{"id":"F2025L00428","name":"National Health (Paperless Prescribing, Dispensing and Claiming Trial) Special Arrangement 2025","slug":"national-health-paperless-prescribing-dispensing-and-claiming-trial-special-arrangement-2025","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":442791,"registerId":"F2025L00428-fast-fetch-1775957731607","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"National Health (Paperless Prescribing, Dispensing and Claiming Trial) Special Arrangement 2025","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n\n\n \n\nNational Health (Paperless Prescribing, Dispensing and Claiming Trial) Special Arrangement 2025\n\nI, Sam Peascod, Assistant Secretary, Digital and Service Design Branch, make the following special arrangement.\n\nDated 25 March 2025 \n\nSam Peascod\n\nDigital and Service Design Branch\n\nMedicare Benefits and Digital Health Division\n\nHealth Resourcing Group\n\nDepartment of Health and Aged Care\n\n \n\n \n\n \n\n \n\nContents\n\n1 Name\n\n2 Commencement\n\n3 Authority\n\n4 Definitions\n\n5 Pharmaceutical Benefits covered by this Special Arrangement\n\n6 Application of Part VII of the Act\n\n7 Prescribing of pharmaceutical benefits\n\n8 Supply of pharmaceutical benefits\n\n9 Claims for supply of pharmaceutical benefit\n\n \n\n \n\n1 Name\n\n(1) This instrument is the National Health (Paperless Prescribing, Dispensing and Claiming Trial) Special Arrangement 2025.\n\n (2) This Special Arrangement may also be cited as PB 35 of 2025\n\n2 Commencement\n\n(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.\n\n- Commencement information\n- Column 1 Column 2 Column 3\n- Provisions Commencement Date/Details\n- 1. The whole of this instrument 1 April 2025. 1 April 2025\n\n\nNote: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.\n\n(2) Any information in column 3 of the table is not part of this Act. Information may be inserted in this column, or information in it may be edited, in any published version of this Act.\n\n3 Authority\n\n This instrument is made under subsection 100(1) of the National Health Act 1953.\n\n4 Definitions\n\nNote: A number of expressions used in this instrument are defined in the Act, including the following:\n\n1. Chief Executive Medicare;\n2. PBS Prescriber;\n3. Pharmaceutical Benefit;\n4. Secretary;\n5. CTS Claim\n\n\n \n\n In this instrument:\n\nAct means the National Health Act 1953.\n\napproved supplier has the same meaning as in Part VII of the Act and whose name and address is specified in Column 2 of the Schedule to this instrument.\n\nauthority approval number has the meaning given by the Regulations.\n\nauthority prescription means an authority prescription as defined in the Regulations.\n\nhospital means the hospital whose name and address is specified in Column 1 of the Schedule to this instrument.\n\npatient of the hospital means an in-patient who occupies a bed in the hospital for the purpose of hospital treatment, or an out-patient who receives hospital treatment.\n\nelectronic medication charting system means a system which facilitates the electronic management of medications and associated electronic medication chart orders for patients of the hospital specified in Column 1 of the Schedule to this instrument.\n\nelectronic medication chart order means an order for a medicine, prepared and approved electronically and which forms part of the hospital’s electronic medication charting system for the purpose of treating a patient of the hospital.\n\nother Special Arrangement means another Special Arrangement under section 100 of the Act.\n\nRegulations means the National Health (Pharmaceutical Benefits) Regulations 2017.\n\nRules means the National Health (Supply of Pharmaceutical Benefits—Under Co‑payment Data and Claims for Payment) Rules 2022.\n\n5 Pharmaceutical Benefits covered by this Special Arrangement\n\n1. This Special Arrangement applies to each pharmaceutical benefit that is generally available for supply under Part VII of the Act.\n2. This Special Arrangement does not apply to a pharmaceutical benefit that can only be supplied under Part VII of the Act in accordance with any other Special Arrangement.\n\n\n6 Application of Part VII of the Act\n\n1. Each pharmaceutical benefit supplied in accordance with this Special Arrangement is supplied under Part VII of the Act.\n2. A provision of Part VII of the Act, or of the Regulations or other instruments made for Part VII of the Act, applies subject to this Special Arrangement.\n\n\n Note: See subsection 100(3) of the Act.\n\n7 Prescribing of pharmaceutical benefits\n\n1. A PBS prescriber may only prescribe a pharmaceutical benefit under this Special Arrangement by creating an electronic medication chart order within an electronic medication charting system in accordance with the requirements of section 41 of the Regulations, as modified by this section.\n2. An order for the supply of a pharmaceutical benefit under this Special Arrangement may only be made for the purpose of treating a patient of the hospital specified in Column 1 of the Schedule.\n\n\nCreating electronic medication orders ‑ generally\n\n1. Paragraph 41(2)(c) of the Regulations does not apply to the creation of an electronic medication chart order within an electronic medication charting system under this Special Arrangement.\n2. The PBS prescriber must electronically authorise the order in the electronic medication charting system.\n\n\nCreating electronic medication orders ‑ authority prescriptions\n\n1. If the prescription is an authority prescription, the electronic medication chart order must contain each authority approval number for the prescription or the relevant streamlined authority code (if any) for the pharmaceutical benefit that is prescribed.\n2. An order for the supply of a pharmaceutical benefit made in accordance with this section is, for the purposes of the Regulations (other than section 61) and the Rules, taken, to be a medication chart prescription written in accordance with section 41 of the Regulations.\n\n\nPrescription in paper‑based form is not required\n\n1. The PBS prescriber is not required to also provide the prescription to the approved supplier in paper‑based form.\n\n\n8 Supply of pharmaceutical benefits\n\n1. An approved supplier may supply a pharmaceutical benefit under this Special Arrangement if the order for the pharmaceutical benefit is for the purpose of treating a patient of the hospital specified in Column 1 of the Schedule.\n2. The approved supplier may supply the pharmaceutical benefit to the person under this Special Arrangement only if the approved supplier is specified in Column 2 of the Schedule.\n3. Sections 45, 47 and 51 of the Regulations apply to the supply of a pharmaceutical benefit by an approved supplier under this Special Arrangement, with the following modifications:\n 1. a reference to a medication chart prescription is taken to be a reference to an electronic medication chart order;\n 2. section 45 applies as if:\n 1. it required the approved supplier, or a person authorised for the purpose by the approved supplier, to verify in the electronic medication chart order that the pharmaceutical benefit has been supplied and the date on which it was supplied; and\n 2. paragraph 45(2)(d) were omitted; and\n 3. a reference in section 51 to writing the words “immediate supply necessary” on the prescription is taken to be a reference to including those words in the electronic medication charting system.\n\n\n9 Claims for supply of pharmaceutical benefit\n\n1. An approved supplier may make a claim for payment for the supply of a pharmaceutical benefit under this Special Arrangement in accordance with the Rules for a CTS claim and the associated provisions under section 99AAA of the Act.\n2. If the Chief Executive Medicare notifies the approved supplier in writing that a copy of the electronic medication chart order is required to be submitted, the approved supplier must submit a copy of the electronic medication chart order to the Department administered by the Minister who administers the Human Services (Centrelink) Act 1997.\n3. If the Chief Executive Medicare notifies the hospital in writing that a copy of the electronic medication chart order is required to be submitted, the approved supplier must submit a copy of the electronic medication chart order to the Department administered by the Minister who administers the Human Services (Centrelink) Act 1997.\n\n\nElectronic pharmacy records\n\n1. For each supply of a pharmaceutical benefit based on an electronic medication chart order in respect of which a claim is made under section 99AAA of the Act by an approved supplier, the supplier must:\n 1. prepare an electronic pharmacy record; and\n 2. retain the electronic pharmacy record for not less than two years after the day on which the pharmaceutical benefit was supplied.\n\n\nNote: This subsection establishes record keeping requirements that correspond to the requirements contained in section 61 of the Regulations.\n\n1. The electronic pharmacy record must contain all information required to be given to the Secretary by an approved supplier in relation to the supply of a pharmaceutical benefit for the purpose of treating a patient of the hospital listed in the Schedule to the Rules for a CTS claim.\n2. If the Chief Executive Medicare notifies the approved supplier in writing that a copy of an electronic pharmacy record is required to be submitted, the approved supplier must submit a copy of the record to the Department administered by the Minister who administers the Human Services (Centrelink) Act 1997.\n3. A notification given under subsection (2), (3) or (6) may apply to one or more electronic medication chart orders or electronic pharmacy records, as appropriate.\n\n\n\n\n\nPAPERLESS PRESCRIBING, DISPENSING AND CLAIMING TRIAL SCHEDULE\n\n \n\n| Column 1 – name and address of hospital | Column 2 – name, address and approval
number of the approved supplier |\n| --- | --- |\n| St Stephen’s Hospital Hervey Bay
182 – 198 Nissen Street Hervey Bay,
Queensland 4655 | St Stephen’s Hospital Hervey Bay
182 – 198 Nissen Street Hervey Bay,
Queensland 4655
Approval Number: HQ341W |\n\n\n \n\n \n","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"The legislation remains tightly scoped to its original purpose. It establishes a paperless prescribing trial for a single Queensland hospital without expanding into unrelated policy areas. The Schedule limits application to St Stephen's Hospital Hervey Bay specifically, confirming this is a controlled pilot rather than scope creep."},"complexity_factors":["Short instrument: only 9 substantive sections plus a single-entry schedule","Limited defined terms: only 8 definitions in section 4, plus 5 terms incorporated by reference from the parent Act","Single-site scope: applies to only one hospital and one approved supplier (listed in Schedule)","Straightforward modifications: sections 7-9 modify existing Regulations but use clear 'apply as if' and 'taken to be' language rather than nested conditionals","No exceptions to exceptions: the structure is linear without recursive carve-outs","Heavy reliance on external instruments: meaning depends on National Health Act 1953, Pharmaceutical Benefits Regulations 2017, and Supply Rules 2022, but these are standard references rather than complex cross-referencing"],"plain_english_summary":"This bill establishes a time-limited trial allowing St Stephen’s Hospital Hervey Bay to use an electronic medication charting system in place of paper PBS prescriptions. It lets hospital doctors and the hospital pharmacy process, supply and claim PBS medicines electronically, with Medicare oversight and electronic record-keeping.\n\nThe pilot affects the hospital’s patients, prescribers, pharmacy and Medicare, and tests whether PBS dispensing can safely move from paper to a fully digital workflow."},"flash_summary":{"complexity_score":6,"scope_assessment":{"changed":false,"description":"This instrument remains focused on a limited, pilot-style purpose: testing paperless prescribing/dispensing/claiming for patients of the hospital named in the Schedule and for supplies made by the named approved supplier. Although it applies to pharmaceutical benefits generally available under Part VII (s 5(1)), supply under the arrangement is confined to the hospital’s patients and the listed supplier (ss 7(2), 8(2)), so it does not expand the law’s geographic or participant scope beyond a narrowly targeted trial. It therefore does not represent a significant scope expansion beyond the original trial purpose."},"complexity_factors":["Short instrument but many cross-references to external instruments (National Health Act 1953; National Health (Pharmaceutical Benefits) Regulations 2017; Rules for CTS claims 2022; section 99AAA of the Act)","Multiple modifications to existing regulatory provisions (e.g. modifications to Regulations sections 41, 45, 47 and 51) rather than standalone rules","Defined terms in section 4 that reference terms defined in the Act and Regulations (creating distributed definitions)","Conditional and procedural requirements (electronic authorisation, authority approval numbers for authority prescriptions, conversion of regulatory duties to electronic equivalents)","Record-keeping and notification obligations with conditional triggers (Chief Executive Medicare may require submission of records)","Schedule limits participation to a single hospital and supplier, requiring implementers to reconcile site-specific operational details","Small drafting irregularity/duplication in notification/submission subsections (s 9(2)–(3)) that may require interpretive clarity","Dependence on external rules for claims (Rules for CTS claim and section 99AAA), which require reading multiple instruments to determine full compliance"],"plain_english_summary":"**What this instrument does (mechanics first)**\n\n- This Special Arrangement authorises a paperless trial for prescribing, dispensing and claiming certain Commonwealth-subsidised medicines (Pharmaceutical Benefits) for patients of a named hospital. The trial starts 1 April 2025 (see commencement table).\n\n- Under the arrangement, a PBS prescriber at the hospital may make a prescription only by creating an \"electronic medication chart order\" inside the hospital’s electronic medication charting system; a separate paper prescription is not required (ss 7(1), 7(3)–(4)).\n\n- Only the approved supplier named in the Schedule may dispense medicines under this trial for the hospital’s patients (s 8(2); Schedule). The Schedule here lists St Stephen’s Hospital Hervey Bay as both the hospital and the approved supplier.\n\n- Supplies made under this arrangement are treated as supplies under Part VII of the National Health Act 1953, but the usual Part VII rules and Regulations apply subject to the modifications set out in this instrument (s 6(1)–(2)).\n\n- The arrangement modifies particular regulatory requirements about how prescriptions and supplies are recorded and verified (for example, treating the electronic medication chart order as the legal prescription; adjusting the operation of Regulations sections 45, 47 and 51) so the electronic record replaces the paper prescription in specified ways (ss 7, 8(3)).\n\n- The approved supplier may claim payment under the usual claims rules (Rules for a CTS claim and section 99AAA of the Act) but must keep an electronic pharmacy record for each supply and retain it for at least two years. If Chief Executive Medicare requests copies of orders or records, the supplier must submit them to the Department responsible for the Human Services (Centrelink) Act 1997 (s 9).\n\n\n**Who is affected**\n\n- The named hospital and its patients: only patients of the hospital listed in Column 1 of the Schedule may be treated under this arrangement (s 7(2)).\n- The named approved supplier: only the supplier named in Column 2 of the Schedule may dispense under the trial (s 8(2)).\n- PBS prescribers who work at the hospital: they must use the hospital’s electronic medication charting system and electronically authorise orders (s 7).\n- Chief Executive Medicare and the Department administering the Human Services Act: they can require copies of electronic orders and records for compliance and claims processing (s 9(2)–(3)).\n\n\n**Why it matters (claimed purpose and practical implications)**\n\n- Officially the instrument enables a trial of paperless prescribing/dispensing/claiming for Commonwealth-subsidised medicines in a hospital setting (title and s 5). Mechanically, it replaces the paper prescription with an electronic medication chart order and adapts the existing Part VII regulatory and claims framework to accept that electronic order as if it were a written prescription (s 7(4); s 8(3)).\n\n- Practical effects and trade-offs:\n - Administrative behaviour change: prescribers must generate and electronically authorise orders inside the hospital’s medication chart system (s 7(1), 7(3)). This reduces the need for duplicate paper handling (s 7(5)).\n - Record-keeping and compliance burdens: suppliers must create, retain (for at least two years) and, if requested, submit electronic pharmacy records and copies of electronic orders to Commonwealth agencies (s 9). That requires secure electronic storage, an audit trail and processes to respond to requests.\n - Narrow participant set: only the listed approved supplier may dispense under the arrangement (s 8(2); Schedule). That concentrates the benefit of the trial on a single supplier and excludes other community pharmacies from participating in the same trial arrangements for those patients.\n - Interaction with existing rules: the instrument does not replace the Act, Regulations or Rules; it modifies how selected provisions operate for the trial (s 6(2)). Implementers must reconcile the instrument’s modifications with the external regulatory provisions it references (for example, sections 41, 45, 47, 51 and 61 of the Regulations and the Rules for CTS claims).\n\n\n**Costs, incentives and risks to note (mechanisms, not judgments)**\n\n- Who pays: claims for payment continue to flow through the usual PBS claims mechanism (s 9(1)), so Commonwealth payments remain available where conditions are met. The hospital/supplier bears the upfront cost of operating or adapting the electronic medication charting system and of maintaining electronic records for the required period.\n\n- Incentives created: the instrument reduces paper-handling time for prescribers and may speed supply where the hospital’s system is efficient. The named supplier gains exclusive access to dispensing under this arrangement for the hospital’s patients (s 8(2); Schedule), creating a concentrated benefit.\n\n- Compliance and operational risk: the arrangement relies on the hospital’s electronic system meeting the regulatory requirements (modifications to s 41 of the Regulations are in play; s 7). If the system fails to capture required details (for authority prescriptions or verification of supply), the supplier or prescriber may face difficulty meeting claim requirements or responding to information requests from Medicare (s 7(3)–(4); s 9(2)).\n\n- Data flow and administrative burden: the Chief Executive Medicare may require submission of electronic orders or records to the Department administering the Human Services Act; the supplier must comply when notified (s 9(2)–(3)). That creates a standing obligation to be able to export and securely transmit records on request.\n\n\n**Implementation issues and drafting notes**\n\n- The instrument is narrowly targeted to a single hospital and supplier (Schedule), which simplifies the pilot but limits generalisability without further arrangements.\n- There are multiple cross-references to the National Health Act, its Regulations and to the Rules; operators will need to check both the instrument and those external provisions to work out full compliance steps (s 6, definitions, and the various references to sections of the Regulations and Rules).\n- There is an apparent drafting oddity in s 9: two similar subsections require the supplier to submit copies of electronic medication chart orders if either the Chief Executive Medicare notifies the supplier or notifies the hospital. The practical effect is that the supplier may be required to respond whether Medicare notifies the supplier directly or notifies the hospital (s 9(2)–(3)), but implementers should clarify the notification and submission workflow.\n\n\n**Bottom line (concise)**\n\nThis is a limited, time-zeroed Special Arrangement to let one hospital and its named approved supplier replace paper prescriptions with hospital electronic medication chart orders for PBS-supplied medicines to that hospital’s patients. It changes workflow (paperless ordering and electronic records), keeps the Act/Regulations/Ru les framework but modifies certain operational requirements, concentrates dispensing rights on the listed supplier, and imposes record-keeping and information-submission obligations linked to Medicare requests (see ss 5–9 and the Schedule)."},"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/national-health-paperless-prescribing-dispensing-and-claiming-trial-special-arrangement-2025","history":"/api/acts/national-health-paperless-prescribing-dispensing-and-claiming-trial-special-arrangement-2025/history","analysis":"/api/acts/national-health-paperless-prescribing-dispensing-and-claiming-trial-special-arrangement-2025/analysis","conflicts":"/api/acts/national-health-paperless-prescribing-dispensing-and-claiming-trial-special-arrangement-2025/conflicts","importantCases":"/api/acts/national-health-paperless-prescribing-dispensing-and-claiming-trial-special-arrangement-2025/important-cases","documents":"/api/acts/national-health-paperless-prescribing-dispensing-and-claiming-trial-special-arrangement-2025/documents"}}