National Coverage Determination (NCD)

Percutaneous image-guided lumbar decompression for lumbar spinal stenosis


Expand All | Collapse All

Tracking Information

Publication Number
Manual Section Number
Manual Section Title
Percutaneous image-guided lumbar decompression for lumbar spinal stenosis
Version Number
Effective Date of this Version
Ending Effective Date of this Version
Implementation Date
Implementation QR Modifier Date

Description Information

Benefit Category
Outpatient Hospital Services Incident to a Physician's Service
Physicians' Services

Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

A.    General

PILD is a posterior decompression of the lumbar spine performed under indirect image guidance without any direct visualization of the surgical area. This is a procedure proposed as a treatment for symptomatic LSS unresponsive to conservative therapy. This procedure is generally described as a non-invasive procedure using specially designed instruments to percutaneously remove a portion of the lamina and debulk the ligamentum flavum. The procedure is performed under x-ray guidance (e.g., fluoroscopic, CT) with the assistance of contrast media to identify and monitor the compressed area via epiduragram.

Indications and Limitations of Coverage

B.    Nationally Covered Indications

Effective for services performed on or after January 09, 2014, the Centers for Medicare & Medicaid Services (CMS) has determined that PILD will be covered by Medicare when provided in a clinical study under section 1862(a)(1)(E) through Coverage with Evidence Development (CED) for beneficiaries with LSS who are enrolled in an approved clinical study that meets the criteria below.

CMS has a particular interest in improved beneficiary function and quality of life, specific characteristics that identify patients who may benefit from the procedure, and the duration of benefit. A clinical study seeking Medicare payment for PILD for LSS must address one or more aspects of the following questions in a prospective, randomized, controlled design using current validated and reliable measurement instruments and clinically appropriate comparator treatments, including appropriate medical or surgical interventions or a sham controlled arm, for patients randomized to the non-PILD group.

The study protocol must specify a statistical analysis and a minimum length of patient follow up time that evaluates the effect of beneficiary characteristics on patient health outcomes as well as the duration of benefit.

  1. Does PILD provide a clinically meaningful improvement of function and/or quality of life in Medicare beneficiaries with LSS compared to other treatments?
  2. Does PILD provide clinically meaningful reduction in pain in Medicare beneficiaries with LSS compared to other treatments?
  3. Does PILD affect the overall clinical management of LSS and decision making, including use of other medical treatments or services, compared to other treatments?

These studies must be designed so that the contribution of treatments in addition to the procedure under study are either controlled for or analyzed in such a way as to determine their impact.

  1. The principal purpose of the research study is to test whether a particular intervention potentially improves the participants’ health outcomes.
  2. The research study is well supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.
  3. The research study does not unjustifiably duplicate existing studies.
  4. The research study design is appropriate to answer the research question being asked in the study.
  5. The research study is sponsored by an organization or individual capable of executing the proposed study successfully.
  6. The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found at 45 CFR Part 46. If a study is regulated by the Food and Drug Administration (FDA), it must be in compliance with 21 CFR parts 50 and 56.
  7. All aspects of the research study are conducted according to appropriate standards of scientific integrity (see
  8. The research study has a written protocol that clearly addresses, or incorporates by reference, the standards listed here as Medicare requirements for CED coverage.
  9. The clinical research study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet this standard only if the disease or condition being studied is life threatening as defined in 21 CFR § 312.81(a) and the patient has no other viable treatment options.
  10. The clinical research study is registered on the website by the principal sponsor/investigator prior to the enrollment of the first study subject.
  11. The research study protocol specifies the method and timing of public release of all prespecified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early. The results must be made public within 24 months of the end of data collection. If a report is planned to be published in a peer reviewed journal, then that initial release may be an abstract that meets the requirements of the International Committee of Medical Journal Editors (
  12. The research study protocol must explicitly discuss subpopulations affected by the treatment under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting of said populations on the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are necessary.
  13. The research study protocol explicitly discusses how the results are or are not expected to be generalizable to the Medicare population to infer whether Medicare patients may benefit from the intervention. Separate discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability or Medicaid eligibility.

Consistent with section 1142 of the Social Security Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meet the above-listed standards and address the above-listed research questions.

C.    Nationally Non-Covered Indications

Effective for services performed on or after January 09, 2014, CMS has determined that PILD for LSS is not reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act.

D.    Other

Endoscopically assisted laminotomy/laminectomy, which requires open and direct visualization, as well as other open lumbar decompression procedures for LSS are not within the scope of this NCD.

Cross Reference

Transmittal Information

Transmittal Number
Revision History

05/2014 - This Change Request (CR) purpose is effective for claims with dates of service on or after January 9, 2014, PILD is covered by Medicare when provided in a clinical study under section 1862(a)(1)(E) through Coverage with Evidence Development (CED) for beneficiaries with LSS who are enrolled in an approved clinical study the necessary criteria. Effective date: 01/09/2014. Implementation date: 10/06/2014. (TN 167) (CR8757)


National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Percutaneous Image-Guided Lumbar Decompression for Lumbar Spinal Stenosis 2 12/07/2016 - N/A View
Percutaneous image-guided lumbar decompression for lumbar spinal stenosis 1 01/09/2014 - 12/07/2016 You are here
CPT Copyright Statement
CPT only copyright 2002-2011 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.
Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.