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. For the reasons discussed herein, the Hearing Officer determines that the preponderance of the evidence is not contrary to the decision of the IRO that a cervical epidural steroid injection (CESI) C6-C7 cervical and/or sacral vertebrae (vertebrae NOC trunk), upper back area is not health care reasonably required for the compensable injury of (Date of Injury).
STATEMENT OF THE CASE
On December 2, 2015, John Bell, a Division hearing officer, held a contested case hearing 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 a cervical epidural steroid injection (CESI) C6-C7 cervical and/or sacral vertebrae (vertebrae NOC trunk), upper back area for the (Date of Injury) compensable injury?
Petitioner/Claimant appeared and was assisted by LS, an ombudsman. Respondent/Carrier appeared and was represented by RH, an attorney.
Claimant sustained a compensable injury to his cervical spine as a result of a motor vehicle accident (MVA) that occurred on (Date of Injury). Carrier accepted a (Date of Injury) compensable injury in the nature of C6-C7 soft disc herniation. After the (Date of Injury) compensable injury, Claimant testified that he underwent various treatments, but, that since (Year of Injury), epidural steroid injections (ESIs) have been the method of treatment recommended and performed by his doctor, RB, M.D. Claimant further testified that he has received approximately eight of those injections since that time, and the relief from those injections lasts approximately from a year to two years. Claimant also indicated that he underwent his last injection in August 2013 and that he has never encountered a problem in getting the injections approved by Carrier. In May 2015, Claimant’s doctor started the process to have another CESI. Claimant’s physician, RB, M.D., requested pre-authorization for a CESI, and Carrier’s utilization review denied the requested treatment. Carrier’s utilization review made a second determination and that physician also denied the requested treatment. Claimant appealed Carrier’s adverse utilization review determinations and an IRO was appointed. The IRO decision upheld the previous denials, and Claimant appealed.
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 Official Disability Guidelines (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 are 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 ODG provides the following guidelines concerning physical medicine in connection with a cervical ESI:
Not recommended based on recent evidence, given the serious risks of this procedure in the cervical region, and the lack of quality evidence for sustained benefit. These had been recommended as an option for treatment of radicular pain (defined as pain in dermatomal distribution with corroborative findings of radiculopathy), with specific criteria for use below. In a previous Cochrane review, there was only one study that reported improvement in pain and function at four weeks and also one year in individuals with radiating chronic neck pain. (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 previous 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) There have been case reports of cerebellar infarct and brainstem herniation as well as spinal cord infarction after cervical transforaminal injection. (Beckman, 2006) (Ludwig, 2005) Quadriparesis with a cervical ESI at C6-7 has also been noted (Bose, 2005) and the American Society of Anesthesiologists Closed Claims Project database revealed 9 deaths or cases of brain injury after cervical ESI (1970-1999). (Fitzgibbon, 2004) 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 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) In other studies, there was evidence for short-term 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) Some have said epidural steroid injections should be reserved for those who may otherwise undergo open surgery for nerve root compromise. (Bigos, 1999) There is limited evidence of effectiveness of epidural injection of methyl prednisolone and lidocaine for chronic MND with radicular findings. (Peloso-Cochrane, 2006) The FDA is warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. (FDA, 2014)
Recent evidence: ESIs should not be recommended in the cervical region, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee concluded. Injecting a particulate steroid in the cervical region, especially using the transforaminal approach, increases the risk for sometimes serious and irreversible neurological adverse events, including stroke, paraplegia, spinal cord infarction, and even death. The FDA has never approved an injectable corticosteroid product administered via epidural injection, so this use, although common, is considered off-label. Injections into the cervical region, as opposed to the lumbar area, are relatively risky, and the risk for accidental injury in the arterial system is greater in this location. (FDA, 2015) An AMA review suggested that ESIs are not recommended higher than the C6-7 level; no cervical interlaminar ESI should be undertaken at any segmental level without preprocedural review; & particulate steroids should not be used in therapeutic cervical transforaminal injections. (Benzon, 2015) According to the American Academy of Neurology (AAN), ESIs do not improve function, lessen need for surgery, or provide long-term pain relief, and the routine use of ESIs is not recommended. They further said that there is in particular a paucity of evidence for the use of ESIs to treat radicular cervical pain. (AAN, 2015) In this comparative-effectiveness study, no significant differences were found between ESI and conservative treatments. (Cohen, 2014) See the Low Back Chapter, where ESIs are recommended as a possible option for short-term treatment of radicular pain in conjunction with active rehab efforts, but they are not recommended for spinal stenosis or for nonspecific low back pain.
While not recommended, cervical ESIs may be supported using Appendix D, Documenting Exceptions to the Guidelines, in which case:
Criteria for the use of Epidural steroid injections, therapeutic:
Note: The purpose of ESI is to reduce pain and inflammation, thereby facilitating progress in more active treatment programs, and avoiding surgery, but this treatment alone offers no significant long-term functional benefit.
- Radiculopathy must be documented by physical examination and 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) for guidance
- If used for diagnostic purposes, a maximum of two injections should be performed. A second block is not recommended if there is inadequate response to the first block. Diagnostic blocks should be at 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.
- In the therapeutic phase, repeat blocks should only be offered if there is at least 50% pain relief for six to eight weeks, with a general recommendation of no more than 4 blocks per region per year.
- Repeat injections should be based on continued objective documented pain and function response.
- Current research does not support a “series-of-three” injections in either the diagnostic or therapeutic phase. We recommend no more than 2 ESI injections.
- It is currently not recommended to perform epidural blocks on the same day of treatment as facet blocks or stellate ganglion blocks or 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;
- Additional criteria based on evidence of risk:
- (m)ESIs are not recommended higher than the C6-7 level;
- (n)Cervical interlaminar ESI is not recommended; &
- (o)Particulate steroids should not be used. (Benzon, 2015)
Criteria for the use of Epidural steroid injections, diagnostic:
To determine the level of radicular pain, in cases where diagnostic imaging is ambiguous, including the examples below:
- To help to evaluate a 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 suggestive of radiculopathy (e.g. dermatomal distribution), and imaging studies have suggestive cause for symptoms but are inconclusive;
- To help to identify the origin of pain in patients who have had previous spinal surgery.
The IRO doctor, an MD board certified in pain medicine, determined the requested treatment was not medically necessary, noting that there was not a comprehensive assessment of recent treatment and Claimant’s response to that recent treatment. He also noted that Claimant underwent prior cervical ESIs, and that the records did not document at least 50% pain relief for at least a six week period, as set forth in the ODG. The IRO physician also noted that the ODG also required documentation of radiculopathy on physical examination corroborated by imaging studies or electrodiagnostic study results. The IRO physician noted the records did not provide definite clinical indications of radiculopathy and that there were not any recent imaging studies.
Claimant testified that ESIs that he has received to his cervical spine since his (Date of Injury) compensable injury provided him with significant relief and helped him to avoid a potential spinal surgery to his cervical spine. Claimant testified as to the beneficial effects of the ESIs and how they provided an improvement to his pain levels and functionality. While it is difficult to dispute Claimant’s testimony in that regard, neither Claimant nor the medical providers cited the ODG treatment guidelines or any other evidence based medical evidence to support their position.
There was no objection to the testimony, reports, or qualifications of any doctor.
The Hearing Officer considered all of the evidence admitted. The Findings of Fact and Conclusions of Law are based on an assessment of all of the evidence whether or not the evidence is specifically discussed in this Decision and Order.
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 Service Lloyds Insurance Company, Carrier.
- On (Date of Injury), Claimant sustained a compensable injury in the course and scope of his employment and Carrier has accepted a C6-C7 soft disc herniation to be compensable.
- Petitioner timely appealed the decision of the Independent Review Organization on September 9, 2015.
- The Independent Review Organization determined Claimant should not have a CESI C6-C7 lumbar and/or sacral vertebrae (vertebrae NOC trunk), upper back area. However, the parties further agree there was a typographical error in the wording of the IRO determination by use of the word lumbar instead of cervical.
- 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.
- A CESI C6-C7 cervical and/or sacral vertebrae (vertebrae NOC trunk), upper back area 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 a CESI C6-C7 cervical and/or sacral vertebrae (vertebrae NOC trunk), upper back area is not health care reasonably required for the compensable injury of (Date of Injury)
Claimant is not entitled to a CESI C6-C7 cervical and/or sacral vertebrae (vertebrae NOC trunk), upper back area 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 Section 408.021 of the Act.
The true corporate name of the insurance carrier is SERVICE LLOYDS INSURANCE COMPANY, and the name and address of its registered agent for service of process is
JOSPEH KELLY-GRAY, PRESIDENT
6907 CAPITAL OF TEXAS HIGHWAY NORTH
AUSTIN, TEXAS 78755
Signed this 10th day of December, 2015.