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Response to Comments: Intraosseous Basivertebral Nerve Ablation

A59599

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Article ID
A59599
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Article Title
Response to Comments: Intraosseous Basivertebral Nerve Ablation
Article Type
Response to Comments
Original Effective Date
01/28/2024
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During the 45-day comment period the A/B MAC received a total of 12 comments.

The A/B MACs appreciate the comments received from stakeholders during the open comment period on the proposed Intraosseous Basivertebral Nerve Ablation Local Coverage Determination (LCD).

Pursuant to the CMS Program Integrity Manual (CMS Pub. 100-08) Chapter 13:

In conducting a review, MACs shall use the available evidence of general acceptance by the medical community, such as published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines.

Accordingly, the final policy and our response to comments are based on the best currently available published clinical evidence, in order to afford the most optimal opportunity for success in Medicare-eligible beneficiaries with Intraosseous Basivertebral Nerve Ablation.

Response To Comments

Number Comment Response
1

Commenter (1) disputes the need for psychological evaluation for patient’s proposed for treatment with BVN Ablation. (2) notes that pain generators may be multiple and overlap, suggesting that additional diagnoses in the region should not preclude individual treatment of each.
Note: these 2 comments appear the dominant themes for which comments have been submitted. Subsequent inclusion of these comments will be referred to this response though noted separately.

(1) Agree that psychological evaluation may be redundant for a patient without documented psychological issues, however, these are not limited to functional problems and include long term drug abuse which, without competent therapy could mask symptoms and positive outcome of any procedure. In the absence of documented psychological disease and ongoing substance use or abuse or, in the instance of ongoing addiction or psychological evaluation, the physical finding of Modic changes correlating with signs and symptoms of basivertebral nerve irritation, additional psychological evaluation would be considered redundant.

(2) Overlapping pain generators may dispute the need for therapy of each. It is recommended that the provider act upon documented signs and symptoms of disease, addressing each potential disease entity in an organized diagnostic pattern to determine the dominant impediment to the patient’s well-being, then address in descending order.

2

Patient reports longstanding LBP with 15-year history of some form of paraspinal RF ablation Q6 mos. in hope of reducing opioid and antispasmodic medications. Encourages continued exploration of therapeutic interventions for treatment 

Comment noted.
3

(1) Suggests the requirement for Modic I or 2 changes noted on MRI would eliminate patients from treatment without these diagnostic elements and is inconsistent with inclusion criteria per NASS coverage recommendations.

(2) See Above relative to psychological assessment. Suggests lack of necessity of interdisciplinary team, in depth psychological evaluation, with multiple evaluations which may lead to unnecessary delays in therapy as well as conflicting indications for inclusion for treatment.

(3) Recommends removal of lifetime limit of one per vertebral body, stating that no current literature supports limitation.

(1) Modic 1 or 2 changes on MR imaging remain the only reproducible diagnostic criteria of BVN irritation as a source of pain per all literature evaluated. If the commenter has evidence to support alternative diagnostic elements either disputing this as diagnostic criteria or supporting alternative diagnosis suggested by Modic 1 or 2 images which would not benefit from BVN ablation, or alternative diagnostic testing with similar relevance for treatment indications, references should be submitted for reconsideration.

(2) See above response for benefit of multidisciplinary exam including in depth psychological evaluation. Multidisciplinary exam includes both imaging as well as history and physical. Psychological exam is recommended secondary to the high incidence of substance dependence in the population presenting for BVN ablation. It is acknowledged that multiple pain management practices incorporate addiction management into therapeutic evaluation and management, such that it is included in the provider’s evaluation for treatment, which would meet this requirement of the LCD.

(3) If data reference is available to support incidence of failed therapy due to incomplete ablation of BVN, or indication for repeat service, it should be submitted for reconsideration. With present data available BVN ablation should be complete without subsequent recurrence. When data support regeneration or incomplete ablation, reconsideration for repeat therapy should be requested.
4

Comment expresses consensus with Determination criteria but also questions need for psychological evaluation, recommending treatment based on findings and lack of response to conservative measures. 

Comments appreciated. See above for response to need for psych eval.  
5

Recommendations made consistent with LCD Draft suggest finalization with allowance of a single level per sessions of treatment and limitation to exclude other para vertebral injections or interventions in the same session. 

We appreciate your recommendations based on the paucity of graded evidence to support use of this intervention. However, it is the feeling of Noridian that treatment should be allowed for documented findings consistent with intravertebral ischemia, edema and necrosis affecting the Basivertebral Nerve of that vertebral body. With evidence supporting at least 2 levels affected, it is inappropriate to restrict treatment to a single level, requiring the patient to return for repeat treatment that could have been more efficiently combined with the first.

Noridian concurs with the restriction to a single type of spinal or paraspinal intervention at a single session same region, in that multiple types could mask benefit or confuse findings and outcome. This limitation will be included in the local coverage determination for JE and JF. Local anesthesia for the procedure would be included in the procedure and not billed separately. It is not expected the addition of steroids to benefit the patient or procedure. Inclusion may trigger review and potential denial as not reasonable and necessary per reimbursable guidelines.

Thank you for your literature review and comment.
6

(1) Commentor suggests indication based on chronicity, failed treatment, and MRI changes with inclusion of expanded definitions for Modic changes covered.
(2) Suggests deletion of extensive multidisciplinary screening as a requirement for treatment.
(3) Requests deletion of contraindication posed by likely alternative etiology.
(4) Does not feel generalized systemic disease such as morbid obesity should be contraindication to treatment; Similarly, does not feel ongoing substance abuse should restrict use in patients.
Recommends the addition of three diagnosis codes for coverage with BVN ablation.

(1) Agree with initial comment regarding indications for treatment.
(2) Will consider expansion of definitions of Modic 1 and 2 changes.
(3) Contraindication to treatment with alternative or concomitant pathology affecting the targeted vertebral body is not deemed of advantage to the patient and could complicate treatment or diagnosis and outcome. No change is planned, though limitations may be further clarified. Similarly, it is recommended that concomitant conditions which may affect treatment outcome be carefully evaluated by the treating physician, including Morbid Obesity and ongoing Substance Abuse. Whereas these co-morbidities associated with BVN generated pain are not treatable by BVN ablation, improvement or outcome may be deterred, compromised, or masked by these issues.
(4) The consideration of specific coding for diagnosis to procedure editing does not permit non-specific addition of marginally related diagnosis codes to the LCD or LCA. 

*Of note, this commentor has potential conflict of interest as stakeholder of marketed device utilized for this procedure.
7

Concurs with previous comments on the lack of benefit to diagnosis or outcome by multidisciplinary team or in-depth psychological evaluation as conditions for treatment.

Please see above comments. While there is little support for multiple evaluations to support BVN ablation, thorough psychological evaluation to assess benefit with ongoing untreated or non-optimized therapy for ongoing substance abuse or major psychiatric diagnoses is recommended for avoidance of intraprocedural as well as subsequent complications attributed to the procedure.

Appreciate your confirmation of reasonable and necessary as a procedure for the stated diagnostic criteria of the Coverage Determination.
8

Expresses concern for the exclusion of patient with non-vertebral pathology that could contribute to symptoms and the requirement that patients undergo screening, evaluation, and diagnosis by a multidisciplinary team to include psychological and physical assessment.

While the cited bullet wording may seem excessive, most of these requirements are necessary for coverage of any service by Medicare or other health care insurer to assure the appropriateness of the service. It would be inappropriate to perform this procedure on a patient without first documenting the inciting etiology is not accompanied by a concomitant condition (tumor or fracture) which may potentially worsen these conditions. Recommended substitution for imaging documentation of the regional pain generator would seem appropriate along with the standard LCD requirements of a (documented) complete history and physical examination. Noridian concurs with the statement of intention of ruling out alternative pathology with alternative treatment if more appropriate.

Due to the high incidence of ongoing substance dependence and abuse in patient with chronic back pain, or any form of chronic pain, the negative impact of this dependence must be considered prior to additional intervention. Should the physician’s pre-operative evaluation include such documentation (complete history and physical), requirements would be considered met.
9

Suggests similar feelings regarding assessment as above but adds the additional expense to the patient for multiple physician visits and extensive psychological testing. 

See above. It is not the desire of Noridian to increase either provider or beneficiary financial burden. It would be expected that standard requirements of patient and disease documentation would include all aspects of evaluation necessary to safely provide this service to our Medicare beneficiaries who may benefit.

10

Recommends NASS language for evaluation of possible concomitant findings that may complicate or contraindicate the use of BVN ablation as the treatment for vertebrogenic back pain. As per other commentors, notes that patients usually have additional pathology that may contribute to back pain.
Additional comment is that expressed by multiple providers and societies above: lack of benefit to multidisciplinary team evaluation.

Please see response to comments above. 
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L39644 - Intraosseous Basivertebral Nerve Ablation
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