National Health (Pharmaceutical Benefits) Amendment Regulations 2006 (No. 2)

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National Health (Pharmaceutical Benefits) Amendment Regulations 2006 (No. 2)1
Select Legislative Instrument 2006 No. 200
I, PHILIP MICHAEL JEFFERY, Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the National Health Act 1953.
Dated 27 July 2006
P. M. JEFFERY
Governor‑General
By His Excellency’s Command
TONY ABBOTT
Minister for Health and Ageing
1              Name of Regulations
                These Regulations are the National Health (Pharmaceutical Benefits) Amendment Regulations 2006 (No. 2).
2              Commencement
                These Regulations commence on 1 March 2007.
3              Amendment of National Health (Pharmaceutical Benefits) Regulations 1960
                Schedule 1 amends the National Health (Pharmaceutical Benefits) Regulations 1960.
Schedule 1        Amendments
(regulation 3)
  
[1]           Part I, heading
substitute
Part 1                 Preliminary
Division 1.1           Interpretation
[2]           Subregulation 5 (1), after definition of applicable amount
insert
approved electronic communication means an electronic communication of a kind approved in writing by the Secretary under regulation 5E for the purposes of the provision in which the expression is used.
[3]           Subregulation 5 (1), after definition of approved hospital authority
insert
approved information technology requirements means information technology requirements of a kind approved in writing by the Secretary under regulation 5F for the purposes of the provision in which the expression is used.
[4]           Subregulation 5 (1), after definition of dependant
insert
electronic communication has the meaning given by subsection 5 (1) of the Electronic Transactions Act 1999.
electronic order form means a form that is approved in writing by the Secretary under subparagraph 16 (1) (b) (ii) for the purposes of lodging an order under paragraph 16 (1) (b).
electronic prescription means a prescription that is prepared and submitted:
                (a)    in accordance with approved information technology requirements (if any), by means of an approved electronic communication; and
               (b)    in accordance with a form approved by the Secretary under sub‑subparagraph 19 (1) (a) (iia) (B).
[5]           Subregulation 5 (1), after definition of entitlement card prescription
insert
information technology requirements has the meaning given by subsection 5 (1) of the Electronic Transactions Act 1999.
[6]           Subregulation 5 (1), definition of Medicare Australia/DVA copy
omit
for a prescription,
insert
for a paper‑based prescription,
[7]           Subregulation 5 (1), after definition of out‑patient medication
insert
paper‑based prescription means a prescription, including an authority prescription, that is prepared in duplicate in accordance with subparagraph 19 (1) (a) (i), (ii) or (iii).
[8]           Subregulation 5 (1), definition of pharmacist/patient copy
substitute
pharmacist/patient copy, for a paper‑based prescription, means the original of the prescription on which appear the words ‘pharmacist/patient copy’.
prescription means a paper‑based prescription or an electronic prescription.
[9]           After section 5
insert in Part I
Division 1.2           Application of Regulations to electronic prescriptions and electronic orders
5A           Preparing electronic prescriptions
                A reference in these Regulations to writing or preparing a prescription, a repeat authorisation or a deferred supply authorisation, whether the expression writing, preparing or any other expression is used, is taken to include:
                (a)    for an electronic prescription — writing or preparing the prescription by means of an electronic form approved by the Secretary under sub‑subparagraph 19 (1) (a) (iia) (B) for the purposes of writing an electronic prescription; and
               (b)    for a repeat authorisation that relates to an electronic prescription — writing or preparing the authorisation by means of an electronic form authorised by the Secretary under subparagraph 26 (1A) (a) (i) for the supply of a pharmaceutical benefit under an electronic prescription; and
                (c)    for a deferred supply authorisation that relates to an electronic prescription — writing or preparing the authorisation by means of an electronic form authorised by the Secretary under paragraph 26A (2) (a) for deferring the supply of a pharmaceutical benefit under an electronic prescription.
5B           Date when a prescription is written or a pharmaceutical benefit is prescribed
                A reference in these Regulations to the day or date on which a prescription is written by a medical practitioner or participating dental practitioner or the day or date on which a pharmaceutical benefit is prescribed is, in relation to an electronic prescription, the day or date on which the prescription is signed by the medical practitioner or dental practitioner.
5C           Requirement to give information in writing
         (1)   If, under these Regulations, a person is required to write information on a prescription, a repeat authorisation, a deferred supply authorisation or an order form, that requirement is taken to have been met in relation to an electronic prescription, an authorisation that relates to an electronic prescription or an electronic order form, if the person gives the information:
                (a)    in accordance with approved information technology requirements (if any); and
               (b)    by means of an approved electronic communication.
         (2)   This regulation applies to a requirement to write information on a prescription, a repeat authorisation, a deferred supply authorisation or an order form, whether the expression write, certify, endorse, identify, indicate, mark, specify, state, or any other expression is used.
5D           Requirement to give a prescription
                If, under these Regulations, a prescription is required to be given or presented to an approved pharmacist or an approved medical practitioner for the purpose of supplying a pharmaceutical benefit to the person for whom the prescription was written, that requirement is taken to have been met in relation to an electronic prescription if:
                (a)    the person who will receive the pharmaceutical benefit (whether or not for the person’s own use) requests the pharmacist or practitioner to supply the pharmaceutical benefit; and
               (b)    the pharmacist or practitioner consents, within the meaning of subsection 5 (1) of the Electronic Transactions Act 1999, to the prescription being given or presented, in accordance with approved information technology requirements (if any), by means of an approved electronic communication; and
                (c)    the prescription is accessible by the pharmacist or practitioner.
5E           Approval of kinds of electronic communications
                The Secretary may, in writing, approve a kind of electronic communication for 1 or more of the following purposes:
                (a)    preparing or submitting an electronic prescription;
               (b)    giving information, for the purposes of these Regulations, in relation to an electronic prescription, an authorisation that relates to an electronic prescription or an electronic order form;
                (c)    giving or presenting an electronic prescription to an approved pharmacist or an approved medical practitioner under these Regulations;
               (d)    submitting an electronic prescription to the Minister in accordance with paragraph 13 (2) (b);
                (e)    lodging an order with an approved pharmacist to obtain a pharmaceutical benefit for the purpose of section 93 of the Act;
                (f)    submitting a receipt for a pharmaceutical benefit received under paragraph 16 (1) (b);
                (g)    giving an acknowledgment under these Regulations for the supply of a pharmaceutical benefit under an electronic prescription or an authorisation that relates to an electronic prescription;
                (h)    doing any other thing that is required or permitted to be done for the purposes of these Regulations.
5F           Approval of information technology requirements
                The Secretary may, in writing, approve information technology requirements for 1 or more of the following purposes:
                (a)    preparing and submitting an electronic prescription;
               (b)    giving information, for the purposes of these Regulations, in relation to an electronic prescription, an authorisation that relates to an electronic prescription or an electronic order form;
                (c)    giving or presenting an electronic prescription to an approved pharmacist or an approved medical practitioner under these Regulations;
               (d)    lodging an order with an approved pharmacist to obtain a pharmaceutical benefit for the purpose of section 93 of the Act;
                (e)    submitting a receipt for a pharmaceutical benefit received under paragraph 16 (1) (b);
                (f)    giving an acknowledgment under these Regulations for the supply of a pharmaceutical benefit under an electronic prescription or an authorisation that relates to an electronic prescription;
                (g)    doing any other thing that is required or permitted to be done for the purposes of these Regulations.
[10]         After subparagraph 13 (3) (a) (iii)
insert
                       (iiia)    in a form approved in writing by the Secretary under sub‑subparagraph 19 (1) (a) (iia) (B) for the purposes of writing an electronic prescription; or
[11]         Subparagraph 13 (3) (b) (ii)
substitute
                         (ii)    by means of an approved electronic communication.
[12]         Paragraph 13 (5) (a)
omit
if a prescription is submitted in accordance with paragraph (2) (a) —
insert
if a paper‑based prescription is submitted in accordance with a form specified in subparagraph (3) (a) (i), (ii) or (iii) or by a method approved under subparagraph (3) (a) (iv) —
[13]         After paragraph 13 (5) (a)
insert
              (aa)    if an electronic prescription is submitted in accordance with a form approved under subparagraph (3) (a) (iiia) — by the Minister signing his or her authorisation of the prescription on the electronic prescription and:
                          (i)    if the Minister requires the medical practitioner to alter the prescription — by returning it, including by means of an electronic communication, to the medical practitioner for alteration before the medical practitioner gives it to the person in respect of whom it was prepared; or
                         (ii)    in any other case:
                                   (A)     by returning it, including by means of an electronic communication, to the medical practitioner; or
                                   (B)     if requested by the medical practitioner — by making the prescription accessible by the person in respect of whom it was prepared or by an approved pharmacist for the purpose of supplying a pharmaceutical benefit to the person in respect of whom the prescription was prepared; or
[14]         Subparagraph 13 (6) (b) (ii)
substitute
                         (ii)    retain, for 1 year from the date on which the variation was made:
                                   (A)     if the prescription is a paper‑based prescription — a copy of the prescription; or
                                   (B)     if the prescription is an electronic prescription — the electronic prescription.
[15]         Subregulation 13 (7)
substitute
         (7)   For subparagraph (6) (b) (ii), the date on which the Minister makes a variation in relation to a person in respect of whom a medical practitioner submits an electronic prescription is:
                (a)    if the electronic prescription was submitted in accordance with paragraph (5) (b) — the date on which the Minister tells the medical practitioner the number that has been allotted to the authorised prescription; and
               (b)    if the electronic prescription was submitted in accordance with paragraph (5) (c) — the date on which the Minister sends, by means of an electronic communication, his or her authorisation of the prescription to the practitioner.
[16]         Subregulation 16 (1)
substitute
         (1)   A medical practitioner, other than an approved medical practitioner, may only obtain a pharmaceutical benefit for the purpose of section 93 of the Act if the medical practitioner lodges with an approved pharmacist:
                (a)    an order, in duplicate, signed by the medical practitioner, in accordance with a form approved in writing by the Secretary; or
               (b)    an order, in accordance with subregulation (1A), that:
                          (i)    is signed by the medical practitioner; and
                         (ii)    is in accordance with an electronic form approved in writing by the Secretary.
      (1A)   An order is lodged with an approved pharmacist under paragraph (1) (b) if:
                (a)    the order is lodged in accordance with approved information technology requirements (if any), by means of an approved electronic communication; and
               (b)    the medical practitioner, or an agent of the medical practitioner, who will receive the pharmaceutical benefit requests the approved pharmacist to supply the pharmaceutical benefit under the order; and
                (c)    the approved pharmacist consents, within the meaning of subsection 5 (1) of the Electronic Transactions Act 1999, to the order being lodged, in accordance with approved information technology requirements (if any), by means of an approved electronic communication; and
               (d)    the order is accessible by the approved pharmacist.
[17]         Subregulation 16 (3)
substitute
         (3)   A medical practitioner, or an agent of a medical practitioner, who receives a pharmaceutical benefit under subregulation (1), must:
                (a)    prepare a receipt for the benefit supplied, using the part of the order form identified for that purpose, that includes the following information:
                          (i)    the date of supply of the benefit;
                         (ii)    if the benefit is received by an agent of the medical practitioner — the agent’s address; and
               (b)    if the order is lodged in accordance with paragraph (1) (a) — give the receipt to the approved pharmacist supplying the benefit; and
                (c)    if the order is lodged in accordance with paragraph (1) (b):
                          (i)    submit the receipt, in accordance with approved information technology requirements (if any), by means of an approved electronic communication; and
                         (ii)    ensure the receipt is accessible by the approved pharmacist supplying the benefit.
[18]         Paragraph 17 (1) (a)
omit
given
insert
lodged
[19]         Sub‑subparagraph 17 (1) (b) (ii) (A)
omit
presented
insert
lodged
[20]         Regulation 18
omit
order given
insert
order lodged
[21]         Paragraph 19 (1) (a)
omit
prescription in duplicate:
insert
prescription:
[22]         Subparagraph 19 (1) (a) (i)
before
by handwriting
insert
in duplicate,
[23]         Subparagraph 19 (1) (a) (ii)
before
by means of
insert
in duplicate,
[24]         After subparagraph 19 (1) (a) (ii)
insert
                        (iia)    by means of a form:
                                   (A)     on which appear the name and address of the medical practitioner or participating dental practitioner and the letters ‘PBS’; and
                                   (B)     that is approved in writing by the Secretary for the purpose of writing an electronic prescription; or
[25]         Subregulation 19 (5)
omit
For subparagraphs (1) (a) (ii) and (iii),
insert
For subparagraphs (1) (a) (ii), (iia) and (iii),
[26]         Paragraph 19A (2) (a)
omit
the face of
[27]         Paragraph 21 (1) (b)
omit
original and the duplicate:
insert
prescription (including, for a paper‑based prescription, both the original and the duplicate):
[28]         Paragraph 21 (2) (b)
omit
the original and the duplicate are marked,
substitute
the prescription (including, for a paper‑based prescription, both the original and the duplicate) is marked,
[29]         After subregulation 21 (2)
insert
         (3)   In this regulation, a reference to the first presentation of a prescription is taken to mean, in relation to an electronic prescription, the first occasion when the prescription is accessed by an approved pharmacist or an approved medical practitioner for the purpose of supplying a pharmaceutical benefit to the person for whom the prescription was written.
[30]         Subregulation 22 (3), including penalty
substitute
         (3)   A medical practitioner or participating dental practitioner referred to in subregulation (1) must ensure that, for a paper‑based prescription, the original and a duplicate of the prescription are received by the relevant pharmacist or medical practitioner no later than 7 days after the day on which the benefit was supplied.
Penalty:   0.2 penalty units.
   (3AA)   A medical practitioner or participating dental practitioner referred to in subregulation (1) must ensure that, for an electronic prescription, the prescription is accessible by the relevant pharmacist or medical practitioner no later than 7 days after the day on which the benefit was supplied.
Penalty:   0.2 penalty units.
[31]         Subregulation 22 (3A)
omit
subregulation (3)
insert
subregulation (3) or (3AA)
[32]         Subregulation 22 (4), including penalty
substitute
         (4)   A medical practitioner or a participating dental practitioner who has communicated with an approved pharmacist or approved medical practitioner under subregulation (2) must ensure that, for a paper‑based prescription, the original and a duplicate of the prescription are received by the relevant pharmacist or medical practitioner no later than 7 days after the day on which the benefit was supplied.
Penalty:   0.2 penalty units.
   (4AA)   A medical practitioner or a participating dental practitioner who has communicated with an approved pharmacist or approved medical practitioner under subregulation (2) must ensure that, for an electronic prescription, the prescription is accessible by the relevant pharmacist or medical practitioner no later than 7 days after the day on which the benefit was supplied.
Penalty:   0.2 penalty units.
[33]         Subregulation 22 (4A)
omit
subregulation (4)
insert
subregulation (4) or (4AA)
[34]         Subparagraphs 25 (3) (b) (ii) and (iii)
substitute
                         (ii)    writes the words ‘immediate supply necessary’:
                                   (A)     for a paper‑based prescription — on the Medicare Australia/DVA copy; or
                                   (B)     for an electronic prescription — on the prescription; and
                         (iii)    signs the Medicare Australia/DVA copy or the electronic prescription, as the case requires; or
[35]         Subparagraphs 25 (3) (c) (ii) and (iii)
substitute
                         (ii)    writes the words ‘immediate supply necessary’:
                                   (A)     for a paper‑based prescription — on the Medicare Australia/DVA copy; or
                                   (B)     for an electronic prescription — on the prescription; and
                         (iii)    signs the Medicare Australia/DVA copy or the electronic prescription, as the case requires.
[36]         Subparagraphs 25 (4) (b) (ii) and (iii)
substitute
                         (ii)    writes the words ‘immediate supply necessary’:
                                   (A)     for a paper‑based prescription — on the Medicare Australia/DVA copy; or
                                   (B)     for an electronic prescription — on the prescription; and
                         (iii)    signs the Medicare Australia/DVA copy or the electronic prescription, as the case requires; or
[37]         Subparagraphs 25 (4) (c) (ii) and (iii)
substitute
                         (ii)    writes the words ‘immediate supply necessary’:
                                   (A)     for a paper‑based prescription — on the Medicare Australia/DVA copy; or
                                   (B)     for an electronic prescription — on the prescription; and
                         (iii)    signs the Medicare Australia/DVA copy or the electronic prescription, as the case requires.
[38]         Subparagraph 26 (1) (a) (i)
omit
an Medicare Australia/DVA copy of a prescription
insert
a Medicare Australia/DVA copy of a paper‑based prescription
[39]         Subparagraphs 26 (1) (a) (ii) and (iii)
after
a pharmacist/patient copy
insert
of a paper‑based prescription
[40]         Subparagraph 26 (1) (a) (iii)
omit
once; and
insert
once; or
[41]         After subparagraph 26 (1) (a) (iii)
insert
                        (iv)    an electronic prescription:
                                   (A)     that contains a direction to supply the benefit more than once; or
                                   (B)     to which is attached or linked, by electronic means, a deferred supply authorisation that contains a direction to supply the benefit more than once; or
                                   (C)     to which is attached or linked, by electronic means, a repeat authorisation that contains a direction to supply the benefit more than once; and
[42]         Subparagraph 26 (1A) (a) (i)
after
form
insert
(including a paper‑based or an electronic form)
[43]         Subparagraphs 26 (1A) (a) (iii) and (iv)
substitute
                         (iii)    if the prescription for the benefit is a paper‑based prescription — attach the repeat authorisation to the pharmacist/patient copy and give the repeat authorisation and pharmacist/patient copy to the person to whom the pharmaceutical benefit is supplied; and
                        (iv)    if the prescription for the benefit is an electronic prescription — attach or link, by electronic means, the repeat authorisation to the electronic prescription and ensure that the person to whom the pharmaceutical benefit is supplied:
                                   (A)     is given a print‑out of the repeat authorisation and prescription; or
                                   (B)     is able to access the repeat authorisation and prescription; and
[44]         Subregulation 26 (2)
after
pharmacist/patient copy
insert
of a paper‑based prescription
[45]         Paragraph 26A (2) (a)
substitute
                (a)    prepare a deferred supply authorisation, on and in accordance with a form (including a paper‑based or an electronic form) authorised by the Secretary, in respect of each pharmaceutical benefit the deferral of the supply of which is requested; and
[46]         Paragraph 26A (2) (b)
omit
regulation 8A;
insert
regulation 8A; and
[47]         Paragraphs 26A (2) (d) and (e)
substitute
                (c)    if the prescription is a paper‑based prescription:
                          (i)    mark on the original and duplicate of the prescription, across the wording relating to the pharmaceutical benefit the supply of which is being deferred, the words ‘original supply deferred’; and
                         (ii)    attach the deferred supply authorisation prepared by the pharmacist, medical practitioner or hospital authority to the pharmacist/patient copy; and
                         (iii)    give the authorisation and pharmacist/patient copy to the person for whom the prescription is written at the same time as the benefit on the original prescription is supplied; and
               (d)    if the prescription is an electronic prescription:
                          (i)    mark on the prescription, in relation to the pharmaceutical benefit the supply of which is being deferred, the words ‘original supply deferred’; and
                         (ii)    attach or link, by electronic means, the deferred supply authorisation prepared by the pharmacist, medical practitioner or hospital authority to the prescription; and
                         (iii)    give a print‑out of the deferred supply authorisation and prescription to the person to whom the pharmaceutical benefit is supplied or ensure that the deferred supply authorisation and prescription are accessible by that person.
[48]         Subregulation 28 (1)
after
marking being initialled
insert
, in the case of a paper‑based prescription,
[49]         After subregulation 31 (1)
insert
      (1A)   If a person is required to write an acknowledgment in accordance with subregulation (1) for the supply of a pharmaceutical benefit under an electronic prescription, or an authorisation that relates to an electronic prescription, that requirement is taken to have been met if:
                (a)    the acknowledgment is given, in accordance with approved information technology requirements (if any), by means of an approved electronic communication; or
               (b)    the person writes the acknowledgment on a print‑out of the electronic prescription or the authorisation that relates to an electronic authorisation.
      (1B)   If a person writes an acknowledgment in accordance with paragraph (1A) (b), the approved pharmacist, approved medical practitioner or approved hospital authority must write on the electronic prescription, or the authorisation that relates to an electronic prescription, that the person has written the acknowledgment on a print‑out of the prescription or authorisation.
Penalty:   0.2 penalty units.
[50]         Subregulation 32 (1), including the penalty
substitute
         (1)   If an approved pharmacist, approved medical practitioner, or approved hospital authority supplies a pharmaceutical benefit (other than a supply of a dangerous drug) he or she must:
                (a)    if the benefit was supplied under a paper‑based prescription or an order lodged under paragraph 16 (1) (a) — retain the forms mentioned in subregulation (2) in his or her possession for at least 1 year from the date of supply; or
               (b)    if the benefit was supplied under an electronic prescription or an order lodged under paragraph 16 (1) (b) — retain the forms mentioned in subregulation (2) for at least 1 year from the date of supply.
Penalty:   0.2 penalty units.
[51]         Subregulation 32 (2)
substitute
         (2)   For subregulation (1), the following forms are specified:
                (a)    in the case of supply upon a prescription not bearing instructions to supply the pharmaceutical benefit more than once:
                          (i)    for a paper‑based prescription — the pharmacist/patient copy; or
                         (ii)    for an electronic prescription — the electronic prescription;
               (b)    in the case of supply upon a prescription bearing instructions to supply the pharmaceutical benefit more than once, if it is supplied on the last occasion on which supply is authorised:
                          (i)    for a paper‑based prescription — the pharmacist/patient copy in respect of which repeat authorisations were issued; or
                         (ii)    for an electronic prescription — the electronic prescription and the repeat authorisation;
                (c)    in the case of supply under section 93 of the Act:
                          (i)    for a paper‑based prescription — the duplicate of the order lodged under regulation 16, or the notification form mentioned in subregulation 18A (3), as the case requires; or
                         (ii)    for an electronic prescription — the electronic order form or the notification form mentioned in subregulation 18A (3), as the case requires.
Note
1.       All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See www.frli.gov.au.
 

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