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Repatriation Pharmaceutical Benefits Scheme (Australian Participants in British Nuclear Tests) 2006 (No. R33 of 2006)
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Repatriation Pharmaceutical Benefits Scheme (Australian Participants in British Nuclear Tests) 2006
Instrument 2006 No. R33 as amended
made under the
Australian Participants in British Nuclear Tests (Treatment) Act 2006
This compilation was prepared on 3 May 2012 taking into account amendments up to the Repatriation Pharmaceutical Benefits Scheme (Australian Participants in British Nuclear Tests) 2006 (Under Co-payment Data Collection) Instrument 2012 (No. R21/2012) (F2012L00745)
Prepared by the Legal Services Group,
Department of Veterans' Affairs, Canberra
In sections 1-3 of this instrument:
Act means the Australian Participants in British Nuclear Tests (Treatment) Act 2006.
Repatriation Pharmaceutical Benefits Scheme means the instrument referred to as the “approved pharmaceutical scheme” in section 4 of the Act as that instrument is incorporated in the Act.
This instrument commences on the day after it is registered on the Federal Register of Legislative Instruments.
The Repatriation Pharmaceutical Benefits Scheme is modified in accordance with the Schedule.
retain, adding at the end:
(Australian Participants in British Nuclear Tests) 2006
Note: the purpose of this provision is to ensure a part of the Repatriation Pharmaceutical Benefits Scheme (RPBS) as incorporated in the Act is retained to ensure the RPBS is modified and not substituted.
substitute:
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Australian Participants in British Nuclear Tests (Treatment) Act 2006
Section 18
Repatriation Commission
CONTENTS
Repatriation Pharmaceutical Benefits Scheme.............................6
Purpose of the Repatriation Pharmaceutical Benefits Scheme.................6
Part 1 — Interpretation.....................................................6
3A. Notification of certain matters in the Explanatory Notes.....................9
3B. Department to notify of certain matters as agent of the Commission...........9
Part 2 — Prescribing of Benefits Procedure by Medical Practitioners..............9
4.. Prior Approval......................................................9
Restrictions........................................................9
Prescribing provisions................................................11
Application of PBS Schedule restrictions and RPBS Schedule restrictions.......11
Prescriptions to conform with State or Territory Law.......................11
10. Form of prescriptions................................................11
11. When prescriptions are invalid.........................................11
12. Maximum quantity and repeats allowed..................................12
13. Prescribing outside the RPBS Schedule or PBS Schedule....................12
14. Medical Practitioner subject to this Scheme...............................12
Part 3 — Supply of Pharmaceutical Benefits....................................13
15. Supply of Pharmaceutical Benefits — Procedure by Community Pharmacists....13
16. Substitution of lesser priced alternative brand of drug.......................13
17. Community Pharmacist to be satisfied as to entitlement.....................13
18. Dispensing of deleted items...........................................14
20. Use of forms as notified by the Department or the Commission...............14
23. Financial responsibility...............................................14
24. Refund in certain circumstances........................................14
Part 4 — Claims by Community Pharmacists...................................14
26. Lodgement of Claims by Community Pharmacists..........................14
27. Payment subject to compliance.........................................15
Part 5 — Payments to Community Pharmacists.................................15
28. Dispensing fee payable to Community Pharmacists.........................15
29. Dispensing fee payable to Approved Medical Practitioners and Approved Hospital Authorities 15
30. Other Fees — similar PBS pharmaceutical benefit..........................16
31. Other Fees — notified rates...........................................16
32. Fees not payable in some circumstances..................................16
33. Community Pharmacist not entitled to demand or receive payments............16
34. Community Pharmacist to issue receipt where certain payments received........16
Part 5A — Under Co-payment Data Collection
Giving information......................................................................................................15
Part 6 — Miscellaneous.....................................................17
35. Standards ………………………………………………………................................17
36. Editions of monographs and standards...................................18
37. Order of precedence.................................................18
40. Discretionary powers................................................18
41. Retention of Documents..............................................18
Repatriation Pharmaceutical Benefits Scheme (Australian Participants in British Nuclear Tests) 2006
Purpose of the Repatriation Pharmaceutical Benefits Scheme (Australian Participants in British Nuclear Tests) 2006
“Act” means the Australian Participants in British Nuclear Tests (Treatment) Act 2006.
“Approved Hospital Authority” means a hospital authority approved under section 94 of the National Health Act 1953 for the purposes of supplying Pharmaceutical Benefits;
“Approved Medical Practitioner” means a medical practitioner approved under section 92 of the National Health Act 1953 for the purposes of supplying Pharmaceutical Benefits;
“Authority Prescription Form” means the form approved under:
(i) subregulation 13(2) of the National Health (Pharmaceutical Benefits) Regulations; or
(ii) paragraph 14 of declaration No. PB 10 of 1993 made under subsection 85(2) of the National Health Act 1953;
“approved supplier” has the meaning given in Part VII of the National Health Act 1953;
“Commission” means the Repatriation Commission continued in existence by section 179 of the Veterans’ Entitlements Act 1986;
“Community Pharmacist” means:
(a) a registered pharmacist approved for the purposes of section 90 of the National Health Act 1953 in charge of a community pharmacy; or
(b) a registered pharmacist approved for the purposes of section 90 of the National Health Act 1953, being the manager of a registered Friendly Society Dispensary; or
(c) an Approved Hospital Authority; or
(d) an Approved Medical Practitioner;
“Department” means the Department of Veterans’ Affairs;
“Diagnostic Agents” means Agents intended to facilitate the determination of human disease and/or human physiological states;
“Drugs” or “Medicines” means “goods for therapeutic use” as defined for human use by the Therapeutic Goods Act 1989;
“Eligible Person” means a person eligible for treatment under the Act who, if one has been granted, holds a Repatriation Health Card - For Specific Conditions;
“Explanatory Notes” means the text entitled “Explanatory Notes” and the text entitled “RPBS Explanatory Notes” that is published in the document, Schedule of Pharmaceutical Benefits for Approved Pharmacists and Medical Practitioners, having the International Standard Serial Number 1037-3667, and dated 1 February 2002, to the extent that that text is not inconsistent with this Scheme;
[Note: see attachment for date changes. This note is not part of this Instrument]
“Medical Practitioner” has the same meaning as “medical practitioner” has in the Health Insurance Act 1973;
“PBS” means the Pharmaceutical Benefits Scheme authorised under the National Health Act 1953;
“PBS Schedule” means the Schedule of Pharmaceutical Benefits constituted by determinations and declarations under Part VII of the National Health Act 1953 (the Act) — by the Minister who administers that Act — as those determinations and declarations are in force from time to time — and includes any such determination, as in force from time to time, the application of which has been varied under a regulation under the Act.
“Pharmaceutical benefits” has the same meaning as “pharmaceutical benefits” in section 4 of the Act;
“Repatriation Health Card - For Specific Conditions” means an identification card, or written authorisation, provided to a person eligible under section 7 of the Act for treatment, subject to the Treatment Principles (Australian Participants in British Nuclear Tests) 2006, for malignant neoplasia;
“RPBS Schedule” means the Schedule of Pharmaceutical Benefits prepared by the Department of Veterans’ Affairs, entitled “Repatriation Schedule of Pharmaceutical Benefits” and dated 1 February 2002;
[Note: see attachment for date changes. This note is not part of this Instrument]
“Scheme” means the Repatriation Pharmaceutical Benefits Scheme (Australian Participants in British Nuclear Tests) 2006.
“Standard Prescription Form” means the form approved under paragraph 19(1)(a) of the National Health (Pharmaceutical Benefits) Regulations;
“Treatment Principles” means the written document prepared by the Repatriation Commission and approved by the Minister under section 16 of the Act and entitled: Treatment Principles (Australian Participants in British Nuclear Tests) 2006.
“VEA RPBS” means the instrument made by the Commission under section 91 of the VEA and entitled the Repatriation Pharmaceutical Benefits Scheme.
“VEA” means the Veterans’ Entitlements Act 1986.
Procedure by Medical Practitioners
Approval in respect of the treatment of an Eligible Person for malignant neoplasia; and
(b) Prior Approval must be sought, in advance, in accordance with an Authority Prescription Form.
(a) items — quantities and repeats: those listed in the RPBS Schedule or PBS Schedule;
(b) surgical appliances and other treatment aids: surgical appliances and other treatment aids provided under the Treatment Principles may not be prescribed unless specifically listed in the RPBS Schedule;
(c) admixtures: the following restrictions apply to admixtures:
(i) admixture of two or more ready‑prepared items into a single combined form, or the addition of one or more supplementary ingredients to a ready‑prepared item, is not recognised as a Pharmaceutical Benefit;
(ii) the extemporaneous prescribing of two or more official formulary preparations in a single combined form, or the addition of one or more supplementary ingredients to an official formulary preparation, is a recognised Pharmaceutical Benefit; and
(iii) where one or more of the components of a preparation specified in subsubparagraph (ii) are non‑RPBS Schedule or non-PBS Schedule items, Prior Approval is required for their prescribing;
(d) conformity with standards: no drug or therapeutic substance shall be prescribed unless it conforms with:
(i) the specific or general standards as determined by the relevant Minister under the Therapeutic Goods Act 1989; or
(ii) the British Pharmacopoeia, the United States Pharmacopoeia, the European Pharmacopoeia, the Australian Pharmaceutical Formulary, or a prescribed Pharmacology text of international standing;
(e) basis for prescribing: the prescribing of therapeutic substances other than on the clinical diagnosis of a Medical Practitioner shall be invalid;
(f) approval for therapeutic use: it is invalid to prescribe:
(i) an item that is not approved for therapeutic use in the treatment of human illness by the relevant Commonwealth, State or Territory Government agencies, or
(ii) an item for use if it is not in accordance with the terms and conditions specified by the relevant Government agencies in approving the item as a therapeutic substance;
(g) Prior Approval for non-conforming items: any drug or medicine intended for use other than in conformity with the requirements in subparagraph (d) requires Prior Approval;
(h) PBS Schedule restricted items: the prescribing of PBS Schedule restricted items is to comply with the restrictions relating to the prescribing of such items as indicated in the PBS Schedule unless Prior Approval is obtained to prescribe otherwise;
(j) RPBS Schedule restricted items: the prescribing of RPBS Schedule restricted items under this Part is to comply with the restrictions relating to the prescribing of such items as indicated in the RPBS Schedule unless Prior Approval is obtained to prescribe otherwise;
(k) Prior Approval for non-Schedule items: the prescribing of an item not included in the RPBS Schedule or PBS Schedule requires Prior Approval.
(a) written by Medical Practitioners on an Authority Prescription Form or Standard Prescription Form as the case requires; or
(b) produced on a computer by a Medical Practitioner approved, under paragraph 19(1)(a) of the National Health (Pharmaceutical Benefits) Regulations, to use computer generated prescriptions, by the Secretary to the Department that administers the National Health Act 1953.
(a) prescribes a Pharmaceutical Benefit for a person in respect of whom another prescription for the same benefit has been written on the same day by the same Medical Practitioner; or
(b) prescribes, on the one form, a Pharmaceutical Benefit that is a drug of addiction and another Pharmaceutical Benefit, and directs that the supply of either Pharmaceutical Benefit is to be repeated (but, if no repeats of either item are ordered, the prescription may be accepted provided that this is in accordance with the relevant State or Territory law); or
(c) prescribes a narcotic drug for the Medical Practitioner writing the prescription; or
(d) prescribes on a Standard Prescription Form an item not listed in the RPBS Schedule or PBS Schedule; or
(e) prescribes on a Standard Prescription Form a benefit in contravention of any of the restrictions set out in paragraph 7.
(a) a valid Standard Prescription Form; or
(b) a valid Authority Prescription Form; or
(c) a valid repeat authorisation form presented with a duplicate prescription in accordance with the requirements under the PBS;
provided that such documents are in accordance with State or Territory law, or this Scheme and the Explanatory Notes, and with any requirements which the Department or the Commission, from time to time, notifies (including those notified under the VEA RPBS and in force at the commencement of this instrument).
(b) Without limiting the generality of subparagraph (a), a Community Pharmacist may refuse to supply a Pharmaceutical Benefit to a person on terms that are appropriate for the supply of the Pharmaceutical Benefit to a holder of a Repatriation Health Card - For Specific Conditions, unless the person produces such a card to the Community Pharmacist that indicates that the person is entitled to receive the Pharmaceutical Benefit on those terms.
(a) a Community Pharmacist charges an Eligible Person an amount in respect of the provision of a Pharmaceutical Benefit; and
(b) information indicating the person’s eligibility under this Scheme was not supplied to the Community Pharmacist; and
(c) the Commission is satisfied that, in the circumstances, the person should be treated as if the relevant information had been supplied,
the person is entitled to be paid by the Commonwealth an amount equal to any amount that the person paid that would not have been payable if the relevant information had been supplied.
(a) prescriptions for the supply of Pharmaceutical Benefits under this Part shall be marked in the S section or S sections (as defined in those rules) with one or more serial numbers allotted in respect of each Pharmaceutical Benefit commencing at “R1” in each claim and continuing consecutively in respect of that claim;
(b) these prescriptions shall be collected into one bundle, separate to the four bundles provided for in those rules, with the prescriptions sorted into the order of the serial numbers allocated under subparagraph (a), with the least serial number at the top of the bundle; and
(c) the information to be provided to the Secretary to the Department that administers the National Health Act 1953, in respect of each supply of a Pharmaceutical Benefit shall include a Form Category (within the meaning of the schedule to those rules) with a value of “8” where the Pharmaceutical Benefit was supplied on an original authority prescription or “9” where the Pharmaceutical Benefit was supplied on a repeat authority prescription, and a Payment Category (within the meaning of that schedule) with a value of “4”.
(a) for goods or services that are provided in an emergency; or
(b) for payment of an after-hours fee; or
(c) for payment for packaging material, postage or freight; or
(d) for payment that represents the required payment under the PBS of the price difference between the drug prescribed and supplied and the lowest priced brand of the same drug listed on the PBS Schedule; or
(e) where payment represents the difference between the Commonwealth’s financial responsibility for the provision of the Pharmaceutical Benefit and the dispensed price of the Pharmaceutical Benefit supplied.
(a) the goods and/or services provided; and
(b) the date of receipt of those goods and/or services by the person.
(a) no claim for payment is made by the Community Pharmacist on the Commission or Department for dispensing the Pharmaceutical benefit; and
(b) the dispensing price of the pharmaceutical benefit is less than, or equal to, the co-payment that would have been paid by the Eligible Person for the pharmaceutical benefit if it had been dispensed at a price for which a co-payment is payable; and
(c) the information is given in accordance with the requirements, to the extent applicable, that apply under section 98C of the National Health Act 1953 to an approved supplier giving information to the Secretary in relation to the supply to a person of a pharmaceutical benefit, as if references in section 98C to an approved supplier and a pharmaceutical benefit are references to, respectively, a Community Pharmacist and a Pharmaceutical benefit and the pharmaceutical benefit has been supplied under the Scheme.
Note: a Community Pharmacist includes an Approved Hospital Authority.
(a) the British Pharmacopoeia or the Pharmaceutical Codex as amended and authorised by regulations under the Therapeutic Goods Act 1989;
(b) the regulations under the Therapeutic Goods Act 1989 which relate to specific standards for drugs;
(c) the Australian Pharmaceutical Formulary which describe drugs and medicinal preparations;
(d) previous editions of the British Pharmacopoeia, Pharmaceutical Codex or the Australian Pharmaceutical Formulary which describe drugs and medicinal preparations; and
(e) the Extra Pharmacopoeia, the European Pharmacopoeia, the United States Pharmacopoeia or similar pharmaceutical texts of international standing which describe drugs.
The Commission may enter into agreements concerning the administration of this Part with the Pharmacy Guild of Australia and, subject to this Part, shall abide by such agreements.
In the event the Commission does not enter into an agreement under paragraph 38, any agreement between the Commission and the Pharmacy Guild of Australia made for the purposes of paragraph 38 of the VEA RPBS applies under this Scheme as if made for the purposes of this Scheme.
Notes to the Repatriation Pharmaceutical Benefits Scheme (Australian Participants in British Nuclear Tests) 2006
Note 1
The Repatriation Pharmaceutical Benefits Scheme (Australian Participants in British Nuclear Tests) 2006 (in force under the Australian Participants in British Nuclear Tests (Treatment) Act 2006) as shown in this compilation comprises Legislative Instrument 2006 No. R33 (see F2007L00199) amended as indicated in the Tables below.
Note: > Note: Table of Legislative Instruments
| Year andnumber | Date of FRLIregistration | Date ofcommencement | Application, saving ortransitional provisions |
|---|---|---|---|
| 2006 No. R33 | 25 January 2007 (see F2007L00199) | 26 January 2007 | |
| 2012 No. R21 | 30 March 2012 (seeF2012L00745) | 1 April 2012 | — |
Note: > Note: Table of Amendments
<table cellspacing="0" cellpadding="0" style="border-collapse:collapse"><thead><tr><td colspan="2" style="width:354.9pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmendHead" style="margin-right:0pt"><span>ad. = added or inserted</span><span> </span><span>am. = amended</span><span> </span><span>rep. = repealed</span><span> </span><span>rs. = repealed and substituted</span></p></td></tr><tr><td style="width:129.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableColHead"><span>Provision affected</span></p></td><td style="width:214.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableColHead"><span>How affected</span></p></td></tr></thead><tbody><tr><td style="width:129.3pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span>Para. 3</span></p></td><td style="width:214.8pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt; margin-bottom:3pt"><span>am. 2012 No. R21</span></p></td></tr><tr><td style="width:129.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span style="font-weight:bold">Part 5A</span></p></td><td style="width:214.8pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt; margin-bottom:3pt"><span></span></p></td></tr><tr><td style="width:129.3pt; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span>Part 5A (para. 32A)</span></p></td><td style="width:214.8pt; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt; margin-bottom:3pt"><span>ad. 2012 No. R21</span></p></td></tr></tbody></table>