The text repeatedly uses a small set of defined or operational concepts and links them to external arrangements. The principal concepts are:

• Approved supplier categories. The text differentiates among approved private hospital authority, approved pharmacist, approved medical practitioner, approved public hospital, and approved public hospital authority (s 18, s 19, s 21). The instrument conditions entitlements on supply being “in accordance with these arrangements.”

• “In accordance with these arrangements.” This phrase appears in multiple sections (ss 18, 19, 21) and functions as a condition precedent to payment entitlement. The instrument does not itself define what compliance requires beyond referencing the schedule’s mechanics and the external PB documents. This introduces an operational dependency: entitlement exists only where supply meets the requirements set out in the instrument plus any embedded reference material.

• Imported arrangements. Two external documents are imported by reference for pricing mechanics:

  • Paragraphs 20-23 of the “arrangements … for highly specialised drugs … No. PB 54 of 2009” are applied to trastuzumab for approved private suppliers (s 18).
  • Paragraphs 33-35 of the “arrangements … for highly specialised drugs … No. PB 125 of 2009” are applied to trastuzumab for the purposes of ascertaining the “dispensed price” for public hospitals (s 20). The text expressly applies those imported paragraphs “as in force from time to time,” meaning that updates to the referenced arrangements will alter payment calculations for trastuzumab without amendment to this instrument.

• “Dispensed price.” For the public hospital/State entitlement in s 19, the “dispensed price” is the monetary base for the Commonwealth payment, and must be ascertained under the referenced paragraphs of PB 125 (s 20). The instrument does not define “dispensed price” itself; it delegates that definition to PB 125.

• Manufacturer’s pack and ex-manufacturer price. For public hospital authority payments (ss 22-24), the unit of account is the manufacturer’s pack: a full pack attracts the ex-manufacturer price plus an 11.1% mark-up (s 22(a)-(b)). Partial packs are priced pro rata based on unit proportion of a full pack (s 23). Where supply exceeds a pack, the rules in ss 22 and 23 are applied in combination (s 24).

• Rounding rule. Prices calculated under ss 22-24 are rounded to the nearest cent, with one half cent counted as one cent (s 25).

• Claims and administrative data. State and Territory Governments must submit a single combined monthly claim for all public hospitals in a jurisdiction, submitted within three months, and each supply line must include the listed fields, including the Medicare Australia Authority Prescription Number and hospital provider number (s 26(a)-(c)).

These concepts establish the paper trail and arithmetic for Commonwealth payments, while creating a reliance on external pricing documents for key price definitions. The instrument therefore combines prescriptive local arithmetic (mark-up, pro rata, rounding, claims timing and data) with externalised price definitions (PB 54 and PB 125 paragraphs).

The instrument identifies specific institutional actors who acquire a direct payment entitlement from the Commonwealth when supplying trastuzumab under the stated arrangements:

• Approved private hospital authorities, approved pharmacists and approved medical practitioners. These categories are entitled to be paid by the Commonwealth “as if” paragraphs 20-23 of No. PB 54 of 2009 applied to trastuzumab (s 18). The entitlement is directly to those approved suppliers, subject to the condition that the supply is “in accordance with these arrangements.” The instrument therefore affects private-sector providers and practitioners who are in the approved classes.

• Approved public hospitals. The entitlement for approved public hospitals is framed differently: where an approved public hospital has supplied trastuzumab in accordance with the arrangements, the State or Territory Government in which the hospital is located is entitled to be paid by the Commonwealth 99.2% of the dispensed price (s 19). This routes the payment to the jurisdictional government rather than to the hospital entity itself.

• Approved public hospital authorities. Separate from s 19, an approved public hospital authority that supplies trastuzumab in accordance with the arrangements is entitled to be paid by the Commonwealth an amount ascertained under ss 22-25 (s 21). The instrument thereby distinguishes between payments made to the State/Territory (s 19) and payments made directly to a public hospital authority (s 21). The text does not state the criteria that determine whether a public hospital’s entitlement sits with the State/Territory or the public hospital authority; it prescribes the mechanics for both payment pathways.

• State and Territory Governments. These governments are the recipients of Commonwealth payments for supplies by approved public hospitals (s 19) and are the entities required to submit claims to Medicare Australia for those payments (s 26(a)). The instrument thus places administrative responsibility for aggregating and submitting claims on State/Territory governments.

• Medicare Australia. The claims procedure in s 26(a) requires that one aggregated monthly claim per jurisdiction be submitted to Medicare Australia, thereby making Medicare Australia the administrative processing point for public hospital claims.

• Other approved suppliers. The instrument contains a note that “Claims by other approved suppliers must be made in accordance with the Act.” That indicates the present schedule does not exhaustively address every supplier category; any supplier outside the listed groups is governed by the Act’s claim processes.

Indirectly affected parties include manufacturers and distributors because payments are calculated against manufacturer’s pack prices or the “dispensed price” defined in external PB documents; and hospital finance and procurement units because they must track pack quantities, manufacturer pack sizes and ex-manufacturer prices to calculate entitlements, and must assemble the required data fields for claims.

Who pays is unambiguous: the Commonwealth is the payer in each entitlement provision (ss 18, 19, 21). Who decides entitlement rests on whether supply was “in accordance with these arrangements,” and on the contents of the external PB documents where they are incorporated by reference.

This instrument creates limited statutory rights to payment and prescribes duties primarily around calculation and claims. The text sets out the following rights and duties.

Rights:

• Right to Commonwealth payment for approved private suppliers. Approved private hospital authorities, approved pharmacists and approved medical practitioners who supply trastuzumab in accordance with these arrangements are entitled to be paid by the Commonwealth as if certain paragraphs of PB 54 applied to trastuzumab (s 18). The right is framed as an entitlement to payment by the Commonwealth, contingent on compliance with the arrangements.

• Right to Commonwealth payment for public hospital supplies. Where an approved public hospital supplies trastuzumab in accordance with these arrangements, the State or Territory government is entitled to be paid by the Commonwealth 99.2% of the dispensed price (s 19). The entitlement transfers to the jurisdiction rather than the hospital entity.

• Right to Commonwealth payment for public hospital authorities. An approved public hospital authority supplying trastuzumab in accordance with these arrangements is entitled to payment from the Commonwealth in amounts calculated under ss 22-25 (s 21). The instrument provides explicit arithmetic rules for these payments.

Duties and administrative obligations:

• Duty to supply “in accordance with these arrangements.” For any entitlement to arise under ss 18, 19 or 21, supply must be made in accordance with the instrument’s arrangements. The text does not elaborate the full set of compliance requirements, but this phrase operates as a predicate for payment entitlements.

• Duty for State/Territory Governments to claim. When an approved public hospital supplies trastuzumab, the State or Territory Government must make a claim for payment to Medicare Australia following specified procedures (s 26). These procedures include:

  • One claim per jurisdiction per calendar month in arrears that consolidates all trastuzumab dispensed by public hospitals in that jurisdiction (s 26(a)).
  • Submission of a claim within three months of the end of the month to which it relates (s 26(b)).
  • Per-supply data requirements to be contained in the claim: State/Territory identifier, hospital provider number, Medicare Australia Authority Prescription Number, original supply or repeat number, supply date, and the number of manufacturer’s packs supplied (s 26(c)(i)-(vi)).

• Duty to calculate payments for public hospital authorities. Public hospital authorities must ensure that quantities supplied are measured against manufacturer’s pack sizes so payments can be calculated in accordance with ss 22-24: full pack pricing plus 11.1% mark-up (s 22), pro rata pricing for broken packs (s 23), combined application for quantities exceeding packs (s 24), and specified rounding (s 25).

• Record-keeping implicit duty. The claim data required in s 26(c) implicitly requires record-keeping of hospital provider numbers, prescription numbers, supply dates and pack counts. The instrument does not prescribe retention periods or sanction for missing records within the text provided.

Delegations, discretions or appellate rights are not set out in the text. The instrument does not specify dispute resolution processes, audit rights, sanctions for non-compliance, or off-ramps for incorrect claims. The entitlement language is framed as a payable Commonwealth obligation, but subject to the supplier meeting the “in accordance with these arrangements” condition and to claims being submitted in the prescribed manner.

The instrument provided contains no express civil penalties, criminal penalties, or specifed enforcement mechanisms within its text. It establishes payment entitlements, calculation rules and claims procedures, but it does not:

• Specify penalties or sanctions for incorrect claims, late claims, overpayments, false statements, or fraudulent claims.

• Spell out audit mechanisms, repayment obligations, clawback procedures, administrative review processes, or review and appeal pathways in the event of disputed payments.

• Provide express powers for Medicare Australia, the Commonwealth or State/Territory officials to refuse, reduce or recover payments on specified grounds within the schedule’s text.

What the text does indicate about enforcement and administrative operation is therefore indirect:

• Claims must be made to Medicare Australia by State/Territory Governments for public hospital supplies (s 26(a)). This designates Medicare Australia as the processing point for public hospital claims and therefore the likely operational agency to validate claims, though the instrument does not itself provide Medicare Australia with explicit powers or obligations in the schedule.

• Payments are tied to supplies “in accordance with these arrangements.” That phrase suggests a compliance threshold which implies that a supply not meeting the arrangements would not attract a Commonwealth payment. However the instrument does not define the consequences for non-compliance or who makes that determination.

• For providers not addressed directly in the schedule, there is a note: “Claims by other approved suppliers must be made in accordance with the Act.” That indicates enforcement and claim processes for other suppliers are governed by the underlying Act, which may contain enforcement provisions not reproduced here. The schedule itself does not import or summarise those enforcement provisions.

Analytically, the absence of explicit penalty or recovery provisions in the text shifts the practical enforcement burden into administrative practice and any relevant provisions of the Act and the referenced PB arrangements. Entities seeking certainty on sanctioning, audit or recovery should therefore consult the Act and the referenced PB documents, because this schedule delegates pricing and claims mechanics while remaining silent on enforcement modalities.

This schedule is expressly interdependent with other statutory instruments and administrative arrangements. The text imports parts of external “highly specialised drugs” arrangements and refers to the Act for other claims processes. The key interactions are:

• Importation of PB documents. The schedule applies paragraphs from two PB documents for price determination:

  • For approved private suppliers, paragraphs 20-23 of the arrangements made under subparagraph 100(1)(b)(i) of the Act for highly specialised drugs set out in No. PB 54 of 2009 are applied as if they applied to trastuzumab (s 18).
  • For the dispensed price used to calculate State/Territory payments to public hospitals, paragraphs 33-35 of arrangements made under subparagraph 100(1)(b)(i) of the Act set out in No. PB 125 of 2009 are applied as if they applied to trastuzumab (s 20). The schedule therefore functions as a bridging instrument that extends the scope of those PB arrangements to trastuzumab without reproducing their text. Because the PB documents are incorporated “as in force from time to time,” amendments to those PB documents will affect the application of this schedule.

• Relationship with the Act. The schedule repeatedly refers to “the Act” (for example in the phrase “arrangements made under subparagraph 100(1)(b)(i) of the Act”) and contains a note that claims by other approved suppliers must be made in accordance with the Act. The schedule therefore presumes the existence of a higher-level Act that establishes approvals, broader claims frameworks and possibly enforcement or audit mechanisms. The schedule modifies or supplements the application of those higher-level arrangements specifically for trastuzumab.

• Administrative interaction with Medicare Australia. Section 26 requires State/Territory claims for public hospital supplies to be submitted to Medicare Australia. That will interface with Medicare Australia’s administrative law, record keeping and claim processing frameworks.

• Commonwealth-State financial arrangements. The schedule creates a specific funding flow from the Commonwealth to State/Territory governments for approved public hospital supplies (s 19), paying 99.2% of the dispensed price. That interacts with broader Commonwealth-State financial relations, but the schedule does not engage with other grants rules or conditionality. The schedule’s requirement that the State/Territory submit a consolidated monthly claim to Medicare Australia creates an operational linkage between Commonwealth payments and State fiscal receipts.

• Manufacturer pack and pricing regimes. The use of manufacturer’s pack, ex-manufacturer price and pro rata calculations for broken packs (ss 22-24) interacts with pharmaceutical supply chain documentation and may require alignment with statutory or regulatory definitions of pack sizes and manufacturer pricing in other instruments, none of which are set out in this text.

• Procedural and evidentiary links. The requirement to include the Medicare Australia Authority Prescription Number, hospital provider number and supply dates in claims (s 26(c)) links this instrument to the identification and prescription frameworks implemented by Medicare Australia and the Act.

In short, the schedule is not a stand-alone pricing or claims code. It operates by reference to the Act and to specified PB documents, and by routing claims through Medicare Australia and State/Territory administrative processes. For operational compliance and for questions about enforcement, audit, provider approvals and the content of the referenced pricing paragraphs, practitioners will need to consult the Act, No. PB 54 of 2009 and No. PB 125 of 2009, and Medicare Australia operating instructions.

The text of the schedule contains no express legislative history or amendment record within its body. It does, however, incorporate by reference two specific PB documents dated 2009:

• No. PB 54 of 2009, paragraphs 20-23, are imported for the purpose of applying the highly specialised drugs arrangements to trastuzumab for approved private suppliers (s 18).

• No. PB 125 of 2009, paragraphs 33-35, are imported for the purpose of ascertaining the dispensed price for approved public hospitals (s 20).

Those references indicate that the schedule relies on PB documents produced in 2009 as the baseline. The schedule also uses the phrase “as in force from time to time” both in s 18 and s 20. That phrase has the operational effect of making the schedule sensitive to future changes to the referenced PB documents without requiring amendment of the schedule itself. Concretely, changes to PB 54 or PB 125 after the date of this instrument will alter the pricing mechanics applied to trastuzumab because the schedule accepts the referenced documents in their current and any future form.

The schedule does not set out prior amendments to itself, does not include commencement dates, and does not record the Act’s passage or subsequent legislative history. It also does not provide transitional provisions for changes to the referenced PB documents. Where a practitioner requires an authoritative amendment history for this specific schedule, or needs to know whether subsequent legislative instruments have altered payment percentages, mark-ups or claims processes, the schedule offers no internal record; the user must consult parliamentary amendment records, the Act, or the administrative publication history of the PB documents.

Because this instrument uses external documents “as in force from time to time,” its effective content on pricing may have shifted since the 2009 PB documents it cites. The schedule itself, as provided, contains no versioning or amendment log.

The text supplied contains no litigation history, judicial interpretations, binding cases or references to court decisions. No case law is cited within the schedule. The instrument therefore does not populate a body of adjudicated law within the document itself.

Consequences of the absence of litigation history in the schedule:

• No authoritatively interpreted definitions or clarifications. Key phrases such as “in accordance with these arrangements,” “approved public hospital authority,” “manufacturer’s pack,” and “dispensed price” are not accompanied by any judicial exposition within the schedule. Any uncertainty over their interpretation will have to be resolved by reference to the Act, the referenced PB documents, administrative practice at Medicare Australia, or by future litigation.

• Reliance on external documents and agency practice. Because much of the pricing mechanism is imported from PB 54 and PB 125 and because claims are sent to Medicare Australia, operational interpretation is likely to live at the administrative level until or unless contested and judicially decided. The schedule itself provides no precedent or litigated examples.

If parties require judicially settled interpretations,on, for example, whether a particular supply qualifies as “in accordance with these arrangements,” or how to treat mixed pack sizes,the schedule provides no guidance and no recorded cases. Practitioners should therefore assume that any legal uncertainty present in the schedule will be resolved through the Act, the referenced PB documents, Medicare Australia guidance and, if contested, by administrative review or litigation outside the schedule text.

The schedule contains several practical pitfalls and potential sources of uncertainty for providers, administrators and finance officers. These are concrete implementation and compliance risks explicitly or implicitly generated by the instrument’s mechanics.

1. Reliance on external PB materials “as in force from time to time.” Sections 18 and 20 import parts of PB 54 and PB 125 without reproducing them. That means the precise rates, formulae or definitions that determine payments for private suppliers and the dispensed price for public hospitals depend on documents not contained in the schedule. A change to PB 54 or PB 125 will change entitlements for trastuzumab suppliers without any amendment to the schedule. The schedule does not provide transitional treatment for such changes.

2. Two parallel payment routes for public hospital supplies. The schedule contains both a State/Territory entitlement (99.2% of dispensed price to the relevant government, s 19) and a separate payment entitlement to approved public hospital authorities calculated under ss 22-24 (s 21). The text does not define the boundary between when a State/Territory claims under s 19 and when a public hospital authority claims under s 21. Practically, hospitals and jurisdictions must clarify which pathway applies to particular hospital entities to avoid double claims, missed claims, or disputes over allocation.

3. Rounding rule could affect aggregated amounts. Section 25 requires rounding to the nearest cent with one half cent counted as one cent. When a large number of partial-pack calculations are aggregated, rounding direction can produce non-trivial net variances. The schedule does not specify whether rounding is to be applied per supply line or at jurisdictional aggregation; given s 25 sits under the public hospital authority payment rules, conservatively applying rounding per calculated price will be necessary unless Medicare Australia or the Commonwealth gives alternative instructions.

4. Manufacturer’s pack size determination. Payments for public hospital authorities are defined in relation to “the quantity contained in the manufacturer’s pack” (ss 22-24). The schedule does not provide an authoritative method for identifying the manufacturer’s pack size where multiple pack sizes exist, or for new pack sizes introduced post-supply. Institutions must ensure they record manufacturer pack sizes contemporaneously with supply.

5. Data requirements and time limits. State/Territory claims must be filed monthly in arrears for all public hospitals in a jurisdiction, and each monthly claim must be submitted within three months of the month’s end (s 26(a)-(b)). The claim must include per-supply prescription numbers, supply dates and pack counts (s 26(c)). Missing or inaccurate fields could lead to rejected claims or delayed payments, yet the schedule provides no remediation timetable. The single-claim-per-jurisdiction requirement also concentrates administrative burden in the State/Territory claims office.

6. Who is “approved” and what “in accordance with these arrangements” means. The schedule presumes the existence of approvals under the Act and that suppliers have made supply “in accordance with these arrangements.” The schedule does not list the approval criteria, nor the elements of compliance entailed by “these arrangements.” Providers need to align local practice to the Act and any administrative guidance to ensure entitlement.

7. Public hospital versus public hospital authority ambiguity. The schedule distinguishes “approved public hospitals” (entitlement routed to State/Territory, s 19) and “approved public hospital authorities” (entitlement direct to authority, s 21). In some jurisdictions hospital governance structures may blur this line, creating ambiguity over who must claim, whether the State or the authority receives payment, and how hospitals budget for trastuzumab costs.

8. No penalty or audit detail in the schedule. The absence of explicit recovery mechanisms or audit powers in the schedule means providers cannot rely on prescribed remediation processes in case of dispute. Operational parties must therefore assume standard Commonwealth grant and Medicare administrative controls apply unless and until clarified.

9. Partial-pack arithmetic where quantities exceed pack size. Section 24 requires applying ss 22 and 23 in combination where ordered quantities exceed a manufacturer’s pack. Implementing that rule requires careful bookkeeping: identify the number of full packs, apply full-pack pricing and mark-up, then price the residual as a pro rata broken pack. Errors in this arithmetic will affect claim value.

10. Interaction with other claim routes. The schedule contains an explicit note that other approved suppliers must claim under the Act. Providers who fall into multiple categories (for example, a private hospital that is an approved authority but also uses approved pharmacists for supply) must determine the correct claims pathway to avoid mischarging.

Each of these points arises directly from the wording and structure of the schedule. The practical upshot is that financial officers, pharmacy procurement teams and State/Territory claims officers must reconcile manufacturer pack records, PB documents, approval status under the Act, and the schedule’s timing and data rules to ensure accurate claims.

The schedule prescribes a discrete set of compliance steps for different supplier types. Below are operational steps grounded in the schedule text that suppliers, hospital finance teams and State/Territory claims administrators should follow to align with the arrangements.

1. Confirm approval status under the Act.

• Ensure the entity supplying trastuzumab is an “approved” supplier under the Act’s approval framework. Payment entitlements in ss 18, 19 and 21 are only triggered where supply is “in accordance with these arrangements,” which presumes approved status. Where approval is unclear, obtain written confirmation of approval from the relevant administrative authority established under the Act.

2. Ensure supply is “in accordance with these arrangements.”

• Document the procedures that make supply “in accordance with these arrangements.” Although the schedule does not define the phrase exhaustively, keep contemporaneous records of prescription authorisations, dosing, dates of supply, and the identity of the approving authority to demonstrate compliance if queried.

3. For approved private suppliers (approved private hospital authorities, pharmacists, medical practitioners).

• Recognise entitlement is governed by paragraphs 20-23 of No. PB 54 of 2009 applied to trastuzumab (s 18). Obtain and maintain an up-to-date copy of No. PB 54 of 2009 and any subsequent amendments because the schedule applies those paragraphs “as in force from time to time.” Implement the pricing and claim formats specified in those paragraphs, and align your billing systems to produce claims to the Commonwealth consistent with PB 54.

4. For approved public hospital supplies that give rise to a State/Territory entitlement.

• State/Territory Governments must submit one consolidated claim per calendar month to Medicare Australia for all public hospitals in the jurisdiction (s 26(a)). Each claim must be submitted within three months of the end of the month (s 26(b)). Ensure the claims unit can assemble each supply line with the required items: State or Territory identifier; hospital provider number; Medicare Australia Authority Prescription Number; original supply or repeat number; supply date; and the number of manufacturer’s packs supplied (s 26(c)). Maintain source records to support each required field for audit.

• For price calculation, ensure the dispensed price is ascertained in accordance with paragraphs 33-35 of No. PB 125 of 2009, applied to trastuzumab (s 20). Obtain No. PB 125 and track any subsequent changes because they directly affect the 99.2% payment to the State/Territory (s 19).

5. For approved public hospital authorities claiming direct payment.

• Apply the arithmetic rules in ss 22-25:
  • If the ordered/supplied quantity equals a manufacturer’s pack, claim the price ex manufacturer for that pack plus an 11.1% mark-up (s 22(a)-(b)).
  • If the ordered/supplied quantity is less than a manufacturer’s pack, calculate the percentage of the pack supplied and apply that percentage to the full pack price determined under s 22 (s 23).
  • If the ordered/supplied quantity exceeds the quantity in a manufacturer’s pack, apply the full-pack calculation for the full packs plus the pro rata calculation for the residual quantity (s 24).
  • Round calculated prices to the nearest cent, with one half cent counted as one cent (s 25).
• Ensure procurement and pharmacy records capture the manufacturer’s pack size at the time of supply and the ex-manufacturer price used to compute the full pack price.

6. Data integrity and record-keeping.

• For all supplier types, keep auditable records that match the claim fields required for public hospital aggregated claims under s 26(c). Records should include prescription authority numbers, supply dates, full/partial pack counts, manufacturer’s pack identification, ex-manufacturer invoices, and hospital provider numbers. Maintain retention policies that align with Medicare Australia and the Act’s record-keeping requirements even though the schedule itself does not state retention periods.

7. Coordinate with Medicare Australia and State/Territory claims units.

• For public hospital supplies, ensure a reliable channel for submitting the one monthly claim per jurisdiction to Medicare Australia. Confirm the electronic submission format, any prescribed templates or codes used by Medicare Australia, and reconcile submitted claims against internal inventory and invoice data before submission.

8. Monitor PB document updates.

• Because ss 18 and 20 apply PB 54 and PB 125 “as in force from time to time,” establish a monitoring process to capture amendments to those documents. Changes may affect calculation methods, eligible costs or allowable mark-ups for private suppliers and the dispensed price for public hospital claims.

9. Resolve ambiguity between State/Territory and authority payment pathways.

• Where organisational structures create ambiguity between “approved public hospitals” and “approved public hospital authorities,” seek written clarification from the Commonwealth or the responsible administrative office established under the Act to confirm which payment pathway applies to each legal entity and who must submit claims.

10. Prepare for audits and reconciliation.

• Even though the schedule does not specify audit processes, treat claims and payment reconciliations as subject to standard Commonwealth and Medicare Australia audit practices. Retain supporting invoices and inventory reconciliations to respond to queries about how manufacturer pack sizes and ex-manufacturer prices were applied.

Following these steps aligns operational practice with the precise mechanics in the schedule: payment entitlements conditioned on supply “in accordance with these arrangements,” reliance on PB 54 and PB 125 for pricing definitions, defined mark-up and pro rata mechanics for hospital authority payments, and a consolidated monthly claims obligation for States and Territories submitted to Medicare Australia.