18Authorisation of medical practitioners

18 Authorisation of medical practitioners

(1) A medical practitioner may apply to the Chief Executive Medicare for authorisation to administer botulinum toxin pharmaceutical benefits under this Special Arrangement for a treatment condition mentioned in the column in Schedule 3 headed ‘Treatment Condition’. (2) The application must be in writing and must set out the following information: (a) the treatment condition or conditions for which the applicant practitioner wants to be authorised; (b) evidence of the applicant practitioner’s specialist qualifications; (c) evidence of the applicant practitioner’s training in the use of botulinum toxin pharmaceutical benefits, including evidence of supervision and the names of the patients treated under supervision; (d) for an applicant practitioner who has been trained overseas: (i) evidence of the training received by the applicant practitioner in the use of botulinum toxin pharmaceutical benefits; and (ii) a letter of support, stating the applicant practitioner’s experience in the use of botulinum toxin pharmaceutical benefits from: (A) an eligible medical practitioner; or (B) the responsible person for a botulinum toxin pharmaceutical benefit that has the same listed drug as is listed in the column in Schedule 3 headed ‘Listed Drug in Relevant Pharmaceutical Benefit’ for a condition that the applicant practitioner seeks to be authorised to administer botulinum toxin pharmaceutical benefits; (3) Unless subsection (4), (5), (6), (7) or (8) applies, for paragraph 2(c), evidence of the applicant practitioner’s training must be in the form of: (a) a letter from a person who is an eligible medical practitioner for this arrangement, stating that the applicant practitioner has been: (i) involved in at least 20 procedures administering a botulinum toxin pharmaceutical benefit; and (ii) the primary operator, under supervision, in at least 10 procedures administering a botulinum toxin pharmaceutical benefit; or (b) a letter from the responsible person for a botulinum toxin pharmaceutical benefit that has the same listed drug as is listed in the column in Schedule 3 headed ‘Listed Drug in Relevant Pharmaceutical Benefit’ for a condition that the applicant practitioner seeks to be authorised to administer botulinum toxin pharmaceutical benefits, stating that the applicant practitioner has been: (i) involved in at least 20 procedures administering a botulinum toxin pharmaceutical benefit; and (ii) the primary operator, under supervision, in at least 10 procedures administering a botulinum toxin pharmaceutical benefit. (4) If an applicant practitioner is a specialist in ophthalmology and seeks authorisation to administer botulinum toxin pharmaceutical benefits, under this Special Arrangement, for the treatment of blepharospasm or hemifacial spasm in a patient 12 years or older and/or the treatment of blepharospasm or hemifacial spasm in an adult, the applicant practitioner must: (a) have been trained by a specialist in ophthalmology in the administration of botulinum toxin pharmaceutical benefits to treat blepharospasm or hemifacial spasm; and (b) provide evidence of the applicant practitioner’s training, in the form of: (i) a letter from a person who is an eligible medical practitioner for this Special Arrangement, stating that the applicant practitioner has been the primary operator, under supervision, in at least 2 procedures administering a botulinum toxin pharmaceutical benefit; or (ii) a letter from the responsible person for a botulinum toxin pharmaceutical benefit that has the same listed drug as is listed in the column in Schedule 3 headed ‘Listed Drug in Relevant Pharmaceutical Benefit’ for the treatment conditions numbered 1 and/or 1A and/or 1B, stating that the practitioner has been the primary operator, under supervision, in at least 2 procedures administering a botulinum toxin pharmaceutical benefit. (5) If an applicant practitioner is a specialist in neurology, otolaryngology head and neck surgery or plastic surgery and seeks authorisation to administer a botulinum toxin pharmaceutical benefit, under this Special Arrangement, for the treatment of blepharospasm or hemifacial spasm in a patient 12 years or older and/or the treatment of blepharospasm or hemifacial spasm in an adult, the applicant practitioner must: (a) have been trained by a specialist in the same specialty as the applicant practitioner in the administration of botulinum toxin pharmaceutical benefits to treat blepharospasm or hemifacial spasm; and (b) provide evidence of the applicant practitioner’s training in the form of the following: (i) a letter from a person who is an eligible medical practitioner for this Special Arrangement, stating that the applicant practitioner has been the primary operator, under supervision, in at least 6 procedures administering a botulinum toxin pharmaceutical benefit; (ii) a letter from the responsible person for a botulinum toxin pharmaceutical benefit that has the same listed drug as is listed in the column in Schedule 3 headed ‘Listed Drug in Relevant Pharmaceutical Benefit’ for the treatment conditions numbered 1 and/or 1A and/or 1B, stating that the applicant practitioner has been the primary operator, under supervision, in at least 6 procedures administering a botulinum toxin pharmaceutical benefit. (6) If an applicant practitioner is a specialist in urology or urogynaecology and seeks authorisation to administer a botulinum toxin pharmaceutical benefit, under this Special Arrangement, for the treatment of urinary incontinence due to neurogenic detrusor overactivity, as demonstrated by urodynamic study for patients with multiple sclerosis, spinal cord injury or who are 18 years or older and have spina bifida, the applicant practitioner must provide evidence of successful training in the form of: (a) a Statutory Declaration outlining their involvement in at least 10 procedures administering botulinum toxin for the treatment of urinary incontinence, including the number performed under supervision; or (b) a written statetment from the provider of a course of training relating to the administration of botulinum toxin for the treatment of urinary incontinence, noting that this may have been completed overseas. (7) If an applicant practitioner is a specialist in neurology and seeks authorisation to administer a botulinum toxin pharmaceutical benefit, under this Special Arrangement, for the treatment of chronic migraine, the applicant practitioner must: (a) provide a statement that confirms the applicant practitioner has been: (i) involved in at least 10 unsupervised procedures administering a botulinum pharmaceutical benefit; or (ii) the primary operator, under supervision, in at least 6 procedures in administering botulinum toxin for chronic migraine; or (iii) provide a letter from a person who is an eligible medical practitioner for this Special Arrangement, stating that the applicant practitioner has been the primary operator, under supervision in at least 6 procedures, administering botulinum toxin pharmaceutical benefit for chronic migraine; and (b) provide a letter from the responsible person stating the applicant practitioner’s experience and/or training in administering a botulinum toxin pharmaceutical benefit for chronic migraine. (8) If an applicant practitioner is a specialist in urology or urogynaecology and seeks authorisation to administer a botulinum toxin pharmaceutical benefit, under this Special Arrangement, for the treatment of urinary incontinence due to idiopathic overactive bladder, the applicant practitioner must provide evidence of successful training in the form of: (a) a Statutory Declaration outlining their involvement in at least 10 procedures administering botulinum toxin for the treatment of urinary incontinence, including the number performed under supervision; or (b) a written statetment from the provider of a course of training relating to the administration of botulinum toxin for the treatment of urinary incontinence, noting that this may have been completed overseas.