Decision #84/23 - Type: Workers Compensation
Preamble
The worker is appealing the decision made by the Workers Compensation Board ("WCB") that they are not entitled to coverage for a peripheral nerve stimulator implantation. A hearing was held on March 8, 2023 to consider the worker's appeal.
Issue
Whether or not the worker is entitled to coverage for a peripheral nerve stimulator implantation.
Decision
The worker is entitled to coverage for a peripheral nerve stimulator implantation.
Background
The WCB accepted the worker’s claim for an injury to their left pinky finger that occurred at work on February 12, 2018 when they were assaulted and sustained an oblique fracture. The worker underwent an open reduction and internal fixation surgery on February 21, 2018 and then attended physiotherapy. Further x-rays revealed the internal fixation screws had broken another part of the bone in the worker’s finger and a second surgery was required, which took place on March 16, 2018.
The worker reported to their treating plastic surgeon that they had ongoing sharp pain at their pinky finger and noted during physiotherapy and occupational therapy, that their hand turned purple or white if cold and they experienced a sharp pain at their pinky finger, with stiffness at the pinky, ring, and middle fingers on their left hand. Due to the worker’s ongoing complaints, the WCB requested the worker attend a call-in examination with a WCB plastic surgery consultant on July 10, 2018. On examining the worker, the consultant concluded the worker met the criteria for complex regional pain syndrome (“CRPS”), type 1. After a call-in examination with a WCB psychiatric consultant on November 6, 2018, the worker’s diagnosis was updated to left pinky finger oblique fracture, CRPS type 1, somatic system disorder and anxiety disorder.
The worker continued to receive medical treatment, including from a pain management clinic. On September 9, 2019, the WCB outlined permanent restrictions of light duties with the left hand and determined the worker was at maximum medical improvement. The WCB determined a permanent partial impairment rating and award in relation to the worker’s injuries on September 18, 2019.
On October 8, 2021, the treating plastic surgeon provided a progress report to the WCB noting the worker had “…longstanding CRPS…now on the burnout phase.” The surgeon indicated this condition was chronic, with the worker having little to no motion in their left pinky finger, daily dysesthesia, and pain, but that the worker had developed mechanisms to manage the pain. The treating surgeon indicated the worker had queried whether amputation of their finger would be beneficial, and the surgeon advised that the worker’s “…abnormal sensations in the D5 (pinky finger) would likely not disappear as these are hardwired into [their] central nervous system at this point time (sic).” The surgeon arranged another appointment to discuss the worker’s options.
The WCB’s plastic surgery consultant reviewed the report from the treating plastic surgeon in conjunction with a call-in examination of the worker on November 30, 2021. The WCB consultant concluded that the proposed surgery of a left small finger amputation was “likely appropriate” in the circumstances outlined by the treating plastic surgeon. On November 8, 2021, the WCB received a report from the treating plastic surgeon indicating the worker agreed to proceed with the amputation and the WCB approved the surgery on November 30, 2021. The surgery took place on December 1, 2021. When the worker saw the treating plastic surgeon on December 14, 2021 for a post-surgery appointment, they reported some initial increased pain after surgery but also reported day to day improvement and advised they had already returned to work. The surgeon proposed that the worker was likely to improve in function over the next few months.
On February 16, 2022, the pain management specialist noted the worker had an “…amputation of fifth digit without significant success in pain control and now continued phantom pain in fifth digit.” They recommended a trial of an ulnar nerve block and considering an implantation for peripheral nerve stimulation. On March 31, 2022, the pain management specialist advised the WCB that an ulnar nerve block performed on the worker, “…produced near complete resolution (95+% improvement)” of their CRPS and phantom limb pain, for the duration of the block. The treating specialist opined that given the worker’s symptoms were resolved with a single nerve block, the worker would be a “…prime candidate for a peripheral ulnar nerve stimulator implantation” and requested the WCB provide coverage for same.
On June 24, 2022, a WCB physical medicine and rehabilitation consultant reviewed the worker’s claim and noted their treating pain management specialist had recommended a Stim Router Neuromodulation System which was to be “…implanted adjacent to the ulnar nerve in the left distal forearm.” The consultant noted a lack of published medical data evaluating and supporting use of implantable peripheral nerve stimulator (“PNS”) devices and further, that most of the published research originated from the device manufacturer, which limited the objective conclusion that could be drawn from the research. The consultant also noted that implanted devices could provoke long term complications including irritation of the surrounding soft tissues and migration of the implanted electrode leads leading to the failure of the device. Accordingly, the consultant concluded they would not recommend support for the proposed implantation of a left distal ulnar nerve stimulator. The WCB advised the worker of the opinion and provided a decision letter on June 29, 2022 advising the WCB would not provide coverage for a PNS implantation.
The treating pain management specialist provided a letter in support of the worker’s request for approval of coverage for the implant device to the WCB on October 18, 2022 and provided articles from two medical studies supporting their position. On October 24, 2022, the worker requested reconsideration of the WCB’s decision to Review Office, relying on the letter and medical articles submitted by their treating specialist to support their request.
On October 26, 2022, Review Office returned the worker’s file to the WCB’s Compensation Services for further investigation regarding the new medical information provided by the treating pain management specialist. The WCB physical medicine and rehabilitation specialist reviewed the additional information on November 8, 2022 and confirmed their previous opinion, noting that “…there remains no material evidence that proceeding to invasive peripheral nerve stimulator implantation would provide [the worker] with any long term benefit.” The WCB advised the worker on November 10, 2022 that there was no change to the earlier decision to the stimulator implantation would not be covered by the WCB.
The worker again requested reconsideration of the WCB’s decision to Review Office on December 1, 2022. In their submission, the worker referred to the submission provided by their pain management specialist and noted they continued to experience difficulties because of CRPS and their belief that the proposed PNS implantation would improve their difficulties and quality of life.
On December 13, 2022, Review Office determined the worker was not entitled to coverage for a PNS implantation. Review Office relied upon the opinions of the WCB physical medicine and rehabilitation specialist, finding that the need for PNS implantation to address the the worker’s left pinky finger injury was not medically supported and accordingly, the WCB would not provide coverage for the device.
The worker’s representative filed an appeal with the Appeal Commission on December 22, 2022 and a hearing was arranged. Following the hearing, the appeal panel requested additional medical information prior to discussing the case further, which was forwarded to the interested parties for comment before the panel met again. On June 22, 2023, the appeal panel met further to discuss the case and render its final decision on the issue under appeal.
Reasons
Applicable Legislation and Policy
The Appeal Commission and its panels are bound by the provisions of The Workers Compensation Act, regulations under the Act and the policies established by the WCB's Board of Directors. The provisions of the legislation in force at the date of accident are applicable.
A worker is entitled to benefits under s 4(1) of the Act when it is established that a worker has been injured as a result of an accident at work. When the WCB determines that a worker has sustained a loss of earning capacity, an impairment or requires medical aid because of an accident, compensation is payable under s 37 of the Act.
Section 27 of the Act provides that the WCB may provide a worker with such medical aid as the board considers necessary to cure and provide relief from an injury resulting from an accident.
The WCB has established Policy 44.120.10, Medical Aid (the “Policy”) which defines key terms and sets out general principles regarding a worker's entitlement to medical aid. The Schedules to the Policy provide additional detail concerning the payment of drugs and medications, medical devices and appliances, non-traditional treatments, travel and emergency expenditures, and appliances damaged or lost because of an accident. The Policy sets out that the general principles that govern the WCB's funding of medical aid are:
• The Board is responsible for the supervision and control of medical aid funded under the Act or this policy.
• The Board determines the appropriateness and necessity of medical aid provided to injured workers in respect of the compensable injury.
• In determining the appropriateness and necessity of medical aid, the Board considers:
o Recommendations from recognized healthcare providers;
o Current scientific evidence about the effectiveness and safety of prescribed/recommended healthcare goods and services;
o Standards developed by the WCB Healthcare Department.
• The Board promotes timely and cost-effective access to medical aid.
• Workers are entitled to select their own health care provider, subject to the Board's control and supervision of medical aid.
• The Board's objectives in funding medical aid are to promote a safe and early recovery and return to work, enable activities of daily living, and eliminate or minimize the impacts of a worker's injuries.
• The WCB will give preference to funding medical aid that is available in Manitoba. The Board may fund medical aid outside Manitoba in exceptional circumstances, subject to Board preapproval.
• The Board determines the fees or charges payable for all medical aid. The Board will not pay any cost in excess of what it considers reasonable for the service or good provided to a worker.
• The Board will recognize only those accounts for medical aid that are submitted within 12 months from the date the medical aid is provided to the injured worker.
• The Board will refuse or limit the funding of any medical aid it considers excessive, ineffective, inappropriate or harmful.
Schedule C of the Policy sets out the general principles regarding the WCB funding of non-traditional treatments. For Schedule C, non-traditional treatments are considered experimental or lack scientific validity to the extent required for widely held acceptance in the Manitoba community of recognized health care providers. Generally, the WCB does not authorize payment of non-traditional treatments, but payment may be authorized on a case-by-case basis when the WCB determines that:
1. The non-traditional treatment will be used for a medical condition that results from a compensable injury;
2. Traditional treatments have not been, and will likely not be effective;
3. The prescribing or recommending health care professional has outlined the number of appointments and treatments required for the non-traditional therapy and the period of time over which the non-traditional treatment is required;
4. There is sufficient reliable scientific evidence to indicate that the prescribed or recommended, non-traditional treatment will promote a timely recovery and return to work, enable activities of daily living or eliminate or minimize the impacts of the worker's injuries;
5. There is sufficient reliable scientific evidence to indicate that the non-traditional treatment will be safe over the anticipated duration for which it is being prescribed or recommended;
6. The side-effects are widely known, well described in the scientific literature, and do not outweigh the potential for benefit in the particular case;
7. Standards have been developed and are in place for the safe use of the non-traditional treatment; and
8. The non-traditional treatment can be provided legally in Canada from a regulated source and is recommended or prescribed by a recognized health care provider.
Worker’s Position
The worker appeared in the hearing on their own behalf and provided an oral submission in support of their appeal. The worker also offered testimony in response to questions posed by members of the appeal panel. A supporter accompanied the worker in the hearing and provided information to the panel during the hearing.
The worker’s position is that the WCB should provide coverage for a PNS implantation as the need for the device has been established in that it is recommended by their treating pain physician as likely to provide a reduction in the worker’s chronic pain arising from the compensable workplace injury as well as offering the possibility of an improved quality of life and an ability to resume working.
In their oral submission, the worker provided a chronological summary of the treatment of the injuries sustained in the accident of February 12, 2018. The worker described that presently, they experience pain every day from waking through to sleeping:
“…without any significant relief at any moment. Pain is a constant in my life and has been a tremendous burden on my family and friends. It's difficult to summarize the life changing five years that followed. Physiotherapy, occupational therapy, countless nerve blocks, acceptance and commitment therapy, cognitive behavior therapy, medications and opioids. Also, depression, hopelessness, persistent sadness, anger and suicidal ideations.”
The worker described to the panel their understanding of the physiological basis for their chronic pain and how the PNS device could help them, noting that:
“My brain is constantly firing pain signals down to the hand, which is constantly firing it back, which is going into a vicious circle now of -- of the cycle. Sometimes in 85% of these cases, they'll go into remission. 15% will remain chronic. When they've gone this long, it's like walking and talking. Now it's etched in my brain that those things are normal to me. So, there is nothing that is stopping it anymore. This device will interfere with the pain signals that are being sent from my brain down to the hand. It will stop them.”
The worker pointed the panel to consider the April 15th 2022 report from the treating pain management physician who noted that the worker would have severe limitations on their ability to work, given their functional constraints related to the injury and secondary to their “constant, chronic and intractable pain associated with … CRPS, which flares with any touch to the hand and becomes a constant burden mentally on this patient. These symptoms are likely to be long term." The worker noted that the physician described the implantation procedure as follows:
"A PNS placement involves a minor procedure that places a small electrical device next to one of the peripheral nerves. These are the nerves that are located beyond the brain or spinal cord. The electrode delivers rapid electro pulses that are felt like mild tingles. Pain is replaced by these pulses. PNS patients have a controller app on their phone that allows them to control the intensity of the stimulus and the sensations they feel. PNS is an emerging therapy that could be an alternative to more invasive procedures like spinal cord stimulation or surgery."
The worker described to the panel their hope of a “life without pain” with the PNS implantation and outlined their expectation that with the PNS device implanted, their need for opioid medication will be eliminated or at least significantly reduced, noting that the studies provided to the panel indicate that this has been the case for those studies. The worker described that “Nobody wants to be on opioids. I don't, like, I certainly don't want to be taking them if this can replace that. I mean, how much healthier is that for you? Quality of life has to be measured with that as well.” The worker also noted that the studies provided indicate no adverse events resulting from the implant.
The worker further indicated their belief that there are no other options available to them at this time to address their chronic pain and that their treating pain physician has indicated this to be the case.
In sum, the worker’s position is that the proposed treatment is likely to provide relief to them from the continuing and debilitating effects of the compensable injury, and that there presently are no other possible medical options available that could offer such relief. Given the limited evidence of adverse side effects or risks and the potential benefits to the worker, including increased daily functional abilities, a possible return to work and reduced reliance on opioids, the WCB should approve coverage of this treatment for the worker and the appeal should be granted.
Employer’s Position
The employer did not participate in the appeal.
Analysis
The question for the panel to determine in this appeal is whether the worker is entitled to coverage for implantation of a peripheral nerve stimulator. For the worker’s appeal to succeed, the panel would have to determine that the implantation of the PNS device is necessary to cure and provide relief from the worker’s compensable injury. As detailed in the reasons that follow, the panel was able to make such a finding and therefore the worker’s appeal is granted.
The panel reviewed the medical reporting in respect of the worker’s chronic pain and noted that the WCB has accepted that the worker’s diagnosis of CRPS arose as a consequence of the compensable workplace injury of February 12, 2018. We further noted that the treating pain physician outlined in a report received by the WCB on October 18, 2022 that despite the left 5th digit amputation, the worker continues to have CRPS as well phantom limb pain related to the amputation. The panel accepts and relies upon this evidence.
The panel noted that the treating physician outlined in the same report that “We have exhausted all modalities of medication and interventional approaches with [the worker] and the only beneficial treatment trail has been a left ulnar nerve block which resulted in a 90% improvement in [their] pain.” Given the outcome of this trial, the physician recommended consideration of implanting a PNS “…for help with [their] ulnar nerve distribution generated pain.” The physician acknowledged that this is “a newer technology” but stated that “…there is a growing set of literature and data supporting this therapy in patients especially those which have a single peripheral nerve related pain disorder (as is the case with [the worker]).”
The panel considered the provisions of the WCB’s Medical Aid Policy applicable to non-traditional treatment of a compensable injury. The Policy provides, as outlined above, that the WCB generally does not authorize payment of non-traditional treatments, which are defined as treatments that are considered experimental or lack scientific validity to the extent required for widely-held acceptance in the Manitoba community of recognized health care providers; however, the WCB will consider authorizing such treatment on a case by case basis when it determines that the criteria set out in the Policy are met.
The panel considered the concerns raised by the WCB medical advisor with respect to the proposed implantation of the PNS device, as outlined in their opinions of June 24, 2022, November 8, 2022, and February 14, 2023. First, the WCB medical advisor noted the lack of published data evaluating the efficacy of and adverse events related to the implantation of these devices, with limited robust, controlled studies and no longer term studies. The medical advisor also noted that “most of the published research” to date has originated from the manufacturer, thus limiting the objectivity of those studies. Second, the medical advisor pointed to potential long term complications of electrical implanted leads as foreign bodies. Third, the medical advisor noted “the most significant unknown complication for these devices relates to the extent to which individuals develop tolerance to the electrical stimulation over time”, suggesting an expectation of only transient benefit. Fourth, the medical advisor referenced “consensus recommendations” in the literature that “…implanted peripheral nerve stimulation remains investigational, with significant potential risk of adverse events (infections, electrode migration and failure); and that extrapolation from experience with implanted electrode spinal cord stimulation…indicates there is a typical development of tolerance.” As such, the WCB medical advisor did not recommend support for the proposed PNS implantation. In the February 14, 2023 opinion, the medical advisor summarized their view that “…there remains no material evidence that proceeding to invasive peripheral nerve stimulator implantation would provide [the worker] with long term benefit, or safety.”
The panel also considered that the worker’s treating pain management physician addressed the WCB medical advisor’s concerns in their letter received October 18, 2022. The physician outlined that the proposed PNS device is a “self-anchoring device which inhibits lead migration” and is removable if needed, noting that the implantation is classified as a “Low-Risk Procedure” by the American Society of Regional Anesthesia Risk Stratification of Pain Procedures, in the same category as peripheral nerve blocks, trigger point injections and peripheral joint injections. The physician also noted that study findings indicated that “Overall, the spectrum of adverse events and their severity is minimal compared to spinal cord stimulator implants in both severity and number.” Further, the physician acknowledged that the “rate of ‘tolerance’ is unknown” but stated that this should not be a reason to deny the worker the care they deserve at this time point in their life, and that the stimulation is adjustable and can be titrated as required based upon the response achieved by the worker to the impulses. The physician further noted that other provincial workers compensation programs in Canada have approved this modality for patients with single nerve peripheral pain.
The panel also considered the further information provided by the treating pain management physician that specifically addressed the non-traditional treatment funding criteria outlined in the Policy, as set out in their May 12, 2023 report. The physician confirmed the treatment proposed is in relation to the compensable injury and that traditional treatments have been exhausted. They outlined the schedule of monitoring and follow up following the proposed treatment. The physician noted that given this is a new therapy, there is not a robust body of evidence but stated their view that “the evidence that is available is promising, especially in this patients’ (sic) case” and noted that “If the therapy works as the evidence has shown then I expect that this could result in a return to work and activities.” The physician confirmed that the therapy has been shown to be “very safe” in the published literature and stated their belief that the “side effects do not outweigh any benefit in this case. The side effects would be minimal if any.” The physician further noted that that standards are in place and this therapy is being used in other provinces for the safe use of this treatment, which can be provided legally in Canada.
Based upon the evidence and opinions on file, and on the standard of a balance of probabilities, the panel is satisfied that in this case, the Policy criteria for funding the implantation of the PNS device are met. The evidence before the panel supports a finding that this treatment will be used for a medical condition resulting from the worker’s compensable injury, and that traditional treatments have not been effective in addressing the ongoing effects of that injury. Further, the evidence provided by the treating pain management physician, in their initial request to the WCB and in subsequent reports, confirms the details of the proposed treatment plan and that this treatment can be legally provided in Canada. The panel is further satisfied that the treatment is not highly invasive and does not involve significant risks to the worker that outweigh the potential benefits. The panel finds that there is sufficient reliable scientific evidence to indicate that the proposed treatment could promote the worker’s return to work and enable activities of daily living or eliminate or minimize the continuing impacts of the worker’s compensable injury. While we acknowledge that the scientific evidence is limited by the fact that this is a relatively new treatment modality and that some of that evidence is further limited in its objectivity and potential bias, the panel is satisfied that the evidence as a whole supports a finding that the treatment will be safe and that the potential side effects are known and do not outweigh the potential benefit to this worker. We are further satisfied that there is evidence of standards in place for the safe use of this treatment and that this will be monitored by both the treating pain management physician as outlined in their reports and by the WCB.
In all these circumstances, the panel finds that the proposed treatment is appropriate and necessary to cure and provide relief to the worker from the effects of the compensable injury and therefore the worker is entitled to coverage for a peripheral nerve stimulator implantation, provided that the treating pain management physician continues to support this non-traditional treatment and provides ongoing support for the treatment and further, that the WCB closely monitors and assesses the clinical reporting in respect of this worker to ensure there is evidence of benefit to the worker in continuing the treatment. The worker’s appeal is granted.
Panel Members
K. Dyck, Presiding Officer
J. Peterson, Commissioner
M. Kernaghan, Commissioner
Recording Secretary, J. Lee
K. Dyck - Presiding Officer
(on behalf of the panel)
Signed at Winnipeg this 18th day of July, 2023