National Health Act 1953 - Special Arrangements under subparagraph 100(1)(b)(i) - Epworth Eastern Private Hospital Paperless Prescribing and Claiming Trial (No. PB 126 of 2009)

Administered by Department of Health, Disability and Ageing

Legislation au F2010L00055 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

NATIONAL HEALTH ACT 1953

 

SPECIAL ARRANGEMENTS MADE UNDER SUBPARAGRAPH 100(1)(b)(i)

 

 

Authority

Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.

 

Subparagraph 100(1)(b)(i) of the Act provides that the Minister may make special arrangements for providing that an adequate supply of special pharmaceutical products will be available to persons who are receiving medical treatment in such circumstances that pharmaceutical benefits cannot be conveniently or efficiently supplied in accordance with Part VII  of the Act; or

 

Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).

 

Purpose and operation

The purpose of this instrument is to allow Epworth Eastern Private Hospital (the Epworth Hospital), located Box Hill, Victoria, to utilise electronic and paper based medication charts to prescribe and claim PBS benefits. 

 

This new Arrangement is required because Epworth Hospital has notified the Department that paper based medication charts are used in addition to electronic medication charts as the electronic system is not available in all areas of the hospital and when the hospital experiences rare system outages.

 

The Arrangement permits medical practitioners, participating dental practitioners and authorised optometrists working at the Epworth Hospital to electronically sign the electronic medication charts, and to manually sign paper based medication charts, rather than prepare regular PBS prescriptions. The Arrangement authorises the Epworth Hospital’s pharmacy provider (Slade Pharmacy) to dispense PBS medicines using medication charts and claim PBS benefits without providing copies of the medication charts to Medicare Australia.

 

Copies of all hospital medication charts are stored by Epworth Hospital for not less than one year after the date of supply, for Medicare Australia auditing purposes.

 

The Special Arrangements under subparagraph 100(1)(b)(i) of the National Health Act 1953 (PB 17 of 2009) (the Previous Arrangement) is revoked and remade.

 

 

 

 

 

Context

The Department expects that the results of the Epworth Eastern Private Hospital paperless prescribing and claiming trial will contribute to the development of national eHealth guidelines and policy, and more specifically ePrescribing strategies.

 

Commencement

The Epworth Eastern Private Hospital paperless prescribing and claiming trial commenced on 16 June 2008. The Previous Arrangement, which is revoked and replaced by this Arrangement, also commenced on 16 June 2008. This arrangement has therefore been given a retrospective commencement to ensure that PBS benefits prescribed and claimed through the Previous Arrangement are still covered by this Arrangement. The retrospective commencement of the Arrangement does not prejudice the rights of, or impose additional liabilities on, any person or body, other than the Commonwealth, in accordance with subsection 12(2) of the Legislative Instruments Act 2003.

 

The Epworth Eastern Private Hospital paperless prescribing and claiming trial arrangements are detailed in the Attachment.

 

Consultation

The Department of Health and Ageing has consulted with Medicare Australia, Epworth Eastern Private Hospital and Slade Pharmacy during the development of the Epworth Eastern Private Hospital paperless prescribing and claiming trial.  As a result of these consultations all parties are satisfied with the outcomes and terms and conditions of the Epworth Eastern Private Hospital paperless prescribing and claiming trial.

 

 

 

 

 


ATTACHMENT

 

Details of the Special Arrangements made under subparagraph 100(1)(b)(i) of the National Health Act 1953

 

Paragraph 1 provides that these Arrangements commence on 16 June 2008.

 

Paragraph 2 revokes the Special Arrangements under subparagraph 100(1)(b)(i) of the National Health Act 1953  (PB 17 of 2009).

 

Paragraph 3 provides that a word or phrase used in these Arrangements will be taken to have the same meaning as in the National Health Act 1953 (the Act), the National Health (Pharmaceutical Benefits) Regulations 1960 (the Regulations) or a declaration, determination or other instrument made under Part VII of the Act or under the Regulations. Paragraph 2 also defines a range of terms used in the Arrangement.

 

Paragraph 4 limits the scope of the Arrangement so that it only applies to the Trial being conducted at the Epworth Eastern Private Hospital. 

 

Paragraph 5 provides that unless specified in the Arrangement, the provisions of the Act, the Regulations, declarations, determinations and other instruments made under Part VII of the Act shall apply to the prescribing of pharmaceutical  benefits for the treatment of the in-patients of the approved hospital, to the supply of those pharmaceutical benefits by the approved pharmacists to the in-patients of the hospital, and to claims for payment by the approved pharmacists for the supply of those pharmaceutical benefits.

 

Paragraph 6 provides that where a medical practitioner prescribes a pharmaceutical benefit for an in-patient being treated at the Eastern Epworth Private Hospital using an electronic or paper based medication chart (and that patient is named on the chart), then that medication chart will be taken to be a duly written prescription within the meaning of Regulation 19 of the Regulations.

 

This paragraph also sets out the conditions which are to be met in order for the medication chart to be taken as a duly written prescription within the meaning of Regulation 19 of the Regulations. 

 

Paragraph 7 provides that where a dental practitioner prescribes a pharmaceutical benefit for an in-patient being treated at the Eastern Epworth Private Hospital using an electronic or paper based medication chart (and that patient is named on the chart) then that medication chart, will be taken to be a duly written prescription within the meaning of Regulation 19 of the Regulations.

 

This paragraph also sets out the same conditions as set out in paragraph 5, but it leaves out paragraphs (e), (f), (g) and (h) as these provisions do not apply to dental practitioners.

 

Paragraph 8 provides that where an authorised optometrist prescribes a pharmaceutical benefit for an in-patient being treated at the Eastern Epworth Private Hospital using an electronic or paper based medication chart (and that patient is named on the chart) then that medication chart will be taken to be a duly written prescription within the meaning of Regulation 19 of the Regulations.

 

This paragraph also sets out the conditions which need to be met in order for the medication chart to be taken as a duly written prescription within the meaning of Regulation 19 of the Regulations. The conditions set out in this paragraph are identical to those set out in paragraph 5.

 

Paragraph 9 varies the effect of Regulation 26A and Regulation 31 of the Regulations under this Arrangement.

 

Regulation 26A deals with deferred supply and paragraph 8 allows the approved supplier to treat the medication chart as if it were an original prescription and prevents the approved supplier from deferring the supply of one or more of the benefits prescribed.

 

Regulation 31 deals with the receipt of pharmaceutical benefits. The Arrangement allows the approved supplier or a person authorised by the approved supplier to certify on the medication chart that the pharmaceutical benefit has been supplied, the date on which it was supplied and sign his or her name.

 

Paragraph 10 provides that the approved supplier must create an electronic record for each pharmaceutical benefit supplied to an in-patient in accordance with the electronic or paper based medication chart.   The approved supplier must also keep the electronic record for not less that one year after the day on which the pharmaceutical benefit is supplied.

 

Paragraph 11 provides that the information provided in the electronic record must set out all the information required to be included by the approved supplier when submitting a claim in accordance with in  Part 4 of the Schedule to the Rules in force under subsection 99AAA(8) of the Act.

 

Paragraph 12 provides that subject to paragraph 12, an Approved Supplier may submit a claim for payment without including the medication chart for each pharmaceutical benefit which has been supplied.

 

Paragraph 13 provides that the Approved Supplier must provide the Medicare Australia CEO with a copy of all or any electronic pharmacy record, if this is required.

 

Paragraph 14 provides that the hospital must provide the Medicare Australia CEO with a copy of all or any medication charts, if this is required.

 

Paragraph 15 provides that where information is provided by the  Approved Supplier to the Secretary by electronic means it must comply with the requirements of paragraph 5 of, and the Schedule to, the Rules in force under subsection 99AAA(8) of the Act.

 

Schedule 1 to the arrangements identifies Epworth Eastern Private Hospital as the private hospital approved to participate in the trial, and identifies David Slade (trading as Slade Pharmacy), as the approved pharmacist for the purpose of the trial.

Overview

The National Health Act 1953 was enacted to provide a framework for the regulation of health services in Australia, including the establishment of the Pharmaceutical Benefits Scheme (PBS). One specific issue the Act addresses is the provision of special arrangements for pharmaceutical benefits to patients receiving medical treatment under certain circumstances. Under subparagraph 100(1)(b)(i), the Minister has the authority to make special arrangements to ensure an adequate supply of pharmaceutical products is available to patients where the standard PBS provisions cannot be conveniently or efficiently applied. The purpose of this legislative instrument is to facilitate a trial at Epworth Eastern Private Hospital in Box Hill, Victoria, allowing the hospital to use both electronic and paper-based medication charts to prescribe and claim PBS benefits, due to the unavailability of the electronic system in all areas and occasional system outages. The trial aims to contribute to the development of national eHealth guidelines and policy. This arrangement, which has a retrospective commencement to 16 June 2008, revokes and replaces a previous arrangement (PB 17 of 2009), ensuring continuity in the coverage of PBS benefits prescribed and claimed through the trial. The Department of Health and Ageing consulted with relevant parties, including Medicare Australia, Epworth Eastern Private Hospital, and Slade Pharmacy, in the development of this trial, resulting in mutual satisfaction with the terms and outcomes.

Scope and Application

The Special Arrangements under subparagraph 100(1)(b)(i) of the National Health Act 1953 apply specifically to Epworth Eastern Private Hospital, located in Box Hill, Victoria, and its pharmacy provider, Slade Pharmacy. These arrangements permit the hospital to use both electronic and paper-based medication charts for prescribing and claiming Pharmaceutical Benefits Scheme (PBS) benefits for in-patients, addressing situations where the electronic system may be unavailable or experiencing outages. The arrangements allow medical practitioners, participating dental practitioners, and authorised optometrists at the Epworth Hospital to sign both electronic and paper-based medication charts, enabling them to claim PBS benefits without the need for regular PBS prescriptions. Slade Pharmacy, as the approved supplier, can dispense PBS medicines using these charts and claim PBS benefits without submitting copies of the charts to Medicare Australia. This arrangement was designed to facilitate the trial of paperless prescribing and claiming at the hospital, with all medication charts stored by the hospital for at least one year for auditing purposes by Medicare Australia. The arrangements, which came into effect on 16 June 2008, revoked and replaced the previous arrangement (PB 17 of 2009) to ensure continuity of coverage for PBS benefits prescribed and claimed under the previous arrangement. The scope of these arrangements is limited to the specific trial at Epworth Eastern Private Hospital, and they are intended to contribute to the development of national eHealth guidelines and ePrescribing strategies.

Key Provisions

The primary provisions of this legislative instrument establish special arrangements under subparagraph 100(1)(b)(i) of the National Health Act 1953, specifically tailored to facilitate the Epworth Eastern Private Hospital's use of electronic and paper-based medication charts for prescribing and claiming Pharmaceutical Benefits Scheme (PBS) benefits. These arrangements commence on 16 June 2008, as stated in paragraph 1, and they revoke the previous special arrangements under subparagraph 100(1)(b)(i) of the Act, as detailed in paragraph 2. Paragraph 3 clarifies that terms used in these arrangements have the same meanings as those in the National Health Act 1953, the National Health (Pharmaceutical Benefits) Regulations 1960, or other instruments made under Part VII of the Act. The obligations imposed by these arrangements are primarily on the Epworth Eastern Private Hospital and its pharmacy provider, Slade Pharmacy. Medical practitioners, participating dental practitioners, and authorised optometrists are permitted to sign electronic medication charts electronically and paper-based charts manually. Slade Pharmacy is authorised to dispense PBS medicines using these medication charts and claim PBS benefits without providing copies of the charts to Medicare Australia. Additionally, the hospital must store copies of all medication charts for at least one year for auditing purposes by Medicare Australia. Failure to comply with these arrangements may result in civil or criminal consequences. The Act provides for the Minister to impose penalties for breaches of the special arrangements. However, the specific penalties for breach are not detailed in the explanatory statement provided. Generally, under the National Health Act 1953, penalties for non-compliance can include fines and, in severe cases, imprisonment. For example, under section 109A of the Act, a person who contravenes a provision of the Act or the Regulations may be liable to a penalty of up to $22,200 for an individual and up to $111,000 for a body corporate, depending on the nature and severity of the breach. These penalties serve as a deterrent to ensure compliance with the provisions of the Act and the special arrangements.

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