MEDICAL POLICY – 6.01.524

Diagnosis and Treatment of Sacroiliac Joint Pain BCBSA Ref. Policy: 6.01.23

Effective Date: Feb. 1, 2020

Last Revised: Jan. 9, 2020

Replaces: N/A

RELATED MEDICAL POLICIES:

2.01.26 Prolotherapy

6.01.25 Percutaneous Vertebroplasty and Sacroplasty

7.01.551 Lumbar Spine Decompression Surgery: Discectomy, Foraminotomy,

Laminotomy, Laminectomy

7.01.555 Facet Joint Denervation

Select a hyperlink below to be directed to that section.

POLICY CRITERIA | DOCUMENTATION REQUIREMENTS | CODING

RELATED INFORMATION | EVIDENCE REVIEW | REFERENCES | HISTORY

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Introduction

The sacroiliac (SI) joints are between the lower spine and the pelvic bones. There is one on each

side of the body. These joints transfer weight and the forces of the upper body to the hips and

legs. Pain can develop in one or both of these joints and may be felt in the lower back, buttocks,

or legs. One way to test if pain is coming from an SI joint is to inject a numbing solution.

Imaging is used to guide and position the needle for the injection. If the numbing agent reduces

pain, it is an indication that an SI joint is the cause. To relieve pain, steroids can be injected into

the joint using the same type of imaging guidance. Another option for pain relief is minimally

invasive fixation/fusion of the sacroiliac joint using a titanium triangular implant. This policy

describes when injections, minimally invasive fixation/fusion of the SI joint, and other certain

treatments may be considered medically necessary to diagnose and treat SI joint pain. This

policy also discusses investigational (unproven) techniques for diagnosing or treating SI pain.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The

rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for

providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can

be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a

service may be covered.

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Policy Coverage Criteria

Service Medical Necessity Anesthetic injection for

diagnosing sacroiliac joint

pain

Injection of anesthetic for the purpose of 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

Corticosteroid injection for

treatment of sacroiliac

joint pain

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 one year

Minimally invasive

fixation/fusion of the SIJ

Minimally invasive fixation/fusion of the sacroiliac joint using

a titanium triangular implant (eg, iFuse®) may be considered

medically necessary when ALL of the following criteria have

been met:

• Documentation of persistent pain of 6 months duration that

interferes with activities of daily living with a visual analog

score (VAS) of 5 or greater;

AND

• Documentation of failure of at least 6 months of nonoperative

treatment that includes:

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Service Medical Necessity o Medication optimization

o Activity modification

o Bracing

o Active therapeutic exercise targeted at the lumbar spine,

pelvis, sacroiliac joint, and hip, which may include a home

exercise program

o Intra-articular SI joint corticosteroid therapeutic injection;

AND

• Confirmation of the SI joint as the pain generator as

demonstrated by all of the following:

o Pain pattern consistent with SI joint pain (typically unilateral

pain caudal [directed toward the tail] to the lumbar spine

[L5 vertebrae] localized over the posterior SI joint)

o Positive finger Fortin test (localized tenderness with

palpation over the sacral sulcus)

o No tenderness of similar severity elsewhere in the pelvic

region (eg, greater trochanter, lumbar spine, coccyx); other

obvious sources of pain do not exist or have been excluded

o Positive response to at least 3 of the following provocative

tests (see Appendix):

▪ Thigh thrust test*

▪ Compression test

▪ Gaenslen’s test

▪ Distraction test

▪ FABER’s test/Patrick’s sign

*Note: The Thrust test is not recommended in pregnant patients or those with

connective tissue disorders

AND

• Diagnostic imaging studies include ALL of the following:

o Imaging (plain radiographs and a CT or MRI) of the

sacroiliac joint excludes the presence of destructive lesions

(eg, tumor, infection) or inflammatory arthropathy of the

sacroiliac joint that would not be properly addressed by

percutaneous SI joint fusion; and

o Imaging of the pelvis (anteroposterior [AP] plain

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Service Medical Necessity radiograph) rules out concomitant hip pathology; and

o 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; and

o Imaging of the SI joint that indicates evidence of injury

and/or degeneration

AND

• Diagnostic confirmation of the SI joint as the pain generator

demonstrated by at least 75% reduction of pain for the

expected duration of the anesthetic used following an image-

guided, contrast-enhanced intra-articular sacroiliac joint

injection on 2 separate occasions (see Related Information)

Minimally invasive fixation/fusion of the sacroiliac joint using

a titanium triangular implant (eg, iFuse®) may be considered

not medically necessary when any of the following conditions

are met:

• Any case that does not fulfill ALL of the above criteria

• Presence of generalized pain behavior (eg, somatoform

disorder) or generalized pain disorders (eg, fibromyalgia)

• Presence of neural compression as seen on imaging (lumbar CT

or MRI) that correlates with symptoms or other more likely

source of pain

• Presence of systemic arthropathy such as ankylosing

spondylitis or rheumatoid arthritis

• Presence of infection, tumor, or fracture

• Presence of acute, traumatic instability of the SI joint

Open sacroiliac joint fusion Open sacroiliac joint fusion procedures may be considered

medically necessary for any of the following indications:

• As an adjunct to sacrectomy or partial sacrectomy related to

tumors involving the sacrum

OR

• As an adjunct to the medical treatment of sacroiliac joint

infection/sepsis

OR

• As a treatment for severe traumatic injuries associated with

pelvic ring fracture

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Service Medical Necessity

Sacroiliac joint fusion performed by an open procedure for any

other indication is considered not medically necessary.

Service Investigational All other conditions and

other devices

Fixation/fusion of the sacroiliac joint for the treatment of back

pain presumed to originate from the SIJ is considered

investigational under all other conditions and with any other

devices not listed above, including, but not limited to:

• Rialto™ SI Joint Fusion System (Medtronic)-cylindrical threaded

implant

• SImmetry® Sacroiliac Joint Fusion System (Zyga Technologies)-

cylindrical threaded implant

• Silex™ Sacroiliac Joint Fusion System (XTANT Medical)-

cylindrical threaded implant

• SambaScrew® (Orthofix)-cylindrical threaded implant

• SI-LOK® Sacroiliac Joint Fixation System (Globus Medical)-

cylindrical threaded implant

Arthrography Arthrography of the sacroiliac joint is considered

investigational.

Radiofrequency

denervation

Radiofrequency denervation of the sacroiliac joint is

considered investigational.

Documentation Requirements The patient’s medical records submitted for review for all conditions should document that

medical necessity criteria are met. The record should include the following:

Office visit notes that contain the relevant history and physical.

• For diagnosing sacroiliac joint pain, provide documentation of the following:

o Three months of conservative management

o The use of imaging to guide placement of the injection

o The use of two different (controlled) diagnostic blocks with 2 anesthetic agents with

differing duration of action

• For corticosteroid injections provide documentation of the following:

o Three months of conservative management

o The use of imaging to guide the location of the injection

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Documentation Requirements o No more than 3 injections are given in one year

• For minimally invasive fixation/fusion of the sacroiliac joint, provide documentation that ALL of

the criteria above have been met plus copies of these diagnostic imaging studies:

o Imaging (plain radiographs and computed tomography or magnetic resonance imaging) of

the sacroiliac joint to exclude the presence of destructive lesions (eg, tumor, infection) or

inflammatory arthropathy of the sacroiliac joint; and

o Imaging of the pelvis (anteroposterior plain radiograph) to rule out concomitant hip

pathology; and

o 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

o Imaging of the sacroiliac joint indicates evidence of injury and/or degeneration

• For open sacroiliac joint fusion, documentation of ANY of these indications:

o As an addition to sacrectomy or partial sacrectomy related to tumors involving the sacrum

OR

o As an addition to the medical treatment of sacroiliac joint infection/sepsis

OR

o As a treatment for severe traumatic injuries associated with pelvic ring fracture

Coding

Code Description

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

27280 Arthrodesis, open, sacroiliac joint, including obtaining bone graft, including

instrumentation, when performed

64625 Radiofrequency ablation, nerves innervating the sacroiliac joint, with image guidance

(ie, fluoroscopy or computed tomography) (new code effective 1/1/20)

64635 Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging

guidance (fluoroscopy or CT); lumbar or sacral, single facet joint

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Code Description

64636 Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging

guidance (fluoroscopy or CT); lumbar or sacral, each additional facet joint

64640 Destruction by neurolytic agent; other peripheral nerve or branch

Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS

codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).

Related Information

This technically demanding procedure should only be done by surgeons who have specific

training and expertise in minimally invasive sacroiliac joint fusion surgery for chronic sacroiliac

joint pain and who regularly use image-guidance for implant placement.

Conservative nonsurgical therapy for the duration specified should include the following:

• Use of prescription strength analgesics for several weeks at a dose sufficient to induce a

therapeutic response

o Analgesics should include anti-inflammatory medications with or without adjunctive

medications such as nerve membrane stabilizers or muscle relaxants, and

• Participation in at least 6 weeks of physical therapy (including active exercise) or

documentation of why the patient could not tolerate physical therapy, and

• Evaluation and appropriate management of associated cognitive, behavioral, or addiction

issues, and

• Documentation of patient compliance with the preceding criteria.

A successful trial of controlled diagnostic lateral branch blocks consists of 2 separate positive

blocks on different days with local anesthetic only (no steroids or other drugs), or a placebo-

controlled series of blocks, under fluoroscopic guidance, that has resulted in a reduction in pain

for the duration of the local anesthetic used (eg, 3 hours longer with bupivacaine than

lidocaine). There is no consensus on whether a minimum of 50% or 75% reduction in pain would

be required to be considered a successful diagnostic block, although evidence that supported a

criterion standard of 75% to 100% reduction in pain with dual blocks. No therapeutic intra-

articular injections (ie, steroids, saline, other substances) should be administered for a period of

at least 4 weeks before the diagnostic block. The diagnostic blocks should not be conducted

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under intravenous sedation unless specifically indicated (eg, the patient is unable to cooperate

with the procedure).

Evidence Review

Description

Sacroiliac joint (SIJ) arthrography using fluoroscopic guidance with an injection of an anesthetic

has been explored as a diagnostic test for SIJ pain. Duplication of the patient’s pain pattern with

the injection of contrast medium suggests a sacroiliac etiology, as does relief of chronic back

pain with injection of local anesthetic. Treatment of SIJ pain with corticosteroids, radiofrequency

ablation (RFA), stabilization, or minimally invasive SIJ fusion has also been explored.

Background

Sacroiliac Joint Pain

Similar to other structures in the spine, it is assumed that the sacroiliac joint (SIJ) may be a

source of low back pain. In fact, before 1928, the sacroiliac joint 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 sacroiliac joint received less research attention.

Diagnosis

Research into SIJ pain has been plagued by a 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 patient. Further confounding study of the SIJ is that multiple structures, (eg, 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.

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Treatments being investigated for SIJ pain include prolotherapy (see Related Policies),

corticosteroid injection, radiofrequency ablation, stabilization, and arthrodesis. Some procedures

have been referred to as SIJ fusion but may be more appropriately called fixation due to 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.

Summary of Evidence

Diagnostic

For individuals who have suspected SIJ pain who receive a diagnostic sacroiliac block, the

evidence includes systematic reviews. Relevant outcomes are test validity, symptoms, functional

outcomes, quality of life, medication use, and treatment-related morbidity. Current evidence is

conflicting on the diagnostic utility of SIJ blocks. The evidence is insufficient to determine the

effects of the technology on health outcomes.

Therapeutic

For individuals who have SIJ pain who receive therapeutic corticosteroid injections, the evidence

includes small RCTs and case series. Relevant outcomes are symptoms, functional outcomes,

quality of life, medication use, and treatment-related morbidity. In general, the literature on

injection therapy of joints in the back is of poor quality. Results from two small RCTs showed

that therapeutic SIJ steroid injections were not as effective as other active treatments. Larger

trials, preferably using sham injections, are needed to determine the degree of benefit of

corticosteroid injections over placebo. The evidence is insufficient to determine the effects of

the technology on health outcomes.

For individuals who have SIJ pain who receive RFA, the evidence includes four small RCTs using

different radiofrequency applications and case series. Relevant outcomes are symptoms,

functional outcomes, quality of life, medication use, and treatment-related morbidity. For RFA

with a cooled probe, the two small RCTs reported short-term benefits, but these are insufficient

to determine the overall effect on health outcomes. The RCT on palisade RFA of the SIJ did not

include a sham control. Another sham-controlled randomized trial showed no benefit from RFA.

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Further high-quality controlled trials are needed to compare this procedure in defined

populations with sham control and with alternative treatments. The evidence is insufficient to

determine the effects of the technology on health outcomes.

For individuals who have SIJ pain who receive SIJ fusion/fixation with a triangular implant, the

evidence includes two nonblinded RCTs of minimally invasive fusion and two case series with

more than 85% follow-up at 2 to 3 years. Relevant outcomes are symptoms, functional

outcomes, quality of life, medication use, and treatment-related morbidity. Both RCTs reported

superior short-term results for fusion, however, a preferable design for assessing pain outcomes

would be independent, blinded assessment of outcomes or, when feasible, a sham-controlled

trial. Longer term follow-up from these RCTs has indicated that the results obtained at six

months persist to two years. An additional cohort study and case series, with sample sizes

ranging from 45 to 149 patients and low dropout rates (

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Table 1. Summary of Key Trials

NCT No. Trial Name Planned

Enrollment

Completion

Date

Ongoing

NCT02074761a Evolusion Study Using the Zyga SImmetry Sacroiliac Joint

Fusion System

250 Aug 2020

NCT03601949a Lateral Branch Cooled Radiofrequency Denervation vs

Conservative Therapy for Sacroiliac Joint Pain

208 Nov 2021

(recruiting)

NCT03507049 Sacroiliac Joint Fusion Versus Sham Operation for

Treatment of Sacroiliac Joint Pain (SIFSO)

60 Apr 2023

(recruiting)

Unpublished

NCT01861899a Treatment of Sacroiliac Dysfunction With SI-LOK®

Sacroiliac Joint Fixation System

55 Nov 2018

(unknown)

NCT02270203a LOIS: Long-Term Follow-Up in INSITE/SIFI 103 Dec 2019

(completed)

NCT: national clinical trial

a Denotes industry-sponsored or cosponsored trial

Clinical Input Received from Physician Specialty Societies and Academic

Medical Centers

While the various physician specialty societies and academic medical centers may collaborate

with and make recommendations during this process, through the provision of appropriate

reviewers, input received does not represent an endorsement or position statement by the

physician specialty societies or academic medical centers, unless otherwise noted.

2017 Input

In response to requests, clinical input focused on sacroiliac joint (SIJ) fusion was received from

10 respondents, including 5 specialty society-level responses from 7 specialty societies (2 were

joint society responses) and 5 physician-level responses from 4 academic centers while this

policy was under review in 2017. Based on the evidence and independent clinical input, the

clinical input supports that the following indication provides a clinically meaningful

https://clinicaltrials.gov/ct2/show/NCT02074761?term=NCT02074761&rank=1https://clinicaltrials.gov/ct2/show/NCT03601949?term=NCT03601949&draw=2&rank=1https://clinicaltrials.gov/ct2/show/NCT03507049?term=NCT03507049&draw=2&rank=1https://clinicaltrials.gov/ct2/show/NCT01861899?term=NCT01861899&rank=1https://clinicaltrials.gov/ct2/show/NCT02270203?term=NCT02270203&rank=1

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improvement in the net health outcome and is consistent with generally accepted medical

practice:

• Use of fusion/stabilization of the SIJ using percutaneous and minimally invasive techniques

for carefully selected patients as outlined in statements from the North American Spine

Society.

2015 Input

In response to requests, focused input on SIJ fusion was received from 5 physician specialty

societies and 3 academic medical centers while this policy was under review in 2015. Most

reviewers considered SIJ fusion to be investigational.

2014 Input

In response to requests, input was received from 4 physician specialty societies and 4 academic

medical centers (5 responses) while this policy was under review in 2014. Input was mixed

concerning the use of arthrography, radiofrequency ablation, and fusion of the SIJ. Most

reviewers considered injection for diagnostic purposes to be medically necessary when using

controlled blocks with at least 75% pain relief, and for injection of corticosteroids for treatment

purposes. Treatment with prolotherapy, periarticular corticosteroid, and periarticular botulinum

toxin were considered investigational by most reviewers.

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.39 The 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. The NASS recommended coverage when ALL of the

following criteria are met:

1. “[Patients] have undergone and failed a minimum 6 months of intensive nonoperative

treatment that must include medication optimization, activity modification, bracing and

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active therapeutic exercise targeted at the lumbar spine, pelvis, SIJ and hip including a home

exercise program.

2. Patient’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 (eg, 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 (eg, 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 patients or those with connective tissue

disorders.

5. Absence of generalized pain behavior (eg, somatoform disorder) or generalized pain

disorders (eg, 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 (eg,

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 (ie, corticosteroid injection).”

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American Society of Interventional Pain Physicians

The American Society of Interventional Pain Physicians (2013) guidelines have been updated.3

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.40 The

guidelines recommended that “Diagnostic sacroiliac joint injections or lateral branch blocks may

be considered for the evaluation of patients with suspected sacroiliac joint pain.” Based on the

opinions of consultants and society members, the guidelines recommend that “Water-cooled

RFA 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.,7,8 The guidelines stated that there is insufficient evidence

to evaluate the 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 2016.41,42 Society recommendations indicated that

patients who met all of the following criteria may be eligible for minimally invasive SIJ fusion:

• “Significant SI [sacroiliac] joint pain … or significant limitations in activities of daily living

because of pain from the SI joint(s).

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• “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 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 patient’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 (NICE) (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 Patients 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.”43

Medicare National Coverage

There is no national coverage determination.

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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, GXI.

A number of percutaneous or minimally invasive fixation/fusion devices have been cleared for

marketing by the FDA through the 510 (k) process. They include the the iFuse® Implant System

(SI Bone), the Rialto™ SI Joint Fusion System (Medtronic), SIJ-Fuse (Spine Frontier), the

SImmetry® Sacroiliac Joint Fusion System (Zyga Technologies), Silex™ Sacroiliac Joint Fusion

System (XTANT Medical), SambaScrew® (Orthofix) and the SI-LOK® Sacroiliac Joint Fixation

System (Globus Medical). FDA product code: OUR.

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14. Sun HH, Zhuang SY, Hong X, et al. The efficacy and safety of using cooled radiofrequency in treating chronic sacroiliac joint

pain: A PRISMA-compliant meta-analysis. Medicine (Baltimore). Feb 2018;97(6):e9809. PMID 29419679

15. Aydin SM, Gharibo CG, Mehnert M, et al. The role of radiofrequency ablation for sacroiliac joint pain: a meta-analysis. PM R. Sep

2010;2(9):842-851. PMID 20869684

16. Mehta V, Poply K, Husband M et al. The Effects of Radiofrequency Neurotomy Using a Strip-Lesioning Device on Patients with

Sacroiliac Joint Pain: Results from a Single-Center, Randomized, Sham-Controlled Trial. Pain Physician, 2018 Dec 5;21(6). PMID

30508988

17. Juch JNS, Maas ET, Ostelo R, et al. Effect of radiofrequency denervation on pain intensity among patients with chronic low back

pain: The Mint Randomized Clinical Trials. JAMA. Jul 04 2017;318(1):68-81. PMID 28672319

18. van Tilburg CW, Schuurmans FA, Stronks DL, et al. Randomized sham-controlled double-blind multicenter clinical trial to

ascertain the effect of percutaneous radiofrequency treatment for sacroiliac joint pain: three-month results. Clin J Pain. Nov

2016;32(11):921-926. PMID 26889616

19. Zheng Y, Gu M, Shi D, et al. Tomography-guided palisade sacroiliac joint radiofrequency neurotomy versus celecoxib for

ankylosing spondylitis: a open-label, randomized, and controlled trial. Rheumatol Int. Sep 2014;34(9):1195-1202. PMID

24518967

20. Patel N, Gross A, Brown L, et al. A randomized, placebo-controlled study to assess the efficacy of lateral branch neurotomy for

chronic sacroiliac joint pain. Pain Med. Mar 2012;13(3):383-398. PMID 22299761

21. Patel N. Twelve-month follow-up of a randomized trial assessing cooled radiofrequency denervation as a treatment for

sacroiliac region pain. Pain Pract. Feb 2016;16(2):154-167. PMID 25565322

22. 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. Mar 2015;9:6. PMID 25785242

23. Polly DW, Cher DJ, Wine KD, et al. Randomized controlled trial of minimally invasive sacroiliac joint fusion using triangular

titanium implants vs nonsurgical management for sacroiliac joint dysfunction: 12-month outcomes. Neurosurgery. Nov

2015;77(5):674-691. PMID 26291338

24. Polly DW, Swofford J, Whang PG, et al. Two-year outcomes from a randomized controlled trial of minimally invasive sacroiliac

joint fusion vs non-surgical management for sacroiliac joint dysfunction. Int J Spine Surg. Sep 2016;10:28. PMID 27652199

25. Darr E, Meyer SC, Whang PG, et al. Long-term prospective outcomes after minimally invasive trans-iliac sacroiliac joint fusion

using triangular titanium implants. Med Devices (Auckl). 2018;11:113-121. PMID 29674852

26. Sturesson B, Kools D, Pflugmacher R, et al. Six-month outcomes from a randomized controlled trial of minimally invasive SI joint

fusion with triangular titanium implants vs conservative management. Eur Spine J. Mar 2017;26(3):708-719. PMID 27179664

27. Dengler J, Sturesson B, Kools D, et al. Referred leg pain originating from the sacroiliac joint: 6-month outcomes from the

prospective randomized controlled iMIA trial. Acta Neurochir (Wien). Nov 2016;158(11):2219-2224. PMID 27629371

28. Dengler JD, Kools D, Pflugmacher R, et al. 1-Year results of a randomized controlled trial of conservative management vs.

minimally invasive surgical treatment for sacroiliac joint pain. Pain Physician. Sep 2017;20(6):537-550. PMID 28934785

Page | 18 of 24 ∞

29. Duhon BS, Cher DJ, Wine KD, et al. Triangular titanium implants for minimally invasive sacroiliac joint fusion: a prospective

study. Global Spine J. May 2016;6(3):257-269. PMID 27099817

30. Duhon BS, Bitan F, Lockstadt H, et al. Triangular titanium implants for minimally invasive sacroiliac joint fusion: 2-year follow-up

from a prospective multicenter trial. Int J Spine Surg. May 2016;10:13. PMID 27162715

31. Vanaclocha V, Herrera JM, Saiz-Sapena N, et al. Minimally Invasive Sacroiliac Joint Fusion, Radiofrequency Denervation, and

Conservative Management for Sacroiliac Joint Pain: 6-Year Comparative Case Series. Neurosurgery. Jan 1 2018;82(1):48-55.

PMID 28431026

32. Spain K, Holt T. Surgical revision after sacroiliac joint fixation or fusion. Int J Spine Surg. Apr 2017;11:5. PMID 28377863

33. Sachs D, Kovalsky D, Redmond A, et al. Durable intermediate-to long-term outcomes after minimally invasive transiliac

sacroiliac joint fusion using triangular titanium implants. Med Devices (Auckl). Jul 2016;9:213-222. PMID 27471413

34. Schoell K, Buser Z, Jakoi A, et al. Postoperative complications in patients undergoing minimally invasive sacroiliac fusion. Spine

J. Nov 2016;16(11):1324-1332. PMID 27349627

35. Tran ZV, Ivashchenko A, Brooks L. Sacroiliac Joint Fusion Methodology - Minimally Invasive Compared to Screw-Type Surgeries:

A Systematic Review and Meta-Analysis. Pain Physician, 2019 Feb 1;22(1). PMID 30700066

36. Rappoport LH, Luna IY, Joshua G. Minimally Invasive sacroiliac joint fusion using a novel hydroxyapatite-coated screw:

preliminary 1-year clinical and radiographic results of a 2-year prospective study. World Neurosurg. May 2017;101:493-497.

PMID 28216399

37. Araghi A, Woodruff R, Colle K, et al. Pain and opioid use outcomes following minimally invasive sacroiliac joint fusion with

decortication and bone grafting: The Evolusion Clinical Trial. Open Orthop J. Feb 2017;11:1440-1448. PMID 29387289

38. Cross WW, Delbridge A, Hales D, et al. Minimally Invasive sacroiliac joint fusion: 2-year radiographic and clinical outcomes with

a principles-based SIJ fusion system. Open Orthop J. Feb 2018;12:7-16. PMID 29430266

39. North American Spine Society (NASS). NASS coverage policy recommendations: Percutaneous sacroiliac joint fusion. 2015;

https://www.spine.org/PolicyPractice/CoverageRecommendations/AboutCoverageRecommendations Accessed January

2020.

40. American Society of Anesthesiologists Task Force on Chronic Pain Management, American Society of Regional Anesthesia and

Pain Medicine. Practice guidelines for chronic pain management: an updated report by the American Society of

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Medicine. Anesthesiology. Apr 2010;112(4):810-833. PMID 20124882

41. Lorio MP, Rashbaum R. ISASS policy statement - minimally invasive sacroiliac joint fusion. Int J Spine Surg. Feb 2014;8. PMID

25694942

42. Lorio MP. ISASS policy statement -- Minimally invasive sacroiliac joint fusion (July 2016). 2016; http://www.isass.org/public-

policy/isass-policy-statement-minimally-invasive-sacroiliac-joint-fusion-july-2016 Accessed January 2020.

43. National Institute for Health and Care Excellence. Minimally invasive sacroiliac joint fusion surgery for chronic sacroiliac pain

[IPG578]. 2017; https://www.nice.org.uk/guidance/ipg578 Accessed January 2020.

Appendix

“Tests that stress the SIJ in order to provoke familiar pain have acceptable inter-examiner

reliability and have clinically useful validity against an acceptable reference standard. Three or

https://www.spine.org/PolicyPractice/CoverageRecommendations/AboutCoverageRecommendationshttp://www.isass.org/public-policy/isass-policy-statement-minimally-invasive-sacroiliac-joint-fusion-july-2016http://www.isass.org/public-policy/isass-policy-statement-minimally-invasive-sacroiliac-joint-fusion-july-2016https://www.nice.org.uk/guidance/ipg578

Page | 19 of 24 ∞

more positive pain provocation SIJ tests have sensitivity and specificity of 91% and 78%

respectively.”

Figure 1 – The Distraction Test

The distraction test (testing right and left SIJ simultaneously).

Note: Vertically oriented pressure is applied to the anterior superior iliac spinous processes

directed posteriorly, distracting the sacroiliac joint.

Page | 20 of 24 ∞

Figure 2 – Thigh thrust test

The thigh thrust test (aka posterior provocation test) (testing the right SIJ).

Note: The sacrum is fixated against the table with the left hand, and a vertically oriented force is

applied through the line of the femur directed posteriorly, producing a posterior shearing force

at the SIJ.

Page | 21 of 24 ∞

Figure 3 – Gaenslen's test

Gaenslen's test (testing the right SIJ in posterior rotation and the left SIJ in anterior rotation).

Note: The pelvis is stressed with a torsion force by a superior/posterior force applied to the

right knee and a posteriorly directed force applied to the left knee.

Page | 22 of 24 ∞

Figure 4 – Compression test

The compression test (testing right and left SIJ).

Note: A vertically directed force is applied to the iliac crest directed towards the floor, i.e.,

transversely across the pelvis, compressing the SIJs.

Page | 23 of 24 ∞

Figure 5 – Sacral thrust test

The sacral thrust test (testing right and left SIJ simultaneously).

Note: A vertically directed force is applied to the midline of the sacrum at the apex of the curve

of the sacrum, directed anteriorly, producing a posterior shearing force at the SIJs with the

sacrum nutated.

Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2582421/ Accessed January 2020

FABER (Patrick’s sign) Test stands for: Flexion, Abduction and External Rotation. These three

movements combined result in a clinical pain provocation test to assist in diagnosis of

pathologies at the SI region.

History

Date Comments 03/01/18 New policy, approved February 13, 2018. This policy replaces the previous policy

6.01.23. Diagnosis and treatment of sacroiliac joint pain are considered medically

necessary when criteria are met. Arthrography and radiofrequency denervation of the

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2582421/

Page | 24 of 24 ∞

Date Comments sacroiliac joint are considered investigational. Open SIJ Fusion is medically necessary

when criteria are met. Percutaneous and minimally invasive SIJ fusion/stabilization

procedures are considered investigational.

02/01/19 Annual Review, approved January 8, 2019, Policy updated with literature review

through September 2018; references 12, 23, and 37-38 added. Policy statement added

to indicate minimally invasive fixation/fusion of the SIJ using a titanium triangular

implant is medically necessary when criteria are met.

12/01/19 Interim Review, approved November 6, 2019. Medical necessity statements for

minimally fixation/fusion of the SIJ reformatted with minor edits for greater clarity.

Intent of the policy statements unchanged.

01/01/20 Coding update, added CPT code 64625 (new code effective 1/1/20).

02/01/20 Annual Review, approved January 9. 2020. Policy updated with literature review

through August 2019; references added. Policy statements unchanged.

Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The

Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and

local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review

and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit

booklet or contact a member service representative to determine coverage for a specific medical service or supply.

CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). ©2020 Premera

All Rights Reserved.

Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when

determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to

the limits and conditions of the member benefit plan. Members and their providers should consult the member

benefit booklet or contact a customer service representative to determine whether there are any benefit limitations

applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

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Premera Blue Cross ។ របែហលជាមាន កាលបរ ិ ឆ ំខានេនៅកងេសចក

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ជាមានព័ ៌ ៉ ងសំ ់អពី ់ ៉ ប់

នដំ ងេនះមានព័ ី

តមានយា ខាន ំ ទរមងែបបបទ ឬការរា

ណ ត៌មានយ៉ា ំ ់ តងសខាន។ េសចក

េចទស ់ ន ុ ត

ណងេនះ។ អ វការបេញញសមតភាព ដលកណតៃថ ចបាស

កតាមរយៈ

ដំ ឹ នករបែហលជារតូ ច ថ ់ ំ ់ ងជាក់ ់

នដ

ន

ី ន

ូ

អ

ូ

ជ

ជ

ំណឹងេនះរបែហល

នានា េដើ ីនងរកសាទុ ៉ បរងស់ ុ ់ ក ឬរបាក់ ំ

អ

មប ឹ កការធានារា ខភាពរបស ជ

ធនកមានសិ ទទលព័ មានេនះ និ ំ យេនៅកុងភាសារបសទិ ួ ត៌ ងជ ននួ

ន

់ កេដាយម

អ

នអ

យេចញៃថល។ ួ

នអស

ន

ិ

លុ ើ ូ ូយេឡយ។ សមទ ទ រស័ព 800-722-1471 (TTY: 800-842-5357)។

Khmer

ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹ ਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ . ਇਸ ਨ ਿਜਸ ਜਵਚ ਖਾਸ

ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ. ਜੇਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ੇਇਛ ੁਕ ਹ ਤਾਂ ਤਹਾਨ ਅ ਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾਂ ਕੁ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ,ਤਹੁਾਨ ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵ ਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ,ਕਾਲ 800-722-1471 (TTY: 800-842-5357).

ਪ ਜਾਬੀ (Punjabi): ਇਸ ਨ ਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ. ਇਸ ਨ ਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤੁਹਾਡੀ

ੰ

ੰ

ੇ ੇ ੇ ੱ ੂ ੋ ੈ ੋੋ ਂ ੁ ੇ ੱ ੋ ੇ ੱੱ ੁ ੱ ੂੁ ੱ ੇ ੱ ੇ ੍ਰ ੈ

ੋ ੰ ੂ ੱ ੁ ੋ ੋ ੈ ੰ

ੋ ੈ ੋ

(Farsi): فارسی فرم بارهدر ھمم اطالعات حاوی است ممکن يهمالعا اين. ميباشد ھمم اطالعات یوحا يهمالعا اين

در ھمم ھای خيتار به باشد.پ رایبستاکنممماش زينهھ اختدپر در مککيا تان بيمهوشش حقظ

Premera Blue Cross طريق از ماش مهبيوشش يا و تقاضا ای پ. يدماين جهتو يهمالعا اين

حق شما. يدشاب داشته اجتياح صیاخ کارھای امانج برای صیمشخ ایھ خيتار به تان، انیمدر ھای کسب برای .نماييد دريافت گانيرا ورط به ودخ زبان به را کمک و اطالعات اين که داريد را اين

استم ) 5357-842-800 مارهباش ماست TTY انکاربر(800-722-1471 مارهش با اطالعات .اييدنم برقرار

้

Polskie (Polish): To ogłoszenie może zawierać ważne informacje. To ogłoszenie może

zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross. Prosimy zwrócic uwagę na kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami. Macie Państwo prawo do bezpłatnej informacji we własnym języku. Zadzwońcie pod 800-722-1471 (TTY: 800-842-5357).

Português (Portuguese): Este aviso contém informações importantes. Este aviso poderá conter informações importantes a respeito de sua aplicação ou cobertura por meio do Premera Blue Cross. Poderão existir datas importantes neste aviso. Talvez seja necessário que você tome providências dentro de determinados prazos para manter sua cobertura de saúde ou ajuda de custos. Você tem o direito de obter e sta informação e ajuda em seu idioma e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357).

Română (Romanian): Prezenta notificare conține informații importante. Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross. Pot exista date cheie în această notificare. Este posibil să fie nevoie să acționați până la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri. Aveți dreptul de a obține gratuit aceste informații și ajutor în limba dumneavoastră. Sunați la 800-722-1471 (TTY: 800-842-5357).

Pусский (Russian): Настоящее уведомление содержит важную информацию. Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross. В настоящем уведомлении могут быть указаны ключевые даты. Вам, возможно, потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами. Вы имеете право на бесплатное получение этой информации и помощь на вашем языке. Звоните по телефону 800-722-1471 (TTY: 800-842-5357).

Fa’asamoa (Samoan): Atonu ua iai i lenei fa’asilasilaga ni fa’amatalaga e sili ona taua e tatau ona e malamalama i ai. O lenei fa’asilasilaga o se fesoasoani e fa’amatala atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua atu i ai. Fa’amolemole, ia e iloilo fa’alelei i aso fa’apitoa olo’o iai i lenei fa’asilasilaga taua. Masalo o le’a iai ni feau e tatau ona e faia ao le’i aulia le aso ua ta’ua i lenei fa’asilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olo’o e iai i ai. Olo’o iai iate oe le aia tatau e maua atu i lenei fa’asilasilaga ma lenei fa’matalaga i legagana e te malamalama i ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471 (TTY: 800-842-5357).

Español ( ): Este Aviso contiene información importante. Es posible que este aviso contenga información importante acerca de su solicitud o cobertura a través de Premera Blue Cross. Es posible que haya fechas clave en este

tiene derecho a recibir esta información y ayuda en su idioma sin costo

aviso. Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura médica o ayuda con los costos. Usted

alguno. Llame al 800-722-1471 (TTY: 800-842-5357).

Spanish

Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471 (TTY: 800-842-5357).

ไทย (Thai): ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกน สขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตอง ดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอท มคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไม่มคาใชจาย โทร 800-722-1471 (TTY: 800-842-5357)

้ี ี ้ ู ํ ั ้ี ี ้ ู ่ี ํ ั ่ี ั ั ื ัุ ุ ่ ี ํ ี ุ ้ํ ิ ํ ่ี ่ ่ื ั ั ุ ุ ื ่ ื ่ีี ่ ้ ่ ุ ี ิ ิ ่ี ้ ั ้ ู ่ ื ้ี ุ ี ่ ้ ่

Український (Ukrainian): Це повідомлення містить важливу інформацію. Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross. Зверніть увагу на ключові дати, які можуть бути вказані у цьому повідомленні. Існує імовірність того, що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того, щоб зберегти Ваше медичне страхування або отримати фінансову допомогу. У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за номером телефону 800-722-1471 (TTY: 800-842-5357).

Tiếng Việt (Vietnamese): Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua chương trình Premera Blue Cross. Xin xem ngày quan trọng trong thông báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình miễn phí. Xin gọi số 800-722-1471 (TTY: 800-842-5357).