Diagnosis and Treatment of Sacroiliac Joint Pain

Policy ID: X-5023-03

Section: Radiology

Effective Date: January 01, 2020

Revised Date: December 01, 2021

Revision Effective Date: January 01, 2022

Last Reviewed: November 23, 2021

Applies To: Commercial and Medicaid Expansion

Description

Sacroiliac Joint Pain

Similar to other structures in the spine, it is assumed the sacroiliac joint (SIJ) may be a source of low back pain. In fact, before 1928, the SIJ was thought to be the most common cause of sciatica. In 1928, the role of the intervertebral disc was elucidated, and from that point forward, the SIJ received less research attention.

Diagnosis

Research into SIJ pain has been plagued by lack of a criterion standard to measure its prevalence and against which various clinical examinations can be validated. For example, SIJ pain is typically without any consistent, demonstrable radiographic or laboratory features and most commonly exists in the setting of morphologically normal joints. Clinical tests for SIJ pain may include various movement tests, palpation to detect tenderness, and pain descriptions by the individual. Further confounding study of the SIJ is that multiple structures, (e.g., posterior facet joints, lumbar discs) may refer pain to the area surrounding the SIJ.

Because of inconsistent information obtained from history and physical examination, some have proposed the use of image-guided anesthetic injection into the SIJ for the diagnosis of SIJ pain. Treatments being investigated for SIJ pain include prolotherapy, corticosteroid injection, radiofrequency ablation, stabilization, and arthrodesis. Some procedures have been referred to as SIJ fusion but may be more appropriately called fixation (this is because there is little to no bridging bone on radiographs). Devices for SIJ fixation/fusion that promote bone ingrowth to fixate the implants include a triangular implant (iFuse Implant System) and cylindrical threaded devices (Rialto, SImmetry, Silex, SambaScrew, SI-LOK). Some devices also have a slot in the middle where autologous or allogeneic bone can be inserted. This added bone is intended to promote fusion of the SIJ.

Regulatory Status

A number of radiofrequency generators and probes have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. In 2005, the SInergy® (Halyard; formerly Kimberly-Clark), a water-cooled single-use probe, was cleared by the FDA, listing the Baylis Pain Management Probe as a predicate device. The intended use is in conjunction with a radiofrequency generator to create radiofrequency lesions in nervous tissue. FDA product code: GXD.

Criteria

Arthrography of the sacroiliac joint is considered investigational

Injection of anesthetic for diagnosing sacroiliac joint pain may be considered medically necessary when the following criteria have been met:

Pain has failed to respond to 3 months of conservative management, which may consist of therapies such as nonsteroidal anti-inflammatory medications, acetaminophen, manipulation, physical therapy, and a home exercise program; and
Dual (controlled) diagnostic blocks with 2 anesthetic agents with differing duration of action are used; and
The injections are performed under imaging guidance

Injection of corticosteroid may be considered medically necessary for the treatment of sacroiliac joint pain when the following criteria have been met:

Pain has failed to respond to 3 months of conservative management, which may consist of therapies such as nonsteroidal anti-inflammatory medications, acetaminophen, manipulation, physical therapy, and a home exercise program; and
The injection is performed under imaging guidance; and
No more than 3 injections are given in 1 year

Minimally invasive fixation/fusion of the sacroiliac joint using a titanium triangular implant may be considered medically necessary when ALL of the following criteria have been met:

Pain is at least 5 on a 0 to 10 rating scale that impacts quality of life or limits activities of daily living; and
There is an absence of generalized pain behavior (e.g., somatoform disorder) or generalized pain disorders (e.g., fibromyalgia); and
Individuals have undergone and failed a minimum 6 months of intensive nonoperative treatment that must include medication optimization, activity modification, bracing, and active therapeutic exercise targeted at the lumbar spine, pelvis, sacroiliac joint, and hip, including a home exercise program; and
Pain is caudal to the lumbar spine (L5 vertebra), localized over the posterior sacroiliac joint, and consistent with sacroiliac joint pain; and
A thorough physical examination demonstrates localized tenderness with palpation over the sacral sulcus (Fortin's point) in the absence of tenderness of similar severity elsewhere; and
There is a positive response to a cluster of 3 provocative tests (e.g., thigh thrust test, compression test, Gaenslen sign, distraction test, Patrick test, posterior provocation test); and
Diagnostic imaging studies include ALL of the following:
- Imaging (plain radiographs and computed tomography or magnetic resonance imaging) of the sacroiliac joint excludes the presence of destructive lesions (e.g., tumor, infection) or inflammatory arthropathy of the sacroiliac joint; and
- Imaging of the pelvis (anteroposterior plain radiograph) rules out concomitant hip pathology; and
- Imaging of the lumbar spine (computed tomography or magnetic resonance imaging) is performed to rule out neural compression or other degenerative condition that can be causing low back or buttock pain; and
- Imaging of the sacroiliac joint indicates evidence of injury and/or degeneration; and
There is at least a 75% reduction in pain for the expected duration of the anesthetic used following an image-guided, contrast-enhanced intra-articular sacroiliac joint injection on 2 separate occasions; and
A trial of a therapeutic sacroiliac joint injection (i.e., corticosteroid injection) has been performed on at least once

Fixation/fusion of the sacroiliac joint for the treatment of back pain presumed to originate from the sacroiliac joint is considered investigational under all other conditions and with any other devices not listed above

Radio frequency denervation of the sacroiliac joint is considered investigational

Procedure Codes

20610

27096

27279

27280

64451

G0259

G0260

Diagnosis Codes

M46.1

M47.898

M47.899

M48.08

M53.2X8

M54.18

M54.30

M54.31

M54.32

M54.40

M54.41

M54.42

M54.5

M54.6

S33.2

S33.6

Professional Statements and Societal Positions Guidelines

Practice Guidelines and Position Statements

North American Spine Society

The North American Spine Society (NASS; 2015) published coverage recommendations for percutaneous sacroiliac joint (SIJ) fusion. NASS indicated that there was relatively moderate evidence. In the absence of high-level data, NASS policies reflect the multidisciplinary experience and expertise of the committee members in order to present reasonable standard practice indications in the United States. NASS recommended coverage when ALL of the following criteria are met:

1. "[Individuals] have undergone and failed a minimum 6 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.

2. Individual's report of typically unilateral pain that is caudal to the lumbar spine (L5 vertebra), localized over the posterior SIJ, and consistent with SIJ pain.

3. 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.

4. 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). Note that the thrust test is not recommended in pregnant individuals or those with connective tissue disorders.

5. Absence of generalized pain behavior (e.g., somatoform disorder) or generalized pain disorders (e.g., fibromyalgia).

6. Diagnostic imaging studies that include ALL of the following:

a. Imaging (plain radiographs and a CT [computed tomography] or MRI [magnetic resonance imaging]) of the SI joint that excludes the presence of destructive lesions (e.g., tumor, infection) or inflammatory arthropathy that would not be properly addressed by percutaneous SIJ fusion.

b. Imaging of the pelvis (AP [anteroposterior] plain radiograph) to rule out concomitant hip pathology.

c. 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.

d. Imaging of the SI joint that indicates evidence of injury and/or degeneration.

7. At least 75% reduction of pain for the expected duration of the anesthetic used following an image-guided, contrast-enhanced intra-articular SIJ injection on 2 separate occasions.

8. A trial of at least one therapeutic intra-articular SIJ injection (i.e., corticosteroid injection)."

American Society of Interventional Pain Physicians

The American Society of Interventional Pain Physicians (2013) guidelines have been updated. The updated guidelines recommend the use of controlled SIJ blocks with placebo or controlled comparative local anesthetic block when indications are satisfied with suspicion of SIJ pain. A positive response to a joint block is considered to be at least a 75% improvement in pain or in the ability to perform previously painful movements. For therapeutic interventions, the only effective modality with fair evidence was cooled radiofrequency neurotomy, when used after the appropriate diagnosis was confirmed by diagnostic SIJ injections.

American Society of Anesthesiologists et al

The American Society of Anesthesiologists and the American Society of Regional Anesthesia and Pain Medicine (2010) updated their joint guidelines for chronic pain management. The guidelines recommended that "Diagnostic sacroiliac joint injections or lateral branch blocks may be considered for the evaluation of individuals with suspected sacroiliac joint pain." Based on opinions of consultants and society members, the guidelines recommend that "Water-cooled radiofrequency ablation may be used for chronic sacroiliac joint pain."

American Pain Society

The practice guidelines from the American Pain Society (2009) were based on a systematic review commissioned by the Society. NA The guidelines stated that there was insufficient evidence to evaluate validity or utility of diagnostic SIJ block as a diagnostic procedure for low back pain with or without radiculopathy; the guidelines further stated that there was insufficient evidence to adequately evaluate benefits of SIJ steroid injection for nonradicular low back pain.

International Society for the Advancement of Spine Surgery

The International Society for the Advancement of Spine Surgery (2014) updated its policy statement on minimally invasive SIJ fusion in 2016. Society recommendations indicated that individuals who met all of the following criteria may be eligible for minimally invasive SIJ fusion:

"Significant SI [sacroiliac] joint pain … or significantly limitations in activities of daily living because of pain from the SI joint(s).
"SI joint pain confirmed with … at least 3 positive physical provocation examination maneuvers that stress the SI joint.
"Confirmation of the SI joint as a pain generator with greater than or equal to 75% acute decrease in pain immediately following fluoroscopically guided diagnostic intra-articular SI joint block using local anesthetic.
"Failure to respond to at least 6 months of non-surgical treatment consisting of non-steroidal anti-inflammatory drugs and/or … one or more of the following: … physical therapy…. Failure to respond means continued pain that interferes with activities of daily living and/or results in functional disability;
"Additional or alternative diagnoses that could be responsible for the individual's ongoing pain or disability have been considered, investigated and ruled out."

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence (2017) guidance on minimally invasive SIJ fusion surgery for chronic sacroiliac pain included the following recommendations:

1.1 "Current evidence on the safety and efficacy of minimally invasive sacroiliac (SI) joint fusion surgery for chronic SI pain is adequate to support the use of this procedure….

1.2 Individuals having this procedure should have a confirmed diagnosis of unilateral or bilateral SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption.

1.3 This technically challenging procedure should only be done by surgeons who regularly use image-guided surgery for implant placement. The surgeons should also have had specific training and expertise in minimally invasive SI joint fusion surgery for chronic SI pain."

Table 18. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT01861899^a

Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation System

Nov-18

NCT02270203^a

LOIS: Long-Term Follow-Up in INSITE/SIFI

103

Dec-19

NCT02074761^a

Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System

250

Aug-20

NCT03230279^a

Randomized Controlled Trial Of Minimally Invasive Sacroiliac Joint Fusion Compared To Radiofrequency Ablation For Sacroiliac Joint Dysfunction

Sep 2023 (withdrawn)

NCT: national clinical trial.

^a Denotes industry-sponsored or cosponsored trial.

ND Committee Review

Internal Medical Policy Committee 11-14-2019 Annual Update

Internal Medical Policy Committee 11-19-2020 Annual Review

Internal Medical Policy Committee 11-23-2021 Coding update: Added Procedure codes 27096; 27279; 27280 and 64451

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: X-5023-02

Section: Radiology

Effective Date: January 01, 2020

Revised Date: December 03, 2020

Revision Effective Date: January 04, 2021

Last Reviewed: November 19, 2020

Archived Date: December 31, 2021

Applies To: Commercial and Medicaid Expansion

Description

Sacroiliac Joint Pain

Diagnosis

Research into SIJ pain has been plagued by lack of a criterion standard to measure its prevalence and against which various clinical examinations can be validated. For example, SIJ pain istypicallywithout any consistent, demonstrable radiographic or laboratory features and most commonly exists in the setting of morphologically normal joints. Clinical tests for SIJ pain may include various movement tests, palpation to detect tenderness, and pain descriptions by the individual. Further confounding study of the SIJ is that multiple structures, (e.g., posterior facet joints, lumbar discs) may refer pain to the area surrounding the SIJ.

Because of inconsistent information obtained from history and physical examination, some have proposed the use of image-guided anesthetic injection into the SIJ for the diagnosis of SIJ pain. Treatments being investigated for SIJ pain include prolotherapy, corticosteroid injection, radiofrequency ablation, stabilization, and arthrodesis.Some procedures have been referred to as SIJfusionbut may be more appropriately called fixation (this is because there is little to no bridging bone on radiographs). Devices for SIJ fixation/fusion that promote bone ingrowth to fixate the implants include a triangular implant (iFuse Implant System) andcylindricalthreaded devices (Rialto, SImmetry, Silex, SambaScrew, SI-LOK). Some devices also have a slot in the middle where autologous or allogeneic bone can be inserted. This added bone is intended to promote fusion of the SIJ.

Regulatory Status

Criteria

Arthrography of the sacroiliac joint is considered investigational

Injection of anesthetic for diagnosing sacroiliac joint pain may be considered medically necessary when the following criteria have been met:

Pain has failed to respond to 3 months of conservative management, which may consist of therapies such as nonsteroidal anti-inflammatory medications, acetaminophen, manipulation, physical therapy, and a home exercise program; and
Dual (controlled) diagnostic blocks with 2 anesthetic agents with differing duration of action are used; and
The injections are performed under imaging guidance

Injection of corticosteroid may be considered medically necessary for the treatment of sacroiliac joint pain when the following criteria have been met:

Pain has failed to respond to 3 months of conservative management, which may consist of therapies such as nonsteroidal anti-inflammatory medications, acetaminophen, manipulation, physical therapy, and a home exercise program; and
The injection is performed under imaging guidance; and
No more than 3 injections are given in 1 year

Minimally invasive fixation/fusion of the sacroiliac joint using a titanium triangular implant may be considered medically necessary when ALL of the following criteria have been met:

Pain is at least 5 on a 0 to 10 rating scale that impacts quality of life or limits activities of daily living; and
There is an absence of generalized pain behavior (e.g., somatoform disorder) or generalized pain disorders (e.g., fibromyalgia); and
Individuals have undergone and failed a minimum 6 months of intensive nonoperative treatment that must include medication optimization, activity modification, bracing, and active therapeutic exercise targeted at the lumbar spine, pelvis, sacroiliac joint, and hip, including a home exercise program; and
Pain is caudal to the lumbar spine (L5 vertebra), localized over the posterior sacroiliac joint, and consistent with sacroiliac joint pain; and
A thorough physical examination demonstrates localized tenderness with palpation over the sacral sulcus (Fortin's point) in the absence of tenderness of similar severity elsewhere; and
There is a positive response to a cluster of 3 provocative tests (eg, thigh thrust test, compression test, Gaenslen sign, distraction test, Patrick test, posterior provocation test); and
Diagnostic imaging studies include ALL of the following:
- Imaging (plain radiographs and computed tomography or magnetic resonance imaging) of the sacroiliac joint excludes the presence of destructive lesions (e.g., tumor, infection) or inflammatory arthropathy of the sacroiliac joint; and
- Imaging of the pelvis (anteroposterior plain radiograph) rules out concomitant hip pathology; and
- Imaging of the lumbar spine (computed tomography or magnetic resonance imaging) is performed to rule out neural compression or other degenerative condition that can be causing low back or buttock pain; and
- Imaging of the sacroiliac joint indicates evidence of injury and/or degeneration; and
There is at least a 75% reduction in pain for the expected duration of the anesthetic used following an image-guided, contrast-enhanced intra-articular sacroiliac joint injection on 2 separate occasions; and
A trial of a therapeutic sacroiliac joint injection (i.e., corticosteroid injection) has been performed on at least once

Radio frequency denervation of the sacroiliac joint is considered investigational

Procedure Codes

20610

27096

27279

27280

64451

G0259

G0260

Diagnosis Codes

M46.1

M47.898

M47.899

M48.08

M53.2X8

M54.18

M54.30

M54.31

M54.32

M54.40

M54.41

M54.42

M54.5

M54.6

S33.2

S33.6

Professional Statements and Societal Positions Guidelines

Practice Guidelines and Position Statements

North American Spine Society

The North American Spine Society (NASS; 2015) published coverage recommendations for percutaneoussacroiliac joint (SIJ)fusion.NASS indicated that there was relatively moderate evidence. In the absence of high-level data, NASS policies reflect the multidisciplinary experience and expertise of the committee members in order to present reasonable standard practice indications in the United States. NASS recommended coverage whenALLof the following criteria are met:

1."[Individuals] have undergone and failed a minimum 6 months of intensive nonoperative treatment that must include medication optimization, activity modification, bracing and active therapeutic exercise targeted at the lumbar spine, pelvis, SIJandhip including a home exercise program.

2.Individual's report of typically unilateral pain that is caudal to the lumbar spine (L5 vertebra), localized over the posterior SIJ, and consistent with SIJ pain.

3.A thorough physical examination demonstrating localized tenderness with palpation over the sacral sulcus (Fortin's point, ie, 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.

4. Positiveresponse 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).Note that the thrust test is not recommended in pregnant individuals or those with connective tissue disorders.

5.Absence of generalized pain behavior (e.g., somatoform disorder) or generalized pain disorders (e.g., fibromyalgia).

6.Diagnostic imaging studies that include ALL of the following:

a.Imaging (plain radiographs and a CT [computed tomography] or MRI [magnetic resonance imaging]) of the SI joint that excludes the presence of destructive lesions (e.g., tumor, infection) or inflammatory arthropathy that would not be properly addressed by percutaneous SIJ fusion.

b. Imaging of the pelvis (AP [anteroposterior] plain radiograph) to rule out concomitant hip pathology.

c.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.

d. Imaging of the SI joint that indicates evidence of injury and/or degeneration.

7.At least 75% reduction of pain for the expected duration of the anesthetic used following an image-guided, contrast-enhanced intra-articular SIJ injection on 2 separate occasions.

8.A trial of at least one therapeutic intra-articular SIJ injection (i.e., corticosteroid injection)."

American Society of Interventional Pain Physicians

The American Society of Interventional Pain Physicians (2013) guidelines have been updated.The updated guidelines recommend the use of controlled SIJ blocks with placebo or controlled comparative local anesthetic block when indications are satisfied with suspicion of SIJ pain. A positive response to a joint block is considered to be at least a 75% improvement in pain or in the ability to perform previously painful movements. For therapeutic interventions, the only effective modality with fair evidence was cooled radiofrequency neurotomy, when used after the appropriate diagnosis was confirmed by diagnostic SIJ injections.

American Society of Anesthesiologists et al

TheAmerican Society of Anesthesiologists and the American Society of Regional Anesthesia and Pain Medicine (2010) updated their joint guidelines for chronic pain management.The guidelines recommended that "Diagnostic sacroiliac joint injections or lateral branch blocks may be considered for the evaluation of individuals with suspected sacroiliac joint pain." Based on opinions of consultants and society members, the guidelines recommend that "Water-cooled radiofrequency ablation may be used for chronic sacroiliac joint pain."

American Pain Society

The practice guidelines from the American Pain Society (2009) were based on a systematic review commissioned by the Society.NAThe guidelines stated that there was insufficient evidence to evaluate validity or utility of diagnostic SIJ block as a diagnostic procedure for low back pain with or without radiculopathy; the guidelines further stated that there was insufficient evidence to adequately evaluate benefits of SIJ steroid injection for nonradicular low back pain.

International Society for the Advancement of Spine Surgery

"Significant SI [sacroiliac] joint pain … or significantly limitations in activities of daily living because of pain from the SI joint(s).
"SI joint pain confirmed with … at least 3 positive physical provocation examination maneuvers that stress the SI joint.
"Confirmation of the SI joint as a pain generator with ≥ 75% acute decrease in pain immediately following fluoroscopically guided diagnostic intra-articular SI joint block usinglocalanesthetic.
"Failure to respond to at least 6 months of non-surgical treatment consisting of non-steroidal anti-inflammatory drugs and/or … one or more of the following: … physical therapy…. Failure to respond means continued pain that interferes with activities of daily living and/or results in functional disability;
"Additional or alternative diagnoses that could be responsible for the individual's ongoing pain or disability have been considered, investigated and ruled out."

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence (2017) guidance on minimally invasive SIJ fusion surgery for chronic sacroiliac pain included the following recommendations:

1.1 "Current evidence on the safety and efficacy of minimally invasive sacroiliac (SI) joint fusion surgery for chronic SI pain is adequate to support the use of this procedure….

1.2 Individuals having this procedure should have a confirmed diagnosis of unilateral or bilateral SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption.

Table 18. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT01861899^a

Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation System

Nov-18

NCT02270203^a

LOIS: Long-Term Follow-Up in INSITE/SIFI

103

Dec-19

NCT02074761^a

Evolusion Study Using the Zyga SImmetrySacroiliacJoint Fusion System

250

Aug-20

NCT03230279^a

Randomized Controlled Trial Of Minimally InvasiveSacroiliacJoint Fusion Compared To Radiofrequency Ablation ForSacroiliacJoint Dysfunction

Sep 2023 (withdrawn)

NCT: national clinical trial.

^aDenotes industry-sponsored or cosponsored trial.

ND Committee Review

Internal Medical Policy Committee 11-14-2019 Annual Update

Internal Medical Policy Committee 11-19-2020 Annual Review

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.

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