Medical Policy


Subject:Radiofrequency and Pulsed Radiofrequency Neurolysis for Trigeminal Neuralgia (TGN)
Policy #:  SURG.00090Current Effective Date:  10/08/2013
Status:ReviewedLast Review Date:  08/08/2013

Description/Scope

This document addresses the use of Radiofrequency (RF) neurolysis and Pulsed radiofrequency (PRF) neurolysis for the treatment of trigeminal neuralgia.

Note: Please see the following related document(s) for additional information:

Position Statement

Medically Necessary:

Radiofrequency (RF) neurolysis is considered medically necessary for those with trigeminal neuralgia who fail medical management, invasive surgery or other percutaneous treatments, or those who cannot tolerate surgery.

Not Medically Necessary:
Radiofrequency (RF) neurolysis is considered not medically necessary for those with trigeminal neuralgia who do not meet the above criteria.

Investigational and Not Medically Necessary:

Pulsed radiofrequency (PRF) neurolysis as a treatment for trigeminal neuralgia is considered investigational and not medically necessary.

Rationale

Radiofrequency Neurolysis: 

A number of clinical studies evaluating the efficacy and safety of RF neurolysis for trigeminal neuralgia have been published in the peer-reviewed medical literature. These studies include four prospective, uncontrolled clinical trials (Taha, 1995; Scrivani, 1999; Zakrzewska, 1999; Mathews, 2000) and one retrospective, uncontrolled chart review (Kanpolat, 2001). Three additional retrospective comparative studies examined the safety and efficacy of RF neurolysis, as compared with other established treatment modalities, including microvascular decompression (MVD), balloon microcompression (BMC), glycerol rhizotomy (GR), partial trigeminal rhizotomy (PTR), neurectomy and alcohol block (Taha, 1996; Oturai, 1996). A literature search did not identify any placebo-controlled studies. The major outcome measures were largely subjective and included pain relief, recurrence rates and side effects, such as facial numbness/degree of sensory loss, trigeminal motor dysfunction and nerve deficits.

In these studies, 83-99% of participants treated with RF neurolysis experienced initial complete pain relief. Taha (1996) reported initial success rates of 98% for RF ablation and MVD with recurrence rates of 20% and 15% for RF neurolysis and MVD, respectively. RF neurolysis resulted in similar initial success rates as observed with BMC, GR and PTR. Pain recurrence rates were highest for GR (54%) followed by RF neurolysis (20% to 23%), BMC (21%), PTR (18%), and MVD (15%). Initial success rates and recurrence rates were lower for neurectomy and alcohol block (42%), compared with RF neurolysis with comparable incidence of complications (Oturai, 1996). Repeat procedures increased long-term efficacy in three studies (Scrivani, 1999; Mathews, 2000; Kanpolat, 2001). Long-term safety data from prospective uncontrolled and retrospective clinical studies are available for a time frame of 6 months to 20 years. Although these studies have methodological limitations and variations in study design, the data suggest that RF neurolysis is a relatively safe and effective treatment option for those with trigeminal neuralgia with few serious, irreversible complications.

Zakrzewska and colleagues (2011) reviewed the literature for RF as compared with MVD treatments. Ablative procedures result in sensory loss, and MVD carries a 0.2-0.4% risk of mortality with a 2-4% chance of ipsilateral hearing loss. However, both procedures provided pain relief, 50% in RF and 70% in MVD over 14 years.

Pulsed Radiofrequency Neurolysis:
There is minimal literature regarding pulsed radiofrequency energy. Erdine and colleagues (2007) reported the results of a trial of 40 participants with trigeminal neuralgia who were randomized to receive either pulsed or conventional RF. Measurements of pain improved in those treated with conventional RF, but in only 2 of 20 who received pulsed RF.  The authors concluded that pulsed RF was not an effective treatment of trigeminal neuralgia. 

Li and colleagues (2012) reported a prospective randomized controlled study of 60 subjects with TGN to compare treatment with continuous RF (CRF) or PRF combined with CRF to the Gasserian ganglion (GG). Subjects were randomized into 3 groups receiving either 75°C CRF for 120s to 180s (SCRF group), 75°C CRF for 240s to 300s (LCRF group), or 42°C PRF for 10 minutes followed by 75°C CRF for 120s to 180s (PCRF group). Participants were assessed for pain intensity, quality of life (QOL) and intensity of facial dysesthesia at baseline, at seven days and 3, 6 and 12 months after the procedure. The efficacy in pain relief was most significant 7 days after treatment and there were no significant differences between groups. After 12 months, greater than 70% of those in each group had complete pain relief, and the QOL in all three groups had increased significantly compared to baseline. The authors concluded that PRF combined with CRF can achieve comparable pain relief to those who receive CRF alone; however shorter exposure of CRF could result in less destruction of the target tissue. Although the outcomes of this study are promising, larger studies with longer follow up are needed to validate the clinical efficacy and safety of treatment using RF combined with PRF.

Background/Overview

Trigeminal neuralgia (TGN), also called tic douloureux, is a neurological condition affecting the sensory division of the fifth cranial (trigeminal) nerve. It is characterized by recurrent episodes of severe pain, which is confined to the distribution of one or more of the trigeminal nerve's three branches: the ophthalmic (V1), maxillary (V2), and mandibular (V3) divisions. The sensory root of the trigeminal nerve supplies the face, teeth, mouth and nasal cavity. In TGN, sudden and excruciating, unilateral (one-sided) facial pain arises, following stimulation of specific trigger zones by movement or touch.

The mechanism of trigeminal neuralgia pain remains controversial. One theory suggests that peripheral injury or disease of the trigeminal nerve increases afferent firing in the nerve perhaps by ephaptic transmission between afferent unmyelinated axons and partially damaged myelinated axons; failure of central inhibitory mechanisms may also be involved. Blood vessel and nerve cross compression, aneurysms, chronic meningeal inflammation, tumors or other lesions may irritate trigeminal nerve roots along the pons. In some cases, no vascular or other lesion is identified rendering the etiology unknown.

RF neurolysis involves the use of heat produced by radio waves, which is percutaneously introduced via electrode placement adjacent to the trigeminal nerve, using fluoroscopic guidance; this creates a lesion within the trigeminal nerve, which interrupts the painful sensory nerve impulses. RF neurolysis also has the potential risk of neuritis. Histological studies have revealed indiscriminate destruction of both small and large fibers following RF neurolysis. For this reason, PRF neurolysis has been investigated as a treatment for chronic pain syndromes. PRF neurolysis is thought to be a non destructive alternative to standard RF neurolysis in that it applies RF energy with a pulsed time cycle that delivers short bursts of RF current instead of a continuous RF flow. By pulsing the electrical current, the needle remains relatively cool (up to 42 degrees Celsius compared to temperatures of 60-69 degrees Celsius with continuous RF) so that the tissue cools slightly between each burst, reducing the risk of destroying nearby tissue and preventing any long-term damage to the nerve. It is postulated that this disrupts the transmission of impulses across small unmyelinated fibers without destroying them while larger fibers remain protected by the myelin sheath.

Definitions

Neuralgia: Pain that extends along one or more nerve pathways.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  A draft of future ICD-10 Coding (effective 10/01/2014) related to this document, as it might look today, is included below for your reference.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met: 

CPT 
61790Creation of lesion by stereotactic method, percutaneous, by neurolytic agent (eg, alcohol, thermal, electrical, radiofrequency); gasserian ganglion [specified as RF]
61791Creation of lesion by stereotactic method, percutaneous, by neurolytic agent (eg, alcohol, thermal, electrical, radiofrequency); trigeminal medullary tract [specified as RF]
64600Destruction by neurolytic agent, trigeminal nerve; supraorbital, infraorbital, mental, or inferior alveolar branch [specified as RF]
64605Destruction by neurolytic agent, trigeminal nerve; second and third division branches at foramen ovale [specified as RF]
64610Destruction by neurolytic agent, trigeminal nerve; second and third division branches at foramen ovale under radiologic monitoring [specified as RF]
  
ICD-9 Diagnosis 
350.1Trigeminal neuralgia, (tic douloureux)
  
ICD-10 ProcedureICD-10-PCS draft codes; effective 10/01/2014:
005K0ZZ-005K4ZZDestruction of trigeminal nerve [by approach; includes codes 005K0ZZ, 005K3ZZ, 005K4ZZ]
  
ICD-10 DiagnosisICD-10-CM draft codes; effective 10/01/2014:
G50.0Trigeminal neuralgia (tic douloureux)

When services are Not Medically Necessary:
For the procedure and diagnosis codes listed above when criteria are not met. 

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary. 

CPT 
64999Unlisted procedure, nervous system [when specified as pulsed radiofrequency]
  
ICD-9 Diagnosis 
350.1Trigeminal neuralgia, (tic douloureux)
  
ICD-10 DiagnosisICD-10-CM draft codes; effective 10/01/2014:
G50.0Trigeminal neuralgia (tic douloureux)
  
References

Peer Reviewed Publications:

  1. Erdine S, Ozyalcin NS, Cimen A, et al. Comparison of pulsed radiofrequency with conventional radiofrequency in the treatment of idiopathic trigeminal neuralgia. Eur J Pain. 2007; 11(3):309-313. 
  2. Kanpolat Y, Savas A, Bekar A, Berk C. Percutaneous controlled radiofrequency trigeminal rhizotomy for the treatment of idiopathic trigeminal neuralgias: 25 year experience with 1,600 patients. Neurosurg. 2001; 48(3):524-534.
  3. Li X, Ni J, Yang L, et al. A prospective study of Gasserian ganglion pulsed radiofrequency combined with continuous  radiofrequency for the treatment of trigeminal neuralgia. J Clin Neurosci. 2012; 19(6):824-828.
  4. Mathews ES, Scrivani SJ. Percutaneous stereotactic radiofrequency thermal rhizotomy for the treatment of trigeminal neuralgia. Mt. Sinai J Med. 2000; 67(4):288-299.
  5. Oturai AB, Jensen K, Eriksen J, Madsen F. Neurosurgery for trigeminal neuralgia. Comparison of alcohol block, neurectomy and radiofrequency coagulation. Clin J Pain. 1996; 12:311-315.
  6. Scrivani SJ, Keith DA, Mathews ES, Kaban LB. Percutaneous stereotactic differential radiofrequency thermal rhizotomy for the treatment of trigeminal neuralgia. J Oral Maxillofac Surg. 1999; 57(2):104-111.
  7. Taha JM, Tew JM. Comparison of surgical treatments for trigeminal neuralgia: Reevaluation of radiofrequency rhizotomy. Neurosurg. 1996; 38(5):865-871.
  8. Taha JM, Tew JM, Buncher CR. A prospective 15-year follow-up of 154 consecutive patients with trigeminal neuralgia treated by percutaneous stereotactic radiofrequency thermal rhizotomy. J Neurosurg. 1995; 83:989-893.
  9. Zakrzewska JM, Jassim S, Bulman JS. A prospective longitudinal study on patients with trigeminal neuralgia who underwent radiofrequency thermocoagulation of the Gasserian ganglion. Pain. 1999; 79(1):51-58.
  10. Zakrzewska JM, McMillan R. Trigeminal neuralgia: the diagnosis and management of this excruciating and poorly understood facial pain. Postgrad Med J. 2011; 87(1028):410-416.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Gronseth G, Cruccu G, Alksne J, et al. Practice parameter: The diagnostic evaluation and treatment of trigeminal neuralgia (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology and the European Federation of Neurological Societies. Neurology. 2008; 71(15):1183-1190.
Web Sites for Additional Information
  1. National Institute of Neurological Disorders and Stroke (NINDS). Trigeminal neuralgia information page. Available at: http://www.ninds.nih.gov/disorders/trigeminal_neuralgia/trigeminal_neuralgia.htm. Accessed on May 31, 2013.
Index

Pulsed Radiofrequency Neurolysis
Radiofrequency Neurolysis for Trigeminal Neuralgia

Document History
StatusDateAction
Reviewed08/08/2013Medical Policy & Technology Assessment Committee (MPTAC) review. No change to position statement. Updated Rationale and Reference section.
Reviewed08/09/2012MPTAC review.  Rationale, Coding and References updated.
Reviewed08/18/2011MPTAC review.  Rationale and References updated.
Revised08/19/2010MPTAC review.  Policy revised by substituting neurolysis for ablation to align policy language with coding language. Title changed. References updated.
Reviewed08/27/2009MPTAC review. References updated.
Revised08/28/2008MPTAC review. Addition of Pulsed Radiofrequency Ablation to investigational and not medically criteria. Rationale, background, coding and references updated.
 02/21/2008The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.
Reviewed08/23/2007MPTAC review. No change to criteria. References were updated.
Reviewed09/14/2006MPTAC review.  No change to criteria. References were updated. Document category changed to SURG.00090 due to applicable codes being surgical.
Revised09/22/2005MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.
Pre-Merger OrganizationsLast Review DateDocument NumberTitle
Anthem, Inc.  None
WellPoint Health Networks, Inc.12/02/20045.01.04Radiofrequency Ablation for Trigeminal Neuralgia