Untitled document
Health Insurance (Section 3C Pathology Services—Cystic fibrosis gene testing) Determination 2018
I, CELIA STREET, delegate of the Minister for Health, make this Determination under subsection 3C(1) of the Health Insurance Act 1973.
Dated 12 June 2018
CELIA STREET
Assistant Secretary
Diagnostic Imaging and Pathology Branch
Medical Benefits Division
Department of Health
Contents
1. Name of Determination
2. Commencement
3. Authority
4. Definitions
5. Treatment of relevant services
6. Application of provisions
Schedule 1 – relevant services
Name of Determination
This Determination is the Health Insurance (Section 3C Pathology Services— Cystic fibrosis gene testing) Determination 2018.
Commencement
This Determination commences on 1 July 2018.
Authority
This Determination is made under subsection 3C(1) of the Health Insurance Act 1973.
Definitions
In this Determination:
Act means the Health Insurance Act 1973.
relevant provisions means all provisions, of the Act and regulations made under the Act, and the National Health Act 1953 and regulations made under that Act, relating to pathology services, professional services or items.
relevant service means a health service, as defined in subsection 3C(8) of the Act, that is specified in the Schedule.
Schedule means the Schedule to this Determination.
Note: The following terms are defined in subsection 3(1) of the Act:
·clinically relevant service
·item
·pathology services table
·professional service
(2) Unless the contrary intention appears, a reference in this Determination to a provision of the Act or the National Health Act 1953 or regulations made under the Act or 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.
Treatment of relevant services
For subsection 3C(1) of the Act:
(a) a relevant service, provided in accordance with this Determination and as a clinically relevant service, is to be treated, for the relevant provisions, as if:
(i)it were both a professional service and a pathology service; and
(ii)there were an item in Group P7 of the pathology services table that:
(A)related to the service; and
(B)specified for the service a fee in relation to each State, being the fee specified in the Schedule in relation to the service.
6. Application of provisions
For any particular patient, item 73345, 73347, 73348 and 73349 is applicable not more than once in a lifetime.
For any particular patient, item 73346 and 73350 is applicable not more than once in a pregnancy.
The testing laboratory used to undertake tests for items 73345, 73346, 73347, 73348, 73349 and 73350 must use a cystic fibrosis transmembrane conductance regulator methodology appropriate to the clinical setting with:
(a) sufficient diagnostic range and sensitivity to detect at least 95% of pathogenic cystic fibrosis transmembrane conductance regulator variants likely to be present in the patient; and
(b) with at least 25 of the most frequently encountered cystic fibrosis transmembrane conductance regulator variants in the Australian population.
Schedule 1 – relevant services
| Group P7—Genetics | ||
| Item | Service | Fee ($) |
| 73345 | Testing of a patient for pathogenic cystic fibrosis transmembrane conductance regulator variants for the purpose of investigating, making or excluding a diagnosis of cystic fibrosis or a cystic fibrosis transmembrane conductance regulator related disorder when requested by a specialist or consultant physician who manages the treatment of the patient, not being a service associated with a service to which item 73347, 73348, or 73349 applies. The patient must have clinical or laboratory findings suggesting there is a high probability suggestive of cystic fibrosis or a cystic fibrosis transmembrane conductance regulator related disorder. | 500.00 |
| 73346 | Testing of a pregnant patient whose carrier status for pathogenic cystic fibrosis transmembrane conductance regulator variants, as well as their reproductive partner carrier status is unknown, for the purpose of determining whether pathogenic cystic fibrosis transmembrane conductance regulator variants are present in the fetus, in order to make or exclude a diagnosis of cystic fibrosis or a cystic fibrosis transmembrane conductance regulator related disorder in the fetus when requested by a specialist or consultant physician who manages the treatment of the patient, not being a service associated with a service to which item 73350 applies. The fetus must have ultrasonic findings of echogenic gut, with unknown familial cystic fibrosis transmembrane conductance regulator variants. | 500.00 |
| 73347 | Testing of a prospective parent for pathogenic cystic fibrosis transmembrane conductance regulator variants for the purpose of determining the risk of their fetus having pathogenic cystic fibrosis transmembrane conductance regulator variants. This is indicated when the fetus has ultrasonic evidence of echogenic gut when requested by a specialist or consultant physician who manages the treatment of the patient, not being a service associated with a service to which item 73345, 73348, or 73349 applies. | 500.00 |
| 73348 | Testing of a patient with a laboratory-established family history of pathogenic cystic fibrosis transmembrane conductance regulator variants, for the purpose of determining whether the patient is an asymptomatic genetic carrier of the pathogenic cystic fibrosis transmembrane conductance regulator variants that have been laboratory established in the family history when requested by a specialist or consultant physician who manages the treatment of the patient, not being a service associated with a service to which item 73345, 73347, or 73349 applies. The patient must have a positive family history, confirmed by laboratory findings of pathogenic cystic fibrosis transmembrane conductance regulator variants, with a personal risk of being a heterozygous genetic carrier of at least 6%. (This includes family relatedness of: parents, children, full-siblings, half-siblings, grand-parents, grandchildren, aunts, uncles, first cousins, and first cousins once-removed, but excludes relatedness of second cousins or more distant relationships). | 250.00 |
| 73349 | Testing of a patient for pathogenic cystic fibrosis transmembrane conductance regulator variants for the purpose of determining the reproductive risk of the patient with their reproductive partner because their reproductive partner is already known to have pathogenic cystic fibrosis transmembrane conductance regulator variants requested by a specialist or consultant physician who manages the treatment of the patient, not being a service associated with a service to which item 73345, 73347, or 73348 applies. | 500.00 |
| 73350 | Testing of a pregnant patient, where one or both prospective parents are known to be a genetic carrier of pathogenic cystic fibrosis transmembrane conductance regulator variants for the purpose of determining whether pathogenic cystic fibrosis transmembrane conductance regulator variants are present in the fetus in order to make or exclude a diagnosis of cystic fibrosis or a cystic fibrosis transmembrane conductance regulator related disorder in the fetus, when requested by a specialist or consultant physician who manages the treatment of the patient, not being a service associated with a service to which item 73346 applies. The fetus must be at 25% or more risk of cystic fibrosis or a cystic fibrosis transmembrane conductance regulator related disorder because of known familial cystic fibrosis transmembrane conductance regulator variants. | 250.00 |
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