DECISION AND ORDER
This case is decided pursuant to Chapter 410 of the Texas Workers’ Compensation Act and Rules of the Division of Workers’ Compensation adopted thereunder.
A benefit contested case hearing was held on October 7, 2008, to decide the following disputed issue:
Is the preponderance of the evidence contrary to the decision of the Independent Review Organization (IR0) that Claimant is not entitled to Clonazepam (1mg 1-2 a day), Methadone (10 mg - 2 in the morning and 1 midday), and Cyclobenzaprine (10 mg – 1 pill 3x prn) for the compensable injury of _________?
Claimant appeared and was assisted by ombudsman, JT. Carrier appeared and was represented by attorney, TW.
It is undisputed that Claimant sustained an injury to his low back during the course and scope of his employment on _________. Claimant underwent an L5-S1 fusion on June 6, 2007. He testified that he continues to have pain in his low back, which radiates down his leg and causes his foot to drop occasionally.
Claimant currently treats with a pain management doctor, Dr. H, and a neurosurgeon, Dr. LG. Dr. LG, the neurosurgeon who performed Claimant’s fusion surgery in June of 2007, followed Claimant’s postoperative progress and noted diminished low back mobility as well as low back, hip and leg pain. He also noted a progressive fusion with stable position.
A postsurgical MRI revealed the hardware, 4 to 5 MM anterolisthesis of L5 on S1, and extradural fluid collections in the surgical region; but, revealed no stenosis or nerve root encroachment at the surgical area or any other level.
Follow-up x-rays showed stable post-operative changes and no hardware complications as late as January 3, 2008.
Dr. H, the pain management doctor, has diagnosed failed back surgery syndrome and prescribed Methadone, Clonazepam and Cyclobenzaprine for treatment of the compensable injury on March 10, 2008.
The carrier denied these medications. The first utilization review doctor, Dr. S, a DO in occupational and preventive medicine, cited the Official Disability Guidelines Low Back and Pain Chapters and denied the requested medications.
The utilization review doctor who reviewed the request on reconsideration, Dr. B, a DO in anesthesiology, a neurosurgeon, also denied the requested medications. He also cited the ODG indications for the requested medications and refused to certify those medications. The doctor explained that the records did not support the effectiveness of Methadone and there was no quantitative assessment on how they help, no expression of the percentage of relief, no mention of how long the relief lasts, no mention of urine tox screens to show compliance, and no mention of increase in function or activity. He further explained that, due to the danger of addiction and withdrawal from Methadone per the ODG, there needs to be documentation of the effectiveness of all pain medications. He stated that per the ODG Benzodiazepines like Clonazepam are not recommended for long-term use (most guidelines limit use to 4 weeks) because long term efficacy is unproven and there is a risk of dependence. Finally, he opined that the records did not support the effectiveness of Cyclobenzaprine, as there was no quantitative assessment of how they help, no mention of the percentage of relief, no mention of how long the effects last; and, it is usually used in short courses, not as a chronic medication. Based on the clinical information submitted and using the referenced sections of the ODG, the doctor denied the requested medications.
An IRO reviewer and board certified anesthesiologist specializing in pain management reviewed the records and upheld the adverse determinations of the utilization review doctors. The IRO denied the medications citing the ODG. The IRO doctor noted that the ODG states that opiates (Methadone) are reasonable and necessary if there is documented improvement in comfort and function; that Clonazepam may be effective for back pain if there is documentation of efficacy; and, Cyclobenzaprine is questionable for chronic pain, but may be effective with documented improvement in function and increased activity. Because the records reviewed lacked documentation regarding efficacy and improvement, the IRO doctor found that the requested medications were not reasonable and necessary.
Texas Labor Code Section 408.021 provides that an employee who sustains a compensable injury is entitled to all health care reasonably required by the nature of the injury as and when needed. Section 401.011(22-a) defines health care reasonably required 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: (A) evidence based medicine; or (B) if that evidence is not available, generally accepted standards of medical practice recognized in the medical community.”
“Evidence based medicine” is further defined, by Section 401.011(18-a) as 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 Division of Workers’ Compensation has adopted treatment guidelines under Division Rule 137.100. That rule requires that health care providers provide treatment in accordance with the current edition of the Official Disability Guidelines(ODG), and treatment provided pursuant to those guidelines is presumed to be health care reasonably required as mandated by the above-referenced sections of the Texas Labor Code.
The initial inquiry, therefore, in any dispute regarding medical necessity, is whether the proposed care is consistent with the ODG. As the utilization review and IRO doctors in the instant case have stated, the ODG allows for the use of all of the medications requested, with specific limitations and requires documentation of improved function and activity as well as efficacy in pain control for use of the medications.
The ODG Treatment Guidelines for chronic pain medications discuss the requested medications as follows:
Medications for subacute 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 MensAntidepressants for neuropathicAntidepressants for non-neuropathicAnti-BoswelliaSerrataInjection with anaestheticsIntrathecalNSAIDsSalicylateUncariaZiconotide (Prialt®).
Benzodiazepines (Clonazepam) Not recommended for long-term use because long-term efficacy is unproven and there is a risk of dependence. Most guidelines limit use to 4 weeks. Their range of action includes sedative/hypnotic, anxiolytic, anticonvulsant, and muscle relaxant. Chronic benzodiazepines are the treatment of choice in very few conditions. Tolerance to hypnotic effects develops rapidly. Tolerance to anxiolytic effects occurs within months and long-term use may actually increase anxiety. A more appropriate treatment for anxiety disorder is an antidepressant. Tolerance to anticonvulsant and muscle relaxant effects occurs within weeks. (BaillargeonInsomnia treatment.
Methadone Recommended as a second-line drug for moderate to severe pain if the potential benefit outweighs the risk. The FDA reports that they have received reports of severe morbidity and mortality with this medication. This appears, in part, secondary to the long half-life of the drug (8-59 hours). Pain relief on the other hand only lasts from 4-8 hours.
Pharmcokinetics: Genetic differences appear to influence how an individual will respond to this medication. Following oral administration, significantly different blood concentrations may be obtained. Vigilance is suggested in treatment initiation, conversion from another opioid to methadone, and when titrating the methadone dose. (WeschulesFredheim 2008)
Adverse effects: Delayed adverse effects may occur due to methadone accumulation during chronic administration. Systemic toxicity is more likely to occur in patients previously exposed to high doses of opioids. This may be related to tolerance that develops related to the N-methyl-D-aspartate (NMDA) receptor antagonist. Patients may respond to lower doses of methadone than would be expected based on this antagonism. One severe side effect is respiratory depression (which persists longer than the analgesic effect). Methadone should be given with caution to patients with decreased respiratory reserve (asthma, COPD, sleep apnea, severe obesity). QT prolongation with resultant serious arrhythmia has also been noted. Use methadone carefully in patients with cardiac hypertrophy and in patients at risk for hypokalemia (including those patients on diuretics). Methadone does have the potential for abuse. Precautions are necessary as well for employees in safety sensitive positions, including operation of a motor vehicle.
The ODG sets out specific steps for prescribing Methadone, all of which are set out at length in the first utilization review doctor’s report.
Cyclobenzaprine Recommended as an option, using a short course of therapy. See Medications for subacute & chronic pain for other preferred options. Cyclobenzaprine (Flexeril®) is more effective than placebo in the management of back pain; the effect is modest and comes at the price of greater adverse effects. The effect is greatest in the first 4 days of treatment, suggesting that shorter courses may be better. (Browning, 2001) Cyclobenzaprine-treated patients with fibromyalgia were 3 times as likely to report overall improvement and to report moderate reductions in individual symptoms, particularly sleep. (Tofferi, 2004) Note: Cyclobenzaprine is closely related to the tricyclic antidepressants, e.g., amitriptyline. See Antidepressants. Cyclobenzaprine is associated with a number needed to treat of 3 at 2 weeks for symptom improvement in LBP and is associated with drowsiness and dizziness. (Kinkade, 2007) Cyclobenzaprine is a skeletal muscle relaxant and a central nervous system (CNS) depressant that is marketed as Flexeril by Ortho McNeil Pharmaceutical.
As noted previously herein, “health care reasonably required” means 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 that evidence is not available, generally accepted standards of medical practice recognized in the medical community. Treatment provided pursuant to the ODG is presumed to be health care reasonably required.
Both of the utilization review doctors and the IRO doctor denied the requested medications citing the relevant provisions of the ODG, specifically the necessity for documentation of improvement with and efficacy of the medications and relatively short courses of some of the medications. It is incumbent on the Claimant, therefore, to provide evidence-based medicine sufficient to overcome the presumption afforded the ODG and the opinions of the doctors correctly applying the ODG.
Other Evidence Based Medicine
When weighing medical evidence, the hearing officer must first determine whether the doctor giving the expert opinion is qualified to offer it, but also, the hearing officer must determine whether the opinion is relevant to the issues in the case and whether the opinion is based upon a reliable foundation. An expert’s bald assurance of validity is not enough. SeeBlack v. Food Lion, Inc., 171 F.3rd 308 (5th Cir. 1999);E.I. Du Pont De Nemours and Company, Inc. v. Robinson, 923 S.W.2d 549 (Tex. 1995). When determining reliability, the hearing officer must consider the evidence in terms of (1) general acceptance of the theory and technique by the relevant scientific community; (2) the expert’s qualifications; (3) the existence of literature supporting or rejecting the theory; (4) the technique’s potential rate of error; (5) the availability of other experts to test and evaluate the technique; (6) the clarity with which the theory or technique can be explained to the trial court; and (7) the experience and skill of the person who applied the technique on the occasion in question. Kelly v. State, 792 S.W.2d 579 (Tex. App.-Fort Worth 1990).
Claimant failed to present an evidence-based medical opinion from a competent source to overcome the IRO’s decision. The medications prescribed by Dr. H departed from the ODG in several respects, specifically in the lack of documentation of their effectiveness in controlling Claimant’s pain and improving his function and activity. Further, the reports of Dr. H do not provide the necessary documentation to support the use of the prescribed medications for Claimant’s compensable injury. Dr. H was asked very specifically, by the ombudsman, to offer an evidence-based medicine opinion regarding the requested medications. His records, without sufficient reference to the ODG or other evidence-based medicine justifying departure from the ODG, do not meet the requisite evidentiary standard required to overcome the presumption afforded 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 ODG.
Even though all the evidence presented was not discussed, it was considered. The Findings of Fact and Conclusions of Law are based on all of the evidence presented.
FINDINGS OF FACT
- The parties stipulated to the following facts:
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), when he sustained a compensable injury.
C.The IRO determined that the requested medications were not reasonable and necessary health care services for the compensable injury of _________.
CONCLUSIONS OF LAW
- The Texas Department of Insurance, Division of Workers’ Compensation, has jurisdiction to hear this case.
- Venue was proper in the (City) Field Office.
- The preponderance of the evidence is not contrary to the decision of IR0 that the medications Clonazepam (1mg 1-2 a day), Methadone (10 mg - 2 in the morning and 1 midday), and Cyclobenzaprine (10 mg – 1 pill 3x prn) are not health care reasonably required for the compensable injury of _________.
Claimant is not entitled to Clonazepam (1mg 1-2 a day), Methadone (10 mg - 2 in the morning and 1 midday), and Cyclobenzaprine (10 mg – 1 pill 3x prn) for the compensable injury of _________.
Carrier is not liable for the benefits at issue in this hearing. Claimant remains entitled to medical benefits for the compensable injury in accordance with Section 408.021.
The true corporate name of the insurance carrier is AMERICAN CASUALTY COMPANY OF READING, PENNSYLVANIA and the name and address of its registered agent for service of process is
CT CORPORATION SYSTEM
350 NORTH ST. PAUL STREET
DALLAS, TEXAS 75201
Signed this 7th day of October, 2008.