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National Health Act 1953
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Department of Health, Disability and Ageing
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C2022C00298 (C140)
01 October 2022
-
05 December 2022
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Part I—Preliminary
1 Short title
2 Commencement
4 Interpretation
6 Delegation
6A External Territories
7A Application of the Criminal Code
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Part II—National health services
8 Interpretation
9 Provision of certain medical and dental services
9A Provision of medical and surgical aids and appliances etc. by the Commonwealth
9B Provision of vaccines
9C Arrangements with States for provision of surgical aids and appliances etc.
10 Arrangements with other Ministers
11 Arrangements with States
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Part III—Continence Aids Payment Scheme
12 Continence Aids Payment Scheme
13 Secretary or Chief Executive Medicare may request information
14 Reviewing decision whether applicant is eligible for the scheme
15 Reviewing decision whether participant is eligible for the scheme
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Part VII—Pharmaceutical benefits
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Division 1—Preliminary
83Z Repeal and saving
84 Interpretation
84AAA Early supply of a specified pharmaceutical benefit
84AA Concessional benefit prescriptions, concession card prescriptions and entitlement card prescriptions
84A Participating dental practitioners
84AAB Authorised optometrists
84AAC Secretary may suspend or revoke approval of authorised optometrist
84AAD Review of decisions relating to authorised optometrists
84AAE Meaning of eligible midwife
84AAF Authorised midwives
84AAG Secretary may suspend or revoke approval of authorised midwife
84AAH Review of decisions relating to authorised midwives
84AAI Meaning of eligible nurse practitioner
84AAJ Authorised nurse practitioners
84AAK Secretary may suspend or revoke approval of authorised nurse practitioner
84AAL Review of decisions relating to authorised nurse practitioners
84AB Pharmaceutical items
84ABA References to pharmaceutical items, combination items or pharmaceutical benefits having a drug
84AC When listed drug is on F1 or F2
84AE Co marketed brands
84AF Responsible person for a brand of a pharmaceutical item
84AG Therapeutic groups
84AH Exempt items
84AI Rounding amounts
84AJ When pharmaceutical benefits are Schedule equivalent
84AK Quantities of pharmaceutical items
Division 1A—Safety net concession cards and pharmaceutical benefits entitlement cards
84B Family relationships
84BA Supplies of out patient medication
84C Eligibility for concession and entitlement cards
84CA Transferred value
84D Pharmaceutical benefits prescription record forms etc.
84DA Issue of safety net concession card
84E Issue of pharmaceutical benefits entitlement card
84F Form of cards
84G Persons covered by card
84H Additional and replacement cards
84HA Fee to approved pharmacist etc. for issuing card
84J Period of effect of card
84K Return of card
84L Offences
Division 2—Supply of pharmaceutical benefits
85 Pharmaceutical benefits
85AAA Pharmaceutical benefits that can only be supplied under the prescriber bag provisions
85AA Pharmaceutical benefits that can only be supplied under special arrangements
85A Determinations of forms of pharmaceutical benefits or pharmaceutical items with respect to classes of persons
85AB Minister may determine that a listed drug is on F1 or F2
85AD Price agreements
85B Price determinations and special patient contributions
85BA Effect of deemed reductions of, or increases to, approved ex manufacturer price
85C Each brand of a pharmaceutical item is to have the same approved ex manufacturer price
85D Proportional ex manufacturer price
85E Minister may enter into deeds with responsible persons
86 Entitlement to receive pharmaceutical benefits
86A Pharmaceutical benefits not to be supplied in respect of persons reasonably believed not to be in Australia
86B Approved supplier may request provision of medicare number
86C On and after 1 January 2001 approved supplier must request provision of medicare number in certain circumstances
86D Power of approved suppliers to record and retain medicare numbers and expiry dates
86E Minister may determine certain persons to be special evidentiary categories
87 Limited charges for pharmaceutical benefits
87A Entitlement to refund in certain circumstances
88 Prescribing of pharmaceutical benefits
88AA Power of PBS prescribers to record and retain medicare numbers and expiry dates
88A Prescription of certain pharmaceutical benefits authorised only in certain circumstances
89 Pharmaceutical benefits to be supplied only on prescription etc.
89A When pharmaceutical benefits may be supplied by approved pharmacists without prescription
90 Approved pharmacists
90A Minister may substitute decision approving pharmacist
90B Request to Minister to approve pharmacist
90C Circumstances in which request may not be made
90D Provision of further information
90E Effect of decision by Minister to approve pharmacist
91 Application to supply pharmaceutical benefits following the death of approved pharmacist
91A Application to supply pharmaceutical benefits at alternative premises because of disaster or exceptional circumstances
91B Application to supply pharmaceutical benefits if approved pharmacist is bankrupt or external administrator in relation to pharmacy
92 Approved medical practitioners
92A Approvals to be subject to conditions
92B Persons not to enter into certain refund agreements
93 Prescriber bag supplies—medical practitioners
93AA Prescriber bag supplies—authorised midwives
93AB Prescriber bag supplies—authorised nurse practitioners
93A Supply of certain pharmaceutical benefits to patients in private hospitals or aged care facilities
94 Approved hospital authorities
95 Suspension or revocation of approval
98 Cancellation by Secretary of approval of pharmacists etc.
98AA Cancellation by Minister of approval of hospital
98AB Notification by Department of alterations to pharmaceutical benefits scheme
98AC Information about supplies
Division 3—Payment for supply of pharmaceutical benefits
98A Establishment of Pharmaceutical Benefits Remuneration Tribunal
98B Functions of Tribunal
98BA Inquiries by Tribunal
98BAA Tribunal must give effect to certain agreements
98BB Constitution of Tribunal
98BC Procedure of Tribunal
98BD Findings etc. of Tribunal to be made public
98BE Date of operation of determination of the Tribunal
98C Determinations by Minister
98E Secrecy
99 Payment for supply of benefits
99AAA Claim for payment relating to supply of benefits
99AAB Certain suppliers exempted from requirement to use the Claims Transmission System
99AAC Declaration by Secretary exempting approved supplier from using Claims Transmission System
Division 3AA—Recovery of payments for the supply of pharmaceutical benefits
99AA Unauthorised payments etc.
99AB Advances
99ABA Recovery of amounts for false or misleading statements
99ABB Notice to produce documents
99ABC Notice of decision to claim amounts as debts
99ABD Review of decisions to claim amounts as debts
99ABE Liability for administrative penalty
99ABF Amount of administrative penalty
99ABG Notice of administrative penalty and review of assessments
99ABH Power to obtain information relating to a debt
99ABI Amounts recoverable once only
99ABJ Garnishee notices
99ABK Failure to comply with garnishee notice
99ABL Recoverable amounts may be set off
Division 3A—Price reductions
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Subdivision A—Preliminary
99AC What this Division is about
99ACA Definitions etc.
Subdivision B—First new brand price reductions for brands of pharmaceutical items that are not combination items
99ACB First new brand price reductions for brands of pharmaceutical items that are not combination items
99ACBA Ministerial determination—brand of pharmaceutical item that is not a combination item is not a new brand
Subdivision C—Price reductions for combination items
99ACC Price reductions for single brands of combination items
99ACD First new brand price reductions for brands of combination items
99ACEA Ministerial determination—brand of pharmaceutical item that is a combination item is not a new brand
Subdivision D—Other statutory price reductions
99ACF Statutory price reductions
99ACG Other price reductions do not apply if a price disclosure reduction has applied
99ACHA 5% statutory price reduction for drugs on F1—fifth anniversary
99ACHB 5% statutory price reduction for drugs on F1—fifth anniversary
99ACJ 10% statutory price reduction for drugs on F1—tenth anniversary
99ACJA 5% statutory price reduction for drugs on F1—tenth anniversary
99ACK 5% statutory price reduction for drugs on F1—15th anniversary
99ACKA 26.1% statutory price reduction for certain drugs—15th anniversary
99ACKB 30% statutory price reduction for certain drugs—15th anniversary
99ACL Special rule—statutory price reduction for drugs on F1
99ACM 5% statutory price reduction for drugs on F1—tenth anniversary
99ACN Catch up price reduction for certain drugs—15th anniversary
99ACNA Catch up price reduction for certain drugs—meaning of previous price reduction under this Division
99ACP 1.48% statutory price reduction for certain drugs—15th anniversary
Subdivision E—Flow on of first new brand price reductions to existing brands and related brands
99ACQ Flow on of price reductions to existing brands of the same pharmaceutical item
99ACR Flow on of first new brand price reductions to related brands
Division 3B—Price disclosure
Subdivision A—Preliminary
99AD What this Division is about
99ADA Division does not apply to exempt items
99ADB Definitions etc.
99ADBA Meaning of data collection period
Subdivision B—Price disclosure requirements
99ADC The price disclosure requirements
99ADD When the price disclosure requirements apply
Subdivision D—Consequences for failing to comply with the price disclosure requirements
99ADF Offence for failing to comply with the price disclosure requirements
99ADG Other consequences for failing to comply with the price disclosure requirements
Subdivision E—Price reduction
99ADH Price reduction based on information provided under the price disclosure requirements
99ADHA Price reduction for brands listing after end of data collection period
99ADHB Flow on price reductions for brands of combination items
Division 3BA—Floor price of a brand of a pharmaceutical item
99ADHC Floor price of a brand of a pharmaceutical item
99ADHD Meaning of previous data collection period
Division 3C—Guarantee of supply
Subdivision A—Preliminary
99AE What this Division is about
99AEA Definitions
Subdivision B—Guarantee of supply
99AEB Guarantee of supply
Subdivision C—Brands that are guaranteed brands
99AEC Guaranteed brand: new brand
99AED Guaranteed brand: first brand to offer a lower price
Subdivision D—Meaning of fails to supply and unable to supply
99AEE Meaning of fails to supply
99AEF Meaning of unable to supply
Subdivision E—Requirement to notify Minister of failure or inability to supply etc.
99AEG Requirement to notify Minister of failure to supply etc.
Subdivision F—Consequences for guaranteed brands of failure or inability to supply
99AEH Minister’s powers if responsible person fails to supply, or is unable to supply, guaranteed brand
Subdivision G—Consequences for other brands
99AEI Minister may increase approved ex manufacturer price if guaranteed brand delisted
99AEJ Minister may determine drug is on F1 if guaranteed brand delisted
99AEK Minister may revoke or vary formulary determination if guaranteed brand delisted
Division 3CA—Discounts and incentives
99AEL Minister’s powers if responsible person offers discounts or incentives for certain brands of pharmaceutical items
Division 4—Provisions relating to members of the Pharmaceutical Benefits Remuneration Tribunal
99A Terms and conditions of appointment
99B Remuneration and allowances
99C Resignation and removal from office
99D Acting Chairperson
99E Acting additional member
Division 4A—Indexation
99F Definitions
99G Indexation
Division 4B—Australian Community Pharmacy Authority
99H Interpretation
99J Establishment of Authority
99K Functions
99L Determination of rules by Minister
99M Powers
99N Membership
99P Terms and conditions not provided for by this Act
99Q Defective appointment not invalid
99R Remuneration and allowances
99S Leave of absence
99T Disclosure of interests
99U Resignation
99V Termination of appointment
99W Meetings
99X Committees
Division 4C—Cost recovery
Subdivision A—Preliminary
99YB What this Division is about
Subdivision B—Payment of fees etc. for certain services
99YBA Payment of fees etc. for certain services
Subdivision C—Consequences if fees not paid
99YBB Minister may refuse to exercise certain powers if prescribed fees not paid
Subdivision D—Review of cost recovery measures
99YBC Review of impact of cost recovery measures
Division 4D—Export restriction
99ZH Definitions
99ZI Restrictions on carriage or consignment of drug like substances
99ZJ Detention of certain drug like substances being carried out of Australia and retention of related documents
99ZK Detention of certain drug like substances consigned for export and retention of related documents
99ZL Examination and inspection powers
99ZM Detention of some drug like substances and not others
99ZN Treatment of detained substances and retained documents
99ZO Treatment by the Chief Executive Medicare of detained substances and retained documents
99ZP Right of compensation in certain circumstances for substances destroyed
99ZQ Disposal of forfeited substances
99ZR Liability for acts done in good faith
99ZS Guidelines for detention of, dealing with, and disposal of, substances
99ZT Forfeiture of substances detained under section 99ZJ or 99ZK
Division 5—General
100 Special arrangements
100A Establishment and membership of the Pharmaceutical Benefits Advisory Committee
100B Appointment etc. of members of the Pharmaceutical Benefits Advisory Committee
100C Termination of appointment
100D Remuneration
101 Functions of Pharmaceutical Benefits Advisory Committee
101A Sub committees of the Pharmaceutical Benefits Advisory Committee
101B Use of computer programs to take administrative action
102 Testing of drugs
103 Offences
104A Pharmacists to furnish statement of stocks
104B Transitional—price increases on 1 October 2022
105 Regulations
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Part VIIA—Reviews by Administrative Appeals Tribunal
105AA Interpretation
105AB Application for review by Tribunal
105AC Statements to accompany notification of decisions
105AD Application for review by Tribunal of decisions of the Australian Community Pharmacy Authority
105AE Time limits
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Part VIII—Committees of Inquiry
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Division 1—Preliminary
107 Interpretation
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Division 3—Pharmaceutical Services Committees of Inquiry
113 Pharmaceutical Services Federal Committee of Inquiry
114 Functions of Federal Committee
115 Pharmaceutical Services State Committees of Inquiry
116 Functions of State Committee
117 Reports not to relate to conduct of PBS prescribers
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Division 4—Provisions applicable to Committees generally
118 Interpretation
119 Membership of Committees
119A Acting Member
120 Chairperson
120A Vacancies in Committees
121 Procedure of Committees
122 Evidence
123 Proceedings in private
124 Determination of questions at meetings
125 PBS prescriber or pharmacist affected by inquiry to be given notice
126 Summoning of witnesses
127 Committee may examine upon oath or affirmation
128 Failure to attend or produce documents
129 Refusal to be sworn or give evidence
130 Protection of witnesses
131 Allowances to witnesses
132 Protection of members
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Part VIIIA—Data matching
132A Definitions
132B Data matching by the Chief Executive Medicare
132C Secretary may disclose therapeutic goods information to the Chief Executive Medicare
132D Private health insurer may disclose information about hospital or general treatment to the Chief Executive Medicare
132E Breach of provision of this Part is an interference with privacy
132F Data matching principles
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Part VIIIB—COVID 19 vaccines and treatments
132G Provision of COVID 19 vaccines and treatments
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Part IX—Miscellaneous
133 Effect of prosecution for offence
133A Territories
134 Effect of suspension or cancellation of approval or authority
134A Publication of particulars of certain action taken under this Act
134B Time for commencing prosecutions
134C Defence in certain prosecutions
134D Civil penalty provisions
134E Obligations not affected by State or Territory laws
134F Conduct by directors, employees or agents
135 Right of Commonwealth officers to practise
135A Officers to observe secrecy
135AAA Prescribers and approved suppliers must observe secrecy in relation to medicare numbers and expiry dates provided for pharmaceutical benefit scheme purposes
135AA Privacy rules
135AB Breaches of the privacy rules
135AC Authorisation of collection of particular health information
135B Prosecution of offences
136 Committees
136A Filling of vacancies on committees
137 Moneys from which payments under this Act are to be made
138 Exercise of Secretary’s powers subject to directions of Minister
138A Telephone access to offices
139 Judicial notice of signature of Secretary
139A Evidence
139C Information with respect to concessional beneficiaries
140 Regulations
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Endnotes
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
