Relevant legislative provisions
28 Sections 9 and 10(1) of the Health Insurance Act provide for the payment of medicare benefits in respect of a range of medical services prescribed in tables set out in regulations made under the Act:
9 Medicare benefits calculated by reference to fees
Medicare benefits under this Part (other than sections 10ACA and 10ADA) shall be calculated by reference to the fees for medical services set out in the table.
10 Entitlement to Medicare benefit
(1) Where, on or after 1 February 1984, medical expenses are incurred in respect of a professional service rendered in Australia to an eligible person, medicare benefit calculated in accordance with subsection (2) is payable, subject to and in accordance with this Act, in respect of that professional service.
Note: For eligible person, medical expenses, medicare benefit and professional service see subsection 3(1).
29 Part VAA of the Act provides for the Professional Services Review Scheme. Section 79A sets out the object of Pt VAA:
The object of this Part is to protect the integrity of the Commonwealth medicare benefits, dental benefits and pharmaceutical benefits programs and, in doing so:
(a) protect patients and the community in general from the risks associated with inappropriate practice; and
(b) protect the Commonwealth from having to meet the cost of services provided as a result of inappropriate practice.
30 Section 80 summarises the main features of the scheme. It is convenient to set out those features in full:
(2) The Professional Services Review Scheme is a scheme for reviewing and investigating the provision of services by a person to determine whether the person has engaged in inappropriate practice.
(3) The Chief Executive Medicare can request the Director to review the provision of services by a person and the Director must decide whether to undertake a review.
(4) Following a review, the Director must:
(a) decide to take no further action in relation to the review; or
(b) enter into an agreement with the person under review; or
(c) make a referral to a Committee.
(5) If the Director enters into an agreement with the person under review, the agreement must be ratified by the Determining Authority before it takes effect. Having an agreement ratified avoids a Committee investigation.
(6) A referral to a Committee initiates an investigation by the Committee into the provision of the services specified in the referral. The Committee can investigate any aspect of the provision of the referred services and its investigation is not limited by any reasons given in a request for review or a Director's report following a review.
(7) Committee members must belong to professions or specialities relevant to the investigation.
(8) Committees can hold hearings and require the person under review to attend and give evidence. Committees also have the power to require the production of documents (including clinical records).
(9) Committees can base findings on investigations of samples of services.
(10) If a Committee finds that the person under review has engaged in inappropriate practice, the finding will be reported to the Determining Authority. The Determining Authority decides what action to take.
(11) Provision is made throughout the scheme for the person under review to make submissions before key decisions are made or final reports are given.
(12) A Committee cannot make a finding of inappropriate practice unless it has given the person under review:
(a) notice of its intention to do so; and
(b) the reasons for the finding; and
(c) an opportunity to respond.
31 Section 86 provides that the Chief Executive Medicare may, and in certain cases must, request the Director of Professional Services Review to review the provision of services by a practitioner:
(1) Subject to subsection (1A), the Chief Executive Medicare may, in writing, request the Director to review the provision of services by a person during the period specified in the request.
Note: For provides services see subsection 81(2).
(1A) If the Chief Executive Medicare becomes aware that the circumstances in which services were rendered or initiated by a person constitute a prescribed pattern of services, the Chief Executive Medicare must make a request under subsection (1) in relation to the services.
(2) The period specified in the request must fall within the 2 year period immediately preceding the request.
(3) The request must include reasons for the request.
Note: If the request is made because of subsection (1A), it may include reasons other than the prescribed pattern of services.
(4) The content and form of the request must comply with any guidelines made under subsection (5).
(5) The Minister may, by legislative instrument, make guidelines about the content and form of requests for review.
32 Section 93 provides that the Director may refer an investigation concerning whether a practitioner engaged in "inappropriate practice" to a Professional Services Review Committee:
(1) The Director may, by writing, set up a Committee in accordance with Division 4, and make a referral to the Committee to investigate whether the person under review engaged in inappropriate practice in providing the services specified in the referral.
(2) If the referral arises from a request made by a Committee to the Director under subsection 106J(1), the Director may, instead of setting up a Committee under subsection (1), make the referral to the Committee that made the request.
(3) Subject to this section, the content and form of a referral must comply with any guidelines made under subsection (4).
(4) The Minister may, by legislative instrument, make guidelines about the content and form of referrals.
(6) If the Director makes a referral, the Director must:
(a) prepare a written report for the Committee, in respect of the services to which the referral relates, giving reasons why the Director thinks the person under review may have engaged in inappropriate practice in providing the services; and
(b) attach the report to the referral.
Note: The reasons given by the Director may relate solely to the services being rendered or initiated in circumstances that constitute a prescribed pattern of services.
(7) Within 7 days after making the referral, the Director must give a copy of the referral and report to the Chief Executive Medicare and the person under review.
(7A) The copy given to the person under review must be accompanied by a written notice setting out the terms of sections 102, 106H and 106K.
(7B) The services that may be specified in the referral are any or all of the services provided by the person under review during the review period.
(7C) Subsection (7B) is not limited by the terms of the Director's report under subparagraph 89C(1)(b)(i).
(7D) Failure to comply with subsection (7) or (7A) does not affect the validity of the referral.
(8) If, in the course of the review that gave rise to the referral:
(a) the Director formed an opinion that any conduct by the person under review caused, was causing, or was likely to cause, a significant threat to the life or health of any person and sent a statement of his or her concerns to a person or body under section 106XA; or
(b) the Director formed an opinion that the person under review failed to comply with professional standards and sent a statement of his or her concerns to an appropriate body under section 106XB;
the referral must contain a statement that the Director formed that opinion and set out the terms of the statement sent to the person or body.
(9) The Director must disregard any opinion formed as mentioned in subsection (8) when making the referral.
33 Section 82 defines "inappropriate practice" in the following way:
Unacceptable conduct
(1) A practitioner engages in inappropriate practice if the practitioner's conduct in connection with rendering or initiating services is such that a Committee could reasonably conclude that:
(a) if the practitioner rendered or initiated the services as a general practitioner - the conduct would be unacceptable to the general body of general practitioners; or
(b) if the practitioner rendered or initiated the services as a specialist (other than a consultant physician) in a particular specialty - the conduct would be unacceptable to the general body of specialists in that specialty; or
(c) if the practitioner rendered or initiated the services as a consultant physician in a particular specialty - the conduct would be unacceptable to the general body of consultant physicians in that specialty; or
(d) if the practitioner rendered or initiated the services as neither a general practitioner nor a specialist but as a member of a particular profession - the conduct would be unacceptable to the general body of the members of that profession.
Prescribed pattern of services
(1A) Subject to subsections (1B) and (1C), a practitioner engages in inappropriate practice in rendering or initiating services during a particular period (the relevant period) if the circumstances in which some or all of the services were rendered or initiated constitute a prescribed pattern of services.
(1B) A practitioner does not, under subsection (1A), engage in inappropriate practice in rendering or initiating services on a particular day during the relevant period if a Committee could reasonably conclude that, on that day, exceptional circumstances existed that affected the rendering or initiating of the services.
(1C) Subsection (1B) does not affect the operation of subsection (1A) in respect of the remaining day or days during the relevant period on which the practitioner rendered or initiated services even if the circumstances in which the services were rendered or initiated on that day or those days would not, if considered alone, have constituted a prescribed pattern of services.
(1D) The circumstances that constitute exceptional circumstances for the purposes of subsection (1B) include, but are not limited to, circumstances that are prescribed by the regulations to be exceptional circumstances.
Causing or permitting inappropriate practice
(2) A person (including a practitioner) engages in inappropriate practice if the person:
(a) knowingly, recklessly or negligently causes, or knowingly, recklessly or negligently permits, a practitioner employed by the person to engage in conduct that constitutes inappropriate practice by the practitioner under subsection (1) or (1A); or
(b) is an officer of a body corporate and knowingly, recklessly or negligently causes, or knowingly, recklessly or negligently permits, a practitioner employed by the body corporate to engage in conduct that constitutes inappropriate practice by the practitioner under subsection (1) or (1A).
34 Pursuant to s 82(3), in determining whether a practitioner engaged in inappropriate practice, a Committee must have regard to whether the practitioner kept adequate and contemporaneous records:
A Committee must, in determining whether a practitioner's conduct in connection with rendering or initiating services was inappropriate practice, have regard to (as well as to other relevant matters) whether or not the practitioner kept adequate and contemporaneous records of the rendering or initiation of the services.
35 Under s 81, the term "adequate and contemporaneous records" is defined to mean "records that meet the standards prescribed by the regulations for the purposes of this definition". The relevant regulations are the Professional Services Review Regulations. Regulations 5 and 6 prescribe the following definitions:
5 An adequate record
For the definition of adequate and contemporaneous records in section 81 of the Act, the standard to be met in order that a record of service rendered or initiated be adequate is that:
(a) the record clearly identify the name of the patient; and
(b) the record contain a separate entry for each attendance by the patient for a service and the date on which the service was rendered or initiated; and
(c) each entry provide clinical information adequate to explain the type of service rendered or initiated; and
(d) each entry be sufficiently comprehensible that another practitioner, relying on the record, can effectively undertake the patient's ongoing care.
6 A contemporaneous record
For the definition of adequate and contemporaneous records in section 81 of the Act, the standard to be met in order that a record of a service rendered or initiated be contemporaneous, is that record must be completed:
(a) at the time the practitioner rendered or initiated the service; or
(b) as soon as practicable after the service was rendered or initiated by the practitioner.
36 Section 106K provides that, in the course of investigating services referred to it, a Committee may have regard to "samples" of the services:
(1) The Committee may, in investigating the provision of services included in a particular class of the referred services, have regard only to a sample of the services included in the class.
(2) If the Committee finds that a person has engaged in inappropriate practice in providing all, or a proportion, of the services included in the sample, then, the person under review is taken, for the purposes of this Part, to have engaged in inappropriate practice in the provision of all, or that proportion, as the case may be, of the services included in the class from which the sample is chosen.
(3) The Minister may, by legislative instrument, make determinations specifying the content and form of sampling methodologies that may be used by Committees for the purposes of subsection (1).
(4) The Committee may use a sampling methodology that is not specified in such a determination if, and only if, the Committee has been advised by a statistician accredited by the Statistical Society of Australia Inc that the sampling methodology is statistically valid.
37 The Health Insurance (Professional Services Review - Sampling Methodology) Determination 2006 (Cth) specifies a sampling methodology for the purpose of s 106K(1). Items 7 and 8 of the Determination provide:
7 Sample
(1) Under this methodology, the Committee must have regard to a sample of no fewer than 25 provided services randomly drawn from a class of referred services being investigated.
(2) The Committee may:
(a) omit a service from the sample; and
(b) include another provided service, randomly drawn from the same class, in its place.
(3) If the Committee omits a service and includes another provided service in its place under subsection (2), the Committee must state its reasons for doing so in the draft report and final report it prepares in respect of the person under review to whom the sample relates.
Note The Committee must prepare a draft report under section 106KD of the Act, and a final report under section 106L of the Act, in relation to its findings.
8 Determining percentage of inappropriate practice in sample
(1) A Committee relying on subsection 106K (1) of the Act must work out, in accordance with subsection (2), the proportion of services in the sample in relation to the provision of which the person under review engaged in inappropriate practice.
(2) For subsection (1), the proportion is to be expressed as a percentage, as follows:
where:
d is the number of services in the sample that the Committee has determined are services in relation to the provision of which the person under review engaged in inappropriate practice, divided by s.
s is the number of services in the sample.
N is the number of services in the class.
(3) The percentage must be expressed as a whole number (if necessary, for that purpose, rounded down to the nearest whole number).
38 The Health Insurance (General Medical Services Table) Regulations 2011 (Cth) (2011 GMS Table Regulations) described the services that are the subject of findings in the Committee's final report:
37 Professional attendance by a general practitioner (other than attendance at consulting rooms or a residential aged care facility or a service to which another item in the table applies), lasting at least 20 minutes and including any of the following that are clinically relevant:
(a) taking a detailed patient history;
(b) performing a clinical examination;
(c) arranging any necessary investigation;
(d) implementing a management plan;
(e) providing appropriate preventive health care;
for 1 or more health related issues, with appropriate documentation - an attendance on 1 or more patients at 1 place on 1 occasion - each patient
…
597 Professional attendance by a general practitioner on not more than 1 patient on 1 occasion - each attendance (other than an attendance in unsociable hours) in an after hours period if:
(a) the attendance is requested by the patient or a responsible person in, or not more than 2 hours before the start of, the same unbroken after hours period, and the patient's medical condition requires urgent treatment; and
(b) if the attendance is performed at consulting rooms - it must be necessary for the practitioner to return to, and specially open, the consulting rooms for the attendance
…
721 Attendance by a medical practitioner (including a general practitioner, but not including a specialist or consultant physician), for preparation of a GP management plan for a patient (other than a service associated with a service to which any of items 735 to 758 apply)
…
5043 Professional attendance by a general practitioner (other than attendance at consulting rooms, a hospital or a residential aged care facility or a service to which another item in the table applies), lasting at least 20 minutes and including any of the following that are clinically relevant:
(a) taking a detailed patient history;
(b) performing a clinical examination;
(c) arranging any necessary investigation;
(d) implementing a management plan;
(e) providing appropriate preventive health care;
for 1 or more health related issues, with appropriate documentation - an attendance on 1 or more patients on 1 occasion - each patient
39 The review period examined by the Committee was 1 December 2011 to 30 November 2012. Therefore, the Health Insurance (General Medical Services Table) Regulations 2012 (Cth) (2012 GMS Table Regulations) were the relevant regulations for services provided by Dr Sevdalis after 1 November 2012, being the commencement date of those regulations and the date upon which they superseded the 2011 GMS Table Regulations, which were the relevant regulations before that date. However, apart from the amounts payable for the relevant services, the 2011 and 2012 regulations are materially the same for the purposes of the applicant's judicial review grounds. I will therefore refer to the 2011 regulations only, unless the context requires specificity as to which of the regulations is relevant.
40 Clause 1.2.3(2) of Schedule 1 of the 2011 GMS Table Regulations provided in respect of the term 'professional attendance' in items 37, 597 and 5043:
(2) A professional attendance includes the provision, for a patient, of any of the following services:
(a) evaluating the patient's condition or conditions including, if applicable, evaluation using a health screening service mentioned in subsection 19 (5) of the Act;
(b) formulating a plan for the management and, if applicable, for the treatment of the patient's condition or conditions;
(c) giving advice to the patient about the patient's condition or conditions and, if applicable, about treatment;
(d) if authorised by the patient - giving advice to another person, or other persons, about the patient's condition or conditions and, if applicable, about treatment;
(e) providing appropriate preventive health care;
(f) recording the clinical details of the service or services provided to the patient.
41 "Clinically relevant service" is defined in s 3(1) of the Act to mean:
a service rendered by a medical or dental practitioner or an optometrist that is generally accepted in the medical, dental or optometrical profession (as the case may be) as being necessary for the appropriate treatment of the patient to whom it is rendered.
42 Clause 2.23.1(2) of Sch 1 of the 2011 GMS Table Regulations provided that item 5043 applied "only to a professional attendance that is provided in an after-hours period", where "after-hours period" was defined to mean any of the following:
(a) a public holiday;
(b) a Sunday;
(c) before 8 am, or after 12 noon, on a Saturday;
(d) before 8 am, or after 6 pm, on any day other than a Saturday, Sunday or public holiday.
43 Clause 2.15.1 of Sch 1 of the 2011 GMS Table Regulations set out the meaning of "patient's medical condition requires urgent treatment" in item 597:
(1) For items 597 to 600, a patient's medical condition requires urgent treatment if:
(a) medical opinion is to the effect that the patient's medical condition requires treatment within the unbroken after hours period in, or before, which the attendance mentioned in the item was requested; and
(b) treatment could not be delayed until the start of the next in hours period.
(2) For subclause (1), medical opinion is to a particular effect if:
(a) the attending practitioner is of that opinion; and
(b) in the circumstances that existed and on the information available when the opinion was formed, that opinion would be acceptable to the general body of medical practitioners.
44 The prescribed fee for each relevant service under the 2011 GMS Table Regulations, described as the "Schedule fee" in s 8(1A) of the Act, was:
(1) for an item 37 service, $69.00 plus either:
(a) $25 divided by the number of patients if there were not more than six patients in a single attendance; or
(b) $1.90 multiplied by the number of patients if there were more than six patients in a single attendance;
(2) $124.90 for an item 597 service;
(3) for an item 5043 service, $80.75 plus either:
(a) $25 divided by the number of patients if there were not more than six patients in a single attendance; or
(b) $1.90 multiplied by the number of patients if there were more than six patients in a single attendance; and
(4) $138.75 for an item 721 service.
45 The Schedule fee for each relevant service under the 2012 GMS Table Regulations was:
(1) for an item 37 service, $70.30 plus either:
(a) $25.45 divided by the number of patients if there were not more than six patients in a single attendance; or
(b) $1.95 multiplied by the number of patients if there were more than six patients in a single attendance;
(2) $127.25 for an item 597 service;
(3) for an item 5043 service, $82.30 plus either:
(a) $25.45 divided by the number of patients if there were not more than six patients in a single attendance; or
(b) $1.95 multiplied by the number of patients if there were more than six patients in a single attendance; and
(4) $141.40 for an item 721 service.
46 The Schedule fees must be read together with s 10(2) of the Act, which provides:
(2) A benefit in respect of a service is:
(a) in the case of a service provided:
(i) as part of an episode of hospital treatment; or
(ii) as part of an episode of hospital‑substitute treatment in respect of which the person to whom the treatment is provided chooses to receive a benefit from a private health insurer;
an amount equal to 75% of the Schedule fee; or
(aa) in the case of a service to which paragraph (a) does not apply and that is prescribed by the regulations for the purposes of this paragraph - an amount equal to 100% of the Schedule fee; or
(b) in any other case - an amount equal to 85% of the Schedule fee.
47 If a Committee makes a finding of inappropriate practice in its final report, s 106L(3) provides that, subject to an irrelevant exception, the Committee must:
(a) give copies of the final report to the person under review and the Director; and
(b) give the final report to the Determining Authority not earlier than 1 month after the day on which a copy of the report is given to the person under review.
48 Section 106SA(1) provides that the Determining Authority must give the person under review an opportunity to make written submissions regarding the Committee's final report:
(1) The Determining Authority must give the person under review a written invitation to make written submissions to the Authority, having regard to the Committee's final report and any information given by the Director under section 106S, about the directions the Authority should make in the draft determination relating to the person.
49 Pursuant to s 106T(1) and (3), the Determining Authority must then produce a draft determination and give it to the person under review, who may make further written submissions in relation to the draft determination:
(1) The Determining Authority must, after taking into account any submissions made by the person under review in accordance with section 106SA:
(a) make a draft determination in accordance with section 106U relating to the person; and
(b) give copies of the draft determination to the person and to the Director.
…
(3) The person under review may, within the 14 day period referred to in subsection (2), make written submissions to the Authority suggesting changes to the directions contained in the draft determination.
50 Section 106TA(1) provides that the Determining Authority must then produce a final determination:
(1) If the Determining Authority has made a draft determination under section 106T, the Authority must, within one month after the end of the 14 day period within which the person under review may make submissions, and after taking into account any submissions made by the person during that 14 day period, make a final determination in accordance with section 106U relating to the person under review.
51 Section 106U prescribes the content of determinations which may be made by the Determining Authority:
(1) A draft determination or a final determination must contain one or more of the following directions:
(a) that the Director, or the Director's nominee, reprimand the person under review;
(b) that the Director, or the Director's nominee, counsel the person under review;
(c) that any medicare benefit or dental benefit that would otherwise be payable for a service in the provision of which the person is stated in a report under section 106L to have engaged in inappropriate practice cease to be payable;
(ca) if any medicare benefit or dental benefit for a service:
(i) that was rendered or initiated by the person under review, by an employee of the person under review, or by an employee of a body corporate of which the person under review is an officer; and
(ii) in connection with the rendering or initiation of which the person under review or such an employee is stated in a report under section 106L (other than a report based on a finding made under subsection 106K(2) or 106KB(3)) to have engaged in inappropriate practice;
has been paid (whether or not to the person under review) - that the person under review repay to the Commonwealth the whole or a part of the medicare benefit or dental benefit that was paid for that service;
(cb) if any medicare benefits or dental benefits for a class of services:
(i) that were rendered or initiated by the person under review, by an employee of the person under review, or by an employee of a body corporate of which the person under review is an officer; and
(ii) in connection with the rendering or initiation of which, or of a proportion of which, the person under review or such an employee is stated in a report under section 106L, based on a finding made under subsection 106K(2), to have engaged in inappropriate practice;
have been paid (whether or not to the person under review) - that the person under review repay to the Commonwealth the whole or a part of the medicare benefits or dental benefits that were paid for the services or that proportion of the services, as the case may be;
(e) if the person under review is a participating optometrist - that the Minister's acceptance of the undertaking by the participating optometrist under section 23B is taken to be revoked, either wholly or in so far as the undertaking covers particular premises;
(ea) if the person under review is a midwife and there is in force in respect of the person an undertaking under section 21B - that the Minister's acceptance of the undertaking is to be taken to be revoked;
(eb) if the person under review is a nurse practitioner and there is in force in respect of the person an undertaking under section 22A - that the Minister's acceptance of the undertaking is to be taken to be revoked;
(f) if the person under review is a person in respect of whom a Part VII authority is in force and the service in connection with which the person is stated in a report under section 106L to have engaged in inappropriate practice involves prescribing or dispensing a pharmaceutical benefit - that the Part VII authority be taken, for the purposes of the National Health Act 1953, to be suspended;
(g) if the person under review is a practitioner - that the practitioner be disqualified, for a specified period starting when the determination takes effect, in respect of one or more of the following:
(i) provision of specified services, or provision of services other than specified services;
(ii) provision of services to a specified class of persons, or provision of services to persons other than persons included in a specified class of persons;
(iii) provision of services within a specified location, or provision of services otherwise than in a specified location;
(h) if the person under review is a practitioner - that the practitioner be fully disqualified for a specified period starting when the determination takes effect.
Note: Medicare benefits and dental benefits are not payable in respect of services rendered or initiated by, or on behalf of, disqualified practitioners (see section 19B of this Act in relation to medicare benefits, and section 20A of the Dental Benefits Act 2008 in relation to dental benefits).
(1A) For the purposes of paragraph (1)(cb), it is to be assumed that all the medicare benefits paid for services in the class of services referred to in that paragraph were paid at the lowest rate that was payable for any of the services included in the class.
…
(2A) A direction under paragraph (1)(f) must specify a period of suspension of up to 3 years, to start when the determination takes effect.
(3) For the purposes of paragraphs (1)(g) and (h), the period specified must not be more than:
(a) if the person under review is a practitioner in relation to whom an agreement under section 92, or a final determination under section 106TA, has previously taken effect - 5 years; or
(b) in any other case - 3 years.