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

Listed below are my comments for the proposed LCD for BVNA:

1. Limiting BVNA to the vertebral bodies from L3 to S1 is similar to the clinical trial protocol; but it is unfortunate that it arbitrarily limits this therapy to these levels.
2. The requirement to use a pain and disability scale is not conventional and may be something that is not done and placed into the patient’s medical record by many practices and a stipulation that may be used for later payment denials.
3. The limitation to patients with pacemakers.
4. The limitation to patients with surgery at the intended treatment level if performed greater than 6 months prior to the BNVA. This would eliminate a huge portion of patients that need to be treated as it would prohibit this in patients with painful adjacent segment disease.
5. The limitation to patients with a T-score of -2.5 or less or with a history of a fragility fracture. These are often precisely the patients who have symptomatic chronic vertebrogenic back pain with Modic changes. These patients often have no other options as there is no adequate surgical treatment in patients with demonstrable osteoporosis.
6. The radiographic limitations are arbitrary. For example, limiting BVNA for a disc protrusion greater than or equal to 5 mm when disc protrusions these sizes are very often asymptomatic and makes no clinical sense. Limiting BVNA for patients with spondylolysis when there is no evidence that this should be a contraindication eliminates 1 of the only viable treatments for them and pushes them into surgery. The limitation to patients with painful facet arthrosis does not take into account what portion of the pain is coming from the facet. What if only 10% is coming from the facet? Does that count as a limitation? It does the way this reads and essentially every patient that has vertebrogenic back pain will have at least some degree of facet arthrosis.
7. The limitation to patients with a BMI over 40 as these are precisely the patients who tend to have chronic vertebrogenic low back pain with Modic changes.

Palmetto GBA appreciates your comments. After further consideration and review, the LCD is revised to remove the limitation for pacemakers.

I am writing to offer comment of the draft Palmetto LCD- DL39420 for basivertebral nerve ablation. If coverage is adopted, the key to successful implementation of this new procedure will be strict adherence to selection criteria. We encouraged adoption of all of the exclusion criteria outlined in the key prospective studies by Fischgrund, Khalil, Truumees and Becker. As such we offer the following specific suggestions:

1. Modify limitation 11.b. The draft LCD excludes spondylolisthesis greater than grade 2 at any level. Grade 2 spondylolisthesis is a 25-50% slippage of one vertebral body in relation to the inferior vertebral body. A typical vertebral body measures approximately 40 mm which equates to 10-20 mm slippage. Proposed LCD only excludes patients with greater than 20 mm of slippage. This is a significantly greater amount of instability that was permitted in any of the prospective trials. The studies by Fischgrund, Khalil, and Truumees excluded any patient with instability caused by spondylolisthesis greater than 2 mm. Performing basivertebral nerve ablation in patients with instability secondary to spondylolisthesis between 2 mm and 20 mm has not been studied. We suggest changing exclusion line 11.b. to Spondylolisthesis greater than 2 mm at any level.
2. Add an exclusion for Modic changes at any level above L3. The studies by Fischgrund, Khalil, and Truumees excluded any patient with Modic changes above L3. Basivertebral nerve ablation is not FDA indicated above L3. Patients with multilevel vertebrogenic pain and those with pain arising from levels above L3 are unlikely to experience the degree of improvement experienced by those with pain generators limited to the treatment region L3-S1.
3. Patients with instability are unlikely to experience as much improvement as those without instability. The Becker study excluded patients with scoliosis. We suggest adding the following exclusion criteria: Patients with scoliosis > 10 degrees.
4. 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. We suggest adding the following exclusion- Moderate to severe depression, evaluated by psychiatric examination or by a validated depression screening test (e.g., Beck Depression Inventory, PHQ-9, etc.) If there is hesitancy to implement such an exclusion criteria and potentially withhold this treatment from this population, then we would suggest adoption of the language included in many spinal cord stimulator policies, Patients must have undergone careful screening, evaluation and diagnosis by a multidisciplinary team prior to implantation. (Such screening must include psychological, as well as physical evaluation).
5. The studies by Fischgrund, Khalil, and Truumees excluded any patient with current litigation related to back pain or injury. Patients with chronic back pain and ongoing litigation do not respond as well to any spinal intervention. We suggest adding the following exclusion criteria: Current litigation related to back pain or injury.
6. Pregnancy is an accepted exclusion criteria in the proposed LCD. We also suggest adding the following exclusion criteria: Less than 6 months postpartum or currently breast feeding. Many women will experience LBP following pregnancy that resolves with time alone.
7. Fischgrund excluded patients taking extended-release narcotics. Truumees and Khalil excluded patients taking extended-release narcotics with addiction behaviors. We suggest adding the following exclusion criteria: Active, untreated substance abuse disorder.

References were provided for review.

Palmetto GBA appreciates the informative comments. Upon review, the LCD is revised with the limitations of spondylolisthesis greater than 2 mm at any level as well as active, untreated substance abuse disorder. A statement will also be added in the LCD which states: “Patients must have undergone careful screening, evaluation, and diagnosis by a multidisciplinary team prior to thermal destruction of the intraosseous BVN. (Such screening must include psychological, as well as, physical evaluation). Documentation of the history and careful screening must be available in the patient chart if requested.”

I am not sure I understand why this procedure is not covered by Medicare.

In my relative’s case, it is medically necessary as they have tried physically therapy, Chiropractor, nerve ablation and other procedures with no pain relief.

The battery powered nerve stimulation procedure is approved by Medicare. This requires a surgical procedure, is more expensive than the Intracept^® Procedure and results are equal or better than nerve stimulation. There is less risk of infection and need for another procedure if leads pull away from spinal nerves when battery stimulation implant is used.

While my relative meets the other Medicare requirements such as more than 6 months of pain, the only thing that currently brings temporary relieve is hydrocodone. If they have to continue using hydrocodone, they may well end up an addict and Medicare will pay for rehabilitation. That makes no sense to me when there is an alternative surgical procedure to eliminate their pain.

We have yet to receive a clear explanation as to why Medicare has declined the surgeon's request for pre-approval of this procedure. We understand Medicare has covered this procedure for some patients, but we cannot get a clear answer from Medicare as to what is different about my relative's case.

I’m sure there are many other similar situations, but most will just accept a declination from Medicare without further action or learning there is a possibility that Medicare may approve this procedure.

I’m sure the physicians and researchers have years of data and studies to support approval of this procedure. However, I want Medicare to hear at least one covered participant’s situation and why they need this procedure approved.

Palmetto GBA appreciates your comments.

We appreciate the opportunity to comment on Palmetto’s Proposed LCD DL39420. We are a medical device company focused on transforming the treatment of chronic vertebrogenic low-back pain. Based on more than 2 decades of research, the Intracept^® procedure, a minimally invasive procedure that uses thermal ablation for destruction of the intraosseous basivertebral nerve was developed. Our comments focus predominantly on additional peer-reviewed publications since the date the request for the LCD was submitted in February 2022.

Historically, clinicians treating chronic low back pain (CLBP) were challenged with limited objective differentiators to identify specific pain sources. This promoted non-specific diagnoses with variable treatment approaches, poor effect sizes, and in some cases, over treatment.^1,2,3 Advancements in spine biochemistry, biomechanics, and pathophysiology has enabled a more sophisticated approach to the diagnoses and treatment of CLBP.⁴ Subgroupings of CLBP are informed by clinical assessment of the anatomical location of the pain generator(s) (e.g., anterior or posterior column), pain location (e.g., lateral or midline), and movements that exacerbate pain (flexion versus extension or rotation), in addition to objective imaging biomarkers and response to diagnostic tests.⁴

The American Academy of Pain Medicine’s publication (July 2022) performed predictive analyses of 296 patients diagnosed with vertebral endplate pain and treated with basivertebral nerve ablation (BVNA) from 3 clinical trials. The conclusions are that vertebral endplate damage (vertebrogenic pain) correlates with a clinical presentation of midline low back pain, typically without radiation, that is exacerbated by forward flexion, sitting, and driving; these clinical findings are consistent with anterior column pain.^5,6 Vertebral endplate defects are associated with intraosseous MRI changes (Type 1 and Type 2 Modic changes) in individuals with chronic LBP and were used as an objective biomarker for vertebrogenic pain in the clinical trials.⁷ Stepwise regression analyses showed that Type 1 and/or Type 2 Modic changes were predictive of response to BVNA.⁵ Pain and functional response was similar for Type 1 or Type 2 Modic changes and for volume or Modic changes (height and area of Modic changes within the vertebral body).⁸ Modic changes that were localized to the endplate responded similarly to those with Modic > 50% of the vertebral height or endplate area demonstrating that Modic changes are binary.⁸

The authors determined that clinical assessment characteristics consistent with vertebrogenic pain and the presence of Type 1 or Type 2 Modic changes is currently the best objective radiographic indicator of vertebrogenic pain. Outcomes of BVNA are not impacted by the volume of Modic changes, location of Modic changes, degree of disc degeneration, or presence/size of endplate defects. Patients with Type 1 and/or Type 2 Modic changes experience similar rates of success after BVNA.^4-6,8

The International Society for the Advancement of Spine Surgery (ISASS) performed a systematic review including independent studies and concluded that “the utilization of intraosseous basivertebral nerve ablation to address vertebrogenic low back pain has become a recognized safe, predictable, and durable surgical method for the management of chronic axial low back pain identified using well-established clinical and MRI findings, Modic type 1 and/or type 2 changes. The procedure is supported by Level I evidence including a systematic review and 2 RCTs demonstrating a statistically significant decrease in pain and an improvement in function with outcomes sustained greater than 5 years after a single treatment.”⁹

The American Society for Pain and Neuroscience (ASPN) released treatment guidelines on vertebrogenic pain and BVNA which was published September 2022.¹⁰ The systematic review was conducted using United States Preventive Services Task Force Criteria Modified for Interventional Spine Procedures¹¹ and assigned a Grade A rating of the quality of evidence for BVNA indicating “there is high certainty that the net benefit is substantial in appropriately selected individuals” with a practice recommendation of “should offer or provide this service”.

Additional comments on the current proposed LCD:

Diagnosis codes:

Patients indicated for basivertebral ablation may have numerous diagnoses due to radiographic anatomic findings. These patients are most specifically described by ICD-10 M54.51, vertebrogenic low back pain. However, these patients may also be appropriately categorized by the following codes:

M47.816, M47.817 – spondylosis without radiculopathy

M51.36, M51.37 – other disc degeneration

M54.50 – low back pain.

In these situations, it is important that the clinical notes document the presence of degenerative endplate changes (Modic).

We encourage Palmetto to consider expanding the list of acceptable codes to include the above.

Specific comments about the coverage guidance are:

Covered indications:

#3 – avoid the use of double negative and instead, would delete this as the issue is dealt with in the limitations section.

In the limitations section:

#7 – The word “Primary” should be added before radicular.

#9 – Should read “primary symptomatic complaint of lumbar”

#11 – Should read – “radiographic evidence of any of the following that correlates with predominant physical complaints”

We appreciate the opportunity to provide these written comments in addition to the comments made during our presentation to the committee on October 10, 2022.

References:

1. Keller A, Hayden J, Bombardier C, van Tulder M. Effect sizes of non-surgical treatments of non-specific low-back pain. Eur Spine J. 2007;16(11):1776-1788.
2. Deyo RA, Mirza SK, Turner JA, Martin BI. Overtreating chronic back pain: time to back off? J Am Board Fam Med. 2009;22(1):62-8.
3. Mafi JN, McCarthy EP, Davis RB, Landon BE. Worsening trends in the management and treatment of back pain. JAMA Intern Med. 2013;173(17):1573-81.
4. Conger A, Smuck M, Truumees E, Lotz JC, DePalma MJ, McCormick ZL. Vertebrogenic pain; a paradigm shift in diagnosis and treatment of axial low back pain. Pain Med. 2022;23(Suppl 2):S63-S71.
5. Boody BS, Sperry BP, Harper K, Macadaeg K, McCormick ZL. The relationship between patient demographic and clinical characteristics and successful treatment outcomes after basivertebral nerve radiofrequency ablation: a pooled cohort study of three prospective clinical trials. Pain Med. 2022;23(Suppl 2):S2-S13.
6. McCormick ZL, Sperry BP, Boody BS, et al. Pain location and exacerbating activities associated with treatment success following basivertebral nerve ablation: an aggregated cohort study of multicenter prospective clinical trial data. Pain Med. 2022;23(Suppl 2):S14-S33.
7. Lotz JC, Fields AJ, Liebenberg EC. The role of the vertebral end plate in low back pain. Global Spine J. 2013;3(3):153-64.
8. McCormick ZL, Conger A, Smuck M, et al. Magnetic resonance imaging characteristics associated with treatment success from basivertebral nerve ablation: an aggregated cohort study of multicenter prospective clinical trials data. Pain Med. 2022:23(Suppl 2):S34-S49.
9. Lorio M, Clerk-Lamalice O, Rivera M, Lewandrowski KU. ISASS policy statement 2022: literature review of intraosseous basivertebral nerve ablation. Int J Spine Surg. 2022;8362. Doi:10.14444/8362.
10. Sayed D, Naidu RK, Patel KV, et al. Best practice guidelines on the diagnosis and treatment of vertebrogenic pain with basivertebral nerve ablation from the American Society of Pain and Neuroscience. J Pain Res. 2022;15:2801-2819.
11. Harris RP, Helfand M, Woolf SH, et al. Current methods of the U.S. preventive services task force: A review of the process. Am J Prev Med. 2001;20(3 Suppl):21-35.

Palmetto GBA appreciates the informative comments. Upon review, the LCD is revised with deletion of the covered indication “Absence of untreated radiculopathy or neurogenic claudication” since this issue is dealt with in the limitations section. Additionally, the LCD is revised to include the word “Primary” before radicular pain into the lower extremities (in the limitations section), the word “Primary” before symptomatic lumbar or lumbosacral spinal stenosis (in the limitations section), and the addition of the statement, “Radiographic evidence of any of the following that correlates with predominant physical complaints” (in the limitations section). An additional reference was also added to the LCD to include, Best practice guidelines on the diagnosis and treatment of vertebrogenic pain with basivertebral nerve ablation from the American Society of Pain and Neuroscience. JPR, September 2022: 2801-2819.

Upon further consideration, the ICD-10 codes for Spondylosis without myelopathy or radiculopathy, lumbar region (M47.816) and Spondylosis without myelopathy or radiculopathy, lumbosacral region (M47.817) will be added to the Billing and Coding article: Thermal Destruction of the Intraosseous Basivertebral Nerve (BVN) for Vertebrogenic Lower Back Pain as ICD-10 codes that support medical necessity.

Proposed LCD DL39420, Thermal Destruction of the Intaosseous Basivertebral Nerve (BVN) for Vertebrogenic Back Pain states under Limitations 11.b, Lumbar/lumbosacral spondylolisthesis less than or equal to Grade 2 at any level. Please note that the exclusion criteria in the SMART Study and in the Smuck study was spondylolisthesis less than or equal to 2 mm. Since the average width of a lumbar vertebra body is 34 mm, a grade 2 spondylolisthesis would be a translation of 17 mm. This would mean that many patients would be inappropriately approved for a procedure that was not designed for their pathology. Intracept^® is not a treatment for back pain secondary to Grade 1 or Grade 2 spondylolisthesis. Thank you for your attention to this matter.

Palmetto GBA appreciates your comments. Upon review, the LCD is revised with the limitations of spondylolisthesis greater than 2 mm at any level as noted in both the SMART study and INTRACEPT study.