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 January 12, 2011 to decide the following disputed issue:
Is the preponderance of the evidence contrary to the decision of the Independent Review Organization (IRO) that the Claimant is not entitled to the pain medication Zanaflex for the compensable injury of ____________?
Petitioner/Claimant appeared and was assisted by MV, ombudsman.
Respondent/Carrier appeared and was represented by SH, attorney.
Claimant sustained a compensable injury to his lumbar spine and both knees on ____________ when he fell from a roof. Claimant has undergone multiple surgeries to his knees and ESI’s to his lumbar spine as a result of this injury. Claimant testified that he continues to suffer from knee and back pain and muscle spasms. Claimant has been diagnosed with chronic intractable pain syndrome. Claimant testified that he has been taking narcotics since the date of injury and that the current combination of medications that he takes has been effective. One of the pain medications/muscle relaxants he has been prescribed is Zanaflex which he testified he has been taking for the past four years to alleviate muscle spasms in his lower extremities and low back. The request for the prescription Zanaflex was denied by the Carrier and referred to an IRO who determined that the chronic use of Zanaflex was not medically necessary. The IRO reviewer noted that the requested medication has application in acute back problems, but there is less indication in chronic problems. The IRO reviewer cited the Official Disability Guidelines (ODG) and concluded that the request cannot be considered reasonable or medically necessary.
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 making decisions about the care of individual patients. 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.
Pursuant to the ODG for muscle relaxants (for pain):
Recommend non-sedating muscle relaxants with caution as a second-line option for short-term treatment of acute LBP and for short-term treatment of acute exacerbations in patients with chronic LBP. (Chou, 2007) (Mens, 2005) (Van Tulder, 1998) (van Tulder, 2003) (van Tulder, 2006) (Schnitzer, 2004) (See, 2008) See the Low Back Chapter. Muscle relaxants may be effective in reducing pain and muscle tension, and increasing mobility. However, in most LBP cases, they show no benefit beyond NSAIDs in pain and overall improvement. Also there is no additional benefit shown in combination with NSAIDs. Efficacy appears to diminish over time, and prolonged use of some medications in this class may lead to dependence. (Schnitzer, 2004) (Van Tulder, 2004) (Airaksinen, 2006) Sedation is the most commonly reported adverse effect of muscle relaxant medications. These drugs should be used with caution in patients driving motor vehicles or operating heavy machinery. Drugs with the most limited published evidence in terms of clinical effectiveness include chlorzoxazone, methocarbamol, dantrolene and baclofen. (Chou, 2004) According to a recent review in American Family Physician, skeletal muscle relaxants are the most widely prescribed drug class for musculoskeletal conditions (18.5% of prescriptions), and the most commonly prescribed antispasmodic agents are carisoprodol, cyclobenzaprine, metaxalone, and methocarbamol, but despite their popularity, skeletal muscle relaxants should not be the primary drug class of choice for musculoskeletal conditions. (See2, 2008)
Classifications: Muscle relaxants are a broad range of medications that are generally divided into antispasmodics, antispasticity drugs, and drugs with both actions. (See, 2008) (van Tulder, 2006)
Tizanidine (Zanaflex®, generic available) is a centrally acting alpha2-adrenergic agonist that is FDA approved for management of spasticity; unlabeled use for low back pain. (Malanga, 2008) Eight studies have demonstrated efficacy for low back pain. (Chou, 2007) One study (conducted only in females) demonstrated a significant decrease in pain associated with subacute and chronic myofascial pain syndrome and the authors recommended its use as a first line option to treat myofascial pain. (Malanga, 2002) May also provide benefit as an adjunct treatment for fibromyalgia. (ICSI, 2007)
Side effects: somnolence, dizziness, dry mouth, hypotension, weakness, hepatotoxicity (LFTs should be monitored baseline, 1, 3, and 6 months). (See, 2008)
Dosing: 4 mg initial dose; titrate gradually by 2 – 4 mg every 6 – 8 hours until therapeutic effect with tolerable side-effects; maximum 36 mg per day. (See, 2008) Use with caution in renal impairment; should be avoided in hepatic impairment. Tizanidine use has been associated with hepatic aminotransaminase elevations that are usually asymptomatic and reversible with discontinuation. This medication is related to clonidine and should not be discontinued abruptly. Weaning should occur gradually, particularly in patients that have had prolonged use. (Zanaflex-FDA, 2008)
As noted above, the ODG sets out criteria for the requested pain medication. Claimant’s pain management doctor, Dr. V, stated in a letter dated August 30, 2010 that the Zanaflex was prescribed as a muscle relaxant to help with muscle spasms in the Claimant’s back and lower extremities. Dr. V concluded by stating, “Medical necessity has been established and the fact that the patient’s symptomology is directly related to his injury and the medications are given for the symptomology.” Although the ODG recommends that weaning should occur gradually, particularly in patients that have had prolonged use, Dr. V has not proposed a weaning process for the Claimant to cease taking the Zanaflex. Dr. V offered an opinion stating that the prescription was medically necessary; however, he failed to present evidence-based medicine to support his opinion. Based on the evidence presented, the Claimant does not meet the criteria set out in the ODG for the continued use of the prescription Zanaflex and the Claimant failed to provide an evidence-based medical opinion contrary to the determination of the IRO. The preponderance of the evidence is not contrary to the IRO decision that Claimant is not entitled to the medication Zanaflex for the compensable injury of ____________.
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. Claimant sustained a compensable injury on ____________.
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 the pain mediation Zanaflex is not health care reasonably required for the compensable injury of ____________.
Claimant is not entitled to the pain medication Zanaflex 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 AMERICAN HOME ASSURANCECOMPANY and the name and address of its registered agent for service of process is:
CORPORATION SERVICE COMPANY
701 BRAZOS STREET, SUITE 1050
AUSTIN, TX 78701
Signed this 12th day of January, 2011.
Carol A. Fougerat