LCD Reference Article Response To Comments Article

Response to Comments: Lumbar Artificial Disc Replacement

A56393

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A56393
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Response to Comments: Lumbar Artificial Disc Replacement
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Response to Comments
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03/21/2019
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The comment period for the Lumbar Artificial Disc Replacement L37826 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 L37826 begins on 3/21/19 and will become effective on 5/6/19.

Response To Comments

Number Comment Response
1

I am writing on behalf of Aesculap Implant Systems, LLC (“Aesculap”) to request that Palmetto GBA withdraw the Draft Local Coverage Determination (“LCD”) for Lumbar Artificial Disc Replacement (DL37826). Aesculap is a medical device manufacturer and distributor of surgical instruments, implants, and innovative systems used for the treatment of the spine and total joint replacements. Aesculap focuses on providing transformative new developments in spine and joint repair that translate into significant and meaningful improvements in the lives of the individuals treated with our devices.

Aesculap appreciates Palmetto GBA’s (“Palmetto”) willingness to revisit its local coverage determination (“LCD”) for lumbar artificial disc replacement (“ADR”) and the opportunity to attend and present at the recent Open Meeting in Alpharetta, Georgia on October 4, 2018.

Aesculap respectfully requests that Palmetto withdraw the Draft Lumbar ADR LCD, retire the current coverage policy, and consider lumbar ADR for Medicare beneficiaries below the age of 60 on a case-by-case basis for the following reasons:

  • Lumbar ADR is an extremely low-volume procedure in the Medicare population. By virtue of the narrow FDA indications for lumbar ADR, the patient population for this technology is limited to at most 50-100 patients per Medicare contractor per year.
  • A recently published Level 1A meta-analysis demonstrates that lumbar ADR provides several clinically meaningful benefits for patients when compared to spinal fusions, including a greater likelihood of functional success as measured by the Oswestry Disability Index (ODI), and a lower risk of adverse events and reoperations at 5 years.i
  • Lumbar ADR has a more than three-fold lower incidence rate of further radiographic deterioration (9.7%) at adjacent levels over five years than fusions (20-30%), and motion preservation created by disc replacement seems to have a protective effect on the progression of adjacent segment disease.ii

These recent studies support the withdrawal of the Draft LCD and also underscore that the 2007 NCD is based on clinical evidence that is now outdated.

Case-by-case consideration of lumbar ADR is appropriate because there is evidence to demonstrate a clinically meaningful benefit for patients below the age of 60. We have attached a list of all of the published references for lumbar ADR (as well as a copy of the slides presented at the Open Meeting with more clinical data included) and invite further consultation with Palmetto as it considers our request to withdraw the Draft LCD and retire the current local coverage policy for lumbar ADR.

Thank you again for your consideration.

Thank you for the comment. We have reviewed the evidence submitted in support of the comment request, which specifically included 2 studies by Zigler et al:

  1. Zigler, Jack, Matthew F. Gornet, Nicole Ferko, Chris Cameron, Francine W. Schranck, and Leena Patel. "Comparison of Lumbar Total Disc Replacement With Surgical Spinal Fusion for the Treatment of Single-Level Degenerative Disc Disease: A Meta-Analysis of 5-Year Outcomes From Randomized Controlled Trials." Global spine journal 8, no. 4 (2018): 413-423.
  2. Zigler JE, Blumenthal SL, Guyer RD, Ohnmeiss DD, Patel L. Progression of Adjacent-level Degeneration After Lumbar Total Disc Replacement: Results of a Post-hoc Analysis of Patients With Available Radiographs From a Prospective Study With 5-year Follow-up. Spine (Phila Pa 1976). 2018;43(20):1395-1400.

In summary, both of the studies above compared lumbar artificial disc replacement to fusion surgery for back pain. The major limitation of the meta-analysis and post-hoc analysis as regards the use of its findings in our coverage decision is related to the choice of control group in the population being treated. The meta-analysis compares lumbar artificial disc replacement to fusion surgery in patients with low back pain, but fusion surgery itself has not been demonstrated to achieve meaningfully better outcomes than conservative management in patients with lower back pain, and fusion surgery is known to have post-operative complications which do not occur in patients who are managed conservatively. As such, comparable or slightly better outcomes for lumbar artificial disc replacement versus fusion surgery suggests only that lumbar artificial disc replacement is comparable to or slightly better than a treatment which itself does not have a clear role in the treatment of lower back pain. Notably, we have also published a draft LCD which reviews the evidence on lumbar fusion and non-covers it for lower back pain due to lack of clinically meaningful efficacy.

It is also worth noting for the second study that “adjacent-level disease” as described in the second study is a radiographic finding. While it is possible that adjacent-level disease could contribute to differences in pain, functional status, or quality of life for patients, this study does not demonstrate that such a possibility is indeed true., and radiographic findings of degeneration in the spine have not been consistently found to correlate with clinical symptoms.

2

In response to the draft Local Coverage Determination (LCD) for lumbar artificial disc replacement for beneficiaries sixty years of age and younger, Centinel Spine requests that the non-coverage LCD be rescinded, allowing beneficiaries who meet the age and other inclusion criteria for Lumbar Total Disc Replacement (TDR) to be considered through the LCD process. Palmetto GBH is the only Medicare Administrative Contractor (MAC) with a negative LCD for Lumbar TDR. This request would align with the other MACs following the National Coverage Determination (NCD) 150.10, which considers lumbar TDR a non-covered service for beneficiaries exceeding sixty years of age. This change would provide the relatively small number of Medicare beneficiaries who meet age and other inclusion criteria access to Lumbar TDR technology when appropriate.

prodisc L TDR was approved by the FDA through a Multicenter, Prospective, Randomized, Controlled, Investigational Device Exemption (IDE) Study in August of 2006 for patients between the ages of eighteen and sixty years. prodisc L TDR has over 200 publications demonstrating long term clinical outcomes within this population. With the exception of BMP-2, it is the most studied and published device in spine surgery. As part of the IDE study, patients were required to undergo at least six months of conservative care before being considered for surgery. Prolonged failed conservative of three to six months has been shown to lead to a continued decrease in quality of life, with 38% of patients from the SPORT Study crossing from non-operative to operative groups at six months, demonstrating the need for surgical intervention in a significant number of patients.

Discectomy is considered to be a conservative surgical intervention and viewed as a first step to failed conservative care. However, discectomy procedures have high failure rates with up to 50% reoperation rates for recurrent herniation at the same procedure level. TDR and fusion procedures provide patients with immediate pain relief, allowing them to return to activities of daily living. These procedures are viable treatment options to failed conservative care for patients with symptomatic Degenerative Disc Disease (DDD) arising from a previously operated lumbar disc. Patients failing conservative treatment should have more than one option to address their DDD, as both TDR and fusion procedures continuously demonstrate long-term clinical efficacy.

The current coverage trend is to define the TDR patient as a subsection of the lumbar fusion population. Over the past ten years, insurance companies have made significant progress in defining the TDR patient, using specific pre-operative inclusion guidelines that align with those used within the IDE Study. These guidelines ensure the appropriate differentiation between fusion and arthroplasty patients to replicate the positive clinical outcomes demonstrated in the FDA IDE study. Based on these long-term clinical outcomes, positive coverage trends continue to increase among national and regional payors, as United Healthcare, Cigna, Humana, and Anthem now cover Lumbar TDR. While secondary to clinical outcomes, there are clear economic benefits from patients’ hospital charge data analysis, in addition to the lower payment to both surgeons and facilities in comparison to fusion procedures.

The Summary of Evidence section states that the only studies that were considered relevant to this coverage determination were designed to assess clinical outcomes or composite outcomes that included at least one clinical measure. There are a number of studies that have been omitted from the literature review that demonstrate clinically relevant outcomes, most notably Zigler and Park with demonstrated ODI improvement of 34.2 points (47.4%) and 18.9 points (57%) respectively. We ask that during final coverage decision, Palmetto also consider the omitted studies that demonstrate clinically relevant outcomes that were not reviewed as part of the Summary of Evidence.

The number of potential Palmetto Beneficiaries that could be eligible for a Lumbar TDR procedure is limited due to the small beneficiary population under the age of sixty that are indicated for Lumbar TDR. We ask that Palmetto rescind the non-coverage LCD, and provide this select group of Medicare beneficiaries who are under the age of sixty and indicated for Lumbar TDR with access to the technology through the LCD process. Thank you for the opportunity to offer comments.

Thank you for the comment. As stated in the comment above: “The current coverage trend is to define the TDR patient as a subsection of the lumbar fusion population.” Our review of the evidence indicates that the subsection of the potential lumbar fusion population that TDR is intended to treat is the same subset of the population in whom lumbar fusion is not an effective treatment, and at the same time that the draft lumbar total disc replacement LCD was released a policy regarding lumbar fusion was also released reviewing this evidence.

The comment also points out that evidence from Ziegler 2012 was not reviewed in the LCD. We did review this paper and cited it in the original draft LCD, and we re-reviewed it in response to this comment. There was not a statistically significant difference between groups in the outcome of ODI in this paper. Park is a paper of which appears to be an observational single arm study. As such, it is not possible to conclude from this study that TDR is better or worse than any other treatment or no treatment at all. While the study may provide evidence that patients have symptom improvement after a lumbar TDR, the key issue as regards coverage is how the outcome would compare to alternative treatment approaches, which this paper does not answer. However, Palmetto GBA did review numerous studies which do answer this question from prospective studies comparing lumbar TDR to a control group.

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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
L37826 - Lumbar Artificial Disc Replacement
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