

CMS has modified its National Coverage Determination for Positron Emission Tomography using FDG (2-[F18] fluoro-2-deoxy-D-glucose) for oncologic conditions under NCD 331. The update formalizes the end of prospective data collection requirements under Coverage with Evidence Development (CED) through the National Oncologic PET Registry (NOPR), a shift that has significant implications for how facilities document and submit claims for FDG PET studies. Billing teams serving oncology, nuclear medicine, and radiology practices need to understand what's covered, what remains non-covered, and how documentation requirements have evolved.

What Changed in CMS NCD 331: End of NOPR Registry Requirements

The most operationally significant change in this policy update is the formal elimination of prospective data collection requirements under CED for all oncologic uses of FDG PET imaging. Previously, coverage for many FDG PET indications was conditioned on the ordering physician enrolling the case in the NOPR registry and submitting prospective data. That requirement is now gone for all oncologic indications, effective for claims with dates of service on and after June 11, 2013.

This change was driven by a CMS reconsideration request from NOPR itself, supported by public input indicating the registry had fulfilled its evidence-development purpose. CMS agreed the existing evidence base is now sufficient to evaluate FDG PET's clinical utility across oncologic uses without ongoing prospective data collection.

For revenue cycle teams, this means any internal workflows, order sets, or intake checklists that included NOPR registry steps should be updated immediately. Failure to update these processes won't necessarily result in a denial today, but outdated documentation requirements create unnecessary administrative burden and audit risk.

CMS FDG PET Coverage: Initial Anti-Tumor Treatment Strategy

The Centers for Medicare & Medicaid Services continues to nationally cover one FDG PET study for beneficiaries with biopsy-proven cancer or cancer strongly suspected based on other diagnostic testing, when the treating physician determines the study is needed for the initial anti-tumor treatment strategy.

To meet medical necessity under this coverage framework, the FDG PET study must serve at least one of these three purposes:

• Determine whether the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure
• Determine the optimal anatomic location for an invasive procedure
• Determine the anatomic extent of tumor when the recommended anti-tumor treatment reasonably depends on that extent

The treating physician's determination is central here. Documentation must reflect a clear clinical rationale tied to one of these three purposes — not simply that the patient has cancer. Vague or generic language in the ordering documentation ("evaluate for cancer") is insufficient for medical necessity support and will expose claims to denial on post-payment review.

Cancer-Specific Coverage Rules Under NCD 331

CMS does not apply a single blanket rule across all cancer types. Several tumor types carry specific coverage parameters that billing teams must know at the line-item level.

Covered with Conditions:

• Breast cancer (male and female): FDG PET for initial anti-tumor treatment strategy is nationally covered only when used in staging distant metastasis. It is not covered for initial staging of axillary lymph nodes in early-stage disease.
• Melanoma: FDG PET for initial anti-tumor treatment strategy is nationally covered except for evaluation of regional lymph nodes.

These cancer-specific carve-outs are a common source of denied claims. A claim submitted for FDG PET to evaluate regional nodes in a melanoma patient, or to stage axillary nodes in an early-stage breast cancer patient, does not meet national coverage criteria under NCD 331 — regardless of how strong the clinical rationale appears in the documentation.

What FDG PET Scans Are NOT Covered Under NCD 331

NCD 331 is explicit that some imaging uses remain outside national coverage. Billing teams should note:

• FDG PET imaging using NaF-18 (fluorine-18 labeled sodium fluoride), ammonia N-13, or rubidium-82 (Rb-82) is outside the scope of this NCD entirely — this policy does not change coverage for those radiopharmaceuticals.
• Breast cancer FDG PET that is not tied to staging of distant metastasis is not covered under the initial anti-tumor treatment strategy framework.
• Melanoma FDG PET specifically for evaluation of regional lymph nodes is not covered.

When submitting claims for diagnoses where coverage is conditional, ensure the claim documentation and supporting notes explicitly address the covered indication — not just the diagnosis.

Affected Codes

The policy document for NCD 331 (v4) does not list specific CPT or HCPCS codes within the published policy data. No ICD-10-CM codes are specified in the policy data for this NCD version.

For the applicable procedure codes used to bill FDG PET studies, billing teams should cross-reference their Medicare Administrative Contractor's (MAC) local coverage articles, which typically map the covered NCD indications to the relevant HCPCS codes for PET imaging. Your MAC's corresponding Local Coverage Article (LCA) is the authoritative source for code-level billing guidance under this NCD.

If your practice management system or clearinghouse flags FDG PET claims for CED-related edits, those edits should be reviewed and retired — the CED requirement no longer applies to oncologic indications under this NCD.

What Your Billing Team Should Do