The Full Board at its meeting on June 19, 2012, considered the above captioned case for Mandatory Full Board Review of the Board Panel Memorandum of Decision (MOD) filed September 21, 2011.
The issue presented for Mandatory Full Board Review is whether the implantation of a bilateral deep brain stimulator for control of the claimant's chronic neuropathic pain should be authorized pursuant to Workers' Compensation Law (WCL) § 13-a.
In a reserved decision filed on December 13, 2010, the Workers' Compensation Law Judge (WCLJ) resolved the C-8.1A issue in favor of the group self-insured trust (GSIT), denying the authorization for a deep brain stimulator.
The Board Panel majority modified the WCLJ decision, authorizing the implantation of a deep brain stimulator and the associated pre-surgical testing and post-surgical monitoring requested by claimant's treating physician, Dr. Kaplitt. The Board Panel majority reached its decision based on the failure of the GSIT to base its objection on a conflicting second opinion rendered by a Board authorized physician, Dr. Kaplitt's credible opinion that the deep brain stimulator will successfully control the claimant's neuropathic pain, and the conclusion that the claimant is more likely to benefit from the deep brain stimulator as there is objective evidence indicating that she previously responded well to a trial of spinal stimulation.
The dissenting Board Panel member determined that authorization for a bilateral deep brain stimulator must be denied as Dr. Kaplitt has requested authorization for a surgical procedure that has been approved for treatment of Parkinson's and other motion related conditions, but has not been approved for the relief of pain.
In its application for Mandatory Full Board Review, the GSIT asserts that the Board Panel's MOD should be reversed as Dr. Kaplitt never testified that the implantation of the bilateral deep brain stimulator was causally related to claimant's work-related injury, the implantation request is not approved by the FDA for the treatment of pain, and an intrathecal pain pump is a less risky and less expensive alternative. The GSIT also argues that the implantation of a deep brain stimulator should be denied as the procedure has not gained general acceptance in the medical community
Upon review, the Full Board votes to adopt the following findings and conclusions.
This case is established for work related injuries to the claimant's neck and back, which occurred on July 1, 2003. The case was amended to include a transient aggravation of a preexisting reflex sympathetic dystrophy (RSD) condition following the attempted surgical placement of a cervical stimulator on April 18, 2008, and through February 9, 2009. The cervical stimulator was implanted by Dr. Benzil, but the procedure failed based on monitor irritability that occurred upon insertion of the stimulator (see May 2, 2008, medical narrative of Dr. Benzil).
In a C-4AUTH (Attending Doctor's Request for Authorization and Carrier's Response) filed with the Board on July 26, 2010, the claimant's treating physician, Dr. Kaplitt requested the implantation of a bilateral deep brain stimulator for relief of the claimant's severe neuropathic pain. In the attached June 2, 2010, medical narrative, Dr. Kaplitt states that he does not recommend a second attempt at implantation of the spinal cord stimulator, but instead recommends the implantation of a deep brain stimulator.
In that portion of the C-4AUTH entitled "Carrier's Response to Authorization Request," the GSIT states that the deep brain stimulator is not recognized by the New York Medical Fee Schedule and has not been approved by the FDA.
The GSIT filed a C-8.1A on July 26, 2010, denying authorization for the bilateral deep brain stimulator, indicating that the medical appliance or program is not covered under the WCL. A conflicting second opinion was not attached to the GSIT's C-8.1A.
In an RFA-1 (Claimant's Request For Further Action) filed on July 28, 2010, the claimant requested an administrative determination or conciliation hearing based on the GSIT's denial of the request for authorization of a bilateral deep brain stimulator.
At a hearing held on September 13, 2010, the WCLJ held the C-8.1A issues in abeyance and scheduled the deposition testimony of Dr. Kaplitt on the issue of the necessity of the deep brain stimulator.
At a deposition held on October 28, 2010, Dr. Kaplitt testified that his specialty is neurological surgery. The claimant presently has ongoing pain that is not responding adequately to medical therapy. The claimant was referred to him to determine the propriety of performing another spinal cord stimulator implantation. He is of the opinion that there was too much risk associated with attempting another spinal cord stimulator implant based on the injury that resulted from the first attempt and the narrow spacing in the claimant's spinal column. The only reasonable alternative would be to consider the implantation of a deep brain stimulator system, which is used with patients with neuropathic pain. The device has been approved by the FDA for movement disorders such as Parkinson's disease and tremor, but not specifically for the treatment of pain. Studies do not support a finding that spine stimulation is "much safer" than brain stimulation. He has written a chapter in the definitive book on neurosurgery dealing with the implantation of brain stimulators. The claimant previously had a positive response to neuro-stimulation and as a result, is a good candidate for a brain stimulator implant. If the surgery is ultimately approved, he would perform the surgery. Over the last ten years, he has done ten brain implants for pain and 40 to 50 each year of the past ten years for other reasons, such as the treatment of Parkinson's disease. In the claimants' case, he would do a trial stimulator first and implant the stimulator permanently only if the claimant derived a benefit from the trial stimulator.
On cross-examination, Dr. Kaplitt testified that two-thirds of the patients who have this procedure done see a relief in their pain symptoms, and since the claimant previously had a successful neuro-stimulation trial, that she is even more likely to have a positive outcome. However, the deep brain stimulator device has not been approved by the FDA for this purpose. There is a low risk of hemorrhage (1%) and infection (roughly 5%) from this procedure, and a slight risk that the device could break or disconnect or migrate away from its target. The claimant could have up to six follow up appointments to reprogram the device within two months of its implantation. A patient who undergoes a deep brain stimulator implantation is seen annually, and will also be seen once the battery in the device has reached its end life. In order for the implantation to be successful, he believes the claimant's pain level would have to go down from six to eight out of ten to three out of ten. FDA approval has not been secured for use of the deep brain stimulator for pain as there are not enough candidates for brain stimulation, who are not candidates for spinal stimulation, to justify the cost of undergoing a study of the issue. The claimant might be a candidate for an intra-thecal pain pump, but generally these pumps are prescribed for patients experiencing nociceptive pain, not the neuropathic pain that he claimant suffers from. The deep brain stimulator is more likely to help the claimant based on the history she provided and the medical literature, but he would not be opposed to the claimant trying a pain pump first. He does not have any concerns with the fact that implantation of the deep brain stimulator involves brain surgery. The claimant is more likely to benefit from the brain stimulator than from a pain pump as she has already responded well to the spinal stimulation. He has no major objection to testing the claimant for an intra-thecal pain pump before reconsidering the implantation of a deep brain stimulator, but he remains of the opinion that she is more likely to benefit from the deep brain stimulator.
Denial of Authorization
Workers' Compensation Law (WCL) § 13-a(5) provides that "No claim for specialist consultations, surgical operations, physiotherapeutic or occupational therapy procedures, x-ray examinations or special diagnostic laboratory tests costing more than one thousand dollars shall be valid and enforceable, as against such employer, unless such special services shall have been authorized by the employer or by the board, or unless such authorization has been unreasonably withheld, or withheld for a period of more than thirty calendar days from receipt of a request for authorization, or unless such special services are required in an emergency, provided, however, that the basis for a denial of such authorization by the employer must be based on a conflicting second opinion rendered by a physician authorized by the board." (See also 12 NYCRR 325-1.4).
The Full Board finds, upon review of the evidence of record, that the implantation of a deep brain stimulator is authorized as the GSIT failed to abide by WCL § 13-a(5), and the C-8.1A issue is resolved in favor of the medical provider. While the GSIT filed C-8.1A objecting to the proposed procedure, the GSIT failed to submit a conflicting second medical opinion rendered by a Board authorized physician as required by WCL § 13-a(5) and 12 NYCRR 325-1.4. There is no medical report containing a contrary medical opinion attached to the GSIT's July 26, 2010, C-8.1A objection, nor was any conflicting medical evidence subsequently filed with the Board between that date and the September 13, 2010, hearing on this issue.
The Full Board additionally finds that the failure of the GSIT to produce the required contrary medical evidence also defeats its contention that alternatives, such as the intra-thecal pain pump, should be tried before the deep brain stimulator is authorized. This contention is simply not supported by the medical evidence of record, despite Dr. Kaplitt's concession that he would not object to trying the pain pump before the deep brain stimulator is utilized. Dr. Kaplitt also testified that claimant is more likely to benefit from the deep brain stimulator than from a pain pump as she has already responded well to the spinal stimulation.
The employer and/or its insurance carrier must provide prompt medical treatment for an injured employee, covering "such medical, dental, surgical, optometric or other attendance or treatment, nurse and hospital service, medicine, optometric services, crutches, eye-glasses, false teeth, artificial eyes, orthotics, prosthetic devices, functional assistive and adaptive devices for such period as the nature of the injury or the process of recovery may require" (WCL § 13[a] [emphasis added]). There is a "fundamental principle that the Workers' Compensation Law is to be liberally construed to accomplish the economic and humanitarian objects of the act. Consistent with this purpose the phrase 'other attendance or treatment' in WCL § 13(a) has been broadly interpreted in the past. (Matter of Smith v Tompkins County Courthouse, 60 NY2d 939  [internal citations omitted]).
The Full Board finds, upon review of the evidence of record, that the GSIT's contention that the deep brain stimulator implantation should be denied as its use for the treatment of pain has not been approved by the FDA, is without merit. The Board has previously authorized the use of a medical procedure for treatment not previously approved by the FDA (see Matter of Lake George Camping Equipment, 2008 NY Wrk Comp 50415507). That the use of a deep brain stimulator has not been expressly approved by the FDA for the treatment of pain does not prevent the Board from directing that the GSIT pay for that treatment when, as here, there is credible medical evidence that the device is necessary for the treatment of claimant's causally related symptoms.
The Full Board finds, upon review of the evidence of record, that the issue as to whether Dr. Kaplitt provided a medical opinion as to the causal relationship of the proposed treatment need not be considered by the Board pursuant to Board Rule 300.13(e)(1)(iii). The GSIT's argument that Dr. Kaplitt failed to provide an opinion as to causal relationship was raised for the first time in its Full Board Review application. These issues were not raised in its C-8.1A objection, at the September 13, 2010, hearing, or in the GSIT's memorandum of law to the WCLJ. Moreover, this claim is established for the neck and back and the medical evidence in the record reflects that claimant has consistently experienced pain as the result of her causally related injury since it occurred in 2003.
Based upon the above, the Full Board finds that the implantation of a bilateral deep brain stimulator for control of the claimant's chronic neuropathic pain is authorized pursuant to WCL § 13-a.
Accordingly, the Full Board votes to MODIFY the WCLJ reserved decision filed on December 13, 2010, in order to authorize the implantation of a bilateral deep brain stimulator and the associated pre-surgical testing and post-surgical monitoring requested by claimant's treating physician, Dr. Kaplitt. No further action is planned at this time.