Summary of the PSR Scheme
5 As outlined in [2] above, the PSR Scheme provides for an administrative system of peer review of the conduct of health professionals in respect of the provision or initiation of services which attract payment of Commonwealth moneys under the Medicare system, or in respect of the prescription of medication under the Pharmaceutical Benefits Scheme. Amendments were made in 1999 to the PSR Scheme by the Health Insurance Amendment (Professional Services Review) Act 1999 (Cth) ("the 1999 amendments"), following the judgment of the Full Court in Adams v Yung (1998) 83 FCR 248. The 1999 amendments introduced new procedures, in particular, increasing the powers and responsibilities of the second respondent under the PSR Scheme.
6 The formal statutory process of review commences with the making by the first respondent of an "investigative referral" of a practitioner's conduct to the second respondent. It is implicit in the grant of power to the first respondent to make such a referral that an investigative referral will necessarily be preceded by the first respondent's own inquiry, albeit limited, into the practitioner. It is also so implicit in the categories of material and information which may be included in an investigative referral pursuant to the Health Insurance (Professional Services Review - Contents of Investigative Referrals) Guidelines 1999 ("the Guidelines"). In this way, the first respondent has assumed the role and responsibility of monitoring patterns of practice and identifying practitioners whose servicing, or prescribing appears abnormal - for example, too voluminous - when compared with their peers. An array of statistical data in respect of the individual practitioner's servicing patterns, and of other practitioners' servicing patterns is generated for the purpose of analysis and comparison.
7 In each State, a Case Management Committee regularly undertakes the review of the patterns of practice. If the relevant Case Management Committee has concerns about a particular practitioner, officers of the first respondent will discuss those concerns with the practitioner. This stage of review is termed "counselling". Counselling is not a formal statutory function under the PSR Scheme, but is undertaken as a matter of practice by the first respondent as a precondition to making an investigative referral.
8 If the concerns remain following counselling, the practitioner will be given a period of time, a minimum of three months, to address the concerns of the Case Management Committee ("the probationary period"). The practitioner's patterns of practice will then again be reviewed following the probationary period.
9 Upon the second review, if the practitioner's servicing remains a concern, the Case Management Committee may recommend that the Medical Director of the first respondent refer to the second respondent the conduct of the practitioner, concerning whether that practitioner may have engaged in "inappropriate practice" in connection with the rendering or initiation of services within the meaning of Part VAA of the HI Act. This is called an investigative referral.
10 In contrast to the PSR Scheme as it stood prior to the 1999 amendments, the second respondent now has substantial powers and responsibilities upon an investigative referral. For example, having commenced the investigation pursuant to s 89(1), the second respondent may decide to dismiss the investigative referral or to enter into an agreement with the practitioner to, for example, repay Medicare benefits, or to establish a Professional Services Review Committee ("PSRC") constituted by the practitioner's peers and make an "adjudicative referral" to that PSRC to determine whether the practitioner has engaged in "inappropriate practice".
11 In the event that the second respondent refers the practitioner to a PSRC and the final report of the relevant PSRC contains a unanimous or majority finding of "inappropriate practice" against the practitioner, the Determining Authority, also established under Pt VAA of the HI Act, will make draft determinations. Those determinations may include reprimand, counselling, repayment of Medicare benefits and complete or partial disqualification of the provision of services for which a Medicare benefit is payable (in the case of complete or partial disqualification, the practical ramifications may be that the practitioner will be inhibited in attracting patients). Once the draft determinations have been submitted to the relevant practitioner and the practitioner has been afforded an opportunity to make submissions on the draft determinations, the Determining Authority will give its final determination.
Factual background
12 Dr Doan commenced practice as a medical practitioner in general practice in Victoria in November 1994. Since that time, he has been in continuous practice as a solo practitioner.
13 In July 2000, Dr Peter Karlik, a general practitioner employed by the first respondent as a Medical Adviser, contacted Dr Doan, and advised him that he and another officer of the first respondent would approach him for counselling for the purposes of the PSR Scheme. The counselling meeting was scheduled for 2 August 2000. In the letter to Dr Doan, dated 24 July 2000, which confirmed the interview set for 2 August, Dr Karlik said:
"As discussed on the telephone the purpose of the meeting is to discuss the pattern of your Medicare statistics and to provide information about the Professional Services Review Scheme.…
Specifically the [first respondent] requested us to provide feedback regarding:
· Clarification of your practice
· Volume of services (annual and daily)
· Average Services per Patient/year
· Acupuncture
· PBS prescribing
…"
14 In preparation for the meeting with Dr Doan, Dr Karlik obtained a copy of the first respondent's file of Dr Doan's Medicare profile and statistics. The file included a report of interview dated 16 August 1996 between Dr Doan and a Dr Mak, an officer of the first respondent. At the meeting, the first respondent's concerns in relation to Dr Doan's high volume of services and high services per patient had been discussed. The file also contained a letter to Dr Doan, dated 18 October 1999, from the first respondent's then Medical Director of the Professional Review Division, in relation to Dr Doan's practice profile for the year 1998. In addition, Dr Karlik obtained the first respondent's Medicare services profile in relation to Dr Doan for a twelve-month period, 1 April 1999 to 31 March 2000.
15 On 2 August 2000, Dr Karlik and Mr Broadbent, a Pharmaceutical Adviser, attended the counselling meeting with Dr Doan. In relation to the counselling meeting, Dr Karlik gave evidence that:
"I am unable to remember the precise words used in this meeting but the substance of our discussions during that counselling interview were the possible concerns that [the first respondent] had identified based on Dr Doan's Medicare services profile which were atypical when compared to other general practitioners in Australia. In my presence, Mr Broadbent discussed issues of a PBS prescribing nature with Dr Doan."
16 During the counselling meeting, Dr Karlik further informed Dr Doan that if the concerns of the first respondent were not allayed, Dr Doan's continued atypical statistics could lead to his practice ultimately being examined under the PSR Scheme. Dr Karlik gave evidence that it was not his role in counselling to make any assurance to practitioners that a reduction in their level of services would see the avoidance of a referral under the PSR Scheme. The decision on referral to the second respondent rests with Dr Janet Mould, Medical Director of the first respondent and Manager, Professional Services Branch.
17 During the counselling visit, Dr Doan was provided with a number of documents, including an information document concerning the PSR Scheme, published July 2000 ("the July 2000 publication"). In particular, the July 2000 publication stated that:
"The meeting, which is also referred to as counselling, provides the opportunity for the practitioner to discuss particular issues with the adviser. This may help to explain why the practitioner's pattern of practice is different from that of their peers.
The adviser will prepare a report of the meeting and a copy of the report will be forwarded to the practitioner with an invitation to comment.
Following the meeting, the concerns will again be considered by the Case Management Committee. The majority of providers interviewed require no further action after the review period. If concerns remain, the practitioner will be given the opportunity to demonstrate a willingness to change. The practitioner's statistics will be reviewed after a minimum of three months.
If, after this review, the practitioner's servicing remains a concern to the HIC, the practitioner's conduct will be referred to the Director of Professional Services Review."
18 Following the counselling meeting, and in accordance with the PSR Scheme Procedures Manual, Dr Karlik prepared a report of interview ("Dr Karlik's Report"). Dr Karlik's report, which is undated, outlines the issues that were discussed with Dr Doan. In particular, Dr Karlik's Report states as follows:
"The Health Insurance Commission requested that Dr. Doan be visited by a Medical Adviser on the basis that analysis of his Medicare statistics indicated that he was in the upper range for the following statistical parameters (in comparison to the group 'VR General Practitioners'):
· Volume of services (annual and daily)
· Average Services per Patient/year
· Acupuncture
· PBS prescribing
…
Dr. Doan is aware that:
· all providers' Medicare and PBS statistics are reviewed and monitored on a regular basis by the Health Insurance Commission as part of the Commission's role in the appropriate payment of benefits
· One of the foundation principles of the Medicare system is that Medicare Benefits are payable for professional services rendered or requested in the treatment of a patient that would be supported as "medically necessary" and "clinically appropriate" to the "general body of opinion of the medical profession".
As part of its statutory role in monitoring the appropriate payment of Medicare benefits, in situations where the Health Insurance Commission has concerns regarding a provider's atypical Medicare and/or PBS profile, the Commission will refer the doctor to the Director, PSR. The PSR process can give an independent peer group adjudication as to whether the Medicare services provided represent inappropriate medical practice. The content and quality of clinical records will have a major influence on the determination of a PSR peer committee should one be set up to assess the appropriateness of a practice.
In Dr. Doan's case his Medicare profile is atypical in the following areas:
· Annual Volume of Total Services (upper 1% of peer group)
· Annual Volume of Level B Services (upper 1% of peer group)
· Daily Volume of Services greater than 70
· Services per Patient
· PBS prescribing
We discussed the Professional Services Review Scheme (page 12-13, MBS 1999) and Dr. Doan is awrae of the deeming rule (80 or more consultation services on 20 or more days in a 12-month period) applying to General Practice (para 8.1.8).
…
Dr. Doan will receive a copy of this report and is invited to comment (in writing) within 14 days if he wishes to make any clarifications or changes.
The report will then be submitted to the Health Insurance Commission who will correspond with him directly."
19 Under cover of letter dated 30 August 2000, Dr Karlik enclosed a copy of his report to Dr Doan. A copy of Mr Broadbent's report of interview was also enclosed. The covering letter stated that the first respondent would consider the two reports following the receipt of any written submissions made by Dr Doan in relation to either report. Dr Doan would then be informed of "the decision made".
20 By letter dated 28 September 2002, the Manager, Professional Review Branch (Victoria/Tasmania), Dr David Wilson, notified Dr Doan that it had been decided that his "practice profile" would be reviewed in "approximately three to six months to determine if the [first respondent's] concerns have been addressed". The letter further stated that if the review showed that the first respondent's concerns had not been allayed, then the first respondent may recommend to the Medical Director that Dr Doan be referred to the second respondent.
21 On 9 January 2001, a report entitled "Post PSR Counselling Review" was prepared by R J Brierly on behalf of the Professional Review Branch Victoria. The last paragraph of the report is titled "Summary" and states as follows:
"A decline in total servicing followed by a return to the previously recorded levels in the subsequent quarter has been main impact of counselling over the review period…. Little positive change is evident with the itemisation of the services raised for discussion during the visit and [Dr Doan's] requesting of pathology reduced temporarily but returned to previous levels shortly afterwards. One improvement was the discontinuation of his high daily servicing as only one date when this was evident was recorded over the review period. Potential for improvement with some of our itemisation concerns is evident but a longer review period will be needed to confirm this eventuality."
22 On 17 January 2001, Dr Karlik prepared a Post PSR Review Recommendation Report in relation to Dr Doan that reviewed his Medicare services profile between 3 August 2000 and 31 December 2000.
23 By letter dated 2 March 2001 ("the 2 March letter"), Dr Wilson wrote to Dr Doan referring to the letter of 28 September 2000 which had advised of a further review of his practice profile. The 2 March letter stated that a further review had been completed and the first respondent's original concerns had not been adequately addressed and the matter would therefore be forwarded to the Manager, Professional Services Branch (Dr Mould) for consideration of referral to the second respondent.
24 The matter was so forwarded to Dr Mould by correspondence dated 6 March 2002 from Dr Wilson:
"Please find attached a matter for your consideration for referral to the Director of Professional Services Review. The case was considered by the Victorian Case Management Committee on 28 February 2001 and a decision was made to accept the recommendation that this matter be referred for your consideration.
For the purposes of the Professional Services Review Scheme, Dr Doan was identified by the artificial neural net. An examination of data detected the following concerns:
o High volume of services
o High volume of daily services
o High average services per patient (SPP)
o Acupuncture itemisation
o High PBS prescribing.
…"
25 By letter dated 30 March 2001, Dr Mould notified Dr Doan that a review of his practice statistics and all relevant documentation revealed that the concerns of the first respondent in relation to rendered services, daily servicing and prescribing of items under the PBS remained. Dr Mould had therefore decided to refer Dr Doan's "conduct" to the second respondent for the second respondent's consideration as to whether Dr Doan had engaged in "inappropriate practice" under the PSR Scheme.
26 By letter dated 10 April 2001 to Dr Mould, Dr Doan expressed concern that the matter had been referred to the second respondent, as he had anticipated that he would be asked for "an explanation in relation to the [first respondent's] concerns before the matter was referred to the [second respondent]". The letter further stated that Dr Doan wished to advise the second respondent of the changes which he had implemented to meet the concerns which had been expressed to him at the time of the counselling visit.
27 On 9 October 2001, the first respondent referred Dr Doan's conduct to the second respondent by Investigative Referral 277. Investigative Referral 277 concerned services rendered by Dr Doan for the calendar year 2000.
28 Subsequently, on 22 October 2001, Dr Doan's solicitors wrote directly to the second respondent seeking that Investigative Referral 277 should not proceed and making submissions in this regard.
29 On 8 November 2001, Finn J gave judgment in the matter Pradhan v Holmes [2001] FCA 1560, finding invalid an investigative referral made under the PSR Scheme as it stood following the 1999 amendments. The finding of invalidity occurred because the conduct referred was "unspecified and unlimited": see Pradhan at [83]. In this way, the investigative referral in Pradhan included a statement that "(t)he attached material is provided for information only and is not intended to limit the conduct referred": see Pradhan at [62]. The same wording was included in Investigative Referral 277.
30 Subsequently, by letter dated 7 December 2001, the second respondent advised Dr Doan as follows:
"Following the recent Federal Court decision in Pradhan v Holmes & Ors I have to inform you that, because of the possibility that Investigative Referral 277 may be invalid, I am unable to complete my investigation into the referred services.
Accordingly, under the provisions of subsection 93A(1) of the Health Insurance Act I have decided to take no further action in respect of Investigative Referral No 277 from the Health Insurance Commission. I have advised the Health Insurance Commission of this decision."
31 By a written referral dated 18 December 2001, the first respondent again referred to the second respondent for investigation, all services rendered by Dr Doan at specific locations within a specified period, 1 January 2000 to and including 31 December 2000, to the second respondent ("Investigative Referral 312"). Investigative Referral 312 therefore concerned the same calendar year of services as Investigative Referral 277.
32 At p 3, Book 1 of Investigative Referral 312, it is stated that the first respondent is concerned that Dr Doan's conduct in connection with the rendering or initiation of rendered services, daily servicing and prescribing under the Pharmaceutical Benefits Scheme may constitute "inappropriate practice" within the meaning of the HI Act. At p 5, Book 1, the first respondent set out the reasons why it considered that Dr Doan may have engaged in inappropriate practice:
"In accordance with subsection 86(4)(b) of the Act, set out below are the reasons why the HIC considers Dr Doan may have engaged in inappropriate practice.
Within the scope of Dr Doan's conduct in connection with the rendering or initiating of the above services, the HIC is concerned that, as indicated by his practice profile, Dr Doan may have:
· rendered or initiated services that were not necessary;
· not provided an appropriate level of clinical input to the services;
· not provided appropriate 'professional services' to his patients; or
· not satisfied the requirements of the relevant items in the Medicare Benefits Schedule Book and the Schedule of Pharmaceutical Benefits.
The concerns of the HIC have been identified and analysed by:
· a review of Dr Doan's practice statistics;
· a comparison of those statistics with the data concerning the practice of all active general practitioners in Australia;
· a counselling meeting between a HIC Medical Adviser and Dr Doan where the above referred conduct was discussed (see Chronological Record of this Investigative Referral);
· a report of that meeting between the HIC Medical Adviser and Dr Doan (see attached); and
· a review of Dr Doan's practice statistics since counselling.
The HIC determined there had been insufficient change to remove overall concerns about the referred conduct above."
33 By letter also dated 18 December 2001, the first respondent invited Dr Doan to make written submissions to the second respondent within 14 days as to why the second respondent should dismiss Investigative Referral 312 without setting up a PSRC.
34 On 14 February 2002, Dr Doan's solicitors provided a written submission in response. At p 2 of the letter it is stated that:
"The three month minimum time period is important. It acknowledges the reality that in some instances patients need to be re-educated about their attendance habits….
In the case of Dr Doan an appropriate period for review would be 1 January 2001 to 31 December 2001. This period commenced not less than three months after counselling. A review of Dr Doan's practice statistics over this period will demonstrate that Dr Doan has implemented change and the changes are having an impact. Dr Doan acknowledges that there was little change in the three or four month period immediately following counselling of 2 August 2000 despite his efforts. It is only through a determination to bring about change that Dr Doan has now succeeded in modifying his patient's expectations."
35 Receipt of those submissions was acknowledged in a letter dated 15 February 2002. The letter advised that "the Director's full consideration will be given to your submission before he makes any decision as required by the Health Insurance Act 1973".
36 By letter dated 11 March 2002, the second respondent notified Dr Doan that he had "decided pursuant to subsection 89(1) of [the HI Act] to investigate Dr Doan's conduct in relation to the referred services". The letter enclosed, amongst other documents, a Notice to Produce Documents or Information pursuant to s 89B of the HI Act.
37 On 5 April 2002, Dr Doan's solicitors again wrote to the second respondent requesting reasons for the decision to investigate his "conduct in relation to the referred services" and the decision "to serve upon him in purported pursuance of section 89B of the Health Insurance Act 1973 a Notice to Produce Documents and to Give Information".
38 On 8 April 2002, Dr Doan filed his application in this proceeding.