Manuel Suarez, MD Medical Director Neighborhood Health Plan

To: Manuel Suarez, M.D.
Medical Director
Neighborhood Health Plan Management Department
5757 Plaza Dr.
Cyprus, CA 30630
Mailstop: CA124-01290
Subject: Denial of Cervical Spinal Injection Procedures
Dear Dr. Suarez,
This letter is in reference to Neighborhood Health Plans Policy regarding the denial of cerivical spinal
injections. Specifically, Neighborhood has developed draconian guidelines which have caused the denial of
cervical facet and epidural injections. Specifically, we have received feedback from our membership with
regard to the treatment of chronic cervical pain:
1. Cervical epidural injections are denied based on lack of evidence
2. Cervical facet injections limited to one set per lifetime
3. Cervical medial branch nerve blocks are denied
Please read the attached Epidural Position Statement which was written by the Florida Society of Interventional
Pain Physicians (FSIPP) and recently presented to the Surgeon General of Florida. This position statement was
based on rigorous evidence-based guidelines developed by the American Society of Interventional Pain
Physicians (ASIPP). In addition, I have included references from Official Disability Guidelines and AHRQ
guidelines regarding cervical epidural and facet injections.
Interlaminar Epidural Injections (ASIPP analysis)
The indicated evidence for cervical interlaminar epidural steroid injections is Level II-11.
1
Benyamin RM, Singh V, Parr AT, Conn A, Diwan S, Abdi S.; Systematic review of the effectiveness of cervical epidurals in the
management of chronic neck pain. Pain Physician. 2009 Jan-Feb;12(1):137-57.
Official Disability Guidelines (ODG) - 2014
Epidural steroid
injection (ESI)
Recommended as an option for treatment of radicular pain (defined as pain in
dermatomal distribution with corroborative findings of radiculopathy). See specific
criteria for use below. In a recent Cochrane review, there was one study that reported
improvement in pain and function at four weeks and also one year in individuals with
chronic neck pain with radiation. (Peloso-Cochrane, 2006) (Peloso, 2005) Other
reviews have reported moderate short-term and long-term evidence of success in
managing cervical radiculopathy with interlaminar ESIs. (Stav, 1993) (Castagnera,
1994) Some have also reported moderate evidence of management of cervical
nerve root pain using a transforaminal approach. (Bush, 1996) (Cyteval, 2004) A
recent retrospective review of interlaminar cervical ESIs found that
approximately two-thirds of patients with symptomatic cervical radiculopathy
from disc herniation were able to avoid surgery for up to 1 year with treatment.
Success rate was improved with earlier injection (< 100 days from diagnosis).
(Lin, 2006) These reports were in contrast to a retrospective review of 1,036 injections
that showed that there were no catastrophic complications with the procedure. (Ma,
2005) The American Academy of Neurology recently concluded that epidural steroid
injections may lead to an improvement in radicular lumbosacral pain between 2 and 6
weeks following the injection, but they do not affect impairment of function or the
need for surgery and do not provide long-term pain relief beyond 3 months, and there
is insufficient evidence to make any recommendation for the use of epidural steroid
injections to treat radicular cervical pain. (Armon, 2007) There is evidence for shortterm symptomatic improvement of radicular symptoms with epidural or selective root
injections with corticosteroids, but these treatments did not appear to decrease the rate
of open surgery. (Haldeman, 2008) (Benyamin, 2009) Epidural steroid injections
should be reserved for those who may otherwise undergo open surgery for nerve root
compromise. (Bigos, 1999) Intramuscular injection of lidocaine for chronic mechanical
neck disorders (MND) and intravenous injection of methylprednisolone for acute
whiplash were effective treatments. There was limited evidence of effectiveness of
epidural injection of methyl prednisolone and lidocaine for chronic MND with
radicular findings. (Peloso-Cochrane, 2006)
AHRQ Guidelines
What is the role of epidural steroid injections for the treatment of cervical radiculopathy from degenerative
disorders?
Transforaminal epidural steroid injections using fluoroscopic or CT guidance may be considered when
developing a medical/interventional treatment plan for patients with cervical radiculopathy from degenerative
disorders. Due consideration should be given to the potential complications.
Grade of Recommendation: C (limited or poor quality studies)
This level of evidence is specific for cervical transforaminal epidural steroid injections, because there is a lack
of high level studies (level 1-2). However, AHRQ does not state "not recommended". The interventional pain
management community is well aware of the risks associated with cervical transforaminal epidural steroid
injections.
With regard to interlaminar epidural steroid injections however, the recommendations are positive and the level
of evidence is high.
Cervical Facet Injections
Medial Branch Blocks
The medial branch facet nerve innervated the facet joint. It is typically block with a very small (< 1 ml) of local
anesthetic outside of the facet joint. It is not an intraarticular injection. Based on Guyatt et al’s criteria2 (Table
1) the recommendation is strong (1B or 1C) for the use of therapeutic cervical, thoracic, and lumbar facet joint
nerve blocks to provide both short-term and long-term relief in the treatment of chronic facet joint pain.
The evidence for diagnosis of cervical facet joint pain is Level I or II-1 based on the USPSTF criteria (Table
2).3
Intraarticular Facet Injections
The evidence for cervical intraarticular injections is lacking. There was no evidence available for thoracic
intraarticular facet joint injections.
Recommendations
Based on the present comprehensive evaluation (ASIPP)4 diagnostic cervical facet joint nerve blocks are
recommended in patients with the following criteria:
Patients suffering with somatic or non-radicular neck pain or headache and upper extremity pain, with
duration of pain of at least 3 months.
Average pain levels of greater than 6 on a scale of 0 to 10.
Pain is at least intermittent or continuous causing functional disability.
Problem has failed to respond and has not resolved with more conservative management, including
physical therapy modalities with exercises, chiropractic management, and non-steroidal antiinflammatory agents.
Lack of preponderance of evidence of discogenic pain, disc herniation, or evidence of radiculitis.
There is no evidence of contraindications for the needle placement and injection of local anesthetics.
Contraindications or inability to undergo physical therapy, chiropractic management, or inability to
tolerate non-steroidal anti-inflammatory drugs.
A positive response is based on the following evidence:
Patient has met the above indications.
Patient responds positively to controlled local anesthetic blocks either with placebo control or
comparative local anesthetic blocks with appropriate response to each local anesthetic with < 1 mL of
local anesthetic.
2
Guyatt G, Gutterman D, Baumann MH, Addrizzo-Harris D, Hylek EM, Phillips B, Raskob G, Lewis SZ, Schünemann
H. Grading strength of recommendations and quality of evidence in clinical guidelines. Report from an American College of Chest
Physicians task force. Chest 2006; 129:174-181.
3
4
Berg AO, Allan JD. Introducing the third U.S. Preventive Services Task Force. Am J Prev Med 2001; 20:S3-S4.
Laxmaiah Manchikanti, MD et al; Comprehensive Evidence-Based Guidelines for Interventional Techniques in the Management of
Chronic Spinal Pain; Pain Physician 2009; 12:699-802
At least 80% relief as criterion standard with ability to perform previously painful movement without
deterioration of the relief (i.e., extension, overhead activity, lateral rotation, flexion, etc.).
The patient’s response should be recorded independently by the assessor - generally a registered nurse
familiar with patient or another physician.
Cervical Medial Branch Neurotomy
Based on USPSTF criteria, the indicated evidence for cervical medial branch radiofrequency neurotomy is
Level II-1 to Level II-2, Level II-2 to II-3 for lumbar radiofrequency neurotomy.
Based on Guyatt et al’s criteria for cervical radiofrequency neurotomy and lumbar radiofrequency neurotomy,
the recommendation is 1C/strong recommendation.
AHCR
The treatment is chronic cervical pain under AHCR guidelines defers to ASIPP guidelines5.
Official Disability Guidelines (ODG) -2014
Facet joint diagnostic
blocks
Recommended prior to facet neurotomy. Diagnostic blocks are performed with the anticipation that if
successful, treatment may proceed to facet neurotomy at the diagnosed levels. Current research indicates
that a minimum of one diagnostic block be performed prior to a neurotomy, and that this be a medial
branch block (MBB). Although it is suggested that MBBs and intra-articular blocks appear to provide
comparable diagnostic information, the results of placebo-controlled trials of neurotomy found better
predictive effect with diagnostic MBB. In addition, the same nerves are tested with the MBB as are
treated with the neurotomy. The use of a confirmatory block has been strongly suggested due to the high
rate of false positives with single blocks (range of 27% to 63%) but this does not appear to be cost
effective or to prevent the incidence of false positive response to the neurotomy procedure itself.
Technique: The described technique of blocking the medial branch nerves in the C3-C7 region (C3-4,
C4-5, C5-6, and C6-7) is to block the named medial branch nerves (two injections). Authors have
described blocking C2-3 by blocking the 3rd occipital nerve. Another technique of blocking C2-3 is to
block at three injection points (vertically over the joint line, immediately above the inferior articular
facet at C2 and immediately below the superior articular facet at C3). (Barnsley, 1993) The medial
branch nerve innervates the facet joint, facet capsular ligaments, the interspinous and supraspinous
ligaments, spinous processes and paraspinal muscles. Relief of pain could be due to blockade of
nociceptive input from any combination of these. It is suggested that the volume of injectate for
diagnostic medial branch blocks be kept to a minimum (a trace amount of contrast with no more than 0.5
cc of injectate) as increased volume may anesthetize these other potential areas of pain generation and
confound the ability of the block to accurately diagnose facet pathology. A recent study has
recommended that the volume be limited to 0.25 cc.
Epidemiology of involved levels: Using cadaver evidence facet arthrosis most commonly affects the
upper cervical levels, and increased with age, and was very rare in patients less than 40 years of age.
C4-5 is the most common level followed by C3-4 and C2-3. This study did not attempt to identify
number of levels of involvement. (Lee, 2009) Number of levels of involvement: In a randomized
controlled trial of therapeutic cervical medial branch blocks it was stated that 48% of patients had 2
joints involved and 52% had three joints involved. (Manchikanti, 2008) These levels were identified by
the pain pattern, local or paramedian tenderness over the area of the facet joint, and reproduction of pain
to deep pressure. (Manchikanti, 2004) Other prevalence studies from this group also indicated that the
majority of patients with cervical involvement were treated at three joints. Target joints were identified
as noted above. (Manchikanti, 2004). There are no studies that have actually tested levels of
5
Manchikanti L, et al; An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain.
Part II: guidance and recommendations Pain Physician 2009 Jul-Aug;12(4):699-802
involvement using individual injections for diagnostic verification.
Criteria for the use of diagnostic blocks for facet nerve pain: ODG
Clinical presentation should be consistent with facet joint pain, signs & symptoms.
1. One set of diagnostic medial branch blocks is required with a response of ≥ 70%. The pain response should
be approximately 2 hours for Lidocaine.
2. Limited to patients with cervical pain that is non-radicular and at no more than two levels bilaterally.
3. There is documentation of failure of conservative treatment (including home exercise, PT and NSAIDs) prior
to the procedure for at least 4-6 weeks.
4. No more than 2 joint levels are injected in one session (see above for medial branch block levels).
5. Recommended volume of no more than 0.5 cc of injectate is given to each joint, with recent literature
suggesting a volume of 0.25 cc to improve diagnostic accuracy.
6. No pain medication from home should be taken for at least 4 hours prior to the diagnostic block and for 4 to 6
hours afterward.
7. Opioids should not be given as a “sedative” during the procedure.
8. The use of IV sedation may be grounds to negate the results of a diagnostic block, and should only be given
in cases of extreme anxiety.
9. The patient should document pain relief with an instrument such as a VAS scale, emphasizing the importance
of recording the maximum pain relief and maximum duration of pain. The patient should also keep medication
use and activity logs to support subjective reports of better pain control.
10. Diagnostic facet blocks should not be performed in patients in whom a surgical procedure is anticipated.
11. Diagnostic facet blocks should not be performed in patients who have had a previous fusion procedure at the
planned injection level.
12. It is currently not recommended to perform facet blocks on the same day of treatment as epidural steroid
injections or stellate ganglion blocks or sympathetic blocks or trigger point injections as this may lead to
improper diagnosis or unnecessary treatment
To summarize:
Cervical epidural steroid injections are effective for the treatment of chronic cervical pain secondary to
radiculopathy, degenerative disease or disc herniations. They have been demonstrated to reduce the need
for cervical intervention.
Cervical intra-articular facet injections lack significant evidence. However, cervical medial branch nerve
blocks demonstrate strong evidence for the diagnosis of cervical pain. Subsequent cervical medial
branch neurotomy (through radiofrequency, etc.} demonstrate strong evidence for the treatment of
chronic cervical pain. Therapeutic cervical medial branch blocks also demonstrate relatively strong
evidence for the treatment of chronic cervical pain
It should be pointed out that the CPT code for both cervical intra-articular facet injections and medial branch
blocks is the same; 64490-64492. Therefore, if you are denying intra-articular facet injections based on the
CPT code, then you are inappropriately denying cervical medial branch nerve blocks as well.
We therefore believe that your analysis is flawed in denying both cervical epidural steroid injections and facet
injections. The claim that Neighborhood has made that there is insufficient evidence to justify these procedures
is a direct contradiction to major evidence-based guidelines that have been developed.
I would appreciate any communication regarding your decision with respect to cervical epidural steroid
injections or any other interventional pain management procedure.
Sincerely,
Sanford M. Silverman, M.D.
President, Florida Society of Interventional Pain Physicians
Table 1- Level of Evidence based on Guyatt et al.
Table 2 - Adapted from U.S. Preventive Services Task Force (USPSTF)