Health Insurance (Positron Emission Tomography) Determination 2008 (No.2).
I, NICOLA ROXON, Minister for Health and Ageing, make this Determination under subsection 3C(1) of the Health Insurance Act 1973.
Dated 10th NOVEMBER 2008
__________________________
NICOLA ROXON
Minister for Health and Ageing
Contents
1. Name of Determination 3
2. Commencement and term 3
3. Revocation of Health Insurance (Positron Emission Tomography) Determination 2008
4. Interpretation 3
5. Circumstances where this Determination applies 4
6. Treatment of certain positron emission tomography services 6
7. Certain positron emission tomography services—items and specifications etc 6
Schedule – Specified health services 7
1. Name of Determination
This Determination is the Health Insurance (Positron Emission Tomography) Determination 2008 (No. 2).
2. Commencement and term
This Determination commences on 1 December 2008 and shall remain in force until midnight on 30 June 2010.
3. Revocation of Health Insurance (Positron Emission Tomography) Determination 2008
This Determination revokes Health Insurance (Positron Emission Tomography) Determination 2008.
4. Interpretation
(1) In this Determination:
accredited site is one that is accredited by ANZAPNM as a site for advanced training in PET.
Act means the Health Insurance Act 1973.
ANZAPNM means the Australian and New Zealand Association of Physicians in Nuclear Medicine Inc, a body incorporated under the Associations Incorporation Act 1987 (WA).
authorised officer means, in relation to functions under this Determination:
(a) an employee of Medicare Australia authorised by the CEO of Medicare Australia; and
(b) an APS employee (within the meaning of the Public Service Act 1999) authorised by the Secretary.
comprehensive facility means:
(a) a building or part of a building; or
(b) buildings, where public access between the buildings is by way of a covered pedestrian walkway;
where each of the following services is provided (whether or not other services are also provided):
(i) PET;
(ii) computed tomography;
(iii) x-ray;
(iv) diagnostic ultrasound;
(v) medical oncology;
(vi) surgical oncology;
(vii) radiation oncology; and
(viii) neurology.
FDG means 18F-fluorodeoxyglucose.
PET means positron emission tomography.
quarter means a period of three months beginning on 1 January, 1 April, 1 July or 1 October of any year.
RACP means the Royal Australasian College of Physicians (ACN 000 039 047).
RANZCR means the Royal Australian and New Zealand College of Radiologists (ACN 000 029 863).
relevant service means a health service, as defined in subsection 3C(8) of the Act that is specified in the Schedule.
throughput requirement has the meaning given by subsection 5(4).
Note Unless the contrary intention appears, expressions used in this determination have the same meanings as in the Act—see section 13 of the Legislative Instruments Act 2003.
(2) Unless the contrary intention appears, in this Determination a reference to a provision of the Act or regulations made under the Act as applied, adopted or incorporated in relation to specifying a matter is a reference to those provisions as in force from time to time and any other reference to provisions of an Act or regulations is a reference to those provisions as in force from time to time.
5. Circumstances where this Determination applies
(1) This Determination applies only in the following circumstances:
(a) where the relevant service is rendered:
(i) pursuant to a written request made by a specialist or a consultant physician who determined that the service was necessary and whose patient the person was; and
Note This circumstance mirrors the requirement in paragraph 16B(1)(b) of the Act that, for a medicare benefit to be payable in respect of an R-type diagnostic imaging service, the service must be rendered pursuant to a written request, but limits which practitioners may request a relevant service
(ii) by or under the personal supervision of:
(A) a credentialled specialist referred to in subsection (2); or
(B) a practitioner possessing the qualifications and experience prescribed in subsection (2A); and
(iii) at an accredited site in a comprehensive facility; and
(iv) using equipment that meets each of the standards specified by ANZAPNM as referred to in subsection (3); and
(b) the owner or operator of the equipment used to provide the relevant services has not been given written notice by an authorised officer that the equipment fails to meet the throughput requirement referred to in subsection (4) and that notice remains in effect; and
(c) if Medicare Australia has given written notice to the owner or operator of the equipment used to provide the relevant service that it requires a statutory declaration to be provided in relation to circumstances referred to in this section, the owner or operator of the equipment has provided a statutory declaration to Medicare Australia in the timeframe specified in the notice; and
(d) if the circumstances declared in a statutory declaration referred to in paragraph (c) have changed, the owner or operator has given Medicare Australia written notice of the change as soon as the changed circumstances have come to the attention of the owner or operator, as the case may be.
(2) A credentialled specialist is a specialist or a consultant physician (not being the requesting practitioner mentioned in subparagraph (1)(a)(i)) credentialled under the 'Joint Nuclear Medicine Specialist Credentialling Program for the Recognition of the Credentials of Nuclear Medicine Specialists for Positron Emission Tomography' overseen by the Joint Nuclear Medicine Credentialling and Accreditation Committee established from time to time by the RACP and the RANZCR.
(2A) For subparagraph (1)(a)(ii), the following qualifications and experience are prescribed:
(a) the practitioner (not being the requesting practitioner mentioned in subparagraph (1)(a)(i)) is a Fellow of the RACP or Fellow of the RANZCR;
(b) the practitioner has reported 400 or more studies forming part of PET services in respect of which a medicare benefit was payable; and
(c) the practitioner holds a current licence from the relevant State radiation licensing body to prescribe and administer the intended PET radiopharmaceuticals to humans.
(3) For subparagraph (1)(a)(iv), the standards specified by ANZAPNM are the:
(a) Interim Recommendations for PET Accreditation (Technical Aspects) dated 16 May 2001 and issued by the Australian and New Zealand Society of Nuclear Medicine (a body incorporated under the Associations Incorporation Act 1984 (NSW)), but not including the NEMA NU 2-2000 standard referred to in that document; and
(b) NEMA NU 2-2001 standard published on 20 June 2001 and issued by the National Electrical Manufacturers Association, a non-stock corporation organised under the General Corporation Law of the State of Delaware (United States of America),
being those documents in existence immediately before this Determination commences.
(4) For paragraph (1)(b), the throughput requirement is that each piece of PET equipment located at the accredited site is used to render at least 20 relevant services each quarter following the quarter when the equipment is first used to render a relevant service.
(5) For paragraph (1)(b), an authorised officer may, by written notice to the owner or operator of the equipment, revoke a notice referred to in that paragraph (1)(b) if satisfied that the equipment will meet the throughput requirement in future, having regard to action taken by the owner or operator (after the notice was given) aimed at meeting that requirement.
6. Treatment of certain positron emission tomography services
A relevant service shall be treated for the purposes of the provisions of the Act and of regulations made under the Act and the provisions of the National Health Act 1953 and of regulations made under the National Health Act 1953
that make provision in respect of professional services or medical services as if:
(a) it was both a professional service and a medical service; and
(b) there was an item of an R-type diagnostic imaging service in the diagnostic imaging services table that:
(i) related to the relevant service; and
(ii) specified in respect of the service a fee in relation to a State, being the fee specified in the Schedule in relation to the State specified.
7. Certain positron emission tomography services—items and specifications etc
Each of the following provisions:
(a) subrule 3(1) of Part 2 of Schedule 1 of the Health Insurance (Diagnostic Imaging Services Table) Regulations 2007 or regulations that replace them;
(b) any regulation made under the Act that identifies an item in the diagnostic imaging services table as an R-type diagnostic imaging service;
(c) regulation 13 of the Health Insurance Regulations 1975, so far as it relates to professional services generally or diagnostic imaging services specifically,
shall have effect as if a relevant service, and the items that, by virtue of paragraph 6(b), relate to a relevant service, were also specified in the provision.
Schedule – Specified health services
Item
Health Service
Fee for all States
61523
Whole body FDG PET study, performed for evaluation of a solitary pulmonary nodule, where the lesion is considered unsuitable for transthoracic fine needle aspiration biopsy, or for which an attempt at pathological characterisation has failed. (R)
$953.00
61529
Whole body FDG PET study, performed for the staging of proven non-small cell lung cancer, where curative surgery or radiotherapy is planned. (R)
$953.00
61541
Whole body FDG PET study, following initial therapy, performed for the evaluation of suspected residual, metastatic or recurrent colorectal carcinoma in patients considered suitable for active therapy.
$953.00
61544
Whole body FDG PET study, following initial therapy, performed for the evaluation of suspected residual, metastatic or recurrent colorectal carcinoma in patients considered suitable for active therapy, with catheterisation of the bladder.
$975.00
61553
Whole body FDG PET study, following initial therapy, performed for the evaluation of suspected metastatic or recurrent malignant melanoma in patients considered suitable for active therapy.
$999.00
61556
Whole body FDG PET study, following initial therapy, performed for the evaluation of suspected metastatic or recurrent malignant melanoma in patients considered suitable for active therapy, with catheterisation of the bladder.
$1021.00
61559
FDG PET study of the brain, performed for the evaluation of refractory epilepsy, which is being evaluated for surgery. (R)
$918.00
61565
Whole body FDG PET study, following initial therapy, performed for the evaluation of suspected residual, metastatic or recurrent ovarian carcinoma in patients considered suitable for active therapy.
$953.00
61568
Whole body FDG PET study, following initial therapy, performed for the evaluation of suspected residual, metastatic or recurrent ovarian carcinoma in patients considered suitable for active therapy with curative intent, with catheterisation of the bladder.
$975.00
Note Subsection 3C(7) of the Act deems an internal territory to form part of the State of New South Wales.
