Part 1
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Commonwealth legislation
This Act has been repealed and is no longer in force. It is retained for historical reference.
This Special Arrangement establishes a Medicare pathway for botulinum toxin (Botox) use in specified serious medical conditions, allowing authorised specialist doctors to order vials directly from suppliers rather than via standard pharmacy prescriptions. It affects eligible patients, trained and authorised specialists, and Medicare administrators, requiring strict clinical criteria, documented specialist training, treatment limits, and mandatory paperwork. The scheme ensures controlled, therapeutic use and tracking to prevent misuse or diversion.
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Direct links to the current provisions in National Health (Botulinum Toxin Program) Special Arrangement 2011 (No. PB 89 of 2011).
(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.
This Special Arrangement commences on 1 December 2011.
Instrument PB 122 of 2008 is revoked.
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.
(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) 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.
(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.
(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) 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.
(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.
(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.
(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.
(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.
(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).
(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.
(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.
(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.
(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.
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.
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.
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.
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.
(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.
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.
(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.
(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.
(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.
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.
(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.
(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.
(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.
(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).
(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.
(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.
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
(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.
This Special Arrangement commences on 1 December 2011.
Instrument PB 122 of 2008 is revoked.
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.
(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) 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.
(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.
(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) 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.
(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.
(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.
(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.
(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.
(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).
(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 phar
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