DECISION AND ORDER
_________, the Petitioner, appealed the decision of the Texas Workers’ Compensation Commission’s Medical Review Division (MRD) to deny preauthorization for an intradiscal electrothermal therapy (IDET) procedure at an ambulatory surgical center. The MRD’s decision found that the IDET was not consistent with the Spine Treatment Guideline of the Texas Workers’ Compensation Commission (the Commission) and was not reasonably required within the meaning of Tex. Lab. Code Ann. §§408.021 and 401.011(19). The Petitioner contended that she meets the criteria for the IDET, that the procedure is necessary, and that it would allow her to return to work. The Administrative Law Judge finds that the Petitioner did not demonstrate that she meets the criteria for the procedure and orders that preauthorization should be denied.
I. Procedural History, Notice, and Jurisdiction
The parties did not contest notice or jurisdiction in this proceeding. Therefore, these matters are addressed in the findings of fact and conclusions of law without further discussion here.
The hearing was held on November 1, 2001. The Petitioner appeared by telephone and was assisted by Anthony Walker, an ombudsman with the Commission. Albertson’s, Inc. (the Respondent) appeared through its counsel, Gregory Solcher. The Commission’s staff had earlier waived appearance and was not present. The record was closed at the conclusion of the hearing on November 1, 2001.
II. Legal Authority
A. Entitlement to Medical Benefits. Section 408.021 of the Texas Workers’ Compensation Act (the Act) provides:
(a)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. The employee is specifically entitled to health care that:
- cures or relieves the effects naturally resulting from the compensable injury;
- promotes recovery; or
- enhances the ability of the employee to return to or retain employment.
Section 401.011(19) of the Act defines "health care" to include "all reasonable and necessary medical . . . services."
B. Preauthorization. Certain categories of health care identified by the Commission require preauthorization, which is dependent upon a prospective showing of medical necessity. For this case, preauthorization is required for ambulatory surgical center care. The parties do not dispute that the procedure sought, the IDET, must also be preauthorized.
C. Spine Treatment Guideline. The Commission’s Spine Treatment Guideline (STG) is a guideline to clarify those services that are reasonably and medically necessary for operative and nonoperative care of the spine. The IDET procedure is not included among the STG’s list of nonoperative interventions. The STG states, however, that the guideline shall not be used as the sole reason for denial when a treatment or service is not listed in the guideline.
III. Reasons for Denial of Preauthorization
A. Background and Medical Opinions. The Petitioner was employed for fourteen years as an assistant market manager with the Respondent. Among her job duties were cutting and grinding meat and lifting heavy boxes. She was first injured when she lifted a box from a pallet, but she continued to work. She was injured again on__________, when she fell and hurt herself again. This injury was determined to be the compensable injury. She continued to work, however, with the aid of Lortab for her pain. With the second injury, C.M. Schade, M.D., became her treating doctor. In November 2000, Dr. Schade diagnosed her with lumbar radicular syndrome, left sciatica, chronic with bulging disk at L5-S1, concordant pain and fissuring at L4-5, L5-S1[,] lumbar facet syndrome, chronic with degenerative facet joint disease at L4-5, and L5-S1[; and] depression, secondary to [the lumbar conditions]. In December 2000, Dr. Schade said she was no longer able to work, and she has not worked since that date.
The Petitioner, who is 41 years old, testified that she has constant lower back pain. She stated she feels constant pins and needles in her left leg, and the same sensation in her right leg if she is on her feet too much or walks too much. She is currently taking Lortab, Celebrex, Topamax, Elavil, and Paxil. The Petitioner had a number of diagnostic tests, including an MRI, a myelogram, a CT myelogram, a discogram, and a CT discogram. The discogram and the post-discogram CT showed concordant pain at L5-S1 and L4-L5. There was some fissuring and extravasation of dye on the right side at L4-L5, but the pathology was normal at L5-S1. The myelogram showed minimal central disc protrusion with no associated canal stenosis or nerve root impingement, and the CT myelogram revealed no nerve root compromise.
The Petitioner testified she has not been through a work hardening program, and the only physical therapy she could recall having been given involved stretching on a table. She is markedly obese, and according to the progress notes of Allen J. Meril, M.D., her obesity makes her a Avery poor surgical candidate for a fusion. However, Dr. Meril and Dr. Schade both believed the Petitioner should have the IDET procedure, given that, in Dr. Schade’s written opinion, she meets all six of the inclusion criteria for the procedure as specified by the procedure’s originators, Dr. Jeffrey Saal and Dr. Joel Saal:
- Function-limiting low back pain of at least six months’ duration;
- Lack of satisfactory improvement with comprehensively applied, nonoperative care program including progressive intensive exercise, epidural steroid injections, and trial of manual therapy, oral anti-inflammatory medications, and activity modifications;
- Normal neurologic examination;
- Negative straight leg raising;
- No neural compressive lesion, as shown by the MRI; and
- Discography with concordant pain reproduction with provocative discography at low pressure, i.e. less than one cc dye volume.
Dr. Schade also asserted that the Petitioner did not have the exclusion criteria, which are inflammatory arthritides, nonspinal conditions that could mimic lumbar pain, or medical or metabolic disorders that would preclude appropriate follow-up and participation.
Donald Mauldin, M.D., performed an independent medical examination of the Petitioner on June 12, 2001. Dr. Mauldin disagreed with Drs. Meril and Schade that the IDET would be beneficial. He diagnosed the Petitioner with lumbar strain. Of particular note was his determination that the Petitioner had positive Waddell findings, and thus, that there was a possibility of symptom magnification. He also opined that the Petitioner would be better served by dietary and work hardening programs, along with detoxification to reduce her dependence on the narcotic pain medications. Dr. Mauldin also criticized the IDET procedure as being Aof questionable value because it has not been proven unequivocally to be of that much benefit on a pure scientific basis.
Dr. Mauldin’s criticism of the IDET procedure was echoed in the testimony at hearing of John Yatsu, M.D., who stated that there has never been a randomized clinical trial of the procedure. While it is gaining some acceptance in the medical community, it is a new modality that has not proven itself over the long term, he said. He also disagreed with Dr. Schade that the Petitioner meets all six of the Saal criteria. In his view, she has sciatica and radiculopathy, which implies a radiating pain, and a pain that would not be addressed by the IDET procedure; IDET is designed to address low axial back pain, or pain in the spine and surrounding tissues. Also, she has sensory losses, which are not normal neurologic findings, and positive straight leg raising tests. Likewise, the discography indicated to Dr. Yatsu a greater degeneration than IDET would treat. Finally, although it is not an enumerated criteria in the Saal study, a viable candidate for IDET would also be a viable candidate for a back fusion. The Petitioner is not, according to Dr. Yatsu.
B. Denial of Preauthorization for Failure to Meet the Criteria. The Administrative Law Judge (ALJ) might be willing to order preauthorization for the IDET, despite the relative newness of the procedure and the fact that is was excluded from the STG, if the Petitioner had demonstrated that she meets the criteria. She did not.
The ALJ found most persuasive three points. First, there is very little evidence that the Petitioner has undertaken a truly comprehensive course of conservative care. The only physical therapy she mentioned involved stretching on a table, and even if, for the sake of the argument, that constituted physical therapy, there is no evidence about how long the course of physical therapy lasted, who supervised it, what it entailed, and why, or even if, it failed. There is some evidence she had some epidural steroid injections, but again, there is no evidence about that particular course of treatment. She has not undertaken either a work hardening program or a weight reduction program, for reasons that go unexplained in the evidence.
Moreover, and perhaps more importantly, the Petitioner is not a good candidate for a back fusion because of her weight. As Dr. Yatsu recognized, the Saal study does not include as a specific criterion candidacy for a fusion, but it is apparent from the study that it is an important factor, and perhaps the preeminent one, in deciding whether a patient should undergo the IDET procedure. According to Dr. Yatsu, it is necessary for the fusion to be an option in the event the IDET procedure is not successful. It is true that Dr. Meril referred to the Petitioner as a surgical candidate, but a very poor one. In the ALJ’s view, this is insufficient assurance that a fusion would be an acceptable alternative to the IDET in this case.
Finally, the ALJ is concerned that there are nonphysiologic bases for the Petitioner’s pain, as demonstrated by the positive Waddell findings. As Dr. Yatsu stated, a structural treatment for pain with no structural basis will not do any good. The ALJ agrees with Dr. Mauldin that the Petitioner would obtain greater benefit from noninvasive treatments and programs that would address her weight and her dependence on narcotic medications.
For these reasons, the ALJ finds that the Petitioner did not prove the IDET procedure is medically necessary to cure or relieve the effects of her injury, to promote recovery, or to return her to work. Therefore, preauthorization for the use of the ambulatory surgical center for the IDET procedure is denied.
IV. Findings of Fact
- On________, the Petitioner ________sustained a work-related compensable injury while working for the Respondent Albertson’s, Inc. as a meat cutter and assistant market manager.
- The Petitioner sustained an injury to her back, diagnosed as lumbar radiculopathy and sciatica.
- The Petitioner’s treating doctor requested preauthorization for intradiscal electrothermal therapy (IDET) at an ambulatory surgical center.
- The request for preauthorization was denied by Intracorp, who performed the utilization review for the Respondent.
- In July 2001, after consideration of the parties’ dispute in MDR Docket No. M2-01-0691-01, the Medical Review Division (MRD) of the Texas Workers’ Compensation Commission (the Commission) issued an order denying preauthorization for the IDET procedure.
- The Petitioner timely filed a request for hearing to contest the MRD’s findings and decision in this matter.
- On August 24, 2001, the Commission provided timely notice of the contested hearing in this matter to all parties. The notice contained a statement of the time, place, and nature of the hearing; a statement of the legal authority and jurisdiction under which the hearing was to be held; a reference to particular sections of the statutes and rules involved; and a short plain statement of the matter to be considered.
- At the hearing held on November 1, 2001, the Petitioner appeared via telephone and was assisted by the Commission’s ombudsman. The Respondent appeared through its counsel. The Commission waived its appearance.
- The IDET procedure is a relatively new modality developed for the treatment of back pain. The procedure has not been subjected to a randomized clinical trial.
- The IDET procedure does not fall within the established treatment standards of the Commission’s Spine Treatment Guideline and its use must be supported by sound clinical rationale.
- Those persons eligible for the IDET procedure must also be candidates for a back fusion.
- A candidate for the IDET procedure must also have undergone a course of conservative therapy and had that conservative therapy fail to produce satisfactory improvement.
- The Petitioner is 41 years old and is markedly obese.
- The Petitioner’s weight prevents her from being a candidate for a back fusion.
- The Petitioner has not undergone physical therapy, a work hardening program, or a weight reduction program.
- Positive Waddell findings indicate that the Petitioner has nonphysiologic, nonstructural bases for her pain, which the IDET procedure is not designed to treat.
V. Conclusions of Law
- The Texas Workers’ Compensation Commission has jurisdiction over the issue presented pursuant to the Texas Workers’ Compensation Act (the Act), Tex. Lab. Code Ann. '413.031.
- The State Office of Administrative Hearings has jurisdiction over matters related to the hearing in this proceeding, including the authority to issue a decision and order, pursuant to '413.031(d) of the Act and Tex. Gov’t Code Ann. ch. 2003.
- Adequate and timely notice of the hearing was provided pursuant to the Administrative Procedure Act, Tex. Gov’t Code Ann. '2001.052.
- Pursuant to '408.021(a) of the Act, 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. The employee is specifically entitled to health care that cures or relieves the effects naturally resulting from the compensable injury, promotes recovery, or enhances the ability of the employee to return to or retain employment.
- Section 413.014 of the Act requires the Commission to specify which health care treatments and services require preauthorization.
- Health care treatments and services such as the IDET procedure, including ambulatory surgical center care, must be preauthorized, pursuant to 29 Tex. Admin. Code '134.600(h)(1).
- The IDET procedure in an ambulatory surgical care center is not a reasonable and necessary treatment for the Petitioner.
- The Petitioner’s request for preauthorization for IDET in an ambulatory surgical center should be denied.
IT IS, THEREFORE, ORDERED that the decision of the Medical Review Division to deny preauthorization of an IDET procedure for the Petitioner ___________is upheld and preauthorization for that procedure is denied.
This decision is final on the date the party is notified of the decision. If the decision is mailed, a party or the party’s representative is presumed to have been notified on the date on which the notice was mailed. 28 Tex. Admin. Code '148.22(h).
Issued the 29th day of November, 2001.
Administrative Law Judge
STATE OFFICE OF ADMINISTRATIVE HEARINGS
- Tex. Lab. Code Ann.'401.001et seq.↑
- Tex. Lab. Code Ann.'413.014; 28 Tex. Admin. Code'134.600.↑
- 28 Tex. Admin. Code'134.600(h)(1).↑
- 4 28 Tex. Admin. Code'134.1001(b)(1).↑
- 28 Tex. Admin. Code'134.1001(g) and (j)(1).↑
- 28 Tex. Admin. Code'134.1001(b)(1).↑
- Exh. 1, p. 7.↑
- To extravasate means to force out, cause to escape, or pass by infiltration or effusion from a proper vessel or channel (as a blood vessel) into surrounding tissue. Merriam Webster’s Medical Dictionary (1995).↑
- Exh. 1, p. 24.↑
- Exh. 1, p. 9.↑
- Dr. Schade did not attend or testify at the hearing.↑
- Exh. 1, p. 7; Exh. 6, Joel S. Saal, M.D., and Jeffrey A. Saal, M.D., Management of Chronic Discogenic Low Back Pain With a Thermal Intradiscal Catheter - A Preliminary Report.↑
- Exh. 1, p.27.↑