DECISION AND ORDER

I. DISCUSSION

American Home Assurance Company (Petitioner) appealed the Findings and Decision of the Texas Workers’ Compensation Commission (Commission) acting through MAXIMUS, an Independent Review Organization (IRO), preauthorizing the use of an interferential and muscle stimulator for a trial period by I.P. (Claimant).^[1]

This decision denies the relief sought by Petitioner.

A hearing convened on December 10, 2003, before Administrative Law Judge (ALJ) Howard S. Seitzman. Dan C. Kelley represented Petitioner. Patrick K. Cougill represented RS Medical (Respondent). Claimant^[2] testified for Respondent, as did Susan Keesee, Respondent’s Insurance Relations Manager. Brad M. Hayes, D.C., testified for Petitioner. There were no contested issues of notice or jurisdiction. The record closed following adjournment of the hearing.

Claimant sustained a work-related injury back injury on or about April 22, 2001. On April 23, 2001, she was seen by Louis Patino, D.C., who diagnosed her with lumbar radiculitis, hip sprain/strain and muscle spasm. Ruy Mireles, M.D., a neurologist, examined Claimant on May 9, 2001, diagnosed a back injury and ordered electromyographs (EMGs), a lumbar spine MRI, and motor nerve conduction velocities (NCVs) to both lower extremities. He also prescribed anti-inflammatory medicine.

W. Noran, M.D., interpreted the May 24, 2001 NCVs as indicative of left peroneal and tibial neuropathy and right sural sensory neuropathy. The somatosensory evoked potential response was indicative of abnormal neuropathic changes below the level of the cauda equina on the left and above the level bilaterally. The neuromuscular junction testing was indicative of abnormal neuropathic changes consistent with nerve root dysfunction at the L5 on the right. Dr. Noran requested clinical

correlation on all of his findings. A June 1, 2001 MRI of the lumbar spine was interpreted by Kevin E. Legendre, M.D., as revealing at the L2-3 level “broad posterior two millimeter annular disc^[3] bulge pressing against the anterior thecal sac.” At the L5-S1 level, the MRI demonstrated “posterior central two to three millimeters discal protrusion/herniation pressing against the anterior aspect of the S1 nerve root bilaterally.” The June 5, 2001 EMGs were interpreted by Dr. Mireles as normal.

Donald L. Kramer, M.D., examined Claimant on July 18, 2001, and recommended diagnostic lumbar median branch blocks to ascertain whether the joints were the anatomic pain generators. A positive response, he concluded, might make Claimant a candidate for a percutaneous facet neurectomy. In the meantime, he recommended she continue rehabilitation of her spine and strengthening of the extensor muscles.

Bilateral lumbar median branch blocks were administered on August 2, 2001, by Dr. Kramer and on September 18, 2001, he administered two myofascial trigger point injections. Dr. Kramer’s follow-up note of October 30, 2001, indicated Claimant received more than one month of total relief as a result of the lumbar median branch blocks but that the pain was “slowly recurring.” Dr. Kramer concluded that Claimant “clearly has lumbar facet arthropathy.” He suggested a repeat of the lumbar median branch blocks and administered six trigger point injections.

Ruben D. Pechero, M.D., examined Claimant on February 7, 2002, and recommended “radical diskectomy anterior approach with anterior cages” and, if needed, reinforcement with posterior instrumentation. On March 19, 2002, Dr. Kramer remarked that the trigger point injections were providing significant relief and the “effect lasted 3-4 weeks for her low back spasm.” He also commented that the scheduled surgery with Dr. Pechero was canceled because of Claimant’s “episode of uncontrolled diabetes mellitus with uncontrolled hyperextension.”^[4]

Claimant was eventually cleared for surgery and, on April 1, 2002, underwent a combined anterior and posterior diskectomy as well as spinal instrumentation and fusion from L5 to S1. On May 14, 2002, Dr. Pechero’s notes reflected that Claimant was walking with the aid of a back chair brace and a walker. Claimant complained of pain and numbness in her left leg and had apparently fallen, landing on her left side. Dr. Pechero recommended a few physical therapy sessions, continued use of the back chair brace, and weaning her off of the walker.

On October 17, 2002, Dr. Pechero noted Claimant’s fusion was in place but that consolidation was retarded. Claimant acknowledged to Dr. Pechero that she had not been wearing her bone growth stimulator.

On November 1, 2002, Claimant underwent a mental health evaluation. Twelve sessions of biofeedback and eight sessions of individual psychotherapy were recommended and commenced. On January 3, 2003, Dr. Pechero recommended a work hardening program. On January 29, 2003, Dr. Pechero’s examination notes record Claimant’s experiencing severe muscle spasms in the lumbar region affecting the dorsal area and cervical spine. The muscle spasms resulted in a

decreased range of motion. Claimant’s medications include Ultracet for pain and Celebrex for inflammation. She was prescribed Parafon Forte for muscle relaxation.

Dr. Pechero’s April 4, 2003 notes record Claimant continued to have “mid lower back” pain with radiculopathy to the lower extremities. Dr. Pechero noted Claimant had a minor stroke to the left side of her body leaving her with numbness and weakness. He noted she is recovering and is able to walk without assistance. Nexium, Celebrex, Ultracet, Skelaxin and Darvocet are prescribed.

A 10% Whole Person Impairment Rating was assessed on April 21, 2003. On May 2, 2003, Dr. Pechero’s notes indicate that although the April 25, 2003 CT scan reveals good fusion in both the cages and posterior lateral elements of L5-S1, Claimant continues to experience “mid-lower back pain.” He refilled her medication and referred her for an epidural injection.

A peer review by David G. Vanderweide, M.D., on May 5, 2003, concluded the nerve conduction studies, somatosensory evoked potentials and neuromuscular junction testing from May 24, 2001, are invalid because there is no evidence that Dr. Noran, who is based in Venus, Florida, performed the studies or that Claimant went to Venus, Florida for the procedure. Dr. Vanderweide concludes the tests were “performed outside of the guidelines recommended by the American Association of Electrodiagnostic Medicine.” Dr. Vanderweide found that Claimant’s injury was likely a lumbar strain, a self-limiting soft tissue injury, and was of insufficient magnitude “to cause disk herniation and internal derangement sufficient to warrant a 360 degree spinal instrumentation and fusion.” He opined that it was an ill-advised operation with a predictably poor outcome. “As a result of the surgical attenuations only,” he concluded, Claimant “is now significantly debilitated.” He continued, “her continued complaints of incapacitating pain, resultant mechanical instability caused by the surgery itself, and the continued use of narcotics…will contribute to both her poor daily function and her ongoing major depressive episode.”

On May 21, 2003, Ihsan Shanti, M.D., performed a transforaminal lumbar epiradicular steroid injection to relieve pain. A second lumbar epiradicular injection with lysis of adhesions was performed on July 2, 2003, by Dr. Shanti.

Dr. Patino prescribed, on March 19, 2002, an RS Medical RS-4i interferential and muscle stimulator for a two-month period for the treatment of lumbar radiculitis. The RS-4i was prescribed to relieve and manage chronic pain, relax muscle spasms, improve function, and improve movement and condition. Thereafter, on May 15, 2002, Dr. Patino requested continued use of the RS-4i for an indefinite period. In May 2003, Petitioner denied the preauthorization request and it also denied the appeal.^[5]

The August 5, 2003 IRO decision required an unspecified trial period with a rental unit to determine whether the RS-4i treatment is useful. If the unit is helpful, then the purchase of an RS-4i would be medically necessary concluded the IRO.

At the hearing, Claimant testified, through an interpreter. She has experienced sharp pain since August 2002 and continues to take pain medication. The pain was milder prior to and

immediately following surgery. The pain increased in August 2002 and the intensity has continued without change. Claimant has fallen on several occasions. Claimant initially used the RS-4i three times per week but now uses the RS-4i twice a day, every other day.^[6] It temporarily relieves discomfort in her back and low back. Claimant testified she also uses the RS-4i for contraindicated purposes. In addition to the RS-4i and the various pain medications, Claimant also uses a heating pad to relieve the pain.

The record contains no usage data from the onboard data collection system located in the RS 4i. Dr. Patino’s clinic note of September 17, 2002, memorialized a telephone conversation with Claimant. Dr. Patino recorded that Claimant is “utilizing less medication due to a reduction in pain and spasms.” He noted she has better daily functioning and, while still in moderate pain, is improving. His treatment plan on that date is to request the continued use of the RS-4i for continued rehabilitation.

Dr. Patino authored a September 17, 2002 letter of medical necessity repeating the elements of his clinic note and also included language regarding the RS-4i provided by Respondent. An April 23, 2003 Progress Report by Dr. Patino repeats the recitation of improvement, decreased pain and a reduction of muscle spasms since March 19, 2002. Finally, in response to a December 4, 2003, questionnaire prepared by Respondent, Dr. Patino recites that the RS-4i provides pain relief, reduction of muscle spasms, and is medically necessary. Dr. Patino did not testify.

The RS Medical RS-4i interferential and muscle stimulator is a class II medical device approved by the United States Food and Drug Administration (FDA) for specified indications. The general efficacy of the device is not an issue so long as the device is prescribed and used for the indications approved by the FDA. Dr. Patino prescribed the RS Medical RS-4i for FDA approved indications. Therefore, the only issue in this proceeding is whether the device is reasonable and medically necessary for Claimant as of the date of the hearing.^[7]

Dr. Hays testified about the general efficacy of the RS-4i. That portion of his testimony, for the reasons stated earlier, is not germane and is, therefore, not discussed. As to the evidence specific to Claimant, Dr. Hayes found nothing in the medical records that supported medical necessity. He remarked that the use of the RS-4i did not alter the treatment plan or the frequency of treatment. He found no evidence that it helped Claimant return to work. Further, he did not believe Claimant was a good candidate because of the minor stroke she suffered. Finally, he noted that the November 1, 2002 Mental Health Assessment recites the pain reducing factors she related to the interviewer. While medication, relaxation, meditation and redirecting thoughts are listed, Dr. Hayes pointed out that the RS-4i is not mentioned. Dr. Hayes believes the maximum time of use of the device would be two months.

Petitioner had the burden of proof in this proceeding. The evidence shows Claimant experienced pain and muscle spasms as a result of her work-related injury and, as anticipated by

Dr. Vanderweide, continues to experience pain and muscle spasms following the surgery for her work-related injury. Claimant uses the RS Medical RS-4i interferential and muscle stimulator on a fairly regular basis and it temporarily relieves Claimant’s discomfort. Contrary to Dr. Patino’s claims, the evidence does not support the proposition that Claimant is improving or that her pain and medication use are decreasing. Claimant’s failure to improve is consistent with Dr. Vanderweide’s prognostication that Claimant will continue to experience pain and debilitation as a result of the April 2002 surgery.

An employee who has sustained a compensable injury is entitled to all health care reasonably required by the nature of the injury 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.

Based on the evidence in the record, the RS Medical RS-4i provides relief to Claimant and is reasonable and medically necessary for indefinite use by Claimant.

II. FINDINGS OF FACT

1. (Claimant), sustained a work-related injury back injury on or about April 22, 2001.
2. On April 23, 2001, Louis Patino, D.C., diagnosed Claimant with lumbar radiculitis, hip sprain/strain and muscle spasm.
3. Ruy Mireles, M.D., a neurologist, examined Claimant on May 9, 2001, and diagnosed a back injury.
4. Dr. Mireles ordered a lumbar spine MRI, and electrodiagnostic tests. He also prescribed anti-inflammatory medicine.
5. Donald L. Kramer, M.D., examined Claimant on July 18, 2001, and administered bilateral lumbar median branch blocks on August 2, 2001.
6. On September 18, 2001, Dr. Kramer administered two myofascial trigger point injections.
7. Dr. Kramer diagnosed Claimant with lumbar facet arthropathy.
8. Ruben D. Pechero, M.D., examined Claimant on February 7, 2002, and recommended a radical diskectomy anterior approach with anterior cages and, if needed, reinforcement with posterior instrumentation.
9. The trigger point injections provided Claimant three to four weeks of relief for her low back spasms.
10. Claimant was eventually cleared for surgery on her work-related injury and, on April 1, 2002, underwent a combined anterior and posterior diskectomy as well as spinal instrumentation and fusion from L5 to S1.
11. In May 2002, Claimant complained of pain and numbness in her left leg.
12. On November 1, 2002, Claimant underwent a mental health evaluation. Twelve sessions of biofeedback and eight sessions of individual psychotherapy were recommended and commenced.
13. s of January 29, 2003, Claimant continued to experience severe muscle spasms in the lumbar region affecting the dorsal area and cervical spine.
14. The muscle spasms resulted in a decreased range of motion.
15. Claimant’s medications included Ultracet for pain, Celebrex for inflammation, and Parafon Forte for muscle relaxation.
16. As of April 2003, Claimant continued to experience pain with radiculopathy to the lower extremities.
17. Claimant also suffered a minor stroke to the left side of her body leaving her with numbness and weakness.
18. As of April 4, 2003, Claimant was able to walk without assistance and her prescriptions included Nexium, Celebrex, Ultracet, Skelaxin and Darvocet.
19. A 10% Whole Person Impairment Rating was assessed on April 21, 2003.
20. An April 25, 2003 CT scan revealed good fusion in both the cages and posterior lateral elements of L5-S1.
21. David G. Vanderweide=s, M.D., peer review of May 5, 2003, concluded Claimant’s injury was likely a lumbar strain, a self-limiting soft tissue injury, and was of insufficient magnitude to cause disk herniation and internal derangement sufficient to warrant a 360 degree spinal instrumentation and fusion.
22. As a result of the surgical attenuations, Claimant is now significantly debilitated, and her continued complaints of incapacitating pain, resultant mechanical instability caused by the surgery itself, and the continued use of narcotics will contribute to both her poor daily function and her ongoing depressive episodes.
23. On May 21, 2003, Ihsan Shanti, M.D., performed a transforaminal lumbar epiradicular steroid injection to relieve pain and a second lumbar epiradicular injection with lysis of adhesions was performed on July 2, 2003, by Dr. Shanti.
24. Claimant’s pain was milder prior to and immediately following surgery.
25. Claimant has experienced sharp pain since August 2002.
26. The intensity of Claimant’s pain has continued without change since August 2002.
27. Claimant continues to take pain medication.
28. Claimant has fallen on several occasions.
29. On March 19, 2002, Dr. Patino prescribed an RS Medical RS-4i interferential and muscle stimulator for a two-month period for the treatment of lumbar radiculitis. The RS-4i was prescribed to relieve and manage chronic pain, relax muscle spasms, improve function, and improve movement and condition.
30. On May 15, 2002, Dr. Patino requested continued use of the RS-4i for an indefinite period.
31. Claimant initially used the RS-4i three times per week but now uses the RS-4i twice a day, every other day.
32. The RS-4i temporarily relieves discomfort in her back and low back.
33. In addition to the RS-4i and the various pain medications, Claimant also uses a heating pad to relieve the pain.
34. The record contains no usage data obtained from the RS-4i’s onboard data collection system.
35. Because of the April 2002 surgery, it is not expected that Claimant’s condition will improve, that her pain will lessen significantly, or that her need for pain medication will decrease.
36. The RS Medical RS-4i interferential and muscle stimulator is a class II medical device approved by the United States Food and Drug Administration (FDA) for specified indications.
37. Dr. Patino prescribed the RS Medical RS-4i for FDA approved indications.
38. In May 2003, Petitioner denied the preauthorization request and it also denied the appeal as not medically necessary.
39. The preauthorization request was reviewed by MAXIMUS, an Independent Review Organization (IRO).
40. The August 5, 2003 IRO decision required a trial period to determine whether the RS-4i treatment is useful, and, if the unit is helpful, then the purchase of an RS-4i would be medically necessary.
41. The IRO decision is deemed a Decision and Order of the Texas Workers’ Compensation Commission (Commission).
42. Petitioner timely requested a hearing to contest the Commission’s decision.
43. By letter dated September 10, 2003, the Commission issued a notice of hearing.
44. Administrative Law Judge Howard S. Seitzman convened a hearing on December 10, 2003, in the hearing rooms of the State Office of Administrative Hearing. The record closed following adjournment of the hearing.
45. Dan C. Kelley represented Petitioner. Patrick K. Cougill represented Respondent.

III. CONCLUSIONS OF LAW

1. The Texas Workers’ Compensation Commission has jurisdiction to decide the issue presented pursuant to the Texas Workers’ Compensation Act, Tex. Lab. Code Ann. § 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, pursuant to Tex. Lab. Code Ann. § 413.031(k) and Tex. Gov’t. Code Ann. ch. 2003.
3. Petitioner timely requested a hearing in this matter pursuant to 28 Tex. Admin. Code (TAC) §§ 102.7 and 148.3.
4. Notice of the hearing was proper and complied with the requirements of Tex. Gov’t. Code Ann. ch. 2001.
5. An employee who has sustained 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. Tex. Lab. Code Ann. § 408.021(a).
6. Claimant is entitled to all health care reasonably required to relieve the pain and other debilitating conditions experienced as a result of the April 2002 surgery.
7. Petitioner had the burden of proof in this matter, which was the preponderance of evidence standard. 28 TAC §§ 148.21(h) and (i); 1 TAC § 155.41(b).
8. Petitioner failed to meet its burden of proof.
9. The indefinite use of an RS Medical RS-4i interferential and muscle stimulator by Claimant is reasonable and medically necessary.

ORDER

THEREFOREIT IS ORDERED that Petitioner American Home Assurance Company’s request for relief is DENIED and the preauthorization of an RS Medical RS-4i interferential and muscle stimulator for indefinite use by I.P. is GRANTED.

Signed February 6, 2004.

HOWARD SEITZMAN
Administrative Law Judge
STATE OFFICE OF ADMINISTRATIVE HEARINGS

1. The decision by the IRO is deemed to be a Commission Decision and Order.↑
2. Claimant testified by telephone, and a translator, also participating by telephone, translated between English and Spanish.↑
3. Disc is sometimes spelled disk.↑
4. The correct reference is more likely hypertension.↑
5. There is no explanation in the record as to the reason for the apparent one year separation between the May 2002 prescription and the May 2003 denial of the request for preauthorization.↑
6. Respondent allowed Claimant to retain and use the RS-4i pending resolution of the dispute.↑
7. The ALJ adopts the reasoning of ALJ Norman that the issue of medical necessity is present need, as of the date of the hearing, and not past need, as of the date of the prescription. SOAH Docket No. 453-03-4229.M2, MDR No. M2-03-1308-01; RS Medical v. City of El Paso (January 6, 2004). ↑