DECISION AND ORDER
This case is decided pursuant to Chapter 410 of the Texas Workers’ Compensation Act and the Rules of the Texas Department of Insurance, Division of Workers’ Compensation. For the reasons discussed herein, the Hearing Officer determines that the preponderance of the evidence is not contrary to the decision of the IRO that Claimant is not entitled to Methadone 10mg #90/month, Roxicodone 15 mg #120/month, and Amitiza 24 mcg #60 for the compensable injury of (Date of Injury).
STATEMENT OF THE CASE
On November 30, 2016, Jacqueline Harrison, a Division hearing officer, held a contested case hearing to decide the following disputed issue:
- Is the preponderance of the evidence contrary to the decision of the Independent Review Organization (IRO) that the Claimant is not entitled to Methadone 10mg #90/month, Roxicodone 15 mg #120/month, and Amitiza 24 mcg #60 for the compensable injury of (Date of Injury)?
Petitioner/Claimant, CW, appeared and was assisted by RH, an ombudsman. Respondent/Carrier appeared and was represented by PS, attorney.
Claimant testified at the November 30, 2016, medical contested case hearing that she was a claims provider at the time of her injury in (Date of Injury). Claimant testified that she fell in the rain when she injured herself which resulted in her undergoing a cervical fusion in 2001, a lumbar spinal fusion in 2002, and in 2003, she had the hardware removed for both surgical procedures. Claimant testified that MB, M.D., is her pain management physician and she has been with him since 2012. Claimant testified that Dr. MB informed her he would need to cut down her prescriptions. Claimant testified that she needs the Methadone 10mg #90/month, Roxicodone 15 mg #120/month, and Amitiza 24 mcg #60 to assist with her daily living activities. Claimant presented her spouse and daughter-in-law to testify on her behalf regarding her daily activities. Claimant’s spouse does not have a medical background and therefore was not qualified as an expert witness. Claimant’s daughter-in-law, although a nurse, testified that she was not familiar with the official disability guidelines.
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. Also, in accordance with Division Rule 133.308(s), "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 pertinent provisions of the ODG applicable to this case are as follows:
Methadone is recommended as a second-line drug for moderate to severe pain, only if the potential benefit outweighs the risk, unless methadone is prescribed by pain specialists with experience in its use and by addiction specialists, where first-line use may be appropriate.
See also Opioids for general guidelines, as well as specific Methadone (Dolophine®, Methadose®) listing for more information and references.
Steps for prescribing methadone:
(1) Basic rules
- Weigh the risks and benefits before prescribing methadone.
- The drug should be used with caution in opioid-naïve patients due to the risk of life-threatening hypoventilation.
- Avoid prescribing 40 mg Methadone diskettes for chronic non-malignant pain. This product is only FDA-approved for detoxification and maintenance of narcotic addiction. DEA has secured an agreement from the manufacturers of this formulation to sell only to licensed Opioid Treatment Programs.
- Closely monitor patients who receive methadone, especially during treatment initiation and dose adjustments.
(2) Know the information that is vital to give the patient:
- Inform the patient that methadone is not a breakthrough medication.
- Inform the patient that they should not be tempted to take more methadone than prescribed if they are not getting pain relief as this can lead to a dangerous build-up that can lead to death.
- All changes in methadone dose should be made by the treating practitioner.
- The patient should be warned to not use alcohol, benzodiazepines or other CNS depressants (particularly at night) unless specifically prescribed by the treating physician.
- Inform the patient of the potential adverse effects of methadone. These include respiratory depression, irregular heartbeat, dizziness, light-headedness, and/or syncope. An emergency number and/or plan should be given to the patient in case symptoms occur. (FDA, 2006)
- Consider starting methadone early in the week to allow for titration and monitoring.
(3) Be familiar with the current SAMHSA health advisory on methadone:
- The medication has become more accessible to unauthorized users.
- It can accumulate in potentially harmful doses (especially during the first few days of treatment).
- There has been a rise in Methadone-associated mortality. (SAMHSA, 2004)
(4) Be familiar with the FDA final policy statement on Methadone that explicitly discusses the topic, “Can Methadone be used for pain control?”
No separate registration is required to prescribe methadone for treatment of pain. (DEA, 2006)
(5) Read the new prescribing information for Methadone and the new patient information section. (Roxane, 2006)
(6) Multiple potential drug-drug interactions can occur with the use of Methadone. A complete list of medications should be obtained prior to prescribing methadone to avoid adverse events, and the patient should be warned to inform any other treating physician that they are taking this medication prior to starting and/or discontinuing medications.
(7) Pre-use cardiac evaluation: Patients should be informed of arrhythmia risk when prescribed methadone. An assessment should be made of history of structural heart disease, arrhythmia, and syncope. No firm guides are agreed upon in terms of pre-treatment or interval EKGs, but recommendation for use is particularly made for patients on high dose drug with cardiac history or evidence of syncope or seizures. (Peng, 2008)
Due to the complexity of dosing and potential for adverse effects including respiratory depression and adverse cardiac events, this drug should be reserved for use by experienced practitioners (i.e. pain medicine or addiction specialists). (ICSI, 2009) Methadone is considered useful for treatment when there is evidence of tolerance to other opiate agonists or when there is evidence of intractable side effects due to opiates. Limited evidence suggests there may be a role for this drug for neuropathic pain, in part secondary to the N-methyl-D-aspartate (NMDA) receptor effect. While methadone is considered safe and effective when used as prescribed it has been suggested by government agencies such as the National Drug Intelligence Center that patients prescribed methadone should be monitored by a physician well trained in the pharmacodynamic and pharmacokinetic properties of the drug, particularly if the patient is opioid naïve. In addition, the patient should be made aware of potential adverse effects including drug-drug interactions. If methadone is used, see Opioids, criteria for use for general recommendations.
FDA Activity: Increased reports by the FDA of severe morbidity and mortality have prompted the following. In November 2006 the FDA issued a black-box warning for methadone that stated, in part, that methadone treatment should only be initiated if potential benefits outweigh risks of treatment. Their particular concerns included respiratory and cardiac related complications, including death. In the same month they issued a monograph, “Information for Healthcare Professionals, Methadone Hydrochloride, FDA ALERT [11/2006]: Death, Narcotic Overdose, and Serious Cardiac Arrhythmias.” In July 2007 the FDA issued “Public Health Advisory, Methadone Use for Pain Control May Result in Death and Life-Threatening Changes in Breathing and Heart Beat.” (National Drug Intelligence Center, 2007)
Pharmacokinetics and pharmacodynamics: Increased morbidity and mortality appears, in part, secondary to the long and variable half-life of the drug (8-59 hours; up to 110 hours in patients with cancer). Pain relief on the other hand only lasts from 4-8 hours. It may take several days to weeks to obtain adequate pain control. 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. Frequent or large dose changes are generally not necessary after initial titration. If analgesia is lost this may reflect the addition of a medication that affects metabolism. (Weschules 2008) (Fredheim 2008)
Adverse effects and mortality: Methadone-related deaths are noted to be increasing at a faster rate than other poisoning deaths using data from the National Center for Health Statistics, increasing by 468% from 1999 to 2005 (total poisoning deaths increased by 66%). Methadone-related poisoning deaths had the greatest percentage increase of deaths compared with other opioids although the actual number of deaths is less than from other opioids or cocaine. The Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS®) System found that from 2003 until 2006 patients that filled prescriptions for methadone had the highest fatal poisoning rate for all people filling prescriptions. Approximately 35% of methadone deaths were characterized as resulting from an abuse situation. Two-thirds involved use of multiple drugs including antidepressants, alcohol and cocaine. Deaths can also occur with too rapid titration. Delayed adverse effects may occur due to methadone accumulation during chronic administration. (Fingerhut, 2008) (Dart, 2007) (Center for Substance Abuse Treatment, 2009) 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 NMDA receptor antagonism properties. 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).
Abuse potential: Methadone does have the potential for abuse. “Street methadone” is primarily used for self-medication of detoxification and withdrawal symptoms. According to CDC, methadone has played a central role in the increase in overdose deaths from prescription painkillers. More than 30% of prescription painkiller deaths involve methadone, even though only 2% of painkiller prescriptions are for this drug. Six times as many people died of methadone overdoses in 2009 than a decade before. (CDC, 2012)
Cardiac safety and EKG monitoring: Methadone use is associated with an increased risk for QT prolongation and torsade de pointes (TdP). Patients who are at most risk for TdP include those on high daily methadone doses, those who take medications that cause QTc prolongation or inhibit CYP34A enzymes, and patients with electrolyte imbalances (low magnesium or potassium). There is no current evidence to firmly advise EKG monitoring when prescribing methadone. Expert opinion includes the use of an EKG for doses of methadone > 100 mg/day or if there are factors that may lead to prolonged QTc intervals (such as underlying cardiac disease). If the QTc interval is > 500 ms methadone should be weaned. (Peng, 2008) Others have suggested EKGs in patients over the age of 40 years and during dose stabilization in “high risk” patients, and a recent consensus guideline recommended a pretreatment EKG to measure QTc interval in all patients prescribed methadone, with a repeat in 30 days and then annually. (Krantz, 2009) Overall, there appears to be a high “tolerance” for EKG monitoring and particularly if there is a history of arrhythmia, syncope, or structural heart disease, or if seizures of syncope develop after initiation of treatment.
See Oxycodone. [Roxicodone ranked #15 in amount billed for WC in 2011. (Coventry, 2012)]
Not recommended for first-line use for treatment of acute or chronic non-malignant pain because short-acting opioids are recommended prior to use of long-acting opioids.
See Opioids, long-acting.
OxyContin® is the brand name of a time-release formula of the analgesic chemical oxycodone, produced by the pharmaceutical company Purdue Pharma. See Opioids for general guidelines, as well as specific Oxycodone controlled release (OxyContin®) listing for more information and references. 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) On April 2, 2010, the FDA approved a new formulation of Oxyontin designed to discourage abuse, but according to the manufacturer, there is no evidence that the reformulation is less subject to misuse, abuse, diversion, overdose or addiction. (FDA, 2010) Due to issues of abuse and Black Box FDA warnings, OxyContin is recommended as second line therapy for long acting opioids. OxyContin ranked #1 in amount billed for WC in 2011. (Coventry, 2012) This study found that introduction of abuse-deterrent formulations (ADF) of OxyContin led to an initial decline in abuse, followed by a plateau, and then significant levels of residual abuse, plus an uptick in heroin use. ADF OxyContin led to a decline in past-month abuse after its introduction (from 45% in January–June 2009 to 26% in July–December 2012), but this decline leveled off, with 25% to 30% of new patients entering treatment reporting past-month abuse from 2012 to 2014. Among individuals who continued to abuse ADF OxyContin, 43% said they changed their preferred route of administration from injected or inhaled to the oral route, 34% managed to defeat the ADF OxyContin mechanism and continued to inject or inhale the drug, and 23% exclusively swallowed the pill regardless of formulation. (Cicero, 2015) Heroin use in the U.S. jumped 63% between 2002 and 2013, driven by both the prescription opioid epidemic and cheaper, more available heroin. Heroin use or dependency is 40 times more likely in people who abuse or are dependent on prescription opioid painkillers. (CDC, 2015)
Recommended only as a possible second-line treatment for opioid-induced constipation.
See Opioid-induced constipation treatment (OIC) for recommendations for treatment.
Lubiprostone works by activating chloride channels on the small intestine mucosa. This leads to chloride rich intestinal fluid secretion, increasing water content in the lumen and subsequently, stool hydration. This works, in part, by counteracting the antisecretory bowel effects of opioids.
Dosing: 24 µg BID (usual adult dose); also supplied as an 8 µg dose.
Clinical trials: In a double-blind RCT (phase3), patients on lubiprostone reported an improvement from baseline in spontaneous bowl movements (SBM) of 27% at 12 weeks. The placebo group had the same response 19% of the time. The number needed to treat was 13. . The overall improvement was 2.2 SBM per week versus 1.6 in the placebo group (P-0.004). At week 8 the treatment group had a mean of 3.3 SBMs per week versus 2.4 in the placebo group (P= 0.005). At week 12 there was the same pattern, but the change was not significant. The use of rescue medications was similar in the lubiprostone and placebo arms. Gastrointestinal adverse effects were more common with lubiprostone than placebo and included nausea, diarrhea and abdominal discomfort. It should be noted that three double-blind, placebo-controlled, 12-week studies were conducted, but only 2 demonstrated that lubiprostone was significantly more effective than placebo. An open-label study has been conducted for 9 months, finding the drug was safe and well tolerated. (Jamal, 2015) (Cryer, 2014) (Spierings, 2015)
The case was reviewed by a, medical doctor who is board certified in Anesthesia and Pain Management, who upheld the denial of the Methadone 10mg #90/month, Roxicodone 15 mg #120/month, and Amitiza 24 mcg #60. It was noted in the IRO denial that while methadone is considered safe and effective when used as prescribed it has been suggested by government agencies such as the National Drug Intelligence Center that claimants prescribed methadone should be monitored by a physician well trained in the pharmacodynamics and pharmacokinetic properties of the drug, particularly if the Claimant is opioid naïve. The IRO reviewer also noted Claimant should be made aware of potential adverse effects including drug-drug interactions. The IRO Reviewer reported that the Roxicodone was an opioid analgesic indicated for moderate to moderately severe pain and is used to manage chronic and acute pain. In order to be medically necessary any opioid analgesic requires review and documentation of pain relief, functional status, appropriate use and a lack of side effects. The IRO Reviewer noted there was no documentation of functional benefit and discontinuation should taper to avoid withdrawal symptoms. Lastly, the IRO Reviewer indicated that Amitiza should be a second line treatment when the first line treatment fails. The IRO Review reported that it was not clear in this case that the first line treatment had failed or that there was documented extenuating circumstances that would support such a deviation from treatment protocols. The IRO Reviewer further explained there was no documentation of a maintained increase in function or decrease in pain with the use of these medications. The IRO Reviewer indicated that ongoing Controlled Substance Utilization Review and Evaluation System reports to monitor for aberrancy and/or reports of intolerance to applicable oral agents had not been evidence.
The medical documentation and testimony offered by Claimant is insufficient to meet her burden of proof. Claimant has not shown by a preponderance of evidence-based medical evidence that the requested Methadone 10mg #90/month, Roxicodone 15 mg #120/month, and Amitiza 24 mcg #60 is health care reasonably required for the compensable injury of (Date of Injury).
The Hearing Officer considered all of the evidence admitted. The Findings of Fact and Conclusions of Law are based on an assessment of all of the evidence whether or not the evidence is specifically discussed in this Decision and Order.
FINDINGS OF FACT
- The parties stipulated to the following facts:
- Venue is proper in the (City) Field Office of the Texas Department of Insurance, Division of Workers’ Compensation.
B.On (Date of Injury), Claimant was the employee of (Employer), Employer.
C. Claimant sustained a compensable injury on (Date of Injury).
- D.On (Date of Injury), Employer provided workers’ compensation insurance with (Carrier), Carrier.
- Carrier delivered to Claimant a single document stating the true corporate name of Carrier, and the name and street address of Carrier’s registered agent, which document was admitted into evidence as Hearing Officer’s Exhibit Number 2.
- The prescribed Methadone 10mg #90/month, Roxicodone 15 mg #120/month, and Amitiza 24 mcg #60 is not health care reasonably required for treatment of the compensable injury of (Date of Injury).
CONCLUSIONS OF LAW
- The Texas Department of Insurance, Division of Workers’ Compensation, has jurisdiction to hear this case.
- Venue is proper in the (City) Field Office.
- The preponderance of the evidence is not contrary to the decision of the IRO that the prescribed Methadone 10mg #90/month, Roxicodone 15 mg #120/month, and Amitiza 24 mcg #60 is not health care reasonably required for the compensable injury of (Date of Injury).
Claimant is not entitled to the prescribed Methadone 10mg #90/month, Roxicodone 15 mg #120/month, and Amitiza 24 mcg #60 for the compensable injury of (Date of Injury).
Carrier is not liable for the benefits at issue in this hearing. Claimant remains entitled to medical benefits for the compensable injury in accordance with §408.021.
The true corporate name of the insurance carrier is (Carrier) and the name and address of its registered agent for service of process is:
C T CORPORATION SYSTEM
1999 BRYAN STREET, SUITE 900
DALLAS, TX 75201-3136
Signed this 9th day of December, 2016.
- Venue is proper in the (City) Field Office of the Texas Department of Insurance, Division of Workers’ Compensation.