PB 57 of 2023

National Health Legislation Amendment (Opioid Dependence Treatment and Maximum Dispensed Quantities) Instrument 2023

I, Adriana Platona, as delegate of the Minister for Health and Aged Care, make the following instrument.

Dated  23 June 2023

Adriana Platona
First Assistant Secretary
Technology Assessment and Access Division

Department of Health and Aged Care

Contents

1 Name

2 Commencement

3 Authority

4 Schedules

Schedule 1—Opioid dependence treatment

National Health (Highly Specialised Drugs Program) Special Arrangement 2021

Schedule 2—Maximum dispensed quantities

National Health (Listing of Pharmaceutical Benefits) Instrument 2012

1  Name

 (1) This instrument is the National Health Legislation Amendment (Opioid Dependence Treatment and Maximum Dispensed Quantities) Instrument 2023.

 (2) This instrument may also be cited as PB 57 of 2023.

2  Commencement

 (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

 (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

  This instrument is made under sections 84AF, 84AK, 85, 85A, 88, 99 and 100 of the National Health Act 1953.

4  Schedules

  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Opioid dependence treatment

National Health (Highly Specialised Drugs Program) Special Arrangement 2021

1  Section 6

Insert:

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.

2  Section 6 (after paragraph (b) of the definition of community access medication)

Insert:

 (ba) medication for the treatment of opioid dependence;

3  Section 6

Insert:

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.

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

 (a) buprenorphine;

 (b) buprenorphine with naloxone;

 (c) methadone.

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

4  Section 6 (definition of shelf life)

Repeal the definition.

5  Section 6 (definition of special arrangement supply)

Omit “section 13”, substitute “sections 13 and 41”.

6  Paragraph 7(4)(a)

Before “a medication”, insert “a benefit that has a drug that is”.

7  Paragraph 7(4)(b)

Before “lanreotide”, insert “a benefit that has the drug”.

8  Paragraph 7(4)(c)

Before “octreotide”, insert “a benefit that has the drug”.

9  Subsection 7(5)

Repeal the subsection, substitute:

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

 (5) The following table has effect.

10  At the end of section 7

Add:

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.

11  Subsection 8(2)

Before “is a medication”, insert “has a drug that”.

12  Subsection 8(3)

Omit “contains”, substitute “has the drug”.

13  Subsection 8(5)

Before “is a medication”, insert “has a drug that”.

14  Subsection 8(6) (heading)

Before “are”, insert “have drugs that”.

15  Paragraph 8(6)(a)

After “benefit”, insert “has a drug that”.

16  Paragraph 13(3)(a)

After “benefit”, insert “has a drug that”.

17  Subsection 14(2)

Repeal the subsection, substitute:

 (2) Subsection 9(1A) of the Listing Instrument (which provides for the pharmaceutical benefits for which medical practitioners are authorised to write prescriptions) does not apply to an HSD pharmaceutical benefit other than the following:

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

 (b) a benefit that has the drug methadone.

18  At the end of section 14

Add:

 (4) Subsection 9(4) of the Listing Instrument (which provides for the pharmaceutical benefits for which authorised nurse practitioners are authorised to write prescriptions) does not apply to an HSD pharmaceutical benefit other than the following:

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

 (b) a benefit that has the drug methadone.

19  Before subsection 20(5)

Insert:

Application of this section

20  Before subsection 21(5)

Insert:

Application of this section

21  Section 23 (heading)

Omit “contain”, substitute “have”.

22  Subsection 23(1)

Omit “contains”, substitute “has the drug”.

23  Sections 25 and 26

Repeal the sections, substitute:

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.

24  At the end of subsection 28(1)

Add:

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

25  At the end of subsection 30(2)

Add:

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.

26  At the end of subsection 31(1)

Add:

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

27  At the end of paragraph 32(1)(a)

Add:

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

28  At the end of paragraph 32(1)(b)

Add:

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

29  At the end of subsection 32(1)

Add:

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

30  Subparagraph 34(1)(a)(i)

Omit “Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2020 (PB 66 of 2020)”, substitute “Approved Pharmacists Commonwealth Price Determination”.

31  Subparagraph 34(1)(a)(ii)

Omit “determination”, substitute “Determination”.

32  Paragraph 34(1)(b)

Repeal the paragraph, substitute:

 (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.

33  Subsection 35(1)

Omit “National Health (Claims and under co‑payment data) Rules 2012 (PB 19 of 2012)”, substitute “National Health (Supply of Pharmaceutical Benefits—Under Co‑payment Data and Claims for Payment) Rules 2022”.

34  Before subsection 37(3)

Insert:

Application of this section

35  At the end of Part 6

Add:

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 Listing Instrument as in force before 1 July 2023.

Schedule 2—Maximum dispensed quantities

National Health (Listing of Pharmaceutical Benefits) Instrument 2012

[1] Schedule 1, Part 1, entry for Adapalene with benzoyl peroxide

substitute:

[2] Schedule 1, Part 1, entry for Alendronic acid

substitute:

[3] Schedule 1, Part 1, entry for Allopurinol

substitute:

[4] Schedule 1, Part 1, entry for Amlodipine

substitute:

[5] Schedule 1, Part 1, entry for Amlodipine with atorvastatin

substitute:

[6] Schedule 1, Part 1, entry for Amlodipine with valsartan

substitute:

[7] Schedule 1, Part 1, entry for Amlodipine with valsartan and hydrochlorothiazide

substitute:

[8] Schedule 1, Part 1, entry for Apixaban

substitute:

[9] Schedule 1, Part 1, entry for Atenolol

substitute: