National Health (Medication Program for Homeless People) Special Arrangement 2021

Part 1—Preliminary

1 Name

(1) This instrument is the National Health (Medication Program for Homeless People) Special Arrangement 2021. (2) This instrument may also be cited as PB 73 of 2021.

3 Authority

This instrument is made under section 100 of the National Health Act 1953.

4 Simplified outline of this instrument

This instrument makes a special arrangement for the supply of eligible pharmaceutical benefits to eligible homeless persons.

The eligible pharmaceutical benefits will be supplied by approved pharmacists and provided directly to eligible homeless persons or alternatively, through a representative from the approved not‑for‑profit organisation, who may act as an ‘agent’ on behalf of the eligible homeless person.

This instrument also deals with payments for these supplies and administrative matters.

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).

5 Definitions

Note: The expression Secretary used in this instrument is defined in the Act.

In this instrument:

Act means the National Health Act 1953.

approval number has the meaning given by subparagraph 15(1)(a)(ii).

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

approved organisation means an organisation for which an approval under section 15 is in force.

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

concessional beneficiary has the same meaning as in Part VII of the Act.

eligible patient: a person is an eligible patient if:

(a) the person is a concessional beneficiary; and
(b) the person is homeless; and
(c) the person has a paper‑based prescription, or a repeat authorisation, for an eligible pharmaceutical benefit; and
(d) the person is unlikely to receive the benefit without assistance under this instrument because the person is incapable of managing the person’s affairs; and
(e) undesirable medical or social consequences are likely to occur if the person does not receive the benefit.

eligible pharmaceutical benefit means a pharmaceutical benefit, other than a pharmaceutical benefit that can only be supplied under Part VII of the Act:

(a) in accordance with a special arrangement under section 100 of the Act; or
(b) under the prescriber bag provisions.

Note: See sections 85AAA and 85AA of the Act.

homeless has the meaning given by section 6.

nominated pharmacist, for an approved organisation, means an approved pharmacist for which a nomination by the organisation is in effect under section 19.

not‑for‑profit entity means:

(a) an entity that is entitled to be registered under the Australian Charities and Not‑for‑profits Commission Act 2012; or
(b) a non‑profit body (within the meaning of the Electronic Transactions Act 1999).

paper‑based prescription has the same meaning as in the Regulations.

pharmaceutical benefit has the same meaning as in Part VII of the Act.

prescriber bag provisions has the same meaning as in Part VII of the Act.

Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.

repeat authorisation has the same meaning as in the Regulations.

special arrangement supply has the meaning given by section 8.

value for safety net purposes has the same meaning as in Part VII of the Act.

6 Definition of homeless

(1) A person is homeless if: (a) the person does not have conventional accommodation; or (b) the person moves frequently from one form of temporary shelter to another.

Note 1: For example, paragraph (a) covers persons living on the streets, sleeping in parks, squatting in derelict buildings or using cars or railway carriages for temporary shelter.

Note 2: For example, paragraph (b) covers persons using emergency accommodation (such as hostels for the homeless or night shelters), teenagers staying in youth refuges, and women and children escaping domestic violence (staying in women’s refuges).

(2) For the purposes of this instrument, a person is not homeless if the person is a care recipient of residential care within the meaning of the Aged Care Act 1997.

7 Application of this instrument

This instrument applies to a supply of an eligible pharmaceutical benefit that is made on or after 1 July 2021.

Part 1—Preliminary

1 Name

(1) This instrument is the National Health (Medication Program for Homeless People) Special Arrangement 2021. (2) This instrument may also be cited as PB 73 of 2021.

3 Authority

This instrument is made under section 100 of the National Health Act 1953.

4 Simplified outline of this instrument

This instrument makes a special arrangement for the supply of eligible pharmaceutical benefits to eligible homeless persons.

The eligible pharmaceutical benefits will be supplied by approved pharmacists and provided directly to eligible homeless persons or alternatively, through a representative from the approved not‑for‑profit organisation, who may act as an ‘agent’ on behalf of the eligible homeless person.

This instrument also deals with payments for these supplies and administrative matters.

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).

5 Definitions

Note: The expression Secretary used in this instrument is defined in the Act.

In this instrument:

Act means the National Health Act 1953.

approval number has the meaning given by subparagraph 15(1)(a)(ii).

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

approved organisation means an organisation for which an approval under section 15 is in force.

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

concessional beneficiary has the same meaning as in Part VII of the Act.

eligible patient: a person is an eligible patient if:

(a) the person is a concessional beneficiary; and
(b) the person is homeless; and
(c) the person has a paper‑based prescription, or a repeat authorisation, for an eligible pharmaceutical benefit; and
(d) the person is unlikely to receive the benefit without assistance under this instrument because the person is incapable of managing the person’s affairs; and
(e) undesirable medical or social consequences are likely to occur if the person does not receive the benefit.

eligible pharmaceutical benefit means a pharmaceutical benefit, other than a pharmaceutical benefit that can only be supplied under Part VII of the Act:

(a) in accordance with a special arrangement under section 100 of the Act; or
(b) under the prescriber bag provisions.

Note: See sections 85AAA and 85AA of the Act.

homeless has the meaning given by section 6.

nominated pharmacist, for an approved organisation, means an approved pharmacist for which a nomination by the organisation is in effect under section 19.

not‑for‑profit entity means:

(a) an entity that is entitled to be registered under the Australian Charities and Not‑for‑profits Commission Act 2012; or
(b) a non‑profit body (within the meaning of the Electronic Transactions Act 1999).

paper‑based prescription has the same meaning as in the Regulations.

pharmaceutical benefit has the same meaning as in Part VII of the Act.

prescriber bag provisions has the same meaning as in Part VII of the Act.

Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.

repeat authorisation has the same meaning as in the Regulations.

special arrangement supply has the meaning given by section 8.

value for safety net purposes has the same meaning as in Part VII of the Act.

6 Definition of homeless

(1) A person is homeless if: (a) the person does not have conventional accommodation; or (b) the person moves frequently from one form of temporary shelter to another.

Note 1: For example, paragraph (a) covers persons living on the streets, sleeping in parks, squatting in derelict buildings or using cars or railway carriages for temporary shelter.

Note 2: For example, paragraph (b) covers persons using emergency accommodation (such as hostels for the homeless or night shelters), teenagers staying in youth refuges, and women and children escaping domestic violence (staying in women’s refuges).

(2) For the purposes of this instrument, a person is not homeless if the person is a care recipient of residential care within the meaning of the Aged Care Act 1997.

7 Application of this instrument

This instrument applies to a supply of an eligible pharmaceutical benefit that is made on or after 1 July 2021.

Part 2—Special arrangement supplies of eligible pharmaceutical benefits

Division 1—Preliminary

8 Definition of special arrangement supply

A supply of an eligible pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is: (a) for supply to an eligible patient; and (b) supplied by a nominated pharmacist for an approved organisation; and (c) supplied on the basis of a paper‑based prescription, or a repeat authorisation, that is annotated with the organisation’s approval number by: (i) the approved organisation; or (ii) in exceptional circumstances, the nominated pharmacist as authorised by the approved organisation.

Division 2—Special arrangement supplies of eligible pharmaceutical benefits

9 Limited charges for supplies (no co‑payment)

Subsection 87(2) of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.

10 Value for safety net purposes for supplies

(1) The value for safety net purposes of a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply. (2) This section has effect despite section 17A of the Regulations.

11 No supply without prescription (continued dispensing)

Section 89A of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.

Division 3—Payment for special arrangement supplies of eligible pharmaceutical benefits

12 Payment for supply of benefits

(1) An approved pharmacist who has made a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is, subject to section 99AAA of the Act and to the conditions determined under section 98C of the Act and applicable at the time of the supply, entitled to be paid by the Commonwealth an amount that is equal to the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply. (2) This section has effect in addition to section 99 of the Act.

13 Claims for payment for supply of benefits

(1) A claim for payment of an amount to which an approved pharmacist is entitled under section 12 in respect of a special arrangement supply of an eligible pharmaceutical benefit must include the approval number of the approved organisation annotated on the prescription or repeat authorisation for the supply. (2) This section has effect in addition to section 99AAA of the Act.

Part 3—Administration

Division 1—Approved organisations

14 Organisations may apply for approval

(1) An organisation may apply to the Secretary to be approved for the purposes of this instrument. (2) The application must: (a) be made in writing; and (b) include one or more nominations of approved pharmacists under section 19; and (c) be made in the form (if any) approved under section 20.

15 Decision on application

(1) If the Secretary receives an application in accordance with section 14 to approve an organisation, the Secretary must, as soon as is reasonably practicable: (a) if the Secretary is reasonably satisfied of the matters mentioned in subsection (2): (i) approve the organisation; and (ii) allocate a unique number (the organisation’s approval number) to the organisation; or (b) otherwise—refuse the application. (2) For the purposes of paragraph (1)(a), the matters are as follows: (a) the organisation is a not‑for‑profit entity; (b) the organisation has a function of providing care to homeless people; (c) the organisation is not an approved pharmacist or an approved hospital authority; (d) were the organisation to be approved, the organisation would assist eligible patients to receive special arrangement supplies of eligible pharmaceutical benefits in accordance with this instrument. (3) The Secretary must give the organisation notice in writing of: (a) the decision; and (b) the date the decision takes effect; and (c) if the decision was to approve the organisation—the organisation’s approval number.

16 Monthly reporting by approved organisations

(1) Within 14 days after the end of a month, an approved organisation must give the Secretary a report of the total number of prescriptions and repeat authorisations presented by the organisation to nominated pharmacists for the organisation for special arrangement supplies of eligible pharmaceutical benefits in the month. (2) The report must be made: (a) in writing; and (b) in the form (if any) approved under section 20.

17 Secretary may request further information from approved organisations

(1) The Secretary may, in writing, ask an approved organisation to give the Secretary further information in relation to prescriptions and repeat authorisations mentioned in section 16. (2) A request for information must: (a) be in writing; and (b) specify a day for complying with the request which is at least 28 days after the day of the request.

18 Approved organisations to supply information on request

If an approved organisation receives a request for information under section 17, the organisation must comply with the request by the day specified in the request.

Division 2—Nominated pharmacists

19 Nominating approved pharmacists

(1) An organisation may nominate an approved pharmacist for the purposes of making special arrangement supplies of eligible pharmaceutical benefits only if the approved pharmacist would be able to: (a) ensure that prescriptions and repeat authorisations for such supplies are annotated with the organisation’s approval number; and (b) maintain records of the value for safety net purposes of such supplies; and (c) make such supplies in urgent circumstances. (2) A nomination under this section must: (a) be included in an application under section 14; or (b) be made to the Secretary: (i) in writing; and (ii) in the form (if any) approved under section 20.

Division 3—Approved forms

20 Secretary may approve forms

The Secretary may, in writing, approve a form for the purposes of a provision of this instrument.

Division 4—Review of decisions

21 Internal review of decisions

Application for review (1) A person who is affected by a decision of the Secretary under this instrument may apply to the Secretary for review of the decision. (2) An application for review must: (a) be in writing; and (b) be made in the form (if any) approved under section 20; and (c) be made within: (i) 28 days after the day the decision first came to the notice of the applicant; or (ii) if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period. Review of decision (3) On receiving an application, the Secretary must: (a) review the decision; and (b) affirm, vary or set aside the decision; and (c) if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside. (4) The decision (the decision on review) of the Secretary takes effect: (a) on the day specified in the decision on review; or (b) if a day is not specified—on the day the decision on review was made. Notice of decision (5) After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following: (a) the terms of the decision; (b) the reasons for the decision.

Part 1—Preliminary

1 Name

(1) This instrument is the National Health (Medication Program for Homeless People) Special Arrangement 2021. (2) This instrument may also be cited as PB 73 of 2021.

3 Authority

This instrument is made under section 100 of the National Health Act 1953.

4 Simplified outline of this instrument

This instrument makes a special arrangement for the supply of eligible pharmaceutical benefits to eligible homeless persons.

The eligible pharmaceutical benefits will be supplied by approved pharmacists and provided directly to eligible homeless persons or alternatively, through a representative from the approved not‑for‑profit organisation, who may act as an ‘agent’ on behalf of the eligible homeless person.

This instrument also deals with payments for these supplies and administrative matters.

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).

5 Definitions

Note: The expression Secretary used in this instrument is defined in the Act.

In this instrument:

Act means the National Health Act 1953.

approval number has the meaning given by subparagraph 15(1)(a)(ii).

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

approved organisation means an organisation for which an approval under section 15 is in force.

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

concessional beneficiary has the same meaning as in Part VII of the Act.

eligible patient: a person is an eligible patient if:

(a) the person is a concessional beneficiary; and
(b) the person is homeless; and
(c) the person has a paper‑based prescription, or a repeat authorisation, for an eligible pharmaceutical benefit; and
(d) the person is unlikely to receive the benefit without assistance under this instrument because the person is incapable of managing the person’s affairs; and
(e) undesirable medical or social consequences are likely to occur if the person does not receive the benefit.

eligible pharmaceutical benefit means a pharmaceutical benefit, other than a pharmaceutical benefit that can only be supplied under Part VII of the Act:

(a) in accordance with a special arrangement under section 100 of the Act; or
(b) under the prescriber bag provisions.

Note: See sections 85AAA and 85AA of the Act.

homeless has the meaning given by section 6.

nominated pharmacist, for an approved organisation, means an approved pharmacist for which a nomination by the organisation is in effect under section 19.

not‑for‑profit entity means:

(a) an entity that is entitled to be registered under the Australian Charities and Not‑for‑profits Commission Act 2012; or
(b) a non‑profit body (within the meaning of the Electronic Transactions Act 1999).

paper‑based prescription has the same meaning as in the Regulations.

pharmaceutical benefit has the same meaning as in Part VII of the Act.

prescriber bag provisions has the same meaning as in Part VII of the Act.

Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.

repeat authorisation has the same meaning as in the Regulations.

special arrangement supply has the meaning given by section 8.

value for safety net purposes has the same meaning as in Part VII of the Act.

6 Definition of homeless

(1) A person is homeless if: (a) the person does not have conventional accommodation; or (b) the person moves frequently from one form of temporary shelter to another.

Note 1: For example, paragraph (a) covers persons living on the streets, sleeping in parks, squatting in derelict buildings or using cars or railway carriages for temporary shelter.

Note 2: For example, paragraph (b) covers persons using emergency accommodation (such as hostels for the homeless or night shelters), teenagers staying in youth refuges, and women and children escaping domestic violence (staying in women’s refuges).

(2) For the purposes of this instrument, a person is not homeless if the person is a care recipient of residential care within the meaning of the Aged Care Act 1997.

7 Application of this instrument

This instrument applies to a supply of an eligible pharmaceutical benefit that is made on or after 1 July 2021.

Part 2—Special arrangement supplies of eligible pharmaceutical benefits

Division 1—Preliminary

8 Definition of special arrangement supply

A supply of an eligible pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is: (a) for supply to an eligible patient; and (b) supplied by a nominated pharmacist for an approved organisation; and (c) supplied on the basis of a paper‑based prescription, or a repeat authorisation, that is annotated with the organisation’s approval number by: (i) the approved organisation; or (ii) in exceptional circumstances, the nominated pharmacist as authorised by the approved organisation.

Division 2—Special arrangement supplies of eligible pharmaceutical benefits

9 Limited charges for supplies (no co‑payment)

Subsection 87(2) of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.

10 Value for safety net purposes for supplies

(1) The value for safety net purposes of a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply. (2) This section has effect despite section 17A of the Regulations.

11 No supply without prescription (continued dispensing)

Section 89A of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.

Division 3—Payment for special arrangement supplies of eligible pharmaceutical benefits

12 Payment for supply of benefits

(1) An approved pharmacist who has made a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is, subject to section 99AAA of the Act and to the conditions determined under section 98C of the Act and applicable at the time of the supply, entitled to be paid by the Commonwealth an amount that is equal to the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply. (2) This section has effect in addition to section 99 of the Act.

13 Claims for payment for supply of benefits

(1) A claim for payment of an amount to which an approved pharmacist is entitled under section 12 in respect of a special arrangement supply of an eligible pharmaceutical benefit must include the approval number of the approved organisation annotated on the prescription or repeat authorisation for the supply. (2) This section has effect in addition to section 99AAA of the Act.

Part 3—Administration

Division 1—Approved organisations

14 Organisations may apply for approval

(1) An organisation may apply to the Secretary to be approved for the purposes of this instrument. (2) The application must: (a) be made in writing; and (b) include one or more nominations of approved pharmacists under section 19; and (c) be made in the form (if any) approved under section 20.

15 Decision on application

(1) If the Secretary receives an application in accordance with section 14 to approve an organisation, the Secretary must, as soon as is reasonably practicable: (a) if the Secretary is reasonably satisfied of the matters mentioned in subsection (2): (i) approve the organisation; and (ii) allocate a unique number (the organisation’s approval number) to the organisation; or (b) otherwise—refuse the application. (2) For the purposes of paragraph (1)(a), the matters are as follows: (a) the organisation is a not‑for‑profit entity; (b) the organisation has a function of providing care to homeless people; (c) the organisation is not an approved pharmacist or an approved hospital authority; (d) were the organisation to be approved, the organisation would assist eligible patients to receive special arrangement supplies of eligible pharmaceutical benefits in accordance with this instrument. (3) The Secretary must give the organisation notice in writing of: (a) the decision; and (b) the date the decision takes effect; and (c) if the decision was to approve the organisation—the organisation’s approval number.

16 Monthly reporting by approved organisations

(1) Within 14 days after the end of a month, an approved organisation must give the Secretary a report of the total number of prescriptions and repeat authorisations presented by the organisation to nominated pharmacists for the organisation for special arrangement supplies of eligible pharmaceutical benefits in the month. (2) The report must be made: (a) in writing; and (b) in the form (if any) approved under section 20.

17 Secretary may request further information from approved organisations

(1) The Secretary may, in writing, ask an approved organisation to give the Secretary further information in relation to prescriptions and repeat authorisations mentioned in section 16. (2) A request for information must: (a) be in writing; and (b) specify a day for complying with the request which is at least 28 days after the day of the request.

18 Approved organisations to supply information on request

If an approved organisation receives a request for information under section 17, the organisation must comply with the request by the day specified in the request.

Division 2—Nominated pharmacists

19 Nominating approved pharmacists

(1) An organisation may nominate an approved pharmacist for the purposes of making special arrangement supplies of eligible pharmaceutical benefits only if the approved pharmacist would be able to: (a) ensure that prescriptions and repeat authorisations for such supplies are annotated with the organisation’s approval number; and (b) maintain records of the value for safety net purposes of such supplies; and (c) make such supplies in urgent circumstances. (2) A nomination under this section must: (a) be included in an application under section 14; or (b) be made to the Secretary: (i) in writing; and (ii) in the form (if any) approved under section 20.

Division 3—Approved forms

20 Secretary may approve forms

The Secretary may, in writing, approve a form for the purposes of a provision of this instrument.

Division 4—Review of decisions

21 Internal review of decisions

Application for review (1) A person who is affected by a decision of the Secretary under this instrument may apply to the Secretary for review of the decision. (2) An application for review must: (a) be in writing; and (b) be made in the form (if any) approved under section 20; and (c) be made within: (i) 28 days after the day the decision first came to the notice of the applicant; or (ii) if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period. Review of decision (3) On receiving an application, the Secretary must: (a) review the decision; and (b) affirm, vary or set aside the decision; and (c) if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside. (4) The decision (the decision on review) of the Secretary takes effect: (a) on the day specified in the decision on review; or (b) if a day is not specified—on the day the decision on review was made. Notice of decision (5) After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following: (a) the terms of the decision; (b) the reasons for the decision.

8 Definition of special arrangement supply

A supply of an eligible pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is: (a) for supply to an eligible patient; and (b) supplied by a nominated pharmacist for an approved organisation; and (c) supplied on the basis of a paper‑based prescription, or a repeat authorisation, that is annotated with the organisation’s approval number by: (i) the approved organisation; or (ii) in exceptional circumstances, the nominated pharmacist as authorised by the approved organisation.

Part 1—Preliminary

1 Name

(1) This instrument is the National Health (Medication Program for Homeless People) Special Arrangement 2021. (2) This instrument may also be cited as PB 73 of 2021.

3 Authority

This instrument is made under section 100 of the National Health Act 1953.

4 Simplified outline of this instrument

This instrument makes a special arrangement for the supply of eligible pharmaceutical benefits to eligible homeless persons.

The eligible pharmaceutical benefits will be supplied by approved pharmacists and provided directly to eligible homeless persons or alternatively, through a representative from the approved not‑for‑profit organisation, who may act as an ‘agent’ on behalf of the eligible homeless person.

This instrument also deals with payments for these supplies and administrative matters.

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).

5 Definitions

Note: The expression Secretary used in this instrument is defined in the Act.

In this instrument:

Act means the National Health Act 1953.

approval number has the meaning given by subparagraph 15(1)(a)(ii).

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

approved organisation means an organisation for which an approval under section 15 is in force.

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

concessional beneficiary has the same meaning as in Part VII of the Act.

eligible patient: a person is an eligible patient if:

(a) the person is a concessional beneficiary; and
(b) the person is homeless; and
(c) the person has a paper‑based prescription, or a repeat authorisation, for an eligible pharmaceutical benefit; and
(d) the person is unlikely to receive the benefit without assistance under this instrument because the person is incapable of managing the person’s affairs; and
(e) undesirable medical or social consequences are likely to occur if the person does not receive the benefit.

eligible pharmaceutical benefit means a pharmaceutical benefit, other than a pharmaceutical benefit that can only be supplied under Part VII of the Act:

(a) in accordance with a special arrangement under section 100 of the Act; or
(b) under the prescriber bag provisions.

Note: See sections 85AAA and 85AA of the Act.

homeless has the meaning given by section 6.

nominated pharmacist, for an approved organisation, means an approved pharmacist for which a nomination by the organisation is in effect under section 19.

not‑for‑profit entity means:

(a) an entity that is entitled to be registered under the Australian Charities and Not‑for‑profits Commission Act 2012; or
(b) a non‑profit body (within the meaning of the Electronic Transactions Act 1999).

paper‑based prescription has the same meaning as in the Regulations.

pharmaceutical benefit has the same meaning as in Part VII of the Act.

prescriber bag provisions has the same meaning as in Part VII of the Act.

Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.

repeat authorisation has the same meaning as in the Regulations.

special arrangement supply has the meaning given by section 8.

value for safety net purposes has the same meaning as in Part VII of the Act.

6 Definition of homeless

(1) A person is homeless if: (a) the person does not have conventional accommodation; or (b) the person moves frequently from one form of temporary shelter to another.

Note 1: For example, paragraph (a) covers persons living on the streets, sleeping in parks, squatting in derelict buildings or using cars or railway carriages for temporary shelter.

Note 2: For example, paragraph (b) covers persons using emergency accommodation (such as hostels for the homeless or night shelters), teenagers staying in youth refuges, and women and children escaping domestic violence (staying in women’s refuges).

(2) For the purposes of this instrument, a person is not homeless if the person is a care recipient of residential care within the meaning of the Aged Care Act 1997.

7 Application of this instrument

This instrument applies to a supply of an eligible pharmaceutical benefit that is made on or after 1 July 2021.

Part 2—Special arrangement supplies of eligible pharmaceutical benefits

Division 1—Preliminary

8 Definition of special arrangement supply

A supply of an eligible pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is: (a) for supply to an eligible patient; and (b) supplied by a nominated pharmacist for an approved organisation; and (c) supplied on the basis of a paper‑based prescription, or a repeat authorisation, that is annotated with the organisation’s approval number by: (i) the approved organisation; or (ii) in exceptional circumstances, the nominated pharmacist as authorised by the approved organisation.

Division 2—Special arrangement supplies of eligible pharmaceutical benefits

9 Limited charges for supplies (no co‑payment)

Subsection 87(2) of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.

10 Value for safety net purposes for supplies

(1) The value for safety net purposes of a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply. (2) This section has effect despite section 17A of the Regulations.

11 No supply without prescription (continued dispensing)

Section 89A of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.

Division 3—Payment for special arrangement supplies of eligible pharmaceutical benefits

12 Payment for supply of benefits

(1) An approved pharmacist who has made a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is, subject to section 99AAA of the Act and to the conditions determined under section 98C of the Act and applicable at the time of the supply, entitled to be paid by the Commonwealth an amount that is equal to the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply. (2) This section has effect in addition to section 99 of the Act.

13 Claims for payment for supply of benefits

(1) A claim for payment of an amount to which an approved pharmacist is entitled under section 12 in respect of a special arrangement supply of an eligible pharmaceutical benefit must include the approval number of the approved organisation annotated on the prescription or repeat authorisation for the supply. (2) This section has effect in addition to section 99AAA of the Act.

Part 3—Administration

Division 1—Approved organisations

14 Organisations may apply for approval

(1) An organisation may apply to the Secretary to be approved for the purposes of this instrument. (2) The application must: (a) be made in writing; and (b) include one or more nominations of approved pharmacists under section 19; and (c) be made in the form (if any) approved under section 20.

15 Decision on application

(1) If the Secretary receives an application in accordance with section 14 to approve an organisation, the Secretary must, as soon as is reasonably practicable: (a) if the Secretary is reasonably satisfied of the matters mentioned in subsection (2): (i) approve the organisation; and (ii) allocate a unique number (the organisation’s approval number) to the organisation; or (b) otherwise—refuse the application. (2) For the purposes of paragraph (1)(a), the matters are as follows: (a) the organisation is a not‑for‑profit entity; (b) the organisation has a function of providing care to homeless people; (c) the organisation is not an approved pharmacist or an approved hospital authority; (d) were the organisation to be approved, the organisation would assist eligible patients to receive special arrangement supplies of eligible pharmaceutical benefits in accordance with this instrument. (3) The Secretary must give the organisation notice in writing of: (a) the decision; and (b) the date the decision takes effect; and (c) if the decision was to approve the organisation—the organisation’s approval number.

16 Monthly reporting by approved organisations

(1) Within 14 days after the end of a month, an approved organisation must give the Secretary a report of the total number of prescriptions and repeat authorisations presented by the organisation to nominated pharmacists for the organisation for special arrangement supplies of eligible pharmaceutical benefits in the month. (2) The report must be made: (a) in writing; and (b) in the form (if any) approved under section 20.

17 Secretary may request further information from approved organisations

(1) The Secretary may, in writing, ask an approved organisation to give the Secretary further information in relation to prescriptions and repeat authorisations mentioned in section 16. (2) A request for information must: (a) be in writing; and (b) specify a day for complying with the request which is at least 28 days after the day of the request.

18 Approved organisations to supply information on request

If an approved organisation receives a request for information under section 17, the organisation must comply with the request by the day specified in the request.

Division 2—Nominated pharmacists

19 Nominating approved pharmacists

(1) An organisation may nominate an approved pharmacist for the purposes of making special arrangement supplies of eligible pharmaceutical benefits only if the approved pharmacist would be able to: (a) ensure that prescriptions and repeat authorisations for such supplies are annotated with the organisation’s approval number; and (b) maintain records of the value for safety net purposes of such supplies; and (c) make such supplies in urgent circumstances. (2) A nomination under this section must: (a) be included in an application under section 14; or (b) be made to the Secretary: (i) in writing; and (ii) in the form (if any) approved under section 20.

Division 3—Approved forms

20 Secretary may approve forms

The Secretary may, in writing, approve a form for the purposes of a provision of this instrument.

Division 4—Review of decisions

21 Internal review of decisions

Application for review (1) A person who is affected by a decision of the Secretary under this instrument may apply to the Secretary for review of the decision. (2) An application for review must: (a) be in writing; and (b) be made in the form (if any) approved under section 20; and (c) be made within: (i) 28 days after the day the decision first came to the notice of the applicant; or (ii) if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period. Review of decision (3) On receiving an application, the Secretary must: (a) review the decision; and (b) affirm, vary or set aside the decision; and (c) if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside. (4) The decision (the decision on review) of the Secretary takes effect: (a) on the day specified in the decision on review; or (b) if a day is not specified—on the day the decision on review was made. Notice of decision (5) After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following: (a) the terms of the decision; (b) the reasons for the decision.

9 Limited charges for supplies (no co‑payment)

Subsection 87(2) of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.

10 Value for safety net purposes for supplies

(1) The value for safety net purposes of a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply. (2) This section has effect despite section 17A of the Regulations.

11 No supply without prescription (continued dispensing)

Section 89A of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.

Part 1—Preliminary

1 Name

(1) This instrument is the National Health (Medication Program for Homeless People) Special Arrangement 2021. (2) This instrument may also be cited as PB 73 of 2021.

3 Authority

This instrument is made under section 100 of the National Health Act 1953.

4 Simplified outline of this instrument

This instrument makes a special arrangement for the supply of eligible pharmaceutical benefits to eligible homeless persons.

The eligible pharmaceutical benefits will be supplied by approved pharmacists and provided directly to eligible homeless persons or alternatively, through a representative from the approved not‑for‑profit organisation, who may act as an ‘agent’ on behalf of the eligible homeless person.

This instrument also deals with payments for these supplies and administrative matters.

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).

5 Definitions

Note: The expression Secretary used in this instrument is defined in the Act.

In this instrument:

Act means the National Health Act 1953.

approval number has the meaning given by subparagraph 15(1)(a)(ii).

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

approved organisation means an organisation for which an approval under section 15 is in force.

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

concessional beneficiary has the same meaning as in Part VII of the Act.

eligible patient: a person is an eligible patient if:

(a) the person is a concessional beneficiary; and
(b) the person is homeless; and
(c) the person has a paper‑based prescription, or a repeat authorisation, for an eligible pharmaceutical benefit; and
(d) the person is unlikely to receive the benefit without assistance under this instrument because the person is incapable of managing the person’s affairs; and
(e) undesirable medical or social consequences are likely to occur if the person does not receive the benefit.

eligible pharmaceutical benefit means a pharmaceutical benefit, other than a pharmaceutical benefit that can only be supplied under Part VII of the Act:

(a) in accordance with a special arrangement under section 100 of the Act; or
(b) under the prescriber bag provisions.

Note: See sections 85AAA and 85AA of the Act.

homeless has the meaning given by section 6.

nominated pharmacist, for an approved organisation, means an approved pharmacist for which a nomination by the organisation is in effect under section 19.

not‑for‑profit entity means:

(a) an entity that is entitled to be registered under the Australian Charities and Not‑for‑profits Commission Act 2012; or
(b) a non‑profit body (within the meaning of the Electronic Transactions Act 1999).

paper‑based prescription has the same meaning as in the Regulations.

pharmaceutical benefit has the same meaning as in Part VII of the Act.

prescriber bag provisions has the same meaning as in Part VII of the Act.

Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.

repeat authorisation has the same meaning as in the Regulations.

special arrangement supply has the meaning given by section 8.

value for safety net purposes has the same meaning as in Part VII of the Act.

6 Definition of homeless

(1) A person is homeless if: (a) the person does not have conventional accommodation; or (b) the person moves frequently from one form of temporary shelter to another.

Note 1: For example, paragraph (a) covers persons living on the streets, sleeping in parks, squatting in derelict buildings or using cars or railway carriages for temporary shelter.

Note 2: For example, paragraph (b) covers persons using emergency accommodation (such as hostels for the homeless or night shelters), teenagers staying in youth refuges, and women and children escaping domestic violence (staying in women’s refuges).

(2) For the purposes of this instrument, a person is not homeless if the person is a care recipient of residential care within the meaning of the Aged Care Act 1997.

7 Application of this instrument

This instrument applies to a supply of an eligible pharmaceutical benefit that is made on or after 1 July 2021.

Part 2—Special arrangement supplies of eligible pharmaceutical benefits

Division 1—Preliminary

8 Definition of special arrangement supply

A supply of an eligible pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is: (a) for supply to an eligible patient; and (b) supplied by a nominated pharmacist for an approved organisation; and (c) supplied on the basis of a paper‑based prescription, or a repeat authorisation, that is annotated with the organisation’s approval number by: (i) the approved organisation; or (ii) in exceptional circumstances, the nominated pharmacist as authorised by the approved organisation.

Division 2—Special arrangement supplies of eligible pharmaceutical benefits

9 Limited charges for supplies (no co‑payment)

Subsection 87(2) of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.

10 Value for safety net purposes for supplies

(1) The value for safety net purposes of a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply. (2) This section has effect despite section 17A of the Regulations.

11 No supply without prescription (continued dispensing)

Section 89A of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.

Division 3—Payment for special arrangement supplies of eligible pharmaceutical benefits

12 Payment for supply of benefits

(1) An approved pharmacist who has made a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is, subject to section 99AAA of the Act and to the conditions determined under section 98C of the Act and applicable at the time of the supply, entitled to be paid by the Commonwealth an amount that is equal to the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply. (2) This section has effect in addition to section 99 of the Act.

13 Claims for payment for supply of benefits

(1) A claim for payment of an amount to which an approved pharmacist is entitled under section 12 in respect of a special arrangement supply of an eligible pharmaceutical benefit must include the approval number of the approved organisation annotated on the prescription or repeat authorisation for the supply. (2) This section has effect in addition to section 99AAA of the Act.

Part 3—Administration

Division 1—Approved organisations

14 Organisations may apply for approval

(1) An organisation may apply to the Secretary to be approved for the purposes of this instrument. (2) The application must: (a) be made in writing; and (b) include one or more nominations of approved pharmacists under section 19; and (c) be made in the form (if any) approved under section 20.

15 Decision on application

(1) If the Secretary receives an application in accordance with section 14 to approve an organisation, the Secretary must, as soon as is reasonably practicable: (a) if the Secretary is reasonably satisfied of the matters mentioned in subsection (2): (i) approve the organisation; and (ii) allocate a unique number (the organisation’s approval number) to the organisation; or (b) otherwise—refuse the application. (2) For the purposes of paragraph (1)(a), the matters are as follows: (a) the organisation is a not‑for‑profit entity; (b) the organisation has a function of providing care to homeless people; (c) the organisation is not an approved pharmacist or an approved hospital authority; (d) were the organisation to be approved, the organisation would assist eligible patients to receive special arrangement supplies of eligible pharmaceutical benefits in accordance with this instrument. (3) The Secretary must give the organisation notice in writing of: (a) the decision; and (b) the date the decision takes effect; and (c) if the decision was to approve the organisation—the organisation’s approval number.

16 Monthly reporting by approved organisations

(1) Within 14 days after the end of a month, an approved organisation must give the Secretary a report of the total number of prescriptions and repeat authorisations presented by the organisation to nominated pharmacists for the organisation for special arrangement supplies of eligible pharmaceutical benefits in the month. (2) The report must be made: (a) in writing; and (b) in the form (if any) approved under section 20.

17 Secretary may request further information from approved organisations

(1) The Secretary may, in writing, ask an approved organisation to give the Secretary further information in relation to prescriptions and repeat authorisations mentioned in section 16. (2) A request for information must: (a) be in writing; and (b) specify a day for complying with the request which is at least 28 days after the day of the request.

18 Approved organisations to supply information on request

If an approved organisation receives a request for information under section 17, the organisation must comply with the request by the day specified in the request.

Division 2—Nominated pharmacists

19 Nominating approved pharmacists

(1) An organisation may nominate an approved pharmacist for the purposes of making special arrangement supplies of eligible pharmaceutical benefits only if the approved pharmacist would be able to: (a) ensure that prescriptions and repeat authorisations for such supplies are annotated with the organisation’s approval number; and (b) maintain records of the value for safety net purposes of such supplies; and (c) make such supplies in urgent circumstances. (2) A nomination under this section must: (a) be included in an application under section 14; or (b) be made to the Secretary: (i) in writing; and (ii) in the form (if any) approved under section 20.

Division 3—Approved forms

20 Secretary may approve forms

The Secretary may, in writing, approve a form for the purposes of a provision of this instrument.

Division 4—Review of decisions

21 Internal review of decisions

Application for review (1) A person who is affected by a decision of the Secretary under this instrument may apply to the Secretary for review of the decision. (2) An application for review must: (a) be in writing; and (b) be made in the form (if any) approved under section 20; and (c) be made within: (i) 28 days after the day the decision first came to the notice of the applicant; or (ii) if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period. Review of decision (3) On receiving an application, the Secretary must: (a) review the decision; and (b) affirm, vary or set aside the decision; and (c) if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside. (4) The decision (the decision on review) of the Secretary takes effect: (a) on the day specified in the decision on review; or (b) if a day is not specified—on the day the decision on review was made. Notice of decision (5) After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following: (a) the terms of the decision; (b) the reasons for the decision.

12 Payment for supply of benefits

(1) An approved pharmacist who has made a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is, subject to section 99AAA of the Act and to the conditions determined under section 98C of the Act and applicable at the time of the supply, entitled to be paid by the Commonwealth an amount that is equal to the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply. (2) This section has effect in addition to section 99 of the Act.

13 Claims for payment for supply of benefits

(1) A claim for payment of an amount to which an approved pharmacist is entitled under section 12 in respect of a special arrangement supply of an eligible pharmaceutical benefit must include the approval number of the approved organisation annotated on the prescription or repeat authorisation for the supply. (2) This section has effect in addition to section 99AAA of the Act.

Part 1—Preliminary

1 Name

(1) This instrument is the National Health (Medication Program for Homeless People) Special Arrangement 2021. (2) This instrument may also be cited as PB 73 of 2021.

3 Authority

This instrument is made under section 100 of the National Health Act 1953.

4 Simplified outline of this instrument

This instrument makes a special arrangement for the supply of eligible pharmaceutical benefits to eligible homeless persons.

The eligible pharmaceutical benefits will be supplied by approved pharmacists and provided directly to eligible homeless persons or alternatively, through a representative from the approved not‑for‑profit organisation, who may act as an ‘agent’ on behalf of the eligible homeless person.

This instrument also deals with payments for these supplies and administrative matters.

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).

5 Definitions

Note: The expression Secretary used in this instrument is defined in the Act.

In this instrument:

Act means the National Health Act 1953.

approval number has the meaning given by subparagraph 15(1)(a)(ii).

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

approved organisation means an organisation for which an approval under section 15 is in force.

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

concessional beneficiary has the same meaning as in Part VII of the Act.

eligible patient: a person is an eligible patient if:

(a) the person is a concessional beneficiary; and
(b) the person is homeless; and
(c) the person has a paper‑based prescription, or a repeat authorisation, for an eligible pharmaceutical benefit; and
(d) the person is unlikely to receive the benefit without assistance under this instrument because the person is incapable of managing the person’s affairs; and
(e) undesirable medical or social consequences are likely to occur if the person does not receive the benefit.

eligible pharmaceutical benefit means a pharmaceutical benefit, other than a pharmaceutical benefit that can only be supplied under Part VII of the Act:

(a) in accordance with a special arrangement under section 100 of the Act; or
(b) under the prescriber bag provisions.

Note: See sections 85AAA and 85AA of the Act.

homeless has the meaning given by section 6.

nominated pharmacist, for an approved organisation, means an approved pharmacist for which a nomination by the organisation is in effect under section 19.

not‑for‑profit entity means:

(a) an entity that is entitled to be registered under the Australian Charities and Not‑for‑profits Commission Act 2012; or
(b) a non‑profit body (within the meaning of the Electronic Transactions Act 1999).

paper‑based prescription has the same meaning as in the Regulations.

pharmaceutical benefit has the same meaning as in Part VII of the Act.

prescriber bag provisions has the same meaning as in Part VII of the Act.

Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.

repeat authorisation has the same meaning as in the Regulations.

special arrangement supply has the meaning given by section 8.

value for safety net purposes has the same meaning as in Part VII of the Act.

6 Definition of homeless

(1) A person is homeless if: (a) the person does not have conventional accommodation; or (b) the person moves frequently from one form of temporary shelter to another.

Note 1: For example, paragraph (a) covers persons living on the streets, sleeping in parks, squatting in derelict buildings or using cars or railway carriages for temporary shelter.

Note 2: For example, paragraph (b) covers persons using emergency accommodation (such as hostels for the homeless or night shelters), teenagers staying in youth refuges, and women and children escaping domestic violence (staying in women’s refuges).

(2) For the purposes of this instrument, a person is not homeless if the person is a care recipient of residential care within the meaning of the Aged Care Act 1997.

7 Application of this instrument

This instrument applies to a supply of an eligible pharmaceutical benefit that is made on or after 1 July 2021.

Part 2—Special arrangement supplies of eligible pharmaceutical benefits

Division 1—Preliminary

8 Definition of special arrangement supply

A supply of an eligible pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is: (a) for supply to an eligible patient; and (b) supplied by a nominated pharmacist for an approved organisation; and (c) supplied on the basis of a paper‑based prescription, or a repeat authorisation, that is annotated with the organisation’s approval number by: (i) the approved organisation; or (ii) in exceptional circumstances, the nominated pharmacist as authorised by the approved organisation.

Division 2—Special arrangement supplies of eligible pharmaceutical benefits

9 Limited charges for supplies (no co‑payment)

Subsection 87(2) of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.

10 Value for safety net purposes for supplies

(1) The value for safety net purposes of a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply. (2) This section has effect despite section 17A of the Regulations.

11 No supply without prescription (continued dispensing)

Section 89A of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.

Division 3—Payment for special arrangement supplies of eligible pharmaceutical benefits

12 Payment for supply of benefits

(1) An approved pharmacist who has made a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is, subject to section 99AAA of the Act and to the conditions determined under section 98C of the Act and applicable at the time of the supply, entitled to be paid by the Commonwealth an amount that is equal to the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply. (2) This section has effect in addition to section 99 of the Act.

13 Claims for payment for supply of benefits

(1) A claim for payment of an amount to which an approved pharmacist is entitled under section 12 in respect of a special arrangement supply of an eligible pharmaceutical benefit must include the approval number of the approved organisation annotated on the prescription or repeat authorisation for the supply. (2) This section has effect in addition to section 99AAA of the Act.

Part 3—Administration

Division 1—Approved organisations

14 Organisations may apply for approval

(1) An organisation may apply to the Secretary to be approved for the purposes of this instrument. (2) The application must: (a) be made in writing; and (b) include one or more nominations of approved pharmacists under section 19; and (c) be made in the form (if any) approved under section 20.

15 Decision on application

(1) If the Secretary receives an application in accordance with section 14 to approve an organisation, the Secretary must, as soon as is reasonably practicable: (a) if the Secretary is reasonably satisfied of the matters mentioned in subsection (2): (i) approve the organisation; and (ii) allocate a unique number (the organisation’s approval number) to the organisation; or (b) otherwise—refuse the application. (2) For the purposes of paragraph (1)(a), the matters are as follows: (a) the organisation is a not‑for‑profit entity; (b) the organisation has a function of providing care to homeless people; (c) the organisation is not an approved pharmacist or an approved hospital authority; (d) were the organisation to be approved, the organisation would assist eligible patients to receive special arrangement supplies of eligible pharmaceutical benefits in accordance with this instrument. (3) The Secretary must give the organisation notice in writing of: (a) the decision; and (b) the date the decision takes effect; and (c) if the decision was to approve the organisation—the organisation’s approval number.

16 Monthly reporting by approved organisations

(1) Within 14 days after the end of a month, an approved organisation must give the Secretary a report of the total number of prescriptions and repeat authorisations presented by the organisation to nominated pharmacists for the organisation for special arrangement supplies of eligible pharmaceutical benefits in the month. (2) The report must be made: (a) in writing; and (b) in the form (if any) approved under section 20.

17 Secretary may request further information from approved organisations

(1) The Secretary may, in writing, ask an approved organisation to give the Secretary further information in relation to prescriptions and repeat authorisations mentioned in section 16. (2) A request for information must: (a) be in writing; and (b) specify a day for complying with the request which is at least 28 days after the day of the request.

18 Approved organisations to supply information on request

If an approved organisation receives a request for information under section 17, the organisation must comply with the request by the day specified in the request.

Division 2—Nominated pharmacists

19 Nominating approved pharmacists

(1) An organisation may nominate an approved pharmacist for the purposes of making special arrangement supplies of eligible pharmaceutical benefits only if the approved pharmacist would be able to: (a) ensure that prescriptions and repeat authorisations for such supplies are annotated with the organisation’s approval number; and (b) maintain records of the value for safety net purposes of such supplies; and (c) make such supplies in urgent circumstances. (2) A nomination under this section must: (a) be included in an application under section 14; or (b) be made to the Secretary: (i) in writing; and (ii) in the form (if any) approved under section 20.

Division 3—Approved forms

20 Secretary may approve forms

The Secretary may, in writing, approve a form for the purposes of a provision of this instrument.

Division 4—Review of decisions

21 Internal review of decisions

Application for review (1) A person who is affected by a decision of the Secretary under this instrument may apply to the Secretary for review of the decision. (2) An application for review must: (a) be in writing; and (b) be made in the form (if any) approved under section 20; and (c) be made within: (i) 28 days after the day the decision first came to the notice of the applicant; or (ii) if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period. Review of decision (3) On receiving an application, the Secretary must: (a) review the decision; and (b) affirm, vary or set aside the decision; and (c) if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside. (4) The decision (the decision on review) of the Secretary takes effect: (a) on the day specified in the decision on review; or (b) if a day is not specified—on the day the decision on review was made. Notice of decision (5) After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following: (a) the terms of the decision; (b) the reasons for the decision.

14 Organisations may apply for approval

(1) An organisation may apply to the Secretary to be approved for the purposes of this instrument. (2) The application must: (a) be made in writing; and (b) include one or more nominations of approved pharmacists under section 19; and (c) be made in the form (if any) approved under section 20.

15 Decision on application

(1) If the Secretary receives an application in accordance with section 14 to approve an organisation, the Secretary must, as soon as is reasonably practicable: (a) if the Secretary is reasonably satisfied of the matters mentioned in subsection (2): (i) approve the organisation; and (ii) allocate a unique number (the organisation’s approval number) to the organisation; or (b) otherwise—refuse the application. (2) For the purposes of paragraph (1)(a), the matters are as follows: (a) the organisation is a not‑for‑profit entity; (b) the organisation has a function of providing care to homeless people; (c) the organisation is not an approved pharmacist or an approved hospital authority; (d) were the organisation to be approved, the organisation would assist eligible patients to receive special arrangement supplies of eligible pharmaceutical benefits in accordance with this instrument. (3) The Secretary must give the organisation notice in writing of: (a) the decision; and (b) the date the decision takes effect; and (c) if the decision was to approve the organisation—the organisation’s approval number.

16 Monthly reporting by approved organisations

(1) Within 14 days after the end of a month, an approved organisation must give the Secretary a report of the total number of prescriptions and repeat authorisations presented by the organisation to nominated pharmacists for the organisation for special arrangement supplies of eligible pharmaceutical benefits in the month. (2) The report must be made: (a) in writing; and (b) in the form (if any) approved under section 20.

17 Secretary may request further information from approved organisations

(1) The Secretary may, in writing, ask an approved organisation to give the Secretary further information in relation to prescriptions and repeat authorisations mentioned in section 16. (2) A request for information must: (a) be in writing; and (b) specify a day for complying with the request which is at least 28 days after the day of the request.

18 Approved organisations to supply information on request

If an approved organisation receives a request for information under section 17, the organisation must comply with the request by the day specified in the request.

19 Nominating approved pharmacists

(1) An organisation may nominate an approved pharmacist for the purposes of making special arrangement supplies of eligible pharmaceutical benefits only if the approved pharmacist would be able to: (a) ensure that prescriptions and repeat authorisations for such supplies are annotated with the organisation’s approval number; and (b) maintain records of the value for safety net purposes of such supplies; and (c) make such supplies in urgent circumstances. (2) A nomination under this section must: (a) be included in an application under section 14; or (b) be made to the Secretary: (i) in writing; and (ii) in the form (if any) approved under section 20.

20 Secretary may approve forms

The Secretary may, in writing, approve a form for the purposes of a provision of this instrument.

Part 1—Preliminary

1 Name

(1) This instrument is the National Health (Medication Program for Homeless People) Special Arrangement 2021. (2) This instrument may also be cited as PB 73 of 2021.

3 Authority

This instrument is made under section 100 of the National Health Act 1953.

4 Simplified outline of this instrument

This instrument makes a special arrangement for the supply of eligible pharmaceutical benefits to eligible homeless persons.

The eligible pharmaceutical benefits will be supplied by approved pharmacists and provided directly to eligible homeless persons or alternatively, through a representative from the approved not‑for‑profit organisation, who may act as an ‘agent’ on behalf of the eligible homeless person.

This instrument also deals with payments for these supplies and administrative matters.

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).

5 Definitions

Note: The expression Secretary used in this instrument is defined in the Act.

In this instrument:

Act means the National Health Act 1953.

approval number has the meaning given by subparagraph 15(1)(a)(ii).

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

approved organisation means an organisation for which an approval under section 15 is in force.

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

concessional beneficiary has the same meaning as in Part VII of the Act.

eligible patient: a person is an eligible patient if:

(a) the person is a concessional beneficiary; and
(b) the person is homeless; and
(c) the person has a paper‑based prescription, or a repeat authorisation, for an eligible pharmaceutical benefit; and
(d) the person is unlikely to receive the benefit without assistance under this instrument because the person is incapable of managing the person’s affairs; and
(e) undesirable medical or social consequences are likely to occur if the person does not receive the benefit.

eligible pharmaceutical benefit means a pharmaceutical benefit, other than a pharmaceutical benefit that can only be supplied under Part VII of the Act:

(a) in accordance with a special arrangement under section 100 of the Act; or
(b) under the prescriber bag provisions.

Note: See sections 85AAA and 85AA of the Act.

homeless has the meaning given by section 6.

nominated pharmacist, for an approved organisation, means an approved pharmacist for which a nomination by the organisation is in effect under section 19.

not‑for‑profit entity means:

(a) an entity that is entitled to be registered under the Australian Charities and Not‑for‑profits Commission Act 2012; or
(b) a non‑profit body (within the meaning of the Electronic Transactions Act 1999).

paper‑based prescription has the same meaning as in the Regulations.

pharmaceutical benefit has the same meaning as in Part VII of the Act.

prescriber bag provisions has the same meaning as in Part VII of the Act.

Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.

repeat authorisation has the same meaning as in the Regulations.

special arrangement supply has the meaning given by section 8.

value for safety net purposes has the same meaning as in Part VII of the Act.

6 Definition of homeless

(1) A person is homeless if: (a) the person does not have conventional accommodation; or (b) the person moves frequently from one form of temporary shelter to another.

Note 1: For example, paragraph (a) covers persons living on the streets, sleeping in parks, squatting in derelict buildings or using cars or railway carriages for temporary shelter.

Note 2: For example, paragraph (b) covers persons using emergency accommodation (such as hostels for the homeless or night shelters), teenagers staying in youth refuges, and women and children escaping domestic violence (staying in women’s refuges).

(2) For the purposes of this instrument, a person is not homeless if the person is a care recipient of residential care within the meaning of the Aged Care Act 1997.

7 Application of this instrument

This instrument applies to a supply of an eligible pharmaceutical benefit that is made on or after 1 July 2021.

Part 2—Special arrangement supplies of eligible pharmaceutical benefits

Division 1—Preliminary

8 Definition of special arrangement supply

A supply of an eligible pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is: (a) for supply to an eligible patient; and (b) supplied by a nominated pharmacist for an approved organisation; and (c) supplied on the basis of a paper‑based prescription, or a repeat authorisation, that is annotated with the organisation’s approval number by: (i) the approved organisation; or (ii) in exceptional circumstances, the nominated pharmacist as authorised by the approved organisation.

Division 2—Special arrangement supplies of eligible pharmaceutical benefits

9 Limited charges for supplies (no co‑payment)

Subsection 87(2) of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.

10 Value for safety net purposes for supplies

(1) The value for safety net purposes of a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply. (2) This section has effect despite section 17A of the Regulations.

11 No supply without prescription (continued dispensing)

Section 89A of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.

Division 3—Payment for special arrangement supplies of eligible pharmaceutical benefits

12 Payment for supply of benefits

(1) An approved pharmacist who has made a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is, subject to section 99AAA of the Act and to the conditions determined under section 98C of the Act and applicable at the time of the supply, entitled to be paid by the Commonwealth an amount that is equal to the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply. (2) This section has effect in addition to section 99 of the Act.

13 Claims for payment for supply of benefits

(1) A claim for payment of an amount to which an approved pharmacist is entitled under section 12 in respect of a special arrangement supply of an eligible pharmaceutical benefit must include the approval number of the approved organisation annotated on the prescription or repeat authorisation for the supply. (2) This section has effect in addition to section 99AAA of the Act.

Part 3—Administration

Division 1—Approved organisations

14 Organisations may apply for approval

(1) An organisation may apply to the Secretary to be approved for the purposes of this instrument. (2) The application must: (a) be made in writing; and (b) include one or more nominations of approved pharmacists under section 19; and (c) be made in the form (if any) approved under section 20.

15 Decision on application

(1) If the Secretary receives an application in accordance with section 14 to approve an organisation, the Secretary must, as soon as is reasonably practicable: (a) if the Secretary is reasonably satisfied of the matters mentioned in subsection (2): (i) approve the organisation; and (ii) allocate a unique number (the organisation’s approval number) to the organisation; or (b) otherwise—refuse the application. (2) For the purposes of paragraph (1)(a), the matters are as follows: (a) the organisation is a not‑for‑profit entity; (b) the organisation has a function of providing care to homeless people; (c) the organisation is not an approved pharmacist or an approved hospital authority; (d) were the organisation to be approved, the organisation would assist eligible patients to receive special arrangement supplies of eligible pharmaceutical benefits in accordance with this instrument. (3) The Secretary must give the organisation notice in writing of: (a) the decision; and (b) the date the decision takes effect; and (c) if the decision was to approve the organisation—the organisation’s approval number.

16 Monthly reporting by approved organisations

(1) Within 14 days after the end of a month, an approved organisation must give the Secretary a report of the total number of prescriptions and repeat authorisations presented by the organisation to nominated pharmacists for the organisation for special arrangement supplies of eligible pharmaceutical benefits in the month. (2) The report must be made: (a) in writing; and (b) in the form (if any) approved under section 20.

17 Secretary may request further information from approved organisations

(1) The Secretary may, in writing, ask an approved organisation to give the Secretary further information in relation to prescriptions and repeat authorisations mentioned in section 16. (2) A request for information must: (a) be in writing; and (b) specify a day for complying with the request which is at least 28 days after the day of the request.

18 Approved organisations to supply information on request

If an approved organisation receives a request for information under section 17, the organisation must comply with the request by the day specified in the request.

Division 2—Nominated pharmacists

19 Nominating approved pharmacists

(1) An organisation may nominate an approved pharmacist for the purposes of making special arrangement supplies of eligible pharmaceutical benefits only if the approved pharmacist would be able to: (a) ensure that prescriptions and repeat authorisations for such supplies are annotated with the organisation’s approval number; and (b) maintain records of the value for safety net purposes of such supplies; and (c) make such supplies in urgent circumstances. (2) A nomination under this section must: (a) be included in an application under section 14; or (b) be made to the Secretary: (i) in writing; and (ii) in the form (if any) approved under section 20.

Division 3—Approved forms

20 Secretary may approve forms

The Secretary may, in writing, approve a form for the purposes of a provision of this instrument.

Division 4—Review of decisions

21 Internal review of decisions

Application for review (1) A person who is affected by a decision of the Secretary under this instrument may apply to the Secretary for review of the decision. (2) An application for review must: (a) be in writing; and (b) be made in the form (if any) approved under section 20; and (c) be made within: (i) 28 days after the day the decision first came to the notice of the applicant; or (ii) if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period. Review of decision (3) On receiving an application, the Secretary must: (a) review the decision; and (b) affirm, vary or set aside the decision; and (c) if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside. (4) The decision (the decision on review) of the Secretary takes effect: (a) on the day specified in the decision on review; or (b) if a day is not specified—on the day the decision on review was made. Notice of decision (5) After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following: (a) the terms of the decision; (b) the reasons for the decision.

21 Internal review of decisions

Application for review (1) A person who is affected by a decision of the Secretary under this instrument may apply to the Secretary for review of the decision. (2) An application for review must: (a) be in writing; and (b) be made in the form (if any) approved under section 20; and (c) be made within: (i) 28 days after the day the decision first came to the notice of the applicant; or (ii) if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period. Review of decision (3) On receiving an application, the Secretary must: (a) review the decision; and (b) affirm, vary or set aside the decision; and (c) if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside. (4) The decision (the decision on review) of the Secretary takes effect: (a) on the day specified in the decision on review; or (b) if a day is not specified—on the day the decision on review was made. Notice of decision (5) After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following: (a) the terms of the decision; (b) the reasons for the decision.