Pending Policies - Surgery


Percutaneous Image-Guided Nerve Cryoablation for Phantom Limb Pain (PLP)

Number:SUR701.035

Effective Date:05-15-2018

Coverage:

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Percutaneous image-guided nerve cryoablation for the treatment of phantom limb pain (PLP) is considered experimental, investigational and/or unproven.

Description:

Background

Sometimes, when a limb is removed during an amputation, an individual will continue to have an internal sense of the lost limb. This phenomenon is known as phantom limb pain (PLP) and experienced by approximately 85% of the 185,000 U.S. individuals who have an arm, leg or portions thereof surgically amputated each year. Their pain is real and is often accompanied by other health problems, such as depression, anxiety, sleep disorders, and a general decrease in quality of life. Scientists believe that following amputation, nerve cells “rewire” themselves and continue to receive messages, resulting in a remapping of the brain’s circuitry. Investigators predict that by 2050, an estimated 3 million U.S. amputees may be living with the chronic burning, stabbing, or aching sensations of phantom limb pain.

The understanding of PLP has improved tremendously in recent years. Investigators previously believed that brain cells affected by amputation simply died off. They attributed sensations of pain at the site of the amputation to irritation of nerves located near the limb stamnos, using imaging techniques such as positron emission tomography (PET) and magnetic resonance imaging (MRI), scientists can actually visualize increased activity in the brain’s cortex when an individual feels phantom pain. When study participants move the stump of an amputated limb, neurons in the brain remain dynamic and excitable. Surprisingly, the brain’s cells can be stimulated by other body parts, often those located closest to the missing limb. Current treatments for PLP may include analgesics, anticonvulsants, and other types of drugs; nerve blocks; electrical stimulation; psychological counseling, biofeedback, hypnosis, and acupuncture; and, in rare instances, surgery. (1)

Percutaneous Cryoablation

Cryoablation or cryoneurolysis has been used for years to treat the pain of metastatic disease. Recently, investigators have been using image guidance to target nerves, enabling treatments for a variety of historically difficult to manage pain syndromes. Percutaneous cryoablation is one treatment being investigated to treat Plunder image guidance, corresponding nerves are targeted with a 17g cryoablation needle (Galil Medical Ice Sphere). Two freeze-thaw cycles are undertaken, dropping the temperature to a negative 40 degrees centigrade for 25 minutes. The tip of the probe forms an ice ball that is noted to surround and destroy the targeted tissue.

Rationale:

Percutaneous image-guided nerve cryoablation was assessed in treating phantom limb pain in a small pilot study conducted by Prologo et al. from Emory University School of Medicine (2) in Atlanta. The Emory team in this proof-of-concept study treated 20 patients with refractory phantom pain following amputation with computed tomography - and ultrasound-guided cryoablation of the nerve and scar tissue in the residual limb. During the procedure, a cryoablation probe was guided through the skin and the temperature dropped to negative 40 degrees for 25 minutes, creating a targeted ablation zone, shutting down nerve signals. The patients were asked to rate their pain on a Visual Analog Scale (VAS) that ranged from 1 (not painful) to 10 (extremely painful) before the procedure and seven and 45 days afterward. The technical success rate was 100% and there were no procedure-related complications. Trends in VAS and Modified Roland Morris Disability Questionnaire (MRMDQ) scores compared to baseline values were observed as mild decreases at 7 days and statistically significant decreases at 45 days post-procedure (p=0.002 and p<0.001, respectively). Before cryoablation, patients' average pain score was 6.4 points. By day 45, it had dropped to 2.4 points. The author’s note that this preliminary data suggests that image-guided nerve cryoablation may be a new therapeutic option for patients with phantom limb pain, a condition that has historically been very difficult to treat. The investigators are continuing to follow the patients to gauge effectiveness at 6 months after treatment and beyond, and have applied for a Department of Defense grant to continue their research.

In another prospective study conducted by Prologo et al. (3) the feasibility, safety, and short-term efficacy of percutaneous image-guided target nerve cryoablation for the treatment of phantom limb pain was conducted in a ten patient, proof of concept, pilot cohort. Ten patients (2 males, 8 females, age range 33-65 years) with refractory phantom pain following amputation were consecutively enrolled from January 2015-June 2015. Each subject underwent percutaneous image-guided (CT and ultrasound) cryoablation of the nerve and/or neuroma in their symptomatic residual limb that corresponded to the distribution of their symptoms. VAS scores and responses to a MRMDQ were documented at baseline, 7 days post-procedure, and on day 45. Analysis of covariance (ANCOVA), with baseline scores included as covariates, was used to evaluate differences in scores over time. The technical success rate of the procedures was 100%. There were no procedure-related complications. Trends in VAS and MRMDQ scores compared to baseline values were observed as mild decreases at 7 days and statistically significant decreases at 45 days post-procedure, respectively). The investigators concluded that image-guided percutaneous nerve cryoablation is feasible and safe, and may represent a new efficacious therapy for patients with phantom pains related to limb loss.

Summary

At this time percutaneous image-guided nerve cryoablation for the treatment of PLP continues to be investigated and caution remains about the current preliminary findings until further research is completed.

2018 Update

A search of peer reviewed literature through March 2018 identified no additional clinical trial publications or other information that would prompt reconsideration of the coverage statement which remains unchanged.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

0440T, 0441T, 0442T

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. National Institute of Neurological Disorders and Stroke. National Institutes of Health (NIH) Pain – Hope Through Research. Available at: http://www.ninds.nih.gov (accessed June 20, 2016).

2. SIR: Cryoablation for phantom limb pain clinical trial underway at Emory. Staff News Brief| Appl Radiol. May 24, 2016. Available at: http://appliedradiology.com (accessed June 20, 2016).

3. Prologo, J. Gilliland, C. Miller, M. et al. Percutaneous image-guided cryoablation for the treatment of phantom limb pain in amputees: a pilot study. as J Vasc Intervent Radiol (JVIR). 2017 Jan; 28(1):24-34. PMID: 27887967

Policy History:

DateReason
5/15/2018 Document updated with literature review. Coverage unchanged. No references added.
7/15/2017 Reviewed. No changes.
7/1/2016 New medical policy. Percutaneous image-guided nerve cryoablation for the treatment of phantom limb pain (PLP) is considered experimental, investigational and/or unproven.

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