National Health (Highly specialised drugs program) Special Arrangement Amendment (Authorised Nurse Practitioners) Instrument 2020 (PB 26 of 2020) (Cth)

PB 26 of 2020

National Health (Highly specialised drugs program) Special Arrangement Amendment (Authorised Nurse Practitioners) Instrument 2020

I, Ben Sladic, as delegate of the Minister for Health, make the following instrument.

Dated 30 March 2020

Ben Sladic

Assistant Secretary
Pharmacy Branch
Technology Assessment and Access Division
Department of Health

Contents

1............ Name............................................................................................................................. 1

2............ Commencement............................................................................................................. 1

3............ Authority....................................................................................................................... 1

4............ Schedules...................................................................................................................... 1

Schedule 1—Amendments  2

National Health (Highly specialised drugs program) Special Arrangement 2010             2

1  Name

(1)  This instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment (Authorised Nurse Practitioners) Instrument 2020.

(2)  This instrument may also be cited as PB 26 of 2020.

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.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1.  The whole of this instrument	Immediately after the commencement of the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 3).	1 April 2020

Note:          This table relates only to the provisions of this instrument as originally made.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 subsection 100(2) 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—Amendments

National Health (Highly specialised drugs program) Special Arrangement 2010

1  Section 4 (definition of accredited prescriber of medication for the treatment of hepatitis B)

After “practitioner”, insert “, or an authorised nurse practitioner,”.

2  Section 4 (definition of accredited prescriber of medication for the treatment of Hepatitis C)

After “practitioner”, insert “, or an authorised nurse practitioner,”.

3  Section 4 (definition of accredited prescriber of medication for the treatment of HIV or AIDS)

After “practitioner”, insert “, or an authorised nurse practitioner,”.

4  Section 4

Insert:

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

5  Section 4 (definition of authorised prescriber)

Repeal the definition, substitute:

authorised prescriber has the meaning given by section 4A.

6  Section 4 (paragraphs (b), (ba) and (c) of the definition of eligible medical practitioner)

Repeal the paragraphs.

7  Section 4

Insert:

medication for the treatment of hepatitis C means medication mentioned in the table in paragraph 3 of the General Statement for drugs for the treatment of hepatitis C.

8  Section 4 (definition of prescriber code)

Repeal the definition.

9  At the end of Division 1 of Part 1

Add:

4A  Definition of authorised prescriber

(1)  An eligible medical practitioner for the prescription of an HSD pharmaceutical benefit under this Special Arrangement to an eligible patient is an authorised prescriber for the HSD pharmaceutical benefit.

(2)  A medical practitioner is an authorised prescriber for each of the following HSD pharmaceutical benefits for the purpose of the treatment of hepatitis C:

(a)  daclatasvir;

(b)  grazoprevir with elbasvir;

(c)  ledipasvir with sofosbuvir;

(d)  ribavirin;

(e)  sofosbuvir.

(3)  A person mentioned in column 1 of an item of the following table is an authorised prescriber for an HSD pharmaceutical benefit mentioned in column 2 of the item.

Authorised prescribers for certain HSD pharmaceutical benefits
Item	Column 1 Person	Column 2 HSD pharmaceutical benefit
1	An accredited prescriber of medication for the treatment of hepatitis B	A medication for the treatment of hepatitis B
2	An accredited prescriber of medication for the treatment of hepatitis C	A medication for the treatment of hepatitis C
3	An accredited prescriber of medication for the treatment of HIV or AIDS	A medication for the treatment of HIV or AIDS

10  Section 8 (heading)

Repeal the heading, substitute:

8  Prescribing of HSD pharmaceutical benefits—authorised prescribers

11  Subsections 8(1), (2) and (3)

Repeal the subsections, substitute:

(1) For the purposes of subsection 88(1) of the Act applying to a medical practitioner who is an authorised prescriber for an HSD pharmaceutical benefit, the benefit is determined.

(2) For the purposes of subsection 88(1E) of the Act applying to an authorised nurse practitioner who is an authorised prescriber for an HSD pharmaceutical benefit, the benefit is determined.

12  Subsection 8(5)

Repeal the subsection, substitute:

(5)  Subsection 9(1A) of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (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 a medication for the treatment of hepatitis C.

13  Subsection 14(1)

Omit “eligible medical practitioner”, substitute “authorised prescriber for the HSD pharmaceutical benefit”.

14  Subsection 15(1)

Omit “eligible medical practitioner”, substitute “authorised prescriber for an HSD pharmaceutical benefit”.

15  Subsection 15(6)

Omit “eligible medical practitioner”, substitute “authorised prescriber for the HSD pharmaceutical benefit”.

16  Section 20

Omit “eligible medical practitioner must not write a repeat prescription for an HSD pharmaceutical benefit”, substitute “authorised prescriber for an HSD pharmaceutical benefit must not write a repeat prescription for the HSD pharmaceutical benefit”.

17  Section 21

Omit “eligible medical practitioner may prescribe an HSD pharmaceutical benefit that has a non‑CAR drug”, substitute “authorised prescriber for an HSD pharmaceutical benefit that has a non‑CAR drug may prescribe the HSD pharmaceutical benefit”.

18  Section 21 (note)

Repeal the note, substitute:

Note:          An authorised prescriber for an HSD pharmaceutical benefit that has a non‑CAR drug may prescribe more than the maximum quantity, or more than the maximum number of repeats, of the HSD pharmaceutical benefit only in accordance with section 30 of the Regulations.

19  Subsection 22A(1)

Omit “eligible medical practitioner prescribes a HSD pharmaceutical benefit referred to in section 9A for supply under Part VII of the Act, and that HSD pharmaceutical benefit”, substitute “authorised prescriber for an HSD pharmaceutical benefit referred to in section 9A prescribes the HSD pharmaceutical benefit for supply under Part VII of the Act, and the HSD pharmaceutical benefit”.

20  Paragraph 22A(1)(a)

Omit “eligible medical practitioner”, substitute “authorised prescriber”.

21  Section 23

Omit “eligible medical practitioner may prescribe an HSD pharmaceutical benefit that has a CAR drug”, substitute “authorised prescriber for an HSD pharmaceutical benefit that has a CAR drug may prescribe the HSD pharmaceutical benefit”.

22  Subsection 23A(1)

Omit “eligible medical practitioner prescribes a HSD pharmaceutical benefit referred to in section 9A for supply under Part VII of the Act, and that HSD pharmaceutical benefit”, substitute “authorised prescriber for an HSD pharmaceutical benefit referred to in section 9A prescribes the HSD pharmaceutical benefit for supply under Part VII of the Act, and the HSD pharmaceutical benefit”.

23  Paragraph 23A(1)(a)

Omit “eligible medical practitioner”, substitute “authorised prescriber”.

24  Subsection 24(1)

Repeal the subsection, substitute:

(1)  An authorised prescriber for an HSD pharmaceutical benefit that has a CAR drug mentioned in subsection (2) may write a prescription for the HSD pharmaceutical benefit to be supplied to an eligible patient on any one occasion only in accordance with the limitation mentioned in subsection (2) for the drug.

25  Subsection 25(1)

Omit “eligible medical practitioner may authorise the repeat supply of an HSD pharmaceutical benefit that has a CAR drug mentioned in subsection (2)”, substitute “authorised prescriber for an HSD pharmaceutical benefit that has a CAR drug mentioned in subsection (2) may authorise the repeat supply of the HSD pharmaceutical benefit”.

26  Section 42

Repeal the section, substitute:

42  Dispensing fee if quantity of repeated supply directed to be supplied on one occasion

If an authorised prescriber for an HSD pharmaceutical benefit, instead of directing a repeated supply of the HSD pharmaceutical benefit, directs the supply on one occasion of a quantity or number of units of the HSD pharmaceutical 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 HSD pharmaceutical benefit will include only one dispensing fee.

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

27  Schedule 1 (table, column headed “Authorised Prescriber”)

Repeal the column.