Commonwealth Coat of Arms of Australia

MRCA Pharmaceutical Benefits Scheme

Instrument 2013 No. MRCC 44

made under section 286 of the

Military Rehabilitation and Compensation Act 2004

 

Compilation No. 11

Compilation date:   1 July 2020

Includes amendments up to: F2020L01026   

 

 

 

 

About this compilation

This compilation

This is a compilation of the MRCA Pharmaceutical Benefits Scheme that shows the text of the law as amended and in force on 1 July 2020 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Selfrepealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

 

 

 

Contents

1A Name of Scheme

1C Transitionalgeneral

1D Transitionalpharmaceutical reimbursement

1 MRCA Pharmaceutical Benefits Scheme

2 Purpose of the MRCA Pharmaceutical Benefits Scheme

Part 1—Interpretation

3 

4 Notification of certain matters in the Explanatory Notes

5 Department to notify of certain matters as agent of the Commission

Part 2—Prescribing of Benefits Procedure by Medical Practitioners

6 Prior Approval

7 Restrictions

8 Prescribing provisions

9 Application of PBS Schedule restrictions and RPBS Schedule restrictions

10 Prescriptions to conform with State or Territory Law

11 Form of prescriptions

11AA   Writing prescriptionsgeneral

11A Writing of prescriptionsprescriptions other than medication chart prescriptions

11B Writing prescriptions—medication chart prescriptions

11C Writing prescriptions—additional requirements for all electronic prescriptions

11D Writing prescriptions—additional information that may be included in electronic prescriptions

12 When prescriptions are invalid

13 Maximum quantity and repeats allowed

14 Prescribing outside the RPBS Schedule or PBS Schedule

15 Medical Practitioner subject to this Scheme

Part 3—Supply of Pharmaceutical Benefits

16 Supply of Pharmaceutical Benefits—Procedure by Community Pharmacists

  16AAA                Pharmaceutical benefits supplied under a special arrangement                  21

16AA Supply of pharmaceutical benefit on basis of medication chart prescription

Continued Dispensing

16A When Pharmaceutical benefits may be supplied by Community Pharmacists without prescription

16AB Information about status of person—continued dispensing and medication chart prescriptions

17 Substitution of lesser priced alternative brand of drug

18 Community Pharmacist to be satisfied as to entitlement

19 Dispensing of deleted items

20 Use of forms as notified by the Department or the Commission

21 Financial responsibility

22 Refund in certain circumstances

23 Expenses incurred in obtaining Pharmaceutical Benefits while not in receipt of a pharmaceutical allowance

Part 4—Claims by Community Pharmacists

24 Lodgement of Claims by Community Pharmacists

25 Claims Requirements and Payment

Part 5—Payments to Community Pharmacists

26 Payment of Dispensed Price

30 Fees not payable in some circumstances

31 Community Pharmacist not entitled to demand or receive payments

32 Community Pharmacist to issue receipt where certain payments received

Part 5A—Pharmaceutical Reimbursement

Definitions: 

33 

34 

35 

36 Eligibility for Payment of Pharmaceutical Reimbursement

37 Calculation of annual value of pharmaceutical allowance component of MRCA supplement, pension supplement, veterans supplement

38 Payment of Pharmaceutical Reimbursement

38A Five Year Limit on Payment of Pharmaceutical Reimbursement

39 Pharmaceutical Reimbursement Calculator

40 

Part 5B—Under Copayment Data Collection

40A Giving information

Part 6—Miscellaneous

41 Standards

Retention of Documents

45 Keeping documentsother than for continued dispensing or medication chart prescriptions

45A Keeping documents—continued dispensing

45B Keeping documents—medication chart prescriptions

46 Agreement with the Pharmacy Guild of Australia

47 Transitional provision relating to the Veterans’ Affairs Pharmaceutical Benefits Schemes (Electronic Prescriptions and Active Ingredient Prescribing) Amendment Instrument 2019

Schedule 1 — Incorporated documents

Endnotes

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

 

1A  Name of Scheme

 

  This instrument is the MRCA Pharmaceutical Benefits Scheme.

1C  Transitionalgeneral

  Any process under the revoked scheme that had not been finalised before the commencement of this Scheme is to be completed under this Scheme as if it had commenced under this Scheme.

1D  Transitionalpharmaceutical reimbursement

  For the purpose of working out a pharmaceutical reimbursement, a copayment by an Eligible Person for a Pharmaceutical benefit under the revoked scheme, that could have been counted for a pharmaceutical reimbursement under the revoked Scheme but in respect of which a pharmaceutical reimbursement had not been made immediately before the commencement of this Scheme, is taken to be a copayment for a Pharmaceutical benefit under this Scheme.

1  MRCA Pharmaceutical Benefits Scheme

  The MCRA Pharmaceutical Benefits Scheme is authorised by, and subject to, section 286 of the Military Rehabilitation and Compensation Act 2004.

2  Purpose of the MRCA Pharmaceutical Benefits Scheme

  The MRCA Pharmaceutical Benefits Scheme enables Community Pharmacists to supply Pharmaceutical benefits to Eligible Persons.

Part 1Interpretation

3

  For the purposes of this Scheme, unless a contrary intention appears:

accepted disability means a service injury, a service disease or a DRCA disability.

Note: service injury and service disease are defined in the Act.

Act means the Military Rehabilitation and Compensation Act 2004.

approval number means a number allotted by the Secretary or the Minister for Health under section 16 of the National Health (Pharmaceutical Benefits) Regulations 2017 to an approval under the National Health Act 1953 of a person described in the section who, under the Scheme, is a Community Pharmacist.

approved hospital means a hospital in respect of which the hospital authority is approved under section 94 of the National Health Act 1953.

Approved Hospital Authority has the meaning given by subsection 84(1) of the National Health Act 1953.

approved information technology requirements means information technology requirements of a kind approved in writing by the Secretary under section 12 of the National Health (Pharmaceutical Benefits) Regulations 2017 for the purposes of the provision in those regulations in which the expression is used.

Approved Medical Practitioner means a medical practitioner approved under section 92 of the National Health Act 1953 for the purposes of supplying Pharmaceutical benefits.

approved supplier has the meaning given in Part VII of the National Health Act 1953.

Authorised Midwife has the meaning given by subsection 84 (1) of the National Health Act 1953.

Authorised Nurse Practitioner has the meaning given by subsection 84 (1) of the National Health Act 1953.

authority prescription means:

  (a) a prescription of a Pharmaceutical benefit for which Prior Approval under section 6 is required;

  (b) an authority prescription as defined in the National Health (Pharmaceutical Benefits) Regulations 2017.

Authority Prescription Form means a prescription in the form, if any, for an authority prescription under the National Health (Pharmaceutical Benefits) Regulations 2017 in force from time to time.

Chief Executive Medicare has the meaning given by the Human Services (Medicare) Act 1973.

claims rules mean the rules, in force from time to time, made under subsections 98AC(4) and 99AAA(8) of the National Health Act 1953.

Commission means the Military Rehabilitation and Compensation Commission established by section 361 of the Act.

Community Pharmacist means:

 (a) a registered pharmacist approved for the purposes of section 90 of the National Health Act 1953 in charge of a community pharmacy; or

 (b) a registered pharmacist approved for the purposes of section 90 of the National Health Act 1953, being the manager of a registered Friendly Society Dispensary; or

 (c) an Approved Hospital Authority; or

 (d) an Approved Medical Practitioner.

concessional beneficiary has the same meaning it has in section 84 of the National Health Act 1953, in force from time to time.

concessional beneficiary safety net has the same meaning it has in section 99F of the National Health Act 1953, in force from time to time.

concession card has the meaning given by subsection 84 (1) of the National Health Act 1953.

continued dispensing supply means the supply of Pharmaceutical benefits in the circumstances in paragraph 16A.

copayment, in respect of a pharmaceutical benefit, means that part of the price of a pharmaceutical benefit that is borne by the Eligible Person in relation to a Pharmaceutical benefit made available under the Scheme.

deferred supply authorisation means the situation described in section 53 of the National Health (Pharmaceutical Benefits) Regulations 2017.

Note:  generally a deferred supply authorisation occurs where a prescription contains a direction to supply more than 1 Pharmaceutical benefit and the Community Pharmacist to whom the prescription is presented, at the request of the person for whom the prescription is written, defers the supply of one or more of the Pharmaceutical benefits.

Department means the Department of Veterans’ Affairs.

dependant, in relation to a concessional beneficiary, has the meaning given by Part VII of the National Health Act 1953.

dispensed price has the meaning it has in the RPBS.

DRCA disability means an injury (within the meaning of the Safety, Rehabilitation and Compensation (Defence-related Claims) Act 1988):

(a)  for which the Military Rehabilitation and Compensation Commission has accepted liability to pay compensation under that Act; and

(b)  for which the person with the injury is entitled to be provided with treatment under Part 3 of Chapter 6 of the Act.

Note 1:  In the Safety, Rehabilitation and Compensation (Defence-related Claims) Act 1988 the definition of injury includes a disease (see section 5A of that Act).

Note 2:  Section 280A of the Act provides eligibility for treatment of a person with an injury under the Safety, Rehabilitation and Compensation (Defence-related Claims) Act 1988.

Drugs or Medicines means goods for therapeutic use as defined for human use by the Therapeutic Goods Act 1989.

electronic medication chart has the meaning given by subsection 11B(8).

electronic prescription means a prescription that is prepared and submitted:

 (a) in accordance with approved information technology requirements (if any), by means of an eligible electronic communication; and

   (b) in accordance with the appropriate form approved by the Secretary  under:

   (i) subparagraph 40(2)(c)(ii) (prescriptions other than medication chart prescriptions) of the National Health (Pharmaceutical Benefits) Regulations 2017; or

   (ii) subsection 41(5) (medication chart prescriptions) of the National Health (Pharmaceutical Benefits) Regulations 2017.

eligible electronic communication means:

 (a) an electronic communication of a kind approved by the Secretary under section 11 of the National Health (Pharmaceutical Benefits) Regulations 2017 for the purposes of the provision in which the expression is used; or

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

Eligible Person means:

 (a) a person who holds a Repatriation Health Card For All Conditions; or

 (b) a person who holds a Repatriation Health Card For Specific Conditions.

entitlement card has the meaning given by subsection 84 (1) of the National Health Act 1953.

Explanatory Notes means:

 (a) the document forming part of the Pharmaceutical Benefits Scheme that is SECTION 1 EXPLANATORY NOTES; and

 (b) the document forming part of the Pharmaceutical Benefits Scheme that is the RPBS Explanatory Notes;

  being the version of the documents in the form in which they exist from time to time.

general patient safety net has the same meaning it has in section 99F of the National Health Act 1953, in force from time to time.

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

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

income support payment is a service pension (defined in subsection 5Q(1) of the Veterans’ Entitlements Act 1986) or an income support supplement (referred to in Part IIIA of the Veterans’ Entitlements Act 1986).

income support payment under the Social Security Act 1991 means a payment referred to in the definition of income support payment in subsection 23(1) of the Social Security Act 1991.

Medical Practitioner has the same meaning as medical practitioner has in the Health Insurance Act 1973.

medicare number has the meaning given by subsection 84 (1) of the National Health Act 1953.

medication chart has the meaning given by subsection 11B(6).

medication chart prescription has the meaning given by section 11B.

member has the meaning it has in the Act and includes a former member.

member of a couple has the meaning it has in subsection 5E(2) of the Veterans’ Entitlements Act 1986.

 

Minister for Health means the Minister administering the National Health Act 1953.

MPBS means the MRCA Pharmaceutical Benefits Scheme.

MPBS prescriber means an Approved Medical Practitioner, an Authorised Midwife or an Authorised Nurse Practitioner.

Note: an RPBS prescriber who is an Authorised Midwife or an Authorised Nurse Practitioner may only prescribe a Pharmaceutical benefit listed on the PBS and a prescription by an Authorised Midwife or an Authorised Nurse Practitioner for a Pharmaceutical benefit that is not available on the PBS is not recognised under the Scheme, even if the Pharmaceutical benefit is available under the Scheme on the prescription of, say, an Approved Medical Practitioner.

MRCA supplement means the compensation payable under section 300 of the Act, in force from time to time.

MRCA Treatment Principles means the determination called the MRCA Treatment Principles, made by the Commission under section 286 of the Act and in force from time to time.

paperbased prescription means a prescription that is prepared in duplicate in accordance with subsection 40(2) of the National Health (Pharmaceutical Benefits) Regulations 2017 in force from time to time.

PBS or Pharmaceutical Benefits Scheme means the document entitled “SCHEDULE OF PHARMACEUTICAL BENEFITS” with International Standard Serial Number 10373667, being the version of the document in the form in which it exists from time to time.

PBS prescriber has the meaning given by subsection 84(1) of the National Health Act 1953.

PBS prescriber number means the number given by the Chief Executive Medicare to a person who may prescribe a pharmaceutical benefit under the National Health Act 1953.

PBS Schedule means the collection of instruments made under Part VII of the National Health Act 1953 (the Act) by the Minister who administers that Act, as those instruments are in force from time to time.

pension supplement has the same meaning it has in subsection 5Q(1) of the Veterans’ Entitlements Act 1986, in force from time to time.

pharmaceutical allowance means the component of the MRCA supplement, veterans supplement or pension supplement or war widow/war widower pension that is to assist with the purchase of Pharmaceutical benefits, the calculated value of which is referred to in paragraph 37 (pharmaceutical allowance component) of Part 5A.

pharmaceutical benefit has a drug has the same meaning as in Part VII of the National Health Act 1953.

Pharmaceutical benefits has the same meaning as pharmaceutical benefits in subsection 91(9) of the Veterans’ Entitlements Act 1986.

pharmaceutical item has the meaning given in Part VII of the National Health Act 1953.

pharmaceutical reimbursement means the financial amount described in paragraphs 3335 of Part 5A.

Prior Approval means the prior approval of the Commission.

relevant streamlined authority code, for a pharmaceutical benefit that is prescribed, means the streamlined authority code that is part of:

(a)      the circumstances determined under paragraph 85(7)(b) of the National

 Health Act 1953 for the Pharmaceutical benefit; or

(b)     the conditions determined under subsection 85A(2A) of the National

 Health Act 1953 for the Pharmaceutical benefit.

Repatriation Health Card For All Conditions means an identification card, or written authorisation, provided to a person eligible under Part 3 of Chapter 6 of the Act for treatment, subject to the MRCA Treatment Principles, for all injuries or diseases.

Repatriation Health Card For Specific Conditions means an identification card, or written authorisation, provided to a person eligible under Part 3 of Chapter 6 of the Act for treatment, subject to the MRCA Treatment Principles, for a service injury or a service disease.

Repatriation Pharmaceutical Benefits Scheme has the same meaning as in the Veterans’ Entitlements Act 1986.

Repatriation Schedule of Pharmaceutical Benefits means all of the content in the Pharmaceutical Benefits Scheme for the part with the heading “Repatriation Pharmaceutical Benefits Scheme”.

repeat authorisation form means the form mentioned in subparagraph 52(3)(a)(i) of the National Health (Pharmaceutical Benefits) Regulations 2017 in force from time to time.

residential care has the meaning given by section 41–3 of the Aged Care Act 1997.

residential care service has the meaning given by the Aged Care Act 1997.

revoked scheme means the MRCA Pharmaceutical Benefits Scheme (Instrument 2004 No. M22).

RPBS means the Repatriation Pharmaceutical Benefits Scheme.

RPBS Explanatory Notes means the document forming part of the Pharmaceutical Benefits Scheme that is the RPBS Explanatory Notes being the version of the document in the form in which it exists from time to time.

RPBS Schedule means the document forming part of the Pharmaceutical Benefits Scheme that is the Repatriation Schedule of Pharmaceutical Benefits, being the version of the document in the form in which it exists from time to time.

safety net, in respect of its application to a person under this Scheme, means the concessional beneficiary safety net or general patient safety net, whichever amount first applies to the person for the purposes of section 84C of the National Health Act 1953, in force from time to time.

Note: under section 84C of the National Health Act 1953 a concession card or entitlement card is issued when a person reaches their Safety Net.  The card is issued for the “relevant entitlement period”.  The relevant entitlement period is the remainder of the calendar year after the card is issued.

Scheduled item means an item in the PBS Schedule or the RPBS Schedule.

Scheme means the MRCA Pharmaceutical Benefits Scheme.

Secretary has the meaning given in Part 1 of the National Health Act 1953.

service injury and service disease have the same meanings given by section 5 of the Act and for a person with a DRCA disability means the person’s injury (within the meaning of the Safety, Rehabilitation and Compensation (Defence-related Claims) Act 1988) that was caused by, or arose out of, the person’s employment in the Defence Force that is covered by the Safety, Rehabilitation and Compensation (Defence-related Claims) Act 1988.

social security pension supplement means a rate or amount worked out under section 20A of the Social Security Act 1991.

special arrangement means the National Health (COVID-19 Supply of Pharmaceutical Benefits) Special Arrangement 2020 (the instrument) made by the Minister for Health under section 100 of the National Health Act 1953 to modify the arrangements for the supply of pharmaceutical benefits under Part VII of that Act.

Standard Prescription Form means a prescription prepared in accordance with subsection 40(2) of the National Health (Pharmaceutical Benefits) Regulations 2017.

Note: a Standard Prescription Form does not include a medication chart prescription.

supply certification form means the form of that name in the claims rules.

veterans supplement means the payment under section 118A of the Veterans’ Entitlements Act 1986.

war widow/war widower pension means a payment received by a war widow/war widowerpensioner comprised of:

 (a) a pension under Part II or IV of the Act at a rate determined under or by reference to subsection 30(1) of the Act; or

 (b) a lump sum mentioned in paragraph 234(1)(b) of the MRCA or a weekly amount mentioned in that paragraph.

Note: MRCA is defined in subsection 5Q(1) of the Act as the Military Rehabilitation and Compensation Act 2004.

Note: references in the Scheme to paragraphs, subparagraphs, sections and subsections are interchangeable.  For example a reference to “paragraph 10” of the Scheme is the same as a reference to “section 10” of the Scheme and vice versa.

4  Notification of certain matters in the Explanatory Notes

  Where it is provided for the Department or the Commission to notify of certain matters under the Scheme, the inclusion of the matter in the RPBS Explanatory Notes and publication of the RPBS Explanatory Notes (as part of the publication of the Pharmaceutical Benefits Scheme which includes the RPBS Explanatory Notes) shall be taken to constitute such notification.

5  Department to notify of certain matters as agent of the Commission

  Where it is provided that the Department may notify of certain matters, the Department may only do so for and on behalf of the Commission, as its agent.

Part 2Prescribing of Benefits Procedure by Medical Practitioners

6  Prior Approval

 (a) The Commission may approve any matters requiring Prior Approval; and

 (b) Prior Approval must be sought, in advance, in accordance with an Authority Prescription Form.

7  Restrictions

  Restrictions apply to the prescribing of certain items. These include:

 (a) itemsquantities and repeats: those listed in the RPBS Schedule or PBS Schedule;

 (b) surgical appliances and other treatment aids: surgical appliances and other treatment aids provided under the MRCA Treatment Principles or under the Act may not be prescribed unless specifically listed in the RPBS Schedule;

 (c) admixtures: the following restrictions apply to admixtures:

 (i) admixture of two or more readyprepared items into a single combined form, or the addition of one or more supplementary ingredients to a readyprepared item, is not recognised as a Pharmaceutical benefit;

 (ii) the extemporaneous prescribing of two or more official formulary preparations in a single combined form, or the addition of one or more supplementary ingredients to an official formulary preparation, is a recognised Pharmaceutical benefit; and

 (iii) where one or more of the components of a preparation specified in subparagraph (ii) are nonRPBS Schedule or nonPBS Schedule items, Prior Approval is required for their prescribing;

 (d)  conformity with standards: no drug or therapeutic substance shall  be prescribed unless it conforms with the specific or general standards as determined by the relevant Minister under the Therapeutic Goods Act 1989.

 (e) basis for prescribing: the prescribing of therapeutic substances other than on the clinical diagnosis of a Medical Practitioner, Authorised Nurse Practitioner or Authorised Midwife shall be invalid;

Note: an RPBS prescriber who is an Authorised Midwife or an Authorised Nurse Practitioner may only prescribe a Pharmaceutical benefit listed on the PBS and a prescription by an Authorised Midwife or an Authorised Nurse Practitioner for a Pharmaceutical benefit that is not available on the PBS is not recognised under the Scheme, even if the Pharmaceutical benefit is available under the Scheme on the prescription of, say, an Approved Medical Practitioner.

 (f) approval for therapeutic use: it is invalid to prescribe:

 (i) an item that is not approved for therapeutic use in the treatment of human illness by the relevant Commonwealth, State or Territory Government agencies, or

 (ii) an item for use if it is not in accordance with the terms and conditions specified by the relevant Government agencies in approving the item as a therapeutic substance;

 (g) Prior Approval for nonconforming items: any drug or medicine intended for use other than in conformity with the requirements in subparagraph (d) requires Prior Approval;

 (h) PBS Schedule restricted items: the prescribing of PBS Schedule restricted items is to comply with the restrictions relating to the prescribing of such items as indicated in the PBS Schedule unless Prior Approval is obtained to prescribe otherwise;

 (j) RPBS Schedule restricted items: the prescribing of RPBS Schedule restricted items under this Part is to comply with the restrictions relating to the prescribing of such items as indicated in the RPBS Schedule unless Prior Approval is obtained to prescribe otherwise;

 (k) Prior Approval for nonSchedule items: the prescribing of an item not included in the RPBS Schedule or PBS Schedule requires Prior Approval.

8  Prescribing provisions

  The PBS Schedule and RPBS Schedule are the primary references for the prescribing of Pharmaceutical benefits.

9  Application of PBS Schedule restrictions and RPBS Schedule restrictions

  Restrictions specified in the PBS Schedule and RPBS Schedule which limit supply of items to a particular class of person, or are reserved for specified purposes or require an authority to prescribe, apply unless Prior Approval is obtained to prescribe otherwise.

10  Prescriptions to conform with State or Territory Law

  For a prescription to be recognised by the Commission it must conform with the provisions of State or Territory law.

11  Form of prescriptions

  Who can write Prescriptions

 (1) Prescriptions are to be written by a Medical Practitioner, Authorised Nurse Practitioner or Authorised Midwife and except where inconsistent with the Scheme are to:

 (a) satisfy the requirements for prescriptions in the National Health (Pharmaceutical Benefits) Regulations 2017; and

 (b) in the case of a prescription written by an Authorised Nurse Practitioner or Authorised Midwifeonly be for a Pharmaceutical benefit the person is permitted to prescribe under the National Health Act 1953 (including under the instruments under that Act).

Note: an RPBS prescriber who is an Authorised Midwife or an Authorised Nurse Practitioner may only prescribe a Pharmaceutical benefit listed on the PBS and a prescription by an Authorised Midwife or an Authorised Nurse Practitioner for a Pharmaceutical benefit that is not available on the PBS is not recognised under the Scheme, even if the Pharmaceutical benefit is available under the Scheme on the prescription of, say, an Approved Medical Practitioner.

11AA  Writing prescriptionsgeneral

  A prescription for the supply of a Pharmaceutical benefit must be written in accordance with;

 (a) either:

 (i) section 11A (prescriptions other than medication chart prescriptions); or

 (ii) section 11B (medication chart prescriptions); and

 (b) if the prescription is an electronic prescription—section 11C (additional requirements for all electronic prescriptions).

Note: other provisions of the Scheme may also contain requirements for writing of prescriptions.

11A  Writing of prescriptionsprescriptions other than medication chart prescriptions

 (1) An MPBS prescriber writes a prescription in accordance with this Scheme if the MPBS prescriber :

 (a) prepares the prescription:

 (i) in duplicate, by handwriting the prescription in ink on a prescription form:

 (A) that is as nearly as practicable 18 centimetres long by 12 centimetres wide; and

 (B) on which appears the name and address of the MPBS prescriber and, subject to subsection (4), the letters ‘RPBS’ or ‘MPBS’ or ‘DVA’; and

 (C) on the original of which appear the words ‘pharmacist/patient copy’; and

 (D) on the duplicate of which appear the words ‘Medicare Australia/DVA copy’; or

 (ii) in duplicate, by means of a computer on a prescription form:

 (A) that is as nearly as practicable 18 centimetres long by 12 centimetres wide; and

 (B) on which appears the name and address of the MPBS prescriber and, subject to subsection (4), the letters ‘RPBS’ or ‘MPBS’ or ‘DVA’; and

 (C) on the original of which appear the words ‘pharmacist/patient copy’; and

 (D) on the duplicate of which appear the words ‘Medicare Australia/DVA copy’; and

 (E) that is approved in writing for the purpose by the Secretary (as defined in the National Health Act 1953); or

 (iia) by means of a form:

 (A) on which appear the name and address of the MPBS prescriber and the letters ‘RPBS’ or ‘MPBS’ or ‘DVA’; and

 (B) that is approved in writing by the Secretary (as defined in the National Health Act 1953) for the purpose of writing an electronic prescription; or

 (iii) by another method approved in writing by the Secretary (as defined in the National Health Act 1953); and

 (b) signs the prescription after it is prepared; and

 (c) for an authority prescription—writes on it that prior approval has been obtained (if the case); and

 (d) specifies on the prescription the date on which the prescription is written; and

 (e) for a Authorised Midwife or Authorised Nurse Practitioner—states in the prescription the number allotted to his or her approval under section 16 of the National Health (Pharmaceutical Benefits) Regulations 2017; and

 (f) states in the prescription the name of the person for whom the Pharmaceutical benefit is prescribed and the address of that person; and

 (g) identifies in the prescription the Pharmaceutical benefit in accordance with subsection (1A); and

 (h) states in the prescription:

 (i) the quantity or number of units of the Pharmaceutical benefit to be supplied; and

 (ii) if the supply of the benefit is to be repeated—the number of times it is to be repeated; and

 (i) if the Pharmaceutical benefit to be supplied is not a readyprepared pharmaceutical benefit (as defined in the National Health (Pharmaceutical Benefits) Regulations 2017)—indicates in the prescription the manner in which the Pharmaceutical benefit is to be administered.

 (1A) For the purposes of paragraph (1)(g), the MPBS prescriber must identify in the prescription:

 (a) if:

 (i) the prescription is prepared in accordance with paragraph (1)(a); or

 (ii) the prescription is for the supply of a Pharmaceutical benefit that has 4 or more drugs; or

 (iii) the prescription is for the supply of a Pharmaceutical benefit that is specified by the Secretary, in writing, for the purposes of subparagraph 40(2A)(a)(iii) of the National Health (Pharmaceutical Benefits) Regulations 2017; or

 (iv) the prescription is for the supply of a Pharmaceutical benefit listed under the heading “Various” in the RPBS Schedule;

  the Pharmaceutical benefit by such particulars as are necessary to identify the Pharmaceutical benefit; or

 (b) otherwise:

 (i) each drug that the Pharmaceutical benefit has; and

 (ii) if the MPBS prescriber considers that it is necessary for the medical treatment of the person for whom the Pharmaceutical benefit is to be supplied to identify a brand of the pharmaceutical item that the Pharmaceutical benefit has—the brand of the pharmaceutical item.

 (1B) If subparagraph (1A)(b)(ii) applies, the brand of the pharmaceutical item must be listed after the drugs that the Pharmaceutical benefit has.

 (1C) Subsection (1A) does not apply to the extent that it would be contrary to a law of a State or Territory that would otherwise apply.

 (2) A prescription written in accordance with this section must not provide for the supply of a Pharmaceutical benefit to:

 (a) a person if the MPBS prescriber has written, on the same day, another prescription for the supply of the same or an equivalent Pharmaceutical benefit to the person; or

 (b) more than 1 person.

 (3) For the purposes of paragraphs (2)(b), (c) and (d), a prescription must not be prepared using a computer program that:

 (a) operates, or may operate, to indicate on a prescription by default, for the purposes of subsection 103(2A) of the National Health Act 1953, that only the brand of pharmaceutical benefit specified in the prescription is to be supplied; or

 (b) if paragraph (2A)(b) of this section applies to the prescription—operates, or may operate, to indicate on a prescription by default a brand of the pharmaceutical item that the pharmaceutical benefit has.

11B  Writing prescriptionsmedication chart prescriptions

Writing prescription by completing section of medication chart

 (1) A MPBS prescriber writes a prescription (a medication chart prescription) for a Pharmaceutical benefit in accordance with this section 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 MPBS prescriber completes a section of a medication chart for the person in relation to the Pharmaceutical benefit in accordance with

 (i) subsection (3) and

 (ii) if the prescription would be an authority prescription other than an authority prescription referred to in subsection (4A) – subsection (4).

 (2) A reference in the Scheme to a prescription, or a medication chart prescription, includes a reference to the completed section of the chart by which a medication chart prescription was written.

 Completing section of medication chart—general

 (3) An MPBS prescriber completes a section of a medication chart in accordance with this subsection for a person (the patient) in relation to a Pharmaceutical benefit if:

 (a) the MPBS prescriber writes in the section of the chart:

 (i) particulars to identify the Pharmaceutical benefit in accordance with subsection (3A); 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 ‘RPBS’ or ‘MPBS’ or ‘DVA’; and

 (b) the chart contains the following information:

 (i) the MPBS prescriber’s full name, address and PBS prescriber number (if a PBS prescriber);

 (ii) the patient’s full name;

 (iii) the patient’s medicare number;

 (iv) the number of any entitlement card or concession card held by the patient;

 (v) if the patient is a concessional beneficiary or the dependant of a concessional beneficiary – the number of any card issued by the Commonwealth and held by the concessional beneficiary that is evidence that the patient is entitled to receive the Pharmaceutical benefit on terms appropriate for the supply of the benefit to a patient of that kind;

 (vi) the name of the residential care service or approved hospital in or at which the patient is receiving treatment;

 (vii) if the patient is receiving treatment in or at a residential care service—the Residential Aged Care Service ID for the residential care service;

 (viii) if the patient is receiving treatment in or at an approved hospital—the patient’s address and;

 (c)  the MPBS 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 National Health Act 1953, that only the brand of Pharmaceutical benefit specified in the prescription is to be supplied; and

 (ea) if paragraph (3A)(b) of this section applies to the prescription—the section of the chart is not completed using a computer program that operates, or may operate, to indicate on a prescription by default a brand of the pharmaceutical item that the pharmaceutical benefit has; 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 subsection 16AA(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) in any case—the section of the chart is completed before the end of the chart’s period of validity under subsection 16AA(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.

 (3A) For the purposes of subparagraph 11B(3)(a)(i), the MPBS prescriber must write in the section of the chart:

 

(a) if:

 

(i) the prescription is prepared by handwriting the prescription on the section of the chart; or

(ii) the prescription is for the supply of a pharmaceutical benefit that has 4 or more drugs; or

(iii) the patient is receiving treatment in or at a residential care service and the medication chart is not an electronic medication chart; or

(iv) the prescription is for the supply of a pharmaceutical benefit that is specified by the Secretary, in writing, for the purposes of subparagraph 40(2A)(a)(iii) of the National Health (Pharmaceutical Benefits) Regulations 2017; or

(v) the prescription is for the supply of a Pharmaceutical benefit listed under the heading “Various” in the RPBS Schedule;

 

 particulars sufficient to identify the pharmaceutical benefit; or

 

 (b) otherwise:

 (i) each drug that the Pharmaceutical benefit has; and

 (ii) if the MPBS prescriber considers that it is necessary for the medical treatment of the patient to identify a brand of the pharmaceutical item that the Pharmaceutical benefit has—the brand of the pharmaceutical item.

 (3B) If subparagraph (3A)(b)(ii) applies, the brand of the pharmaceutical item must be listed after the drugs that the pharmaceutical benefit has.

 (3C) Subsection (3A) does not apply to the extent that it would be contrary to a law of a State or Territory that would otherwise apply.

Completing section of medication chart—authority prescriptions

 (4) An MPBS prescriber completes a section of a medication chart in accordance with this subsection for a person for the purpose of writing an authority prescription if the section of the chart contains:

(a)      the authority approval number (if one is given); or

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

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

 (4A) Subparagraph (1)(b)(ii) does not apply to authority prescriptions that have been authorised in accordance with authority required procedures that are incorporated by reference into the circumstances determined for a Pharmaceutical benefit under subsection 85B(4) of the National Health Act 1953.

Note: If the authority required procedures referred to in subsection (4A) require a streamlined authority code or an authority approval number to be written on an authority prescription, and the code or number is not written on the authority prescription, the special patient contribution is not payable by the Commonwealth: see subsection 85B(4) of the National Health Act 1953.

  Medication charts

 (6) A medication chart is a chart in a form (if any) approved under subsection (7) 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.

 (7) The form of a medication chart is approved if the Secretary (as defined in the National Health Act 1953) has approved it.

Electronic medication charts

 (8) An electronic medication chart is a medication chart in a form approved by the Secretary under subsection 41(5) of the National Health (Pharmaceutical Benefits) Regulations 2017 for the purpose of writing an electronic prescription.

11C  Writing prescriptions—additional requirements for all electronic prescriptions

  An MPBS prescriber writes an electronic prescription in accordance with this section if the MPBS prescriber:

 (a) includes in the metadata of the prescription:

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

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

 (b) states in the prescription:

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

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

11D  Writing prescriptions—additional information that may be included in electronic prescriptions

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

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

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

12  When prescriptions are invalid

  A prescription is not a valid Pharmaceutical benefit if the Medical Practitioner, Authorised Nurse Practitioner or Authorised Midwife:

 (a) except where the prescription is a medication chart prescription, prescribes a Pharmaceutical benefit for a person in respect of whom another prescription for the same benefit has been written on the same day by the same Medical Practitioner, Authorised Nurse Practitioner or Authorised Midwife; or

 (b) prescribes, on the one form, a Pharmaceutical benefit that is a drug of addiction and another Pharmaceutical benefit, and directs that the supply of either Pharmaceutical benefit is to be repeated (but, if no repeats of either item are ordered, the prescription may be accepted provided that this is in accordance with the relevant State or Territory law); or

 (c) prescribes a narcotic drug for the Medical Practitioner, Authorised Nurse Practitioner or Authorised Midwife writing the prescription; or

 (d) prescribes on a Standard Prescription Form an item not listed in the RPBS Schedule or PBS Schedule; or

 (e) prescribes on a Standard Prescription Form a benefit in contravention of any of the restrictions set out in paragraph 7; or

 (f) where the prescription is by an Authorised Nurse Practitioner or Authorised Midwife for an Eligible Personprescribes a Pharmaceutical benefit that is not available to the Eligible Person under the PBS.

 

Note: an MPBS prescriber who is an Authorised Midwife or an Authorised Nurse Practitioner may only prescribe a Pharmaceutical benefit listed on the PBS and a prescription by an Authorised Midwife or an Authorised Nurse Practitioner for a Pharmaceutical benefit that is not available on the PBS is not recognised under the Scheme, even if the Pharmaceutical benefit is available under the Scheme on the prescription of, say, an Approved Medical Practitioner.

13  Maximum quantity and repeats allowed

  The quantity and repeats for Scheduled items are to be confined to those specified in the RPBS Schedule or PBS Schedule.  However, where inadequate, the Medical Practitioner, Authorised Nurse Practitioner or Authorised Midwife may seek Prior Approval to prescribe a quantity greater, or a greater number of repeats, than the maximum listed in the RPBS Schedule or PBS Schedule.

Note: an RPBS prescriber who is an Authorised Midwife or an Authorised Nurse Practitioner may only prescribe a Pharmaceutical benefit listed on the PBS and a prescription by an Authorised Midwife or an Authorised Nurse Practitioner for a Pharmaceutical benefit that is not available on the PBS is not recognised under the Scheme, even if the Pharmaceutical benefit is available under the Scheme on the prescription of, say, an Approved Medical Practitioner.

14  Prescribing outside the RPBS Schedule or PBS Schedule

  If a Medical Practitioner is of the clinical opinion that there are no therapeutic alternatives available in the RPBS Schedule or PBS Schedule for the treatment of an Eligible Person, the Medical Practitioner may seek Prior Approval from the Commission to prescribe an item not contained in those Schedules.

15  Medical Practitioner subject to this Scheme

  Where a Medical Practitioner, Authorised Nurse Practitioner or Authorised Midwife prescribes for an Eligible Person, the Medical Practitioner, Authorised Nurse Practitioner or Authorised Midwife shall be subject to the terms and conditions of this Scheme and the Explanatory Notes.

Note: an RPBS prescriber who is an Authorised Midwife or an Authorised Nurse Practitioner may only prescribe a Pharmaceutical benefit listed on the PBS and a prescription by an Authorised Midwife or an Authorised Nurse Practitioner for a Pharmaceutical benefit that is not available on the PBS is not recognised under the Scheme, even if the Pharmaceutical benefit is available under the Scheme on the prescription of, say, an Approved Medical Practitioner.

Part 3Supply of Pharmaceutical Benefits

16  Supply of Pharmaceutical BenefitsProcedure by Community Pharmacists

  Subject to paragraph 16AAA (special arrangements) and paragraph 16A (continued dispensing), a Community Pharmacist is required to supply a Pharmaceutical benefit only upon the surrender of:

 (a) a valid Standard Prescription Form; or

 (b) a valid Authority Prescription Form; or

 (c) a valid repeat authorisation form presented with a duplicate prescription in accordance with the requirements under the PBS; or

 (d) a valid medication chart prescription;

  provided that such documents are in accordance with State or Territory law and this Scheme and the Explanatory Notes, and with any requirements which the Department or the Commission, from time to time, notifies.

Note: The Commonwealth introduced medication chart prescribing (MCP) in stages.  Firstly there was a trial of MCP in certain residential care services and then it was adopted for residential care services.  Secondly, on 1 April 2015, a trial of MCP at certain hospitals commenced.  The intention in the MPBS is to ensure MCP under the MPBS can only occur for patients in residential care services or hospitals where it could occur in respect of those patients under the National Health (Pharmaceutical Benefits) Regulations 2017.

16AAA  Pharmaceutical benefits supplied under a special arrangement

(1)                A Community Pharmacist will be required to supply a Pharmaceutical

 benefit to an Eligible Person under a special arrangement if:

(a)                the supply is made in accordance with the conditions specified in

 the National Health (COVID-19 Supply of Pharmaceutical Benefits) Special Arrangement 2020 as in force from time to time:

(i)                 as if the supply under the Scheme is a supply covered by the instrument; and

(ii)         the instrument has effect under subsections (2), (3), (4), (5), (6), (7), (8), (9), (10) and (11) of this section; and

(iii)             to the extent that those conditions are applicable to the supply; and

(iv)             the supply of the Pharmaceutical benefit occurs before the repeal of the National Health (COVID-19 Supply of Pharmaceutical Benefits) Special Arrangement 2020;

(b)          the supply otherwise conforms to this section.

(2)                For the purposes of paragraph (1)(a) of this section, the National Health (COVID-19 Supply of Pharmaceutical Benefits) Special Arrangement 2020 has effect in accordance with the following table.

 

Modified effect of the National Health (COVID-19 Supply of Pharmaceutical Benefits) Special Arrangement 2020 instrument

 

Item

Column 1

The instrument has effect as if a reference to …

Column 2

were a reference to …

1

a paper-based repeat authorisation

a repeat authorisation form

2

a PBS prescriber

a person who prescribes a Pharmaceutical benefit under the Scheme

3

a pharmaceutical benefit

a Pharmaceutical benefit

4

an approved hospital authority

an Approved Hospital Authority

5

an approved pharmacist

a Community Pharmacist

6

 a CTS claim

a claim under the claims rules

7

Part VII of the Act

the Scheme

8

section 44 of the Regulations

section 16 of the Scheme

9

subsections 40(1), (2) and (2A) of the Regulations

subsections 11A(1) and (1A) of the Scheme

10

subsection 40(2) of the Regulations

subsection 11A(1) of the Scheme

Further modifications of the instrument

(3)                    The special arrangement referred to in paragraph (1)(a) has effect as if the definition of “approved hospital authority” in subsection 6(1) of the instrument is omitted.

(4)                    The special arrangement referred to in paragraph (1)(a) has effect as if the definition of “approved hospital authority dispenser” in subsection 6(1) of the instrument is replaced with the following:

approved hospital authority dispenser means the Community Pharmacist or approved medical practitioner by whom, or under whose supervision, a Pharmaceutical benefit supplied by an Approved Hospital Authority will be dispensed.

(5)                    The special arrangement referred to in paragraph (1)(a) has effect as if the definition of “CTS claim” in subsection 6(1) of the instrument is omitted.

(6)                    The special arrangement referred to in paragraph (1)(a) has effect as if the definition of “medication chart prescription” in subsection 6(1) of the instrument is replaced with the following:

    medication chart prescription has the same meaning as in the Scheme.

 

(7)                         The special arrangement referred to in paragraph (1)(a) has effect as if the definition of “paper-based prescription” in subsection 6(1) of the instrument is replaced with the following:

paper-based prescription has the same meaning as in the Scheme.

(8)                         The special arrangement referred to in paragraph (1)(a) has effect as if section 8 of the instrument is replaced with the following:

8 Application of the Scheme

A provision of the Scheme applies subject to this Special Arrangement.

(9)                         The special arrangement referred to in paragraph (1)(a) has effect as if subsection 9(1) was omitted and replaced with the following:

(1)           Division 2 of Part 2 of this Special Arrangement applies to the supply of a pharmaceutical benefit by an approved supplier based on a paper-based prescription (excluding a medication chart prescription) written as the result of a telehealth attendance or phone attendance provided on or after 20 March 2020 to which an item in a Fee Schedule (a document incorporated as in force from time to time for the purposes of the Treatment Principles) applies.

(10)                     The special arrangement referred to in paragraph (1)(a) has effect as if subsection 9(4) of the instrument is omitted.

(11)                     The special arrangement referred to in paragraph (1)(a) has effect as if subsection 10(4) of the instrument is replaced with the following:

(4)           If the prescription is or would be an authority prescription, the supplier may supply the Pharmaceutical benefit under this section only if prior approval has been obtained.

 

16AA  Supply of pharmaceutical benefit on basis of medication chart prescription

 (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 – a Community Pharmacist; or

 (b) if the person in respect of whom the Pharmaceutical  benefit is to be supplied is receiving treatment in or at an approved hospitala Community Pharmacist or the Approved Hospital Authority.

 (2) A Community Pharmacist may supply a Pharmaceutical benefit on the basis of a medication chart prescription only if:

 (a) the Community Pharmacist 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 subsections 11B(3) and (4) (if applicable) have been complied with; and

 (b) the date on which the Pharmaceutical benefit is supplied is:

 (i) during the period of validity of the medication chart; and

 (ii) no later than the stop date (if any) indicated in the prescription; and

 (c) the Community Pharmacist writes on the medication chart or the copy of the chart, the following for the supply:

 (i) the Community Pharmacist’s name and any approval number under section 16 of the National Health (Pharmaceutical Benefits) Regulations 2017;

 (ii) an identification number for the supply;

 (iii) the date on which the Pharmaceutical benefit is supplied.

 (3) For paragraph (2)(b), the period of validity of a medication chart for a person receiving treatment in or at a residential care service:

 (a) starts on the day in a calendar month (the first calendar month) when the first prescription for a Pharmaceutical benefit is written in the medication chart; and

 (b) ends on the last day of the third calendar month that starts after the first calendar month.

Example: The first prescription is written in a medication chart on 11 June. The period of validity of the medication chart starts on 11 June and ends on 30 September.

Note: calendar month is defined in section 2B of the Acts Interpretation Act 1901.

 (3A) For paragraph (2)(b), 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 11B(3)(f)).

 (4) A Community Pharmacist 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:

 (a) the prescription indicates that an ongoing supply of the Pharmaceutical benefit is authorised for the period of validity of the chart; or

 (b) the prescription indicates a stop date for the supply of the Pharmaceutical benefit and, based on the dose and frequency of administration of the Pharmaceutical benefit indicated in the prescription, more than one supply of a maximum quantity of the Pharmaceutical item or Pharmaceutical benefit is needed before the stop date is reached.

Note: See paragraph 85A(2)(a) of the National Health Act 1953, the PBS Schedule, and the RPBS Schedule, in relation to maximum quantities of pharmaceutical items or pharmaceutical benefits.

 (5) If paragraphs (4)(a) and (b) do not apply, a Community Pharmacist 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.

Note: The following information entered in the prescription may also indicate the quantity of the Pharmaceutical benefit that is needed:

(a) the dose and frequency of administration of the Pharmaceutical benefit;

(b) the date of prescribing, or the start date (if any) for administration of the Pharmaceutical benefit;

(c) the stop date (if any) for administration of the Pharmaceutical benefit.

 (6) However, for a supply:

 (a) on the basis of a prescription mentioned in paragraph (4)(a); or

 (b) mentioned in paragraph (5);

  a Community Pharmacist may supply up to a maximum quantity of the pharmaceutical item or Pharmaceutical benefit even if the period of validity of the medication chart will end before administration of that quantity in accordance with the prescription would finish.

Continued Dispensing

16A  When Pharmaceutical benefits may be supplied by Community Pharmacists without prescription

  Pharmaceutical benefits covered by PBS and National Health Act section 89A instruments

 (1) A Community Pharmacist may, at or from premises in respect of which the pharmacist is for the time being approved under the National Health Act 1953, supply a Pharmaceutical benefit to an Eligible Person without a prescription for that supply if:

 (a) the Pharmaceutical benefit is covered by the Scheme and  an instrument in force under subsection 89A(3) of the National Health Act 1953; and

                                                                  

 (b) the supply is made in accordance with the conditions specified in the instrument:

  (i) as if the supply under the Scheme is a supply covered by the  

   instrument; and

  (ii) as the instrument has effect under subsection (1B) of this section; and

 (c) the supply otherwise conforms to this section.

                     Certain Pharmaceutical benefits not covered by PBS

 (1A) A Community Pharmacist may, at or from premises in respect of which the pharmacist is for the time being approved under the National Health Act 1953, supply a Pharmaceutical benefit to an Eligible Person without a prescription for that supply if:

 (a) the Pharmaceutical benefit is specified in the table in Schedule 2 to the Repatriation Pharmaceutical Benefits Scheme; and

 (b) the supply is made in accordance with the conditions specified in the National Health (Continued Dispensing – Emergency Measures) Determination 2020:

 (i) as if the supply under the Scheme is a supply covered by that

  instrument; and

  (ii) as that instrument has effect under subsection (1B) of this

   section; and

  (iii) to the extent that those conditions are applicable to the

   supply; and

 (c) the supply otherwise conforms to this section.

  Modified effect of National Health Act section 89A instruments

 (1B) For the purposes of subparagraphs (1)(b)(ii) and (1A)(b)(ii) of this section, an instrument in force under subsection 89A(3) of the National Health Act 1953 has effect in accordance with the following table.

 

Modified effect of National Health Act section 89A instruments

 

Item

Column 1

The instrument has effect as if a reference to …

Column 2

were a reference to …

1

a PBS prescriber

a person who prescribes a Pharmaceutical benefit under the Scheme

2

a pharmaceutical benefit

a Pharmaceutical benefit

3

a pharmaceutical item

a Pharmaceutical benefit

4

an approved pharmacist

a Community Pharmacist

5

paragraph 85A(2)(a) of the Act

the Scheme

6

paragraph 89A(3)(a) of the Act

the Scheme

7

Part VII of the Act

the Scheme

8

subsection 89A(1) of the Act

the Scheme

9

a statement that particular conditions are satisfied

a statement that particular conditions, as they have effect under this subsection, are satisfied

 

                     Other matters

 

 (2) If a Community Pharmacist makes a supply in accordance with subsection (1) or (1A), then this Scheme applies in relation to the supply as if the Eligible Person had presented the pharmacist with a prescription that had been written in accordance with this Scheme.

 (3) The supply of a Pharmaceutical benefit in accordance with this section is a continued dispensing supply.

 

 (4) A Community Pharmacist must not supply a Pharmaceutical benefit under this section unless the pharmacist writes on the repeat authorisation form for the supply:

 (a) the pharmacist’s name and approval number under section 16 of the National Health (Pharmaceutical Benefits) Regulations 2017; and

 (b) an identification number for the supply; and

 (c) the date on which the Pharmaceutical benefit is supplied by the pharmacist.

Note: a failure to observe these requirements means the supply is not a continued dispensing supply.

 (5) For a continued dispensing supply a Community Pharmacist or Approved Medical Practitioner must collect the following information at the time of supply:

 

 (a) information about whether the patient is, at the time of the supply:

 (i) a concessional beneficiary or a dependant of a concessional beneficiary; or

 (ii) the holder of a concession card or entitlement card;

 (b) for a person mentioned in subparagraph (a) (i)—the number specified on a card, issued by the Commonwealth, as an entitlement number (however described) in relation to the person;

 (c) for a person mentioned in subparagraph (a) (ii)—the number of the concession card or entitlement card.

 (6) The Community Pharmacist or Approved Medical Practitioner must include the information collected under subsection (5) 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 National Health Act 1953.

Note: a failure to observe these requirements means the supply is not a continued dispensing supply.

 (7) For the supply of a Pharmaceutical benefit by a Community Pharmacist on the basis of a previous prescription from a PBS prescriber or RPBS prescriber, if the PBS prescriber or RPBS 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 National Health Act 1953, instead of directing a repeated supply, the direction does not apply for the purposes of the continued dispensing supply.

 (8) If, for a continued dispensing supply, a Pharmaceutical benefit is supplied a number of times greater than the number specified in the prescription, then subject to subsection 51(2) of the National Health (Pharmaceutical Benefits) Regulations 2017  (the regulations), subregulation (3) or (4) of those regulations applies as if:

 

 (a) the person had presented the supplier with a prescription that:

 (i) had been written by a PBS prescriber or RPBS prescriber in accordance with the National Health Act 1953, the regulations and the Scheme; and

 (ii) did not include a medicare number; and

 (iii) did not direct a repeated supply of a Pharmaceutical benefit; and

 (b) subparagraphs (3)(b)(ii) and (c)(ii) or (4)(b)(ii) and (c)(ii), of the regulations, 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), of the regulations, were omitted, and the supplier were required to sign the repeat authorisation form mentioned in paragraph (b).

 (9) A Community 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 continued dispensing supply, however, the pharmacist must not use the form for authorising a repeated supply of the pharmaceutical benefit under this section.

 (10) For a continued dispensing supply a Community Pharmacist is 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 benefits but if it is not practicable for the pharmacist to obtain, from the person a written acknowledgement, the pharmacist must write on the repeat authorisation form for the supply:

 (a) the date on which the Pharmaceutical benefit were supplied by the pharmacist; and

 (b) the reason why it was not practicable for the pharmacist to obtain the written acknowledgement.

16AB  Information about status of person—continued dispensing and medication chart prescriptions

 (1) This section applies in relation to:

 (a) the supply of a Pharmaceutical benefit to a person (the patient) by a Community Pharmacist (the supplier) under subsection 16A (continued dispensing); and

 (b) the supply of a Pharmaceutical benefit by a Community Pharmacist, on the basis of a medication chart prescription written for a person (the patient);

 (2) The supplier must collect the following information at the time of supply:

 (a) information about whether the patient is, at the time of the supply:

 (i) a concessional beneficiary or a dependant of a concessional beneficiary; or

 (ii) the holder of a concession card or entitlement card;

 (b) for a person mentioned in subparagraph (a)(i)—the number specified on a card, issued by the Commonwealth, as an entitlement number (however described) in relation to the person;

 (c) for a person mentioned in subparagraph (a)(ii)—the number of the concession card or entitlement card.

 (3) The supplier must include the information collected under subsection (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 National Health Act 1953.

17  Substitution of lesser priced alternative brand of drug

  Where a valid prescription, issued by a Medical Practitioner, Authorised Nurse Practitioner or Authorised Midwife, prescribes a brand of drug listed on the PBS or RPBS Schedule, a Community Pharmacist may substitute, with the approval of the prescriber, a lesser priced alternative PBS or RPBS listed brand of the drug in lieu of the brand prescribed and shall endorse the original, duplicate and repeat authorisation accordingly.

Note: an RPBS prescriber who is an Authorised Midwife or an Authorised Nurse Practitioner may only prescribe a Pharmaceutical benefit listed on the PBS and a prescription by an Authorised Midwife or an Authorised Nurse Practitioner for a Pharmaceutical benefit that is not available on the PBS is not recognised under the Scheme, even if the Pharmaceutical benefit is available under the Scheme on the prescription of, say, an Approved Medical Practitioner.

18  Community Pharmacist to be satisfied as to entitlement

 (a) A Community Pharmacist shall not supply a Pharmaceutical benefit to a person on terms that are appropriate for the supply of a Pharmaceutical benefit to a holder of a Repatriation Health Card For All Conditions, a Repatriation Health Card For Specific Conditions or a Repatriation Pharmaceutical Benefits Card, unless the Community Pharmacist is satisfied that the person is entitled to receive the Pharmaceutical benefit on those terms.

 (b) Without limiting the generality of subparagraph (a), a Community Pharmacist may refuse to supply a Pharmaceutical benefit to a person on terms that are appropriate for the supply of the Pharmaceutical benefit to a holder of a Repatriation Health Card For All Conditions, a Repatriation Health Card For Specific Conditions or a Repatriation Pharmaceutical Benefits Card, unless the person produces such a card to the Community Pharmacist that indicates that the person is entitled to receive the Pharmaceutical benefit on those terms.

19  Dispensing of deleted items

  Prescriptions, including repeat authorisations, for items deleted from the RPBS Schedule or PBS Schedule may not be dispensed as Pharmaceutical benefits as from the date of effect of deletion, unless the prescriptions for the items comply with Prior Approval arrangements under this Part.

20  Use of forms as notified by the Department or the Commission

  When supplying a Pharmaceutical benefit under this Scheme a Community Pharmacist will use and issue such forms, as are notified by the Department or the Commission from time to time, in the manner notified by the Department or the Commission.

21  Financial responsibility

 (1) In respect of each Pharmaceutical benefit provided to an Eligible Person under this Scheme, the Commission will accept financial responsibility for:

 (a) subject to (b) all of the dispensed price but the copayment that would be payable by the person if the person were a concessional beneficiary; or

Note 1: (a) deems the person to be a concessional beneficiary for the purposes of working out the copayment.

Note 2: copayments not covered by the the MRCA supplement, pension supplement or veterans supplement or war widow/war widower pension may be reimbursed under Part 5A up to the safety net amount for a person.

 

 (b) if the safety net applies to the person, all of the dispensed price.

22  Refund in certain circumstances

  Where:

 (a) a Community Pharmacist charges an Eligible Person an amount in respect of the provision of a Pharmaceutical benefit; and

 (b) information indicating the person’s eligibility under this Scheme was not supplied to the Community Pharmacist; and

 (c) the Commission is satisfied that, in the circumstances, the person should be treated as if the relevant information had been supplied,

  the person is entitled to be paid by the Commonwealth an amount equal to any amount that the person paid that would not have been payable if the relevant information had been supplied.

23  Expenses incurred in obtaining Pharmaceutical Benefits while not in receipt of a pharmaceutical allowance

  Where a person would have been eligible to receive a pharmaceutical allowance under section 300 of the Act during a period, but the Department:

 (a) did not have the information needed to enable the Commission to make payment of the pharmaceutical allowance; and

 (b) has obtained that information since that period; and

  the person:

 

 (c) was not in receipt of that allowance during that period; and

 (d) has incurred expenses in obtaining Pharmaceutical benefits during that period which could be obtained under this Scheme; and

 (e) has provided material which satisfies the Commission that the person has incurred those expenses,

  the Commission may reimburse the person for any or all of those expenses.  The maximum amount which may be reimbursed is the amount that the person would have been entitled to receive by way of pharmaceutical allowance during that period had the Department had the information needed to enable the Commission to make payment of the allowance.

Part 4Claims by Community Pharmacists

24  Lodgement of Claims by Community Pharmacists

  Claims by Community Pharmacists under this Part shall be made in accordance with section 99AAA of the National Health Act 1953 as though references in that section, and in the rules made under that section which relate to the supply of and payment for Pharmaceutical benefits under that Act and its Regulations, were references to the supply of, and payment for, Pharmaceutical benefits, except that:

 (a) prescriptions for the supply of Pharmaceutical benefits under this Part shall be marked in the S section or S sections (as defined in those rules) with one or more serial numbers allotted in respect of each Pharmaceutical benefit commencing at “R1” in each claim and continuing consecutively in respect of that claim;

 (b) these prescriptions shall be collected into one bundle, separate to the four bundles provided for in those rules, with the prescriptions sorted into the order of the serial numbers allocated under subparagraph (a), with the least serial number at the top of the bundle; and

 (c) the information to be provided to the Secretary to the Department that administers the National Health Act 1953, in respect of each supply of a Pharmaceutical benefit shall include a Form Category (within the meaning of the schedule to those rules) with a value of “8” where the Pharmaceutical benefit was supplied on an original authority prescription or “9” where the Pharmaceutical benefit was supplied on a repeat authority prescription, and a Payment Category (within the meaning of that schedule) with a value of “4”.

Note (1): this provision incorporates into the Scheme, among other relevant “National Health Act 1953 requirements” (particularly the requirements in the claims rules made under subsections 98AC(4) and 99AAA(8) of the National Health Act 1953), the requirement for a claimant to include a “supply certification form” with a claim (manual and electronic).

Note (2): if a claim is made electronically, the supply certification form is to be given electronically (claims rules).

Note (3): for electronic claims, prescriptions need not be provided (claims rules).

25  Claims Requirements and Payment

 (1) The payment of a claim under the Scheme is subject to:

 (a) compliance with the Scheme, in particular section 24; and

 (b) submission of a completed supply certification form under the claims rules.

Part 5Payments to Community Pharmacists

26  Payment of Dispensed Price

  The amount payable to a Community Pharmacist for the supply of a Pharmaceutical benefit under the Scheme is the dispensed price.

 

Note: the dispensed price includes a dispensing fee.

30  Fees not payable in some circumstances

  The dispensed price may not be payable to a Community Pharmacist where that person does not satisfy the requirements of paragraph 18 and supplies Pharmaceutical benefits to a person who is not an Eligible Person.

31  Community Pharmacist not entitled to demand or receive payments

  A Community Pharmacist is not entitled to demand of, or receive from, a person in receipt of a Pharmaceutical benefit, payment in money or a valuable consideration for goods and services rendered under this Scheme except:

 (a) for goods or services that are provided in an emergency; or

 (b) for payment of an afterhours fee; or

 (c) for payment for packaging material, postage or freight; or

 (d) for payment that represents the required payment under the PBS of the price difference between the drug prescribed and supplied and the lowest priced brand of the same drug listed on the PBS Schedule; or

 (e) where payment represents the difference between the Commonwealth’s financial responsibility for the provision of the Pharmaceutical benefit and the dispensed price of the Pharmaceutical benefit supplied.

32  Community Pharmacist to issue receipt where certain payments received

  Where a payment is received, under any of subparagraphs 31(a), (b), (c) or (d), from a person in receipt of a Pharmaceutical benefit, the Community Pharmacist is required to issue that person an official receipt which states:

 (a) the goods and/or services provided; and

 (b) the date of receipt of those goods and/or services by the person.

Part 5APharmaceutical Reimbursement

Definitions: 

  In this Part:

member means an Eligible Person eligible for payment of a pharmaceutical reimbursement.

veteran means a person eligible under the Repatriation Pharmaceutical Benefits Scheme for the payment known as the “pharmaceutical reimbursement”.

33

  The Commission may, subject to this Part, accept financial responsibility for the pharmaceutical reimbursement.

Note: if the Commission accepts financial responsibility for a cost in relation to the provision of a Pharmaceutical benefit to an Eligible Person, the Commonwealth pays that cost.

34

  The pharmaceutical reimbursement is a financial amount that would compensate an Eligible Person for outofpocket expenses:

 (a) that the person incurred in respect of a Pharmaceutical benefit provided under this Scheme; or

 (b) that the person incurred in respect of a Pharmaceutical benefit provided other than under this Scheme but provided on or from a date when the Commission accepted liability to provide treatment to the person under the Act.

Note 1: under the Acts Interpretation Act 1901 words in the singular number (e.g. Pharmaceutical benefit) include the plural and words in the plural number include the singular.

Note 2: paragraph (b) covers what are known as “MEPIs” (Medical Expenses Privately Incurred).  Under the Act eligibility for treatment can be backdated for 3 months before a claim for pension is received and treatment costs incurred in that period e.g. copayments for Pharmaceutical benefits, may be met by the Department.

35

  The amount of pharmaceutical reimbursement is worked out under 39.

36  Eligibility for Payment of Pharmaceutical Reimbursement

 (1) To be eligible for payment of the pharmaceutical reimbursement an Eligible Person must:

 (a) have rendered warlike service; and

 (b) be entitled to compensation under section 68 or section 75 of the Act or suffer from a SRCA disability.

Note (1): warlike service is defined in subsection 6(1) of the Act.

Note (2): section 68 is about compensation for a service injury or disease that has resulted in an impairment likely to continue indefinitely and section 75 (interim compensation) is about compensation under section 68 or section 71 where an impairment has not stabilised. 

Note (3): section 69 of the Act generally requires the degree of impairment to be at least 10 impairment points before compensation is payable under s.68 but in certain cases it can be 5.

37  Calculation of annual value of pharmaceutical allowance component of MRCA supplement, pension supplement, veterans supplement

  The annual value of the pharmaceutical allowance is calculated as follows:

 (a) for a member in receipt of the MRCA supplement or veterans supplement at different times throughout the year, the amount of $6 per fortnight, indexed according to section 198F of the Veterans’ Entitlements Act 1986:

 (i) as if the amount of $6 is the dollar amount in subsection 198F(1);

 (ii) since September 2009 (i.e. once annually since 1 January 2010), calculated at a daily rate and valued according to the number of days in the calendar year the MRCA supplement or veterans supplement was payable;

 (b) Subject to (d), for a member in receipt of an income support payment or an income support payment under the Social Security Act 1991 that attracts a pension supplement or a social security pension supplement greater than the basic amount of pension supplement, the amount of $6 per fortnight, indexed according to Division 18 of Part IIIB of the Veterans’ Entitlements Act 1986:

 (i) as if the amount of $6 is an amount of PS rate (pension supplement rate) in Item 1A of the CPI Indexation Table in section 59B;

 (ii) since September 2009 (i.e. each 20 March and 20 September commencing 20 March 2010), calculated at a daily rate and valued according to the number of days in the calendar year pension supplement was payable;

 (c) for a member in receipt of pension supplement, who is a member of a couple and whose partner is a member or veteran50% of the amount in (b).

Note:  “partner” is defined in section 5 of the Act.

 (d) for a member in receipt of pension supplement who is a member of a couple and whose partner does not receive an income support payment or an income support payment under the Social Security Act 1991 that attracts a social security pension supplement greater than the basic amount of pension supplement50% of the amount in (b).

Note: “partner” is defined in section 5 of the Act.

38  Payment of Pharmaceutical Reimbursement

 (1) On and after 1 January 2013 the pharmaceutical reimbursement is payable to a person eligible for it under this Part.

 (2) Subject to (3), the pharmaceutical reimbursement is payable in the first quarter in each calendar year in respect of copayments the person made for a Pharmaceutical benefit under this Scheme in the previous calendar year not being a calendar year before 1 January 2012.

Note 1: calendar year is defined in section 2B of the Acts Interpretation Act 1901.

 (3) The pharmaceutical reimbursement is not payable for a person in the first quarter in a calendar year as mentioned in (2) if the data necessary to calculate the payment for the person is not available to the Department in which case the pharmaceutical reimbursement is payable to the person as soon as practicable after the data is available.

 

38A  Five Year Limit on Payment of Pharmaceutical Reimbursement

 

 (1) Unless the Commission is of the opinion that there are special circumstances, a pharmaceutical reimbursement shall not be paid in respect of copayments incurred by a person more than 5 calendar years before the Commission decision to accept financial responsibility for the pharmaceutical reimbursement for the person.

 (2) If the Commission decides there are special circumstances in relation to a person, then it is to determine a date on and from which copayments are to be counted for the pharmaceutical reimbursement for the person.

 

39  Pharmaceutical Reimbursement Calculator

 (1) The pharmaceutical reimbursement for an Eligible Person is worked out as follows:

  Step 1 add the copayments for the Pharmaceutical benefits incurred by the person in the previous calendar year (sum of copayments) up to the threshold of payments according to the safety net and disregarding any uncounted copayment.

  Step 2 compare the sum of copayments with the sum of the pharmaceutical allowance component of the MRCA supplement, pension supplement, veterans supplement and war widow/war widower pension payable to the person in respect of the previous calendar year.

  Step 3 if the sum of copayments (amount 1) exceeds the sum of the pharmaceutical allowance component of the MRCA supplement, pension supplement, veterans supplement and war widow/war widower pension payable (amount 2), the amount by which amount 1 exceeds amount 2 is the pharmaceutical reimbursement for the person.

Note: the amount of any of these supplements may be zero.

40 

  For the Pharmaceutical Reimbursement Calculator an uncounted copayment is a copayment for a Pharmaceutical benefit where the copayment is not counted for the purposes of the safety net applying to the person.

Note: included here are copayments for Pharmaceutical benefits dispensed under the “Safety Net 20 Day Rule” (subsection 84C(4AA)) of the National Health Act 1953.

Part 5BUnder Copayment Data Collection

40A  Giving information

 (1) A Community Pharmacist who gives information to the Secretary in relation to the supply, under the Scheme, of a Pharmaceutical benefit by the pharmacist to an Eligible Person, is taken to have given that information under, and for the purposes of, the Scheme, provided that:

 (a)  no claim for payment is made by the Community Pharmacist on the Commission or Department for dispensing the Pharmaceutical benefit; and

 (b) the dispensing price of the pharmaceutical benefit is less than, or equal to, the copayment that would have been paid by the Eligible Person for the pharmaceutical benefit if it had been dispensed at a price for which a copayment is payable; and

 (c) the information is given in accordance with the requirements, to the extent applicable, that apply under section 98C of the National Health Act 1953 to an approved supplier giving information to the Secretary in relation to the supply to a person of a pharmaceutical benefit, as if references in section 98C to an approved supplier and a pharmaceutical benefit are references to, respectively, a Community Pharmacist and a Pharmaceutical benefit and the pharmaceutical benefit has been supplied under the Scheme.

Note: a Community Pharmacist includes an Approved Hospital Authority.

Part 6Miscellaneous

41  Standards

 The minimum acceptable standard for a Pharmaceutical benefit is that described in the regulations under the Therapeutic Goods Act 1989 which relate to specific standards for drugs.

Retention of Documents

45  Keeping documentsother than for continued dispensing or medication chart prescriptions

 (1) If a Community Pharmacist supplies a Pharmaceutical benefit, other than a Pharmaceutical benefit that is:

 (a) a dangerous drug (defined below); or

 (b) supplied under section 16A (continued dispensing); or

 (c) supplied on the basis of a medication chart prescription;

  the Community Pharmacist must keep a document specified in subsection (2) that relates to the supply for at least 2 years after the supply.

 (2) For subsection (1), the following documents 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 paperbased prescription—the pharmacist/patient copy and the Medicare Australia/DVA copy; or

 (ii) for an electronic prescription—the electronic prescription, or a copy of the electronic prescription;

 (ab) in the case of supply upon a prescription bearing instructions to supply the Pharmaceutical benefit more than once, if it is supplied on the first occasion on which supply is authorised:

 (i) for a paperbased prescription—the Medicare Australia/DVA copy ; or

 (ii) for an electronic prescription—the electronic prescription, or a copy of the electronic prescription and the repeat authorisation;

 (ac) in the case of supply upon a prescription bearing instructions to supply the Pharmaceutical benefit more than once, if it is supplied other than on the first or last occasion on which supply is authorised:

 (i) for a paperbased prescription—the repeat authorisation for the most recent previous supply; or

 (ii) for an electronic prescription—the electronic prescription, or a copy of the electronic prescription and the repeat authorisation for the most recent previous supply;

 (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 paperbased prescription—the pharmacist/patient copy and the repeat authorisation for the most recent previous supply; or

 (ii) for an electronic prescription—the electronic prescription, or a copy of the electronic prescription and the repeat authorisation for the most recent previous supply;

 

Note: The document may be kept in an electronic form (see subsection 12(2) of the Electronic Transactions Act 1999).

 

 (3) In this section:

dangerous drug means a drug or medicinal preparation in respect of which the law of the State or Territory in which the prescription is written provides that a pharmacist who dispenses that drug or medicinal preparation, or who dispenses it on the last of a number of occasions of supply indicated in a prescription for its supply, must take possession of the prescription and cancel it or deliver it to the authority administering that law.

45A  Keeping documents—continued dispensing

 (1) If a Community Pharmacist supplies a Pharmaceutical benefit to a person under section 16A (continued dispensing), the pharmacist is to keep the following information for at least 2 years from the date on which the Pharmaceutical benefit was supplied by the Community Pharmacist:

 (a) the information that supports the claim for payment made under section 24 (in effect, under section 99AAA of the National Health Act 1953) in relation to the supply of the Pharmaceutical benefit including the repeat authorisation form;

 (b) the information, about the supply of the Pharmaceutical benefit, that is given to the MPBS prescriber who most recently prescribed the Pharmaceutical benefit to the person.

 

Note: The document may be kept in an electronic form (see subsection 12(2) of the Electronic Transactions Act 1999).

 

45B  Keeping documents—medication chart prescriptions

(1) If a Community Pharmacist supplies a Pharmaceutical benefit on the basis of a medication chart prescription, the pharmacist is to keep the medication chart, or a copy of the medication chart on which the Community Pharmacist wrote the details mentioned in 16AA(2)(c) in relation to the prescription, for at least 2 years from the date of supply.

 

Note: The document may be kept in an electronic form (see subsection 12(2) of the Electronic Transactions Act 1999).

 

46  Agreement with the Pharmacy Guild of Australia

  The Commission may enter into agreements concerning the administration of this Part with The Pharmacy Guild of Australia and, subject to this Part, shall abide by such agreements.

47  Transitional provision relating to the Veterans’ Affairs Pharmaceutical Benefits Schemes (Electronic Prescriptions and Active Ingredient Prescribing) Amendment Instrument 2019

 (1) This section applies in relation to a prescription for the supply of a pharmaceutical benefit that is written before 1 February 2021.

 (2) Despite the amendments of section 11A of the MRCA Pharmaceutical Benefits Scheme made by Part 2 of Schedule 2 to the Veterans’ Affairs Pharmaceutical Benefits Schemes (Electronic Prescriptions and Active Ingredient Prescribing) Amendment Instrument 2019, a prescription that is not a medication chart prescription is taken to have been written in accordance with section 11A if the prescription is written in accordance with that section as in force immediately before 31 October 2019.

 (3) Despite the amendments of section 11B of the MRCA Pharmaceutical Benefits Scheme made by Part 2 of Schedule 2 to the Veterans’ Affairs Pharmaceutical Benefits Schemes (Electronic Prescriptions and Active Ingredient Prescribing) Amendment Instrument 2019, a prescription that is a medication chart prescription is taken to have been written in accordance with section 11B if the prescription is written in accordance with that section as in force immediately before 31 October 2019.

Schedule 1 Incorporated documents

 

The following documents are incorporatedbyreference into the Scheme in the form in which they exist from time to time:

          Explanatory Notes

 http://www.pbs.gov.au/info/healthpro/explanatorynotes

         RPBS Explanatory Notes

 https://www.pbs.gov.au/info/browse/rpbs/rpbsexplanatorynotes

         PBS or Pharmaceutical Benefits Scheme

 http://www.pbs.gov.au/browse/publications

         RPBS Schedule

 http://www.pbs.gov.au/browse/rpbs

 Note: “RPBS Schedule” is defined to mean the Repatriation Schedule of Pharmaceutical Benefits which               is further defined.

 

Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Editorial changes

The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.

If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.

If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.

 

Endnote 2—Abbreviation key

ad = added or inserted

o = order(s)

am = amended

Ord = Ordinance

amdt = amendment

orig = original

c = clause(s)

par = paragraph(s)/subparagraph(s)

C[x] = Compilation No. x

    /subsubparagraph(s)

Ch = Chapter(s)

pres = present

def = definition(s)

prev = previous

Dict = Dictionary

(prev…) = previously

disallowed = disallowed by Parliament

Pt = Part(s)

Div = Division(s)

r = regulation(s)/rule(s)

ed = editorial change

reloc = relocated

exp = expires/expired or ceases/ceased to have

renum = renumbered

    effect

rep = repealed

F = Federal Register of Legislation

rs = repealed and substituted

gaz = gazette

s = section(s)/subsection(s)

LA = Legislation Act 2003

Sch = Schedule(s)

LIA = Legislative Instruments Act 2003

Sdiv = Subdivision(s)

(md) = misdescribed amendment can be given

SLI = Select Legislative Instrument

    effect

SR = Statutory Rules

(md not incorp) = misdescribed amendment

SubCh = SubChapter(s)

    cannot be given effect

SubPt = Subpart(s)

mod = modified/modification

underlining = whole or part not

No. = Number(s)

    commenced or to be commenced

 

Endnote 3—Legislation history

 

Number

Registration

Commencement

Application, saving and transitional provisions

2013 No. MRCC44

29 Nov 2013 (F2013L02012)

30 Nov 2013

 

2015 No. R1/MRCC1

30 Mar 2015 (F2015L00376)

1 Apr 2015

s 3, s 4

2015 No. MRCC45

24 Dec 2015 (F2015L02137)

Sch Part A: 25 Dec 2015 (s 2(1) item 2
Sch Part B: 1 Jan 2016 (s 2(1) item 3)

2016 No. R49/MRCC49

06 Dec 2016 (F2016L01872)

 

1 Jan 2017

2017 No. R14/MRCC14

21 June 2017 (F2017L00705)

 

1 July 2017

2017 No. R7/MRCC7

14 December 2017 (F2017L01618)

 

1 January 2018

2018 No. R34/MRCC34

22 June 2018 (F2018L00847)

Sch 2: 1 July 2018 (s 2)

2019 No. R44/MRCC44

30 Oct 2019 (F2019L01387)

Sch 2: 31 Oct 2019 (s 2)

2020 No. R7/MRCC7

13 January 2020

(F2020L00100)

Sch 1: 13 Jan 2020 (s 2)

 

2020 No. R13/MRCC13

18 April 2020

(F2020L00437)

Sch 1: 18 Apr 2020 (s 2)

 

2020 No. R21/MRCC21

17 Aug 2020

(F2020L01026)

Sch 1: 1 Jul 2020 (s 2)

 

 

Endnote 4—Amendment history

 

Provision affected

How affected

s 1B....................

rep LIA s 48D

Part 1

 

s 3.....................

am 2015 No R1/MRCC1; F2015L02137; am F2017L01618; am F2018L00847; am F2019L01387; ed C8; am F2020L00100; am F2020L00437; am F2020L01026

s 4.....................

rs 2015 No R1/MRCC1

Part 2

 

s 7.....................

rs. F2017L01618

s 11....................

am. F2017L01618

s 11AA..................

ad 2015 No. R1/MRCC1; am F2019L01387

s 11A...................

ad 2015 No. R1/MRCC1; am F2017L01618; am F2019L01387

s 11B...................

rs 2015 No. R1/MRCC1; am F2015L02137 am F2019L01387; ed C8; am F2020L01026

s 11C...................

rep 2015 No. R1/MRCC1; ad F2019L01387

s 11D...................

ad F2019L01387

Part 3

 

s 16....................

s 16AAA………………………...

am 2015 No R1/MRCC1; am F2017L01618; am F2020L00437

ad. F2020L00437

s 16AA..................

ad. 2015 No. R1/MRCC1; am F2017L01618

s 16A...................

am. F2017L01618; am. F2020L00100

s 16AB..................

ad. 2015 No. R1/MRCC1

Part 4

 

s 24A...................

rep. 2015 No. R1/MRCC1

s 24....................

am 2015 No. R1/MRCC1

s 24B...................

rep. 2015 No. R1/MRCC1

s 25....................

rs. 2015 No. R1/MRCC1

Part 5

 

s 26....................

rs F2015L02137

s 27....................

rep F2015L02137

s 28....................

rep F2015L02137

s 29....................

rep F2015L02137

s 30....................

am F2015L02137

Part 5A

 

s 37....................

rs. 2015 No. R1/MRCC1

Part 6

 

s 41....................

rs. F2017L01618

s 42....................

rep. F2017L01618

s 43....................

rep. F2017L01618

s 45....................

rs 2015 No. R1/MRCC1; am F2017L01618; am F2019L01387

 

s 45A...................

ad. 2015 No. R1/MRCC1; am. F2017L01618

s 45B...................

ad. 2015 No. R1/MRCC1; am. F2017L01618

s 47....................

ad F2019L01387; am F2020L01026

Schedule 1................

am. 2015 No. R1/MRCC1

 

rs F2015L02137; rs F2017L00705; rs F2017L01618; rs F2018L00847; am F2020L01026