TL;DR: The Centers for Medicare & Medicaid Services modified NCD 358 governing PILD (percutaneous image-guided lumbar decompression) coverage, effective 2026-03-04. Coverage remains restricted to beneficiaries enrolled in approved clinical studies under Coverage with Evidence Development (CED). Here's what billing teams need to know.
CMS updated its PILD lumbar spinal stenosis coverage policy under NCD 358 in the Medicare system. This policy does not list specific CPT or HCPCS codes in the current data. That alone should put your billing team on alert — billing PILD without confirming your study enrollment status and code set will produce claim denials fast.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | CMS (Centers for Medicare & Medicaid Services) |
| Policy | Percutaneous Image-Guided Lumbar Decompression for Lumbar Spinal Stenosis |
| Policy Code | NCD 358 |
| Change Type | Modified |
| Effective Date | 2026-03-04 |
| Impact Level | High |
| Specialties Affected | Interventional Radiology, Neurosurgery, Pain Management, Orthopedic Surgery |
| Key Action | Confirm your facility is enrolled in a CMS-approved CED clinical study before billing PILD for any Medicare beneficiary |
CMS Percutaneous Image-Guided Lumbar Decompression Coverage Criteria and Medical Necessity Requirements 2026
The CMS PILD coverage policy is one of the more restrictive national coverage determinations active right now. Coverage is not available as a routine benefit. CMS covers PILD only under Coverage with Evidence Development (CED) — meaning your patient must be enrolled in an approved clinical study for a claim to have any shot at reimbursement.
This has been the structure since January 9, 2014. The 2026 modification to NCD 358 continues that framework. If you're thinking "we've billed this before without a study," stop and audit those claims now.
What Is PILD?
PILD is a posterior lumbar decompression procedure. It's performed under indirect image guidance — fluoroscopic or CT — without direct visualization of the surgical area. The procedure uses specially designed instruments to percutaneously remove a portion of the lamina and debulk the ligamentum flavum.
An epiduragram, using contrast media, identifies and monitors the compressed area during the procedure. CMS classifies this as a treatment for symptomatic lumbar spinal stenosis (LSS) unresponsive to conservative therapy.
The procedure is billed under Outpatient Hospital Services (incident to a physician's service) and Physicians' Services benefit categories.
Medical Necessity Under NCD 358
For medical necessity to be established under this coverage policy, the beneficiary must meet two conditions. First, the patient has LSS that has not responded to conservative therapy. Second — and this is the hard stop — the patient must be enrolled in a CMS-approved clinical study.
CMS won't accept a claim for PILD lumbar decompression billing outside that study structure, regardless of how well-documented the medical necessity is. Strong clinical documentation helps, but it doesn't substitute for study enrollment.
What the Approved Study Must Look Like
CMS is specific about study design. The clinical study must address at least one of three questions:
| # | Covered Indication |
|---|---|
| 1 | Does PILD provide a clinically meaningful improvement of function or quality of life in Medicare beneficiaries with LSS compared to other treatments? |
| 2 | Does PILD provide a clinically meaningful reduction in pain compared to other treatments? |
| 3 | Does PILD affect the overall clinical management of LSS and decision-making — including use of other medical treatments — compared to other treatments? |
The study must use a prospective, randomized, controlled design. It must use validated and reliable measurement instruments. And it must include clinically appropriate comparator treatments — medical or surgical interventions, or a sham-controlled arm for the non-PILD group.
CMS is also looking at the duration of benefit. The study protocol must specify a statistical analysis plan and a minimum patient follow-up period to evaluate both beneficiary characteristics and long-term outcomes.
Additional Study Criteria
Beyond design requirements, the study must meet all of the following:
| # | Covered Indication |
|---|---|
| 1 | The principal purpose is to test whether PILD improves health outcomes |
| 2 | The study is well-supported by available scientific and medical information, or it clarifies outcomes of interventions already in common clinical use |
| 3 | The study does not duplicate existing research without justification |
| 4 | The design is appropriate to answer the research question |
| 5 | The sponsoring organization or individual can execute the study successfully |
| 6 | The study complies with all applicable federal regulations for human subject protection — 45 CFR Part 46 and, where applicable, FDA regulations under 21 CFR Parts 50 and 56 |
These aren't suggestions. CMS uses these criteria to evaluate whether a study qualifies for CED coverage. If the study your facility is participating in doesn't meet all of them, claims will be denied.
Prior Authorization and Study Enrollment
NCD 358 does not describe a traditional prior authorization process for PILD. The gatekeeping mechanism here is study approval, not a standard prior auth workflow. That's an important distinction for your billing team.
You're not submitting a prior authorization request to a Medicare Administrative Contractor. You're confirming that the clinical study itself has received CMS approval. Your compliance officer should be able to provide documentation of that approval. If they can't, don't bill the procedure.
CMS PILD Exclusions and Non-Covered Indications
PILD is not covered as a standard Medicare benefit. Full stop. If a patient is not enrolled in a CMS-approved clinical study, the procedure is non-covered regardless of diagnosis, clinical severity, or documented failure of conservative treatment.
CMS does not list PILD as experimental in the way some payers use that term — meaning they're not saying the procedure is disproven. What they're saying is that the evidence base is still insufficient to support routine coverage. That's a meaningful distinction, but it doesn't change the billing outcome: no approved study, no reimbursement.
Billing PILD outside the CED framework for Medicare patients isn't just a claim denial risk. It's a compliance exposure. If your facility has been billing this procedure outside an approved study, loop in your compliance officer before the effective date of the updated policy.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| LSS in a patient enrolled in a CMS-approved CED clinical study (on or after January 9, 2014) | Covered under CED | No codes listed in NCD 358 policy data | Prospective, randomized, controlled study design required; study must address CMS research questions |
| LSS unresponsive to conservative therapy — outside an approved CED study | Not Covered | N/A | No routine coverage available under Medicare; study enrollment is required |
| PILD performed outside a prospective, randomized, controlled study design | Not Covered | N/A | Study must meet all CMS structural and compliance requirements |
| PILD in a study that does not meet 45 CFR Part 46 human subject protections | Not Covered | N/A | Federal regulatory compliance is a hard requirement, not advisory |
CMS PILD Billing Guidelines and Action Items 2026
PILD lumbar decompression billing under NCD 358 is narrow. Your margin for error is small. Here are your action items before and after the March 4, 2026 effective date.
| # | Action Item |
|---|---|
| 1 | Audit every active PILD claim against CED enrollment status now. Before the effective date passes, pull every open or pending PILD claim for Medicare beneficiaries. Confirm each patient is enrolled in an approved clinical study. If any are not, do not submit — and review any recently submitted claims for potential exposure. |
| 2 | Confirm your clinical study has CMS approval and meets all NCD 358 criteria. Don't assume approval. Get written documentation from the study sponsor confirming CMS has approved the study and that it meets the prospective, randomized, controlled design requirements. Keep this on file for every PILD claim you submit. |
| 3 | Identify the correct CPT/HCPCS codes for PILD with your MAC. NCD 358 does not list specific codes in the current policy data. Contact your Medicare Administrative Contractor directly to get the applicable billing codes for PILD procedures. Don't guess. Incorrect codes on a CED claim will result in claim denial and may complicate audit trails. |
| 4 | Update your charge capture and billing workflows to require study enrollment verification. Build a hard stop into your charge capture process. No PILD claim should move forward without a documented study enrollment confirmation attached to the encounter. This protects your facility from inadvertent non-covered billing. |
| 5 | Review your ABN process for PILD patients who are not study-enrolled. If you perform PILD on a Medicare beneficiary outside an approved study, an Advance Beneficiary Notice of Noncoverage (ABN) is required before the procedure. Your front-end staff and clinical teams need to know this. Missing the ABN means you can't bill the patient either. |
| 6 | Loop in your compliance officer before billing under the modified NCD 358. This policy modification went into effect March 4, 2026. If your facility is performing PILD and hasn't reviewed billing guidelines against the updated coverage policy, that conversation needs to happen immediately. The intersection of CED requirements and compliance obligations is not a place to improvise. |
| 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 Percutaneous Image-Guided Lumbar Decompression Under NCD 358
Covered CPT Codes (When Study Enrollment Criteria Are Met)
The current NCD 358 policy data does not list specific CPT or HCPCS codes. This is a significant gap for billing teams. You need to contact your Medicare Administrative Contractor to confirm which codes apply to PILD in your region before submitting claims under this coverage policy.
| Code | Type | Description |
|---|---|---|
| Not listed in NCD 358 policy data | — | Contact your MAC for applicable PILD procedure codes |
Key ICD-10-CM Diagnosis Codes
NCD 358 does not list specific ICD-10-CM codes. The underlying condition covered is lumbar spinal stenosis (LSS). Work with your coding team and MAC to identify the appropriate M-series diagnosis codes for LSS that align with your clinical documentation.
| Code | Description |
|---|---|
| Not listed in NCD 358 policy data | Confirm with your MAC; document LSS diagnosis and failure of conservative therapy |
The absence of code-level specificity in this policy is itself a billing risk. Don't treat it as a minor detail. An incorrect code on a PILD claim tied to a CED study can disrupt the entire reimbursement chain and create audit problems for the study sponsor as well.
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