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HEALTH INSURANCE (DIAGNOSTIC IMAGING SERVICES TABLE) AMENDMENT REGULATIONS 2010 (NO. 1) (SLI NO 65 OF 2010)
EXPLANATORY STATEMENT
Select Legislative Instrument 2010 No. 65
Health Insurance Act 1973
Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2010 (No. 1)
Subsection 133(1) of the Health Insurance Act 1973 (the Act) provides that the
Governor-General may make regulations, not inconsistent with the Act, prescribing all matters required or permitted by the Act to be prescribed, or necessary or convenient to be prescribed for carrying out or giving effect to the Act.
The Act provides, in part, for payments of Medicare benefits in respect of professional services rendered to eligible persons. Section 9 of the Act provides that Medicare benefits shall be calculated by reference to the fees for medical services, including diagnostic imaging services set out in prescribed tables.
Section 4AA of the Act provides that the regulations may prescribe a table of diagnostic imaging services that sets out items of diagnostic imaging services, the amount of fees applicable in respect of each item and rules of interpretation for the diagnostic imaging services table. This table is remade each year. The Health Insurance (Diagnostic Imaging Services Table) Regulations 2009 (the Principal Regulations) currently prescribe such a table, the Diagnostic Imaging Services Table (the DIST).
The purpose of the Regulations is to amend the Principal Regulations to prescribe 15 nuclear medicine items relating to Positron Emission Tomography (PET) services currently specified in the Health Insurance (Positron Emission Tomography) Determination 2009 (No. 2) (the 3C Determination) made under section 3C(1) of the Act. The Regulations insert additional rules 27A, 27B, 27C and 27D into Schedule 1 to the Principal Regulations covering the criteria that must be met in order for Medicare benefits to be payable for PET services provided.
Section 3C of the Act permits the Minister for Health and Ageing to determine that services, which otherwise are not Medicare eligible, are deemed to be so. PET services were listed under such a 3C Determination for a specified period during which data was collected to inform a health technology assessment with a view to gathering evidence to support permanent funding under the Medicare Benefits Schedule. These interim arrangements were put in place in 2001. That process is now completed, and the rationale for listing PET services under a 3C determination no longer exists. Under the Regulations, the PET services therefore are listed on the DIST, like all other diagnostic imaging treatments.
The Regulations insert 15 additional nuclear medicine items, items 61523 to 61613, into Schedule 1 to the Principal Regulations. Originally items 61523 to 61613 were set out in the 3C Determination. Moving these items to the Principal Regulations normalise the management of PET services, making arrangements consistent with other treatments on the DIST.
The Regulations provide substantially the same rules of interpretation, items and fees as in the 3C Determination for the PET services. The Regulations make a minor amendment to the criteria currently set out in section 5 of the 3C Determination.
Rule 27D sets out that a statutory declaration regarding the owner or operator’s status in terms of meeting certain provisions within the rules (such as whether he or she is a credentialed specialist) is required to be given by the owner or operator to the Medicare Australia CEO. This provision differs slightly from the requirement in the 3C Determination, which only requires a statutory declaration to be provided if requested by the Medicare Australia. The remaining provisions set out in rules 27A, 27B and 27C substantially reflect the requirements currently in the 3C Determination.
Items 61523 to 61613 only apply if the criteria set out in rule 27A, 27B and 27C are met. Additionally, these items only apply if the owner or operator of the equipment used to perform the services is not in breach of rule 27D.
Details of the Regulations are set out in the Attachment.
The Act specifies no conditions that need to be satisfied before the power to make the Regulations may be exercised.
No specific consultation has been undertaken with industry in relation to the amendments as the amendments merely reflect requirements currently contained in a determination made under subsection 3C(1) of the Health Insurance Act 1973. However, industry has been notified of the changes and that the amendments normalise the PET arrangements.
The Regulations are a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Regulations 1 to 3 and Schedule 1 commence on 1 May 2010 and Schedule 2 commences immediately after the commencement of Schedule 1 to the Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No. 6).
The commencement date of 1 May 2010 for the regulations 1 to 3 and Schedule 1 reflects the preferred date indicated by industry. The Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No. 6) commences on 1 July 2010 to insert PET item 61650 into Group I4 of the Diagnostic Imaging Services Table. Schedule 2 to the Regulations is required to commence after this date in order for item 61650 to appear in the correct numerical order within Group I4 of the Diagnostic Imaging Services Table.
DETAILS OF THE HEALTH INSURANCE (DIAGNOSTIC IMAGING SERVICES TABLE) AMENDMENT REGULATIONS 2010 (No. 1)
Regulation 1 – Name of Regulations
This Regulation provides that the title of the Regulations is the Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2010 (No. 1).
Regulation 2 – Commencement
This Regulation provides for regulations 1 to 3 and Schedule 1 to commence on
1 May 2010 and for Schedule 2 to commence immediately after the commencement of Schedule 1 to the Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No. 6).
Regulation 3 – Amendment of Health Insurance (Diagnostic Imaging Services Table) Regulations 2009
The Regulations provide that Schedules 1 and 2 amend the Health Insurance (Diagnostic Imaging Services Table) Regulations 2009 (the Principal Regulations).
Note that the Health Insurance (Positron Emission Tomography) Determination 2009 (No. 2) includes a provision that specifies the number of services to be rendered by each piece of PET equipment at each accredited site. Currently the number of services rendered substantially exceeds the number specified therefore the requirement is redundant and has been omitted.
Schedule 1 – Amendments commencing on 1 May 2010
Item [1] – Schedule 1, Part 2, subrule 2(1), before definition of (Anaes.)
This item inserts a definition of ‘accredited site’ in Schedule 1, Part 2, subrule 2(1) of the Principal Regulations. An ‘accredited site’ is a site accredited by ANZAPNM (as defined in item 2 below) as a site for advanced training in PET. Medicare rebateable PET services can only be rendered in accredited sites (see rule 27A as inserted by item [10] below).
This item inserts a definition of
‘comprehensive facility’ into Schedule 1, Part 2
subrule 2(1) of the Principal Regulations. This definition is for the purposes
of rule 27A
(item 10 refers).
This item inserts a definition of ‘credentialled specialist’ into Schedule 1, Part 2, subrule 2(1) of the Principal Regulations to mean: a specialist or consultant physician (within the meaning of subsection 3(1) of the Act) who is credentialed under the Joint Nuclear Medicine Specialist Credentialling Program. This definition is for the purposes of rule 27B (item 10 refers).
Item [7] – Schedule 1, Part 2, subrule 2(1) after definition of non-metropolitan hospital
This item insert a definition of ‘PET’ into Schedule 1, Part 2, subrule 2(1) of the Principal Regulations after the definition of non-metropolitan hospital. PET means positron emission tomography.
Item [8] – Schedule 1, Part 2, subrule 2(1), after definition of providing practitioner
Item [9] - Schedule 1, Part 2, subrule 19(1)
This item removes from Schedule 1, Part 2 of the Principal Regulations “Subject to subrules (2) and (4)” and inserts “Subject to subrule (2)”. This amendment is a technical amendment that rectifies a drafting error, as subrule (4) no longer exists in the Principal Regulations.
Item [10] – Schedule 1, rule 27, except the note
This item substitutes the current rule 27 in respect of “nuclear scanning services – other than PET” whilst retaining the note in relation to item 61650. This item makes clear the criteria applying to those items in respect of nuclear scanning services other than PET services for items 613202 to 61505 and item 61650. The note in respect of item 61650 is retained until 1 July 2010, when the Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No. 6) commences.
This item also inserts new rules 27A, 27B, 27C and 27D that set out the criteria to be met for items 61523 to 61613 to apply as previously provided for in the 3C Determination. In summary those criteria are that:
· the service is a service referred in writing by a specialist or consultant physician;
· the service is performed at an accredited site in a comprehensive facility;
· the service is performed by or under the personal supervision of a credentialed specialist or a practitioner possessing prescribed qualifications and experience; and
· the equipment used to render the service meet identified technical standards.
Under rule 27A the services must be requested in writing by the patient’s practitioner, who is a specialist or consultant physician within the meaning of subsection 3(1) of the Act who has decided that the service is necessary. The service must be performed at an accredited site in a comprehensive facility and in accordance with rules 27B and 27C. ‘Comprehensive facility’ is defined in subrule 2(1) (item 3 refers). Items 61523 to 61613 do not apply if the owner or operator contravenes rule 27D, notwithstanding other criteria are met.
Rule 27B sets out that PET services are provided by, or under the personal supervision of either a:
a) credentialed specialist; or
b) a medical practitioner, who is a Fellow of RACP and RANZCR (item 8 above refers) that has reported on at least 400 studies that formed part of PET services for which a medicare benefit was payable and who is authorised under State or Territory law to prescribe and administer to humans PET radiopharmaceuticals. Neither person referred to above can be a ‘requesting practitioner’.
Rule 27C specifies the technical requirements that equipment used for rendering the PET services are required to meet. There are two requirements, which the equipment must meet:
a) the standards, Requirements for PET Accreditation (Instrumentation & Radiation Safety) dated 4 May 2007 issued by the Australian and New Zealand Society of Nuclear Medicine Inc; and
b)
the NEMA NU 2-2007 Standard published on 27 June 2007 by the National
Electrical Manufacturers Association. This is the current standard and has not
been amended.
These requirements are reviewed every five years and, if necessary, updated by publication of a new requirement. The Principal Regulations are subsequently amended to reflect any new technical requirements.
Rule 27D sets out that the owner or operator of the PET equipment must provide a statutory declaration to the Medicare Australia CEO covering the information set out in subrule 27D(1). This requirement is to enable checking of compliance with the Principal Regulations (as amended). Failure to provide the statutory declaration means that items 61523 to 61613 do not apply and therefore Medicare benefits will not be payable (subrule 27A(2) refers). Owners and operators of PET equipment are able to find a proforma statutory declaration on Medicare Australia’s website.
.
Subrule 27D(2) places a further obligation on owners and operators to notify the Medicare Australia CEO where circumstances set out their statutory declaration have changed as soon as they become aware of the changes.
Item [11] - Schedule 1, Part 3, of the Principal Regulations, after item 61505, in Group I4
This item inserts into Schedule 1, Part 3, of the Principal Regulations after item 61505, in Group I4, the 15 new nuclear medicine items for PET services, items 61523 to 61613. It sets out their respective item numbers, descriptors and fees.
Schedule 2 – Amendments commencing on 1 July 2010
Item 1 – Schedule 1, rule 27, note
This item removes the ‘note’ from Schedule 1, rule 27 of the Principal Regulations. This amendment is a technical amendment to remove the ‘note’ the end of rule 27 as it is no longer required as a result of the commencement of the Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No. 6).
Item 2 – Schedule 1, Part 3, item 61650
This item moves item 61650 from its location after item 61505 in Group I4, inserting item 61650 after item 61613 in Group I4. This amendment is a technical amendment to relocate item 61650 to appear in the correct numerical order as a result of the commencement of the Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No. 6).