LCD L38994: Epidural Steroid Injections for Pain Management

Compliance with the provisions in this Local Coverage Determination (LCD) may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

Low back pain (LBP) is highly prevalent, with reports of 50-84% of adults experiencing back pain at some point, with a high prevalence in adults 65 and older and the highest cause of disability globally. Low back and neck pain can influence the quality of life and function, and is associated with depression and anxiety. 1,2 In a 2018 National Health Interview Survey, the Centers for Disease Control (CDC) reported 28% of men and 31.6% of women age ≥ 18 had lower back pain in the past 3 months. 3 There is debate and a lack of consensus on which modalities are best to treat chronic low back pain (CLBP). 4

The epidural space lies outside the dural membrane inside the spinal canal. It runs the length of the spine and, in addition to the exiting nerve roots, contains fatty tissue and blood vessels. The spinal nerve roots can be affected by a number of processes as they travel through the epidural space, including but not limited to compression from herniation of the nucleus pulposus of the intervertebral discs, degenerative changes involving combinations of the spinal ligaments, discs, zygapophyseal (facet) joints, intraspinal synovial cysts, osteophytes, and mechanical derangements of the spine such as spondylolisthesis. As a result of mechanical irritation, inflammation, injury to a spinal nerve root or other processes, the spinal nerve roots can become a significant and disabling source of radicular pain. 1 Epidural steroid injections (ESIs) have been used as a non-surgical modality to treat low back and neck pain. These procedures typically involve the injection of a solution containing corticosteroids and/or anesthetic into the epidural space, although saline may be included at times.

The ESI can be performed in 3 ways. Interlaminar epidural steroid injection (ILESI) approaches the epidural space from the posterior spine between the 2 vertebral laminae near the midline. In the transforaminal epidural steroid injection (TFESI) approach, the injectant is delivered through the neuroforamen dorsal to the nerve root within the intervertebral foramen. The caudal epidural steroid injection (CESI) approach enters through the sacral hiatus at the sacral canal to access the epidural space. 1,4

The treatment of individuals with spinal disorders, including pain, can be complex, and it is recommended that all individuals being considered for interventional spinal procedures undergo a thorough evaluation and be treated following development of a comprehensive care plan.

Covered Indications

• ESI will be considered medically reasonable and necessary when the following 3 requirements are met:

• History, physical examination, and concordant radiological image-based diagnostic testing and supporting 1 of the following 5 :

• Lumbar, cervical or thoracic radiculopathy, radicular pain and/or neurogenic claudication due to central disc herniation, osteophyte or osteophyte complexes, severe degenerative disc disease, producing foraminal or central spinal stenosis 5 ; OR

• Post-laminectomy syndrome 6-8

• Acute herpes zoster associated pain 6

AND

• Radiculopathy, radicular pain and/or neurogenic claudication is severe enough to greatly impact quality of life or function. An objective pain scale or functional assessment must be performed at baseline (prior to interventions). The same scale* must be repeated at each follow-up for assessment of response.

AND

• Pain duration of at least 4 weeks, and the inability to tolerate noninvasive conservative care or medical documentation of failure to respond to 4 weeks of noninvasive conservative care or acute herpes zoster refractory to conservative management where a 4-week wait is not required. 9

• The ESIs must be performed under computed tomography (CT) or fluoroscopy image guidance with contrast, 10 unless the patient has a documented contrast allergy or pregnancy where ultrasound guidance without contrast may be considered.

• TFESIs involving a maximum of 2 levels in 1 spinal region are considered medically reasonable and necessary. It is important to recognize that most conditions would not ordinarily require ESI at 2 levels in 1 spinal region. 11

• CESIs and ILESIs involving a maximum of 1 level are considered medically reasonable and necessary. 11

• It is medically reasonable and necessary to perform TFESIs bilaterally only when clinically indicated.

• Repeat ESI when the first injection directly and significantly provided improvement of the condition being treated may be considered medically reasonable and necessary when the medical record documents a minimum of consistent 50% improvement in pain for at least 3 months or at least 50% consistent improvement in the ability to perform previously painful movements and ADLs as compared to baseline measurement using the same scale . 7,8 If a patient fails to respond well to the initial ESI, a repeat ESI after 14 days can be performed, using a different approach, level and/or medication if appropriate, with the rationale and medical necessity for the second ESI documented in the medical record.

• An initial injection of contrast is required to confirm epidural placement, unless the patient has a contraindication to contrast. The subsequent ESIs should include corticosteroids and may be combined with anesthetics or saline. 1

• The ESIs should be performed in conjunction with conservative treatments. 9

• Patients should be part of an active rehabilitation program, home exercise program or functional restoration program. 10,12

*Note: The scales used to measure pain or disability must be documented in the medical record. Acceptable scales include but are not limited to: verbal rating scales, Numerical Rating Scale (NRS) and Visual Analog Scale (VAS) for pain assessment, and Pain Disability Assessment Scale (PDAS), Oswestry Disability Index (ODI), Oswestry Low Back Pain Disability Questionnaire (ODQ), Quebec Back Pain Disability Scale (QBPDS), Roland Morris Pain Scale, Back Pain Functional Scale (BPFS), and the Patient-Reported Outcomes Measurement Information System (PROMIS) profile domains to assess function.

Limitations

• Injections performed without image guidance or by ultrasound are not considered reasonable and necessary except in cases of documented contraindication to contrast media (e.g., allergy, pregnancy). 13-15

• ESIs performed with biologicals or other substances not Food and Drug Administration (FDA) designated for this use is considered investigational and not medically reasonable and necessary.

• It is not considered medically reasonable and necessary to perform multiple blocks (ESI, sympathetic blocks, facet blocks, trigger point injections, etc.) during the same session as ESIs, with the exception of a facet synovial cyst and ESI performed in the same session.

• Use of moderate or deep sedation, general anesthesia, and monitored anesthesia care (MAC) is usually unnecessary or rarely indicated for these procedures and, therefore, not considered medically reasonable and necessary. 16 Even in patients with a needle phobia and anxiety, typically oral anxiolytics suffice. In exceptional and unique cases, documentation must clearly establish the need for such sedation in the specific patient.

• ESIs to treat non-specific LBP, axial spine pain, complex regional pain syndrome, widespread diffuse pain, pain from neuropathy from other causes, cervicogenic headaches are considered investigational and therefore are not considered medically reasonable and necessary. 6,17,18

• ESIs are limited to a maximum of 4 sessions per spinal region in a rolling 12-month period. 7

• It is not considered medically reasonable and necessary for more than 1 spinal region to be injected in the same session. 11

• It is not considered medically reasonable and necessary to perform TFESIs at more than 2 nerve root levels during the same session. 11

• It is not considered medically reasonable and necessary to perform CESIs or ILESIs at more than 1 level during the same session. 11

• It is not medically reasonable and necessary to perform CESIs or ILESIs bilaterally. 14

• It is not medically reasonable and necessary to prescribe a predetermined series of ESIs. 8

• Steroid dosing should be the lowest effective amount.

• It generally would not be considered medically reasonable and necessary for treatment with ESI to extend beyond 12 months. 19,20 Frequent continuation of ESIs over 12 months may trigger a focused medical review. Use beyond 12 months requires the following:

• Pain is severe enough to cause a significant degree of functional disability or vocational disability.

• ESI provides at least 50% sustained improvement of pain and/or 50% objective improvement in function (using same scale as baseline).

• Rationale for the continuation of ESIs including but not limited to patient is high-risk surgical candidates, the patient does not desire surgery, recurrence of pain in the same location relieved with ESIs for at least 3 months.

• The primary care provider must be notified regarding continuation of procedures and prolonged repeat steroid use.

ESIs should not be performed when contraindicated including but not limited to: suspected or active localized spinal infection, significant systemic infection, compressive lesions of the spinal cord, conus medullaris or cauda equina, suspicion or major risk factors for cancer. 11

Provider Qualifications

Medicare Program Integrity Manual states services will be considered medically reasonable and necessary only if performed by appropriately trained providers.

Procedures listed and included in this LCD do not constitute anesthesia services. Evaluation, methods and techniques specified are not considered routine for surgical or perioperative anesthesia.

Patient safety and quality of care mandate that healthcare professionals who perform epidural injections/procedures for chronic pain (not surgical anesthesia) are appropriately trained and/or credentialed by a formal residency/fellowship program and/or are certified by either an accredited and nationally recognized organization or by a post-graduate training course accredited by an established national accrediting body or accredited professional training program whose core curriculum includes the performance and management of the procedures addressed in this LCD. Credentialing or privileges are required for procedures performed in inpatient and outpatient settings. 21,22

All aspects of care must be within the provider’s medical licensure and scope of practice. Reimbursement for procedures utilizing imaging techniques may be made to providers who meet training requirements for the procedures in this LCD only if their respective state allows such in their practice act and formally licenses or certifies the practitioner to use and interpret these imaging modalities (ionizing radiation and associated contrast material, magnetic resonance imaging (MRI), ultrasound). At a minimum, training must cover and develop an understanding of anatomy and drug pharmacodynamics and kinetics as well as proficiency in diagnosis and management of disease, the technical performance of the procedure, and utilization of the required associated imaging modalities.

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in Centers for Medicare and Medicaid Services (CMS) payment policy manuals, any and all existing CMS national coverage determinations (NCDs), and all Medicare payment rules.

Definitions

Acute LBP – LBP, which is present for up to 6 weeks.

CESI – The administration via injection of contrast (absent allergy to contrast), followed by the introduction of corticosteroids and possibly a local anesthetic (LA) into the epidural space of the spine by inserting a needle through the sacral hiatus under fluoroscopic guidance into the epidural space at the sacral canal.

Cervicobrachialgia - Pain in the neck radiating to the arm, caused by compression of nerve roots of the cervical spine.

Conservative Therapy – Consists of an appropriate combination of medication (for example, non-steroidal anti-inflammatory [NSAIDs], analgesics, etc.) in addition to physical therapy, spinal manipulation therapy, cognitive behavioral therapy (CBT), home exercise program, or other interventions based on the individual’s specific presentation, physical findings, and imaging results.

Disability – Activity limitations and/or participation restrictions in an individual with a health condition, disorder or disease. 23

Discogenic Pain – Pain originating from damaged vertebral disc, particularly, but not always, due to degenerative disc disease.

ESI – The administration via injection of contrast (absent allergy to contrast), followed by the introduction of a corticosteroid and possibly a LA into the epidural space of the spine.

GRADE – A system developed by the GRADE Working Group to address the shortcomings of present grading systems in healthcare. The GRADE system uses a common, sensible, and transparent approach to grading the quality of evidence. The results of applying the GRADE system to clinical trial data are displayed in a table known as a GRADE profile.

Impairment – A significant deviation, loss, or loss of use of any body structure or body function in an individual with a health condition, disorder or disease. 23

ILESI – An injection of contrast (absent allergy to contrast), followed by the introduction of a corticosteroid and possibly a LA into the epidural space of the spine either through a paramedian or midline interlaminar approach under fluoroscopic guidance.

Level – The spinal roots that enter and exit the spinal column between each of the vertebral segments cervical (C1-C8), thoracic (T1-T2), lumbar levels (L1-L5), and sacral (S1-S5).

Multidisciplinary Biopsychosocial Rehabilitation (MBR) – Targets physical as well as psychological and social aspects of LBP, and involves a team of healthcare providers with different professional backgrounds and training. 10

Non-Radicular Back Pain – The radiating non-neuropathic pain which is not causally related to a spinal nerve root irritation and does not produce reproducible neuropathic symptoms in an objective dermatomal pattern.

Neural Foramina – (also called intervertebral foramen) The openings between each pair of vertebra where a number of structures pass through.

Neurogenic Claudication – (also known as pseduoclaudication) The physical manifestation of leg pain, leg weakness, or leg heaviness exacerbated by walking and relieved with leaning forward or sitting down.

Nonspecific LBP – Back pain that cannot be attributed to a specific disease or spinal pathology .

Osteophyte – An exostosis or benign osteoma of the facet joints or vertebral endplates.

Osteophyte Complex – The protrusion of disc material, buckling of the ligamentum flavum, joint hypertrophy, and osteophytes.

Peripheral Neuropathic Pain – Pain is causally related to a lesion or disease of the peripheral somatosensory nerves.

Post-Laminectomy Syndrome – A group of symptoms following a lumbar laminectomy which include diffuse LBP with associated dull and aching pain involving the legs.

Radicular Back Pain – Radicular pain is nerve root pain radiating from the affected spinal segment in a distribution concordant with the known distribution of the nerve root.

Radiculopathy – Radiating neuropathic pain causally related to the spinal nerve root irritation, which extends distally, producing neuropathic pain in a myotomal or dermatomal pattern.

Radiculitis – Inflammation of the nerve roots which produces radicular pain without objective neurological findings on physical examination.

Session – A time period, which includes all procedures (i.e., medial branch blocks (MBB), intraarticular injections (IA), facet cyst ruptures, and radiofrequency ablations (RFAs)) performed during 1 day.

TFESI – An epidural injection performed via a paramedian approach to enter the epidural space by placing the needle in the posterior-superior quadrant of the intervertebral foramen (neuroforamen) to inject near the dorsal root ganglion and exiting spinal nerve root (previously known as a selective nerve root block (SNRB)).

SNRB – A diagnostic injection of contrast (absent allergy to contrast) of a single nerve root to assist with surgical planning, followed by the introduction of a LA by inserting a needle into the neuroforamen under fluoroscopic or CT guidance. SNRB’s are erroneously referred to as a TFESI, although technically, SNRB’s involve the introduction of anesthetic only used for diagnostic purposes.

Spinal Stenosis – The narrowing of the central spinal canal or foraminal openings, usually due to spinal degeneration that occurs with aging. It may also be the result of spinal disc herniation, osteoarthritis, or a tumor. Lumbar spinal stenosis results in LBP and pain or abnormal sensations in the legs, thighs, feet, or buttocks, or loss of bladder and bowel control. Neurogenic claudication is often a clinical condition that results from spinal stenosis.

Spondylolisthesis- A disorder of the spinal cord in which 1 vertebra slips onto the vertebra below it resulting in pain in lower back or legs.

Subacute Pain – The temporal definition of pain occurring during the 6 to 12-week time period.

Chronic Pain – The temporal definition of pain occurring 12 weeks after the onset of the pain.

Contractor Advisory Committee (CAC) Meeting 2/11/2021

A Multi-jurisdictional CAC meeting of subject matter experts (SMEs) was convened on 02/11/2021 regarding epidural injections and procedures. The transcript, voting results, and audio are available on each MACs website. The panel consisted of experts in pain management including anesthesiology and physical medicine and rehabilitation, as well as neuroradiology, internal medicine and a certified nurse anesthetist with representation throughout the country and including academic and clinical experts. The panel will be referred to as SMEs, and their input incorporated through the review to correlate the evidence with expert input.

Summary of Evidence

Acute LBP, defined as LBP with less than 4 weeks duration, has an excellent prognosis to recover within the first 4 to 6 weeks. Initially, treatments include non-invasive therapies, including pharmacologic and non-pharmacological measures. Patients with acute or subacute nonspecific LBP typically would not be considered candidates for interventional therapies, as they could still improve with non-invasive therapies, and there is little evidence on the efficacy of invasive therapies in this circumstance. 24 The American College of Physicians (ACP) offers a strong recommendation for non-pharmacological measures as the first line treatment. Recommended non-pharmacological measures include conservative measures such as superficial heat, exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction having moderate-quality evidence. For pharmacologic therapy, they recommend NSAIDs as first line treatment, and muscle relaxants as second-line treatment. 25 Systemic steroids may provide benefits with 3 randomized control trials (RCTs) showing benefit, especially in the short term. The benefit of anticonvulsants and antidepressants is overall low quality, but there is potential benefit in some patients. 26 A systematic review comparing ESIs to conservative treatment for patients with lumbosacral radicular pain reported that ESIs were more effective for alleviating lumbosacral radicular pain but not function in both short- and intermediate-term compared to conservative treatment; however, this effect was not maintained at long-term follow-up. 27 It is standard practice to utilize conservative treatment measures for the management of acute LBP. When back pain persists over 12 weeks, it is considered CLBP, and spontaneous recovery is less likely. The SMEs voted 3/5 (range 2-5) that there is evidence to support periods of conservative management prior to treatment with epidural injections. The panel discussed time for conservative care is related stronger to the natural history of the disease than the evidence, as it has not been well studied. The panel voted low confidence (2/5; range 1-5) in terms of evidence to support documentation of failure of at least 2 classes of medication prior to ESI. The use of medication is more controversial due to the risk associated with non-steroidal anti-inflammatory, specifically gastrointestinal complications, and the risk of opioid addiction with opioid use. Other medications remain available, but there is not strong evidence to support 1 specific category of medication.

Patients with LBP should be evaluated for the underlying condition, and targeted treatments implemented. History and physical examination, including a neurological exam to evaluate for radicular pain, should be performed. Imaging should be targeted to identify specific differential diagnoses and is not typically indicated in the early evaluation of LBP. 28 The American College of Radiology (ACR) offers evidence-based criteria for imaging for LBP. 29 According to the ACR criteria, patients who have acute, subacute, or chronic LBP or radiculopathy with persistent or progressive symptoms during or following 6 weeks of conservative management are considered candidates for surgery or intervention. Imaging may be considered for patients who have had no improvement in their back pain after 6 weeks of medical management and physical therapy. Imaging is classified as “may be appropriate”, with MRI of the lumbar spine without contrast classified as “usually appropriate” and CT if MRI is unavailable as needed for diagnostics. The American College of Occupational and Environmental Medicine guidelines state that while diagnostic tests are not indicated for the majority of LBP, the literature supports CT or MRI. 30 The ESIs are utilized as an option for a specific diagnosis, and therefore a thorough evaluation to achieve diagnosis is a necessary step prior to consideration of ESIs. In most cases, by the time ESIs are considered, imaging has been completed as part of the evaluation. Any prior imaging should be reviewed for anatomy prior to interventional procedures. The SMEs voted low confidence (2/5; range 1-4) that radicular pain should be concordant with a radiologist’s interpretation of an advanced diagnostic study demonstrating compression of the involved nerve root. The concern was that the imaging study is a static image in a dynamic process and the compression may be missed in the supine position even if present. The SMEs felt there was benefit in obtaining imaging to aid in diagnosis, such as to reveal anatomical features that may guide treatment options or alter approach, selection of needle size and appropriate segmental level. There was also concern that imaging would not reveal non-anatomical sources like chemical radiculitis.

Safety