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Timestamp: 2018-12-16 03:29:19
Document Index: 20416654

Matched Legal Cases: ['art 2', 'art 2', 'art 2', 'art 2', 'art 3', 'art 4', 'art 5', 'art 6']

National Health (Pharmaceutical Benefits) Amendment Regulation 2012 (No. 3) (Australia)
National Health (Pharmaceutical Benefits) Amendment Regulation 2012 (No. 3)
Link to law: https://www.comlaw.gov.au/Details/F2012L01443
National Health (Pharmaceutical Benefits) Amendment Regulation 2012 (No. 3)1
Select Legislative Instrument 2012 No. 141
I, QUENTIN BRYCE, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulation under the National Health Act 1953.
This regulation is the National Health (Pharmaceutical Benefits) Amendment Regulation 2012 (No. 3).
3 Amendment of National Health (Pharmaceutical Benefits) Regulations 1960
Schedule 1 amends the National Health (Pharmaceutical Benefits) Regulations 1960.
[1] Subregulation 5 (1), definition of authority prescription, including the note
authority prescription means a prescription that prescribes a pharmaceutical benefit and that has been authorised:
(a) in accordance with subregulation 13 (5); or
(b) in accordance with authority required procedures that:
(i) are part of the circumstances determined by the Minister under paragraph 85 (7) (b) of the Act for the pharmaceutical benefit; or
(ii) are part of the conditions determined by the Minister under subsection 85A (2A) of the Act for the pharmaceutical benefit; or
(iii) are incorporated by reference into the circumstances determined for the pharmaceutical benefit under subsection 85B (5) of the Act.
[2] Subregulation 5 (1), definition of concessional benefit prescription
[3] Subregulation 5 (1), definition of concession card prescription
[4] Subregulation 5 (1), definition of entitlement card prescription
[5] Subregulation 5 (1)
medication chart prescription means a prescription mentioned in subregulation 19AA (1).
[6] Subregulation 5 (1), definition of paper-based prescription
, including an authority prescription,
[7] Subregulation 5 (1)
paperless claim for payment means a claim for a payment from the Commonwealth, in relation to the supply of a pharmaceutical benefit:
(a) using the Claims Transmission System, within the meaning given by subsection 99AAA (1) of the Act; and
(b) to which, or in which, prescriptions, repeat authorisations or deferred supply authorisations are not required to be attached or included.
[8] Subregulation 5 (1)
supply certification form: see subregulation (4).
[9] Subregulation 5 (1), definition of prescription
prescription means a paper-based prescription or an electronic prescription, and includes an authority prescription and a medication chart prescription.
[10] Subregulation 5 (1)
repeat authorisation form means the form mentioned in subparagraph 26 (1A) (a) (i), 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)
[12] Subregulation 5 (1)
residential medication chart has the meaning given by subregulation 19AA (6).
[13] After subregulation 5 (3)
(4) In these Regulations, a supply certification form means a form that:
(a) is included by an approved supplier in a paperless claim for payment as certification that the supply of a pharmaceutical benefit is made in accordance with the Act; and
(i) the name and approval number of the supplier;
(ii) the address of the premises at or from which the pharmaceutical benefits mentioned in subparagraph (iv) are supplied, being premises at or from which the supplier is approved to supply pharmaceutical benefits;
(iii) the number used by the supplier to identify the claim period;
(iv) for each type of prescription that is covered by the claim—the serial numbers of the pharmaceutical benefits that have been supplied and that are the subject of the claim, identified using a range of serial numbers for each of the following categories:
(B) concessional beneficiaries, dependants of concessional beneficiaries and holders of concession cards;
(v) the total number of claims for each category mentioned in sub-subparagraphs (iv) (A) to (C);
(vi) a certification that the pharmaceutical benefits mentioned in subparagraph (iv) have been supplied in accordance with the Act and instruments made under that Act;
(vii) a declaration that the information in the form is correct, and signed by the supplier or an authorised representative of the supplier;
(viii) particulars that identify the person signing the form under subparagraph (vii).
Example for subparagraph (b) (iv)
[14] Part II, heading
Part 2 Approvals under Part VII of the Act
[15] Part IIAAA, heading
Part 2A Co-marketed brands
[16] Part IIAA, heading
Part 2B Safety net concession cards
[17] Regulation 9AF
9AF Prescribed offices
For subsection 84DA (5) of the Act, each office mentioned in Schedule 6 is a prescribed office.
[18] Part IIA, heading
Part 2C Pharmaceutical benefits entitlement cards
[19] Regulation 9BA
9BA Prescribed offices
For subsection 84E (5) of the Act, each office mentioned in Schedule 6 is a prescribed office.
[20] Part III, heading
Part 3 Pharmaceutical benefits
[21] After subregulation 13 (1)
Note See subsection 85A (3A) of the Act for the Minister’s power to determine rules relating to an authorisation of a variation.
[22] Part IV, heading
Part 4 Supply of pharmaceutical benefits by particular PBS prescribers
[23] Part V, heading
Part 5 Prescriptions and supply
[24] Before regulation 19
18B Purpose of Part
(1) Unless otherwise specified, this Part is made for section 105 of the Act.
(2) This Part:
(a) prescribes terms and conditions relating to the supply of pharmaceutical benefits; and
(b) provides rules about writing prescriptions.
[25] Subregulation 19 (1)
including an authority prescription,
other than a medication chart prescription,
[26] Paragraph 19 (1) (b)
for an authority prescription —
for an authority prescription other than an authority prescription mentioned in subregulation (6)—
[27] Subparagraph 19 (1) (b) (ii)
(ii) the streamlined authority code that is part of:
(A) the circumstances determined by the Minister under paragraph 85 (7) (b) of the Act for the pharmaceutical benefit that is prescribed; or
(B) the conditions determined by the Minister under subsection 85A (2A) of the Act for the pharmaceutical benefit that is prescribed; and
[28] Paragraph 19 (1) (c)
and signs the prescription
[29] Subregulation 19 (1), note
[30] Subregulation 19 (2)
a prescription, other than a medication chart prescription,
[31] After subregulation 19 (5)
(6) Paragraph (1) (b) 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 for a pharmaceutical benefit under subsection 85B (5) of the Act.
Note If a streamlined authority code or an authority approval number must be written on an authority prescription, and the code or number is not written on the authority prescription, the special patient contribution mentioned in subsection 85B (4) of the Act is not payable by the Commonwealth: see subsection 85B (5) of the Act.
[32] After regulation 19
19AA Item in residential medication chart is prescription
(1) A completed item in a residential medication chart is a prescription (a medication chart prescription) if the chart contains the information set out for the chart in a condition determined under paragraph 93A (2) (b) of the Act.
(3) A medication chart prescription must not be prepared 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.
(4) If a section in a residential medication chart requires a streamlined authority code (if any) to be entered, the code is the streamlined authority code that is part of:
(b) the conditions determined by the Minister under subsection 85A (2A) of the Act for the pharmaceutical benefit that is prescribed; or
(c) the circumstances determined for the pharmaceutical benefit under subsection 85B (5) of the Act.
(5) However, a streamlined authority code mentioned in paragraph (4) (c) does not need to be entered in a section of a chart for the section to be a completed item.
Note If the streamlined authority code is not written in the section of the chart, the special patient contribution mentioned in subsection 85B (4) of the Act is not payable by the Commonwealth: see subsection 85B (5) of the Act.
completed item in a residential medication chart means a section of the chart:
(a) in which the medical practitioner prescribing the pharmaceutical benefit has:
(i) entered the information about the pharmaceutical benefit that the section requires the medical practitioner to enter; and
(b) in which appears the letters ‘PBS’.
(a) for prescribing, and recording the administration of, pharmaceutical benefits to persons receiving residential care; and
(b) that contains the standard fields and characteristics for the chart, as set out in a condition determined under paragraph 93A (2) (b) of the Act.
Note A residential medication chart may also be used for prescribing, and recording the administration of, drugs, medicines and other substances that are not pharmaceutical benefits.
[33] Regulation 19A, heading
19A Information about status of person
[34] Before subregulation 19A (1)
(1A) This regulation does not apply in relation to a medication chart prescription.
Note See regulation 21C for information about the status of a person for a medication chart prescription, and for a continued dispensing supply under section 89A of the Act.
[35] Regulation 20
[36] Before subregulation 21 (1)
(1A) This regulation does not apply in relation to the supply of a pharmaceutical benefit, under subsection 93A (4) of the Act, on the basis of a medication chart prescription.
Note See regulation 21A.
[37] After regulation 21
21A Supply of pharmaceutical benefit on basis of medication chart prescription
(1) This regulation applies in relation to the supply of a pharmaceutical benefit, under subsection 93A (4) of the Act, on the basis of a medication chart prescription.
(2) An approved pharmacist or an approved medical practitioner may supply a pharmaceutical benefit on the basis of a medication chart prescription only if:
(a) a copy of the residential medication chart is given to the approved pharmacist or approved medical practitioner; and
(b) the residential medication chart is written in accordance with any requirements for the chart in these Regulations and any conditions determined under paragraph 93A (2) (b) of the Act; and
(c) the date on which the pharmaceutical benefit is supplied by the approved pharmacist or approved medical practitioner is:
(i) during the period of validity of the residential medication chart; and
(d) the approved pharmacist or approved medical practitioner writes on the copy of the residential medication chart the following for the supply:
(i) the approved pharmacist’s or approved medical practitioner’s name and approval number under regulation 8A;
The first prescription is written in a residential medication chart on 11 June. The period of validity of the residential medication chart starts on 11 June and ends on 30 September.
(4) An approved pharmacist or an approved medical practitioner may supply up to a maximum quantity of a pharmaceutical item or pharmaceutical benefit more than once on the basis of a particular medication chart prescription for the pharmaceutical benefit only if:
Note See paragraph 85A (2) (a) of the Act in relation to maximum quantities of pharmaceutical items or pharmaceutical benefits.
(5) If paragraphs (4) (a) and (b) do not apply, an approved pharmacist or an approved medical practitioner may only supply the quantity of the pharmaceutical benefit needed to give effect to the prescription, up to a maximum quantity of the pharmaceutical item or pharmaceutical benefit.
(a) on the basis of a prescription mentioned in paragraph (4) (a); or
(b) mentioned in subregulation (5);
an approved pharmacist or an approved medical practitioner may supply up to a maximum quantity of the pharmaceutical item or pharmaceutical benefit even if the period of validity of the residential medication chart will end before administration of that quantity in accordance with the prescription would finish.
(7) An approved hospital authority must not supply a pharmaceutical benefit on the basis of a medication chart prescription.
21B Continued dispensing supply of pharmaceutical benefit
(1) This regulation applies in relation to the supply of a pharmaceutical benefit to a person by an approved pharmacist under subsection 89A (1) of the Act.
(2) The approved pharmacist must not supply the pharmaceutical benefit unless the approved pharmacist writes on the repeat authorisation form for the supply:
(a) the approved pharmacist’s name and approval number under regulation 8A; and
(c) the date on which the pharmaceutical benefit is supplied by the approved pharmacist.
21C Information about status of person—continued dispensing and medication chart prescriptions
(1) This regulation applies in relation to:
(a) the supply of a pharmaceutical benefit to a person (the patient) by an approved pharmacist under subsection 89A (1) of the Act; and
(b) the supply of a pharmaceutical benefit by an approved medical practitioner or approved pharmacist, under subsection 93A (4) of the Act, on the basis of a medication chart prescription written for a person (the patient).
(2) The approved pharmacist or approved medical practitioner must collect the following information at the time of supply:
(3) The approved pharmacist or approved medical practitioner must include the information collected under subregulation (2) in the claim for a payment from the Commonwealth in relation to the supply using the Claims Transmission System, within the meaning given by subsection 99AAA (1) of the Act.
[38] Subregulation 22 (5)
(5) This regulation does not apply to:
(a) a pharmaceutical benefit for which the prescription must be in writing, under a law of the State or Territory where the premises of the approved pharmacist are located; and
(b) a pharmaceutical benefit to be supplied, under subsection 93A (4) of the Act, on the basis of a medication chart prescription.
[39] Paragraph 24 (1) (a)
[40] Subregulation 24 (2)
[41] After subregulation 24 (2)
(3) However, this regulation does not apply in relation to the writing of a medication chart prescription.
[42] After regulation 24
24A Continued dispensing—repeated supply not to be supplied on one occasion
(1) This regulation applies in relation to the supply (the continued dispensing supply) of a pharmaceutical benefit by an approved pharmacist under subsection 89A (1) of the Act on the basis of a previous prescription from a PBS prescriber.
(2) If the PBS prescriber directed in the prescription the supply on one occasion of a quantity or number of units of the pharmaceutical benefit allowable under subsection 88 (6) of the Act, instead of directing a repeated supply, the direction does not apply for the purposes of the continued dispensing supply.
[43] Paragraph 25 (2) (a)
[44] After subregulation 25 (4)
(5) Subject to subregulation (2), if the pharmaceutical benefit is supplied to a person by an approved pharmacist (the supplier) under subsection 89A (1) of the Act, subregulation (3) or (4) applies as if:
(i) had been written by a PBS prescriber in accordance with the Act and these Regulations; and
(iii) did not direct a repeated supply of the pharmaceutical benefit; and
(b) subparagraphs (3) (b) (ii) and (c) (ii) or (4) (b) (ii) and (c) (ii) were omitted, and the words ‘immediate supply necessary’ were required to be written on the repeat authorisation form for the supply; and
(c) subparagraphs (3) (b) (iii) and (c) (iii) or (4) (b) (iii) and (c) (iii) were omitted, and the supplier were required to sign the repeat authorisation form mentioned in paragraph (b).
Medication chart prescriptions
(6) Subject to subregulation (2), if the pharmaceutical benefit is supplied by an approved pharmacist or an approved medical practitioner (the supplier), under subsection 93A (4) of the Act, on the basis of a medication chart prescription:
(b) subregulation (3) or (4) applies as if:
[45] Before subregulation 26 (1)
(1AA) This regulation does not apply in relation to the supply of a pharmaceutical benefit, under subsection 93A (4) of the Act, on the basis of a medication chart prescription.
[46] After regulation 26
26AA Repeat authorisation form—continued dispensing
(1) An approved pharmacist must use a repeat authorisation form for the purposes of making a claim for a payment from the Commonwealth under section 99AAA of the Act in relation to a supply of a pharmaceutical benefit under subsection 89A (1) of the Act.
(2) However, the approved pharmacist must not use the form for authorising a repeated supply of the pharmaceutical benefit under that subsection.
[47] Before subregulation 26A (1)
[48] Regulation 30
For subsection 87 (4) of the Act, when
[49] Subregulation 31 (1)
(a) the person receives a pharmaceutical benefit under Part VII of the Act (whether or not for the person’s own use) from an approved supplier; and
(b) the supply of the pharmaceutical benefit by the approved supplier is not a supply under subsection 89A (1) of the Act; and
(c) at the time of supply, the approved supplier is not permitted to make a paperless claim for payment in relation to the supply of the pharmaceutical benefit; and
(d) at the time of supply, the approved supplier asks the person to write on the prescription, repeat authorisation or deferred supply authorisation for the pharmaceutical benefit:
(i) an acknowledgment that the person has received the benefit; and
(ii) the date on which the person received the benefit; and
(iii) if the benefit is not for the person’s own use—the person’s address; and
(e) it is practicable for the person to comply with the request mentioned in paragraph (d); and
(f) the person does not comply with the request mentioned in paragraph (d).
Penalty: 0.2 penalty units.
[50] Subregulations 31 (3) and (4)
(3) An approved supplier commits an offence if:
(a) the approved supplier supplies a pharmaceutical benefit under Part VII of the Act, other than under subsection 89A (1) of the Act; and
(b) it is not practicable for the approved supplier to obtain, from the person receiving the pharmaceutical benefit (whether or not for the person’s own use), a written acknowledgement that the person has received the benefit; and
(c) the approved supplier does not make a paperless claim for payment in relation to the supply of the pharmaceutical benefit; and
(d) the approved supplier does not certify on the prescription, repeat authorisation or deferred supply authorisation for the pharmaceutical benefit:
(i) the date on which the pharmaceutical benefit was supplied by the approved supplier; and
(ii) the reason why it was not practicable for the approved supplier to obtain the written acknowledgement mentioned in paragraph (b).
Paperless claim for payment from Commonwealth
(4) An approved supplier commits an offence if:
(b) the approved supplier makes a paperless claim for payment in relation to the supply of the pharmaceutical benefit; and
(c) the approved supplier does not include a completed supply certification form in the paperless claim for payment.
Continued dispensing supply of pharmaceutical benefit
(a) the person receives a pharmaceutical benefit (whether or not for the person’s own use) from an approved pharmacist under subsection 89A (1) of the Act; and
(b) at the time of the supply, the approved pharmacist asks the person to write on the repeat authorisation form for the supply:
(i) an acknowledgement that the person has received the pharmaceutical benefit; and
(c) it is practicable for the person to comply with the request mentioned in paragraph (b); and
(d) the person does not comply with the request mentioned in paragraph (b).
(6) An approved pharmacist commits an offence if:
(a) the approved pharmacist supplies a pharmaceutical benefit to a person under subsection 89A (1) of the Act; and
(b) it is not practicable for the approved pharmacist to obtain, from the person receiving the pharmaceutical benefit (whether or not for the person’s own use), a written acknowledgement that the person has received the benefit; and
(c) the approved pharmacist does not write on the repeat authorisation form for the supply:
(i) the date on which the pharmaceutical benefit was supplied by the approved pharmacist; and
(ii) the reason why it was not practicable for the approved pharmacist to obtain the written acknowledgement mentioned in paragraph (b).
(7) An offence against this regulation is an offence of strict liability.
[51] Part VI, heading
[52] Before regulation 32
31B Purpose of Part
Unless otherwise specified, this Part is made for section 105 or 140 of the Act.
[53] After subregulation 32 (1)
(1A) However, subregulation (1) does not apply to:
(a) the supply of a pharmaceutical benefit under subsection 89A (1) of the Act; or
(b) the supply of a pharmaceutical benefit, under subsection 93A (4) of the Act, on the basis of a medication chart prescription.
Note See regulations 32A and 32B.
[54] After regulation 32
32A Keeping documents—continued dispensing
(1) This regulation applies if an approved pharmacist supplies a pharmaceutical benefit to a person under subsection 89A (1) of the Act.
(2) The approved pharmacist commits an offence if:
(b) the approved pharmacist does not keep the following information for at least 2 years from the date on which the pharmaceutical benefit was supplied by the approved pharmacist:
(i) the information that supports the claim for payment made under section 99AAA of the Act in relation to the supply of the pharmaceutical benefit;
(ii) the information, about the supply of the pharmaceutical benefit, that is given to the PBS prescriber who most recently prescribed the pharmaceutical benefit to the person.
(3) An offence against this regulation is an offence of strict liability.
32B Keeping documents—medication chart prescriptions
(1) This regulation applies if an approved pharmacist or an approved medical practitioner supplies a pharmaceutical benefit, under subsection 93A (4) of the Act, on the basis of a medication chart prescription.
(2) The approved pharmacist or approved medical practitioner commits an offence if:
(a) the approved pharmacist or approved medical practitioner supplies a pharmaceutical benefit on the basis of a medication chart prescription; and
(b) the approved pharmacist or approved medical practitioner does not keep a copy of the residential medication chart in which the prescription is written for at least 2 years from the date on which the last pharmaceutical benefit was supplied by the approved pharmacist or approved medical practitioner on the basis of a prescription in the residential medication chart.
[55] Regulation 35, at the foot
Note See also paragraph 103 (5) (f) of the Act.
[56] Paragraph 36 (2) (d)
[57] After paragraph 36 (2) (d)
(e) the supply of a pharmaceutical benefit, under subsection 93A (4) of the Act, on the basis of a medication chart prescription.
[58] After regulation 37
37AA Payment for pharmaceutical benefit supplied on basis of medication chart prescription
For subsection 93A (6) of the Act, an approved pharmacist or approved medical practitioner who supplied a pharmaceutical benefit under subsection 93A (4) of the Act, to a prescribed institution mentioned in paragraph 93A (1) (b) of the Act, is entitled to payment from the Commonwealth for the supply of the pharmaceutical benefit at the rate, and subject to the conditions:
(a) determined by the Minister; and
(b) that apply at the time of the supply.
[59] Part VIA, heading
Part 6A Price reductions
[60] Regulation 37A, heading
37A Definitions for Part
[61] Regulation 37EA
prices of a listed brands of pharmaceutical items
price of a listed brand of a pharmaceutical item
[62] Regulation 38, heading
38 Definitions for Part
[63] Regulation 38A, heading
38A Appointments to Committee—nominating bodies
[64] Regulation 38B, heading
38B Number of nominations for appointment