National Health Act 1953 - Special Arrangements under subsection 100(1)(b)(i) - Epworth Eastern Private Hospital Paperless Prescribing and Claiming Trial (No. PB 17 of 2009)

Administered by Department of Health, Disability and Ageing

Legislation au F2009L00303 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

NATIONAL HEALTH ACT 1953

 

INSTRUMENT PB 17 of 2009 – SPECIAL ARRANGEMENTS MADE UNDER SECTION 100 (SPECIAL ARRANGEMENTS:  EPWORTH EASTERN PRIVATE HOSPITAL PAPERLESS PRESCRIBING AND CLAIMING TRIAL)

 

 

Authority

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

 

Subsection 100(1) 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:

(a) who are living in isolated areas; or

(b) who are receiving medical treatment in such circumstances that pharmaceutical benefits:

(i) cannot be conveniently or efficiently supplied in accordance with Part VII  of    the Act; or

(ii) are inadequate for that medical treatment.

 

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

This arrangement is made under subsection 100(1)(b)(i) of the Act (the Arrangement).

 

The purpose of the Arrangement, PB 17 of 2009, is to amend the relevant requirements of the Act, the Regulations and other relevant legislative instruments made under the Act to allow pharmaceutical benefits to be prescribed and supplied through a paperless prescribing, and claiming trial at the Epworth Eastern Private Hospital. The trial also allows the Slade Pharmacy (the hospital’s approved supplier) to use a paperless claiming procedure to claim payment for each pharmaceutical benefit supplied.

 

Context

The Department expects that the results of the Epworth Eastern Private Hospital Paperless Prescribing and Claiming Trial (the Trial) will contribute to the development of national eHealth guidelines and policy, and more specifically ePrescribing strategies. The outcomes of the Trial will inform the development of national ePrescribing standards and guidelines, which will assist in the facilitation of a national ePrescribing solution.

 

 

 

Application

The Trial allows prescribers at Epworth Eastern Private Hospital to use electronic medication charts to prescribe PBS medicines, instead of paper based prescriptions and to electronically sign medication charts.

 

It also allows Slade Pharmacy to supply pharmaceutical benefits using a paper copy of the medication chart and to claim payment from the Medicare Australia CEO without having to submit a paper copy of each medication chart with the claim.

 

The Approved Supplier must then create an electronic record of the medication chart.

Copies of all electronic records are stored by the Approved Supplier for not less than one year after the date the pharmaceutical benefit is supplied to allow the Medicare Australia CEO to audit the claim if required.

 

Details

The Trial commenced on 16 June 2008. The Arrangement therefore will also commence on 16 June 2008. The Arrangement was not registered on 16 June 2008 as the program area was not aware of this requirement. However, steps have been taken to ensure that all future instruments will be registered in advance of their commencement.

 

The Arrangement will operate retrospectively from its commencement date (that is         16 June 2008) to the date it is registered on the Federal Register of Legislative Instruments.

 

The Arrangement is beneficial in nature. Its purpose is to ensure that pharmaceutical benefits can continue to be prescribed and supplied to patients and payment can be claimed using the alternative procedures set out under the Trial. Even though the Arrangement will be retrospective, it will not infringe subsection 12(2) of Legislative Instruments Act 2003 (that is it should not adversely affect the rights of anyone except the Commonwealth).

 

The details for the Arrangements are set out 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 Trial.  As a result of these consultations all parties are satisfied with the outcomes, terms and conditions of the Trial.

 

 

 

 

 

 

 

 

ATTACHMENT

 

Details of the Arrangement made under Section 100 of the National Health Act 1953

 

Paragraph 1 provides that the Arrangement commenced on 16 June 2008.

 

Paragraph 2  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 3 limits the scope of the Arrangement so that it only applies to the Trial being conducted at the Epworth Eastern Private Hospital. 

 

Paragraph 4 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 5 provides that where a medical practitioner prescribes a pharmaceutical benefit for an in-patient being treated at the Eastern Epworth Private Hospital using a 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 6 provides that where a dental practitioner prescribes a pharmaceutical benefit for an in-patient being treated at the Eastern Epworth Private Hospital using a 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 7 provides that where an authorised optometrist prescribes a pharmaceutical benefit for an in-patient being treated at the Eastern Epworth Private Hospital using a 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 8 varies Regulation 26A and Regulation 31 of the Regulations.

 

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 9 provides that the approved supplier must create an electronic record for each pharmaceutical benefit supplied to an in-patient in accordance with the 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 10 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 11 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 12 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 13 provides that the Approved Supplier must provide the Medicare Australia CEO with a copy of all or any medication charts, if this is required.

 

Paragraph 14 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.

 

 

 

 

The Schedule

 

The Schedule 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 Supplier for the purpose of the Trial.

 

 

Overview

The National Health Act 1953, enacted by the Commonwealth Parliament, establishes the Pharmaceutical Benefits Scheme (PBS) to ensure all Australians have access to reliable, timely, and affordable medicines. The Act, particularly under section 100, allows the Minister to make special arrangements for providing adequate pharmaceutical products to those in isolated areas or receiving medical treatment where conventional PBS supply is inefficient or inadequate. The Special Arrangements, PB 17 of 2009, are an amendment to the Act that enables a paperless prescribing and claiming trial at Epworth Eastern Private Hospital. This trial permits prescribers to use electronic medication charts and for Slade Pharmacy, the hospital’s approved supplier, to implement a paperless claiming procedure for PBS medicines. The objective of this arrangement is to contribute to the development of national eHealth guidelines and ePrescribing standards, facilitating a national ePrescribing solution. The trial, which began on 16 June 2008, operates retrospectively from its commencement date until its registration on the Federal Register of Legislative Instruments, ensuring that pharmaceutical benefits can be prescribed, supplied, and claimed using the trial’s alternative procedures without adversely affecting the rights of anyone except the Commonwealth.

Scope and Application

The National Health Act 1953 provides a legislative framework for the Pharmaceutical Benefits Scheme (PBS), ensuring access to a wide range of medicines for Australians. Under the Act, the Minister can make special arrangements to ensure adequate supply of special pharmaceutical products to certain individuals or in specific circumstances where conventional PBS provisions may not apply. The Special Arrangement PB 17 of 2009, established under this provision, specifically addresses the Epworth Eastern Private Hospital Paperless Prescribing and Claiming Trial, allowing for electronic prescribing and claiming procedures. This arrangement applies to the Trial conducted at Epworth Eastern Private Hospital, facilitating the use of electronic medication charts for prescribing PBS medicines and enabling paperless claiming processes by Slade Pharmacy, the hospital's approved supplier. The Arrangement is designed to contribute to the development of national eHealth guidelines and ePrescribing standards. It came into effect retrospectively from 16 June 2008 and is intended to ensure the continuity of pharmaceutical benefits without adverse effects on rights, pending registration on the Federal Register of Legislative Instruments.

Key Provisions

The special arrangements under section 100 of the National Health Act 1953 (the Act) (section 100) allow the Minister to make provisions for the adequate supply of special pharmaceutical products in certain circumstances, including when pharmaceutical benefits cannot be conveniently or efficiently supplied in accordance with Part VII of the Act or are inadequate for that medical treatment (subsection 100(1)). This specific arrangement, PB 17 of 2009, allows for a paperless prescribing and claiming trial at the Epworth Eastern Private Hospital. This trial permits prescribers at the hospital to use electronic medication charts to prescribe Pharmaceutical Benefits Scheme (PBS) medicines, and allows the hospital’s approved supplier, Slade Pharmacy, to use a paperless claiming procedure to claim payment for each pharmaceutical benefit supplied (paragraphs 5 and 11). The parties involved in the trial, including Epworth Eastern Private Hospital, Slade Pharmacy, and Medicare Australia, are required to adhere to the conditions set out in the Arrangement. This includes prescribers using electronic medication charts for in-patients, Slade Pharmacy supplying pharmaceutical benefits using a paper copy of the medication chart and claiming payment electronically without submitting a paper copy of each medication chart with the claim, and the approved supplier creating an electronic record of the medication chart (paragraphs 4, 5, 6, 7, and 9). The approved supplier must also provide the Medicare Australia Chief Executive Officer with a copy of all or any electronic pharmacy record or medication charts if required (paragraphs 12 and 13). There are no explicit offences, penalties, or civil/criminal consequences mentioned for breach of the Arrangement. However, the Arrangement is beneficial in nature and is intended to ensure that pharmaceutical benefits can continue to be prescribed and supplied to patients and payment can be claimed using the alternative procedures set out under the Trial (paragraph 14). The Arrangement does not adversely affect the rights of anyone except the Commonwealth and will not infringe subsection 12(2) of the Legislative Instruments Act 2003 (paragraph 14). It is important to note that the Arrangement is subject to registration on the Federal Register of Legislative Instruments, and steps have been taken to ensure that all future instruments will be registered in advance of their commencement (paragraph 15).

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