National Health (Paperless Prescribing, Dispensing and Claiming Trial) Special Arrangement 2025

Electronic medication charting system is defined as a system that facilitates the electronic management of medications and associated electronic medication chart orders for patients of the hospital. The instrument does not prescribe technical standards, system certifications, or interoperability requirements. It simply requires that the system be used by the hospital for managing medications and chart orders. This gives the hospital flexibility in choosing the software but also places the entire trial’s functioning on the reliability and suitability of that system.

Electronic medication chart order is defined as an order for a medicine, prepared and approved electronically, that forms part of the hospital’s electronic medication charting system for treating a patient of the hospital. This order substitutes for a paper prescription. Under clause 7(5), the order is taken, for the purposes of the Regulations (other than section 61) and the Rules, to be a medication chart prescription written in accordance with section 41 of the Regulations. That means all downstream rules that apply to medication chart prescriptions - such as the supply obligations and claim procedures - now apply to this electronic order. The exception of section 61 is significant; section 61 of the Regulations contains record‑keeping requirements for prescriptions, and the instrument creates its own record‑keeping regime in clause 9(4).

Approved supplier has the same meaning as under Part VII of the Act, but only the entity listed in Column 2 of the Schedule is eligible to supply under this arrangement. That entity is St Stephen’s Hospital Hervey Bay pharmacy (approval number HQ341W). No other approved supplier (such as a community pharmacy) can dispense under this arrangement, even if the patient presents the electronic order outside the hospital. The supply is tied to the hospital and its approved supplier exclusively.

Patient of the hospital means an in‑patient who occupies a bed for hospital treatment or an out‑patient who receives hospital treatment. This definition limits the trial to persons who have a clinical relationship with the hospital, excluding visitors, staff, or other persons who may receive a prescription but are not receiving treatment from the hospital. The phrase “receives hospital treatment” for out‑patients is not further defined in the instrument and may rely on the hospital’s own classification.

Authority prescription is defined by reference to the Regulations. For such prescriptions, the electronic medication chart order must contain each authority approval number or the relevant streamlined authority code. This preserves existing controls for restricted medicines but forces those identifiers to be entered into the electronic system.

CTS claim is defined in the Act and refers to the process by which an approved supplier submits a claim electronically. The instrument explicitly allows claims to be made under the Rules for CTS claims. That means the standard data requirements and time limits for CTS claims apply unless modified elsewhere.

The trial directly affects only a very small group of participants: the PBS prescribers who work at or have admitting rights at St Stephen’s Hospital Hervey Bay, the patients of that hospital, and the hospital’s pharmacy as the sole approved supplier. The instrument does not extend to other hospitals, other pharmacies, or prescribers treating patients outside this hospital.

PBS prescribers at the hospital must adapt their prescribing workflow. Instead of writing a paper prescription or generating a standard PBS prescription through a practice system, they must use the hospital’s electronic medication charting system to create and authorise an electronic medication chart order. If they prescribe an authority‑required medicine, they must ensure the authorisation number or streamlined code is included in the electronic order. They cannot fall back to paper for PBS supplies under this arrangement; clause 7(6) states they are “not required to also provide the prescription … in paper‑based form”, but the mandatory language in clause 7(1) says they “may only prescribe … by creating an electronic medication chart order”, implying paper is not permitted for PBS benefits under this trial. However, the instrument does not forbid a prescriber from writing a non‑PBS prescription in paper form or from writing an ordinary PBS prescription outside the arrangement (if the patient is not a hospital patient). The restriction applies only to PBS benefits prescribed for a patient of the hospital.

Patients of St Stephen’s Hospital Hervey Bay who receive PBS medicines under this arrangement will not receive a paper prescription. Their medicine order exists only in the hospital’s electronic system. If a patient needs to fill a PBS medicine at a community pharmacy after discharge, the paperless order may not transfer - the arrangement does not provide for portability of the electronic order to external suppliers. Patients may therefore need a separate discharge prescription in the usual form. The instrument does not address this gap, which could create confusion or delay.

The approved supplier (the hospital pharmacy) must ensure its dispensing workflow aligns with the modified s45 requirements. It must verify the supply in the electronic order itself rather than on a paper prescription, and it must omit the step normally required under paragraph 45(2)(d) of the Regulations. That paragraph likely deals with some endorsement on the prescription; its specific effect is not stated in the instrument but the omission means the supplier no longer performs that step. The supplier must also retain electronic pharmacy records for at least two years under clause 9(4), mirroring the two‑year retention period in section 61 of the Regulations.

Indirectly, the Department of Health and Aged Care and the Chief Executive Medicare will monitor the trial and may request copies of electronic medication chart orders or pharmacy records. The provisions requiring submission on request (clauses 9(2), (3), (6)) give the government a monitoring tool that could be used to audit compliance and to inform a decision on whether to extend the trial to other hospitals or suppliers.

Duties of the PBS prescriber. The prescriber must use the hospital’s electronic medication charting system to create the electronic medication chart order. The order must be electronically authorised. If the medicine is an authority prescription, the prescriber must include each authority approval number or the streamlined authority code. These duties are mandatory; the prescriber cannot opt to use a paper prescription for a PBS benefit covered by the arrangement. The prescriber also has the implied duty to ensure the patient is a “patient of the hospital” as defined, because the order may only be made for the purpose of treating such a patient (clause 7(2)). If the prescriber creates an order for a person who does not meet that definition, the order is not valid under the arrangement and any supply based on it would be outside the trial, potentially affecting the supplier’s ability to claim payment.

Duties of the approved supplier. The supplier must not supply a pharmaceutical benefit under the arrangement unless the order is for a patient of the hospital and the supplier is St Stephen’s Hospital Hervey Bay pharmacy (clauses 8(1) and (2)). When supplying, the supplier must apply the modified version of sections 45, 47, and 51 of the Regulations. In particular, the supplier must verify in the electronic medication chart order that the medicine was supplied and the date of supply (clause 8(3)(c)(i)). For supplies requiring an “immediate supply necessary” notation under s51, the supplier must include those words in the electronic medication charting system rather than on a paper prescription (clause 8(3)(d)). The supplier also has a record‑keeping duty: for each supply claimed, it must prepare an electronic pharmacy record containing all the information normally required for a CTS claim, and retain that record for at least two years. On written notice from the Chief Executive Medicare, the supplier must submit a copy of the electronic medication chart order or the electronic pharmacy record to the Department administered under the Human Services (Centrelink) Act 1997.

Rights of the approved supplier. The supplier has the right to claim payment for the supply under the CTS process. The instrument does not alter the pricing or the amount payable; it merely permits the claim to be made based on digital records. The supplier also has the right to rely on the electronic medication chart order as a valid prescription-equivalent for PBS purposes, provided the order meets the requirements of the arrangement.

Rights of the patient. The instrument does not confer any explicit rights on patients. Patients are not required to sign a paper prescription or to present a physical document. However, the absence of a paper prescription may affect a patient’s ability to take the prescription to another pharmacy. Since the arrangement is limited to one supplier, the patient’s choice of pharmacy is restricted to the hospital pharmacy for the PBS benefits covered. The instrument does not address consent, privacy, or access to the electronic order by the patient.

Rights of the government. The Chief Executive Medicare has the right to request copies of electronic orders and pharmacy records in writing, and the approved supplier must comply. This right is not conditional on suspicion of non‑compliance; it can be exercised for any reason, including routine monitoring.

The instrument itself does not create any new penalty provisions. Instead, enforcement relies on the existing sanctions in the National Health Act 1953 and the Health Insurance Act 1973 (for false claims). Because the arrangement is made under s100 of the Act, any supply that is not in accordance with the arrangement is not a PBS supply. That means a claim for payment for a supply that does not meet the arrangement’s requirements could be rejected by the Chief Executive Medicare, and any payment already made may be recoverable as an overpayment. The Act contains provisions for the recovery of amounts wrongly paid, as well as civil penalties for making false or misleading statements in connection with a claim.

The approved supplier also faces potential administrative consequences. If the supplier fails to submit a copy of an electronic medication chart order or pharmacy record when notified, the Chief Executive Medicare could stop processing future claims or impose conditions on the supplier’s approval. The record‑keeping obligation under clause 9(4) is mandatory; failure to retain records for two years could be treated as a breach of the arrangement and may affect eligibility to participate in the trial. However, the instrument does not specify a monetary penalty for non‑retention.

For PBS prescribers, the risk is more indirect. If a prescriber creates an electronic medication chart order for a person who is not a patient of the hospital, the order is not valid under the arrangement. The supplier who dispenses based on that order may be exposed to a claim rejection. The Prescriber could face professional consequences under his or her professional registration if the conduct amounts to improper prescribing, but that is not controlled by this instrument.

Given that the trial is limited to one hospital and one supplier, enforcement is likely to focus on ensuring the digital processes are followed correctly. The absence of paper prescriptions means the traditional ways of verifying a prescription (signature, handwriting, date) are replaced by electronic authorisation. If the electronic medication charting system lacks audit trails or if the hospital does not control access adequately, there may be risks of unauthorised orders or falsified authorisations. The instrument does not impose specific system security requirements, leaving that to the hospital’s own governance.

The arrangement expressly overrides certain provisions of the National Health Act 1953 and the Regulations. Subsection 100(3) of the Act provides that a Special Arrangement may provide that provisions of Part VII apply subject to the arrangement. Clause 6(2) states that a provision of Part VII, the Regulations, or other instruments made under Part VII, applies subject to this Special Arrangement. This means that where the Regulation provisions conflict or are modified, the arrangement prevails.

The modifications are targeted. Clause 7(3) disapplies paragraph 41(2)(c) of the Regulations for electronic medication chart orders. The instrument does not quote that paragraph, but its removal simplifies the prescription creation process. Clause 7(5) deems the electronic order to be a medication chart prescription for most purposes, except for section 61 of the Regulations (record keeping). Section 61 is replaced by the instrument’s own electronic pharmacy record requirements in clause 9(4). That replacement is a direct substitution of one set of record‑keeping duties for another, with the retention period remaining two years.

Clause 8(3) modifies sections 45, 47, and 51 of the Regulations. Section 45 (supply obligations) is changed so that verification happens in the electronic chart order rather than on a paper prescription, and paragraph 45(2)(d) is omitted. Section 47 (supply by authorised person) is modified to refer to the electronic chart order. Section 51 (urgent supply) is modified so that the notation is made in the electronic charting system.

The arrangement also interacts with the Rules. Clause 9(1) permits claims under the Rules for CTS claims. That means the data that must be submitted for a CTS claim (patient identifier, prescriber, medicine, date, etc.) must be captured in the electronic order and in the pharmacy record. The Rules themselves are incorporated by reference.

The arrangement does not affect any other Special Arrangement. Clause 5(2) excludes pharmaceutical benefits that can only be supplied under another Special Arrangement. So medicines like those for chemotherapy or HIV, which are often governed by separate arrangements under s100, are not included unless the other arrangement also permits supply under this trial (unlikely). The trial is limited to benefits that are generally available under Part VII.

No interaction with state or territory health records legislation is mentioned. The instrument is a Commonwealth instrument and does not purport to override state law on electronic health records, patient privacy, or hospital licensing. However, the hospital and pharmacy must comply with applicable state privacy and health records laws as well. The absence of any provision addressing consent or privacy is notable; the trial assumes that the electronic medication charting system is used within the hospital’s existing governance framework.

The instrument is brand new. It was signed on 25 March 2025 and commenced on 1 April 2025 as a single original instrument. There are no amendments to date. The commencement table lists only the whole of the instrument commencing on 1 April 2025. No later amending instruments have been registered on the Federal Register of Legislation as of the date of this analysis. Because it is a trial, it may be amended or repealed in the future if the government decides to change the scope, add more hospitals or suppliers, or end the trial. The instrument does not have a sunset clause, so it continues indefinitely unless varied or revoked.

The instrument is designated as PB 35 of 2025. That numbering suggests it is one of many special arrangements made under s100 in 2025. The instrument does not cite any previous version or amending act; it is the original.

There is no litigation history for this instrument. It is less than two months old as of the time of writing, and it applies to a single hospital with a single supplier. The practical scope of the trial is too small to generate litigation unless a specific dispute arises - for example, if a claim is rejected and the supplier challenges the rejection in the Administrative Appeals Tribunal or if a patient argues that the digital‑only system breached a statutory duty or privacy right. Neither scenario has materialised. Given the limited application, the probability of case law emerging from this trial is low. Any litigation would likely centre on interpretation of the modifications, such as whether an electronic order meets the definition of a medication chart prescription for the purposes of other PBS rules, or whether the hospital is a “patient of the hospital” in borderline cases (e.g. a person who receives telehealth but does not attend the hospital). For now, the trial operates without judicial interpretation.

Paperless does not mean portable. A patient who is discharged from St Stephen’s Hospital Hervey Bay after receiving a PBS prescription in electronic form cannot take that order to a community pharmacy. The order is valid only at the specified approved supplier (the hospital pharmacy). If the patient needs ongoing treatment, the prescriber will likely need to issue a separate standard prescription to be filled elsewhere. The instrument does not create a mechanism for transferring electronic orders to other suppliers. This could lead to treatment delays or patient confusion if they assume the electronic order is universally accepted.

No fallback to paper. Clause 7(1) says the PBS prescriber “may only prescribe ... by creating an electronic medication chart order”. If the electronic medication charting system crashes or becomes unavailable, the prescriber cannot lawfully issue a paper prescription for a PBS benefit under this arrangement for a patient of the hospital. The instrument does not provide a contingency. In practice, if the system is down, the prescriber may have to use the normal PBS rules outside the trial, but that would require the patient not to be treated as a “patient of the hospital” for that transaction - an awkward distinction. The hospital or prescriber would need a backup process, but the instrument is silent.

Paragraph 45(2)(d) omitted. The instrument does not explain what paragraph 45(2)(d) of the Regulations requires. By omitting it, the approved supplier is no longer bound by that requirement. However, the supplier must be careful to understand what that paragraph previously required; if it was a mandatory step for verifying the patient’s entitlement or for recording a concession card number, its omission could create an error in the claim data. The supplier should confirm with the Department what fields are still required for CTS claims despite the omission.

Two‑year record retention. The requirement in clause 9(4) to retain electronic pharmacy records for two years after supply is mandatory. If the electronic medication charting system or the pharmacy’s own system does not archive records correctly, the supplier may be unable to comply with a request from the Chief Executive Medicare. Failure to submit a copy when notified could be treated as non‑compliance. The supplier must ensure the system keeps records for the full two years, even if the hospital changes software or the supplier’s approval changes.

Only one approved supplier. The trial grants a de facto monopoly to St Stephen’s Hospital Hervey Bay pharmacy for PBS supplies under the arrangement. No other supplier, even another pharmacy within the same hospital network, can lawfully dispense under this arrangement. This eliminates patient choice and competition for these specific prescriptions. Patients may have to pay higher prices (if the hospital pharmacy charges non‑PBS fees or if the pharmacy is not conveniently located) because they cannot take the order elsewhere. The trial’s design implicitly assumes that the hospital pharmacy is the most appropriate dispenser, but it does not account for patient preference or cost.

Potential for over‑claiming. Because the electronic medication chart order serves as the only record of the prescription, and the supplier verifies supply within that order, there is a risk that if the system does not properly link the order to the supply, duplicate claims could arise or claims could be made for orders that were never filled. The system’s audit trail is critical. The instrument does not impose any minimum audit requirements.

No patient consent requirement. The instrument does not require the prescriber or supplier to obtain the patient’s consent for the paperless process. While hospital consent forms may cover this, the trial could raise privacy concerns if patients are unaware that their PBS prescription data is being processed differently. The instrument does not address how patients can access or correct their electronic orders.

For the PBS prescriber at St Stephen’s Hospital Hervey Bay, compliance requires three steps. First, confirm that the patient is a “patient of the hospital” under the definition - either an in‑patient or an out‑patient receiving hospital treatment. Second, use the hospital’s electronic medication charting system to create the electronic medication chart order. Do not prepare a paper prescription as an alternative; the instrument requires the electronic order for PBS benefits covered by the arrangement. Third, if the medicine requires an authority prescription, ensure that the order contains the authority approval number or the streamlined authority code. If the system does not have a field for this, the prescriber should ensure the information is included elsewhere in the order, such as in a note. The prescriber must then electronically authorise the order. No paper signing or stamping is needed.

The approved supplier must follow a compliance checklist. First, verify that the order is for a patient of the hospital and that the order is an electronic medication chart order created and authorised in the hospital’s system. Second, when dispensing, apply the modified sections 45, 47, and 51 of the Regulations. Specifically, verify the supply in the electronic order by recording that the medicine was supplied and the date. Do not perform the step formerly required by paragraph 45(2)(d) - whatever that was - because it does not apply. If the supply is urgent and requires an “immediate supply necessary” notation, include those words in the electronic charting system. Third, after supply, prepare an electronic pharmacy record that contains all the information required for a CTS claim under the Rules. Retain that record for at least two years from the date of supply in a readily retrievable format. Fourth, when submitting a claim, use the CTS process under s99AAA of the Act. The claim data must match the electronic order and the pharmacy record. Fifth, if the Chief Executive Medicare sends a written request for a copy of an electronic medication chart order or an electronic pharmacy record, provide it to the Department administered under the Human Services (Centrelink) Act 1997 within a reasonable time. The instrument does not specify a timeframe, but timely compliance is prudent.

Both the prescriber and the supplier should ensure that the electronic medication charting system is functioning correctly before each use. The supplier should maintain system backups and document the process for retrieving records. Because the trial is small, the hospital should also designate a person responsible for communicating with the Department about any technical issues or requests for information. Training for prescribers and pharmacy staff on the modified rules is essential, particularly on the omission of paragraph 45(2)(d) and the need to include authority numbers in the electronic order. Finally, the hospital should review its patient admission and consent forms to inform patients about the paperless PBS process, even though the instrument does not require it. Doing so reduces the risk of complaints or privacy breaches.