National Health (Pharmaceutical Benefits) Amendment (Medication Chart Prescriptions) Regulation 2015

Link to law: https://www.comlaw.gov.au/Details/F2015L00310

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National Health (Pharmaceutical Benefits) Amendment (Medication Chart Prescriptions) Regulation 2015
 
Select Legislative Instrument No. 23, 2015
I, General the Honourable Sir Peter Cosgrove AK MC (Ret’d), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulation.
Dated   12 March 2015
Peter Cosgrove
Governor‑General
By His Excellency’s Command
Sussan Ley
Minister for Health
 
  
  
Contents
1............ Name................................................................................................... 1
2............ Commencement................................................................................... 1
3............ Authority............................................................................................. 1
4............ Schedules............................................................................................ 1
Schedule 1—Medication chart prescriptions                                                         2
Part 1—Amendments                                                                                                    2
National Health (Pharmaceutical Benefits) Regulations 1960                         2
Part 2—Application and transitional provisions                                            22
National Health (Pharmaceutical Benefits) Regulations 1960                       22
Schedule 2—Other amendments                                                                                 25
National Health (Pharmaceutical Benefits) Regulations 1960                       25
 
1  Name
                   This is the National Health (Pharmaceutical Benefits) Amendment (Medication Chart Prescriptions) Regulation 2015.
2  Commencement
                   This instrument commences on 1 April 2015.
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                   Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 1—Medication chart prescriptions
Part 1—Amendments
National Health (Pharmaceutical Benefits) Regulations 1960
1  Subregulation 5(1) (definition of approved hospital)
Repeal the definition, substitute:
approved hospital means a hospital in respect of which the hospital authority is approved under section 94 of the Act.
2  Subregulation 5(1) (definition of approved hospital authority)
Repeal the definition, substitute:
approved hospital authority has the meaning given by subsection 84(1) of the Act.
3  Subregulation 5(1)
Insert:
CTS claim has the meaning given by subsection 84(1) of the Act.
deferred supply authorisation means a deferred supply authorisation prepared under paragraph 26A(2)(a).
4  Subregulation 5(1) (paragraph (b) of the definition of electronic prescription)
Repeal the paragraph, substitute:
                     (b)  in accordance with the appropriate form under:
                              (i)  sub‑subparagraph 19(1)(a)(iia)(B) (prescriptions other than medication chart prescriptions); or
                             (ii)  subregulation 19AA(5) (medication chart prescriptions).
5  Subregulation 5(1)
Insert:
medication chart has the meaning given by subregulation 19AA(4).
6  Subregulation 5(1) (definition of medication chart prescription)
Repeal the definition, substitute:
medication chart prescription has the meaning given by subregulation 19AA(1).
7  Subregulation 5(1) (definition of paperless claim for payment)
Repeal the definition.
8  Subregulation 5(1) (definition of prescription)
Repeal the definition.
9  Subregulation 5(1)
Insert:
repeat authorisation means a repeat authorisation prepared under subparagraph 26(1A)(a)(i).
10  Subregulation 5(1) (definition of repeat authorisation form)
Omit “, which is used, among other purposes, to support a claim for a payment from the Commonwealth under section 99AAA of the Act in relation to a supply of a pharmaceutical benefit”.
11  Subregulation 5(1)
Insert:
residential care service has the same meaning as in the Aged Care Act 1997.
12  Subregulation 5(1) (definition of residential medication chart)
Repeal the definition.
13  Subregulation 5(1)
Insert:
special patient contribution has the same meaning as in Part VII of the Act.
14  Subregulation 5(1) (definition of supply certification form)
Repeal the definition.
15  Subregulation 5(4)
Repeal the subregulation.
16  Paragraph 5A(a)
After “sub‑subparagraph 19(1)(a)(iia)(B)”, insert “or subregulation 19AA(5)”.
17  Regulation 5D
Omit “an approved pharmacist or an approved medical practitioner”, substitute “an approved supplier”.
18  Paragraphs 5D(a), (b) and (c)
Omit “the pharmacist or practitioner”, substitute “the approved supplier”.
19  Paragraph 5E(c)
Omit “an approved pharmacist or an approved medical practitioner”, substitute “an approved supplier”.
20  Paragraph 5E(d)
Omit “13(2)(b)”, substitute “13(3)(b)”.
21  Paragraph 5E(e)
After “93”, insert “, 93AA or 93AB”.
22  Paragraph 5F(c)
Omit “an approved pharmacist or an approved medical practitioner”, substitute “an approved supplier”.
23  Paragraph 5F(d)
After “93”, insert “, 93AA or 93AB”.
24  Subregulations 13(1) to (4)
Repeal the subregulations, substitute:
             (1)  For subsection 85A(3) of the Act, the Minister may vary the application of a determination under paragraph 85A(2)(a) or (b) of the Act in relation to a practitioner in the class covered by subregulation (2).
             (2)  A practitioner is in the class covered by this subregulation if:
                     (a)  the practitioner has written a prescription, in accordance with regulation 19 or 19AA (disregarding paragraphs 19(1)(b) and 19AA(3)(a) to (c)), that:
                              (i)  is not in accordance with a determination mentioned in subregulation (1); and
                             (ii)  in the case of a medication chart prescription—is written for a person who is receiving treatment in or at an approved hospital; and
                     (b)  the prescription is submitted to the Minister in accordance with subregulation (3).
             (3)  A prescription is submitted in accordance with this subregulation if:
                     (a)  the practitioner, or an employee of the practitioner, submits:
                              (i)  the prescription itself; or
                             (ii)  for a medication chart prescription that is not an electronic prescription—the medication chart by which the prescription was written, or a copy of so much of that chart as would indicate that subregulation 19AA(2) has been complied with; or
                     (b)  the practitioner submits details of the prescription:
                              (i)  by telephone; or
                             (ii)  by means of an approved electronic communication.
25  Subregulation 13(5)
Omit “in relation to a person”, substitute “in relation to a practitioner”.
26  Paragraph 13(5)(a)
Omit “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)”, substitute “for a paper‑based prescription (other than a prescription submitted in accordance with paragraph (3)(b))”.
27  Subparagraph 13(5)(a)(ii)
Repeal the subparagraph, substitute:
                             (ii)  by returning it to the practitioner; or
                            (iii)  if requested by the practitioner—by sending it to the person in respect of whom it was written; or
28  After paragraph 13(5)(a)
Insert:
                  (aaa)  for a medication chart prescription (other than an electronic prescription or a prescription submitted in accordance with paragraph (3)(b))—by the Minister:
                              (i)  signing his or her authorisation of the prescription on the medication chart, or the copy of the medication chart, submitted in accordance with subparagraph (3)(a)(ii); and
                             (ii)  if the Minister requires the practitioner to alter the prescription—indicating this on the medication chart or copy; and
                            (iii)  returning the medication chart or copy to the practitioner; or
29  Paragraph 13(5)(aa)
Omit “if an electronic prescription is submitted in accordance with a form approved under subparagraph (3)(a) (iiia)”, substitute “for an electronic prescription (other than a prescription submitted in accordance with paragraph (3)(b))”.
30  Paragraph 13(5)(aa)
Omit “signing”, substitute “writing”.
31  Subparagraph 13(5)(aa)(i)
Omit “before the practitioner gives it to the person in respect of whom it was prepared”.
32  Subparagraph 13(5)(aa)(ii)
Repeal the subparagraph, substitute:
                             (ii)  by returning it, including by means of an electronic communication, to the practitioner; or
                            (iii)  if requested by the practitioner—by making the prescription accessible by the person in respect of whom it was written, or by an approved supplier for the purpose of supplying a pharmaceutical benefit to the person in respect of whom the prescription was written; or
33  Paragraph 13(5)(b)
Omit “paragraph (2)(b)”, substitute “subparagraph (3)(b)(i)”.
34  Paragraph 13(5)(b)
Before “orally”, insert “by the Minister authorising the prescription”.
35  Paragraph 13(5)(c)
Omit “paragraph (2)(b)”, substitute “subparagraph (3)(b)(ii)”.
36  Paragraph 13(5)(c)
After “authorisation”, insert “of the prescription”.
37  Subparagraph 13(6)(b)(ii)
Repeal the subparagraph, substitute:
                             (ii)  retain the prescription, or a copy of the prescription showing the number marked in accordance with subparagraph (i), for 1 year from the date on which the variation was made.
38  Subregulations 13(7)(a) and (b)
Omit “if the electronic prescription was submitted”, substitute “for a variation”.
39  Regulation 18
Repeal the regulation, substitute:
18  Prescriber bag supplies—payment for pharmaceutical benefits
             (1)  An approved pharmacist who supplies a pharmaceutical benefit to a practitioner on an order under regulation 16 is entitled to be paid by the Commonwealth for the supply the sum of:
                     (a)  the Commonwealth price of the pharmaceutical benefit; and
                     (b)  the special patient contribution for a brand of the pharmaceutical item that is the pharmaceutical benefit (if any).
             (2)  Payment by the Commonwealth under subregulation (1) is subject to the conditions set out in a determination under paragraph 98C(1)(b) of the Act that is in force at the time the benefit is supplied, as if the benefit had been supplied other than under section 93, 93AA, or 93AB of the Act.
40  Before subregulation 18A(1)
Insert:
Offence—obtaining pharmaceutical benefit for purposes of section 93 of the Act by lodging order under regulation 16
41  Before subregulation 18A(2)
Insert:
Offence—obtaining pharmaceutical benefit for purposes of section 93 of the Act more than once each month
42  Subregulation 18A(3)
Repeal the subregulation, substitute:
Offence—not giving notice of obtaining pharmaceutical benefit for purposes of section 93 of the Act (manual claim)
             (3)  An approved medical practitioner commits an offence if he or she:
                     (a)  obtains a pharmaceutical benefit for the purpose of the supply of the benefit under section 93 of the Act; and
                     (b)  makes a claim for a payment under section 99AAA of the Act, in relation to obtaining the benefit for such a supply, using the manual system referred to in that section; and
                     (c)  does not, when making the claim, give notice to the Secretary that he or she has obtained the benefit.
Penalty:  0.2 penalty units.
43  Subregulation 18A(5)
Omit “1 year”, substitute “2 years”.
44  After subregulation 18A(5)
Insert:
Offence—not creating record of obtaining pharmaceutical benefit for purposes of section 93 of the Act (CTS claim)
          (5A)  An approved medical practitioner commits an offence if he or she:
                     (a)  obtains a pharmaceutical benefit for the purpose of the supply of the benefit under section 93 of the Act; and
                     (b)  makes a CTS claim in relation to obtaining the benefit for such a supply; and
                     (c)  does not create a written record of having obtained the benefit as soon as practicable after obtaining it.
Penalty:  0.2 penalty units.
          (5B)  For subregulation (5A), the record must be:
                     (a)  in a form authorised by the Secretary; and
                     (b)  signed and dated by the practitioner.
          (5C)  An approved medical practitioner who creates a record under subregulation (5A) must retain the record for at least 2 years from the date on which it was created.
Penalty:  0.2 penalty units.
45  Before subregulation 18A(6)
Insert:
Strict liability applies to offences
46  Subregulation 18A(6)
Omit “or (5)”, substitute “, (5), (5A) or (5C)”.
47  Subregulation 18A(7)
Repeal the subregulation, substitute:
Entitlement to payment
             (7)  An approved medical practitioner is entitled to payment from the Commonwealth for obtaining a pharmaceutical benefit for the purpose of the supply of the benefit under section 93 of the Act if:
                     (a)  the pharmaceutical benefit is obtained in accordance with these Regulations; and
                     (b)  the approved medical practitioner makes a claim for a payment under section 99AAA of the Act in relation to obtaining the benefit for such a supply; and
                     (c)  if the claim is made using the manual system referred to in that section—the approved practitioner gives a notice to the Secretary in accordance with subregulation (3).
             (8)  The approved medical practitioner is entitled to payment under subregulation (7) at the rate applicable under regulation 18 for the supply of the same benefit on an order under regulation 16.
48  After regulation 18B
Insert:
18C  Writing prescriptions—general
                   A prescription for the supply of a pharmaceutical benefit must be written in accordance with:
                     (a)  regulation 19 (prescriptions other than medication chart prescriptions); or
                     (b)  regulation 19AA (medication chart prescriptions).
Note:          Other provisions of these Regulations may also contain requirements for the writing of prescriptions.
49  Regulation 19 (heading)
Repeal the heading, substitute:
19  Writing prescriptions—prescriptions other than medication chart prescriptions
50  Subregulation 19(1)
Omit “A prescription, other than a medication chart prescription, is duly written only if a PBS prescriber”, substitute “A PBS prescriber writes a prescription in accordance with this regulation if the PBS prescriber”.
51  Subparagraph 19(1)(b)(i)
Repeal the subparagraph, substitute:
                              (i)  each authority approval number allotted by the Minister or the Chief Executive Medicare for the prescription, unless the prescription is to be posted or delivered to the Minister or Chief Executive Medicare for authorisation; or
52  Subregulation 19(2)
Omit “However, a prescription, other than a medication chart prescription, will not be taken to be duly written by the PBS prescriber if it provides for”, substitute “A prescription written in accordance with this regulation must not provide for”.
53  Regulation 19AA
Repeal the regulation, substitute:
19AA  Writing prescriptions—medication chart prescriptions
Writing prescription by completing section of medication chart
             (1)  A PBS prescriber writes a prescription (a medication chart prescription) for a pharmaceutical benefit in accordance with this regulation if:
                     (a)  the person for whom the pharmaceutical benefit is prescribed is receiving treatment in or at:
                              (i)  a residential care service at which the person is receiving residential care; or
                             (ii)  an approved hospital; and
                     (b)  the PBS prescriber completes a section of a medication chart for the person in relation to the pharmaceutical benefit in accordance with:
                              (i)  subregulation (2); and
                             (ii)  if the prescription would be an authority prescription—subregulation (3).
Completing section of medication chart—general
             (2)  A PBS prescriber completes a section of a medication chart in accordance with this subregulation for a person (the patient) in relation to a pharmaceutical benefit if:
                     (a)  the PBS prescriber writes in the section of the chart:
                              (i)  particulars sufficient to identify the pharmaceutical benefit; and
                             (ii)  the date on which the pharmaceutical benefit is prescribed; and
                            (iii)  the pharmaceutical benefit’s dose, frequency of administration and route of administration; and
                            (iv)  the letters “PBS” or “RPBS”; and
                     (b)  the chart contains the following information:
                              (i)  the PBS prescriber’s full name, address and PBS prescriber number;
                             (ii)  the patient’s full name;
                            (iii)  the name of the residential care service or approved hospital in or at which the patient is receiving treatment;
                            (iv)  if the patient is receiving treatment in or at a residential care service—the Residential Aged Care Service ID for the residential care service;
                             (v)  if the patient is receiving treatment in or at an approved hospital—the patient’s address; and
                     (c)  the PBS prescriber writes his or her signature:
                              (i)  in the section of the chart; and
                             (ii)  except in the case of an electronic prescription—on the cover page of the chart; and
                     (d)  the section of the chart does not provide for the supply of a pharmaceutical benefit to more than one person; and
                     (e)  the section of the chart is not completed using a computer program that operates, or may operate, to indicate on a prescription by default, for subsection 103(2A) of the Act, that only the brand of pharmaceutical benefit specified in the prescription is to be supplied; and
                      (f)  if the patient is receiving treatment in or at an approved hospital—the chart specifies the day on which the chart’s period of validity ends under subregulation 21A(3A), which must be the last day of one of the following periods starting on the day the first prescription for a pharmaceutical benefit is written in the chart:
                              (i)  1 month;
                             (ii)  4 months;
                            (iii)  12 months; and
                     (g)  if the patient is receiving treatment in or at a residential care service—the pharmaceutical benefit is not mentioned in Schedule 8 to the current Poisons Standard (within the meaning of the Therapeutic Goods Act 1989); and
                     (h)  in any case—the section of the chart is completed before the end of the chart’s period of validity under subregulation 21A(3) or (3A).
Note:          A section in a medication chart may set out fields that only need to have information filled in if the information is relevant to the particular prescription concerned.
Example:    For paragraph (f), the first prescription is written in a medication chart on 11 June in a particular year. The day specified in the chart as the day on which the chart’s period of validity ends must be 10 July or 10 October in that year, or 10 June in the following year.
Completing section of medication chart—authority prescriptions
             (3)  A PBS prescriber completes a section of a medication chart in accordance with this subregulation for a person for the purpose of writing an authority prescription if the section of the chart contains:
                     (a)  each streamlined authority code (if any) that is part of the circumstances determined under paragraph 85(7)(b) of the Act for the pharmaceutical benefit that apply in relation to the writing of the prescription; and
                     (b)  each streamlined authority code (if any) that is part of the conditions determined under subsection 85A(2A) of the Act for the pharmaceutical benefit that apply in relation to the writing of the prescription; and
                     (c)  if the person is receiving treatment in or at a hospital—each authority approval number (if any) allotted by the Minister or Chief Executive Medicare for the prescription.
Medication charts
             (4)  A medication chart is a chart in a form (if any) approved under subregulation (5) that is used for prescribing, and recording the administration of, pharmaceutical benefits to persons receiving treatment in or at a residential care service or a hospital, whether or not the chart:
                     (a)  is used for any other purpose; or
                     (b)  contains any other information.
Note:          For paragraph (a), the chart may also be used (for example) to prescribe, and record the administration of, drugs, medicines and other substances that are not pharmaceutical benefits.
             (5)  The Secretary may, in writing, approve one or more forms for the purposes of subregulation (4), including one or more forms for the purpose of writing an electronic prescription.
54  Subregulation 21(1A)
Omit “, under subsection 93A(4) of the Act,”.
55  Subregulation 21A(1)
Repeal the subregulation, substitute:
             (1)  A pharmaceutical benefit may only be supplied on the basis of a medication chart prescription by:
                     (a)  if the person in respect of whom the pharmaceutical benefit is to be supplied is receiving treatment in or at a residential care service—an approved pharmacist or an approved medical practitioner; or
                     (b)  if the person in respect of whom the pharmaceutical benefit is to be supplied is receiving treatment in or at an approved hospital—an approved pharmacist or the approved hospital authority.
56  Subregulation 21A(2)
Omit “An approved pharmacist or an approved medical practitioner”, substitute “An approved supplier”.
57  Paragraphs 21A(2)(a) and (b)
Repeal the paragraphs, substitute:
                     (a)  the approved supplier has seen:
                              (i)  the medication chart by which the prescription was written; or
                             (ii)  a copy of so much of the chart as would indicate that subregulation 19AA(2), and subregulation 19AA(3) (if applicable), have been complied with; and
58  Paragraph 21A(2)(c)
Omit “by the approved pharmacist or approved medical practitioner”.
59  Subparagraph 21A(2)(c)(i)
Omit “residential”.
60  Subparagraph 21A(2)(c)(ii)
Omit “is”.
61  Paragraph 21A(2)(d)
Omit “the approved pharmacist or approved medical practitioner writes on the copy of the residential medication chart”, substitute “the approved supplier writes on the medication chart, or the copy of the chart,”.
62  Subparagraph 21A(2)(d)(i)
Omit “approved pharmacist’s or approved medical practitioner’s”, substitute “approved supplier’s”.
63  Subregulation 21A(3)
Omit “a residential medication chart”, substitute “a medication chart for a person receiving treatment in or at a residential care service”.
64  Paragraph 21A(3)(a)
Omit “residential”.
65  Subregulation 21A(3) (example)
Omit “residential” (wherever occurring).
66  After subregulation 21A(3)
Insert:
          (3A)  For paragraph (2)(c), the period of validity of a medication chart for a person receiving treatment in or at a hospital:
                     (a)  starts on the day when the first prescription for a pharmaceutical benefit is written in the chart; and
                     (b)  ends at the end of the day specified in the chart as the day on which the chart’s period of validity ends (see paragraph 19AA(2)(f)).
67  Subregulations 21A(4), (5) and (6)
Omit “approved pharmacist or an approved medical practitioner”, substitute “approved supplier”.
68  Subregulation 21A(6)
Omit “residential”.
69  Subregulation 21A(7)
Repeal the subregulation.
70  Subregulation 21B(2)
Omit “the repeat”, substitute “a repeat”.
71  Paragraph 21C(1)(a)
After “approved pharmacist”, insert “(the supplier)”.
72  Paragraph 21C(1)(b)
Omit “approved medical practitioner or approved pharmacist, under subsection 93A(4) of the Act,”, substitute “approved supplier (the supplier)”.
73  Subregulations 21C(2) and (3)
Omit “The approved pharmacist or approved medical practitioner”, substitute “The supplier”.
74  Subregulation 22(1)
After “approved pharmacist”, insert “or an approved medical practitioner (the supplier)”.
75  Subregulation 22(1)
Omit “pharmacist” (second occurring), substitute “supplier”.
76  Paragraph 22(1)(a)
Omit “pharmacist”, substitute “supplier”.
77  Paragraph 22(1)(b)
Repeal the paragraph, substitute:
                     (b)  the PBS prescriber has given the supplier a copy of the prescription.
78  Subregulation 22(2)
Repeal the subregulation, substitute:
             (2)  If the prescription is or would be an authority prescription, the supplier may supply the pharmaceutical benefit under subregulation (1) only if:
                     (a)  the Minister or the Chief Executive Medicare has notified the PBS prescriber (orally or by other means) that each relevant authorisation will be given; and
                     (b)  the PBS prescriber informs the supplier of that notification before the pharmaceutical benefit is supplied.
79  Subregulation 22(5)
Repeal the subregulation, substitute:
             (5)  This regulation does not apply to:
                     (a)  a pharmaceutical benefit if:
                              (i)  the pharmaceutical benefit would be supplied under this regulation by an approved pharmacist; and
                             (ii)  the relevant prescription must be in writing under a law in force in the State or Territory in which the premises, at or from which the pharmaceutical benefit would be supplied, are located; or
                     (b)  a pharmaceutical benefit if:
                              (i)  the pharmaceutical benefit would be supplied under this regulation by an approved medical practitioner; and
                             (ii)  the relevant prescription must be in writing under a law in force in the area in respect of which the medical practitioner is approved; or
                     (c)  in any case—a pharmaceutical benefit to be supplied on the basis of a medication chart prescription.
80  Subregulation 25(6)
Repeal the subregulation, substitute:
Medication chart prescriptions
             (6)  Subject to subregulation (2), if the pharmaceutical benefit is supplied by an approved supplier on the basis of a medication chart prescription:
                     (a)  subregulation (1) does not apply; and
                     (b)  subregulation (3) or (4) applies as if the words “immediate supply necessary” and the supplier’s signature were required to be written by the approved supplier on the part of the medication chart, or the part of the copy of that chart, that contains the completed section by which the prescription was written.
81  Subregulation 26(1AA)
Omit “, under subsection 93A(4) of the Act,”.
82  Regulation 26AA
Repeal the regulation.
83  Subregulation 26A(1A)
Omit “, under subsection 93A(4) of the Act,”.
84  Paragraph 31(1)(c)
Repeal the paragraph, substitute:
                     (c)  the pharmaceutical benefit is not supplied by the approved supplier on the basis of a medication chart prescription; and
85  Paragraph 31(1)(d)
Omit “for the pharmaceutical benefit”, substitute “on the basis of which the supply of the pharmaceutical benefit was made”.
86  Subregulations 31(1B) and (2)
Omit “approved pharmacist, approved medical practitioner or approved hospital authority”, substitute “approved supplier”.
87  Subregulation 31(2)
Omit “pharmacist, medical practitioner or hospital authority”, substitute “approved supplier”.
88  Paragraph 31(3)(c)
Repeal the paragraph, substitute:
                     (c)  the pharmaceutical benefit is not supplied by the approved supplier on the basis of a medication chart prescription; and
89  Paragraph 31(3)(d)
Omit “for the pharmaceutical benefit”, substitute “on the basis of which the supply of the pharmaceutical benefit was made”.
90  Subregulation 31(4)
Repeal the subregulation.
91  Regulation 32 (heading)
Repeal the heading, substitute:
32  Keeping documents—other than for continued dispensing or medication chart prescriptions
92  Subregulations 32(1), (1A) and (2)
Repeal the subregulations, substitute:
             (1)  If an approved supplier supplies a pharmaceutical benefit, other than a pharmaceutical benefit that is:
                     (a)  a dangerous drug; or
                     (b)  supplied under subsection 89A(1) of the Act (continued dispensing); or
                     (c)  supplied on the basis of a medication chart prescription;
the approved supplier must keep a document required by subregulation (3A), (3B) or (3C) that relates to the supply for at least 2 years after the supply.
Penalty:  0.2 penalty units.
Note:          For a pharmaceutical benefit supplied as mentioned in paragraph (b) or (c), see regulations 32A and 32B.
93  After subregulation 32(3)
Insert:
Electronic prescriptions
          (3A)  For subregulation (1), if the supply was on the basis of an electronic prescription, the approved supplier must keep:
                     (a)  the electronic prescription; and
                     (b)  any repeat authorisation or deferred supply authorisation on the basis of which the supply was made.
Paper‑based prescriptions
          (3B)  For subregulation (1), the approved supplier must keep a document referred to in an item in the following table if:
                     (a)  the supply was on the basis of a paper‑based prescription; and
                     (b)  the supply is of a kind referred to in that item.
Note:          If a supply is covered by more than one item in the table, then documents must be kept under each of those items.
 
Documents to be kept for paper‑based prescriptions

Item
Kind of supply
Document

1
Both of the following apply in relation to the supply:
(a) the supply was the first or only supply of a pharmaceutical benefit authorised by the prescription;
(b) a CTS claim is made for the supply.
The Medicare Australia/DVA copy.

2
Both of the following apply in relation to the supply:
(a) the supply was on the basis of a repeat authorisation or a deferred supply authorisation;
(b) a CTS claim is made for the supply.
The repeat authorisation or deferred supply authorisation.

3
After the supply, there are no remaining supplies of pharmaceutical benefits that are authorised by the prescription.
The pharmacist/patient copy.

 
Orders lodged under regulation 16
          (3C)  For subregulation (1), if the supply is on the basis of an order lodged under regulation 16, the approved supplier must keep:
                     (a)  if a CTS claim is made for the supply—the order; and
                     (b)  if a claim is made for the supply using the manual system referred to in section 99AAA of the Act—the duplicate of the order.
Definition
94  Subregulation 32A(1)
Repeal the subregulation.
95  Subregulation 32A(2)
Omit “The approved pharmacist”, substitute “An approved pharmacist”.
96  Subparagraph 32A(2)(b)(i)
After “benefit”, insert “, including the repeat authorisation form”.
97  Subregulations 32B(1) and (2)
Repeal the subregulations, substitute:
             (1)  An approved supplier commits an offence if:
                     (a)  the approved supplier supplies a pharmaceutical benefit on the basis of a medication chart prescription; and
                     (b)  the approved supplier does not keep the medication chart, or the copy of the medication chart, on which the approved supplier wrote the details mentioned in paragraph 21A(2)(d) in relation to the prescription, for at least 2 years from the date of the supply.
Penalty:  0.2 penalty units.
98  Paragraph 36(2)(e)
Omit “, under subsection 93A(4) of the Act,”.
99  Paragraph 36(3)(a)
Omit “within the meaning given by Part VII of the Act”.
100  Subregulation 36(3) (note)
Repeal the note.
101  Regulation 37AA
Repeal the regulation.
Part 2—Application and transitional provisions
National Health (Pharmaceutical Benefits) Regulations 1960
102  At the end of Part 8
Add:
Division 4—Provisions for National Health (Pharmaceutical Benefits) Amendment (Medication Chart Prescriptions) Regulation 2015
57  Application of amendments—general
                   Except as set out in this Division, the amendments made by Part 1 of Schedule 1 to the National Health (Pharmaceutical Benefits) Amendment (Medication Chart Prescriptions) Regulation 2015 apply in relation to a prescription written on or after 1 April 2015.
58  Savings provision—medication chart prescriptions for persons receiving treatment in or at a residential care service
             (1)  A PBS prescriber may write a medication chart prescription during the period of 2 years starting on 1 April 2015 in accordance with regulations 19 and 19AA as in force immediately before that date.
Note:          Before 1 April 2015, a medication chart prescription could only be written to prescribe a pharmaceutical benefit for a person receiving treatment in or at a residential care service.
             (2)  For subregulation (1), a reference in regulation 19AA (as in force immediately before 1 April 2015) to a condition determined under paragraph 93A(2)(b) of the Act is a reference to any condition determined under that paragraph that applies under the National Health (Residential Medication Chart) (Repeal) Determination 2015 for the purposes of this regulation.
             (3)  These Regulations (other than regulation 31), as in force immediately before 1 April 2015, continue to apply in relation to a medication chart prescription written under subregulation (1).
Note:          For the application of regulation 31 in relation to a medication chart prescription written under subregulation (1), see subregulations 60(3) and (4).
59  Transitional provision—medication chart prescriptions for persons receiving treatment in or at a hospital
             (1)  Subregulation (2) applies in relation to the writing of a prescription for a pharmaceutical benefit under regulation 19AA, as in force on or after 1 April 2015, if:
                     (a)  the person for whom the pharmaceutical benefit is to be prescribed is receiving treatment in or at an approved hospital; and
                     (b)  a declaration made by the Minister under subregulation (3) of this regulation is in force at the time the prescription is written; and
                     (c)  either of the following apply:
                              (i)  the prescription is written before 1 July 2016;
                             (ii)  the prescription would be an electronic prescription and is written on or after 1 July 2016 and before 1 April 2017.
             (2)  The hospital must be a listed approved hospital under the declaration.
             (3)  The Minister may, by legislative instrument, declare that an approved hospital is a listed approved hospital for the purposes of this regulation.
Note 1:       For variation and revocation, see subsection 33(3) of the Acts Interpretation Act 1901.
Note 2:       See also subsection 13(3) of the Legislative Instruments Act 2003 (rule‑maker may identify matter by referring to a class or classes of matters).
60  Application of amendments to document retention provisions
             (1)  Regulation 18A, as amended by Part 1 of Schedule 1 to the National Health (Pharmaceutical Benefits) Amendment (Medication Chart Prescriptions) Regulation 2015, applies in relation to a pharmaceutical benefit obtained by an approved medical practitioner on or after 1 April 2015.
             (2)  However, if:
                     (a)  an approved medical practitioner obtains a pharmaceutical benefit for the purpose of supplying the pharmaceutical benefit under section 93 of the Act; and
                     (b)  information relating to the pharmaceutical benefit is given in accordance with the old Claims Rules, as those Rules continue to apply under rule 12 of the new Claims Rules;
then regulation 18A, as in force immediately before 1 April 2015, applies in relation to the obtaining of the pharmaceutical benefit.
             (3)  Regulations 31, 32 and 32A, as amended by Part 1 of Schedule 1 to the National Health (Pharmaceutical Benefits) Amendment (Medication Chart Prescriptions) Regulation 2015, apply in relation to the supply of a pharmaceutical benefit on or after 1 April 2015.
             (4)  However, if information relating to the supply is given in accordance with the old Claims Rules as those Rules continue to apply under rule 12 of the new Claims Rules, then regulations 31, 32 and 32A, as in force immediately before 1 April 2015, apply in relation to the supply of the pharmaceutical benefit.
             (5)  In this Regulation:
new Claims Rules means the National Health (Claims and under co‑payment data) Rules 2012, as in force on 1 April 2015.
old Claims Rules means the National Health (Claims and under co‑payment data) Rules 2012, as in force immediately before 1 April 2015.
61  Repeal of this Division
                   This Division is repealed on 1 April 2019.
Schedule 2—Other amendments
  
National Health (Pharmaceutical Benefits) Regulations 1960
1  Regulations 3 and 4
Repeal the regulations.
2  Part 2A
Repeal the Part.
3  Regulation 37B
Repeal the regulation.
4  Regulation 48
Repeal the regulation, substitute:
48  Remuneration for chair and members of sub‑committees
Fees and allowances payable to chairs
             (1)  For paragraph 140(a) of the Act, the fees and allowances payable to the Chair of the Drug Utilisation Sub‑Committee and the Chair of the Economics Sub‑Committee are the amounts payable to the Chairperson (within the meaning of section 118 of the Act) of the Pharmaceutical Services Federal Committee of Inquiry in accordance with a determination made by the Remuneration Tribunal, as in force from time to time.
Fees and allowances payable to other members
             (2)  For paragraph 140(a) of the Act, the fees and allowances payable to a member (other than the Chair) of the Drug Utilisation Sub‑Committee or the Economics Sub‑Committee are the amounts payable to a member (other than the Chairperson) of the Pharmaceutical Services Federal Committee of Inquiry in accordance with a determination made by the Remuneration Tribunal, as in force from time to time.
5  Division 2 of Part 8
Repeal the Division.
6  Schedules 3, 5 and 9
Repeal the Schedules.