FUTURE LCD Reference Article Response To Comments Article

Response to Comments: Facet Joint Interventions for Pain Management

A59795

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Article ID
A59795
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Article Title
Response to Comments: Facet Joint Interventions for Pain Management
Article Type
Response to Comments
Original Effective Date
07/07/2024
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This article is in response to comment received for the revision to Facet Joint Interventions for Pain Management received by CGS Administrators, National Government Services, Noridian Healthcare Solutions, Palmetto GBA, WPS Government Health Administrators, First Coast Service Options and Novitas Solutions during the open comment period for this revision.

Response To Comments

Number Comment Response
1

The American Society of Interventional Pain Physicians (ASIPP) submitted a letter to allow therapeutic facet joint procedures to be performed by intraarticular injections or medial branch blocks. This was accompanied by supporting literature which has been added to the LCD. A provider in the Novitas/FC jurisdiction also submitted a comment in support of the ASIPP recommendations.

The LCD has been updated based on the submitted literature to allow IA or MBB for therapeutic injections when appropriate. However, the evidence does not support use as first line treatment except in exceptional cases defined within the LCD. 

2

When you use the term “moderate anesthesia,” do you mean “moderate sedation” or just “anesthesia” in the following sentence? The American Society of Anesthesiology (ASA) Statement on Anesthesia Care During Interventional Pain Procedures was included. 

The LCD did not used the term “moderate anesthesia.” The LCD used the term “Moderate Sedation/Anesthesia” and “monitored anesthesia care (MAC).” This word choice aligns with the ASA Statement on Anesthesia Care During Interventional Pain Procedures. While this is consistent with the ASA language to ensure clarity the policy has been updated to “Moderate Sedation”. 

3

Several commenters submitted concern about limitation of anesthesia for Radiofrequency Ablation (RFA) procedures. One included the ASA Statement on Anesthetic Care During Interventional Pain Procedures for Adults and recommend the policy be consistent with standard of care.

A CRNA (WPS jurisdiction) expresses concern with the RFA limitations. They provided a list of concerns including ability to remain motionless, pain, ability to tolerate the procedure, payment if they elect to pay out of pocket and that moderate anesthesia is reasonable for facet RFA. No supporting literature was submitted.

Another comment (Noridian jurisdiction) states that not allowing anesthesia for nerve blocks and ablation may jeopardize the safety of the procedure and in their opinion that it not the best practice.

The same comment was submitted by multiple anesthesia providers (Novitas/FC). The comments discussed that with the nationwide opioid crisis emphasis has been placed on treating the source of chronic pain rather than prescribing opiods. Facet joint interventions are procedures that may help a patient’s chronic pain while decreasing their opiod 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 included.

Thank you for your comments. We agree that there are circumstances that anesthesia is necessary for RFA consistent with the ASA Statement on Anesthetic Care During Interventional Pain Procedures for Adults. The policy does not prohibit the use of sedation/anesthesia under these circumstances for facet RFA. It does however clarify that this 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 provider should document why the anesthesia is necessary for the individual patients.

The section of the LCD titled Anesthesia explains the concerns with routine use of moderate sedation/MAC or deeper anesthetics. This includes the risk associated with the anesthesia itself which is higher in elderly patients, and the ability to respond to normal comments which improves the safety of these procedures and is consistent with societal guidance.

The comment who expressed concern regarding the anesthesia requirements increasing risk to patients was not supported by evidence and conflicts with current evidence and societal standards. There was no examples or literature provided to support their concerns.

4

WPS and Noridian received comments from providers (same letter) to request expansion of coverage:
1. To allow 3rd level facet procedures. They state that 3rd levels procedures are not common but there is not evidence they are not effective. The availability of a CPT code for 3rd level supports there is a need for 3rd level RFAs.
2. While they agree sedation is rarely needed for facet injections or RFA they express concern for the need for sedation for facet cyst rupture/aspiration which can be painful.
3. Request expansion of the therapeutic joint injections as a first line option.
4. At a minimum, the LCD should be revised to clarify that diagnostic facet procedures are unnecessary in several situations, most commonly, when facet cyst rupture/aspiration is the goal. They also state that limitations on facet cyst aspiration/rupture should apply to each individual cyst.
No supporting literature was provided.

Thank you for your comments.
1. There was no supporting evidence submitted that 3rd levels are effective and necessary. Most importantly there are no criteria to determine patient selection and outcomes for 3rd level facet procedures. If literature is published that further defines this, it can be submitted through the LCD reconsideration process.
2. We agree the ASA statement does not address cyst rupture/aspiration and that it may be indicated in certain cases. This was added to limitation number 3 which states that moderate sedation will be considered on individual basis for RFA and added cyst rupture/aspiration. Documentation of why it is medically necessary is expected.
3. Evidence to support therapeutic joint injections as first line therapy was not submitted. If literature is published that further defines this, it can be submitted through the LCD reconsideration process.
4. We agree that diagnostics injections should not be required for facet cyst rupture/aspiration, and this is not an expectation of the LCD. The required documentation is that advanced diagnostic studies to confirm the finding of a facet joint synovial cyst and clinical/physical exam findings consistent with this diagnosis. The clarification of per cyst was added to the LCD.

5

A provider in Missouri comments: While RFA can be an excellent option for many people, there are some instances where facet injections are more appropriate as a first-line option and multiple examples are provided. No supporting literature was included.

Thank you for your comments. We understand there are exceptional circumstances in which RFA is not recommended, which is why the policy allows the use of therapeutic injections are first line therapy in exceptional cases. The policy states: “Documentation of why the patient is not a candidate for radiofrequency ablation (such as established spinal pseudarthrosis, implanted electrical device).” These cases should be submitted with documentation as to why the provider feels that RFA is contraindicated or not medically necessary for consideration. All other requirements of the policy and frequency limit for therapeutic injections still apply. If literature is published to further define this population, it can be considered through the LCD reconsideration process. 

6

A comment letter was received by IPSIS. They request:
Under not reasonable and necessary section to change number 4 “Facet joint procedure performed after anterior lumbar interbody fusion (ALIF)” to "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)".

This portion of the LCD was not open to comment and there was no literature requested to support this change. In RTC Article (A58613 ) several commenters expressed concerns with limitation of facet procedures after posterior fusion so this was removed from the policy. If there is literature to support allowing facet procedures after ALIF or limiting them for PLIF this can be submitted for consideration through the LCD reconsideration process.

7

From IPSIS:
6. “Diagnostic injections or MBB at the same level as the previously successful RFA procedure”
The LCD currently indicates under covered indications that (#8), “If there is an extended time, 2 years or more, since the last RFA or there is a question as to the source of the recurrent pain, then diagnostic procedures must be repeated” and then contradicts this indication by limitation #6. We propose eliminating #6 (above) in the “not reasonable and necessary” section and modifying #8 in the Limitations section to read: “If there is a question as to the source of the recurrent pain then.
diagnostic procedures must be repeated.”

Thank you for your comment we agree and this change has been made. 

8

A comment was received (Novitas) 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 comment. The policy continues these procedures and does not prevent appropriate use of facet joint procedures. 

9

A comment was submitted (Novitas) 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.

Thank you for your comment. There was no supporting literature submitted to support this change. 

10

There was concern regarding the codes M71.30 and M71.38 which are not consistent with facet cyst.

Codes M71.30 and M71.38 were removed from the billing and coding article.

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Medicare BPM Ch 15.50.2 SAD Determinations
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