Medical Policy



Subject: Radiofrequency Neurolysis and Pulsed Radiofrequency Therapy for Trigeminal Neuralgia
Document #: SURG.00090 Current Effective Date:    09/27/2017
Status: Revised Last Review Date:    08/03/2017

Description/Scope

This document addresses the use of radiofrequency (RF) neurolysis and pulsed radiofrequency (PRF) therapy for the treatment of trigeminal neuralgia (TN).

Note: Please see the following related documents 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) therapy 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 (Mathews, 2000; Scrivani, 1999; Taha, 1995; Zakrzewska, 1999) 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 (Oturai, 1996; Taha, 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 (Kanpolat, 2001; Mathews, 2000; Scrivani, 1999). 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 Therapy

Erdine and colleagues (2007) reported the results of a trial of 40 participants with trigeminal neuralgia who were randomized to receive either PRF or conventional RF. Measurements of pain improved in those treated with conventional RF, but in only 2 of 20 who received PRF. The authors concluded that PRF therapy was not an effective treatment of trigeminal neuralgia.  

Li and colleagues (2012) reported a prospective randomized controlled study of 60 subjects with TN to compare treatment with continuous RF (CRF) or PRF combined with CRF to the Gasserian ganglion (GG). Subjects were randomized into three groups receiving either 75°C CRF for 120s (seconds) 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 7 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.

Chua and colleagues (2012) conducted a retrospective review of 36 individuals treated for TN with PRF. Telephonic follow-up interviewed 34 participants. From the retrospective review of the documented clinical results of all 34 individuals, the percentages of those who showed excellent pain relief (greater than or equal to 80% pain relief) at 2, 6, and 12 months were 73.5% (25/34), 61.8% (21/34), and 55.9% (19/34), respectively, those with satisfactory pain relief (50-80% pain relief) at 2, 6, and 12 months were 14.7% (5/34), 17.6% (6/34), and 17.6% (6/34), respectively, and those showing less than satisfactory pain relief (less than 50% pain relief) at 2, 6, and 12 months were 11.8% (4/34), 20.6% (7/34), and 23.5% (8/34), respectively. No complications were reported, and no one required hospitalization. The authors acknowledged that more research is required to qualify PRF for TN as an accepted treatment modality.

The use of pulsed radiofrequency (PRF) for the treatment of TN, either as a sole treatment or combined with RF, is controversial. Studies supporting the benefit of PRF for TN consist of small studies, case studies or retrospective reviews (Liao, 2017; Thapa, 2015; Zhao, 2015). While some studies have reported potential benefit with PRF therapy under specific circumstances (Yao, 2016), further larger randomized studies are needed to evaluate efficacy and safety in the clinical setting.

Background/Overview

TN 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 TN, 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.

The annual incidence of TN is an estimated 4-5 cases per 100,000 individuals (AAN, 2008). In the majority of cases, TN can be medically managed using drug therapy. For those individuals unwilling, unable, or refractory to drug therapy, there are several options in addition to RF neurolysis. These options include, but are not limited to surgery, gamma knife or microvascular decompression (AAN, 2008).

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 has been investigated as a treatment for chronic pain syndromes. PRF therapy 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

Neurolysis: The release of a nerve sheath by cutting it longitudinally; operative breaking up of neural adhesions.

Neuralgia: An intense burning or stabbing pain that extends along one or more nerve pathways caused by irritation or nerve damage from systemic disease, inflammation, infection, and compression or physical irritation of a nerve.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. 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  
61790 Creation of lesion by stereotactic method, percutaneous, by neurolytic agent (eg, alcohol, thermal, electrical, radiofrequency); gasserian ganglion [specified as RF]
61791 Creation of lesion by stereotactic method, percutaneous, by neurolytic agent (eg, alcohol, thermal, electrical, radiofrequency); trigeminal medullary tract [specified as RF]
64600 Destruction by neurolytic agent, trigeminal nerve; supraorbital, infraorbital, mental, or inferior alveolar branch [specified as RF]
64605 Destruction by neurolytic agent, trigeminal nerve; second and third division branches at foramen ovale [specified as RF]
64610 Destruction by neurolytic agent, trigeminal nerve; second and third division branches at foramen ovale under radiologic monitoring [specified as RF]
   
ICD-10 Procedure  
  For the following codes when specified as radiofrequency neurolysis:
005K0ZZ-005K4ZZ Destruction of trigeminal nerve [by approach; includes codes 005K0ZZ, 005K3ZZ, 005K4ZZ]
   
ICD-10 Diagnosis  
G50.0 Trigeminal neuralgia

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  
64999 Unlisted procedure, nervous system [when specified as pulsed radiofrequency therapy]
   
ICD-10 Diagnosis  
G50.0 Trigeminal neuralgia
   
References

Peer Reviewed Publications:

  1. Chua NHL, Halim W, Beems T, Vissers KCP. Pulsed Radiofrequency Treatment for Trigeminal Neuralgia. Anesth Pain. 2012; 1(4):257-261.
  2. 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. 
  3. Hitchon PW, Holland M, Noeller J, et al. Options in treating trigeminal neuralgia: Experience with 195 patients. Clin Neurol Neurosurg. 2016; 149:166-170.
  4. 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. Neurosurgery. 2001; 48(3):524-534.
  5. 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.
  6. Mathews ES, Scrivani SJ. Percutaneous stereotactic radiofrequency thermal rhizotomy for the treatment of trigeminal neuralgia. Mt Sinai J Med. 2000; 67(4):288-299.
  7. 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(4):311-315.
  8. 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.
  9. Taha JM, Tew JM Jr. Comparison of surgical treatments for trigeminal neuralgia: reevaluation of radiofrequency rhizotomy. Neurosurgery. 1996; 38(5):865-871.
  10. Taha JM, Tew JM Jr, 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(6):989-993.
  11. Thapa D, Ahuja V, Dass C, Verma P. Management of refractory trigeminal neuralgia using extended duration pulsed radiofrequency application. Pain Physician. 2015; 18(3):E433-E435.
  12. Yao P, Hong T, Zhu YQ, et al. Efficacy and safety of continuous radiofrequency thermocoagulation plus pulsed radiofrequency for treatment of V1 trigeminal neuralgia: A prospective cohort study. Medicine (Baltimore). 2016; 95(44):e5247.
  13. 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.
  14. 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.
  15. Zhang X, Zhao H, Tang Y, et al. Comparison of the Efficacy of Reoperation, Percutaneous Radiofrequency Thermocoagulation When Microvascular Decompression of Trigeminal Neuralgia Is Invalid. J Craniofac Surg. 2016; 27(7):e688-e690.
  16. Zhao WX, Wang Q, He MW, et al. Radiofrequency thermocoagulation combined with pulsed radiofrequency helps relieve postoperative complications of trigeminal neuralgia. Genet Mol Res. 2015; 14(3):7616-7623.

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. Reaffirmed April 30, 2014. Available at: http://www.neurology.org/content/71/15/1183.long. Accessed on June 21, 2017.
  2. Zakrzewska JM, Akram H. Neurosurgical interventions for the treatment of classical trigeminal neuralgia. Cochrane Database Syst Rev. 2011;(9):CD007312.
Websites for Additional Information
  1. Facial Pain Association. What is Trigeminal Neuralgia? Available at: http://fpa-support.org/learn/.  Accessed on June 21, 2017.
  2. National Institute of Neurological Disorders and Stroke (NINDS). Trigeminal neuralgia information page. Available at: https://www.ninds.nih.gov/Disorders/All-Disorders/Trigeminal-Neuralgia-Information-Page .  Accessed on June 21, 2017.
Index

Pulsed radiofrequency
Radiofrequency lesioning
Radiofrequency neurolysis for trigeminal neuralgia
Radiofrequency thermocoagulation

Document History
Status Date Action
Revised 08/03/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Revised to remove abbreviation (TGN) from the title and to change references to this abbreviation to TN within the document. Updated Rationale, Background, Definitions, Index, References and Websites sections.
Reviewed 08/04/2016 MPTAC review. Updated Rationale and References sections. Removed ICD-9 codes from Coding section.
Revised 08/06/2015 MPTAC review. Revised document title and position statement to clarify that pulsed radiofrequency therapy is not 'neurolysis'. Updated Rationale, Background, and Reference sections.
Reviewed 08/14/2014 MPTAC review. Updated Rationale and Reference sections.
Reviewed 08/08/2013 MPTAC review. Updated Rationale and Reference section.
Reviewed 08/09/2012 MPTAC review. Rationale, Coding and References updated.
Reviewed 08/18/2011 MPTAC review. Rationale and References updated.
Revised 08/19/2010 MPTAC review. Policy revised by substituting neurolysis for ablation to align policy language with coding language. Title changed. References updated.
Reviewed 08/27/2009 MPTAC review. References updated.
Revised 08/28/2008 MPTAC review. Addition of Pulsed Radiofrequency Ablation to investigational and not medically criteria. Rationale, background, coding and references updated.
  02/21/2008 The 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.
Reviewed 08/23/2007 MPTAC review. References were updated.
Reviewed 09/14/2006 MPTAC review.  References were updated. Document category changed to SURG.00090 due to applicable codes being surgical.
Revised 09/22/2005 MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.
Pre-Merger Organizations Last Review Date Document Number Title
Anthem, Inc.     None
WellPoint Health Networks, Inc. 12/02/2004 5.01.04 Radiofrequency Ablation for Trigeminal Neuralgia