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Commonwealth legislation
This Act has been repealed and is no longer in force. It is retained for historical reference.
This instrument sets out how specified chemotherapy medicines are to be prescribed, authorised, supplied and paid for when given to public hospital non-admitted, day-admitted or recently discharged patients. It lists which drugs and forms qualify, requires authorisation (including via a Medicare Australia electronic system), prescribes record‑keeping and electronic claim formats, allows hospitals to charge patients modest co‑payments, and entitles hospitals to Commonwealth payment for the balance.
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Direct links to the current provisions in National Health Act 1953 - Arrangements made under subparagraph 100(1)(b)(i) - Chemotherapy Pharmaceuticals Access Program (No. PB 43 of 2006).
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
COMMONWEALTH OF AUSTRALIA
National Health Act 1953
ARRANGEMENTS MADE UNDER SUBPARAGRAPH 100(1)(b)(i)
CHEMOTHERAPY PHARMACEUTICALS ACCESS PROGRAM
No. PB 43 of 2006
I, JOAN CORBETT, Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Ageing and delegate of the Minister for Health and Ageing, pursuant to subparagraph 100(1)(b)(i) of the National Health Act 1953, hereby make the following Arrangements for the purpose of providing that an adequate supply of special pharmaceutical products will be available to persons who are receiving treatment with chemotherapy pharmaceuticals at public hospitals as non-admitted patients, day admitted patients or patients on discharge:
Commencement
(b) The Arrangements made on 26 July 2006 with effect from 1 August 2006 (No. PB 37 of 2006) are repealed with effect from the commencement of these Arrangements.
Definitions
(a) unless the contrary intention appears, a word or phrase will be taken to have the same meaning as in the Act, the Regulations or a declaration, determination or other instrument made under Part VII of the Act or under the Regulations;
(b) “Act” means the National Health Act 1953;
(c) “Medicare Australia CEO” means the Chief Executive Officer of Medicare Australia;
(d) “chemotherapy pharmaceutical” means a special pharmaceutical product in relation to which, by virtue of paragraphs 5, 8 and 12, these Arrangements apply;
(e) “Medicare Australia authority notification computer system” means a computer system operated by the Medicare Australia CEO for the purpose of receiving messages from medical practitioners and sending authorisations for supply of chemotherapy pharmaceuticals or refusals of such authorisations, having an electronic mail address approved by the Medicare Australia CEO;
(f) “hospital” means a public hospital that is participating in the arrangements provided for in Appendix F to Australian Health Care Agreements;
(g) “medical practitioner” means a medical practitioner, within the meaning of the Health Insurance Act 1973, who is affiliated with the hospital in or at which the patient is receiving treatment;
(h) “patient” means a person receiving treatment as a non-admitted patient, a day admitted patient or a patient on discharge of the hospital of which the approved hospital authority is the governing body;
(i) “Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act.
Entitlement to receive chemotherapy pharmaceuticals under these Arrangements
(a) is, or is to be treated as, an eligible person within the meaning of the Health Insurance Act 1973; and
(b) is receiving treatment as a non-admitted patient, a day admitted patient or a patient on discharge, of a hospital as defined in paragraph 2(f); and
(c) is receiving medical treatment by a medical practitioner, within the meaning of the Health Insurance Act 1973, who is affiliated with the hospital in or at which the patient is receiving treatment;
is entitled to receive chemotherapy pharmaceuticals under these Arrangements without the payment or furnishing of money or other consideration other than a charge made in accordance with paragraphs 20 and 20A.
The special pharmaceutical products to which these Arrangements apply are the chemotherapy pharmaceuticals specified in column 1 of Schedule 1.
The prescribing of a chemotherapy pharmaceutical is authorised under these Arrangements only in the circumstances, if any, specified in column 2 of Schedule 1 in relation to the chemotherapy pharmaceutical.
The following circumstances are specified in relation to each chemotherapy pharmaceutical:
(a) where a class of persons is specified in column 2 of Schedule 1 — the chemotherapy pharmaceutical is to be supplied for the treatment of a person included in that class of persons; or
(b) where a disease or condition is specified in column 2 of Schedule 1 —
(i) if subsubparagraph (ii) does not apply — the chemotherapy pharmaceutical is to be supplied for the treatment of that disease or condition in relation to any person; or
(ii) if the disease or condition is specified in relation to a specified class of persons — that the chemotherapy pharmaceutical is to be supplied for the treatment of that disease or condition in a person included in that class of persons; or
(c) where a purpose is specified in column 2 of Schedule 1 — the chemotherapy pharmaceutical is to be supplied for that purpose.
Where strength, type of unit, size of unit or other particulars of form are specified in column 2 of Schedule 2 or column 2 of Schedule 3 in relation to a special pharmaceutical product, each specified form of the product is a chemotherapy pharmaceutical, and these Arrangements do not apply in relation to the special pharmaceutical product in any other form.
The manner of administration specified in column 3 of Schedule 2 or column 4 of Schedule 3 in relation to a chemotherapy pharmaceutical is the only manner of administration that may be directed to be used in relation to that product.
The maximum quantity or number of units of a chemotherapy pharmaceutical that may, in one prescription, be directed to be supplied on any one occasion is:
(a) where the name of the chemotherapy pharmaceutical is specified in column 1 of Schedule 2 — the quantity or number, if any, specified in column 4 of that Schedule in relation to the chemotherapy pharmaceutical; or
(b) where the name of the chemotherapy pharmaceutical is specified in column 1 of Schedule 3 and the chemotherapy pharmaceutical is prescribed in accordance with the provisions of column 3 of that Schedule — the quantity or number, if any, specified in column 5 of that Schedule in relation to the chemotherapy pharmaceutical.
(a) where the name of the chemotherapy pharmaceutical is specified in column 1 of Schedule 2 — the number, if any, specified in column 5 of that Schedule in relation to the chemotherapy pharmaceutical; or
(b) where the name of the chemotherapy pharmaceutical is specified in column 1 of Schedule 3 and the chemotherapy pharmaceutical is prescribed in accordance with the provisions of column 3 of that Schedule — the number, if any, specified in column 6 of that Schedule in relation to the chemotherapy pharmaceutical.
<table cellspacing="0" cellpadding="0" style="border-collapse:collapse"><tbody><tr><td style="width:30.05pt; 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="tNormal" style="font-size:10pt"><span style="font-style:italic">Letters</span></p></td><td style="width:159.3pt; 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="tNormal" style="font-size:10pt"><span style="font-style:italic">Manufacturer’s Name</span></p></td><td style="width:10.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span style="font-style:italic"></span></p></td><td style="width:31.75pt; 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="tNormal" style="font-size:10pt"><span style="font-style:italic">Letters</span></p></td><td style="width:173.45pt; 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="tNormal" style="font-size:10pt"><span style="font-style:italic">Manufacturer’s Name</span></p></td></tr><tr style="height:11.25pt"><td style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>AP</span></p></td><td style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>AstraZeneca Pty Ltd</span></p></td><td rowspan="16" style="width:10.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span></span></p></td><td style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>MX</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Mayne Pharma Pty Ltd</span></p></td></tr><tr style="height:11.25pt"><td style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>AV</span></p></td><td style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Aventis Pharma Pty Limited</span></p></td><td rowspan="2" style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>NV</span></p></td><td rowspan="2" style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Novartis Pharmaceuticals Australia Pty Ltd</span></p></td></tr><tr style="height:11.25pt"><td style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>AW</span></p></td><td style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Arrow Pharmaceuticals Limited</span></p></td></tr><tr style="height:11.25pt"><td rowspan="3" style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>BQ</span></p></td><td rowspan="3" style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Bristol-Myers Squibb Pharmaceuticals A Division of Bristol-Myers Squibb Australia Pty Ltd</span></p></td><td style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>OA</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Orphan Australia Pty Ltd</span></p></td></tr><tr style="height:11.25pt"><td style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>OR</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Organon (</span><span>Australia</span><span>) Pty Limited</span></p></td></tr><tr style="height:11.25pt"><td style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>PF</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Pfizer Pty Limited</span></p></td></tr><tr style="height:11.25pt"><td style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>BX</span></p></td><td style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Baxter Healthcare Pty Limited</span></p></td><td style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>PH</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Pharmacia Australia Pty Limited</span></p></td></tr><tr style="height:11.25pt"><td rowspan="2" style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>FB</span></p></td><td rowspan="2" style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Pierre Fabre Medicament Australia Pty Limited</span></p></td><td style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>PU</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Pharmacia & Upjohn Pty Limited</span></p></td></tr><tr style="height:11.5pt"><td rowspan="2" style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>RE</span></p></td><td rowspan="2" style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Real-RL Division of GlaxoSmithKline Australia Pty Ltd</span></p></td></tr><tr style="height:11.25pt"><td style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>GK</span></p></td><td style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>GlaxoSmithKline Australia Pty Ltd</span></p></td></tr><tr style="height:11.25pt"><td style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>HX</span></p></td><td style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Hexal Australia Pty Ltd</span></p></td><td style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>RO</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Roche Products Pty Ltd</span></p></td></tr><tr style="height:11.25pt"><td style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>IT</span></p></td><td style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>InterPharma Pty Ltd</span></p></td><td style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>SE</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Servier Laboratories (Aust.) Pty Ltd</span></p></td></tr><tr style="height:11.25pt"><td style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>JC</span></p></td><td style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Janssen-Cilag Pty Ltd</span></p></td><td style="width:31.75pt; padding-right:5.4pt; padd
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