LCD Reference Article Response To Comments Article

Response to Comments: Facet Joint Interventions for Pain Management

A59816

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Article ID
A59816
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Article Title
Response to Comments: Facet Joint Interventions for Pain Management
Article Type
Response to Comments
Original Effective Date
06/27/2024
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The following are the comment summaries and contractor responses for Novitas Solutions Local Coverage Determination (LCD) DL34892 Facet Joint Interventions for Pain Management which was posted for comment on February 15, 2024, and presented at the March 1, 2024 Open Meeting. All comments were reviewed and incorporated into the final LCD where applicable.

Response To Comments

Number Comment Response
1

The same comment was submitted by multiple anesthesia providers. The comments discussed that with the nationwide opioid crisis emphasis has been placed on treating the source of chronic pain rather than prescribing opioids. Facet joint interventions are procedures that may help a patient’s chronic pain while decreasing their opioid use. The concern is that these procedures involve pain and discomfort and if patients are moving or uncooperative during the procedure due to the pain serious complications may arise. The commenters are requesting that anesthesia sedation for the procedures be an option for patients. No supporting literature was submitted.

Thank you for your comments. Please note that the proposed LCD states that moderate or deep sedation, general anesthesia, and monitored anesthesia are not medically reasonable and necessary for facet joint injections. The LCD does not prohibit moderate anesthesia for radiofrequency ablation (RFA) procedures. However, consistent with the LCD, it is not acceptable for routine use including patient preference or anxiety which can be managed with oral anxiolytics. In cases where there is longstanding well-documented history of inability to cooperate, medical conditions that would prohibit performance of the procedure, or inability to remain motionless anesthetic for Facet RFA will be considered. The medical record should support the need for anesthesia when indicated. Reports from the American Society of Anesthesiologist committee and the Spine Intervention Society Factfinder concluded that default use of sedation is not associated with clear health/outcome benefits and is associated with rare but serious increased risk. The reports indicated that most patients are satisfied with care when receiving injections without sedation and that it should be used judiciously.

2

A comment was received indicating that facet joint injections are essential to maintain healthy daily life for many individuals and that cutting funds would have catastrophic impact on the health of many individuals. The commenter requested that we continue these treatment options.

Thank you for your comment. It is not the intent of the contractor to jeopardize the health of any patient. The proposed LCD is not eliminating coverage for facet joint interventions. Rather, the LCD has been revised to provide clarification regarding the use of anesthesia for the services as well as the number of levels treated.

3

A comment was received from the American Society of Interventional Pain Physicians (ASIPP) requesting that coverage is provided for therapeutic facet joint procedures to be performed by intraarticular injections (IA) or medial branch blocks (MBB) . The commenter submitted 6 articles to support their request.

Thank you for your comment. Following review of the submitted literature, the final LCD has been revised to allow IA or MBB for therapeutic injections when appropriate, consistent with the indications and limitations in the LCD.

4

A comment was submitted requesting that the language under Limitation #4 be revised to include exceptions such as spinal scoliosis, spinal fusion surgery, old compression fracture that changes spinal dynamics, patients with documented falls and injuries, and patients with scan documented multilevel spinal pathology. No supporting evidence was submitted.

Thank you for your comment. After review, the contractor is not making any change to this area. If there is supporting evidence available, you may submit it following the reconsideration process once the LCD is effective.

5

A comment was submitted by an interventional pain practice indicating that they agree with the proposed changes submitted by the ASIPP.

Thank you for your comment, please refer to the response to Comment #3.

6

A comment was submitted by the International Pain and Spine Intervention Society (IPSIS) requesting the following: 1) Revise # 4 under the situations that are not medically reasonable and necessary that states “Facet joint procedure performed after anterior lumbar interbody fusion or ALIF” to say "Facet joint procedure performed at the same level as a successful and previously fused segment, such as at the same level as an anterior or posterior interbody fusion (ALIF or PLIF)". IPSIS feels this clarification is essential to prevent inappropriate denials within the same spinal region. 2) Eliminate #6, “Diagnostic injections or MBB at the same level as the previously successful RFA procedure under the situations that are not medically reasonable and necessary” and revise #8 “If there is an extended period of time, 2 years or more, since the last RFA and there is a question as to the source of the recurrent pain then diagnostic procedures must be repeated” in the Limitations section to say “If there is a question as to the source of the recurrent pain then diagnostic procedures must be repeated.” IPSIS indicates that it is not reasonable and necessary to repeat MBBS after 2 years of pain relief from an RFA. They went on to discuss that requiring repeat MBBs prolongs the time period of pain and incurs unnecessary procedures and expenses. Further they feel that #6 in the not reasonable and necessary list contradicts the covered indication allowing repeat blocks, when deemed necessary by the physician. Finally, IPSIS indicates that if there is any doubt as to whether RFA is appropriate then MBBs should be done regardless of the amount of time that has elapsed.

Thank you for your comments. In response to the request to revise #4, no supporting literature was submitted to support this request. Additionally, this section of the proposed LCD was not open for comment with this revision. Once the LCD is finalized, full-text literature in support of this request may be submitted following the reconsideration process. Regarding the request related to #6 and #8, the contractor agrees with the recommendation and this change has been made in the final LCD.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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