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 July 28, 2011 to decide the following disputed issues:
Is the preponderance of the evidence contrary to the decision of the Independent Review Organization (IRO) that the Claimant is not entitled to reimbursement of $5.41 for Neurontin, prescribed by Dr. K on or about on January 14, 2011, for the compensable injury of (Date of Injury)?
Petitioner/Claimant (hereinafter Claimant) appeared and was assisted by JO, ombudsman. Respondent/Carrier (hereinafter Carrier) appeared and was represented by SS Chandler, attorney.
The Claimant sustained a compensable injury on (Date of Injury) to her neck and back while assisting a patient at work. She is status post L3-S1 decompression and fusion in 1992. Also she is status-post hardware removal and partial lumbar refusion in 1997. She has additionally had a cervical fusion. Following the 1992 operation Claimant began treating with Dr. S, a psychiatrist, for depression. Over the course of ten years, Dr. S prescribed Neurontin and psychotropic medications for Claimant. He stopped treating workers’ compensation patients and Claimant changed treating doctors to Dr. K (1), a pain management physician. Dr. K (1) continued the medications previously prescribed by Dr. S. In a September 9, 2010 report, Dr. K (1) discussed that Neurontin was being prescribed for ongoing neuropathic pain. On April 20, 2011 Claimant changed treating doctors to Dr. B.
On January 13, 2011 Claimant requested reimbursement of $5.41 for Neurontin ordered by Dr. K (2). Claimant explained that when she went to her gynecologist, Dr. K (2), for her annual checkup, she was having muscle spasms in her feet to the point it interfered with her exam. So Dr. K (2) ordered Neurontin for her. Claimant purchased the prescribed Neurontin and requested reimbursement in the amount of $5.41 for her out-of-pocket expenses. The January 17, 2011 letter from the adjuster acknowledged receipt of the Neurontin prescription and payment by Claimant. Carrier denied reimbursement, citing an August 3, 2010 RME report by Dr. A that stated she no longer needed medical care for the (Date of Injury).
On February 23, 2011 an IRO reviewer reviewed the records and upheld the adverse determinations of the carrier. According to the IRO report, the IRO reviewer is board certified in orthopedic surgery. The IRO doctor noted that there was no evidence of active radiculopathy, neuropathy, or muscle spasms to warrant use of Neurontin. Also there was no documentation that supports that Neurontin has an indication for treatment of depression. In addition, Dr. K (2), as the prescriber, is not an expert in the field of either pain management or orthopedics. Also the Official Disability Guidelines (ODG)does not support the chronic use of the requested medication.
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, and 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 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 initial inquiry, therefore, in any dispute regarding medical necessity, is whether the proposed care is consistent with the ODG. The ODGallows for the use of the medication requested, with specific limitations and requires documentation of improved function and activity as well as efficacy in pain control for use of the medication.
The ODGTreatment Guidelines for chronic pain medications discusses the requested medication as follows:
“Medications for Sub-Acute and Chronic Pain
Recommended as indicated below. Relief of pain with the use of medications is generally temporary, and measures of the lasting benefit from this modality should include evaluating the effect of pain relief in relationship to improvements in function and increased activity. Before prescribing any medication for pain the following should occur: (1) determine the aim of use of the medication; (2) determine the potential benefits and adverse effects; (3) determine the patient’s preference. Only one medication should be given at a time, and interventions that are active and passive should remain unchanged at the time of the medication change. A trial should be given for each individual medication. Analgesic medications should show effects within 1 to 3 days, and the analgesic effect of antidepressants should occur within 1 week. A record of pain and function with the medication should be recorded. (Mens, 2005) The recent AHRQ review of comparative effectiveness and safety of analgesics for osteoarthritis concluded that each of the analgesics was associated with a unique set of benefits and risks, and no currently available analgesic was identified as offering a clear overall advantage compared with the others. (Chou, 2006) There is multiple medication choices listed separately (not all recommended).
Anti-epilepsy drugs (AEDs) are also referred to as anti-convulsants.
Recommended for neuropathic pain (pain due to nerve damage), but not for acute nociceptive pain (including somatic pain). (Gilron, 2006) (Wolfe, 2004) (Washington, 2005) (ICSI, 2005) (Wiffen-Cochrane, 2005) (Attal, 2006) (Wiffen-Cochrane, 2007) (Gilron, 2007) (ICSI, 2007) (Finnerup, 2007) There is a lack of expert consensus on the treatment of neuropathic pain in general due to heterogeneous etiologies, symptoms, physical signs and mechanisms. Most randomized controlled trials (RCTs) for the use of this class of medication for neuropathic pain have been directed at postherpetic neuralgia and painful polyneuropathy (with diabetic polyneuropathy being the most common example). There are few RCTs directed at central pain and none for painful radiculopathy. (Attal, 2006) The choice of specific agents reviewed below will depend on the balance between effectiveness and adverse reactions. See also specific drug listings below: Gabapentin (Neurontin®); Pregabalin (Lyrica®); Lamotrigine (Lamictal®); Carbamazepine (Tegretol®); Oxcarbazepine (Trileptal®); Phenytoin (Dilantin®); Topiramate (Topamax®); Levetiracetam (Keppra®); Zonisamide (Zonegran®); & Tiagabine (Gabitril®)
Outcomes: A “good” response to the use of AEDs has been defined as a 50% reduction in pain and a “moderate” response as a 30% reduction. It has been reported that a 30% reduction in pain is clinically important to patients and a lack of response of this magnitude may be the “trigger” for the following: (1) a switch to a different first-line agent (TCA, SNRI or AED are considered first-line treatment); or (2) combination therapy if treatment with a single drug agent fails. (Eisenberg, 2007) (Jensen, 2006) After initiation of treatment there should be documentation of pain relief and improvement in function as well as documentation of side effects incurred with use. The continued use of AEDs depends on improved outcomes versus tolerability of adverse effects. AEDs are associated with teratogenicity, so they must be used with caution in woman of childbearing age. Preconception counseling is recommended for anticonvulsants (due to reductions in the efficacy of birth control pills). (Clinical Pharmacology, 2008) Manufacturers of antiepileptic drugs will need to add a warning to their labeling indicating that use of the drugs increases risk for suicidal thoughts and behaviors, according to an FDA Alert issued December 16. (FDA MedWatch, 2008)
Gabapentin (Neurontin®, Gabarone™, generic available)has been shown to be effective for treatment of diabetic painful neuropathy and postherpetic neuralgia and has been considered as a first-line treatment for neuropathic pain. (Backonja, 2002) (ICSI, 2007) (Knotkova, 2007) (Eisenberg, 2007) (Attal, 2006) This RCT concluded that gabapentin monotherapy appears to be efficacious for the treatment of pain and sleep interference associated with diabetic peripheral neuropathy and exhibits positive effects on mood and quality of life. (Backonja, 1998) It has been given FDA approval for treatment of post-herpetic neuralgia. The number needed to treat (NNT) for overall neuropathic pain is 4. It has a more favorable side-effect profile than Carbamazepine, with a number needed to harm of 2.5. (Wiffen2-Cochrane, 2005) (Zaremba, 2006)Gabapentin in combination with morphine has been studied for treatment of diabetic neuropathy and postherpetic neuralgia. When used in combination the maximum tolerated dosage of both drugs was lower than when each was used as a single agent and better analgesia occurred at lower doses of each. (Gilron-NEJM, 2005) Recommendations involving combination therapy require further study.
Mechanism of action: This medication appears to be effective in reducing abnormal hypersensitivity (allodynia and hyperalgesia), to have anti-anxiety effects, and may be beneficial as a sleep aid. (Arnold, 2007).”
Claimant failed to present an evidence-based medical opinion from a competent source to overcome the IRO’s decision. Dr. K (2), the prescribing doctor, as a gynecologist, treated Claimant for a condition unrelated to the compensable injury, and prescribed the medication as a favor to Claimant. The medical reports by Dr. B, dated April 20, 2011 and July 5, 2011 were created after the February 23, 2011 IRO review and cannot be considered in determining the medical necessity of proposed treatment. Although the Claimant’s pain management doctor, Dr. K (1) in a September 9, 2010 letter answered questions concerning the requested medications, he did not provide any documentation to support the long-term use of the prescribed medications for Claimant’s compensable injury. At the MCCH Claimant introduced literature that Neurontin can be used for arthritic pain, but failed to offer analysis of the articles from a qualified expert to show the relevance of the contents of the articles to Claimant’s situation justifying departure from the ODG. The literature in evidence does not meet the requisite evidentiary standard required to overcome the IRO. The preponderance of the evidence is not contrary to the IRO decision and the requested medication does not meet the usage criteria set out in the ODG.
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 Charter Oak Fire Insurance Company, Carrier.
- D.D.The IRO determined that Claimant is not entitled to reimbursement of $5.41 for Neurontin, prescribed by Dr. K (1) on or about on January 14, 2011, since Neurontin was not reasonable and necessary health care services for the compensable injury of (Date of Injury). li>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 medication Neurontin, as prescribed by Dr. K, on or about on January 14, 2011, 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 medication Neurontin, as prescribed by Dr. K (1), on or about on April 14, 2011, is not health care reasonably required for the compensable injury of (Date of Injury).
The Claimant is not entitled to reimbursement of $5.41 for Neurontin, prescribed by Dr. K (1) on or about on January 14, 2011, 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 CHARTER OAK FIRE INSURANCE COMPANY and the name and address of its registered agent for service of process is
CORPORATION SERVICE COMPANY d/b/a
CSC – LAWYERS INCORPORATING SERVICE COMPANY
211 EAST 7TH STREET
AUSTIN, TEXAS 78701-3218
Signed this 2nd day of August, 2011.