FUTURE LCD Reference Article Response To Comments Article

Response to Comments: Thermal Destruction of the Intraosseous Basivertebral Nerve (BVN) for Vertebrogenic Lower Back Pain

A60430

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Contractor Name	Contract Type	Contract Number	Jurisdiction	States
National Government Services, Inc.	A and B and HHH MAC	13101 - MAC A	J - K	Connecticut

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General Information

Article ID
A60430

Article Title
Response to Comments: Thermal Destruction of the Intraosseous Basivertebral Nerve (BVN) for Vertebrogenic Lower Back Pain

Article Type
Response to Comments

Original Effective Date
07/15/2026

Retirement Date
N/A

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Article Guidance

Article Text

As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the Thermal Destruction of the Intraosseous Basivertebral Nerve (BVN) for Vertebrogenic Lower Back Pain LCD. The official notice period for the final LCD begins on May 28, 2026, and the final determination will become effective on July 15, 2026.

Response To Comments

Number	Comment	Response
1	Multiple individuals commented concerning the linkage of the procedure to the single proprietary Intracept device.	Wellpoint Federal appreciates the comments. After further consideration and review, the LCD has been revised to remove proprietary language and to reflect neutrality.
2	Several commenters requested that the psychological assessment criterion be allowed to be rendered by the treating physician in clearing a patient for the BVN procedure. They recommended that BVN eligibility criteria should remain focused on the established clinical and imaging indicators that accurately identify vertebrogenic pain and that psychological evaluation only be carried out when clinically appropriate. Proposed language change “There is no evidence of severe or untreated psychological issues and this has been attested to by the physician ordering the Intracept procedure.”	The studies by Fischgrund, Khalil, and Truumees excluded any patient with moderate to severe depression as defined by a score >24 on the Beck Depression Inventory. Patients with chronic back pain and moderate to severe depression do not respond as well to any spinal intervention. The language in the LCD will remain unchanged.
3	Commenters argue that multidisciplinary evaluation is unnecessary, may delay care, and may waste resources. They request removal of the word “multidisciplinary” from the LCD. Commenters also recommend clarifying that imaging findings should be interpreted in conjunction with the overall clinical presentation and that radiographic findings alone should not preclude coverage when vertebrogenic pain remains the primary diagnosis.	The LCD is intended to support appropriate patient selection and ensure that other clinically relevant causes of low back pain have been considered prior to basivertebral nerve ablation. Clinical findings, imaging results, and the overall clinical presentation should be considered together when determining whether vertebrogenic pain is the primary diagnosis. Radiographic findings should not be interpreted in isolation. The multidisciplinary evaluation language has been reviewed and will be retained to promote safe and clinically appropriate use of the procedure.
4	Commenters request that the LCD allow alternative imaging modalities, such as CT/SPECT, when MRI cannot be safely performed and when there is evidence of endplate changes. Commenters also note that radiology reports may use varying terminology and may not always specifically state “Modic changes” despite evidence of endplate signal alterations. Commenters recommend improving clarity in imaging-related limitations and allowing physician interpretation to reduce unnecessary barriers and administrative burden.	MRI findings demonstrating Modic type 1 or type 2 endplate changes remain the primary imaging criterion for basivertebral nerve ablation, consistent with the available evidence base. We recognize that terminology in radiology reports may vary and that physician interpretation should be considered in the context of the full clinical record. When MRI cannot be safely performed, alternative imaging may be reviewed when clinically appropriate; however, coverage requires documentation sufficient to support vertebrogenic pain as the primary diagnosis.
5	Commenters argue that the exclusion of patients with diagnosed osteoporosis, defined as T-score less than -2.5, is too rigid and should distinguish between untreated or unstable osteoporosis and treated osteoporosis. Commenters recommend allowing coverage for appropriately selected patients with treated osteoporosis when supported by documented risk-benefit counseling and shared decision making. Commenters also recommend eliminating BMI restrictions and adding safety considerations such as active pulse generators.	Osteoporosis, BMI-related limitations, and implanted-device considerations are included as safety considerations to support appropriate patient selection, procedural feasibility, and expected benefit. The LCD language has been reviewed. At this time, these limitations will be retained where clinically relevant. Documentation of bone health status, treatment history, risk-benefit counseling, shared decision making, and device-related safety considerations may be considered as part of the overall clinical review where applicable.
6	Commenters recommend adding the phrase “predominant radicular pain” to the exclusion criteria to reinforce appropriate patient selection and align with established clinical practice and analogous coverage policies.	The current limitations section includes “primary radicular pain” as a limitation. This language is intended to exclude patients whose predominant pain generator is radicular rather than vertebrogenic.
7	Commenter argues that the proposed LCD requires stronger patient selection criteria. The commenter recommends requiring at least 6 months of failed non-surgical treatment, including 6 weeks of supervised physical therapy; requiring Modic changes on MRI confirmed by an independent radiologist; and requiring an epidural anesthetic injection showing at least 80% pain relief to confirm the basivertebral nerve as the true pain source.	The LCD criteria are intended to balance appropriate patient selection with access to medically necessary care. The policy requires documentation supporting chronic vertebrogenic low back pain, failure of conservative management, and qualifying imaging findings. Additional requirements such as mandatory independent radiology confirmation or diagnostic epidural anesthetic injection have been reviewed but are not being added at this time.
8	Commenter argues that the LCD should avoid overly rigid procedural requirements, such as fixed ablation temperature and duration, and should defer to physician judgment and FDA-approved device guidance.	The LCD is intended to align coverage with evidence-based use and applicable FDA-cleared device parameters. The policy does not intend to override physician judgment when care is provided consistent with FDA-approved device guidance and generally accepted standards of practice.
9	Commenter recommends allowing repeat ablation in certain cases when clinically appropriate.	Coverage for repeat ablation requires documentation supporting medical necessity and clinical appropriateness, including the patient’s clinical history, prior treatment response, current symptoms, and relevant imaging or diagnostic findings.

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Contents

Response to Comments: Thermal Destruction of the Intraosseous Basivertebral Nerve (BVN) for Vertebrogenic Lower Back Pain

Document Note

Note History

Contractor Information

Article Information

General Information

CMS National Coverage Policy

Article Guidance

Response To Comments

Coding Information

Bill Type Codes

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Revenue Codes

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CPT/HCPCS Codes

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CPT/HCPCS Modifiers

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ICD-10-CM Codes that Support Medical Necessity

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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

ICD-10-PCS Codes

Group 1

Additional ICD-10 Information

Bill Type Codes

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Revenue Codes

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Other Coding Information

Group 1

Coding Table Information

Revision History Information

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