National Health Act 1953 Arrangements made under subparagraph 100(1)(b)(i) Botulinum Toxin Program (No. PB 39 of 2005) (Cth)

COMMONWEALTH OF AUSTRALIA

National Health Act 1953

ARRANGEMENTS MADE UNDER SUBPARAGRAPH 100(1)(b)(i)

BOTULINUM TOXIN PROGRAM

No. PB 39 of 2005

I, JOAN CORBETT, Assistant Secretary, Pharmaceutical Benefits 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:

1.   These Arrangements commence on 1 December 2005.

2.   The Arrangements made on 30 July 2004 with effect from 1 August 2004 are repealed with effect from the commencement of these Arrangements.

3.   Special pharmaceutical products available under these Arrangements.

(A)    The following special pharmaceutical products 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 years of age or older; or

(c)spasmodic torticollis, either as monotherapy or as adjunctive therapy to current standard care

(ii)   Clostridium Botulinum Type A Toxin–Haemagglutinin Complex, 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 years of age or older; or

(b)spasmodic torticollis, either as monotherapy or as adjunctive therapy to current standard care

4.   Patients who may be treated under these Arrangements.

(A)Only a patient who is the holder, or 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.

(B)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.

5.   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)    ophthalmology, neurology, plastic surgery or otolaryngology head and neck surgery, 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; or

(ii)   rehabilitation, paediatrics, neurology or orthopaedic surgery, in the case of treatment of dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients who are 2 years of age and older; or

(iii)     neurology,  rehabilitation or plastic surgery, in the case of treatment of spasmodic torticollis, either as monotherapy or as adjunctive therapy to current standard care.

(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, and a letter of support from a practitioner who is already registered to participate under these Arrangements; 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.

(C)    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, and a letter of support from a practitioner who is already registered to participate under these Arrangements; 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 Limited in relation to the supply and use of Clostridium Botulinum Type A Toxin–Haemagglutinin Complex.

6.   Unused vials.

(A)    Any vials of botulinum toxin remaining unused from a supply ordered for the treatment of patients under these Arrangements 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 treat hemifacial spasm, blepharospasm, dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients and/or spasmodic torticollis may retain a maximum of 5 vials of Botox. A medical practitioner who is registered to treat dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients and/or spasmodic torticollis may also retain a maximum of 5 vials of Dysport.

7.   Forms for the supply and use of botulinum toxin under these Arrangements.

(A)    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 – 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 condition for which botulinum toxin was administered;

(viii)details of the medical practice, including full name and address of the medical practitioner;

(ix)     provider number of the administering medical practitioner;

(x)      signature of the administering 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: 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, two boxes have been provided: one for dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients and one for spasmodic torticollis.  The administering 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 [phone]), 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 medical practitioners 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.

8.   Requests for orders.

(A)    Requests for orders for the supply of botulinum toxin should be directed to Medicare Australia’s Hobart office, telephone [phone].  Orders will be placed with the suppliers by the Medicare Australia CEO for delivery to the medical practice.

9.   Completed documentation.

(A)    On completion of treatment, medical practitioners should forward the Patient Usage Forms, accompanied by the signed delivery documentation for botulinum toxin supplied, to:

Supervisor

Pharmaceutical Processing

Medicare Australia

GPO Box 9826

Hobart  Tas  7001

Telephone:        [phone]

Facsimile:         [phone]

Dated this twenty third day of November 2005.

JOAN CORBETT

Assistant Secretary

Pharmaceutical Benefits Branch

Department of Health and Ageing

Delegate of the Minister for Health and Ageing