National Health Act 1953 Amendment special arrangements made under subparagraph 100(1)(b)(i) Botulinum Toxin Program (No. PB 29 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 29 of 2009

Amendment special arrangements made under subparagraph 100(1)(b)(i) of the National Health Act 1953

I, DECLAN O’CONNOR-COX, Assistant Secretary, Access and Systems Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsection 100(2) of the National Health Act 1953.

31 March 2009

DECLAN O’CONNOR-COX

Assistant Secretary

Access and Systems Branch

Department of Health and Ageing

Amendment Special Arrangements —Botulinum Toxin Program

1              Commencement

This instrument commences on 1 April 2009.

2              Amendment of PB 122 of 2008

Schedule 1 amends PB 122 of 2008.

Schedule 1        Amendments

[1]           Subparagraph 3(A)(i)

at the end of subparagraph 3(A)(i)(d) add the following:

; or

e) the treatment of moderate to severe spasticity of the upper limbs in cerebral palsy patients 2 years of age or older; or

f) the treatment of moderate to severe spasticity [defined as MAS greater than or equal to 3 using the modified Ashworth scale] of the upper limb in adults following a stroke as a 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 with botulinum toxin to be authorised is 4 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 the patient does not respond (decrease of MAS greater than 1 in at least one joint) after two treatments.  Contraindications to treatment include established severe contracture and known sensitivity to botulinum toxin.

[2]       Subparagraph 3(A)(ii)

omit from the subparagraph:

d) 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 ( 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 the 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.

and substitute:

d) the treatment of moderate to severe spasticity [defined as MAS greater than or equal to 3 using the modified Ashworth scale] of the upper limb in adults following a stroke as a 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 with botulinum toxin to be authorised is 4 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 the patient does not respond (decrease of MAS greater than 1 in at least one joint) after two treatments.  Contraindications to treatment include established severe contracture and known sensitivity to botulinum toxin.

[3]        Subparagraph 5(A)

omit from the subparagraph:         

(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, rehabilitation, geriatric medicine, orthopaedic surgery or plastic surgery.

and substitute:

(iv) In the case of treatment of moderate to severe spasticity of the upper limbs in a cerebral palsy patient 2 years of age or older – rehabilitation, paediatrics, neurology or orthopaedic surgery; or

(v) 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, rehabilitation, geriatric medicine, orthopaedic surgery or plastic surgery

[4]       Subparagraph 5(C)

omit from the subparagraph:

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.   

and substitute:

A medical practitioner who wishes to use botulinum toxin for the treatment of dynamic equinus foot deformity, spasmodic torticollis, or upper limb spasticity in cerebral palsy patients must apply in writing to the Medicare Australia CEO for registration to participate under these Arrangements.   

[5]  Subparagraph 5(D)

omit all text from subparagraph 5(D) and substitute:

(D)   A medical practitioner who wishes to use 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 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 practitioners 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 or Ipsen Pty Ltd 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 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 the Arrangements, or a letter of support from Allergan Australia Pty Ltd or Ipsen Pty Ltd, as the case may be, clearly indicating the doctors experience in the use of 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 Allergan Australia Pty Ltd in relation to the supply and use of Botulinum Toxin Type A Purified Neurotoxin Complex, or Ipsen Pty Ltd (and their distributor) in relation to the supply and use of Clostridium Botulinum Toxin Type A Toxin-Hemagglutinin Complex.

[5]       Sub Paragraph 6(B)

Omit from subparagraph:

(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, dynamic equinus foot deformity due to spasticity in cerebral palsy patients 18 years or older who were commenced on PBS subsidised treatment botulinum toxin as a paediatric patient or spasmodic torticollis may retain a maximum of 5 vials of Botox.

and substitute:

(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, dynamic equinus foot deformity due to spasticity in cerebral palsy patients 18 years or older who were commenced on PBS subsidised treatment botulinum toxin as a paediatric patient, spasmodic torticollis, moderate to severe spasticity of the upper limbs in cerebral palsy patients 2 years of age or older, or moderate to severe spasticity of the upper limbs in adults following stroke may retain a maximum of 5 vials of Botox

[6]       Subparagraph 7(A)(Part 1)

omit from subparagraph:

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 cerebral palsy patients, 2 to 17 years of age inclusive, continuing treatment of dynamic equinus foot deformity due to spasticity in ambulant cerebral palsy patient 18 years of age or older who was commenced on PBS-subsidised treatment with botulinum toxin as a paediatric patient or spasmodic torticollis, either as monotherapy or as an adjunct therapy to current standard care.

And substitute:

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 cerebral palsy patients, 2 to 17 years of age inclusive, continuing treatment of dynamic equinus foot deformity due to spasticity in ambulant cerebral palsy patient 18 years of age or older who was commenced on PBS-subsidised treatment with botulinum toxin as a paediatric patient, spasmodic torticollis, either as monotherapy or as an adjunct therapy to current standard care or moderate to severe spasticity of the upper limbs in cerebral palsy patients 2 years of age or older.

[7]       Subparagraph 7(A)(Part 2)

omit all text from subparagraph(7)(A)(Part 2) and substitute the following:

Part 2 - This part relates to each administration of botulinum toxin made for treatment of moderate to severe spasticity (defined as MAS greater than or equal to 3 using the 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 of botulinum toxin to be authorised is 4 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 greater than 1 in at least one joint) after two treatments.  Contra-indications to treatment include established severe contracture and known sensitivity to botulinum toxin.

A Patient Acknowledgement Form, signed by the patient and the administering registered medical practitioner, must be provided for the initial application of botulinum toxin.  The Patient Acknowledgement Form is to be the Form referred to at 7(J) below.

The administering registered medical practitioner and the patient must complete and sign a Patient Usage Form for each administration of botulinum toxin made.  The Patient Usage Form is to be the Form referred to at 7(J) below and the following data must be supplied on that Form:

(i)         date of administration of 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 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.

[8]       Subparagraph 7(B)

omit from subparagraph:

(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/ adult ambulant cerebral palsy patient previously commenced treatment as a paediatric patient 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/ adult ambulant cerebral palsy patient previously commenced treatment as a paediatric patient, one for spasmodic torticollis and one for severe spasticity of the upper limbs in adults following a stroke.

and substitute:

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, six 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/ adult ambulant cerebral palsy patients who previously commenced treatment as a paediatric patient, one for spasmodic torticollis, one for upper limb spasticity in a cerebral palsy patient and one for moderate to severe spasticity of the upper limbs in adults following stroke. 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/ adult ambulant cerebral palsy patients who previously commenced treatment as a paediatric patient, one for spasmodic torticollis and one for severe spasticity of the upper limbs in adults following a stroke.

[9]  Subparagraph 7(C)

omit from subparagraph:

(C)At the end of each treatment period, the Patient Usage Forms and, where appropriate, Patient Acknowledgement Forms (required for each initial application for patients being treated for spasticity of the upper limbs), 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.

and substitute:

(C)       At the end of each treatment period, the Patient Usage Forms and, where appropriate, Patient Acknowledgement Forms (required for each initial application for patients being treated for spasticity of the upper limbs following stroke), 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.