Local Coverage Determination (LCD)

Minimally-invasive Surgical (MIS) Fusion of the Sacroiliac (SI) Joint

L36406

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Document Note

Note History

Contractor Information

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Document Information

Source LCD ID
N/A
LCD ID
L36406
Original ICD-9 LCD ID
Not Applicable
LCD Title
Minimally-invasive Surgical (MIS) Fusion of the Sacroiliac (SI) Joint
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL36406
Original Effective Date
For services performed on or after 04/01/2016
Revision Effective Date
For services performed on or after 10/10/2019
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
02/15/2016
Notice Period End Date
03/31/2016
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Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.


Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Abstract
Studies have reported the source of chronic lower back, buttock, groin, or lower extremity pain is from disorders of the sacroiliac (SI) joint in 10% to 26% of cases (1-4). Nevertheless, sacroiliac joint dysfunction is a controversial topic as there is no single clinical, imaging, or provocative test that definitively confirms the SI joint as a primary source of pain (4). In addition, the SI joint may be a referred site of pain, including from a degenerative disc at L5-S1, spinal stenosis, or osteoarthritis of the hip.

SI joint pathology may include degenerative and inflammatory arthritis, post-traumatic arthritis, post-partum instability, post-infectious arthritis, joint degeneration related to previous lumbar spinal fusion, joint damage from previous posterior iliac crest bone graft harvesting, and neoplastic processes (3). This policy is directed at minimally-invasive surgical (MIS) fusion of the sacroiliac (SI) joint for treatment of degenerative sacroilitis or sacroiliac disruption.

Traditionally, treatment begins with conservative management (e.g., physical therapy, activity modification and analgesic medication). Open SI joint fusion has long been another option, albeit sparingly used given the significant morbidity associated with the depth and anatomic location of the SI joint. Recent survey data show MIS-SI joint fusion displacing open SI joint fusion (5). MIS-SI joint fusion involves percutaneous insertion of a metallic device across the SIJ that is intended to fuse the joint rather than just stabilize the joint as with simple of insertion of screws. Smith reported a retrospective multi-center comparison of MIS-SI joint fusion with open SI joint fusion in 114 and 149 patients, respectively (6), with MIS-SI joint fusion demonstrating statistically positive outcomes. Though both groups seemed to improve, there was reportedly an average of 3.5 points less pain in the percutaneous group.

Until recently, most of the relevant published studies on MIS-SI joint fusion, though generally positive in efficacy and safety in patients resistant to conservative care, were relatively small, single surgeon series, non-randomized and non-controlled, lacked blind outcomes assessment, and with limited follow-up of 1-2 years (7-18). In a post-market analysis of 5319 patients with a mean follow-up of four months (range 0-30) performed by one of the manufacturers (SI Bone, San Jose, CA, USA), 3.8% reported complications (e.g., pain, nerve impingement, and recurrent SIJ pain), and improper device placement occurred in 1.4%, all presenting in the early post-operative period (19).

However, more sophisticated studies are emerging. Duhon reports early (12 months in 172 patients) positive results of an ongoing multicenter, prospective, single arm trial (Sacroiliac Joint Fusion With iFuse Implant System (SIFI)) of minimally invasive SI joint fusion using iFuse (20). While there were significant reductions in pain and disability from baseline, the study suffers from being non-controlled, and only reporting relatively short-term data. The first multi-center prospective, randomized controlled trial comparing MIS-SI joint fusion (N=102) with specific, targeted non-surgical treatment (N=46) of the SI joint was recently published (21). By 6 months, success as measured by a composite of pain reduction, absence of serious adverse events or neurological worsening, and absence of repeat surgery, was found in 81.4% of operative patients and 24% of non-surgical patients. Clinically important (15 points) Oswestry Disability Index (ODI) improvement at 6 months occurred in 75% and 27.3% of surgical and non-surgical patients, respectively.

In summary, MIS-SI joint fusion studies, while still moderate in terms of data quality and follow-up time, consistently show improved pain scores with fewer complications than open fusion in patients with non-infectious, non-traumatic related SI pain. This along with positive CAC member feedback, and society guideline recommendations (NASS, ISASS) leads NGS to cover MIS-SI joint fusion for the following carefully selected patients per recently published NASS guidelines (22).

Indications of Coverage

Minimally-invasive surgical (MIS) fusion of the sacroiliac (SI) joint is considered medically necessary when ALL of the following criteria are met:

  • Have moderate to severe pain with functional impairment and pain persists despite a minimum six months of intensive nonoperative treatment that must include medication optimization, activity modification, bracing, and active therapeutic exercise targeted at the lumbar spine, pelvis, SIJ and hip including a home exercise program
  • Patient’s report of typically unilateral pain that is caudal to the lumbar spine (L5 vertebrae), localized over the posterior SIJ, and consistent with SIJ pain
  • A thorough physical examination demonstrating localized tenderness with palpation over the sacral sulcus (Fortin’s point, i.e. at the insertion of the long dorsal ligament inferior to the posterior superior iliac spine or PSIS) in the absence of tenderness of similar severity elsewhere (e.g. greater trochanter, lumbar spine, coccyx) and that other obvious sources for their pain do not exist
  • Positive response to a cluster of 3 provocative tests (e.g. thigh thrust test, compression test, Gaenslen’s test, distraction test, Patrick’s sign, posterior provocation test).
  • Absence of generalized pain behavior (e.g. somatoform disorder) or generalized pain disorders (e.g. fibromyalgia)
  • Diagnostic imaging studies that include ALL of the following:
    • Imaging (plain radiographs and a CT or MRI) of the SI joint that excludes the presence of destructive lesions (e.g. tumor, infection), fracture, traumatic SIJ instability, or inflammatory arthropathy that would not be properly addressed by percutaneous SIJ fusion
    • Imaging of the pelvis (AP plain radiograph) to rule out concomitant hip pathology
    • Imaging of the lumbar spine (CT or MRI) to rule out neural compression or other degenerative condition that can be causing low back or buttock pain
  • At least 75 percent reduction of pain for the expected duration of two anesthetics (on separate visits each with a different duration of action), and the ability to perform previously painful maneuvers, following an image-guided, contrast-enhanced intra-articular SIJ injection.
  • A trial of at least one therapeutic intra-articular SIJ injection (i.e. corticosteroid injection)



Summary of Evidence

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Analysis of Evidence (Rationale for Determination)

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Proposed Process Information

Synopsis of Changes
Changes Fields Changed
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Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
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Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
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MAC Meeting Information URLs
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Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
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Contact for Comments on Proposed LCD

Coding Information

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CPT/HCPCS Codes

Group 1

Group 1 Paragraph

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ICD-10-CM Codes that Support Medical Necessity

Group 1

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Group 1 Codes:

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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

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Additional ICD-10 Information

General Information

Associated Information
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Sources of Information

This bibliography presents those sources that were obtained during the development of this policy. National Government Services is not responsible for the continuing viability of Web site addresses listed below.

1. Fortin JD, Aprill CN, Ponthieux B, Pier J. Sacroiliac joint: pain referral maps upon applying a new injection/arthrography technique. Part II: Clinical evaluation, Spine. 1994;19:1483-9.

2. Fortin JD, Dwyer AP, West S, Pier J. Joint: pain referral maps upon applying a new injection/arthrography technique. Part I. Asymptomatic volunteers. Spine. 1994;19:1475-82.

3. DePalma MJ, Ketchum JM, Saullo TR. Etiology of chronic low back pain in patients having undergone lumbar fusion. Pain Medicine. 2011;12(5):732-739.

4. Liliang PC, Lu K, Liang CL, Tsai YD, Wang KW, Chen HJ. Sacroiliac joint pain after lumbar and lumbosacral fusion: findings using dual sacroiliac joint blocks. Pain Medicine 2011;12(4):565-570.

5. Lorio MP, Polly DW Jr, Ninkovic I, et al. Utilization of minimally invasive surgical approach for sacroiliac joint fusion in surgeon population of ISASS and SMISS membership. Open Orthopaedics Journal 2014;8:1-6.

6. Smith, AG, Capobianco R, Cher D, et al. Open versus minimally invasive sacroiliac joint fusion: a multi-center comparison. Annals of Surgical Innovation and Research 2013;7:14.

7. Sachs D, Capobianco R. One year successful outcomes for novel sacroiliac joint arthrodesis system. Ann Surg Innov Res. 2012;6(1):13.

8. Rudolf, L. Sacroiliac joint arthrodesis-MIS technique with titanium implants: report of the first 50 patients and outcomes. Open Orthop.2012;6;495–502.

9. Duhon BS, Cher DJ, Wine KD, Lockstadt H, Kovalsky D, Soo CL. Safety and 6-month effectiveness of minimally invasive sacroiliac joint fusion: a prospective study. Med Devices (Auckl). 2013;6:219-29.

10. Sachs, D. Minimally Invasive versus open sacroiliac joint fusion: a comparison of process measures and description of technique. Int. Soc. Adv. Spine Surg.2013;187.

11. Cummings J Jr, Capobianco RA. Minimally invasive sacroiliac joint fusion: one-year outcomes in 18 patients. Ann Surg Innov Res 2013;7(1):12.

12. Sachs D1, Capobianco R. Minimally invasive sacroiliac joint fusion: one-year outcomes in 40 patients. Adv Orthop. 2013;536128.

13. Kim JT1, Rudolf LM, Glaser JA. Outcome of percutaneous sacroiliac joint fixation with porous plasma-coated triangular titanium implants: an independent review. Open Orthop J. 2013;7:51-6.

14. Gaetani P, Miotti D, Risso A, et al. Percutaneous arthrodesis of sacro-iliac joint: a pilot study. J Neurosurg Sci. 2013;57(4):297-301.

15. Mason LW, Chopra I, Mohanty K. The percutaneous stabilisation of the sacroiliac joint with hollow modular anchorage screws: a prospective outcome study. Eur Spine J. 2013;22(10):2325-31.

16. Rudolf L. MIS fusion of the SI joint: does prior lumbar spinal fusion affect patient outcomes? Open Orthop J. 2013;17;7:163-8.

17. Endres S, Ludwig E. Outcome of distraction interference arthrodesis of the sacroiliac joint for sacroiliac arthritis. Indian J Orthop. 2013;47(5):437-42.

18. Schroeder JE, Cunningham ME, Ross T, Boachie-Adjei O. Early results of sacro-iliac joint fixation following long fusion to the sacrum in adult spine deformity. HSS J. 2014;10(1):30-5. Epub 2013 Dec 11.

19. Miller L, Reckling WC, Block JE. Analysis of postmarket complaints database for the iFuse SI Joint Fusion System®: a minimally invasive treatment for degenerative sacroiliitis and sacroiliac joint disruption. Med. Devices Evid. Res.2013;77. doi:10.2147/MDER.S44690.

20. Duhon BS, Cher DJ, Wine KD, Lockstadt H, Kovalsky D, Lockstadt H. Triangular titanium implants for minimally invasive sacroiliac joint fusion: a prospective study. Global Spine J. 2015. Epub 2015 Aug 11. DOI: 10.1055/s-0035-1562912.

21. Whang P, Cher D, Polly D, et al. Sacroiliac joint fusion using triangular titanium implants vs. non-surgical management: six-month outcomes from a prospective randomized controlled trial. Int J Spine Surg. 2015;9:6.

22. North American Spine Society (NASS) coverage policy recommendation June 1, 2015. NASS Coverage Policy

23. Polly DW, Cher DJ, Wine KD, et al. Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion Using Triangular Titanium Implants vs. Non-Surgical Management for Sacroiliac Joint Dysfunction: 12-Month Outcomes. Neurosurgery. 2015. Epub 2015 Aug 20.

24. Heiney J, Capobianco R, Cher D. A Systematic Review of Minimally Invasive Sacroiliac Joint Fusion Utilizing A Lateral Transarticular Technique. Int J Spine Surg. 2015;9: Article 40. doi 10.14444/2040.

Bibliography

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Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
10/10/2019 R2

The link to the NASS Coverage Policy was corrected.

  • Other
10/10/2019 R1

Consistent with Change Request 10901, all coding information, National coverage provisions, and Associated Information (Documentation Requirements, Utilization Guidelines) have been removed from the LCD and placed in the related Billing and Coding Article, A57431. There has been no change in coverage with this LCD revision.

  • Revisions Due To Code Removal
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10/18/2019 10/10/2019 - N/A Currently in Effect You are here
10/04/2019 10/10/2019 - N/A Superseded View
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Keywords

  • iFuse

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