LCD Reference Article Response To Comments Article

Response to Comments: Sacroiliac Joint Injections and Procedures

A59319

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A59319
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Response to Comments: Sacroiliac Joint Injections and Procedures
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Response to Comments
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03/19/2023
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Comments on the proposed policy Sacroiliac Joint Injections and Procedures (DL39455) were received by CGS Administrators, LLC, National Government Services, Inc, Noridian Healthcare Solutions, LLC, Palmetto GBS and WPS Insurance Corporation. Comments are compiled and responses are listed below for final policy on Sacroiliac Joint Injections and Procedures.

Response To Comments

Number Comment Response
1

A Multi-Society letter was sent to CGS, Palmetto, WPS, NGS and Noridian from the American Academy of Pain Medicine, American Academy of Physical Medicine and Rehabilitation, American Society of Anesthesiologists, American Society of Neuroradiology, American Society of Regional, Anesthesia and Pain Medicine, American Society of Spine Radiology. Georgia Society of Interventional Pain Physicians, North American Neuromodulation Society, North American Spine Society, Society of Interventional Radiology and Spine Intervention Society. The comment letter reviews the complex neuroanatomical considerations of SIJ pain. To summarize they state “It is important to note that the intraarticular joint and the PSIJC are two different pain generators with different innervations. It logically follows that they should require different treatments to appropriately target the structures responsible for their respective generation of pain [Kennedy 2015, Yang 2021, King 2015, Yang 2019]. Intraarticular injections target anterior innervation. If pain is originating from the PSIJC, intraarticular injections will not result in significant improvements in pain or function. As currently proposed, patients with pain originating from the PSIJC have no interventional treatment options. Intraarticular SIJ injections do not diagnose or treat pain originating from the PSIJC.”

We agree with the commenters, and this highlights the concerns that intraarticular SIJs do not predict who will respond to SIJ radiofrequency ablation procedures.

2

The same commenters explain the role of diagnostic L5 dorsal ramus and sacral lateral branch blocks involving injecting a small amount of local anesthetic onto the L5 primary dorsal ramus and S1-S3 dorsal rami lateral branches and that they do not diagnose pain from within the SIJ but rather posterior sacroiliac joint complex (PSIJC) (the site for RFA) pain. They provide suggested guidelines to use these blocks as diagnostic predictors for response to SIJ RFA using 2 blocks with 75% improvement on two separate occasions.

We appreciate the societies suggestions for the criteria to utilize diagnostic L5 dorsal ramus and sacral lateral branch blocks for predication of responders to RFA, however the criteria submitted is not supported by existing evidence. The pivotal studied reference for a role of SLBB blockade is Dreyfuss et al 2009 which was a double blinded RCT evaluating multi-site, multi-depth sacral lateral branch blocks (SLBB) in asymptomatic volunteers demonstrating multi-site, multi-depth SLBB were 70% effective and do not effectively block the intra-articular portion of the SIJ. There are several serious limitations to this study and lack of evidence basis for the recommendations for use as predictors for SNRF response:

  1. There are no placebo-controlled trials of sacral nerve blocks to confirm this theory.
  2. Subjects were asymptomatic so extrapolation to a population with pain is uncertain.
  3. Study is limited by high risk of bias due to imprecision due to very small sample size with 20 subjects and only 10 in active treatment arm.
  4. There are no studies that measure a cut-off threshold (% improvement) for positive response from SLBB for response to RFA.

5. There are no studies that determine the false positive or negative rate for prediction of response to RFA from SLBB and if a second injection mitigates false positive results.

3

The same commenters advocate for coverage of L5 dorsal ramus and sacral lateral branch radiofrequency neurotomy (LBRFN) and offer suggested coverage criteria for RFA based on positive response to SLBB (see comment #2) for those with pain of at least 3-month duration with functional deficit despite conservative management. They advocate for repeat RFA for those with 50% or greater response lasting at least 6 months. Four citations were included to support this recommendation (Yang 2019, Yang 2021, King 2015, NASS recommendations 2020). 

The systematic reviews provided in support of this recommendation are not new literature and are included in the evidence review of the LCD. These systematic reviews highlight the limitations in the evidence surrounding LBRFN.

In review of 32 studies for SLBRFA of which two utilized SLBB (Yang 2019). One used single-site, single-depth, anesthetic blocks of sacral lateral branches and L5 dorsal ramus with 75% pain relief required for progression to RFA (Patel 2012) and the other one used a set of single-site, single-depth RFAs with 50% pain relief (Juch 2017). Most studies used intraarticular injections to predict response which as stated in comment #1 does not correlate with innervation of the posterior SIJC.

There are multiple limitations in the systematic reviews (which is also discussed in the LCD with references cited):

  1. There is no consistent selection criteria for SIJ pain.
  2. There are multiple different types of blocks used for diagnosis in different anatomical locations, different doses and types of anesthetics, lack of consistent cut off for improvement, number of diagnostic injections (0-2), time to reassessment of pain, tool to measure response to pain, type of RFA used, which nerves were ablated during the procedure, time to follow and assessment leading to significant heterogenicity in this body of literature. While meta-analysis has been conducted the results must be interpreted with caution in light of this degree of heterogenicity which limits reliability of meta-analysis.
  3. Reasonable and necessary requirements based on Section 1862(a) (1) (A) of the Social Security Act requires services are furnished in accordance with accepted standards of medical practice require the service is:
  4. Safe and effective
  5. Not experimental or investigational
  6. Appropriate, including the duration and frequency in terms of whether the service or item is:
  • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the beneficiary’s condition or to improve the function of a malformed body member;
  • Furnished in a setting appropriate to the beneficiary’s medical needs and condition;
  • Ordered and furnished by qualified personnel; and
  • One that meets, but does not exceed, the beneficiary’s medical need

 

A significant factor which has not been established in the published literature for LBRFN is appropriate use of SIJ RFA. Currently there is expert opinion guidelines as provided in the commenter’s letter and NASS Guidelines. The comment letter references Appropriate Use Criteria for Fluoroscopically Guided Diagnostic and Therapeutic Sacroiliac Interventions: Results from the Spine Intervention Society Convened Multispecialty Collaborative by MacVicar et al 2017 which acknowledges the two systematic reviews that utilize a standardized grading criteria applied to this body of evidence with GRADE did not identify high quality evidence and given lack of high-quality were reliant on expert opinion. Despite expert opinion on best practices there is tremendous variability within the literature and in current practices. There is lack of consistency within the literature to establish standards for patient selection and the existing studies report effectiveness outcomes that are based on selection criteria that have been refuted even by the experts without new studies to determine the optimal criteria creating no clear standards. The lack of established practice standards, patient selection and assessment criteria, frequency of treatment and long-term outcomes in the existing literature SLBRFA requires additional investigation to provide clarity to meet the requirements of reasonable and necessary. We agree that investigational/experimental is not the best classification of the challenge, but rather insufficient data and lack of appropriate use criteria which can only be resolved with further investigation and this has been clarified in the LCD.

 

4

The same commenters referenced two RCT to support efficacy of SLBRFA. “The best available evidence on radiofrequency neurotomy of the L5 dorsal ramus and sacral lateral branches are two randomized controlled trials (RCT) that have demonstrated the efficacy of the procedure [Cohen 2019, Patel 2012]. A pooled, between-group analysis of these RCTs revealed that those treated with radiofrequency neurotomy were four times more likely to achieve ≥50% pain reduction at three months compared with sham (proportion rate ratio/relative risk [4.84 (95% CI 1.19–19.73]) {Yang 2021}. Despite the level of benefit shown in the pooled analysis, both these studies used patient selection criteria which is less than ideal for identifying PSIJC-mediated pain. Thus, the true benefit of radiofrequency neurotomy is likely superior in a properly selected patient population. Ultimately, there appears to be a therapeutic effect with treatment responder rates ranging from 32–89%, which is likely attributable to wide ranging variability in patient selection in the available studies for review [Yang 2019]. Additionally, LBRFN has been shown to provide long-term pain relief, with studies reporting that 50-70% of patients achieved ≥50% pain reduction at up to 18-24 months [Ho 2013, Romero 2015], and pain relief can be reinstated with a repeat procedure [Kurklinsky 2020]."

The two referenced RCT were included in the evidence review of the LCD and are not new literature. Figure 1 in the LCD summarizes the analysis of this literature using GRADE concluding low certainty of the evidence for RFA compared to placebo for pain relief. The treatment responder rates ranging from 32–89% is no better than a flip of the coin leaving the true effectiveness of this procedure uncertain.

Three studies were submitted that were not included in the evidence review so have been added to the LCD. These studies were not initially included due to low quality inherit to their study design. This included two small retrospective studies and one small prospective study concluding long term benefit of radiofrequency ablation. (Ho 2013, Romero 2015, Kurklinsky 2020) While these studies suggest some potential long-term benefits and claim higher responses than the RCT (50-70% achieving pain relief) there are too many variables to draw a reliable conclusion. Without a comparison to placebo, it is uncertain if the benefit is a result of the disease course improving overtime, additional interventions the patient received throughout this time period, the result of the radiofrequency ablation, placebo effect or other factors. 

5

The same commenters submitted a 2020 paper on reduction of opioid intake after cooled radiofrequency denervation for sacroiliac joint pain and highlight during the current opioid crisis that LBRFN has been shown to reduce opioid dependency. 

While the small retrospective study submitted is promising it is limited by the challenges with selection criteria, retrospective study design, potential influence of physician prescribing practices, comorbidities including previous back surgery and chronic pain in the patient population, considerable variation in the opioid use outcomes and small sample size. There is not sufficient evidence to claim SIJ RFA impacts opiate use based on this single uncontrolled study of 27 patients most of which remained on opiates after the SNRFA. Lack of long-term outcomes or comparison to placebo leaves us without understanding if the opiate use patterns would be similar in those who had not undergone the procedure or if the procedure was the variable that impacted opiate use pattern. 

6

The same commenters state that the designation of a CPT code (effective 1/1/2020) supports the strength and quality of the evidence in support of the safety and effectiveness of LBRFN. 

The designation of a CPT code does not ensure a service meets the reasonable and necessary criteria within Medicare. There are several factors within the Medicare definition of reasonable and necessary that have not been met regarding LBRFN.
1. There is a lack of “accepted standards of medical practice” as best practice has not been established (see Comment #3).
2. Uncertain applicability to Medicare population as the mean age in these studies is consistently below the mean Medicare beneficiary.
3. Uncertainty if this procedure is “at least as beneficial as an existing and available medically appropriate alternative” over other available options for treatment ranging from medical to surgical as there is lack of high-quality evidence and no comparison studies that address if this procedure offers improvement. Additionally, it is not covered by most commercial insurance carriers.

7

The same commenters state within “the “Limitations” that sacroiliac joint injections to treat “axial spine pain” are investigational, and therefore, not considered medically reasonable and necessary. As written, the language could possibly be construed as excluding pain over the sacrum. Therefore, we recommend the language be revised to "axial spine pain primarily above the level of L5.”

We agree this can be a potential source of confusion and the LCD has been reworded as suggested.

8

Comments and literature were received from AVANOS Medical makers of radiofrequency ablation devices. That while they believe additional evidence through randomized controlled trials would be beneficial, they do not agree that radiofrequency ablation of the sacroiliac joint is experimental or investigational. They reported studies have shown no significant complications from cold sacroiliac joint procedures (Sun 2018).

We agree with the commenter that there are no reports in the literature for severe adverse safety outcomes, however the high heterogeneity, small sample sizes and lack of long-term outcome data within the current literature limits the ability to understand long term effectiveness and clinical outcomes. The fundamental problem is lack of appropriate medical practices for this procedure and additional investigation is needed to establish this.

In Sun 2018, a pooled meta-analysis of 240 patients from 7 studies was performed. This included retrospective, observational and two small, randomized control trials. The risk of bias assessments did not address imprecision which is significant due to the small sample sizes. Most concerning is pulling multiple study designs in the same analysis. Combining randomized studies with observational studies in a network meta-analysis is not recommended per the Cochrane Handbook. While meta-analysis was conducted the results must be interpreted with caution. (Reference Cochrane Handbook 11.3.4 https://training.cochrane.org/handbook/current/chapter-11)

9

The same commenters expressed concern that the statement regarding the role of cryoanalgesia for SJ pain that follows the cooled radiofrequency ablation paragraph may be confusing. They are concerned that we are referring to cooled radiofrequency ablation as cryoanalgesia and states that these are separate procedures.

We agree that these are separate procedures and to clarify confusion have added a clarifying sentence into the LCD as well as a definition of cryoanalgesia into the definition section.

10

The same commenter states that removing neuroablative techniques leave patients who are non-surgical candidates who are often older with comorbidities or those wishing to avoid surgery without other options other than opioids when conservative measures fail. 

See Comment #5. At this point there is little data on the effectiveness of SNRFA past 3 months and long-term outcomes, if there is a reduction in opiate use and surgery from the procedure and the applicability to Medicare population as patients >65 was underrepresented in most studies.

11

The same commenters point out The American Society of Pain and Neuroscience (ASPN) has recommended supporting LSBRN with evidence GRADE II-1B.

This is not new evidence and is reviewed in the LCD. The paper acknowledges that intra-articular injections do not necessarily correlate with RFA success and blocking intervention at a different depth may be more effective, “but there are no placebo-controlled trials for lateral sacral nerve block to confirm this thought process” creating a treatment gap. They offer a Grade B recommendation stating that “Lateral sacral branch radiofrequency neurotomy may be used for the treatment of posterior sacral ligament and joint pain following positive response to appropriately placed diagnostic blocks.” However, they do not define “appropriate blocks”. They acknowledge that this is not determined: “The main limitation found within the literature is the heterogeneity of the studies involved. Most studies utilized intra-articular joint injections to select patients for sacral lateral branch RFN. As identified by Dreyfuss et al., the use of diagnostic nerve blocks in the posterior sacral nerve supply is more appropriate and prognostic for outcomes of RF. Not only is further research needed for the use of diagnostic sacral nerve blocks but also with neurotomy itself. Studies used conventional RF, pulsed RF, and cooled RF, with variable parameters and procedural times. The present literature suggests the clinical efficacy of unipolar, bipolar, cooled and pulsed RF; however, studies are limited and are of fair quality at best. (Lee 2021)”

12

The same commenters submitted a 2022 systematic review by Lowe et al. 

Thank you for the submission of this new literature which was published after the LCD draft was already submitted. This paper has been added to the LCD. This review includes 16 RCTs of which 15 reported positive results for RFA. Of significance, many of the included studies reported RFA outcomes for facet, SIJ, intravertebral disc or a combination and were not specific to SIJ. The review did not breakdown the number of patients in each study with SNRFA, although the evidence tables indicate the larger portion undergoing facet RFA. The SR concludes “taken in aggregate” the total body of research supports this intervention however one cannot draw conclusions about pooled data in this setting as they are reporting a positive trend in RFA and not specific to SIJ. The placebo-controlled trials that address SNRFA specifically were discussed but not analyzed separately. It is unclear how this conclusion is drawn when the literature reviewed includes studies that evaluate facet which has a more robust body of literature to support RFA than SIJ RFA and separate analysis of the SIJ specific literature was not conducted within this SR.

13

The American Academy of Physical Medicine and Rehabilitation (AAPM&R) submitted comments and state disagreement with the position of SIJ RFA being investigational and state it is an important tool in the arsenal used by physiatrists who focus on more conservative non-opioid, non-surgical measures to treat back pain. They participated in the multi work group letter that is addressed in comments #1-7. They also state a new prospective RCT is underway with 3-month and 12-month data, but not yet published. 

See Comments #1-5, & 10. We look forward to the publication of additional literature that may help to provide further clarification on this subject and can be submitted through the LCD reconsideration process once published in a peer review journal. 

14

A provider submitted comments to CGS stating their support for coverage for SIJ RFA. They feel that this offers an option between conservative managements and surgical intervention especially beneficial to patients who are poor surgical candidates and as an alternative to opiates. They also expressed concern in the Medicare population with risk of falls and refer to the recent systematic review by Lowe (2022) as evidence. They also submitted a comment on facet procedures.

Thank you for your comments. Please see Comments 3, 4, 5, 10 and 12. This policy does not address facet procedures and any changes to that policy can be considered via the LCD reconsideration process.

15

A comment letter was received from Stryker stating their concerns regarding the SIJ RFA being considered investigational and not reasonable and necessary. They state that they do not feel that the proposed LCD aligns with the clinical evidence or expert recommendation presented at the CAC meeting on 3/10/22. 

The CAC meeting is recorded and publicly available. Despite acknowledging the limitations of the evidence, the multi-jurisdictional subject matter expert panel felt there is a role for radiofrequency ablation as an option for management of SIJ pain. While we are grateful for the input from the SMEs, their role is advisory in nature and does not determine policy. Policy decisions are not made or discussed at the time of an advisory meeting. Consideration of expert input from the SMEs and evidence review is subsequently conducted to determine if a service meets the requirements for reasonable and necessary. Why SIJ RFA does not meet the criteria for reasonable and necessary is elaborated in Comment #3.  

16

The same commenters state the analysis excluded several high-quality studies from consideration citing Patel’s 2016 study as being excluded from the Grade Pro analysis. They also state that the evidence analysis excluded all studies without a sham arm which is overly restrictive.

Patel 2016 was included and cited in the proposed LCD. While the Patel (2016) did follow patients out to 12 months there was no comparative arm due the cross-over design at 3 months therefore there was no longer a placebo arm to study limiting data to 3 months. As the analysis was specific to placebo-controlled studies it no longer qualified, and this data was already included in the analysis from Patel 2012 which represented the portion of this study that was sham-controlled.

 

To conduct an analysis, the study must share the same study design. If RCT trials are available, they are use over observational studies due to the inherit weakness of observation studies. In systematic reviews including both RCTs and observational studies, their meta-analysis should be explicitly separated (Paul, M., & Leeflang, M. M. Reporting of systematic reviews and meta-analysis of observational studies. Clinical Microbiology and Infection, 2021 27(3), 311-314). The GradePro analysis was conducted in accordance with GRADE guidelines (Grade handbook https://training.cochrane.org/handbook/current/chapter-24/see Chapter 24 on including non-randomized studies on intervention effects). As cited in all of the systematic reviews of SIJ RFA the extreme heterogeneity of this literature is problematic as explained in Comment # 3 & 4.

17

The same commenter states that multi-specialty societies have provided selection criteria for the patients undergoing SIJ RFA and request adopting those as standard for coverage.

See Comments #1-4.

18

The same commenter state that the proposed SIJ policy contraindicates the facet joint policy.

Sacroiliac joints are not the same as facet joints with different anatomical function, location, and innervation. There is a different body of literature that addresses the facet joint. The facet joint policy does not impact the reasonable and necessary determinations related to the sacroiliac joint.

19

Comments were received from Medtronic which produces equipment for radiofrequency ablation. The commenter states that the literature for sacroiliac joint injections is fraught with some of the same problems as found in the literature for radiofrequency ablation but is considered R&N while RFA was not and request RFA be considered R&N as well. 

We agree there are limitations within the literature surrounding SIJ injections as reviewed in the LCD. However, there was consistency in the ability to create a criterion for patient selection that was supported by literature. Shortcomings remain in the literature regarding acceptable standards of practice, but there is a role for SIJ injections especially in traumatic injuries, short term (< 6 month) pain relief and as a diagnostic tool in determining the source of complex back pain. Based on the available evidence combined with favorable input from our SMEs it was determined injections of SIJ meet the definition of reasonable and necessary as outlined in the LCD. This area would certainly benefit from further research especially in regard to duration of pain relief with therapeutic injections and role of repeat injections.  

20

The same commenters submitted 2 new references to support RFA for SIJ pain. Both studies were pooled data between SIJ and RFA population focusing on comparison of RFA techniques (Shih 2020 & Maccagnano 2022).

Thank you for submission of these studies which have been added to the LCD. The 2020 SR/MA Shih et al. for SIJ RFA improvement in pain reports high heterogenicity with I2 =92% and 96% for thermal and cooled RFA respectively. The authors recognize the lack of standards in the RFA techniques may be a cause of the high heterogenicity and acknowledge that “our results may not be reliable”. While they conclude positive findings with SIJ RFA the authors acknowledge that a comparison of the efficacy among three radio frequency techniques in the treatment of low back pain has not been well investigated, and acknowledge the results lack a high level of evidence and more high-quality trials are needed. (Shih, Shen et al. 2020)

A 2022 systematic review pairing thermal versus cooled radiofrequency ablation in patients with sacroiliac joint pain included nine studies with a total of 276 patients. The authors conclude there was no statistical difference between the two techniques examined and the literature is currently lacking calling for additional studies period.(Maccagnano, Noia et al. 2022)

21

The Society for Interventional Radiology (SIR) submitted the following comments: they do not feel that RA is investigational and may prevent patient access to this opiate alternative procedure. They cite seven papers that highlight the history of radiofrequency ablation which include RFA conducted by strip lesion, conventional monopolar, unipolar and bipolar, cooled, Simplicity III RFA and quadripolar RFA with improvement in 36-60% of subjects.

See comment #3-5. While these small individual studies show a trend towards improvement with RFA this exemplifies the challenges within the existing body of literature related to RFA procedure highlighting 7 different techniques without standardized practices require for a service to be considered reasonable and necessary. The lack of appropriate patient selection may be a factor in the wide range in results (36-60% in this set of papers). 

22

The same commenters cite the six Level 1 manuscripts, including 5 sham-controlled trials with evidence to support effectiveness of RFA (Patel 2012, Cohen 2008, van Tilburg 2016, Mehta 2018, Patel 2016). They also cite meta-analysis (Chen 2019) that show similar findings and also discussed in LCD. They provide an evidence table for the citations included to support RFA. 

These papers are discussed in the SIJ Denervation Section of the LCD- see Figure 1 for detailed analysis as well as Comment #3, 4, 8 & 16 for further details and response. Thank you for the through literature review. We cannot consider unpublished studies, cost analysis or non-peer-reviewed literature (textbook chapters or technical papers), but the remaining references in the letter have been reviewed as part of the LCD development and Shih (2020), Chappel (2020), Sun (2018), and Juch (2017) were add to the LCD. Case reports, series and small retrospective studies were not added to LCD.

23

A comment was received from MedTek requesting the addition of M53.3, Sacrococcygeal disorders, not elsewhere classified to the covered code. They state M533 is noted to be “NEC”, not elsewhere classified. They state most SIJ procedures in their review are billed with M53.3. They also request the M47.817 lumbosacral spondylosis be added stating “M47818, Spondylosis without myelopathy or radiculopathy, sacral and sacrococcygeal region, is listed as covered in the draft LCA and describes sacral spondylosis, however, most patients will not have this documented as an isolated condition, as they will also have lumbar spondylosis”.

We agree with the addition of the code M53.3 as this describes a diagnosis that meet the coverage criteria not otherwise represented in the current included codes. While we agree patients may have more than one diagnosis M47.818 is specific to the conditions that align with coverage while M47.817 is not therefore will not be added.

24

A letter was submitted on behalf of the Connecticut Pain Society and states concerns regarding increasing opiate use, increasing paperwork due to documentation requirements, concern regarding limitations on performing multiple procedures, the cut off of 75% for injections being too high and concern or lack of coverage for regenerative therapies. There was no supporting literature included. 

See Comment #5 & 26. Documentation requirements should align with the information obtained from the patient as part of the assessment and plan of care and therefore should not be onerous. If there is supporting literature regarding any of the additional concerns this can be considered through the LCD reconsideration process. 

25

Multiple providers commented on the benefit of the SIJ RFA procedure, recommending coverage and express disagreement with determination it is investigational. No supporting literature was provided.

Thank you for your comments. See comment #3.

26

A provider comment expresses concern about considering RFA as investigational stating it is an effective, viable option for treating SIJ pain. They compare SIJ to facet RFA and that limiting SIJ RFA will increase fusion rates which will result in more failed procedures. No supporting literature was provided. 

Thank you for your comments. We understand the technical components of RFA are similar between facet and SIJ joints but there are notable differences. The literature for facet, despite some gaps, has demonstrated that properly selected patients may benefit from RFA, however the literature for SIJ lacks a selection criterion to determine which patients may benefit from this procedure as explained in Comments 3 & 4. There was no supporting literature provided to support the statement regarding fusions.

27

Stakeholders commented concern regarding SIJ RFA being considered investigational as a treatment option for chronic pain patients with sacroiliitis and that this may increase opioid use and increase cost and use of a largely unproven surgery to fuse the joint. The provider states they have immense success with the procedure. They submit the Lowe 2022 study for evidence stating that this assessed 16 randomized control trials instead of the 6 sham studies used to formulate the LCD concluding benefit for up to one year.

Thank you for your comments. See Comments 3-5, and 12. 

28

A stakeholder comment expresses concerns about Covered Indications A. #4 and B #4 that the LCD requires clinical findings and imaging studies do not suggest other obvious causes of pain as there can be multiple sources of pain in the same patient. They also state concern with the limitations for multiple injections stating that an approach that includes multiple injections may be beneficial in some patients. No additional literature was submitted.

Thank you for your comment. While we understand a single patient may have multiple pain sources, if the pain source is not diagnosed correctly, it is not possible to target appropriate treatment. This may put the patient at risk or repetitive and potentially unindicated procedures. Therefore, we affirm multiple blocks on the same day could lead to improper or lack of diagnosis or limit the ability to access response and determine if repeat injections are necessary. If literature supports a multiple injection approach this can be considered through the LCD reconsideration process.

29

A stakeholder comments they have performed over 200 SIJ RFA procedures with an average of 75% long term relief (>18 months, often 24-36 months) with the bipolar strip lesion technique and states it is not investigational

Thank you for your comments. This data is unpublished and there is no supporting literature provided. Future studies may provide the guidance needed for patient selection and techniques that can result in success rates explained in your comments, however current rates range from 32-89% (See Comment #4).

30

ASIPP/SIPMS/ Puerto Rico Society of Interventional Pain physicians submitted comments which support the use of diagnostic L5 dorsal ramus and SLBB blocks for patient selection for LBRFN. They state that even though there are no significant studies, stand alone or comparative, it is an extremely useful modality. They request coverage for LBRFN using SLBB criteria. They also discuss cost effectiveness. They expressed concerns that this policy may increase surgical intervention and opioid use. They submit Lowe 2022 for additional evidence.

See Comments 2,3,5 & 12. There are no studies we identified or that were submitted that determine the percentage of patients who undergo RFA that ultimately go on to surgical management or that RFA reduces the need for surgical fusion. The lack of long-term outcome data in the current body of literature limits our understanding of the long-term impacts, failure rates of LBRFA, how long patients continue to receive LBRFA, or other treatment modalities pursued after SIJ RFA. 

31

The same commenter suggested using the Pain Disability Index for assessment of pain disability. 

Thank you for the comment and Pain Disability Index is included in the LCD under acceptable scale to measure function.  

32

A stakeholder comments concern that the policy may be harmful to Medicare patients by eliminating a middle option before SIJ fusion which has a greater risk of morbidity than SIJ RFA or opiates. 

Thank you for your comments. See Comment #5 & 30. No supporting literature was provided. 

33

A commenter expresses concern about SIJ RFA being considered experimental and explains the location and technique they use they use that has resulted in high success rates. 

Thank you for your comments. This data is unpublished and there is no supporting literature provided. Future studies may provide the guidance needed for patient selection and techniques that can result in success rates explained in your comments, however current rates range from 32-89% (See Comment #4). 

34

A commentor states that just because a service has not been investigated extensively does not mean it is not reasonable or necessary. They also expressed that requirement to perform injections under CT or fluoroscopic guidance seems like a waste of medical resources. 

Thank you for your comments. See Comment #3. The overwhelming body of literature states these procedures should be performed under CT or fluoroscopic guidance and no literature was submitted to support performance without image guidance. 

35

A commenter expresses concerns about the removal of SIJ RFA coverage and states that in their practice they perform a very limited number of these procedures each year but have excellent results in those patients. Their patients typically return for treatment every 1-3 years. They do not feel removal of this procedure is in the best interest of those patients.

Thank you for your comments. This data is unpublished and there is no supporting literature provided. Future studies may provide the guidance needed for patient selection and techniques that can result in success rates explained in your comments, however current rates range from 32-89% (See Comment #4). There is a lack of long-term outcome data and duration of relief from RFA with only short term (<12 month) data available. 

36

A stakeholder states they have had success with this procedure in their practice and support the letter submitted by SIS in support of SIJ RFA. They also expressed concern that the documentation requirements are too detailed and rigid.

Thank you for your comments. See Comments #1-7. Please note that within the LCD the provider has the ability to select the pain/functional scale that works best for them including verbal and visual scales. The remaining documentation requirements should align with the information obtained from the patient as part of the assessment and plan of care and therefore should not be onerous.

37

A multi-specialty letter was received expressing concern about non-coverage of SIJ RFA. The author state 2 RCT target L5 dorsal ramus and SLBB and the pooled analysis shows >50% pain relief at three months compared to sham with studies ranging from 32-89% success rates. They state there is a CPT code for the procedure as a testament to safety and efficacy. 

See Comments 2-4, & 6.

38

A comment was received by a stakeholder expressing the necessity for SJ joint injections to utilize fluoroscopy or CT guidance and that articular placement cannot be confirmed with ultrasound. They recommend that the LCD require contrast for any procedure and if there is not proper placement it should be billed as a trigger point injection. 

Thank you for your comment. We agree that CT or fluoroscopy should be used for SIJ procedures. We do understand however there are some exceptional circumstances, specifically contrast allergy or pregnancy, when contrast cannot be used. In these cases, the documentation must explain the medical necessity of the procedure and why contrast could not be used. In all other cases contrast should be used. 

39

A commenter asks “Please clarify if the requirement of a diagnostic SI joint injection with resultant >75% benefit will be applied to those patients historically and currently receiving therapeutic SIJ injections”

Yes, the requirements will apply to all patients after the effective date of the LCD. 

40

The same commenter request coverage for SIJ RFA and submitted the following as Level I-A evidence to support this (Cohen 2008, Patel 2012, van Tilburg 2016, Salman 016, Juch 2017 and Nilesh 2012). The comment letter did not include what criteria the Level I-A was based. Nilesh et al has been added to the LCD. The others were already included in the LCD.  

See Comments 3 & 4. 

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Coding Information

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Revision History Information

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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
L39455 - Sacroiliac Joint Injections and Procedures
Related National Coverage Documents
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SAD Process URL 1
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SAD Process URL 2
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Statutory Requirements URLs
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Rules and Regulations URLs
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CMS Manual Explanations URLs
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Public Versions
Updated On Effective Dates Status
01/27/2023 03/19/2023 - N/A Currently in Effect You are here

Keywords

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