Description/Background
Therapeutic Spinal Epidural Injections or Select Nerve Root Blocks (Transforaminal) are types of interventional pain management procedures. The therapeutic use of epidural injections is for short-term pain relief associated with acute back pain or exacerbation of chronic back pain. With therapeutic injections, a corticosteroid is injected close to the target area with the goal of pain reduction. Epidural injections should be used in combination with other conservative treatment* modalities and not as stand-alone treatment for long-term back pain relief. There are different approaches used when administering spinal epidural injections:

• Interlaminar epidural injections, with steroids, access the epidural space between two vertebrae (Interlaminar) to treat cervical, lumbar or thoracic pain with radicular pain. These procedures should be performed using fluoroscopic guidance. Interlaminar epidural injections are the most common type of epidural injection.
• Transforaminal epidural injections (also called selective nerve root blocks) access the epidural space via the intervertebral foramen where the spinal nerves exit (cervical, lumbar or thoracic region). They are used both diagnostically and therapeutically. Some studies report lack of evidence and risks of transforaminal epidural injections. These procedures are always aided with fluoroscopic guidance.
• Caudal epidural injections, with steroids, are used to treat back and lower extremity pain, accessing the epidural space through the sacral hiatus, providing access to the lower nerve roots of the spine. These procedures should be performed using fluoroscopic guidance. Failed back surgery syndrome is the most common reason for the caudal approach.

The rationale for the use of spinal epidural injections is that the sources of spinal pain, e.g., discs and joints, are accessible and amenable to neural blockade.

Medical necessity management for epidural injections includes an initial evaluation including history and physical examination and a psychosocial and functional assessment. The following must be determined: nature of the suspected organic problem; non-responsiveness to conservative treatment*; level of pain and functional disability; conditions that may be contraindications to epidural injections; and responsiveness to prior interventions.

Interventional pain management specialists do not agree on how to diagnose and manage spinal pain; there is a lack of consensus with regard to the type and frequency of spinal interventional techniques for treatment of spinal pain. The American Society of Interventional Pain Physicians (ASIPP) guidelines and International Spine Intervention Society (SIS) guidelines provide an algorithmic approach that provides a step-by-step procedure for managing chronic spinal pain based upon evidence-based guidelines. It is based on the structural basis of spinal pain and incorporates acceptable evidence of diagnostic and therapeutic interventional techniques available in managing chronic spinal pain.

The guidelines and algorithmic approach referred to above include the evaluation of evidence for diagnostic and therapeutic procedures in managing chronic spinal pain and recommendations for managing spinal pain. The Indications and Contraindications presented within this document are based on the guidelines and algorithmic approach. Prior to performing this procedure, shared decision-making between patient and physician must occur, and the patient must understand the procedure and its potential risks and results (moderate short-term benefits, and lack of long-term benefits).

Policy 
EPIDURAL INJECTIONS OR SELECTIVE NERVE BLOCKS (caudal, interlaminar, and transforaminal) (Injection of local anesthetics with corticosteroids) are considered Medically Necessary for the following conditions:

Acute pain or exacerbation of chronic radicular pain with the following clinical timeframes:

• Neck or Back Pain with acute radicular pain:
  • after 2 weeks or more of acute radicular pain that has failed to respond or poorly responded to appropriate conservative (including medication) management unless the medical reason this conservative treatment cannot be done is clearly documented ; OR
• Failed back surgery syndrome or epidural fibrosis causing radicular pain:
  • typically not done immediately post-surgery. Documentation requires a medical reason that clearly indicates why an injection is needed.
  • patient must engage in some form of other appropriate conservative treatment* for a minimum of 6 weeks in the last 6 months or details of engagement in other forms of active conservative non-operative treatment if teh patient had any prior spinal injections prior to epidural injections unless the medical reason this conservative treatment cannot be done is clearly documented; OR
• Spinal stenosis (foraminal, central or disc disease) causing  axial or radicular pain
  • Patient must engage in some form of other active conservative treatment* for a minimum of 6 weeks in the last 6 months; OR details of engagement in other forms of active conservative non-operative treatment, if the patient had any prior spinal injections prior to epidural injections, unless the medical reason this conservative treatment cannot be done is clearly documented; (Manchikanti, 2013; Summers, 2013).
• Diagnostic transforminal injection to identify the pain generator for surgical planning (Manchikanti, 2013).

AND

•  Average pain levels of ≥6 on a scale of 0 to 10 or intermittent or continuous pain causing functional disability

Policy Guidelines
FREQUENCY OF REPEAT THERAPEUTIC INJECTIONS: 

Epidural injections may be repeated only as medically necessary. Each epidural injection requires an authorization and the following criteria must be met for repeat injections:

• Documented proof that the prior injection had a positive response by significantly decreasing the patient’s pain (at least 30% reduction in pain after initial injections or significant documented functional improvement) (NASS, 2013). Or a second injection may be performed at a different spinal level or with a different epidural technique, if there is documentation of a question about the pain generator or there is evidence of multilevel pathology (ODG, 2017); AND
• No more than 3 procedures in a 12-week period of time per region, with at least 14 days between injections in the initial therapeutic phase. At least 50% or more cumulative pain relief obtained for a minimum of 6 weeks after initial injections (Manchikanti, 2013); AND
• The patient continues to have documented functional disability or pain level ≥ 6 on a scale of 0 to 10 (Manchikanti, 2013, 2011; NASS, 2013; Summers, 2013); AND
• The patient is actively engaged in other forms of active conservative non-operative treatment, unless pain prevents the patient from participating in conservative therapy* (Qassem, 2017; Summers, 2013);AND 
• In the first year of treatment, which may include an initial series of 3 injections in the initial therapeutic phase and additional injections in the maintenance phase, a total of 6 epidural injections, per region, may be performed (Manchikanti, 2013).  
• Repeat injections after the initial therapeutic phase should be done at intervals of at least 2 months, provided that previous injections resulted in at least 50% relief or functional improvement for at least 2 months, and are limited to a maximum total of 4 therapeutic procedures per region per 12 months (Manchikanti, 2013; NASS, 2013). If special circumstances are documented (e.g., elderly patient with severe spinal stenosis and not an operative candidate) then repeat injections are limited to a maximum of 6 procedures in 12 months (NASS, 2013).

NOTE: Each epidural injection requires an authorization. 

• If the neural blockade is applied for different regions, injections may be administered at intervals of no sooner than 7 days for most types of procedures (Manchikanti, 2013).
• Injecting multiple regions or performing multiple procedures during the same visit may be deemed medically unnecessary unless documentation is provided outlining an unusual situation (ODG, 2017).
• No more than 2 levels of transforaminal blocks should be done in one day (Singh, 2017). 
• An intraspinal injection* of opioid or other substance for the purpose of completing a trial for an implantable infusion pump is approvable using NIA_CG_310.

NOTE:  See Background section

EXCLUSIONS
These requests are excluded from consideration under this guideline:

• Implantation of intrathecal catheters or ports for chemotherapy
• Intrathecal injections for muscular dystrophy
• Post-operative pain control

CONTRAINDICATIONS FOR EPIDURAL INJECTIONS

• Bleeding diathesis and full anticoagulation (risk of epidural hematoma);
• Severe spinal stenosis resulting in intraspinal obstruction;
• Local infection at injection site;
• Predominantly psychogenic pain;
• Sepsis;
• Hypovolemia;
• Uncontrolled diabetes;
• Uncontrolled glaucoma;
• High concentrations of local anesthetics in patients with multiple sclerosis;
• For diagnosis or treatment of facet mediated pain;
• Known or suspected allergic reaction to steroid medications;
• Spinal infection; or
• Acute fracture

Rationale
Assessment of efficacy for therapeutic intervention involves a determination of whether the intervention improves health outcomes. The optimal study design for this purpose is a randomized controlled trial (RCT) that includes clinically relevant measures of health outcomes. Intermediate outcome measures, also known as surrogate outcome measures, may also be adequate if there is an established link between the intermediate outcome and true health outcomes. Nonrandomized comparative studies and uncontrolled studies can sometimes provide useful information on health outcomes but are prone to biases such as noncomparability of treatment groups, placebo effect and variable natural history of the condition.

The evidence base on the efficacy of epidural steroid injections (ESIs) for back pain is large, with many RCTs published. In addition to the RCTs, there have been numerous systematic reviews of RCTs published. This literature review will therefore concentrate on a representative sample of the available systematic reviews of RCTs, emphasizing those published most recently.

Sciatica/Radiculopathy
Lumbar Radiculopathy/Sciatica
A systematic review of ESIs for the management of sciatica was published by Pinto et al. in 2012.³ This review included RCTs that provided information on at least 1 of the outcomes of overall pain, leg pain, back pain or disability status. There were a total of 25 publications included in the review, representing 23 unique trials. The sample size in the trials ranged from 23 to 325, with most studies enrolling fewer than 100 patients. Using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) classification, the level of quality was determined to be high for each outcome. 

Pooled results for each of the outcomes are summarized in Table 1. The magnitude of the between-group differences is small, and statistically significant only for the outcomes of short-term leg pain and short-term disability. The greatest magnitude of difference was 6.2 units on a 0-to-100 visual analog scale (VAS) for short-term leg pain. This magnitude of difference is below the minimally important difference for a 0 to 100 pain scale, which is generally considered to be in the range of 10 to 30 units.⁷ 

Table 1. Pooled Results From a Systematic Review of ESIs for the Management of Sciatica 

Outcome (0-100 Scale)	Weighted Mean Difference Between Groups (95% CI)
	Short Term	Long Term
Leg pain	-6.2 (-9.0 to -3.0)	-4.8 (-10.2 to 0.7)
Back pain	0.5 (-3.9 to 4.8)	3.4 (-2.4 to 9.2)
Disability	-3.1 (-5.0 to -1.2	-2.7 (-6.8 to 1.3)

Adapted from Pinto et al.³
CI: confidence interval; ESI: epidural steroid injection.

In 2012, Benyamin et al. published a systematic review that included RCTs and non-RCTs of epidural injections in patients with low back pain and/or leg pain.² There were 19 studies that met the inclusion criteria. Most of these trials (13/19) compared epidural steroids with an active control and 5 of 19 used a placebo control. A qualitative summary of studies was performed, without any quantitative meta-analysis. Subgroup analysis was performed on studies that included patients with disc herniation and radiculopathy. The authors also separated the intervention into studies that used fluoroscopic guidance. Of the 8 studies that used fluoroscopic guidance, all reported short-term results that favored ESIs. Among 4 trials that reported longer term follow-up at 1 year, results from 2 were positive and 2 were negative. 

In 2009, Chou et al. reviewed the evidence for ESIs in the treatment of low back pain with radiculopathy, as part of their examination of nonsurgical interventional therapies for low back pain.⁴ The authors identified 17 RCTs reporting on short-term benefit, and 4 RCTs reporting on longer term benefit. For short-term benefits, the results were mixed. A total of 10 of 17 trials reported no benefit for ESIs, and 7 of 17 reported a statistically significant benefit. Of the 7 trials that were rated higher quality, 4 of 7 reported a benefit for ESIs and 3 of 7 reported no benefit. Subgroup analysis by type of placebo control (epidural or soft-tissue injection) revealed that most trials using a soft-tissue control injection (5/6) reported a benefit, while most of the trials using an epidural control injection (9/11) reported no benefit. Other subgroup analyses based on duration of symptoms, use of imaging to confirm prolapsed disc and study quality did not show any significant differences.

A systematic review by Manchikanti et al. in 2012 identified 13 RCTs that evaluated ESIs for the treatment of lumbar radiculopathy.⁵Two of these trials compared epidural steroids with placebo and the remaining compared epidural steroids with an active control. No pooled analysis was performed. The authors reported that most of the trials reported positive effects associated with ESIs for both short- and long-term pain relief. 

An earlier systematic review and meta-analysis was published in 1995 by Watts and Silagy.⁸ This review included 11 trials of epidural steroids that were judged to be of good quality and had a combined enrollment of 907 patients. At 60 days post-treatment, the odds ratio (OR) of pain relief (defined as greater than 75% reduction in pain scores) was 2.61 (95% confidence interval [CI], 1.90 to 3.77) for the epidural steroid group compared with the control group. At 12-month follow-up, a statistically significant improvement in pain relief was noted for the group receiving ESIs (OR = 1.87; 95% CI, 1.31 to 2.68).

Several individual RCTs have been completed since publication of the most recent systematic reviews.^9,10,11 These trials have corroborated the results of previous research, generally reporting a small benefit for treatment with ESI. The largest of these trials was a double-blind, sham-controlled study that compared ESI with gabapentin in 145 patients with lumbar radiculopathy.⁹ There were no differences between groups for the primary outcome of change in pain scores. At 1 month, the change in pain scores in the ESI group was -2.2 (SD = 2.4) versus -1.7 (SD = 2.6) in the gabapentin group (p = 0.25); at 3 months, the change in pain scores were -2.0 (SD = 2.6) in the ESI group versus -1.6 (SD = 2.7) in the gabapentin group (p = 0.43). ESI was superior to gabapentin on some secondary outcomes at 1 month (e.g., percent successful outcome, 66% in ESI group vs. 46% in gabapentin group; p = 0.02); however, at 3 months, these differences were no longer significant.

In the RCT with the longest follow-up of 2 years, 120 patients were randomized to ESI or sham control.¹¹ Primary outcome measures were at least 50% improvement on the Oswestry Disability Index and the numeric pain rating scale. There were no differences between groups reporting a good response, with 57% in the ESI group and 65% in the sham group reporting at least 50% improvement at 2 years (p = NS). Another RCT randomized 63 patients from general medical practices in the Netherlands to usual care or usual care plus 1 injection of ESI.¹⁰ The main outcomes were change in numeric pain scores and the Roland-Morris Disability Questionnaire (RMDQ) score. A small, statistically significant difference was found in favor of the ESI group on both outcomes, but was considered too small to be clinically relevant.  

Cervical Radiculopathy
There are a smaller number of published trials on the use of epidural steroids for cervical radiculopathy. Two systematic reviews were identified that summarized the literature on cervical epidural injections for treatment of cervical radiculopathy.^12,13 

A 2009 review by Benyamin et al. included studies of epidural injections for neck pain that was present for more than 3 months, with or without radiculopathy.¹² The authors identified 3 RCTs that met their inclusion criteria, all of which treated patients with cervical radiculopathy, but only 1 of which compared epidural steroids with a control condition. One of the other trials compared 2 different preparations of steroids and the third trial compared steroids plus morphine with steroids alone. In the single trial comparing steroids with control, 42 patients were randomized to ESIs (n=24) or to steroid injections in the adjacent neck muscle (n = 18). One week after the last epidural injection, more patients in the epidural group reported good pain relief compared with control (76% vs. 36%, p not reported) and at 1-year follow-up, the difference in the percentage of patients reporting good pain improvement persisted in favor of the epidural steroid group (68% vs. 12%, p not reported).

In 2012, Diwan et al. performed a systematic review of ESIs for chronic neck and upper- extremity pain and reported separately on the evidence for cervical radiculopathy.¹³ This analysis included 4 RCTs, 3 of which were included in the Benyamin 2009 review. The fourth RCT, which was the largest (n = 120) and rated the highest in quality, randomized patients to epidural steroid plus local anesthetic versus local anesthetic alone, and reported on pain relief at 6 and 12 months. At 6 months, the percentage of patients experiencing pain relief was 82% for the steroid group versus 73% for the control group, a difference that was not statistically significant. At 12 months, outcomes were also similar, with 72% of patients in the steroid group reporting pain relief compared with 68% in the control group.

Since the time these systematic reviews were published, Cohen et al. reported the results of an RCT in 2014 that compared ESI, conservative treatment or a combination of both for patients with cervical radiculopathy.¹⁴ A total of 169 patients were randomized to conservative care (physical therapy plus medications), ESIs or a combination of both treatments. The primary outcomes were neck and arm pain measured at 1 and 3 months post-treatment. There were no differences noted between ESI and conservative care on any of the outcome measures. The group receiving combination therapy had a greater reduction in arm pain at 1 month compared with the 2 individual treatments, and had a greater success rate at 3 months (56.9% vs. 26.8%, p = 0.006). 

Section Summary: Sciatica/Radiculopathy
There are a large number of small RCTs that evaluate ESIs for treatment of lumbar radiculopathy/sciatica and cervical radiculopathy, and a number of systematic reviews that summarize these trials. For short-term pain relief, the direction of benefit in virtually all trials is in favor of epidural injections, and the differences between groups examined in the studies reached statistical significance in some trials but not others. Most systematic reviews do not perform quantitative meta-analysis, thus limiting their ability to examine these small trials with increased power. In 1 meta-analysis that reported pooled results, there was a statistically significant improvement in pain at 6 months, but the mean difference was less than the minimally important clinical difference for a 0-to-100 VAS designated for pain measurement. For long-term pain relief at 1 year or beyond, most trials report negative results, and no pooled analysis reports significant differences.

Spinal Stenosis
In the 2012 systematic review by Benyamin et al., there were 6 RCTs identified that treated patients with spinal stenosis, 5 of which compared steroid injections with a local anesthetic alone.² Two of the trials reported between-group differences in favor of steroid injections, 3 reported significant improvement in pain for the steroid group but did not report between-group differences and the final trial reported no significant improvement for the steroid group.

The systematic review in 2009 by Chou et al. identified 3 small placebo-controlled trials on treatment of spinal stenosis, but in 2 of these studies only a subset of treated patients had spinal stenosis.⁴ The authors rated the quality of this evidence poor and concluded that it was not possible to determine whether epidural steroids offer a benefit for spinal stenosis. 

In 2012, Manchikanti et al. identified 4 RCTs of ESIs for treatment of lumbar spinal stenosis.⁵ Although 2 of these trials compared epidural steroids with control and reported on pain relief and/or disability, neither reported that pain relief with epidural steroids was superior to control, either in the short or the long term. 

The systematic review by Diwan et al. in 2012 identified 1 RCT that treated cervical spinal stenosis in 60 patients.¹³ In this trial, there were no significant differences in the percentage of patients reporting pain relief in the epidural group compared with control at 6 months (87% vs. 80%) or at 12 months (73% vs. 70%). 

Since the publication of the systematic reviews, a moderately large-sized RCT of ESIs for the treatment of spinal stenosis was published by Friedly et al. in 2014.¹⁵ This double-blind trial randomized 400 patients with lumbar central spinal stenosis and at least moderate to severe leg pain (≥ 4 on 0-10 VAS) or disability (≥ 7 on RMDQ, 0 – 24 scale) due to spinal stenosis to treatment with ESIs plus lidocaine or lidocaine alone. One repeat injection could be given at 3 weeks at the discretion of the patient and treating physician. The primary outcomes were the patient’s rating of pain in the buttocks, hip or leg at 6 weeks following initial treatment and the RMDQ score at 6 weeks. Secondary outcomes included the same outcome measures at 3 weeks post-treatment, measures of back pain, percent responders (defined either as ≥ 30% reduction in pain or ≥ 50% reduction in pain) and scores on several quality-of-life scales.

At 6-week follow-up, there were no significant differences in the primary outcomes between groups. The change in pain on the VAS for the steroid group was -2.8 compared with -2.6 for the control group (adjusted between-group mean difference, -0.2 points; 95% CI, -0.8 to 0.4; p = 0.48), and the change in the RMDQ score was -4.2 points for the steroid group versus -3.1 points for the control group (adjusted between-group mean difference, -1.0 points; 95% CI, -2.1 to 0.1; p = 0.07). There were small, statistically significant differences in measures of pain and disability at 3 weeks, but these were less than the minimal clinical difference for the scales, and differences did not persist at 6 weeks. On the secondary outcomes at 6 weeks, there were generally no between-group differences except for 2 subscales of the quality-of-life measures (symptoms of depression on 8-item Patient Health Questionnaire, and satisfaction on the Swiss Spinal Stenosis Questionnaire).

Section Summary: Spinal Stenosis
There are few RCTs that evaluate epidural steroids for spinal stenosis, and the published systematic reviews do not perform pooled analysis of the available trials. Most published trials do not report significant benefit for epidural steroids, including a moderately large-sized RCT published in 2014. This evidence does not support that ESIs improve outcomes for patients with spinal stenosis.

Nonspecific Low Back Pain
A Cochrane review was published in 2008 on injection therapy for subacute and chronic low back pain.¹⁶ This review included RCTs that enrolled patients with low back pain for at least 1 month and reported pain outcomes. A total of 18 studies met the inclusion criteria, 10 of which were considered to be at low risk for bias. Due to high levels of heterogeneity, pooled analysis was not performed. Of the 18 included studies, 5 reported a benefit for treatment with epidural steroids. There were 2 placebo-controlled studies of short-term outcomes of leg pain. Neither of these studies reported a significant improvement of pain associated with epidural injections. Three studies compared epidural steroids with nonsteroidal anti-inflammatory drugs, and none of these reported significant improvements for patients treated with epidural steroids.

The 2012 systematic review by Benyamin et al.² identified 3 trials of ESIs for nonspecific low back pain, 1 randomized and 2 nonrandomized. The randomized trial reported a greater percentage of patients with pain relief following ESI compared with local anesthetic alone (83% vs. 73%), but this between-group difference was not statistically significant. The 2 nonrandomized studies reported improvements for patients treated with epidural steroids, but no between-group comparisons were done. 

Manchikanti et al. addressed the indication of nonspecific low back pain (axial low back pain) in their systematic review.⁵ However, there were no RCTs identified that met their inclusion criteria, and only 3 nonrandomized studies were included. This evidence was insufficient to form conclusions on the efficacy of epidural steroids for nonspecific low back pain. 

Section Summary: Nonspecific Low Back Pain
The evidence on ESIs for nonspecific low back pain is limited. Small RCTs have been published, but these have generally been judged to be of low quality, and most studies do not report significant improvements in the group receiving ESIs. This evidence is not sufficient to determine whether epidural steroids improve outcomes in the treatment of nonspecific low back pain.

Mixed Indications
A systematic review by Choi et al. published in 2013 included trials of ESIs for back pain, regardless of specific indication.¹⁷ There were a total of 29 studies included in the review, of which 23 of 29 met at least 5 of 11 quality criteria. The authors noted evidence for noncomparability of groups (selection bias) at baseline, particularly for the baseline pain levels. For pain outcomes, combined analysis revealed a statistically significant difference in favor of epidural steroids at 6 months (weighted mean difference, -0.41; 95% CI, -0.66 to -0.16) but a nonsignificant result at 12 months. For disability level, there were no statistically significant differences between groups at either 6- or 12-month follow-up. There was also no difference reported in the need for future surgery for patients receiving ESIs. 

Safety
Potential adverse effects (AEs) of ESIs can include complications of the injection itself, such as inadvertent puncture of the dura, bleeding and infections. Additional complications may be related to the administration of steroids, including suppression of the hypothalamic-pituitary axis and the immune system.

The AEs of ESIs are not well reported in the treatment trials. In 1 systematic review, only 4 of 15 included trials reported on AEs.¹⁸ In addition to this lack of reporting, the available trials are generally small and, therefore, not adequate for determining rates of uncommon AEs. A consensus panel convened in part by the U.S. Food and Drug Administration (FDA) reviewed the literature on serious neurologic complications following ESI.¹⁹ The evidence was restricted to case reports and reports of malpractice claims. Reports included direct needle injury to the spinal cord, arterial injury, swelling of an unrecognized epidural lesion and paraplegia/stroke. Based on the pattern of reports, the report concluded that stroke and paraplegia were likely caused by intraarticular injection of particulate steroids. Therefore, the rate of AEs is mostly uncertain. 

In the systematic review by Chou et al.,⁴ it was noted that while there are case reports in the literature of serious adverse events (SAEs) such as paralysis and infection due to epidural injections, SAEs were rarely reported in the clinical trials. Of the 17 trials included in the review that reported on the use of epidural injections for treatment of low back pain with radiculopathy, 10 of 17 did not report AEs at all, and the AEs reported in the other trials were generally transient and mild. In 1 high-quality trial with systematic reporting of AEs, 3.3% of patients (4/120) experienced a post-injection headache, 0.8% (1/120) experienced post‒dural puncture headache, 1.7% (2/120) experienced post-injection nausea and 4.2% (5/120) experienced other AEs. 

In 2014, FDA issued a drug safety communication on rare but serious neurologic problems associated with ESIs.²⁰ This communication stated that the safety of ESIs has not been established and that FDA has not approved corticosteroids for this use. Potential serious adverse neurologic events include loss of vision, stroke, paralysis and death. The FDA subsequently assembled an expert panel that issued a report in 2015.¹⁹ This report included a series of recommendations regarding the ESI technique, including clinically relevant issues related to its performance, such as the use of particulate steroids, use of contrast and use of sedation. 

Epidural steroids are generally compounded medications, because the specific preparations for clinical use are prepared at a pharmacy rather than by the manufacturer of the drug. In 2012, several patients were identified who developed fungal meningitis complications following ESI due to contaminated medication obtained from a single pharmacy.²¹ The U.S. Centers for Disease Control and Prevention (CDC) subsequently obtained preliminary data on 137 patients across 10 states affected by this outbreak. Of those, 12 of 137 patients (9%) died, 3 of 137 (2%) had suffered a stroke and 3 of 137 (2%) had osteomyelitis or epidural abscess. The contamination was attributed to faulty sterilization procedures at the pharmacy that compounded the medications. 

Section Summary: Safety
AEs, both minor and serious, can occur following ESIs. For serious neurologic events, the evidence consists of case reports and, as a result, the rate of SAEs is uncertain. Few SAEs have been reported in the RCTs, but there is also a lack of systematic reporting in the available trials. Minor AEs that are self-limited (e.g., headache) are more common, but the evidence is not sufficient to determine the actual rate of such events. Further research is needed to determine the true rate of AEs attributable to ESIs. The FDA consensus panel has issued guidelines for the technical performance of ESI with the goal of reducing potential serious neurologic events.

Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed in Table 2.

Table 2. Summary of Key Trials 

NCT No.	Trial Name	Planned Enrollment	Completion Date
Ongoing
NCT01934868	A Comparison of the Long-Term Outcomes of Prolotherapy Versus Interlaminar Epidural Steroid Injections (ESI) for Lumbar Pain Radiating to the Leg	160	May 2017
Unpublished
NCT02196883	A Prospective, Randomized, Single Blind Study Comparing Transforaminal Epidural Steroid Injections at the Level of MRI Pathology vs. Clinical Symptoms	Not stated	May 2015
NCT01495923	Randomized, Double-blind, Comparative-effectiveness Study Comparing Epidural Steroid Injections to Gabapentin in Patients With Lumbosacral Radiculopathy	145	Completed

NCT: national clinical trial. 

Summary of Evidence
The evidence for epidural steroid injections (ESIs) in patients who have lumbar or cervical radiculopathy includes many small randomized controlled trials (RCTs) and a number of systematic reviews of these RCTs. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, medication use and treatment-related morbidity. The evidence base lacks large-scale, high-quality trials and has a high degree of variability among the available trials in terms of patient populations, techniques of epidural injections and comparison treatments. The results of individual trials are mixed, with some reporting significant benefits for the ESI group and others reporting no benefit. Most systematic reviews do not perform pooled analyses due to heterogeneity of trials. In the 2 reviews that reported quantitative results, short-term pain relief at up to 6 months follow-up was superior in patients treated with epidural steroids. None of the analyses reported long-term benefits for treatment with ESIs. Adverse events are generally mild, but were not well reported in these trials. Serious adverse events (SAEs) can occur, but the rate of SAEs is unknown. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.

The evidence for ESIs in patients who have spinal stenosis includes 1 moderately large RCT, a few small RCTs and systematic reviews of these RCTs. Relevant outcomes include symptoms, functional outcomes, health status measures, quality of life, medication use and treatment-related morbidity. The largest RCT and the majority of smaller trials do not report a benefit for ESIs. The evidence is sufficient to determine qualitatively that the technology is unlikely to improve the net health outcome.

The evidence for ESIs in patients who have nonspecific low back pain includes a number of small RCTs and systematic reviews of these RCTs. Relevant outcomes include symptoms, functional outcomes, health status measures, quality of life, medication use and treatment-related morbidity. The majority of trials are of low quality and do not report a benefit for ESIs. The evidence is insufficient to determine the effects of the technology on health outcomes.

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.

In response to requests for clinical input on ESIs, input was received from 5 academic medical centers and 6 specialty societies. Consensus was reached among reviewers that: treatment of cervical radiculopathy is medical necessary with the same criteria as for lumbar radiculopathy; the minimum period of time for conservative therapy should be 4 weeks or less; fluoroscopic guidance should be used in all cases of ESIs; and, fluorography (imaging of the epidural space is investigational. There was mixed input on the optimal timing to assess response, the number of levels that should be treated at 1 time and the maximum number of injections to be given in 1 year.

Practice Guidelines and Position Statements
American Association of Neurological Surgeons
The 2014 update of the guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine from the American Association of Neurological Surgeons²² states that lumbar ESIs are an option for short-term relief of chronic low back pain without radiculopathy in patients with degenerative disease of the lumbar spine (level III evidence). Caudal ESIs are an option for reducing low back pain without radiculopathy of greater than 6 weeks in duration in patients with degenerative disease of the lumbar spine (level III evidence).

Agency for Healthcare Research and Quality
The Agency for Healthcare Research and Quality issued an evidence-based practice center systematic review protocol in 2014. Pain Management Injection Therapies for Low-Back Pain²³ states that between 1994 and 2001, the “use of epidural injections increased by 271 percent and facet joint injections increased by 231 percent among Medicare beneficiaries. Despite these dramatic increases, use of injection therapies for low back pain remains controversial. Systematic reviews of injection therapies have come to conflicting conclusions regarding the benefits of injection therapies, and clinical practice guidelines provide discordant recommendations regarding their use. Important challenges in conducting a review of this topic include sparse data from randomized trials for most injection therapies (with the exception of epidural steroids), inconsistency of results across trials, as well as variability across studies in the methods used to select patients for inclusion, the specific techniques used, the comparisons evaluated and the outcomes assessed.”

North American Spine Society
The 2012 North American Spine Society (NASS) clinical guidelines for multidisciplinary spine care diagnosis and treatment of lumbar disc herniation with radiculopathy²⁴ stated there were no studies available that directly addressed the role of ESIs or selective nerve root blocks in the diagnosis of patient selection for subsequent surgical treatment of a lumbar disc herniation with radiculopathy. 

In 2011, NASS revised its clinical guidelines for multidisciplinary spine care diagnosis and treatment of degenerative lumbar spinal stenosis.²⁵ It made the following recommendation: a multiple injection regimen of radiographically-guided transforaminal ESI or caudal injections is suggested to produce medium-term (3 to 36 months) relief of pain in patients with radiculopathy or neurogenic intermittent claudication from lumbar spinal stenosis (grade C recommendation). 

NASS issued 2010 clinical guidelines for multidisciplinary spine care diagnosis and treatment of cervical radiculopathy from degenerative disorders.²⁶ IT made the following recommendation: Transforaminal ESIs using fluoroscopic or CT guidance may be considered when developing a medical/interventional treatment plan for patients with cervical radiculopathy from degenerative disorders. Due consideration should be given to the potential complications (grade C recommendation). 

The 2013 NASS issued a review and recommendation statement for lumbar transforaminal epidural steroid injections (LTFESI).²⁷ The following recommendations were made: 

Transforaminal epidural steroid injections using fluoroscopic or CT guidance may be considered when developing a medical/interventional treatment plan for patients with cervical radiculopathy from degenerative disorders. Due consideration should be given to the potential complications. Level of evidence III.

Patients with lumbar scoliotic stenosis and radiculopathy experience significantly higher success rates if their symptoms were present for less than 3 months. Level of evidence IV. 

There is no significant difference between EMG-positive and -negative groups in terms of pain difference, but a mild functional improvement in an EMG-positive patient undergoing LTFESI. Level of evidence V. 

In 2011 NASS issued a review and recommendation statement for cervical ESIs.²⁸ The following recommendation was made: Both transforaminal and interlaminar ESIs may be considered to provide short- and long-term relief of cervical radiculitis (grade C recommendation). 

American Society of Anesthesiologists
The 2010 guidelines on chronic pain management from the American Society of Anesthesiologists²⁹ state that transforaminal epidural injections should be performed with appropriate image guidance to confirm correct needle position and spread of contrast before injecting therapeutic substances. Image guidance may be considered for interlaminar epidural injections to confirm correct needle position and spread of contrast before injecting therapeutic substance.

American College of Physicians
The American College of Physicians issued a 2008 guideline for the diagnosis and treatment of low back pain³⁰ that stated: “Patients with persistent low back pain and signs and symptoms of radiculopathy or spinal stenosis should be evaluated with MRI (preferred) or CT only if they are potential candidates for surgery or epidural steroid injection. (Strong recommendation, moderate-quality evidence).” 

American Pain Society
The American Pain Society published guidelines on the use of interventional therapies for low back pain in 2009,¹ based on a systematic review of the evidence published in the same year.⁴ These guidelines made the following recommendations regarding ESIs: 

In patients with persistent radiculopathy due to herniated lumbar disc, it is recommended that clinicians discuss risks and benefits of epidural steroid injections as an option (weak recommendation, moderate quality evidence). It is recommended that shared decision making regarding epidural steroid injection include a specific discussion about inconsistent evidence showing moderate short-term benefits, and lack of long-term benefits. 

There is insufficient evidence to adequately evaluate benefits and harms of epidural steroid injection for spinal stenosis. 

There is insufficient evidence to adequately evaluate benefits of local injections, botulinum toxin injection, epidural steroid injection, intradiscal electrothermal therapy, therapeutic medial branch block, radiofrequency denervation, sacroiliac joint steroid injection or intrathecal therapy with opioids or other medications for nonradicular back pain. 

American Society of Interventional Pain Physicians
The American Society of Interventional Pain Physicians published updated guidelines for interventional techniques in chronic spinal pain.³¹ The following recommendations were made regarding ESIs of the lumbar spine: 

• The evidence is good in managing disc herniation or radiculitis for caudal, interlaminar and transforaminal epidural injections; 
• The evidence is fair for axial or discogenic pain without disc herniation, radiculitis or facet joint pain with caudal and interlaminar epidural injections, and limited for transforaminal epidural injections; 
• The evidence is fair for spinal stenosis with caudal, interlaminar and transforaminal epidural injections; 
• The evidence is fair for postsurgery syndrome with caudal epidural injections and limited with transforaminal epidural injections. 

The following recommendations were made regarding ESIs of the cervical spine: 

• The evidence is good for cervical interlaminar epidural injections for cervical disc herniation or radiculitis. 
• The evidence is fair for axial or discogenic pain, spinal stenosis and postsurgery syndrome. 

American Academy of Neurology
The American Academy of Neurology published guidelines in 2007 on the use of epidural steroids for lumbosacral radiculopathy.³² These guidelines made the following recommendations:

• “(E)pidural steroid injections may result in some improvement in radicular lumbosacral pain when determined between 2 and 6 weeks following the injection, compared to control treatment (Level C, Class I – III). The average magnitude of effect is small, and the generalizability of the observation is limited by the small number of studies, limited to highly selected patient populations, the few techniques and doses studied, and variable comparison treatments.”
• “(I)n general, epidural steroid injections for radicular lumbosacral pain have shown no impact on average impairment of function, on need for surgery or on long-term pain relief beyond 3 months. Their routine use for these indications is not recommended (Level B, Class I – III).”
• “(T)here is insufficient evidence to make any recommendation for the use of epidural steroid injections to treat radicular cervical pain (Level U).” 

U.S. Preventive Services Task Force Recommendations
Not applicable

References

1. 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). May 1 2009;34(10):1066-1077. PMID 19363457
2. Benyamin RM, Manchikanti L, Parr AT, et al. The effectiveness of lumbar interlaminar epidural injections in managing chronic low back and lower extremity pain. Pain Physician. Jul-Aug 2012;15(4):E363-404. PMID 22828691
3. Pinto RZ, Maher CG, Ferreira ML, et al. Epidural corticosteroid injections in the management of sciatica: a systematic review and meta-analysis. Ann Intern Med. Dec 18 2012;157(12):865-877. PMID 23362516
4. Chou R, Atlas SJ, Stanos SP, et al. Nonsurgical interventional therapies for low back pain: a review of the evidence for an American Pain Society clinical practice guideline. Spine (Phila Pa 1976). May 1 2009;34(10):1078-1093. PMID 19363456
5. Manchikanti L, Buenaventura RM, Manchikanti KN, et al. Effectiveness of therapeutic lumbar transforaminal epidural steroid injections in managing lumbar spinal pain. Pain Physician. May-Jun 2012;15(3):E199-245. PMID 22622912
6. Cluff R, Mehio AK, Cohen SP, et al. The technical aspects of epidural steroid injections: a national survey. Anesth Analg. Aug 2002;95(2):403-408, table of contents. PMID 12145061
7. Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. Feb 2008;9(2):105-121. PMID 18055266
8. Watts RW, Silagy CA. A meta-analysis on the efficacy of epidural corticosteroids in the treatment of sciatica. Anaesth Intensive Care. Oct 1995;23(5):564-569. PMID 8787255
9. Cohen SP, Hanling S, Bicket MC, et al. Epidural steroid injections compared with gabapentin for lumbosacral radicular pain: multicenter randomized double blind comparative efficacy study. BMJ. 2015;350:h1748. PMID 25883095
10. Spijker-Huiges A, Winters JC, van Wijhe M, et al. Steroid injections added to the usual treatment of lumbar radicular syndrome: a pragmatic randomized controlled trial in general practice. BMC Musculoskelet Disord. 2014;15:341. PMID 25304934
11. Manchikanti L, Cash KA, Pampati V, et al. Transforaminal epidural injections in chronic lumbar disc herniation: a randomized, double-blind, active-control trial. Pain Physician. Jul-Aug 2014;17(4):E489-501. PMID 25054399
12. Benyamin RM, Singh V, Parr AT, et al. Systematic review of the effectiveness of cervical epidurals in the management of chronic neck pain. Pain Physician. Jan-Feb 2009;12(1):137-157. PMID 19165300
13. Diwan S, Manchikanti L, Benyamin RM, et al. Effectiveness of cervical epidural injections in the management of chronic neck and upper extremity pain. Pain Physician. Jul-Aug 2012;15(4):E405-434. PMID 22828692
14. Cohen SP, Hayek S, Semenov Y, et al. Epidural steroid injections, conservative treatment, or combination treatment for cervical radicular pain: a multicenter, randomized, comparative-effectiveness study. Anesthesiology. Nov 2014;121(5):1045-1055. PMID 25335172
15. Friedly JL, Comstock BA, Turner JA, et al. A randomized trial of epidural glucocorticoid injections for spinal stenosis. N Engl J Med. Jul 3 2014;371(1):11-21. PMID 24988555
16. Staal JB, de Bie R, de Vet HC, et al. Injection therapy for subacute and chronic low-back pain. Cochrane Database Syst Rev. 2008(3):CD001824. PMID 18646078
17. Choi HJ, Hahn S, Kim CH, et al. Epidural steroid injection therapy for low back pain: a meta-analysis. Int J Technol Assess Health Care. Jul 2013;29(3):244-253. PMID 23769210
18. Koes BW, Scholten RJ, Mens JM, et al. Efficacy of epidural steroid injections for low-back pain and sciatica: a systematic review of randomized clinical trials. Pain. Dec 1995;63(3):279-288. PMID 8719528
19. Rathmell JP, Benzon HT, Dreyfuss P, et al. Safeguards to prevent neurologic complications after epidural steroid injections: consensus opinions from a multidisciplinary working group and national organizations. Anesthesiology. May 2015;122(5):974-984. PMID 25668411
20. US Food and Drug Administration. Epidural Corticosteroid Injection: Drug Safety Communication - Risk of Rare But Serious Neurologic Problems. 2014; http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm394530.htm. Accessed Aug. 6, 2015.
21. Centers for Disease Control and Prevention (CDC). Multistate outbreak of fungal infection asociated with injection of methylprednisolone acetate solution from a single compounding pharmacy. MMWR Morb Mortal Wkly Rep. 2012;61:839.
22. American Association of Neurological Surgeons (AANS). Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine, part 13, therapeutic injections. 2014; http://thejns.org/doi/pdf/10.3171/2014.4.SPINE14281. Accessed Aug. 6, 2015.
23. Agency for Healthcare Research and Quality (AHRQ). Pain management injection therapies for low-back pain. 2014; http://www.ahrq.gov/research/findings/ta/topicrefinement/injection-protocol.pdf. Accessed Aug. 6, 2015.
24. North American Spine Society (NASS). Clinical guidelines for multidisciplinary spine care diagnosis and treatment of lumbar disc herniation with radiculopathy. 2012; https://www.spine.org/Documents/ResearchClinicalCare/Guidelines/LumbarDiscHerniation.pdf. Accessed Aug. 6, 2015.
25. (NASS) NASS. Clinical guidelines for multidisciplinary spiine care diagnosis and treatment of degenerative lumbar spinal stenosis. 2011; https://www.spine.org/Documents/ResearchClinicalCare/Guidelines/LumbarStenosis.pdf. Accessed Aug. 6, 2015.
26. (NASS) NASS. Clinical guideline for multidisciplinary spine care diagnosis and treatment of cervical radiculopathy from degenerative disorders. 2010; https://www.spine.org/Documents/ResearchClinicalCare/Guidelines/CervicalRadiculopathy.pdf. Accessed Aug.6, 2015.
27. North American Spine Society (NASS). Review and recommendation statement for lumbar traforaminal epidural steroid injections. 2013; https://www.spine.org/Documents/ResearchClinicalCare/LTFESIReviewRecStatement.pdf. Accessed Aug. 6, 2015.
28. North American Spine Society (NASS). Review and recommendation statement for cervical epidural steroid injections. 2011; https://www.spine.org/Documents/ResearchClinicalCare/CESIReviewRecStatement.pdf. Accessed Aug. 6, 2015.
29. American Society of Anesthesiologist (ASA). Guidelines on chronic pain management. 2010; http://www.asahq.org/quality-and-practice-management/standards-and-guidelines/search?q=Chronic Pain. Accessed Aug. 6, 2015.
30. American College of Physicians (ACP). Guidelines for the diagnosis and treatment of low-back pain. 2008; http://www.aafp.org/afp/2008/0601/p1607.html. Accessed Aug. 6, 2015.
31. 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(2 Suppl):S49-283. PMID 23615883
32. American Academy of Neurology (AAN). Use of epidural steroid injections to treat lumbosacral radicular pain. 2007; https://www.aan.com/Guidelines/Home/GetGuidelineContent/250. Accessed Aug. 6, 2015
33. Boswell MV, Trescot AM, Datta S, et al. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician 2007; 10:7-111.
34. Chou R, Atlas SJ, Stanos SP. Nonsurgical interventional therapies for low back pain: a review of the evidence for an American Pain Society Clinical Practice Guideline. Spine 2009; 34(10): 1078-1093.
35. Datta S, Everett CR, Trescot AM, et al. An updated systematic review of the diagnostic utility of selective nerve root blocks. Pain Physician 2007; 10:113-128.
36. DePalma MJ, Slipman CW. Evidence-informed management of chronic low back pain with epidural steroid injections. The Spine Journal 2008:8:45-55.
37. Genevay S, Atlas SJ. Lumbar spinal stenosis. Best Pract Res Clin Rheumatol 2010; 24(2): 253-265.
38. Goodman BS, Posecion LWF, Mallempati S, et al. Complications and pitfalls of lumbar interlaminar and transforaminal epidural injections. Curr Rev Musculoskelet Med 2008; 1:212-222.
39. Huston CW. Cervical epidural steroid injections in the management of cervical radiculitis: interlaminar versus transforaminal. A Review. Curr Rev Musculoskelet Med 2009; 2(1):30-42.
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Coding Section

Codes	Number	Description
CPT	62310	Injection(s), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; cervical or thoracic
	62311	Injection(s), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; lumbar or sacral (caudal)
	62320 (effective 1/1/2017)	Injection(s), of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlamiar epidural or subarachnoid, cervical or thoracic; without imaging guidance
	62321 (effective 1/1/2017)	With imaging guidance (i.e., fluoroscopy or CT)
	62322 (effective 1/1/2017)	Injection(s), of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlamiar epidural or subarachnoid, lumbar or sacral (caudal); without imaging guidance
	62323 (effective 1/1/2017)	With imaging guidance (ie, fluoroscopy or CT)
	77003	Spinal or epidural injection: Injecting contrast for fluoroscipoc guidance.
	64479	Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); cervical or thoracic, single level
	64480	Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); cervical or thoracic, each additional level (List separately in addition to code for primary procedure)   Note: Use code 64480 in conjunction with code 64479
	64483	Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); lumbar or sacral, single level
	64484	Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); lumbar or sacral, each additional level (List separately in addition to code for primary procedure)   Note: Use code 64484 in conjunction with code 64483
ICD-10-CM	M54.12	Radiculopathy, cervical region
	M54.13	Radiculopathy, cervicothoracic region
	M54.16	Radiculopathy, lumbar region
	M54.17	Radiculopathy, lumbosacral region
ICD-10-PCS		ICD-10-PCS codes are only used for inpatient services.
	3E0S33Z	Introduction, epidural space, percutaneous, anti-inflammatory
Type of Service
Place of Service

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

Definitions
*Conservative Therapy: (spine) should include a multimodality approach consisting of a combination of active and inactive components. Inactive components, such as rest, ice, heat, modified activities, medical devices, acupuncture and/or stimulators, medications, injections (epidural, facet, not including trigger point) and diathermy can be utilized. Active modalities may consist of physical therapy, a physician supervised home exercise program** and/or chiropractic care.

**Home Exercise Program (HEP) — the following two elements are required to meet guidelines for completion of conservative therapy:

• Information provided on exercise prescription/plan AND
• Follow up with member with documentation provided regarding completion of HEP, (after suitable 4-6 week period) or inability to complete HEP due to physical reason - i.e., increased pain, inability to physically perform exercises. (Patient inconvenience or noncompliance without explanation does not constitute "inability to complete" HEP).

Terminology: Interlaminar Epidural; Selective Nerve Root Injection (transforaminal only); Transforaminal Injection; Injections of Spinal Canal

Hip-spine syndrome — Hip-spine syndrome is a condition that includes both debilitating hip osteoarthritis and low back pain. Abnormal spinal sagittal alignment and difficulty in maintaining proper balance, as well as a wobbling gait, may be caused by severe osteoarthritis of the hip joint. Epidural injections are used to determine a primary pain generator in this condition.

Spondylolisthesis and nerve root irritation — Degenerative lumbar spondylolisthesis is the displacement of a vertebra in the lower part of the spine; one lumbar vertebra slips forward on another with an intact neural arch and begins to press on nerves. The most common cause, in adults, is degenerative disease, although it may also result from bone diseases and fractures. Degenerative spondylolisthesis is not always symptomatic. Epidural injections may be used to determine a previously undocumented nerve root irritation as a result of spondylolisthesis.

Lumbar spinal stenosis with radiculitis — Spinal stenosis is narrowing of the spinal column or of the neural foramina where spinal nerves leave the spinal column, causing pressure on the spinal cord. The most common cause is degenerative changes in the lumbar spine. Neurogenic claudication is the most common symptom, referring to "leg symptoms encompassing the buttock, groin and anterior thigh, as well as radiation down the posterior part of the leg to the feet." In addition to pain, leg symptoms can include fatigue, heaviness, weakness and/or paresthesia. Some patients may also suffer from accompanying back pain. Symptoms are worse when standing or walking and are relieved by sitting. Lumbar spinal stenosis is often a disabling condition, and it is the most common reason for lumbar spinal surgery in adults over 65 years. The most common levels of stenosis are L3 through L5, but it may occur at multilevels in some patients. Radiculitis is the inflammation of a spinal nerve root that causes pain to radiate along the nerve paths. Epidural injections help to ascertain the level of the pain generator in this condition.

Postoperative epidural fibrosis — Epidural fibrosis is a common cause of failed back surgery syndrome. With the removal of a disc, the mechanical reason for pain may be removed, but an inflammatory condition may continue after the surgery and may cause pain. Epidural corticosteroids, with their anti-inflammatory properties, are used to treat postoperative fibrosis and may be used along with oral Gabapentin to reduce pain.

Lumbar herniated disc — Epidural steroid injections have been proven to be effective at reducing symptoms of lumbar herniated discs. Evidence shows that they can be successful in 42% to 56% of patients who do not improve after 6 weeks of conservative treatment. Observation and epidural steroid injection are effective nonsurgical treatments for this condition.

Failed back surgery syndrome — Failed back surgery syndrome (FBSS) is characterized by persistent or recurring low back pain, with or without sciatica, following lumbar surgery. The most common cause of FBSS is epidural fibrosis, which be triggered by a surgical procedure such as discectomy. The inflammation resulting from the surgical procedure may start the process of fibrosis and cause pain. Epidural steroid injections are administered to reduce pain.

Discogenic pain - Discogenic pain is predominant low back pain without disc herniation. Eighty percent to 90% of low back pain is commonly believed to be of unknown etiology. The term, discogenic disc disease, may refer to degenerative disc disease or to internal disc disruption syndrome. Patients with the latter condition may have painful invertebral discs despite minimal degenerative changes. In the United States, discogenic pain accounts for 25% of cases of chronic low back pain. Evidence has shown that epidural steroid injections are effective for short-term improvement of discogenic pain.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

History From 2016 Forward    

07/20/2022	Annual review, no change to policy intent.
07/14/2021	Annual review, no change to policy intent.
05/05/2020	Interim review, moving annual review date to July and updating policy and guidelines. Adding exclusion section.
03/02/2020	Annual review, adding "diagnostic transforaminal injection to identify the pain generator for surgical planning" to criteria and updating statements regarding frequency requirements. No other changes.
03/06/2019	Annual review, changing the following policy statement: "if the neural blockade is applied for different regions, injections may be administered at intervals of no sooner than 14 days" to 7 days. No other changes made.
03/19/2018	Annual review, no change to policy intent.
11/21/2017	Updated coding with M54.12 and M54.13 codes. No change to policy intent.
03/15/2017	Interim review updating policy and guidelines for clarity and specificity.
02/06/2017	Annual review, no change to policy intent.
11/28/2016	Updating Coding Section with 2017 Codes.
02/02/2016	NEW POLICY