National Health (Supplies of out-patient medication) Determination 2012 (No. PB 105 of 2012)

Administered by Department of Health, Disability and Ageing

Legislation au F2012L02504 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

NATIONAL HEALTH ACT 1953

 

NATIONAL HEALTH (SUPPLIES OF OUT-PATIENT MEDICATION) DETERMINATION 2012

 

PB 105 of 2012

 

Authority

 

Subsection 84BA(2) of the National Health Act 1953 (the Act) provides that the Minister must determine the amount that will be taken to have been paid to a public hospital for supplies of out-patient medication for the purposes of safety net.

 

Purpose

 

Part VII of the Act regulates when benefits will be paid by the Commonwealth in respect of drugs and medicinal preparations that are listed on the Pharmaceutical Benefits Scheme (‘PBS’). As such, it is the legislative basis by which the Commonwealth provides reliable, timely and affordable access to a wide range of medicines to Australians.

 

Division 1A of Part VII of the Act provides for a ‘safety net scheme’ in relation to pharmaceutical benefits.  The safety net scheme is designed to provide financial protection for those patients and their families who require a large number of pharmaceutical benefits.

 

Subsection 84(1) defines ‘out-patient medication’ as meaning a drug or medicinal preparation that is supplied through the out-patient department of a public hospital. A drug or medicinal preparation that is supplied by a public hospital as out-patient medication may or may not be a pharmaceutical benefit under Part VII of the Act.

 

Subsection 84BA(1) of the Act provides that the purpose of section 84BA is to make provision so that account may be taken of payments made by a person to a public hospital authority for supplies of out-patient medication, when it is being ascertained, for the purpose of Part VII of the Act, whether the person is eligible to be issued with a safety net concession card or a safety net entitlement card. 

 

Subsection 84BA (2) of the Act provides that prior to the commencement of the relevant entitlement period (a calendar year), the Minister must determine in writing the amounts that will be taken to have been paid to a public hospital for supplies of out-patient medication made by a hospital during the relevant entitlement period. 

 

Subsection 84BA(3) of the Act provides that, in making a determination, the Minister may determine:

a)      different amounts in respect of a supply of out-patient medication, having regard to the State or Territory in which the hospital supplying the medication is situated; and

b)     different amounts in respect of supplies made to

  1. concessional beneficiaries and their dependants,
  2. holders of a concession card; and
  3. general patients (other than holders of a concession card).

 

This instrument differs from the instrument made under subsection 84BA(2) for the previous entitlement period because the maximum value of the supply of out-patient medication to a person who is a general patient and who is not the holder of a concession card has changed from $28.30 to $28.90. This instrument, among other things, determines different amounts in respect of the supply of out-patient medication by public hospitals depending on whether the public hospital is participating in Pharmaceutical Reform Arrangements within the meaning of the National Health Reform Agreement.

 

The Federal Financial Relations Act 2009 refers to the National Health Reform Agreement as agreed to by the Council of Australian Governments on 2 August 2011 as amended from time to time. A copy of the National Health Reform Agreement can be obtained at the Council of Australian Governments (“COAG”) website at http://www.coag.gov.au.

 

Details of this instrument are set out in the Attachment.

 

This instrument commences on 1 January 2013.

 

This instrument is a legislative instrument for the purpose of the Legislative Instrument Act 2003.

 

Consultation

 

Historically, the Department of Health and Ageing has consulted with the State and Territory Health Departments through the Highly Specialised Drugs Working Party (HSDWP).  The HSDWP was a working party of the Australian Health Ministers’ Advisory Council (AHMAC) and was made up of representatives from each State and Territory Health Department and the Australian Government.  This Working Party has now been discontinued as a second tier committee of the Hospitals Principal Committee on recommendations endorsed by AHMAC.

 

Through the HSDWP the State and Territory Health Departments agreed to the value of out-patient medication being 80% of the general co-payment each year.

 

 

 

 


ATTACHMENT

Details of the National Health (Supplies of out-patient medication) Determination 2012

 

1 Name of Instrument  

 

This section provides that the name of this Determination is the National Health (Supplies of out-patient medication) Determination 2012 and that it can also be cited as PB 105 of 2012.

 

2 Commencement

 

This section provides that this Determination commences on 1 January 2013.

 

3  Revocation

 

This section revokes the previous determination made under subsection 84BA(2), being the National Health (Supplies of out-patient medication) Determination 2011 (PB 103 of 2011).

 

4 Interpretation

 

This section provides for the meaning of certain words and phrases appearing in the Determination, and also states that unless the contrary intention appears, a word or expression that is defined in the Act shall be taken to have the same meaning as in the Act.

 

5 Amount taken to have been paid to a public hospital for the supply of out-patient medication

 

This section provides that the amount, for the purposes of Part VII of the Act, taken to have been paid to a public hospital for the supply of out-patient medication is the lesser of either:

  • the maximum value of the supply of out-patient medication; or
  • the amount charged.

 

The term out-patient medication is defined in subsection 84(1) of the Act to mean a drug or medicinal preparation supplied through the out-patient department of a public hospital.

 

6    Maximum value of the supply of out-patient medication to a person who is a concessional beneficiary, a dependent of a concessional beneficiary or a holder of a concession card

 

This section provides that the maximum value of the supply of out-patient medication to a person who is a concessional beneficiary, a dependant of a concessional beneficiary or the holder of a concession card is an amount that is equivalent to the amount referred to in paragraph 87(2)(a) of the Act for the supply of a pharmaceutical benefit by an approved pharmacist or approved medical practitioner. 

 

The terms concessional beneficiary, dependant and concession card are defined in subsection 84(1) of the Act.

 

The relevant charge under paragraph 87(2)(a) of the Act will be $5.90 when this instrument commences on 1 January 2013. These charges are periodically adjusted under section 99G of the Act.

 

7   Maximum value of the supply of out-patient medication to a person who is a general patient and who is not a holder of a concession card

 

Subsection 7(1) provides that the maximum value of the supply of out-patient medication to a person who is a general patient and who is not the holder of a concession card is $28.90. 

 

Subsection 7(2) provides that this section does not apply to supplies of out-patient medication made by a public hospital located in Queensland or a public hospital that is participating in Pharmaceutical Reform Arrangements within the meaning of the National Health Reform Agreement. The National Health Reform Agreement is defined in section 4 of this Determination.

 

8  Maximum value of the supply of out-patient medication by a Queensland public hospital to person who is a general patient and who is not the holder of a concession card

 

This section provides for the maximum value of a supply of out-patient medication to a person who is a general patient and who is not the holder of a concession card for supplies of out-patient medication made by public hospitals located in Queensland.

 

Paragraph 8(2)(a) specifies that where the medication is a pharmaceutical benefit and the Commonwealth price for that pharmaceutical benefit exceeds the amount referred to in paragraph 87(2)(e) of the Act, the maximum value is an amount equivalent to the amount referred to in paragraph 87(2)(e) of the Act for the supply of a pharmaceutical benefit by an approved pharmacist or an approved medical practitioner.

 

The relevant amount under paragraph 87(2)(e) of the Act will be $36.10 when this instrument commences on 1 January 2013. These charges are periodically adjusted under section 99G of the Act.

 

Paragraph 8(2)(b) specifies that where the medication is a pharmaceutical benefit and the Commonwealth price for that pharmaceutical benefit does not exceed the amount referred to in paragraph 87(2)(e) of the Act, the maximum value is the price for that pharmaceutical benefit ascertained in accordance with the determination made under subsection 84C(7) of the Act as in force from time to time.

 

Paragraph 8(2)(c) specifies that where the medication is a drug or medicinal preparation that is not a pharmaceutical benefit, the maximum value is the amount ascertained by taking as a basis the cost to the hospital of that drug or medicinal preparation and applying, as if that cost were the approved ex-manufacturer price or proportional ex-manufacturer price, the determination under subsection 84C(7) of the Act as in force from time to time.

 

9  Maximum value of the supply of out-patient medication by a participating public hospital to a person who is a general patient and who is not a holder of a concession card

 

This section provides for the maximum value of a supply of out-patient medication to a person who is a general patient and who is not the holder of a concession card for supplies of out-patient medication made by public hospitals that are participating in Pharmaceutical Reform Arrangements within the meaning of the National Health Reform Agreement, except if the public hospital is located in the State of Queensland.

 

Paragraph 9(2)(a) specifies that where the medication is a pharmaceutical benefit, the maximum value of the pharmaceutical benefit shall be the maximum value of the pharmaceutical benefit ascertained in accordance with subregulation 9A(5) of the National Health (Pharmaceutical Benefits) Regulations 1960 as if the pharmaceutical benefit had been supplied by an approved pharmacist or an approved medical practitioner.

 

Paragraph 9(2)(b) specifies that where the medication is a drug or medicinal preparation that is not a pharmaceutical benefit, the maximum value is the amount ascertained by taking as a basis the cost to the hospital of that drug or medicinal preparation and applying, as if that cost were the approved ex-manufacturer price or proportional ex-manufacturer price, the determination under subsection 84C(7) of the Act as in force from time to time.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Overview

The National Health Act 1953 was enacted to provide a framework for the regulation of healthcare services and pharmaceutical benefits in Australia, aiming to ensure that Australians have reliable, timely, and affordable access to a wide range of medicines. A significant aspect of this Act is the safety net scheme introduced in Division 1A of Part VII, designed to offer financial protection for patients requiring a large number of pharmaceutical benefits. To address the issue of determining the amounts that will be considered as payments made to public hospitals for supplies of out-patient medication, which is critical in assessing eligibility for safety net concession cards, the Minister is mandated under subsection 84BA(2) of the Act to make specific determinations. The National Health (Supplies of out-patient medication) Determination 2012, enacted to commence on 1 January 2013, serves to specify these amounts, taking into account variations based on the state or territory in which the hospital is located and the type of patient (concessional beneficiaries, dependents of concessional beneficiaries, holders of a concession card, or general patients). This legislative instrument was developed in consultation with state and territory health departments and aims to align with the National Health Reform Agreement.

Scope and Application

The National Health (Supplies of Out-patient Medication) Determination 2012 applies to the determination of amounts taken into account for the supply of out-patient medication by public hospitals for the purposes of the safety net scheme under Part VII of the National Health Act 1953. This Determination applies to all public hospitals within the Commonwealth of Australia and sets out different maximum values for out-patient medication supplies depending on the patient category and whether the hospital participates in Pharmaceutical Reform Arrangements. The amounts specified in the Determination are effective from 1 January 2013, and they vary based on whether the patient is a concessional beneficiary, a dependent of a concessional beneficiary, a holder of a concession card, or a general patient. The maximum value for general patients not holding a concession card has been adjusted to $28.90, while for concessional beneficiaries and concession card holders, it is equivalent to the general co-payment amount, which is $5.90 as of 1 January 2013. The Determination also provides different maximum values for public hospitals in Queensland and those participating in Pharmaceutical Reform Arrangements, which are determined based on the Commonwealth price for pharmaceutical benefits or the cost to the hospital of the drug or medicinal preparation. This instrument revokes the previous determination made in 2011, and its application is subject to adjustments under section 99G of the National Health Act 1953.

Key Provisions

The National Health (Supplies of out-patient medication) Determination 2012 (subsection 84BA(2)) establishes the amounts that will be considered as payments made to a public hospital for supplies of out-patient medication, which is crucial for determining eligibility for the safety net scheme under the National Health Act 1953. The primary operative sections of this Determination are those that specify the maximum values for the supply of out-patient medication to concessional beneficiaries, concession card holders, and general patients. Specifically, Section 6 outlines that the maximum value for concessional beneficiaries, dependents of concessional beneficiaries, and holders of a concession card is equivalent to the amount charged for a pharmaceutical benefit, which is $5.90 as of 1 January 2013. Section 7 sets the maximum value for general patients who are not holders of a concession card at $28.90, unless they are supplied medication by a hospital in Queensland or a hospital participating in Pharmaceutical Reform Arrangements, in which case different provisions apply. The obligations imposed by the Act on parties governed by this Determination include ensuring that the amounts charged for out-patient medication are appropriately documented and considered when determining eligibility for safety net benefits. Public hospitals must adhere to the specified maximum values and ensure that their charges do not exceed these limits. Additionally, the Minister is required to determine these amounts in writing before the commencement of each entitlement period. Any breach of the provisions outlined in the Determination can lead to civil and criminal consequences. For instance, if a public hospital charges an amount that exceeds the specified maximum value for out-patient medication, it may not be eligible to have those payments considered when determining a patient's eligibility for safety net benefits. Furthermore, if a hospital knowingly charges above the set maximum values, it may face legal action. The penalties for such breaches are not explicitly stated in the Determination, but they would typically involve financial penalties or other enforcement actions under the National Health Act 1953.

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