National Health (Pharmaceutical Benefits Scheme Hospital Medication Chart Paperless Claiming Trial) Special Arrangement 2017

Several key concepts define the operation of the trial. Medication chart has the meaning given by subregulation 41(4) of the PBS Regulations - broadly, a chart used in a hospital to order and record administration of medicines. The instrument does not reproduce that regulation, but it is central to the trial. In-patient is defined as a person who occupies a bed in the hospital for the purpose of hospital treatment and is not a staff member receiving treatment in their own quarters. The note clarifies that this includes public or private patients being discharged from in-patient care. This definition is narrower than a general “patient” and excludes out-patients and day procedure patients who do not occupy a bed.

Approved supplier is an entity whose name, address and approval number appear in Column 2 of the Schedule. Only these entities may supply under the trial, and only to in-patients of the hospital listed in the same item. The Schedule shows six hospitals but only three approval numbers, with HPS Pharmacies Knox serving three hospitals (Bellbird, Cotham, Victoria Clinic, Ringwood - actually four? The Schedule shows: Item 3 Bellbird, Item 4 Cotham, Item 5 Victoria Clinic, Item 6 Ringwood all reference “HPS Pharmacies Knox” approval number 23929K. So one pharmacy serves four hospitals; another serves St John of God Midland (51862N) and Knox Private (23929K) - wait, Knox Private is item 2 with HPS Pharmacies Knox 23929K, same as the others. So effectively one pharmacy (HPS Knox) covers Knox, Bellbird, Cotham, Victoria Clinic, Ringwood; and HPS Midland covers St John of God Midland. The supplier group is the same two individuals (Anthony Wyatt & Tin Huynh) but at different locations.

Electronic pharmacy record is the digital substitute for the paper prescription. It must contain all information required by Schedule 1 to the Rules for an online claim, except for Items 16, 19 and 19A. Item 16 relates to prescriber’s address? Item 19 and 19A likely relate to prescriber’s signature or other identifiers. This exemption simplifies electronic capture but may affect downstream verification.

Duly written prescription and authority prescription are referenced. A medication chart meeting the conditions in section 7 is deemed a duly written prescription, which triggers the normal PBS supply and claiming rules subject to the modifications. The instrument also links to the concept of “authority prescription” (defined in the Regulations) but does not modify those requirements; the medication chart must still bear the authority approval number if needed.

Old Arrangements refers to PB 14 of 2017, which this instrument replaces. Section 9 treats outstanding prescriptions from the old trial as valid under this arrangement, avoiding discontinuity.

The trial directly affects a narrow set of actors. Hospitals: six private hospitals in Australia (St John of God Midland Private in WA, Knox Private, Bellbird Private, Cotham Private, The Victoria Clinic, and Ringwood Private in Victoria). Their in-patients are the recipients of the pharmaceutical benefits. Approved suppliers: effectively HPS Pharmacies operating from three premises (Midland WA, Knox VIC). These suppliers must comply with the electronic record keeping and claiming procedures. PBS prescribers: doctors who prepare medication charts for in-patients at these hospitals. Their prescriptions are deemed duly written only if they include the Medicare card number (including sub-numerate), the prescriber’s identification number issued by the Department of Human Services, and other matters for non-general patients as per regulation 42. In-patients: individuals occupying a bed in the specified hospitals. Their personal information (Medicare number) must appear on the chart, creating privacy considerations. The Department of Health and Chief Executive Medicare: they receive electronic claims and can request paper copies later. Other PBS suppliers: those not listed in the Schedule cannot use the trial’s paperless mechanism. This creates a two-tier system: the trial participants enjoy reduced paperwork, while other suppliers (including public hospitals and other private hospitals) must continue submitting paper prescriptions or use different electronic claiming arrangements under other instruments. The trial’s narrow scope may confer a competitive advantage to HPS Pharmacies and the listed hospitals by reducing administrative costs and claim turnaround times. However, the compliance burden shifts from paper handling to precise electronic record creation and retention. Patients: they are not directly burdened but may be affected if their Medicare details are incorrectly recorded or if the electronic record fails to capture required data, potentially delaying supply or claims. Private health insurers: indirect effect, as PBS subsidies cover the pharmaceutical benefits, not hospital treatment itself; no direct impact. The taxpayer: funds the PBS subsidies regardless, but the trial aims to reduce government processing costs (unstated in instrument). Overall, the trial is a small experiment affecting a handful of entities, but the precedent may influence future policy.

The instrument imposes specific duties on approved suppliers and hospitals, and grants certain rights to the Secretary. Approved supplier duties: (1) Keep an electronic pharmacy record for each medication chart where a pharmaceutical benefit is supplied to an in-patient and for which a claim is made under section 99AAA of the Act (section 8(3)(a)). (2) Retain that record for at least two years after the day of supply (section 8(3)(b)). (3) Ensure the electronic record contains all information required by Schedule 1 to the Rules for an online claim, except for Items 16, 19 and 19A (section 8(4) and (5)). (4) Supply benefits as if medication charts were original prescriptions, but with two modifications: first, where a chart directs supply of multiple benefits, the supplier must not defer supply of any one or more of them under regulation 53 of the PBS Regulations (section 8(2)(a)). This means all benefits on the chart must be supplied at the same time or the supplier cannot use the trial’s claiming method. Second, instead of the usual endorsement requirements of regulation 57, the supplier (or an authorised person) must write on the medication chart that the benefit has been supplied, with the date, and sign it (section 8(2)(b)). This paper annotation is retained even though the claim is electronic. (5) Furnish a copy of electronic pharmacy records if the Secretary notifies the hospital that copies are required (section 8(7)). The Secretary may also require hospitals to submit copies of the medication charts themselves (section 8(8)). (6) Provide information electronically to the Chief Executive Medicare that complies with the Rules for online claims and under-co-payment data requirements under section 98AC of the Act (section 8(9)), subject to the same exemptions.

Rights of approved suppliers: They may furnish a claim unaccompanied by the paper medication charts (section 8(6)). This is the core benefit of the trial: reduced physical handling. They also have the right to rely on the deeming provision in section 7 that the medication chart is a duly written prescription if the listed conditions are met. Hospitals’ duties: only indirectly; if the Secretary requests copies of medication charts, the hospital must submit them (section 8(8)). The hospital is also the location for the deeming of the in-patient’s address (section 7(a)). PBS prescribers’ duties: they must ensure the medication chart includes the Medicare card number with sub-numerate, the prescriber’s ID number, and for non-general patients, the matters in regulation 42. Prescribers also must not direct increased quantities beyond the maximum quantity determined under paragraph 85A(2)(a) - but if they do, the direction is taken as a direction for the maximum (section 7(e)). Secretary’s rights: to request copies of electronic pharmacy records or medication charts after the fact. This is a post-payment verification power that deters abuse while allowing the trial to proceed without upfront paper submission.

The instrument itself does not create new penalties. Enforcement relies on existing provisions in the National Health Act 1953 and the PBS Regulations. Non-compliance with the duties under this special arrangement may jeopardise the supplier’s ability to claim PBS subsidies, trigger recovery of overpayments, or lead to administrative sanctions. The Act contains provisions for false or misleading statements, and the PBS framework includes audit and compliance mechanisms by the Department of Health and the Chief Executive Medicare. The instrument gives the Secretary the explicit right to request copies of electronic records or medication charts (section 8(7) and (8)); failure to comply with such a request could be treated as non-compliance with a condition of the special arrangement, potentially resulting in the supplier being excluded from the trial or having claims rejected. Because the arrangement is a trial, there is likely close monitoring; any significant non-compliance could result in termination of the trial for the particular hospital or supplier, though the instrument does not specify termination provisions. The retention requirement of two years creates an exposure: if the electronic pharmacy record is lost or corrupted within that period, the supplier may be unable to satisfy a later request, risking clawback of subsidies paid. The exemption of Items 16, 19 and 19A from the electronic record reduces the risk of non-compliance on those data fields, but other fields must be accurate. The instrument does not prescribe penalties for failure to annotate the medication chart with supply details (section 8(2)(b)). However, that annotation serves as evidence of supply; its absence could cast doubt on whether supply occurred, potentially affecting claims. The transitional provisions (section 9) merely validate prior prescriptions under the old arrangement, not penalties. Overall, enforcement is indirect, via the Act, regulations, and the Secretary’s administrative powers. The limited number of participants (one supplier group) makes oversight straightforward. There is no provision for criminal penalties or infringement notices within the instrument. The trial’s paperless nature may reduce the risk of lost documents but increases reliance on data accuracy; errors in electronic records are easier to check algorithmically, so non-compliance may be detected more readily.

This instrument is a “special arrangement” made under section 100(1) of the National Health Act 1953. Its effect is to modify the standard operation of Part VII of the Act in relation to the supply and claiming of pharmaceutical benefits for the hospitals and suppliers covered. Section 5(2) makes explicit that a provision of Part VII, or of regulations or other instruments made for Part VII, applies subject to this special arrangement. This means where the special arrangement provides a different rule, it prevails over the general law. For example, the normal requirement to submit original prescriptions with a claim (implied by the PBS claiming rules) is overridden by section 8(6) allowing paperless claiming. The usual endorsement requirements of regulation 57 are replaced by the simplified annotation in section 8(2)(b). The PBS Rules made under sections 99AAA(8) and 98AC(4) of the Act are directly engaged: the electronic pharmacy record must comply with Schedule 1 to the Rules for an online claim, except for the exempted items. The instrument also interacts with the National Health (Pharmaceutical Benefits) Regulations 2017, incorporating definitions (medication chart, authority prescription, duly written prescription) and referencing regulations 16, 40, 41, 42, 49, 53, and 57. It does not modify those regulations for persons outside the trial.

The instrument explicitly does not apply to pharmaceutical benefits that can only be supplied under other special arrangements under section 100 (section 6(2)). This preserves the exclusivity of those other arrangements (e.g., for specialised drugs). It also does not apply to “medication chart prescription” (section 6(3)) - a term not defined, which may create an interaction with other instruments or regulations that do define that term. If “medication chart prescription” is a separate concept under, say, the National Health (Pharmaceutical Benefits) Regulations or another special arrangement, then benefits prescribed that way are not eligible for the trial, even if they appear on a medication chart. This could cause confusion. The instrument does not expressly revoke the earlier trial (PB 14 of 2017) but section 9 transitionals effectively replace it. It does not interact with state health legislation; the hospitals are private and operate under their own licensing. The instrument does not address privacy law, but the collection of Medicare numbers and other personal health information is subject to the Privacy Act 1988 and the hospital’s own obligations. The trial’s electronic records may also interact with My Health Record or other eHealth systems, though not mentioned.

This instrument, PB 54 of 2017, was made on 13 July 2017 by Julianne Quaine, Assistant Secretary, Pharmaceutical Access Branch, Department of Health, as delegate of the Minister for Health. It commenced on the day after registration on the Federal Register of Legislation. The instrument replaced an earlier special arrangement: the National Health (Multiple Hospitals Paperless Claiming Trial) Special Arrangement 2017 (PB 14 of 2017). Section 9 contains transitional provisions that treat prescriptions written under the old arrangement as valid under this arrangement if supply had not yet occurred. The instrument itself has not been amended according to the text provided; no subsequent amending instruments are referenced. The “old Arrangements” definition at section 9(2) indicates that PB 14 of 2017 is the direct predecessor. Nothing in the text suggests that PB 54 of 2017 has been repealed or superseded, but given its trial nature, it likely had a finite duration or was later replaced by a more comprehensive arrangement. The instrument is listed as PB 54 of 2017 in the series, indicating it is a legislative instrument registered on the Federal Register. Because the text is as at original making, any later amendments are not visible. This is a significant limitation: users must check the current Register for amendments or sunsetting. The instrument does not contain a sunset clause. The trial’s narrow scope suggests it may have been superseded by broader paperless claiming arrangements (e.g., the PBS ePrescribing framework). The repeal or expiry of this instrument would revert the hospitals and suppliers to standard claiming procedures unless another special arrangement applies.

The instrument does not mention any litigation, and there is no information in the source text about court cases involving this particular special arrangement. Given its narrow trial nature, it is unlikely to have generated reported litigation. The small number of participants and the administrative nature of PBS claiming disputes (often resolved internally or through the Administrative Appeals Tribunal) reduce the probability of public litigation. However, because the instrument modifies rights and obligations under the National Health Act, a dispute could theoretically arise over interpretation of terms such as “medication chart prescription” (undefined) or the scope of the Secretary’s power to request records. For example, a hospital or supplier might challenge a request for copies as exceeding the Secretary’s authority, or a claim rejection might be challenged in the AAT or Federal Court. But no such cases are recorded in the instrument itself. Users should search case law databases for references to PB 54/2017 or to “paperless claiming trial” in PBS contexts. The instrument’s transitional provisions from PB 14 of 2017 also create no litigation history. In the absence of any cited cases, the safest statement is that the instrument has not, according to the source, been the subject of any reported litigation. This is not to say it cannot be litigated in future. The deeming provisions in section 7(e) regarding increased quantities could potentially clash with the Act’s maximum quantity provisions, but no court has yet ruled on that specific interaction within this trial. The exemption of Items 16, 19 and 19A might also be tested if a missing data field causes a claim to be rejected. However, the instrument is silent on litigation.

Several provisions contain traps for the unwary. First, section 6(3) states: “This Special Arrangement does not apply to a pharmaceutical benefit prescribed using a medication chart prescription.” The term “medication chart prescription” is not defined in this instrument. This creates a serious ambiguity. If a prescriber writes on a medication chart, is that a “medication chart prescription” or a “medication chart”? The instrument defines “medication chart” by reference to subregulation 41(4) of the Regulations, but then adds a separate term. The note to section 6 references section 85AA of the Act about s100 only drugs, but the exclusion seems broader. In practice, this might mean that any benefit prescribed on a medication chart that is also a “prescription” (which the chart itself is deemed to be under section 7) is excluded from the arrangement, defeating the trial’s purpose. This is likely a drafting error, but a cautious supplier would seek clarification.

Second, the address of the in-patient is deemed to be “the location within the hospital” for the purpose of paragraph 40(1)(b) of the Regulations (section 7(a)). That paragraph normally requires the patient’s address on the prescription. The deeming avoids needing a home address, but if the patient is not in a specific ward (e.g., in transit), the “location” may be ambiguous. Failure to record a precise location may render the prescription invalid under the deeming.

Third, section 7(b) requires the medication chart to bear the Medicare card number including the sub-numerate. If the patient has no Medicare card (e.g., eligible overseas visitor with different coverage), the chart cannot meet this condition, and the deeming fails. The instrument does not provide an alternative.

Fourth, for non-general patients (private patients), section 7(c) requires the chart to bear “the matters prescribed by regulation 42 of the Regulations”. Regulation 42 imposes additional prescription requirements (likely the prescriber’s address, patient’s address, etc.). Compliance must be checked against the current regulations.

Fifth, the supplier must not defer supply of any benefit listed on the chart (section 8(2)(a)). If one benefit is out of stock, the supplier cannot supply the others under the trial and must either supply all at once or revert to standard paper-based claiming for that chart.

Sixth, despite the paperless claim, the supplier must still write on the physical medication chart that the benefit has been supplied, with date and signature (section 8(2)(b)). This means the physical chart must be located and endorsed; it cannot be discarded immediately.

Seventh, the electronic pharmacy record must be retained for at least two years. The instrument does not specify the format, encryption, or backup requirements. A failure to produce a readable record upon request could be treated as non-compliance.

Eighth, section 6(2) excludes benefits that can only be supplied under other special arrangements. If a patient needs a drug that is listed under two different special arrangements, the supplier must ensure it is not a s100 only drug for that patient. The interplay between this instrument and other special arrangements is complex.

Ninth, the transitional provisions (section 9) only cover prescriptions written under the old arrangement that had not been supplied. But prescriptions supplied before commencement are not validated; any error under the old arrangement remains.

Tenth, the schedule lists specific hospitals and approved suppliers. If a supplier changes location or hospital ownership changes, the arrangement may no longer apply unless the instrument is updated. Using a pharmacy not listed in the Schedule invalidates the paperless claiming.

To comply with this special arrangement, an approved supplier must follow a step-by-step process. First, verify that the hospital is listed in the Schedule and that the supplier’s name, address and approval number match the item for that hospital. Only then can the supplier supply pharmaceutical benefits under the trial to in-patients of that hospital. Second, ensure that each medication chart used as the basis for supply meets the conditions in section 7: (a) the chart must bear the Medicare card number with sub-numerate; (b) for non-general patients, the chart must include the matters required by regulation 42 of the PBS Regulations; (c) the chart must show the prescriber’s identification number issued by the Department of Human Services (see regulation 16); and (d) if the chart directs an increased quantity under section 88(6) of the Act, the supplier should treat that direction as for the maximum quantity determined under section 85A(2)(a). If any of these elements are missing, the chart is not deemed a duly written prescription, and the supply must be made under standard PBS claiming rules (including paper submission) or not at all.

Third, when supplying, the supplier must not defer supply of any benefit listed on the chart. All benefits ordered must be supplied at the same time; otherwise, the trial’s claiming method cannot be used for that chart. Fourth, after supply, the supplier (or an authorised person) must write on the medication chart that the benefit was supplied, the date, and sign it. This paper annotation must be done even though the claim will be electronic. Fifth, the supplier must create an electronic pharmacy record for each medication chart where a benefit is supplied and a claim is to be made. The record must contain all information required by Schedule 1 to the Rules for an online claim, except that Items 16, 19 and 19A are exempt. The supplier must ensure the record complies with the Rules for online claiming and also the under-co-payment data provision under section 98AC of the Act. Sixth, the supplier must retain that electronic record for at least two years after the day of supply. Adequate backup and storage systems are essential.

Seventh, the supplier may then furnish a claim to the Chief Executive Medicare without attaching the paper medication charts. The claim must be submitted electronically according to the Rules. Eighth, if the Secretary notifies the hospital that copies of electronic pharmacy records or medication charts are required, the supplier or hospital (as applicable) must promptly submit those copies to the Department of Health. The supplier should keep contact details of the hospital’s administration to coordinate this. Ninth, the supplier must only supply pharmaceutical benefits that are generally available under Part VII of the Act; benefits that are only available under other special arrangements (s100 only drugs) are excluded. Also, the supplier should be cautious about the undefined term “medication chart prescription” in section 6(3). Until clarified, it may be prudent to avoid using a medication chart that could be characterised as a “medication chart prescription” - perhaps one that is not part of the trial’s designated chart system? The safest approach is to use only medication charts that are specifically recognised by the hospital under this arrangement and to ensure that the chart is not a separate “prescription” form. Finally, the supplier should monitor any updates or replacement arrangements, as this trial may be superseded by a broader instrument. Regular checking of the Federal Register of Legislation is recommended. The supplier should also have a fallback procedure for any case where the trial’s conditions cannot be met, such as reverting to standard paper-based claiming for that supply. Documentation of compliance steps and staff training on the electronic record requirements will reduce the risk of errors.