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At a Glance:
Title:
453-02-0373-m2
Date:
February 8, 2002
Status:
Pre-Authorization

453-02-0373-m2

February 8, 2002

DECISION AND ORDER

American Home Assurance Company (Carrier) appealed the decision of the Texas Workers’ Compensation Commission’s (Commission) Medical Review Division (MRD) that authorized intradiscal electro thermal therapy (IDET) at an ambulatory surgical center for ___ (___or Claimant), an injured worker. MRD determined IDET for Claimant was reasonably required within the meaning of the Texas Workers’ Compensation Act, TEX. LABOR CODE (LABOR CODE) §§ 408.021 and 401.011(19). The Administrative Law Judge (ALJ) concludes MRD correctly determined that IDET for Claimant is reasonably required within the meaning of the LABOR CODE.

I. JURISDICTION, NOTICE, AND PROCEDURAL HISTORY

There are no contested issues regarding notice of hearing or venue. Those matters, therefore, are addressed in the Findings of Fact and Conclusions of Law without further discussion here.

Administrative Law Judge Carol Wood convened a hearing on this matter on November 27, 2001. Petitioner appeared at the hearing, represented by Ron Johnson, attorney. Arun Lall, M.D. (Dr. Lall), appeared pro se. The Commission did not appear. At the close of the hearing, the record remained open until December 12, 2001, to receive written final arguments.

II. LEGAL AUTHORITY

Certain categories of health care identified by the Commission require preauthorization, which is dependent upon a prospective showing of medical necessity. LABOR CODE § 413.014; 28 TEX. ADMIN. CODE (TAC) § 134.600. As clarified in an advisory entitled “Prospective Review of Intra Discal Electro Thermal Treatment (IDET),” the Commission stated it did not include IDET as a normative course of treatment in the amended Spine Treatment Guideline (effective February 1, 2000) because there were no existing scientific studies to support the use of IDET as a normal course of treatment. Commission Advisory 2001-04 (signed April 11, 2001). However, although IDET is not spinal surgery for purposes of the spinal surgery second opinion process under 28 TAC § 133.206, preauthorization is required pursuant to 28 TAC § 134.600(h)(1) if the IDET procedure is performed as ambulatory surgical center care. Commission Advisory 2001‑04.

III. EVIDENCE AND ARGUMENTS PRESENTED

A. Background

IDET is a method of management for chronic discogenic low back pain. During the procedure, the physician inserts a catheter into the painful disc and applies controlled levels of thermal energy (heat) to a broad section of the affected disc to alter the structure and sensitivity of the disc wall. Among the desired effects of the procedure are contraction of collagen tissue and desensitization of the nerve tissue within the disc.[1]

Claimant is a 31 year old female who sustained a work-related injury on_______, that resulted in severe lower back pain. A November 16, 1999, MRI of her lumbar region revealed disc herniation at the L5-S1 level. Claimant was treated by various health care providers and ultimately was referred to Dr. Lall who conducted an initial evaluation on January 17, 2001. Based on the MRI and the initial evaluation, Dr. Lall diagnosed Claimant as having lumbar intervertebral disc displacement and lumbar radiculopathy. Dr. Lall performed a discography on April 9, 2001, and that same day sent Claimant to another imaging facility for a post-discography CT scan.

Upon review of the discogram results, Dr. Lall determined Claimant was a candidate for IDET and requested preauthorization. Carrier denied preauthorization citing the following: IDET is still an investigational procedure whose long-term effects and efficacy are unknown; Claimant has some radicular symptoms; a discogram was performed, but the concordance of pain is unknown; the Spine Treatment Guideline does not address IDET as an acceptable treatment for back pain; and Claimant has multilevel disease and the success of IDET in this situation is unknown.

On July 17, 2001, Dr. Lall filed a request for medical dispute resolution. Concurring with the opinion of an independent medical examiner, Son Ngugen, M.D., MRD issued an order for Dr. Lall to perform IDET for Claimant as ambulatory surgical center care.

B. Whether IDET is a reasonable and medically necessary treatment for Claimant

Carrier presented testimony from John Yatsu, M.D., a board certified general surgeon. He stated that IDET does not have a “long-term track record” but represents a deviation from the Guideline recommendations. Dr. Yatsu noted IDET was developed by the Saal brothers at Stanford University. Carrier argues the Saal brothers’ study published in Spine[2] and their two-year follow-up presented at the October, 2000, meeting of the North American Spine Society indicate IDET can be safe and effective but only for the controlled population used in their study.

The inclusion criteria set forth by the Saal brothers is the following: (1) unremitting, persistent low back pain of at least 6 months duration; (2) lack of satisfactory improvement with a comprehensively applied non-operative care program including back education, activity modification, progressive intensive exercise, at least one fluoroscopically guided epidural corticosteroid injection, a trial of manual physical therapy, and oral anti-inflammatory medication; (3) normal neurologic exam; (4) negative straight leg raise; (5) an MRI that did not demonstrate a neural compressive lesion; and (6) discography demonstrating concordant pain at low pressurization [i.e., at less than or equal to 1.25 cc’s or 1millilitre (ml) dye volume] at one or more levels.[3] As an additional inclusion criterion, Dr. Yatsu interpreted the Saal brothers’ study to require a prospective IDET candidate to also be a candidate for interbody fusion surgery and to have either an orthopedic or neurosurgical opinion expressing such. (Ex. No. 2, p.3)

Carrier contends Claimant failed to meet two of the Saals’ inclusion criteria: (1) in Claimant’s discography report, Dr. Lall described dye volumes of 1.8 and 2.00 cc’s at low pressurization; and (2) there is no documentation (i.e., no orthopedic or neurosurgical opinion) that Claimant is a candidate for interbody fusion. For these reasons, Claimant asserts Dr. Lall failed to demonstrate that IDET was the proper treatment for Claimant.

Dr. Lall, however, testified Claimant met all of the Saals’ inclusion criteria. Regarding the discography report, Dr. Lall stated Claimant had experienced concordant pain at less than 1 ml dye volume and thus met the inclusion criterion. He pointed out that, at the radiologist’s request, he had purposely used additional dye volumes of 1.8 and 2.00 cc’s to prevent dye absorption. Dr. Lall explained he did so because that same day he was sending Claimant to another imaging location for a post-discography CT scan and that CT scan could possibly have taken place up to three or four hours after Dr. Lall performed the discography. He further testified Claimant had exhausted all physical therapy, had not one but three epidural injections, had negative straight leg raises, and had taken oral anti-inflammatory medications over a year. Lastly, Dr. Lall totally rejected Dr. Yatsu’s assertion that being a candidate for interbody fusion surgery is an additional inclusion criterion for IDET.

Dr. Lall argued Claimant had a normal neurologic examination, her lumbar MRI did not reveal a neural compressive lesion, and discography of Claimant’s lumbar region revealed annular tears at the L4-L5 and L5-S1 levels. Dr. Lall asserted that, based on his review of Claimant’s medical history, the nature of her injury, the results of his physical examination of Claimant, a review of all available diagnostic tests, and Claimant’s failure to improve with various conservative measures over an 18-month period, he concluded Claimant was a candidate for IDET.

IV. ANALYSIS AND DECISION

The ALJ concurs with MRD’s determination that IDET for Claimant is reasonably required with the meaning of LABOR CODE §§408.021 and 401.011 (19). The ALJ finds that the testimony and evidence presented by Dr. Lall is more persuasive than that of Dr. Yatsu. First and foremost, Dr. Lall pointed out that, in April, 1999, he was trained in IDET at Stanford by the Saal brothers-- that is, by the very same physicians who developed the procedure and on whose inclusion criteria Dr. Yatsu and Carrier rely. Additionally, Dr. Lall testified that since May, 1999, he has performed approximately 25 IDET procedures a year. Dr. Yatsu, on the other hand, testified he has not had an active surgical practice in the last two years.

After reviewing the Saal brothers’ study and follow-up paper presented in October, 2000, the ALJ agrees with Dr. Lall that the Saals’ inclusion criteria do not include a requirement that an IDET prospect also must be a candidate for interbody fusion surgery. This ALJ concurs with the reading of the Saals’ study and their inclusion criteria set forth by the ALJ in SOAH Docket No. 453-00-1565.M2, footnote no.4. That is, as noted by the ALJ in that case, the Saals study lists six inclusion and three exclusion criteria to determine whether an individual is a candidate for IDET. Despite Dr. Yatsu’s contention expressed in Ex. No.2, nowhere in the Saals’ study is it stated an additional inclusion criterion is that a candidate for IDET must have either an orthopedic or neurosurgical opinion declaring the individual is a candidate for interbody fusion.

Furthermore, Dr. Lall testified Claimant met all the Saals’ inclusion criteria. In response to Carrier’s assertion that Claimant did not meet the sixth inclusion criterion, that is, discography demonstrating concordant pain at low pressurization, Dr. Lall provided a persuasive explanation. He testified Claimant experienced concordant pain at less than 1 ml dye volume; however, at the radiologist’s request, he purposely used additional dye to prevent dye absorption because Claimant was scheduled for a post-discography CT scan later that same day at a different location.[4]

Based on the above discussion, the ALJ finds that IDET for HV in an ambulatory surgical center is reasonably required and grants Dr. Lall’s request for preauthorization for performing the procedure as ambulatory surgical center care.

V. FINDINGS OF FACT AND CONCLUSIONS OF LAW

FINDINGS OF FACT

  1. On_________, ____ (Claimant) sustained a work-related injury that resulted in severe lower back pain.
  2. An MRI of Claimant’s lumbar region on November 16, 1999, revealed disc herniation at the L5-S1 level.
  3. Claimant’s injury is covered by American Home Assurance Company (Carrier) for worker’s compensation insurance.
  4. Arun Lall, M.D., conducted an initial evaluation of Claimant on January 17, 2001, and diagnosed Claimant as having intervertebral disc displacement and lumbar radiculopathy.
  5. On April 9, 2001, Dr. Lall performed a discography on Claimant’s lumbar region that revealed annular tears at the L4-L5 and L5-S1 levels.
  6. On April 9, 2001, Dr. Lall sent Claimant to another imaging facility for a post-discography CT scan.
  7. In April, 2001, Dr. Lall concluded Claimant was a candidate for intradiscal electro thermal therapy (IDET) and requested preauthorization for the procedure at an ambulatory surgical center.
  8. On May 1 and July 10, 2001, Carrier denied preauthorization for IDET, and on July 19, 2001, Dr. Lall filed a request with the Workers’ Compensation Commission’s (Commission) for medical dispute resolution.
  9. On August 30, 2001, upon consideration of the parties’ dispute, the Commission’s Medical Review Division (MRD) issued a decision ordering Carrier to pay the reasonable and necessary costs for the requested procedure.
  10. Carrier filed a request for hearing to contest the findings and decision of the MRD.
  11. On October 11, 2001,the Commission provided notice of the contested hearing in this matter to all parties. The notice of hearing 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 the particular sections of the statutes and rules involved; and a short, plain statement of the matters to be considered.
  12. On November 27, 2001, Administrative Law Judge Carol Wood convened a hearing on the matter in Austin, Texas, and both Carrier and Dr. Lall appeared.
  13. IDET is a method of management for chronic discogenic low back pain.
  14. During the procedure, the physician inserts a catheter into the painful disc and applies controlled levels of thermal energy (heat) to a broad section of the affected disc to alter the structure and sensitivity of the disc wall.
  15. Among the desired effects of the procedure are contraction of collagen tissue and desensitization of the nerve tissue within the disc.
  16. IDET was developed by Drs. Joel and Jeffrey Saal at Stanford University.
  17. The inclusion criteria set forth by the Saal brothers is the following:
    1. unremitting, persistent low back pain of at least 6 months duration;
    2. lack of satisfactory improvement with a comprehensively applied non-operative care program including back education, activity modification, progressive intensive exercise, at least one fluoroscopically guided epidural corticosteroid injection, a trial of manual physical therapy, and oral anti-inflammatory medication;
    3. normal neurologic exam;
    4. negative straight leg raise;
    5. an MRI that did not demonstrate a neural compressive lesion; and
    6. discography demonstrating concordant pain at low pressurization [i.e., at less than or equal to 1.25 cc’s or 1millilitre (ml) dye volume] at one or more levels.
  18. In April, 1999, Dr. Lall was trained in IDET at Stanford by the Saal brothers who developed the IDET procedure.
  19. Since May 1999, Dr. Lall has performed approximately 25 IDET procedures a year.
  20. Claimant met all the Saals’ inclusion criteria set forth in their article entitled “Management of Chronic Discogenic Low Back Pain with a Thermal Intradiscal Catheter: A Preliminary Report,” published in 25 Spine 388 (2000), and in their two-year follow-up presented at the October, 2000, meeting of the North American Spine Society.
  21. After her injury on_________, Claimant exhausted all physical therapy, had three epidural injections, had negative straight leg raises, and took oral anti-inflammatory medications for over a year.
  22. Claimant had a discography on April 9, 2001, demonstrating concordant pain at low pressurization, i.e., at less than 1 ml dye volume.
  23. Son K. Nguyen, M.D., an independent medical examiner of the Commission’s choice, concurred with Dr. Lall that Claimant was a candidate for IDET.

CONCLUSIONS OF LAW

  1. The Texas Workers’ Compensation Commission (Commission) has jurisdiction to decide the issue presented, pursuant to the Texas Workers’ Compensation Act, TEX. LABOR CODE (LABOR CODE) § 413.031.
  2. 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. LABOR CODE § 413.031(d) and TEX. GOV’T CODE (GOV’T CODE) ch. 2003.
  3. Adequate and timely notice of hearing was provided pursuant to the Administrative Procedure Act, GOV’T CODE §2001.052.
  4. 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. LABOR CODE § 408.021(a).
  5. The Commission shall specify which health care treatments and services require express preauthorization. LABOR CODE § 413.014.
  6. Health care treatments and services such intradiscal electro thermal therapy (IDET) performed as ambulatory surgical center care must be preauthorized pursuant to 28 TEX. ADMIN. CODE (TAC) §134.600(h)(1).
  7. The requestor, Dr. Lall, has provided a sound clinical rationale and the necessity of IDET for Claimant performed as ambulatory surgical center care, pursuant to 28 TAC § 134.1001(e).
  8. Based on Findings of Fact Nos. 18 - 21, IDET performed as ambulatory surgical center care is a reasonable and necessary treatment for Claimant.

ORDER

THEREFORE, IT IS ORDERED that the request of Dr. Arun Lall for preauthorization of intradiscal electro thermal therapy (IDET) for Claimant ___ performed as ambulatory surgical center care be granted and American Home Assurance Company pay the reasonable and necessary costs for the treatment per the Texas Workers’ Compensation Act and Commission Rules.

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 decision was mailed. 28 TAC §148.22(h).

Issued this 8th day of February, 2002.

STATE OFFICE OF ADMINISTRATIVE HEARINGS

CAROL WOOD
Administrative Law Judge

  1. Saal and Saal, “Management of Chronic Discogenic Low Back Pain with a Thermal Intradiscal Catheter: A Preliminary Report,” 25 Spine 388 (2000).
  2. Id.
  3. Id. See Ex. No.1, pp. 47 and 91.
  4. The facts in this case are unlike those in Docket No. 453-00-1565.M2, wherein the doctor who administered the discography on the claimant failed to testify that concordant pain was produced “at less than 2mL dye volume.”
End of Document
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