Local Coverage Determination (LCD)

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

L36494

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Proposed LCD
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Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L36494
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
DL36494
Original Effective Date
For services performed on or after 02/01/2016
Revision Effective Date
For services performed on or after 01/04/2024
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
12/17/2015
Notice Period End Date
01/31/2016
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Issue

Issue Description

Annual review, no changes were made.

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, and society guideline recommendations (NASS, ISASS) leads CGS 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
N/A
MAC Meeting Information URLs
N/A
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
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
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Revenue Codes

Code Description
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CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

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ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

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

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information
Documentation Requirements

The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD. (See Indications and Limitations of Coverage section) This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

Medical record documentation must be available to Medicare upon request.

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, M. J., J. M. Ketchum and T. R. Saullo (2011)."Etiology of chronic low back pain in patients having undergone lumbar fusion.” Pain Medicine 12(5): 732-739

4. Liliang, P.-C., K. Lu, C.-L. Liang, Y.-D.Tsai, K.-W.Wang and H.-J.Chen (2011). "Sacroiliac joint pain after lumbar and lumbosacral fusion: findings using dual sacroiliac joint blocks." Pain Medicine 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, 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. J. 6, 495–502 (2012).

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 Dec 13;6:219-29.

10. Sachs, D. Minimally Invasive versus Open Sacroiliac Joint Fusion: A Comparison of Process Measures and Description of Technique. in Int. Soc. Adv. Spine Surg. 187 (2013).

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, Bettaglio R, Bongetta D, Custodi V, Silvani V. Percutaneous arthrodesis of sacro-iliac joint: a pilot study. J Neurosurg Sci. 2013 Dec;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 Oct;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 May 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 Sep;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 Feb;10(1):30-5. Epub 2013 Dec 11.

19. Miller, L., Reckling, W. C. & Block, J. E. 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. 77 (2013). 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. https://www.spine.org

23. Polly DW, Cher DJ, Wine KD, Whang PG, Frank CJ, Harvey CF, Lockstadt H, Glaser JA, Limoni RP, Sembrano JN, and the INSITE Study Group. "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

Bibliography

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Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
01/04/2024 R10

R10

Revision Effective: 01/04/2024

Revision Explanation: Annual review, no changes were made.

12-29-2023: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
01/05/2023 R9

R9

Revision Effective: 01/05/2023

Revision Explanation: Annual review, no changes were made.

12/29/2022: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
01/06/2022 R8

R8

Revision Effective: 01/06/2022

Revision Explanation: Annual review, no changes were made.

12/29/2021: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
12/24/2020 R7

R7

Revision Effective: 12/24/2020

Revision Explanation: Annual review, no changes were made.

12/17/2020: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
12/26/2019 R6

R6

Revision Effective: 12/26/2019

Revision Explanation: Annual review no changes made.

12/20/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
09/19/2019 R5

R5

Revision Effective: 09/19/2019 Revision Explanation: Converted policy into new policy template that no longer includes coding section based on CR 10901. For Approval, no changes.

09/13/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To Code Removal
09/19/2019 R4

R4

Revision Effective: 09/19/2019 Revision Explanation: Converted policy into new policy template that no longer includes coding section based on CR 10901.

09/12/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To Code Removal
02/01/2016 R3

R3

Revision Effective: N/A

Revision Explanation: Annual review no changes made.

12/21/2018-At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual review)
02/01/2016 R2

Revision #: R2
Revision Effective: N/A
Revision Explanation: Annual review no changes made.

12/21/2017-At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (annual review)
02/01/2016 R1 Revision #: R1
Revision Effective: N/A
Revision Explanation: Annual review no changes made.
  • Other (Annual Review)
N/A

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Updated On Effective Dates Status
12/29/2023 01/04/2024 - N/A Currently in Effect You are here
12/29/2022 01/05/2023 - 01/03/2024 Superseded View
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Keywords

  • iFuse

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