Explanatory Statement

Health Insurance (Point of Care Testing in General Practice) Determination HS/03/2005

Issued by the authority of the Minister for Health and Ageing

Background

1                            The Department of Health and Ageing is funding the Point of Care Testing (PoCT) Trial in General Practice (PoCT trial) to investigate the clinical value, cost effectiveness and reliability of conducting simple pathology tests in a practitioners' consulting rooms during the course of patient consultations. 

2                            Ordinarily, practitioners would need to request an approved pathology practitioner (APP) to conduct the relevant pathology test in an approved pathology laboratory (APL) and then discuss the results with the patient. 

3                            By performing simple pathology tests during a patient consultation, practitioners will be able to make immediate and informed decisions about patient care. 

4                            Four pathology tests have been identified as being appropriate for the PoCT trial. Those pathology tests (defined as 'relevant services' in the Determination) are listed in the Schedule.

5                            During the first six months of the PoCT trial, participating practitioners will request an APP to render a pathology service (by reference to an existing item number in the pathology services table) which is equivalent to the relevant service to be rendered as part of the PoCT trial.  This will be done for quality assurance purposes, enabling the Trial manager and the treating practitioner to monitor the accuracy of the results obtained for services rendered as part of the trial.

6                            Adelaide Research and Innovation Pty Ltd (the Trial manager), the commercial arm of the University of Adelaide, Department of General Practice has been contracted to the Department of Health and Ageing to manage the PoCT trial. 

7                            The PoCT trial is expected to run from 1 September 2005 to 28 February 2007 and will involve approximately [60] general practices in urban, rural and remote locations across Australia. 

8                            Medical practitioners performing the relevant services and any person performing the services on their behalf will have to receive training and be accredited for the purposes of the PoCT trial.  The training and accreditation framework has been developed in conjunction with the Department and will be overseen by the Trial Manager. 

9                            As is required for all medical trials, patients must consent to being part of the PoCT trial and must sign appropriate consent forms.  Suitable patients will be identified by the practitioners participating in the trial.

10                        The services rendered as part of the PoCT trial will attract medicare benefits if performed by an accredited person in the circumstances described in the Determination. 

Object

11                        The object of the Determination is to authorise the payment of medicare benefits for services rendered as part of the PoCT trial and to specify the provisions of the Health Insurance Act 1973 and Health Insurance Regulations 1975 that will apply to those services.

Notes on sections

Section 1

12                        Section 1 provides for the name of the Determination.

Section 2

13                        This section provides that the Determination commences on 1 September 2005.

14                        This is consistent with paragraph 4(1)(a) of the Determination, which provides for medicare benefits to be paid only for relevant services rendered during the PoCT trial period, being after 31 August 2005 and before 1 March 2007.

Section 3

15                        Subsection 3(1) defines terms used in the Determination.

16                        A key term is 'relevant service' which means a service defined in paragraph 3C(8)(a) of the Act which is specified in the Schedule of the Determination.  There are four such relevant services in the Schedule.

17                        Another key term is 'designated general practice'.  This is a practice accredited for the purposes of the trial and which has entered into a contract for the purposes of the trial with the Trial manager.  Medical practitioners in a particular designated general practice will also receive training and be accredited to carry out, or have carried out on their behalf, relevant services for the purposes of the trial. 

18                        If medical practitioners leave the practice to which their PoCT accreditation relates, they will need to approach the Trial manager and request accreditation in relation to the new practice location.

19                        Subsection 3(2) provides that a reference to the Act or regulations made under the Act are references to provisions of the Act or regulations made under the Act as in force from time to time (as authorised by subsection 3C(3) of the Act).

Section 4

         Subsection 4(1)

20                        Subsection 4(1) provides that the Determination only applies to a relevant service where:

(a) the relevant service is rendered after 31 August 2005 but before 1 March 2007 by or on behalf of a medical practitioner participating in the PoCT trial (paragraph 4(1)(a)); and

(b) the medical practitioner referred to in paragraph (a) has determined the relevant service to be necessary for his or her patient participating in the PoCT trial (paragraph 4(1)(b)); and

(c) the relevant service is bulk-billed (paragraph 4(1)(c)).

21                        These three circumstances are explained in more detail below.  All three circumstances must be met for the Determination to apply.

Paragraph 4(1)(a)

22                        Paragraph 4(1)(a) provides that the relevant service must be rendered after 31 August 2005 and before 1 March 2007.  This is consistent with the PoCT trial period of 1 September 2005 to 28 February 2007. 

23                        Paragraph 4(1)(a) also refers to the relevant service being rendered by or on behalf of a medical practitioner (which is defined in subsection 3(1) of the Act) who is participating in the PoCT trial.  The requirement for a medical practitioner to be 'participating in the PoCT trial' is explained in subsection 4(2).

Paragraph 4(1)(b)

24                        Paragraph 4(1)(b) provides that the medical practitioner must have determined the relevant service to be necessary for his or her patient participating in the PoCT trial.  This mirrors the requirement imposed on medical practitioners under subsection 16A(1) of the Act (which does not apply in respect of the relevant services for the PoCT trial) that a medical practitioner make a professional judgment that a particular pathology service is necessary for that patient.

Paragraph 4(1)(c)

25                        Paragraph 4(1)(c) provides that the relevant service for the patient participating in the trial must be bulk-billed.  The term 'bulk-billed' is defined in subsection 4(7) of the Determination.

         Subsection 4(2)

26                        Subsection 4(2) provides that a medical practitioner is ‘participating in the PoCT trial’ for the purpose of paragraph 4(1)(a) if, and only if, the requirements set out in paragraphs 4(2)(a), 4(2)(b) and 4(2)(c) have been met.  These requirements are explained in detail below.

Paragraph 4(2)(a)

27                        Paragraph 4(2)(a) requires the medical practitioner to have completed the necessary training provided as part of the PoCT trial and to be accredited for the purposes of the trial under the arrangements for the trial, which are set out in the report Design for a Trial and an Evaluation Framework for the Introduction of Point of Care Testing into General Practice in Australia, available on the Department's homepage or on request to the Department.  The training will equip practitioners and people assisting them with the skills necessary to carry out the relevant services. 

28                        Accreditation will be evidence of having completed the training.  The accreditation process will be carried out by the Trial manager, in accordance with its contractual obligations with the Department of Health and Ageing.

Paragraph 4(2)(b)

29                        Subparagraph 4(2)(b)(i) requires the relevant service to be rendered at the designated general practice (ie: practice location) to which the practitioner's accreditation relates.   The Trial manager will enter into a contract with each designated practice for the purposes of the PoCT trial and notify the practice that it is accredited.  Services rendered by or on behalf of an accredited medical practitioner as part of the trial must be performed only at the practice location to which his or her accreditation relates.

30                        Subparagraph 4(2)(b)(ii) restricts the purposes for which a relevant service may be rendered to a patient participating in the PoCT trial.  Relevant services may be rendered only for the purposes of monitoring a patient's existing condition which is a condition relevant to the trial and to the particular health services specified in the Schedule. 

31                        This provision ensures that medicare benefits will not be payable for services used for diagnostic or population screening purposes. 

32                        Subparagraph 4(2)(b)(iii) provides that the relevant service must be performed as part of a patient consultation relating to the patient's existing condition.  The provision of the service must therefore have a temporal connection with a patient consultation.  A medicare benefit is payable in respect of both the consultation (in accordance with the general medical services table as set out in the Health Insurance (General Medical Services Table) Regulations) and the relevant service (in accordance with the Determination).

Paragraph 4(2)(c)

33                        Paragraph 4(2)(c) provides that the relevant service must be rendered to a patient who is over 18 years of age, is participating in the PoCT trial in respect of an existing condition relevant to the trial and the relevant service is rendered for the proper monitoring of that condition, and who has agreed to participate in the trial.

34                        Evidence of agreement to participate in the trial will be required in the form of a signed consent form (or forms, as the case may be), given to the practitioner prior to the rendering of the relevant service.  If the patient subsequently withdraws consent, no medicare benefit will be payable for any health services mentioned in the Schedule which are rendered after that time.

         Subsection 4(3)

35                        Subsection 4(3) explains when a relevant service is taken to be rendered on behalf of a medical practitioner participating in the PoCT trial, for the purposes of paragraph 4(1)(a) of the Determination. 

36                        Subsection 4(3) provides that a relevant service is only rendered on behalf of a medical practitioner participating in the PoCT trial if the service is rendered:

(a) after the medical practitioner has determined that the service is necessary; and

(b) by a person who has completed the training provided as part of the PoCT trial and has been accredited by the Trial manager for the purposes of the PoCT trial.

         Subsections 4(4) – (6)

37                        To participate in the PoCT trial, designated general practices, medical practitioners and persons assisting medical practitioners must be accredited by the Trial manager in accordance with the particular requirements of the PoCT trial and the accreditation must remain in effect. 

38                        Subsections 4(4) to 4(6) refer to the evidence that is required to show whether or not an accreditation as part of the PoCT trial exists for the purposes of the Determination and, if an accreditation under the PoCT trial is no longer in effect, the point in time when it is taken not to be in effect for the purposes of the Determination.

         Subsection 4(7)

39                        Subsection 4(7) defines the term 'bulk-billed' for the purpose of section 4.  It operates so that a service that is bulk-billed, as required by paragraph 4(1)(c) of the Determination, is dealt with in the same way as any other professional service that is bulk-billed under the Act.

Section 5

40                        Section 5 identifies which provisions of the Act and the regulations will apply in respect of a relevant service.

41                        It provides that all provisions of the Act and the Health Insurance Regulations 1975 which make provision in relation to professional services or medical services will apply, other than provisions that deal with pathology services specifically.  This means that provisions such as section 16A of the Act and Part IIA (which deal with pathology services) will not apply in respect of the relevant services specified in the Determination.

42                        Excluding provisions relating to pathology services specifically ensures that the PoCT trial can proceed in accordance with the trial requirements and without some of the restrictions on pathology services that could adversely impact on the effectiveness of the trial. 

43                        However, the Determination and the PoCT trial requirements ensure that the relevant services will be rendered in circumstances virtually identical to those that would apply if the relevant services were rendered under existing requirements for pathology services rendered by general practitioners in their rooms.  This is necessary to ensure the integrity of the trial results.

Schedule

44                        The Schedule sets out the relevant services that may be rendered as part of the PoCT trial and assigns to each service the applicable item number, item descriptor and fee.