Epidural steroid injections for spinal pain commercial

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UnitedHealthcare? Commercial Medica l Policy

Epidural Steroid Injections for Spinal Pain

Policy Number: 2022T0616D Effective Date: June 1, 2022

Instructions for Use

Table of Contents

Page

Coverage Rationale .......................................................................1

Documentation Requirements......................................................2

Definitions ......................................................................................2

Applicable Codes ..........................................................................3

Description of Services .................................................................4

Clinical Evidence............................................................................5

U.S. Food and Drug Administration............................................10

References ................................................................................... 10

Policy History/Revision Information ...........................................12

Instructions for Use......................................................................13

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Occipital Neuralgia and Headache) ? Office Based Procedures ? Site of Service

Community Plan Policy ? Epidural Steroid Injections for Spinal Pain

Medicare Advantage Coverage Summary ? Pain Management and Rehabilitation

Coverage Rationale

Epidural Steroid Injections (ESI) are proven and medically necessary when the following criteria are met: The injection is intended for the short-term management of acute or subacute radicular pain; and

? The radicular pain is unresponsive to conservative treatment: o Pharmacotherapy such as NSAIDS or acetaminophen 3 weeks; or o Activity modification 4 weeks (including but not limited to heavy lifting, bending, spinal torsion activities); or o PT or home exercise 4 weeks

The following are unproven and not medically necessary due to insufficient evidence of efficacy: The use of ultrasound guidance for ESIs ESI for all other indications of the spine not included above

Epidural Steroid Injection Limitations

A maximum of three (3) ESI sessions (per region, regardless of level, location, or side) per year o A session is defined as one date of service in which ESI injection(s) are performed o A region is defined by either the region of the cervical, thoracic or lumbosacral o A year is defined as the 12-month period starting from the date of service of the first approved injection Repeat ESIs may be provided only if: o The initial injection resulted in 50% pain relief achieved for 3 or more months o The initial injection resulted in a functional improvement as measured by validated measurement tools, such as The

Oswestry Disability Index o Repeat injections do not exceed 3 per year, per region

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Documentation Requirements

CPT Codes*

Required Clinical Information

Epidural Steroid Injections for Spinal Pain

62320 62322 64484

For initial Injection, medical notes documenting the following, when applicable:

Diagnosis History of the medical condition(s) requiring treatment or surgical intervention Documentation of signs and symptoms; including onset, duration, and frequency Physical exam Relevant medical history Treatments tried, failed, or contraindicated; include the dates and reason for discontinuation History of epidural injections in the previous 12 months, including location and clinical response to previous injections Relevant surgical history, including dates Reports of all recent imaging studies and applicable diagnostics Physician treatment plan, including: o Location of proposed injection (side and level) o Plan for use of ultrasound guidance

For subsequent injection, in addition to the above, also include the response to initial epidural injection, including:

Duration of the effect Percentage of pain reduction Functional improvement as measured on a validated measurement tool, such as the Oswestry Disability Index

*For code descriptions, refer to the Applicable Codes section.

Definitions

Acute Low Back Pain: Low back pain present for up to six weeks. The early acute phase is defined as less than two weeks and the late acute phase is defined as two to six weeks, secondary to the potential for delayed-recovery or risk phases for the development of chronic low back pain. Low back pain can occur on a recurring basis. If there has been complete recovery between episodes, it is considered acute recurrent. (Goertz et al. 2012)

Conservative Therapy: Consists of an appropriate combination of medication (for example, NSAIDs, analgesics, etc.) in addition to physical therapy, spinal manipulation therapy, cognitive behavioral therapy (CBT) or other interventions based on the individual's specific presentation, physical findings and imaging results. (AHRQ 2013; Qassem 2017; Summers 2013)

Epidural Steroid Injections (ESI): Is a nonsurgical treatment for managing radiculopathy caused by disc herniation or degenerative changes in the vertebrae. Steroids are injected directly into the epidural space of the spine. The goal of ESI is to relieve pain, improve function, and improve quality of life. (Patel 2021)

Non-Radicular Back Pain: Pain which does not radiate along a dermatome (sensory distribution of a single root). Appropriate imaging does not reveal signs of spinal nerve root compression and there is no evidence of spinal nerve root compression seen on clinical exam. (Lenahan, 2018)

Owestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire): A tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the `gold standard' of low back functional outcome tools. (Fairbank 2000)

Radicular Back Pain: Pain which radiates from the spine into the extremity along the course of the spinal nerve root. The pain should follow the pattern of a dermatome associated with the irritated nerve root identified. (Lenahan, 2018)

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Radiculopathy: Radiculopathy is characterized by pain which radiates from the spine to extend outward to cause symptoms away from the source of the spinal nerve root irritation. (Lenahan, 2018)

Sub-Acute Low Back Pain: Low back pain with duration of greater than six weeks after injury but no longer than 12 weeks after onset of symptoms. (Goertz et al., 2012)

Applicable Codes

The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply.

CPT Code 62320

62321

62322 62323

64479 64480 64483 64484

Description 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, interlaminar epidural or subarachnoid, cervical or thoracic; without imaging guidance

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, interlaminar epidural or subarachnoid, cervical or thoracic; with imaging guidance (i.e., fluoroscopy or CT)

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, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); without imaging guidance

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, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); with imaging guidance (i.e., fluoroscopy or CT)

Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); cervical or thoracic, single level

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)

Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); lumbar or sacral, single level

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)

CPT? is a registered trademark of the American Medical Association

Diagnosis Code All Regions

Description

M47.25

Other spondylosis with radiculopathy, thoracolumbar region

M51.15

Intervertebral disc disorders with radiculopathy, thoracolumbar region

M96.1

Postlaminectomy syndrome, not elsewhere classified

Cervical/Thoracic

G54.2

Cervical root disorders, not elsewhere classified

G54.3

Thoracic root disorders, not elsewhere classified

M47.21

Other spondylosis with radiculopathy, occipito-atlanto-axial region

M47.22

Other spondylosis with radiculopathy, cervical region

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Cervical/Thoracic

M47.23 M47.24 M50.10 M50.11 M50.121 M50.122

Other spondylosis with radiculopathy, cervicothoracic region Other spondylosis with radiculopathy, thoracic region Cervical disc disorder with radiculopathy, unspecified cervical region Cervical disc disorder with radiculopathy, high cervical region Cervical disc disorder at C4-C5 level with radiculopathy

Cervical disc disorder at C5-C6 level with radiculopathy

M50.123 M50.13 M51.14 M54.11

Cervical disc disorder at C6-C7 level with radiculopathy Cervical disc disorder with radiculopathy, cervicothoracic region Intervertebral disc disorders with radiculopathy, thoracic region Radiculopathy, occipito-atlanto-axial region

M54.12

Radiculopathy, cervical region

M54.13

Radiculopathy, cervicothoracic region

M54.14

Radiculopathy, thoracic region

M54.15

Radiculopathy, thoracolumbar region

S24.2XXA

Injury of nerve root of thoracic spine, initial encounter

Lumbar/Sacral

G54.4

Lumbosacral root disorders, not elsewhere classified

M47.26

Other spondylosis with radiculopathy, lumbar region

M47.27

Other spondylosis with radiculopathy, lumbosacral region

M47.28

Other spondylosis with radiculopathy, sacral and sacrococcygeal region

M48.062

Spinal stenosis, lumbar region with neurogenic claudication

M51.16

Intervertebral disc disorders with radiculopathy, lumbar region

M51.17

Intervertebral disc disorders with radiculopathy, lumbosacral region

M54.16

Radiculopathy, lumbar region

M54.17

Radiculopathy, lumbosacral region

M54.18

Radiculopathy, sacral and sacrococcygeal region

M54.30

Sciatica, unspecified side

M54.31

Sciatica, right side

M54.32

Sciatica, left side

M54.40

Lumbago with sciatica, unspecified side

M54.41

Lumbago with sciatica, right side

M54.42

Lumbago with sciatica, left side

S34.21XA

Injury of nerve root of lumbar spine, initial encounter

S34.22XA

Injury of nerve root of sacral spine, initial encounter

Description of Services

Spine pain, in particular pain in the lower back, is a common concern, affecting up to 90% of Americans at some point in their lifetime. The majority of episodes are mild and self-limiting, and up to 50% of affected persons will have more than one episode. It is a symptom of a variety of different conditions, including injury, spinal stenosis, disc herniation or degenerative changes in the vertebrae. Epidural steroid injections (ESIs) may be used as a non-surgical modality to treat low back and neck pain and involve the injection of a solution containing corticosteroids and/or anesthetic into the epidural space. The ESI can be performed via interlaminar (ILESI), transforaminal (TFESI), or caudal approaches (caudal ESI).

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Epidural steroid injections generally require local anesthetic only. However, for some patients, moderate/conscious sedation, non-intravenous sedation, and monitored anesthesia care (MAC) may be necessary. These sedation procedures are generally safe when administered by trained, certified providers with appropriate monitoring, but are not without risk. Examples of procedures that typically do not require moderate sedation or an anesthesia care team include but are not limited to epidural steroid injections; epidural blood patch; trigger point injections; shoulder, hip, sacroiliac, facet, and knee joint injections; medial branch nerve blocks; and peripheral nerve blocks (American Society of Anesthesiologists, 2021).

Clinical Evidence

Ultrasound Guidance

There is limited evidence in the peer-reviewed literature demonstrating the overall health benefit of the use of ultrasonic guidance during spinal injections over the use of fluoroscopy or CT-guidance.

Ultrasound-guided spine injection therapy is a comparatively new technique in the management of axial and radicular pain from degenerative lumbar spinal conditions and may be a reasonable alternative to conventional methods of injection guidance. In 2020, Tay et al. completed a retrospective clinical audit of 42 patients who underwent ultrasound-guided lumbar spinal injection at a single institution for chronic axial and radicular pain in an acute public hospital sports medicine center between June 1, 2018 and June 1, 2019. 27 patients (64.3%) receiving facet joint injections and 18 patients (42.9%) receiving nerve root injections. The majority (90.5%) of patients experienced an improvement of > 30% in pain intensity at 3 months post-injection, using the Numerical Rating Scale pain score (p < 0.001); with 40 patients (95.2%) reporting a reduction in Oswestry Disability Index score (p < 0.001). No complications were reported. It was concluded that the experience of this institution confirms the safety, feasibility, and effectiveness of ultrasound-guided lumbar spinal injection for the treatment of axial and radicular pain. The authors also note that ultrasound-guided spinal injection remains technically challenging and requires a steep learning phase, as well as careful patient selection, and that the study was not designed to directly compare outcomes for ultrasoundguided injection against the conventional standard of care. A larger dataset is required to confirm the efficacy of ultrasoundguided spine injection and the rate of adverse events, and a prospective study would be useful to determine clinical factors predicting success. This study is also limited by lack of comparison group and a small number of participants standard of care. A larger dataset is required to confirm the efficacy of ultrasound-guided spine injection and the rate of adverse events, and a prospective study would be useful to determine clinical factors predicting success. This study is also limited by lack of comparison group and a small number of participants.

Epidural Steroid Injections

Overall, the volume of evidence for the use of therapeutic epidural injections in the treatment of acute and chronic back pain is large. Clinical studies have shown that epidural steroid injections have provided short-term improvement and may be considered in the treatment of selected patients with radicular pain as part of an active therapy program. There is however insufficient evidence to demonstrate that epidural steroid injections are effective in the treatment of back pain in the absence of radicular symptoms.

In a 2021 Hayes evolving evidence review regarding epidural steroid injections (ESI) for the treatment of thoracic spine pain, it was concluded that thoracic disc herniation is rare, and patients may present with thoracic axial pain, but no radicular pain. The clinical evidence is limited, and the results of one randomized controlled trial suggests that ESI, either anesthetic alone or anesthetic plus corticosteroid, for chronic thoracic pain in patients who primarily had disc-associated pain provides clinical benefits at up to 2 years.

Helm et al. (2021) conducted a systematic review and meta-analysis of the efficacy and safety of transforaminal epidural steroid injections for 4 indications: radicular pain from spinal stenosis and failed back surgery syndrome; and for axial low back pain. The available literature on transforaminal injections was reviewed and the level of evidence was classified on a 5-point scale based on the quality of evidence developed by the US Preventive Services Task Force (USPSTF) and modified by the American Society of Interventional Pain Physicians (ASIPP). Data sources included relevant literature from 1966 to April 2020, and manual searches of the bibliographies of known primary and review articles. Pain relief and functional improvement were the primary outcome measures. A minimum of 6 months pain relief follow-up was required. Eighteen randomized controlled trials met the inclusion criteria. Eleven randomized controlled trials dealt with various aspects of transforaminal injections for radicular pain due to disc herniation and show Level 1 evidence supporting the use of transforaminal injections for this condition. A meta-

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analysis showed that at both 3 and 6 months, there was highly statistically significant improvement in both pain and function with both particulate and nonparticulate steroids. For radicular pain from central stenosis there is one moderate quality study, with Level IV evidence. For radicular pain caused by failed back surgery syndrome there is one moderate quality study, with Level IV evidence. For radicular pain from foraminal stenosis and for axial pain there is Level V evidence, opinionbased/consensus, supporting the use of transforaminal injections. The authors concluded that Level I evidence indicates transforaminal injections are generally safe but have been associated with major neurological complications related to spinal cord infarction. Due to concern over the role of particulate steroids, multiple other injectates have been evaluated, including nonparticulate steroids, tumor necrosis factor alpha (TNF-a) inhibitors, and local anesthetics without steroids, and none have been proven superior. This review is limited by the paucity of literature for some indications.

Verheijen et al. (2021) conducted a systematic review and meta-analysis comparing epidural steroid injections (ESIs) with placebo injections in sciatica patients. The review included a total of 17 out of 732 reports: epidural placebo (n = 13), nonepidural placebo (n = 2), and both placebo groups (n = 2). The primary outcome measures were pooled using a random-effects model for 6-week, 3-month, and 6-month follow-up. Secondary outcomes were described qualitatively. Results showed that ESI was superior compared to epidural placebo at 6 weeks (-8.6 [-13.4; -3.9]) and 3 months (-5.2 [-10.1; -0.2]) for leg pain and at 6 weeks for functional status (-4.1 [-6.5; -1.6]), though the minimally clinical important difference (MCID) was not met. There was no difference in ESI and placebo for back pain, except for non-epidural placebo at 3 months (6.9 [1.3; 12.5]). Proportions of treatment success were not different. ESI reduced analgesic intake in some studies and complication rates were low. Of the 17 trials, five were considered low risk of bias, two raised some concerns, and 10 studies were considered high-risk. One serious adverse event was documented (retroperitoneal hematoma after ESI) and several minor complications related to needle placement and corticosteroid were noted. Limitations of the review include a low quality of evidence and limited number of comparison studies. The authors concluded that ESIs compared to placebo is considered safe and effective treatment for short-term pain management, however, at three and six months, no proven additional value of ESI compared to placebo was noted.

In a 2020 meta- analysis of randomized controlled trials, Yang et al. compared the clinical effectiveness of epidural steroid injections (ESI) versus conservative treatments for patients with lumbosacral radicular pain. A search was conducted on relevant studies published between 2000 and January 10, 2019 and randomized controlled trials directly comparing the efficacy of ESI with conservative treatment were selected. Primary Outcomes included pain relief, functional improvement using The Oswetry Disability Index, or successful events. 6 randomized controlled trials (249 patients with ESI and 241 patients with conservative treatment) were identified and included in this meta-analysis. The results showed that ESI was beneficial for pain relief at short-term (1-3 months) and intermediate-term (3-6 months) when compared with conservative treatment, but this effect was not maintained at long-term (6 months to one year) follow-up. In terms of functional improvement, the overall outcome of meta-analysis showed that ESI did not have any advantage over conservative treatment at short-term and intermediate-term follow-up. Successful event rates were significantly higher in patients who received ESI than in patients who received conservative treatment. There were no statistically significant differences in functional improvement after ESI and conservative treatment at short-term and intermediate-term follow-up. The authors concluded that the use of ESI is more effective for alleviating lumbosacral radicular pain than conservative treatments in terms of short-term and intermediate term. Patients also reported more successful outcomes after receiving ESI when compared to conservative treatment. However, this effect was not maintained at long-term follow-up. The limitations of this meta-analysis resulted from the variation in types of interventions and small sample size.

A 2019 Hayes health technology assessment regarding epidural steroid injections for cervical radiculopathy concluded that the evidence did not demonstrate any beneficial effect of ESIs on pain or disability associated with cervical radiculopathy compared with epidural injection of anesthetic alone. Although complications reported in the reviewed studies were generally mild and transient, serious AEs have occurred, including paraplegia, meningitis, and epidural abscess. Differences, often subtle, in the injection route, region, steroid, anesthetic, and patient pathology result in a vast array of procedural options for ESI, and such variability makes interpretation of existing ESI data difficult.

Smith et al (2019) published the results of a systematic review of 19 studies assessing the efficacy of lumbar transforaminal steroid injection for radicular pain due to lumbar disc herniation. Placebo controlled RCTs, pragmatic studies, and observational studies were included in the analysis. Utilizing a threshold of 50% reduction in pain, treatment success rates across studies were 63% (Range: 58 to 68%) at 1-month, 74% (Range: 68-80%) at 3-months, 64% (59-69%) at 6-months, and

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