Federal Register of Legislation - Australian Government

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Determinations/Health as made
This Determination gives effect to new rule 28 of the Diagnostic Imaging Services Table and will ensure that rule 28 will apply to positron emission tomography services specified in the Determination and allow a Medicare rebate increase for relevant diagnostic imaging services that are provided out of hospital and are bulk-billed.
Administered by: Health
Registered 16 Oct 2009
Tabling HistoryDate
Tabled HR21-Oct-2009
Tabled Senate26-Oct-2009
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Health Insurance (Positron Emission Tomography) Determination 2009 (No. 2)

 

I, BRIAN RICHARDS, delegate of the Minister for Health and Ageing, make this Determination under subsection 3C(1) of the Health Insurance Act 1973.

Dated   8 OCTOBER 2009

 

 

 

 

BRIAN RICHARDS

Delegate of the 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 2009.

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 2009 (No. 2).

2.                       Commencement and term

This Determination commences on 1 November 2009 and shall remain in force until midnight on 30 June 2010.

3.                       Revocation of Health Insurance (Positron Emission Tomography) Determination 2009

This Determination revokes Health Insurance (Positron Emission Tomography) Determination 2009.

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.

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.

GEJ means gastro-oesophageal junction.

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) of this Determination.

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 or the National Health Act 1953 or regulations made under the National Health Act 1953 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)   Requirements for PET Accreditation (Instrumentation and Radiation Safety) dated May 2007 issued by the Australian and New Zealand Society of Nuclear Medicine; and

(b)  NEMA NU 2-2001 Standard published on 20 June 2001 and issued by the National Electrical Manufacturers Association.

(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 2009 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;

(d)                    subrule 28(1)(a) of Part 2 of Schedule 1 of the Health Insurance (Diagnostic Imaging Services Table) Regulations 2009 or regulations that replace them,

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 (R).

 

$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 (R).

 

$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 (R).

 

$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 (R).

 

$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 (R).

 

$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 catheterisation of the bladder (R).

 

$975.00


 

Item

Health Service

Fee for all States

61577

Whole body FDG PET study, performed for the staging of proven oesophageal or GEJ carcinoma, in patients considered suitable for active therapy (R).

 

$953.00


61580

Whole body FDG PET study, performed for the staging of proven oesophageal or GEJ carcinoma, in patients considered suitable for active therapy, with catheterisation of the bladder (R).

 

$975.00

61598

Whole body FDG PET study performed for the staging of biopsy-proven, newly diagnosed or recurrent head and neck cancer (R).

 

$953.00

61604

Whole body FDG PET study performed for the evaluation of patients with suspected residual head and neck cancer after definitive treatment, and who are suitable for active therapy (R).

 

$953.00

61610

Whole body FDG PET study performed for the evaluation of metastatic squamous cell carcinoma of unknown primary site involving cervical nodes (R).

 

$953.00

61613

Whole body FDG PET study performed for the evaluation of metastatic squamous cell carcinoma from an unknown primary site involving cervical nodes, with catheterisation of the bladder (R).

 

$975.00

 

Note  Subsection 3C(7) of the Act deems an internal territory to form part of the State of New South Wales.