National Health Act 1953 Arrangements made under subparagraph 100(1)(b)(i) Botulinum Toxin Program (No. PB 38 of 2008) (Cth)
COMMONWEALTH OF AUSTRALIA
National Health Act 1953
ARRANGEMENTS MADE UNDER SUBPARAGRAPH 100(1)(b)(i)
BOTULINUM TOXIN PROGRAM
No. PB 38 of 2008
I, Declan O’Connor-Cox, Assistant Secretary, Access and Systems Branch, Department of Health and Ageing and delegate of the Minister for Health and Ageing, pursuant to subparagraph 100(1)(b)(i) of the National Health Act 1953, hereby make the following Arrangements for the purpose of providing that an adequate supply of special pharmaceutical products will be available to persons requiring treatment with botulinum toxin:
These Arrangements commence on 1 April 2008.
The Arrangements made under subparagraph 100(1)(b)(i) - Botulinum Toxin Program (No. PB 39 of 2005) are repealed.
Special pharmaceutical products available under these Arrangements.
(A) The following special pharmaceutical products (being two forms of botulinum toxin) are available under these Arrangements for the purposes specified in respect of each product:
(i) Botulinum Toxin Type A Purified Neurotoxin Complex, lyophilised powder for intramuscular injection 100 units vial (Botox) (manufactured by Allergan Australia Pty Ltd) for the treatment of:
a) blepharospasm associated with dystonia, including benign blepharospasm and VIIth nerve disorders (hemifacial spasm) in patients 12 years and older; or
b) dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, 2 to 17 years of age inclusive; or
c) spasmodic torticollis, either as monotherapy or as adjunctive therapy to current standard care
(ii) Clostridium Botulinum Type A Toxin–Haemagglutinin Complex (clostridium botulinum toxin), lyophilised powder for intramuscular injection 500 units vial (Dysport) (manufactured by Ipsen Pty Limited, and distributed by Clifford Hallam Pharmaceutical) for the treatment of:
a)dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, 2 to 17 years of age inclusive; or
b)spasmodic torticollis, either as monotherapy or as adjunctive therapy to current standard care
c)moderate to severe spasticity (defined as MAS greater than or equal to 3 using the modified Ashworth scale) of the upper limbs in adults following a stroke, as second line therapy when standard management has failed ( e.g. physiotherapy and/or oral spasticity agents) or as an adjunct to physical therapy. Maximum number of treatments to be authorised is four per upper limb per lifetime. Treatment should not be initiated until 3 to 6 months post-stroke in patients who do not have established severe contracture. Treatment should be discontinued if patient does not respond (decrease of MAS>1 in at least one joint) after two treatments. Contra-indications to treatment include established severe contracture, known sensitivity to botulinum toxin.
(B) A reference in this Arrangement to ‘botulinum toxin’ is a reference to either or both of the two types of botulinum toxin mentioned in (A) above,
Patients who may be treated under these Arrangements.
Only a patient who is the holder, or in the case of a dependent child whose parent or legal guardian is the holder, of a Medicare Card, and who is an Australian resident within the meaning of the Health Insurance Act 1973 is eligible to receive special pharmaceutical products under these Arrangements.
A patient will be eligible to receive special pharmaceutical products under these Arrangements only if the patient is suffering from one of the medical conditions specified at paragraph 3 for the particular special pharmaceutical product.
(C) Special pharmaceutical products will not be supplied under these Arrangements for administration to a patient who is admitted to a public hospital, unless the patient is admitted as a day patient, or is admitted for a period of not more than 24 hours.
(D) Special pharmaceutical products supplied and administered under these Arrangements are free of charge to patients.
Medical Practitioners who may participate under these Arrangements
(A) Only medical practitioners who hold the following specialist qualifications are eligible to be registered to participate under these Arrangements:
(i)In the case of treatment of blepharospasm associated with dystonia, including benign blepharospasm and VIIth nerve disorders (hemifacial spasm) in patients who are 12 years and older - ophthalmology, neurology, plastic surgery or otolaryngology head and neck surgery; or
(ii)In the case of treatment of dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients who are 2 to 17 years of age inclusive - rehabilitation, paediatrics, neurology or orthopaedic surgery; or
(iii)In the case of treatment of spasmodic torticollis, either as monotherapy or as adjunctive therapy to current standard care - neurology, rehabilitation or plastic surgery; or
(iv), In the case of moderate to severe spasticity (defined as MAS greater than or equal to 3 using the modified Ashworth scale) of the upper limbs in adults following a stroke - neurology or rehabilitation.
(B) A medical practitioner who wishes to use botulinum toxin for the treatment of blepharospasm or hemifacial spasm must apply in writing to the Chief Executive Officer of Medicare Australia (Medicare Australia CEO) for registration to participate under these Arrangements.
The application must be accompanied by:
(i)details of the practitioner’s specialist qualifications; and
(ii)details of the practitioner’s training in the use of botulinum toxin, including details of supervision and the names of the patients treated under supervision; and
(iii)evidence of the practitioner’s training in the use of botulinum toxin in the form of:
(a) a letter from Allergan Australia Pty Ltd, stating that the practitioner has been the primary operator under supervision in not less than 2 botulinum toxin procedures in the case of a specialist in ophthalmology, or not less than 6 botulinum toxin procedures in the case of a specialist in neurology, plastic surgery or otolaryngology head and neck surgery; or
(b) a letter from a practitioner who is already registered to participate under these Arrangements, stating that the applicant practitioner has been the primary operator under supervision in not less than 2 botulinum toxin procedures in the case of a specialist in ophthalmology, or not less than 6 botulinum toxin procedures in the case of a specialist in neurology, plastic surgery or otolaryngology head and neck surgery; or
(c) in the case of a practitioner who has been trained overseas, extensive details of the training received in the use of botulinum toxin. An application by an overseas trained practitioner must also be accompanied by a letter of support from a practitioner who is already registered to participate under these Arrangements, or a letter of support from Allergan Australia Pty Ltd clearly indicating the doctor’s experience in the use of botulinum toxin; and
(iv)a written undertaking to comply with the requirements of these Arrangements; and
(v)written consent for the Medicare Australia CEO to supply details of the practitioner’s name and address to Allergan Australia Pty Ltd in relation to the supply and use of Botulinum Toxin Type A Purified Neurotoxin Complex.
A medical practitioner who wishes to use botulinum toxin for the treatment of dynamic equinus foot deformity or spasmodic torticollis must apply in writing to the Medicare Australia CEO for registration to participate under these Arrangements.
The application must be accompanied by:
(i) details of the practitioner’s specialist qualifications; and
(ii) details of the practitioner’s training in the use of botulinum toxin, including details of supervision and the names of the patients treated under supervision; and
(iii) evidence of the practitioner’s training in the use of botulinum toxin in the form of:
(a)a letter from either Allergan Australia Pty Ltd or Ipsen Pty Limited, as the case may be, stating that the practitioner has been involved with not less than 20 botulinum toxin procedures and has been the primary operator under supervision in not less than 10 botulinum toxin procedures; or
(b)a letter from a practitioner who is already registered to participate under these Arrangements, stating that the applicant practitioner has been involved with not less than 20 botulinum toxin procedures and has been the primary operator under supervision in not less than 10 botulinum toxin procedures; or
(c)in the case of a practitioner who has been trained overseas, extensive details of the training received in the use of botulinum toxin. An application by an overseas trained practitioner must also be accompanied by a letter of support from a practitioner who is already registered to participate under these Arrangements, or a letter of support from Allergan Australia Pty Ltd or Ipsen Pty Ltd, as the case may be, clearly indicating the doctor’s experience in the use of botulinum toxin; and
(iv) a written undertaking to comply with the requirements of these Arrangements; and
(v) written consent for the Medicare Australia CEO to supply details of the practitioner’s name and address to Allergan Australia Pty Ltd in relation to the supply and use of Botulinum Toxin Type A Purified Neurotoxin Complex, or Ipsen Pty Ltd in relation to the supply and use of Clostridium Botulinum Type A Toxin–Haemagglutinin Complex.
(D) A medical practitioner who wishes to use clostridium botulinum toxin for the treatment of moderate to severe spasticity (defined as MAS greater than or equal to 3 using the modified Ashworth scale) of the upper limbs in adults following a stroke, as second line therapy when standard management has failed, must apply in writing to the Medicare Australia CEO for registration to participate under these Arrangements.
The application must be accompanied by:
(i) details of the practitioner’s specialist qualifications; and
(ii) details of the practitioner’s training in the use of clostridium botulinum toxin, including details of supervision and the names of the patients treated under supervision: and
(iii) evidence of the practitioner’s training in the use of clostridium botulinum toxin in the form of:
(a) a letter from Ipsen Pty Ltd as the case may be, stating that the practitioner has been involved with not less than 20 clostridium botulinum toxin procedures and has been the primary operator under supervision in not less than 10 clostridium botulinum toxin procedures; or
(b) a letter from a practitioner who is already registered to participate under these Arrangements, stating that the applicant practitioner has been the primary operator under supervision in not less that 20 clostridium botulinum toxin procedures and has been the primary operator under supervision in not less than 10 clostridium botulinum toxin procedures; or
(c ) in the case of a practitioner who has trained overseas, extensive details of training received in the use of clostridium botulinum toxin. An application by an overseas trained practitioner must also be accompanied by a letter of support from a practitioner who is already registered to participate under the arrangements, or a letter of support from Ipsen Pty Ltd clearly indicating the doctor’s experience in the use of clostridium botulinum toxin; and
(iv) a written undertaking to comply with requirements of these Arrangements; and
(v) written consent for the Medicare Australia CEO to supply details of the practitioner’s name and address to Ipsen Pty Ltd (and their distributor) in relation to the supply and use of Clostridium Botulinum Type A Toxin- Haemagglutinin Complex.
(E) The Medicare Australia CEO will advise the practitioner in writing if they are registered to participate, and the condition or conditions they are registered to treat, under these Arrangements.
Unused vials
(A) Any vials of botulinum toxin remaining unused from a supply ordered for the treatment of patients are to be used when the medical practitioner next treats patients under these Arrangements, unless the vials of botulinum toxin are being retained for emergency purposes in the circumstances permitted in paragraph 6(B) of these Arrangements.
(B) Each medical practitioner registered to participate under these Arrangements may retain a small quantity of botulinum toxin on hand for emergency purposes. A medical practitioner who is registered to participate under these Arrangements to treat hemifacial spasm, blepharospasm, dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients or spasmodic torticollis may retain a maximum of 5 vials of Botox.
A medical practitioner who is registered to participate under these Arrangements to treat dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, spasmodic torticollis or moderate to severe spasticity of the upper limb in adults following a stroke may retain a maximum of 5 vials of Dysport.
(C ) Vials of botulinum toxin retained by the medical practitioner must be monitored for correct storage conditions and expiry dates. Medicare Australia will not replace vials that have expired or have been damaged.
Forms for the supply and use of botulinum toxin under these Arrangements
(A) This sub-paragraph is in two parts.
Part 1 - This part relates to each administration of botulinum toxin made for blepharospasm, associated with dystonia, including benign blepharospasm and VIIth nerve disorders (hemifacial spasm) in patients 12 years and older, dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, 2 to 17 years of age inclusive or spasmodic torticollis, either as monotherapy or as adjunctive therapy to current standard care.
The administering medical practitioner who is registered to participate under these Arrangements, and the patient (or, in the case of a patient who is less than 16 years of age, the patient’s parent or legal guardian), must complete and sign a Patient Usage Form for each administration of botulinum toxin made. The following data must be supplied on the Patient Usage Form:
(i) date of administration of the botulinum toxin;
(ii) patient’s full Medicare number, being an eleven digit number that includes the patient’s individual reference number;
(iii) patient identification – full name and residential address;
(iv) form of agreement given by the patient or, in the case of a patient less than 16 years of age, the patient’s parent or legal guardian, to receive the treatment;
(v) signature of the patient or, in the case of a patient less than 16 years of age, the patient’s parent or legal guardian;
(vi) quantity of botulinum toxin administered;
(vii) the number of vials of botulinum toxin on hand;
(viii) the condition for which botulinum toxin was administered;
(ix) details of the medical practice, including full name and address of the registered medical practitioner;
(x) provider number of the administering registered medical practitioner specific to the supply of the botulinum toxin for the patient named.
(xi) signature of the administering registered medical practitioner.
Part 2 - This part relates to each administration of clostridium botulinum toxin made for treatment of moderate to severe spasticity (defined as MAS greater than or equal to 3 using modified Ashworth scale) of the upper limb in adults following a stroke, as second line therapy when standard management has failed (eg physiotherapy and/or oral spasticity agents) or as an adjunct to physical therapy. Maximum number of treatments to be authorised is 4 per upper limb per lifetime. Treatment should not be initiated until 3 or 6 months post-stroke in patients who do not have established severe contracture. Treatment should be discontinued if patient does not respond (decrease of MAS>1 in at least one joint) after two treatments. Contra-indications to treatment include established severe contracture, known sensitivity to botulinum toxin.
A Patient Acknowledgement Form, signed by the patient and the treating medical practitioner, must be provided for the initial application of Dysport.
The administering medical practitioner who is registered to participate under these Arrangements and the patient must complete and sign a Patient Usage Form for each administration of clostridium botulinum toxin made. The following data must be supplied on the Patient Usage Form:
(i) date of administration of the clostridium botulinum toxin;
(ii) patient’s full Medicare number, being an eleven digit number that includes the patient’s individual reference number;
(iii) patient identification – full name and residential address;
(iv) form of agreement given by the patient;
(v) signature of the patient;
(vi) quantity of clostridium botulinum toxin administered;
(vii) the number of vials of botulinum toxin on hand;
(viii) the condition for which clostridium botulinum toxin was administered;
(ix) details of the medical practice, including full name and address of the registered medical practitioner;
(x) provider number of the administering registered medical practitioner specific to the supply of the clostridium botulinum toxin for the patient named;
(xi) signature of the administering registered medical practitioner.
(B) Provision has been made on the Patient Usage Form for details of the condition for which botulinum toxin was administered, to be provided. In respect of the supply of Botox, four boxes have been provided on the Form: one for hemifacial spasm, one for blepharospasm, one for dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients and one for spasmodic torticollis. In respect of the supply of Dysport, three boxes have been provided: one for dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, one for spasmodic torticollis and one for severe spasticity of the upper limbs in adults following a stroke.
The administering registered medical practitioner should tick the appropriate box to indicate the condition that is being treated with botulinum toxin.
(C) At the end of each treatment period, the Patient Usage Forms together with all delivery documentation received by the medical practitioner, must be forwarded to the Medicare Australia CEO for verification.The delivery documentation must be signed by the person who receives the botulinum toxin on behalf of the medical practice.
(D) On receiving the delivery documentation from a medical practitioner, including information as to the quantity of the drug received, the Medicare Australia CEO will match the documents with the invoice received from the supplier. The supplier will provide an invoice for payment to the Medicare Australia CEO. The invoice will be matched with the patient data supplied from the delivery documentation and the Patient Usage Form. When matched, payment will be made by the Medicare Australia CEO.
(E) Payment to the supplier for botulinum toxin used under these Arrangements is dependant upon the medical practice supplying to the Medicare Australia CEO all the relevant documentation to verify the supply and usage of botulinum toxin. Additional supplies of botulinum toxin will not be made available until all documentation for supplies already made has been received and verified by the Medicare Australia CEO.
(F) Medical practitioners who use botulinum toxin to treat conditions other than those specified in these Arrangements must not combine such private botulinum toxin orders with orders for botulinum toxin that will be used to treat patients under these Arrangements. The suppliers of botulinum toxin have agreed to provide accounts for orders that have been lodged under these Arrangements separately from accounts for private botulinum toxin orders.
(G) Botulinum toxin supplied under these Arrangements will be billed to the Medicare Australia CEO and the medical practitioner will not be required to make any payments to the supplier for botulinum toxin that is to be used for patients being treated under these Arrangements.
(H) Invoices relating to accounts to be paid by the Medicare Australia CEO will have “Medicare Australia reimbursable” printed on the delivery documentation. This documentation should be forwarded to the Medicare Australia CEO, either by fax (03 6215 5640), or mail, within seven days of delivery of the botulinum toxin, to ensure payments are made to the supplier within the specified timeframe. The medical practitioner may make a copy of the delivery docket, which must then be forwarded, together with the Patient Usage Forms to the Medicare Australia CEO for verification of the patient’s eligibility and payment directly to the supplier. Accounts for botulinum toxin ordered for the treatment of patients not covered by these Arrangements will be directed to the medical practitioner’s practice for reimbursement.
(I) The arrangements for the supply of botulinum toxin to a registered medical practitioner will be based on advice from the supplier as botulinum toxin must be managed and stored under special conditions. The conditions, if any, advised by the supplier must be adhered to.
(J) The Patient Usage Form and Patient Acknowledgement Form can be obtained from the Medicare Australia website at .
Requests for orders
(A) Requests for orders for the supply of botulinum toxin should be directed to Medicare Australia’s Hobart office, telephone 1800 700 270 (option 4). Orders will be placed with the suppliers by the Medicare Australia CEO for delivery to the registered medical practitioner.
Documentation
(A) On completion of treatment, medical practitioners should forward the Patient Usage Form and, where appropriate, Patient Acknowledgement Form, accompanied by the signed delivery documentation for botulinum toxin supplied, to:
Botulinum Toxin Program
Provider Operations Branch
Medicare Australia
GPO Box 9826
Hobart Tas 7001
Telephone: 1800 700 270 (option 4)
Facsimile: (03) 6215 5640
Dated this 26th day of March 2008.
Declan O’Connor-Cox
Declan O’Connor-Cox
Assistant Secretary
Access and Systems Branch
Department of Health and Ageing
Delegate of the Minister for Health and Ageing
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