National Health (Entitlement to Pharmaceutical Benefits—Special Evidentiary Categories) Determination 2017

The instrument relies on several defined terms that ground its operation. Eligible person is not defined in the instrument; the note to section 5 directs readers to subsection 4(1A) of the National Health Act 1953 and subsection 3(1) of the Health Insurance Act 1973. This means the supplier must cross‑reference those Acts to determine who qualifies as an eligible person for PBS purposes. The term approved supplier has the same meaning as in Part VII of the Act - effectively a pharmacist or pharmacy approved to supply pharmaceutical benefits. PBS prescriber is similarly defined by reference to Part VII and includes medical practitioners, nurse practitioners, and others authorised to prescribe PBS medicines. Medicare card and medicare number adopt the Part VII meanings, which tie to the Medicare enrolment system administered by Services Australia. Special number means, as per Part VII, a number allocated under this Determination - in practice, one of the six fixed numbers in section 14. Reciprocal health care agreement means an agreement under section 7 of the Health Insurance Act 1973, covering countries such as the United Kingdom, New Zealand, Ireland, and several others; persons covered by such agreements are treated as eligible persons for limited medical services and PBS access. The instrument creates six classes of persons. The first is eligible persons requiring drugs or medicinal preparations in an emergency (paragraph 7(a)). This is not the same as “clinical urgency” in paragraph 7(e); the emergency class requires a risk of imminent death, serious ill health or serious injury, whereas clinical urgency covers cases where immediate supply is clinically necessary to initiate or continue treatment without interruption. The emergency class is the more severe category. The second class covers foreign persons covered by reciprocal health care agreements (paragraph 7(b)). The third covers persons without a Medicare number who a PBS prescriber identifies as entitled to pharmaceutical benefits (paragraph 7(c)) - here the prescriber effectively certifies entitlement on the prescription. The fourth class covers persons without a Medicare number who an approved supplier considers are entitled to pharmaceutical benefits (paragraph 7(d)) - a broader, supplier‑judgment class. The fifth class is eligible persons requiring drugs or medicinal preparations as a matter of clinical urgency (paragraph 7(e)). The sixth class covers persons for whom an inapplicable Medicare number is shown on a seemingly valid Medicare card or document (paragraph 7(f)) - a situation where a card appears valid but the Medicare number does not match the person in the Chief Executive Medicare’s records, and the supplier has had a previous claim rejected and cannot obtain another number. The concept of entitlement to pharmaceutical benefits otherwise than by provision of a Medicare number is the central idea: the instrument operates as the exclusive mechanism for evidencing entitlement without a Medicare number. If a person does not fall within one of these six classes, the supplier cannot supply a PBS benefit without a valid Medicare number. The instrument does not create new entitlements; it merely provides alternative evidence pathways for existing entitlements.

The primary duty‑bearers under the instrument are approved suppliers - that is, pharmacists and pharmacy operators who supply pharmaceutical benefits. They bear the burden of satisfaction: before supplying a PBS medicine to a person who does not present a Medicare number, the supplier must be satisfied of a list of matters specific to each class. This imposes a compliance cost. The supplier must exercise judgment, examine documents (passports, prescriptions, Medicare cards) and in some cases ask specific questions (for example, under section 9(3), the supplier must ask the person or their agent whether they have a Medicare number). In the class of persons with an inapplicable Medicare number (paragraph 7(f)), the supplier must have made a previous claim that was rejected and must obtain a true and readable photocopy or photograph of the Medicare card. This may require keeping records of rejected claims and maintaining a photocopying or photographing procedure. PBS prescribers are indirectly affected. For the class in paragraph 7(c) (persons without a Medicare number identified by prescriber), the prescriber must indicate on the prescription that they consider the person entitled. This shifts some evidentiary burden onto the prescriber, although the instrument does not specify how the prescriber must form that view. Persons without a Medicare number are the ultimate beneficiaries: overseas visitors from reciprocal countries, eligible persons in emergencies, persons whose Medicare cards are lost or contain an erroneous number, and persons who cannot reasonably obtain a Medicare number. They gain access to PBS medicines without having to produce a Medicare number, but the supplier’s discretion remains a gatekeeping function. The Commonwealth (Department of Health, Services Australia) is affected as payer. The instrument controls how claims for payment can be made without a Medicare number. Using the correct special number is a condition for the claim to be processed. The class‑level special numbers mean the Commonwealth loses person‑level tracking for these dispensing events. This creates a risk of duplicate or ineligible claims, though the supplier must still be satisfied of the person’s eligibility and the class conditions. Other stakeholders include Medicare compliance auditors, who may review claims made under special numbers and verify whether the supplier’s satisfaction was reasonable. The instrument also affects software vendors who operate pharmacy dispensing systems, as those systems must include the six special numbers and possibly logic to ensure the supplier has checked the required matters.

The instrument imposes specific duties on approved suppliers. For each of the six classes, the supplier must be satisfied of a set of mandatory matters. These duties are structured as preconditions to the supplier being satisfied that a person is included in that class. If any precondition is not met, the supplier cannot lawfully claim payment under that class. The duties are:

• For the emergency class (section 8): no reason to believe the person is not eligible; risk of imminent death, serious ill health or serious injury; and that supply must be immediate or within a period too short to establish eligibility or identity.

• For the reciprocal health care agreement class (section 9): the person holds a current passport from a reciprocal agreement country (must be examined); and the supplier has asked whether the person has a Medicare number and has no reason to believe they do.

• For the prescriber‑identified class (section 10): the prescriber has indicated entitlement on the prescription; no reason to believe the person is not eligible; and no reason to believe the person has a Medicare card/document showing a Medicare number.

• For the supplier‑considered class (section 11): the person is an eligible person (not a reciprocal‑agreement‑treated person); and either no reason to believe the person has a Medicare card/document, or it is not reasonable to require them to provide or permit obtaining a Medicare number.

• For the clinical urgency class (section 12): no reason to believe the person is not eligible; and immediate supply is clinically necessary to initiate or continue treatment.

• For the inapplicable Medicare number class (section 13): no reason to believe the person is not eligible; the supplier has made a previous claim for that person that included a seemingly valid Medicare number; that claim was rejected because the number did not match the person in the Chief Executive Medicare’s records; and the supplier cannot obtain another Medicare number for the person. Additionally, the supplier must obtain a true and readable photocopy or photograph of the Medicare card or document.

The instrument creates a right for persons falling within these classes to receive pharmaceutical benefits without providing a Medicare number. However, the right is not absolute; it depends on the supplier’s satisfaction of the conditions. The supplier has a duty to be satisfied, but the instrument does not give the person a right to demand supply if the supplier is not satisfied. The supplier also has a right to claim payment from the Commonwealth using the assigned special number (section 14), but this is contingent on proper satisfaction of the conditions. There is no duty on the person to provide information beyond what the supplier requests (such as the passport examination under section 9(2)), but the supplier must have asked about Medicare number in the reciprocal class. The instrument does not create any private rights of action; enforcement is through the compliance framework of Part VII of the National Health Act and the Health Insurance Act.

The instrument itself does not create penalties. It is a determination made under subsection 86E(1) of the National Health Act 1953, and enforcement occurs under the Act’s existing provisions. Section 86E allows the Minister to determine matters relating to evidence of entitlement. Contravention of the determination’s requirements may lead to the rejection of a claim for payment under Part VII. If a supplier supplies a pharmaceutical benefit to a person without meeting the evidentiary conditions, the Commonwealth can refuse to pay the claim. This is the primary economic penalty: the supplier bears the cost of the medicine and dispensing fee. Additionally, Part VII of the Act contains offence provisions for false or misleading statements. For example, if a supplier certifies that they are satisfied of matters when they are not, that may constitute an offence under section 140 (false statements) or section 141 (avoiding payment) of the Act. The instrument’s requirements are evidentiary; making a claim using an incorrect special number or claiming a person falls within a class when the supplier did not genuinely hold the requisite satisfaction could attract penalties. The Act provides for criminal penalties including fines and imprisonment for serious fraud (such as knowingly making false claims). Civil penalties may also apply under Part VAB of the Health Insurance Act 1973 for false statements. The instrument also creates audit risk. The Department of Health may conduct post‑payment reviews, and claims made under special numbers may be flagged for higher scrutiny because they involve non‑Medicare persons. The requirement to retain photocopies or photographs (section 13(2)) for the inapplicable class imposes a record‑keeping obligation. Failure to maintain that evidence may result in the claim being disallowed on review. For the reciprocal class, the requirement to examine the passport and ask about Medicare number is procedural; if a supplier does not do so and a subsequent audit reveals that the person was not covered by a reciprocal agreement, the supplier may have to repay the benefit. There is no private right of enforcement. The Commonwealth enforces through the provider compliance framework, including warning letters, payment recovery, and, in serious cases, referral to the Professional Services Review or the Director of Public Prosecutions. Pharmacists should also consider that professional registration obligations under the Health Practitioner Regulation National Law may apply if they fail to comply with legislative requirements.

The instrument operates within the broader framework of the National Health Act 1953, particularly Part VII which establishes the Pharmaceutical Benefits Scheme. It is a subordinate legislative instrument, so it must be read consistently with the Act. Any conflict would see the Act prevail. The Health Insurance Act 1973 is also relevant because it governs Medicare eligibility and defines “eligible person”. The note to section 5 of the instrument specifically cross‑references subsection 4(1A) of the National Health Act and subsection 3(1) of the Health Insurance Act for the definition of eligible person. Reciprocal health care agreements are made under section 7 of the Health Insurance Act; the instrument’s class in paragraph 7(b) relies on the existence and terms of those agreements. The instrument does not override the terms of those agreements; it merely provides a procedural mechanism for claiming PBS benefits without a Medicare number when a person is covered. The Privacy Act 1988 is relevant because the instrument requires suppliers to examine passports (section 9(2)) and to obtain photocopies or photographs of Medicare cards (section 13(2)). Collecting and retaining personal information may trigger obligations under the Australian Privacy Principles. Suppliers must ensure they have a lawful basis for collection. The instrument arguably provides that basis for the purposes of PBS claiming, but suppliers should still have a privacy policy and handle copies securely. The Health Records Act 2001 (Victoria) or similar state laws may also apply. The instrument interacts with the National Health (Pharmaceutical Benefits) Regulations 2017 and the National Health (Pharmaceutical Benefits) Determination series, which set out the list of pharmaceutical benefits, prices, and conditions of supply. The special numbers allocated in section 14 must be used in claims; those claims must also comply with the regulations regarding claiming formats and time limits. The 2001 Determination (repealed by Schedule 1) was the predecessor. This instrument updated the drafting but retained essentially the same classes and numbers. The note in the commencement table states that the table will not be amended to reflect later amendments; future amendments would need to be made separately. There is no interaction with state emergency services laws, although the concept of “emergency” in section 8 may align with general law interpretations. The instrument does not affect the supplier’s duty of care under common law or professional obligations. If a supplier dispenses in an emergency under section 8, they must still comply with standard professional practice standards.

The instrument was made on 27 September 2017 by Louise Clarke, Acting First Assistant Secretary, Technology Assessment and Access Division, as delegate of the Minister for Health. It commenced on 1 October 2017. It repealed the entire National Health (Entitlement to Pharmaceutical Benefits , Special Evidentiary Categories) Determination 2001 (Schedule 1). The 2001 Determination had been in force for sixteen years. The 2017 instrument essentially remade the earlier one. There is no evidence in the source text that the 2017 instrument amended any other instrument or was itself subsequently amended. The provision numbering is different: the 2001 instrument had a similar structure but was replaced entirely. The explanatory material (not provided) might indicate whether the 2017 version made substantive changes or merely restated the 2001 instrument with modern drafting conventions. The definitions section (s 5) is more detailed, including explicit cross‑references to the Act and the Health Insurance Act for “eligible person” (via a note). The earlier determination may have relied on those definitions tacitly. The allocation of special numbers in section 14 repeats the same six numbers as the 2001 version (the numbers appear unchanged from the earlier instrument, though the text does not confirm this). The classes are identical to those in the 2001 determination. The procedural requirement to examine a passport (s 9(2)) and to obtain a photocopy of a Medicare card for the inapplicable class (s 13(2)) may have been new or clarified; the source does not disclose the earlier version. The repeal of the 2001 instrument means any reference to the “PB 17 of 2001” (assumed) must now be to PB 83 of 2017. The instrument is not subject to automatic repeal under the Legislation Act 2003 sunsetting provisions? It would likely be reviewed before expiry. As of the date of this determination, no amendments have been made. Readers should check the Federal Register of Legislation for any subsequent amendments.

The source text does not name any cases. There is no reference to litigation, court interpretations, or tribunal decisions. The instrument is largely procedural and has not generated reported case law. It is possible that disputes over the satisfaction of matters could arise in the context of Medicare compliance audits or Professional Services Review proceedings, but such disputes would be administrative rather than judicial. The Administrative Appeals Tribunal (now the Administrative Review Tribunal) could review decisions about the disallowance of claims or recovery of payments. However, no such cases are widely reported. The instrument has been in force since 2017 with no recorded litigation. The concepts of “no reason to believe” and “clinically necessary” could be tested in a tribunal setting, but the absence of case law means suppliers must rely on ordinary meaning and departmental guidance. The instrument’s evidentiary requirements are relatively straightforward, reducing the likelihood of complex litigation. The class of “eligible persons requiring drugs or medicinal preparations in an emergency” (s 8) could intersect with emergency medicine case law, but the instrument itself has not been judicially considered. Suppliers should not expect extensive precedential guidance; they must exercise professional judgment and document their reasoning.

Several aspects of the instrument may trap unwary suppliers. First, the “no reason to believe” standard appears in multiple classes (ss 8(a), 10(b), 10(c), 11(b)(i), 12(a), 13(a)). This is a lower threshold than “know” or “prove”, but it is not the same as “no reason to suspect”. A supplier who has objective information that could raise a reasonable belief that the person is not eligible must act on it. For example, if a person cannot produce any identification and the supplier has no way to confirm even basic identity, the supplier may have reason to believe the person is not eligible. The term “reason to believe” imports an objective test. A supplier who fails to make reasonable inquiries may later be found to have had a reason to believe. Second, the class distinction between “emergency” (s 8) and “clinical urgency” (s 12) is critical. Emergency requires imminent death, serious ill health or serious injury. Clinical urgency requires clinically necessary immediate supply to initiate or continue treatment. A supplier who uses the emergency special number for a non‑life‑threatening urgent condition may be misclassifying the claim. The emergency class also requires that the supply period is too short to establish eligibility, whereas clinical urgency does not explicitly require that. Third, the reciprocal class (s 9) requires the supplier to examine the passport (s 9(2)) and ask about a Medicare number (s 9(3)). The supplier must not rely on the person’s oral claim alone; they must physically look at the passport and check it is unexpired. The instrument does not say the passport must be a valid travel document, only that it has not expired. Also, the supplier must ask about a Medicare number - it is not enough to assume the person does not have one. Fourth, the “supplier considers” class (s 11) has a potential catch: the person must be an “eligible person” but not a person treated as eligible under a reciprocal health care agreement (s 11(a)). So if a person from a reciprocal agreement country does not have their passport and the supplier considers them eligible, the supplier cannot use this class. They would need to use the reciprocal class (s 9), but that requires a passport. Effectively, a reciprocal agreement person without a passport cannot get PBS under any special class unless it is an emergency or clinical urgency, which may not apply. Fifth, the inapplicable Medicare number class (s 13) requires that the supplier has previously made a claim that was rejected because the number did not match. This means the supplier cannot use this class for a new patient; they must have attempted a claim first. If a patient presents with a card that shows a number that is clearly the wrong person (e.g., a green Medicare card with a dad’s name but the child is present), the supplier cannot simply go to this class without having submitted a claim that was rejected. They would need to first attempt a claim (which will be rejected) and then on the second supply use the special number. This could cause a delay. Sixth, the special numbers are class‑level, not person‑level. This means the Commonwealth cannot easily track whether a particular person is receiving multiple supplies under the same number. A supplier could theoretically use the same special number for different individuals in the same class. The only safeguard is the supplier’s satisfaction documentation. If the supplier does not keep adequate records (such as the person’s name or identifier), it will be impossible to defend the claim on audit. Seventh, the record‑keeping obligation is only explicit for the photocopy of the Medicare card in s 13(2). For other classes, the instrument does not prescribe what records must be kept. But the supplier must still be able to demonstrate satisfaction of the matters. If audited, the supplier will bear the evidentiary burden. A prudent supplier should keep notes of the basis for satisfaction: for example, why they believed there was no reason to believe the person was not eligible, or why immediate supply was clinically necessary. Eighth, the cross‑reference for “eligible person” is not self‑contained. The supplier must know the definitions in the National Health Act and Health Insurance Act, which may have been amended. For example, permanent residents, Special Category Visa holders, and certain other persons are eligible, but some temporary visa holders are not. The supplier cannot simply rely on the person’s claim of eligibility. Ninth, the instrument does not address minors or persons lacking capacity. The agent mentioned in s 9(3) may be relevant, but the supplier must still assess whether the agent’s statements are reliable. Tenth, the instrument’s silence on refusal of supply does not give a person a right to insist on a special number claim; the supplier retains discretion to refuse supply if not satisfied. The supplier may also choose to supply privately (not under PBS) if the person does not meet the class, but that is outside the instrument.

Compliance requires a systematic approach by approved suppliers. The supplier should first determine whether the person presenting for a PBS medicine has a Medicare number. If they do, use the normal claiming process. If they do not, the supplier must assess which of the six classes the person may fall into. The instrument sets out preconditions; the supplier should work through them sequentially. The following steps are suggested:

1. Identify the class: Ask the person why they have no Medicare number. If they claim an emergency, assess whether there is imminent risk of death, serious ill health or serious injury. If they are a foreign visitor, ask about a reciprocal health care agreement and ask to see their passport. If they are an Australian resident who has lost their card, consider the prescriber‑identified class or the supplier‑considered class.

2. For the emergency class (s 8): Verify that the person appears to be in immediate danger. If possible, get a brief verbal confirmation from the prescriber if they are reachable. Document the nature of the emergency and why supply could not wait. Use special number 2543 77541 1 1.

3. For the reciprocal class (s 9): Examine the passport to confirm it is from a reciprocal agreement country (see current list on Department of Human Services website). Ensure the passport has not expired. Ask the person (or their agent) whether they have a Medicare number. If they say no and there is no reason to believe otherwise, proceed. Record the passport country and number (but be aware of privacy obligations). Use special number 2543 77596 1 1.

4. For the prescriber‑identified class (s 10): Look at the prescription - the prescriber must have indicated on it that they consider the person entitled. The instrument does not specify the wording; any clear indication should suffice. The supplier must still have no reason to believe the person is not eligible and no reason to believe they have a Medicare card showing a number. If the person has a Medicare card but the number is scratched out, that may give reason to believe the card shows a number. Use special number 2543 77666 1 1.

5. For the supplier‑considered class (s 11): This class can be used only if the person is an eligible person (not reciprocal agreement treated). The supplier must be satisfied the person is eligible (e.g., permanent resident but no card). Then, either the supplier has no reason to believe they have a Medicare card, or it is not reasonable to require them to provide or allow the supplier to obtain a Medicare number. For example, if the person lives in a remote area and cannot access Medicare phone services, it may be unreasonable to require them to obtain their number. Document the reasoning. Use special number 2543 77684 1 1.

6. For the clinical urgency class (s 12): The supplier must believe the person is eligible and that immediate supply is clinically necessary to initiate or continue treatment without interruption. This is broader than emergency but still requires a clinical judgment. If the prescriber has indicated urgency on the prescription, that helps. If not, the pharmacist may need to speak with the prescriber. Use special number 2543 75299 1 1.

7. For the inapplicable Medicare number class (s 13): This requires that a prior claim for the same person was rejected because the Medicare number did not match. The supplier must have a true and readable photocopy or photograph of the Medicare card. If the supplier cannot obtain another number, they can use this class but only after the claim rejection. Keep the photocopy as evidence. Use special number 2543 77833 1 1.

8. Document everything: For all classes, the supplier should create a written record of why they were satisfied of each matter. For example, for emergency, note the risk. For reciprocal, note the passport examined and the response to the Medicare number question. For clinical urgency, note the clinical reason. For supplier‑considered, note why it was not reasonable to obtain a Medicare number. Retain these records for at least the period required by the PBS compliance framework (likely several years).

9. Use the correct special number: Section 14 assigns a unique number per class. Using the wrong number may result in claim rejection. Double‑check the number before lodging.

10. Train staff: All pharmacists and dispensing staff should be familiar with the six classes and the preconditions. Create a quick‑reference guide. Ensure that if the pharmacist is not on duty, the staff know to defer supply until a pharmacist can assess the class.

11. Review claims regularly: Monitor rejection reports from the PBS claiming system. A rejected claim may indicate an incorrect use of a special number or failure to meet a precondition. Correct errors promptly.

12. Seek professional indemnity advice: Given that the supplier’s judgment may be scrutinised years later, consider documenting the basis in a patient‑specific note. Professional indemnity insurers may have specific requirements.

By following these steps, the approved supplier can minimise the risk of non‑compliance and ensure that eligible persons receive pharmaceutical benefits without a Medicare number in appropriate circumstances.