National Health (Supplies of out-patient medication) Amendment Determination 2021

Administered by Department of Health, Disability and Ageing

Legislation au F2021L01900 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

National Health Act 1953

 

National Health (Supplies of out-patient medication) Amendment Determination 2021

 

PB 136 of 2021

 

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 relevant entitlement period for the purposes of the Pharmaceutical Benefits Scheme (PBS) patient safety net threshold.

 

Subsection 33(3) of the Acts Interpretation Act 1901 provides that where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character (including rules, regulations or by-laws), the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument.

 

Purpose

 

This instrument makes a minor amendment to the National Health (Supplies of out-patient medication) Determination 2019 (No. 2) (PB 110 of 2019) (the determination). In particular, this instrument updates the 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.

 

Background

 

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 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) of the Act defines out-patient medication as a drug or medicinal preparation 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 concession card or an  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 (within the meaning of subsection 84(4) or (7) of the Act),
  2. holders of a concession card; and
  3. general patients (other than holders of a concession card).

 

This amending determination updates the 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 from $33.00 to $34.00.

 

Consultation

 

Historically, the Department of Health has consulted with 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 Commonwealth. 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, excluding hospitals which are in Queensland or participating in the Pharmaceutical Reform Arrangements.

 

State and territory health departments have been provided with the new 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 and no additional comments have been received.

 

Commencement

 

This instrument commences on 1 January 2022.

 

Details of the instrument are set out in the Attachment. This instrument is a legislative instrument for the purpose of the Legislation Act 2003.


ATTACHMENT

Details of the National Health (Supplies of out-patient medication) Amendment Determination 2021

 

1 Name

 

This section provides that the name of this instrument is the National Health (Supplies of out‑patient medication) Amendment Determination 2021. The instrument can also be cited as PB 136 of 2021.

 

2 Commencement

 

This section provides that this instrument commences on 1 January 2022.

 

3 Authority

 

This section provides that the instrument is made under section 84BA of the National Health Act 1953.

 

 4              Schedules

 

This section provides that each instrument that is specified in a Schedule to the instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the instrument has effect according to its terms.

 

Schedule 1—Amendments

 

National Health (Supplies of out-patient medication) Determination 2019 (No 2) (the determination)

 

1  Section 8(1)

 

This section repeals 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, which is currently $33.00. This section replaces the amount of $33.00 with $34.00.

Statement of Compatibility with Human Rights

 

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

National Health (Supplies of out-patient medication) Amendment Determination 2021

(PB 136 of 2021)

 

This legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

 

Overview of the legislative instrument

 

This legislative instrument is made pursuant to subsection 84BA(2) of the National Health Act 1953, which determines the amounts that will be taken to have been paid to a public hospital for supplies of out-patient medication.

 

This instrument makes an amendment to the National Health (Supplies of out-patient medication) Determination 2019 (No. 2) (PB 110 of 2019) (the determination). In particular, this instrument updates the maximum value a general patient pays for out-patient medications.

 

Human rights implications

 

This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

 

The Pharmaceutical Benefits Scheme (PBS) is a benefit scheme which assists with advancement of this human right by providing for subsidised access to medicines.

 

This legislative instrument specifies what will be taken to have been paid to a public hospital for supplies of out-patient medication for the purposes of the PBS patient safety net threshold.

 

The safety net scheme is designed to provide financial protection for those patients and their families who require a large number of pharmaceutical benefits.

 

Conclusion

 

This legislative instrument is compatible with human rights because it advances the protection of human rights.

 

 

 

Nikolai Tsyganov

Acting Assistant Secretary
Pricing and PBS Policy Branch

Technology Assessment and Access Division
Department of Health

Overview

The National Health (Supplies of out-patient medication) Amendment Determination 2021 (PB 136 of 2021) is an amendment made under the authority of the National Health Act 1953. This determination specifically targets the adjustment of the maximum value for the supply of outpatient medication to general patients who do not hold a concession card, increasing it from $33.00 to $34.00. The purpose of this amendment is to align the maximum payment for outpatient medications with the general co-payment, thereby maintaining the integrity of the Pharmaceutical Benefits Scheme (PBS) and ensuring that patients receive consistent and fair treatment. The determination is set to commence on 1 January 2022, reflecting the policy objective to provide timely updates to legislative instruments to accommodate changes in healthcare costs and requirements.

Scope and Application

The National Health (Supplies of out-patient medication) Amendment Determination 2021 amends the National Health (Supplies of out-patient medication) Determination 2019, specifically updating the maximum value of the supply of out-patient medication for a general patient who is not a holder of a concession card, from $33.00 to $34.00. This amendment applies to all public hospitals in Australia and is effective from 1 January 2022, as per the legislative instrument made under section 84BA of the National Health Act 1953. The Act itself is a Commonwealth statute that regulates the payment of benefits for pharmaceutical products listed on the Pharmaceutical Benefits Scheme (PBS), with the primary aim of providing reliable, timely, and affordable access to a wide range of medicines for Australians. This determination specifically pertains to the calculation of out-patient medication costs, ensuring that these costs are appropriately factored into the PBS patient safety net threshold, which offers financial protection to patients and their families requiring extensive pharmaceutical benefits.

Key Provisions

The main operative sections of the National Health (Supplies of out-patient medication) Amendment Determination 2021 (No. 2) (PB 136 of 2021) include Schedule 1, which details the amendment made to the National Health (Supplies of out-patient medication) Determination 2019 (No. 2) (PB 110 of 2019). Specifically, section 1 of Schedule 1 repeals the previous maximum value of $33.00 for the supply of out-patient medication to a person who is a general patient and who is not a holder of a concession card, and replaces it with a new maximum value of $34.00 (subsection 8(1)). This amendment is intended to update the maximum amount that will be taken to have been paid to a public hospital for supplies of out-patient medication, for the purposes of the Pharmaceutical Benefits Scheme (PBS) patient safety net threshold. The obligations and requirements imposed by the Act on the parties it governs include the obligation on the Minister to determine the amount that will be taken to have been paid to a public hospital for supplies of out-patient medication, prior to the commencement of the relevant entitlement period (subsection 84BA(2)). The Minister must consider different amounts for different categories of patients, including concessional beneficiaries, holders of a concession card, and general patients (subsection 84BA(3)). The Act also requires the Minister to consult with state and territory health departments through the Highly Specialised Drugs Working Party (HSDWP), although the HSDWP has since been discontinued. The obligations of the Act are designed to ensure that the PBS patient safety net threshold is applied fairly and consistently across different categories of patients and different states and territories. The National Health (Supplies of out-patient medication) Amendment Determination 2021 (No. 2) (PB 136 of 2021) does not impose any specific offences, penalties, or civil/criminal consequences for breach. However, the Act does provide for the imposition of penalties for non-compliance with the requirements of the PBS patient safety net threshold. For example, subsection 113(1) of the National Health Act 1953 provides that a person who contravenes a provision of the Act, or a determination made under the Act, is liable to a penalty of up to $22,200. In addition, subsection 113(2) provides that a corporation that contravenes a provision of the Act, or a determination made under the Act, is liable to a penalty of up to $111,000. These penalties are intended to deter non-compliance with the requirements of the Act and to promote the fair and consistent application of the PBS patient safety net threshold.

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