Medical Policy



Subject: Stereotactic Radiofrequency Pallidotomy
Document #: SURG.00016 Current Effective Date:    06/28/2017
Status: Revised Last Review Date:    05/04/2016

Description/Scope

This document addresses the use of stereotactic radiofrequency pallidotomy for the treatment of Parkinson's disease.  Stereotactic radiofrequency pallidotomy is a surgical procedure that uses stereotactic (3-D) imaging procedures to identify the target globus pallidus followed by surgical placement of radiofrequency emitting needles to create thermal lesions designed to relieve the symptoms of Parkinson's disease.

Note: Please see the following for related topics:

Position Statement

Medically Necessary:

Unilateral stereotactic radiofrequency pallidotomy with microelectrode mapping is considered medically necessary for individuals with Parkinson's disease who meet all of the following criteria:

  1. Accurate diagnosis of idiopathic Parkinson's disease (striatonigral degeneration has been ruled out as a cause for symptoms); and
  2. Severe levodopa-induced dyskinesia or disease characterized by severe bradykinesia, dystonia, or akinesia/rigidity, or by marked 'on-off' fluctuations; and
  3. No evidence of dementia.

Not Medically Necessary:

Unilateral stereotactic radiofrequency pallidotomy with microelectrode mapping is considered not medically necessary when any of the following contraindications are present:

  1. History of encephalitis or neuroleptic treatment; or
  2. Evidence of dementia or focal brain abnormality on magnetic resonance imaging (MRI); or
  3. Medical conditions that might increase risk of hemorrhage (for example, poorly controlled hypertension); or
  4. A medical, neurological, or orthopedic disorder that might compromise assessment (cerebrovascular disease, metabolic disorders, spinal stenosis).

Unilateral stereotactic radiofrequency pallidotomy with microelectrode mapping is considered not medically necessary when the criteria above are not met.

Investigational and Not Medically Necessary:

Bilateral stereotactic radiofrequency pallidotomy is considered investigational and not medically necessary for all indications.

The use of unilateral stereotactic radiofrequency pallidotomy is considered investigational and not medically necessary for all indications not addressed above.

Rationale

Results of small randomized trials and cohort studies have reported that unilateral stereotactic radiofrequency pallidotomy with microelectrode mapping is a relatively safe and effective method of managing symptoms of advanced Parkinson's disease (PD) refractory to pharmacological management (deBie, 1999, 2001; Green, 2002; Masterman, 1998; Vitek, 2003).  In these studies, unilateral stereotactic radiofrequency pallidotomy has resulted in significant improvements in dyskinesia, bradykinesia, and other symptoms of PD.  It must be noted that this procedure is considered inappropriate in individuals with several comorbidities, including specific central nervous system disorders and coagulopathies, which may compromise the proper assessment of the individual or the success of the surgical procedure. 

A 1999 technology assessment issued by the American Academy of Neurology (AAN) offered the following recommendation (Hallett, 1999): "Unilateral pallidotomy is indicated for advanced PD with motor fluctuations and drug-induced involuntary movements (dyskinesias) along with significant bradykinesia and rigidity, with or without tremor."

Although there was initial interest in bilateral stereotactic radiofrequency pallidotomy, this procedure has been abandoned due to severe motor and psychiatric complications (Merello, 2001).  The AAN assessment also noted that bilateral pallidotomy is associated with a higher incidence of neurologic adverse effects, particularly speech complications.

Deep brain stimulation using implanted electrodes is another treatment of advanced PD.  This treatment may be preferred by physicians and individuals due to its reversible nature and the ability to provide bilateral stimulation.  One small randomized trial comparing unilateral pallidotomy with bilateral deep brain stimulation suggests that the latter treatment is more effective in reducing symptoms compared to pallidotomy (Esselink, 2004).  For these reasons, the use of unilateral pallidotomy has declined over the past several years in favor of deep brain stimulation.  The declining role of pallidotomy is reflected in 2006 practice parameters issued by the American Academy of Neurology regarding the treatment of Parkinson's disease (Pahwa, 2006).  These guidelines do not address pallidotomy.

Background/Overview

Description of Parkinson's Disease 

Parkinson's disease (PD) is a progressive, incurable disease caused by the slow continuous loss of nerve cells in a part of the brain that controls muscle movement.  Common symptoms of the disease include tremors or involuntary movement in the jaw and extremities, slowed movement, muscle stiffness, gradual loss of voluntary movement, gradual loss of automatic movement, postural instability and depression.  It is estimated that over a half million people in the U.S. are affected, and approximately 50,000 new cases are diagnosed annually.  PD is primarily an age-related disease, with average age of onset being about 60 years of age, but development of PD in people as young as 20 has been reported.  The exact cause of PD is not known, but there is some evidence that there may be an inheritable component to the disease. 

There is no known cure for PD.  Primary management of the disease is through pharmacological therapy with one or several drugs to relieve the symptoms of the disease.  No drug has been shown to effectively slow the progression of the disease.  As PD progresses pharmacotherapy becomes less and less effective in managing the symptoms of the disease.  When an individual's symptoms are inadequately controlled for a period of 3 months, the individual's disease may be considered medically unresponsive and surgical therapy may be considered. 

Description of Stereotactic Radiofrequency Pallidotomy

Stereotactic radiofrequency pallidotomy involves placing thermal lesions in the globus pallidus, a part of the brain that is responsible for the symptoms of PD.  For this procedure the individual's head is placed into a stereotactic frame, which is anchored to the individual's skull through the skin with four pins.  This frame ensures accurate location of the target internal brain structures with magnetic resonance imaging (MRI) and special computerized mapping techniques.  These computer programs also assist in planning the surgical approach.  During the surgery, a small hole is made in the individual's skull through which the surgeon uses a special electrode to precisely map the location of the globus pallidus.  When mapping is complete, the electrode is removed and replaced with a needle that produces the radiofrequency thermal lesions.

Definitions

Akinesia: Difficulty beginning or maintaining a body motion. 

Bradykinesia: An abnormal slowness of movement, sluggishness of physical and mental responses.

Dementia: A mental disorder characterized by a general loss of intellectual abilities, involving impairment of memory, judgment, and abstract thinking, as well as changes in personality.

Dyskinesia: Impairment of voluntary movement, resulting in fragmentary or incomplete movements.

Dystonia: A neurological movement disorder characterized by involuntary muscle contractions, which force certain parts of the body into abnormal, sometimes painful, movements or postures.

Encephalitis: Inflammation of the brain that may be due to a wide variety of causes.

Levodopa: A drug commonly used to treat the symptoms of Parkinson's disease.

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  
61720 Creation of lesion by stereotactic method, including burr hole(s) and localizing and recording techniques, single or multiple stages; globus pallidus or thalamus [stereotactic pallidotomy]
   
ICD-10 Procedure  
  For the following codes when specified as stereotactic radiofrequency pallidotomy:
00580ZZ Destruction of basal ganglia, open approach
00583ZZ Destruction of basal ganglia, percutaneous approach
00584ZZ Destruction of basal ganglia, percutaneous endoscopic approach
   
ICD-10 Diagnosis  
G20 Parkinson's disease (primary and idiopathic)
G21.0-G21.9 Secondary parkinsonism
G24.01 Drug induced subacute dyskinesia
T42.8X5S Adverse effect of antiparkinsonism drugs and other central muscle-tone depressants, sequela

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

When services are Investigational and Not Medically Necessary:
For procedure codes listed above for all other diagnoses not listed; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

References

Peer Reviewed Publications:

  1. deBie RM, de Haan RJ, Nijssen PC, et al. Unilateral pallidotomy in Parkinson's disease: a randomised, single-blind, multicentre trial. Lancet. 1999; 354(9191):1665-1669.
  2. deBie RM, Schuurman PR, Bosch DA, et al. Outcome of unilateral pallidotomy in advanced Parkinson's disease: cohort study of 32 patients. J Neurol Neurosurg Psychiatry. 2001; 71(3):375-382.
  3. Esselink RA, de Bie RM, de Haan RJ, et al. Long-term superiority of subthalamic nucleus stimulation over pallidotomy in Parkinson disease. Neurology. 2009; 73(2):151-153.
  4. Esselink RA, de Bie RM, de Haan RJ, et al. Unilateral pallidotomy versus bilateral subthalamic nucleus stimulation in PD: a randomized trial. Neurology. 2004; 62(2):201-207.
  5. Green J, McDonald WM, Vitek JL, et al. Neuropsychological and psychiatric sequelae of pallidotomy for PD: clinical trial findings. Neurology. 2002; 58(6):858-865.
  6. Hallett M, Litvan I. Task Force on Surgery for Parkinson's Disease. Evaluation of surgery for Parkinson's disease: a report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 1999; 53(9):1910-1921.
  7. Masterman D, DeSalles A, Baloh RW, et al. Motor, cognitive, and behavioral performance following unilateral ventroposterior pallidotomy for Parkinson disease. Arch Neurol. 1998; 55(9):1201-1208.
  8. Merello M, Starkstein S, Nouzeilles MI, et al. Bilateral pallidotomy for treatment of Parkinson's disease induced corticobulbar syndrome and psychic akinesia avoidable by globus pallidus lesion combined with contralateral stimulation. J Neurol Neurosurg Psychiatry. 2001; 71(5):611-614.
  9. Vitek JL, Bakay RA, Freeman A, et al. Randomized trial of pallidotomy versus medical therapy for Parkinson's disease. Ann Neurol. 2003; 53(5):558-569.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Pahwa R, Factor SA, Lyons KE, et al. Quality Standards Subcommittee of the American Academy of Neurology. Practice Parameter: treatment of Parkinson disease with motor fluctuations and dyskinesia (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2006; 66(7):983-995.  
Websites for Additional Information
  1. National Library of Medicine: Medical Encyclopedia. Parkinson's disease. Available at: https://medlineplus.gov/ency/article/000755.htm .  Accessed on February 23, 2017.
Document History

Status

Date

Action

Revised 05/04/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Updated formatting in Position Statement section. Updated Description section.
Reviewed 05/05/2016 MPTAC review.  Removed ICD-9 codes from Coding section.
Reviewed 05/07/2015 MPTAC review. 
Reviewed 05/15/2014 MPTAC review.  
Reviewed 05/09/2013 MPTAC review.  
Reviewed 05/10/2012 MPTAC review. 
Reviewed 05/19/2011 MPTAC review. Updated Coding section.
Reviewed 05/13/2010 MPTAC review. 
Reviewed 05/21/2009 MPTAC review. 
Reviewed 05/15/2008 MPTAC review. 
  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 05/17/2006 MPTAC review.  
Reviewed 06/08/2006 MPTAC review. 
Revised 07/14/2005 MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.
Pre-Merger Organizations

Last Review Date

Document Number

Title

Anthem, Inc.

07/27/2004

SURG.00016 Stereotactic Radiofrequency Pallidotomy
WellPoint Health Networks, Inc.

06/24/2004

4.03.04 

 

Stereotactic Radiofrequency Pallidotomy for the Treatment of Parkinson's Disease