Clinical Appropriateness Guidelines

Musculoskeletal Appropriate Use Criteria: Interventional Pain Management

Description and Application of the Guidelines The Carelon Clinical Appropriateness Guidelines (hereinafter “the Carelon Clinical Appropriateness Guidelines” or the “Guidelines”) are designed to assist providers in making the most appropriate treatment decision for a specific clinical condition for an individual. The Guidelines establish objective and evidence-based criteria for medical necessity determinations, where possible, that can be used in support of the following:

• To establish criteria for when services are medically necessary

• To assist the practitioner as an educational tool

• To encourage standardization of medical practice patterns

• To curtail the performance of inappropriate and/or duplicate services

• To address patient safety concerns

• To enhance the quality of health care

• To promote the most efficient and cost-effective use of services The Carelon guideline development process complies with applicable accreditation and legal standards, including the requirement that the Guidelines be developed with involvement from appropriate providers with current clinical expertise relevant to the Guidelines under review and be based on the most up-to-date clinical principles and best practices.

Resources reviewed include widely used treatment guidelines, randomized controlled trials or prospective cohort studies, and large systematic reviews or meta-analyses. Carelon reviews all of its Guidelines at least annually.

Carelon makes its Guidelines publicly available on its website. Copies of the Guidelines are also available upon oral or written request. Additional details, such as summaries of evidence, a list of the sources of evidence, and an explanation of the rationale that supports the adoption of the Guidelines, are included in each guideline document.

Carelon applies objective and evidence-based criteria, and takes individual circumstances and the local delivery system into account when determining the medical appropriateness of health care services. The Carelon Guidelines are just guidelines for the provision of specialty health services.

These criteria are designed to guide both providers and reviewers to the most appropriate services based on a patient’s unique circumstances. In all cases, clinical judgment consistent with the standards of good medical practice should be used when applying the Guidelines.

Guideline determinations are made based on the information provided at the time of the request. It is expected that medical necessity decisions may change as new information is provided or based on unique aspects of the patient’s condition. The treating clinician has final authority and responsibility for treatment decisions regarding the care of the patient and for justifying and demonstrating the existence of medical necessity for the requested service.

The Guidelines are not a substitute for the experience and judgment of a physician or other health care professionals. Any clinician seeking to apply or consult the Guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment. The Guidelines do not address coverage, benefit or other plan specific issues. Applicable federal and state coverage mandates take precedence over these clinical guidelines, and in the case of reviews for Medicare Advantage Plans, the Guidelines are only applied where there are not fully established CMS criteria.

If requested by a health plan, Carelon will review requests based on health plan medical policy/guidelines in lieu of the Carelon Guidelines. Pharmaceuticals, radiotracers, or medical devices used in any of the diagnostic or therapeutic interventions listed in the Guidelines must be FDA approved or conditionally approved for the intended use. However, use of an FDA approved or conditionally approved product does not constitute medical necessity or guarantee reimbursement by the respective health plan.

The Guidelines may also be used by the health plan or by Carelon for purposes of provider education, or to review the medical necessity of services by any provider who has been notified of the need for medical necessity review, due to billing practices or claims that are not consistent with other providers in terms of frequency or some other manner.

General Clinical Guideline Clinical Appropriateness Framework Critical to any finding of clinical appropriateness under the guidelines for a specific diagnostic or therapeutic intervention are the following elements:

• Prior to any intervention, it is essential that the clinician confirm the diagnosis or establish its pretest likelihood based on a complete evaluation of the patient. This includes a history and physical examination and, where applicable, a review of relevant laboratory studies, diagnostic testing, and response to prior therapeutic intervention.

• The anticipated benefit of the recommended intervention is likely to outweigh any potential harms, including from delay or decreased access to services that may result (net benefit).

• Widely used treatment guidelines and/or current clinical literature and/or standards of medical practice should support that the recommended intervention offers the greatest net benefit among competing alternatives.

• There exists a reasonable likelihood that the intervention will change management and/or lead to an improved outcome for the patient. Providers may be required to submit clinical documentation in support of a request for services. Such documentation must a) accurately reflect the clinical situation at the time of the requested service, and b) sufficiently document the ordering provider’s clinical intent. If these elements are not established with respect to a given request, the determination of appropriateness will most likely require a peer-to-peer conversation to understand the individual and unique facts that would justify a finding of clinical appropriateness.

During the peer-to-peer conversation, factors such as patient acuity and setting of service may also be taken into account to the extent permitted by law. Simultaneous Ordering of Multiple Diagnostic or Therapeutic Interventions Requests for multiple diagnostic or therapeutic interventions at the same time will often require a peer-to-peer conversation to understand the individual circumstances that support the medical necessity of performing all interventions simultaneously.

This is based on the fact that appropriateness of additional intervention is often dependent on the outcome of the initial intervention.

Additionally, either of the following may apply:

• Current literature and/or standards of medical practice support that one of the requested diagnostic or therapeutic interventions is more appropriate in the clinical situation presented; or

• One of the diagnostic or therapeutic interventions requested is more likely to improve patient outcomes based on current literature and/or standards of medical practice. Repeat Diagnostic Intervention In general, repeated testing of the same anatomic location for the same indication should be limited to evaluation following an intervention, or when there is a change in clinical status such that additional testing is required to determine next steps in management. At times, it may be necessary to repeat a test using different techniques or protocols to clarify a finding or result of the original study. Repeated testing for the same indication using the same or similar technology may be subject to additional review or require peer-to-peer conversation in the following scenarios:

• Repeated diagnostic testing at the same facility due to technical issues

• Repeated diagnostic testing requested at a different facility due to provider preference or quality concerns Interventional Pain Management © 2026 Carelon Medical Benefits Management. All rights reserved. 5

• Repeated diagnostic testing of the same anatomic area based on persistent symptoms with no clinical change, treatment, or intervention since the previous study • Repeated diagnostic testing of the same anatomic area by different providers for the same member over a short period of time

Repeat Therapeutic Intervention

In general, repeated therapeutic intervention in the same anatomic area is considered appropriate when the prior intervention proved effective or beneficial and the expected duration of relief has lapsed.

A repeat intervention requested prior to the expected duration of relief is not appropriate unless it can be confirmed that the prior intervention was never administered. Requests for ongoing services may depend on completion of previously authorized services in situations where a patient’s response to authorized services is relevant to a determination of clinical appropriateness.

Epidural and Intradiscal Injection Procedures and Diagnostic Selective Nerve Root Blocks Description Epidural steroid injection (ESI) involves the administration of corticosteroid via insertion of a needle into the epidural space surrounding the spinal neural elements. Despite the lack of consistent evidence to support its efficacy, the procedure is widely used in patients with chronic back, neck, and radicular pain. In 2014, the U.S. Food and Drug Administration issued a drug safety communication about epidural injection of corticosteroids, citing the risk for rare but serious adverse effects (loss of vision, stroke, paralysis, and death). The best evidence supporting its use comes from trials that looked specifically at patients with radiculopathy due to disc herniation, where short-term benefit has been demonstrated. Injections may be performed as part of a diagnostic workup of radicular pain, or as a therapeutic modality when multiple noninvasive treatment strategies have failed. Injections may be performed via an interlaminar approach, transforaminal approach, or caudal approach (through the sacral hiatus). Diagnostic selective nerve root block (SNRB) is a related procedure that utilizes a small amount of anesthetic, injected via transforaminal approach, to anesthetize a specific spinal nerve root without spreading into the epidural space. Diagnostic SNRBs are used to evaluate a patient’s anatomical level and/or source of radicular pain that is not clear on imaging studies and are often used in presurgical planning and decision making.

Clinical Indications The following general requirements apply to all indications except where they differ from the specific requirements. The specific requirements take precedence over any stated general requirement.

General Information

The terms in the section provide operational definitions when they are referenced as requirements in the guideline. Documentation supporting medical necessity should be submitted at the time of the request and must include the following components: Conservative management1 should include a combination of strategies to reduce inflammation, alleviate pain, and correct underlying dysfunction, including physical therapy AND at least one complementary conservative treatment strategy. • Physical therapy requirement includes ANY of the following: o Physical therapy rendered by a qualified provider of physical therapy services o Supervised home treatment program that includes ALL of the following: ▪ Participation in a patient specific or tailored program ▪ Initial active instruction by MD/DO/PT with redemonstration of patient ability to perform exercises ▪ Compliance (documented or by clinician attestation on follow-up evaluation) o Exception to the physical therapy requirement in unusual circumstances (for instance, intractable pain so severe that physical therapy is not possible) when clearly documented in the medical record • Complementary conservative treatment requirement includes ANY of the following: Interventional Pain Management © 2026 Carelon Medical Benefits Management.

o Anti-inflammatory medications and analgesics2 o Adjunctive medications such as nerve membrane stabilizers or muscle relaxants2 o Alternative therapies such as acupuncture, chiropractic manipulation, massage therapy, activity modification, and/or a trial period of rest (e.g., from the aggravating/contributing factors) where applicable 1 Additional condition or procedure-specific requirements may apply and can be found in the respective sections of the guideline. 2 In the absence of contraindications Clinical reevaluation – In most cases, reevaluation should include a physical examination. Direct contact by other methods, such as telephone communication or electronic messaging, may substitute for in-person evaluation when circumstances preclude an office visit.

Failure of conservative management requires ALL of the following: • Patient has completed a full course of conservative management (as defined above) for the current episode of care • Worsening of or no significant improvement in signs and/or symptoms upon clinical reevaluation • More invasive forms of therapy are being considered Documentation of compliance with a plan of therapy that includes elements from these areas is required where conservative management is appropriate.

Reporting symptom severity – Severity of pain and its associated impact on activities of daily living (ADLs) and instrumental ADLs (IADLs) are key factors in determining the need for intervention. For purposes of this guideline, significant pain and functional impairment refer to pain that is at least 3 out of 10 in intensity and is associated with inability to perform at least two (2) ADLs and/or IADLs.

Imaging studies – All imaging must be performed and read by an independent radiologist. If discrepancies should arise in the interpretation of the imaging, the radiology report will supersede. The results of all imaging studies should correlate with the clinical findings in support of the requested procedure.

Procedural Best Practices to Prevent Neurologic Complications

All providers are expected to adhere to the procedural best practices for epidural steroid injections established by the U.S. Food and Drug Administration (FDA) Safe Use Initiative in 2015. The FDA Safe Use Initiative convened an expert multidisciplinary working group and 13 specialty stakeholder societies to review the existing evidence regarding neurologic complications associated with epidural corticosteroid injections. Seventeen procedural clinical considerations aimed at enhancing the safety of these injections, including the appropriate use of particulate steroids, were published. Providers are strongly encouraged to review the consensus opinions of the multidisciplinary working group (see Safeguards to Prevent Neurologic Complications after Epidural Steroid Injections: Consensus Opinions from a Multidisciplinary Working Group and National Organizations, available at: https://anesthesiology.pubs.asahq.org/article.aspx?articleid=2119175). Note: Preauthorization is required for notification purposes only (medical necessity review is not required) when CPT 62320 and 62322 are used for post-procedural pain with any of the following ICD-10-CM diagnoses: G89.11 Acute pain due to trauma, G89.12 Acute post-thoracotomy pain, or G89.18 Other acute post procedural pain.

Epidural Injections

Procedural Requirements and Restrictions

• Injections must be performed under fluoroscopy or CT guidance with contrast to confirm needle placement, unless CT or fluoroscopy cannot be performed due to contraindications. • A maximum of one spinal region may be treated per session (date of service). An anatomic spinal region for epidurals is defined as cervical/thoracic or lumbar/sacral.

A maximum of four (4) therapeutic injection sessions may be performed in each spinal region in a rolling 12-month period regardless of the type of approach (transforaminal, interlaminar, or caudal) or the number of levels involved.

• An initial injection is defined as no prior injections in the previous 12 months or more. A successful injection is defined as one that provides at least 50% relief for at least 3 months. If the initial injection fails to provide at least 50% relief within the first 2 weeks, a one-time second injection may be performed no sooner than 2 weeks after the initial one. This one-time second injection should also use a different approach, level, or steroid. The rationale and medical necessity for the second injection must be documented in the medical record.

• No more than two (2) transforaminal injections (each level meeting criteria below) may be performed at a single setting (e.g., single level bilaterally or two levels unilaterally). Injecting one level bilaterally would be considered two injections. Injecting two levels, each unilaterally, would also be considered two injections.

• For caudal or cervical/thoracic/lumbar interlaminar injections, only one injection per session may be performed and NOT in conjunction with a transforaminal injection. A session is defined as all epidural steroid injections or spinal procedures performed on a single day.

• Epidural injections should not be combined with any other procedure on spine except under special circumstances such as presence of a large facet joint synovial cyst or large effusion compressing a spinal nerve root in which case a transforaminal injection combined with an intraarticular facet synovial cyst aspiration and steroid injection may be given together.

• The primary care provider should be notified regarding the continuation of procedures beyond 12 months and prolonged repeat steroid use.

• This guideline does not apply when epidural injections (without any corticosteroid injectate) are used for postoperative pain management.

• This guideline does not apply when epidural injection is used for an implantable infusion pump trial.

Therapeutic Epidural Steroid Injection (Interlaminar, Caudal, Transforaminal)

Therapeutic epidural steroid injection of the cervical, thoracic, or lumbar spine may be considered medically necessary when ALL of the following criteria are met:

• Significant radicular pain (corresponding to a specific dermatomal distribution with or without paresthesia, numbness or weakness), radiculopathy (cervical, thoracic, or lumbar), or neurogenic claudication (lumbar) with associated functional impairment and completed physical exam

• Evidence of EITHER of the following is seen on an advanced imaging study* (MRI or CT) and correlates with the clinical findings: o Nerve root compression secondary to herniated disc (advanced imaging should be performed within the previous 18 months) o Spinal stenosis (central, lateral recess, foraminal, extraforaminal)

• The radicular pain has not responded to at least 4 weeks of appropriate conservative management, unless there is clear evidence of radiculopathy**, in which case epidural steroid injection may be performed following 2 weeks of conservative management

***For caudal and interlaminar approaches, the initial epidural injection for a given episode of pain in the lumbar spine may be performed without confirmatory advanced imaging if the reported symptoms and exam findings are clearly diagnostic of radiculopathy.* **

Clear evidence of radiculopathy is defined as pain distributed along specific nerve root with corresponding dermatomal sensory changes, myotomal weakness, and/or reflex abnormality.

Repeat Therapeutic Epidural Steroid Injection

An injection is considered a repeat injection if the last injection was performed within the previous 12 months. If 12 months or more have elapsed, it is considered a new (initial) injection.

Repeat therapeutic epidural steroid injection may be considered medically necessary when ALL of the following criteria are met:

• Significant radicular pain, radiculopathy (cervical, thoracic, or lumbar), or neurogenic claudication (lumbar) with associated functional impairment

• The prior injection produced at least a 50% reduction in pain and functional improvement of at least 3 months’ duration as documented in a follow-up evaluation

• Evidence of nerve root compression or stenosis at the requested levels and laterality as reported on advanced imaging (MRI or CT). The imaging findings should correlate with the clinical findings that are documented. For herniated nucleus pulposus (HNP), advanced imaging should be performed within the 18 months preceding the current request. If there is a fixed lesion at the targeted level (central, lateral recess, foraminal, or extraforaminal stenosis) not due to HNP, then there is no requirement for repeat imaging.

• The patient continues to receive conservative management between injections.