Financial Services Commission of Ontario
Commission des services financiers de l’Ontario
Neutral Citation: 2006 ONFSCDRS 123
FSCO A05-000934
BETWEEN:
VENETTA PACQUETTE
Applicant
and
CERTAS DIRECT INSURANCE COMPANY
Insurer
DECISION ON A PRELIMINARY ISSUE
Before:
David Muir
Heard:
July 11, 12 and 13, 2006, in Hamilton, Ontario
Appearances:
Steven Newell and Tim Prashad for Ms. Pacquette
Kevin Griffiths for Certas Direct Insurance Company
Issues:
The Applicant, Venetta Pacquette, was injured in a motor vehicle accident on November 29, 2002. She applied for and received statutory accident benefits from Certas Direct Insurance Company ("Certas"), payable under the Schedule.1 The parties were unable to resolve their disputes through mediation, and Ms. Pacquette applied for arbitration at the Financial Services Commission of Ontario under the Insurance Act, R.S.O. 1990, c.I.8, as amended.
The preliminary issue is:
Is the use of Botox in the treatment of chronic pain and cervicogenic headache a treatment which is experimental in nature and therefore not payable under the Schedule?
Result:
The use of Botox in the treatment of chronic pain and cervicogenic headache is not a treatment which is experimental in nature and therefore it is payable under the Schedule.
EVIDENCE AND ANALYSIS:
Ms. Pacquette submitted a treatment plan dated March 15, 2004 wherein the use of Botox was recommended for the treatment of chronic pain and cervicogenic headache. The treatment was recommended by Dr. Larry Kahn, the Director of the Hamilton Pain Management Center.
Certas rejected the claim solely on the basis that the treatment is experimental in nature and accordingly they submit they are not required to fund it under the Schedule. In this regard, they relied upon an earlier decision from FSCO in Palmer and State Farm Mutual Automobile Insurance Company, (FSCO A00-001286, December 20, 2001), wherein the arbitrator agreed with the insurer that the use of Botox was experimental in that context.
The parties called two witnesses - Dr. Kami for Ms. Pacquette and Dr. Devlin, who had previously given evidence in the Palmer matter. Both witnesses were qualified as experts in their respective specialities. Both have a point of view but gave their evidence in a fair and dispassionate manner.
Botox is licensed for use for certain purposes in Canada. The treatment of chronic pain and cervicogenic headache are not uses for which it has been licenced. This does not end the matter, for the evidence of both Dr. Kahn and Dr. Devlin was that many, many medications are used for purposes other than those for which they have been expressly licensed. Each physician cited examples of medications which are used widely for purposes other than those for which they have been licensed by Health Canada.
It was also agreed as between the two experts that the presence or absence of properly conducted clinical trials was not necessarily determinative of whether a treatment was experimental in nature, with the caveat that a strong negative trial would normally militate against the use of a medication. Dr. Devlin cited the example of an anti-seizure medication, gambo-pentin (SP), which is widely used in the treatment of phantom limb pain and for which there is no research literature at all.
Dr. Devlin and Dr. Kahn were agreed that the literature on the use of Botox in this context was limited and the research work not compelling one way or the other. However, Dr. Kahn saw it as pointing in the direction of Botox's efficacious use in that what he characterized as the "trend line" was positive and there were no strong negative studies. Dr. Kahn testified that he also relied upon his intuition, the clinical experience from his practice and those of colleagues/mentors, the literature including papers delivered at conferences, as well as the growing acceptance of the use of Botox in this context within the medical community.
Dr. Devlin tended to see the glass as half empty, citing the weaknesses in the studies and the conclusions of even the most positive being limited to a call for further research.
The question becomes ultimately whether the use of Botox in treating chronic pain and cervicogenic headache is or is becoming the standard of care amongst those treating these conditions. Dr. Devlin does not accept that it is yet. Dr. Kahn, an expert in the treatment of pain, claims that it has in effect become an accepted therapy if not the standard of care, despite the weaknesses in the studies.
Having considered the evidence as well as the authorities provided to me by the parties, I have concluded that the use of Botox in the treatment of chronic pain and cervicogenic headache is no longer experimental in nature.
A review of the cases provided indicates that arbitrators have generally taken a large and liberal view of the interpretation of this exception to the requirement to pay a medical benefit.
In Caruso and General Accident Assurance Co. of Canada, (OIC A96-000644, March 27, 1997), the arbitrator considered this same language in reference to a claim for a specialized orthopaedic mattress:
Neither the Act nor the Schedule defines "experimental," and I was provided with no authority for defining this term. The Insurer's evidence and submissions on this point focussed on the Insurer's claim that the product has no proven therapeutic value. Although I am not persuaded of the benefits of the Kenko Sleep System, based on the evidence I received, I do not accept the Insurer's very broad definition of "experimental."
Arbitrators have often commented on the remedial character of the statutory accident benefit scheme, and especially the provisions concerning medical (and rehabilitation) benefits. The legislative objective of facilitating expeditious adjustment of claims for medical benefits is evident in [various sections of the existing Schedule]. Considering the medical benefits provisions in their entirety, I do not accept that the drafters of section 36(2) intended to give insurers an absolute right to refuse a medical benefit claim just because medical experts disagree about the therapeutic value of the benefit claimed. Such a broad interpretation of the term "experimental" could apply to many treatment modalities for which insurers currently pay benefits. I am reluctant to draw such a conclusion in the absence of any authoritative definition of "experimental."
I accept this general statement, as have other arbitrators, so far as it goes.
Certas did not take the position that the Palmer decision was binding upon me but it does stand for the proposition that the use of Botox in the treatment of chronic pain was, at the time of the decision, experimental in nature. A careful review of the decision is revealing however. As noted earlier, Dr. Devlin gave evidence on this point in that case, however, on the question here, whether the use of Botox to treat chronic pain and cervicogenic headache was experimental, the Applicant, Mr. Palmer, lead no "persuasive" evidence at all. That is not the case here.
If I were left to decide this issue solely on the basis of Dr. Devlin's evidence, I would likely have come to the same conclusion. However, Dr. Kahn, an anaesthetist and expert in the treatment of pain, who has been using Botox as a treatment for chronic pain and cervicogenic headache for several years, gave evidence in this case. I accept his evidence that there is some support in the literature, although he recognized its weaknesses. I also accept his evidence that the use of Botox in the treatment of chronic pain is becoming increasingly common amongst anaesthetists who work with chronic pain. In this regard, Dr. Kahn presented several papers which support his view that there is a growing body of evidence which suggests that the use of Botox may be effective for the treatment of chronic pain and cervicogenic headache in some patients. One, a survey of the practice of anaesthetists working with chronic pain patients in the Canadian Journal of Anaesthesia, supports the view that the use of Botox in the treatment of chronic pain and cervicogenic headache is growing amongst anaesthetists. I accept his evidence as well that there are articulated medical theories with supporting research, underlying the claim that it may be effective in treating these conditions.2
Certas relied on Driver and Traders General Insurance Co./HB Group, (FSCO A01-000841, January 8, 2003) and characterized it as the leading case in this area. The issue in this case was the entitlement of the applicant to payment for "a unique form of therapy known as Vistasp", a form of massage and physiotherapy. The arbitrator described the therapy as follows:
I concluded from the evidence before me that Vistasp therapy is a form of hands-on body therapy similar to massage, unique to Victor Guard; that it is a passive modality of treatment; that it is not very well understood by the three, or possibly four, health practitioners who have even heard of it; and that it is not a form of treatment known or accepted by any recognised body in the health field. As no objective, reliable evidence was presented at the hearing to establish an accepted scientific or medical basis for the therapy, or to substantiate the claims made for it that it is an effective, safe treatment for whiplash, chronic pain, migraine or fibromyalgia, I am not persuaded that it even meets the first, or threshold criterion, under section 14 of the Schedule, that it is a "good or service of a medical nature."
Despite this conclusion the arbitrator went on to consider the meaning and effect of "experimental in nature":
"Experimental," in my view, belongs on a continuum which might look something like this: "completely unknown, known to a few, experimental (in the process of being tried and tested), recognised as effective by the wider health community, accepted as a therapy for identified conditions.) ...
I would find ... that Vistasp is experimental in nature, on the basis of the decision of Arbitrator Allen in Palmer ... that a treatment is considered to be experimental for a specific condition, although it may be a conventional treatment for other conditions, where there is expert medical evidence that research results to date are inconclusive, "... and no convincing evidence currently exists on the usefulness of the treatment for the conditions claimed."
The views expressed by the arbitrator in Driver must be considered in light of the facts before her. It was not a close case, as was made plain in the opening summation of the arbitrator's finding of facts surrounding Vistasp set out above. However, read against the entirely different factual situation, some of the arbitrator's remarks can be understood as imposing too high a bar on applicants seeking the funding of treatments that may not be completely accepted in the literature. Morever, as set out above, the evidence of both experts in my case was that there were many medications which are routinely used for purposes without any support in the literature at all.
I agree that scientific principles must underlay the interpretation of these terms, but I return to the comments of the arbitrator in the Caruso cases, supra. The Schedule was intended to be a remedial regime. We are specifically concerned here with the rapid provision of therapeutic medical service. There is no requirement that an applicant prove to a medical certainty that a treatment will be therapeutic. Equally, to my mind, the test is not whether or not it is certain, as a matter of scientific certainty, that a given therapy is proven effective and therefore no longer experimental in nature.
I accept the view of Dr. Kahn that, based on his intuition, the growing anecdotal evidence from his clinical practice and those of colleagues and mentors that the therapy is effective for some patients; the literature that offers some support for its utility and the absence of a strong study indicating that it is ineffective; the absence of any indication that used in this way it causes harm; and the existence of a plausible scientific basis for its use as set out in peer-reviewed journals, that the use of Botox can be effective in treating chronic pain and cervicogenic headache. To my mind, these factors are sufficient to move this therapy along the continuum from experimental towards the standard of care.
EXPENSES:
I understand that this preliminary issue will most likely conclude this arbitration. In this circumstance, the issue of expenses will likely need to be dealt with. As Ms. Pacquette was completely successful on the only issue in dispute I exercise my discretion to award Ms. Pacquette her expenses incurred in this preliminary issue hearing.
July 24, 2006
David Muir
Arbitrator
Date
Financial Services Commission of Ontario
Commission des services financiers de l’Ontario
Neutral Citation: 2006 ONFSCDRS 123
FSCO A05-000934
BETWEEN:
VENETTA PACQUETTE
Applicant
and
CERTAS DIRECT INSURANCE COMPANY
Insurer
ARBITRATION ORDER
Under section 282 of the Insurance Act, R.S.O. 1990, c.I.8, as amended, it is ordered that:
- The use of Botox in the treatment of chronic pain and cervicogenic headache is not a treatment which is experimental in nature and therefore it is payable under the Schedule.
July 24, 2006
David Muir
Arbitrator
Date
Footnotes
- The Statutory Accident Benefits Schedule —Accidents on or after November 1, 1996, Ontario Regulation 403/96, as amended.
- See "Fibromyalgia/Chronic Pain Syndrome: An Alternative Medicine Perspective", Ko et. al, published in the Critial Reviews ™in Physical and Rehabilitation Medicine, 17(1):000-000 (2005); and "The Use of Botulinum Toxins in the Management of Pain and Headache", Michael A. Royal, MD, published in the Pain Practice, Vol. 1, No.3, 2001 215-235.