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
1Does PILD provide a clinically meaningful improvement of function or quality of life in Medicare beneficiaries with LSS compared to other treatments?
2Does PILD provide a clinically meaningful reduction in pain compared to other treatments?
3Does 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
1The principal purpose is to test whether PILD improves health outcomes
2The study is well-supported by available scientific and medical information, or it clarifies outcomes of interventions already in common clinical use
3The study does not duplicate existing research without justification
+ 3 more indications

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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
+ 1 more indications

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This policy is now in effect (since 2026-03-04). Verify your claims match the updated criteria above.

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.

+ 3 more action items

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Sample Version Diff Line-by-line changes
Previous VersionCurrent Version
Coverage is considered experimental and investigational for all indicationsCoverage is considered medically necessary when specific criteria are met
Prior authorization is not requiredPrior authorization is required for initial treatment
Documentation must include clinical historyDocumentation must include clinical history
+ 1 more action items

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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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