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New Regulations for Pharmaceutical Benefits Scheme Prescribers

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This article applies to pharmaceutical benefit scheme prescribing practitioners.

National Health (Pharmaceutical Benefits) Amendment (2024 Measures No. 1) Regulations 2024 (Cth)

On 1 April 2024, the National Health (Pharmaceutical Benefits) Amendment (2024 Measures No. 1) Regulations 2024 (Cth) commenced and amended the National Health (Pharmaceutical Benefits) Regulations 2017 (Cth) (the Regulations).

Amendments to prescriber bag supplies

Regulation 33 has been amended to clarify that it only applies to practitioners who are not approved medical practitioners. An approved medical practitioner means a medical practitioner for the time being approved, or deemed to be approved, under section 92 of the Act. Practitioner, for the purposes of regulation 33, means a medical practitioner, an authorised midwife and an authorised nurse practitioner.

New regulation 33(3A) provides that practitioners may only obtain a pharmaceutical benefit that has a drug mentioned in an item of Schedule 1 of the National Health (Prescriber Bag Supplies) Determination 2024 (Cth) in the form mentioned in that item at a particular time if, at that time:

  • the quantity (if any) of pharmaceutical benefits that have that drug in that form that the practitioner has in their possession and that they have previously obtained under regulation 33 is less than the maximum quantity set out in that item; and
  • if the group number mentioned in that item is the same as the group number mentioned in another item, the quantity (if any) of pharmaceutical benefits that have the drug mentioned in the other item in the form mentioned in the other item that the practitioner has in their possession and that they have previously obtained under regulation 33 is less than the maximum quantity set out in the other item.
Amendments related to writing prescriptions

The definition of authority prescription has been amended to now mean a prescription that prescribes a pharmaceutical benefit and that:

  • has been written in accordance with an authorisation under section 30 of the Act; or
  • has been authorised in accordance with authority required procedures that:
    • are part of the circumstances determined by the Minister under section 85(7)(b) of the Act for the pharmaceutical benefit; or
    • are part of the conditions determined by the Minister under section 85A(2A) of the Act for the pharmaceutical benefit; or
  • if neither the first or second dot point of this definition applies, has been authorised as part of the circumstances determined for the pharmaceutical benefit under section 85B(4) of the Act.

Regulation 40 sets out the requirements for writing a valid PBS prescription that is not a medication chart prescription, while regulation 41 sets out the requirements for writing a valid PBS medication chart prescription. Both regulations 40 and 41 have been amended to align with the definition of authority prescription as well as the amendments to regulation 30.

Repeals – regulation 57 and the National Health (COVID-19 Supply of Pharmaceutical Benefits) Special Arrangement 2020 (Cth)

Regulation 57 of the Regulations in relation to the receipt of pharmaceutical benefits, has been repealed. Additionally, on 1 April 2024, the National Health (COVID-19 Supply of Pharmaceutical Benefits) Special Arrangement 2020 (Cth) (the Special Arrangement) was repealed in accordance with clause 4 of the Special Arrangement. Importantly, the Special Arrangement continues to apply on and after 1 April 2024 in relation to the supply of a pharmaceutical benefit made under the Special Arrangement before 1 April 2024.

Conclusion

Organisations should ensure that their PBS prescribing practitioners are made aware of the changes to prescriber bag supplies and writing prescriptions provisions as discussed.

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