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Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2010 (No. 1)

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Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2010 (No. 1)1
Select Legislative Instrument 2010 No. 65
I, QUENTIN BRYCE, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Health Insurance Act 1973.
Dated 14 April 2010
QUENTIN BRYCE
Governor-General
By Her Excellency’s Command
NICOLA ROXON
Minister for Health and Ageing
Contents
                        1     Name of Regulations                                                        2
                        2     Commencement                                                              2
                        3     Amendment of Health Insurance (Diagnostic Imaging Services Table) Regulations 2009           2
Schedule 1             Amendments commencing on 1 May 2010                    3
Schedule 2             Amendments commencing immediately after commencement of Schedule 1 to the Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No 6)         10
 
 
 
 
1              Name of Regulations
                These Regulations are the Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2010 (No. 1).
2              Commencement
                These Regulations commence as follows:
                (a)    on 1 May 2010 — regulations 1 to 3 and Schedule 1;
               (b)    immediately after the commencement of Schedule 1 to the Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No 6) — Schedule 2.
3              Amendment of Health Insurance (Diagnostic Imaging Services Table) Regulations 2009
                Schedules 1 and 2 amend the Health Insurance (Diagnostic Imaging Services Table) Regulations 2009.
Schedule 1        Amendments commencing on 1 May 2010
(regulation 3)
 
[1]           Schedule 1, Part 2, subrule 2 (1), before definition of (Anaes.)
insert
accredited site means a site accredited by ANZAPNM as a site for advanced training in PET.
[2]           Schedule 1, Part 2, subrule 2 (1), after definition of (Anaes.)
insert
ANZAPNM means the Australian and New Zealand Association of Physicians in Nuclear Medicine (ABN 99 665 425 983).
[3]           Schedule 1, Part 2, subrule 2 (1), after definition of bulk‑billed
insert
comprehensive facility means a building or part of a building, or more than 1 building if public access between the buildings is by a covered pedestrian walkway, where all of the following services are performed (whether or not other services are also performed):
                (a)    PET;
               (b)    computed tomography;
                (c)    diagnostic ultrasound;
               (d)    medical oncology;
                (e)    neurology;
                (f)    radiation oncology;
                (g)    surgical oncology;
                (h)    x-ray.
[4]           Schedule 1, Part 2, subrule 2 (1), after definition of computed tomography
insert
credentialled specialist means a specialist or consultant physician 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 JNMCAC.
[5]           Schedule 1, Part 2, subrule 2 (1), after definition of CT equipment
insert
FDG means 18F-fluorodeoxyglucose.
GEJ means gastro-oesophageal junction.
[6]           Schedule 1, Part 2, subrule 2 (1), after definition of item
insert
JNMCAC means the Joint Nuclear Medicine Credentialling and Accreditation Committee of the RACP and RANZCR.
[7]           Schedule 1, Part 2, subrule 2 (1), after definition of non‑metropolitan hospital
insert
PET means positron emission tomography.
[8]           Schedule 1, Part 2, subrule 2 (1), after definition of providing practitioner
insert
RACP means The Royal Australasian College of Physicians (ABN 90 270 343 237).
RANZCR means The Royal Australian and New Zealand College of Radiologists (ABN 37 000 029 863).
[9]           Schedule 1, Part 2, subrule 19 (1)
omit
Subject to subrules (2) and (4),
insert
Subject to subrule (2),
[10]         Schedule 1, Part 2, rule 27, except the note
substitute
27            Nuclear scanning services — other than PET
                Items 61302 to 61505 and item 61650 apply only if:
                (a)    the performance of the service does not involve the use of positron‑emission radio‑isotopes or a PET scanner; and
               (b)    the service is performed:
                          (i)    by a specialist or consultant physician whose name is included in a register, given to the Medicare Australia CEO by the JNMCAC, of participants in the Joint Nuclear Medicine Specialist Credentialling Program of the JNMCAC; or
                     (ii)    by a person acting on behalf of a specialist or consultant physician mentioned in subparagraph (i); and
                (c)    the final report of the service is compiled by the specialist or consultant physician who performed the preliminary examination of the patient and the estimation and administration of the dosage of radiopharmaceuticals.
27A         PET nuclear scanning services
     (1)       Items 61523 to 61613 apply only if the service is performed on a person:
                (a)    at the written request of a specialist or consultant physician (the requesting practitioner) if:
                          (i)    the person is the requesting practitioner’s patient; and
                         (ii)    the requesting practitioner decides that the service is necessary; and
               (b)    at an accredited site in a comprehensive facility; and
                (c)    in accordance with rules 27B and 27C.
     (2)       Also, the items apply only if the owner or operator of the equipment used to perform the service is not in breach of rule 27D.
27B         PET nuclear scanning services — performance under personal supervision
     (1)       For rule 27A, the service must be performed on a person by or under the personal supervision of:
                (a)    a credentialled specialist other than the requesting practitioner; or
               (b)    a medical practitioner other than the requesting practitioner if the medical practitioner:
                          (i)    is a Fellow of the RACP or RANZCR; and
                         (ii)    has reported 400 or more studies forming part of PET services for which a medicare benefit was payable; and
                         (iii)    is authorised under State or Territory law to prescribe and administer to humans the PET radiopharmaceuticals that are to be administered to the person.
     (2)       In this rule:
requesting practitioner has the same meaning as in paragraph 27A (1) (a).
27C         PET nuclear scanning services — equipment
                For rule 27A, the service must be performed on a person using equipment that meets the following requirements:
                (a)    the Requirements for PET Accreditation (Instrumentation & Radiation Safety) dated 4 May 2007 issued by the Australian and New Zealand Society of Nuclear Medicine Inc;
               (b)    the NEMA Standards Publication NU 2-2007, Performance Measurements of Positron Emission Tomographs, published by the National Electrical Manufacturers Association (USA).
27D         PET nuclear scanning services — statutory declaration
         (1)   The owner or operator mentioned in subrule 27A (2) must have given a statutory declaration to the Medicare Australia CEO that includes the following information:
                (a)    whether the owner or operator is a credentialled specialist or a medical practitioner who satisfies the requirements mentioned in subparagraphs 27B (1) (b) (i) to (iii);
               (b)    whether the place where the owner or operator provides the service is an accredited site in a comprehensive facility;
                (c)    whether the equipment meets the requirements mentioned in rule 27C;
               (d)    the facility’s address;
                (e)    the provider number for the facility given by the Medicare Australia CEO;
                (f)    the location specific practice number for the facility given by the Minister;
                (g)    the models, serial numbers and manufacturers of the equipment.
         (2)   If the matters declared in the statutory declaration change, the owner or operator must give the Medicare Australia CEO written notice of the change as soon as the owner or operator knows about the change.
[11]         Schedule 1, Part 3, after item 61505, in Group I4
insert
61523
Whole body FDG PET study, performed for evaluation of a solitary pulmonary nodule, if:
   (a)  the nodule is considered unsuitable for transthoracic fine needle aspiration biopsy; or
   (b)  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, if 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 a patient 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 a patient 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 a patient 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 a patient considered suitable for active therapy, with catheterisation of the bladder (R)
1 021.00

61559
FDG PET study of the brain, performed for the evaluation of refractory epilepsy, that 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 a patient 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 a patient considered suitable for active therapy, with catheterisation of the bladder (R)
975.00

61577
Whole body FDG PET study, performed for the staging of proven oesophageal or GEJ carcinoma, in a patient 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 a patient 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 a patient with suspected residual head and neck cancer after definitive treatment, and who is 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)
Note   Item 61650 is taken to be an item in the table — see the Health Insurance (LeukoScan) Determination HS/08/2006.
975.00

 
Schedule 2        Amendments commencing immediately after commencement of Schedule 1 to the Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No 6)
(regulation 3)
 
[1]           Schedule 1, Part 2, rule 27, note
omit
[2]           Schedule 1, Part 3, item 61613, note
omit
[3]           Schedule 1, Part 3, item 61650
relocate after item 61613 in Group I4
Note
1.       All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au.