{"id":"F2009L02597","name":"National Health Act 1953 - Special Arrangements under section 100(1) - Special Authority Program - Trastuzumab (No. PB 56 of 2009)","slug":"f2009l02597","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":327214,"registerId":"commonwealth-F2009L02597-current","compilationNumber":null,"startDate":"2026-04-08","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Payments to approved private hospital au","sectionType":"part","heading":"Payments to approved private hospital authorities","content":"# Payments to approved private hospital authorities\n\n18. An approved private hospital authority, approved pharmacist or approved medical practitioner that has supplied trastuzumab in accordance with these arrangements, is entitled to be paid by the Commonwealth as if paragraphs 20 to 23 of the arrangements made under subparagraph 100(1)(b)(i) of the Act for highly specialised drugs and set out in No. PB 54 of 2009 as in force from time to time apply to trastuzumab.","sortOrder":0},{"sectionNumber":"Payments to approved public hospitals","sectionType":"part","heading":"Payments to approved public hospitals","content":"# Payments to approved public hospitals\n\n19. Where an approved public hospital has supplied trastuzumab in accordance with these arrangements, the Government of the State or Territory in which the public hospital is located is entitled to be paid by the Commonwealth 99.2% of the dispensed price for the supply of the drug.\n\n20. For the purposes of 19, the dispensed price is to be ascertained in accordance with paragraphs 33 to 35 of the arrangements made under subparagraph 100(1)(b)(i) of the Act for highly specialised drugs and set out in No. PB 125 of 2009 as in force from time to time as if those arrangements applied to trastuzumab.","sortOrder":1},{"sectionNumber":"Payments to approved public hospital aut","sectionType":"part","heading":"Payments to approved public hospital authorities","content":"# Payments to approved public hospital authorities\n\n21. An approved public hospital authority that has supplied trastuzumab in accordance with these arrangements is entitled to be paid by the Commonwealth the amount ascertained in accordance with paragraphs 22 to 25.\n\n22. Where a quantity of trastuzumab that is ordered and supplied by an approved public hospital authority is equal to the quantity contained in the manufacturer’s pack, the approved public hospital authority is entitled to be paid by the Commonwealth the sum of:\n\n(a) the price ex manufacturer of the manufacturer’s pack; and\n\n(b) a mark-up of 11.1%.\n\n23. Where a quantity of trastuzumab that is ordered and supplied by an approved public hospital authority is less than the quantity contained in the manufacturer’s pack, the approved public hospital authority is entitled to be paid by the Commonwealth the amount calculated by:\n\n(a) ascertaining the percentage that the quantity or number of units in the broken quantity bears to the quantity or number of units in the manufacturer’s pack; and\n\n(b) applying that percentage to the price for a complete manufacturer’s pack ascertained in accordance with paragraph 22.\n\n24. Where a quantity of a highly specialised drug that is ordered and supplied by an approved public hospital authority is more than the quantity contained in the manufacturer’s pack, the sum of:\n\n(a) the amount calculated in accordance with paragraph 22; and\n\n(b) the amount calculated in accordance with paragraph 23\n\n25. Prices calculated for the purposes of paragraphs 22 to 24 shall be taken to the nearest cent, with one half cent being counted as 1 cent.\n\nPayment arrangements for the supply of trastuzumab by approved public hospitals\n\n26. Where an approved public hospital supplies trastuzumab, the State or Territory Government in which the public hospital is located must make a claim for payment in accordance with the following procedures:\n\n(a) one claim for payment per State or Territory must be submitted to Medicare Australia in respect of all trastuzumab dispensed by all public hospitals within each State and Territory in a calendar month in arrears;\n\n(b) a claim in respect of a calendar month must be submitted within three months of the end of that month;\n\n(c) for each supply of trastuzumab, the claim must include the following information:\n\n(i) the State or Territory;\n\n(ii) the hospital provider number;\n\n(iii) the Medicare Australia Authority Prescription Number;\n\n(iv) the original supply or repeat number;\n\n(v) the supply date; and\n\n(vi) the number of manufacturer’s packs supplied.\n\nNote: Claims by other approved suppliers must be made in accordance with the Act.","sortOrder":2},{"sectionNumber":"SCHEDULE 1","sectionType":"part","heading":null,"content":"#   \nSCHEDULE 1","sortOrder":3}],"analysis":{"summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"Establishes payment rates and claim procedures for trastuzumab supplied under the Special Authority Program (s 100(1) of the National Health Act 1953)."},"complexity_factors":["Reliance on cross-referenced instruments for pricing formulas","Different payment rules for three categories of suppliers","Detailed broken-pack and rounding calculations","Administrative claim procedures for State/Territory governments"],"plain_english_summary":"This instrument, made under s100 of the National Health Act, sets the Commonwealth payments for trastuzumab (Herceptin) supplied through the Special Authority Program. It specifies how approved private hospitals, pharmacists and clinicians are paid (by reference to existing highly specialised drug rules), and how approved public hospitals and public hospital authorities are remunerated (including a 99.2% dispensed‑price payment to jurisdictions and a manufacturer‑pack price plus 11.1% mark‑up for hospital authorities, with broken‑pack proration).\n\nIt also requires one monthly Medicare claim by each state/territory for public‑hospital supplies and sets time and content requirements for those claims."}},"importantCases":[],"_links":{"self":"/api/acts/f2009l02597","history":"/api/acts/f2009l02597/history","analysis":"/api/acts/f2009l02597/analysis","conflicts":"/api/acts/f2009l02597/conflicts","importantCases":"/api/acts/f2009l02597/important-cases","documents":"/api/acts/f2009l02597/documents"}}