DECISION AND ORDER

R.S. Medical (Petitioner) appealed the decision of the Texas Workers= Compensation Commission’s (Commission) designee, an independent review organization (IRO), in MDR Docket No. M2-04-1355-01, which upheld the denial by the City of Carrollton (City) of preauthorization of the indefinite rental or purchase of a medical device called a RS-4i for use by a workers= compensation claimant (Claimant). The denial was based on its finding that the RS-4i was not medically necessary healthcare. This decision finds that the device is medically necessary healthcare for Claimant but that Petitioner is not entitled to reimbursement for rental of the device prior to the date of this Decision and Order.

I. JURISDICTION, NOTICE, AND PROCEDURAL HISTORY

There were no contested issues of jurisdiction, notice or venue. Therefore, those issues are addressed in the findings of fact and conclusions of law without further discussion here.

The hearing in this matter convened April 12, 2005, at the State Office of Administrative Hearings, 300 W. 15^th Street, Austin, Texas, with Administrative Law Judge (ALJ) Ann Landeros presiding. The record also closed that date. Petitioner was represented by its designated employee representative, Patrick Cougill. Attorney William Weldon represented the City. The Commission did not participate in the hearing.

II. DISCUSSION

A. Background Facts

In ___, Claimant sustained an injury to his back compensable under the Texas Workers’ Compensation Act (Act). At the time of the compensable injury, the City was self-insured for workers’ compensation coverage. The injury left Claimant with low back pain for which he takes narcotic drugs and muscle relaxants. In October 2003, Claimant’s treating physician, Jonathan Blau, M.D., prescribed the RS-4i, an interferential and muscle stimulator device approved by the FDA for use to relieve chronic pain, for a two-month trial period.

Claimant rented the RS-4i from Petitioner at the rate of $250 a month plus the cost of supplies. In March 2004, Dr. Blau renewed the prescription for an indefinite period. Because the

prescription renewal sent the cost over $500, Petitioner sought preauthorization for Claimant’s long-term rental or purchase of the RS-4i.

The City denied preauthorization, claiming the RS-4i is the functional equivalent of a TENS unit, is not useful for treatment of chronic pain, and is not medically necessary durable medical equipment for Claimant. In July 2004, the IRO reviewer sustained the denial, writing:

Enclosed office notes [through January 2004] did not substantiate the continued benefit of the trial interferential stimulator unit. Office notes do not reflect a reduction in his use of opiates, nor did they include any increase in function. The office notes indicated that the claimant continues with fairly high levels of pain and is well past the acute care since the injury started in 2002. It is noted that therapies such as the RS4i are not productive in treating chronic low back pain. In fact, the use of TENS units in a med-analysis in another study showed no significant benefits following the first month of use. (Pet. Ex. 1, p. 50).

Petitioner timely appealed the IRO’s decision upholding the denial. Petitioner seeks preauthorization retroactive to the date of Dr. Blau’s renewal prescription.

B. Evidence

Petitioner presented the testimony of Claimant and its insurance relations manager, Susan Keesee and various documents. Carrier presented only documentary evidence.

Petitioner

Claimant testified that he suffers from chronic pain in his low back and legs. Most days he takes at least one hydrocodone and one Skelexin pill and wears a Duragesic 75 micron patch for pain relief. His goal is to keep his drug use to a minimum. Using the RS-4i device significantly reduces his pain and allows him to reduce his use of narcotics and muscle relaxants. He uses the device daily, except when traveling. According to the RS-4i’s on-board data memory, Claimant has been using the device regularly since October 2003. Claimant reported that he uses the device in place of muscle relaxing medications. Comparing the RS-4i with a TENs unit, which he used in the first eight months post-injury, Claimant stated he gets more relief from the RS-4i because it seems to reach deeper tissue.

Petitioner’s employee Ms. Keesee testified she is a registered nurse whose job includes training on the use of the RS-4i. She is familiar with the Federal Drug Administration’s (FDA) approval process as it relates to the device. As shown in the FDA’s approval letter for the device, it is approved for use to relieve and manage chronic pain. (Pet. Ex.1, p. 42).

Ms. Keesee denied tht the RS-4i is a TENs unit. The devices differ in that, while both are muscle stimulators, the RS-4i also has an interferential mode. In its interferential mode, the RS-4i uses two different frequencies of electric current. When currents interfere with each other, the resulting electric signal is thought to block the Apain gate in the nerve and provide pain relief and reduce muscle spasms. Because there is less skin resistence, which causes pain, with the RS-4i than

with a TENS unit, the patient can use higher amplitudes of current and get deeper into the tissue with the RS-4i.

According to Ms. Keesee, during use, the RS-4i automatically alternates between the interferential current mode and the muscle stimulator mode. The former provides pain relief, while the latter helps re-educate and improve the muscle by increasing circulation, improving tone, and restoring function.

Ms. Keesee also stated that the Commission’s rules did not require preauthorization for durable medical equipment (DME) until the provider had a reason to believe the cost would exceed $500. Therefore, Petitioner did not seek preauthorization for the first two months rental of the device because the cost for that rental was under the threshold amount of preauthorization. She stated that Petitioner had to seek preauthorization only before billing for amounts over the $500 DME threshold. Therefore, Petitioner did not need preauthorization before providing the device to Claimant, but only before billing for amounts over $500. Petitioner did not know its bill would exceed $500 until Dr. Blau wrote the renewal prescription, so it did not seek preauthorization until that time.

If preauthorization is granted, Ms. Keesee stated Petitioner would be entitled to reimbursement for the rental of the RS-4i back to the date of the prescription.

City

City presented documentary evidence which included the IRO decision, Dr. Blau’s office notes for Claimant from September 2003 through February 2004, pages that appear to be from other IRO decisions denying purchase of a muscle stimulator device, and an abstract from the journal Physical Therapy, that concluded TENS units are not effective in treating low back pain.^[1] (City Ex. 1, p.12).

In additional to denying that the RS-4i is medically necessary for Claimant, the City also argued that preauthorization can only be prospective so that Petitioner is not entitled to reimbursement for the cost of DME provided prior to preauthorization. Petitioner asserted that the City had waived this argument by not raising it before the IRO.

C. Legal Standards

Petitioner has the burden of proof in this proceeding. 28 TAC ” 148.21(h) and (i); 1 TAC 155.41. Pursuant to the Act, 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). Health care includes all reasonable and necessary medical services including a medical appliance or supply. TEX. LAB. CODE

ANN. ‘ 401.011(19)(A). A medical benefit is a payment for health care reasonably required by the nature of the compensable injury. TEX. LAB. CODE ANN. ‘ 401.011(31). The IRO was authorized to hear the medical dispute pursuant to 28 TAC ‘ 133.308.

For a carrier to be liable for reimbursement of durable medical equipment, the DME must be preauthorized unless the item costs less than $500. 28 TAC ‘ 134.600. Preauthorization is a prospective approval obtained from the insurance carrier by the requestor or injured employee prior to providing the health care treatment or services. 28 TAC 134.600(a)(5).

D. Analysis

Petitioner met its burden of proof to show that the RS-4i is medically necessary healthcare for Claimant and should be preauthorized. Claimant testified that the RS-4i reduces his pain. One objective measurement of the efficacy of the device is that Claimant is able to reduce his use of muscle relaxers and narcotics when he uses the RS-4i. A medical device that reduces the pain from a compensable injury is medically necessary healthcare as defined in TEX. LAB. CODE ANN. ‘ 408.021(a).

Carrier’s citation to studies that have found TENS units ineffective at reduction of low back pain were not enough to rebut Claimant’s testimony. The RS-4i can reach deeper tissue than the TENS units and while a TENS unit is a muscle stimulator, the RS-4i combines a muscle stimulator with interferential mode. Because the RS-4i does not have the same limitations as a TENS units, it is not clear the RS-4i suffers from the same inadequacies that the cited abstract noted in the TENS units. Claimant’s testimony that the RS-4i relieves pain, coupled with his reduced use of pain medication, was more persuasive than the City’s documentary evidence.

Petitioner is not entitled to reimbursement for providing the RS-4i to Claimant before the date of this decision because the DME was provided before preauthorization was obtained. The Commission’s rule at 28 TAC 134.600(a)(5) could not be clearer-when preauthorization for DME is required, it must be obtained before the device is provided or the carrier is not required to reimburse for the DME. As to Petitioner’s assertion the City waived its retroactive preauthorization argument, neither party can waive the requirements of the Commission’s rule. Additionally, if the concept of waiver applies here, Petitioner failed to establish the scope of the City’s argument to the IRO to show waiver. To be entitled to reimbursement, Petitioner needed to obtain preauthorization before it provided the RS-4i to Claimant.

III. FINDINGS OF FACT

1. Claimant sustained a compensable injury in ___.
2. At the time of the injury, the City of Carrollton (City) was self-insured for workers= compensation insurance coverage for Claimant.
3. Claimant suffers from chronic low back pain that requires him to wear a narcotic patch and take hydrocodone and Skelexin medication to control pain and reduce muscle spasms.
4. Beginning with a two month trial period in October 2003, RS Medical (Petitioner) has continuously provided the RS-4i device to Claimant.
5. In March 2004, Claimant’s treating doctor, Jonathan Blau, M.D., renewed Claimant’s prescription for an interferential and muscle stimulator device, the RS-4i.
6. The RS-4i is approved by the Federal Drug Administration for use to relieve chronic pain.
7. The RS-4i operates in two sequential modes, interferential (two electric current frequencies interfere with each other to produce an electric signal that may block nerve pain) and muscle stimulator (which mechanically moves the muscles to improve tone, function, and blood circulation).
8. Petitioner rents the RS-4i for $250 a month plus the cost of supplies while the device costs $2,495 to purchase.
9. An open-ended rental or purchase of the RS-4i will cost more than $500.
10. After Dr. Blau wrote the renewal prescription, Petitioner sought preauthorization for Claimant’s indefinite use or purchase of the RS-4i from the City.
11. The City denied Petitioner’s preauthorization request.
12. Petitioner appealed the denial to the Commission, which referred the appeal to an IRO. The IRO upheld the City’s denial of preauthorization.
13. Petitioner timely appealed the IRO decision.
14. Pursuant to the Commission Staff’s notice of hearing, all parties appeared or were represented at the hearing held April 12, 2005.
15. Since October 2003, Claimant has used the RS-4i on a regular basis.
16. Use of the RS-4i reduces Claimant’s low back pain and allows him to reduce the amount of muscle relaxers and narcotic medications he otherwise needs for pain relief.
17. The RS-4i is medically necessary healthcare for Claimant.

IV. CONCLUSIONS OF LAW

1. The Texas Workers= Compensation Commission (Commission) has jurisdiction over this matter pursuant to the Texas Workers’ Compensation Act (Act), TEX. LAB.CODEANN. ‘ 413.031.
2. The State Office of Administrative Hearings has jurisdiction over this proceeding, including the authority to issue a decision and order, pursuant to ‘ 413.031(d) of the Act and TEX. GOV=TCODE ANN. ch. 2003.
3. The IRO was authorized to hear the medical dispute pursuant to 28 TEX. ADMIN. CODE (TAC) §133.308.
4. The hearing was conducted pursuant to the Administrative Procedure Act, TEX. GOV’T CODE ANN. ch. 2001 and the Commission’s rules, 28 TAC § 133.308(u).
5. Adequate and timely notice of the hearing was provided in accordance with TEX. GOV=T CODE ANN. ” 2001.051 and 2001.052.
6. Petitioner had the burden of proof in this proceeding. 28 TAC ” 148.21(h) and (i); 1 TAC ‘ 155.41.
7. Pursuant to the Act, 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).
8. Health care includes all reasonable and necessary medical services. TEX. LAB. CODE ANN. ‘ 401.011(19)(A). A medical benefit is a payment for health care reasonably required by the nature of the compensable injury. TEX. LAB. CODE ANN. ‘ 401.011(31).
9. For a carrier to be liable for reimbursement of durable medical equipment, the DME must be preauthorized unless the item costs less than $500. 28 TAC § 134.600.
10. Preauthorization is a prospective approval obtained from the insurance carrier by the requestor or injured employee prior to providing the health care treatment or services. 28 TAC 134.600(a)(5).
11. The RS-4i is reasonable and medically necessary healthcare for Claimant and should be preauthorized.
12. Petitioner is not entitled to reimbursement for Claimant’s rental or purchase of the RS-4i before the date of this Decision and Order.

ORDER

It is ORDERED that the durable medical equipment known as the RS-4i, an interferential and muscle stimulator device provided by RS Medical, is medically necessary healthcare and is preauthorized for Claimant’s use for as long as medically necessary.

It is further ORDERED that RS Medical is entitled to reimbursement for Claimant’s rental or purchase of the RS-4i beginning on the date of this Decision and Order. It is also ORDERED that RS Medical is not entitled to reimbursement from the City of Carrollton for the cost of Claimant’s rental or purchase of the RS-4i incurred before the date of this Decision or Order, if that rental or purchase cost was $500 or more.

Signed April 19, 2005.

ANN LANDEROS
Administrative Law Judge
STATE OFFICE OF ADMINISTRATIVE HEARINGS

1. Philadelphia Panel Evidence-Based clinical Practice Guidelines on Selected Rehabilitation Interventions for Low Back Pain, Physical Therapy, Volume 81, No. 10 (October 2001).↑