National Health (Botulinum Toxin Program) Special Arrangement 2025

The instrument is built around several interlocking statutory concepts, most of which derive their content from cross-references to the National Health Act 1953, the Listing Instrument, or other delegated legislation.

Botulinum toxin pharmaceutical benefit: This is defined exhaustively by Schedule 1. Only four specific listed brands are captured: Botox (botulinum toxin type A purified neurotoxin complex, lyophilised powder for injection 100 units), Dysport in two presentations (Clostridium botulinum type A toxin-haemagglutinin complex, lyophilised powder for I.M. injection 300 units and 500 units), and Xeomin (incobotulinumtoxinA, lyophilised powder for injection 100 units). Each has been declared by the Minister under section 85(2) of the Act, with the form, manner of administration and brand determined under subsections 85(3), (5) and (6) respectively. No other botulinum toxin products fall within the ambit of this instrument.

Special arrangement supply: This is the core transactional concept, defined in section 9(1). Six cumulative conditions must be satisfied. The recipient must be an eligible patient. The supply must be made by an approved hospital authority. A valid prescription must be provided either prior to supply or within seven days after administration. The benefit must be directly administered to the patient by an eligible medical practitioner. Where the Minister has determined a maximum quantity under paragraph 85A(2)(a) of the Act, the prescription must direct supply of no more than that quantity. Any conditions attached to writing such a prescription under subsection 85A(2A) must also be satisfied. The note to the subsection makes explicit that the supplier cannot physically hand the product to the patient.

Eligible medical practitioner: Section 7 adopts a purposive test hinging on the circumstances codes embedded in the Listing Instrument (as in force on 1 October 2025). A medical practitioner is eligible for a particular patient and a particular botulinum toxin pharmaceutical benefit if, under paragraph 85(7)(b) of the Act, a prescription for that benefit may be written in circumstances that include one or more sets of circumstances relating to a patient or a medical practitioner, and at least one of those sets of circumstances exists in relation to the particular patient and practitioner. The relevant circumstances codes are found in the table in Part 1 of Schedule 4 to the Listing Instrument, cross-referenced against the pharmaceutical benefit in Part 1 of Schedule 1 to that instrument. This definition ensures that only practitioners whose prescribing rights align with the patient’s clinical indication and registration status can administer the product under the program.

Eligible patient: Section 8 imposes a three-limb test. First, the person must be entitled to receive pharmaceutical benefits under section 86 of the Act. Second, the person must fall within the PBS prescribing circumstances determined under paragraph 85(7)(b), again by reference to the Listing Instrument circumstances codes. Third, the person must be receiving treatment in one of three specified settings: in or at a private hospital; in or at a public hospital as a non-admitted patient, a day-admitted patient, or an in-patient admitted for less than 24 hours; or by an eligible medical practitioner at a business address for which the practitioner holds a provider number under the Health Insurance Regulations 2018. Patients admitted to a public hospital for 24 hours or longer are excluded, reflecting the principle that such patients are already funded through public hospital arrangements rather than through this special PBS pathway.

Dispensed price: The definition bifurcates by hospital type. For public hospital supplies, the dispensed price is calculated under section 13 and consists only of the approved ex-manufacturer price or proportional ex-manufacturer price for the relevant pack quantities and broken quantities, without any mark-ups. For private hospital supplies, section 15 incorporates those same ex-manufacturer price elements plus, for ready-prepared pharmaceutical benefits, a tiered mark-up under section 16 and the ready-prepared dispensing fee. The ready-prepared dispensing fee takes its meaning from the Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2020.

Same benefit rule: Section 11 contains a bespoke rule for determining when two botulinum toxin prescriptions written on the same day are taken to be for the same pharmaceutical benefit, which is relevant to the application of paragraph 40(3)(a) of the National Health (Pharmaceutical Benefits) Regulations 2017. Prescriptions are treated as being for the same benefit only if they relate to treatment of one of ten specified conditions (for example, moderate to severe spasticity of the upper limb, urinary incontinence, chronic migraine) or if they share the same circumstances code under the Listing Instrument.

The instrument affects four distinct groups, each with specific rights and obligations.

Approved hospital authorities are the exclusive legal suppliers under this instrument. Both public and private hospital authorities must hold approval under Part VII of the Act for the purpose of supplying pharmaceutical benefits to patients receiving treatment in or at the relevant hospital. Section 10(1) authorises them, despite section 94 of the Act, to extend their supply activities to patients receiving treatment from the hospital, not merely those physically in or at the hospital. Section 10(2) then provides that references in Part VII of the Act and its subordinate instruments to a person receiving treatment in or at a hospital are taken to include a person receiving treatment from the hospital. This drafting ensures the payment and charging provisions operate seamlessly across these expanded treatment settings.

Medical practitioners who hold PBS prescriber status and satisfy the eligible medical practitioner definition under section 7 are central to the administration pathway. Their eligibility is patient-specific and benefit-specific, tethered to the Listing Instrument circumstances codes. They must directly administer the product. They cannot write a prescription and hand it to a patient for later dispensing at a pharmacy, because community pharmacies are excluded entirely from the supply chain. The practitioner must also ensure that any prescription presented after administration reaches the approved hospital authority within the seven-day window prescribed by subparagraph 9(1)(d)(ii).

Patients must satisfy the eligibility criteria in section 8. The most significant practical limitation is the exclusion of public hospital in-patients admitted for 24 hours or longer. Patients receiving botulinum toxin treatment for any of the listed indications who meet the PBS entitlement, circumstances code, and treatment-setting requirements can access subsidised product through this pathway. CTG registered patients receive additional co-payment relief through the modified application of the CTG Special Arrangement.

The Commonwealth as payer is affected through the detailed payment calculations in Parts 3 and 4. The amount payable to an approved hospital authority under subsection 99(4) of the Act is the amount by which the dispensed price exceeds the amount the authority was entitled to charge the patient under section 87 of the Act. This effectively means the Commonwealth meets the gap between the regulated patient charge and the calculated cost of the product, including allowable mark-ups for private hospitals.

The supply pathway created by this instrument imposes a strict choreography of interrelated duties.

Approved hospital authorities have the right to make special arrangement supplies (section 10(1)) and to claim payment from the Commonwealth (sections 12 and 14, read with subsection 99(4) of the Act). Their correlative duties include ensuring that the supply meets all six conditions in section 9(1) before claiming payment, maintaining accurate records of whether supplies are made to CTG registered patients (section 19(1) requires a specific indicator on manual claims under section 99AAA of the Act), and complying with the patient charging limits under section 87 of the Act. They must also ensure they do not add mark-ups to public hospital supplies, as the note to section 13(1) explicitly states that no mark-ups may be added to the cost of a pharmaceutical benefit for which payment is claimed by an approved hospital authority for a public hospital.

Eligible medical practitioners have the right to administer botulinum toxin pharmaceutical benefits under this instrument, but only to eligible patients and only where the circumstances codes permit. Their duties include writing valid prescriptions that comply with any maximum quantity determinations under paragraph 85A(2)(a) and any conditions determined under subsection 85A(2A), ensuring the prescription reaches the hospital authority within the seven-day post-administration window if not provided in advance, and directly administering the product (they cannot delegate the act of supply to the patient).

Patients have the right to receive subsidised botulinum toxin treatment under this instrument if they meet the eligibility criteria and are treated in an approved setting. Their charging obligations are limited under section 87 of the Act, and for CTG registered patients, further reduced or eliminated under the modified application of the CTG Special Arrangement in Part 4.

The disapplication of certain PBS Regulations is an important structural feature. Section 9(2) removes the operation of three regulatory provisions that would otherwise interfere with the special arrangement supply model. Section 48 of the National Health (Pharmaceutical Benefits) Regulations 2017, which requires surrender of a written prescription before supply, does not apply. This makes sense because the prescription may be presented up to seven days after administration. Section 49, concerning circumstances in which a repeated supply quantity can be directed on one occasion, and section 55, concerning urgent prescription presentation, are similarly disapplied.

The instrument itself does not create new penalty provisions. Rather, it operates within the existing enforcement framework of Part VII of the National Health Act 1953. Breaches of the supply conditions set out in section 9(1) would mean that the supply does not qualify as a special arrangement supply, with the consequence that the approved hospital authority would not be entitled to payment under section 12 or 14. A claim for payment in respect of a non-complying supply would fall to be assessed under the general provisions of the Act, including any relevant offence or civil penalty provisions concerning false or misleading claims for Commonwealth payments.

The instrument’s disapplication of certain regulatory provisions in section 9(2) carries its own compliance implication. Because sections 48, 49 and 55 of the Pharmaceutical Benefits Regulations 2017 do not apply, neither the hospital authority nor the medical practitioner can rely on the flexibility those provisions afford. The seven-day backdating rule in subparagraph 9(1)(d)(ii) provides a limited window, but once that window closes, the supply cannot be retrospectively regularised.

For CTG supplies, section 19 requires manual claims to include an indicator that the supply was made to a CTG registered patient. A failure to include this indicator would not necessarily invalidate the underlying entitlement to payment, but it would constitute a non-compliance with the claim requirements and could delay or jeopardise payment processing.

The instrument sits within a dense legislative ecosystem, and its interaction provisions are carefully drawn.

National Health Act 1953: The instrument is made under sections 99 and 100. The note to section 5 makes clear that Part VII of the Act, and all regulations or instruments made under it, have effect subject to this instrument. This paramountcy is given statutory force by subsection 100(3) of the Act. Where the instrument is silent, Part VII continues to apply, including section 87 (patient charging), section 99AAA (claims for payment), section 94 (hospital authority approval), and the various Ministerial determination powers under section 85.

National Health (Pharmaceutical Benefits) Regulations 2017: Section 9(2) expressly disapplies sections 48, 49 and 55. Other regulatory provisions continue to apply except to the extent of inconsistency. Section 11 modifies the operation of paragraph 40(3)(a) of those Regulations for the purpose of determining when two botulinum toxin prescriptions written on the same day are for the same benefit.

National Health (Listing of Pharmaceutical Benefits) Instrument 2024: The Listing Instrument provides the circumstances codes that determine both eligible medical practitioner status (section 7) and eligible patient status (section 8). It also contains the maximum quantity determinations for ready-prepared pharmaceutical benefits (subsection 16(2) note). The instrument explicitly references the Listing Instrument as in force on 1 October 2025, providing a fixed reference point.

Commonwealth price determinations: Section 12(2) provides that the public hospital payment rate applies despite the National Health (Commonwealth Price,Pharmaceutical Benefits Supplied By Public Hospitals) Determination 2017 (PB 25 of 2017). Section 14(2) provides similarly for the private hospital determination, PB 99 of 2020. These override provisions ensure the bespoke dispensed price calculations in sections 13 and 15 are not displaced by the generally applicable hospital pricing instruments.

CTG Special Arrangement: Part 4 creates a modified application of the National Health (Closing the Gap - PBS Co-payment Program) Special Arrangement 2016. Section 18(1) provides that, despite section 87 of the Act and sections 12 and 14 of this instrument, the co-payment reduction provisions (subsections 11(1) to (4) of the CTG Special Arrangement) and the payment by Commonwealth provision (section 13 of the CTG Special Arrangement) apply to the special arrangement supply. The modification in section 18(2) ensures that references in the CTG Special Arrangement to a supply under that instrument are read as references to the special arrangement supply, and references to a CTG supplier are read as references to the approved hospital authority. Section 18(3) disapplies the notes to subsections 11(2) and (3) of the CTG Special Arrangement because those notes concern claims under the CTG Special Arrangement, whereas claims under this instrument are separately dealt with under section 19.

Health Insurance Act 1973 and Health Insurance Regulations 2018: Through the note 2 to section 6 and paragraph 8(c)(iii), the concepts of medical practitioner, private hospital, specialist and provider number draw their meaning from the Health Insurance Act 1973 and associated regulations.

The instrument is itself a remake, as the transitional provision in section 20 makes clear. The predecessor instrument, the National Health (Botulinum Toxin Program) Special Arrangement 2015, has been repealed. Section 20 provides that any thing done under the 2015 instrument that could be done under the 2025 instrument has effect as if it had been done under the 2025 instrument. This covers both supplies of pharmaceutical benefits and claims for payment.

The text does not provide explicit policy reasons for the remake. However, the reference in section 7 and section 8 notes to the Listing Instrument as in force on 1 October 2025 suggests that the update was timed to align with a particular iteration of the PBS listings and circumstances codes. The 2015 Special Arrangement had been in operation for approximately a decade and would have required updating to reflect changes in the statutory framework, including the enactment of the CTG Special Arrangement in 2016 and the various Commonwealth price determinations.

No amendment history is available from the text of the instrument as made, as it was registered as a new instrument rather than an amendment to the 2015 instrument.

The text of the instrument contains no reference to litigation, court challenges, or controversies. No decided cases are cited or alluded to in the instrument’s provisions, notes or explanatory material.

From a structural perspective, the areas most likely to generate dispute are the eligibility determinations for medical practitioners and patients, both of which depend on the circumstances codes in the Listing Instrument as in force on 1 October 2025. A medical practitioner or patient whose circumstances do not fit neatly within the coded categories may find themselves excluded from the program. The seven-day backdating rule in subparagraph 9(1)(d)(ii) is another potential flashpoint: if a prescription is presented on day eight, the supply would not meet the definition of a special arrangement supply and the hospital authority would bear the financial risk.

The exclusion of public hospital in-patients admitted for 24 hours or longer (paragraph 8(c)(ii)) may also raise questions of interpretation, particularly where a patient’s admission status changes during treatment or where the treatment spans midnight in a way that blurs the distinction between a day-admitted patient and a short-stay in-patient.

Several provisions contain traps for the unwary that practitioners and hospital administrators should flag in their compliance systems.

The seven-day backdating window in subparagraph 9(1)(d)(ii) is absolute. There is no discretion to extend it, and no mechanism for retrospective approval if the prescription arrives on day eight. Because section 55 of the Pharmaceutical Benefits Regulations 2017 (urgent prescriptions) has been disapplied by section 9(2), the usual flexibility for late prescription presentation is unavailable. Hospital pharmacy departments should maintain a strict log of administration dates and prescription receipt dates.

Community pharmacy supply is completely excluded. This is not merely discouraged but legally impossible under the instrument. A prescription written for a botulinum toxin pharmaceutical benefit and taken to a community pharmacy cannot be filled under this program. The note to section 9(1) underscores that the product cannot physically be handed to the patient. Practitioners who are accustomed to prescribing PBS medicines for pharmacy dispensing must adjust their workflow accordingly.

The definition of "same" benefit for multiple same-day prescriptions (section 11) is narrower than the default rule. Two prescriptions for botulinum toxin products are taken to be for the same benefit only if they relate to treatment of one of the ten specified conditions or share the same circumstances code. If a practitioner writes prescriptions for two different indications (say, chronic migraine and upper limb spasticity) on the same day, those prescriptions may not be treated as being for the same benefit under paragraph 40(3)(a) of the Pharmaceutical Benefits Regulations, with consequences for how the regulatory provisions on repeat supplies and quantities apply.

Public and private hospital pricing rules are materially different. A private hospital authority may add the ready-prepared dispensing fee and the tiered mark-up under section 16. A public hospital authority may not. If a public hospital authority mistakenly claims a mark-up, the Commonwealth may recover the overpayment. The dispensed price calculation for broken quantities differs between the two settings because the private hospital formula in section 15(2)(b)(ii) applies the percentage not merely to the approved ex-manufacturer price or proportional ex-manufacturer price but to the sum of that price plus the applicable mark-up, rounded to the nearest cent.

The CTG co-payment pathway requires a specific manual claim indicator. Section 19(1) applies only to manual system claims under section 99AAA of the Act. If an electronic claiming pathway is used, different requirements may apply under that system. The note to section 18(3) clarifies that the notes to subsections 11(2) and (3) of the CTG Special Arrangement, which deal with claims under that instrument, do not apply; claims are instead governed by section 19. This means approved hospital authorities must ensure their claims staff understand that the CTG patient indicator must be included specifically in the manual claim documentation.

The definition of eligible patient excludes public hospital in-patients admitted for 24 hours or longer. A patient who is admitted for what is expected to be a short stay but ends up exceeding 24 hours may retrospectively fall outside the definition. Hospital authorities should monitor admission duration for any patient receiving a special arrangement supply in a public hospital setting and be prepared to absorb the cost if the 24-hour threshold is crossed.

All four Schedule 1 products are single-entity, single-brand items. There are no interchangeable biosimilars or generic equivalents within the scope of the instrument. This means that substitution rules that might otherwise apply under PBS arrangements are not relevant to this program.

Compliance requires attention to three distinct phases: patient and practitioner eligibility verification, supply execution, and payment claiming.

Phase 1: Eligibility verification. Before any supply is contemplated, confirm that the patient meets the three-limb test in section 8. Verify the patient’s PBS entitlement under section 86 of the Act. Check the Listing Instrument (as in force on 1 October 2025) to confirm that at least one circumstances code listed for the relevant botulinum toxin pharmaceutical benefit applies to the patient. Confirm the treatment setting: if a public hospital, ensure the patient is not an in-patient admitted for 24 hours or longer; if a private hospital, any admission status is acceptable; if a medical practitioner’s rooms, confirm the practitioner holds a valid provider number for that address under the Health Insurance Regulations 2018. Separately verify that the medical practitioner satisfies the eligible medical practitioner definition in section 7 by reference to the same Listing Instrument circumstances codes. Check whether the patient is a CTG registered patient for purposes of Part 4.

Phase 2: Supply execution. The approved hospital authority must be the supplier of record. The eligible medical practitioner must directly administer the product to the patient. Ensure that the prescribed quantity does not exceed any maximum quantity determined under paragraph 85A(2)(a) of the Act and that any conditions determined under subsection 85A(2A) are satisfied (these are found in the Listing Instrument). If the prescription is presented prior to supply, it must be a valid prescription written by a PBS prescriber and must be given or presented to the approved hospital authority before administration. If the prescription is presented after administration, it must reach the hospital authority within seven calendar days. Maintain documentation of both the administration date and the prescription receipt date.

Phase 3: Payment claiming. Calculate the dispensed price according to the correct formula. For public hospital supplies, use section 13: sum the approved ex-manufacturer price or proportional ex-manufacturer price for each whole pack quantity, calculate any broken quantity amount by the percentage method in section 13(2), and round to the nearest cent under section 13(3). Do not add mark-ups or dispensing fees. For private hospital supplies, use section 15: include the approved ex-manufacturer price or proportional ex-manufacturer price, the applicable mark-up under section 16 (tiered by reference to the maximum quantity price band), and the ready-prepared dispensing fee. Apply the correct broken quantity formula from section 15(2), which incorporates the mark-up into the percentage calculation, and round under section 15(3). Determine the patient charge under section 87 of the Act. The Commonwealth payment is the amount by which the dispensed price exceeds the section 87 charge. If the patient is CTG registered, apply the modified CTG co-payment reduction under section 18 and include the CTG indicator on manual claims under section 19. If a claim is made using the manual system under section 99AAA of the Act, the claim must include the CTG registered patient indicator where applicable.

Record-keeping. Retain evidence of the valid prescription (including date of receipt by the hospital authority), the administration record showing direct administration by an eligible medical practitioner, the patient’s eligibility assessment (including the applicable circumstances code), the patient’s PBS entitlement status, and the dispensed price calculation worksheet. For CTG supplies, retain evidence of the patient’s CTG registration status under subsection 10(2) of the CTG Special Arrangement. These records should be maintained for the period required under general PBS record-keeping obligations, as this instrument does not specify a separate retention period.