Humana Neuroablative Techniques for Chronic Pain Form

Neuroablative techniques in pain management consist of several surgical and non-surgical methods to denervate a nerve. The goal of denervation is to interrupt the pain signals that are sent to the brain from the joints and nerves. An additional objective is to reduce the likelihood of, or to delay, any recurrence by selectively destroying pain fibers without causing excessive sensory loss, motor dysfunction or other complications.Many techniques accomplish denervation including, but may not be limited to:

• Chemical neurolysis, which may also be referred to as chemical ablation, chemical denervation or chemodenervation, involves the injection of neurolytic agents (eg, alcohol, hypertonic saline, phenol). This proposed treatment option for chronic pain generally results in a permanent ablation of the nerve. (Refer to Coverage Limitations section)
• radiofrequency ablation (RFA), in that it maintains the tissue temperature immediately adjacent to the electrode at 60oC while the target tissue (nerve) is heated to 75oC or higher. This purportedly allows for a larger volume of treated tissue without the risk of damage to the adjacent tissue. Examples of devices used for this procedure include, but may not be limited to, the Accurian RF Platform (when used in the cooled RF mode), COOLIEF Cooled RF Probe and Coolief Sinergy (Coolief Sinergy is specifically for the sacroiliac joint). (Refer to Coverage Limitations section)
• Cryosurgery may also be referred to as cryoablation or cryodenervation and is a technique of using extreme cold to destroy tissue, which is cooled to below -20oC by a probe circulating liquid nitrogen. (Refer to Coverage Limitations section)
• Cryotherapy is similar to cryosurgery, in that it uses extreme cold to destroy tissue, but is generally used to specifically target cardiac tissue or peripheral nerves. The CryoNB (cryo nerve block) therapy is an example of cryotherapy; it is performed with the CryoICE cryoSPHERE cryoablation probe and is proposed as a method for blocking postoperative pain by temporarily ablating peripheral nerves. (Refer to Coverage Limitations section)
• Facet denervation is one of the most commonly performed neuroablative procedures; it involves the destruction or interruption of a facet joint nerve (medial branch nerve) to relieve chronic pain in the cervical, thoracic or lumbar spine regions.
• Intracept Intraosseous Nerve Ablation System is a specialized radiofrequency ablation device, which has been granted US Food & Drug Administration (FDA) approval strictly for destruction of the basivertebral nerve of the L3-S1 vertebrae. It is proposed as a treatment option for low back pain.
• iovera◦ System is similar to cryosurgery, in that it uses cold to ablate a peripheral sensory nerve, but it is done in such a manner that it only produces a temporary denervation and subsequent interruption of the pain signals. It is purported that the nerves will slowly regenerate, and once the function is reestablished, normal nerve conduction resumes. This treatment may also be described as a cold injection or an iovera◦ injection.

Neuroablative Techniques for Chronic Pain

Effective Date: 11/02/2023

Revision Date: 11/02/2023

Review Date: 11/02/2023

Policy Number: HUM-0387-024

Page: 3 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• It has been suggested as a possible treatment for knee pain associated with osteoarthritis or for postoperative pain management in conjunction with total knee arthroplasty (replacement). (Refer to Coverage Limitations section)
• Laser ablation is proposed as a noninvasive treatment which uses laser energy to ablate a peripheral nerve. (Refer to Coverage Limitations section)
• traditional radiofrequency neurotomy. It delivers short bursts of radiofrequency current instead of a continuous flow, which purportedly allows the needle to remain relatively cool so that the tissue temperature decreases slightly between each burst, reducing the risk of destroying nearby tissue. Examples of devices used for this procedure include, but may not be limited to, the Accurian RF Platform, IonicRF Generator, MultiGen 2 RF Generator System or NeuroTherm NT2000IX (when any of these devices are used in pulsed mode). (Refer to Coverage Limitations section)
• Radiofrequency ablation (RFA) may also be referred to as nonpulsed radiofrequency ablation, percutaneous radiofrequency neuroablation, radiofrequency coagulation, radiofrequency denervation, radiofrequency lesioning, radiofrequency neuroablation, radiofrequency neurotomy or rhizotomy (articular rhizolysis). This percutaneous procedure utilizes radiofrequency current/energy to heat and ablate/denervate the target nerve. This technique involves the constant application of energy, usually at 80-85oC via an image-guided needle electrode inserted through the skin to the affected nerve. Examples of devices used for RFA include, but may not be limited to, the Baylis Pain Management Radiofrequency Generator and G4 RF Generator.

This policy addresses neuroablative/denervation (rhizotomy) procedures only, and should be distinguished from intradiscal electrothermal procedures, which is a treatment for back pain that applies heat to the disc or disc wall. For information regarding electrothermal intradiscal procedures, please refer to Electrothermal Intradiscal Therapies Medical Coverage Policy.

Neuroablative Techniques for Chronic Pain

Effective Date: 11/02/2023

Revision Date: 11/02/2023

Review Date: 11/02/2023

Policy Number: HUM-0387-024

Page: 4 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

For information regarding other conditions that may be treated with neuroablative techniques, please refer to the following:

• Headache, occipital neuralgia
  • Headache and Occipital Neuralgia Treatments
• Plantar fasciitis
  • Plantar Fasciitis Treatments

Coverage Determination

Facet Joint Denervation

Humana members may be eligible under the Plan for denervation of the facet joint* via nonpulsed radiofrequency ablation when the following criteria are met:

1. Severe neck or back (primarily axial) pain that limits daily activities, thought to be due to facet joint syndrome (symptoms of facet joint syndrome include absence of radiculopathy, pain that is aggravated by extension, rotation or lateral bending of the spine and is not typically associated with any neurological deficits); AND
2. Failure to improve after 12 weeks of conservative treatment under the direction of a healthcare professional, including ALL of the following:
   • Activity/lifestyle modification; AND
   • Medications (eg, nonsteroidal anti-inflammatory drugs [NSAIDs], non-narcotic analgesics) if medically appropriate and not contraindicated; AND
   • Physical therapy (PT), including a home exercise program (HEP) (for information regarding coverage determination/limitations, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy); AND
3. A maximum of 2 levels of facet joints per side, per anatomical region** may be treated during a session; AND
4. Real-time imaging guidance (computed tomography [CT] scan or fluoroscopy) must be used with the denervation to assure proper placement of the RF probe (this is considered integral to the primary procedure and not separately reimbursable); AND
5. Two diagnostic, temporary intra-articular facet joint injections or medial branch blocks (both must be the same type injection/block) have been performed at the level to be denervated and have provided the individual a significant reduction in pain^ (for information regarding coverage determination/limitations for facet joint injections, please refer to Injections for Chronic Pain Conditions Medical Coverage Policy)

*The nerve to the facet joint that may be ablated is the medial branch nerve.

**For the purpose of denervation of the facet joint, there are 3 anatomical regions of the spine (defined as [1] the cervical and thoracic spine, [2] the lumbar spine, and [3] the sacral spine).

Neuroablative Techniques for Chronic Pain

Effective Date: 11/02/2023

Revision Date: 11/02/2023

Review Date: 11/02/2023

Policy Number: HUM-0387-024

Page: 5 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

(Refer to Coverage Limitations section regarding sacroiliac joint (SIJ) denervation)^{Significant reduction in pain after a diagnostic facet joint injection/medial branch block is defined as an 80% pain relief (with the duration being consistent with the agent used for the injection).}

Subsequent Facet Denervation Procedures:

• Severe neck or back (primarily axial) pain that limits daily activities, thought to be due to facet joint syndrome (symptoms of facet joint syndrome include absence of radiculopathy, pain that is aggravated by extension, rotation or lateral bending of the spine and is not typically associated with any neurological deficits); AND
• Provided that greater than 50% pain relief is obtained for 12 weeks, further facet denervation procedures should be at intervals of at least 6 months per anatomical region^**, at a maximum of twice (per side, per level) per rolling 12 month period^{^^}; AND
• Repeat facet denervation must be performed on the same side and level(s) as the previously successful RFA (no repeat diagnostic facet injections are required for subsequent denervation procedures at that same side/level); AND
• Requests for facet denervation on the opposite side and/or different level than the previously successful RFA must meet the initial diagnostic, temporary injection criteria above; AND

Neuroablative Techniques for Chronic Pain

Effective Date: 11/02/2023

Revision Date: 11/02/2023

Review Date: 11/02/2023

Policy Number: HUM-0387-024

Page: 6 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

If an extended period of time (2 years or more) has passed since the last RFA procedure, or if there is question as to the source of the recurrent pain, diagnostic facet joint injections/medial branch blocks must be repeated^{^^}A rolling 12 month period is 12 months after an event, regardless of what month the initial event took place (if the first denervation procedure was performed on October 1, 2023, the rolling 12 month period would end September 30, 2024).

Intraosseous Basivertebral Nerve Ablation

• Humana members may be eligible under the Plan for intraosseous basivertebral nerve ablation of vertebral levels L3-S1, using the Intracept system when the following criteria are met:
• Chronic vertebrogenic low back pain that limits daily activities, of at least 6 months duration; AND
• Failure to improve after 6 months of conservative treatment under the direction of a healthcare professional, including ALL of the following:
  • Activity/lifestyle modification; AND
  • Medications (eg, nonsteroidal anti-inflammatory drugs [NSAIDs], non-narcotic analgesics) if medically appropriate and not contraindicated; AND
  • PT, including a home exercise program (HEP) (for information regarding coverage determination/limitations, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy); AND
• Imaging studies confirm the absence of any non-vertebrogenic pathology that could explain the etiology of the individual’s low back pain including, but not limited to, fracture, tumor, infection or significant deformity; AND
• Individual is skeletally mature; AND
• Magnetic resonance imaging (MRI) demonstrates Modic Type 1 or Type 2 changes in at least one vertebral endplate at one or more levels from L3-S1; AND

Neuroablative Techniques for Chronic Pain

Effective Date: 11/02/2023

Revision Date: 11/02/2023

Review Date: 11/02/2023

Policy Number: HUM-0387-024

Page: 7 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Modic changes are identified at each level to be treated; AND
• MRI report (reviewed/interpreted by radiologist) submitted with request; AND

Skeletally mature refers to a system of fused skeletal bones which occurs when bone growth ceases.

Trigeminal Nerve Denervation

Humana members may be eligible under the Plan for denervation of the trigeminal nerve via nonpulsed radiofrequency ablation when the following criteria are met:

• Diagnosis of trigeminal neuralgia; AND
• Failure of 12 weeks of conservative treatment (pharmacological) under the direction of a healthcare professional, or inability to tolerate side effects of the medications

Note: The criteria for neuroablative techniques for chronic pain are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Coverage Limitations

Humana members may NOT be eligible under the Plan for denervation of the facet joint for any indications other than those listed above OR any of the following:

• By any ablative technique other than nonpulsed RFA including, but not limited to, cooled or pulsed RFA/radiofrequency denervation; OR
• Diagnostic facet blocks and denervation procedures performed on the same day

All other indications are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Neuroablative Techniques for Chronic Pain

Effective Date: 11/02/2023

Revision Date: 11/02/2023

Review Date: 11/02/2023

Policy Number: HUM-0387-024

Page: 8 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may NOT be eligible under the Plan for intraosseous basivertebral nerve ablation by any ablative technique other than with the Intracept system OR for any indications other than those listed above including, but may not be limited to:

• Active systemic infection, or infection at the intended treatment level; OR
• Coagulopathy; OR
• Correlation of primary physical complaints with the following findings via imaging studies:
  • Lumbar/lumbosacral disc extrusion/protrusion of greater than 5 mm at levels L3-S1; OR
  • Lumbar/lumbosacral spondylolisthesis greater than or equal to 2 mm at any level; OR
  • Lumbar/lumbosacral spondylosis at levels L3-S1; OR
  • Symptomatic lumbar/lumbosacral facet arthrosis/effusion at levels L3-S1; OR
• Morbid obesity (BMI greater than 40); OR
• Osteoporosis (metabolic bone disease), previous treatment of spine fragility fracture, trauma/compression fracture or spinal cancer; OR
• Pregnancy; OR
• Previous lumbar/lumbosacral spine surgery at the intended treatment level (exception for discectomy/laminectomy performed more than 6 months prior to basivertebral nerve ablation, and the radicular pain was resolved); OR
• Primary radicular pain (neurogenic claudication) in the lower extremities; OR
• Severe cardiac or pulmonary compromised; OR
• Substance abuse disorder (active/untreated); OR
• Symptomatic lumbar or lumbosacral spinal stenosis, confirmed with imaging studies

All other indications are considered not medically necessary as defined in the member’s individual certificate.

Neuroablative Techniques for Chronic Pain

Effective Date: 11/02/2023

Revision Date: 11/02/2023

Review Date: 11/02/2023

Policy Number: HUM-0387-024

Page: 9 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Please refer to the member's individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for denervation of the trigeminal nerve for any indications other than those listed above OR by any ablative technique other than nonpulsed RFA. All other indications are considered not medically necessary as defined in the member's individual certificate. Please refer to the member's individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for any ablative procedure/technique OR for any indication other than those listed above including, but not limited to:

• Chemical neurolysis (also referred to as chemical ablation, chemical denervation or chemodenervation); OR
• Cooled radiofrequency denervation (including, but not limited to, the COOLIEF Cooled RF Probe and Coolief Sinergy); OR
• Cryosurgery (cryoablation/cryodenervation); OR
• Cryotherapy (including, but not limited to, cryo nerve block therapy); OR
• Destruction by neurolytic agent; OR
• Endoscopic radiofrequency ablation/rhizotomy for any indication including, but not limited to, the facet joint/nerve; OR
• iovera○ System, for any indication including, but not limited to, knee osteoarthritis or before/during/after total knee replacement surgery; OR
• Laser ablation; OR
• Pulsed radiofrequency denervation, for any indication; OR
• Radiofrequency ablation for the treatment of chronic pain including, but not limited to, the following conditions/areas of the body/nerves regardless of the type of neuroablative technique used:
  • Coccygodynia (coccydynia); OR
  • Complex regional pain syndrome (CPRS)/reflex symptomatic dystrophy; OR
  • Dorsal root ganglia; OR
  • Genicular nerve; OR
  • Hip, knee or pelvic/pelvis osteoarthritis/pain; OR
  • Morton's neuroma; OR
  • Nerves innervating the SIJ (the dorsal sacral rami lateral branch); OR
  • Post herniorrhaphy groin pain; OR
  • Presacral neurectomy for treatment of pain related to endometriosis; OR
  • Pudendal neuralgia; OR
  • Sacroiliac joint (SIJ); OR
  • Sural nerve for ankle pain; OR
  • Terminal (peripheral) nerve ending; OR
  • Trigger point(s)

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for monitored anesthesia care (MAC)𝐾 for ablative procedures for chronic pain. This is considered not medically necessary as defined in the member's individual certificate. Please refer to the member's individual certificate for the specific definition. Standard medical practice consists of local anesthesia and moderate sedation𝑂𝑃 (CPT 99152, 99153).

Neuroablative Techniques for Chronic Pain Effective Date: 11/02/2023 Revision Date: 11/02/2023 Review Date: 11/02/2023 Policy Number: HUM-0387-024 Page: 10 of 27 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may NOT be eligible under the Plan for moderate sedation𝑂 administered by a provider (physician or CRNA) OTHER THAN the physician who is performing the ablative procedure for chronic pain (CPT 99156, 99157). This is considered not medically necessary as defined in the member's individual certificate.

Please refer to the member’s individual certificate for the specific definition.^ǂThese statements for moderate sedation, MAC or general anesthesia with pain management interventions apply only to ADULTS. Moderate sedation (CPT 99151, 99152, 99153, 99155, 99156, 99157), MAC or general anesthesia with pain management interventions may be medically necessary for individuals 17 years of age or younger.^ǂǂ

Moderate sedation services are provided by the same physician or other qualified health care professional who is performing the diagnostic or therapeutic procedure that the sedation supports. This requires the presence of an independent trained observer (eg, a circulating nurse) to assist in the monitoring of the individual’s level of consciousness and vital signs.

Additional information about chronic pain may be found from the following websites:

• American Academy of Orthopaedic Surgeons
• American College of Rheumatology
• National Institute of Neurological Disorders and Stroke
• National Library of Medicine

Alternatives to facet denervation include, but may not be limited to, the following:

• Medical Alternatives
• Orthopedic or spine surgery

Neuroablative Techniques for Chronic Pain

Effective Date: 11/02/2023

Revision Date: 11/02/2023

Review Date: 11/02/2023

Policy Number: HUM-0387-024

Page: 12 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Alternatives to intraosseous basivertebral nerve ablation include, but may not be limited to, the following:

• Orthopedic or spine surgery

Alternatives to neuroablative techniques for chronic pain (other than facet joint pain or trigeminal neuralgia) include, but may not be limited to, the following:

• Injections/nerve blocks (please refer to Injections for Chronic Pain Conditions Medical Coverage Policy)
• Orthopedic or spine surgery
• Physical therapy (please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy)
• Prescription drug therapy

Alternatives to trigeminal nerve denervation include, but may not be limited to, the following:

• Gamma knife (stereotactic radiosurgery) (please refer to Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy Medical Coverage Policy)
• Surgical decompression of the trigeminal nerve

Physician consultation is advised to make an informed decision based on an individual’s health needs.