Local Coverage Article Response to Comments

Response to Comments: Cervical Disc Replacement


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Article ID
Article Title
Response to Comments: Cervical Disc Replacement
Article Type
Response to Comments
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The comment period for the Cervical Disc Replacement L38033 Local Coverage Determination (LCD) began on 5/6/19 and ended on 6/20/19. The comments below were received from the provider community. The notice period for L38033 begins on 9/12/19 and will become effective on 10/28/19.

Response To Comments


In response to the draft Local Coverage Determination (LCD) for Cervical Disc Replacement (DL38033), [We are] fully supportive of the proposed LCD Coverage Guidance Document in its entirety. The proposed policy affords patients and providers with an appropriate treatment option and no changes are requested.

Thank you for your comment.


[We] support the finalization of this proposed/draft LCD. We greatly appreciate Palmetto affirming the ability of cervical disc replacement to “maintain anatomical disc space height, normal segmental lordosis, and physiological motion patters at the index and adjacent cervical level with reduced risk of adjacent level DD commonly seen above or below a fusion site”. This proposed LCD will appropriately allow licensed healthcare providers the ability to offer their patients an alternative treatment to spinal fusion that encourages spinal motion and maintains the normal biomechanics of the cervical spine. As stated in the proposed LCD, Palmetto will consider FDA-approved prosthetic cervical discs reasonable and necessary for the treatment of Medicare beneficiaries with symptomatic cervical degenerative disease of herniated disc when medical necessity criteria are met. We respectfully request that you incorporate a discussion on [our] Artificial Cervical Disc in the final LCD for Cervical Disc Replacement, DL38033. This inclusion will ensure that all FDA-approved cervical discs are discussed within the LCD.

We respectfully disagree. The LCD process is intended to provide coverage guidance for services, including drugs and devices, for which there is sufficient peer-reviewed high quality evidence to support medical necessity in the Medicare population. FDA approval alone is not sufficient to warrant Medicare coverage. No supporting research was submitted with this comment. Due to the unavailability of U.S.-based, high-quality, peer-reviewed published clinical research of this device, we must conclude that it is still investigational and therefore unreasonable to consider for coverage at this time. Upon availability of this evidence, we can reconsider coverage upon request.


For Coverage Limitation #6, we believe the statement should be revised to state: “The Beneficiary is free from absolute contraindications to cervical disc replacement” For Investigational Coverage Limitation bullet #4, we disagree with this limitation. Patients that meet all other indications and are having surgery for adjacent level disease (a disc that has degenerated next to a prior fusion) are potentially good candidates for artificial disc replacement instead of another fusion. While we understand these were not the patients studied in large trials, the alternative treatment (another fusion) has a poor track record of success. For Investigational Coverage Limitation bullet #9. We believe this bullet should be qualified. We believe, in the studies this was listed as moderate and severe arthropathy.

Strict adherence to careful patient selection contributed significantly to demonstrating the net health benefit for CDR. These criteria are necessary to reasonably attribute intractable cervical radicular pain or myelopathy to a specific disc level. Moreover, CDR only replaces the disc therefore, the posterior elements, such as the facets and ligaments, are required to be free from anatomic malformation. However, we agree that it is reasonable to include patients with mild disease when the source of cervical radicular pain or myelopathy can be clearly attributed to the corresponding disc. Therefore, we will qualify this exclusion as suggested. We also agree to qualify the contraindications as absolute and more clearly indicate those clinical characteristics where CDR is not reasonable. Lastly, given the absence of literature to establish the safety and efficacy of CDR in patients with a previous fusion, it is by definition investigational. Therefore, this limitation will remain as is.

Associated Documents

Related Local Coverage Documents
DL38033 - (MCD Archive Site)
Related National Coverage Documents
Public Versions
Updated On Effective Dates Status
09/04/2019 09/12/2019 - N/A Currently in Effect You are here