The MBS appeal
6 Dr Chang is an ophthalmologist. He practises at the Sydney Retina Clinic and Day Surgery (the Clinic), which is owned and operated by ACS. Dr Chang is the sole director and secretary of ACS.
7 This case concerns the amount payable by Bupa, as a private health insurer, to ACS for intravitreal injections performed by Dr Chang at the Clinic. Bupa is required to pay "second tier default benefits", the amount of which is dependent on the applicable MBS item of the procedure performed.
8 MBS items 42738 and 42739 describe the procedure for intravitreal injections in identical terms, save that item 42739 contains the additional part underlined below:
PARACENTESIS OF ANTERIOR CHAMBER OR VITREOUS CAVITY, or both, for the injection of therapeutic substances, or the removal of aqueous or vitreous humours for diagnostic or therapeutic purposes, one or more of, as an independent procedure, for a patient requiring anaesthetic services (Anaes.)
9 Item 42739 entailed payment of a 60-70% higher second tier default benefit than item 42738.
10 The dispute concerns 4,101 claims made by ACS between 13 September 2012 and 10 August 2015 under item 42739 where the "anaesthetic service" said to be required by patients was a 0.25mg tablet of Xanax (active ingredient alprazolam) taken orally 15-30 minutes before the procedure.
11 Bupa contended, and contends on appeal, that the claims should have been made under item 42738, and seeks to recover the difference between what it paid under item 42739 and what it would have paid under item 42738, being $521,703.
12 After opening submissions, the primary judge sought to clarify the issues of law and fact necessary to be decided. Following what his Honour described as "extended discussion and debate", the parties agreed on the terms of a document called "agreed issues of fact and law for determination", which relevantly included these issues:
…
4. What were the circumstances in which Dr Chang came to administer alprazolam to patients on a regular basis during the Relevant Period?
5. In submitting the … claims to BUPA (Claims), did ACS represent to BUPA in trade and commerce that Dr Chang:
a. had performed a procedure identified by [the Higher Item] (Representations)?; or
b. genuinely considered, on reasonable grounds, as an ophthalmologist, that he had performed a procedure falling within [the Higher Item]? (see RS [7])
6. Is BUPA entitled to advance the alternative claim identified at 7(b) below?
7. If the answer to 5(a) is yes, did the conduct in making the Representations amount to contravening conduct (in all cases where the Representations were made) because:
a. administering alprazolam is not an anaesthetic service; or
b. [if] the answer to 6 is yes, in the alternative, even if administering alprazolam (in the form of 0.25 mg dose of Xanax) is an anaesthetic service, it was not for a patient requiring an anaesthetic service because, at best, it was desirable to reduce anxiety and the dosage was so low that its clinical effect is likely to be negligible? (see T 264.19 - 265.23).
13 Bupa's main pleaded case was brought under the Australian Consumer Law (ACL). The essence of it was the contention that the administration by Dr Chang of alprazolam (Xanax), in the absence of an anaesthetist (the Oral Sedation Procedure), was not an "anaesthetic service" which could attract MBS item 42739. The primary judge summarised the pleaded ACL case against the respondents as follows (J at [13]):
(a) each time the Company [ACS] submitted a claim for payment of the "second tier default benefit" in respect of the medical procedure identified by the Higher Item in circumstances where: (i) Dr Chang had performed a procedure at the Clinic constituting paracentesis of anterior chamber or vitreous cavity; (ii) the patient undergoing the procedure received sedation in the form of oral sedation involving Xanax in a titrated dose; (iii) no invoice was rendered by an anaesthetist in respect of the procedure (Oral Sedation Procedure); the Company expressly represented to Bupa, by the invoice and claim form, that Dr Chang had performed a procedure identified by the Higher Item (Representations): SOC [17], [24];
(b) Dr Chang aided, abetted, counselled or procured the making of the Representations: SOC [25];
(c) the Representations were misleading or deceptive, or likely to mislead or deceive, because Dr Chang had in fact performed a procedure identified by the Lower Item and not the Higher Item: SOC [21], [27]; and
(d) the Oral Sedation Procedure is not a medical procedure identified by the Higher Item because it does not meet the relevant definition (SOC [11], [20]) and by reason of the fact that in "June 2016, Bupa obtained advice from an external consultant, Dr Tony Webber, that the Oral [Sedation] Procedure is not a medical procedure identified by [the Higher Item]": SOC [23].
14 Bupa does not now pursue that case, and does not challenge the primary judge's finding "that the administration of low dose Xanax by the Oral Sedation Procedure can constitute an anaesthetic service and can attract [item 42739] when it is required or, in other words, when it is medically necessary in an individual case" (J at [81]).
15 Bupa contends, however, that the primary judge erred in rejecting its alternative un-pleaded case posed by question 7(b) in the agreed issues of fact and law for determination (set out at [12] above).
16 Bupa accepts that its alternative case required the primary judge to ask whether Bupa had established that the Xanax was not required, in that it was not medically necessary, in any of the 4,101 procedures the subject of Bupa's claims.
17 The respondents agreed that "[t]he critical issue in relation to Bupa's alternative claim was whether Bupa had satisfied its onus of establishing that the alprazolam was not medically necessary in any of the 4,101 cases in which it was administered by Dr Chang for the two reasons it had raised", namely, "because the dosage was too low to have a clinical effect, or any clinical effect was likely to be negligible and … because the use of alprazolam could, at best, reduce anxiety".
18 The primary judge described Bupa's alternative claim as an "all or nothing case" - that is, Bupa had to establish that the Oral Sedation Procedure was not required in any of the 4,101 cases the subject of its claim.
19 Bupa therefore accepts that it must lose if, on the evidence, it was established that the Oral Sedation Procedure was required, or medically necessary, in even one of the 4,101 cases.
20 Bupa contends, however, that the MBS appeal should be allowed, and that judgment should be entered against Dr Chang and ACS in the amount of $521,703 plus interest, because the primary judge did not ask himself the correct question - but instead asked a different question, viz "whether Bupa had proved that the oral sedation procedure could never be medically necessary" and that, as a result "regardless of the evidence before the Court, Bupa was also required to disapprove an hypothesis: that Xanax could be medically necessary as an anaesthetic service in some circumstances".
21 In his oral submissions, Mr Hutley put Bupa's case that the primary judge asked the wrong question as follows:
We say the problem with his Honour's formulation is that [he] asked a hypothetical and abstracted question divorced from the evidence as to the relevant medical procedures in this case. Logically, we are faced with an indeterminacy of reference. To prove that Xanax could never be medically necessary, we first need to know the circumstances in which it was asserted that Xanax could be medically necessary.
The universe of possible circumstances to which any conceivable dosage of Xanax could be applied was never investigated, nor sensibly could it or should it have been … It was logically guaranteed failure because one is dealing with an unknown unknown, and the theoretical possibility that something could be medically necessary in unknown circumstances. What his Honour, we submit, ought to have done was to consider the evidence pertaining to the relevant 4101 procedures, and ask the proper question being whether that evidence established, on the balance of probabilities, that the Xanax was or was not required in those procedures or, perhaps, that we hadn't established, on the balance of probabilities, that it was not required.
22 In our view, the primary judge was under no misapprehension as to the relevant question that he was required to address. Further, there was ample uncontradicted evidence to support his Honour's conclusion that the answer to the question identified by Bupa at [16] above was "No".
23 The primary judge correctly characterised the issue to be determined in light of Bupa's concession as follows (J at [22]):
… Bupa expressly accepted the contention advanced by the respondents that this was an "all or nothing" case. Accordingly, [Bupa] was content for the case to be determined on the basis that the "anaesthetic services" alleged were not required in any case by reason of the nature of the Oral Sedation Procedure and the failure of the procedure to attract the Higher Item description when the description was properly construed (T263-265).
(Emphasis in original).
24 In our view, his Honour's reference to "any case" in that passage from his reasons was obviously a reference to the cohort of the 4,101 procedures the subject of Bupa's claim.
25 Further, the primary judge elsewhere squarely and correctly posed the issues to be addressed arising from agreed questions 6 and 7(b), set out at [12] above, as "… whether Bupa is entitled to advance the alternative claim that even if administering a 0.25 mg dose of Xanax by the Oral Sedation Procedure is an 'anaesthetic service', it does not attract the Higher Item because the dosage was so low it was, at best, a service which was merely desirable to reduce anxiety, and it was not clinically necessary" (J at [26]).
26 Having correctly identified the issue before him on Bupa's alternative case, his Honour gave the following reasons for rejecting it:
69. The central problem for Bupa's "all or nothing" case (that is, that the Oral Sedation Procedure could never attract the Higher Item because it involved Xanax being administered) is that I do not accept that 0.25 mg of Xanax or a larger titrated dose could never be medically necessary. The evidence of Dr Chang, which I accept, was that an intravitreal injection involves the entry of a small needle into the interior of the eye and in order for the intravitreal injection to be performed effectively and safely it is necessary for the patient's head and eye to remain still. If the patient moves unexpectedly, haemorrhaging may occur within the layers of the interior of the eye damaging the lens or retina due to incorrect placement of the needle. Perhaps not surprisingly, some patients are stressed in confronting the prospect of an eye injection and this vexation may cause them to move their eye or head unexpectedly, while other patients have ocular movement disorders or tremors or conditions such as dementia where movement is involuntary.
70. In the light of this evidence, I do not understand how I could conclude that the Oral Sedation Procedure (be it a dosage of 0.25 mg or some bespoke titrated dosage), must never have been medically necessary for such persons. For all I know, this may have been a small number of patients. Indeed, it may amount to a percentage which roughly coincides with the 15% of the patient cohort who continue to receive the Oral Sedation Procedure. Alternatively, it may be a percentage consistent with the very small number of Higher Item charges made without an accompanying anaesthetist's bill charged by the four other private hospitals referred to in the evidence of Mr Anfinsen. I simply do not know, and this is not enough to make out Bupa's "all or nothing" case.
71. Moreover, the conclusion that the Oral Sedation Procedure was an anaesthetic service and could attract the Higher Item provided it was medically necessary for it to be administered is one that is not unreasonable and accords with the opinion evidence.
…
94. The difficulty for Bupa is that, as explained above, there is no factual basis for a finding that the only anaesthetic administered in all cases was 0.25 mg of Xanax; the evidence was that, at least in exceptional cases, a titrated dose was administered. Additionally, there is no evidence supporting a finding that in every case the patient did not require an anaesthetic service; Dr Chang gave unchallenged evidence, which I accept, that at least some patients required an anaesthetic service to address underlying movement disorders such as Parkinson's disease: T127.22-28; and see also [69] above. Any evidence as to necessity from Associate Professor Forrest (based on a review of only 12 patient files) does not address the fact that in some, even if only in a small number of cases, it cannot be said it has been proven that it was not necessary for the Oral Sedation Procedure, which I accept was an anaesthetic service, to be administered (in a 0.25 mg or greater dosage).
95. Bupa's closing written submissions suggested that Dr Chang's evidence did not affirmatively establish that patients "required" low-dose oral Xanax, but this is not to the point. Bupa had the evidentiary and persuasive burden of proving its misleading and deceptive conduct case, which was presented on an "all or nothing" basis as explained above. It follows, it cannot succeed as framed.
(Emphases in original).
27 It seems to us that the primary judge made it clear in those reasons that he rejected Bupa's case that it had established that the administration of low-dose Xanax by the Oral Sedation Procedure was not medically necessary in any of the 4,101 procedures the subject of the claim. And it also seems to us plain that the primary judge had in mind, and could only have had in mind, the cohort of cases the subject of Bupa's claim, not some "universe of possible circumstances" or "unknown unknown" realm referred to by Mr Hutley in his oral submissions.
28 In any event, as Mr Jackman SC, who appeared with Mr Klineberg and Mr Langshaw for the respondents, submitted, Dr Chang gave detailed, and unchallenged, evidence about the circumstances in which he administered the Oral Sedation Procedure, including in his affidavit sworn 13 April 2018 as follows:
120. The introduction of low-dose Alprazolam to the treatment of intravitreal injections, where appropriate, is something which I considered in 2012, and I still consider now, was best for patient care. The re-banding of MBS item 42739 had nothing to do with the introduction of low-dose Alprazolam to the Clinic and Day Surgery. I would have introduced the new procedure and Alprazolam Regime even if MBS item 42739 had not been re-banded in September 2012 and irrespective of whatever banding MBS Item 42739 had at any point in time.
Alprazolam Regime - its introduction in September 2012 and subsequent changes
121. The use of low-dose Alprazolam started to increase steadily from September 2012 as patients (and medical and nursing staff) started to see the benefit of the use of Alprazolam including reduced patient anxiety and improved comfort and tolerance to the intravitreal injection.
122. However, I manage my patients with individualised care depending on appropriate clinical decision-making. This means patients were provided with an anaesthetic service only when necessary. When no anaesthetic service was provided, the intravitreal injections were billed under MBS item 42738. For some patients the decision to use Alprazolam would change from treatment to treatment depending on the then current medical assessment and preferences of the patient. For example, the choice of sedation may be informed by the level of anxiety and therefore tolerance the patient was experiencing on the day of treatment or for other reasons such as the patient needing to drive home from the treatment that day.
…
132. As part of my continuous refinement of my treatment practice, I continually investigate other clinical strategies to fine tune and improve the quality, safety and tolerability of intravitreal injections.
133. These changes I have introduced since the commencing to use (sic) Alprazolam include:
(a) introducing the use of Chlorhexidine as an antiseptic to prepare the front of the eye as it was less irritant (sic) than Betadine, which I had used previously;
(b) less extensively applied antiseptic on patients during the procedures;
(c) applying topical anaesthesia in a more localized and intensive manner; and
(d) applying a lubricant medication to soothe the eye after the injection.
134. I invited patients who had since September 2012 received intravitreal injections with Alprazolam to try the injections without it but with the above changes.
135. Through the introduction of those new changes, many patients became sufficiently comfortable with the intravitreal injection process itself that they no longer felt that they required Alprazolam. For some patients, however, the medical decision was to continue to use Alprazolam when receiving intravitreal injections.
29 It is true that some of the evidence there referred to was not specifically referred to by the primary judge. But in circumstances where his Honour clearly accepted other unchallenged evidence given by Dr Chang about the circumstances in which the administration of low-dose Xanax might be medically necessary, the mere failure to refer to all of the evidence is of no moment.
30 It is also true, as Mr Jackman conceded, that the judge's reference to page 127 of the transcript at [94] of his reasons is wrong because that passage of transcript does not address the question of the medical necessity of low doses of Xanax. In our view, however, that error is inconsequential, and might be equated with a typographical mistake, because the use of alprazolam as a matter of medical necessity in intravitreal injections was the subject of Dr Chang's unchallenged evidence, as well as the unchallenged evidence of other medical practitioners, to which the primary judge referred in his reasons.
31 For those reasons, the MBS appeal must fail.