National Health (Highly Specialised Drugs Program) Special Arrangement 2021

National Health (Highly Specialised Drugs Program) Special Arrangement 2021

PB 27 of 2021

made under sections 85, 85A, 88, 99 and 100 of the

National Health Act 1953

Compilation No. 63

Compilation date: 1 July 2026

Includes amendments: F2026L00801 and F2026L00901

This compilation is in 2 volumes

Each volume has its own contents

About this compilation

This compilation

This is a compilation of the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 that shows the text of the law as amended and in force on 1 July 2026 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au).

Application, saving and transitional provisions

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Presentational changes

The Legislation Act 2003 provides for First Parliamentary Counsel to make presentational changes to a compilation. Presentational changes are applied to give a more consistent look and feel to legislation published on the Register, and enable the user to more easily navigate those documents.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. Any modifications affecting the law are accessible on the Register.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

Contents

Part 1—Preliminary

Division 1—General

1 Name

3 Authority

5 Simplified outline of this instrument

6 Definitions

7 Definition of authorised prescriber

8 Definition of eligible patient

Division 2—Supplies of HSD pharmaceutical benefits from hospitals

9 Supplies of HSD pharmaceutical benefits by approved hospital authorities to patients receiving treatment from hospitals

Division 3—HSD hospital authorities

10 HSD hospital authorities

11 References to approved suppliers and approved hospital authorities

12 Numbers allotted to HSD hospital authorities

Part 2—Special arrangement supplies of HSD pharmaceutical benefits

Division 1—Preliminary

13 Definition of special arrangement supply

Division 2—Prescribing of HSD pharmaceutical benefits

15 Prescription circumstances—general (Act s 85(7)(a) and (b))

16 Prescription circumstances—authority required procedures

18 When medication chart prescriptions not to be written

19 Prescriptions not to direct repeated supplies for visitors to Australia

20 Maximum quantity or number of units (Act s 85A(2)(a))

21 Maximum number of repeats (Act s 85A(2)(b))

23 Records to be kept—prescriptions for HSD pharmaceutical benefits that have eculizumab for the treatment of atypical haemolytic uraemic syndrome

Division 3—Supplying HSD pharmaceutical benefits

24 Special patient contribution for certain HSD pharmaceutical benefits

25 Conditions for approved pharmacists

26 Supplies need not be directly to persons

27 Repeated supplies of pharmaceutical benefits

Part 3—Payment for special arrangement supplies of HSD pharmaceutical benefits

Division 1—Supplies by approved hospital authorities for public hospitals

28 Rates of payment for approved hospital authorities for public hospitals (Act s 99(4))

29 Dispensed price for approved hospital authorities for public hospitals

Division 2—Supplies by other approved suppliers

30 Entitlement to, and amount of, payment for approved pharmacists and approved medical practitioners

30A Paragraph 99AAAB(1)(b) of the Act does not apply to certain HSD pharmaceutical benefits

31 Rates of payment for approved hospital authorities for private hospitals (Act s 99(4))

32 Dispensed price for approved suppliers other than approved hospital authorities for public hospitals

33 Mark‑up for ready‑prepared pharmaceutical benefits

34 Dispensing fee

Part 3A—Supply to CTG registered patients by CTG suppliers

34A Application of this Part

34B Application of the CTG Special Arrangement—co‑payment and payment etc.

Part 4—Claims for payment for special arrangement supplies of HSD pharmaceutical benefits

35 Rules for providing information about supplies—definition of under co‑payment data

35A Claim for payment if an eligible patient is a CTG registered patient

Part 5—Miscellaneous

36 Compliance and audit arrangements

37 Value for safety net purposes for supplies

Part 6—Application, saving and transitional provisions

Division 1—Provisions relating to this instrument as made

38 HSD hospital authorities

Division 2—Provisions relating to the National Health Legislation Amendment (Opioid Dependence Treatment and Maximum Dispensed Quantities) Instrument 2023

39 Purpose of this Division

40 Definitions

41 Definition of special arrangement supply

42 Prescriptions directing supply for dispensing over time

43 Prescriptions directing supply of buprenorphine for injection

44 Prescriptions directing supply of methadone

45 First supply on or after 1 July 2023 deemed to be supply on first presentation

46 Supply on first presentation of prescription (Regulations s 44)

47 Repeat authorisations (Regulations s 52)

48 Prescriptions written in electronic form—additional procedures for giving information (Claims Rules s 7) and keeping documents

49 Information to be given using Claims Transmission System (Claims Rules Sch 1)

50 Pre‑commencement benefits

Division 3—Provisions relating to the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (Increases in Maximum Quantity and Number of Repeats for Complex Authority required (CAR) Medicines) Instrument 2026

51 Prescriptions directing increased maximum quantities or numbers of units of HSD pharmaceutical benefits that have a CAR drug

52 Prescriptions directing increased maximum number of repeats of HSD pharmaceutical benefits that have a CAR drug

Schedule 1—HSD pharmaceutical benefits and related information

1 Highly specialised drugs and HSD pharmaceutical benefits

Schedule 2—Maximum quantities and repeats for certain HSD pharmaceutical benefits

1 Maximum quantity or number of units and maximum number of repeats

Schedule 3—Circumstances and purposes

1 Circumstances and purposes

Part 1—Preliminary

Division 1—General

1  Name

 (1) This instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement 2021.

 (2) This instrument may also be cited as PB 27 of 2021.

3  Authority

  This instrument is made under sections 85, 85A, 88, 99 and 100 of the National Health Act 1953.

5  Simplified outline of this instrument

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).

6  Definitions

Note 1: A number of expressions used in this instrument are defined in the Act, including the following:

(a) Chief Executive Medicare;

(b) hospital;

(c) public hospital.

Note 2: Under subsection 4(1A) of the Act, a word or phrase defined for the purposes of the Health Insurance Act 1973 has the meaning that it would have if used in that Act. Expressions used in this instrument that are defined in that Act include the following:

(a) eligible person;

(b) medical practitioner;

(c) private hospital;

(d) specialist.

  In this instrument:

accredited prescriber of medication for the treatment of hepatitis B means a medical practitioner, or an authorised nurse practitioner, approved by a State or Territory to prescribe medication for the treatment of hepatitis B in accordance with this instrument.

accredited prescriber of medication for the treatment of hepatitis C means a medical practitioner, or an authorised nurse practitioner, approved by a State or Territory to prescribe medication for the treatment of hepatitis C in accordance with this instrument.

accredited prescriber of medication for the treatment of HIV or AIDS means a medical practitioner, or an authorised nurse practitioner, approved by a State or Territory to prescribe medication for the treatment of HIV or AIDS in accordance with this instrument.

accredited prescriber of medication for the treatment of schizophrenia means a medical practitioner approved by a State or Territory to prescribe medication for the treatment of schizophrenia in accordance with this instrument.

Act means the National Health Act 1953.

affiliated: a specialist is affiliated with a hospital if the specialist is:

 (a) a staff specialist of the hospital; or

 (b) a visiting or consulting specialist of the hospital.

approved ex‑manufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.

approved hospital authority has the same meaning as in Part VII of the Act, as affected by section 11 of this instrument.

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

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

Approved Pharmacists Commonwealth Price Determination means the Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2020.

Approved Pharmacists Conditions Determination means the National Health (Pharmaceutical Benefits) (Conditions for approved pharmacists) Determination 2017.

approved supplier has the same meaning as in Part VII of the Act, as affected by section 11 of this instrument.

authorised nurse practitioner has the same meaning as in Part VII of the Act.

authorised prescriber has the meaning given by section 7.

CAR drug (short for Complex Authority Required drug) means any of the following highly specialised drugs:

 (a) abatacept;

 (b) adalimumab;

 (c) ambrisentan;

 (d) anifrolumab;

 (e) avatrombopag;

 (f) azacitidine;

 (g) benralizumab;

 (h) bosentan;

 (i) burosumab;

 (j) difelikefalin;

 (k) dupilumab;

 (l) eculizumab;

 (m) eflornithine;

 (n) elexacaftor with tezacaftor and with ivacaftor, and ivacaftor;

 (o) eltrombopag;

 (p) epoprostenol;

 (q) etanercept;

 (r) iloprost;

 (s) infliximab;

 (t) ivacaftor;

 (u) lenalidomide;

 (v) lumacaftor with ivacaftor;

 (w) macitentan;

 (x) macitentan with tadalafil;

 (y) mepolizumab;

 (z) midostaurin;

 (aa) nusinersen;

 (ab) omalizumab;

 (ac) onasemnogene abeparvovec;

 (ad) pasireotide;

 (ae) patisiran;

 (af) pegcetacoplan;

 (ag) pegvisomant;

 (ah) pomalidomide;

 (ai) ravulizumab;

 (aj) riociguat;

 (ak) risdiplam;

 (al) romiplostim;

 (am) rozanolixizumab;

 (an) selexipag;

 (ao) sildenafil;

 (ap) tadalafil;

 (aq) teduglutide;

 (ar) tezacaftor with ivacaftor and ivacaftor;

 (as) tezepelumab;

 (at) tocilizumab;

 (au) ustekinumab;

 (av) vanzacaftor with tezacaftor and with deutivacaftor;

 (aw) vedolizumab;

 (ax) vutrisiran;

 (ay) zilucoplan.

circumstances code means the letter “C” followed by a number.

community access medication means any of the following:

(a) medication for the treatment of hepatitis B;

(b) medication for the treatment of HIV or AIDS, other than a pharmaceutical benefit that has the drug:

 (i) azithromycin; or

 (ii) doxorubicin ‑ pegylated liposomal; or

 (iii) rifabutin;

(c) medication for the treatment of opioid dependence;

(d) medication for continuing treatment of schizophrenia;

(e) edaravone;

(f) lanreotide;

(g) octreotide, if:

 (i) the description of its form includes “Injection (modified release)”; and

 (ii) it is for continuing treatment.

CTG registered patient has the same meaning as in the CTG Special Arrangement.

CTG Special Arrangement means the National Health (Closing the Gap—PBS Co‑payment Program) Special Arrangement 2026.

CTG supplier has the same meaning as in the CTG Special Arrangement.

dangerous drug has the same meaning as in the Approved Pharmacists Commonwealth Price Determination.

dangerous drug fee has the same meaning as in the Approved Pharmacists Commonwealth Price Determination.

day admitted patient: a person is a day admitted patient of a hospital on a day if, on that day, the person:

 (a) is admitted to the hospital (other than through the hospital’s emergency department); and

 (b) receives treatment; and

 (c) is discharged from the hospital;

in accordance with a pre‑existing plan for the person’s treatment.

dispensed price:

 (a) for a special arrangement supply of an HSD pharmaceutical benefit by an approved hospital authority for a public hospital—has the meaning given by section 29; and

 (b) for a special arrangement supply of an HSD pharmaceutical benefit by an approved supplier other than an approved hospital authority for a public hospital—has the meaning given by section 32.

EFC patient has the meaning given by subsection 8(7).

eligible patient has the meaning given by section 8.

erythropoietin stimulating agent means any of the following:

 (a) darbepoetin alfa;

 (b) epoetin alfa;

 (c) epoetin lambda;

 (d) methoxy polyethylene glycol-epoetin beta.

General statement for drugs for the treatment of hepatitis C has the same meaning as in the Listing Instrument.

highly specialised drug means a listed drug mentioned in Schedule 1.

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

HSD hospital authority means a hospital authority for which:

 (a) an approval under section 94 of the Act, as modified by section 10 of this instrument, is in force; or

 (b) an approval mentioned in section 38 of this instrument is in force.

HSD pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.

listed drug has the same meaning as in Part VII of the Act.

Listing Instrument means the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024).

medication chart prescription has the same meaning as in the Regulations.

medication for the treatment of hepatitis B means any of the following:

 (a) entecavir;

 (b) lamivudine;

 (c) tenofovir.

medication for the treatment of hepatitis C means medication mentioned in the table in clause 3 of the General statement for drugs for the treatment of hepatitis C.

medication for the treatment of HIV or AIDS means any of the following:

 (a) abacavir;

 (b) abacavir with lamivudine;

 (c) atazanavir with cobicistat;

 (d) azithromycin;

 (e) bictegravir with emtricitabine with tenofovir alafenamide;

 (f) cabotegravir;

 (g) cabotegravir and rilpivirine;

 (h) darunavir;

 (i) darunavir with cobicistat;

 (j) darunavir with cobicistat, emtricitabine and tenofovir alafenamide;

 (k) dolutegravir;

 (l) dolutegravir with abacavir and lamivudine;

 (m) dolutegravir with lamivudine;

 (n) dolutegravir with rilpivirine;

 (o) doxorubicin ‑ pegylated liposomal;

 (p) emtricitabine with rilpivirine with tenofovir alafenamide;

 (q) emtricitabine with tenofovir alafenamide;

 (r) etravirine;

 (s) ganciclovir;

 (t) lamivudine;

 (u) lamivudine with zidovudine;

 (v) lopinavir with ritonavir;

 (w) maraviroc;

 (x) nevirapine;

 (y) raltegravir;

 (z) rifabutin;

 (aa) rilpivirine;

 (ab) ritonavir;

 (ac) tenofovir;

 (ad) tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat;

 (ae) tenofovir with emtricitabine;

 (af) tenofovir with emtricitabine and efavirenz;

 (ag) valganciclovir;

 (ah) zidovudine.

medication for the treatment of opioid dependence means any of the following:

 (a) buprenorphine;

 (b) buprenorphine with naloxone;

 (c) methadone.

medication for the treatment of schizophrenia means clozapine.

ODT pharmaceutical benefit means an HSD pharmaceutical benefit that has a drug that is a medication for the treatment of opioid dependence.

pack quantity has the same meaning as in Part VII of the Act.

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

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

price to pharmacists has the same meaning as in the Approved Pharmacists Commonwealth Price Determination.

proportional ex‑manufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.

purposes code means the letter “P” followed by a number.

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

residential care service has the same meaning as in the Regulations.

special arrangement supply has the meaning given by sections 13 and 41.

UNAR drug (short for Unrestricted—No Authority Required drug) means any of the following highly specialised drugs:

 (a) rituximab.

7  Definition of authorised prescriber

Specialists affiliated with hospitals

 (1) A specialist is an authorised prescriber for an HSD pharmaceutical benefit for a patient receiving treatment in, at or from a hospital if the specialist is affiliated with the hospital.

Medical practitioners—with the agreement of specialists

 (2) A medical practitioner is an authorised prescriber for an HSD pharmaceutical benefit for a patient receiving treatment in, at or from a hospital if all of the following apply:

 (a) the benefit is for continuing treatment for the patient;

 (b) the patient’s treatment is being managed by a specialist;

 (c) it is impractical for the patient to obtain a prescription for the benefit from the specialist;

 (d) the specialist has agreed to the prescribing of the benefit for the patient by the medical practitioner.

Medical practitioners—if authorised by Commonwealth and State authorities

 (3) A medical practitioner is an authorised prescriber for an HSD pharmaceutical benefit for a patient if all of the following apply:

 (a) the HSD pharmaceutical benefit is for continuing treatment for the patient;

 (b) the medical practitioner is authorised (however described) by an authority of the Commonwealth for the purposes of this provision;

 (c) the medical practitioner is authorised (however described) by an authority of the State or Territory in which the hospital is located for the purposes of this provision.

Medical practitioners—specified medications

 (4) A medical practitioner is an authorised prescriber for the following HSD pharmaceutical benefits:

 (a) a benefit that has a drug that is a medication for the treatment of hepatitis C;

 (b) a benefit that has the drug edaravone;

 (c) a benefit that has the drug lanreotide;

 (d) a benefit that has the drug octreotide, if:

 (i) the description of its form includes “Injection (modified release)”; and

 (ii) it is for continuing treatment;

 (e) a benefit that has an erythropoietin stimulating agent.

Accredited prescribers—HSD pharmaceutical benefits for the treatment of hepatitis B, hepatitis C, HIV or AIDS, and schizophrenia

 (5) The following table has effect.

Authorised nurse practitioners and medical practitioners—ODT pharmaceutical benefits

 (6) Each of the following is an authorised prescriber for an ODT pharmaceutical benefit:

 (a) an authorised nurse practitioner;

 (b) a medical practitioner.

Authorised nurse practitioners—erythropoietin stimulating agents

 (6A) An authorised nurse practitioner is an authorised prescriber for an HSD pharmaceutical benefit for a patient if the pharmaceutical benefit has an erythropoietin stimulating agent.

 (7) To avoid doubt, a person is not an authorised prescriber, within the meaning of this instrument, for an HSD pharmaceutical benefit only because the person is authorised in accordance with section 12 of the Listing Instrument to write a prescription for the supply of the pharmaceutical benefit.

Note: A supply of an HSD pharmaceutical benefit is not a special arrangement supply of the benefit unless the supply was prescribed by an authorised prescriber for the benefit (see section 13 of this instrument).

8  Definition of eligible patient

Persons receiving treatment by medical practitioners at or from public hospitals other than as admitted patients

 (1) A person is an eligible patient for an HSD pharmaceutical benefit if the person:

 (a) is, or is to be treated as, an eligible person; and

 (b) is receiving medical treatment by a medical practitioner at or from a public hospital; and

 (c) is receiving that treatment as:

 (i) a non‑admitted patient of the hospital; or

 (ii) a day admitted patient of the hospital; or

 (iii) a patient on discharge from the hospital; and

 (d) is not an EFC patient (see subsection (7)) for the benefit.

Persons receiving treatment by authorised nurse practitioners at or from public hospitals other than as admitted patients—medication for the treatment of hepatitis C

 (2) A person is an eligible patient for an HSD pharmaceutical benefit that has a drug that is a medication for the treatment of hepatitis C if the person:

 (a) is, or is to be treated as, an eligible person; and

 (b) is receiving medical treatment by an authorised nurse practitioner at or from a public hospital; and

 (c) is receiving that treatment as:

 (i) a non‑admitted patient of the hospital; or

 (ii) a day admitted patient of the hospital; or

 (iii) a patient on discharge from the hospital.

Persons receiving treatment by medical practitioners in public hospitals as admitted patients—HSD pharmaceutical benefits that contain eculizumab for the treatment of atypical haemolytic uraemic syndrome

 (3) A person is an eligible patient for an HSD pharmaceutical benefit that has the drug eculizumab for the treatment of atypical haemolytic uraemic syndrome if the person:

 (a) is, or is to be treated as, an eligible person; and

 (b) is receiving medical treatment by a medical practitioner in a public hospital; and

 (c) is receiving that treatment as an admitted patient (other than a day admitted patient) of the hospital.

Persons receiving treatment by medical practitioners in, at or from private hospitals

 (4) A person is an eligible patient for an HSD pharmaceutical benefit if the person:

 (a) is, or is to be treated as, an eligible person; and

 (b) is receiving medical treatment by a medical practitioner in, at or from a private hospital; and

 (c) is not an EFC patient (see subsection (7)) for the benefit.

Persons receiving treatment by authorised nurse practitioners in, at or from private hospitals—medication for the treatment of hepatitis C

 (5) A person is an eligible patient for an HSD pharmaceutical benefit that has a drug that is a medication for the treatment of hepatitis C if the person:

 (a) is, or is to be treated as, an eligible person; and

 (b) is receiving medical treatment by an authorised nurse practitioner in, at or from a private hospital.

Persons receiving HSD pharmaceutical benefits that have drugs that are community access medications

 (6) A person is an eligible patient for an HSD pharmaceutical benefit if:

 (a) the benefit has a drug that is a community access medication; and

 (b) the person is, or is to be treated as, an eligible person.

EFC patient

 (7) A person is an EFC patient for an HSD pharmaceutical benefit that has a UNAR drug if the benefit is or will be prescribed to the person:

 (a) in accordance with the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2024; or

 (b) for the purposes of chemotherapy treatment for cancer.

Persons receiving treatment by authorised nurse practitioners at or from public hospitals other than as admitted patients—azithromycin, doxorubicin ‑ pegylated liposomal or rifabutin

 (8) A person is an eligible patient for an HSD pharmaceutical benefit that has the drug azithromycin, doxorubicin ‑ pegylated liposomal or rifabutin if the person:

 (a) is, or is to be treated as, an eligible person; and

 (b) is receiving medical treatment by an authorised nurse practitioner at or from a public hospital; and

 (c) is receiving that treatment as:

 (i) a non‑admitted patient of the hospital; or

 (ii) a day admitted patient of the hospital; or

 (iii) a patient on discharge from the hospital.

Persons receiving treatment by authorised nurse practitioners in, at or from private hospitals—azithromycin, doxorubicin ‑ pegylated liposomal or rifabutin

 (9) A person is an eligible patient for an HSD pharmaceutical benefit that has the drug azithromycin, doxorubicin ‑ pegylated liposomal or rifabutin if the person:

 (a) is, or is to be treated as, an eligible person; and

 (b) is receiving medical treatment by an authorised nurse practitioner in, at or from a private hospital.

Persons receiving treatment by authorised nurse practitioners at or from public hospitals other than as admitted patients—erythropoietin stimulating agents

 (10) A person is an eligible patient for an HSD pharmaceutical benefit that has an erythropoietin stimulating agent if the person:

 (a) is, or is to be treated as, an eligible person; and

 (b) is receiving medical treatment by an authorised nurse practitioner at or from a public hospital; and

 (c) is receiving that treatment as:

 (i) a non‑admitted patient of the hospital; or

 (ii) a day admitted patient of the hospital; or

 (iii) a patient on discharge from the hospital.

Persons receiving treatment by authorised nurse practitioners in, at or from private hospitals—erythropoietin stimulating agents

 (11) A person is an eligible patient for an HSD pharmaceutical benefit that has an erythropoietin stimulating agent if the person:

 (a) is, or is to be treated as, an eligible person; and

 (b) is receiving medical treatment by an authorised nurse practitioner in, at or from a private hospital.

Division 2—Supplies of HSD pharmaceutical benefits from hospitals

9  Supplies of HSD pharmaceutical benefits by approved hospital authorities to patients receiving treatment from hospitals

 (1) In this instrument, and in Part VII of the Act and regulations or other instruments made for the purposes of that Part, a reference to an approved hospital authority supplying pharmaceutical benefits to patients receiving treatment in or at the hospital of which it is the governing body or proprietor includes a reference to the hospital authority supplying HSD pharmaceutical benefits to patients receiving treatment from the hospital.

 (2) This section applies in addition to section 94 of the Act.

Division 3—HSD hospital authorities

10  HSD hospital authorities

 (1) Section 94 of the Act applies as if that section permitted the Minister to approve a hospital authority for the purpose of its supplying HSD pharmaceutical benefits to patients receiving treatment in, at or from the hospital of which it is the governing body or proprietor if the dispensing of those benefits is performed:

 (a) other than at the hospital; and

 (b) by or under the direct supervision of a medical practitioner or pharmacist.

 (2) Subsection (1) applies despite subsection 94(5) of the Act.

11  References to approved suppliers and approved hospital authorities

  In this instrument, and in Part VII of the Act and regulations or other instruments made for the purposes of that Part, a reference to an approved supplier or an approved hospital authority includes a reference to an HSD hospital authority.

12  Numbers allotted to HSD hospital authorities

  For the purposes of Part VII of the Act and regulations or other instruments made for the purposes of that Part, a number allotted to an HSD hospital authority under either of the following provisions is taken to have been allotted by the Minister under subsection 16(4) of the Regulations:

 (a) subsection 52(3) of the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010);

 (b) subsection 52(3) of the National Health (Highly specialised drugs program for public hospitals) Special Arrangements Instrument 2010 (PB 63 of 2010).

Part 2—Special arrangement supplies of HSD pharmaceutical benefits

Division 1—Preliminary

13  Definition of special arrangement supply

Prescriptions written for public hospital patients

 (1) A supply of an HSD pharmaceutical benefit to a person is a special arrangement supply of the benefit if:

 (a) the person is an eligible patient for the benefit; and

 (b) the benefit is supplied by:

 (i) for any benefit—an approved hospital authority for a public hospital; or

 (ii) for a benefit that has a CAR drug or UNAR drug—an approved pharmacist; and

 (c) the benefit is supplied on the basis of a prescription written:

 (i) when the person was receiving medical treatment in, at or from a public hospital; and

 (ii) by an authorised prescriber for the benefit; and

 (iii) unless the benefit has a UNAR drug—in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 for the benefit.

Prescriptions written for private hospital patients

 (2) A supply of an HSD pharmaceutical benefit to a person is a special arrangement supply of the benefit if:

 (a) the person is an eligible patient for the benefit; and

 (b) the benefit is supplied by:

 (i) an approved hospital authority for a private hospital; or

 (ii) an approved pharmacist; and

 (c) the benefit is supplied on the basis of a prescription written:

 (i) when the person was receiving medical treatment in, at or from a private hospital; and

 (ii) by an authorised prescriber for the benefit; and

 (iii) unless the benefit has a UNAR drug—in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 for the benefit.

Community access arrangements

 (3) A supply of an HSD pharmaceutical benefit to a person is a special arrangement supply of the benefit if:

 (a) the benefit has a drug that is a community access medication; and

 (b) the person is an eligible patient for the benefit; and

 (c) the benefit is supplied by an approved supplier; and

 (d) the benefit is supplied on the basis of a prescription written:

 (i) by an authorised prescriber for the benefit; and

 (ii) in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 for the benefit.

Division 2—Prescribing of HSD pharmaceutical benefits

15  Prescription circumstances—general (Act s 85(7)(a) and (b))

 (1) For the purposes of paragraph 85(7)(a) of the Act, an HSD pharmaceutical benefit, other than a benefit that has a UNAR drug, is a relevant pharmaceutical benefit for the purposes of section 88A of the Act.

 (2) For the purposes of paragraph 85(7)(b) of the Act, the circumstances in which a prescription for a special arrangement supply of an HSD pharmaceutical benefit, other than a benefit that has a UNAR drug, may be written are the circumstances mentioned in Schedule 3 to this instrument for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 to this instrument for the benefit.

 (3) This section applies in addition to section 13 of the Listing Instrument.

16  Prescription circumstances—authority required procedures

 (1) This section applies to a prescription for a special arrangement supply of an HSD pharmaceutical benefit if the circumstances mentioned in Schedule 3 (if any) in which the prescription is written include:

 (a) Compliance with Authority Required procedures; or

 (b) Compliance with Written Authority Required procedures.

 (2) Section 19 of the Listing Instrument applies to the prescription as if:

 (a)  a reference to Part 1 of Schedule 4 to that instrument were a reference to Schedule 3 to this instrument; and

 (b)  a reference to an authorised prescriber were a reference to an authorised prescriber within the meaning of this instrument.

18  When medication chart prescriptions not to be written

Persons receiving treatment in residential care services

 (2) Subparagraph 41(1)(a)(i) of the Regulations does not apply to a prescription for a special arrangement supply of an HSD pharmaceutical benefit.

19  Prescriptions not to direct repeated supplies for visitors to Australia

 (1) An authorised prescriber for an HSD pharmaceutical benefit must not write a prescription directing a repeated supply of an HSD pharmaceutical benefit to a person who is a visitor to Australia even if the person is, in accordance with section 7 of the Health Insurance Act 1973, to be treated as an eligible person within the meaning of that Act.

 (2) This section applies despite section 85A of the Act.

20  Maximum quantity or number of units (Act s 85A(2)(a))

 (1) For the purposes of paragraph 85A(2)(a) of the Act, this section sets out the maximum quantity or number of units of the pharmaceutical item in an HSD pharmaceutical benefit that may, in one prescription for a special arrangement supply of the benefit, be directed by an authorised prescriber to be supplied on any one occasion.

Supply for particular purposes

 (2) If:

 (a) a purposes code is mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

 (b) the supply of the benefit is for purposes mentioned in Schedule 3 to this instrument for the purposes code;

the maximum quantity or number of units is the quantity or number of units is mentioned in the column headed “Maximum quantity” in Schedule 1 to this instrument for the benefit and the purposes code.

Supply for all purposes—HSD pharmaceutical benefits not in Schedule 2

 (3) If:

 (a) a purposes code is not mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

 (b) a quantity or number of units is mentioned in the column headed “Maximum quantity” in Schedule 1 to this instrument for the benefit;

the maximum quantity or number of units is that quantity or number of units.

Supply for all purposes—HSD pharmaceutical benefits in Schedule 2

 (4) If:

 (a) a purposes code is not mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

 (b) the words “See Schedule 2” appear in the column headed “Maximum quantity” in Schedule 1 to this instrument for the benefit; and

 (c) the prescription is written in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 2 to this instrument for the benefit;

the maximum quantity or number of units is the quantity or number of units that is applicable under Schedule 2 to this instrument for the benefit and the circumstances code.

Application of this section

 (5) To the extent that this section provides for a matter not provided for in the Listing Instrument, this section applies in addition to the Listing Instrument.

 (6) To the extent that this section makes a different provision for a matter provided for in the Listing Instrument, this section applies despite the Listing Instrument.

21  Maximum number of repeats (Act s 85A(2)(b))

 (1) For the purposes of paragraph 85A(2)(b) of the Act, this section sets out the maximum number of occasions an authorised prescriber may, in one prescription, direct that a special arrangement supply of an HSD pharmaceutical benefit be repeated.

Supply for particular purposes

 (2) If:

 (a) a purposes code is mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

 (b) the supply is for purposes mentioned in Schedule 3 to this instrument for the purposes code;

the maximum number is the number mentioned in the column headed “Maximum repeats” in Schedule 1 to this instrument for the benefit and the purposes code.

Supply for all purposes—HSD pharmaceutical benefits not in Schedule 2

 (3) If:

 (a) a purposes code is not mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

 (b) a number is mentioned in the column headed “Maximum repeats” in Schedule 1 to this instrument for the benefit;

the maximum number is that number.

Supply for all purposes—HSD pharmaceutical benefits in Schedule 2

 (4) If:

 (a) a purposes code is not mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

 (b) the words “See Schedule 2” appear in the column headed “Maximum repeats” in Schedule 1 for the benefit; and

 (c) the prescription is written in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 2 to this instrument for the benefit;

the maximum number is the number that is applicable under Schedule 2 to this instrument for the benefit and the circumstances code.

Application of this section

 (5) To the extent that this section provides for a matter not provided for in the Listing Instrument, this section applies in addition to the Listing Instrument.

 (6) To the extent that this section makes a different provision for a matter provided for in the Listing Instrument, this section applies despite the Listing Instrument.

23  Records to be kept—prescriptions for HSD pharmaceutical benefits that have eculizumab for the treatment of atypical haemolytic uraemic syndrome

 (1) If an authorised prescriber for an HSD pharmaceutical benefit that has the drug eculizumab for the treatment of atypical haemolytic uraemic syndrome writes a prescription for a special arrangement supply of the benefit, a copy of any clinical records relating to the prescription, including records required to demonstrate that the prescription was written in compliance with the circumstances and purposes determined in relation to the benefit under subsection 85(7) of the Act, must be kept by:

 (a) the approved hospital authority for the hospital in, at or from which the eligible patient is receiving treatment; or

 (b) if the approved hospital authority is not able to keep the records—the authorised prescriber.

 (2) The records must be kept for 2 years after the date the prescription to which the records relate is written.

Division 3—Supplying HSD pharmaceutical benefits

24  Special patient contribution for certain HSD pharmaceutical benefits

 (1) This section applies to a special arrangement supply of an HSD pharmaceutical benefit mentioned in the following table.

 (2) The special patient contribution for a pack quantity of a listed brand of a pharmaceutical item mentioned in the table is the amount that is the difference between:

 (a) the price that would have been the dispensed price for that quantity of the brand of the pharmaceutical item if that dispensed price had been based on the claimed price (within the meaning of Part VII of the Act) mentioned in the table for that quantity; and

 (b) the dispensed price for that quantity of the brand of the pharmaceutical item.

 (3) This section applies despite subsection 85B(5) of the Act.

25  Conditions for approved pharmacists

Special arrangement supplies of certain HSD pharmaceutical benefits

 (1) The Approved Pharmacists Conditions Determination does not apply to the dispensing or supply of an HSD pharmaceutical benefit if:

 (a) the manner of administration of the benefit is injection or extracorporeal circulation; and

 (b) the benefit does not have a drug that is a community access medication; and

 (c) the supply is a special arrangement supply of the benefit.

ODT pharmaceutical benefits—special arrangement supplies through agents

 (2) If a supply of an ODT pharmaceutical benefit is a special arrangement supply of the benefit mentioned in subsection 26(2) of this instrument, the Approved Pharmacists Conditions Determination applies to the dispensing and supply of the benefit as if paragraph 6(e), subsection 9(1), section 10, paragraphs 14(a) and (b) and section 15 of that Determination were omitted.

ODT pharmaceutical benefits—special arrangement supplies other than through agents

 (3) If a supply of an ODT pharmaceutical benefit is a special arrangement supply of the benefit other than a special arrangement supply of the benefit mentioned in subsection 26(2) of this instrument, the Approved Pharmacists Conditions Determination applies to the dispensing and supply of the benefit as if paragraph (c) of the definition of dispensing step in section 5 of that Determination were omitted.

26  Supplies need not be directly to persons

Supplies of HSD pharmaceutical benefits by HSD hospital authorities

 (1) An HSD hospital authority may make a special arrangement supply of an HSD pharmaceutical benefit to a person:

 (a) other than directly to the person; or

 (b) through an agent.

Supplies of ODT pharmaceutical benefits by approved pharmacists and approved hospital authorities

 (2) An approved pharmacist or an approved hospital authority may make a special arrangement supply of an ODT pharmaceutical benefit to a person through a person or organisation:

 (a) that has premises in a State or Territory; and

 (b) that is authorised (however described) by an authority of the State or Territory for the purposes of supplying medication for the treatment of opioid dependence.

Application of this section

 (3) This section applies in addition to section 94 of the Act.

27  Repeated supplies of pharmaceutical benefits

  Section 51 of the Regulations does not apply to a special arrangement supply of HSD pharmaceutical benefits.

Part 3—Payment for special arrangement supplies of HSD pharmaceutical benefits

Division 1—Supplies by approved hospital authorities for public hospitals

28  Rates of payment for approved hospital authorities for public hospitals (Act s 99(4))

 (1) For the purposes of subsection 99(4) of the Act, the amount payable to an approved hospital authority for a public hospital in respect of a special arrangement supply of an HSD pharmaceutical benefit by the authority is the amount, if any, by which the dispensed price for the supply of the benefit exceeds the amount that the hospital authority was entitled to charge under section 87 of the Act in respect of the supply.

Note 1: Section 87 of the Act limits the amounts that approved hospital authorities can charge patients for the supply of pharmaceutical benefits.

Note 2: However, see Part 3A in relation to a special arrangement supply of an HSD pharmaceutical benefit to a CTG registered patient by a CTG supplier.

 (2) This section applies despite the National Health (Commonwealth Price—Pharmaceutical Benefits Supplied By Public Hospitals) Determination 2017 (PB 25 of 2017).

Note: See subsection 99(4) of the Act (read with section 9 of this instrument) for the entitlement of an approved hospital authority to payment for the supply of pharmaceutical benefits to patients receiving treatment in, at or from a hospital in respect of which the authority is approved.

29  Dispensed price for approved hospital authorities for public hospitals

 (1) The dispensed price for a special arrangement supply of an HSD pharmaceutical benefit by an approved hospital authority for a public hospital is as follows:

 (a) if the quantity of the benefit supplied is equal to a multiple of a pack quantity of the benefit—the sum of the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for each pack quantity;

 (b) if the quantity of the benefit supplied is less than a pack quantity of the benefit (a broken quantity)—the amount worked out in accordance with subsection (2);

 (c) if neither paragraph (a) or (b) applies to the quantity of the benefit supplied—the sum of:

 (i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for each pack quantity; and

 (ii) the amount calculated in accordance with subsection (2) for the remainder of the quantity that is a broken quantity.

Broken quantities

 (2) For the purposes of paragraph (1)(b) and subparagraph (1)(c)(ii), the amount for a broken quantity is worked out by:

 (a) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and

 (b) applying that percentage to the approved ex‑manufacturer price or proportional ex‑manufacturer price (as applicable) for the pack quantity.

Rounding

 (3) The dispensed price under subsection (1) is rounded to the nearest cent (rounding 0.5 cents upwards).

Division 2—Supplies by other approved suppliers

30  Entitlement to, and amount of, payment for approved pharmacists and approved medical practitioners

 (1) This section applies if:

 (a) an approved pharmacist or approved medical practitioner has supplied an HSD pharmaceutical benefit; and

 (b) the supply is a special arrangement supply of the benefit.

Note: However, see Part 3A in relation to a special arrangement supply of an HSD pharmaceutical benefit to a CTG registered patient by a CTG supplier.

 (2) The approved pharmacist or approved medical practitioner is, subject to section 99AAA of the Act and the conditions determined under section 98C of the Act that are applicable at the time of the supply, entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the benefit exceeds the amount that the approved pharmacist or approved medical practitioner was entitled to charge under section 87 of the Act in respect of the supply.

Note: Section 87 of the Act limits the amounts that approved pharmacists and approved medical practitioners can charge patients for the supply of pharmaceutical benefits.

 (3) This section applies despite subsections 99(2) and (2AA) of the Act.

30A  Paragraph 99AAAB(1)(b) of the Act does not apply to certain HSD pharmaceutical benefits

  Paragraph 99AAAB(1)(b) of the Act does not apply to a special arrangement supply of an HSD pharmaceutical benefit if:

 (a) the manner of administration of the benefit is injection or extracorporeal circulation; and

 (b) the benefit is not a community access medication.

31  Rates of payment for approved hospital authorities for private hospitals (Act s 99(4))

 (1) For the purposes of subsection 99(4) of the Act, the amount payable to an approved hospital authority for a private hospital in respect of a special arrangement supply of an HSD pharmaceutical benefit by the authority is the amount, if any, by which the dispensed price for the supply of the benefit exceeds the amount that the authority was entitled to charge under section 87 of the Act in respect of the supply.

Note 1: Section 87 of the Act limits the amounts that approved hospital authorities can charge patients for the supply of pharmaceutical benefits.

Note 2: However, see Part 3A in relation to a special arrangement supply of an HSD pharmaceutical benefit to a CTG registered patient by a CTG supplier.

 (2) This section applies despite the National Health (Commonwealth Price ‑ Pharmaceutical benefits supplied by private hospitals) Determination 2020 (PB 99 of 2020).

Note: See subsection 99(4) of the Act (read with section 9 of this instrument) for the entitlement of an approved hospital authority to payment for the supply of pharmaceutical benefits to patients receiving treatment in, at or from a hospital in respect of which the authority is approved.

32  Dispensed price for approved suppliers other than approved hospital authorities for public hospitals

 (1) The dispensed price for a special arrangement supply of an HSD pharmaceutical benefit by an approved supplier other than an approved hospital authority for a public hospital is as follows:

 (a) if the quantity of the benefit supplied is equal to a multiple of a pack quantity of the benefit—the sum of:

 (i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for each pack quantity; and

 (ia) if the approved supplier is an approved pharmacist—the wholesale mark‑up for a pack quantity of a ready‑prepared pharmaceutical benefit worked out in the table in section 11 of the Approved Pharmacists Commonwealth Price Determination for the approved ex‑manufacturer price or proportional ex‑manufacturer price (as applicable) for that pack quantity; and

 (ii) if the benefit is a ready‑prepared pharmaceutical benefit—the mark‑up mentioned in section 33 for each pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards); and

 (iii) the dispensing fee for the benefit in accordance with section 34; and

 (iv) if the benefit is a ready‑prepared pharmaceutical benefit and a dangerous drug—the dangerous drug fee;

 (b) if the quantity of the benefit supplied is less than a pack quantity of the benefit (a broken quantity)—the sum of:

 (i) the amount worked out in accordance with subsection (2); and

 (ii) the dispensing fee for the benefit in accordance with section 34; and

 (iii) if the benefit is a ready‑prepared pharmaceutical benefit and a dangerous drug—the dangerous drug fee;

 (c) if the quantity of the benefit supplied is more than a multiple of a pack quantity of the benefit—the sum of:

 (i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for each pack quantity; and

 (ia) if the approved supplier is an approved pharmacist—the wholesale mark‑up for a pack quantity of a ready‑prepared pharmaceutical benefit worked out in the table in section 11 of the Approved Pharmacists Commonwealth Price Determination for the approved ex‑manufacturer price or proportional ex‑manufacturer price (as applicable) for that pack quantity; and

 (ii) if the benefit is a ready‑prepared pharmaceutical benefit—the mark‑up mentioned in section 33 for each pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards); and

 (iii) the amount worked out in accordance with subsection (2) for the remainder of the quantity that is a broken quantity; and

 (iv) the dispensing fee for the benefit in accordance with section 34; and

 (v) if the benefit is a ready‑prepared pharmaceutical benefit and a dangerous drug—the dangerous drug fee.

Broken quantities

 (2) For the purposes of subparagraphs (1)(b)(i) and (c)(iii), the amount for a broken quantity is worked out by:

 (a) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and

 (b) applying that percentage to the sum of:

 (i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for the pack quantity; and

 (ia) if the approved supplier is an approved pharmacist—the wholesale mark‑up for a pack quantity of a ready‑prepared pharmaceutical benefit worked out in the table in section 11 of the Approved Pharmacists Commonwealth Price Determination for the approved ex‑manufacturer price or proportional ex‑manufacturer price (as applicable) for that pack quantity; and

 (ii) if the benefit is a ready‑prepared pharmaceutical benefit—the mark‑up mentioned in section 33 for the pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards).

Rounding

 (3) The dispensed price under subsection (1) is rounded to the nearest cent (rounding 0.5 cents upwards).

33  Mark‑up for ready‑prepared pharmaceutical benefits

Approved suppliers other than approved pharmacists

 (1) Subsection (2) applies if an approved supplier is not an approved pharmacist.

 (2) For the purposes of subparagraphs 32(1)(a)(ii), (c)(ii) and (2)(b)(ii), the mark‑up for a pack quantity of an HSD pharmaceutical benefit that is a ready‑prepared pharmaceutical benefit is:

 (a) if the pack quantity of the benefit is equal to the maximum quantity of the benefit mentioned in section 20—the amount mentioned in the following table for the approved ex‑manufacturer price (AEMP) or proportional ex‑manufacturer price (PEMP) (as applicable) for that quantity; or

 (b) if the pack quantity of the benefit is less than the maximum quantity of the benefit mentioned in section 20:

 (i) if the mark‑up mentioned in the following table for the maximum quantity is a monetary amount—that monetary amount reduced proportionately for the relative quantities; or

 (ii) if the mark‑up mentioned in the following table for the maximum quantity is a percentage of the AEMP or PEMP (as applicable)—that percentage of the AEMP or PEMP for the pack quantity.

Approved pharmacists

 (3) Subsection (4) applies if an approved supplier is an approved pharmacist.

 (4) For the purposes of subparagraphs 32(1)(a)(ii), (c)(ii) and (2)(b)(ii), the mark‑up for a pack quantity of an HSD pharmaceutical benefit that is a ready‑prepared pharmaceutical benefit is:

 (a) if the pack quantity of the benefit is equal to the maximum quantity of the benefit mentioned in section 20—the amount mentioned in the following table for the price to pharmacists (PTP) for that quantity; or

 (b) if the pack quantity of the benefit is less than the maximum quantity of the benefit mentioned in section 20:

 (i) if the mark‑up mentioned in the following table for the maximum quantity is a monetary amount—that monetary amount reduced proportionately for the relative quantities; or

 (ii) if the mark‑up mentioned in the following table for the maximum quantity is a percentage of the price to pharmacists—that percentage of the price to pharmacists for the pack quantity.

Note: See the definition of price to pharmacists in section 6.

34  Dispensing fee

 (1) For the purposes of subparagraphs 32(1)(a)(iii), (b)(ii) and (c)(iv):

 (a) the dispensing fee for the supply of an HSD pharmaceutical benefit is:

 (i) if the benefit has a drug mentioned in subsection (2) in the form mentioned in that subsection for the drug—the extemporaneously‑prepared dispensing fee (within the meaning of the Approved Pharmacists Commonwealth Price Determination); or

 (ii) if subparagraph (i) does not apply—the ready‑prepared dispensing fee (within the meaning of that Determination); and

 (b) if the authorised prescriber who prescribed the benefit, instead of directing a repeated supply of the benefit, directed the supply on one occasion of a quantity or number of units of the benefit, not exceeding the total quantity or number of units that could be prescribed if the authorised prescriber directed a repeated supply, the dispensed price for the supply of the benefit includes:

 (i) only one dispensing fee; and

 (ii) only one dangerous drug fee.

Note: See section 49 of the Regulations for the circumstances in which such a supply may be directed.

 (2) For the purpose of subparagraph (1)(a)(i), the drugs and the forms for the drugs are as follows:

 (a) mycophenolic acid as a powder for oral suspension containing mycophenolate mofetil 1g per 5 mL, 165mL;

 (b) valganciclovir as a powder for oral solution 50mg (as hydrochloride) per mL, 100 mL.

Part 3A—Supply to CTG registered patients by CTG suppliers

34A  Application of this Part

  This Part applies to a special arrangement supply (the relevant supply) of an HSD pharmaceutical benefit under this Special Arrangement if the relevant supply is made:

 (a) to an eligible patient who is a CTG registered patient; and

 (b) by an approved supplier who is a CTG supplier.

34B  Application of the CTG Special Arrangement—co‑payment and payment etc.

 (1) Despite sections 28, 30, 31 and 37 of this Special Arrangement, subsections 10(1), (2), (3) and (10) (co‑payment reduction etc.), section 11 (value for safety net purposes) and section 12 (payment by Commonwealth) of the CTG Special Arrangement apply in relation to the relevant supply under this Special Arrangement with the modification set out in subsection (2) of this section.

 (2) A reference in the CTG Special Arrangement to a special arrangement supply (within the meaning of the CTG Special Arrangement) of a pharmaceutical benefit is taken to be a reference to the relevant supply under this Special Arrangement.

 (3) However, the notes to subsections 10(2) and (3) of the CTG Special Arrangement do not apply in relation to the relevant supply under this Special Arrangement.

Note: The notes to subsections 10(2) and (3) of the CTG Special Arrangement relate to CTG suppliers making claims for payment under the CTG Special Arrangement. Claims for payment in relation to the relevant supply under this Special Arrangement are instead dealt with under Part 4 of this Special Arrangement.

Part 4—Claims for payment for special arrangement supplies of HSD pharmaceutical benefits

35  Rules for providing information about supplies—definition of under co‑payment data

  The National Health (Supply of Pharmaceutical Benefits—Under Co‑payment Data and Claims for Payment) Rules 2022 apply to a special arrangement supply of an HSD pharmaceutical benefit by an approved supplier as if the definition of under co‑payment data in that instrument were replaced with the following definition:

under co‑payment data means information relating to a special arrangement supply of an HSD pharmaceutical benefit by an approved supplier where the amount payable by the Commonwealth is nil because the dispensed price for the supply of the benefit does not exceed the amount that the supplier was entitled to charge under section 87 of the Act in respect of the supply.

35A  Claim for payment if an eligible patient is a CTG registered patient

  If:

 (a) a claim for payment for a special arrangement supply of an HSD pharmaceutical benefit made under the National Health (Supply of Pharmaceutical Benefits—Under Co‑payment Data and Claims for Payment) Rules 2022 is made using the manual system referred to in section 99AAA of the Act; and

 (b) the claim is made:

 (i) by an approved supplier who is a CTG supplier; and

 (ii) in relation to a special arrangement supply of an HSD pharmaceutical benefit to an eligible patient who is a CTG registered patient;

the claim must include an indicator that the eligible patient is a CTG registered patient.

Part 5—Miscellaneous

36  Compliance and audit arrangements

 (1) If an approved supplier makes a special arrangement supply of an HSD pharmaceutical benefit, the approved supplier must keep adequate, secure and auditable records of all supplied HSD pharmaceutical benefits for which a claim is made.

 (2) The records must be kept in systems that are able to be audited by the Chief Executive Medicare on reasonable notice being given to the approved supplier.

37  Value for safety net purposes for supplies

Supplies by approved hospital authorities

 (1) The value for safety net purposes for a special arrangement supply of an HSD pharmaceutical benefit to a person by an approved hospital authority is the amount paid by the person for the supply of the benefit that is equivalent to the amount chargeable under subsection 87(5) of the Act for the supply of the benefit less the amount chargeable under that subsection because of subsection 87(2A) of the Act.

Note: However, see Part 3A in relation to a special arrangement supply of an HSD pharmaceutical benefit to a CTG registered patient by a CTG supplier.

Supplies by approved pharmacists and approved medical practitioners

 (2) The value for safety net purposes for a special arrangement supply of an HSD pharmaceutical benefit to a person by an approved pharmacist or approved medical practitioner is the amount paid by the person for the supply of the benefit that is equivalent to the amount chargeable under section 87 of the Act for the supply of the benefit less the amount chargeable under subsection 87(2A) of the Act.

Note: However, see Part 3A in relation to a special arrangement supply of an HSD pharmaceutical benefit to a CTG registered patient by a CTG supplier.

Application of this section

 (3) This section applies despite regulation 17A of the Regulations.

Part 6—Application, saving and transitional provisions

Division 1—Provisions relating to this instrument as made

38  HSD hospital authorities

  Despite the repeal of the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010):

 (a) an approval that was in force under subsection 52(2) of that instrument immediately before 1 April 2021; and

 (b) an approval that was continued in force under section 53 of that instrument as if it were an approval under subsection 52(2) of that instrument, and was in force immediately before 1 April 2021;

continues in force as if it were an approval under section 94 of the Act, as modified by section 10 of this instrument.

Division 2—Provisions relating to the National Health Legislation Amendment (Opioid Dependence Treatment and Maximum Dispensed Quantities) Instrument 2023

39  Purpose of this Division

  This Division makes provision in relation to certain pre‑commencement prescriptions for the purpose of the application of Part VII of the Act, and regulations and other instruments made for the purposes of that Part, to those prescriptions.

40  Definitions

  In this Division:

Claims Rules means the National Health (Supply of Pharmaceutical Benefits—Under Co‑payment Data and Claims for Payment) Rules 2022.

pre‑commencement benefit: see section 50.

pre‑commencement prescription: a prescription is a pre‑commencement prescription if:

 (a) the prescription was written:

 (i) before 1 July 2023; and

 (ii) by an authorised nurse practitioner or a medical practitioner; and

 (iii) for the supply to a person of a drug that is a medication for the treatment of opioid dependence; and

 (iv) in the circumstance that the prescription was for the treatment of opiate dependence, including for detoxification (withdrawal) and maintenance of withdrawal; and

 (b) immediately before 1 July 2023, a pre‑commencement benefit could have been supplied to the person on the basis of the prescription.

41  Definition of special arrangement supply

  A supply of an ODT pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is supplied:

 (a) on or after 1 July 2023; and

 (b) to a person who is, or is to be treated as, an eligible person; and

 (c) by an approved supplier; and

 (d) on the basis of a pre‑commencement prescription (as affected by this Division, if applicable); and

 (e) in accordance with this Division.

42  Prescriptions directing supply for dispensing over time

 (1) This section applies if a pre‑commencement prescription directed the supply of a specified quantity or number of units (whether expressed as a total or as a dose) to be dispensed over a specified period of time (the directed dispensing period).

Deemed variation of application of determination of maximum number or quantity of units

 (2) If the specified quantity or number of units, or the quantity or number of units required for the doses over the directed dispensing period, is more than the maximum quantity or number of units mentioned in Schedule 1 for the pharmaceutical benefit to be supplied on the basis of the prescription:

 (a) the application of the determination of the maximum quantity or number of units under paragraph 85A(2)(a) of the Act for the benefit is taken to have been varied under section 30 of the Regulations; and

 (b) the prescription is taken to have been authorised in accordance with subsection 30(4) of the Regulations; and

 (c) the number P2023OD is taken to have been allotted to, and marked on, the prescription as mentioned in subsection 30(5) of the Regulations.

Deemed modification of prescription—remaining period of up to 28 days

 (3) If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the period remaining in the directed dispensing period (the remaining period) is not more than 28 days, the prescription is taken to direct the supply on one occasion of the total quantity or number of units required for the remaining period.

Deemed modification of prescription—remaining period of 29 to 55 days

 (4) If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining period is more than 28 days but not more than 55 days, the prescription is taken to direct the supply on one occasion of the total quantity or number of units required for 28 days.

Deemed modification of prescription—remaining period of 56 to 83 days

 (5) If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining period is more than 55 days but not more than 83 days, the prescription is taken to direct:

 (a) the supply on any one occasion of the total quantity or number of units required for 28 days; and

 (b) that the supply be repeated once.

Deemed modification of prescription—remaining period of 84 days or more

 (6) If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining period is 84 days or more, the prescription is taken to direct:

 (a) the supply on any one occasion of the total quantity or number of units required for 28 days; and

 (b) that the supply be repeated twice.

43  Prescriptions directing supply of buprenorphine for injection

 (1) This section applies if:

 (a) a pre‑commencement prescription is for the supply of the drug buprenorphine with the manner of administration injection (the medication); and

 (b) the prescription directed the supply of a specified quantity or number of units of the medication (the directed quantity) that is more than the quantity of the medication mentioned in subsection (2) (the standard quantity for the medication).

 (2) For the purposes of paragraph (1)(b), the standard quantity for the medication is:

 (a) if the brand of the medication is Buvidal Weekly—4; or

 (b) if the brand of the medication is Buvidal Monthly or Sublocade—1.

Deemed modification of prescription—remaining quantity of not more than standard quantity

 (3) If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the quantity or number of units of the medication that remains to be supplied (the remaining quantity) is not more than the standard quantity for the medication, the prescription is taken to direct the supply on one occasion of the remaining quantity.

Deemed modification of prescription—remaining quantity of more than standard quantity but less than twice standard quantity

 (4) If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining quantity is more than the standard quantity for the medication but is less than twice the standard quantity for the medication, the prescription is taken to direct the supply on one occasion of the standard quantity for the medication.

Deemed modification of prescription—remaining quantity of more than twice standard quantity but less than 3 times standard quantity

 (5) If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining quantity is more than twice the standard quantity for the medication but is less than 3 times the standard quantity for the medication, the prescription is taken to direct:

 (a) the supply on any one occasion of the standard quantity for the medication; and

 (b) that the supply be repeated once.

Deemed modification of prescription—remaining quantity of 3 times standard quantity or more

 (6) If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining quantity is 3 times the standard quantity for the medication or more, the prescription is taken to direct:

 (a) the supply on any one occasion of the standard quantity for the medication; and

 (b) that the supply be repeated twice.

44  Prescriptions directing supply of methadone

 (1) This section applies if a pre‑commencement prescription is for the supply of the drug methadone.

 (2) On the basis of the prescription, the person for whom the prescription was written is entitled to receive, and an approved supplier may supply to the person, any ODT pharmaceutical benefit that has the drug methadone.

 (3) This section applies despite section 89 and paragraph 103(2)(a) of the Act.

45  First supply on or after 1 July 2023 deemed to be supply on first presentation

  If the first supply of an ODT pharmaceutical benefit by an approved supplier on the basis of a pre‑commencement prescription on or after 1 July 2023 is not a supply of that benefit on first presentation of the prescription, it is taken to be a supply of that benefit on first presentation of the prescription.

46  Supply on first presentation of prescription (Regulations s 44)

  Subparagraphs 44(2)(a)(i) and (3)(a)(i) of the Regulations do not apply to a special arrangement supply of an ODT pharmaceutical benefit on the basis of a pre‑commencement prescription.

47  Repeat authorisations (Regulations s 52)

 (1) Section 52 of the Regulations applies to the supply of an ODT pharmaceutical benefit on the basis of a pre‑commencement prescription to which subsection 42(5) or (6) or 43(5) or (6) of this instrument applies as if the benefit were supplied in the circumstances set out in subsection 52(2) of the Regulations.

 (2) Subsection 52(3) of the Regulations applies in relation to a pre‑commencement prescription as if the prescription had been authorised in accordance with authority required procedures that are part of the circumstances determined by the Minister under paragraph 85(7)(b) of the Act for the pharmaceutical benefit to be supplied on the basis of the prescription.

48  Prescriptions written in electronic form—additional procedures for giving information (Claims Rules s 7) and keeping documents

Additional procedures for giving information

 (1) Section 7 of the Claims Rules applies in relation to a pre‑commencement prescription written in electronic form as if a reference in that section to the prescription were a reference to a print‑out of the prescription.

Keeping print‑outs of prescriptions

 (2) If an approved supplier supplies a pharmaceutical benefit on the basis of a pre‑commencement prescription written in electronic form, the approved supplier must keep a print‑out of the prescription for at least 2 years from the date the pharmaceutical benefit was supplied by the approved supplier.

49  Information to be given using Claims Transmission System (Claims Rules Sch 1)

General

 (1) The table in clause 1 of Schedule 1 to the Claims Rules applies to a pre‑commencement prescription as follows:

 (a) as if, for the purposes of item 2 of the table, the Authority Prescription Number for the prescription were 00000641;

 (b) as if, for the purposes of item 8 of the table, the prescription were signed on 1 July 2023;

 (c) if the authorised nurse practitioner or medical practitioner who wrote the prescription did not write their PBS prescriber number on the prescription—as if, for the purposes of item 28 of the table, that number were written on the prescription;

 (d) if the authorised nurse practitioner or medical practitioner who wrote the prescription did not write their prescriber ID on the prescription—as if, for the purposes of item 31 of the table, that number were written on the prescription;

 (e) if the prescription was written in electronic form—as if, for the purposes of item 32 of the table, the prescription were a paper‑based prescription;

 (f) as if, for the purposes of item 40 of the table, the authorised nurse practitioner or medical practitioner who wrote the prescription had written on the prescription:

 (i) the words “Streamlined Authority Code”; and

 (ii) the relevant streamlined authority code included in any circumstances mentioned in an item of the table in Part 1 of Schedule 4 to the Listing Instrument for the writing of a prescription for a pharmaceutical benefit for the treatment of opioid dependence.

Pre‑commencement prescriptions written in electronic form

 (2) Clause 2 of Schedule 1 to the Claims Rules does not apply to a pre‑commencement prescription written in electronic form.

50  Pre‑commencement benefits

  Each pharmaceutical benefit specified in the following table is a pre‑commencement benefit.

Note: The drugs mentioned in the table were declared by the Minister under subsection 85(2) of the Act, and the forms, manners of administration and brands mentioned in the table were determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively—see the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) as in force before 1 July 2023.

Division 3—Provisions relating to the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (Increases in Maximum Quantity and Number of Repeats for Complex Authority required (CAR) Medicines) Instrument 2026

51  Prescriptions directing increased maximum quantities or numbers of units of HSD pharmaceutical benefits that have a CAR drug

 (1) This section applies to the special arrangement supply of an HSD pharmaceutical benefit that has a CAR drug that is made on or after 1 February 2026 if:

 (a) the supply is made on the basis of a prescription that was written before 1 February 2026; and

 (b) the prescription directs the supply on any one occasion of a quantity or number of units of the pharmaceutical item in the HSD pharmaceutical benefit that is more than the applicable maximum quantity for the pharmaceutical item; and

 (c) before 1 February 2026, the Minister purported under section 30 of the Regulations to:

 (i) authorise the variation of the application of the determination of the applicable maximum quantity; and

 (ii) allot a number to the prescription.

Note: Former section 22 of this instrument prevented the Minister from authorising, under section 30 of the Regulations, a variation of the application of the determination of the maximum quantity or number of units of a pharmaceutical item in an HSD pharmaceutical benefit that a prescriber could direct to be supplied on any one occasion.

 (2) The Minister is taken to have authorised, under subsection 30(2) of the Regulations, the variation of the determination of the applicable maximum quantity in relation to the prescription and the person who wrote the prescription.

 (3) The number purportedly allotted to the prescription is taken to have been allotted to the prescription in accordance with subsection 30(3) of the Regulations.

 (4) In this section, the applicable maximum quantity, for the pharmaceutical item in the HSD pharmaceutical benefit prescribed for supply, means the quantity or number of units of the pharmaceutical item determined for paragraph 85A(2)(a) of the Act under subsection 20(2), 20(3) or 20(4) of this instrument (whichever is applicable).

52  Prescriptions directing increased maximum number of repeats of HSD pharmaceutical benefits that have a CAR drug

 (1) This section applies to the special arrangement supply of an HSD pharmaceutical benefit that has a CAR drug that is made on or after 1 February 2026 if:

 (a) the supply is made on the basis of a prescription that was written before 1 February 2026; and

 (b) the prescription directs the supply of the HSD pharmaceutical benefit be repeated on a number of occasions that is more than the applicable maximum number of repeats for the pharmaceutical benefit; and

 (c) before 1 February 2026, the Minister purported under section 30 of the Regulations to:

 (i) authorise the variation of the application of the determination of the applicable maximum number of repeats; and

 (ii) allot a number to the prescription.

Note: Former section 22 of this instrument prevented the Minister from authorising, under section 30 of the Regulations, a variation of the application of the determination of the maximum number of occasions on which the supply of an HSD pharmaceutical benefit may, in one prescription, be directed to be repeated.

 (2) The Minister is taken to have authorised, under subsection 30(2) of the Regulations, the variation of the determination of the applicable maximum number of repeats in relation to the prescription and the person who wrote the prescription.

 (3) The number purportedly allotted to the prescription is taken to have been allotted to the prescription in accordance with subsection 30(3) of the Regulations.

 (4) In this section, the applicable maximum number of repeats, for the HSD pharmaceutical benefit prescribed for supply, means the number of occasions an authorised prescriber may, in one prescription, direct the supply of the HSD pharmaceutical be repeated, determined for paragraph 85A(2)(b) of the Act under subsection 21(2), 21(3) or 21(4) of this instrument (whichever is applicable).

Schedule 1—HSD pharmaceutical benefits and related information

Note: See the definitions of highly specialised drug and HSD pharmaceutical benefit in section 6, and sections 13, 15, 20 and 21.

1  Highly specialised drugs and HSD pharmaceutical benefits

 (1) Each listed drug specified in the following table is a highly specialised drug.

 (2) Each pharmaceutical benefit specified in the following table is an HSD pharmaceutical benefit.

 (3) The following table also specifies circumstances, purposes, maximum quantities and maximum repeats for HSD pharmaceutical benefits.

Note: The drugs mentioned in the table have been declared by the Minister under subsection 85(2) of the Act. The forms, manners of administration and brands mentioned in the table have been determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively.