DECISION AND ORDER
This case is decided pursuant to Chapter 410 of the Texas Workers’ Compensation Act and Rules of the Division of Workers’ Compensation adopted thereunder.
A contested case hearing was held on June 3, 2013 to decide the following disputed issue:
- Is the preponderance of the evidence contrary to the decision of
- the IRO that the claimant is not entitled to right lumbar transforaminal ESI L1-2, OP caudal ESI L4-5 for the compensable injury of (Date of Injury)?
Petitioner/Claimant appeared and was assisted by TL, ombudsman.
Respondent/Carrier appeared and was represented by BJ, attorney.
The evidence presented in the hearing revealed that Claimant sustained a compensable injury to include his back on (Date of Injury), while swinging a sledge hammer when he heard something pop in his back. The evidence presented indicates that Claimant has received conservative treatment for the compensable injury, including medications, physical therapy, epidural steroid injections (ESIs). The evidence also indicated that Claimant has been prescribed Dilaudid 8mg, Soma 350 mg, Naprosyn 500 mg, Percocet 10-325 mg and Ultram 50 mg. The prospective medical necessity for right lumbar transforaminal ESI L1-2, OP caudal ESI L4-5 was denied after an initial review by a Utilization Review Agent (URA) and this denial was upheld by a second URA following a request for reconsideration. Claimant then requested a review by an Independent Review Organization (IRO).
Independent Review Organization (hereinafter "IRO") and the IRO reviewer, specializing in Neurological Surgery, upheld the previous adverse determinations based on the following sources: medical judgment, clinical experience, expertise in accordance with accepted medical standards, and ODG - Official Disability Guidelines & Treatment Guidelines(hereinafter "ODG"). Consequently, Petitioner appealed the IRO decision.
Texas Labor Code Section 408.021 provides that an employee who sustains a compensable injury is entitled to all health care reasonably required by the nature of the injury as and when needed. Health care reasonably required is further defined in Texas Labor Code Section 401.011 (22a) as health care that is clinically appropriate and considered effective for the injured employee's injury and provided in accordance with best practices consistent with evidence based medicine or, if evidence based medicine is not available, then generally accepted standards of medical practice recognized in the medical community. Health care under the Texas Workers' Compensation system must be consistent with evidence based medicine if that evidence is available. Evidence based medicine is further defined in Texas Labor Code Section 401.011 (18a) to be the use of the current best quality scientific and medical evidence formulated from credible scientific studies, including peer-reviewed medical literature and other current scientifically based texts and treatment and practice guidelines. The Commissioner of the Division of Workers' Compensation is required to adopt treatment guidelines that are evidence-based, scientifically valid, outcome-focused and designed to reduce excessive or inappropriate medical care while safeguarding necessary medical care. Texas Labor Code Section 413.011(e). Medical services consistent with the medical policies and fee guidelines adopted by the commissioner are presumed reasonable in accordance with Texas Labor Code Section 413.017(1).
In accordance with the above statutory guidance, the Division of Workers' Compensation has adopted treatment guidelines by Division Rule 137.100. This rule directs health care providers to provide treatment in accordance with the current edition of the ODG, and such treatment is presumed to be health care reasonably required as defined in the Texas Labor Code. Thus, the focus of any health care dispute starts with the health care set out in the ODG. Also, in accordance with Division Rule 133.308 (t), "A decision issued by an IRO is not considered an agency decision and neither the Department nor the Division is considered parties to an appeal. In a Contested Case Hearing (CCH), the party appealing the IRO decision has the burden of overcoming the decision issued by an IRO by a preponderance of evidence-based medical evidence."
The pertinent provisions of the ODG applicable to this case are as follows, to wit:
Epidural steroid injections (ESIs), therapeutic: Recommended as a possible option for short-term treatment of radicular pain (defined as pain in dermatomal distribution with corroborative findings of radiculopathy) with use in conjunction with active rehab efforts. See specific criteria for use below. Radiculopathy symptoms are generally due to herniated nucleus pulpous or spinal stenosis, although ESIs have not been found to be as beneficial a treatment for the latter condition.
Short-term symptoms: The American Academy of Neurology recently concluded that epidural steroid injections may lead to an improvement in radicular 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. (Armon, 2007) Epidural steroid injection can offer short-term pain relief and use should be in conjunction with other rehab efforts, including continuing a home exercise program. There is little information on improved function or return to work. There is no high-level evidence to support the use of epidural injections of steroids, local anesthetics, and/or opioids as a treatment for acute low back pain without radiculopathy. (Benzon, 1986) (ISIS, 1999) (DePalma, 2005) (Molloy, 2005) (Wilson-MacDonald, 2005) A recent RCT of 29 patients divided into three groups addressed the use of ESIs for treatment of spinal stenosis. A control group with no treatment was compared to a group receiving passive physical therapy for two weeks and another receiving an interlaminar ESI at the stenotic level. At two weeks the group that received the ESI had significantly better pain relief than the other two groups. When the three groups were compared there was no statistical difference except in pain intensity and Roland Morris Disability Index and this was at two weeks only. The authors stated that improvement only appeared to be in the early phase of treatment. (Koc, 2009)
Use for chronic pain: Chronic duration of symptoms (> 6 months) has also been found to decrease success rates with a threefold decrease found in patients with symptom duration > 24 months. The ideal time of either when to initiate treatment or when treatment is no longer thought to be effective has not been determined. (Hopwood, 1993) (Cyteval, 2006) Indications for repeating ESIs in patients with chronic pain at a level previously injected (> 24 months) include a symptom-free interval or indication of a new clinical presentation at the level.
Transforaminal approach: Some groups suggest that there may be a preference for a transforaminal approach as the technique allows for delivery of medication at the target tissue site, and an advantage for transforaminal injections in herniated nucleus pulpous over translaminar or caudal injections has been suggested in the best available studies. (Riew, 2000) (Vad, 2002) (Young, 2007) This approach may be particularly helpful in patients with large disc herniations, foraminal stenosis, and lateral disc herniations. (Colorado, 2001) (ICSI, 2004) (McLain, 2005) (Wilson-MacDonald, 2005) Two recent RCTs of caudal injections had different conclusions. This study concluded that caudal injections demonstrated 50% pain relief in 70% of the patients, but required an average of 3-4 procedures per year. (Manchikanti, 2011) This higher quality study concluded that caudal injections are not recommended for chronic lumbar radiculopathy. (Iversen, 2011)
Fluoroscopic guidance: Fluoroscopic guidance with use of contrast is recommended for all approaches as needle misplacement may be a cause of treatment failure. (Manchikanti, 1999) (Colorado, 2001) (ICSI, 2004) (Molloy, 2005) (Young, 2007)
Factors that decrease success: Decreased success rates have been found in patients who are unemployed due to pain, who smoke, have had previous back surgery, have pain that is not decreased by medication, and/or evidence of substance abuse, disability or litigation. (Jamison, 1991) (Abram, 1999) Research reporting effectiveness of ESIs in the past has been contradictory, but these discrepancies are felt to have been, in part, secondary to numerous methodological flaws in the early studies, including the lack of imaging and contrast administration. Success rates also may depend on the technical skill of the interventionalist. (Carette, 1997) (Bigos, 1999) (Rozenberg, 1999) (Botwin, 2002) (Manchikanti , 2003) (CMS, 2004) (Delport, 2004) (Khot, 2004) (Buttermann, 2004) (Buttermann2, 2004) (Samanta, 2004) (Cigna, 2004) (Benzon, 2005) (Dashfield, 2005) (Arden, 2005) (Price, 2005) (Resnick, 2005) (Abdi, 2007) (Boswell, 2007) (Buenaventura, 2009) Also see Epidural steroid injections, “series of three” and Epidural steroid injections, diagnostic. ESIs may be helpful with radicular symptoms not responsive to 2 to 6 weeks of conservative therapy. (Kinkade, 2007) Epidural steroid injections are an option for short-term pain relief of persistent radiculopathy, although not for nonspecific low back pain or spinal stenosis. (Chou, 2008) As noted above, injections are recommended if they can facilitate a return to functionality (via activity & exercise). If post-injection physical therapy visits are required for instruction in these active self-performed exercise programs, these visits should be included within the overall recommendations under Physical therapy, or at least not require more than 2 additional visits to reinforce the home exercise program.
With discectomy: Epidural steroid administration during lumbar discectomy may reduce early neurologic impairment, pain, and convalescence and enhance recovery without increasing risks of complications. (Rasmussen, 2008)
An updated Cochrane review of injection therapies (ESIs, facets, trigger points) for low back pain concluded that there is no strong evidence for or against the use of any type of injection therapy, but it cannot be ruled out that specific subgroups of patients may respond to a specific type of injection therapy. (Staal-Cochrane, 2009) Recent studies document a 629% increase in expenditures for ESIs, without demonstrated improvements in patient outcomes or disability rates. (Deyo, 2009) There is fair evidence that epidural steroid injection is moderately effective for short-term (but not long-term) symptom relief. (Chou3, 2009) This RCT concluded that caudal epidural injections containing steroids demonstrated better and faster efficacy than placebo. (Sayegh, 2009) ESIs are more often successful in patients without significant compression of the nerve root and, therefore, in whom an inflammatory basis for radicular pain is most likely. In such patients, a success rate of 75% renders ESI an attractive temporary alternative to surgery, but in patients with significant compression of the nerve root, the likelihood of benefiting from ESI is low (26%). This success rate may be no more than that of a placebo effect, and surgery may be a more appropriate consideration. (Ghahreman, 2011) According to this RCT, the use of MRI before ESIs does not improve patient outcomes and has a minimal effect on decision making, but the use of MRI might have reduced the total number of injections required and may have improved outcomes in a subset of patients. Given these potential benefits as well as concerns related to missing important rare contraindications to epidural steroid injection, plus the small benefits of ESIs themselves, ODG continues to recommend that radiculopathy be corroborated by imaging studies and/or electrodiagnostic testing. (Cohen, 2012) In this RCT there were no statistically significant differences between any of the three groups at any time points. This study had some limitations: only one type of steroid in one dose was tested; the approach used was caudal and transforaminal injections might provide superior results. (Weiner, 2012) Effects are short-term and minimal. At follow-up of up to 3 months, epidural steroids were associated with statistically significant reductions in mean leg pain and mean disability score, but neither of these short-term improvements reached the threshold for clinical significance. There were no significant differences in either leg pain or disability at 12 months follow-up. (Pinto, 2012)
Criteria for the use of Epidural steroid injections:
Note: The purpose of ESI is to reduce pain and inflammation, thereby facilitating progress in more active treatment programs, reduction of medication use and avoiding surgery, but this treatment alone offers no significant long-term functional benefit.
- Radiculopathy must be documented. Objective findings on examination need to be present. Radiculopathy must be corroborated by imaging studies and/or electrodiagnostic testing.
- Initially unresponsive to conservative treatment (exercises, physical methods, NSAIDs and muscle relaxants).
- Injections should be performed using fluoroscopy (live x-ray) and injection of contrast for guidance.
- Diagnostic Phase: At the time of initial use of an ESI (formally referred to as the “diagnostic phase” as initial injections indicate whether success will be obtained with this treatment intervention), a maximum of one to two injections should be performed. A repeat block is not recommended if there is inadequate response to the first block (< 30% is a standard placebo response). A second block is also not indicated if the first block is accurately placed unless:
- (e)there is a question of the pain generator;
- (f)there was possibility of inaccurate placement; or
- (g)there is evidence of multilevel pathology.
- (h)In these cases a different level or approach might be proposed. There should be an interval of at least one to two weeks between injections.
- No more than two nerve root levels should be injected using transforaminal blocks.
- No more than one interlaminar level should be injected at one session.
- Therapeutic phase: If after the initial block/blocks are given (see “Diagnostic Phase” above) and found to produce pain relief of at least 50-70% pain relief for at least 6-8 weeks, additional blocks may be supported. This is generally referred to as the “therapeutic phase.” Indications for repeat blocks include acute exacerbation of pain, or new onset of radicular symptoms. The general consensus recommendation is for no more than 4 blocks per region per year. (CMS, 2004) (Boswell, 2007)
- Repeat injections should be based on continued objective documented pain relief, decreased need for pain medications, and functional response.
- Current research does not support a routine use of “series-of-three” injections in either the diagnostic or therapeutic phase. We recommend no more than 2 ESI injections for the initial phase and rarely more than 2 for therapeutic treatment.
- It is currently not recommended to perform epidural blocks on the same day of treatment as facet blocks or sacroiliac blocks or lumbar sympathetic blocks or trigger point injections as this may lead to improper diagnosis or unnecessary treatment.
- Cervical and lumbar epidural steroid injection should not be performed on the same day. (Doing both injections on the same day could result in an excessive dose of steroids, which can be dangerous, and not worth the risk for a treatment that has no long-term benefit.)
Epidural steroid injections, “series of three”
Not recommended. Original recommendations that suggested a “series of three injections” generally did so prior to the advent of fluoroscopic guidance. These previous recommendations were based primarily on case studies and anecdotal evidence (Class IV and V data). (Abram, 1999) (Warr, 1972) (Hickey, 1987) There does not appear to be any evidence to support the current common practice of a series of injections. (Novak, 2008) Contemporary research studies with higher levels of evidence (including two controlled trials) have suggested that on average, two or less ESIs are required in patients with successful outcomes from the use of ESIs to treat disc related lumbar radiculopathy. (Lutz, 1998) (Vad, 2002) (Riew, 2000) While all of these latter studies have utilized repeat injections, there has been no evidence-based research to explain why this practice is required, or the mechanism for possible action. Since the introduction of fluoroscopically guided ESIs, it has been suggested that there is little evidence to repeat an accurately placed epidural injection in the presence of mono-radiculopathy, regardless of whether there is partial or no response. (McLain, 2005) A recent randomized controlled trial of blind ESIs found no evidence to support repeat injections, because at six weeks there was no significant difference found between the ESI group and a placebo controlled group in terms of any measured parameter. (Price, 2005) A repeat injection has been suggested if there is question of accurate dermatomal diagnosis, if pain may be secondary to a different generator, or in the case of multilevel pathology. (McLain, 2005) There is a lack of support for 2nd epidural steroid injection if the 1st is not effective. (Cuckler, 1985) With fluoroscopic guidance, there is little support to do a second epidural if there is no response to the first injection. There is little to no guidance in current literature to suggest the basis for the recommendation of a third ESI, and the routine use of this practice is not recommended.
Epidural steroid injections, diagnostic
Recommended as indicated below. Diagnostic epidural steroid transforaminal injections are also referred to as selective nerve root blocks, and they were originally developed as a diagnostic technique to determine the level of radicular pain. In studies evaluating the predictive value of selective nerve root blocks, only 5% of appropriate patients did not receive relief of pain with injections. No more than 2 levels of blocks should be performed on one day. The response to the local anesthetic is considered an important finding in determining nerve root pathology. (CMS, 2004) (Benzon, 2005) When used as a diagnostic technique a small volume of local is used (<1.0 ml) as greater volumes of injectate may spread to adjacent levels. When used for diagnostic purposes the following indications have been recommended:
- To determine the level of radicular pain, in cases where diagnostic imaging is ambiguous, including the examples below:
- To help to evaluate a radicular pain generator when physical signs and symptoms differ from that found on imaging studies;
- To help to determine pain generators when there is evidence of multi-level nerve root compression;
- To help to determine pain generators when clinical findings are consistent with radiculopathy (e.g., dermatomal distribution) but imaging studies are inconclusive;
- To help to identify the origin of pain in patients who have had previous spinal surgery.
Epiduroscopic laser neural decompression
In the instant case, the IRO reviewer, specializing in Neurological Surgery, noted there was insufficient evidence regarding efficacy of the epidural steroid injections. Although the Claimant reported subjective improvement in terms of pain, there was no documentation regarding any significant functional improvement or the ability of the Claimant to reduce medications. The reviewer noted the current evidence based guidelines recommend that there be at least 6-8 weeks of improvement following epidural steroid injections including functional improvement and reduction of medication.
The party appealing the IRO decision has the burden of overcoming the decision issued by an IRO by a preponderance of evidence-based medical evidence. Accordingly, Petitioner as the party appealing the IRO decision had the burden to either show through the opinion of a qualified expert that he meets the ODG or, if he does not, that his situation falls outside the ODG in some respect [e.g. the ODG does not address his specific situation]. In other words, Claimant/Petitioner needed to overcome the IRO with evidence-based medical evidence outside of what is contained in the ODG to establish that the requested treatment was medically necessary.
Dr. S testified on behalf of Petitioner/Claimant. Dr. S noted that he initially saw Claimant on September 18, 2012, and on November 6, 2012, Claimant received a caudal lumbar epidural steroid injection, L4-5, and transforaminal injection, L1-2 on the right. On cross examination, Dr. S noted Claimant had some improvement from the injection. However 4 weeks later Claimant’s pain was level 4-7 on a scale of 0-10.
Dr. T testifying on behalf of Respondent/Carrier indicated there were no recent electrodiagnostic studies conducted to indicate the present of radiculopathy as well as little if any change in Claimant’s medication regime and there is poor documentation to support a repeat of injection. Lastly, there was no evidence in the record to indicate that Claimant met any exception to the ODG.
There was insufficient evidence-based medical evidence explaining how the ODG criteria for the requested treatment was met and to establish that the requested treatment was medically necessary. Therefore, the Claimant/Petitioner has failed to meet his burden that the decision of the IRO should be reversed that Claimant is not entitled to right lumbar transforaminal ESI L1-2, OP caudal ESI L4-5 for the compensable injury of ((Date of Injury)).
Even though all the evidence presented was not discussed, it was considered. The Findings of Fact and Conclusions of Law are based on all of the evidence presented.
FINDINGS OF FACT
- The parties stipulated to the following facts:
- Venue is proper in the (City) Field Office of the Texas Department of Insurance, Division of Workers’ Compensation.
- On (Date of Injury), Claimant was the employee of (Employer), Employer.
- On (Date of Injury), employer provided workers compensation insurance with Texas Mutual Insurance Company, Carrier.
- On (Date of Injury), Claimant sustained a compensable injury.
- Carrier delivered to Claimant a single document stating the true corporate name of Carrier, and the name and street address of Carrier’s registered agent, which document was admitted into evidence as Hearing Officer’s Exhibit Number 2.
- The Independent Review Organization (IRO) determined that the health care at issue in this case was not reasonably required for the compensable injury of (Date of Injury).
- A right lumbar transforaminal ESI L1-2, OP caudal ESI L4-5, is not health care reasonably required for the compensable injury of (Date of Injury).
CONCLUSIONS OF LAW
- The Texas Department of Insurance, Division of Workers’ Compensation, has jurisdiction to hear this case.
- Venue is proper in the (City) Field Office.
- The preponderance of the evidence is not contrary to the decision of the IRO that right lumbar transforaminal ESI L1-2, OP caudal ESI L4-5, is not health care reasonably required for the compensable injury of (Date of Injury).
Claimant is not entitled to a right lumbar transforaminal ESI L1-2, OP caudal ESI L4-5, for the compensable injury of (Date of Injury).
Carrier is not liable for the benefits at issue in this hearing. Claimant remains entitled to medical benefits for the compensable injury in accordance with §408.021.
The true corporate name of the insurance carrier is TEXAS MUTUAL INSURANCE COMPANY and the name and address of its registered agent for service of process is
RICHARD J. GERGASKO
6210 EAST HIGHWAY 290
AUSTIN, TEXAS 78723
Signed this 8th day of July, 2013.