DECISION AND ORDER
This case is decided pursuant to 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 Claimant is not entitled to prescription for a Duragesic patch 100mcg, requested 45 (changed every 48 hours) for the compensable injury of (Date of Injury).
STATEMENT OF THE CASE
A contested case hearing was held on November 17, 2016, with the record closing in December 19, 2016, to decide the following disputed issue:
Is the preponderance of the evidence contrary to the decision of the IRO that Claimant is not entitled to a Duragesic patch 100mcg, requested 45 (changed every 48 hours) for the compensable injury of (Date of Injury)?
Petitioner/Claimant appeared and was assisted by DS, ombudsman. Although duly notified, Petitioner/Provider failed to appear for the contested case hearing, and did not respond to the Division’s 10-day letter.Respondent/Carrier appeared and was represented by PB, attorney.
The following witnesses testified:
For Claimant: AP
For Carrier: None
The following exhibits were admitted into evidence:
Hearing Officer’s Exhibits HO-1 and HO-2.
Claimant’s Exhibits C-1 through C-5.
Carrier’s Exhibits CR-A through CR-G.
Although properly notified, Petitioner/Provider failed to appear for the contested case hearing scheduled for 8:30 am on November 17, 2016. A letter advising that the hearing had convened and that the record would be held open for ten days to afford Petitioner/Provider the opportunity to respond and request that the hearing be rescheduled to permit him to present evidence on the disputed issue was mailed to Petitioner/Provider on December 2, 2016. Petitioner/Provider failed to respond to the 10-day letter and the record was closed on December 19, 2016.
Claimant sustained a compensable back injury on (Date of Injury), when cases of canned fruit fell on her as she was involved in her regular duties in the cafeteria of (Employer), Employer. She has undergone multiple spinal surgeries since the date of injury, but none have afforded lasting relief. She came under the care of JC, MD, a pain management specialist. Dr. JC has prescribed a Duragesic patch 100mcg, requested 45 (changed every 48 hours) that he believes is medically necessary to relieve Claimant’s pain. Carrier reviewed the necessity for the Duragesic patch 100mcg in light of the Official Disability Guidelines (ODG) and refused to authorize its purchase. Claimant appealed the denial and an Independent Review Organization was appointed by the Texas Department of Insurance in accordance with Rule 133.308. After consideration of the information provided, the IRO upheld Carrier’s denial of the requested Duragesic patch 100mcg as not reasonably necessary for treatment of the compensable injury. Dr. JC thereafter filed a request for a contested case hearing as provided for by Rule 133.308(s). The contested case hearing was held on November 17, 2016.
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 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, 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 adopted treatment guidelines by Division Rule 137.100. The 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. A decision issued by an IRO is not considered an agency decision and the Department and the Division are not considered parties to an appeal. In a contested case hearing, the party appealing the IRO decision has the burden of overcoming the decision issued by the IRO by a preponderance of the evidence-based medical evidence. (Rule 133.308 (s).)
On May 20, 2016, preauthorization was requested for the drugs prescribed by Dr. JC. In a report dated May 27, 2016, HK, MD, utilization review agent, determined that the request should be denied because visual analog scale (VAS) scores, with and without medication, had not been documented, and there was no clear documentation of functional improvement with this medication. Additionally, Dr. HK wrote that the combination of the Duragesic 100 mcg and Norco 10/325 mg exceeds the morphine equivalent dose (MED) recommendation of a 100 mg per day. She also commented that there have also been no urine drug screen results or risk assessments submitted for review. Dr. HK wrote that medical necessity cannot be established at this time.
Dr. JC requested that an IRO be appointed to review Carrier’s denial of preauthorization of the prescription for Duragesic patch 100mcg. The Division appointed Envoy Medical Systems, LP, as the IRO. Envoy Medical Systems, LP submitted the request for review of the prescription to a physician who is board certified in anesthesiology & pain management. The physician reviewer upheld the denial of the prescription, citing his medical judgment, clinical experience and expertise in accordance with accepted medical standards and the ODG as the bases for his determination. Additionally, the physician reviewer wrote that previously the Duragesic has been tried and the patient was weaned off the medication, and she is currently being prescribed Butrans.In part, the physician reviewer wrote:
There should be documentation of improvement of the end comfort and functionality to warrant opiate therapy. In addition, Duragesic is a “no” drug in the Texas Workers Compensation formulary.
In Dr. JC’s office notes, and in his appeal letters, he does not quantitate the degree of functionality and improvement in pain scores with Duragesic. It is not clear, but it appears from his last note, that the injured worker’s comfort and functionally have not deteriorated after weaning off Duragesic.
Rather, in Dr. JC’s note of 7/08/16, it appears that the injured worker is maintaining functionality and has an acceptable level of pain with the Butrans regimen. There is no evidence that Duragesic meets the ODG criteria in this individual.
Claimant argues that the recommendations of the ODG regarding the use of the drug prescribed by Dr. JC should not be followed because her case is outside of the norm. Claimant asserts that she should be considered an outlier, and the IRO determination should be overturned.
The pain section of the ODG contains the following:
Duragesic® (fentanyl transdermal system)
Not recommended as a first-line therapy.
See Opioids, long-acting. Also, See Fentanyl
Duragesic is a long-acting opioid. Duragesic is the trade name of a fentanyl transdermal therapeutic system, which releases fentanyl, a potent opioid, slowly through the skin. It is manufactured by ALZA Corporation and marketed by Janssen Pharmaceutica (both subsidiaries of Johnson & Johnson). The FDA-approved product labeling states that Duragesic is indicated in the management of chronic pain in patients who require continuous opioid analgesia for pain that cannot be managed by other means. Due to the significant side effects, not for use in routine musculoskeletal pain. The FDA announced it will require color changes to the writing that appears on fentanyl pain patches (Duragesic and generics) so they can be seen more easily and to emphasize that unintended exposure can cause death. This is part of an effort to prevent accidental exposure to the patches, which can cause serious harm and death in children, pets, and others. (FDA, 2013) FDA is alerting the public about potential for deaths from accidental exposure to fentanyl transdermal patches. (FDA, 2015). [Duragesic ranked #9 in amount billed for WC in 2011. (Coventry, 2012)]
There is no expert medical evidence that would tend to show that the recommendations contained in the ODG do not apply to Claimant or that the drug prescribed by Dr. JC is reasonably required for the compensable injury of (Date of Injury). Under the facts presented, Claimant has failed to prove, by a preponderance of the evidence-based medical evidence, that the determination of the IRO is incorrect.
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:
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 the (Employer), Employer.
C. On (Date of Injury), Employer provided workers’ compensable insurance with (Carrier), Carrier.
D. Claimant sustained a compensable injury on (Date of Injury).
E. The IRO determined that Claimant should not have a Duragesic patch 100mcg, requested 45 (changed every 48 hours) for the compensable injury of (Date of Injury).
Claimant is not entitled to a Duragesic patch 100mcg requested 45 (changed every 48 hours) 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
CT CORPORATION SYSTEM
1999 BRYAN STREET, SUITE 900
DALLAS, TX 75201-3136
Signed this 29th day of December, 2016.