Commencement information
1. The whole of this instrument	The day after this instrument is registered	8 April 2020

Schedule 1—Amendments

National Health (COVID-19 Supply of Pharmaceutical Benefits) Special Arrangement 2020

1 Section 5 (including note)

Repeal the section, substitute:

5 Simplified outline of this instrument

This instrument makes a special arrangement to make the supply of pharmaceutical benefits to patients who have been prescribed a pharmaceutical benefit as the result of a Medicare telehealth attendance or telephone attendance more convenient and effective. Medicare telehealth and telephone attendances have been introduced as a temporary measure in response to the impact of human coronavirus (COVID-19).

The instrument modifies arrangements for the supply of a pharmaceutical benefit on a paper-based prescription to enable certain supplies to be made based on an image of the prescription provided to the approved supplier by the PBS prescriber.

Note: Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).

2 Subsection 6(1)

Insert:

approved hospital authority has the same meaning as in Part VII of the Act.

approved hospital authority dispenser means the pharmacist or practitioner by whom, or under whose supervision, a pharmaceutical benefit supplied by an approved hospital authority will be dispensed.

CTS claim has the same meaning as in Part VII of the Act.

3 Subsection 6(1) (definition of patient at risk of COVID-19 virus)

Repeal the definition.

4 Subsection 6(1) (definition of phone attendance)

Repeal the definition, substitute:

phone attendance has the same meaning as in section 6 of the Health Insurance (Section 3C General Medical Services – COVID-19 Telehealth and Telephone Attendances) Determination 2020.

Poisons Standard means the current Poisons Standard (within the meaning of the Therapeutic Goods Act 1989).

5 Subsection 6(1) (definition of telehealth attendance)

Repeal the definition, substitute:

telehealth attendance has the same meaning as in section 6 of the Health Insurance (Section 3C General Medical Services – COVID-19 Telehealth and Telephone Attendances) Determination 2020.

6 Subsection 6(2)

Repeal the subsection, substitute:

(2) A reference in this Special Arrangement to the Act, the Regulations, the Health Insurance (Section 3C General Medical Services – COVID-19 Telehealth and Telephone Attendances) Determination 2020, the Health Insurance Act 1973 or the Therapeutic Goods Act 1989 is a reference to that legislation as in force from time to time.

(3) A reference in this Special Arrangement to a digital image of a prescription includes a reference to a digital image of so much of the prescription as would indicate that subsections 40(1), (2) and (2A) of the Regulations have been complied with.

7 Subsection 7(1)

Repeal the subsection, substitute:

(1) Division 2 of this Special Arrangement applies to all pharmaceutical benefits available for supply under Part VII of the Act other than a pharmaceutical benefit:

(a) referred to in Schedule 8 to the Poisons Standard, or referred to in both Schedule 4 and Appendix D to the Poisons Standard; and

(b) which may not be supplied on the basis of a digital image of a prescription or a copy of prescription under a law in force in the State or Territory in which the pharmaceutical benefit would be supplied.

8 Section 9

Repeal the section, substitute:

9 Supplies to which the Special Arrangement applies

(1) Division 2 of this Special Arrangement applies to the supply of a pharmaceutical benefit by an approved supplier based on a paper-based prescription (excluding a medication chart prescription) written as the result of a telehealth attendance or phone attendance provided on or after 20 March 2020 to which any of the following apply:

(a) an item in Group A40, Group M18 or Group M19 of the general medical services table;

(b) items 91850 to 91858 of Group T4 of the general medical services table;

(c) an item specified in the Health Insurance (Section 3C General Medical Services – COVID-19 Telehealth and Telephone Attendances) Determination 2020.

(2) However, Division 2 of this Special Arrangement does not apply to the supply of a pharmaceutical benefit if:

(a) the pharmaceutical benefit would be supplied by an approved pharmacist or approved hospital authority and the relevant prescription must be in writing under a law in force in the State or Territory in which the premises, at or from which the pharmaceutical benefit would be supplied, are located; or

(b) the pharmaceutical benefit would be supplied by an approved medical practitioner and the relevant prescription must be in writing under a law in force in the area in respect of which the medical practitioner is approved.

(3) Division 3 of this Special Arrangement applies to the supply of a pharmaceutical benefit by an approved supplier.

(4) In this section, item includes an item relating to a service specified in a determination in force under subsection 3C(1) of the Health Insurance Act 1973.

Note: Subsection 3C(1) enables the Minister to determine that, for the purposes of the Health Insurance Act 1973, the National Health Act 1953 and associated legislation, a health service not already specified in the general medical services table is to be treated as a professional or medical service and that the health service should be treated as if there were an item in that table.

9 Section 10

Repeal the section, substitute:

10 Modified application of section 44 of the Regulations - supplies on first presentation of prescription

(1) The requirements for the supply of a pharmaceutical benefit on the first presentation of a prescription in section 44 of the Regulations are modified as set out in this section for a supply to which Division 2 of this Special Arrangement applies.

(2) Despite section 44 of the Regulations, an approved pharmacist or approved medical practitioner may supply a pharmaceutical benefit to a person on the first presentation of a prescription if a PBS prescriber has given the approved pharmacist or medical practitioner a digital image of the prescription or a copy of the prescription.

Note: a paper-based prescription for a pharmaceutical benefit will commonly include a part of the prescription that is the pharmacist/patient copy and a part of the prescription that is the Medicare/DVA copy - see subsection 40(2) of the Regulations.

(3) An approved hospital authority may supply a pharmaceutical benefit to a person on the first presentation of a prescription if a PBS prescriber has given the approved hospital authority dispenser a digital image of the prescription or a copy of the prescription.

(4) If the prescription is or would be an authority prescription, the approved supplier may supply the pharmaceutical benefit only if:

(a) where the pharmaceutical benefit prescribed has a relevant streamlined authority code:

(i) the PBS prescriber informs the approved pharmacist, approved medical practitioner or approved hospital authority dispenser of that code before the pharmaceutical benefit is supplied; or

(ii) the digital image of the prescription displays the code; or

(b) both:

(i) the Minister or the Chief Executive Medicare has notified the PBS prescriber (orally or by other means) that each relevant authorisation will be given; and

(ii) the PBS prescriber informs the approved pharmacist, approved medical practitioner or approved hospital authority dispenser of that notification before the pharmaceutical benefit is supplied.

10 Section 11

Repeal the section, substitute:

11 Modified application of section 51 of the Regulations - repeated supplies of pharmaceutical benefits

(1) The requirements for repeated supplies of a pharmaceutical benefit in section 51 of the Regulations are modified as set out in this section where the approved supplier has been given a digital image or copy of a prescription referred to in subsection 10(1) by a PBS prescriber.

(2) Where the supplier of a pharmaceutical benefit to which subsection 51(4) of the Regulations applies reasonably believes that:

(a) a supply of the benefit that was previously supplied to the person has been destroyed, lost or stolen; or

(b) having regard to the person’s circumstances, the supply of the benefit is necessary, without delay, for the treatment of the person;

the supplier of the benefit meets the requirements of paragraph 51(4)(b) or 51(4)(c) of the Regulations, as appropriate, if the supplier writes the words “immediate supply necessary” and signs the copy of the prescription, the digital image of the prescription or a print out of the digital image of the prescription.

12 Modified application of section 52 of the Regulations - repeat authorisations

(1) The requirements for repeat authorisations of a pharmaceutical benefit in section 52 of the Regulations are modified as set out in this section for a supply to which subsection (2) applies.

(2) This subsection applies if an approved supplier supplies a pharmaceutical benefit under this special arrangement based on:

(a) a copy or digital image of a prescription referred to in subsection 10(1) given to the approved supplier by a PBS prescriber and that contains a direction to supply the benefit more than once; or

(b) a copy of a prescription or a print out of a digital image of a prescription referred to in subsection 10(1) given to the approved supplier by a PBS prescriber and to which is attached a deferred supply authorisation that contains a direction to supply the benefit more than once or a repeat authorisation that contains a direction to supply the benefit more than once;

and subsequent supplies of the pharmaceutical benefit can be made under the prescription at the time of supply.

Requirement to prepare repeat authorisation

(3) The requirements of subparagraph 52(3)(a)(iii) of the Regulations are met if the approved supplier:

(a) attaches the repeat authorisation to a print out of the digital image of the prescription or the copy of the prescription; and

(b) retains the repeat authorisation and the print out of the digital image of the prescription or the copy of the prescription.

13 Modified application of section 53 of the Regulations - deferred supply

(1) The requirements for deferred supply of a pharmaceutical benefit in section 53 of the Regulations are modified as set out in this section for a supply to which subsection (2) applies.

(2) This subsection applies where an approved supplier:

(a) supplies one or more pharmaceutical benefits based on a copy of a prescription or a digital image of a prescription referred to in subsection 10(1) and given to the approved supplier by a PBS prescriber; and

(b) defers, in accordance with subsection 53(2) of the Regulations, the supply of one or more pharmaceutical benefits directed to be supplied based on the prescription.

(3) The requirements of paragraph 53(3)(c) of the Regulations are met if the supplier of the benefit:

(a) writes the words “original supply deferred" on the copy of the prescription, the digital image of the prescription or a print out of the digital image of the prescription; and

(b) attaches the deferred supply authorisation to a print out of the digital image of the prescription or the copy of the prescription; and

(c) retains the deferred supply authorisation and print out of the digital image of the prescription or the copy of the prescription.

(4) Where the supplier of the benefit writes the words "original supply deferred" on the digital image of the prescription, the print out referred to in paragraph (3)(c) must be of the digital image including that writing.

14 Keeping documents - approved suppliers

An approved supplier must keep a document referred to in an item in the following table for a period of 2 years from the date of supply if:

(a) the supply was made on the basis of:

(i) a digital image or copy of a paper-based prescription for a pharmaceutical benefit given to the approved supplier by a PBS prescriber; or

(ii) a deferred supply authorisation or repeat supply authorisation prepared in relation to a pharmaceutical benefit included in a digital image or copy of a paper-based prescription; and

(b) the supply is of a kind referred to in that item.

Documents to be kept
Item	Kind of supply	Document
1	Both of the following apply in relation to the supply: (a) the supply was the first or only supply of a pharmaceutical benefit authorised by the prescription; (b) a CTS claim is made for the supply.	The digital image, print out of the digital image or the copy of the prescription.
2	Both of the following apply in relation to the supply: (a) the supply was on the basis of a repeat authorisation or a deferred supply authorisation; (b) a CTS claim is made for the supply.	The repeat authorisation or deferred supply authorisation.
3	After the supply, there are no remaining supplies of pharmaceutical benefits that are authorised by the prescription.	The digital image, print out of the digital image or the copy of the prescription.

15 Keeping documents - PBS prescribers

Where a PBS prescriber has written a prescription referred to in subsection 10(1) and the PBS prescriber has given an approved medical practitioner, approved pharmacist or approved hospital authority dispenser a digital image or copy of the prescription, the PBS prescriber must keep the prescription for a period of at least 2 years from the date the prescription.

11 Section 12

Renumber as section 16.

12 At the end of the instrument

Add:

Part 3— Application, savings and transitional provisions

13 Continued application of Special Arrangement as in force before commencement of the National Health (COVID-19 Supply of Pharmaceutical Benefits) Amendment (Expansion of Telehealth and Telephone Attendances) Special Arrangement 2020

(1) This Special Arrangement, as in force immediately before the commencement of this section, continues to apply on and after that commencement in relation to the supply of a pharmaceutical benefit made under this Special Arrangement before that commencement.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1. The whole of this instrument	The day after this instrument is registered	8 April 2020