UNITED HEALTH CARE MEDICAL POLICIES
EPIDURAL STEROID AND FACET INJECTIONS Policy Number: 2012T0004P Eff Date 1/12
The use of ultrasound guidance for facet joint injection(s) and epidural steroid injection(s) is unproven. There is insufficient clinical evidence regarding its safety and/or efficacy in published peer-reviewed medical literature. The available published evidence for ultrasound guidance for facet and epidural injections is limited to a small feasibility study and a cadaver study.
MEDIAL BRANCH BLOCKS
Diagnostic facet joint injection and/or facet nerve block (e.g., medial branch block) is
proven to localize the source of pain to the facet joint in persons with spinal pain.
Facet joint injection, as a diagnostic procedure prior to radiofrequency ablation, is not
recommended in patients with: neurologic abnormalities, more than one pain syndrome, definitive clinical and/or imaging findings, previous spinal surgery at the clinically suspected levels, or known etiology of spinal pain
Therapeutic facet joint injection is unproven for the treatment of chronic spinal pain.
Clinical evidence about the very existence of facet joint syndrome is conflicting, and evidence from studies is inadequate regarding the superiority of periodic facet joint injections compared to placebo in relieving chronic spinal pain.
EPIDURAL STEROID INJECTIONS
Epidural steroid injection is proven for the treatment of acute and sub-acute sciatica or
radicular pain of the low back caused by spinal stenosis, disc herniation or degenerative
changes in the vertebrae. Epidural steroid injections have a clinically established role in the short-term management of low back pain when the following two criteria are met:
The pain is associated with symptoms of nerve root irritation and/or low back pain due to disc extrusions and/or contained herniations AND The pain is unresponsive to conservative treatment, including but not limited to pharmacotherapy, exercise or physical therapy
Epidural steroid injection is unproven for all other indications of the lumbar spine.
There is a lack of evidence from randomized controlled trials indicating that epidural steroid injections effectively treat patients with lumbar pain not associated with sciatica or radicular pain.
Note: This policy does not apply to obstetrical epidural anesthesia utilized during labor and delivery.
RADIOFREQUENCY FACET NEUROTOMY Policy Number: 2012T0107K Eff Date 1/12
Thermal radiofrequency ablation of facet joint nerves is proven for chronic cervical,
thoracic and lumbar pain when confirmed by:
temperature 60 degrees Celsius or more, duration of ablation 40 - 90 seconds, positive response to medial branch block injection at the side and level of the proposed ablation, ANDconfirmation of needle placement by fluoroscopic guided imaging
Thermal radiofrequency ablation is proven when performed
at a frequency of six months or longer (maximum of 2 times over a 12 month period), ANDprovided there has been a 50% or greater documented reduction in pain for 10 to 12 weeks.
Thermal radiofrequency ablation is unproven when:
performed more frequently than every six months; ornegative response to a medial branch block injection
More frequent ablation increases risk of adverse events without improving the clinical outcome.
Documentation requirements for the aforementioned procedures must include:
Temperature of administration of procedure
Duration of ablation
Specific identification of side and level of medial branch blocks
Specific cervical, thoracic and/or lumbar ablated by side and level
Percentage of pain relief with prior ablation if applicable
Duration of improvement from previous ablation if applicable.
Thermal radiofrequency ablation is unproven for the treatment of all other sources of
spinal pain including the following:diabetic neuropathy, sacroiliac pain, complex regional pain, syndrome or regional pain disorders and syndromes in the absence of spinal pain: definitive clinical and/or imaging findings identifying a condition requiring surgical treatment; identified specific causes of spinal pain (e.g., disc herniation) requiring definitive treatment
Studies of radiofrequency ablation for other conditions were limited, uncontrolled, and insufficient
to support conclusions regarding efficacy or duration of effect. Additional well-designed, longer term
randomized controlled trials are required to evaluate the safety and efficacy of
radiofrequency ablation and to compare this technique with other medical or surgical therapies for
The following ablation procedures are unproven for the treatment of spinal pain:
Pulsed radiofrequency therapy of the facet nerves of the cervical, thoracic, or lumbar
region, sacral nerve root or dorsal root ganglion.
Radiofrequency ablation with temperature less than 60 degrees Celsius
Cryoablation (cryodenervation, cryoneurolysis, cryosurgery, or cryoanesthesia)
Chemical ablation (including but not limited to alcohol, phenol or sodium morrhuate
Laser ablation (including pulsed, continuous, or low level)
There is insufficient evidence to establish the efficacy of the ablation therapies bulleted
immediately above to reduce or relieve spinal pain. Studies are limited by small sample size and
lack of long term follow-up. Additional well designed studies are needed to establish the efficacy of these procedures.
DISCOGENIC PAIN TREATMENTS Policy Number: 2012T0105I Eff Date 1/2012
The following thermal intradiscal procedures (TIPs) and percutaneous discectomy using other methods are unproven for the treatment of discogenic pain:
Intradiscal electrothermal therapy (IDET)
Intradiscal biacuplasty (IDB)
Percutaneous intradiscal radiofrequency thermocoagulation (PIRFT)
Nucleoplasty (percutaneous disc decompression)
Percutaneous lumbar discectomy (by other method)
Percutaneous laser disc decompression (PLDD)
Percutaneous endoscopic diskectomy with or without laser (PELD)
Yeung Endoscopic Spinal Surgery (YESS)
Percutaneous intradiscal annuloplasty
The evidence is insufficient to demonstrate short or long-term health benefits. Studies are primarily uncontrolled and limited to small sample size. Larger comparative studies are needed to evaluate the safety and effectiveness of these procedures. Annulus fibrosis repair (i.e., XClose) following spinal surgery is unproven. Evidence is limited to a single narrative review. Further studies are needed to establish whether annulus fibrosis repair is beneficial for health outcomes in patients with low back pain following spinal surgery.
EPIDUROSCOPY, EPIDURAL LYSIS OF ADHESIONS AND FUNCTIONAL ANESTHETIC DISCOGRAPHY Policy Number: 2011T0206I Eff Date 5/11
Epiduroscopy (including spinal myeloscopy) is unproven for the diagnosis of back pain. There is insufficient evidence to conclude that epiduroscopy can improve patient management or disease outcomes. The available studies primarily evaluated the feasibility of the procedure and the ability to visualize normal and pathological structures with an epiduroscope. None of the studies systematically evaluated the accuracy of epiduroscopy for diagnosis of causes of back pain and neurological signs.
Percutaneous and endoscopic epidural lysis of adhesions is unproven for the treatment of back pain. There is insufficient evidence to conclude that epidural lysis of adhesions can provide sustained reduction in chronic back pain in patients with a presumptive diagnosis of epidural adhesions. No published studies have evaluated this procedure relative to open surgical procedures for chronic back pain. Further validation with larger study populations and long term follow up is needed to verify the effectiveness of epidural adhesiolysis in the treatment of back pain.
Functional anesthetic discography (FAD) is unproven for the diagnosis of back pain.
PROLOTHERAPY FOR MUSCULOSKELETAL PAIN Policy Number: 2011T0498F Eff May 2011
Prolotherapy is unproven. The available studies are limited to those that include short to medium–term follow-up with no significant functional improvement compared to placebo. Additional studies are needed to further define treatment parameters and to determine whether a clinically significant improvement is achieved
BOTULINUM TOXINS A and B Policy Number: 2012D0017J Effective Date: 1/1/2012
Botulinum toxin type A [onabotulinumtoxinA (Botox®), abobotulinumtoxinA (Dysport™)] is proven in the treatment of the following conditions: 1) Achalasia31,38-41,44
2) Anal fissures, chronic25-30,36-7
3) Cervical dystonia (spasmodic torticollis)1,81
4) Detrusor-sphincter dyssynergia due to spinal cord injury or disease71,117-21,138,144
5) Hand dystonia (writer's, musician's or typist's cramp)147
6) Hand tremor12-3,43,147,166
7) Hemifacial spasm (seventh cranial nerve disorders)84-7,104-8,147,165
8) Hyperhidrosis1,138 including gustatory sweating (Frey's Syndrome)45-8,76,136-8,192
9) Neurogenic detrusor hyperreflexia52,63,110-1,138,141,143,146,252-3,255,260,278-80
10) Oromandibular dystonia4-7,11,126
11) Piriformis syndrome99-100,244
13) Spasmodic dysphonia (laryngeal dystonia)4,8-10,147
14) Spasticity associated with cerebral palsy; multiple sclerosis; stroke; or other injury, disease, or
tumor of the brain or spinal cord1,21-4,49,92-3,196-9
15) Strabismus and blepharospasm associated with dystonia1,147
16) Tongue dystonia4-7,11,126
17) Torsion dystonia3,4,7
18) Voice tremor9,16-17,167
Botulinum toxin type A [onabotulinumtoxinA (Botox)] is proven in the treatment of chronic migraine headache1 - OnabotulinumtoxinA (Botox) is FDA approved for the prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer).
Additional information to support medical necessity review where applicable:
The International Headache Society defines the following criteria for chronic migraine:287
Headache (tension-type and/or migraine) on ≥15 days per month for at least 3 months
Occurring in a patient who has had at least five attacks fulfilling criteria for migraine without aura
On ≥8 days per month for at least 3 months headache has fulfilled C1 and/or C2 below, that is, has fulfilled criteria for pain and associated symptoms of migraine without aura 1) Has at least two of the following a) unilateral location b) pulsating quality c) moderate or severe pain intensity d) aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs)
AND 2) Has at least one of the following a) nausea and/or vomiting b) photophobia and phonophobia AND
3) Treated and relieved by triptan(s) or ergot before the expected development of C1 above
No medication overuse and not attributed to another causative disorder
OnabotulinumtoxinA should be reserved for patients who have failed trials of preventative anti-migraine medications from two of the following classes: beta-blockers, calcium channel blockers, anticonvulsants, and/or antidepressants 289 (with or without concomitant behavioral and/or physical therapies) after titration to maximum tolerated doses.
Botulinum toxin type A [incobotulinumtoxinA (Xeomin®)] is proven in the treatment of the following conditions:
1) Cervical dystonia (spasmodic torticollis)288
2) Blepharospasm associated with dystonia288
3) Spasticity associated with cerebral palsy; multiple sclerosis; stroke; or other injury, disease, or
tumor of the brain or spinal cord282-3
Botulinum toxin type B [rimabotulinumtoxinB (Myobloc®)] is proven in the treatment of the following conditions:
1) Cervical dystonia (spasmodic torticollis)2
3) Neurogenic detrusor hyperreflexia138,142,146 AbobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), and rimabotulinumtoxinB (Myobloc) are unproven in the treatment of chronic migraine headache.34-5,131-2,138,168-9,170-1,108-7,281,296
Botulinum toxin types A and B are unproven in the treatment of the following conditions: 1) Acquired nystagmus18-20,172-3
2) Anismus (pelvic floor dyssynergia)51,78,139,140
3) Benign prostatic hyperplasia109,130,146,285
4) Brachial plexus palsy69,70,237-8
5) Chronic daily headache133-135, 138,179,188
6) Chronic low back pain60,138
7) Chronic prostatic pain53,146
8) Cricopharyngeal dysphagia42,64-5,148-64
9) Epiphora following salivary gland transplantation77
10) Esophageal spasm74,190-1
11) Gastroparesis (including diabetic gastroparesis)89,90,98,145,270-7,290
12) Gustatory epiphora (Crocodile tears)48,77,193-5
13) Head tremor14-15
14) Lateral epicondylitis (tennis elbow)95,248-51
15) Lichen simplex94
16) Lower urinary tract (voiding) dysfunction71,88,122-3,146
17) Motor tics62,189
18) Myofascial pain syndrome59,75,96,226-36
19) Nasal hypersecretion83,247,284
20) Pain and/or wound healing after hemorrhoidectomy125,265-6
21) Pancreas divisum72
22) Pelvic floor spasticity (and associated pain conditions)146,291
23) Postparotidectomy sialoceles56
24) Post-thoracotomy pseudoangina75
25) Proctalgia fugax82,146,292
26) Severe bruxism57,80,205-12
27) Severe paradoxical vocal cord movement55,204
28) Sphincter of Oddi dysfunction50,102,200-3
29) Stiff-person syndrome97,254
30) Temporomandibular disorders58,213-25,243
31) Tension headache32-33,61,103,127-9,138,174-8
32) Thyroid associated ophthalmopathy73,239-42
33) Tourette's syndrome124,189,261-4
34) Traumatic sixth nerve palsy91,256-9
35) Trigeminal neuralgia293-295
36) Trismus and stridor in amyotrophic lateral sclerosis79,245