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.