print Print Back Back

Sacroiliac Joint Fusion

Policy Number: MP-555

 

Latest Review Date: January 2019

Category: Surgery                                                                  

Policy Grade:  B

 

Description of Procedure or Service

Sacroiliac joint fusion is a surgical procedure which fuses the iliac bone (pelvis) to the spine (sacrum) for stabilization. It is performed for a variety of conditions including trauma, infection, cancer, and spinal instability. Similar to other structures in the spine, it is assumed that the sacroiliac joint may be a source of low back pain. Fusion of the sacroiliac joint was initially described as a treatment option for low back pain in 1925. Given the depth of and anatomic location of the SI joint, signicant morbidity was associated with open fusion approach and limited usage of these procedures.

Research into sacroiliac joint pain has been thwarted by any criterion standard to measure its prevalence and against which various clinical examinations can be validated. For example, sacroiliac joint 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 sacroiliac joint pain may include various movement tests, palpation to detect tenderness, and pain descriptions by the patient. Further confounding study of the sacroiliac joint is that multiple structures, such as posterior facet joints and lumbar discs, may refer pain to the area surrounding the sacroiliac joint.

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 (refer to policy # 235 Prolotherapy), corticosteroid injection, radiofrequency ablation, stabilization, and arthrodesis. For indications and coverage criteria related to diagnosis and other treatments of SIJ pain, refer to policy #558 Diagnosis and Treatment of Sacroiliac Joint Pain.

Over the past few decades, techniques utilizing trans-iliac approaches to fuse the sacroiliac joint have been developed. Minimally invasive technology has been applied to these approaches and has resulted in the development of percutaneous SI joint fusion procedures in recent years.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.

Policy:

Effective for dates of service on or after March 18, 2019 

Minimally invasive fusion/stabilization of the sacroiliac joint using an FDA approved device may be considered medically necessary when ALL of the following criteria are met:

  1. Pain is at least 5 on a 0 to 10 rating scale that impacts quality of life or limits activities of daily living; AND
  2. There is an absence of generalized pain behavior (e.g., somatoform disorder) or generalized pain disorders (e.g., fibromyalgia); AND
  3. Patients 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
  4. Pain is caudal to the lumbar spine (L5 vertebra), localized over the posterior sacroiliac joint, and consistent with sacroiliac joint pain; AND
  5. 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
  6. 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
  7. Diagnostic imaging studies include ALL of the following:
    1. 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
    2. Imaging of the pelvis (anteroposterior plain radiograph) rules out concomitant hip pathology; AND
    3. 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
    4. Imaging of the sacroiliac joint indicates evidence of injury and/or degeneration; AND
    5. 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
    6. A trial of a therapeutic sacroiliac joint injection (i.e., corticosteroid injection) has been performed on at least once.

Minimally invasive fusion/stabilization of the sacroiliac joint is not medically necessary and investigational for all other indications.

Sacroiliac joint fusion, performed by an open procedure, may be considered medically necessary when ONE of the following criterion is met:

  • 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 (e.g., osteomyelitis; pyogenic sacroiliitis) or sepsis; OR
  • as a treatment for severe traumatic injuries associated with pelvic ring fracture.

Sacroiliac joint fusion, performed by an open procedure for any other indication not listed above is considered not medically necessary and investigational.

 

Effective for dates prior to March 18, 2019:

Sacroiliac joint fusion, performed by an open procedure, may be considered medically necessary when one of the following criteria is met:

  • 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 (e.g., osteomyelitis; pyogenic sacroiliitis) or sepsis; OR
  • as a treatment for severe traumatic injuries associated with pelvic ring fracture.

Sacroiliac joint fusion, performed by an open procedure, for any other indication not listed above; including but not limited to the treatment of mechanical low back pain, arthritis, or any other type of back pain, is considered not medically necessary and investigational.

Sacroiliac joint fusion, performed by percutaneous or minimally invasive techniques, is considered not medically necessary and investigational.

Key Points:

Clinical Context and Test Purpose

The purpose of SIJ fixation/fusion with a cylindrical threaded implant is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with SIJ pain.

The question addressed in this evidence review is: Does the use of SIJ fixation/fusion with a cylindrical threaded implant improve the net health outcome in individuals with SIJ pain?

The following PICOTS were used to select literature to inform this review.

Patients

The relevant population of interest is individuals with SIJ pain.

Interventions

The therapy being considered is SIJ fixation/fusion with a cylindrical threaded implant.

Comparators

The following therapy is currently being used to treat SIJ pain: conservative therapy.

Outcomes

The general outcomes of interest are symptoms (e.g., reductions in pain), functional outcomes, quality of life, reductions in medication use, and treatment-related morbidity.

Timing

Follow-up of 2 years is of interest to monitor outcomes.

Setting

Patients with SIJ pain are actively managed by spine or musculoskeletal specialists, rheumatologists, and primary care providers in an outpatient setting.

Study Selection Criteria

Methodologically credible studies were selected using the principles outlined in indication 2.

 

SIJ Fusion/Fixation With a Triangular Implant

Randomized Controlled Trials

INSITE

Whang et al (2015) reported an industry-sponsored nonblinded RCT, Investigation of Sacroiliac Fusion Treatment (INSITE) of the iFuse Implant System in 148 patients and 2-year follow-up was reported by Polly et al (2016). However, by 12 months, almost all patients in the control group had crossed over to SIJ fusion, precluding a comparison between groups. Trial inclusion was based on a determination of the SIJ as a pain generator from a combination of a history of SIJ-localized pain, positive provocative testing on at least 3 of 5 established physical tests, and at least a 50% decrease in SIJ pain after image-guided local anesthetic injection into the SIJ. Trial characteristics are summarized in Table 1. The duration of pain before enrollment averaged 6.4 years (range, 0.47-40.7 years). A large proportion of subjects (37%) had previously undergone lumbar fusion, SIJ steroid injections (86%), and RFA (16%).

Patients were randomized 2:1 to minimally invasive SIJ fusion (n=102) or to nonsurgical management (n=46). Nonsurgical management included a stepwise progression of nonsurgical treatments, depending on individual patient choice. During follow-up, control patients received physical therapy (97.8%), intra-articular steroid injections (73.9%), and RFA of sacral nerve roots (45.7%). The primary outcome measure was the 6-month success rate, defined as the proportion of treated subjects with a 20-mm improvement in SIJ pain in the absence of severe device-related or neurologic adverse events or surgical revision. Patients in the control arm could crossover to surgery after 6 months. Baseline scores indicated that the patients were severely disabled, with VAS pain scores averaging 82.3 out of 100, and ODI scores averaging 61.9 out of 100 (0=no disability, 100=maximum disability).

Results from the INSITE trial are shown in Table 2. At 6 months, success rates were 23.9% in the control group vs 81.4% in the surgical group (posterior probability of superiority >0.999). A clinically important (>=15-point) improvement in ODI score was found in 27.3% of controls compared with 75.0% of fusion patients. Measures of quality of life (36-Item Short-Form Health Survey, EuroQol-5D) also improved to a greater extent in the surgery group. Of the 44 nonsurgical management patients still participating at 6 months, 35 (79.5%) crossed over to fusion. Compared with baseline, opioid use at 6 months decreased from 67.6% to 58% in the surgery group and increased from 63% to 70.5% in the control group (p=0.082). At 12 months, opioid use was similar between groups (55% vs 52%, p=0.61).

Polly et al (2016) reported 2-year outcomes from the SIJ fusion arm of this RCT (see Table 3). Of 102 subjects originally assigned to SIJ fusion and treated, 89 (87%) were evaluated at 2 years. In this report, clinical outcomes were based on the amount of improvement in SIJ pain and in ODI scores. The improvement was defined as a change of 20 points in SIJ pain score and 15 points in ODI score. Substantial improvement was defined as a change of 25 points in SIJ pain score—or an SIJ pain score of 35 or less—and an improvement of 18.8 points in ODI score. At 24 months, 83.1% had improvements in SIJ pain score, and 68.2% had improvements in ODI scores. By 24 months, the proportion taking opioids was reduced from 68.6% at baseline to 48.3%.

Three-year follow-up results of the INSITE and Sacroiliac Joint Fusion with iFuse Implant System trials were published by Darr et al (2018). Of 103 patients with SIJ dysfunction who were treated with minimally invasive SIJ fusion with triangular titanium implants, 60 (72.3%) patients reported an improvement in ODI scores of at least 15 points from baseline to 3 years. The mean ODI score decreased from 56 to 28 for the same timeframe, an improvement of 28 points (p<0.001); similarly, the mean SIJ pain score decreased to 26.2, reflecting a decrease of 55 points (p<0.001). Over 3 years of follow-up, 168 adverse events were reported in 75 patients, although only 22 of these events involved the pelvis. The study was limited by its lack of long-term data from a control group not receiving surgical treatment.

iMIA

In 2016 and 2017, the iFuse Implant System Minimally Invasive Arthrodesis (iMIA) study group reported another industry-sponsored multicenter RCT of the iFuse Implant System in 103 patients. Selection criteria were similar to those of the trial by Whang et al (2015), including at least a 50% pain reduction on SIJ block. The mean pain duration was 4.5 years, and about half of the patients were not working due to lower back pain. Additionally, 33% of patients had undergone prior lumbar fusion. Nonsurgical management included physical therapy and exercises at least twice per week; interventional procedures (e.g., steroid injections, RFA) were not allowed. The primary outcome was change in VAS pain score at 6 months.

All patients assigned to iFuse underwent the procedure, and follow-up at 6 months was available for 49 of 51 patients in the control group and for all 52 patients in the iFuse group. Six-month results as reported by Sturesson et al (2016) are shown in Table 2. At 6 months, VAS pain scores improved by 43.3 points in the iFuse group and by 5.7 points in the control group (p<0.001). ODI scores improved by 25.5 points in the iFuse group and by 5.8 points in the control group (p<0.001, between groups). An improvement in lower back pain by at least 20 VAS points (minimal clinically important difference) was achieved in 78.8% of the SIJ fusion group vs 22.4% of controls; p<0.001). Quality of life outcomes showed a greater improvement in the iFuse group than in the control group. Changes in pain medication use were not reported. Patients in the conservative management group were allowed to cross over to SIJ fusion at 6 months.

Twelve-month results from the iMIA trial were reported by Dengler et al (2017) (see Table 3). Twenty-one patients in the conservative management group had little or no improvement in symptoms and crossed over to SIJ fusion after the 6-month visit. Fourteen (56%) of the 25 patients who remained in the conservative management group had at least a 20-point improvement in VAS back pain score (22.4% of patients assigned to conservative management). At 12 months, low back pain had improved by 42 points (standard deviation SD,, 27.0) on a 100-point VAS in the SIJ fusion group compared with 14 points (SD=33.4) in the conservative management group (p<0.001). Mean ODI scores improved by 25 points in the SIJ fusion group compared with 8.7 points in controls (p<0.001).

Table 1. Summary of Key RCT Characteristics

Study; Trial

Countries

Sites

Dates

Participants

Interventions

Active

Comparator

Whang et al (2015); INSITE

U.S.

19

2013-2014

Patients 21-70 y with confirmed diagnosis of unilateral or bilateral SIJ dysfunction due to degenerative sacroiliitis and/or SIJ disruption

102 randomized to SIJ fusion

46 randomized to nonsurgical management

Sturesson et al (2017); iMIA

EU (Belgium, Germany, Italy, Sweden)

9

2013-2015

Patients 21-70 y with LBP for >6 mo and diagnosed with SIJ as primary pain generatora

52 randomized to SIJ fusion

51 randomized to conservative management

LBP: low back pain; RCT: randomized controlled trial; SIJ: sacroiliac joint.a The 3 criteria for diagnosis of SIJ pain were as follows: pain was present or near the posterior superior iliac spine; there were at least 3 positive findings on 5 provocative tests; at least a 50% pain reduction on fluoroscopically guided injection of local anesthetic into the joint.

Table 2. Summary of 6-Month iFuse Results From INSITE and iMIA

Results

VAS Score

Success End Point

ODI Score

SF-36 PCS Score

EQ-5D TTO Index

Ctl

iFuse

Ctl

iFuse

Ctl

iFuse

Ctl

iFuse

Ctl

iFuse

INSITE

Baseline

82.2

82.3

61.1

62.2

30.8

30.2

0.47

0.44

Follow-up

70.4

29.8

23.9%

81.4%a

56.4

31.9

32.0

42.8

0.52

0.72

Change

-12.1

-52.6a

-4.9

-30.3a

1.2

12.7

0.05

0.29

iMIA

Baseline

73.0

77.7

Follow-up

67.8

34.4

Change

-5.7

-43.3

-5.8

-25.5

0.11

0.37

Adapted from Whang et al (2015) The success end point was defined as a reduction in VAS pain score of >=20, absence of device-related events, absence of neurologic worsening, and absence of surgical intervention.Ctl: control; EQ-5D TTO Index: EuroQoL Time Tradeoff Index; ODI: Oswestry Disability Index; SF-36 PCS: 36-Item Short-Form Health Survey Physical Component Summary; VAS: visual analog scale. a p<0.001.

Table 3. Extended Follow-Up From the INSITE and iMIA Trials

Outcome Measures

Baseline (SD)

6 Months (SD)

12 Months (SD)

24 Months (SD)

INSITE

Sacroiliac joint fusion pain score

82.3

29.8

26.7

Percent >=20-point improvement pain

83.1%

Sacroiliac joint fusion ODI score

57.2

31.9

28.7

% >=15-point improvement ODI

68.2%

iMIA

Low back pain

Conservative management

73.0 (13.8)

67.8 (20.3)

58.9 (28.2)

Sacroiliac joint fusion

77.7 (11.3)

34.4 (23.9)

35.2 (25.5)

Leg pain

Conservative management

47.1 (31.1)

46.5 (31.4)

41.7 (32.4)

Sacroiliac joint fusion

52.7 (31.5)

22.6 (25.1)

24.0 (27.8)

ODI

Conservative management

55.6 (13.7)

50.2 (17.2)

46.9 (20.8)

Sacroiliac joint fusion

57.5 (14.4)

32.0 (18.4)

32.1 (19.9)

Adapted from Dengler et al (2017). ODI: Oswestry Disability Index; SD: standard deviation.

Tables 4 and 5 display notable gaps identified in each study.

Table 4. Relevance Gaps

Study; Trial

Populationa

Interventionb

Comparatorc

Outcomesd

Follow-Upe

Whang et al (2015); INSITE

Sturesson et al (2017); iMIA

1. Patients with other contributory sources of LBP might have been enrolled with SIJ-caused LBP patients

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.LBP: low back pain; SIJ: sacroiliac joint.a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.

b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest.

c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.

d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.

e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 5. Study Design and Conduct Gaps

Study; Trial

Allocationa

Blindingb

Selective Reportingd

Data Completenesse

Powerd

Statisticalf

Whang et al (2015); INSITE

Sturesson et al (2017); iMIA

1. Intervention was unblinded

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.

a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.

b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.

c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.

d Follow-Up key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).

e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.

f Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Subsection Summary: Randomized Controlled Trials

Two RCTs have reported outcomes past 6 months, after which crossover was allowed. Both studies reported significantly greater reductions in VAS pain scores and ODI scores in SIJ fusion patients than in control groups. The reductions in pain and disability observed in the SIJ fusion group at 6 months were maintained out to 1 year compared with controls who had not crossed over. The RCTs were nonblinded without a placebo or an active control group. However, pain has a significant subjective and psychologic component. Cognitive behavioral techniques to address pain were specifically excluded from the types of treatment that control subjects could obtain. Thus, as relates to trial design, an independent assessment of pain outcomes would have been preferable.

Nonrandomized Studies

Prospective cohort studies with good follow-up rates are more likely to provide valid estimates of outcomes. Principal results of the studies at 2- to 3-year follow-up are shown in Table 6.

Results from a cohort of 172 patients undergoing SIJ fusion reported to 2 years were published by Duhon et al (2016). Patients were formally enrolled in a single-arm trial (NCT01640353) with planned follow-up for 24 months. Success was defined as a reduction of pain score of 20-mm on a 100-mm VAS, absence of device-related adverse events, absence of neurologic worsening, and absence of surgical reintervention. Enrolled patients had a mean VAS pain score of 79.8, a mean ODI score of 55.2, and a mean pain duration of 5.1 years. At 6 months, 136 (80.5%) of 169 patients met the success end point, which met the prespecified Bayesian probability of success rate. Mean VAS pain scores were 30.0 at 6 months and 30.4 at 12 months. Mean ODI scores were 32.5 at 6 months and 31.4 at 12 months. At 2 years, 149 (87%) of 172 patients were available for follow-up. The VAS pain score at 2 years was 26.0, and the ODI score was 30.9. Thus, 1-year outcomes were maintained at 2 years. Other outcomes (e.g., quality of life scores) showed similar maintenance or slight improvement compared with 1-year outcomes. Use of opioid analgesics decreased from 76.2% at baseline to 55% at 2 years. Over the 2-year follow-up, 8 (4.7%) patients required revision surgery.

Table 6. Two- to 3-Year Outcomes of the iFuse Implant in Cohorts and Case Series

Studies and Outcomes

Mean Baseline Value

Mean 2- to 3-Year Value

Difference or % Achieving Outcome

Follow-Up Rate

Duhon et al (2016)

Pain score (range, 0-100)

79.8

26.0

53.3

86.6% (149/172)

Oswestry Disability Index score

55.2

30.9

24.5

SF-36 score

31.7

40.7

8.9

EQ-5D TTO score

0.43

0.71

0.27

Sachs et al (2016)

Pain score (range 0-10)

7.5

2.5

Oswestry Disability Index score

28.2

All differences between baseline and 2- to 3-year values were statistically significant.

EQ-5D TTO Index: EuroQoL Time Tradeoff Index; SF-36: 36-Item Short-Form Health Survey.

Nonrandomized Comparative Studies

Two retrospective nonrandomized comparative studies have been published. Vanaclocha et al (2018) found greater pain relief with SIJ fusion than with conservative management or SIJ denervation., Spain and Holt (2017) reported a retrospective review of surgical revision rates following SIJ fixation with either surgical screws or the iFuse triangular implant. Revision rates were lower with the iFuse device than observed with surgical screws.

Subsection Summary: Nonrandomized Studies

In general, cohort studies and case series have shown improvements in VAS pain scores and other outcomes measures consistent in magnitude to the RCTs. The subset of studies with good (>85%) follow-up rates generally showed that short-term outcomes were maintained. Two studies of reasonable sample size with good follow-up showed results maintained to 2 years. These results are consistent with the medium-term durability of treatment. Analysis of an insurance database reported an overall incidence of complications to be 16.4% at 6 months and cumulative revision rate at 4 years of 3.54%.

Section Summary: SIJ Fusion/Fixation With a Triangular Implant

The evidence on SIJ fusion/fixation with a triangular implant includes 2 nonblinded RCTs of minimally invasive fusion and 2 case series with more than 85% follow-up at 2 to 3 years. Both RCTs reported superior short-term results for fusion, however, a preferable design for assessing pain outcomes would be an 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 6 months persist to 2 years. An additional cohort study and case series with sample sizes ranging from 45 to 149 patients and low dropout rates (<15%) also showed reductions in pain and disability at 2 years. One small case series showed outcomes that persisted to 5 years. The cohort studies and case series are consistent with the durability of treatment benefit. Analysis of an insurance database reported an overall incidence of complications to be 16.4% at 6 months and the cumulative revision rate at 4 years of 3.54%.

 

SIJ Fusion/Fixation with a Cylindrical Threaded Implant

Clinical Context and Test Purpose

The purpose of SIJ fixation/fusion with a cylindrical threaded implant is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with SIJ pain.

The question addressed in this evidence review is: Does the use of SIJ fixation/fusion with a cylindrical threaded implant improve the net health outcome in individuals with SIJ pain?

The following PICOTS were used to select literature to inform this review.

 

Patients

The relevant population of interest is individuals with SIJ pain.

Interventions

The therapy being considered is SIJ fixation/fusion with a cylindrical threaded implant.

Comparators

The following therapy is currently being used to treat SIJ pain: conservative therapy.

Outcomes

The general outcomes of interest are symptoms (e.g., reductions in pain), functional outcomes, quality of life, reductions in medication use, and treatment-related morbidity.

Timing

Follow-up of 2 years is of interest to monitor outcomes.

Setting

Patients with SIJ pain are actively managed by spine or musculoskeletal specialists, rheumatologists, and primary care providers in an outpatient setting.

Study Selection Criteria

Methodologically credible studies were selected using the principles outlined in indication 2.

 

Prospective Studies

Rappoport et al (2017) reported on an industry-sponsored prospective study of SIJ fusion with a cylindrical threaded implant (SI-LOK). The study included 32 patients using a diagnosis of SIJ dysfunction who had failed nonoperative treatment, including medication, physical therapy, and therapeutic injections. A diagnostic injection was performed to confirm the source of pain to the SIJ. The procedure included drilling to prepare for screw insertion and implantation of 3 screws, at least one of which was slotted. The slotted screws were packed with an autogenous bone graft from the drill reamings. Pain and disability scores were reduced following device implantation (see Table 17), and revisions within the first 12 months of the study were low (n=2). Follow-up will continue through 2 years.

 

Araghi et al (2017) published interim results from an industry-sponsored prospective cohort study evaluating pain and ODI outcomes for patients treated for SIJ pain with the SImmetry system. For the 50 patients enrolled at the time of publication, the mean VAS score had decreased from 76.2 at baseline to 35.1 at 6 months after the procedure (p<0.001), with 36 (72%) patients achieving minimal clinically important difference (at least a 20-point reduction). The mean ODI score likewise showed significant improvement from baseline to 6 months, decreasing from 55.5 to 35.3 (p<0.001). Over half of the cohort (56% n=28,) achieved the minimal clinically important difference (15-point reduction) on the ODI. Prior to surgery, 66% (n=33) of the cohort were on opioids, decreasing to 30% (n=15) at the 6-month follow-up (p<0.001). Quality of life was assessed with the EQ-5D time trade-off index: at baseline, the mean EQ-5D was 0.51, decreasing to 0.69 after 6 months (p<0.001). Likewise, improvements in the Physical and Mental Components Summary scores of the 36-Item Short-Form Health Survey were significantly improved at 6 months, compared with baseline. The strength of findings was limited by the small sample size and short follow-up; without full enrollment of 250 patients, the trial is underpowered to detect contributing factors to fusion and pain relief. Also, the trial does not have a control group. Follow-up data will be published at 1 and 2 years.

 

Case Series

Cross et al (2018) published a case series of 19 patients from 3 centers who underwent minimally invasive SIJ fusion with decortication, placement of bone graft, and fixation with threaded implants. At 12 months, bridging bone across the SIJ was observed in 79% (n=15) of patients, increasing to 94% (n=17 of 18 patients with data available) at 24 months. At 24 months postprocedure, 88% (n=15) had fusion within the decorticated area, and the same percentage of patients (88% n=15,) had solid fusion. While the study was not powered to detect associations between radiographic fusion and clinical outcomes, the authors reported a significant change in the mean numeric rating scale score for pain, from preprocedure to 24-month follow-up: patients showed an average 73% reduction in low back pain (7.9/10 decreased to 2.1/10, p<0.01; effect size, -2.9). The industry-sponsored study had a small sample size, but provided follow-up data at 2 years after SIJ fusion with a threaded implant, indicating a need for larger comparative studies to confirm the favorable radiographic fusion results suggested by the study.

 

Table 7. Pain and Disability Scores After Implantation With a Cylindrical Threaded Implant

Outcome Measures

Baseline

3 Months (SD)

6 Months (SD)

12 Months (SD)

p

Low back pain

55.8 (26.7)

28.5 (21.6)

31.6 (26.9)

32.7 (27.4)

<0.01

Left leg pain

40.6 (29.5)

19.5 (22.9)

16.4 (25.6)

12.5 (23.3)

<0.01

Right leg pain

40.0 (34.1)

18.1 (26.3)

20.6 (25.4)

14.4 (21.1)

<0.05

Oswestry Disability Index

55.6 (16.1)

33.3 (16.8)

33.0 (16.8)

34.6 (19.4)

<0.01

Adapted from Rappoport et al (2017). SD: standard deviation.

 

Section Summary: SIJ Fixation/Fusion With Cylindrical Threaded Implant

There is limited evidence on the fusion of the SIJ with devices other than the triangular implant. One-year results from a prospective cohort of 32 patients who received a cylindrical slotted implant showed reductions in pain and disability similar to results obtained for the triangular implant. However, there is uncertainty in the health benefit of SIJ fusion/fixation with this implant design. Therefore, controlled studies with a larger number of patients and longer follow-up are needed to evaluate this device.

 

Summary of Evidence

For individuals who SIJ pain who receive SIJ fusion/fixation with a triangular implant, the evidence includes 2 nonblinded RCTs of minimally invasive fusion and 2 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 6 months persist to 2 years. An additional cohort study and case series, with sample sizes ranging from 45 to 149 patients and low dropout rates (<15%), have also shown reductions in pain and disability at 2 years. One small case series showed outcomes that persisted to 5 years. These cohort studies and case series are consistent with the durability of treatment benefit, but only if there is a true benefit of treatment. Analysis of an insurance database reported an overall incidence of complications to be 16.4% at 6 months and cumulative revision rate at 4 years of 3.54%. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have SIJ pain who receive SIJ fusion/fixation with a cylindrical threaded implant, the evidence includes a prospective cohort. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. The prospective cohort study will follow patients for 2 years following implantation of slotted screws filled with autologous bone. Results at 1 year are consistent with findings from the studies using a triangular implant. However, longer follow-up and controlled trials are needed to evaluate this type of implant. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

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. A majority of reviewers considered SIJ fusion to be investigational.

International Society for the Advancement of Spine Surgery (ISASS)

The International Society for the Advancement of Spine Surgery (ISASS) published a policy statement on minimally invasive sacroiliac joint fusion in 2014. These recommendations were updated in a 2016 statement. ISASS has specific criteria for patients who may be eligible for minimally invasive sacroiliac joint fusion. These recommendations may be found on the ISASS website.

North American Spine Society

The North American Spine Society (NASS) published coverage recommendations for percutaneous sacroiliac joint (SIJ) fusion in 2015. 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. “[Patients] 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. 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, 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 patients 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:
    1. 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.
    2. Imaging of the pelvis (AP [anteroposterior] plain radiograph) to rule out concomitant hip pathology.
    3. 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.
    4. 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).”

National Institute for Health and Care Excellence

National Institute for Health and Care Excellence guidance was published in 2017 on minimally invasive SIJ fusion surgery for chronic sacroiliac pain. The recommendations included:

      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…. provided that standard arrangements are in place for clinical governance, consent and audit.
      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.
      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.”

U.S. Preventive Services Task Force Recommendations

Not Applicable.

 

Key Words:

Sacroiliac Joint Arthrodesis, SInergy, SI sacroiliac joint stabilization for arthrodesis, SI-FIX Sacroiliac Joint Fusion System ,IFUSE Implant System, SImmetry Sacroiliac Joint Fusion System and the SI-LOK, Minimally invasive sacroiliac joint fusion, percutaneous sacroiliac joint fusion, Silex, XTANT, SambaScrew, Si Bone, titanium triangular implant

 

Approved by Governing Bodies:

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 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).

Benefit Application:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

Current Coding: 

CPT Codes:

22899    Unlisted procedure, spine
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
27299              Unlisted procedure, pelvis or hip joint

          

            

    

References:

  1. 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 Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology. Apr 2010; 112(4):810-833.
  2. Ackerman SJ et al. Comparison of the costs of nonoperative care to minimally invasive surgery for sacroiliac joint disruption and degenerative sacroiliitis in a United States Medicare population: potential economic implications of a new minimally-invasive technology. Clinicoecon Outcomes Res. 2013; 5:575-587.
  3. 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.
  4. Ashman B, Norvell DC, Hermsmeyer JT. Chronic sacroiliac joint pain: fusion versus denervation as treatment options. Evid Based Spine Care J 2010; 1(3):35-44.
  5. Boswell MV, Trescot AM, Datta S et al. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician 2007; 10(1):7-111.
  6. Cher DJ, Reckling WC, Capobianco RA. Implant survivorship analysis after minimally invasive sacroiliac joint fusion using the iFuse Implant System((R)). Med Devices (Auckl). Dec 2015; 8:485-492.
  7. Chou R, Loeser JD, Owens DK et al. Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society. Spine (Phila Pa 1976) 2009; 34(10):1066-1077.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. Dreyfuss P, Michaelsen M, Pauza K et al. The value of medical history and physical examination in diagnosing sacroiliac joint pain. Spine (Phila Pa 1976) 1996; 21(22):2594-2602.
  13. Duhon et al. Safety and 6-month effectiveness of minimally invasive sacroiliac joint fusion: a prospective study. Med Dev (Auckl) 2013; 6:219-229.
  14. 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. 2016; 10:13.
  15. Duhon B, Cher D, 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.
  16. Graham-Smith et al. Open versus minimally invasive sacroiliac joint fusion: a multi-center comparison of perioperative measures and clinical outcomes. Ann Surg Innov Res 2013; 7:1-12.
  17. Hansen HC, McKenzie-Brown AM, Cohen SP, et al. Sacroiliac joint interventions: a systematic review. Pain Physician. Jan 2007; 10(1):165-184.
  18. Hansen H, Manchikanti L, Simopoulos TT, et al. A systematic evaluation of the therapeutic effectiveness of sacroiliac joint interventions. Pain Physician. May-Jun 2012; 15(3):E247-278.
  19. Heiney J, Capobianco R, Cher D. A systematic review of minimally invasive sacroiliac joint fusion using lateral transarticular technique. Intern J of Spine 2015; 9(40).
  20. International Society for the Advancement of Spine Surgery (ISASS) statement on minimally invasive SI joint fusion coding changes. www.isass.org/public_policy/2013-08-07-isass-statement-minimally-invasive-si-joint-fusion-coding-changes.html.
  21. International Society for the Advancement of Spinal Surgery (IASS). Recommendations for Coverage Criteria for Sacroiliac Joint Fusion. 2015; www.isass.org/public_policy/2015-03-19-coverage-criteria-for-minimallyinvasive-si-joint-fusion-2015.html.
  22. International Society for the Advancement of Spinal Surgery (ISASS). ISASS policy 2016 update- minimally invasive sacroilliac joint fusion. 2016; www.isass.org/public-policy/isass-policy-statement-minimally-invasive-sacroiliac-joint-fusion-july-2016/.
  23. Lorio MP, Rashbaum R. ISASS policy statement - minimally invasive sacroiliac joint fusion. Int J Spine Surg. 2014; 8.
  24. Manchikanti L, Abdi S, Atluri S, et al. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. Apr 2013; 16(2Suppl):S49-283.
  25. Manchikanti L, Boswell MV, Singh V et al. Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician 2009; 12(4):699-802.
  26. Manchikanti L, Datta S, Derby R, et al. A critical review of the American Pain Society clinical practice guidelines for interventional techniques: part 1. Diagnostic interventions. Pain Physician. May-Jun 2010; 13(3):E141-174.
  27. Manchikanti L, Datta S, Gupta S, et al. A critical review of the American Pain Society clinical practice guidelines for interventional techniques: part 2. Therapeutic interventions. Pain Physician. Jul-Aug 2010; 13(4):E215-264.
  28. Mason LW, Chopra I, Mohanty K. The percutaneous stabilisation of the sacroiliac joint with hollow modular anchorage screws: a prospective outcome study. Eur Spine J 2013; 22(10):2325-2331.
  29. Miller L et al. Analysis of the postmarket complaints database for the iFuse SI Joint Fusion System®: a minimally invasive treatment for degenerative sacroiliitis and sacroiliac joint disruption. Med Device (Auckl) 2013; 6:77-84.
  30. North American Spine Society (NASS). NASS coverage policy recommendations: Percutaneous sacroiliac joint fusion. 2015; https://www.spine.org/PolicyPractice/CoverageRecommendations/CoverageRecommendations.aspx.
  31. 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.
  32. Polly D, Swofford J, Whang P, 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. 2016; 10:28.
  33. 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.
  34. Rudolf L. Sacroiliac Joint Arthrodesis-MIS Technique with Titanium Implants: Report of the First 50 Patients and Outcomes. Open Orthop J 2012; 6:495-502.
  35. Rudolf L. MIS sacroiliac (SI) joint fusion in the context of previous lumbar spine fusion: 5 patients with 24 month follow up. In Int. Soc. Adv. Spine Surg. 107(2013).
  36. Rudolf L, Capobianco R. Five-year clinical and radiographic outcomes after minimally invasive sacroiliac joint fusion using triangular implants. Open Orthop J. 2014; 8:375-383.
  37. Rupert MP, Lee M, Manchikanti L et al. Evaluation of sacroiliac joint interventions: a systematic appraisal of the literature. Pain Physician 2009; 12(2):399-418.
  38. Sachs D, Capobianco R. One year successful outcomes for novel sacroiliac joint arthrodesis system. Ann Surg Innov Res 2012; 6(1):13.
  39. Sachs D, Capobianco R, Cher D, et al. One-year outcomes after minimally invasive sacroiliac joint fusion with a series of triangular implants: a multicenter, patient-level analysis. Med Devices (Auckl). 2014; 7:299-304.
  40. 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). 2016; 9:213-222.
  41. 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.
  42. Schwarzer AC, Aprill CN, Bogduk N. The sacroiliac joint in chronic low back pain. Spine (Phila Pa 1976) 1995; 20(1):31-37.
  43. Smith AG, Capobianco R, Cher D et al. Open versus minimally invasive sacroiliac joint fusion: a multi-center comparison of perioperative measures and clinical outcomes. Ann Surg Innov Res. Oct 30 2013; 7(1):14.
  44. Spain K, Holt T. Surgical revision after sacroiliac joint fixation or fusion. Int J Spine Surg. Apr 2017; 11:5.
  45. Spiker WR, Lawrence BD, Raich AL et al. Surgical versus injection treatment for injection-confirmed chronic sacroiliac joint pain. Evid Based Spine Care J 2012; 3(4):41-53.
  46. 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.
  47. 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. Apr 20 2017.
  48. Weksler N, Velan GJ, Semionov M et al. The role of sacroiliac joint dysfunction in the genesis of low back pain: the obvious is not always right. Arch Orthop Trauma Surg 2007; 127(10):885-888.
  49. Whang P, Cher D, Polly D, et al. Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion Using Triangular Titanium Implants vs. Non-Surgical Management for Sacroiliac Joint Dysfunction: 12 month Outcomes. Neurosurgery 2015.
  50. 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.
  51. Wise CL, Dall BE. Minimally invasive sacroiliac arthrodesis: outcomes of a new technique. J Spinal Disord Tech 2008; 21(8):579-584.

Policy History:

Medical Policy Panel February 2014

Medical Policy Group, February 2014

Medical Policy Administration Committee, February 2014

Available for comment March 7 through April 20, 2014

Medical Policy Group, June 2014 (4): Added more References

Medical Policy Panel, May 2014

Medical Policy Group, September 2014 (3):  2014 Updates to Key Points, Key Words, Governing Bodies & References; no change in policy statement

Medical Policy Group, November 2014: 2015 Annual Coding Update – verbiage change to code 27280 to add ‘open’ and ‘including instrumentation when performed’. Also added code 27279 to current coding and created Previous Coding section to include deleted code 0334T.

Medical Policy Panel, May 2015

Medical Policy Group, September 2015 (2): 2015 Updates to Key Points and References; no change to policy statement.

Medical Policy Panel, November 2015

Medical Policy Group, November 2015 (2): 2015 Updates to Key Points and References; no change to policy statement.

Medical Policy Panel, October 2016

Medical Policy Group, October 2016 (7): 2016 Updates to Key Points and References; no change to policy statement.

Medical Policy Panel, December 2017

Medical Policy Group, January 2018 (7): 2018 Updates to Key Points, Key Words, Approved by Governing Bodies, and References; no change to policy statement.

Medical Policy Panel, November 2018

Medical Policy Group, January 2019 (7): Updated Policy Statement- coverage statement added for minimally invasive fusion/stabilization of the sacroiliac joint. Added Keywords: Si Bone, titanium triangular implant. Updated References. Removed Previous Coding section- 0334T was deleted effective 1/1/15. 

Available for comment February 1, 2019 through March 17, 2019. 

                                                                                                                                               

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.