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MEDICAL POLICY – 7.01.564
Pulsed Radiofrequency
Effective Date: Oct. 1, 2019
Last Revised: Sept. 5, 2019
Replaces: N/A
RELATED MEDICAL POLICIES:
7.01.147 Ablation Procedures for Peripheral Neuromas
7.01.555 Facet Joint Denervation
7.01.565 Ablative Procedures of Peripheral Nerves to Treat
Pain
Select a hyperlink below to be directed to that section.
POLICY CRITERIA | CODING | RELATED INFORMATION
EVIDENCE REVIEW | REFERENCES | HISTORY
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Introduction
Radiofrequency ablation is a way of destroying part of nerves to
treat pain. An electrical current
is produced by radio waves. The current is applied to a small
area of nerve tissue, thus
destroying (ablating) part of the nerve and interrupting pain
signals. Pulsed radiofrequency is
similar to radiofrequency ablation in that it is still being
studied. Instead of a constant current
being applied, pulsed radiofrequency calls for short bursts of
energy. These intermittent bursts
of energy allow more electrical current to be applied while
keeping temperatures below the
range that would ablate the nerve. Pulsed radiofrequency is
investigational (unproven) to treat
pain. More, larger, and longer studies are needed to see if this
technique is safe and effective.
Note: The Introduction section is for your general knowledge and
is not to be taken as policy coverage criteria. The
rest of the policy uses specific words and concepts familiar to
medical professionals. It is intended for
providers. A provider can be a person, such as a doctor, nurse,
psychologist, or dentist. A provider also can
be a place where medical care is given, like a hospital, clinic,
or lab. This policy informs them about when a
service may be covered.
Policy Coverage Criteria
https://www.premera.com/medicalpolicies/7.01.147.pdfhttps://www.premera.com/medicalpolicies/7.01.555.pdfhttps://www.premera.com/medicalpolicies/7.01.565.pdf
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Procedure Investigational Pulsed radiofrequency Pulsed
radiofrequency for the treatment of various chronic
pain syndromes is considered investigational, including but
not limited to the following:
• Chronic facial and head pain (persistent idiopathic facial
pain
(PIFP)/spheno-palatine ganglion)
• Coccydynia
• Complex regional pain syndrome (reflex sympathetic
dystrophy)
• Diabetic peripheral neuropathy
• Discogenic pain
• Facet joint pain (cervical, lumbar, thoracic,
sacro-iliac)/
zygapophyseal joint pain
• Headaches (eg, cervicogenic, migraines, cluster, tension)
• Inguinal neuralgia
• Intercostal neuralgia (post-surgical thoracic pain)
• Low back pain
• Lumbo-sacral radicular pain (eg, dorsal root ganglion)
• Meralgia paresthetica (burning pain in the outer thigh
related
to lateral femoral cutaneous nerve entrapment)
• Metacarpal or metatarsal joint pain of the hands and feet
• Morton’s neuroma
• Myofascial pain syndrome
• Neck pain
• Occipital neuralgia
• Ophthalmic neuralgia
• Orchialgia (testicular pain/spermatic cord)
• Osteoarthritis of the knee or hip
• Pelvic pain (eg, superior hypogastric plexus treatment for
interstitial cystitis)
• Peripheral neuromas
• Piriformis syndrome (buttock pain and/or pain in the back
of
the lower extremity related to sciatic nerve irritation)
• Plantar fasciitis
• Post herpetic neuralgia (ophthalmic neuralgia)
• Pudendal neuralgia
• Sacro-iliac joint pain
• Shoulder pain (suprascapular nerve)
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Procedure Investigational • Tarsal tunnel syndrome (compression
neuropathy from
entrapment of the posterior tibial nerve)
• Trigeminal neuralgia
• Vulvodynia
Coding
Code Description
CPT 64999 Unlisted procedure, nervous system
Note: CPT codes, descriptions and materials are copyrighted by
the American Medical Association (AMA). HCPCS
codes, descriptions and materials are copyrighted by Centers for
Medicare Services (CMS).
Related Information
N/A
Evidence Review
Description
Pulsed radiofrequency (PRF) is a non- or minimally
neurodestructive technique, where short
bursts of radiofrequency energy are applied to nervous tissue to
treat various chronic pain
syndromes. It is seen as an alternative to continuous
(non-pulsed) radiofrequency ablation, as it
is theorized to have significantly less complications or side
effects. Its exact mechanism of action
is unclear.
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Background
Pulsed radiofrequency was first used in 1996 as a less
destructive alternative to continuous (non-
pulsed) radiofrequency. Pulsed radiofrequency is delivered in
short bursts, twice per second,
followed by a quiet phase in which no current is applied. This
allows for cooling of the electrode
keeping it below the neurodestructive threshold of 45° C.
Pulsing the radiofrequency current
allows the power output of the generator to be greatly
increased, allowing for far stronger
electrical fields than in continuous radiofrequency. For
example, the voltage output is usually 15-
25 volts for the continuous mode radiofrequency. The pulsed
radiofrequency output is 45 volts.
As a result, higher voltages can be applied in pulsed
radiofrequency. Because the average
temperature near the pulsed radiofrequency electrode does not
reach the neurodestructive
range, the risk of destroying nearby tissue is reduced.
Pulsed radiofrequency has been used in the treatment of
peripheral neuropathies, arthrogenic
pain, painful trigger points, radiculopathy, and many other
chronic pain syndromes. Unlike the
known side effects of continuous radiofrequency such as,
neuritis-like reactions, motor deficits,
and the risk of deafferentation pain syndrome, pulsed
radiofrequency seems to have few side
effects and is seen as relatively safe. However, even though
there is much anecdotal evidence
which favors the use of pulsed radiofrequency for the use of
pain relief without nervous tissue
damage, especially in the treatment of neuropathic pain, there
is a lack of randomized
controlled trials (RCTs) substantiating its efficacy. The
evidence is insufficient to determine the
effects of the technology on health outcomes.
Summary of Evidence
For individuals with various chronic pain syndromes, especially
neuropathic pain who received
pulsed radiofrequency, the evidence includes a small number of
RCTs, non-randomized
controlled trials, prospective uncontrolled trials,
retrospective studies, case series, and case
reports. The majority of the uncontrolled and observational
studies reported clinical efficacy of
pulsed radiofrequency, however many of these studies had
limitations. The controlled clinical
data is limited and with inconsistent findings. Further research
in the clinical and biological
effects of pulsed radiofrequency is needed including
well-designed, randomized controlled
clinical trials with a large sample size and long-term follow-up
to determine the therapeutic
effect and safety of this treatment modality. There is also a
lack of data comparing pulsed
radiofrequency with conventional treatments. As such, it is
unknown if pulsed radiofrequency
offers any treatment advantage over other conventional
treatments. The evidence is insufficient
to determine the effects of the technology on health
outcomes.
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Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this
review are listed in Table 1.
Table 1. Summary of Key Clinical Trials
NCT No. Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT03567590 The Efficacy and Safety of Sphenopalatine
Ganglion
Pulsed Radiofrequency Treatment for Cluster Headache
80 May 2021
NCT02915120 Ultrasound-Guided Pulsed Radiofrequency in the
Treatment of Patients with Osteoarthritis Knee
142 Dec 2020
NCT03228316 Superior Hypogastric Plexus Block Versus Pulsed
Radiofrequency for Chronic Pelvic Cancer Pain
40 Not yet recruiting,
Estimated start
date Oct 2019
NCT: national clinical trial
Practice Guidelines and Position Statements
American Society of Interventional Pain Physicians
The American Society of Interventional Pain Physicians (ASIPP)
published an updated guideline
on interventional techniques in the management of chronic spinal
pain Part II guidance and
recommendation which states the following:
• Lumbar spine
o The evidence for therapeutic facet joint interventions is good
for conventional
radiofrequency, limited for pulsed radiofrequency, fair to good
for lumbar facet joint
nerve blocks, and limited for intraarticular injections
o For sacroiliac interventions, the evidence for cooled
radiofrequency neurotomy is fair;
limited for intraarticular injections and periarticular
injections; and limited for both
pulsed radiofrequency and conventional radiofrequency
neurotomy
https://clinicaltrials.gov/ct2/show/NCT03567590?term=NCT03567590&rank=1https://clinicaltrials.gov/ct2/show/NCT02915120?term=NCT02915120&rank=1https://clinicaltrials.gov/ct2/show/NCT03228316?term=NCT03228316&rank=1
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• Cervical Spine
o Evidence for therapeutic facet joint intervention is fair for
conventional cervical
radiofrequency neurotomy
• Thoracic Spine
o Evidence is limited for radiofrequency neurotomy
Medicare National Coverage
There is no national coverage determination.
Regulatory Status
A number of radiofrequency generators and probes have been
cleared for marketing through
the U.S. Food and Drug Administration (FDA) 510(k) process.
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diagnosis and treatment of occipital neuralgia. Anesth Pain Med
2013;3(2):256-9. PMID:24282778
82. Vanelderen P, Rouwette T, De Vooght P, et al. Pulsed
radiofrequency for the treatment of occipital neuralgia: A
prospective
study with 6 months of follow-up. Reg Anesth Pain Med.
2010;35(2):148-151.PMID:20301822.
83. Weiss AL, Ehrhardt KP, Tolba R. Atypical facial pain: A
comprehensive, evidence-based review. Curr Pain Headache Rep.
2017;21(2):8PMID:28251523.
84. Werner MU, Bischoff JM, Rathmell JP, Kehlet H. Pulsed
radiofrequency in the treatment of persistent pain after
inguinal
herniotomy: A systematic review. Reg Anesth Pain Med.
2012;37(3):340-343.PMID:22476237.
85. Whitworth LA, Feler CA. Application of spinal ablative
techniques for the treatment of benign chronic painful
conditions:
History, methods, and outcomes. Spine. 2002;27(22):2607-2612;
discussion 2613.PMID:12436001.
86. Zakrzewska JM, Akram H. Neurosurgical interventions for the
treatment of classical trigeminal neuralgia. Cochrane Database
Syst Rev. 2011;(9):CD007312.PMID:21901707.
87. Zhang J, Shi DS, Wang R. Pulsed radiofrequency of the second
cervical ganglion (C2) for the treatment of cervicogenic
headache. J Headache Pain. 2011 12(5):569-71.
PMID:216118080..
History
-
Page | 11 of 11 ∞
Date Comments 09/01/18 New policy, approved August 14, 2018,
effective December 6, 2018. Add to Surgery
section. Policy created with a literature review through July
2018. Pulsed
radiofrequency for the treatment of various chronic pain
syndromes is considered
investigational.
10/01/19 Annual Review, approved September 5, 2019. Policy
updated with literature review.
References added. Policy statement unchanged.
Disclaimer: This medical policy is a guide in evaluating the
medical necessity of a particular service or treatment. The
Company adopts policies after careful review of published
peer-reviewed scientific literature, national guidelines and
local standards of practice. Since medical technology is
constantly changing, the Company reserves the right to review
and update policies as appropriate. Member contracts differ in
their benefits. Always consult the member benefit
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coverage for a specific medical service or supply.
CPT codes, descriptions and materials are copyrighted by the
American Medical Association (AMA). ©2019 Premera
All Rights Reserved.
Scope: Medical policies are systematically developed guidelines
that serve as a resource for Company staff when
determining coverage for specific medical procedures, drugs or
devices. Coverage for medical services is subject to
the limits and conditions of the member benefit plan. Members
and their providers should consult the member
benefit booklet or contact a customer service representative to
determine whether there are any benefit limitations
applicable to this service or supply. This medical policy does
not apply to Medicare Advantage.
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Română (Romanian): Prezenta notificare conține informații
importante. Această notificare poate conține informații importante
privind cererea sau acoperirea asigurării dumneavoastre de sănătate
prin Premera Blue Cross. Pot exista date cheie în această
notificare. Este posibil să fie nevoie să acționați până la anumite
termene limită pentru a vă menține acoperirea asigurării de
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obține gratuit aceste informații și ajutor în limba dumneavoastră.
Sunați la 800-722-1471 (TTY: 800-842-5357).
Pусский (Russian): Настоящее уведомление содержит важную
информацию. Это уведомление может содержать важную информацию о
вашем заявлении или страховом покрытии через Premera Blue Cross. В
настоящем уведомлении могут быть указаны ключевые даты. Вам,
возможно, потребуется принять меры к определенным предельным срокам
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имеете право на бесплатное получение этой информации и помощь на
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o le polokalame, Premera Blue Cross, ua e tau fia maua atu i ai.
Fa’amolemole, ia e iloilo fa’alelei i aso fa’apitoa olo’o iai i
lenei fa’asilasilaga taua. Masalo o le’a iai ni feau e tatau ona e
faia ao le’i aulia le aso ua ta’ua i lenei fa’asilasilaga ina ia e
iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olo’o e
iai i ai. Olo’o iai iate oe le aia tatau e maua atu i lenei
fa’asilasilaga ma lenei fa’matalaga i legagana e te malamalama i ai
aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471 (TTY:
800-842-5357).
Español ( ): Este Aviso contiene información importante. Es
posible que este aviso contenga información importante acerca de su
solicitud o cobertura a través de Premera Blue Cross. Es posible
que haya fechas clave en este
tiene derecho a recibir esta información y ayuda en su idioma
sin costo
aviso. Es posible que deba tomar alguna medida antes de
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los costos. Usted
alguno. Llame al 800-722-1471 (TTY: 800-842-5357).
Spanish
Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng
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pamamagitan ng Premera Blue Cross. Maaaring may mga mahalagang
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Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตอง
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มคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไม่มคาใชจาย
โทร 800-722-1471 (TTY: 800-842-5357)
้ี ี ้ ู ํ ั ้ี ี ้ ู ่ี ํ ั ่ี ั ั ื ัุ ุ ่ ี ํ ี ุ ้ํ ิ ํ ่ี ่
่ื ั ั ุ ุ ื ่ ื ่ีี ่ ้ ่ ุ ี ิ ิ ่ี ้ ั ้ ู ่ ื ้ี ุ ี ่ ้ ่
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Ваше звернення щодо страхувального покриття через Premera Blue
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У Вас є право на отримання цієї інформації та допомоги безкоштовно
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Cross. Xin xem ngày quan trọng trong thông báo này. Quý vị có thể
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