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. For the reasons discussed herein, the Hearing Officer determines that Claimant is entitled to a routine refill of intrathecal pain pump with Sufentanil for the compensable injury of (Date of Injury).
A contested case hearing was held on June 14, 2016 to decide the following disputed issue:
- Is the preponderance of the evidence contrary to the decision of
the Independent Review Organization that Claimant is not entitled to a routine refill of intrathecal pain pump with Sufentail for the compensable injury of (Date of Injury)?
Claimant appeared and was assisted by SB, ombudsman. Respondent/Carrier appeared and was represented by DS, adjuster. Petitioner/Provider, Dr. MR, appeared by telephone as a witness in this matter.
Claimant sustained a compensable injury to her cervical spine and lumbar spine on (Date of Injury) when her vehicle was rear-ended by another vehicle. Claimant currently treats with Dr. MR, pain management specialist, for her pain complaints. Dr. MR has diagnosed Claimant with cervicalgia. Claimant’s current treatment consists of oral medications and an intrathecal pain pump. Dr. MR has been prescribing Sufentanil for Claimant’s pain pump for several years. Dr. MR requested a routine refill of intrathecal pain pump with Sufentail. Dr. MR’s request was denied twice by the Carrier's utilization review agents and their denial was upheld by the Independent Review Organization (IRO).
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. Healthcare 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 in accordance with 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 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."
With regard to Implantable drug-delivery systems (IDDSs), the ODG provides as follows:
Recommended only as an end-stage treatment alternative for selected patients for specific conditions indicated in the criteria below, after failure of at least 6 months of less invasive methods, and following a successful temporary trial. There is insufficient evidence to recommend the use of implantable drug-delivery systems (IDDS) for the treatment of chronic pain. There are no high quality studies on this topic that document that this therapy is safe and effective. Further, significant complications and adverse events have been documented and the data identifies a substantial risk to patients. (Washington State Health Care Authority, 2008) Results of studies of opioids for musculoskeletal conditions (as opposed to cancer pain) generally recommend short use of opioids for severe cases, not to exceed 2 weeks, and do not support chronic use (for which a pump would be used). This treatment may be considered relatively late in the treatment continuum, when there is little hope for effective management of chronic intractable pain from other therapies. (Angel, 1998) (Kumar, 2002) (Hassenbusch, 2004) (Boswell, 2005) (Deer, 2009) (Patel, 2009) For most patients, it should be used as part of a program to facilitate restoration of function and return to activity, and not just for pain reduction. The specific criteria in these cases include the failure of at least 6 months of other conservative treatment modalities, intractable pain secondary to a disease state with objective documentation of pathology, further surgical or other intervention is not indicated, there are no contraindications to a trial, psychological evaluation unequivocally states that the individual has realistic expectations and the pain is not psychological in origin, and a temporary trial has been successful prior to permanent implantation as defined by a 50% reduction in pain. (Tutak, 1996) (Yoshida, 1996) (BlueCross, 2005) (United Health Care, 2005) See also Opioids and the Low Back Chapter. In a study of IDDS in 136 patients with low back pain, after one year 87% of the patients described their quality of life as fair to excellent, and 87% said they would repeat the implant procedure. However, complication rates (i.e., infection, dislodging, and cerebrospinal fluid leak) are likely to rise with time in these procedures and more longitudinal outcome studies need to be conducted. (Deer, 2004) In one survey involving 429 patients with nonmalignant pain treated with intrathecal therapy, physician reports of global pain relief scores were excellent in 52.4% of patients, good in 42.9%, and poor in 4.8%. In another study of 120 patients, the mean pain intensity score had fallen from 93.6 to 30.5 six months after initiation of therapy. In both studies, patients reported significant improvement in activities of daily living, quality of life measures, and satisfaction with the therapy. (Winkelmuller, 1996) (Paice, 1997) One study in patients suffering from chronic low back pain caused by failed back syndrome found a 27% improvement after 5 years for patients in the intrathecal drug therapy group, compared with a 12% improvement in the control group. (Kumar, 2002) Supporting empirical evidence is significantly supplemented and enhanced when combined with the individually based observational evidence gained through an individual trial prior to implant. This individually based observational evidence should be used to demonstrate effectiveness and to determine appropriate subsequent treatment. Generally, use of implantable pumps is FDA approved and indicated for chronic intractable pain. Treatment conditions may include FBSS, CRPS, Arachnoiditis, Diffuse Cancer Pain, Osteoporosis, and Axial Somatic Pain. As we have gained more experience with this therapy, it has become apparent that even intrathecal opioids, when administered in the long term, can be associated with problems such as tolerance and other side effects. Consequently, long-term efficacy has not been convincingly proven. However, it is important to note that there is a distinction between "tolerance" and "addiction", and the levels of drugs administered intrathecally should be significantly below what might be needed orally in their absence. (Osenbach, 2001) (BlueCross BlueShield, 2005) See also Intrathecal drug delivery systems, medications
Safety Precautions & Warnings: Oral opioid prescribing, use and how to best keep patients as safe as possible have all have been the subject of increasing discussion, in part, due to related accidental deaths. (Phillips, 2008) Use of intrathecal opioids, as for all routes of administration, is not without risk. Constipation, urinary retention, nausea, vomiting, and pruritus are typical early adverse effects of intrathecal morphine and are readily managed symptomatically. Other potential adverse effects include granuloma formation, amenorrhea, loss of libido, edema, respiratory depression, death, and pump and catheter malfunctions. (Winkelmuller, 1996) (Paice, 1997) (Washington State Health Care Authority#2, 2008) Common causes of mortality in implanted pump patients appear to be preventable through adherence to dosing and monitoring information for drugs approved for chronic intrathecal administration. Follow product instructions and dosing recommendations. Failure to comply with all implanted infusion pump product instructions can lead to technical errors or improper use and result in additional surgical procedures, a return of underlying symptoms, or a clinically significant drug underdose or fatal drug overdose. (Medtronic, 2009) The mortality rate in the implanted pump population is higher than some operative benchmarks and similar at approximately 30 days and 1-year post discharge to open spine surgery in the Medicare population. (Coffey, 2009) Patients who receive the implanted device should be monitored in an adequately equipped facility for a sufficient time to monitor drug effects. When using concomitant medications with respiratory or CNS depressant effects, appropriate supervision and monitoring should be provided. (Medtronic, 2009)
Patient selection (in addition to criteria below): Cole 2003 recommends that, after other criteria are met, patients with neuropathic pain are better candidates for spinal cord stimulation (SCS), and patients with nociceptive pain are better candidates for intrathecal drug delivery (IDD). It also recommends psychological evaluation and clearance before any implantation, plus positive response to a trial. (Cole, 2003)
Indications for Implantable drug-delivery systems:
Implantable infusion pumps are considered medically necessary when used to deliver drugs for the treatment of:
o Primary liver cancer (intrahepatic artery injection of chemotherapeutic agents);
o Metastatic colorectal cancer where metastases are limited to the liver (intrahepatic artery injection of chemotherapeutic agents);
o Head/neck cancers (intra-arterial injection of chemotherapeutic agents);
o Severe, refractory spasticity of cerebral or spinal cord origin in patients who are unresponsive to or cannot tolerate oral baclofen (Lioresal®) therapy (intrathecal injection of baclofen)
Permanently implanted intrathecal (intraspinal) infusion pumps for the administration of opioids or non-opioid analgesics, in the treatment of chronic intractable pain, are considered medically necessary when:
Used for the treatment of malignant (cancerous) pain and all of the following criteria are met:
(1) Strong opioids or other analgesics in adequate doses, with fixed schedule (not PRN) dosing, have failed to relieve pain or intolerable side effects to systemic opioids or other analgesics have developed; and
(2) Life expectancy is greater than 3 months (less invasive techniques such as external infusion pumps provide comparable pain relief in the short term and are consistent with standard of care); and
(3) Tumor encroachment on the thecal sac has been ruled out by appropriate testing; and
(4) No contraindications to implantation exist such as sepsis or coagulopathy; and
(5) A temporary trial of spinal (epidural or intrathecal) opioids has been successful prior to permanent implantation as defined by a 50% reduction in pain. A temporary trial of intrathecal (intraspinal) infusion pumps is considered medically necessary only when criteria 1-4 above are met.
Used for the treatment of non-malignant (non-cancerous) pain with a duration of greater than 6 months and all of the following criteria are met and documented by treating providers in the medical record:
(1) Non-opioid oral medication regimens have been tried and have failed to relieve pain and improve function (see functional improvement); and
(2) At least 6 months of other conservative treatment modalities (injection, surgical, psychologic or physical), have been ineffective in relieving pain and improving function; and
(3) Intractable pain secondary to a disease state with objective documentation of pathology in the medical record (per symptoms, physicial examination and diagnostic testing); and
(4) Further surgical intervention or other treatment is not indicated or likely to be effective; and
(5) Independent psychological evaluation has been obtained and evaluation states that the pain is not primarily psychologic in origin, the patient has realistic expectations and that benefit would occur with implantation despite any psychiatric comorbidity; and
(6) No contraindications to implantation exist such as sepsis, spinal infection, anticoagulation or coagulopathy; and
(7) There has been documented improvement in pain and function in response to oral opioid medications but intolerable adverse effects preclude their continued use; and
(8) A temporary trial of spinal (epidural or intrathecal) opiates has been successful prior to permanent implantation as defined by at least a 50% to 70% reduction in pain and documentation in the medical record of functional improvement and associated reduction in oral pain medication use. A temporary trial of intrathecal (intraspinal) infusion pumps is considered medically necessary only when criteria 1-7 above are met.
(9) For average hospital LOS if criteria are met, see Hospital length of stay (LOS).
If treatment is determined to be medically necessary, as with all other treatment modalities, the efficacy and continued need for this intervention and refills should be periodically reassessed and documented.
Medications for IDDS if determined to be medically necessary:
First stage: Morphine is generally the initial IDDS medication. The maximum recommended dose for this drug is 15 mg/day with a concentration of 20 mg/mL. An alternative non-FDA approved medication is hydromorphone. The maximum recommended dose for this medication is 4 mg/day with a concentration of 10 mg/mL. Other opioids (including Fentanyl and Sufentanil) have been used for intrathecal chronic non-malignant pain but are non-FDA approved and have little research associated with their use. (Waara-Wolleat, 2006) (Deer, 2007) The previous 2003 Polyanalgesic conference recommended a maximum dose of intrathecal morphine at 15 mg/day with a maximum concentration of 30 mg/mL. They also recommended a maximum dose of hydromorphone of 10 mg/day with a concentration of 30 mg/mL. (Hassenbusch, 2004) The newer maximum concentrations were recommended, in part, to prevent granulomas.
Second stage: If side effects occur, an upper limit of dosing is reached, or neuropathic pain is present, clonidine is next recommended as an addition to an opioid (maximum recommended dose of 1 mg/day and a concentration of 2 mg/mL). Bupivacaine has also been recommended as an alternative to clonidine (maximum dose of 30 mg/day and a concentration of 40 mg/mL). Clonidine, which is FDA approved for intrathecal delivery, is thought to provide analgesic effect via a non-opioid mechanism. It has been found to offer only short-term relief when used as a single agent. (Deer, 2007)
Third stage: The recommendation has been made to add both clonidine and bupivacaine. Baclofen has been used to treat intractable spasticity from brain injury, cerebral palsy, and spinal cord injury and has resulted in improvement in muscle tone and pain relief. (Guillaume, 2005) See also Ziconotide (Prialt®), which is recommended after documentation of a failure of a trial of intrathecal morphine or hydromorphone (Dilaudid).
Refills: IDDSs dispense drugs according to instructions programmed by the clinician to deliver a specific amount of drug per day or to deliver varying regimens based on flexible programming options, and the pump may need to be refilled at regular intervals. The time between refills will vary based on pump reservoir size, drug concentration, dose, and flow rate. A programming session, which may occur along with or independent of a refill session, allows the clinician to adjust the patient’s prescription as well as record or recall important information about the prescription. (Hassenbusch, 2004) According to the FDA, the manufacturer’s manuals should be consulted for specific instructions and precautions for initial filling, refilling and programming. (FDA, 2010) For most pumps, the maximum dose that can be delivered between refills is 1000mg. If refills are usually administered after 16 to 17 mL have been infused, and most pumps are 18-20mL, the minimum time between each visit is 42 days if the daily dose rate is 20 mg/day. Given that a refill visit presents a good opportunity for monitoring, this panel suggested that the concentration be adjusted to allow refill visits a minimum of every 4 to 6 weeks, and maximum of every 2–3 months. (Bennett, 2000)
Claimant testified concerning the medical treatment that she has received for her compensable injury. Claimant also testified about her current pain complaints and how the pain pump with Sufentanil has allowed her to perform her activities of daily living. Claimant testified that she had severe side effects when she was initially given Morphine for her pain pump. Claimant also testified that she is allergic to hydromorphone (Dilaudid). According to Claimant’s testimony and the medical records, Claimant has had no adverse effects from taking Sufentanil. Claimant’s testimony regarding her medical history and the effects of her medications on her condition was credible.
Dr. MR, Petitioner/Provider, testified that he began treating Claimant more than ten years ago. He testified that Claimant met the ODG selection criteria for the pain pump. According to Dr. MR, during the trial period, Claimant was given Morphine for her pain pump, but she experienced significant side effects. Due to Claimant’s medical history of an allergic reaction, Dr. MR did not give Claimant Dilaudid for her pain pump.
According to Dr. MR, Sufentanil is an FDA approved medication that is used to sedate patients and fentanyl patches are used for pain. Dr. MR testified that he has used Sufentanil in his practice for fifteen years and the use of the medication in the pain pumps is generally accepted in the medical community. Dr. MR testified, and his medical records indicate, that Claimant has demonstrated significant functional improvement while taking the Sufentanil. Claimant has taken Sufentanil for ten years. Dr. MR’s testimony is supported by the evidence-based medical literature that is in evidence concerning the use of Sufentanil in pain pumps.
The testimony of the Claimant and Dr. MR was considered. The medical records in evidence were also reviewed. Dr. MR's testimony supports the medical necessity of a routine refill of intrathecal pain pump with Sufentanil for this Claimant. The Petitioner/Provider and Claimant have shown by a preponderance of evidence-based medical evidence that the requested routine refill of intrathecal pain pump with Sufentanil is 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
- 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 (Date of Injury), Claimant was the employee of (Employer), Employer.
C.On (Date of Injury), the employer provided workers’ compensation insurance coverage with (Carrier), Carrier.
D.Claimant sustained a compensable injury on (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 contrary to the decision of the IRO that a routine refill of intrathecal pain pump with Sufentanil is not health care reasonably required for the compensable injury of (Date of Injury).
Claimant is entitled to a routine refill of intrathecal pain pump with Sufentanil for the compensable injury of (Date of Injury).
Carrier is 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:
10200 RICHMOND AVE. SUITE 275
HOUSTON, TX 77042
Signed this 20th day of June, 2016.