Response to Comments: Minimally Invasive Arthrodesis of the Sacroiliac Joint (SIJ)

The Society of Interventional Radiology (SIR) is a nonprofit, professional medical society representing over 8,500 practicing interventional radiology physicians, trainees, students, scientists, and clinical associates. We are dedicated to improving patient care through the limitless potential of image-guided therapies, including expertise in treating sacroiliac joint dysfunction. Our members represent practicing vascular and interventional radiologists in the United States. The SIR appreciates the opportunity to comment on the proposed local coverage determination for minimally invasive (MI) arthrodesis of the sacroiliac joint (SIJ).

We strongly disagree with your proposed policy that states MI Arthrodesis of the SIJ WITHOUT placement of a transfixation device is NOT considered medically reasonable and necessary. The posterior allograft has now been proven to be favorable to outcomes reported for an FDA-cleared lateral approach, e.g., iFuse (SI-BONE, Inc. San Jose, CA). Not all posterior implants are distraction arthrodesis, and some posterior devices can be transfixing. These results suggest that the posterior approach allograft implant system is a safe and effective treatment for sacroiliac joint dysfunction at 12 months, with favorable results compared to outcomes reported for an FDA-approved lateral approach. (Calodney, 2024).

Numerous published peer-reviewed prospective, retrospective, and biomechanical studies demonstrate the appropriate diagnosis and the safety, efficacy, and durability of SIJ fusion using a posterior allograft. Two important publications, and several more referenced below, support the safety & efficacy of a posteriorly placed allograft bone fusion implant, which is currently used for minimally invasive arthrodesis of the sacroiliac joint WITHOUT placement of a transfixation device. Five references were submitted from over twenty possibilities to successfully support the Category I 27278 code, which has only been in existence since January 1, 2024. It was determined at that time that the amount and quality of the evidence were sufficient for a Category I CPT^® designation.

Safety, Efficacy, and Durability of Outcomes: Results from SECURE: A Single Arm, Multicenter, Prospective, Clinical Study on a Minimally Invasive Posterior Sacroiliac Fusion Allograft Implant (Calodney, 2024)

• Prospective study assessing outcomes up to 12-months in patients receiving the posterior allograft implant procedure.
• N=117
• The mean improvement in VAS scores at 12 months was 43.3 from a baseline mean VAS score of 76.2. In comparison to studies using the lateral implant, the iMIA study had a mean improvement in VAS scores at 12 months of 41.6 (baseline score 77.7), and the INSITE study had a mean improvement in VAS scores at 12 months of 54.2 (baseline score 82.3).
• The mean improvement in ODI scores at 12 months was 25.3 from a baseline mean ODI score of 52.4. In comparison to studies using the lateral implant, the iMIA study had a mean improvement in ODI scores at 12 months of 25.0 (baseline score 57.5), and the INSITE study had a mean improvement in VAS scores at 12 months of 29.3 (baseline score 57.2).
• All serious adverse events (SAE) reported during the study (4) were determined to be unrelated to the implant, with only 1 SAE related to the procedure (anesthesia). In comparison to the previously published iMIA study (n=52) using the lateral implant, iMIA reported 17 AEs, 8 SAEs, and 2 implant or procedure related SAEs. In the INSITE study (n=98), 179 AEs were reported, 22 SAEs, in which 18 SAEs were implant or procedure related.

A Multicenter Retrospective Analysis of the Long-Term Efficacy and Safety of a Novel Posterior Sacroiliac Fusion Device (Sayed, 2021)

• 12-month retrospective outcomes for 50 patients
• Real-world evidence suggests that MI posterior SIJ fusion with the posteriorly placed allograft procedure is a viable approach for medically refractory sacroiliitis management with long-term efficacy and safety.
• Patients selected for this review included those with a documented history and physical exam findings of sacroiliitis, who failed conservative management, who had undergone at least one satisfactory diagnostic local anesthetic SIJ injection, and who underwent MI posterior approach SIJ fusion with a posteriorly placed cortical bone allograft.
• The average NRS was 6.98 pre-fusion and 3.06 at the last 12-month follow-up visit.
• There were no serious adverse events or major complications associated with any of the 50 implants.
• One patient experienced an episode of device migration, which required the placement of a second allograft to further stabilize the joint. This patient subsequently had 100% relief at subsequent follow-up.

Additionally, the proposed policy references “North American Spine Society (NASS) reports there is insufficient evidence to make a recommendation for or against SIJF compared with medical treatment for the treatment of LBP due to SIJ dysfunction.” However, the most recent NASS Coverage Policy September 2021 recommendations state, “The NASS Coverage Committee recommends coverage for minimally invasive SIJ fusions when all 8 criteria have been met. Minimally invasive SIJ Fusions have been shown to be relatively safe with a minimal EBL, low infection rate, low complication rate, and low revision surgery rates. The clinical efficacy for SIJ Fusion in appropriately selected patients has been shown to be more effective than nonoperative care and more cost-effective.”

Furthermore, the proposed policy states a “query of other payer LCDs reveals that for those that have an LCD on MIS of SIJ, MI posterior dorsal approach to access the SIJ, including use of implants other than those which are placed across the joint (i.e., transfixing) to promote fusion (e.g., allograft, nonmetallic implants), is considered experimental, investigation, or unproven. Based on all these factors, the MIS approach that does not transfix the SIJ is not considered reasonable and necessary”. SIR queried Medicare LCDs and did not find any for MIS of SIJ. SIR has concerns about using “other payers” LCDs to base criteria that the Medicare Administration is utilizing for investigational/experimental being the same criteria as for-profit insurance companies.

We are asking that the proposed LCD Minimally Invasive Arthrodesis of the Sacroiliac Joint (SIJ) remove the non-coverage language for MI arthrodesis of the SIJ WITHOUT placement of a transfixation device. There is more than adequate clinical evidence, expert opinion, and commentary, and a substantial number of societies that support this technique for SI joint fusion. As we have seen from the evidence, this technique is very safe, equally effective to other techniques, and is an opioid-sparing alternative treatment for SI joint dysfunction.

We thank the CMS contractors for considering expanded access to minimally invasive arthrodesis of the sacroiliac joint.

References were provided for review.

Thank you for your comments. The literature that you cited was also reviewed and cited in the LCD creation. The 12-month results of prospective observational SECURE study, not available at time of publication of this LCD but now has been added to the review as well as the bibliography. It should be noted that the SECURE trial has the same limitations and risk of bias at 12 months as it did at 6 months: lack of a control group and missing outcome data with partial cohort in the analysis as 24 subjects were lost to follow-up. As stated in the Analysis of Evidence, the study has several limitations including absence of control group, high loss to follow-up, absence of blinding, potential bias from funding source and conflicts of interest, lack of generalizability including mean age below Medicare population (60.3), short duration of follow-up, missing data, and limited data on procedure standardization. The conclusions of this study need to be interpreted with caution due to its serious limitations.

The creation of a CPT^® Category 1 code by the AMA does not necessarily equate to coverage. This LCD aligns with the statutory requirement for the Medicare program to cover services that are reasonable and necessary (R&N), as stipulated by the Social Security Act, while investigational services are non-covered. Procedures without sufficient quality supporting evidence are investigational.

The Statement “The NASS Coverage Committee recommends coverage for minimally invasive SIJ fusions when all 8 criteria have been met. Minimally invasive SIJ Fusions have been shown to be relatively safe with a minimal EBL, low infection rate, low complication rate, and low revision surgery rates. The clinical efficacy for SIJ Fusion in appropriately selected patients has been shown to be more effective than nonoperative care and more cost-effective.” The Societal Recommendation and Guidelines have now been included in the Analysis of Evidence, along with evaluation of the limitations to those guidelines and recommendations. The recommendations state MI SIJF has demonstrated safety and efficacy in properly selected patients, and acknowledge much of the supporting literature is subject to potential bias largely due to industry sponsored research. “NASS use an evidence-based approach to spinal care when possible” making it unclear how the literature was selected and used to develop the recommendations. Population specifics such as gender and age, clinical condition, comorbidities, excluded populations were not defined. It is unclear who the recommendations are referring to when stating “properly selected patients.” While conflict of interests were disclosed, there was no description how competing interests may have influenced the development of recommendations, nor does it describe or mention steps taken to minimize it. The group member’s role in the recommendation process is also unclear.

As to inclusion of other payer policy positions on this subject, we will remove them from the LCD as they are not applied to coverage decisions in Medicare.

Carolinas Pain Institute commented: Summary of existing evidence as detailed in this text is recent and accurate. Still, understanding of joint mechanics and real word outcomes is missing. Serious complications with joint transfixion were also omitted that include serious vascular complications and nerve damage. No one should have fatal event, serious bleeding or permanent nerve damage just for pain control.

Moreover, after completing more than 150 of posterior stabilization procedures and reviewing outcomes of the first 100, I submit to you patient outcomes. 81% of the patients had more than 50% of pain relief and only one patient required wound revision because of dehiscence. No other complications were observed.

Procedure is simple, requiring less of anesthetic, pain medications and recovery time than any transfixion of sacroiliac joint. Therefore, should be also more cost effective.

Based on biomechanics studies (Amirdelfan et al. 2023) provides same inhibition of multiplanar joint motion as transfixion.

Please consider maintaining coverage of this beneficial approach for many of our patients, especially senior patient population that are exposed to higher risk of anesthesia and peri operative complications when undergoing aggressive joint transfixion!

Thank you for your comments. No literature was submitted. If there is new peer-reviewed published literature to demonstrate the procedure is effective, safe and improves outcomes, it can be considered for coverage via the LCD reconsideration process. The study by Sayed and Amerdelfan (2023) was reviewed and cited in the LCD. Biomechanics of 6 cadaveric specimens, while interesting, is not sufficient to meet reasonable and necessary criteria.

A physician commented: I fully support SI arthrodesis. It is a very effective procedure for treating sacroiliac pain, which very prevalent. This is one of the more effective advanced procedures available to pain physicians for the treatment of SI joint pain long term and is minimally invasive.

Thank you for your comments.

Carolina Health Specialists commented: Medicare patients with chronic pain need access to the minimally invasive SI-joint arthrodesis/LinQ procedure in the office-based setting (CPT^® 27278).

I’m an Interventional Pain physician. I’d like to comment on Medicare’s proposed LCD regarding CPT^® 27278 for Minimally invasive SI joint arthrodesis (LinQ Procedure, PainTeq). I was very pleased when it was brought to my attention that Medicare had initially approved this procedure to be done in office-based fluoroscopy suites as the data on it looks very beneficial for patients who have failed other conservative treatment options and require repeated SI joint injections.

On 3/14/24 I did my first one of these in my office-based fluoroscopy suite, on a 58-year-old female with chronic, years-long sacroiliac pain (M46.1). She met all the same criteria as is required for those in a hospital-based setting (>75% pain relief after 2 or more SI joint injections, failure of conservative treatment, PT/bracing, oral analgesics, screening hip x-rays and pelvis CT or MRI and lack of other explanation for her pain). I used the same oral premedication protocol I used for in-office spinal cord stimulator trials and in-office kyphoplasty (oral benzodiazepine combined with an oral opiate 60 min prior, in a patient dependent dose) combined with careful and generous local anesthesia before and during the procedure. The patient was monitored with a cardiac monitor and continuous pulse ox and remained responsive and comfortable the during the procedure.

The procedure went perfectly, without complication. She was seen at follow up 8 days later for suture removal and was already reporting >70% pain relief, doing very well and hopeful. She no longer requires opiates for pain control. The procedure exceeded both my and her expectations. My experience, as well as my patient’s, match up with the data presented on the reasonableness and necessity of this procedure in the office-based setting.

It then came as a great shock when I was told the MAC is planning a complete reversal on this decision and plans to prevent it from being done further, in this setting. It seems to me it will do patients a great disservice to force them to go into the hospital setting where they are at risk of general anesthesia, hospital acquired infection, DVTs and emboli from not being as mobile, as well as unnecessarily increasing the cost of this procedure in hospital. This is a minimally invasive procedure that can be done in the office-based procedure setting with fluoroscopy by Interventional Pain Physicians. I believe this procedure is both reasonable and necessary, in an office-based setting.

I respectfully ask that the MAC approve in-office site of service for the minimally invasive SI-joint arthrodesis/LinQ procedure (CPT^® 27278). I think that will be a great benefit to my patients, by increasing access, reducing the risk of hospital-based complications and reduce costs cost overall, compared to the hospital based setting.

Thank you for your comments. No literature was submitted. If there is new peer-reviewed published literature it can be considered for coverage via the LCD reconsideration process.

SI BONE commented: Thank you for the opportunity to provide comments on the proposed LCD for Minimally Invasive Arthrodesis of the Sacroiliac Joint (SIJ). SI-BONE, Inc. is a manufacturer of innovative medical devices used in the treatment of sacropelvic conditions and diseases including sacroiliac joint dysfunction. More than 28,000 Medicare beneficiaries each year receive treatment for these conditions. We appreciate the opportunity to comment on this important, proposed policy.

FDA Consensus Testing Standards for SIJ Implants

As a routine applicant to the U.S. FDA for 510(k) clearance of our devices, we adhere to the FDA’s recognized consensus standards for biomechanical test methods established by the American Society for Testing and Materials (ASTM). ASTM consensus standards now cover the materials and methods for the static and dynamic testing of SIJ fusion device assemblies, and SIJ implants designed to promote arthrodesis at the sacroiliac joint. Since December 2022, the FDA has recognized several standards for testing of sacroiliac joint products and has accepted definitions that we believe are highly relevant and may be helpful to your upcoming policy decision making. The ASTM F3574-22 Standard Test Methods for Sacroiliac Joint Fusion Devices provides Palmetto GBA an important guidepost for its proposed LCD, because all manufacturers of the various types of SIJ devices available to U.S. patients will now adhere to its definitions of implants in order to gain FDA 510(k) clearance.

The definitions of implant types per ASTM are also helpful because they align closely with definitions of procedures and implants described under CPT^® codes 27279 and 27278. These 2 CPT^® codes drive the U.S. procedural market of minimally invasive SIJ fusion procedures commonly performed and reported by clinicians and researchers. These codes are the substance of the proposed LCD.

Figure 1 above illustrates the 2 implant types as described in ASTM F3574 that align with CPT^® 27279 and 27278. CPT^® 27279 describes transfixing/transverse implant trajectory, and 27278 describes intra-articular or in-line implant trajectory.

ASTM F3574-22 “Transverse Implants” for SIJ Fusion are Described by CPT^® 27279

Per the ASTM F3574-22:

“Transverse implants are devices intended to be implanted with a trajectory across the sacroiliac joint by being implanted first into the iliac or sacral bone, subsequently through the joint space, and finally into the opposite (sacral or iliac bone); this type of device may be from a lateral approach or a posterior approach but will be inserted through one of the articulating bones and extend into the other articulating bone. A screw design is common for transverse implants. Note: sacroiliac joint fusion screws are typically implanted in pairs or in sets of three.”            

The above description of transverse SIJ implants set forth by ASTM for standard test methods aligns with the requirement per CPT^® 27279 that “transfixing devices” be used in the procedure. These implants traverse 2 bone cortices of the articulating bone on 1 side of the joint, cross the joint and 1 bone cortex of the other articulating bone and terminate within the bone. CPT^® 27279 implants are subject to shear forces at the SI joint, the ground reaction forces pushing up, and the forces from the weight of the spine/torso/body pushing down (Figure 2). These implants require biomechanical testing in cantilever bending (Figure 3) as this testing modality best simulates forces experienced by the implants based on their position in the body.

Examples of common CPT^® 27279 “transfixing devices” (ASTM “transverse implants”) available to U.S. patients and Palmetto beneficiaries include:

Current Transverse SIJ Implants Available to U.S. Patients

MAC LCD Policy Implications: “Transfixing Implants” for SIJ Fusion

We are supportive of the MACs’ efforts to develop a policy on this topic. There are numerous definitions of SIJ implants within FDA standards that the MAC should consider for purposes of its LCD process. We believe the overlapping definitions of ASTM and CPT^® also align with what the MACs intend to support, from a policy standpoint. In the definition of CPT^® 27279, the AMA uses the word “transfixing” to describe the same type of implants called “transverse” by the ASTM, used by the FDA to guide the testing of implants for clearance. In the ASTM document, transverse SIJ implants are those that take a lateral, posterolateral, or posteromedial trajectory, and are all subject to the same tests. This is because the biomechanical tests of implants that go across bone, across the articular SI joint, and into bone on either side requires the same kind of cantilever and fulcrum testing.

The MACs should develop LCD policy around these ASTM definitions of “transverse SIJ implants,” particularly in the absence of further clarity from the AMA as to the meaning of “transfixing.” This would clarify the types of procedures The MACs intend to support, now and in the future as technology and technique in this space both continue to evolve, and as manufacturers seek FDA clearance of their devices.

ASTM F3574-22 “In-line Implants” for SIJ Fusion are Described by CPT^® 27278

Per the ASTM F3574-22:

“In-line implants are devices intended to be implanted with a trajectory primarily within the sacroiliac joint space; this kind of device may have integrated fixation (that is, screws, blades) into the sacrum and ilium integrated into the implants, and which go into the sacrum and/or ilium bone once placed within the joint.”        

The motion of the SIJ is primarily rotation of the sacrum with respect to the ilium. Implants that are “in-line” with the SIJ must withstand nutation and counternutation, as depicted in Figure 4 below.

The family of implants placed “in-line,” or “intra-articular” as described in CPT^® 27278, experience significant torsional moments and shear forces. The recommended testing for this family of implants is torsion and shear testing as depicted in Figure 5 below.

Examples of common CPT^® 27278 “non-transfixing,” “intra-articular” implants (ASTM “in-line implants”) available to U.S. patients and Palmetto beneficiaries, including those with design features for integrated fixation, include:

Current In-Line SIJ Implants Available to U.S. Patients, with Integrated Fixation

Policy Implications for “Nontransfixing Implants” for SIJ Fusion

There are numerous definitions within FDA’s consensus standards that the MACs should consider for purposes of its LCD development process on this topic. In the definition of CPT^® 27278, the AMA uses the phrase “without placement of transfixation device” to implicate the same type of implants called “in-line” by the ASTM, which has been used by the FDA as part of the testing of implants. In the ASTM, these implants are described as being “within the SI joint space.” They are all subject to the same torsional and shear testing, regardless of whether they have additional stabilization, or not. This is because the biomechanical tests of implants that go between bone and into a joint space require the same type of testing in order to gain market clearance. These should be appropriately categorized by the MACs as non-transfixing for purposes of this LCD, and providers should report the use of each of the implants in Table 2 via CPT^® 27278, and seek additional clarification as needed from the AMA. This would clarify the types of procedures the MACs intend to support, for current and future procedures.

As a summary, our recommendations for policy implementation of SIJ implants are as follows:

Recommendations for MAC Policy Implementation: SIJ Implants and Procedures

Based on Known Standards and Definitions from FDA, ASTM, and AMA/CPT^®

We thank the MACs for the thoughtful review and evaluation of minimally invasive SIJ procedures, and hope this information showing alignment of the ASTM-defined SIJ implant families and the associated biomechanical testing rationale with CPT^® codes 27279 and 27278 is helpful to its policy decision making.

We hope the information provided in our comment is helpful to you as you consider finalizing this draft LCD and policy.

Tables and references were provided for review.

Thank you for your comments. The LCD has been updated to include the ASTM definitions in order to further clarify the distinction between the 2 CPT^® codes. However, because the terminology utilized by the AMA is how billing and coding is submitted, until such time as the AMA updates the language, this LCD will utilize existing AMA language. The CPT^® language will be updated in the 2026 book and has been included in the definitions distinguishing the 2 procedures.

On behalf of the Pain Society of the Carolinas and the Tennessee Pain Society, whose members are the pain management physicians, advanced practice providers, and healthcare practitioners who care for pain patients in North Carolina, South Carolina, and Tennessee. We are writing to express our concerns regarding the proposed local coverage determination (LCD) for minimally invasive arthrodesis of the sacroiliac joint (SIJ). While we appreciate CMS's commitment to evidence-based practices, we firmly believe that the posterior approach, which does not involve placement of a transfixation device, should be considered a viable option for appropriate candidates. Our reasons for disagreement are as follows:

1. Safety and Efficacy:

• • The posterior approach has been described since 2008 and has demonstrated safety and efficacy in clinical practice. Numerous studies have reported positive outcomes, including pain relief and improved function for patients with SIJ dysfunction.
  • By excluding the posterior approach, we may inadvertently limit patient access to a less invasive technique that reduces the risk to the neurovascular bundle. This approach is particularly valuable for patients who may be at higher risk for complications associated with more invasive procedures.

2. Patient-Centered Care:

• • The posterior approach for arthrodesis without the need for a transfixation device can be performed under conscious sedation rather than general anesthesia, which may be preferable for certain patients.
  • As healthcare providers, we strive to offer patient-centered care that considers individual preferences and risk profiles. The posterior approach aligns with this goal by providing an alternative option that balances clinical effectiveness with patient comfort and safety as part of shared decision making.

3. Clinical Evidence:

• • Per the LCD, there are recent studies that have reinforced the safety and efficacy of the posterior approach for SIJ arthrodesis.
  • While the lateral approach has been well published, the posterior approach provides an alternative means of stabilization. Preliminary case series reveal consistent decreases in pain scores and low complication rates. This evidence supports its inclusion as a valid option for appropriate candidates.
  • The posterior approach, when appropriately selected, offers a valuable addition to our armamentarium.

4. Covered Indications:

• • While we appreciate the covered indications outlined in the proposed LCD, we recommend revisiting the contraindication related to patients with a more generalized pain process.
  • It is essential to recognize that patients with generalized pain may also have isolated SIJ dysfunction. Excluding them from consideration based solely on the presence of generalized pain may not accurately reflect their clinical needs.

In summary, we respectfully request that CMS reconsider its stance on the posterior approach for SIJ arthrodesis. We believe that evidence supports its safety, efficacy, and potential benefits for appropriate candidates. By acknowledging the posterior approach as a valid option, we can enhance patient outcomes and promote individualized care.

Thank you for your dedication to improving patient care and ensuring access to evidence-based treatments. We look forward to further dialogue and collaboration.

References were provided for review.

Thank you for your comments. No literature was submitted. If there is new peer-reviewed published literature it can be considered for coverage via the LCD reconsideration process. Patients with generalized pain disorders are excluded from sacroiliac joint injections per the cited LCD, and as such would not be candidates for MI SIJ Fusion.

CPT^® 27278 represents a phenomenal, truly minimally interventional treatment in pain management that benefits patients. Arthrodesis with bone graft without instrumental transfixation works. It is one of the few procedures that patients report very little discomfort from with life changing improvements due to pain relief.

Let’s not take away an effective treatment just because something new that may be equally beneficial exists.

Please, please listen to care providers and not lobbyists. I have improved patients’ lives with this procedure and would gladly add transfixation option to those I think may have instability in their joint, but not for all.

Like the adage goes, “ If it’s not broken let’s not break it”!

Thank you for your comments. No literature was submitted. If there is new peer-reviewed published literature it can be considered for coverage via the LCD reconsideration process.

On March 14th I had the LinQ SI Joint Stabilization System implanted on my left side in my doctor’s office. The whole procedure took 1 hr and 15 min. My husband dropped me off and ran an errand and got back a few minutes after I was done. It was so quick and easy. If I had to go to the hospital the check-in process would take almost that long and my husband would of been required to stay there. If I need my right side done in future I'd only have it done if it was in the doctor's office. I went for my 6 week check up and the doctor asked my pain level and I said what pain there is none. I am thrilled the doctor found out about this procedure.

For over 6 years I had to go every few months for shots (which wasn't a pleasant procedure) but after this procedure (also not pleasant but one and done) I will no longer need them.

I highly recommend you continue to approve this procedure to be done in a doctor's office.

Thank you for your comment.

On behalf of the American Society of Interventional Pain Physicians (ASIPP) representing over 4000 members we appreciate the opportunity to provide comments on this important proposed LCD for SI fusion. ASIPP was organized in 1998 to promote the development and practice of safe, high quality, cost-effective interventional pain management techniques for the diagnosis and treatment of pain and related disorders and to ensure patient access to appropriate interventions. ASIPP has leading expertise in the field of sacroiliac treatments, including SIJF. As a society, we have physician members who have been successfully performing SIJF for over 7+ years; including lateral, oblique (dorsal-lateral), posterior approaches utilizing both allograft and synthetic device.

We would first like to address the incorrect statement within the LCD regarding the “approach” dictating whether a device transfixes the joint: Page 5 of 10 under subsection Arthrodesis without Placement of Transfixation Device- “The aforementioned transfixation procedure is typically performed from a lateral approach. The procedures that are non-transfixation approaches are usually performed from a dorsal (posterior) approach though at times are combined into a dorsa-lateral approach. Rather than transfixing the SIJ, these procedures utilize distraction arthrodesis.

In response to this statement:

1. Allograft and Posterior Titanium Devices: Many allograft implants do not transfix the joint and are implanted intra-articular into the joint and do not penetrate to the bone on either side of the joint (illum and sacrum) However, devices do not need to transfix the joint to provide fusion of the SI Joint. This was proven with the reported fusion rate provided in the Prospective, 20-center 2-year clinical trial with 171 patient known as the DIANA Trial. This posterior stand-alone device is an example of distraction arthrodesis, which still provides a safe and efficacious approach for fusion. CMS has for many years, paid for allograft and devices under the same CPT^® code, 27279.

The review of approaches, devices and allograft implants were performed in 2021, and 2022 by the CPT^® Editorial Panel Committee in the public meeting. It was the conclusion of the physician reviewers at the time, there was no need to establish an additional code, as the CPT^® code 27279 is non-directional, meaning the approach was not impactful to the procedure performed, and any approach could be utilized. Additionally, CPT^® did not see relevance in performance to whether an allograft or synthetic device was utilized as an implant. The same two physician reviewers from CMS Coverage and Analysis Group -Baltimore were present for all CPT^® Panel Meetings and did not raise issue regarding coverage or differentiating between allograft and device. These physician reviewers sit on the Editorial Board as non-voting members and are continually consulted regarding each item on the CPT^® agenda.

On the 3^rd subsequent meeting where 27279 and 27280 were on the Editorial Review Agenda in May 2022, CPT^® made the decision to split the code for the procedures that both provide fusion, however one code 27279 is transfixing, and the newly created code of 0775T that immediately transferred to a Category I code 6 months later, 27278 is non-transfixing and intra-articular. The definition is relevant to the placement of the implant and not the approach. Again, the codes are non-directional. These facts can be confirmed by the transcripts from CPT^® meetings or simply verifying with the Lead Editorial CPT^® Reviewer for SIJF. Thus, to state in the proposed LCD that if a device is non-transfixing it is non-covered, does not follow clinical rationale and evidence.

2. Posterior-Transfixing Devices: Stand-alone posterior titanium implants, however, can transfix the joint as determined by the FDA clearance. Many of these devices performed bio-mechanical testing (including transfixation). Data reflects performance that is equivalent, if not superior in some cases, to SI-Bone I-Fuse lateral system. the statement that devices need to have a lateral approach to transfix the joint, is simply false. Table 1 is a summary of some of the posterior allograft and titanium implant studies.

3. Dorsal-Lateral (Posterior-Lateral) Furthermore, most if not all dorsal-lateral (MAC reference to direction) or what is known as lateral-oblique or posterior-lateral approaches transfix the joint. This data can be verified through the 510(k) of most posterior-lateral approach devices.

The safety benefit of an oblique approach are similar to those described in the safety benefit of a posterior approach: Avoidance of major structural vasculature, nerve bundles, and avoidance of dissection of ligament and muscle tissue. In contrast to LTI (lateral), the PLTI (posterior-lateral) technique has a more posterior starting point and takes an oblique trajectory across the SI joint. It was developed to lower the risk of injury/irritation of the S1 and S2 nerves within the foramina and to the branches of the superior gluteal artery. The meta-analysis of 8 peer published papers performed by Whang et al, reflected a safety profile of AE and SAE for lateral-oblique (posterior-lateral) approach at 1.11%. Well within an acceptable safety standard.

In comparison with the most recent intra-articular (posterior) allograft publication, the SECURE study, Painteq LLC reflected a 1 year adverse event rate of 4.3% as Intent to Treat Analysis (ITT) on N=117 implanted patients. However, if the statistical analysis remained consistent throughout the SECURE Study outcomes, Per Protocol Analysis (PP) would have been calculated as was reported for all other study measurements, N=83 (PP statistical analysis was performed for ODI, VAS). Thus, the Adverse Event Rate would actually be 6.0%, which is higher than reported but still within acceptable adverse event rates.

Conversely the MACs cited Polly paper reflects “Two Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction” reflect an adverse event rate of 23% including a significant amount of serious adverse events over less severe adverse events. Other lateral publications show improved safety profile, compared to the Polly paper, however, lateral outcomes still reflect adverse event rates in the double digits.

We have included 10 published peer review papers in Table 2 that reflect safety and efficacy of oblique approach (posterior-lateral). Additionally, you will find that some of the peer publications mentioned in the proposed LCD included studies which were labeled lateral but were actually a combination of lateral and posterior-lateral as defined by the protocol in the clinical trials that allowed for physician preference whether to perform lateral or posterior-lateral approach.

In summary, any of the approaches can transfix the joint, thus coverage should not be defined by approach, and rather clinically whether the device transfixes the joint, or is implanted intra-articular (non-transfixing as defined by the AMA CPT^® Editorial Board).

NASS Recommendations:

In regards to the NASS recommendation as stated in the Proposed LCD: “Because of these issues, the North American Spine Society (NASS) reports there is insufficient evidence to make a recommendation for or against SIJF compared with medical treatment for the treatment of LBP due to SIJ dysfunction” The MACs made no citations or context of where this statement originated. NASS has published the most recent NASS Coverage Policy Recommendations September 2021 which stated: This Coverage Recommendation is limited the to the insertion of, usually more than one, structural device traversing the SIJ intended to fuse to the bone or lead to the fusion of the joint itself”.

COVERAGE RECOMMENDATION: “The NASS Coverage Committee recommends coverage for minimally invasive SIJ fusions when all 8 criteria have been met. Minimally invasive SIJ Fusions have been shown to be relatively safe with minimal EBL, low infection rate, low complication rate, and efficacy for SIJ Fusion in appropriately selected patients has been shown to be more effective than nonoperative care and more cost effective.” Thus the Proposed LCD statement is in direct conflict with what NASS has published.

On behalf of ASIPP members we have provided compelling data and explanations of current SIJF. We ask that SIJF devices/allograft regardless of approach, both transfixing, and intra-articular be a covered benefit for the many Medicare patients who need options based on their contributing comorbid conditions: Bone age, level of osteoarthritis, osteoporosis, cardiac involvement, anticoagulant therapy ability/speed of recovery due to autoimmune disease, diabetes, obesity, prior lumbar surgery that results in a high propensity within 2 to 3 years of sacroiliac joint pain and disease.

We appreciate the opportunity to comment on this important issue and welcome any questions you may have.

Tables and references were provided for review.

Thank you for your comments. The LCD did not separate the 2 procedures by approach. It did address the fact that most of the non transfixation procedures are posterior in approach and most of the transfixation procedures are lateral in approach. There is no statement in the LCD that devices must utilize a lateral approach to transfix the joint. The LCD cited specifically the language that is used by CPT^® to distinguish these 2 approaches. CPT^® as well as Dr. Swann, the orthopedic surgeon who reviewed the CCA were in agreement with this distinction and this is supported by ASTM. We will add clarifying language as well as citing ASTM definitions, so that no one is confused thinking the distinction between transfixation approach and non transfixation/intra-articular approach has anything to do with directionality. The CPT^® language will be updated in the 2026 book and has been included in the definitions distinguishing the 2 procedures.

The statement “The NASS Coverage Committee recommends coverage for minimally invasive SIJ fusions when all 8 criteria have been met. Minimally invasive SIJ Fusions have been shown to be relatively safe with a minimal EBL, low infection rate, low complication rate, and low revision surgery rates. The clinical efficacy for SIJ Fusion in appropriately selected patients has been shown to be more effective than nonoperative care and more cost-effective.” Please see Response to Comment #1 for further discussion.

Table 1 in the letter states that there were 4 articles that were not reviewed by Palmetto. Two of them (Aranke 2022 and Lee 2021) were reviewed and cited in the LCD. The other 2 by Lynch et al. and by Mehta et al. were retrospective observational studies according to the chart; however, this reviewer and our researchers were unable to find the Mehta article in a search of PubMed. The Lynch article was an industry sponsored patient registry of 57 patients. Treatment options must fulfill all criteria of what is reasonable and necessary with peer-reviewed literature to support those treatment options as choices. This shall include published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines. Proprietary information, submitted by a requestor, not available to the public shall not be considered.

The studies mentioned in Table 2 by Raikar and Caheuque were reviewed and cited in the LCD. The Chin study was a case series with 3 patients. The Claus study was comparing 2 different transfixation devices. The Chaves study concerned SI-LOK which is also a transfixation device, as is Integrity-SI and Sacrix. None of those mentioned in Table 2 are intra-articular/non-transfixing. And as stated, the differentiation is NOT in approach but by the ability to transfix or NOT transfix, which is how the AMA CPT^® language differentiates the 2. The CPT^® language will be updated in the 2026 book and has been included in the definitions distinguishing the 2 procedures.

We appreciate the MAC’s efforts in the development of proposed coverage updates for Minimally Invasive Arthrodesis of the Sacroiliac Joint (SIJ). As a global leader in medical technology, services, and solutions, Medtronic offers a variety of products and therapies across the MAC jurisdictions, including an FDA-authorized therapy for SIJ fusion. As such, we recognize the critical role MACs hold in outlining coverage criteria and providing patient access to critical therapies.

Overall, Medtronic believes the language included in the proposed LCDs captures core requirements that will serve to improve access to medically necessary care for Medicare beneficiaries. Nevertheless, we would like to offer the following comments regarding the characterization of SIJ procedures in the proposed LCDs for further consideration prior to finalization of the policies.

Specifically, the proposed LCDs state that “the procedures that are non-transfixation approaches are usually dorsal (posterior) approach…Rather than transfixing the joint, these procedures utilize distraction arthrodesis.” While this may be true for some intra articular devices, several FDA-cleared SIJ fusion devices transfix the joint through posterior and/or inferior/posterior approaches to the anatomy. From a CPT^® coding perspective, 27279 (Arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect visualization) with image guidance, includes bone graft when performed, and placement of transfixing device) and 27278 (Arthrodesis, sacroiliac joint, percutaneous, with image guidance, includes placement of intra-articular implant(s) (e.g., machine bone allograft(s), synthetic devices(s) without transfixing device) are non-directional, and differentiated primarily by whether or not the device is transfixing the joint.

Since neither of codes described above specify direction, we recommend that the MACs remove the discussion of approach in any coverage policies to avoid confusion. We would also recommend focusing the discussion on coverage for transfixing versus non-transfixing devices, rather than the direction of approach for placement.

Thank you for the opportunity to present this feedback on the proposed LCDs.

Thank you for your comments. The LCD did not separate the 2 procedures by approach. It did address the fact that most of the non-transfixation procedures are posterior in approach and most of the transfixation procedures are lateral in approach. The LCD cited specifically the language that is used by CPT^® to distinguish these 2. CPT^® as well as the orthopedic surgeon who reviewed the CCA were in agreement with this distinction and this is supported by ASTM. We will add clarifying language citing ASTM definitions as well. The CPT^® language will be updated in the 2026 book and has been included in the definitions distinguishing the 2 procedures.

SAIL Fusion is pleased to submit comments to the Contactor Medical Directors regarding DL39797 Minimally Invasive Arthrodesis of the Sacroiliac Joint (SIJ).

SAIL Fusion is a medical device company advancing the treatment of SIJ dysfunction. SAIL’s BowTie™ technology and surgical technique minimizes tissue disruption, thoroughly prepares the joint, and provides rigid fixation to enable a true and robust SI joint fusion. The implant is comprised of an interarticular component, an iliac screw, and a transfixation screw. All implant components are titanium and available in various sizes to accommodate varying patient anatomy. The BowTie SI Joint Fusion System is indicated for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the Bowtie SI Fusion System is implanted, both the Iliac and Transfix Screw components must be used.

CPT^® 27279 vs. 27278 are Differentiated by Achieving Transfixation, Not Approach

There was much discussion in the draft LCD regarding the approach used to place a device that would be reported using CPT^® 27278 vs. 27279. The CPT^® Editorial Panel, however, never qualified or focused on the use of 27279 based on the directional approach of the incision. The establishment of 27278 was not intended to distinguish the codes based on approach, but instead by the placement of a transfixation device, defined as follows per CPT^® 2024:

Code 27279 describes percutaneous arthrodesis of the sacroiliac joint using a minimally invasive technique to place an internal fixation device(s) that passes through the ilium, across the sacroiliac joint and into the sacrum, thus transfixing the sacroiliac joint.”

By contrast, CPT^® 27278 achieves arthrodesis through the removal of synovial tissue and decortication of the joint surface, thus enabling the biologic process of joint arthrodesis. An allograft or synthetic device is placed intraarticularly and achieves stabilization through longitudinal buttressing of the sacroiliac joint or distraction.

The ability to achieve transfixation by other approaches is also discussed in the draft LCD. Raikar (2023) describes the placement of iFuse Implant System place via a posterior lateral approach, as opposed to the traditional lateral approach used for this device. As noted in the draft LCD, transfixation was achieved with benefit of a avoiding the need to dissect gluteal fascia to reach the ileum, thereby decreasing blood loss. Cahueque (2023) also reported superior results using a posterior oblique technique:

• Data analysis suggests better functionality for the posterior oblique vs. lateral technique using ODI.
• Data analysis suggests greater pain reduction with the posterior oblique vs. lateral technique using VAS.
• Prior lumbar fusion did not affect SIJ fusion outcomes via posterior oblique technique.
• Posterior oblique technique reduced operative time >50% compared to lateral technique.
• Shorter hospital stays for patients who underwent SIJ fusion via the posterior oblique technique.

There are several transfixation devices currently on the market that are placed using posterior-inferior approach and the BowTie technology will also be placed in this manner as well. As such, when discussing the difference between CPT^® 27278 and 27279, the emphasis should be on the achievement of placing a transfixation device as defined by CPT^®, and not the approach used to achieve the transfixation.

CPT^® 27278 is Medically Necessary

Category I CPT^®

As you are likely aware, CPT^® 27278 was established to replace Category III CPT^® Code 0775T. While there are several criteria that must be met to qualify for Category I, one of the most difficult to meet is substantial support of clinical efficacy in the peer-reviewed literature. The studies must be “well-designed” and a least one must have a minimum level of evidence of IIIa/IIIb (i.e. case-controlled study). A second important criteria that must be demonstrated is widespread use among providers.

Hybrid Devices

Several “hybrid” systems that have been cleared by the FDA as a complete system. These systems require two separate incisions, one for the placement of a transfixation device; and a second for placement of an intra-articular device. The BowTie SI Joint Fusion System is an example of a hybrid system: The BowTie Device and Iliac Screw are placed intra-articularly through one incision, and the Transfixation Screw is placed laterally through a separate incision. These represent two distinct procedures and are reported with CPT^® 27278 and 27279 respectively. Moreover, the labeling specifies that both components must be used.

Additional Supporting Studies

The draft LCD did not discuss several relevant studies demonstrating the safety and efficacy of arthrodesis of the SI joint using a device that is placed intraarticularly. There are two in particular that we believe merit your attention:

The first is the recently available 12-month data from the SECURE trial (Calodney, 2024). While the six-month data from the SECURE trial is discussed in the draft LCD, this additional data addresses your concern regarding lack of long-term outcomes data. The key outcomes are presented below:

The second study is a multicenter retrospective analysis by Sayed et al, (2021). This was a multicenter retrospective review of patients who had an allograft placed intra-articularly to achieve SI joint arthrodesis.

• Data for 50 patients was available with an average follow-up time of 20 months.
• The average Numeric Rating Scale (NRS) was 6.85 at baseline and 2.86 at last follow-up.
• No major adverse events or complications were associated with any of the 50 implants.

Professional Society Support

The American Society of Pain and Neuroscience (ASPN), the American Society of Interventional Pain Physicians (ASIPP), the North American Spine Society (NASS), and the Pacific Spine and Pain Society all support SI joint fusion using an intra-articular allograft/device as being medically necessary and an important treatment option for patients.

• ASPN Guideline for the Treatment of Sacroiliac Disorders (2024
  • Minimally invasive posterior SI stabilization with allograft is considered medically necessary when the appropriate clinical criteria have been met.
    • Grade: A (ASPN recommends the service. There is high certainty that the net benefit is substantial.)
    • Level of Evidence: 1-B (Well-designed, controlled, non-randomized clinical trials (prospective observational studies conforming to STROBE criteria))/
    • Level of Certainty of Net benefit: High

• • While the quantity of evidence is currently more robust with the lateral approach given its preexistence, available studies suggest that that the posterior approach has at least similar efficacy with a lower risk profile

• The NASS Coverage Committee “recommends coverage for minimally invasive SIJ fusions when all 8 criteria have been met. Minimally invasive SlJ Fusions have been shown to be relatively safe with a minimal EBL, low infection rate, low complication rate, and low revision surgery rates. Much of the literature is subjected to potential bias since there is a high rate of industry sponsored data, however, multiple SIJ fusion devices have shown similar results. The clinical efficacy for SIJ fusion in appropriately selected patients has been shown to be more effective than nonoperative care and more cost-effective.”
• The public comments on behalf of ASIPP paralleled the ASPN Guidelines

As noted by from ASIPP, this statement does not exclude non-transfixing devices.

Closing Remarks

In summary:

• CPT^® 27278 and 27279 should not differentiate the approach used to place the device, but by whether or the device achieves arthrodesis via transfixation or longitudinal internal buttressing/distraction.
• There is sufficient data to support the safety and efficacy of 27278; and
• Both procedures are supported by the leading relevant specialty societies.

We would like to thank you for the opportunity to submit comments on the draft LCD for Minimally Invasive Arthrodesis SIJ Fusion and hope that the final LCD will reflect our input.

A table was provided for review.

Thank you for your comments. The LCD did not separate the 2 procedures by approach. It did address the fact that most of the non-transfixation procedures are posterior in approach and most of the transfixation procedures are lateral in approach. The LCD cited specifically the language that is used by CPT^® to distinguish these 2. CPT^® as well as the orthopedic surgeon who reviewed the CCA were in agreement with this distinction and this is supported by ASTM. We will add clarifying language citing ASTM definitions as well. The CPT^® language will be updated in the 2026 book and has been included in the definitions distinguishing the 2 procedures.

The Statement “The NASS Coverage Committee recommends coverage for minimally invasive SIJ fusions when all 8 criteria have been met. Minimally invasive SIJ Fusions have been shown to be relatively safe with a minimal EBL, low infection rate, low complication rate, and low revision surgery rates. The clinical efficacy for SIJ Fusion in appropriately selected patients has been shown to be more effective than nonoperative care and more cost-effective.” For further discussion, please refer to Response to Comments #1.

The position and guidelines by ASPN, ISASS, NASS as well as the limitations of those recommendations have been added to the LCD. For ISASS position, please refer to response to Comment #12.

The creation of a CPT^® Category 1 code by the AMA does not necessarily equate coverage. This LCD aligns with the statutory requirement for the Medicare program to cover services that are reasonable and necessary (R&N), as stipulated by the Social Security Act, while investigational services are non-covered. Procedures without sufficient quality supporting evidence are investigational.

The 12-month results of prospective observational SECURE study, not available at the time of our original LCD publication, but has since been added to the LCD. It should be noted that the SECURE trial has the same limitations and risk of bias at 12 months as it did at 6 months: lack of a control group and missing outcome data with partial cohort in the analysis as 24 subjects were lost to follow up. The SECURE study was a multicenter prospective study to present the results of preliminary data that was previously published on safety, efficacy, and durability of the minimally invasive sacroiliac posterior fusion with a LinQ allograft implant. It had several limitations, including the absence of a control group, high loss to follow-up, absence of blinding and potential bias from the funding source and conflicts of interest, lack of generalizability, short duration of follow-up, missing data, and limited data on procedure standardization. The conclusions of the study need to be interpreted with caution due to its serious limitations. This was added to the Analysis of Evidence.

The Sayed study was reviewed and cited in the LCD. Raikar (2023) is a case series of 20 patients who had placement of iFuse Implant System place via a posterior lateral approach and represents low quality literature based on the study design and not sufficient for coverage.

On behalf of the International Society for the Advancement of Spine Surgery (ISASS), a leading professional society for Spine Surgeons, we appreciate the opportunity to provide input regarding the MAC’s proposed MIS sacroiliac joint procedure policy. We are requesting that the MACs accept our coverage recommendation for the procedure appropriately defined by CPT^® code 27279 and our non-coverage recommendation for the procedure appropriately defined by CPT^® code 27278 as discussed in the proposed LCD.

There are five main points we put forth for your consideration:

• The MACs should finalize its proposed coverage position and criteria for CPT^® code 27279. The literature, clinical evidence, and historical utilization of the procedure represented by this CPT^® code since its inception in 2015 substantiates that it is medically reasonable and necessary for many Medicare beneficiaries. We do not believe that prior authorization of this code is necessary (as will be discussed below).
• The MACs should finalize its proposed non-coverage position for CPT^® code 27278. We do not believe that there is enough rigorous scientific data to consider this procedure a medically necessary standard of care, despite the issuance of a Category I CPT^® code recently. The SECURE study, which is a main study supporting efficacy of the product utilized in the procedure defined by CPT^® code 27278, exhibits several flaws, including protocol issues, methodological shortcomings, and concerns about participants lost to follow-up. The protocol, only available in its latest version dated April 2022 after enrollment was complete, prevents review of changes from prior versions. Additionally, the protocol incorrectly refers to the allograft product as a “device”, when it is actually a human cell, tissue, and cellular-based product (HCT/P), lacking FDA clearance or approval of traditional spine implants. The discrepancy in sample size (50 stated in the protocol versus 100 on gov versus 159 actually enrolled) raises questions about the target sample size (why was it exceeded?). Interim analysis occurring on a “monthly basis” suggests a potential unplanned stoppage of the study. The absence of listed clinical trial standards of conduct and adverse event definition further undermines the study’s reliability. Until more scientifically sound research is conducted and clinically meaningful results are published on the procedure represented by 27278, we support Palmetto’s proposed noncoverage policy at this time. We also believe that non-coverage of this code, along with a clearer AMA definition of what defines “transfixation” (see below), should resolve the miscoding issues that have been occurring over the last few years.
• The MACs should allow for coverage of medically necessary “hybrid” procedures that utilize a combination of CPT^® code 27279 and 27278 for the same surgical episode as an exception when needed. There are clinical circumstances in which patients may require a hybrid SI fusion. The rationale for maintaining hybrid procedure coverage involving the legacy 27279 and new 27278 codes billed together additionally lies in unique medical scenarios where a hybridized approach is required to address unique medical conditions such as sacral dysmorphism, bony defects, patients in whom orthopedic osseous bridging bone is mandated, or to facilitate revision strategies for patients. In some patients, there may be insufficient “real estate” within native sacral bone to facilitate adequate bone capture and stabilization. ISASS asserts that when the hybrid procedure is performed and documented correctly, coding should involve 27279 as the primary legacy procedure and 27278 as an additional adjunct, marked with a modifier (e.g., 51).
• The MAC’s policy decisions should not be based on ASTM standardized testing. We assert that this would be inappropriate, in that ASTM tests are mechanical rather than biomechanical, and their standardized configurations may not reflect clinical relevance, including biomechanical stresses and strains and tissue tolerances. While ASTM tests like cantilever bending provide information on screw/triangular implant strength, they do NOT, however, directly address SIJ stability or risk mitigation assessments related to implant designs. Cantilever bending may induce artefactual failure modes and does not accurately represent clinically relevant in vivo failure modes for lateral technologies. Additionally, the irregular shape and loading planes of the SIJ necessitate a deeper understanding of its biomechanics to assess stability properly. Relying solely on mechanical testing without considering clinical relevance and biomechanical evaluations may NOT adequately address the complexity of SIJ stabilization. Criteria for improved long-term stabilization potential of an SIJ device include the following: successful bone capture of the sacrum and ileum for secure fixation to avoid failure modes at the bone interface and/or of the device so as to prevent loosening and/or migration of the device; compression of the joint to reduce micromotion and enhance stability; and implementation of such criteria into the design of the transfixation system regardless of the approach. These criteria add another layer that is closer to aligning with clinical relevancy.
• The MACs should look beyond the recent comments on surgical approach to the SI joint/space (dorsal, posterior, lateral) and, rather, focus on the concepts of transfixation and fusion to better define the procedures represented by CPT^® codes 27279 and 27278. We recommend that MACs seek guidance from the AMA, as well as from the Spine Specialty Societies, on the definitions of transfixation and fusion as they relate to these procedures. The number of SI joint implants commercially available in the market today is continuing to expand. The CPT^® code definitions have left an unfortunate gap in the interpretation of which procedures (and associated technologies) “transfix” as currently defined by CPT^® 27279, and which “distract” as currently defined by 27278. The AMA has made it clear that linearity is NOT restricted in the use of 27279 procedurally. The procedure descriptor assigned to this code should be clarified by the AMA in the CPT^® code nomenclature such that each implant can be clearly classified, and procedures coded appropriately. We believe that this gap has led to coding misrepresentations, which have inappropriately impacted procedure volumes reported by 27279 in particular. In response, ISASS is developing a ‘white paper’ that will seek to provide guidance and clarity on the appropriate coding for these procedures and their associated technologies. However, for the purposes of this LCD in the near term, we propose that the essential considerations for meeting the requirements for 27279 are the following:
  • Does the implant transfix(ate)? By this we mean: the implant prevents distraction and/or compresses the joint with the intention to fuse it, regardless of the approach. Impaling a joint involves the penetration of the joint space by a portion of the implant, while transfixing a joint occurs when the implant bridges the joint space, making contact with structures on both sides. Transfixion requires that the majority of the implant be extra-articular, not intra-articular, so as to be compliant with current procedural terminology describing 27279 and 27278, respectively. Please also note for the sake of clarity and consistency:
    • An intra-articular implant may or may not have attachments, but the majority of an intra-articular implant is, by definition, intra-articular.
    • The current AMA CPT^® guideline defining 27279 SIJ arthrodesis includes “placement of a transfixing device that goes through three distinct structures of the pelvis: the medial cortical bone of the ilium, the sacroiliac joint, and the lateral cortex of the sacrum.”

• • Is there bone capture? Is the majority of the implant billed with 27279 encompassed by the area or volumetric space within the sacrum and ileum, which are extra-articular, rather than the SI joint itself? By this we mean: the implant is not just an intra-articular spacer utilized for interference fit and distraction of the joint.
  • Is the range of motion reduced or eliminated without distraction and sufficiently sustained to promote osseous bridging? A solid SIJ arthrodesis is synonymous with proper immobilization of the joint.

ISASS is working to contribute more clarity on these definitions and will provide the MACs with information as it becomes available. ISASS does not endorse any specific MIS SIJ system. There are numerous technologies available that have received FDA 510(k) clearance for use in MIS or percutaneous SIJF/stabilization. The instrumentation and linearity, regardless of the approach utilized in a MIS SIJ procedure, is the purview of surgeon preference.

References were provided for review.

Thank you for your support of the LCD. We will be interested in the future white paper to provide further insight on this topic. We agree with the need to consider the function and outcome of the procedure and not the approach. While the LCD did not separate the 2 procedures by approach, it does address the fact that most of the non transfixation procedures are posterior in approach and most of the transfixation procedures are lateral in approach. We will add clarifying language including ASTM definitions and further discussion as to the differences in the procedures that pierce the cortical surface and those that do not. The CPT^® language will be updated in the 2026 book and has been included in the definitions distinguishing the 2 procedures.. We agree that CPT^® language can be confusing; however, the MACS have no control over that aspect.

We also agree with your citation as to the limitations of the SECURE study. We have included those limitations in our Analysis of Evidence.

Finally, we also agree that a hybrid procedure should be rare, but can be necessary and would support CPT^® recommending that to be coded as 27279, with a modifier signifying additional work in a hybrid approach. The 2026 CPT^® book will address that.

We appreciate the opportunity to submit comments on the proposed local coverage determination (“LCD”) for the MACs entitled “Minimally Invasive Arthrodesis of the Sacroiliac Joint (SIJ)”.

Nevro Corporation (“Nevro”) is a global medical device company focused on providing innovative products that improve the quality of life of patients suffering from debilitating chronic pain. Specific to this draft LCD, Nevro has developed and commercialized transfixing and non-transfixing products specifically for use in the minimally invasive surgery of sacroiliac (SI) joint to allow the opportunity for long-term fusion.

We respectfully disagree with the characterization of minimally invasive surgery (MIS) of SIJ without a transfixation device as experimental, investigational, or unproven. We request that the MACs revise the draft LCD to grant coverage for these services where specific criteria are met. We ask the MACs to consider and adopt the following revisions and recommendations in the LCD, if finalized:

• Amend the covered indications for MIS without placement of transfixation device to incorporate appropriate criteria for when this procedure would be medically reasonable or necessary
• Revise the summary of evidence statements that specifically denote a directionality for MIS of the SIJ with and without placement of transfixation device

Below are our detailed comments providing the rationale for our recommendations.

I. Amend the Covered Indications and Limitations

The current language in the draft LCD states that “MI Arthrodesis of the SIJ WITHOUT placement of a transfixation device is NOT considered medically reasonable and necessary.” In reviewing the evidence, the MACs appear to base its non-coverage position for MIS on SIJ without placement of transfixation on a few different factors:

• • Lack of positive endorsement from the International Society for the Advancement Spinal Surgery in the 2020 clinical guidelines
  • Volume of evidence compared to the evidence for procedures with transfixation
  • Coverage policies from other non-Medicare payors

With regards to ISASS, the most recently published guideline from 2020 takes a neutral position on the SI joint fusion without placement of fixation device. The guideline does not specifically advise against this type of procedure but also does not specifically endorse. Cohen et al noted that these procedures have clinical benefits including shorter length of surgical procedure and lower resource utilization.

There is less published evidence on these MIS without transfixation device versus procedures with transfixation but that is to be expected given that these procedures are newer, with less opportunity to conduct additional studies and aggregate real world evidence.

As to the coverage positions taken by non-Medicare payors, these policies should not serve as the benchmark for the MACs. These payors (e.g., Cigna) are permitted to consider additional evidence when evaluating procedures and technologies (e.g., health economics, cost effectiveness) that are not considered in Medicare fee-for-service coverage policies.

For these reasons outlined above, we ask the MACs to remove the general non-coverage position and rather, establish specific medical criteria that must be met in order for the procedure to be medically reasonable and necessary. This approach would be consistent with language in the draft policy on MIS on SIJ with the placement of a transfixation device. This modified position on coverage would allow Medicare beneficiaries access to a broader range of clinical options to address their chronic, non-radicular pain. To facilitate the revision of the draft language, we propose the following clinical criteria for when procedures without transfixation would be clinically appropriate.

Minimally Invasive (MI) Arthrodesis of the sacroiliac joint (SIJ) WITHOUT placement of a transfixation device is considered medically reasonable and necessary when ALL of the following criteria are met:

• Detailed pain duration for a minimum of at least six months
• Tenderness of SI Joint / Positive Fortin Finger Test
• Tried and failed conservative therapy including pharmacotherapy, physical therapy and/or home exercise program
• Positive Provocative Testing (typically ≥ 3) which could include: Faber’s Test / Patrick’s Sign, Thigh Thrust Test, Compression Test, Gaenslen Test, Distraction Test, Active Straight Leg Raise, Long Ligament Test
• Diagnostic imaging (MRI / CT / X-Ray) of SI joint, pelvis and lumbar spine with confirmatory imaging findings
• Two separate SI Joint Injections with documented pain relief ≥ 75% including at least one therapeutic injection

Where the MACs establish coverage for a category of procedures (e.g., with and without fixation devices), any FDA-cleared or approved devices or FDA-registered tissue products (e.g., bone tissue/allograft) that meet the relevant code descriptors should be covered (where all patient criteria are met). The FDA clearance process, where applicable, involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market. Limiting coverage to any subset of devices could create an unfair competitive advantage, and would be detrimental to patients by limiting access to technologies with demonstrated clinical benefit.

II. Directionality of 27279 and 27278

The Summary of Evidence within the draft LCD focuses, in part, on the approach of the minimally invasive surgery (e.g., posterior (dorsal) vs. lateral trans-iliac). The focus on the surgery’s directional approach is not consistent with CPT^® code descriptions of transfixing (27279) vs. non-transfixing (27278). It is also inconsistent with the conclusion by Raikar et al that there are other approaches in addition to the lateral approach that still result in transfixation rather than distraction.

27278 Arthrodesis, sacroiliac joint, percutaneous, with image guidance, including placement of intra-articular implant(s) (e.g., bone allograft[s], synthetic device[s]), without placement of transfixation device

27279 Arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect visualization), with image guidance, includes obtaining bone graft when performed, and placement of transfixing device

As evidenced above, these codes are and have always been non-directional, and differentiated by whether the device is transfixing the joint or not.

Furthermore, the regulatory pathway for FDA clearance of these types of medical devices, which is based on the biomechanical testing guidelines as defined by the American Society for Testing Materials (ASTM), further supports that these codes are non-directional. As an example, Nevro1 (cleared under the name “Camber Sacroiliac (SI) Fixation System”) meets the transverse and inline ASTM guidelines for a SI fixation device and was cleared as a fixation device by the FDA on February 27, 2024. As part of its review, the FDA determined that the device was substantially equivalent (in terms of safety and efficacy) to other transfixing devices. The indications for use for this FDA cleared device is “for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis”.

Variances in surgical techniques with similar work and to accomplish similar clinical goals are not generally prescribed within CPT^®. The draft LCD states, for example, that transfixing of the SI joint may be accomplished by different anatomical approaches and devices that satisfy the 27279 descriptor. Directionality should remain within the medical discretion of the physician based on their clinical judgment of the appropriate surgical technique best suited to meet the patient's medical needs. We request that the MACs revise the discussion in the evidentiary review to be consistent with the current CPT^® code descriptions.

Tables and references were provided for review.

Thank you for your comments. The LCD did not separate the 2 procedures by approach. It did address the fact that most of the non-transfixation procedures are posterior in approach and most of the transfixation procedures are lateral in approach. The LCD cited specifically the language that is used by CPT^® to distinguish these 2 procedures. CPT^® as well as the orthopedic surgeon who reviewed the CCA were in agreement with this distinction and this is supported by ASTM. We will add further clarifying language citing ASTM definitions as well.

The comment feels that the coverage decision was based on lack of positive endorsement from the International Society for the Advancement Spinal Surgery. However, please see The ISASS position in Comment #12.

• Overall, in the 2020 clinical guidelines, volume of evidence compared to the evidence for procedures with transfixation, and coverage policies from other non-Medicare payors. To clarify these assumptions the policy is based on the quality of evidence for the procedure and if it provides a high level of certainty in the effect of the procedure to produce the desired outcome. While ISASS guidelines are cited in the LCD, other societal guidelines are also included, and coverage policies from non-Medicare payers are not considered in the coverage decision. Finally, the quantity of evidence is not a determining factor for coverage but the quality of evidence which for MI Arthrodesis of the SIJ WITHOUT placement of a transfixation is low and not sufficient to provide certainty that improvement is indeed due to the procedure and no other factors. If additional evidence provides this level of certainty, it can be submitted through the LCD reconsideration process.

Finally, our review is not based on FDA clearance or the existence of a CPT^® code. Our review of these 2 distinct procedures is based on the literature, to ensure that a covered procedure is reasonable and necessary and improves the lives of beneficiaries.

The American Society of Pain and Neuroscience (ASPN) wishes to comment on the proposed LCD on Minimally Invasive Arthrodesis of the Sacroiliac Joint. ASPN is currently comprised of more than 4,000 physicians from the specialties of Anesthesiology, Neurology, Neurosurgery, Orthopedic Surgery, Physical Medicine and Rehabilitation, Interventional Pain Management, Interventional Radiology, and Preventive Medicine & Public Health. Our membership comprises a significant proportion of physicians who perform sacroiliac joint procedures. At ASPN, our policy team is steadfast in advocating for preserving evidence based safe and effective therapies for our members while also making sure that treatments with limited or unproven evidence stay within the conforms of a research protocol.

On behalf of the over 4,000 members of ASPN, we express our concern that the proposed LCD, DL39797, ‘Minimally Invasive Arthrodesis of the Sacroiliac Joint,’ in its current form, will deny access to a safe, effective, and durable treatment option for sacroiliac joint dysfunction to Medicare Beneficiaries. Minimally invasive sacroiliac joint fusion is a treatment option for patients with sacroiliac joint dysfunction when injections are no longer effective and before considering open surgical treatment options with much higher rates of mortality and morbidity. Specifically, we have great concern that non-coverage of posterior sacroiliac fusion with an allograft (non-transfixing), would eliminate a critical step in the safe and algorithmic approach to sacroiliac joint pain in Medicare beneficiaries.

We would like to thank the Contractor Advisory Committee (CAC) team for adumbrating the proposed LCD addressing minimally invasive arthrodesis of the SI joint. Although we commend the analysis of evidence we are deeply concerned about the recommendation on “minimally invasive arthrodesis of SI joint WITHOUT placement of transfixation device” section. This is a widely performed procedure by our members and there are multiple high-quality studies published for this procedure in peer-reviewed literature. Non-coverage of this particular approach would eliminate a low-risk, effective, proven, and durable treatment for those suffering from sacroiliac joint disease.

There has never been a single study or publication which demonstrates that transfixation is necessary to fuse a sacroiliac joint or produces any difference in outcomes in pain, function or biomechanically at the level of the joint, itself. Rather, the term “transfixation” was merely a term created to draw distinction between techniques when the CPT^® code was created by the American Medical Association (AMA) CPT^® Editorial Panel.

Posterior sacroiliac fusion (aka “sacroiliac fusion without transfixation) is not a “new” therapy or treatment, but rather a different way of performing a sacroiliac fusion – a therapy whose efficacy and utility is not in question. The posterior approach referenced in this letter was created as an alternate way of fusing the joint, but in a less invasive manner. A biomechanical studies have been performed on the posterior approach which proves unequivocally that this variation of the procedure leads to the same amount of immobilization of the joint compared to the lateral transfixing approach.

Although proven to be an effective treatment for sacroiliac disease, lateral “transfixation" surgical sacroiliac fusion is typically done under general anesthesia due to the level of invasiveness inherent to the technique and carries higher associated surgical risks. (Dengler et al). This distinction can carry increased risk for those patients over the age of 65 carrying comorbidities. Real world experience and published literature on the posterior “non-transfixing” allograft approach is a technique in which the majority of patients can be treated without requirement of general anesthesia due to its lower invasive profile.

Published Peer-Reviewed Literature

There are numerous published peer-reviewed prospective, retrospective, and biomechanical studies demonstrating not only the appropriate diagnosis, but the safety, efficacy, and durability of SIJ fusion using a posterior allograft.

We appreciate the thoroughness of the CAC in reviewing the literature and eloquently stating in the proposed LCD on page 6 “Placement of SIJF allograft implant via a posterior approach is intended to be less invasive and avoid risks associated with encountering the neurovascular bundle. Examples of posterior SIJ stabilization devices are LinQ (PainTEQ), CornerLoc ( Foundation Fusion Solutions, LLC) and TransFasten(CaptivaSpine) etc…”

The most important distinction to draw is that THIS IS NOT A DIFFERENT THERAPY – SIJF via posterior approach is merely a different technique for accomplishing the same outcome. In the publication, A Cadaver-Based Biomechanical Evaluation of a Novel Posterior Approach to Sacroiliac Joint Fusion: Analysis of the Fixation and Center of the Instantaneous Axis of Rotation (Sayed et al.) the authors demonstrated that SIJF via posterior approach stabilizes the sacroiliac joint to the same degree as a traditional transfixing fusion – thus proving both techniques lead to the exact same outcome at the level of the sacroiliac joint.

Since the publication of the proposed LCD, we now have access to the most recently published 12-month data from SECURE: A Single Arm, Multicenter, Prospective, Clinical Study on a Minimally Invasive Posterior Sacroiliac Fusion Allograft Implant Study. Calodney et al. summarized their findings as follows.

These results suggest that the posterior approach LinQ Implant System is a safe and effective treatment for sacroiliac joint dysfunction at 12 months, with results that are favorable compared to outcomes reported for an FDA-cleared lateral approach. (Calodney, 2024)

Safety, Efficacy, and Durability of Outcomes: Results from SECURE: A Single Arm, Multicenter, Prospective, Clinical Study on a Minimally Invasive Posterior Sacroiliac Fusion Allograft Implant (Calodney, 2024) Summary:

• Prospective study assessing outcomes up to 12-month in patients receiving the posterior allograft implant LinQ procedure.
• N=117
• The mean improvement in VAS scores at 12 months was 43.3 from a baseline mean VAS score of 76.2. In comparison to studies using the lateral implant, the iMIA study had a mean improvement in VAS scores at 12 months of 41.6 (baseline score 77.7), and the INSITE study had a mean improvement in VAS scores at 12 months of 54.2 (baseline score 82.3).
• The mean improvement in ODI scores at 12 months was 25.3 from a baseline mean ODI score of 52.4. In comparison to studies using the lateral implant, the iMIA study had a mean improvement in ODI scores at 12 months of 25.0 (baseline score 57.5), and the INSITE study had a mean improvement in VAS scores at 12 months of 29.3 (baseline score 57.2).
• All serious adverse events reported during the LinQ study (4) were determined to be unrelated to the implant, with only 1 SAE related to the procedure (anesthesia). In comparison to the previously published iMIA study (n=52) using the lateral implant, they reported 17 AE’s, 8 SAE’s, and 2 implant or procedure related AE’s. In the INSITE study (n = 98), 179 AE’s were reported, 22 SAE’s, in which 18 AE’s were implant or procedure related.

In addition to the above prospective multicenter trial, Deer et al. conducted a multicenter retrospective observational study of patients with refractory SIJ pain treated with posterior allograft sacroiliac fusion. A total of 111 patients were included in the study and underwent posterior SIJF via LinQ SIJF procedure for refractory SIJ related pain following the use of spinal cord stimulation (SCS), interspinous spacer (ISS), intrathecal drug delivery(IDDS) and/or minimally invasive lumbar decompression (MILD). Overall, mean patient reported pain relief following SIJF was 67.6%. This study provides clinical evidence that posterior arthrodesis without placement of transfixation device can be highly effective in salvaging refractory patients from other therapies. To our knowledge, this is the only study which looked at the salvage rates. Even the transfixation devices for SIJF have not reported any successful salvage data in the literature.

Similarly, Caheuque et al. conducted a retrospective cohort study that analyzed outcomes of posterior SIJF. In addition to significant improvement in pain, they also demonstrated a substantial reduction in operative time ( > 50%) and duration of hospital stay with posterior approach as compared to the lateral cohort. This further makes a compelling health economics argument for posterior devices to be more cost efficient than lateral transfixation devices.

ASPN SIJ Best Practice Guidelines

ASPN has SIJ Best Practice Guideline which include a section on minimally invasive SI joint arthrodesis. This guideline is designed to ensure patients are properly selected and the technology is utilized appropriately, i.e., when followed correctly they prevent under and/or over utilization. These are the de facto standard of care in the communities served by ASPN member physicians. In specific reference to the issue at hand, ASPN has provided the following guidance:

1. Recommendation I: Minimally invasive posterior SI stabilization with allograft is considered medically necessary when the appropriate clinical criteria have been met.
   •  Grade: A
   • Level of Evidence: 1-B
   • Level of Certainty of Net benefit: High

Additionally ASPN has developed an evidence-based eligibility and exclusion criteria for the surgical approach for posterior sacroiliac fusion with allograft that we would highly recommend that MAC’s CAC utilize for the coverage of this procedure:

Medical Criteria and Exclusions for SI fusion and stabilization (all approaches):

Inclusions

1. A failure of conservative measures to at least include physical therapy and injections.
2. Pain persisting a minimum of 6 months that interferes with functional activities as documented by both a pain score of VAS/NRS of 5 or greater and an ODI of 30 or more.
3. Failure of at least one therapeutic sacroiliac joint injection (less than 50% pain relief for three months duration).
4. Predominant pain pattern consistent with sacroiliac joint pathology.
5. Positive response from at least three validated maneuvers for sacroiliac joint dysfunction.
6. Positive Fortin finger test.
7. Diagnostic imaging: either CT or MRI that excludes destructive lesions of the sacroiliac joint.
8. Diagnostic confirmation of the SI joint as the pain generator demonstrated by at least one image guided (CT or fluoroscopy) intraarticular injection of the SI joint with 50% or greater pain relief for the expected duration of the local anesthetic.

Exclusions

1. Infection or fracture (unrelated to implant)
2. Tumor
3. Acute traumatic instability

• Recommendation II: The use of implants composed of human cell and tissue products for sacroiliac fusion is considered medically necessary only if the guidelines set forth by the FDA Regulation of Human Cells and Tissue is followed and should be registered in the FDA Human Cell and Tissue Establishment Registration.
  
  • Grade: A
  • Level of Evidence: N/A
  • Level of Certainty of Benefit: High

• Recommendation III: ASPN supports the utilization of sacroiliac fusion and stabilization devices with published, peer-reviewed, multi-center, prospective evidence of at least 6 months duration to assess efficacy and safety.
  • Grade: A
  • Level of Evidence: 1-A
  • Level of Certainty of Benefit: High

The ASPN Policy team vehemently opposes the rationale of determination provided in the proposed LCD. The diagnostic algorithm has been clearly validated through numerous studies and endorsed by multiple societies including ASPN. There are also appropriate use criteria validated and published by numerous societies including IPSIS and North American Spine Society (NASS). NASS further validated the appropriate use of CPT^® 27278 and CPT^® 27279 addressing the approach both with and without transfixing device.

We also disagree with the statement in the proposed LCD that clinical evidence for the non-transfixation procedure is far lower than transfixation devices. The body of evidence specifically for triangular titanium implants (TTI) with a porous surface (SI Bone) may appear to be high as this implant has been FDA approved and available in the market much longer than other fusion devices. The SIJF procedure with TTI has higher morbidity with potentially higher risk of increased adverse events when compared to equally effective posterior SIJF devices without transfixation of the SI joint.

Should this proposed LCD pass, providers will only have one option to offer for this particular patient population and will ultimately force patients to undergo the more invasive and more expensive treatment option – this will ultimately cost more money for the MACs and their members. Current fee rates for posterior allograft results in a significant cost savings in health expenditure when compared to the fee rates for transfixation devices.

Additionally, due to the safety profile of the posterior allograft technique, the lower cost office setting provides the possibility of a significant cost savings in healthcare expenditures compared to the transfixation methods that require a hospital or surgical center setting. ASPN Advocacy & Policy team formally recommends reversing the draft coverage policy and rationale for determination specifically for “SIJ arthrodesis WITHOUT placement of transfixation device”. There are numerous published peer-reviewed prospective, retrospective, and biomechanical studies demonstrating not only the appropriate diagnosis, but the safety, efficacy, and durability of SIJ fusion using a posterior allograft.

We strongly encourage the MAC’s CAC delete the statement “MI arthrodesis of the SIJ WITHOUT placement of a transfixation device is NOT considered medically reasonable and necessary.”

OR

Consider amending the currently proposed LCD as follows to retain access for safe, cost efficient, opioid sparing alternative treatments for SI joint pathologies: “MI arthrodesis of SIJ WITHOUT placement of a transfixation device (posterior allograft) is considered medically reasonable and necessary only when medical criteria has been established.” ASPN would support consideration of introducing a prior authorization process for both 27278 and 27279 CPT^® codes to ascertain utilization management and better ensure the appropriate utilization of surgical management of sacroiliac disease.

We look forward to working with the MACs on this important LCD.

Tables and references were provided for review.

MACs may not institute a prior authorization process unless specifically instructed to do so by CMS.

It has been clarified in the LCD that the procedure is not defined by the directionality of the approach. However, most published data describes the use of a lateral transfixing approach. See previous comments and response to comments regarding this.

The SECURE study was a multicenter prospective study to present the results of preliminary data that was previously published on safety, efficacy and durability of the minimally invasive sacroiliac posterior fusion with a LinQ allograft implant. It had several limitations, including the absence of a control group, high loss to follow-up, absence of blinding and potential bias from the funding source and conflicts of interest, lack of generalizability, short duration of follow-up, missing data, and limited data on procedure standardization. The conclusions of the study need to be interpreted with caution due to its serious limitations.

The Deer et al. study, was a multicenter retrospective observational study of patients with refractory sacroiliac joint pain treated by interventional pain physicians at 1 of 8 different pain management centers and had several limitations. These included lack of randomization and controls, short-term follow-up and risk of bias.

The Caheuque et al. study involving a retrospective cohort of 45 patients was limited by lack of randomization and a control group, small sample size, short-term follow-up and a mean age of patients that was below the Medicare mean (62.9), as well as a single surgeon and limiting generalizability.

There are several concerns with the ASPN SIJ best practice guidelines that are outlined in the Summary of Evidence section of the LCD.

Contractors may not consider cost or cost savings in coverage determinations.

On behalf of the International Sacroiliac Medical Expert Group e.V. (SIMEG) members we are pleased to provide comments regarding Sacroiliac (SI) Fusion. SIMEG, a non-profit association based in Germany and operating internationally, was founded in 2013 by orthopedic surgeons to promote scholarship, research, training and continuing education, together with quality assurance in the field of diagnosing and treating sacroiliac joint (SIJ) dysfunction. SIMEG does not favor any surgical procedure or implant system. Our ethical code is unbiased research. We are dedicated to providing patient access for care based on research evidence. SIMEG is considered the leading group of experts in the field of SI diagnosis and treatment based on years of research in biomechanics, conservative care, and SI joint fusion. SIMEG members include, but not limited to, trauma surgeons, orthopedic surgeons, neurosurgeons, neurologists, physiotherapists and scientists. As a society, we have physician members who have been successfully performing SIJ fusions for 30+ years with multiple approaches, devices and complexities, including revisions.

We would like to address the statement within the LCD regarding the “approach” dictating whether a device transfixes the joint: Page 5 of 10 under subsection Arthrodesis without Placement of Transfixation Device- “The aforementioned transfixation procedure is typically performed from a lateral approach. The procedures that are non-transfixation approaches are usually performed from a dorsal (posterior) approach though at times are combined into a dorsa-lateral approach. Rather than transfixing the SIJ, these procedures utilize distraction arthrodesis. This statement is not supported by the evidence of years of biomechanical and current research. All surgical approaches can transfix the joint given the proper instrumentation and methodologies where the resultant instrumentation (i.e., device, device assembly, or construct) sufficiently engage both the ilium and sacrum thereby bridging both sides of the joint, providing stabilization and preventing motion. It is important to note that this can take many forms and, in some instances, can also include distraction arthrodesis (or ligamentotaxis) in addition to transfixation, they are not mutually exclusive. Furthermore, the group of devices/allografts that do not transfix the joint have also demonstrated the ability to fuse the joint. In most instances, the patient population being treated has a very stable joint given the extensive ligamentous structures supporting the joint and the interlocking features of the surfaces of the joint and so even the devices/allograft which do not transfix the joint can provide satisfactory stabilization resulting in fusion.

1. The least Invasive of procedures are arguably allograft or devices that are placed intra-articularly and that do not extend (e.g., pierce) into the bones of the joint. These implants work by various biomechanical methods, distraction arthrodesis and/or anti-migration surfaces, while resting within the joint, and are intended to fuse the joint. This is appropriately described in CPT^® code 27278, that is intra-articular placement, not approach, non-transfixing, but still leading to fusion of the joint. Studies including allograft made by various different manufacturers have shown very low adverse event rates, improved pain scores and functional scores. (Table 1) Allograft has been used for years within the spine for fusion in the lumbar, thoracic and cervical segments, and has shown to be an acceptable medium for fusion. Allograft is routinely added with devices in many procedures during a SIJ fusion regardless of approach or final implant locati Allografts are often used in revisions of previous failed SI joint fusions, as additional bone growth is critical in patients who have device loosening/failure and require either a multi-planer approach, or bone to supplement the Medicare patient with low bone density. Revisions with allograft as a separate or additional supplement date back decades, and can be noted in peer reviewed literature.

2. Additionally, several transfixing posterior devices have been on the market over the last few years and have received clearance based on rigorous testing required by FDA reflecting their ability to transfix the SI joint. However, devices do not necessarily need to transfix the joint in order to lead to joint fusion but may do so by ligamentotaxis or distraction arthrodesis. The goal is to fuse the joint, and not necessarily by transfixing the joint. Reported fusion rate provided in the prospective, 20-center 2-year clinical trial with 171 patients using a stand-alone device is an example of distraction arthrodesis, which still provides a safe and efficacious approach for fusion.

3. Dorsal-Lateral (Posterior-Lateral or Oblique) These terms all represent the same positioning that are equally invasive as lateral, but provide a much better safety profile. There are no known stand-alone allografts in this space, and all devices and systems are cleared through the FDA for transfixing the joint are intended for fusion. The safety profile as mentioned above is safer than lateral and are similar to those described in the safety benefit of a posterior approach: Avoidance of major gluteal artery vasculature, nerve bundles, and avoidance of dissection of ligament and muscle ti Meta-analysis of 8 peer published papers not considered by Palmetto GBA, by Whang et al, reflected a safety profile of AE and SAE for lateral-oblique (posterior-lateral) approach at 1.11%, well within the FDA acceptable safety standards.

The MACs cited a paper by Polly “Two Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction” which demonstrated an adverse event rate of 23% including a significant amount of serious adverse events. Additionally, concerning is that the paper is not representative of the Medicare population and reflected only 9% of the patients who received SIJF were of Medicare age. We find this concerning as great consideration needs to be taken in account for patient bone age, density, osteoporosis and osteoarthritis among a host of other Medicare age co-morbidities. Patient bone age can vary and change dramatically in patients who are 55 and older.

We have included 8 published peer reviewed papers in Table 2 that reflect safety and efficacy of the posterior-lateral approach. In MAC’s review of the publications mentioned in the LCD, you will find that some of the peer publications mentioned lateral approach, but were actually a combination of lateral and posterior-lateral approaches as defined by the protocol in the clinical trials that allowed for physician preference whether to perform lateral or posterior-lateral approach. Further worth nothing are the revisions in some circumstances which have a high rate of success, were hybrid approach procedures of both posterior-lateral or lateral combined with a posterior allograft.

Table 2 Posterior-Lateral (dorsal-lateral) Peer Reviewed Studies

The information provided reflects years of clinical expertise and research with current methods and devices and demonstrates that various devices can transfix the joint, thus coverage should not be defined by approach.

On behalf of SIMEG members we have provided data and reasoning supporting various SIJF’s. We ask that SIJF devices/allograft, regardless of approach, both transfixing, and intra-articular be a covered benefit for the many Medicare patients who need options based on their contributing comorbid conditions.

Accordingly, we respectfully recommend the MACs:

1. Finalize coverage for both CPT^® 27278 and 27279, including the combination of both codes for “hybrid” procedures with appropriate modifier;

2. Not determine coverage based on surgical approach;

3. Delineate the use of CPT^® 27278 and 27279 based on whether the procedure is conducted in an open versus MIS manner and also the device’s labeling, the Indications for Use as clearly documented on Form FDA 3881 and the Device Description as documented in the 510(k) Summary which form part of the device’s FDA 510(k) clearance letter:

a. Examples of devices where FDA requires the use of a separate “transfixing device” (that does not form part of the implant assembly) in addition to an “intra-articular implant”, use CPT^® 27278 and 27279

• K232259: “The Patriot-SI Posterior Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the Patriot-SI Posterior Implant System (i.e., an “in-line” or “intraarticular” device) is implanted, it must be used with a Spinal Simplicity Liberty-SI Lateral System device (i.e., a “transfixing” device) implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct.”
• K232878: “The TransLoc 3D Posterior Implant is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the TransLoc 3D Posterior Implant is implanted, it must be used with a TransLoc 3D Screw implanted across the same sacroiliac joint.”

b. Examples of devices where FDA requires the use of a “transfixing device” component (that forms part of the implant assembly) in addition to an “intra-articular implant” such that the assembly as a whole acts as a “transfixing device, use CPT^® 27279

• K232149: “The BowTie™ SI Joint Fusion System is indicated for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the BowTie SI Fusion System is implanted, both the Iliac and Transfix Screw components must be used."

• K221047: “The Aurora Spine SILO TFX MIS Sacroiliac Joint Fixation System includes the SILO TFX Cone, SILO TFX Screw, and the SILO TFX Locking Screw and associated manual surgical instruments. The SILO TFX Cone is comprised of titanium alloy and incorporates a hollow conical shaped barrel with two openings for bone screws for additional anchoring. During the procedure, the implant is inserted in line with the SI Joint via a posterior surgical approach, and bone graft material is placed in the barrel of the implant to facilitate additional bone incorporation after surgery.”

c. Example of device where the implant(s) alone acts as a “transfixing device, use CPT^® 27279:

• K180818: “The Tenon Medical Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.” NOTE: the labeling does not require extra components or supplemental fixation.

We appreciate the opportunity to comment on this important issue and welcome any questions you may have.

Tables and references were provided for review.

It has been clarified in the LCD that the procedure is not defined by the directionality of the approach. However, most published literature describes the use of a lateral transfixing approach.

It is not customary for the Medicare Contractors to list individual device limitations in an LCD, but to expect providers using such products to do so according to the FDA labeling and instructions.

We agree that it is important to consider the co-morbidities of any patient when decisions are made about treatment options but treatment options must fulfill all criteria of what is reasonable and necessary with peer reviewed literature to support those treatment options as choices. This shall include published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines. Proprietary information, submitted by a requestor, not available to the public shall not be considered.

Coverage is NOT determined by “surgical approach” but rather by the peer-reviewed evidence that coverage of a CPT^® code is reasonable and necessary. The CPT^® language will be updated in the 2026 book and has been included in the definitions distinguishing the 2 procedures.

The MACS cannot alter CPT^® instruction regarding hybrid approaches; however, this will be clarified in the CPT^® 2026 book.

We are writing to express concern with the MAC’s proposed LCD with respect to minimally invasive (MI) sacroiliac joint (SIJ) fusion. We are a group of physicians and scientists who treat patients suffering from SIJ dysfunction and actively participate in pre-clinical and clinical research on this subject.

Our primary concern is regarding the MAC’s position holding that: “MI Arthrodesis of the SIJ WITHOUT placement of a transfixation device is NOT considered reasonable and necessary.”

We offer several seminal points of discussion as follows:

1. While the proposed LCD identifies that the body of published literature supporting posterior SIJ fusion is less robust than that supporting lateral SIJ fusion, this in no way negates the clinical utility of posterior SIJ fusion. Rather, the fewer number of publications is simply a result of it being recently more frequently utilized. In fact, like other areas of spine surgery, the evolution and refinement of the posterior SIJ procedure has followed a typical developmental path over time from more invasive to less invasive as a direct result of the need to reduce surgical morbidity, speed recovery and improve patient outcomes and, thus, reflects a substantial improvement over the more tissue disruptive lateral approach. The compendium of clinical findings showing improved patient outcomes following posterior SIJ fusion as noted in the LCD are further corroborated by Lynch et al who reported on observational data from a 57 patient multi-center registry using the posterior approach that demonstrated uniform and statistically significant improvement in all clinical outcomes (p <0.001 for all comparisons), including an average 3-point improvement in back pain severity from 6.8 preoperatively to 3.8 at 6 months.
2. It is important to note that the terminology transfixation and distraction arthrodesis is arcane and has not been historically or commonly used to describe spinal arthrodesis procedures. These terms appear to have been recently co-opted by the International Society of Spine Surgery (ISASS) in their assessment of SIF fusion as an attempt to differentiate lateral from posterior SIJ interventions. In fact, as a procedure, the literature on so-called distraction arthrodesis is restricted almost exclusively to lower extremity subtalar arthrodesis and the term does not appear in the spine literature. That said, we would argue that all commonly employed lumbar fusion procedures of the anterior column, for example, employ some form of distraction of the intervertebral joint space with interbody cage placement which is used to re-establish disc height and maintain neural decompression irrespective of whether the cage is standalone, expandable or affixed to the adjacent vertebral bodies.
3. The posterior SIJ fusion procedure with allograft implantation represents a legitimate attempt to achieve bony arthrodesis. Indeed, McQuire et al. reported an almost 90% fusion rate using cortical allograft bone implanted in the intra-articular region of the SIJ using a posterior approach. At the fundamental level, arthrodesis constitutes the uniting of two bones at a joint via the artificial induction of joint ossification by surgery. The American Academy of Orthopaedic Surgeons describes the procedure as a “welding process”. Achieving a solid arthrodesis across the joint space is, therefore, agnostic to the surgical approach as has been demonstrated in the lumbar spine where there are multiple accepted approach trajectories. The primary goal of all SIJ fusion procedures is to restore anatomical alignment, decompress the neural elements, stabilize the joint to resist forces in all axes of movement, and provide the optimal environment for bone fusion to occur.
4. Posterior SIJ fusion without transfixation includes the necessary technical characteristics to qualify as an arthrodesis procedure. The surgical method involves a series of procedural steps that reflect the work necessary to establish a solid and stabile bony fusion across the SIJ. Specifically, specialized instruments are used to access and prepare the joint space for fusion by decortication of the articular bone surfaces. To encourage bone to form ectopically necessitates the use of an array of bone grafts to provide the necessary physiological milieu to induce ossification across the joint space to form an extra-anatomic bony bridge. Normally the cortical allograft implant used in posterior SIJ fusion is packed with local autograft and/or demineralized bone matrix. Osseointegration is enhanced by placing the grafting material(s) on the bleeding surface of vascularized freshly decorticated bone.
5. Despite slight procedural modifications and implant placement locations within the SIJ, all posterior SIJ fusion procedures employ distinctly similar cortical allograft implant materials. All of the commercially available structural allograft implants noted in the LCD and others fall within FDA’s definition of homologous use and minimal manipulation of structural tissues, and are classified under section 361 of the Public Health Service (PHS) Act, and regulations in 21 Code of Federal Regulations (CFR) Part 1271. As these allograft implants are all minimally manipulated and surgical techniques are alike, performance characteristics and clinical outcomes are comparable. Any claims of superior performance would suggest off-label marketing and subject that allograft implant to the FDA’s medical device regulatory oversight and pathway for approval.

Lastly, in response to the statement within the proposed LCD that “There were no systematic reviews, with or without meta-analysis, or RCTs found in the literature search”, it should be noted that published Level I evidence from systematic reviews of RCTs and/or individual RCTs is not a requirement for establishing a Category 1, CPT^® code. The highest level required is Level IIa.

We should also point out that MI posterior SIJ fusion may offer the patient a less invasive, interim solution in their continuum of care. The joint distraction alone may provide sufficient neural decompression to afford satisfactory symptom amelioration and spare the patient from the more tissue disruptive lateral procedure or at least delay lateral SIJ fusion for several years.

In the end, as new technologies and surgical technique refinements become available that provide better ways of accomplishing a similar outcome, reimbursement needs to keep apace of these advancements.

In summary, we urge the MACs to join the undersigned to cover this procedure under CPT^® code 27278 (Arthrodesis, sacroiliac joint, percutaneous, with image guidance, including placement of intra-articular implant(s) (e.g. bone allograft[s], synthetic device[s]), without placement of transfixing device). After reviewing the above comments, it is hoped that the MACs will consider revising their proposed LCD to reflect the above clarifications, new evidence and provide coverage accordingly. The undersigned welcome the opportunity to further elaborate on the comments provided herein and are willing to facilitate a conference call with MAC Medical Directors to discuss the coverage issue further if that would be of assistance. We look forward to working with the MACs to improve patient access to care and outcomes.

References were provided for review.

Contractors are required to use published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines. Proprietary information, submitted by a requestor, not available to the public shall not be considered. The 57 patient registry by Lynch et al. did not meet this criteria. The study by McGuire included no patients in the Medicare age range, as average age was 42 and oldest patient was 63. These 2 studies will be added to the LCD as reviewed but not cited.

Assignment of a category I CPT^® code by the AMA does not automatically confer coverage under the Medicare Program, as noted in CPT^®’s own disclaimer.

The Outpatient Endovascular and Interventional Society (OEIS) is a patient centric society focused on ensuring quality healthcare for patients in all settings including the outpatient hospital, ASC and office based interventional suites. We are a multi-specialty society representing over 1,000 professionals involved in performing interventional procedures across the United States including interventional radiologists, vascular surgeons and interventional cardiologists.

OEIS appreciates the opportunity to comment on your respective proposed LCDs, all entitled ‘Minimally Invasive Arthrodesis of the Sacroiliac Joint.’ We are collating our comments as this appears to be a multi-jurisdictional effort by Medicare.

In their current form, with the proposed LCDs stating: ‘MI Arthrodesis of the SIJ WITHOUT placement of a transfixation device is NOT considered medically reasonable and necessary,’ they will inappropriately deny Medicare Beneficiaries [patients] access to a safe, effective, and durable treatment option for those suffering from the debilitating effects of sacroiliac joint dysfunction and likely cause a variety of adverse consequences including physicians performing increased low back procedures, increased use of short-term injections, return of patients to opioids, and in general cause patient malaise. Important to note, the posterior allograft approach, i.e., non-transfixing, is backed by a significant and continually emerging body of science, professional society guidelines from ASPN (American Society of Pain and Neuroscience) and a revised statement from NASS (North American Spine Society) and provides a lower cost treatment alternative to the lateral multi screw-based transfixing approach.

We ask that the LCDs be revised so that minimally invasive sacroiliac joint fusion without placement of a transfixation device, i.e., posterior allograft approach, be considered medically reasonable and necessary when the patient selection criteria you have listed, i.e., duration of LBP of at least six months, positive provocative maneuvers, injections, imaging, etc., is fulfilled.

The following provides detail on the issues we outlined above:

Emerging Body of Science

At last count there are over a dozen published peer-reviewed studies that show the posterior allograft approach to be a safe, effective, and durable treatment option for patients with SIJ dysfunction. Most recent is the SECURE (prospective multi-center single-arm) study published by Calodney, et al, Journal Pain Research, April 2024. SECURE used a product called LinQ (PainTEQ, Tampa, FL); for convenience, please see this link (Publications - PainTEQ ) which will take you to the manufacturer’s website showing articles with sub-links whereby you can get the full-text version of the articles which you ask for in your LCD comments. Specifically, the SECURE study concludes:

• Conclusions The results suggest that use of the LinQ System is safe, effective and durable in the management of chronic, low back pain associated with sacroiliac disease compared to a similar benchmark system. In addition, the LinQ System may be superior to this system in terms of safety as evidenced by less fluoroscopy time, less time in the hospital and a lower incidence of implant/procedure-related AEs. These findings suggest that the posterior approach may be associated with an improved safety profile over the traditional lateral approach and help to address criticism of interventionalists to safely and appropriately diagnose and treat SIJ dysfunction by a posterior fusion strategy. Further, the data support safe and effective treatment of this patient population with this specific approach by interventionalists when proper patient selection is performed, along with proper procedural technique.

In the ‘Analysis of Evidence (Rationale for Determination)’ section of the proposed LCDs detailing why MI SIJ fusion without a transfixing device is not medically reasonable and necessary, it states: ‘The evidence that exists is of low quality and is entirely industry supported.’ It is important to note the proposed determination that MI Arthrodesis of the SIJ WITH placement of a transfixation device is considered medically reasonable and necessary is based upon at least seven industry funded and sponsored articles in the bibliography. This is common and appropriate for manufacturers to support their technologies’ high-level clinical studies.

Another factor to consider is that you [MACs] began reimbursing for the aforementioned ‘benchmark system,’ — typically billed using CPT^® code 27279 — many years ago, and prior to it being supported by a multi-year RCT. Commendably, the manufacturer subsequently then embarked on long-term RCT studies. Products used in the posterior approach similarly will be developing longer-term corroborating data, but in the professional opinion of OEIS, posterior allograft SIJ fusion w/o a transfixation device, currently has sufficient published peer-reviewed data and demonstrated pain reduction outcome utilization to be deemed medically reasonable and necessary today.

Professional Society Guidelines / Statements (ASPN & NASS)

As of this writing, the professional society ASPN has made public they have developed ‘ASPN SIJ Best Practice Guidelines’ which recommend the use of posterior allograft products when supported by published peer-reviewed published data. According to ASPN, they will be making these Guidelines available very soon as they’ve been accepted for publication.

NASS has recently issued a new statement of the use of CPT^® codes 27278 and 27279, MIS SIJ fusion with and without a transfixing device (NASS’ SpineLine Apr 2024). Given NASS too is now supportive of the use of posterior allograft, this would be a consensus of support that the posterior allograft can be used on properly selected patients as described above. The NASS SpineLine April 2024 merely outlined coding requirements and had no statement of support for or against, nor any literature.

Site of service/Procedure cost

The safety and efficacy of posteriorly placed allograft bone fusion implants without transfixation device has been demonstrated by Calodney, 2024 and Sayed, 2021 as well as the five references submitted to support the category one status of CPT^® code 27278 (dorsal arthrodesis). Indeed, it is not an insignificant milestone to achieve category one status and CPT^® code 27278 was granted category one status precisely because the amount and quality of the data met the rigorous standard for safety and efficacy demanded by the process. CPT^® code 27278 was also deemed safe to perform in an office based setting and offers additional savings. This fact along with the current established national facility reimbursement rates (see chart below) makes 27278 a cost saving procedure for Medicare beneficiaries. As both procedures (27278- dorsal arthrodesis and 27279 – lateral arthrodesis) have comparable safety and efficacy profiles, Medicare beneficiaries most certainly would benefit significantly from lower cost procedures as they often have a 20% copay.

The ambulatory surgery center (ASC) place of service allowable for 27278 and 27279.

Given both procedures have comparable outcomes as demonstrated in the published literature, we certainly recommend allowing the less costly alternative to be offered to patients. Patients deserve the lower cost alternative as many are on fixed incomes.

Increased Utilization of Lateral Multi Screw-Based Approach

Should the posterior allograft non-transfixing approach be deemed not medically reasonable and therefore not reimbursable, there is concern that physicians will simply perform lateral transfixing procedures using a variety of hardware, including multiple screws. This is highly problematic as it may cause an increased rate of serious adverse effects (SAEs). In the SECURE study, the authors conclude that: ‘… the posterior approach may be associated with an improved safety profile over the traditional lateral approach…’ Candidly, our recommendation is that Medicare reimburse for a procedure that has an improved safety profile and not ‘encourage’ physicians to perform procedures that may have a lesser safety profile, ‘just because it is reimbursable.’

Increased Use of Short-Term Injections

The SECURE study demonstrated significant pain relief for the overwhelming number of patients in the study. To that end, as patients suffering from chronic low back pain move through the continuum of care, they typically progress from oral pain medications to injections to minimally invasive surgery and then to more invasive surgery if needed. Not long ago, many commercial payors and most MACs stopped reimbursing radio frequency ablation (RFA). This has resulted in patients often going from medications to more frequent injections which typically have diminishing short-term relief and then on to a more invasive surgical procedure. By deeming the use of posterior allograft [non-transfixing device] as medically reasonable, fewer short-term injections are likely to be given and a more prudent treatment continuum can be used by physicians.

Return of Patients to Opioids

An important factor to consider is that many SIJ dysfunction patients need a less invasive option such as posterior allograft fusion to move to after injections have begun to lose their effectiveness. Without this option, many patients will sadly and unfortunately be forced to return to or begin the use of opioids to manage their pain. This would have devastating consequences and we certainly hope this does not occur as society has learned the lesson of over utilization of opioids.

We respectfully request that the proposed LCD’s regarding minimally invasive arthrodesis of the sacroiliac joint (SIJ) remove the non-coverage language for minimally invasive arthrodesis of the SI joint without placement of a transfixation device. The clinical evidence and current literature as well as expert opinion and multi-societal support of SI joint fusion without placement of a transfixation device is more than adequate to support removal of the non-coverage language.

Thank you in advance for your consideration of these comments.

Tables and references were provided for review.

Thank you for your comments. Medicare Contractors are not permitted to consider cost or cost savings in coverage decisions. Moreover, there have been no head-to-head studies between the procedures.

Assignment of a category I CPT^® code by the AMA does not automatically confer coverage under the Medicare Program, as noted in CPT^®’s own disclaimer.

Please see the Summary of Evidence section in the LCD for analysis of the SECURE 12 study and Guidelines statements.

Industry funded and sponsored articles may potentially introduce the risk of bias. It is important for those studies to outline how that risk of bias was mitigated to minimize those effects on outcome.

Contractors are currently required to consider the following when making coverage decisions: “Published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines. Proprietary information, submitted by a requestor, not available to the public shall not be considered.”

On behalf of multiple manufacturers on this comment letter, we represent over a 1/3 of the devices on market within the SI fusion space. As competitors who rarely if ever collaborate, we are compelled to do so as the assumptions that have gone into the Proposed LCD are false clinically, as well as how specific devices function. As some of the manufacturers can attest, this is a fast-evolving space, much faster than what we have seen in other specialties such as cardiology and ophthalmology with the use of human allograft and advancements to design in synthetics, including metal. (e.g., titanium, nitinol, PEEK).

Until recently, sacroiliac joint (SIJ) dysfunction was not well understood, and pain generators were thought only to be caused by pathologies of the lumbar spine or lumbar facet joints. Great advancements in Orthopedic, Neurosurgery, and Interventional Pain Management have been made in understanding SIJ as a pain generator. Some of the first minimally invasive fusions were performed with lumbar screws that were utilized for SIJ stabilization. Subsequently SI-Bone came to market, and created a procedure with a threadless fusion rod that was less invasive than an open procedure, but still had high surgical risks. For many years, this became the gold standard as there was little to no competition in the marketplace. Physicians realized that a lateral approach had high surgical risks and began finding ways of reducing the surgical safety risk, and began implanting some of the same screws, rods, and triangular implants in a less risk approach, the posterior-lateral, (oblique, or dorsal-lateral) approach. This dramatically reduced the number of surgical complications from double digits in the lateral group to 1.1% in the posterior-lateral group.

Further work was done with utilizing allograft machined as a device under the FDA Registration 361 for Human Tissue. Many of these allografts utilize the strongest and most porous bone of the human body. The femur bone. For example: Cornerloc^® machined allograft accepts only 5% of human bone out of 100 femur samples prior to proceeding with further processing and being released to inventory. Their bone, and others’, is cut or machined to maintain the properties of a screw, cone, or implant to those of similar design in a lumbar fusion. These allografts could be implanted and fuse the joint as intended in even a less invasive approach than lateral by implanting the bone intra-articular. The mechanism of action for these implants vary. Some utilize distraction arthrodesis, while others use different methods of fixation. The designs of these implants vary. Some allografts have small teeth or fenestrations to grab onto a prepared joint surface. (Preparing the joint for all allograft placement includes at least one of methods: drilling, rasping, chiseling, or broaching) the patient’s ilium and sacrum to promote fusion) These allografts have been on the market for 7+ years. Various publications and meta-analysis have been performed beyond those promoted by a single manufacturer. In totality of the literature, adverse event rates have been extremely low, pain scores are decreased dramatically and consistent across published data, and functional scores improved. (Table 1)

We have commissioned KNG Health Consulting Group, LLC to examine data of allografts in comparison with lateral SIJF for time to failure or revisions. Two groups were used as a proxy for triangular rods and screws inserted lateral/posterior-lateral compared to those of allograft.

The proxy that was utilized to define the groups was Group 1 was interventional pain specialties that during the 4-year time period, were almost exclusively utilizing allograft as an implant in an ASC. Group 2 was Orthopedic and Neurosurgery performing lateral or posterior lateral in OPPS. The 5% data sample was used representing 7800 patients in total. Allograft time to failure was defined as needing another SIJF on the same side. Detailed methods are defined in the report. The data reflects from a 4 -year time of 2018-2021, allograft time to failure- as defined as needing another SIJF on the same side. The revision rate was 3.3% over the 4-year period reflecting an extremely low rate, and undeniably demonstrating efficacy of machined allograft. This rate was slightly higher than that of Group 2 with a revision rate over 4 years of 1.7%. The average age for Group 1 patients was slightly higher than that for Group 2. Both revision rates have been shown to be extremely low in comparison to other lumbar spinal surgical procedures. Arguably patients seen in interventional pain have a greater complexity of co-morbidities and multiple pain issues.

We would like to thank the companies who paid for the research grant to commission this project, and agreed to disclose the outcomes, regardless of the data outcomes. CornerLoc™, Invictus^®, Omnia Medical^®.

Other devices manufactured from titanium have also been designed to be able to be implanted in a posterior approach. All the devices have been cleared by the FDA with a safety profile equivalent to predicate of laterally or posterior-lateral implanted devices. These devices have gone through the required testing by the FDA to perform transfixation when the device mechanism of action is transfixation. Other devices such as what were used in the DIANA trial, do not transfix the joint, but still promote and maintain fusion at 2 years.

We would like to stress the importance of whether the device transfixes the joint or not, is not the measure of success or failure. The goal is to fuse the joint, as defined by both CPT^® arthrodesis (fusion) codes of 27279 and 27278.

All stand-alone FDA Cleared posterior devices that are not performed with supplemental fixation as a system, have all gone through the required FDA OUR testing or the newly required ASTM F3574-22 standards. One example of the testing and performance for these stand-alone posterior transfixation devices reflects performance in transfixing and shear testing that outperformed the comparison products of lateral and posterior-lateral fusion devices.

Therefore, we would like to address the incorrect statement within the LCD regarding the “approach” dictating whether a device transfixes the joint: Page 5 of 10 under subsection Arthrodesis without Placement of Transfixation Device- “The aforementioned transfixation procedure is typically performed from a lateral approach. The procedures that are non-transfixation approaches are usually performed from a dorsal (posterior) approach though at times are combined into a dorsa-lateral approach. Rather than transfixing the SIJ, these procedures utilize distraction arthrodesis.

Table 1 Allograft Peer Review Publications

Posterior-Lateral The devices in table 2 all transfix the joint. Confusion concerning these posterior-lateral devices was further evident in the ASPN Guidelines published recently, as they list some of the devices as posterior and others as lateral, when they are actually neither. (Reference of data table 9 in ASPN Guidelines). Additionally, ASPN did not have a comprehensive literature table of publications for posterior lateral as we have created in Table 2. The devices in Table 2 can be verified through the 510(k) of posterior-lateral approach transfixing devices.

The safety benefits of an oblique approach are similar to those described in the safety benefit of a posterior approach: Avoidance of nerves and structural vessels as well as avoidance of dissection of ligament and muscle tissue. In Contrast to LTI (lateral), the PLTI (posterior-lateral) technique has a more posterior starting point and takes an oblique trajectory across the SI joint. It was developed to lower the risk of injury/irritation of the S1 and S2 nerves within the foramina and to the branches of the superior gluteal artery.

We have included published peer review papers in Table 2 that reflect safety and efficacy of an oblique approach (posterior-lateral). Some of the peer publications mentioned in the proposed LCD included studies which were labeled lateral but were both a combination of lateral and posterior-lateral as allowed by the clinical protocol of the study.

Table 2 Posterior-Lateral (dorsal-lateral) Peer Review Studies

In summary, any of the approaches can transfix the joint, coverage should not be defined by approach as stated by CPT^®. Both transfixing and non-transfixing systems can fuse the joint, which clinically is the goal. We should not focus on the mechanism in which this occurs. Respectfully, we strongly feel that whether or not fixation occurs is determined by the FDA, and not arbitrary standards of definition that are currently trying to be manipulated by a single manufacturer to create a definition change that would result in limiting any competition, to benefit their means.

We ask that the MACs cover all devices/implants based on the evidence and comments put forth here today. We welcome dialogue with the MACs and Industry, to provide any additional clarification or answer to questions they may have.

Tables and References were provided for review.

Thank you for your comments. The LCD did not separate the 2 procedures by approach. It did address the fact that most of the non-transfixation procedures are posterior in approach and most of the transfixation procedures are lateral in approach. The LCD cited specifically the language that is used by CPT^® to distinguish these 2. CPT^® as well as the orthopedic surgeon who reviewed the CCA were in agreement with this distinction and this is supported by ASTM. We will add clarifying language citing ASTM definitions as well. The CPT^® language will be updated in the 2026 book and has been included in the definitions distinguishing the 2 procedures.

Thank you for sharing the KNG Health Consulting Group, LLC Report to examine data of allografts in comparison with lateral SIJF for time to failure or revisions and other White Papers. Contractors are required to consider the following when making decisions about coverage:

“Published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines. Proprietary information, submitted by a requestor, not available to the public shall not be considered.”

If there is new peer-reviewed published literature to demonstrate the procedure is effective, safe and improves outcomes, it can be considered for coverage via the LCD reconsideration process.

On behalf of Tenon Medical, we thank you for the opportunity to provide comments on the topic of SI Fusion.

Tenon Medical is dedicated to innovative operative solutions for the SI Joint – focused on safety, the effective application of proven principles of arthrodesis and the efficient application of such.

As follow-up to my presentation during the open meeting the following comments are submitted. The emergence of 27278, arthrodesis of the SI Joint utilizing an intra articular device, requires clarity between devices that “transfix” the joint vs. those that are “intra articular” in nature.

Several of the speakers reinforced that both AMA and FDA have verified that “transfix” is not a directional or approach description, and instead, refers to the placement of the device bridging the joint and anchoring in bone on either side of the joint. This is in direct contrast to “intra-articular” – which refers to being within the joint, facilitating distraction. As noted during the presentation, a number of posterior and posterior-inferior approach technologies have been affirmed to meet transfixing criteria with an example cited below (CATAMARAN SI Joint Fixation Device).

Note that 90% of the implant volume is anchored in sacral or ilium bone, with a mere 10% within the joint. Despite efforts by some in industry to re define these rather simple terms, this implant is specifically NOT intra-articular and meets any reasonable definition of transfixing. Specifically:

• The implant prevents distraction and/or compresses with the intention to fuse the joint
• The implant bridges the joint, making contact with structures on both sides of the joint
• The majority of the implant is outside the joint
• The implant goes through three specific structures: the medial cortical bone of the ilium, the sacroiliac joint and the lateral cortex of the sacrum
• The implant is anchored in sacral and ilium bone
• The placement of the implant along the longitudinal axis of the joint reduces or eliminates motion of the joint

In addition, the adherence to authentic arthrodesis principles – including robust fixation, defect creation / joint prep and grafting - has produced clear and definitive radiographic proof of bridging bone fusion (12-month CT as part of IRB controlled, post-market, multi-center trial), as determined by an independent 3rd party radiologist. This evidence bolsters the transfixing nature of this technology.

Tenon Medical will continue to aggressively innovate in this space, with specific focus on safety of approach combined with the proven principles of arthrodesis as our guide. Thank you for the opportunity to comment and for supporting these innovative therapies.

Images were provided for reference.

It has been clarified in the LCD that the procedure is not defined by the directionality of the approach. However, most published data describe the use of a lateral transfixing approach.

I commend the MAC’s efforts to maintain Medicare beneficiaries' access to CPT^® 27279 Lateral Minimally Invasive Sacroiliac Joint Fusion (MIS SIJF), while addressing concerns about new evidence for other, emerging treatments. However, I have two concerns: 1) the ambiguity surrounding the definition of "transfixing" and 2) the unnecessary bracing trial requirement in the draft LCD. As a board-certified spinal neurosurgeon, I value the opportunity to address these key issues in SIJ pain treatment.

1. There is a critical need for defining the term ''transfixing"/'transfixation" as used in CPT^® codes 27279 and 27278. Transfixing transiliac MIS SIJF as described by CPT^® code 27279 represents the gold standard treatment option for SIJ dysfunction, but the lack of clarity within the MAC’s proposed LCD poses a risk of ambiguity, potentially leading to overutilization. MACs may find two resources helpful in understanding and clarifying techniques and devices that "transfix" per CPT^® 27279 language. NASS Spineline , March/April 2024 edition offers clear guidance on appropriately coding MIS SIJF by approach and device.

"New Code 27278 describes percutaneous placement of an intraarticular stabilization device or implant into the sacroiliac joint using a minimally invasive technique that does not transfix the SI ioint. These procedures are typically performed using a dorsal or posterior approach...New Code 27278 places a device interposed within the SJ Joint that may engage the sacrum and ileum.

"Although, CPT^® does not define the term "transfixing device", the clinical example for code 27279 in CPT^® Changes 2015 states that "the implant needs to be within the osseous confines of the sacrum and ilium" and more specifically, an implant is advanced "across the ilium, across the SI joint, and into the sacrum...Code 27279 includes placement of a device that transfixes across the joint.

Based on this guidance from NASS, it is clear that posteriorly placed devices (which may engage the sacrum or ilium bones on either side of the implant) should be reported using CPT^® 27278. By contrast, transfixing devices advancing across one ilium bone, across the joint, and into the sacrum bone should be coded with CPT^® 27279.

It is also clear that the posterior approach is often done by medical professionals that are not spine surgeons. I have seen case after case of posterior grafts done that are not adequately placed in the sacroiliac joint and this is disturbing. If placed by a spinal surgeon, augmenting a procedure may be effective but more often the posterior approach is at best a temporary solution to a real problem. The lateral approach is truly the most effective way to treat this issue that has come to our attention as a major cause of pain in select patients.

2. The use of bracing trials in the conservative care phase of SIJ dysfunction is an unnecessary part of appropriately identifying the SIJ, as the pain generator for two reasons: 1) The lack of clinical evidence demonstrating effectiveness and 2) the increased burden placed on patients already grappling with a chronically painful condition.

A. The empirical evidence supporting the effectiveness of SJJ bracing remains inconclusive. Without clear evidence demonstrating the superiority of outcomes in patients who undergo a bracing trial versus those who do not, imposing this requirement increases treatment burden for both the patient and the provider.

B. Patients already grappling with chronic pain and functional limitations may find the additional requirement of wearing a brace for an extended period burdensome. Moreover, the efficacy of a bracing trial hinges on patient compliance, which cannot always be guaranteed. This raises ethical questions about imposing unnecessary hardships on patients without a clear benefit. As an surgeon that helped BCBS of South Carolina set up their criteria, it was clear that this treatment only prolonged the problem and or increased costs.

I would like to commend the MACs for addressing MIS SIJF utilization management concerns and encourage continued engagement with stakeholders to develop an LCD that demonstrates clear guidance on appropriate medical necessity and coding based on implant type and surgical approach. Thank you for considering my comments. If possible, I would like an opportunity to have a conversation regarding this issue to perhaps better elucidate my thoughts and concerns.

Thank you for your comments. There was no literature associated with this comment. Bracing is one of many options in conservative therapy. The use of conservative therapy prior to MIS is not predicated on any particular option.

As to clarification of definitions, please see the updated LCD as well as previous comments and response to comments.

Fusion of the dorsal sacroiliac joint is described by CPT^® code 27278 (Arthrodesis, sacroiliac joint, percutaneous, with image guidance, including placement of intra-articular implant(s) (e.g., bone allograf[s], synthetic device[s]), without placement of transfixation device), and has extensive supporting literature, more than adequate to be a covered service by Medicare Administrative Contractors. The AMA CPT^® literature requirements for creation of category I codes represent quite a high bar, which was met by the procedures described by CPT^® 27278 (including dorsal sacroiliac joint fusion).

The indications for dorsal sacroiliac joint fusion (CPT^® 27278) are essentially the same as those for CPT^® 27279 (Arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect visualization), with image guidance, includes obtaining bone graft when performed, and placement of transfixing device). However, the former is less invasive than lateral sacroiliac joint fusion (CPT^® 27279), making it an excellent alternative in the relatively older, frail patient population served by Medicare. Therefore, it is vital to preserve access to this less invasive procedure with adequate coverage of CPT^® 27278, for matching indications with respect to CPT^® 27279.

Thank you for your comment. No literature was received with this comment.

Assignment of a Category I CPT^® code does not automatically confer coverage, as noted by CPT^®’s own disclaimer.

Contractors must consider published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines when making coverage decisions. Proprietary information, submitted by a requestor, not available to the public shall not be considered.

We write to you today to express our concerns regarding the American Society of Pain and Neuroscience ("ASPN") Guideline for the Treatment of Sacroiliac Disorders ("Guideline(s)") released on May 3, 2024, and request its removal from consideration when reviewing comments on your proposed LCD.

First and foremost, this society has multiple disclosed and undisclosed conflicts of interest that warrant a deeper discussion other than the disclaimer at the conclusion of the publication shown under "Funding". This disclaimer states "Development of this guideline was supported by unrestricted educational grants from SI Bone and PainTEQ". In addition, the Guideline is riddled with inconsistencies and inaccuracies that lead to a contradictory recommendation, which calls into question the objectives of the publication entirely, given the aforementioned conflicts of interest. As the American Society of interventional Pain Physicians ("ASIPP") representative indicated during his presentation on the MAC’s April JM Open Meeting at 10:00 am EST call, this LCD process seems to be company driven with nefarious intent to gain a monopoly on a code rather than a true MAC initiated request. It is unclear why funding would have been accepted and earmarked for this project from two companies with a vested interest in the Guideline's outcome other than to benefit the companies themselves, rather than to the clinical benefit of patients. To put money into perspective, the ASPN society has booth and lab fees fee that are exponentially higher than societies that have existed 20 years longer, so general society funding could and should have been allocated to avoid even the slightest appearance of a conflict of interest. It is evident the resulting recommendations of the Guideline were written in such a way as to favor SI Bone and PainTEQ, and to prevent almost any other company from competing in the market.

Consider the statements on page 1630 under Table 9 Summary of Clinical Studies on SIJ Fusion/Stabilization:

"While the quantity of evidence is currently more robust with the lateral approach given its preexistence, available studies suggest that that the posterior approach has at least similar efficacy with a lower risk profile':

"Implant ma/position causing symptoms resulting from inadvertent nerve root injury is more likely with the lateral approach, and published data suggests a tower rate of adverse events with the posterior approach. Meta-regression analysis showed that acute ma/position was significantly associated with the lateral approach"

"Risks of the lateral approach are significantly less than risks of open approach but are higher than risks associated with the posterior approach. In a combined cohort of four studies involving 237 subjects who underwent posterior approach sacroiliac fusion, there were no serious adverse events reported, including no implant breakage, bone fracture, infection, bleeding requiring surgery, viscous perforation, but only one device migration."

"Posterior sacroiliac fusion approach appears to have a significantly lower safety risk profile due to avoidance of critical neurovascular structures that can be encountered with lateral and posterolateral approaches."

If that is the case, then why is the recommendation on page 1632:

"The current evidence is insufficient to determine the medical necessity of emerging techniques for minimally invasive sacroiliac fusion such as posterior-transfixing, and hybrid approaches"

Those statements are incongruent and clearly demonstrate the bias of this publication. Neither of the companies that funded this publication have a device that fits the description in this recommendation whereas most other manufacturers do. And with the conflicts of interest that have been discussed, it is highly unlikely that this is a coincidence.

While taking this into consideration, various publications published by PainTEQ from years 2020 to present were reviewed. Eight individuals were identified as owners and/or had company stock options. They are as follows:

• Timothy Deer
• Dawood Sayed
• Jason Pope
• Steven Falowski
• Ramana Naidu
• Stephen Pyles
• Corey Hunter
• Kasra Amirdelfan

And according to the ASPN website as of the date of this letter, Timothy Deer is listed as Chairman and Co-Founder while Dawood Sayed is listed as Vice Chairman and Co-Founder. In addition, Jason Pope is listed as Immediate-Past President, Steven Falowski is listed as Vice President, and Kasra Amirdelfan is listed as Executive Board Vice President Clinical Affairs. While Corey Hunter may not have a role within ASPN, he is the acting President of the North American Neuromodulation Society ("NANS"). Please note that three of the individuals listed above were authors of the Guideline and all parties were mentioned in research that was used in the publication and the resulting recommendations. It is also worth pointing out that Hemant Kalia was the chosen ASPN representative to present on the various recent Open Meetings wherein he disclosed no conflicts. This is an obvious misrepresentation as he was representing the views of ASPN, which, as mentioned above, has many conflicts.

Subsequently, when cross referencing said publications and the Guideline with a review of the Centers for Medicare & Medicaid Services ("CMS") Open Payments system, it was determined that no disclosure of PainTEQ ownership or options holders could be found, including the individual parties mentioned above. The Open Payments system was created to allow CMS, the MACs, patients, regulators, and others to assess the conflicts of interest in situations exactly like this one.

According to the Guideline section titled Management of Conflict of Interest, "All authors were required to disclose conflicts of interest prior to assignment of topics. The senior authors determined the extent of the conflict of interest ensuring balanced inquiry and evaluation for each manuscript section. One of the co-primary authors without conflict were identified for each section and was the adjudication determination official tor any issues of potential conflict. All authors were asked to recuse themselves on any recommendation potentially affected by a disclosed conflict. Additionally, authors without conflict vetted all recommendations for bias." Yet nowhere does the publication identify the senior authors. Based on the position in the author listing, it can logically be concluded that the senior authors were Timothy Deer and Dawood Sayed both of whom, as mentioned above, are clearly conflicted given their ownership of PainTEQ. These conflicts should automatically discredit their discretion of other authors' conflicts of interest.

Dawood Sayed has also recently served as the editor of the Journal of Pain Research, an APSN owned and operated journal, a journal in which a majority of the PainTEQ publications have been published and deemed "peer reviewed". Dr. Bruce Ball, a highly respected pioneer of the SI joint disfunction industry with a large array of peer reviewed research and publications, posted the following regarding the most recent publication published by PainTEQ titled Safety, Efficacy, and Durability of Outcomes: Results from SECURE: A Single Arm, Multicenter, Prospective, Clinical Study on a Minimally Invasive Posterior Sacroiliac Fusion Allograft Implant {SECURE): "The fact that the Journal of Pain Research published this paper baffles me and gives me a sense of disappointment. This is supposed to be a peer reviewed journal. In this case it either wasn't reviewed or those reviewing it were not capable of performing a literary review. Either way the publishing of this article should be an embarrassment to the journal and to anyone in the scientific community that authorized this publishing. This paper was paid for by the manufacturing company for this device, and a majority of the major authors are financially connected in various ways to this company, to include leadership roles. It is very unfortunate tor those of us in the real scientific community to know that papers such as this can be published for a price and then used to promote produce to unsuspecting surgeons and patients." Dr. Dall's comments have reverberated throughout the industry and shined a light on what has been perceived yet unspoken.

The same SECURE publication Dr. Dall is referring to is also being used in the Guideline publication as one of the seminal pieces of work leading to their recommendations. It should be pointed out that the terminology used in the Guideline could be confusing when compared to the American Medical Association's Level of Evidence Table (LOE).

According to the AMA's LOE table, 1-a data is:

 "Evidence obtained from systematic review of randomized controlled trials"

and 1-b data is:

 "Evidence obtained from an individual randomized controlled trial"

"Randomized Controlled Trial(s): An epidemiological experiment in which subjects in a population are randomly allocated into groups, usually called study and control groups, to receive or not receive an experimental preventive or therapeutic procedure, maneuver, or intervention. The results are assessed by rigorous comparison of rates of disease, death, recovery, or other appropriate outcome in the study and control groups"

Perhaps the authors were not intending to mislead the readers by using a similar connotation when referring to the various levels of evidence, but this should be mentioned for clarity, nonetheless. Given the extent of the above conflicts and the discrepancies within the mentioned publications, heightened scrutiny must be applied to the Guideline and its recommendations.

A recent text exchange between a PainTEQ Area Sales Manager and a physician further illustrates the ongoing undisclosed conflicts. The PainTEQ representative states that "We were the only company on the call and presented" (at the MAC meeting). He is clearly referring to PainTEQ as ASPN which poses the question, if the general employees of PainTEQ are representing themselves as ASPN, how prevalent must those conversations be within the two organizations?

For years, PainTEQ has been referring to 0775T and now 27278 as "our code" in various press releases, which has been interpreted as marketing hype until the Guideline publication. It is now evident that PainTEQ has been strategizing to use its various physician ownership and alter-ego of ASPN to attempt to gain exclusivity of a reimbursement code. A code for a procedure which has been in existence longer than their company has been established as well as a procedure with data from multiple manufacturers showing its safety and efficacy as has clearly been provided from multiple sources.

In further concerns of the credibility of PainTEQ with regards to clinical benefit, it should not go unnoticed that PainTEQ Is not and has never been registered with the Food and Drug Administration ("FDA"). This is very unusual for a company representing themselves as a medical device manufacturer. Registering with the FDA requires a significant investment in personnel and company infrastructure to comply with government rules and regulations. It also instills a culture of quality by requiring adverse events and outcomes to be tracked and reported. It can be inferred that PainTEQ's funds and focus have been allocated toward sales and marketing rather than proper government registration or regulation, which should question their device and its related studies.

In summary, it is requested that the ASPN Guideline be removed from your considerations on your proposed LCD.

We are aware of the industry sponsorship of the society, their Journal Of Pain Research as well as the publications in that journal and elsewhere. This was addressed in our Analysis of Evidence. All comments received are considered and addressed here as part of transparency and incorporating 21^st Century Cures Act direction.

On behalf of the International Sacroiliac Medical Expert Group e.V. (SIMEG) members we are pleased to provide comments regarding Sacroiliac (SI) Fusion. SIMEG, a non-profit association based in Germany and operating internationally, was founded in 2013 by orthopedic surgeons to promote scholarship, research, training and continuing education, together with quality assurance in the field of diagnosing and treating sacroiliac joint (SIJ) dysfunction. SIMEG does not favor any surgical procedure or implant system. Our ethical code is unbiased research. We are dedicated to providing patient access for care based on research evidence. SIMEG is considered the leading group of experts in the field of SI diagnosis and treatment based on years of research in biomechanics, conservative care, and SI joint fusion. SIMEG members include, but not limited to, trauma surgeons, orthopedic surgeons, neurosurgeons, neurologists, physiotherapists and scientists. As a society, we have physician members who have been successfully performing SIJ fusions for 30+ years with multiple approaches, devices and complexities, including revisions.

We recommend the following criteria under the section “Covered Indications” should be amended (underline denotes additions, strikethrough denotes deletions):

“4. LBP below L5 without radiculopathy” should be changed to: “4. LBP below L5 with or without referred lower extremity pain but without compressive radiculopathy.”

             [Comment: Patients with SIJ dysfunction often have lower extremity referred pain and associated neurologic symptoms.]

“5. Clinical findings and/or imaging studies do not suggest any other diagnosed or obvious cause of the lumbosacral pain (such as central spinal stenosis with neurogenic claudication/myelopathy, foraminal stenosis or disc herniation with concordant radicular pain/radiculopathy, infection, tumor, fracture, pseudoarthrosis, or pain related to spinal instrumentation). With the understanding there could be concomitant SIJ and lumber pathologies contributing to the patient’s symptoms that may need to be treated independently but does not exclude proceeding with either treatment based on the medical workup.”

“9. A trial of at least 1 therapeutic intra-articular SIJ injection (i.e., corticosteroid injection) [Commenter requested the following verbiage be removed: that results in a 50% reduction of pain for the expected duration of the injected agent”].

             [Comment: Corticosteroids do not have predictable amount or duration of pain relief.]

“10. Diagnostic imaging studies that include ALL the following:

Imaging (plain radiographs and a computed tomography (CT) or magnetic resonance imaging (MRI)) of the SIJ that excludes the presence of destructive lesions (e.g., tumor, infection), fracture, traumatic SIJ instability (certain fracture and instability patterns are appropriately treated with percutaneous SIF), or inflammatory arthropathy that would not be properly addressed by percutaneous SIJ fusion (SIJF)”

With regards to the following statement made in the LCD:

“Traditional open SIJF procedures are complex and invasive, involving open exposure of the joint with instrumented fixation and/or bone graft harvesting, and are typically associated with lengthy hospital stays, large blood loss and prolonged recovery times. Outcomes of traditional SIJF procedures were observed to be so poor with a high rate of reported non-union that these procedures were virtually abandoned over the last few decades.10 However, in the case of revision surgery, nonunion, and aberrant anatomy, open arthrodesis should be performed.”

More recent less invasive open posterior sacroiliac joint fusions by multiple surgeons and using different techniques and technologies can be accomplished with minimal blood loss and complications with high fusion rates and significant pain and disability reduction. Additionally, the LCD citation #10 mentioned above is potentially biased as it is an industry sponsored publication by a company that promotes MIS SIJ procedures.

We would like to also address the statement within the LCD regarding the “approach” dictating whether a device transfixes the joint: under subsection Arthrodesis without Placement of Transfixation Device- “The aforementioned transfixation procedure is typically performed from a lateral approach. The procedures that are non-transfixation approaches are usually performed from a dorsal (posterior) approach though at times are combined into a dorsa-lateral approach. Rather than transfixing the SIJ, these procedures utilize distraction arthrodesis. This statement is not supported by the evidence of years of biomechanical and current research. All surgical approaches can transfix the joint given the proper instrumentation and methodologies where the resultant instrumentation (i.e., device, device assembly, or construct) sufficiently engages both the ilium and sacrum thereby bridging both sides of the joint, providing stabilization and preventing motion. It is important to note that this can take many forms and, in some instances, can also include distraction arthrodesis (or ligamentotaxis) in addition to transfixation, they are not mutually exclusive. Furthermore, the group of devices/allografts that do not transfix the joint have also demonstrated the ability to fuse the joint. In most instances, the patient population being treated has a very stable joint given the extensive ligamentous structures supporting the joint and the interlocking features of the surfaces of the joint and so even the devices/allograft which do not transfix the joint can provide satisfactory stabilization resulting in fusion.

1. The least invasive of procedures are arguably allograft or devices that are placed “intra-articularly” and that do not extend (e.g., pierce) into the bones of the joint. These implants work by various biomechanical methods, distraction arthrodesis and/or anti-migration surfaces, while resting within the joint, and are intended to fuse the joint. This is appropriately described in CPT^® code 27278, that is “intra-articular” placement, not approach, non-transfixing, but still may lead to fusion of the joint. Studies including allograft made by various different manufacturers have shown very low adverse event rates, improved pain scores and functional scores. (Table 1) Allograft has been used for years within the spine for fusion in the lumbar, thoracic and cervical segments, and has shown to be an acceptable medium for fusion. Allograft is routinely added with devices in many procedures during a SIJ fusion regardless of approach or final implant location. Allografts are often used in revisions of previous failed SI joint fusions, as additional bone growth is critical in patients who have device loosening/failure and require either a multi-planer approach, or bone to supplement the Medicare patient with low bone density. Revisions with allograft as a separate or additional supplement date back decades, and can be noted in peer reviewed literature. As with all joint fusion procedures, it is critical to follow orthopedic fusion principles in order to achieve reasonable fusion rates and durable clinical success which include: adequate joint preparation with removal of ligament and cartilage tissues down to bleeding bone and placement of the allograft or implant on dense subchondral bone, ideally under compression, with adequate immobilization or fixation.
2. Additionally, several transfixing posterior devices have been on the market over the last few years and have received clearance based on rigorous testing required by FDA reflecting their ability to transfix the SI joint. However, devices do not necessarily need to transfix the joint in order to lead to joint fusion but may do so by ligamentotaxis or distraction arthrodesis. The goal is to fuse the joint, and not necessarily by transfixing the joint. The reported fusion rate provided in the prospective, 20-center 2-year clinical trial with 171 patients using a stand-alone device is an example of distraction arthrodesis, albeit at 31%, which still provides a safe and efficacious approach for fusion.
3. Dorsal-Lateral (Posterior-Lateral or Oblique) These terms all represent the same positioning and are similarly invasive to lateral, but provide a much better safety profile. There are no known stand-alone allografts in this space, and all devices and systems are cleared through the FDA for transfixing the joint are intended for fusion. The safety profile as mentioned above is safer than lateral and are similar to those described in the safety benefit of a posterior approach: Avoidance of major gluteal artery vasculature, nerve bundles, and reduced dissection of ligament and muscle tissue. Meta-analysis of 8 peer published papers not considered by the MACs, by Whang et al, reflected a safety profile of AE and SAE for lateral-oblique (posterior-lateral) approach at 1.11%, well within the FDA acceptable safety standards.

The MACs cited a paper by Polly “Two Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction” which demonstrated an adverse event rate of 23% including a significant amount of serious adverse events. Additionally, concerning is that the paper is not representative of the Medicare population and reflected only 9% of the patients who received SIJF were of Medicare age. We find this concerning as great consideration needs to be taken in account for patient bone age, density, osteoporosis and osteoarthritis among and host of other Medicare age co-morbidities. Patient bone age can vary and change dramatically in patients who are 55 and older.

We have included 8 published peer reviewed papers in Table 2 that reflect safety and efficacy of the posterior-lateral approach. In the MAC’s review of the publications mentioned in the LCD, you will find that some of the peer publications mentioned lateral approach, but were actually a combination of lateral and posterior-lateral approaches as defined by the protocol in the clinical trials that allowed for physician preference whether to perform lateral or posterior-lateral approach. Further worth noting are the revisions in some circumstances which have a high rate of success, were hybrid approach procedures of both posterior-lateral or lateral combined with a posterior allograft.

The information provided reflects years of clinical expertise and research with current methods and devices and demonstrates that various devices can transfix the joint, thus coverage should not be defined by approach.

On behalf of SIMEG members we have provided data and reasoning supporting various SIJF’s. We ask that SIJF devices/allograft, regardless of approach, both transfixing, and “intra-articular” be a covered benefit for the many Medicare patients who need options based on many factors including their bone density, lumbosacral anatomy, prior lumbosacral fusions and medical comorbidities.

Accordingly, we respectfully recommend the MACs:

1. Finalize coverage for both CPT^® 27278 and 27279, including the combination of both codes for “hybrid” procedures with appropriate modifier;

2. Not determine coverage based on surgical approach, placement location or device/allograft;

3. Delineate the use of CPT^® 27278 and 27279 based on whether the procedure is conducted in an open versus MIS manner and also the device’s labeling, the Indications for Use as clearly documented on Form FDA 3881 and the Device Description as documented in the 510(k) Summary which form part of the device’s FDA 510(k) clearance letter:

a. Examples of devices where FDA requires the use of a separate “transfixing device” (that does not form part of the implant assembly) in addition to an “intra-articular implant”, use CPT^® 27278 and 27279:

• K232259: “The Patriot-SI Posterior Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the Patriot-SI Posterior Implant System (i.e., an “in-line” or “intraarticular” device) is implanted, it must be used with a Spinal Simplicity Liberty-SI Lateral System device (i.e., a “transfixing” device) implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct.”
• K232878: “The TransLoc 3D Posterior Implant is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the TransLoc 3D Posterior Implant is implanted, it must be used with a TransLoc 3D Screw implanted across the same sacroiliac joint.”

b. Examples of devices where FDA requires the use of a “transfixing device” component (that forms part of the implant assembly) in addition to an “intra- articular implant” such that the assembly as a whole acts as a “transfixing device, use CPT^® 27279:

• K232149: “The BowTie™ SI Joint Fusion System is indicated for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the BowTie SI Fusion System is implanted, both the Iliac and Transfix Screw components must be used.”
• K221047: “The Aurora Spine SILO TFX MIS Sacroiliac Joint Fixation System includes the SILO TFX Cone, SILO TFX Screw, and the SILO TFX Locking Screw and associated manual surgical instruments. The SILO TFX Cone is comprised of titanium alloy and incorporates a hollow conical shaped barrel with two openings for bone screws for additional anchoring. During the procedure, the implant is inserted in line with the SI Joint via a posterior surgical approach, and bone graft material is placed in the barrel of the implant to facilitate additional bone incorporation after surgery.”

c. Example of device where the implant(s) alone acts as a “transfixing device, use CPT^® 27279:

• K180818: “The Tenon Medical Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.” NOTE: the labeling does not require extra components or supplemental fixation.

Tables and references were provided for review.

Thank you for your comments. The MACS utilize the distinction between the 2 procedures that is provided by the language that AMA CPT^® utilizes. The distinction is NOT based on directionality. The CPT^® language will be updated in the 2026 book and has been included in the definitions distinguishing the 2 procedures.

We appreciate the opportunity to comment on the proposed LCD for minimally invasive surgical (MIS) sacroiliac (SI) joint (SIJ) fusion procedures. SI-BONE is a pioneer in MIS SI joint fusion procedures, manufacturing and distributing innovative solutions since 2009. We are proud to be today’s market leader in SI joint fusion procedures, and we continue to support our patients and providers with our growing array of innovative technologies. Our perspective on the market may be of value to the MACs, and we appreciate the opportunity to share our information with you. In summary:

We recommend the MACs reach out to the AMA for clarity on transfixation. Before finalizing your LCD and policy position on this topic, the MACs will need clarification from the AMA as to the definition of “transfixation” and “transfixing,” language which is used in Current Procedural Terminology (CPT^®) codes 27278 and 27279, respectively. By doing so, the MACs may develop a better policy that addresses all of today’s known SI joint implants, and aligns with both the AMA CPT^® language and the FDA testing standards for SI joint implants per ASTM F3574-221, as required by the FDA for clearance. MACs should clarify the procedures and implant types it intends to cover now, perhaps while more evidence and data emerges for others, to help meet your goals of allowing appropriate, evidence-based, and medically necessary care for Medicare beneficiaries.

There are two major procedure types. CPT^® code 27279 describes transfixing devices; these devices must be tested according to ASTM standards (where the term “transverse” is used) to gain regulatory clearance in the U.S. By contrast, CPT^® code 27278 describes an intra-articular (“in-line”) approach to SI joint fusion, a procedure that requires a different amount of physician work, is performed in a different anatomic area, utilizes different stabilization and fusion strategies, and is performed with different devices/implants. The devices utilized for 27278 have a different intended function and are tested differently than devices used to transfix the SI joint as in the 27279 approach, and which have unique ASTM / FDA testing requirements.

We acknowledge that the crowded SIJ implant marketplace can make understanding the variety of procedures confusing. We hope this document sheds light.

The two major procedure types have markedly different clinical evidence bases. The primary evidence base for minimally invasive SI joint fusion supports devices that transfix the joint. Because the procedures and their associated implants differ significantly, clinical outcome and safety information from transfixing procedures cannot be generalized to support intra-articular (in-line) procedures. More specifically, evidence for lateral transfixing procedures reported via CPT^® 27279 is extremely robust and mature. These studies cannot be compared to studies of other, emerging procedures, including posterior intra-articular procedures (CPT^® 27278) or combined/hybrid procedures where both in-line and transfixing devices are placed. No study has been published in the peer-reviewed literature that is specifically designed to compare the two procedure types.

In this comment letter, we draw analogies between SI joint fusion devices and the more familiar set of devices used for lumbar fusion (specifically, intervertebral body cages and pedicle screws). This is because the testing the FDA requires of SI joint implants has direct history and relationship to that of thoracolumbar pedicle screw and intervertebral cage instrumentation. These analogies may help the MACs to understand the importance of the different SI joint fusion procedures. We also provide background information on for the two MIS SI joint fusion procedures.

As a source of truth the MACs may rely upon for policy development, we are focusing our comments on the U.S. regulatory framework as well as procedural coding environment for the two minimally invasive SI joint fusion procedures. Below we provide a review of the regulatory environment for SI joint fusion devices and detail on the two main procedure types. We highlight the differences between procedures, evidence basis and FDA test requirements. It is remarkable to us, as it may be to the MACs, that the AMA, FDA and ASTM are well-aligned on the distinct nature of the two main procedure types and testing requirements for the two different implant types utilized in the procedures.

This comment letter will provide the MACs with the following:

1. Growth of FDA-cleared devices for SI joint fusion
2. Overview of the types of SI joint implants supporting CPT^® 27279 and 27278 procedures
3. Overview of the evidence bases supporting each type of SI joint procedure
4. Concerning, overly aggressive marketing of posterior SI joint implants claiming they are 27279
5. Overview of FDA-required biomechanical testing for the two types of SI joint implants described by ASTM 3574 for Product Code OUR (SI joint fusion)
6. Recommendations for the MACs policy based on evidence and consensus definitions

Growth of FDA-Cleared Devices for SI Joint Fusion

The number of devices cleared by the FDA for minimally invasive SI joint fusion has accelerated in the last few years. This growth has been fueled by significantly increased attention on the diagnosis of SI joint pain and dysfunction by the clinical provider community as well as commercial interests. SI-BONE was one of the first companies to obtain FDA clearance (2008) for a device with unique features specific for fusion of the SI joint. Since then, FDA has issued 116 clearances for SI joint fusion devices under product code OUR (sacroiliac joint fixation/fusion), representing 56 products. Figure 1 shows the cumulative number of FDA clearances for all devices (orange) and SI joint fusion devices (black); the graph demonstrates an accelerating number of clearances for SI joint fusion devices.

Overview of SI Joint Fusion Procedure Types

There are two main types of SI joint fusion procedures: transfixing (transverse) and intra-articular (in-line). Table 1 provides key features of the two procedure types, including implant types, trajectories for placement, mechanism of action, CPT^® coding and terminology, and ASTM terminology. (ASTM testing is described in a section below.) Figure 2 provides a pictorial representation of these approaches. Further detail is provided below.

In the transfixing procedure type, using transverse SIJ implants (shown in green callouts in Figure 2), metallic implants are placed across the joint from the ilium to the sacrum. These can be placed in a lateral or oblique lateral (posterolateral) trajectory. Most such devices are screws (see further details below). One end of the device is in the ilium and the other end is in the sacrum. The devices are secured in place acutely by apposition between implant and cortical bone. Some devices have porous surfaces that promote fixation within bone and joint fusion. Use of screws to transfix the SI joint is similar to use of pedicle screws in lumbar fusion (further details below).

In the intra-articular (in-line) procedure type, using in-line SIJ implants (shown in red callouts in Figure 2), devices or allografts are placed within the SI joint, typically using a posterior approach. Most of these products are placed “standalone” into the SI joint. These products are proposed to work acutely by two mechanisms:

• Ligamentotaxis is based on the concept that excessive joint motion can cause pain. An implant placed into the joint can stretch the joint to the limits of its ligamentous attachments. Such a stretched joint becomes stabilized acutely in this configuration. Ligamentotaxis has been utilized as a stabilization strategy in lumbar fusion procedures by placing standalone cages in the intervertebral body space (i.e., cages alone without pedicle screw supplemental fixation). This strategy was not successful in the lumbar spine as the ligamentous tissue tends to stretch out over time. This approach was abandoned in the 1980s as ineffective.

• Distraction arthrodesis. Over the long term, the joint becomes fused by either 1) bone growth onto/across porous surfaces (for metallic in-line/intra-articular implants) or 2) creeping substitution (i.e., the allograft is reabsorbed and replaced by autologous bone).

Some available products have features of both transfixing and in-line procedures (see below).

These nuances are reflected in both CPT^® coding and language as well as ASTM testing standards (discussed further below). CPT^® code 27279 describes devices that transfix the SI joint. According to CPT^® lay description for coders, and the typical patient vignette adopted by the AMA RVS Update Committee (RUC), transfixation means that implants must pass through the ilium, go across the SI joint, and into the sacrum. For “transfixing” devices placed into the ilium, across the SI joint, and into the sacrum, ASTM standards use the term “transverse.” For devices placed directly into the SI joint via a posterior trajectory, ASTM standards use the term “in-line.” Therefore “transfixing” (AMA) and “transverse” (ASTM) are synonyms. Similarly, CPT^® code 27278 uses the terminology that describes intra-articular placement without the placement of transfixation devices. CPT^® 27278 is compatible with the ASTM term “in-line.” Thus ASTM 3574’s “transverse” is equivalent to CPT^® 27279’s “transfixing,” and ASTM 3574’s “in-line” is equivalent to CPT^® 27278’s “intra-articular.”

Devices Available for SI Joint Fusion, by Procedure Type

As of May 2024, FDA has granted 116 clearances for products categorized with product code OUR. Additionally, several allograft products are currently marketed for SI joint fusion that are regulated as human cells, tissues, or cellular or tissue-based products (HCT/Ps). Such implants do not require FDA clearance or approval and have much fewer criteria for adverse event reporting to FDA.

Table 2 summarizes the number of FDA-cleared devices or HCT/P products currently available by procedure and product type. A complete listing of devices and allografts is provided in the Appendix.

Literature Support by Procedure Type

The literature support for these products is highly variable (Table 3). The vast majority of published studies are on transfixing devices. Hardly any studies support inline approaches. Details are provided below.

Transverse. The vast majority of published studies used metallic devices that transfix the SI joint. Of these studies, the most studied lateral transfixing device is iFuse Implant System. iFuse Implant System is the only device that has the following:

• Has undergone evaluation in two randomized trials against non-surgical management. These Level 1 trials directly showed the benefit of surgical over non-surgical treatment in patients with chronic (>6 months) SI joint pain.
• Has independently adjudicated radiographic analysis
• Has published cost-effectiveness information.

In-line allografts. Very little literature supports placement of human cadaveric allografts directly into the SI joint. There is one retrospective study and one prospective study (SECURE). SECURE is a multicenter prospective clinical trial of the PainTEQ LinQ implant. One-year data were recently published.

In-line metallic devices. Two older studies (one prospective and one retrospective) reported outcomes after placement of a predecessor device to NADIA called DIANA. DIANA is not FDA-cleared. These two studies showed improvements in SI joint pain that were less than the meta-analytic mean pain improvement with placement of transfixing devices placed in a lateral transiliac trajectory (Figure 3).

In-line devices that require transverse screws, in-line devices with bone anchors, and in-line devices with a screw component. There are no published studies of these devices.

In summary, the literature support for transfixing devices, especially those placed by a lateral transiliac trajectory, is far larger and of far higher quality compared to other devices. Many devices have no published studies. Allograft studies are few and of poor quality.

Concerns About Overly Aggressive Marketing of Posterior, In-Line, Intra-Articular SIJ Implants Claiming They “Transfix” to Capture 27279 Reimbursement

Prior to the AMA’s addition of CPT^® 0775T in 2023, converted to 27278 in 2024 to describe intra-articular non-transfixing procedures, most MIS SIJ procedures were simply reported via CPT^® 27279 as a “catch-all.” Although the code always required a transfixing device, and the vignette and descriptions clearly describe an implant that goes through the ilium from lateral to medial, across the SI joint, and into the sacrum, the Medicare claims data from 2015-2020 shows a very clear spike in utilization of CPT^® 27279 by new specialty types (“nonsurgeons") that did not yet have access to lateral transfixing implant technologies. Therefore, they have been performing primarily posterior implant placement procedures, and reporting them under 27279.

Included in these results, several devices with a posterior/intra-articular/in-line trajectory have received FDA 510k clearance based upon biomechanical testing for in-line / intra-articular implants: Catamaran (Tenon Medical), Nevro1 / V1 (Nevro Corp.), SiLO TFX (Aurora), SIJoin T3 (VGI Medical), and TiLink-P (SurGenTec). As these implants are placed between the ilium and sacrum these in-line implants are tested in shear and torsion, like an intervertebral body device (using testing described in ASTM F2077). Despite the way they are cleared by the FDA as an in-line SIJ implant, they are each marketing themselves as “transfixing” as if they had tested as transverse implants. This is to take advantage of the smoother reimbursement experience via CPT^® 27279, as opposed to being considered a different code, or Unlisted.

One company, Nevro, is promoting their implant (Nevro1) as “transfixing.” On May 14, 2024 at the BofA Securities 2024 Healthcare Conference, a recent major wall street investor conference, Nevro stated publicly the procedure to implant Nevro1 is clearly a simpler, posterior procedure compared to the lateral transfixing 27279 procedure:

“But now that [physicians] have a tool available to them [the Nevro1] that has a much simpler approach and a safer approach, a posterior approach versus a lateral approach…”

“We just got approval in the quarter to be able to use the device [the Nevro1] without a lateral screw, and we have the indications of transfixing and also, we use for our mechanical testing the data that we used for that.”

                              - Kevin Thornal, President, CEO, Nevro Corp.

The standalone Nevro1 implant does not itself transfix the SI joint, by any definition, without the addition of a separate lateral transfixing screw. The standalone Nevro1 in-line SIJ implant was not tested in cantilever bending as required per ASTM 2193 of transverse implants, because it does not have the requisite length within the ilium and sacrum bones for such testing. The entire width of the Nevro1 implant is only 26mm. Its mechanism of action is ligamentotaxis for immediate stabilization, with self-deploying flanges that provide added stability during this period by engaging with the bone by a matter of a few mm, while fusion (distraction arthrodesis) occurs. The implant placement trajectory and mechanism of action is much more akin to the 27278 procedure type (intra-articular placement of biomechanical implant or bone allograft product), than it is to the 27279 lateral transfixing procedure type.

In addition to the Nevro1 implant depicted in the anatomical model above, depicted below are the resting positions within the joint (in-line/intra-articular) for this class of posterior-with-stabilization implants:

Regulatory Requirements

Most transfixing implants are medical devices and need FDA clearance through the 510k pathway prior to commercialization. This pathway requires testing (see below). Death and/or serious injuries caused or potentially caused by medical devices must be reported to FDA per 21 CFR 803. Most in-line implants are allografts, which are regulated as human cells, tissues, or cellular or tissue-based products (HCT/Ps). Because these implants are minimally manipulated, they are not considered medical devices and there is no FDA clearance or approval process. For this reason, there is also no biomechanical testing required. Finally, because allografts are not medical devices, a death or serious injury needs to be reported to FDA only if it involves communicable disease related to the HCT/P.

Device Testing Strategies

Formed in 1898, ASTM International is a developer of international standards used in a wide variety of disciplines. ASTM publishes numerous standard specifications and test methods for medical devices. These methods are relied upon by FDA and other international regulatory bodies to confirm that devices are suitable for their intended use.

The FDA product code for SI joint devices is OUR. FDA’s requirements for OUR devices (Figure 7) requires testing per ASTM F3574-22 (Figure 8).

ASTM F3574 describes a series of tests for SI joint fusion devices. The standard notes that “test methods are intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic SIJ fusion device assemblies.” The standard goes on to carefully distinguish test types for devices placed either inline or across the joint. It describes tests for “device assemblies intended to be implanted with a trajectory in line with the joint space (in-line implant) or for comparison of SIJ fusion devices intended for implantation across the joint space (transverse implant). This dichotomization of SI joint fusion devices conforms with the information presented above and is also consistent with CPT^® coding (Table 5).

ASTM 3574-22 distinguishes tests to be performed for transverse implants vs. in-line implants (Table 6). The test set is distinct for the two types of devices. It should be noted that none of these tests is required for allografts marketed as HCT/Ps. Details on some of the testing listed in Table 6 are provided in the Appendix.

Evolution of Thoracolumbar and SI Joint Testing for FDA Clearance / Product Codes

The ASTM and testing that applies to SIJ implants is an evolution of FDA product codes and biomechanical testing with origins in spinal instrumentation and devices. The product code currently used by the FDA to classify SI joint implants (product code: OUR) originated from thoracolumbar spine pedicle screws and intervertebral cages. The same tests are applied to thoracolumbar pedicle screws as are applied to SI joint fusion products that are “transverse” to the joint. Similarly, the same tests are applied to intervertebral thoracolumbar fusion cages as are applied to SI joint fusion products that are “in-line” with the joint:

The ASTM testing methods standard for SI joint implants originated from lumbar spinal hardware, and it is very instructive to CGS’ proposed LCD and policy position on this topic:

• Thoracolumbar pedicle screw systems are tested in cantilever bending as a worst case (loading condition where the implant is most likely to fail). Transverse SI joint implants are also tested in cantilever bending as a worst case. Pedicle screws are typically tested (loaded) to failure at the head neck junction as this is the location where they experience the greatest load. Transverse SI joint implants are typically tested (loaded) at approximately 2 cm down the implant. The average width of the ilium (distance to the SI joint) in the area where these implants are placed is two cm. The SI joint is the location where a transverse implant experiences the greatest load. This occurs at approximately 2 cm from the end of the implant. For this reason, transverse implants are typically tested/loaded at this worst case distance. In-line implants cannot be tested in this manner.
• Lumbar spine intervertebral cages, including those with or without integrated fixation features like screws or flanges, are tested/loaded to failure in shear and/or torsion. These are the worst caseloads that these types of implants experience in the body. In-line SIJ implants, including those with or without integrated fixation features like screws, flanges, pontoons, keels, etc. are also subject to the same shear and torsion testing/loading. In fact, some of the intra-articular SI joint devices cleared by the FDA for SI joint fusion were initially cleared as ALIF spinal fusion cages. These implants are tested in shear and/or torsion.

Summary

Transfixing implants for SI joint fusion should be regarded separately from in-line implants. In summary:

• The number of currently marketed products for SI joint fusion is large.

• Generally, these products use one of two mechanisms to fuse the joint: transfixation (implants, typically medical devices, placed across the joint) or in-line placement (implants, typically allografts, placed within the joint).

• These two implant types function differently and their biomechanical characteristics are also quite different. Therefore, both preclinical testing and clinical study information from one implant type cannot be generalized to the other implant type.

• Joint transfixation is an accepted biomechanical principle. Distraction arthrodesis, the underlying mechanism of action for inline devices, is no longer in use for lumbar fusion procedures.

• For medical device clearance, US FDA requires compliance with ASTM 3574, an independent international standard that clearly distinguishes the two device types and different use cases (CPT^® procedures). Different biomechanical tests are required for the different types of implants. Similar testing strategies apply to lumbar implants.

• The ASTM classification into transfixing and in-line implants correlates directly with AMA CPT^® coding (27279 for transfixing and 27278 for inline).

• Published studies supporting transfixing implants (CPT^® 27279) is extensive, and includes randomized trials, independent radiographic assessment and cost-effectiveness analysis.

• In contrast, published clinical evidence for inline implants is very small and problematic (no randomized trials, small number of low-quality studies, no radiographic assessment).

• Finally, adverse event reporting responsibilities for transfixing implants (medical devices) are more extensive than those for inline implants (mostly allografts).

We recommend MACs develop policy using the following logic and definitions:

Recommendations for MAC Policy Implementation: SIJ Implants and Procedures

Based on Known Standards and Definitions from FDA, ASTM, and AMA/CPT^®

We thank the MACs for the thoughtful review and evaluation of minimally invasive SIJ procedures, and hope this information regarding CPT^® codes 27279 and 27278 is helpful to its policy decision making.

We hope the information provided in our comment is helpful to you as you consider finalizing this draft LCD and policy.

Tables and references were provided for review.

We appreciate your comments. The CPT^® language will be updated in the 2026 book and has been included in the definitions distinguishing the 2 procedures.

On behalf of the Medical Device Manufacturers Association (MDMA), below please find comments on the proposed local coverage determination (LCD) for minimally invasive arthrodesis of the sacroiliac joint (SIJ).

MDMA is a national trade association that provides educational and advocacy assistance to hundreds of innovative companies in the field of medical technology. Our members, the majority of which are small to mid-sized medical device companies, have a strong record of delivering breakthrough therapies to treat chronic diseases and life-threatening conditions while lowering the cost of care. MDMA’s mission is to ensure that patients have timely access to the latest advancements of safe and effective medical technologies that improve health outcomes.

I. MACs should delay adoption of the proposed LCD pending clarification of the definitions for CPT^® codes 27278 and 27279 by the AMA CPT^® Editorial Panel.

Code development for minimally invasive SIJ arthrodesis began in 2015, with new codes added as recently as 2024. The AMA has been working in concert with its CPT^® advisors and experts across multiple specialties to clarify and further refine code descriptions to incorporate all procedures currently available to U.S. patients. This work is not complete. For example, it has become clear that the terms “transfixation” and “transfixing” require further refinement and clarification. Newly FDA-cleared SIJ fusion devices may not be well described in the current CPT^® coding definitions and guidance and additional clarification may be needed to effect the best coverage policies and resolve confusion regarding coding.

MDMA believes that the CPT^® editorial process represents the appropriate forum for this work as opposed to the Medicare coverage determination process. Moreover, we understand that the CPT^® Editorial Panel Executive Committee discussed the need to clarify the definition of transfixation as it relates to CPT^® codes 27278 and 27279 at its most recent meeting, and the topic is expected to be formally considered at an upcoming Panel meeting. Because the CPT^® Editorial Panel will be reviewing this issue, we urge CGS and other Medicare Administrative Contractors (MACs) to hold off on any further development of final LCDs for minimally invasive SIJ arthrodesis until that work is complete and it can be reflected in Medicare coverage policy.

II. A broad non-coverage policy for minimally invasive arthrodesis of the SIJ without placement of a transfixation device is not supported by available evidence, would deny individual Medicare beneficiaries access to a therapy that is medically reasonable and necessary for their care, and would hamper collection of additional clinical evidence in the Medicare population.

We are also concerned with the basis upon which the MACs are proposing to broadly deny coverage of minimally invasive arthrodesis of the SIJ without placement of a transfixation device. This proposal appears to be based in part on a comparison of the amount of peer-reviewed clinical evidence available for procedures described by CPT^® code 27278 relative to those reported by CPT^® code 27279. However, the difference in the volume of studies is to be expected given where the procedures are in their respective lifecycle. (This is evidenced by the fact that 27279 became effective January 1, 2015—nine years before 27278 became effective January 1, 2024.) Procedures reported in 27279 have been performed longer and should be expected to have more literature (both volume and duration) compared to 27278. This does not mean that 27278 has inadequate evidence. CGS should not change coverage policy for 27278 from case-by-case review to non-coverage due to the argument that 27278 has not yet reached the same volume of evidence as 27279. Furthermore, without evidence supporting a conclusion that procedures described by 27279 are not reasonable or necessary for most if not all Medicare beneficiaries, MACs should maintain access to those procedures for beneficiaries who decide, in consultation with their physicians, that it is the most appropriate therapy for them, subject to medical review. In addition to denying access to the therapy most appropriate for individual beneficiaries, a broad denial of coverage would also severely hamper the ongoing collection of evidence needed to inform future refinement of MACs coverage policy for SIJ arthrodesis.

We are also concerned that the proposed LCD gives inappropriate weight to coverage policies from other payers, including commercial payers, without adequately scrutinizing the evidentiary basis for those policies. The proposed LCD states explicitly that MAC’s “[q]uery of other payer LCDs reveals that for those that have an LCD on MIS of SIJ, MI posterior dorsal approach to access the SIJ, including use of implants other than those which are placed across the joint (i.e., transfixing) to promote fusion (e.g., allograft , nonmetallic implants), is considered experimental, investigation, or unproven.” The Centers for Medicare & Medicaid Services (CMS) has recently adopted new requirements for Medicare Advantage (MA) plans use of internally generated coverage criteria in the absence of an NCD, which were further discussed and clarified in a recent FAQ document sent to MA plans.1 These new requirements were issued in response to broad concerns that MA plans have adopted coverage policies broadly restricting access to items and services that are, in fact, medically reasonable and necessary for many Medicare beneficiaries. We do not believe that MACs should be referencing coverage policies from commercial payers without scrutinizing whether those policies were developed in accordance with Medicare requirements.

In summary, for the reasons discussed above, we believe it is inappropriate for MACs to move forward with finalizing the proposed LCD for minimally invasive arthrodesis of the SIJ at this time.

Thank you for your comment. The CPT^® language will be updated in the 2026 book and has been included in the definitions distinguishing the 2 procedures. We have removed any references to commercial policies. Denial of coverage for 27278 does not hamper continued research in this area and we would welcome a request for revision of this LCD should new literature be provided. Coverage is based on peer-reviewed literature that demonstrates that the procedure is reasonable and necessary. The volume of the literature is not the deciding factor, it is the quality of the literature that matters.

I am writing to request coverage of CPT^® code 27278 for a minimally invasive sacroiliac (SI) joint procedure for my patient. I have been treating patients for chronic SI joint pain and dysfunction. Before submitting and performing CPT^® Code 27278, patients have been worked up with a proper physical exam, have undergone multiple injections as well as trialing and failing multiple medications to help their SI Joint dysfunction.

A thorough physical examination is completed before performing CPT^® code 27278 that can reveal and prove SI Joint dysfunction. These findings, in conjunction with the patient's history and imaging results, are indicative of SI Joint dysfunction.

Before ordering, patients have undergone numerous conservative treatment options without adequate relief from the symptoms. These treatments have included but are not limited to:

1. Physical therapy
2. Non-steroidal anti-inflammatory medications (NSAIDs)
3. Oral corticosteroids
4. Oral narcotic medications
5. SI joint injections
6. Activity modification and pain management education

Despite these efforts, patients continue to experience debilitating pain and limited functionality.

A minimally invasive SI joint procedure is medically necessary for patients in these situations. This procedure has a high success rate in reducing pain and improving functionality for patients with SI joint dysfunction who have failed conservative treatments as evidenced by multiple evidence-based studies.

Minimally Invasive Procedure Benefits: The minimally invasive SI joint procedure offers several advantages compared to traditional open surgery. These benefits include:

1. Outpatient surgery
2. Reduced postoperative pain
3. Faster recovery time
4. Lower risk of complications and infection
5. Minimal scarring

Minimally Invasive SI Joint Surgery: Overview and Benefits:

Minimally invasive sacroiliac (SI) joint surgery, also known as SI joint fusion or stabilization, is a cutting-edge procedure that aims to alleviate pain and restore function in patients suffering from chronic SI joint dysfunction. This innovative technique has emerged as a reliable and effective treatment option for patients who have not experienced adequate relief from conservative therapies.

The sacroiliac joint is the connection between the sacrum (the triangular bone at the base of the spine) and the ilium (the large, wing-shaped bone that forms the pelvis). Dysfunction in the SI joint can lead to debilitating pain and reduced mobility. Minimally invasive SI joint surgery involves the use of specialized instruments and techniques to stabilize the affected joint, thus alleviating pain and allowing the patient to regain their quality of life.

Benefits of Minimally Invasive SI Joint Surgery:

1. Reduced tissue trauma: Unlike traditional open surgery, which requires a large incision and extensive muscle dissection, the minimally invasive approach utilizes small incisions and specialized instruments to access the SI joint. This results in less trauma to the surrounding tissues and a lower risk of complications.
2. No hospital stays: Due to the less invasive nature of the procedure, patients typically do not require a hospital stay. This allows them to return to the comfort of their own homes and begin their recovery process sooner.
3. Faster recovery: Minimally invasive SI joint surgery generally results in a quicker recovery period, as patients experience less postoperative pain and tissue damage. This enables them to return to their normal activities and work more quickly, reducing the overall impact on their lives.
4. Lower risk of complications: The minimally invasive technique reduces the risk of complications associated with traditional open surgery, such as infection, blood loss, and nerve damage. This contributes to a safer and more predictable surgical outcome.
5. Minimal scarring: Small incisions used in minimally invasive SI joint surgery result in minimal scarring, providing an added cosmetic benefit to the patient.

Multiple studies have been performed including the most recent publication of the SECURE (a single arm, multicenter, prospective, clinical study on a minimally invasive posterior sacroiliac fusion device) study. This study showed as compared to lateral SI joint fusion, the posterior approach is safe, effective, and durable as compared to the lateral approach. This study also showed that the posterior approach may be associated with an improved safety profile.

In summary, minimally invasive SI joint surgery is a highly effective procedure for treating patients with chronic SI joint dysfunction who have not found relief through conservative treatments. The numerous benefits of this approach, including reduced tissue trauma, shorter hospital stays, faster recovery, lower risk of complications, and minimal scarring, make it a superior choice for patients seeking lasting relief from their SI joint pain and improved quality of life.

Thank you for your comments. This LCD does cover minimally invasive surgery of the SIJ and does not require patients to be subjected to an open procedure. The 12-month results of SECURE were not available at time of publication, but the 6-month results were and were cited and reviewed. A PDF of the 12-month study was not provided by the commenter, but will be added by the MACs to the bibliography. It should be noted that the SECURE trial has the same limitations and bias at 12 months as it did at 6 months: industry sponsored, researcher in employ of industry, lack of a control group and partial cohort in the analysis. This was also not a RCT, and 24 subjects were lost to follow-up .Furthermore, this study was single arm and was not compared to other procedures in safety, durability or efficacy.

After reviewing your draft LCD and Summary of Evidence regarding Minimally Invasive Arthrodesis of the SI joint, I believe that several of your quoted articles do support coverage of devices that use the dorsal (posterior) approach.

References were provided for review.

Thank you for your comment.

I am writing to express my deep concern regarding the recent decision to withhold payment for the posterior allograft procedure under Medicare code 27278. As a dedicated physician specializing in treating SI joint dysfunction, I have witnessed firsthand the transformative impact of this procedure on my patients' lives.

This procedure has consistently proven to be both safe and effective in alleviating the debilitating pain associated with SI joint dysfunction. In fact, in my practice, 55 cases have been completed with remarkable success rates, with 90 to 95 percent of patients experiencing significant pain relief ranging from 75 to 100 percent. These outcomes are not isolated to my practice alone. They are supported by recent research, including a comprehensive 12-month study published in the Journal of Pain Research, which underscores the safety and effectiveness of procedures like this in managing SI joint dysfunction.

However, despite the overwhelming evidence in favor of this type of procedure, withholding payment for this intervention places an unjust burden on patients who are desperate for relief from the debilitating effects of this condition. Denying coverage for a treatment that has been proven to significantly improve patients' quality of life is not only unjust but also contradicts the mission of Medicare to ensure access to necessary medical interventions.

I urge you to reconsider this decision and promptly reinstate coverage for this procedure under Medicare code 27278. By doing so, we can ensure that patients have access to the care they need and deserve, in line with the latest evidence-based practices and medical standards. By withholding payment for this procedure, many of my patients are being deprived of a viable solution to their suffering. SI joint dysfunction is a condition that profoundly impacts the quality of life of those afflicted, and the denial of coverage for this procedure only exacerbates their physical and emotional distress.

Thank you for your attention to this urgent matter. I remain committed to advocating for the best interests of my patients and ensuring they receive the care they deserve.

References were provided for review.

Thank you for your comments. The literature that you cited was also reviewed and cited in the LCD creation. The 12-month results of SECURE were not available at time of publication, but the 6-month results were and were cited and reviewed. A PDF of the 12-month study was not provided by the commenter, but will be added by the MACs to the bibliography. It should be noted that the SECURE trial has the same limitations and bias at 12 months as it did at 6 months: industry sponsored, researcher in employ of industry, lack of a control group and partial cohort in the analysis. This was also not a RCT and 24 subjects were lost to follow-up.

The dorsal SI joint fusion procedure described by CPT^® code 22728 has ample literature to be a covered service by Medicare. It should be noted that CPT^® has stringent literature requirements for creation of category I codes, and the procedures described by 22728 did indeed meet those literature requirements.

Dorsal SI joint fusion procedures described by 22728 are an excellent alternative to the more invasive lateral SI joint fusion procedures described by CPT^® code 22729, especially the elderly/frail Medicare population for which this coverage is being determined.

There is no reason that CPT^® code 22728 should be a non-covered service. It should be covered for the same indications as CPT^® code 22729.

Thank you for your comment. No literature was provided. Creation of a CPT^® code does not necessarily confer coverage of the code.

I am writing to Medicare and specifically MACs due to my serious concern regarding the negative coverage determination for the posterior approach for SI joint fusion procedures.

• The posterior allograft procedure has been a safe and effective procedure that I use to treat SI joint dysfunction in my patients.
• I have performed approximately 50 SI joint fusions with most of my patients receiving >75% pain relief in follow up. The follow ups thus far have ranged from 3 months to 2.5 years.
• Withholding payment for this procedure is keeping many of my patients from experiencing pain relief as this disease is debilitating for many of them.
• Denying coverage for a treatment that has been proven to significantly improve patients' quality of life is not only unjust but also contradicts the mission of Medicare to ensure access to necessary medical interventions.
• Ensuring a patient centric stepwise approach is very important for Medicare patients. Moving to the most invasive approach (lateral SI joint fusion) should not be the only option for patients with diagnosed SI joint dysfunction. The ~20% of patients that do not do well with this treatment is high enough to justify other less invasive and effective options for our Medicare population

References were provided for review.

Thank you for your comment. No literature was provided.