Commonwealth Coat of Arms of Australia

 

National Health (Pharmaceutical Benefits) Amendment (Electronic Prescriptions) Regulations 2019

I, General the Honourable David Hurley AC DSC (Retd), GovernorGeneral of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations.

Dated 08 August 2019

David Hurley

GovernorGeneral

By His Excellency’s Command

Greg Hunt

Minister for Health

 

 

 

Contents

1 Name

2 Commencement

3 Authority

4 Schedules

Schedule 1—Amendments

National Health (Pharmaceutical Benefits) Regulations 2017

1  Name

  This instrument is the National Health (Pharmaceutical Benefits) Amendment (Electronic Prescriptions) Regulations 2019.

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

31 October 2019.

31 October 2019

Note: This table relates only to the provisions of this instrument as originally made.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 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  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 1Amendments

 

National Health (Pharmaceutical Benefits) Regulations 2017

1  Subsection 5(1) (definition of approved electronic communication)

Repeal the definition.

2  Subsection 5(1)

Insert:

electronic medication chart has the meaning given by subsection 41(6).

3  Subsection 5(1) (paragraph (a) of the definition of electronic prescription)

Omit “approved electronic”, substitute “eligible electronic”.

4  Subsection 5(1)

Insert:

eligible electronic communication means:

 (a) an electronic communication of a kind approved by the Secretary under section 11 for the purposes of the provision in which the expression is used; or

 (b) if no such approval is in force for the purposes of the provision in which the expression is used—any electronic communication.

healthcare identifier has the same meaning as in the Healthcare Identifiers Act 2010.

healthcare provider organisation has the same meaning as in the Healthcare Identifiers Act 2010.

5  Paragraph 9(1)(b)

Omit “approved”, substitute “eligible”.

6  Paragraph 10(b)

Omit “approved electronic”, substitute “eligible electronic”.

7  Sections 30 and 33

Omit “approved electronic” (wherever occurring), substitute “eligible electronic”.

8  Paragraphs 39(a) and (b)

Repeal the paragraphs, substitute:

 (a) either:

 (i) section 40 (prescriptions other than medication chart prescriptions); or

 (ii) section 41 (medication chart prescriptions); and

 (b) if the prescription is an electronic prescription—section 41A (additional requirements for all electronic prescriptions).

9  Paragraph 40(1)(b)

Omit “to be supplied”, substitute “prescribed”.

10  Subparagraph 41(1)(b)(ii)

After “authority prescription”, insert “other than an authority prescription referred to in subsection (3A)”.

11  Paragraph 41(2)(g)

After “service”, insert “and the chart is not an electronic medication chart”.

12  Paragraphs 41(3)(a) and (b)

Repeal the paragraphs, substitute:

 (a) each authority approval number for the prescription, unless the prescription is to be posted or delivered to the Minister or Chief Executive Medicare for authorisation; or

 (b) the relevant streamlined authority code for the pharmaceutical benefit that is prescribed.

13  After subsection 41(3)

Insert:

Authority prescriptions that have been authorised in accordance with certain authority required procedures

 (3A) Subparagraph (1)(b)(ii) does not apply to authority prescriptions that have been authorised in accordance with authority required procedures that are incorporated by reference into the circumstances determined under subsection 85B(4) of the Act.

Note: If the authority required procedures referred to in subsection (3A) require a streamlined authority code or an authority approval number to be written on an authority prescription, and the code or number is not written on the authority prescription, the special patient contribution is not payable by the Commonwealth: see subsection 85B(4) of the Act.

14  At the end of section 41

Add:

Electronic medication charts

 (6) An electronic medication chart is a medication chart in a form approved under subsection (5) for the purpose of writing an electronic prescription.

15  After section 41

Insert:

41A  Writing prescriptions—additional requirements for all electronic prescriptions

  A PBS prescriber writes an electronic prescription in accordance with this section if the PBS prescriber:

 (a) includes in the metadata of the prescription:

 (i) the conformance identifier provided to the Australian Digital Health Agency in relation to the software used to prepare the prescription; and

 (ii) a unique identifier for the prescription generated by that software; and

 (b) states in the prescription:

 (i) the healthcare identifier (if any) assigned to the PBS prescriber; and

 (ii) the healthcare identifier assigned to a healthcare provider organisation to which the PBS prescriber is linked (within the meaning of the Healthcare Identifiers Act 2010).

41B  Writing prescriptions—additional information that may be included in electronic prescriptions

  An electronic prescription may include either or both of the following:

 (a) the date of birth of the person for whom the pharmaceutical benefit is prescribed;

 (b) the reason why the pharmaceutical benefit is prescribed to that person.

16  Paragraph 57(2)(a)

Omit “approved electronic”, substitute “eligible electronic”.

17  Subsection 59(3)

After “purposes”, insert “of”.

18  Paragraph 59(3)(a)

After “electronic”, insert “prescription, or a copy of the electronic”.