Appeal type: unknown
Decision: unknown

 
The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules state that acute low back pain, defined as low back pain with less than four weeks duration, has an 
excellent prognosis to recover within the first four to six weeks. Initially, treatments include non-invasive 
therapies, including pharmacologic and non-pharmacological measures. Patients with acute or subacute 
nonspecific low back pain typically would not be considered candidates for interventional therapies, as they 
could still improve with noninvasive therapies, and there is little evidence on the efficacy of invasive therapies 
in this circumstance.24 The American College of Physicians offers a strong recommendation for non-
pharmacological measures as the first line treatment. Recommended non-pharmacological measures include 
conservative measures such as superficial heat, exercise, multidisciplinary rehabilitation, acupuncture, 
mindfulness-based stress reduction having moderate-quality evidence. For pharmacologic therapy, they 
recommend non-steroidal anti-inflammatory drugs (NSAIDs) as first line treatment, and muscle relaxants, as 
second-line treatment.25 Systemic steroids may provide benefits with three randomized control trials showing 
benefit, especially in the short term. The benefit of anticonvulsants and antidepressants is overall low quality, 
but there is potential benefit in some patients.26 A systematic review comparing ESIs to conservative treatment 
for patients with lumbosacral radicular pain reported that ESIs were more effective for alleviating lumbosacral 
radicular pain but not function in both short and intermediate -term compared to conservative treatment, 
however this effect was not maintained at long-term follow-up.27 It is standard practice to utilize conservative 
treatment measures for the management of acute low back pain. When back pain persists over twelve weeks, it 
is considered chronic low back pain, and spontaneous recovery is less likely. The SMEs voted 3/5 (range 2-5) 
that there is evidence to support periods of conservative management prior to treatment with epidural 
injections. The panel discussed time for conservative care is related stronger to the natural history of the 
disease than the evidence, as it has not been well studied. The panel voted low confidence (2/5; range 1-5) in 
terms of evidence to support documentation of failure of at least two classes of medication prior to ESI. The 
use of medication is more controversial due to the risk associated with non-steroidal anti-inflammatory, 
specifically gastrointestinal complications, and the risk of opioid addiction with opioid use. Other medications 
remain available, but there is not strong evidence to support one specific category of medication. 
 
Patients with low back pain should be evaluated for the underlying condition, and targeted treatments 
implemented. History and physical examination, including a neurological exam to evaluate for radicular pain, 
should be performed. Imaging should be targeted to identify specific differential diagnoses and is not typically 
indicated in the early evaluation of low back pain.28 The American College of Radiology (ARC) offers 
evidence-based criteria for imaging for low back pain.29 According to the ARC Criteria, patients who have 
acute, subacute, or chronic low back pain or radiculopathy with persistent or progressive symptoms during or 
following six weeks of conservative management are considered candidates for surgery or intervention. Imaging may be considered for patients who have had no improvement in their back pain after six weeks of 
medical management and physical therapy. Imaging is classified as "may be appropriate", with magnetic 
resonance imaging (MRI) of the lumbar spine without contrast classified as "usually appropriate" and 
computed tomography (CT) if MRI is unavailable" as needed for diagnostics. The American College of 
Occupational and Environmental Medicine guidelines state that while diagnostic tests are not indicated for the 
majority of low back pain, the literature supports CT or MRI.30 The ESIs are utilized as an option for a 
specific diagnosis, and therefore a thorough evaluation to achieve diagnosis is a necessary step prior to 
consideration of ESIs. In most cases, by the time ESIs are considered, imaging has been completed as part of 
the evaluation. Any prior imaging should be reviewed for anatomy prior to interventional procedures. The 
SMEs voted low confidence 2/5; (range 1-4) that radicular pain should be concordant with a radiologists 
interpretation of an advanced diagnostic study demonstrating compression of the involved nerve root. The 
concern was that the imaging study is a static image in a dynamic process and the compression may be missed 
in the supine position even if present. The SMEs felt there was benefit in obtaining imaging to aid in diagnosis, 
such as to reveal anatomical features that may guide treatment options or alter approach, selection of needle 
size and appropriate segmental level. There was also concern that imaging would not reveal non-anatomical 
sources like chemical radiculitis. 
Frequency, laterality and multiple level injections 
Existing evidence and societal guidance support conservative management for acute back pain. There is little 
data regarding the frequency of ESIs for patients who are candidates for intervention. A 2018 prospective 
cohort study of 102 patients who had ESI for radicular symptoms related to disc herniation (n=57) or cervical 
disc herniation (n=45) and had a second injection administered for persistent pain were followed for one year. 
Seventeen patients had a second injection for lumbar herniation (29.8%) and seven for cervical herniation 
(15.6%) at a mean of 65.3 days (SD 46.5) and 47 days (SD 37.2), respectively. All but one patient who had 
surgery responded satisfactorily with a mean VAS for leg pain of 8.8 mm (SD 10.3) and a mean VAS for arm 
pain of 6.3 mm (SD 9) one year after the second injection, respectively. They concluded repeat injections were 
acceptable treatment in symptomatic patients without satisfactory relief after the first injection.
85
 Limitations of 
this study conducted in Europe were different standards for ESI and repeat injection, risk of recall bias, and 
varying times to the second injection. In a study by the same authors, 1002 consecutive patients were 
prospectively assessed on short-term response to ESIs for various indications. They determined ten-day 
outcomes of the second injection were as good as the outcome of the primary injection for a lumbar herniation: 
(72.2% better, 24.7% the same, and 3.1% worse following 295 primary injections compared with 70.1% better, 
24.8% the same and 5.1% worse after 117 second injections; p = 0.593). For cervical herniation, the 
improvement was reported in 63.1%, the same in 28.6%, and worse in 8.3% after 84 primary injections 
compared with 52.2% better, 34.8% the same, and 13% worse after 23 second injections; p = 0.602). This study 
was also a European population and did not use validated outcome scores.
86
 Other studies have also reported 
improvements with second injections, but high variability in timing and number of injections and inclusion of 
other spinal procedures challenge interpretation. A 2016 prospective observational study included 184 patients 
who underwent TFESI for axial neck or radicular arm pain due to herniated disc or spinal stenosis. A group of 
partial responders (n=108) was scheduled to undergo repeat injection at two-three weeks. The other group 
(n=76) of partial responders received repeat injections for aggravation of pain. They concluded the scheduled 
repeat injection group showed a significantly longer time to reinjection and improved clinical benefits.
67
 This 
was limited by a lack of a control group, lack of standardization in the total number of injections, and unclear 
randomization. 
A 2014 retrospective observational study evaluated 933 patients with a total of 2,087 TFESI. Injections were 
repeated at intervals of at least two weeks for a duration of up to one year from index injection. Of the total 
patients in the database (933/4,161) 22.4% received repeat injections during the study period, and the cohort 
showed a significant decrease in improvement with subsequent injections (p=0.0311). This study is limited by 
retrospective design and high variability in the duration between injections and steroid preparations. They 
found most patients did not require repeat injections for treatment of lumbar radicular pain but did find those with an incomplete initial response who received early repeat injections within three months can achieve a 
cumulative benefit.
87
 
On the contrary, several authors reported no difference in long-term outcomes in patients receiving a second 
injection nor a reduction in the need for surgery.
88, 89
 The 2005 WEST study was a multicenter, double-blinded 
randomized placebo-controlled trial with 228 patients with sciatica. The patients were randomized to either 
three lumbar ESIs with steroid or placebo (saline) at intervals of three weeks. At three weeks, they discovered 
that the ESI group had a transient benefit over the placebo group (75% improvement in ODQ, 12.5 vs. 3.7%; 
number needed to treat, 11.4). No benefit was demonstrated from 6 to 52 weeks. They concluded that ESIs did 
not improve physical function, hasten return to work or reduce the need for surgery and did not find a benefit of 
repeated ESIs over single injection. They advocate a multidisciplinary approach for management.
90
 Limitations 
were the use of 75% cut off for improvement while most studies use 50%, and assessment of disability but not 
pain assessment. 
A 2013 systematic analysis identified nine studies with = 50% pain relief after TFESIs for radicular pain after a 
single injection and reported 94% required a single injection and 4% required a second injection to achieve this 
level of pain relief. The use of three or four injections was rare.
7
 
A 2014 retrospective observational study investigated if repeat lumbar TFESIs resulted in pain relief which has 
waned since index injection, and if a cumulative benefit could be achieved by repeat injections within three 
months of the index injection. 4,161 patients received single-level TFESIs for radicular pain with or without 
radiculopathy. Between two weeks and one year from index injection, 933 subjects (22.4%) had repeat 
injection within one year. The data indicates that 18% of subjects had two injections, 3.6% had three or more 
injections. They concluded there was cumulative benefit of repeat injections within three months of the index 
injection.
87
 Limitations of the study included the retrospective design, a high number of patients lost to follow 
up and no standardization in terms of timing of the repeat injection(s). 
Using quality assurance databases from radiology and two medicine and rehabilitation (PM&R) practices, 
16,638 consecutive procedures in all spine segments (14,956 TFESI; 1,682 ILESI) were evaluated for major 
and minor adverse safety outcomes. The most frequent complication was a vasovagal reaction in 1.2% and 
dural puncture in 0.06%. They reported no major adverse reactions, no long-term sequelae from any 
intermediate or delayed minor adverse events. They concluded both TFESI and IESI are safely performed with 
low immediate and delayed adverse event rates when informed by evidence-based procedural guidelines. Of 
note, multiple patients in this population had bilateral procedures or two-level injections without additional 
safety concerns.
34
 
A 2016 study was conducted for 184 patients who underwent TFESI for axial neck and radicular arm pain with 
single ESI. Group A (n=108) was comprised of partial responders defined as a numerical rating scale =3 and 
received scheduled repeat injections at two to three weeks after the first injection. Group B (n=76) was 
comprised of partial responders who did not receive a repeat injection but received intermittent injections for 
aggravation of pain. Total number of injections within one year and NRS score <3 were recorded, and they 
concluded Group A showed a significantly longer time to re-injection and a longer time between injections. 
The average number of injections was 2.48 in Group A, with four patients receiving more than three injections 
and 2.98 in Group B with 16 patients receiving >3 injections.
91
 This study is limited by retrospective design 
and selection bias as patients who did not follow up for a year or choose surgery were excluded. 
Subject matter experts were asked about their confidence that the evidence demonstrates ESIs provided relief 
for a minimum of six weeks after injection with score of 4/5 (range 1-5). 
 The panel was split regarding repeating ESIs if the initial treatment did not result in substantial pain 
relief with the majority feeling that repeating in a different level would be appropriate (3/5; range 1-5), 
but not at the same level that did not achieve improvement with ESI.  When asked if there is literature on a safe or harmful number of ESIs per year 7/11 SMEs voted no. 
There was not a consensus among the panel in terms of the number of ESIs that would be considered 
safe or harmful in a twelve-month time period with a range of three-four in twelve months suggested. 
 In response to the question concerning the literature providing input on the safety of multiple levels of 
ESIs performed in the same session, 6 out of 11 voted no. When asked the number of levels they felt 
would be safe the range was one to three per session. 
 Half (5/10) did not feel the literature provides input on a safe duration of time between the 
administration of separate ESIs in the same spinal region and the recommended duration ranged from 
two weeks to three months. One SME stated, the need for individual assessment and response to prior 
injections as well as goals of treatment management versus resolution are factors that can influence this 
decision. 
 Subject matter experts were asked about their level of confidence in the evidence to support repeat 
epidural injections for long-term management of chronic back pain >6 months and there was not a 
consensus. Comments included lack of supporting evidence for ESIs for chronic pain management. This 
must be balanced against patients who do have good results with injections and wish to avoid surgery 
when clinical benefit is evident. 
You can find this rule at Centers for Medicare and Medicaid Services, Local Coverage Determination (LCD) 
L39036, Epidural Steroid Injections for Pain Management. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.