National Health (Botulinum Toxin Program) Special Arrangement 2011 (No. PB 89 of 2011) (Cth)

Case

National Health (Botulinum Toxin Program) Special Arrangement 2011 (PB 89 of 2011)

made under the

National Health Act 1953

Compilation No. 5

Compilation date:    1 April 2015

Includes amendments up to:            PB 33 of 2015

Registered:   2 April 2015

About this compilation

This compilation

This is a compilation of the National Health (Botulinum Toxin Program) Special Arrangement 2011 (PB 89 of 2011) that shows the text of the law as amended and in force on 1 April 2015 (the compilation date).

This compilation was prepared on 2 April 2015.

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 ComLaw ( 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 ComLaw 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.

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 ComLaw for the compiled law.

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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

Part 1—Preliminary  1

1............ Name of Special Arrangement....................................................................................... 1

2............ Commencement............................................................................................................. 1

3............ Revocation..................................................................................................................... 1

4............ Definitions..................................................................................................................... 1

Part 2—Botulinum toxin pharmaceutical benefits  3

5............ Pharmaceutical benefits covered by this Special Arrangement...................................... 3

6............ Application of Part VII of the Act................................................................................. 3

7............ Responsible person....................................................................................................... 3

8............ No prescriber or prescription......................................................................................... 4

9............ Section 100 only supply................................................................................................ 4

Part 3—Entitlement to botulinum toxin pharmaceutical benefits  5

10.......... Eligible persons............................................................................................................. 5

11.......... Entitlement to botulinum toxin pharmaceutical benefits for treatment of moderate to severe spasticity of the upper limbs in adults following a stroke........................................................................................... 5

12.......... Entitlement to botulinum toxin pharmaceutical benefits for treatment of severe primary axillary hyperhidrosis in patient aged 12 years or more, etc............................................................................................. 7

12A....... Entitlement to botulinum toxin pharmaceutical benefits for treatment of urinary incontinence due to neurogenic detrusor overactivity, as demonstrated by urodynamic study etc................................................. 7

12B....... Entitlement to botulinum toxin pharmaceutical benefits for treatment of chronic migraine       8

12C....... Entitlement to botulinum toxin pharmaceutical benefits for treatment of urinary incontinence due to idiopathic overactive bladder........................................................................................................................... 8

Part 4—Supply of botulinum toxin pharmaceutical benefits  9

13.......... Supply of botulinum toxin pharmaceutical benefits....................................................... 9

14.......... Requests for supply....................................................................................................... 9

15.......... Authorised persons..................................................................................................... 10

Part 5—Administration of botulinum toxin pharmaceutical benefits  11

16.......... Requirements for administering botulinum toxin pharmaceutical benefit under this Special Arrangement               11

17.......... Eligible medical practitioners....................................................................................... 11

17A....... Eligible medical practitioner in relation to chronic migraine......................................... 11

17B....... Eligible medical practitioner in relation to urinary incontinence due to idiopathic overactive bladder       11

18.......... Authorisation of medical practitioners......................................................................... 12

19.......... Notification of result of application............................................................................. 14

20.......... Registered practice locations........................................................................................ 15

21.......... Forms for supply and use of botulinum toxin pharmaceutical benefit under this Special Arrangement    15

22.......... Reporting requirements............................................................................................... 16

23.......... Supplier conditions must be met.................................................................................. 17

Part 6—Claims and payments  18

24.......... How claims are made.................................................................................................. 18

25.......... Payments for supply of botulinum toxin pharmaceutical benefit................................. 18

Part 7—Miscellaneous  19

26.......... Unused vials................................................................................................................ 19

27.......... Changes to provider numbers...................................................................................... 20

28.......... Addresses, telephone and fax numbers for this Special Arrangement......................... 20

Part 8—Transitional arrangements  21

29.......... Claims lodged but not determined, supplies made but not claimed for, etc under old Arrangement         21

Schedule 1—Pharmaceutical benefits to which this Special Arrangement applies and related information  23

Schedule 2—Responsible Person Codes  24

Schedule 3—Treatment Conditions  25

Endnotes28

Endnote 1—About the endnotes  28

Endnote 2—Abbreviation key  29

Endnote 3—Legislation history  30

Endnote 4—Amendment history  31

Part 1—Preliminary

1  Name of Special Arrangement

(1)  This Special Arrangement is the National Health (Botulinum Toxin Program) Special Arrangement 2011.

(2)  This Special Arrangement may also be cited as PB 89 of 2011.

2  Commencement

This Special Arrangement commences on 1 December 2011.

3  Revocation

Instrument PB 122 of 2008 is revoked.

4  Definitions

In this Special Arrangement:

ABN has the same meaning as in the A New Tax System (Australian Business Number) Act 1999.

Act means the National Health Act 1953.

applicant practitioner means a medical practitioner who has applied, under section 18, for authorisation to administer botulinum toxin pharmaceutical benefits, but has not been authorised.

blepharospasm associated with dystonia includes benign blepharospasm and 7th nerve disorders.

botulinum toxin pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.

eligible medical practitioner has the meaning given by section 17.

eligible patient means a person who, under subsection 10(1), is eligible to receive a botulinum toxin pharmaceutical benefit.

medical practitioner has the same meaning as in subsection 3(1) of the Health Insurance Act 1973.

Medicare number means an 11 digit number issued by the Chief Executive Medicare that includes a person’s individual reference number.

moderate to severe spasticity means a rating of at least 3, using the modified Ashworth scale (MAS).

other Special Arrangement means another Special Arrangement under section 100 of the Act.

provider number has the meaning given by regulation 2 of the Health Insurance Regulations 1975.

registered practice location has the meaning given by section 20.

Regulations means the National Health (Pharmaceutical Benefits) Regulations 1960.

specialist has the same meaning as in subsection 3(1) of the Health Insurance Act 1973.

standard management means treatment using physiotherapy or oral spasticity agents, or both.

Note: Terms used in this Special Arrangement have the same meaning as in the Act—see section 13 of the Legislative Instruments Act 2003. These terms include:

·      pharmaceutical benefit

·      pharmaceutical item.

Part 2—Botulinum toxin pharmaceutical benefits

5  Pharmaceutical benefits covered by this Special Arrangement

(1)  This Special Arrangement applies to each botulinum toxin pharmaceutical benefit mentioned in Schedule 1.

(2)  Each botulinum toxin pharmaceutical benefit is a brand of a listed drug mentioned in Schedule 1:

(a)  in the form mentioned in Schedule 1 for the listed drug; and

(b)  with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

Note:          Each listed drug mentioned in Schedule 1 has been declared by the Minister under subsection 85(2) of the Act. The form, manner of administration and brand mentioned in Schedule 1 have been determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively.

  1. Application of Part VII of the Act

(1)  Each botulinum toxin pharmaceutical benefit supplied in accordance with this Special Arrangement is supplied under Part VII of the Act.

(2)  A provision of Part VII of the Act, or of regulations or other instruments made for Part VII of the Act, applies, subject to this Special Arrangement.

Note: See subsection 100(3) of the Act.

7  Responsible person

(1)  If a code is mentioned in the column in Schedule 1 headed ‘Responsible Person’ for a brand of a pharmaceutical item, the person mentioned in paragraph (2)(a) is the responsible person for the brand of the pharmaceutical item.

(2)  For subsection (1):

(a)  the person is the person mentioned in Schedule 2 for the code, with the ABN, if any, mentioned in Schedule 2 for the person; and

(b)  the pharmaceutical item is the listed drug mentioned in Schedule 1:

(i)  in the form mentioned in Schedule 1 for the listed drug; and

(ii)  with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

Note 1:       A person signified by a code in the column headed ‘Responsible Person’ in Schedule 1 has been determined by the Minister, under section 84AF of the Act, to be the responsible person for the brand of the pharmaceutical item.

Note 2:       Each botulinum toxin pharmaceutical benefit mentioned in Schedule 1 is a brand of a pharmaceutical item.

8  No prescriber or prescription

(1)  Subsection 88 (1) of the Act (authorising medical practitioners to prescribe pharmaceutical benefits) does not apply to the supply of a botulinum toxin pharmaceutical benefit under this Special Arrangement.

(2) If a botulinum toxin pharmaceutical benefit is supplied in accordance with this Special Arrangement, regulations 13, 19, 19AA, 21, 21A, 22, 24, 25, 26, 26A, 28 and 31 of the Regulations do not apply to the supply.

(3)  If a botulinum toxin pharmaceutical benefit is supplied in accordance with this Special Arrangement, the following determinations do not apply to the supply:

(a) a determination made under section 88 of the Act about authorised prescribers for the botulinum toxin pharmaceutical benefit;

(b) a determination made under paragraph 85(7)(b) of the Act about the circumstances in which a prescription for the botulinum toxin pharmaceutical benefit may be written;

(c) a determination made under paragraph 85A(2)(a) of the Act about the maximum quantities or number of units of the pharmaceutical item in the botulinum toxin pharmaceutical benefit that may, in one prescription, be directed to be supplied on any one occasion;

(d) a determination made under paragraph 85A(2)(b) of the Act about the maximum number of occasions on which the supply of the botulinum toxin pharmaceutical benefit may, in one prescription, be directed to be repeated.

  1. Section 100 only supply

(1)  If the letter ‘D’ is mentioned in the column in Schedule 1 headed ‘Section 100 only’ for a listed drug, the listed drug may be supplied only in accordance with this Special Arrangement and any other Special Arrangement relating to the listed drug.

(2)  A botulinum toxin pharmaceutical benefit that has a drug mentioned in subsection (1) is not available for general supply on the Pharmaceutical Benefits Scheme.

Note: The Minister has declared, under subsection 85(2A) of the Act, that the listed drug can only be supplied under a section 100 Special Arrangement.

Part 3—Entitlement to botulinum toxin pharmaceutical benefits

10  Eligible persons

(1)  Subject to sections 11, 12, 12A, 12B and 12C, a person is eligible to receive a botulinum toxin pharmaceutical benefit under this Special Arrangement if:

(a)  either:

(i)  the person holds a Medicare Card; or

(ii)  if the person is a dependent child—the parent or guardian of the child holds a Medicare Card; and

(b)  the person is an Australian resident; and

(c)  the person is diagnosed with a condition mentioned for the botulinum toxin pharmaceutical benefit in the column in Schedule 3 headed ‘Treatment Condition’, by a medical practitioner who has one or more of the specialist qualifications mentioned in the column in Schedule 3 headed ‘Specialist Qualifications’ for the condition; and

(d)  the person is not being treated in a public hospital.

(2)  For paragraph (1)(d), a person is not being treated in a public hospital if, at the time of treatment:

(a)  the person is a day patient; or

(b)  the person has been admitted for less than 24 hours.

(3)  A botulinum toxin pharmaceutical benefit supplied and administered under this Special Arrangement is to be supplied and administered to the eligible patient without payment or other consideration.

(4) Section 87 of the Act does not apply to the supply of a botulinum toxin pharmaceutical benefit under this Special Arrangement.

(5)  In this section:

Australian resident has the same meaning as in the Health Insurance Act 1973.

11  Entitlement to botulinum toxin pharmaceutical benefits for treatment of moderate to severe spasticity of the upper limbs in adults following a stroke

(1)  This section applies to eligible patients receiving treatment for moderate to severe spasticity of the upper limbs in adults following a stroke:

(a)  as second line therapy when standard management has failed; or

(b)  as an adjunct to physical therapy.

(2)  The maximum number of treatment periods of botulinum toxin pharmacecutical benefits a person mentioned in subsection (1) is eligible to receive is 4 (total Botulinum Toxin Type A Purified Neurotoxin Complex, Clostridium Botulinum Type A Toxin-Haemagglutinin Complex and IncobotulinumtoxinA) per upper limb per lifetime.

(3)  A person mentioned in subsection (1) is not eligible to receive a botulinum toxin pharmaceutical benefit under this Special Arrangement, for treatment to an upper limb, if the person has previously received the maximum number of treatment periods of botulinum toxin pharmaceutical benefits mentioned in subsection (2) to the same upper limb.

(4)  A person mentioned in subsection (1) who has been diagnosed with a stroke is not eligible to receive a botulinum toxin pharmaceutical benefit under this Special Arrangement unless:

(a)  the person does not have established severe contracture; and

(b)  at least 3 months have elapsed since the person was diagnosed with the stroke.

(5)  A person mentioned in subsection (1) is not eligible to receive a botulinum toxin pharmaceutical benefit under this Special Arrangement if:

(a)  after 2 treatment periods with botulinum toxin pharmaceutical benefit, (total Botulinum Toxin Type A Purified Neurotoxin Complex, Clostridium Botulinum Type A Toxin-Haemagglutinin Complex and IncobotulinumtoxinA) per upper limb the person has not responded to the treatment; or

(b)  the person demonstrates:

(i)  established severe contracture; or

(ii)  a known sensitivity to any of the following drugs:

(A)  Botulinum Toxin Type A Purified Neurotoxin Complex;

(B)  Clostridium Botulinum Type A Toxin‑Haemagglutinin Complex;

(C)  IncobotulinumtoxinA

(6)  However, a person to whom subparagraph (4)(b)(ii) applies is eligible to receive a botulinum toxin pharmaceutical benefit under this Special Arrangement if an eligible medical practitioner considers that it is appropriate to treat the patient with a botulinum toxin pharmaceutical benefit, despite the known sensitivity.

(7)  A person to whom subparagraph 11(5)(a) applies is considered to have not responded to the treatment if the person has not had a decrease in spasticity rating of greater than 1, using the modified Ashworth scale (MAS), in at least one joint.

12  Entitlement to botulinum toxin pharmaceutical benefits for treatment of severe primary axillary hyperhidrosis in patient aged 12 years or more, etc

(1)  This section applies to eligible patients receiving treatment for severe primary axillary hyperhidrosis if:

(a)  the patient is aged 12 years or more; and

(b)  after a period of treatment with topical aluminium chloride hexahydrate:

(i)  the person demonstrates an intolerance to topical aluminium chloride hexahydrate; or

(ii)  the person has not responded to the treatment.

(2)  A person mentioned in subsection (1) is not eligible to receive a botulinum toxin pharmaceutical benefit under this Special Arrangement if the person has been treated with a botulinum toxin pharmaceutical benefit:

(a)  for 3 treatment periods in the 12 month period preceding the proposed treatment; or

(b)  in the 4 month period preceding the proposed treatment.

12A  Entitlement to botulinum toxin pharmaceutical benefits for treatment of urinary incontinence due to neurogenic detrusor overactivity, as demonstrated by urodynamic study etc

(1)  This section applies to eligible patients receiving treatment of urinary continence due to neurogenic detrusor overactivity, as demonstrated by urodynamic study in patients who have

(a)  multiple sclerosis, or

(b)  a spinal cord injury, or

(c)  who are 18 years or older and have spina bifida.

(2)  A person mentioned in subsection (1) is not eligible to receive a botulinum toxin pharmaceutical benefit under this Special Arrangement unless:

(a)  the condition is inadequately controlled by anti‑cholinergic therapy,

(b)  the person has experienced at least 14 episodes of urinary incontinence per week prior to commencement of treatment with a botulinum toxin pharmaceutical benefit, and

(c)  the person is willing and able to self‑catheterise.

(3)  A person mentioned in subsection (1) is not eligible to receive a botulinum toxin pharmaceutical benefit under this Special Arrangement if the person does not achieve a 50% or greater reduction from baseline in urinary incontinence episodes 6‑12 weeks after the first treatment.

12B  Entitlement to botulinum toxin pharmaceutical benefits for treatment of chronic migraine

(1)  This section applies to eligible patients receiving treatment for chronic migraine who:

(a)  are aged 18 years or more, and

(b)  have experienced an average of 15 or more headache days per month, with at least 8 days of migraine, over a period of at least 6 months, prior to commencement of treatment with a botulinum toxin pharmaceutical benefit, and

(c)  have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications prior to commencement of treatment with a botulinum toxin pharmaceutical benefit; and

(d)  have been appropriately managed for medication overuse headache by their medical practitioner prior to treatment with botulinum toxin pharmaceutical benefit.

(2)  A person mentioned in subsection (1) is not eligible to receive a botulinum toxin pharmaceuetical benefit under this Special Arrangement if the person does not achieve and maintain a 50% or greater reduction from baseline in the number of headache days per month after two treatment cycles (each of 12 weeks duration).

12C  Entitlement to botulinum toxin pharmaceutical benefits for treatment of urinary incontinence due to idiopathic overactive bladder

(1)  This section applies to eligible patients receiving treatment of urinary incontinence due to idiopathic overactive bladder who:

(a)  are aged 18 years or more; and

(b)  are willing and able to self‑catheterise; and

(c)  have experienced at least 14 episodes of urinary incontinence per week prior to commencement of treatment with a botulinum toxin pharmaceutical benefit; and

(d)  have been inadequately controlled by therapy involving at least two alternative anti‑cholinergic agents.

(2)  A person mentioned in subsection (1) is not eligible to receive a botulinum toxin pharmaceuetical benefit under this Special Arrangement if the person does not achieve a 50% or greater reduction from baseline in urinary incontinence episodes 6‑12 weeks after the first treatment.

Part 4—Supply of botulinum toxin pharmaceutical benefits

13  Supply of botulinum toxin pharmaceutical benefits

(1)  A responsible person must supply a botulinum toxin pharmaceutical benefit to an eligible medical practitioner under this Special Arrangement if:

(a)  a request for supply of the botulinum toxin pharmaceutical benefit has been made by the eligible medical practitioner, or an authorised person, under section 14, for the treatment of an eligible patient; and

(b)  because of the request, the Chief Executive Medicare has placed an order for the botulinum toxin pharmaceutical benefit with the responsible person.

(2)  If botulinum toxin pharmaceutical benefit is supplied under subsection (1), the eligible medical practitioner, or a person authorised by the eligible medical practitioner to take delivery of botulinum toxin pharmaceutical benefits on behalf of the registered practice location at which the botulinum toxin pharmaceutical benefit was supplied, must sign any documents relating to the delivery of the botulinum toxin pharmaceutical benefit.

14  Requests for supply

(1)  A request for the supply of a botulinum toxin pharmaceutical benefit, for the treatment of an eligible patient, under this Special Arrangement may be made to the Chief Executive Medicare by mail, fax or telephone to the address, fax number or telephone number mentioned in section 28.

(2)  A request for supply under subsection (1) must:

(a)  be made by:

(i)  an eligible medical practitioner; or

(ii)  an authorised person; and

(b)  contain sufficient information to enable the Chief Executive Medicare to determine that the medical practitioner who makes the request is an eligible medical practitioner.

(3)  If the Chief Executive Medicare receives a request under subsection (1) and is satisfied about the matters mentioned in subsection (2), the Chief Executive Medicare must place an order with the responsible person for the botulinum toxin pharmaceutical benefit that is requested.

(4)  An eligible medical practitioner must not request the supply of a botulinum toxin pharmaceutical benefit under this Special Arrangement by making a request to a responsible person.

(5)  In this section:

authorised person means a person authorised by an eligible medical practitioner, under section 15, to send a request for supply.

15  Authorised persons

(1)  An eligible medical practitioner may authorise another person who is employed or engaged at the eligible medical practitioner’s registered practice location to send a request under subsection 14(1).

(2)  An eligible medical practitioner may authorise one or more persons for each of the eligible medical practitioner’s registered practice locations.

(3)  An authority under subsection (1) must:

(a)  be in writing; and

(b)  be signed by the eligible medical practitioner; and

(c)  for each provider number, mention the registered practice location at which the eligible medical practitioner will administer the botulinum toxin pharmaceutical benefit; and

(d)  be in the form published on the Medicare website; and

(e)  be sent to the Chief Executive Medicare, by mail or by fax.

Part 5—Administration of botulinum toxin pharmaceutical benefits

16  Requirements for administering botulinum toxin pharmaceutical benefit under this Special Arrangement

A botulinum toxin pharmaceutical benefit to which this Special Arrangement applies may only be administered:

(a)  to an eligible patient; and

(b)  in relation to a condition mentioned for the botulinum toxin pharmaceutical benefit in the column in Schedule 3 headed ‘Treatment Condition’; and

(c)  by a medical practitioner who is an eligible medical practitioner for the condition.

17  Eligible medical practitioners

For this Special Arrangement, a medical practitioner is an eligible medical practitioner for a condition mentioned for a botulinum toxin pharmaceutical benefit in the column in Schedule 3 headed ‘Treatment Condition’ if the medical practitioner:

(a)  holds a specialist qualification mentioned in the column in Schedule 3 headed ‘Specialist Qualifications’ for the condition; and

(b)  has been authorised by the Chief Executive Medicare, under section 18, to administer a botulinum toxin pharmaceutical benefit for the condition, under this Special Arrangement; and

(c)  has provided to the Chief Executive Medicare a written undertaking to comply with the requirements of this Special Arrangement.

17A  Eligible medical practitioner in relation to chronic migraine

A medical practitioner who has the specialist qualification of neurology and is an eligible medical practitioner in relation to any condition mentioned in Schedule 3 other than chronic migraine, is taken to be an eligible medical practitioner in relation to chronic migraine.

17B  Eligible medical practitioner in relation to urinary incontinence due to idiopathic overactive bladder

A medical practitioner who has the specialist qualification of urology or urogynaecology and is an eligible medical practitioner in relation to any condition mentioned in Schedule 3 other than urinary incontinence due to idiopathic overactive bladder, is taken to be an eligible medical practitioner in relation to urinary incontinence due to idiopathic overactive bladder.

18  Authorisation of medical practitioners

(1)  A medical practitioner may apply to the Chief Executive Medicare for authorisation to administer botulinum toxin pharmaceutical benefits under this Special Arrangement for a treatment condition mentioned in the column in Schedule 3 headed ‘Treatment Condition’.

(2)  The application must be in writing and must set out the following information:

(a)  the treatment condition or conditions for which the applicant practitioner wants to be authorised;

(b)  evidence of the applicant practitioner’s specialist qualifications;

(c)  evidence of the applicant practitioner’s training in the use of botulinum toxin pharmaceutical benefits, including evidence of supervision and the names of the patients treated under supervision;

(d)  for an applicant practitioner who has been trained overseas:

(i)  evidence of the training received by the applicant practitioner in the use of botulinum toxin pharmaceutical benefits; and

(ii)  a letter of support, stating the applicant practitioner’s experience in the use of botulinum toxin pharmaceutical benefits from:

(A)  an eligible medical practitioner; or

(B)  the responsible person for a botulinum toxin pharmaceutical benefit that has the same listed drug as is listed in the column in Schedule 3 headed ‘Listed Drug in Relevant Pharmaceutical Benefit’ for a condition that the applicant practitioner seeks to be authorised to administer botulinum toxin pharmaceutical benefits;

(3)  Unless subsection (4), (5), (6), (7) or (8) applies, for paragraph 2(c), evidence of the applicant practitioner’s training must be in the form of:

(a)  a letter from a person who is an eligible medical practitioner for this arrangement, stating that the applicant practitioner has been:

(i)  involved in at least 20 procedures administering a botulinum toxin pharmaceutical benefit; and

(ii)  the primary operator, under supervision, in at least 10 procedures administering a botulinum toxin pharmaceutical benefit; or

(b)  a letter from the responsible person for a botulinum toxin pharmaceutical benefit that has the same listed drug as is listed in the column in Schedule 3 headed ‘Listed Drug in Relevant Pharmaceutical Benefit’ for a condition that the applicant practitioner seeks to be authorised to administer botulinum toxin pharmaceutical benefits, stating that the applicant practitioner has been:

(i)  involved in at least 20 procedures administering a botulinum toxin pharmaceutical benefit; and

(ii)  the primary operator, under supervision, in at least 10 procedures administering a botulinum toxin pharmaceutical benefit.

(4)  If an applicant practitioner is a specialist in ophthalmology and seeks authorisation to administer botulinum toxin pharmaceutical benefits, under this Special Arrangement, for the treatment of blepharospasm or hemifacial spasm in a patient 12 years or older and/or the treatment of blepharospasm or hemifacial spasm in an adult, the applicant practitioner must:

(a)  have been trained by a specialist in ophthalmology in the administration of botulinum toxin pharmaceutical benefits to treat blepharospasm or hemifacial spasm; and

(b)  provide evidence of the applicant practitioner’s training, in the form of:

(i)  a letter from a person who is an eligible medical practitioner for this Special Arrangement, stating that the applicant practitioner has been the primary operator, under supervision, in at least 2 procedures administering a botulinum toxin pharmaceutical benefit; or

(ii)  a letter from the responsible person for a botulinum toxin pharmaceutical benefit that has the same listed drug as is listed in the column in Schedule 3 headed ‘Listed Drug in Relevant Pharmaceutical Benefit’ for the treatment conditions numbered 1 and/or 1A and/or 1B, stating that the practitioner has been the primary operator, under supervision, in at least 2 procedures administering a botulinum toxin pharmaceutical benefit.

(5)  If an applicant practitioner is a specialist in neurology, otolaryngology head and neck surgery or plastic surgery and seeks authorisation to administer a botulinum toxin pharmaceutical benefit, under this Special Arrangement, for the treatment of blepharospasm or hemifacial spasm in a patient 12 years or older and/or the treatment of blepharospasm or hemifacial spasm in an adult, the applicant practitioner must:

(a)  have been trained by a specialist in the same specialty as the applicant practitioner in the administration of botulinum toxin pharmaceutical benefits to treat blepharospasm or hemifacial spasm; and

(b)  provide evidence of the applicant practitioner’s training in the form of the following:

(i)  a letter from a person who is an eligible medical practitioner for this Special Arrangement, stating that the applicant practitioner has been the primary operator, under supervision, in at least 6 procedures administering a botulinum toxin pharmaceutical benefit;

(ii)  a letter from the responsible person for a botulinum toxin pharmaceutical benefit that has the same listed drug as is listed in the column in Schedule 3 headed ‘Listed Drug in Relevant Pharmaceutical Benefit’ for the treatment conditions numbered 1 and/or 1A and/or 1B, stating that the applicant practitioner has been the primary operator, under supervision, in at least 6 procedures administering a botulinum toxin pharmaceutical benefit.

(6)  If an applicant practitioner is a specialist in urology or urogynaecology and seeks authorisation to administer a botulinum toxin pharmaceutical benefit, under this Special Arrangement, for the treatment of urinary incontinence due to neurogenic detrusor overactivity, as demonstrated by urodynamic study for patients with multiple sclerosis, spinal cord injury or who are 18 years or older and have spina bifida, the applicant practitioner must provide evidence of successful training in the form of:

(a)  a Statutory Declaration outlining their involvement in at least 10 procedures administering botulinum toxin for the treatment of urinary incontinence, including the number performed under supervision; or

(b)  a written statetment from the provider of a course of training relating to the administration of botulinum toxin for the treatment of urinary incontinence, noting that this may have been completed overseas.

(7)  If an applicant practitioner is a specialist in neurology and seeks authorisation to administer a botulinum toxin pharmaceutical benefit, under this Special Arrangement, for the treatment of chronic migraine, the applicant practitioner must:

(a)  provide a statement that confirms the applicant practitioner has been:

(i)  involved in at least 10 unsupervised procedures administering a botulinum pharmaceutical benefit; or

(ii)  the primary operator, under supervision, in at least 6 procedures in administering botulinum toxin for chronic migraine; or

(iii)  provide a letter from a person who is an eligible medical practitioner for this Special Arrangement, stating that the applicant practitioner has been the primary operator, under supervision in at least 6 procedures, administering botulinum toxin pharmaceutical benefit for chronic migraine; and

(b)  provide a letter from the responsible person stating the applicant practitioner’s experience and/or training in administering a botulinum toxin pharmaceutical benefit for chronic migraine.

(8)  If an applicant practitioner is a specialist in urology or urogynaecology and seeks authorisation to administer a botulinum toxin pharmaceutical benefit, under this Special Arrangement, for the treatment of urinary incontinence due to idiopathic overactive bladder, the applicant practitioner must provide evidence of successful training in the form of:

(a)  a Statutory Declaration outlining their involvement in at least 10 procedures administering botulinum toxin for the treatment of urinary incontinence, including the number performed under supervision; or

(b)  a written statetment from the provider of a course of training relating to the administration of botulinum toxin for the treatment of urinary incontinence, noting that this may have been completed overseas.

19  Notification of result of application

If an applicant practitioner makes an application under section 18, the Chief Executive Medicare must:

(a)  decide whether or not to grant the application; and

(b)  within 28 days of deciding whether or not to grant the application—notify the applicant practitioner, in writing:

(i)  whether or not the application has been granted; and

(ii)  if the application has been granted, the treatment conditions for which the applicant practitioner has been authorised to administer botulinum toxin pharmaceutical benefits.

20  Registered practice locations

(1)  An eligible medical practitioner is authorised to administer botulinum toxin pharmaceutical benefits to eligible patients under this Special Arrangement only at a registered practice location.

(2)  An eligible medical practitioner may have more than one registered practice location.

(3)  For this Special Arrangement:

registered practice location, for an eligible medical practitioner, means an address for which the eligible medical practitioner has a provider number.

21  Forms for supply and use of botulinum toxin pharmaceutical benefit under this Special Arrangement

(1)  An eligible medical practitioner must not administer a botulinum toxin pharmaceutical benefit under this Special Arrangement unless the eligible medical practitioner has completed, for each administration of a botulinum toxin pharmaceutical benefit, a Patient Usage Form.

(2)  The Patient Usage Form must be signed by:

(a)  the eligible medical practitioner; and

(b)  either:

(i)  the patient; or

(ii)  if the patient is not able to sign the form—the patient’s agent; or

(iii)  if the patient is aged less than 16 years—the patient’s parent or legal guardian.

(3)  The Patient Usage Form must contain the following information:

(a)  the date that the botulinum toxin pharmaceutical benefit was administered;

(b)  the patient’s Medicare number;

(c)  the patient’s full name;

(d)  a form of agreement to receive the treatment, given by:

(i)  the patient; or

(ii)  if the patient is not able to sign the form—the patient’s agent; or

(iii)  if the patient is aged less than 16 years—the patient’s parent or legal guardian;

(e)  the botulinum toxin pharmaceutical benefit administered;

(f)  the quantity of the botulinum toxin pharmaceutical benefit administered;

(g)  the remaining number of vials of the botulinum toxin pharmaceutical benefit held by the eligible medical practitioner;

(h)  the condition for which the botulinum toxin pharmaceutical benefit was administered;

(i)  evidence of:

(i)  the registered practice location at which the botulinum toxin pharmaceutical benefit was administered; and

(ii)  the full name and address of the eligible medical practitioner who administered the botulinum toxin pharmaceutical benefit;

(j)  the provider number of the eligible medical practitioner who administered the botulinum toxin pharmaceutical benefit to the patient.

(4)  An eligible medical practitioner must not administer a botulinum toxin pharmaceutical benefit under this Special Arrangement to an eligible patient unless, before the first administration of the botulinum toxin pharmaceutical benefit in a treatment period, a Patient Acknowledgment Form has been completed and signed by:

(a)  the eligible medical practitioner; and

(b)  either:

(i)  the patient; or

(ii)  if the patient is not able to sign the form—the patient’s agent; or

(iii)  if the patient is aged less than 16 years—the patient’s parent or legal guardian.

Note:          The Patient Usage Form and the Patient Acknowledgment Form can be obtained from the Medicare website.

22  Reporting requirements

(1)  At the end of each treatment period for an eligible patient, the eligible medical practitioner must give to the Chief Executive Medicare for verification the following:

(a)  the completed and signed Patient Acknowledgment Form;

(b)  for each administration of botulinum toxin pharmaceutical benefit in the treatment period—the completed and signed Patient Usage Form.

(2)  After the end of a treatment period, an eligible medical practitioner must not request the further supply of a botulinum toxin pharmaceutical benefit for the treatment of the eligible patient under this Special Arrangement unless:

(a)  the requirements of subsection (1) have been met; and

(b)  the Chief Executive Medicare has verified that the requirements of this Special Arrangement have been complied with for any botulinum toxin pharmaceutical benefit supplied to the eligible medical practitioner for the treatment of the eligible patient under this Special Arrangement.

23  Supplier conditions must be met

If an eligible medical practitioner is supplied with a botulinum toxin pharmaceutical benefit under this Special Arrangement, the eligible medical practitioner must comply with any conditions notified, by the responsible person, for the management and storage of the botulinum toxin pharmaceutical benefit.

Part 6—Claims and payments

24  How claims are made

(1)  If a responsible person supplies a botulinum toxin pharmaceutical benefit to an eligible medical practitioner under this Special Arrangement, the responsible person may make a claim for payment for the supply by sending to the Chief Executive Medicare, within 7 days after the supply:

(a)  an invoice; and

(b)  any documents, signed in accordance with the requirements of subsection 13(2), relating to the delivery of the botulinum toxin pharmaceutical benefit to the eligible medical practitioner during the treatment period.

(2)  The invoice must be endorsed with the words ‘Medicare reimbursable’.

(3)  The invoice may be sent to the Chief Executive Medicare by mail or by fax to the address or fax number mentioned in section 28.

25  Payments for supply of botulinum toxin pharmaceutical benefit

(1)  If the requirements of subsection (2) have been met, a responsible person who makes a claim for payment under subsection 24(1) is entitled to be paid the ex‑manufacturer price for the botulinum toxin pharmaceutical benefit.

(2)  The Chief Executive Medicare may only make a payment for the supply of a botulinum toxin pharmaceutical benefit in a treatment period if the Chief Executive Medicare has:

(a)  received, from the eligible medical practitioner, the documents mentioned in subsection 22(1); and

(b)  received, from the responsible person for the botulinum toxin pharmaceutical benefit supplied to the eligible medical practitioner, the documents mentioned in subsection 24(1); and

(c)  verified that the botulinum toxin pharmaceutical benefit has been supplied in accordance with the requirements of this Special Arrangement.

Part 7—Miscellaneous

26  Unused vials

(1)  If a vial of a botulinum toxin pharmaceutical benefit from a supply ordered for the treatment of an eligible patient remains unused at the conclusion of the eligible patient’s treatment period, the vial is to be used when the eligible medical practitioner next treats eligible patients under this Special Arrangement.

(2)  However, subject to subsections (3) and (4), an eligible medical practitioner may hold a small quantity of botulinum toxin pharmaceutical benefits for the treatment of a condition mentioned in Schedule 3, under this Special Arrangement, in an emergency situation.

(3)  An eligible medical practitioner who is authorised, under this Special Arrangement, to administer a botulinum toxin pharmaceutical benefit that has the listed drug Botulinum Toxin Type A Purified Neurotoxin Complex to treat a treatment condition mentioned in the column in Schedule 3 headed ‘Treatment Condition’ must not hold more than 5 vials of a botulinum toxin pharmaceutical benefit that has the listed drug Botulinum Toxin Type A Purified Neurotoxin Complex.

(4)  An eligible medical practitioner who is authorised, under this Special Arrangement, to administer a botulinum toxin pharmaceutical benefit that has the listed drug Clostridium Botulinum Type‑A Toxin‑Haemagglutinin Complex to treat a treatment condition numbered 2, 3, 4 or 7 in the column in Schedule 3 headed ‘Treatment Condition Number’ must not hold more than 5 vials of a botulinum toxin pharmaceutical benefit with the Clostridium Botulinum Type A Toxin–Haemagglutinin Complex drug.

(5)  An eligible medical practitioner who is authorised, under this Special Arrangement, to administer a botulinum toxin pharmaceuctical benefit that has the listed drug IncobotulinumtoxinA to treat a treatment condition numbered 1B, 4A or 7 in the column in Schedule 3 headed ‘Treatment Condition Number’ must not hold more than 5 vials of a botulinum toxin pharmaceutical benefit with the IncobotulinumtoxinA drug.

(6)  The Chief Executive Medicare must not arrange, or pay for, the replacement of vials of a botulinum toxin pharmaceutical benefit that have expired or have been lost or damaged.

(7)  An eligible medical practitioner must notify the Chief Executive Medicare by telephone, on the number mentioned in section 28, before transferring vials of a botulinum toxin pharmaceutical benefit that have been supplied under this Special Arrangement to another eligible medical practitioner.

(8)  A vial of a botulinum toxin pharmaceutical benefit supplied under this Special Arrangement must not be transferred to a medical practitioner who is not an eligible medical practitioner.

(9)  If an eligible medical practitioner (the first eligible medical practitioner) sends a botulinum toxin pharmaceutical benefit to another registered practice location, or to another eligible medical practitioner, the first eligible medical practitioner is responsible for ensuring that, during transit, the botulinum toxin pharmaceutical benefit is handled and stored in accordance with handling and storage conditions advised by the responsible person.

(10)  The Chief Executive Medicare must not arrange, or pay, for replacement of any vial of a botulinum toxin pharmaceutical benefit that is lost or damaged during relocation.

27  Changes to provider numbers

(1)  If the Chief Executive Medicare issues an eligible medical practitioner with a new or additional provider number, under which the eligible medical practitioner intends to administer botulinum toxin pharmaceutical benefits under this Special Arrangement, the eligible medical practitioner, or a person authorised under section 15, must notify the Chief Executive Medicare of the new or additional provider number.

(2)  The Chief Executive Medicare must not place an order for supply of a botulinum toxin pharmaceutical benefit under this Special Arrangement with a responsible person for a provider number that has been changed unless the Chief Executive Medicare has previously been told of the new provider number, under subsection (1).

28  Addresses, telephone and fax numbers for this Special Arrangement

(1)  For this Special Arrangement, the address to be used when giving material to the Chief Executive Medicare is:

Botulinum Toxin Program

Complex Programs

Department of Human Services – Medicare

GPO Box 9826

HOBART TAS 7001

(2)  For this Special Arrangement, the telephone number to be used when giving information to the Chief Executive Medicare by telephone is 1800 700 270.

(3)  For this Special Arrangement, the fax number to be used when giving material to the Chief Executive Medicare by fax is 1300 154 190.

Part 8—Transitional arrangements

29  Claims lodged but not determined, supplies made but not claimed for, etc under old Arrangement

(1)  A claim for payment that was lodged, but a decision on whether or not to pay the claim was not made, under the old Arrangement is, after the commencement of this Special Arrangement, taken to be a claim made, and may be processed, under this Special Arrangement.

(2)  A supply of a pharmaceutical benefit that was made under the old Arrangement, but for which no claim has been lodged, prior to the commencement of this Special Arrangement is, after the commencement of this Special Arrangement, taken to be a supply made under this Special Arrangement.

(3)  A medical practitioner who was a registered medical practitioner under the old Arrangement for a condition is, after the commencement of this Special Arrangement, taken to be an eligible medical practitioner under this Special Arrangement for the treatment condition in Schedule 3 that corresponds most closely with that condition.

Note:          As the medical practitioner is taken to be an eligible medical practitioner under this Special Arrangement, they are not required, under paragraph 17(c) of this Special Arrangement, to submit a new undertaking.

(4)  An application for authorisation of a medical practitioner to administer pharmaceutical benefits that was lodged, but not finally determined, under the old Arrangement is, after the commencement of this Special Arrangement, taken to be an application made, and may be processed, under this Special Arrangement.

(5)  A person who was authorised under the old Arrangement to request the supply of a pharmaceutical benefit on behalf of a registered medical practitioner (the medical practitioner) is, after the commencement of this Special Arrangement, taken to be authorised to request the supply of a pharmaceutical benefit, on behalf of the medical practitioner, as an eligible medical practitioner, under this Special Arrangement.

(6)  A request for supply of a pharmaceutical benefit made under the old Arrangement is, after the commencement of this Special Arrangement, taken to be a request for supply made, and may be processed, under this Special Arrangement.

(7)  An order made by the Chief Executive Medicare under the old Arrangement for the supply of a pharmaceutical benefit is, after the commencement of this Special Arrangement, taken to be an order made, and may be processed, under this Special Arrangement.

(8)  A Patient Usage Form or Patient Acknowledgement Form that has been provided to the Chief Executive Medicare by a registered medical practitioner (the medical practitioner) under the old Arrangement is, after the commencement of this Special Arrangement, taken to have been provided to the Chief Executive Medicare, by the medical practitioner, as an eligible medical practitioner, under this Special Arrangement.

(9)  A location that is a registered practice location for the old Arrangement is taken to be a registered practice location for this Special Arrangement.

(10)  For the processing of an application, claim, order or request, or for the supply of a pharmaceutical benefit, under this Part, a reference in the old Arrangement to a special pharmaceutical product is taken to be a reference to a pharmaceutical benefit.

(11)  In this section:

old Arrangement means the Arrangements—Botulinum Toxin Program (PB 122 of 2008), as in force immediately before 1 December 2011.

Schedule 1—Pharmaceutical benefits to which this Special Arrangement applies and related information

(sections 4, 5, 7 and 9)

Listed Drug Form Manner of Administration Brand Responsible Person Section 100 only
Botulinum Toxin Type A Purified Neurotoxin Complex Lyophilised powder for injection 100 units Injection Botox AG D
Clostridium Botulinum Type A Toxin‑Haemagglutinin Complex Lyophilised powder for injection 300 units Injection Dysport IS D
Clostridium Botulinum Type A Toxin–Haemagglutinin Complex Lyophilised powder for injection 500 units Injection Dysport IS D
IncobotulinumtoxinA Lyophilised powder for injection 100 units Injection Xeomin EZ D

Schedule 2—Responsible Person Codes

(section 7)

Code Responsible Person Australian Business Number
AG Allergan Australia Pty Limited 85 000 612 831
IS Ipsen Pty Ltd 47 095 036 909
EZ Merz Australia Pty Ltd 62 151 073 559

Schedule 3—Treatment Conditions

(sections 10, 16, 17, 18, 26 and 29)

Treatment Condition Number Treatment Condition Listed Drug in Relevant Pharmaceutical Benefit Specialist Qualifications
1 Treatment of blepharospasm or hemifacial spasm in a patient 12 years or older Botulinum Toxin Type A Purified Neurotoxin Complex

Neurology

Opthalmology

Otolaryngology head and neck surgery

Plastic Surgery

1A Treatment of blepharospasm or hemifacial spasm in an adult Clostridium Botulinum Type A Toxin‑Haemagglutinin Complex

Neurology

Opthalmology

Otolaryngology head and neck surgery

Plastic Surgery

1B Treatment of blepharospasm in an adult

IncobotulinumtoxinA

Neurology

Opthalmology

Otolaryngology head and neck surgery

Plastic surgery

2 Treatment of dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients aged 2 or more and less than 18

Botulinum Toxin Type A Purified Neurotoxin Complex

Clostridium Botulinum Type A Toxin–Haemagglutinin Complex

Neurology

Orthopaedic surgery

Paediatrics

Rehabilitation

3 Continuing treatment of dynamic equinus foot deformity due to spasticity in ambulant cerebral palsy patients aged 18 or more who were commenced on PBS‑subsidised treatment with Botulinum Toxin Type A Purified Neurotoxin Complex as a paediatric patient

Botulinum Toxin Type A Purified Neurotoxin Complex

Clostridium Botulinum Type A Toxin–Haemagglutinin Complex

Neurology

Orthopaedic surgery

Paediatrics

Rehabilitation

4 Treatment of spasmodic torticollis, either as monotherapy or as adjunctive therapy to current standard care

Botulinum Toxin Type A Purified Neurotoxin Complex

Clostridium Botulinum Type A Toxin–Haemagglutinin Complex

Neurology

Plastic surgery

Rehabilitation

4A Treatment of spasmodic torticollis in an adult, either as monotherapy or as adjunctive therapy to current standard care IncobotulinumtoxinA

Neurology

Plastic surgery

Rehabilitation

5 Treatment of moderate to severe spasticity of the upper limbs, in cerebral palsy patients aged 2 or more and less than 18 Botulinum Toxin Type A Purified Neurotoxin Complex

Neurology

Orthopaedic surgery

Paediatrics

Plastic surgery

Rehabilitation

6 Continuing treatment of moderate to severe spasticity of the upper limbs in cerebral palsy patients aged 18 or more who were commenced on PBS‑subsidised treatment with Botulinum Toxin Type A Purified Neurotoxin Complex as a paediatric patient Botulinum Toxin Type A Purified Neurotoxin Complex

Neurology

Orthopaedic surgery

Paediatrics

Plastic surgery

Rehabilitation

7 Treatment of moderate to severe spasticity of the upper limbs in adults following a stroke, as second line therapy when standard management has failed or as an adjunct to physical therapy

Botulinum Toxin Type A Purified Neurotoxin Complex

Clostridium Botulinum Type A Toxin–Haemagglutinin Complex IncobotulinumtoxinA

Geriatric medicine

Neurology

Orthopaedic surgery

Plastic surgery

Rehabilitation

8 Treatment of severe primary axillary hyperhidrosis in patients aged 12 or more if, after treatment with topical aluminium chloride hexahydrate, patient is intolerant to topical aluminium chloride hexahydrate or the patient has not responded to the treatment Botulinum Toxin Type A Purified Neurotoxin Complex

Dermatology

Neurology

Paediatrics

9 Treatment of urinary incontinence due to neurogenic detrusor overactivity, as demonstrated by urodynamic study in patients who have multiple sclerosis, or a spinal cord injury, or who are 18 years or older and have spina bifida. Botulinum Toxin Type A Purified Neurotoxin Complex

Urology

Urogynaecology

10 Treatment of chronic migraine in patients who are 18 years or older. Botulinum Toxin Type A Purified Neurotoxin Complex Neurology
11 Treatment of urinary incontinence due to idiopathic overactive bladder in patients who are 18 years or older. Botulinum Toxin Type A Purified Neurotoxin Complex

Urology

Urogynaecology

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

Endnotes about misdescribed amendments and other matters are included in a compilation only as necessary.

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.

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 amendment is set out in the endnotes.

Endnote 2—Abbreviation key

A = Act orig = original
ad = added or inserted par = paragraph(s)/subparagraph(s)
am = amended     /sub‑subparagraph(s)
amdt = amendment pres = present
c = clause(s) prev = previous
C[x] = Compilation No. x (prev…) = previously
Ch = Chapter(s) Pt = Part(s)
def = definition(s) r = regulation(s)/rule(s)
Dict = Dictionary Reg = Regulation/Regulations
disallowed = disallowed by Parliament reloc = relocated
Div = Division(s) renum = renumbered
exp = expires/expired or ceases/ceased to have rep = repealed
    effect rs = repealed and substituted
F = Federal Register of Legislative Instruments s = section(s)/subsection(s)
gaz = gazette Sch = Schedule(s)
LI = Legislative Instrument Sdiv = Subdivision(s)
LIA = Legislative Instruments Act 2003 SLI = Select Legislative Instrument
(md) = misdescribed amendment SR = Statutory Rules
mod = modified/modification Sub‑Ch = Sub‑Chapter(s)
No. = Number(s) SubPt = Subpart(s)
o = order(s) underlining = whole or part not
Ord = Ordinance     commenced or to be commenced

Endnote 3—Legislation history

Title FRLI registration Commencement Application, saving and transitional provisions
PB 89 of 2011 30 Nov 2011 (see F2011L02498) 1 Dec 2011
PB 21 of 2012 29 Mar 2012 (see F2012L00713) 1 Apr 2012 s 4
PB 67 of 2013 24 Sept 2013 (see F2013L01737) 1 Oct 2013 s 4
PB 13 of 2014 27 Feb 2014 (see F2014L00198) 1 Mar 2014
PB 87 of 2014 29 Oct 2014 (F2014L01429) 1 Nov 2014 (s 2)
PB 33 of 2015 1 Apr 2015 (F2015L00431) 1 Apr 2015 (s 2(1))

Endnote 4—Amendment history

Provision affected How affected
Part 2
s 8........................................ am PB 33 of 2015
Part 3
s 10...................................... am PB 67 of 2013; PB 13 and 87 of 2014
s 11...................................... am PB 33 of 2015
s 12A................................... ad PB 67 of 2013
am PB 13 of 2014
s 12B................................... ad PB 13 of 2014
am PB 33 of 2015
s 12C................................... ad PB 87 of 2014
Part 5
s 17A................................... ad PB 13 of 2014
s 17B................................... ad PB 87 of 2014
am PB 33 of 2015
s 18...................................... am PB 21 of 2012; PB 67 of 2013; PB 13 and 87 of 2014; PB 33 of 2015
Part 7
s 26...................................... am 33 of 2015
Schedule 1
Sch 1.................................... am PB 21 of 2012; PB 33 of 2010
Schedule 2
Sch 2.................................... am PB 33 of 2010
Schedule 3
Sch 3.................................... am PB 21 of 2012; PB 67 of 2013; PB 13 and 87 of 2014; PB 33 of 2010
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