CMS Won't Pay for Wrong-Site Surgery — Here's What NCD 328 Means for Your Claims
CMS has modified National Coverage Determination (NCD) 328, which governs Medicare's non-coverage policy for surgical or other invasive procedures performed on the wrong body part. This update, effective March 12, 2026, reinforces a long-standing billing reality: if a procedure is performed on the incorrect body part due to practitioner error, Medicare will not reimburse it — full stop. For billing teams and revenue cycle directors across virtually every surgical specialty, understanding exactly what triggers this non-coverage determination is essential to avoiding denied claims and compliance risk.
| Field | Detail |
|---|---|
| Payer | Centers for Medicare & Medicaid Services (CMS) |
| Policy | Surgical or Other Invasive Procedure Performed on the Wrong Body Part |
| Policy Code | NCD 328 |
| Change Type | Modified |
| Effective Date | 2026-03-12 |
| Impact Level | High |
| Specialties Affected | Surgery (all), Orthopedics/Spine, Cardiology, Interventional Radiology, Dermatology, Transplant, Urology, and any specialty performing invasive procedures |
| Key Action | Audit your informed consent workflows and wrong-site prevention protocols to ensure documentation clearly supports the body part actually treated. |
What NCD 328 Covers — and Why CMS Won't Pay for Wrong-Site Procedures
The Centers for Medicare & Medicaid Services does not cover any surgical or other invasive procedure performed on the wrong body part. The policy rationale is straightforward: a procedure performed on an incorrect site cannot be considered a "reasonable and necessary" treatment for the Medicare beneficiary's documented medical condition. Reasonable and necessary is the bedrock standard for Medicare coverage, and a wrong-site procedure fails it by definition.
This determination has roots in the National Quality Forum's (NQF) 2002 "Serious Reportable Events in Healthcare" consensus report, which established the concept of "never events" — adverse outcomes considered serious, largely preventable, and unacceptable in any care setting. Wrong-site surgery has remained on the NQF's never events list through all subsequent revisions, which now include 28 items. CMS aligned its coverage policy with this framework, making explicit that the Medicare program will not absorb the financial cost of these errors.
How CMS Defines "Wrong Body Part" Under NCD 328
The policy is precise about what qualifies as a wrong-body-part procedure. A surgery or invasive procedure is considered to have been performed on the wrong body part when it is not consistent with the correctly documented informed consent for that patient. This explicitly includes:
- Left vs. right errors — operating on the wrong side of the body (wrong appendage or organ)
- Wrong level errors — performing spinal surgery at the incorrect vertebral level
The documentation anchor here is the informed consent form. If the procedure performed does not match what the patient consented to, NCD 328 is triggered.
Important Exceptions CMS Recognizes
The policy carves out several scenarios that do not constitute a wrong-body-part event under this NCD:
- Emergent intraoperative findings — situations that arise during surgery whose urgency precludes obtaining new informed consent
- Incidental pathology discovery — when a surgeon discovers pathology in close proximity to the intended site and the risk of a second surgery outweighs the benefit of patient consultation
- Unusual physical configurations — unexpected anatomical findings such as adhesions, extra vertebrae, or atypical spine levels that alter the surgical plan
These exceptions matter enormously for surgical billing teams. A spine surgeon who identifies an extra vertebra intraoperatively and adjusts the operative level is not, under this policy, performing a wrong-site procedure. The key is documentation — the operative note must clearly capture the clinical reasoning for any deviation from the original surgical plan.
Which Procedures Fall Under This NCD
The scope of NCD 328 is broad. CMS defines surgical and other invasive procedures as operative procedures in which skin or mucous membranes and connective tissue are incised, or an instrument is introduced through a natural body orifice. The policy explicitly covers all of the following:
- All procedures described by codes in the surgery section of the CPT code set
- Percutaneous transluminal angioplasty and cardiac catheterization
- Minimally invasive procedures involving biopsies or placement of probes or catheters requiring entry into a body cavity through a needle or trocar
- Minimally invasive dermatological procedures — including biopsy, excision, and deep cryotherapy for malignant lesions
- Multi-organ transplantation
What's excluded from this definition: instruments used purely for examination (such as otoscopes) and very minor procedures like drawing blood.
The breadth of this definition means NCD 328 is relevant far beyond the OR. Interventional radiologists, cardiologists, dermatologists, and any provider performing biopsies or catheter-based procedures are all within scope.
Medicare Benefit Categories Affected by NCD 328
This NCD applies across a wide range of Medicare benefit categories, meaning the non-coverage determination can affect claims billed under multiple settings and provider types:
- Inpatient Hospital Services
- Outpatient Hospital Services (incident to a physician's service)
- Physicians' Services
- Skilled Nursing Facility
- Home Health Services
- Federally Qualified Health Center Services
- Rural Health Clinic Services
- Diagnostic Tests (other)
Billing teams in hospital outpatient departments, ambulatory surgery centers, and physician practices all need to understand this policy applies to their claims environment.
| 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
This policy does not list specific CPT, HCPCS, or ICD-10 codes. NCD 328 applies categorically to all procedures in the CPT surgery section and any other invasive procedures as defined above — meaning no single code list can capture its full scope. The non-coverage determination is triggered by the circumstances of the procedure (performed on the wrong body part relative to documented informed consent), not by the specific procedure code billed.
This has an important practical implication: your billing system cannot flag this risk through code-based edits alone. The risk management and compliance protocols upstream of billing are what prevent NCD 328 denials.
What Your Billing Team Should Do
| # | Action Item |
|---|---|
| 1 | Immediately audit your informed consent documentation workflow. Within the next 30 days, confirm that consent forms clearly identify the specific body part, laterality, and — for spine cases — the intended surgical level. This is the document CMS will look to when evaluating a claim under NCD 328. |
| 2 | Educate coders and billers on the intraoperative exception criteria. When operative notes document a deviation from the planned surgical site, coders need to verify the note includes explicit clinical justification (emergent finding, adjacent pathology risk, anatomical anomaly). Without that documentation, a deviation from consent looks like a wrong-site event. |
| 3 | Establish a clear internal process for reporting and non-billing of confirmed wrong-site events. If a wrong-site procedure does occur, do not submit a Medicare claim for it — NCD 328 makes it non-covered by definition. Review your facility's never event reporting obligations, as these events likely trigger additional state and accreditation reporting requirements beyond the Medicare billing impact. |
| 4 | Review your denial management workflows for any existing NCD 328-related denials. Pull claims denied under medical necessity for surgical procedures over the past 12 months and flag any that may be connected to documentation gaps around body part or laterality. These may represent appeals opportunities — or process failures to fix. |
| 5 | Coordinate with your compliance and clinical teams to ensure surgical site verification protocols (such as the Joint Commission's Universal Protocol) are fully implemented and that documentation from those protocols is captured in the medical record supporting each claim. |
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