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 September 24, 2009 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 spinal cord stimulator trial for the compensable injury of _______?
Petitioner/Claimant appeared and was assisted by TT, ombudsman. Respondent/Carrier appeared and was represented by NI, attorney.
The claimant sustained a compensable injury to the lumbar spine for which he underwent a 360 fusion in 2001. As part of his treatment, the claimant underwent nerve blocks, physical therapy, occupational therapy, a home exercise program and ESI injections. In order to manage his pain, the claimant underwent a spinal cord stimulator trial that was approved on or about November 15, 2002 that failed. As a result, an intrathecal pain pump was implanted on March 21, 2003 as an alternative pain management tool. The claimant's level of narcotics in his pump was recently titrated down to very minimal levels. The claimant's request for removal of his intrathecal pain pump is not part of this request. The claimant now requests another trial of a spinal cord stimulator citing that he no longer wishes to be tied to long term narcotics as he believes it would be detrimental to his health. The Independent Review Organization (IRO) upheld the adverse determination for the petitioner's request stating that the Official Disability Guidelines (ODG) would not support re-trial of a previously non-effective modality and noted that the claimant is stable with a low dose intrathecal pain pump.
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.
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."
On the date of this medical contested case hearing, the ODG provides the following with regard to spinal cord stimulation:
Recommended only for selected patients in cases when less invasive procedures have failed or are contraindicated. See the Pain Chapter for Indications for stimulator implantation. There is some evidence supporting the use of Spinal Cord Stimulation (SCS) for Failed Back Surgery Syndrome (FBSS) and other selected chronic pain conditions. Spinal Cord Stimulation is a treatment that has been used for more than 30 years, but only in the past five years has it met with widespread acceptance and recognition by the medical community. In the first decade after its introduction, SCS was extensively practiced and applied to a wide spectrum of pain diagnoses, probably indiscriminately. The results at follow-up were poor and the method soon fell in disrepute. In the last decade there has been growing awareness that SCS is a reasonably effective therapy for many patients suffering from neuropathic pain for which there is no alternative therapy. There are several reasons for this development, the principal one being that the indications have been more clearly identified. The enhanced design of electrodes, leads, and receivers/stimulators has substantially decreased the incidence of re-operations for device failure. Further, the introduction of the percutaneous electrode implantation has enabled trial stimulation, which is now commonly recognized as an indispensable step in assessing whether the treatment is appropriate for individual patients. These implantable devices have a very high initial cost relative to conventional medical management (CMM); however, over the lifetime of the carefully selected patient, SCS may lead to cost-saving and more health gain relative to CMM for FBSS. See the Pain Chapter for complete list of references. Fair evidence supports the use of spinal cord stimulation in failed back surgery syndrome, those with persistent radiculopathy after surgery, according to the recently released joint American College of Physicians/ American Pain Society guideline recommendations on surgery and interventional treatments. (Chou, 2008) The National Institute for Health and Clinical Excellence (NICE) of the UK just completed their Final Appraisal Determination (FAD) of the medical evidence on spinal cord stimulation (SCS), concluding that SCS is recommended as a treatment option for adults with failed back surgery syndrome lasting at least 6 months despite appropriate conventional medical management. (NICE, 2008)
Recent research: New 24-month data is available from a study randomizing 100 failed back surgery syndrome patients to receive spinal cord stimulation (SCS) plus conventional medical management (CMM) or CMM alone. At 24 months, the primary outcome was achieved by 37% randomized to SCS versus 2% to conventional medical management (CMM), and by 47% of patients who received SCS as final treatment versus 7% for CMM. All 100 patients in the study had undergone at least one previous anatomically successful spine surgery for a herniated disk but continued to experience moderate to severe pain in one or both legs, and to a lesser degree in the back, at least six months later. Conventional medical therapies included oral medications, nerve blocks, steroid injections, physical and psychological therapy and/or chiropractic care. (Kumar, 2008) There is fair evidence that spinal cord stimulation is moderately effective for failed back surgery syndrome with persistent radiculopathy, though device-related complications are common. (Chou3, 2009)
Recommended only for selected patients in cases when less invasive procedures have failed or are contraindicated, for specific conditions indicated below, and following a successful temporary trial. Although there is limited evidence in favor of Spinal Cord Stimulators (SCS) for Failed Back Surgery Syndrome (FBSS) and Complex Regional Pain Syndrome (CRPS) Type I, more trials are needed to confirm whether SCS is an effective treatment for certain types of chronic pain. (Mailis-Gagnon-Cochrane, 2004) (BlueCross BlueShield, 2004) See indications list below. See Complete list of SCS_References. This supporting evidence is significantly supplemented and enhanced when combined with the individually based observational evidence gained through an individual trial prior to implant. This individually based observational evidence should be used to demonstrate effectiveness and to determine appropriate subsequent treatment.
Indications for stimulator implantation:
Failed back syndrome (persistent pain in patients who have undergone at least one previous back operation and are not candidates for repeat surgery), when all of the following are present: (1) symptoms are primarly (sic) lower extremity radicular pain; there has been limited response to non-interventional care (e.g. neuroleptic agents, analgesics, injections, physical therapy, etc.); (2) psychological clearance indicates realistic expectations and clearance for the procedure; (3) there is no current evidence of substance abuse issues; (4) there are no contraindications to a trial; (5) Permanent placement requires evidence of 50% pain relief and medication reduction or functional improvement after temporary trial. Estimates are in the range of 40-60% success rate 5 years after surgery. Neurostimulation is generally considered to be ineffective in treating nociceptive pain. The procedure should be employed with more caution in the cervical region than in the thoracic or lumbar due to potential complications and limited literature evidence.
Although the claimant stated that he believes that a second trial would now be effective as his pain is now left-sided rather than right-sided, the medical evidence did not support this contention. In fact, the evidence reveals that when approached about this request his treating doctor, Dr. H, stated he was reluctant to perform the requested procedure. The claimant did not present a statement or testimony from his doctor or any other doctor to support his contention that a second trial would render a different result. The claimant had the burden of proof to overcome the IRO determination and the claimant failed to present an evidence-based medical opinion from a competent source to meet that burden. Therefore, the claimant has not met the requisite evidentiary standard to overcome the IRO decision and the preponderance of the evidence is not contrary to the IRO decision that the claimant is not entitled to a spinal cord stimulator trial.
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:
A.Venue is proper in the (City) Field Office of the Texas Department of Insurance, Division of Workers’ Compensation.
B. On _______, Claimant was the employee of (Employer).
C.The claimant sustained a compensable injury to the lumbar spine on _______.
D.The Independent Review Organization determined that the claimant should not have a spinal cord stimulator trial.
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 spinal cord stimulator trial is not health care reasonably required for the compensable injury of _______.
Claimant is not entitled to spinal cord stimulator trial for the compensable injury of _______.
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 NORTH AMERICAN SPECIALTY INSURANCE COMPANY and the name and address of its registered agent for service of process is
CT CORPORATION SYSTEM
350 NORTH SAINT PAUL STREET
DALLAS, TEXAS 75201
Signed this 28th day of September, 2009.