LCD Reference Article Response To Comments Article

Response to Comments: Lumbar Spinal Fusion

A56397

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Article ID
A56397
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Article Title
Response to Comments: Lumbar Spinal Fusion
Article Type
Response to Comments
Original Effective Date
03/21/2019
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The comment period for the Lumbar Spinal Fusion L37848 Local Coverage Determination (LCD) began on ­10/1/18 and ended on 11/15/18. The comments below were received from the provider community. The notice period for L37848 begins on 3/21/19 and will become effective on 5/6/19.

Response To Comments

Number Comment Response
1

We appreciate the opportunity to comment on proposed LCD DL37848 Lumbar Spinal Fusion. After reviewing LCDs and coverage articles from other MACs and conferring with our Neurosurgeons we’ve identified the following which warrant additional consideration:

Medical Necessity

Dissimilar to the LCD issued by First Coast Service Option, MAC for the JN jurisdiction, your proposed LCD delineates only 4 indications for coverage: 1) instability; 2) spinal deformity; 3) revision of pseudoarthosis; and 4) symptomatic disc compression. It seems more appropriate to mirror First Coast by also including spinal stenosis, post spinal fusion complications, spondylolisthesis/spondylosis and the many other commonly indicated conditions of degenerative disc disease that exist.

Restricting coverage to only 4 indications creates disparity and unfairness among Medicare beneficiaries across the country.

Documentation Requirements

The documentation requirements in the proposed LCD are extremely more stringent than First Coast’s LCD, Local Coverage Articles of other MACs, and the Supplemental Medical Review Contractor (SMRC) review criteria. For example:

Symptomatic Spinal Deformity

- In 2b, documentation of at least 1 year of non-response to non-operative treatment is required when confirmation by diagnostic testing, or at most, 6 months of non-operative treatment would appear to suffice.

- In 2 c – e, the measurement criteria is unnecessarily rigid. In other words, patients are not “one size fits all”.

Formatting

- The formatting of the policy makes it difficult to discern any sort hierarchy (what is most and least important) or what requirements apply to which standard.

In summary, the covered indications and documentation requirements proposed in the LCD appear to address the exception and not the rule/ standard. Furthermore, the LCD doesn’t adequately account for the medically reasonable and necessary needs for this surgery nor address which documentation is pertinent to truly corroborate medical necessity. Last but not least, the proposed LCD contradicts that of our neighboring MAC, creating an inequality among Medicare beneficiaries, a benefit that should be uniform across the country. Thank you for your time and consideration,

First Coast Service Options (Jurisdiction JN). L33382 Lumbar Spinal Fusion for Instability and Degenerative Disc Conditions.

Noridian Healthcare Solutions (Jurisdiction JF). A53975 Spinal Fusion Services: Documentation Requirements.

Noridian Healthcare Solutions (Jurisdiction JE). https://med.noridianmedicare.com/web/jea/topics/documentation-requirements/spinal-fusion

Thank you for the comment.

The comment implies that our policy does not cover fusion for the following indications which are covered elsewhere: “spinal stenosis, post spinal fusion complications, spondylolisthesis/spondylosis” This is partially correct.

The policy does not cover fusion for spinal stenosis alone, and this is based on the literature reviewed in the policy indicating that there is not a meaningful benefit to adding fusion to decompression for spinal stenosis alone. However, there may be patients with spinal stenosis who have a comorbid spinal condition, which does warrant fusion. Please note that NASS recommendations to payers (cited in the LCD) also do not recommend coverage of spinal fusion for stenosis by itself.

Additionally, while the policy does not cover fusion for post spinal fusion complications broadly, it does cover specific complications, for which fusion would be reasonable and necessary, such as instability, infection, etc….

The policy does not cover fusion for spondylolisthesis / spondylosis alone, because based on the literature review we did not find that there is evidence to support this indication. However, these conditions may cause or be associated with other spinal deformities which are covered by the LCD.

Additionally, the comment indicates that the measurement criteria in item 2 are unnecessarily rigid. These measurements are generally consistent with recommended criteria from NASS in its coverage recommendations to payers.

Finally, while the policy does not entirely align with NASS recommendations to payers and CNS guidelines (due to our review of recent evidence that we believe does not support this position statements) we believe that the coverage indications mostly agree with the recommendations of these large clinical bodies.

2

HCA is a major hospital provider in multiple states within Palmetto’s Jurisdictions J and M. We maintain a focus on patients and are engaged in many quality initiatives. These initiatives focus on the delivery of high quality patient care, including compliance with local and national coverage determinations. It is in this spirit that we are submitting the following comments on Palmetto’s Draft Local Coverage Determination DL37848 (Lumbar Spinal Fusion).

For Indication 1.i., “Iatrogenic causes, including expected instability as a consequence of another medically necessary spine procedure.”, we ask that Palmetto please define the types of spinal procedures they have in mind (e.g. laminectomy, >50% removal of facet joint).

  • We believe that coverage criteria 2.b. for symptomatic spinal deformity, “Nonresponse to at least one year of non-operative treatment”, is not supported by medical literature. In fact, most studies of spinal deformity (in particular adult degenerative scoliosis) have shown no benefit to active non-operative treatment.
  • For coverage criteria 2.d. for symptomatic spinal deformity, “Progression of deformity by at least 10 degrees in 1 year”, we do not believe the statement is evidence-based. A patient with 10 degrees progression over the course of 2 years that also meets criteria a. and b. should be a candidate for a covered lumbar spinal fusion procedure.
  • We do not agree with coverage criteria 3.a for pseudoarthrosis following an initial spine surgery, “The patient had a period of reduced pain initially following surgery”. For a patient with instability prior to the first surgery there may have been no period of pain relief.
  • For coverage criteria 3.d. for pseudoarthrosis following an initial spine surgery, “The patient has exhausted available conservative treatment measures”, a patient with pseudoarthrosis is unlikely to benefit from Physical Therapy or injections. Therefore, we ask that Palmetto define the conservative treatment measures that should be exhausted prior to lumbar spinal fusion.
  • For Group 1 ICD-10-CM diagnosis codes, we have noted that combination diagnosis codes reflecting the patient has degenerative disc disease with another related condition are listed as covered (e.g. M51.05 – M51.17). However, the diagnosis code for lumbar degenerative disc disease without another related condition (M51.36 – Other intervertebral disc degeneration, lumbar region) is not included as a covered diagnosis. In order to allow all eligible beneficiaries coverage of this treatment we request that Palmetto add diagnosis code M51.36 as a covered diagnosis code.

We appreciate your thoughtful review of our request. If you have any questions, please do not hesitate to contact me.

Thank you for the comment. We will address each specific concern:

We have not specified the spinal procedure that we have in mind, to allow surgeons to provide fusions for any spinal procedures in which instability may be a likely cause. Some patients have anatomically complex spines, or they require procedures which may require significant alteration of the integrity of the spine. As such, we will individual surgeons to use generally accepted principles to determine whether or not a fusion is reasonable and necessary to avoid instability.

While agree that there is not strong evidence supporting use of conservative management for symptomatic spinal deformities (not meeting other coverage criteria in the LCD), but there is a lack of high quality evidence to support surgery as well. In general, there is not much high quality evidence supporting any particular treatment approach to this patient population. However, we are allowing coverage of this condition at the discretion of a surgeon to avoid limiting treatment options in a patient for whom no other treatments have been effective.

We will remove the time limit regarding progression of the spinal deformity to leave room for judgement of an individual provider.

For coverage criterion 2.b, we have clarified some of the coverage text to indicate that one of the criteria must be a met. If a patient has instability, then this will be a covered indication for surgery regardless of whether pseudoarthrosis is also present.

For coverage criterion 3.d, the evidence does not clearly indicate that any therapy, including surgery, is likely to improve symptoms more than any conservative approach. However, to avoid limiting access to coverage for patients we are covering fusion as a treatment approach when the pain is refractory to conservative measures. We will leave discretion to individual surgeons regarding whether any additional conservative treatment approaches are warranted, but as the LCD notes, this consideration must be reflected in the record.

As regards the covered ICD-10 codes, based on the coverage information in the LCD M51.36 would not be a covered indication. This ICD-10 code reflects a very common medical condition within the Medicare population, and one that the evidence does not suggest warrants fusion surgery in the absence of complicating factors.

3

The policy indicates that fusion is not covered for mild spondlylolisthesis. There are a number of other factors that play into the decision. It’s more complicated than just whether the slip is mobile or not. If there is any listhesis present, the decision whether to fuse is based on the risk of developing post-operative instability or slip progression. Factors such as 1) degree of pre-op instability; 2) Disc height; 3) Amount of facet resection to achieve decompression required; 4) Orientation of the facets (sagittal vs coronal) and 5) amount of axial back pain present 6) Extent of decompression, 7) regional angular deformity as well as translational deformity, and 8) precise location of stenosis all play into the decision. Unfortunately, “mild spondylolisthesis” is an inexact and misleading term. There is no minimum number of millimeters in the literature below which fusion is considered not to be indicated. The decision for fusion or no fusion is based on multiple factors. There is simply no good definition or reliable measurement of instability that would correspond to expected outcomes. Until recent publications in the New England Journal which for the most part were misinterpreted, most recognized the presence of spondylolisthesis as an indication for fusion. This should be preserved. The concept of a fixed vs mobile slip logically should play a role in the decision, but until that can be better defined, the option for fusion with spondylolisthesis should be maintained, regardless of the size of the slip. For now, we strongly recommend leaving it up to the surgeon to determine when fusion is needed.

Thank you for the comment. Radiographic or clinical evidence of instability, and expected iatrogenic instability are both covered by the LCD without any specific measurement criteria (indication 1), which was by design specifically because this can be a complex decision. As such, we believe that this LCD would not prohibit coverage of the circumstances described by the comments.

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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
L37848 - Lumbar Spinal Fusion
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