TL;DR: The Centers for Medicare & Medicaid Services modified NCD 331 governing FDG PET imaging for oncologic conditions, effective February 19, 2026. The biggest structural change ended the prospective data collection requirement under Coverage with Evidence Development (CED) for all oncologic uses — here's what that means for your billing team.
This CMS FDG PET coverage policy update under NCD 331 Medicare closes a chapter that started in 2013. The National Oncologic PET Registry (NOPR) CED requirement — which had required participating providers to submit data prospectively to justify coverage — is officially done. FDG PET billing for oncologic indications now operates under standard coverage rules without that registry overhead.
| Field | Detail |
|---|---|
| Payer | CMS (Centers for Medicare & Medicaid Services) |
| Policy | Positron Emission Tomography (FDG) for Oncologic Conditions |
| Policy Code | NCD 331 |
| Change Type | Modified |
| Effective Date | February 19, 2026 (CED framework ended for dates of service on/after June 11, 2013) |
| Impact Level | High — eliminates CED data collection burden across all oncologic PET indications |
| Specialties Affected | Oncology, Nuclear Medicine, Radiology, Radiation Oncology, Surgical Oncology |
| Key Action | Remove NOPR registry enrollment from your FDG PET workflow and confirm documentation aligns with the medical necessity criteria now carrying the full coverage weight |
CMS FDG PET Coverage Criteria and Medical Necessity Requirements 2026
The core of the CMS FDG PET coverage policy hasn't changed — what changed is how you prove compliance with it. The CED registry is gone. Medical necessity documentation now does all the work.
CMS continues to cover one FDG PET study for beneficiaries with biopsy-proven or strongly suspected cancer. The treating physician must determine the scan is needed for the initial anti-tumor treatment strategy. That determination must fall into one of three specific purposes.
The three covered purposes for initial anti-tumor treatment strategy:
| # | Covered Indication |
|---|---|
| 1 | To determine whether the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure |
| 2 | To determine the optimal anatomic location for an invasive procedure |
| 3 | To determine the anatomic extent of tumor when the recommended anti-tumor treatment depends on that extent |
All three of those gates still apply. The difference is that your documentation now has to carry those criteria on its own — there's no NOPR data submission acting as a secondary safety net for coverage. Your medical necessity documentation is the only thing standing between you and a claim denial.
CMS's position on why FDG PET reimbursement is justified: the evidence shows FDG PET results are useful in determining appropriate initial anti-tumor treatment strategy, improve health outcomes, and meet the "reasonable and necessary" standard under §1862(a)(1)(A) of the Social Security Act. That statutory anchor is worth knowing — it's the legal basis for coverage, and it's what a Medicare Administrative Contractor (MAC) will reference if coverage is disputed.
This policy does not involve prior authorization in the traditional sense. But don't confuse the absence of a formal prior authorization requirement with a low bar for documentation. The medical necessity criteria are specific, and MACs will scrutinize claims against them.
This update also does not change coverage for PET imaging using NaF-18 (fluorine-18 labeled sodium fluoride), ammonia N-13, or rubidium-82 (Rb-82). Those radiopharmaceuticals operate under separate coverage frameworks. Make sure your billing team doesn't inadvertently apply this update to those agents.
CMS FDG PET Exclusions and Non-Covered Indications
Not every oncologic use of FDG PET gets a green light. CMS maintains specific carve-outs where national coverage does not apply.
Breast cancer: FDG PET is nationally covered only for staging distant metastasis in breast cancer. It is not covered for other staging purposes in breast cancer under this NCD.
Melanoma: FDG PET is covered for initial anti-tumor treatment strategy in melanoma — except for evaluation of regional lymph nodes. That specific use is excluded.
The policy establishes a tiered structure: some indications are nationally covered, some are nationally non-covered, and some fall to local coverage determination (LCD) — meaning your MAC decides. If your patient population includes cancers where FDG PET coverage is not nationally confirmed, check your MAC's LCD before billing. Assuming national coverage applies universally will generate denials.
The distinction between "nationally non-covered" and "covered at MAC discretion" matters for billing. Nationally non-covered indications cannot be overridden by local policy. MAC-discretion indications can be covered if your MAC's LCD says so. Know which bucket your indication falls into before the claim goes out.
Coverage Indications at a Glance
| Indication | Status | Notes |
|---|---|---|
| Initial anti-tumor treatment strategy — general (biopsy-proven or strongly suspected cancer) | Covered | One FDG PET study; treating physician must determine necessity for one of three specific purposes |
| Breast cancer — staging distant metastasis | Covered | Only this specific use; other breast cancer staging not nationally covered |
| Breast cancer — other staging uses | Not Covered (nationally) | Check MAC LCD for any local coverage |
| Melanoma — initial anti-tumor treatment strategy | Covered | Excludes evaluation of regional lymph nodes |
| Melanoma — regional lymph node evaluation | Not Covered (nationally) | Excluded from coverage under this NCD |
| All other oncologic indications — CED/NOPR data collection | No longer required | CED requirement ended for dates of service on/after June 11, 2013; confirmed by this update |
| PET with NaF-18, ammonia N-13, or rubidium-82 | Not addressed by this NCD | Separate coverage frameworks apply; this update does not change those |
| Suspected cancer without biopsy proof or strong diagnostic basis | Not Covered | Physician must document biopsy-proven or strongly suspected cancer |
CMS FDG PET Billing Guidelines and Action Items 2026
The CED requirement is gone. That's the headline. But the work your billing team needs to do right now is less about celebration and more about making sure your documentation processes don't have a gap where NOPR used to be.
| # | Action Item |
|---|---|
| 1 | Remove NOPR registry enrollment from your FDG PET ordering workflow immediately. If your physicians or ordering staff have been prompted to enroll patients in NOPR as part of the FDG PET ordering process, that step is obsolete. Delete it from your intake forms, EHR order sets, and any pre-authorization checklists. |
| 2 | Audit your FDG PET documentation templates against the three medical necessity criteria. Your notes need to explicitly document which of the three purposes applies: candidate determination for an invasive procedure, optimal anatomic location for an invasive procedure, or tumor extent for treatment planning. Generic "staging" language isn't enough. |
| 3 | Confirm your MAC's LCD for any oncologic indications not nationally covered. For breast cancer indications outside distant metastasis staging, melanoma regional lymph node evaluation, and any cancer type not addressed in CMS's national coverage table, pull your MAC's active LCD before billing. Don't assume national coverage applies. |
| 4 | Update your charge capture and documentation training materials to reflect the February 19, 2026 effective date. Any internal billing guidelines referencing NOPR or CED requirements for oncologic FDG PET are now outdated. Update them before your next billing cycle touches claims with dates of service after this effective date. |
| 5 | Verify that your team isn't misapplying this update to NaF-18, ammonia N-13, or Rb-82 PET studies. This NCD 331 update applies specifically to FDG (2-[F18] fluoro-2-deoxy-D-glucose). The other radiopharmaceuticals have separate coverage rules. Mixed radiopharmaceutical use in your patient population is a common source of miscoding. |
| 6 | Brief your oncology physicians on the documentation shift. With CED gone, the physician's determination of medical necessity is the primary coverage justification. If your physicians are used to NOPR providing a coverage safety net, they need to know that documentation quality now carries that load entirely. |
If your practice has a high volume of FDG PET claims across multiple cancer types, talk to your compliance officer before finalizing updated billing guidelines. The line between nationally covered and MAC-discretion indications can generate claim denial risk if your team draws it wrong.
| 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 FDG PET Under NCD 331
The policy data for NCD 331 (version 4) does not list specific CPT or HCPCS codes within the coverage document itself.
For FDG PET billing, the relevant procedure codes are typically found in CMS's claims processing instructions and your MAC's billing guidelines rather than the NCD text. Common codes associated with FDG PET oncologic imaging — such as those in the 78xxx nuclear medicine range — should be confirmed through your MAC's LCD and the current Medicare Physician Fee Schedule. Do not rely on this NCD alone to determine which procedure codes to submit.
Confirm your codes with your MAC or a qualified billing consultant before updating your charge capture. Applying outdated or incorrect codes to FDG PET claims is a straightforward path to claim denial and potential overpayment recovery.
Get the Full Picture
Track this policy across versions, search 1,500+ policies by CPT code, and get real-time alerts when any payer changes coverage.