Epidural Steroid Injections for Spinal Pain – Commercial ...

UnitedHealthcare? Commercial and Individual Exchange Medical Policy

Epidural Steroid Injections for Spinal Pain

Policy Number: 2023T0616H Effective Date: October 1, 2023

Instructions for Use

Table of Contents

Page

Application ..................................................................................... 1

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

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

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

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

Description of Services ................................................................. 5

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

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

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

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

Instructions for Use .....................................................................12

Related Commercial/Individual Exchange Policies ? Ablative Treatment for Spinal Pain ? Anesthesia Policy, Professional ? Facet Joint and Medical Branch Block Injections for

Spinal Pain ? Occipital Nerve Injections and Ablation (Including

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

Application

UnitedHealthcare Commercial

This Medical Policy applies to all UnitedHealthcare Commercial benefit plans.

UnitedHealthcare Individual Exchange

This Medical Policy applies to Individual Exchange benefit plans in all states except for Colorado.

Coverage Rationale

Epidural Steroid Injections (ESI) are proven and medically necessary when all of the following criteria are met: The injection is intended for the management of Radicular Pain as evidenced by history and physical exam; and

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

? There is evidence of structural and/or functional nerve root involvement; and The injection is performed under fluoroscopic or CT guidance.

Conditions that would contraindicate ESIs include but are not limited to: Spinal neoplasm Rapidly progressing neurological deficit Epidural abscess

Epidural Steroid Injections for Spinal Pain

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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 four (4) 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 Subsequent ESIs may be provided only if: o Radicular pain has returned and/or deterioration in function has occurred; and o The previous injection resulted in 50% pain relief or functional improvement for less than three months as measured

by validated measurement tools and there has been a reassessment of the individual and the injection site and technique; or o The previous injection resulted in 50% pain relief or functional improvement for three or more months as measured by validated measurement tools

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 demonstrating presence of radicular pain Relevant medical history related to the spine or surrounding tissues Treatments (e.g., pharmacotherapy, exercises) tried, failed, or contraindicated; include the dates, duration of treatment, and reason for discontinuation 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 fluoroscopic, CT, or ultrasound guidance

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

Dates, location, and duration of the effect for the prior 12 months Percentage of pain reduction and/or functional improvement as measured on a validated measurement tool

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

Definitions

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) Functional Impairments: Limitations due to illness; dysfunction in social and occupational spheres of life. (Ust?n 2009)

Epidural Steroid Injections for Spinal Pain

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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)

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)

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

Description

All Regions

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

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Diagnosis Code

Description

Cervical/Thoracic

M47.22 M47.23 M47.24 M50.10 M50.11 M50.121 M50.122

Other spondylosis with radiculopathy, cervical region 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

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

M54.11

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.A0

Intervertebral annulus fibrosus defect, lumbar region, unspecified size

M51.A1

Intervertebral annulus fibrosus defect, small, lumbar region

M51.A2

Intervertebral annulus fibrosus defect, large, lumbar region

M51.A3

Intervertebral annulus fibrosus defect, lumbosacral region, unspecified size

M51.A4

Intervertebral annulus fibrosus defect, small, lumbosacral region

M51.A5

Intervertebral annulus fibrosus defect, large, lumbosacral region

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

Epidural Steroid Injections for Spinal Pain

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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, 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).

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.

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

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