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At a Glance:
Title:
16028-nnr
Date:
June 20, 2016

16028-nnr

June 20, 2016

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.

ISSUES

A contested case hearing was held on June 14, 2016 to decide the following disputed issue:

  1. Is the preponderance of the evidence contrary to the IRO decision that an epidural steroid injection at L5-S1 is not health care reasonably required for the compensable injury of (Date of Injury)?

PARTIES PRESENT

Claimant appeared and was represented by LT, attorney. Carrier appeared and was represented by CM, attorney.

BACKGROUND INFORMATION

Claimant sustained a compensable injury to his lumbar spine on (Date of Injury). JK, MD, pain management doctor, requested approval for one epidural steroid injection. Pre-authorization was denied by Carrier. The IRO doctor, a medical doctor, upheld the denial for the requested treatment.

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(s), "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.

With regard to the epidural steroid injection (ESI), the ODG Low Back Chapter on epidural steroid injection (ESIs), therapeutic, provides as follows:

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. Not recommended for spinal stenosis or for nonspecific low back pain. See specific criteria for use below. Radiculopathy symptoms are generally due to herniated nucleus pulposus or spinal stenosis, but ESIs have not been found to be as beneficial a treatment for the latter condition. According to SPORT, ESIs are associated with less improvement in spinal stenosis. (Radcliff, 2013)

Wilson-MacDonald, 2005)

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.

For spinal stenosis: The use of epidural steroid injection (ESI) in patients with lumbar spinal stenosis is common, but there is little evidence in the literature to demonstrate its long-term benefit. Despite equivalent baseline status, ESIs are associated with significantly less improvement at 4 years among all patients with spinal stenosis. Furthermore, ESIs were associated with longer duration of surgery and longer hospital stay. There was no improvement in outcome with ESI whether patients were treated surgically or nonsurgically. There was no distinct surgical avoidance noted with ESI. (Friedly, 2014)

Chien, 2014)

Fluoroscopic guidance: Fluoroscopic guidance with use of contrast is recommended for all approaches as needle misplacement may be a cause of treatment failure. (Young, 2007)

Boswell, 2007) (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. (Manchikanti, 2012)

Patient selection: Radiculopathy must be documented, as indicated in the ODG criteria. In addition, 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. (Brummett, 2013)

MRIs: 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)

Fracture risk: Lumbar ESIs are associated with an increased risk for spinal fracture. Each single additional ESI increased the risk for fracture by 21%, with an increasing number of ESIs associated with an increasing likelihood of fracture. Use of ESIs seems to promote deterioration of skeletal quality. This definable fracture risk should be balanced with the best available evidence regarding the long-term efficacy of ESIs, which is limited. Clinicians should consider these findings before prescribing ESIs for elderly patients. (Mandel, 2013)

Recent research: 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-CochraneChoi, 2013) 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. (Neck Chapter, where ESIs are 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.

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.

(1) Radiculopathy (due to herniated nucleus pulposus, but not spinal stenosis) must be documented. Objective findings on examination need to be present. Radiculopathy must be corroborated by imaging studies and/or electrodiagnostic testing.

(2) Initially unresponsive to conservative treatment (exercises, physical methods, NSAIDs, muscle relaxants & neuropathic drugs).

(3) Injections should be performed using fluoroscopy (live x-ray) and injection of contrast for guidance.

(4) 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: (a) there is a question of the pain generator; (b) there was possibility of inaccurate placement; or (c) there is evidence of multilevel pathology. 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.

(5) No more than two nerve root levels should be injected using transforaminal blocks.

(6) No more than one interlaminar level should be injected at one session.

(7) 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. (Boswell, 2007)

(8) Repeat injections should be based on continued objective documented pain relief, decreased need for pain medications, and functional response.

(9) Current research does not support a routine use of a “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.

(10) 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.

(11) 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.)

In support of his position, Claimant offered medical records from treating doctor, SB, DC, and his referrals JK, MD, and SE, MD. Claimant also relies on the report of DWC-appointed designated doctor, CH, DC. Dr. JK prescribed the disputed ESI in his March 16, 2015 report, Dr. JK wrote:

Patient recently had MRIs performed on the cervical and lumbar spines. MRI of the cervical spine dated 3/3/15 shows an impression leftward disc herniation measuring approximately 4 mm at C2-3 and C3 for treating moderate left lateral recess stenosis without central spinal canal stenosis or cord compression. Right were [sic] disc herniation measuring 3 mm at C5-6 and C6-7. MRI of the lumbar spine of the same date and Impression shows a leftward disc herniation measuring 8 mm at L5-S1 creating prominent central spinal canal and left lower recess stenosis. He is also a [sic] leftward disc herniation at approximately 4 mm at L4-5 resulting in mild central spinal canal and left lateral recess stenosis. Disc herniation measuring 3-4 mm at T11/12 but quite seen [sic] on this performing exam. As a result of the findings of the MRI we have recommended lumbar epidural injection to begin with at the L4-5 and L5-S1 on the left.

On April 9, 2015, Dr. KB’s physical examination revealed numbness following the C7 dermatome of the left upper extremity, positive left sitting straight leg raise, and left leg pain radiating to left little finger. Dr. KB noted that muscle testing revealed some weakness of the hip flexors and extensors and muscle guarding of the lumbar paraspinals due to pain primarily on the left. Dr. KB also wrote that deep tendon reflexes of the lower extremities appeared intact bilaterally and within normal limits. Dr. KB diagnosed cervical disk herniation, lumbar disc herniation with concomitant sciatica, and cervical radiculopathy. Dr. SE examined Claimant on November 10, 2015, and wrote that Claimant still has pain in his back with radiation down his left leg. Dr. SE opined that the left leg pain is truly radicular, going down past the level of the knee and into the foot. According to Dr. SE, Claimant continued to show weakness in the left extensor halluces longus, and the left quadriceps reflex was reduced. Dr. CH agreed that Claimant has cervical disc herniation at C2-C3, C3-C4, C5-C6, C6-C7 and lumbar herniation at L5-S1.

Carrier provided the report of GF, MD, Carrier’s post-designated doctor required medical examination doctor, to support its agreement with the IRO. Dr. GF examined Claimant on February 19, 2016, and stated that Claimant’s examination revealed no atrophy and no absent reflexes. According to Dr. GF, based on Claimant’s presentation, he does not have clinical radiculopathy.

The IRO doctor opined that Claimant did not meet the ODG criteria. On October 26, 2015 he wrote:

The patient [Claimant] sustained a low back injury on (Date of Injury) and has completed a course of physical therapy. The Official Disability Guidelines Low Back Chapter states that radiculopathy must be documented. Findings on examination need to be present. Radiculopathy must be corroborated by Imaging studies and/or electrodiagnostic testing. Per note dated 9/28/2015, straight leg raising is negative. Manual muscle testing is negative.

He concluded:

There are no objective findings of radiculopathy on the physical examination to support the performance of an epidural steroid injection. As such, it the of opinion of the reviewer the request for 1 epidural steroid injection at L5-S1 is not recommended as medically necessary and the prior denials are upheld.

The report of the IRO doctor is more persuasive in that he demonstrates a thorough familiarity with ODG criteria in relation to this case. He used evidence-based medicine and the ODG to support his opinion.

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

  1. The parties stipulated to the following facts:
    1. Venue is proper in the (City) Field Office of the Texas Department of Insurance, Division of Workers’ Compensation.
    2. On (Date of Injury), Claimant was the employee of (Employer), Employer.
    3. On (Date of Injury), Claimant provided workers compensation insurance with (Carrier), Carrier.
    4. Claimant sustained a compensable lumbar injury on (Date of Injury).
    5. Carrier denied pre-authorization for an epidural steroid injection at L5-S1.
    6. The Texas Department of Insurance appointed Clear Resolutions Inc. as the Independent Review Organization in this matter.
    7. The Independent Review Organization upheld Carrier’s denial of the preauthorization of Carrier’s denial of the pre-authorization of the epidural steroid injections at L5-S1.
  2. 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.
  3. The preponderance of the evidence is not contrary to the decision of the Independent Review Organization that the epidural steroid injection at L5-S1 is not health care reasonably required for the compensable injury of (Date of Injury).

CONCLUSIONS OF LAW

  1. The Texas Department of Insurance, Division of Workers’ Compensation, has jurisdiction to hear this case.
  2. Venue is proper in the (City) Field Office.
  3. The preponderance of the evidence is not contrary to the decision of the Independent Review Organization that the epidural steroid injection at L5-S1 is not health care reasonably required for the compensable injury of (Date of Injury).

DECISION

The epidural steroid injection at L5-S1 is not health care reasonably required for the compensable injury of (Date of Injury).

ORDER

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 (Carrier) and the name and address of its registered agent for service of process is

CORPORATION SERVICE COMPANY

211 EAST 7th STREET, SUITE 620

AUSTIN, TX 78701-3218

Signed this 20nd day of June, 2016.

EARLY MOYE
Hearing Officer

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