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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.

ISSUE

A medical contested case hearing was opened on October 17, 2012 with the record closing on November 5, 2012 to decide the following disputed issue:

Is the preponderance of the evidence-based medical evidence contrary to the decision of the Independent Review Organization (IRO) that the Claimant is not entitled to prescriptions for Soma and Oxycontin on July 1, 2011 for the compensable injury of (Date of Injury)?

PARTIES PRESENT

On October 17, 2012, the Claimant/Petitioner (hereinafter “Claimant”) failed to appear. SFG, ombudsman, was present to assist the Claimant. Carrier/Respondent (hereinafter “Carrier”) appeared and was represented by SG, attorney.

After the October 17, 2012 hearing, the Claimant was sent a letter by the undersigned allowing him an opportunity to present good cause for his absence and evidence on the disputed issue. The Claimant responded to the letter but did not want to have the hearing placed back on the docket. The record is devoid of any evidence showing good cause for his absence on October 17, 2012.

BACKGROUND INFORMATION

The Claimant failed to appear at the hearing and he did not avail himself of the opportunity to present his case. Having failed to appear and offer evidence regarding the medical necessity of the disputed prescriptions, the Claimant failed to prove that the preponderance of the evidence-based medical evidence is contrary to the decision of the IRO that the Claimant is not entitled to the prescriptions for Soma or Oxycontin for his compensable (Date of Injury) injury.

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

  1. The Carrier admitted 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), Employer had workers’ compensation insurance coverage with Charter Oak Fire Insurance Co., Carrier.
    4. On (Date of Injury), the Claimant sustained a compensable injury while in the course and scope of his employment with (Employer).
    5. On September 1, 2011, the IRO upheld the Carrier’s denial of the prescriptions for Soma and Oxycontin for the Claimant’s compensable (Date of Injury) injury.
  2. No evidence was presented to show that the Claimant meets the criteria found in the Official Disability Guidelines for prescriptions for Soma and Oxycontin for his compensable (Date of Injury) injury, and no other evidence was presented to support the medical necessity of the said prescriptions.
  3. The Claimant did not have good cause for failing to appear at the October 17, 2012 medical contested case hearing held herein.
  4. Prescriptions for Soma and Oxycontin are not health care reasonably required for the compensable injury of (Date of Injury).
  5. The undersigned mailed a single document stating the true corporate name of the Carrier, and the name and street address of Carrier’s registered agent, which was admitted into evidence as Hearing Officer Exhibit Number 2, to the Claimant at his last known address.

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 IRO that prescriptions for Soma and Oxycontin are not health care reasonably required for the compensable injury of (Date of Injury).

DECISION

Claimant is not entitled to prescriptions for Soma and Oxycontin as they are 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 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 CO.

211 EAST 7TH STREET, STE. 620

AUSTIN, TX 78701-3218

Signed this 13th day of November, 2012.

Patrice Fleming-Squirewell
Hearing Officer

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.

ISSUE

A medical contested case hearing was held on October 25, 2012 to decide the following disputed issue:

Is the preponderance of the evidence contrary to the decision of the Independent Review Organization (IRO) that Claimant is not entitled to 30 tablets of Topiramate 200 MG for date of service of February 9, 2012 for the compensable injury of (Date of Injury)?

PARTIES PRESENT

Claimant/Petitioner (hereinafter Claimant) appeared and was assisted by BO, ombudsman. Carrier/Respondent (hereinafter Carrier) appeared and was represented by RL, attorney.

EVIDENCE PRESENTED

The following witnesses testified:

For Claimant: Claimant.

For Carrier: None.

The following exhibits were admitted into evidence:

Hearing Officer’s Exhibits HO-1A, HO-1B, HO-2, HO-3, and HO-4.

Claimant’s Exhibits C-1 through C-5.

Carrier’s Exhibits CR-A through CR-C.

BACKGROUND INFORMATION

The evidence presented in the hearing revealed that Claimant sustained a compensable injury to include her low back on (Date of Injury) following a fall while trying to step out of a stalled office elevator. The evidence presented indicates that Claimant has received conservative treatment for the compensable injury, including medications, physical therapy, epidural steroid injections (ESIs), and the placement of a spinal cord stimulator that was later removed. The evidence also indicated that Claimant has been prescribed Topiramate (also known as “Topamax”), an anti-convulsant/anti-epilepsy medication, for pain control since 2002. The retrospective medical necessity of 30 tablets of a 200 MG dosage of this medication was denied after an initial review by a Utilization Review Agent (URA) and this denial was upheld by a second URA following a request for reconsideration. Claimant then requested a review by an Independent Review Organization (IRO).

The IRO reviewer upheld the denial of the medication based on the Official Disability Guidelines (ODG) and the reviewer’s medical judgment, clinical experience and expertise in accordance with accepted medical standards. The IRO reviewer cited pertinent excerpts from the ODG, which recommend the medication for “neuropathic” pain (i.e., “pain initiated or caused by a primary lesion or dysfunction of the nervous system.” See Carrier’s Exhibit CR-C, p. 9). The ODG do not recommend this type of medication for acute “nociceptive” pain (i.e., “pain caused by activation of nociceptors, which are sensory neurons found throughout the body. A nociceptor is ‘a receptor preferentially sensitive to a noxious stimulus or to a stimulus which would become noxious if prolonged’”. See Carrier’s Exhibit CR-C, p. 9). The IRO reviewer did not find that Claimant had any evidence of neuropathic pain, or a history of epilepsy or migraine headaches for which the medication could be used. Though the IRO reviewer observed that Claimant has diabetes, the reviewer did not find evidence that the medication was prescribed for complications stemming from that condition, such as painful polyneuropathy. Claimant testified in the hearing that she actually began taking Topiramate four years before she was diagnosed with diabetes. Claimant appealed the unfavorable decision of the IRO to this medical contested case hearing (MCCH).

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 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."

With regard to Topiramate, the ODG Low Back Chapter provides, as follows:

Under study. There is one randomized controlled study that has investigated topiramate for chronic low back pain. (Muehlbacher, 2006) This study specifically stated that there were no other studies to evaluate the use of this medication for this condition. In terms of the Oswestry low back pain questionnaire scale, the differences in the placebo group and treatment group were significant, although the mean score in both groups remained ≥ 34. Reduction in pain rating index appeared to be correlated with weight reduction. Weight loss was significantly more pronounced in the group treated with topiramate than in those treated with placebo. The authors felt additional research was required to see if the results could be replicated and how long-lasting benefits were. There are no other articles available that evaluate the use of other anti-epilepsy drugs in the treatment of chronic non-specific, non-neuropathic axial low back pain. See the Pain Chapter, Anti-epilepsy drugs (AEDs) for general guidelines, as well as specific Topiramate listing.

The ODG Pain Chapter provides, in pertinent part, as follows concerning Topiramate in the section related to anti-epilepsy drugs:

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)

Specifically studied disease states: (also see below for specific drugs)

Painful polyneuropathy:AEDs are recommended on a trial basis (gabapentin/pregabalin) as a first-line therapy for painful polyneuropathy (with diabetic polyneuropathy being the most common example). The other first-line options are a tri-cyclic antidepressant (if tolerated by the patient), or a SNRI antidepressant (such as duloxetine). (Attal, 2006) (Jensen, 2006)

Postherpetic neuralgia:Gabapentin and pregabalin are recommended. (Attal, 2006) (Backonja, 2004)

Central pain:There are so few trials (with such small sample size) that treatment is generally based on that recommended for peripheral neuropathy, with gabapentin and pregabalin recommended. Lamotrigine has been found to be effective for central post-stroke pain (see below for specific drugs), and gabapentin has also been found to be effective. (Backonja, 2004)

Acute pain:Not indicated due to lack of evidence.

Chronic non-specific axial low back pain:A recent review has indicated that there is insufficient evidence to recommend for or against antiepileptic drugs for axial low back pain. (Chou, 2007) There is one randomized controlled study that has investigated topiramate for chronic low back pain. (Muehlbacher, 2006) This study specifically stated that there were no other studies to evaluate the use of this medication for this condition. Patients in this study were excluded if they were taking opioids. No patient had undergone back surgery. In terms of the Oswestry low back pain questionnaire scale, the differences in the placebo group and treatment group were significant, although the mean score in both groups remained ≥ 34. Reduction in pain rating index appeared to be correlated with weight reduction. See Topiramate below. The authors felt additional research was required to see if the results could be replicated and how long-lasting benefits were. There are no other articles available that evaluate the use of other anti-epilepsy drugs in the treatment of chronic non-specific, non-neuropathic axial low back pain.

Other Antiepileptic Drugs

Topiramate (Topamax®, generic available)has been shown to have variable efficacy, with failure to demonstrate efficacy in neuropathic pain of “central” etiology. It is still considered for use for neuropathic pain when other anticonvulsants fail. Topiramate has recently been investigated as an adjunct treatment for obesity, but the side effect profile limits its use in this regard. (Rosenstock, 2007)

The decision of the IRO reviewer, as noted above, was largely based on the ODG. Carrier relied on the URA and IRO decisions, as well as the evidence-based medical studies provided as part of its evidence, to argue that anti-convulsant/anti-epileptic medication, such as Topiramate, is not medically necessary treatment for Claimant’s compensable injury. Claimant, as the party challenging the IRO decision, has the burden of proof to overcome the IRO decision by a preponderance of evidence-based medical evidence. Evidence-based medical evidence entails the opinion of a qualified expert that has some basis in evidence-based medicine. Expert evidence is required in all medical necessity disputes and, though Claimant put forth highly credible testimony in the hearing, her lay testimony is not probative on questions requiring expert evidence, such as the inquiry into the medical necessity of the medication at issue. The records provided by Claimant in support of her position, including the reports of the Carrier-selected independent medical examination (IME) doctor, MD, M.D., and treating physician, VR, M.D., were considered, but those records did not provide an adequate explanation, with a sufficient foundation in evidence-based medicine, to establish the medical necessity of the 200 MG of Topiramate at issue for her compensable injury of (Date of Injury). As Claimant did not meet her burden of proof, a preponderance of the evidence is held not to be contrary to the decision of the IRO that 30 tablets of Topiramate 200 MG for date of service of February 9, 2012 is not health care reasonably required for the compensable injury of (Date of Injury).

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

  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), and sustained a compensable injury.
    3. On (Date of Injury), Employer provided workers’ compensation insurance coverage through Insurance Company of North America.
    4. The Independent Review Organization (IRO) determined that the health care at issue in this case was not reasonably required for the compensable injury of (Date of Injury).
  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. 30 tablets of Topiramate 200 MG for date of service of February 9, 2012 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 IRO that 30 tablets of Topiramate 200 MG for date of service of February 9, 2012 is not health care reasonably required for the compensable injury of (Date of Injury).

DECISION

Claimant is not entitled to 30 tablets of Topiramate 200 MG for date of service of February 9, 2012 for the compensable injury of (Date of Injury).

ORDER

Carrier is not liable for the benefits at issue in this hearing, and it is so ordered. Claimant remains entitled to medical benefits for the compensable injury in accordance with §408.021.

The true corporate name of the insurance carrier is INSURANCE COMPANY OF NORTH AMERICA and the name and address of its registered agent for service of process is:

C T CORPORATION SYSTEM

350 NORTH ST PAUL STREET

DALLAS, TEXAS 75201

Signed this 29th day of October, 2012.

Jennifer Hopens
Hearing Officer

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 January 26, 2012 to decide the following disputed issue:

  1. Is the preponderance of the evidence contrary to the decision of the Independent Review Organization that Claimant is not entitled to reimbursement of $115.02 for Cymbalta prescribed by Dr. B on April 20, 2011 for the compensable injury of (Date of Injury)?

PARTIES PRESENT

Petitioner/Claimant appeared and was assisted by JO, ombudsman.

Respondent/Carrier appeared and was represented by SC, attorney.

BACKGROUND INFORMATION

Claimant, an oncology nurse, sustained injuries to her cervical and lumbar spine on (Date of Injury) when she was assisting a patient into a chair. The patient grabbed Claimant around the neck because he thought she was going to lift him up and, in doing so, he pulled Claimant down by her neck resulting in injuries to her spine. Claimant underwent a cervical fusion and two lumbar surgeries. She also received physical therapy. Claimant is currently controlling her symptoms with medications.

Claimant began treating with Dr. B on April 20, 2011. Dr. B took a detailed history, performed a physical examination, and prescribed medications. Dr. B specifically prescribed Tylenol and Cymbalta. Claimant testified, and the medical records also reflect, that she had been taking both medications for several years prior to her visit with Dr. B. Dr. B’s medical report indicates that since surgery is no longer an option that he wanted Claimant to see a pain management specialist. In the meantime, he stated he would prescribe several medications including Tylenol Extra Strength and Celebrex.

Claimant presented her prescriptions to the pharmacy and the Carrier did not authorize the Celebrex and Tylenol. Claimant paid for both medications and submitted her request for reimbursement to the Carrier. The Carrier denied payment. The Carrier based its denial on the report of orthopedic surgeon, Dr. A, who performed a required medical examination on August 3, 2010. Dr. A was asked to answer specific questions concerning reasonable and necessary medical treatment. Dr. A was specifically asked if Claimant needed to continue taking Celebrex, Gabapentin, Cymbalta, and Pantoprazole. Dr. A opined that the prescribed medications were not reasonable, necessary, or related to the compensable injury.

Claimant appealed the Carrier’s denial of her medications and an IRO was appointed to perform a retrospective review of the medical necessity of the reimbursement of the medications Cymbalta and Tylenol. The IRO physician, a board certified orthopedic surgeon, determined that there was a clear clinical indications for the Tylenol but not for the Cymbalta.

Upon receiving an unfavorable decision from the IRO, Claimant requested a Medical Contested Case Hearing to resolve the dispute over the medical necessity of Cymbalta and to seek reimbursement for the money she paid for her prescription.

DISCUSSION

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 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.”

With regard to Cymbalta the ODG provides as follows:

Recommended as an option in first-line treatment of neuropathic pain. Duloxetine (Cymbalta®) is a norepinephrine and serotonin reuptake inhibitor antidepressant (SNRIs). It has FDA approval for treatment of depression, generalized anxiety disorder, and for the treatment of pain related to diabetic neuropathy, with effect found to be significant by the end of week 1 (effect measured as a 30% reduction in baseline pain). The starting dose is 20-60 mg/day, and no advantage has been found by increasing the dose to twice a day, except in fibromyalgia. The medication has been found to be effective for treating fibromyalgia in women with and without depression, 60 mg once or twice daily. (Arnold, 2005) The most frequent side effects include nausea, dizziness and fatigue. GI symptoms are more common early in treatment. The side effect profile of Duloxetine is thought to be less bothersome to patients than that of tricyclic antidepressants. Note: On October 17, 2005, Eli Lilly and the U.S. Food and Drug Administration (FDA) notified healthcare professionals of revision to the PRECAUTIONS/Hepatotoxicity section of the prescribing information for Cymbalta. Postmarketing reports of hepatic injury (including hepatitis and cholestatic jaundice) suggest that patients with preexisting liver disease who take duloxetine may have an increased risk for further liver damage. The new labeling extends the Precaution against using Cymbalta in patients with substantial alcohol use to include those patients with chronic liver disease. It is recommended that Cymbalta not be administered to patients with hepatic insufficiency. See the Stress Chapter for more information and references. See Antidepressants for chronic pain for general guidelines, as well as specific Duloxetine listing for more information and references. On June 13, 2008, the FDA approved a new indication for duloxetine HCl delayed-release capsules (Cymbalta®; Eli Lilly and Company) for the management of fibromyalgia in adults. The FDA notes that although duloxetine was effective for reducing pain in patients with and without major depressive disorder, the degree of pain relief may have been greater in those with comorbid depression. Treatment of fibromyalgia with duloxetine should be initiated at 30 mg/day for 1 week and then uptitrated to the recommended 60-mg dose. (Waknine, 2008) Note: This drug was recently included in a list of 20 medications identified by the FDA's Adverse Event Reporting System that are under FDA investigation. (FDA, 2008) An FDA panel concluded that Cymbalta was effective in treating chronic low back pain, and they voted in favor of Eli Lilly's request to broaden the indication to include the treatment of chronic pain. (FDA, 2010) On November 4, 2010, the FDA approved duloxetine HCl delayed-release capsules (Cymbalta; Eli Lilly and Co) for the once-daily treatment of chronic musculoskeletal pain. Regulatory approval followed a positive vote regarding the use of duloxetine to treat chronic low back pain, but the committee did not express the same confidence in the drug's usefulness as a treatment for osteoarthritis. Despite this, duloxetine has been approved for both chronic low back pain and osteoarthritis. The recommended dose is 60 mg daily. Duloxetine delayed-release capsules previously were approved for the treatment of major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, and fibromyalgia. (FDA2, 2010)

The IRO physician reviewer relied on medical judgment, clinical experience and expertise in accordance with accepted medical standards and the ODG. All were used as the screening criteria and clinical basis for making the decision to overturn Carrier’s denial of Tylenol and uphold Carrier’s denial of the Cymbalta. As it relates to the Cymbalta, the physician reviewer stated:

As noted in the Division mandated Official Disability Guidelines, Cymbalta is recommended as an option in first-line treatment of neuropathic pain. Duloxetine (Cymbalta) is a norepinephrine and serotonin reuptake inhibitor antidepressant (SNRIs). It has FDA approval for treatment of depression, generalized anxiety disorder, and for the treatment of pain related to diabetic neuropathy, with effect found to be significant by the end of week 1 (effect measured as a 30% reduction in baseline pain). Although, in this case there is not a neuropathic pain situation and there is no diabetic neuropathy, anxiety disorder or depression. Therefore, this would not be clinically indicated.

To overcome the IRO decision, Claimant offered her testimony and the medical records of the various providers that have treated her condition. Claimant testified that has been prescribed Cymbalta for more than ten years and that the medication is necessary to treat her back pain. Claimant testified that the medication reduces her pain level, helps her to focus, and allows her to live with her problems. Claimant also presented medical reports from Dr. B (2), Dr. B, and Dr. L to support her position.

Dr. B (2) performed a required medical examination on August 26, 2008 and he opined that Claimant’s medications, including Cymbalta, were medically reasonable and necessary. Dr. B (2) went on to state that Claimant would require treatment indefinitely.

Dr. B responded to the IRO decision in a letter dated July 5, 2011. Dr. B states that he believes Claimant should continue the medication regimen that she was placed on prior to seeing him. Dr. B notes that Claimant’s medications are not the types of medications that are addictive or that are abused. Dr. B provides general reasons why Claimant’s medication regimen should be continued, but does not specifically address the medical necessity of Cymbalta.

Claimant was referred to pain management specialist, Dr. L, by Dr. B. Dr. L examined Claimant on December 1, 2011. In his report, Dr. L stated that Claimant has been able to function very well with the use of non-addictive medications, Cymbalta and gabapentin. Therefore, he believes it is in her best interest to continue these medications. Dr. L states that these medications provide Claimant with the most comfort and the least suffering and to deny these medications could cause the Claimant additional suffering.

Claimant’s testimony was credible and the medical evidence was considered. However, the Petitioner/Claimant has not shown by a preponderance of evidence-based medical evidence that the requested medication, Cymbalta, is health care reasonably required for the compensable injury. Therefore, Claimant is also not entitled to reimbursement in the amount of $115.02 for Cymbalta prescribed by Dr. B on April 20, 2011.

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

  1. The parties stipulated to the following facts:
    1. A.Venue is proper in the (City) Field Office of the Texas Department of Insurance, Division of Workers’ Compensation.
    2. B. On (Date of Injury), Claimant was the employee of (Employer), Employer.
    3. Claimant sustained a compensable injury on (Date of Injury).
    4. The Independent Review Organization determined that Claimant is not entitled to reimbursement for Cymbalta for the compensable injury of (Date of Injury).
  • 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.
  • Cymbalta is not health care reasonably required for the compensable injury of (Date of Injury).
  • The preponderance of the evidence is not contrary to the decision of the IRO rendered on July 15, 2011 that Petitioner/Claimant is not entitled to reimbursement of the medication Cymbalta 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 IRO that Cymbalta is not health care reasonably required for the compensable injury of (Date of Injury).

    DECISION

    Claimant is not entitled to reimbursement in the amount of $115.02 for Cymbalta prescribed by Dr. B on April 20, 2011 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 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 CO.

    211 EAST 7TH STREET, STE. 620

    AUSTIN, TX 78701-3218

    Signed this 3rd day of February, 2012.

    Jacquelyn Coleman
    Hearing Officer

    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 November 01, 2011, to decide the following disputed issues:

    Regarding Docket No 03275125-06:

    1. Is the preponderance of the evidence contrary to the decision of the IRO that the claimant is not entitled to office visits coded 99213 for September 16, 2010 and January 27, 2011, for the compensable injury of (Date of Injury)?

    Regarding Docket No 03275125-07:

    1. Is the preponderance of the evidence contrary to the decision of the IRO that the claimant is not entitled to office visits for October 25, 2010, and November 08, 2010, for the compensable injury of (Date of Injury)?

    Regarding Docket No 03275125-08:

    1. Is the preponderance of the evidence contrary to the decision of the IRO that claimant is not entitled to DOS September 01, 2010 and October 13, 2010, the use of pantoprazole sodium; DOS September 07, 2010, the use of hydrocodone; DOS September 07, 2010, the use of ketorolac tromethamine; DOS October 13, 2010, the use of cyclobenzaprine; and DOS October 13, 2010, the use of Oxycontin or oxycodone for the compensable injury of (Date of Injury)?

    PARTIES PRESENT

    Petitioner/Claimant appeared and was assisted by NW, ombudsman. Respondent/Carrier appeared and was represented by KM, attorney.

    BACKGROUND INFORMATION

    On (Date of Injury), Claimant sustained an injury to his lumbar spine from repetitive work. He ultimately has had two lumbar surgeries and extensive conservative care including medications, injections, therapies and the PRIDE program. He is currently seeing a pain management doctor and has regular visits to control his pain and keep his medications followed.

    Each of the three IRO reports disagree with the requested office visits and medications, except the IRO doctor under Docket No 03275125-08 agrees with the use of Baclofen for muscle spasms caused by Claimant’s multiple surgeries. Claimant contends all of the requested office visits and medications were medically necessary given his condition and to control his pain.

    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. 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. (Division Rule 133.308 (t).)

    Under the Official Disability Guidelines in reference to office visits under the pain section, the following recommendation is made:

    Recommended as determined to be medically necessary. Evaluation and management (E&M) outpatient visits to the offices of medical doctor(s) play a critical role in the proper diagnosis and return to function of an injured worker, and they should be encouraged. The need for a clinical office visit with a health care provider is individualized based upon a review of the patient concerns, signs and symptoms, clinical stability, and reasonable physician judgment. The determination is also based on what medications the patient is taking, since some medicines such as opiates, or medicines such as certain antibiotics, require close monitoring. As patient conditions are extremely varied, a set number of office visits per condition cannot be reasonably established. The determination of necessity for an office visit requires individualized case review and assessment, being ever mindful that the best patient outcomes are achieved with eventual patient independence from the health care system through self care as soon as clinically feasible. The ODG Codes for Automated Approval (CAA), designed to automate claims management decision-making, indicates the number of E&M office visits (codes 99201-99285) reflecting the typical number of E&M encounters for a diagnosis, but this is not intended to limit or cap the number of E&M encounters that are medically necessary for a particular patient. Office visits that exceed the number of office visits listed in the CAA may serve as a “flag” to payors for possible evaluation, however, payors should not automatically deny payment for these if preauthorization has not been obtained. Note: The high quality medical studies required for treatment guidelines such as ODG provides guidance about specific treatments and diagnostic procedures, but not about the recommended number of E&M office visits. Studies have and are being conducted as to the value of “virtual visits” compared with inpatient visits; however the value of patient/doctor interventions has not been questioned. (Dixon, 2008) (Wallace, 2004) Further, ODG does provide guidance for therapeutic office visits not included among the E&M codes, for example Chiropractic manipulation and Physical/Occupational therapy.

    The IRO doctor notes there is no documentation in the Official Disability Guidelines for the use of pantoprazole sodium for the use of chronic pain or depression or opiate dependency. It is used for hyper acidity and reflux.

    The Official Disability Guidelines places hydrocodone and Oxycontin under “opioids” and defines them as:

    "Hydrocodone/Acetaminophen (Anexsia®, Co-Gesic®, Hycet™; Lorcet®, Lortab®; Margesic-H®, Maxidone™; Norco®, Stagesic®, Vicodin®, Xodol®, Zydone®; generics available): Indicated for moderate to moderately severe pain. Note: there are no FDA-approved hydrocodone products for pain unless formulated as a combination. Side Effects: See opioid adverse effects. Analgesic dose: The usual dose of 5/500mg is 1 or 2 tablets PO every four to six hours as needed for pain (Max 8 tablets/day). For higher doses of hydrocodone (>5mg/tab) and acetaminophen (>500mg/tab) the recommended dose is usually 1 tablet every four to six hours as needed for pain. Hydrocodone has a recommended maximum dose of 60mg/24 hours. The dose is limited by the dosage of acetaminophen, which should not exceed 4g/24 hours.

    Oxycodone immediate release (OxyIR® capsule; Roxicodne® tablets; generic available), Oxycodone controlled release (OxyContin®): [Boxed Warning]: Oxycontin® Tablets are a controlled release formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. Oyxcontin tablets are NOT intended for use as a prn analgesic. Side Effects: See opioid adverse effects. Analgesic dose: (Immediate release tablets) 5mg every 6 hours as needed. Controlled release: In opioid naive patients the starting dose is 10mg every 12 hours. Doses should be tailored for each individual patient, factoring in medical condition, the patient’s prior opioid exposure, and other analgesics the patient may be taking. See full prescribing information to calculate conversions from other opioids. Note: See manufacturer’s special instructions for prescribing doses of over 80mg and 160mg. Dietary caution: patients taking 160mg tablets should be advised to avoid high fat meals due to an increase in peak plasma concentration. (Product information, Purdue Pharma)"

    Both of these medications refer the reader to "Opioids" in the Official Disability Guidelines. Below are applicable sections from the ODG for Opioids:

    CRITERIA FOR USE OF OPIOIDS

    Therapeutic Trial of Opioids

    1. Establish a Treatment Plan. The use of opioids should be part of a treatment plan that is tailored to the patient. Questions to ask prior to starting therapy:
      1. (a)Are there reasonable alternatives to treatment, and have these been tried?
      2. (b)Is the patient likely to improve? Examples: Was there improvement on opioid treatment in the acute and subacute phases? Were there trials of other treatment, including non-opioid medications?
      3. (c)Has the patient received a screen for the risk of addiction? Is there likelihood of abuse or an adverse outcome? See Substance abuse (tolerance, dependence, addiction). See Opioids, screening for risk of addiction. (Webster, 2008) (Ballyantyne, 2007)
      4. (d)Ask about Red Flags indicating that opioids may not be helpful in the chronic phase: (1) Little or no relief with opioid therapy in the acute and subacute phases. (2) The patient has been given a diagnosis in one of the particular diagnostic categories that have not been shown to have good success with opioid therapy: conversion disorder; somatization disorder; pain disorder associated with psychological factors (such as anxiety or depression, or a previous history of substance abuse). Patients may misuse opioids prescribed for pain to obtain relief from depressed feelings, anxiety, insomnia, or discomforting memories. There are better treatments for this. (Sullivan, 2006) (Sullivan, 2005) (Wilsey, 2008) (Savage, 2008)
      5. (e)When the patient is requesting opioid medications for their pain and inconsistencies are identified in the history, presentation, behaviors or physical findings, physicians and surgeons who make a clinical decision to withhold opioid medications should document the basis for their decision.
    2. Steps to Take Before a Therapeutic Trial of Opioids:
      1. (a)Attempt to determine if the pain is nociceptive or neuropathic. Also attempt to determine if there are underlying contributing psychological issues. Neuropathic pain may require higher doses of opioids, and opioids are not generally recommended as a first-line therapy for some neuropathic pain.
      2. (b)A therapeutic trial of opioids should not be employed until the patient has failed a trial of non-opioid analgesics.
      3. (c)Before initiating therapy, the patient should set goals, and the continued use of opioids should be contingent on meeting these goals.
      4. (d)Baseline pain and functional assessments should be made. Function should include social, physical, psychological, daily and work activities, and should be performed using a validated instrument or numerical rating scale. See Function Measures.
      5. (e)Pain related assessment should include history of pain treatment and effect of pain and function.
      6. (f)Assess the likelihood that the patient could be weaned from opioids if there is no improvement in pain and function.
      7. (g)The patient should have at least one physical and psychosocial assessment by the treating doctor (and a possible second opinion by a specialist) to assess whether a trial of opioids should occur. When subjective complaints do not correlate with imaging studies and/or physical findings and/or when psychosocial issue concerns exist, a second opinion with a pain specialist and a psychological assessment should be obtained. (Sullivan, 2006) (Sullivan, 2005) (Wilsey, 2008) (Savage, 2008) (Ballyantyne, 2007)
      8. (h)The physician and surgeon should discuss the risks and benefits of the use of controlled substances and other treatment modalities with the patient, caregiver or guardian.
      9. (i)A written consent or pain agreement for chronic use is not required but may make it easier for the physician and surgeon to document patient education, the treatment plan, and the informed consent. Patient, guardian, and caregiver attitudes about medicines may influence the patient's use of medications for relief from pain. See Guidelines for Pain Treatment Agreement. This should include the consequences of non-adherence.
      10. (j)Consider the use of a urine drug screen to assess for the use or the presence of illegal drugs.
    3. Initiating Therapy
      1. (a)Intermittent pain: Start with a short-acting opioid trying one medication at a time.
      2. (b)Continuous pain: extended-release opioids are recommended. Patients on this modality may require a dose of “rescue” opioids. The need for extra opioid can be a guide to determine the sustained release dose required.
      3. (c)Only change 1 drug at a time.
      4. (d)Prophylactic treatment of constipation should be initiated.
      5. (e)If partial analgesia is not obtained, opioids should be discontinued.
    4. On-Going Management. Actions Should Include:
      1. (a)Prescriptions from a single practitioner taken as directed, and all prescriptions from a single pharmacy.
      2. (b)The lowest possible dose should be prescribed to improve pain and function.
      3. (c)Office: Ongoing review and documentation of pain relief, functional status, appropriate medication use, and side effects. Pain assessment should include: current pain; the least reported pain over the period since last assessment; average pain; intensity of pain after taking the opioid; how long it takes for pain relief; and how long pain relief lasts. Satisfactory response to treatment may be indicated by the patient's decreased pain, increased level of function, or improved quality of life. Information from family members or other caregivers should be considered in determining the patient's response to treatment. The 4 A's for Ongoing Monitoring: Four domains have been proposed as most relevant for ongoing monitoring of chronic pain patients on opioids: pain relief, side effects, physical and psychosocial functioning, and the occurrence of any potentially aberrant (or nonadherent) drug-related behaviors. These domains have been summarized as the "4 A's" (analgesia, activities of daily living, adverse side effects, and aberrant drug-taking behaviors). The monitoring of these outcomes over time should affect therapeutic decisions and provide a framework for documentation of the clinical use of these controlled drugs. (Passik, 2000)
      4. (d)Home: To aid in pain and functioning assessment, the patient should be requested to keep a pain dairy that includes entries such as pain triggers, and incidence of end-of-dose pain. It should be emphasized that using this diary will help in tailoring the opioid dose. This should not be a requirement for pain management.
      5. (e)Use of drug screening or inpatient treatment with issues of abuse, addiction, or poor pain control. (Webster, 2008)
      6. (f)Documentation of misuse of medications (doctor-shopping, uncontrolled drug escalation, drug diversion).
      7. (g)Continuing review of overall situation with regard to nonopioid means of pain control.
      8. (h)Consideration of a consultation with a multidisciplinary pain clinic if doses of opioids are required beyond what is usually required for the condition or pain does not improve on opioids in 3 months. Consider a psych consult if there is evidence of depression, anxiety or irritability. Consider an addiction medicine consult if there is evidence of substance misuse. (Sullivan, 2006) (Sullivan, 2005) (Wilsey, 2008) (Savage, 2008) (Ballyantyne, 2007)
    5. Recommended Frequency of Visits While in the Trial Phase (first 6 months):
      1. (a)Every 2 weeks for the first 2 to 4 months
      2. (b)Then at approximate 1 ½ to 2-month intervals

    Note: According to the California Medical Board Guidelines for Prescribing Controlled Substances for Pain, patients with pain who are managed with controlled substances should be seen monthly, quarterly, or semiannually as required by the standard of care. (California, 1994)

    1. When to Discontinue Opioids: See Opioid hyperalgesia. Also see Weaning of Medications. Prior to discontinuing, it should be determined that the patient has not had treatment failure due to causes that can be corrected such as under-dosing or inappropriate dosing schedule. Weaning should occur under direct ongoing medical supervision as a slow taper except for the below mentioned possible indications for immediate discontinuation. The patient should not be abandoned.
      1. (a)If there is no overall improvement in function, unless there are extenuating circumstances
      2. (b)Continuing pain with the evidence of intolerable adverse effects; lack of significant benefit (persistent pain and lack of improved function despite high doses of opiates- e.g. > 120 mg/day morphine equivalents)
      3. (c)Decrease in functioning
      4. (d)Resolution of pain
      5. (e)If serious non-adherence is occurring
      6. (f)The patient requests discontinuing
      7. (g)Immediate discontinuation has been suggested for: evidence of illegal activity including diversion, prescription forgery, or stealing; the patient is involved in a motor vehicle accident and/or arrest related to opioids, illicit drugs and/or alcohol; intentional suicide attempt; aggressive or threatening behavior in the clinic. It is suggested that a patient be given a 30-day supply of medications (to facilitate finding other treatment) or be started on a slow weaning schedule if a decision is made by the physician to terminate prescribing of opioids/controlled substances.
      8. (h)Many physicians will allow one “slip” from a medication contract without immediate termination of opioids/controlled substances, with the consequences being a re-discussion of the clinic policy on controlled substances, including the consequences of repeat violations.
      9. (i)If there are repeated violations from the medication contract or any other evidence of abuse, addiction, or possible diversion it has been suggested that a patient show evidence of a consult with a physician that is trained in addiction to assess the ongoing situation and recommend possible detoxification. (Weaver, 2002)
      10. (j)When the patient is requesting opioid medications for their pain and inconsistencies are identified in the history, presentation, behaviors or physical findings, physicians and surgeons who make a clinical decision to withhold opioid medications should document the basis for their decision.
    2. When to Continue Opioids
      1. (a) If the patient has returned to work
      2. (b)If the patient has improved functioning and pain

    Under the Official Disability Guidelines in reference to ketorolac tromethamine, the following recommendation is made under the NSAIDs section:

    Ketorolac (Toradol®, generic available): 10 mg. [Boxed Warning]: The oral form is only recommended for short-term (up to 5 days) in management of moderately severe acute pain that requires analgesia at the opioid level and only as continuation following IV or IM dosing, if necessary. This medication is not indicated for minor or chronic painful conditions. Increasing doses beyond a daily maximum dose of 40 mg will not provide better efficacy, and will increase the risk of serious side effects. The FDA boxed warning would relegate this drug to second-line use unless there were no safer alternatives.Dosing: Acute pain (transition from IV or IM) for adults < 65 years of age: 20mg PO followed by 10mg PO every 4 to 6 hours (max 40 mg/day). An oral formulation should not be given as an initial dose. (Toradol® Package Insert) The FDA has approved a nasal formulation of ketorolac (Sprix) for short-term pain management. (FDA, 2010)

    Under the Official Disability Guidelines in reference to cyclobenzaprine, the following recommendation is made under the muscle relaxants section:

    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)

    Cyclobenzaprine (Flexeril®, Fexmid™, generic available, ER as Amrix®): Recommended for a short course of therapy. Immediate release (eg, Flexeril, generic) recommended over extended release (Amrix) due to recommended short course of therapy (also note substantial increase in cost for extended release without corresponding benefit for short course of therapy). Limited, mixed-evidence does not allow for a recommendation for chronic use. Cyclobenzaprine is a skeletal muscle relaxant and a central nervous system depressant with similar effects to tricyclic antidepressants (e.g. amitriptyline). Cyclobenzaprine is more effective than placebo in the management of back pain, although the effect is modest and comes at the price of adverse effects. It has a central mechanism of action, but it is not effective in treating spasticity from cerebral palsy or spinal cord disease. Cyclobenzaprine is associated with a number needed to treat of 3 at 2 weeks for symptom improvement. The greatest effect appears to be in the first 4 days of treatment. (Browning, 2001) (Kinkade, 2007) (Toth, 2004) See Cyclobenzaprine. Cyclobenzaprine has been shown to produce a modest benefit in treatment of fibromyalgia. Cyclobenzaprine-treated patients with fibromyalgia were 3 times more likely to report overall improvement and to report moderate reductions in individual symptoms (particularly sleep). A meta-analysis concluded that the number needed to treat for patients with fibromyalgia was 4.8. (ICSI, 2007) (Tofferi, 2004) A recent RCT found that time to relief was better with immediate release compared to extended release cyclobenzaprine. (Landy, 2011)

    As for the individual office visits, Claimant testified why he went to each visit. Primarily, the visits were done in the process of changing pain management doctors to a doctor closer to his home. Claimant failed to show by a preponderance of evidence-based medicinal evidence that the requested office visits are health care reasonably required for the compensable injury.

    As for the medications other than cyclobenzaprine, Claimant failed to present an evidence-based medical opinion from a competent source to overcome the IRO’s decision. Claimant’s records, without sufficient reference to the Official Disability Guidelines or other evidence-based medicine justifying departure from the Official Disability Guidelines, do 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 medications do not meet the criteria set out in the Official Disability Guidelines.

    As for cyclobenzaprine (an anti-spasmodic), the IRO doctor stated it was not medically necessary as the Baclofen (also an anti-spasmodic) -- which he agreed was consistent with the Official Disability Guidelines -- was sufficient for the muscle spasms and that it was not appropriate or necessary when taken in combination with the Baclofen. The IRO doctor stated the use of Baclofen was reasonable in keeping with Claimant’s multiple back surgeries and spasms. However, the medications were not taken together. The Baclofen was stopped because it did not agree with Claimant. The doctor switched Claimant to cyclobenzaprine. The Official Disability Guidelines and evidence-based medicine support the use of the cyclobenzaprine.

    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

    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), Employer provided workers’ compensation insurance with North American Specialty Insurance Company, Carrier.
      4. On (Date of Injury), Claimant sustained a compensable injury.
      5. For Docket No 03275125-06, the Independent Review Organization board certified anesthesiology/pain medication M.D. determined Claimant should not have office visits coded 99213 for September 16, 2010, and January 27, 2011.
      6. For Docket No 03275125-07, the Independent Review Organization board certified anesthesiologist specializing in pain management determined Claimant should not have office visits for October 25, 2010, and November 08, 2010.
      7. For Docket No 03275125-08, the Independent Review Organization board certified psychiatrist and neurology physician determined Claimant should not have DOS September 01, 2010 and October 13, 2010, the use of pantoprazole sodium; DOS September 07, 2010, the use of hydrocodone; DOS September 07, 2010, the use of ketorolac tremethamine; DOS October 13, 2010, cyclobenzaprine; and DOS October 13, 2010, the use of Oxycontin or oxycodone.
    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. Office visits coded 99213 for September 16, 2010 and January 27, 2011 are not health care reasonably required for the compensable injury of (Date of Injury).
    4. Office visits for October 25, 2010, and November 08, 2010, are not health care reasonably required for the compensable injury of (Date of Injury).
    5. DOS September 01, 2010 and October 13, 2010, the use of pantoprazole sodium; DOS September 07, 2010, the use of hydrocodone; DOS September 07, 2010, the use of ketorolac tremethamine; and DOS October 13, 2010, the use of Oxycontin or oxycodone are not health care reasonably required for the compensable injury of (Date of Injury).
    6. DOS October 13, 2010, cyclobenzaprine is health care reasonably required for the compensable injury of (Date of Injury).
    7. The IRO doctor in Docket No. 03275125-08 found that DOS September 13, 2010, the use of Baclofen is 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.

    In Docket No. 03275125-06:

    1. The preponderance of the evidence is not contrary to the decision of the IRO that office visits coded 99213 for September 16, 2010 and January 27, 2011, are not health care reasonably required for the compensable injury of (Date of Injury).

    In Docket No. 03275125-07:

    1. The preponderance of the evidence is not contrary to the decision of the IRO that office visits for October 25, 2010, and November 08, 2010, are not health care reasonably required for the compensable injury of (Date of Injury).

    In Docket No. 03275125-08:

    1. The preponderance of the evidence is not contrary to the decision of the IRO that DOS September 01, 2010 and October 13, 2010, the use of pantoprazole sodium; DOS September 07, 2010, the use of hydrocodone; DOS September 07, 2010, the use of ketorolac tremethamine; and DOS October 13, 2010, the use of Oxycontin or oxycodone are not health care reasonably required for the compensable injury of (Date of Injury).
    2. The preponderance of the evidence is contrary to the decision of the IRO that DOS October 13, 2010, cyclobenzaprine is not health care reasonably required for the compensable injury of (Date of Injury).
    3. The preponderance of the evidence is not contrary to the decision of the IRO that DOS September 13, 2010, the use of Baclofen is health care reasonably required for the compensable injury of (Date of Injury).

    DECISION

    In Docket No. 03275125-06:

    Claimant is not entitled to office visits coded 99213 for September 16, 2010 and January 27, 2011,

    In Docket No. 03275125-07:

    Claimant is not entitled to office visits office visits for October 25, 2010, and November 08, 2010,

    In Docket No. 03275125-08:

    Claimant is not entitled to DOS September 01, 2010 and October 13, 2010, the use of pantoprazole sodium; DOS September 07, 2010, the use of hydrocodone; DOS September 07, 2010, the use of ketorolac tremethamine; and DOS October 13, 2010, the use of Oxycontin or oxycodone for the compensable injury of (Date of Injury).

    Claimant is entitled to DOS September 13, 2010, the use of Baclofen, and DOS October 13, 2010, cyclobenzaprine for the compensable injury of (Date of Injury).

    ORDER

    Carrier is not liable for the benefits at issue in this hearing with the exception Carrier is liable for the Baclofen and cyclobenzaprine 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 N. ST. PAUL

    DALLAS, TX 75201.

    Signed this 2nd day of November, 2011.

    KEN WROBEL
    Hearing Officer

    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 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)?

    PARTIES PRESENT

    Petitioner/Claimant (hereinafter Claimant) appeared and was assisted by JO, ombudsman. Respondent/Carrier (hereinafter Carrier) appeared and was represented by SS Chandler, attorney.

    BACKGROUND INFORMATION

    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

    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), Employer provided workers’ compensation insurance with Charter Oak Fire Insurance Company, Carrier.
    2. 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.

    3. 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

    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 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).

    DECISION

    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).

    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 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

    SUITE 620

    AUSTIN, TEXAS 78701-3218

    Signed this 2nd day of August, 2011.

    Judy L.Ney
    Hearing Officer

    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 July 22, 2011 to decide the following disputed issue:

    Is the preponderance of the evidence contrary to the decision of the Independent Review Organization (IRO) that Claimant is not entitled to reimbursement for the prescription medications Hydrocodone, Lunesta and Lorazepam charged on January 26, 2010 through October 5, 2010 for the compensable injury of (Date of Injury)?

    PARTIES PRESENT

    Petitioner/Claimant appeared, by telephone, and was assisted by IE, ombudsman.

    Respondent/Carrier appeared and was represented by WS, attorney.

    BACKGROUND INFORMATION

    Claimant sustained a compensable injury to his lumbar spine on (Date of Injury) when he was using a drill and twisted to the left. Claimant has undergone treatment in the form of an ESI, physical therapy, a TENS unit, pain medications, acupuncture, and he completed a pain management program. Claimant underwent spinal surgery on May 18, 2011. Claimant was prescribed Hydrocodone for pain, Lunesta for anxiety and sleep and Lorazepam for anxiety. The Claimant paid out of pocket for these prescriptions for the period from January 26, 2010 through October 5, 2010. The Carrier denied payment for these medications and the request was referred to an IRO, identified as board certified in anesthesiology and pain management, who determined that the medications were not medically necessary pursuant to the recommendations in the Official Disability Guidelines (ODG).

    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 [is] considered [a party] 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."

    ODG Recommendations:

    CRITERIA FOR USE OF OPIOIDS

    Long-term Users of Opioids (6-months or more)

    1) Re-assess

    1. Has the diagnosis changed?
      1. What other medications is the patient taking? Are they effective, producing side effects?
      2. What treatments have been attempted since the use of opioids? Have they been effective? For how long?
      3. Document pain and functional improvement and compare to baseline. Satisfactory response to treatment may be indicated by the patient's decreased pain, increased level of function, or improved quality of life. Information from family members or other caregivers should be considered in determining the patient's response to treatment. Pain should be assessed at each visit, and functioning should be measured at 6-month intervals using a numerical scale or validated instrument.
      4. Document adverse effects: constipation, nausea, vomiting, headache, dyspepsia, pruritis, dizziness, fatigue, dry mouth, sweating, hyperalgesia, sexual dysfunction, and sedation.
      5. Does the patient appear to need a psychological consultation? Issues to examine would include motivation, attitude about pain/work, return-to-work, social life including interpersonal and work-related relationships.
      6. Is there indication for a screening instrument for abuse/addiction. See Substance Abuse Screening.
      7. Strategy for maintenance
      8. Do not attempt to lower the dose if it is working
      9. Supplemental doses of break-through medication may be required for incidental pain, end-of dose pain, and pain that occurs with predictable situations. This can be determined by information that the patient provides from a pain diary or evaluation of additional need for supplemental medication.
      10. The standard increase in dose is 25 to 50% for mild pain and 50 to 100% for severe pain (Wisconsin)
      11. Visit Frequency
      12. There is no set visit frequency. This should be adjusted to the patient’s need for evaluation of adverse effects, pain status, and appropriate use of medication, with recommended duration between visits from 1 to 6 months.

      ODG Recommendations for Sedatives:

      Recommend that treatment be based on the etiology, with the medications recommended below. See Insomnia. Pharmacological agents should only be used after careful evaluation of potential causes of sleep disturbance. Failure of sleep disturbance to resolve in a 7 to 10 day period may indicate a psychiatric and/or medical illness. (Lexi-Comp, 2008) Primary insomnia is generally addressed pharmacologically. Secondary insomnia may be treated with pharmacological and/or psychological measures. The specific component of insomnia should be addressed: (a) Sleep onset; (b) Sleep maintenance; (c) Sleep quality; & (d) Next-day functioning.

      Pharmacologic Treatment: There are four main categories of pharmacologic treatment: (1) Benzodiazepines; (2) Non-benzodiazepines; (3) Melatonin receptor agonists; & (4) Over-the-counter medications. The majority of studies have only evaluated short-term treatment (i.e., ≤ 4 weeks) of insomnia; therefore more studies are necessary to evaluate the efficacy and safety of treatments for long-term treatment of insomnia. In 2007, the FDA requested that manufacturers of all sedative-hypnotic drugs strengthen product labeling regarding risks (i.e., severe allergic reactions and complex sleep-related behaviors, such as sleep driving). It is recommended that treatments for insomnia should reduce time to sleep onset, improve sleep maintenance, avoid residual effects and increase next-day functioning. (Morin, 2007) (Reeder, 2007) (1) Benzodiazepines: FDA-approved benzodiazepines for sleep maintenance insomnia include estazolam (ProSom®), flurazepam (Dalmane®), quazepam (Doral®), and temazepam (Restoril®). Triazolam (Halcion®) is FDA-approved for sleep-onset insomnia. These medications are only recommended for short-term use due to risk of tolerance, dependence, and adverse events (daytime drowsiness, anterograde amnesia, next-day sedation, impaired cognition, impaired psychomotor function, and rebound insomnia). These drugs have been associated with sleep-related activities such as sleep driving, cooking and eating food, and making phone calls (all while asleep). Particular concern is noted for patients at risk for abuse or addiction. Withdrawal occurs with abrupt discontinuation or large decreases in dose. Decrease slowly and monitor for withdrawal symptoms. Benzodiazepines are similar in efficacy to benzodiazepine-receptor agonists; however, the less desirable side-effect profile limits their use as a first-line agent, particularly for long-term use. (Holbrook, 2000) (Ramakrishnan, 2007) (Buscemi, 2007) (Morin, 2007) (Wafford, 2008) (Benca, 2005).

      The Claimant testified that he was taking the Hydrocodone for pain, Lunesta to help him sleep and the Lorazepam for anxiety. Claimant testified that he did not take the Lunesta on a regular basis and that the anxiety and depression he was experiencing was a result of his compensable injury. A Decision and Order dated July 3, 2010 determined that the claimed depression, anxiety and adjustment disorder were not part of the compensable injury. The Claimant offered medical records from his treating surgeon, Dr. S, dated between May 18, 2011 and June 28, 2011 which indicate that Dr. S was prescribing Hydrocodone, Lorazepam and Zanaflex post-spinal surgery and a “peer to peer” call on April 8, 2011 with Dr. B regarding the necessity for Hydrocodone and Lorazepam pre-surgery; however, the records in evidence do not address the necessity for the medications for the period from January 26, 2010 through October 5, 2010. The Claimant failed to provide an evidence-based medical opinion sufficient to overcome the determination of the IRO; therefore, the preponderance of the evidence-based medical evidence is not contrary to the IRO decision that Claimant is not entitled to reimbursement for the prescription medications Hydrocodone, Lunesta, Lorazepam charged on January 26, 2010 to October 5, 2010 for the compensable injury of (Date of Injury).

      Even though all the evidence presented may not have been discussed in detail, it was considered; the Findings of Fact and Conclusions of Law are based on all of the evidence presented.

      FINDINGS OF FACT

      1. The parties stipulated to the following facts:
      1. A.Venue is proper in the (City) Field Office of the Texas Department of Insurance, Division of Workers’ Compensation.
        1. On (Date of Injury), Claimant was the employee of (Employer).
        2. C.Claimant sustained a compensable injury on (Date of Injury).

          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.Claimant does not meet the requirements of the ODG for the prescription medications Hydrocodone, Lunesta and Lorazepam for the period from January 26, 2010 through October 5, 2010 and he failed to present other evidence based medicine sufficient to overcome the determination of the IRO.

        3. Prescription medications Hydrocodone, Lunesta and Lorazepam were not health care reasonably required for Claimant’s compensable injury of (Date of Injury) for the period of January 26, 2010 through October 5, 2010.

        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 based medical evidence is not contrary to the decision of the IRO that the prescription medications Hydrocodone, Lunesta and Lorazepam was not health care reasonably required for Claimant’s compensable injury of (Date of Injury) for the period from January 26, 2010 through October 5, 2010.

        DECISION

        Claimant is not entitled to reimbursement for prescription medications Hydrocodone, Lunesta and Lorazepam charged on January 26, 2010 through October 5, 2010 for his 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 ACE FIRE UNDERWRITERS INSURANCE COMPANY and the name and address of its registered agent for service of process is:

        CT CORPORATION SYSTEM

        350 NORTH ST. PAUL STREET

        DALLAS, TX 75201

        Signed this 22nd day of July, 2011.

        Carol A. Fougerat
        Hearing Officer

        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 February 5, 2009, to decide the following disputed issue:

        1. Is the preponderance of the evidence contrary to the decision of the IRO that Claimant is not entitled to work hardening/conditioning for the dates of service of December 26, 2006, through December 29, 2006, for which the health care provider billed $1,536.00?

        PARTIES PRESENT

        Petitioner/Subclaimant appeared and was represented by FP, lay representative.

        Respondent/Carrier appeared and was represented by PS, attorney.

        BACKGROUND INFORMATION

        Claimant was injured on ____________, when she was working as a school custodian, taking trash out, and slipped and fell. Claimant had a prior workers’ compensation injury from ___________, with reported cervical spine pain, contusion in the right knee, and internal derangement of the right shoulder.

        On December 27, 2006, designated doctor, Dr. JH, M.D., examined Claimant and opined that Claimant “has marked signs of symptom magnification.” He further stated that Claimant had no abnormal neurological findings in either upper or lower extremities. The MRI was physiologically normal in both the cervical and lumbar areas. He then opined, “Putting all of this together (normal neurological, normal MRIs and symptom magnification) this lady would not benefit from any additional treatment directed toward the cervical or lumbar spine.” He also opined that, “The right knee also needs no additional supervised treatment or prescription medicine.” He also stated that if he gave her the benefit of the doubt, he would recommend MRI imaging of the right shoulder. He further opined that Claimant is not totally disabled for any employment and she could return to work with restrictions for the right upper extremity, but as far as the lumbar and cervical, there would be no restrictions.

        On November 22, 2006, Dr. MM, D.O., referred Claimant to the (Healthcare Provider) for work hardening for the cervical and lumbar spine. (Healthcare Provider) was CARF accredited at the time the medical services in dispute were rendered. Therefore, pre-authorization was unnecessary. However, any subsequent billing is subject to retrospective review for medical necessity. That is the heart of the dispute, whether the medical services for work hardening for dates of service for December 26, through December 29, 2006, were medically necessary.

        When the bills were submitted to the Carrier for payment for work hardening for dates of service from December 26, 2006, through December 29, 2006, Carrier denied as unnecessary medical treatment based on peer review. The peer review was by Dr. CC, D.O., who opined that Claimant should not be participating in a work hardening program because there was no objective data to support a work hardening program.

        As a result of Carrier’s denial reconsideration was requested, and the denial was upheld. Subclaimant then requested an IRO. In IRO Case 11279, which was for retrospective review of medical necessity, the case was reviewed by a chiropractor, and the denial was upheld.

        In the “Analysis and Explanation” section of the IRO determination, it stated as follows:

        The work hardening/conditioning and work hardening/conditioning each additional hour for the dates of 12/26/06 thru 12/29/06 are not reasonable or medically necessary according to the below referenced criteria. The medical records reveal that the patient met her current job demands and the peer review doctor also agreed that no further work hardening/conditioning are necessary. If a patient is at the current demand level of their job, then it is necessary to integrate them back into their work environment. There is no reason to continue work hardening/conditioning if the goals have been met. Therefore, the work hardening/conditioning and work hardening/conditioning each additional hour for the dates of 12/26/06 thru 12/29/06 are not reasonable or medically necessary.

        Dr. K testified that he disagreed with the peer review report of Dr. CC because the lifting categories in the FCE were inappropriately stated and it was uncertain as to whether there had been any verification of Claimant’s work duties/lifting requirements from the Employer.

        As the parties recognized, the dates of service for the work hardening program were from December 26, 2006, through December 29, 2006, which is prior to the effective date of Rule 137.100(h) which provides that Rule 137.100 applies to all health care provided on or after May 1, 2007. Rule 137.100 provides that the health care providers shall provide treatment in accordance with the current edition of the ODG, excluding return to work pathways. See Appeal No. 071108-s.

        The IRO determination noted that at the time of the dates of service, there were no applicable ODG Guidelines. Medical necessity disputes must be decided, in the absence of applicable ODG Guidelines on evidence based medicine. Texas Labor Code Sec. 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.

        At the February 5, 2009, CCH, no evidence based medicine was offered to overcome the IRO determination of non-entitlement.

        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

        1. 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), and sustained a compensable injury.

      2. Carrier delivered to Subclaimant 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. Work hardening/conditioning for the dates of service of December 26, 2006, through

      December 29, 2006, is not health care reasonably required for the compensable

      injury of ____________.

      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 IRO that Claimant is not entitled to work hardening/conditioning for the dates of service of December 26, 2006, through December 29, 2006, for which the health care provider billed $1,536.00.

      DECISION

      Claimant is not entitled to work hardening/conditioning for the dates of service of December 26, 2006, through December 29, 2006, for which the health care provider billed $1,536.00, as it is not reasonably required medical care for the compensable injury of ____________.

      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 WORKERS COMPENSATION SOLUTIONS, and the name and address of its registered agent for service of process is:

      JERRY EDWARDS

      1004 MARBLE HEIGHT DR.

      MARBLE FALLS, TX 78654

      Signed this 11th day of February, 2009

      Cheryl Dean
      Hearing Officer

      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 benefit contested case hearing was held on May 13, 2008, to decide the following disputed issues:

      1. Whether the health care provider is entitled to reimbursement of $1,708.00 for service dates of April 4, 11, 12, and 13, 2007 at $427.00 per day for a work hardening program because the treatment was reasonably required health care?

      PARTIES PRESENT

      Petitioner/Subclaimant appeared and was represented by an (attorney). Carrier appeared and was represented by EL, (adjuster).

      AGREEMENT

      The parties reached an agreement. The agreement only resolves the issues to be decided at this hearing. The agreement does not resolve all issues regarding the claim and is not a settlement.

      In this decision, this Agreement section constitutes the findings of facts and the Decision Section constitutes the conclusions of law.

      The Hearing Officer found:

      1. Carrier delivered to the health care provider 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 parties agreed as follows:

      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 of the Texas Department of Insurance, Division of Workers’ Compensation.
      3. On _______, Claimant was the employee of (employer) when he sustained a compensable injury.
      4. Carrier will pay (health care provider) the total sum of $500.00 as a full and final settlement for the services rendered to Claimant on April 4, 11, 12, and 13, 2007, for work hardening in compromise of the original bill which was $427.00 per day or a total of $1,708.00.

      DECISION

      Carrier will pay (health care provider) the total sum of $500.00 as a full and final settlement for the services rendered to Claimant on April 4, 11, 12, and 13, 2007, for work hardening in compromise of the original bill which was $427.00 per day or a total of $1,708.00.

      ORDER

      Carrier is ordered to pay benefits in accordance with this decision, the Texas Workers’ Compensation Act, and the Commissioner’s Rules.

      The true corporate name of the insurance carrier is HARTFORD FIRE INSURANCE COMPANY and the name and address of its registered agent for service of process is

      CORPORATION SERVICE COMPANY

      701 BRAZOS STREET, SUITE 1050

      AUSTIN, TEXAS 78701

      Signed this 13th day of May, 2008.

      Charles T. Cole
      Hearing Officer

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