National Health Act 1953 - Determination under subsection 99AAC(2) (No. PB 9 of 2000)

Administered by Department of Health, Disability and Ageing

Legislation au F2007B00450 Not in force Legislative Instrument

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COMMONWEALTH OF AUSTRALIA

National Health Act 1953

PHARMACEUTICAL BENEFITS

DETERMINATION UNDER SUBSECTION 99AAC (2)

No. PB 9 of 2000

 

I, ALAN WILLIAM STEVENS, Acting Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Aged Care and Delegate of the Minister for Health and Aged Care, pursuant to subsection 99AAC (2) of the National Health Act 1953, hereby make the following Determination:

 

1. (a) This Determination is taken to have commenced on 1 July 2000.

 

 (b) Determination No. PB 19 of 1996 under subsection 99AAC (2) of the National Health Act 1953 made on 15 November 1996 with effect from 1 December 1996 is repealed.

 

2. In this Determination:

 

 (a) unless the contrary intention appears, a word or expression shall be taken to have the same meaning as in Part VII of the Act;

 

 (b) “Act” means the National Health Act 1953;

 

 “Claims Transmission System” has the same meaning as in section 99AAA of the Act;

 

“Commission” means the Health Insurance Commission established by the Health Insurance Commission Act 1973;

 

“Managing Director” means the Managing Director of the Commission;

 

“Secretary” means the Secretary to the Department of Health and Aged Care.

 

3. The Secretary must declare in writing under subsection 99AAC (1) of the Act that an approved supplier is exempted from the operation of subsection 99AAA (4) of the Act (being the subsection that requires an approved supplier to use the Claims Transmission System to give information to the Secretary in relation to the supply of pharmaceutical benefits) in respect of the supply of pharmaceutical benefits from particular premises if:

 

 (a) the approved supplier applies to the Secretary for exemption in accordance with the form approved by the Managing Director; and

 

 (b) the approved supplier provides with his or her application:

 

  (i) where there is no supply of electricity available to those premises — a statement in writing by the approved supplier; or

 

  (ii) where the supply of electrical power to those premises is, by virtue of its variability or unreliability, likely to interfere unreasonably with the normal operation of a computer in those premises — a letter or certificate issued by the authority or organisation responsible for the supply of electrical power to those premises;

 

attesting to:

 

  (iii) the fact that there is no supply of electricity available or the fact of that variability or unreliability; and

 

  (iv) the period during which that respective state of affairs is, in the opinion of the approved supplier, authority or organisation, likely to continue; and

 

 (c) the Secretary is satisfied:

 

  (i) in the case of a statement made in accordance with subsubparagraph (b) (i) — that the statement is correct; or

 

  (ii) in the case of a letter or certificate issued in accordance with subsubparagraph (b) (ii) — that the letter or certificate has been properly issued by the authority or organisation by which it purports to have been issued.

 

4. In making a declaration in accordance with paragraph 3, the Secretary must specify the period for which the exemption is to be effective, being a period of either:

 

 (a) one year from the date on which the declaration is made by the Secretary; or

 

 (b) the period attested to by the approved supplier, authority or organisation under subsubparagraph 3 (b) (iv);

 

 whichever is shorter.

 

5. The Secretary must, at a particular time, declare in writing under subsection 99AAC (1) of the Act that an approved supplier is exempted from the operation of subsection 99AAA (4) of the Act (being the subsection that requires an approved supplier to use the Claims Transmission System to give information to the Secretary in relation to the supply of pharmaceutical benefits) in respect of the supply of pharmaceutical benefits from particular premises if:

 

 (a) the Secretary has received an application from the approved supplier in accordance with subparagraph 3 (a); and

 

 (b) the Secretary has not made a declaration under subsection 99AAC (1) of the Act exempting the approved supplier from the operation of subsection 99AAA (4) of the Act in respect of those premises; and

 

 (c) the Secretary has not informed the approved supplier in accordance with subsection 99AAC (4) of the Act that the Secretary has decided not to make such a declaration; and

 

 (d) the approved supplier proposes to make a claim within one week from that time in respect of the supply of pharmaceutical benefits.

 


6. In making a declaration in accordance with paragraph 5, the Secretary must specify the period for which the exemption is to be effective, being a period of not more than the time required for the approved supplier to submit the claim referred to in subparagraph 5 (d).

 

7. The Secretary must declare in writing under subsection 99AAC (1) of the Act that an approved pharmacist is exempted from the operation of subsection 99AAA (4) of the Act (being the subsection that requires an approved supplier to use the Claims Transmission System to give information to the Secretary in relation to the supply of pharmaceutical benefits) in respect of the supply of pharmaceutical benefits from particular premises if:

 

(a) the approved pharmacist was, immediately before 1 July 2000, in receipt of a remote pharmacy allowance approved under section 99ZAA of the National Health Act 1953, as in force on 30 June 2000, in respect of those premises; and

 

(b  the approved pharmacist has not used the Claims Transmission System to give information to the Secretary in relation to the supply of pharmaceutical benefits from those premises.

 

8. In making a declaration in accordance with paragraph 7, the Secretary must specify that the declaration will be revoked if the approved pharmacist commences to use the Claims Transmission System to give information to the Secretary in relation to the supply of pharmaceutical benefits from those premises.

 

 

Dated this   seventh   day of    July   2000.

 

 

 

 

 

 

 

 

ALAN WILLIAM STEVENS

Acting Assistant Secretary

Pharmaceutical Benefits Branch

Department of Health and Aged Care

Delegate of the Minister for Health and Aged Care

 

 

 

Overview

The National Health Act 1953 was enacted to provide for the administration of national health programs and the provision of health services, including the Pharmaceutical Benefits Scheme (PBS). This legislation was introduced to address the need for a coordinated and comprehensive approach to the provision of health services across Australia. The Act empowers the Commonwealth Parliament to establish and administer various health-related programs and schemes, including the PBS, which aims to ensure affordable access to necessary medications. The Pharmaceutical Benefits Determination under subsection 99AAC (2) made by Alan William Stevens, Acting Assistant Secretary of the Pharmaceutical Benefits Branch, Department of Health and Aged Care, and Delegate of the Minister for Health and Aged Care, specifies the criteria and conditions under which approved suppliers and pharmacists can be exempted from certain requirements of the PBS, such as the obligation to use the Claims Transmission System for submitting information related to the supply of pharmaceutical benefits. This Determination aims to ensure flexibility and accommodate specific circumstances that may impede the normal operation of the PBS.

Scope and Application

The Pharmaceutical Benefits Determination under subsection 99AAC(2) of the National Health Act 1953 pertains specifically to the exemption of approved suppliers and approved pharmacists from the requirement to use the Claims Transmission System (CTS) for reporting pharmaceutical benefit claims. The determination applies to approved suppliers and approved pharmacists who are engaged in the supply of pharmaceutical benefits and are subject to the National Health Act. The exemption criteria include circumstances where there is no supply of electricity to the premises or where the electrical supply is deemed unreliable or inconsistent with the proper operation of a computer system required for CTS usage. The exemptions can be granted for a period up to one year or the duration specified by the supplier or the responsible authority for electrical supply. Furthermore, the Secretary may also exempt suppliers who have not yet transitioned to using the CTS, provided they were receiving a remote pharmacy allowance before 1 July 2000 and have not started using the CTS. These exemptions are subject to written declaration by the Secretary and are subject to revocation if the pharmacist begins using the CTS. This determination extends the application of the National Health Act by providing specific circumstances under which the use of the CTS can be exempted, thereby ensuring flexibility in compliance based on operational capabilities and conditions.

Key Provisions

This Determination under the National Health Act 1953 (section 99AAC (2)) sets out the conditions under which approved suppliers and pharmacists may be exempted from certain obligations related to the supply of pharmaceutical benefits. The key sections (3, 5, and 7) detail the specific circumstances and procedures for such exemptions. Section 3 specifies that the Secretary can exempt an approved supplier from using the Claims Transmission System if the supplier applies for exemption and provides a written statement or a certificate attesting to the unavailability or unreliability of electrical power at their premises. Section 5 outlines the circumstances where the Secretary must declare an exemption if the supplier proposes to make a claim within a week. Section 7 allows for exemptions for approved pharmacists who were receiving a remote pharmacy allowance before 1 July 2000 and have not yet used the Claims Transmission System. The Act imposes obligations on approved suppliers and pharmacists to comply with the requirements for using the Claims Transmission System unless exempted. Approved suppliers must apply for exemption in the approved form and provide the necessary documentation. The Secretary, upon reviewing the application and supporting documents, must then make a written declaration of exemption for a specified period, which cannot exceed the duration stated in the application or one year, whichever is shorter. Similarly, approved pharmacists who were receiving a remote pharmacy allowance prior to 1 July 2000 and have not yet used the Claims Transmission System can be exempted, though such exemption will be revoked if they begin using the system. The Determination does not explicitly state any offences, penalties, or consequences for breaches. However, non-compliance with the requirements for using the Claims Transmission System, or failure to apply for and obtain an exemption where applicable, could potentially lead to administrative or regulatory consequences under the broader framework of the National Health Act 1953. It is essential for approved suppliers and pharmacists to adhere to the specified procedures to avoid any adverse outcomes.

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Health Law
Instrument
Legislative Instrument
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Definitions & Interpretation
Exemptions & Exclusions
Reporting & Disclosure Obligations
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Pharmaceutical Benefits

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