LCD L40263: Peripheral Nerve Injections and Procedures for Chronic Pain

Definitions

Acute pain - The temporal definition of pain persisting for up to 4 weeks after the onset of the pain.

Subacute Pain – The temporal definition of pain occurring during the 4 to 12-week time period.

Chronic pain - The temporal definition of pain persisting for greater than or equal to 12 weeks after the onset of the pain.

Peripheral nerve block (PNB) - injection of local anesthetic near specific nerves outside of the central nervous system (brain/spinal cord) to interrupt pain signals.

Peripheral nerve injection (PNI) - injection near specific nerves. When used for delivery of steroid rather than interruption of pain signal it is referred to as injection, although the terms are sometimes interchangeable as all PNBs are injections, even though not all injections are PNBs.

Peripheral nerve denervation - loss or interruption of nerve supplies to muscle, organ or tissue and can be used therapeutically to destroy nerves as a modality to treat chronic pain. Mechanisms can include radiofrequency ablation [RFA] (thermal denervation), neurotomy (cutting), chemical destruction (use of agent to damage nerve permanently), and cryoneurolysis.

Coverage Guidance

This LCD is arranged by type of injection or denervation, and the indications for which it may be considered with coverage criteria outlined in the section. The LCD focuses on therapeutic injections/blocks and percutaneous denervation (usually RFA or cryotherapy). Surgical neurotomy or cutting procedures are beyond the scope of this LCD. The Limitation Section below applies to coverage for all conditions unless it is specifically made in the coverage section for the condition.

The injection types are in the following order:

• Median Nerve Injection(s)

• Sympathetic block(s)- Stellate Ganglion Block and Lumbar Sympathetic Block(s)

• Digital nerve block(s)

• Ganglion Impar Block(s)

• Genicular nerve block(s) (GNB)

• Morton’s Neuroma Nerve Injection(s)

• Occipital Nerve Block(s)

• Posterior tibial nerve block(s)

• Pudendal Nerve Block (s)

• Suprascapular Nerve Block (s)

• Trigeminal Neuralgia Nerve Block(s)

• Thoracic Nerve Block(s)

Indications and Limitations of Coverage

• A PNI involves the use of an anesthetic with or without corticosteroids, and does not include injections of biologics (e.g., platelet rich plasma, stem cells, amniotic fluid, dextrose, etc.) and/or any other injectates (e.g., vitamins, ozone, etc.).

• During denervation procedures for patients with implanted electrical devices (i.e., spinal cord stimulation, peripheral nerve stimulation, cardiac devices, etc.) and intrathecal pump delivery devices, providers should follow manufacturer instructions and extra planning as indicated to ensure safety of the procedure.

• Use of moderate or deep sedation, general anesthesia, and monitored anesthesia care (MAC) is usually unnecessary or rarely indicated for nerve injections and, therefore, not considered medically reasonable and necessary. 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 for the specific patient. 1

• Repetitive, regular or scheduled therapeutic PNIs are not reasonable and necessary for long-term pain management unless coverage is specified within the LCD.

• "Dry needling" of neuromas or peripheral nerves is not medically necessary and will be a non-covered procedure.

• It is not routinely necessary to perform peripheral nerve procedures on the same day as other injections (e.g., epidural steroid, facet, or trigger point injections) for neuropathic or nociceptive pain. If performed, the medical necessity of each procedure must be clearly documented in the medical record.

• A therapeutic PNI or denervation not listed as covered in the LCD is non-covered.

• Ultrasound guidance is considered reasonable and necessary only when it is necessary to identify superficial and deeper nerves, prior to the PNI to enhance accuracy, safety, and visualize needle placement.

• Fluoroscopic guidance may be reasonable and necessary when performing reasonable and necessary RFA of a peripheral nerve to enhance accuracy, safety, and visualize needle placement. Use of image guidance for non-covered injections is also considered not reasonable and necessary.

• An informed consent with risks and benefits is reviewed and documented in the medical record, including awareness of the risks of nerve damage and worsening pain.

• PNIs and procedures to treat widespread diffuse pain (i.e., fibromyalgia, myofascial pain, and chronic pain syndrome), or systemic polyneuropathies are investigational and, therefore, are not considered medically reasonable and necessary.

• Electrical stimulation is not considered reasonable and necessary when performing PNI. 2

Contraindications

PNIs are contraindicated when there is an allergy to local anesthetics, beneficiary refusal or an active infection at the injection site. Relative contraindications are: inability to cooperate, severe cognitive impairment, unstable psychiatric illness, psychological overlay to the chronic pain, or coagulopathies.

Provider Qualifications:

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

Patient safety and quality of care mandate that healthcare professionals who perform neural procedures 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. If the practitioner works in a hospital facility at any time and/or is credentialed by a hospital for any procedure, the practitioner must be credentialed to perform the same procedure in the outpatient setting. 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.

In addition to the above requirements, non-physician providers, such as certified nurse anesthetists, with certain exceptions, may certify, order, and establish the plan of care as authorized by State law (See Sections 1861[s][2] and 1862[a][14] of Title XVIII of the Social Security Act; 42 CFR, Sections 410.74, 410.75, 410.76, and 419.22; 58 FR 18543, April 7, 2000). Each practitioner must provide only those services within the scope of practice for each state.

Background

Chronic pain is pain that is experienced most days or every day in the past 3 months. 3 It is the most common reason adults seek medical care. 4 Chronic pain is associated with decreased quality of life, 5,6 opioid misuse, 7 increased anxiety and depression, 8 and unmet mental health needs. 9

In 2023, 24.3% of adults experienced chronic pain, and 8.5% of adults experienced high-impact chronic pain (or 34.9% of adults who had chronic pain). Chronic pain has a higher incidence in women, American Indian, Alaska Native adults, and those aged 65 and older. 10

The prevalence of neuropathic pain may be as high as 7 to 8%, accounting for 20 to 25% of individuals with chronic pain. 11 Best-practice recommendations for the treatment of peripheral neuropathic pain suggest first-line options including serotonin-norepinephrine reuptake inhibitors (SNRIs) (e.g., duloxetine and venlafaxine), gabapentin, tricyclic antidepressants, topical lidocaine, and transcutaneous electrical nerve stimulation. Pregabalin, tramadol, and combination therapy (combining antidepressants with gabapentinoids) are recommended as second-line treatments. High-concentration capsaicin patches and botulinum toxin A (BTX-A) are also recommended as second-line treatments, specifically for focal peripheral neuropathic pain. Third-line treatment options include strong opioids, as a last resort, in the absence of alternatives. Additionally, psychotherapy, including cognitive behavioral therapy and mindfulness, is recommended as a second-line therapy in conjunction with other treatments. 12

PNIs have been proposed as an additional option for the management of chronic pain, both for diagnostic and therapeutic purposes. A nerve block is a form of regional anesthesia that attempts to inhibit impulse transmission distally in a nerve terminal, thus terminating the pain signal perceived by the cortex. PNIs generally involve the injection of a LA with or without corticosteroids using various techniques. PNIs may also have a role in diagnosing and informing subsequent treatments, such as RFA or cryoneurolysis for chronic pain conditions. 13 Denervation procedures aim to destroy a nerve to disrupt its ability to transmit pain signals and can be performed with heat (thermal) or cooled RFA. Effects can be long-lasting, but nerve regeneration is common. Cryoneurolysis uses extreme cold to freeze and disrupt nerve function, causing temporary nerve function loss. The purpose of this LCD is to provide the scope of indications that are supported as reasonable and necessary for the usage of therapeutic PNIs and peripheral nerve denervation procedures for chronic pain management in appropriate patients.

Literature Analysis

This summary of the evidence is formatted by the type of intervention and outcome classification (i.e., efficacy/effectiveness, undesirable effects, patient experience, physical performance, and health care utilization). The findings of published evidence syntheses (e.g., systematic reviews, evidence reports) are prioritized when applicable to specific key research questions. The literature analysis emphasizes the research designs most applicable to the key questions (e.g., randomized controlled trials (RCTs) for efficacy-related questions). Multiple publications from the same dataset are grouped together in the analysis regardless of study design. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach domains of study limitations (risk of bias), indirectness (applicability), imprecision, and inconsistency formed the basis of appraisal of the certainty of evidence for efficacy/effectiveness studies.

A. Median Nerve Injections

Coverage

Median nerve injections may be considered for the management of carpal tunnel syndrome (CTS) in patients with clinical symptoms and physical exam findings consistent with CTS.

Limitations