Medicare Benefits Schedule - Note TN.11.1

The Therapeutic Goods Administration (TGA) assesses each indication for the therapeutic use of botulinum toxin on an individual basis.  There are currently three botulinum toxin agents with TGA registration (Botox®, Dysport® and Xeomin®).  Each has undergone a separate evaluation of its safety and efficacy by the TGA as they are neither bioequivalent, nor dose equivalent.  When claiming under an item for the injection of botulinum toxin, only the botulinum toxin agent specified in the item can be used.  Benefits are not payable where an agent other than that specified in the item is used. 

The TGA assesses each indication for the therapeutic use of botulinum toxin by assessment of clinical evidence for its use in paediatric or adult patients.  Where an indication has been assessed for adult use, data has generally been assessed using patients over 12 years of age.  Paediatric indications have been assessed using data from patients under 18 years of age.  Botulinum toxin should only be administered to patients under the age of 18 where an item is for a paediatric indication, and patients over 12 years of age where the item is for an adult indication, unless otherwise specified. 

Items for the administration of botulinum toxin can only be claimed by a medical practitioner who is recognised as an eligible medical practitioner for the relevant indication under the arrangements under Section 100 of the National Health Act 1953 (the Act) relating to the use and supply of botulinum toxin.  The specialist qualifications required to administer botulinum toxin vary across the indications for which the medicine is listed on the PBS, and are detailed within the relevant PBS restrictions available at: www.pbs.gov.au/browse/section100-mf 

Item 18354 for the treatment of equinus, equinovarus or equinovalgus is limited to a maximum of 4 injections per patient on any day (2 per limb).  Accounts should be annotated with the limb which has been treated.  Item 18292 may not be claimed for the injection of botulinum toxin, but may be claimed where a neurolytic agent (such as phenol) is used, in addition to botulinum toxin injection(s), to treat the obturator nerve in patients with a dynamic foot deformity. 

Treatment under item 18375 or 18379 can only continue if the patient achieves at least a 50% reduction in urinary incontinence episodes from baseline from the start of week 6 through to the end of week 12 after the first treatment.  The term 'continue' means the patient can be retreated under item 18375 or 18379 at some point after the 12 week period (for example; 6 to 12 months after the first treatment).  This requirement is in line with the PBS listing for the supply of the medicine for this indication under Section 100 of the Act. 

Item 18362 for the treatment of severe primary axillary hyperhidrosis allows for a maximum number of 3 treatments per patient in a 12 month period, with no less than 4 months to elapse between treatments. 

Botulinum toxin which is not supplied and administered in accordance with the arrangements under Section 100 of the Act is not required to be provided free of charge to patients.  Where a charge is made for the botulinum toxin administered, it must be separately listed on the account and not billed to Medicare.  Since 1 September 2015, PBS patient co-payments have applied to botulinum toxin supplied and administered in accordance with the arrangements under Section 100 of the Act. 

The Department of Human Services (DHS) has developed a Health Practitioner Guideline to substantiate that a patient had a pre-existing condition at the time of the service which is located on the DHS website.

Related Items: 18350 18351 18353 18354 18360 18361 18362 18365 18366 18368 18369 18370 18372 18374 18375 18377 18379

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Botulinum Toxin Type A Purified Neurotoxin Complex (Botox), injection of, for the treatment of hemifacial spasm in a patient who is at least 12 years of age, including all such injections on any one day

Fee: $137.45 Benefit: 75% = $103.10 85% = $116.85

(See para TN.11.1 of explanatory notes to this Category)

Clostridium Botulinum Type A Toxin-Haemagglutinin Complex (Dysport), injection of, for the treatment of hemifacial spasm in a patient who is at least 18 years of age, including all such injections on any one day

Fee: $137.45 Benefit: 75% = $103.10 85% = $116.85

(See para TN.11.1 of explanatory notes to this Category)

Botulinum Toxin Type A Purified Neurotoxin Complex (Botox) or Clostridium Botulinum Type A Toxin-Haemagglutinin Complex (Dysport) or IncobotulinumtoxinA (Xeomin), injection of, for the treatment of cervical dystonia (spasmodic torticollis), including all such injections on any one day

Fee: $274.85 Benefit: 75% = $206.15 85% = $233.65

(See para TN.11.1 of explanatory notes to this Category)

Botulinum Toxin Type A Purified Neurotixin Complex (Botox) or Clostridium Botulinum Type A Toxin-Haemagglutinin Complex (Dysport), injection of, for the treatment of dynamic equinus foot deformity (including equinovarus and equinovalgus) due to spasticity in an ambulant cerebral palsy patient, if:

(a)    the patient is at least 2 years of age; and

(b)    the treatment is for all or any of the muscles subserving one functional activity and supplied by one motor nerve,     with a maximum of 4 sets of injections for the patient on any one day (with a maximum of  2 sets of injections for     each lower limb), including all injections per set

(Anaes.)

Fee: $137.45 Benefit: 75% = $103.10 85% = $116.85

(See para TN.7.5, TN.11.1 of explanatory notes to this Category)

Botulinum Toxin Type A Purified Neurotoxin Complex (Botox), or Clostridium Botulinum Type A Toxin Haemagglutinin Complex (Dysport), injection of, for the treatment of moderate to severe focal spasticity, if:

(a)    the patient is at least 18 years of age; and

(b)    the spasticity is associated with a previously diagnosed neurological disorder; and

(c)    treatment is provided as:

    (i)    second line therapy when standard treatment for the conditions has failed; or

    (ii)    an adjunct to physical therapy; and

(d)    the treatment is for all or any of the muscles subserving one functional activity and supplied by one motor nerve,     with a maximum of 4 sets of injections for the patient on any one day (with a maximum of 2 sets of injections for     each limb), including all injections per set; and

(e)    the treatment is not provided on the same occasion as a service mentioned in item 18365

Fee: $137.45 Benefit: 75% = $103.10 85% = $116.85

(See para TN.11.1 of explanatory notes to this Category)

Clostridium Botulinum Type A Toxin-Haemagglutinin Complex (Dysport) or Botulinum Toxin Type A Purified Neurotoxin Complex (Botox), injection of, for the treatment of moderate to severe upper limb spasticity due to cerebral palsy if:

(a) the patient is at least 2 years of age; and

(b) the treatment is for all or any of the muscles subserving one functional activity and supplied by one motor nerve, with a maximum of 4 sets of injections for the patient on any one day (with a maximum of 2 sets of injections for each upper limb), including all injections per set

(Anaes.)

Fee: $137.45 Benefit: 75% = $103.10 85% = $116.85

(See para TN.11.1 of explanatory notes to this Category)

Botulinum Toxin type A Purified Neurotoxin Complex (Botox), injection of, for the treatment of severe primary axillary hyperhidrosis, including all injections on any one day, if:

(a)    the patient is at least 12 years of age; and

(b)    the patient has been intolerant of, or has not responded to, topical aluminium chloride hexahydrate; and

(c)    the patient has not had treatment with botulinum toxin within the immediately preceding 4 months; and

(d)    if the patient has had treatment with botulinum toxin within the previous 12 months - the patient had treatment on no     more than 2 separate occasions

(Anaes.)

Fee: $271.55 Benefit: 75% = $203.70 85% = $230.85

(See para TN.11.1 of explanatory notes to this Category)

Botulinum Toxin Type A Purified Neurotoxin Complex (Botox) or Clostridium Botulinum Type A Toxin-Haemagglutinin Complex (Dysport) or IncobotulinumtoxinA (Xeomin), injection of, for the treatment of moderate to severe spasticity of the upper limb following an acute event, if:

(a) the patient is at least 18 years of age; and

(b) treatment is provided as:

    (i)  second line therapy when standard treatment for the condition has failed; or

    (ii) an adjunct to physical therapy; and

(c) the patient does not have established severe contracture in the limb that is to be treated; and

(d) the treatment is for all or any of the muscles subserving one functional activity and supplied by one motor nerve, with a maximum of 4 sets of injections for the patient on any one day (with a maximum of 2 sets of injections for each upper limb), including all injections per set; and

(e) for a patient who has received treatment on 2 previous separate occasions - the patient has responded to the treatment

Fee: $137.45 Benefit: 75% = $103.10 85% = $116.85

(See para TN.11.1 of explanatory notes to this Category)

Botulinum Toxin Type A Purified Neurotoxin Complex (Botox), injection of, for the treatment of strabismus, including all such injections on any one day and associated electromyography

(Anaes.)

Fee: $172.15 Benefit: 75% = $129.15 85% = $146.35

(See para TN.11.1 of explanatory notes to this Category)

Botulinum Toxin Type A Purified Neurotoxin Complex (Botox), injection of, for the treatment of spasmodic dysphonia, including all such injections on any one day

Fee: $293.90 Benefit: 75% = $220.45 85% = $249.85

(See para TN.11.1 of explanatory notes to this Category)

Clostridium Botulinum Type A Toxin-Haemagglutinin Complex (Dysport) or IncobotulinumtoxinA (Xeomin), injection of, for the treatment of unilateral blepharospasm in a patient who is at least 18 years of age, including all such injections on any one day

(Anaes.)

Fee: $49.55 Benefit: 75% = $37.20 85% = $42.15

(See para TN.11.1 of explanatory notes to this Category)

Botulinum Toxin Type A Purified Neurotoxin Complex (Botox), injection of, for the treatment of unilateral blepharospasm in a patient who is at least 12 years of age, including all such injections on any one day

(Anaes.)

Fee: $49.55 Benefit: 75% = $37.20 85% = $42.15

(See para TN.11.1 of explanatory notes to this Category)

Botulinum Toxin Type A Purified Neurotoxin Complex (Botox), injection of, for the treatment of bilateral blepharospasm, in a patient who is at least 12 years of age; including all such injections on any one day

(Anaes.)

Fee: $137.45 Benefit: 75% = $103.10 85% = $116.85

(See para TN.11.1 of explanatory notes to this Category)

Clostridium Botulinum Type A Toxin-Haemagglutinin Complex (Dysport) or IncobotulinumtoxinA (Xeomin), injection of, for the treatment of bilateral blepharospasm in a patient who is at least 18 years of age, including all such injections on any one day

(Anaes.)

Fee: $137.45 Benefit: 75% = $103.10 85% = $116.85

(See para TN.11.1 of explanatory notes to this Category)

Botulinum Toxin Type A Purified Neurotoxin Complex (Botox), intravesical injection of, with cystoscopy, for the treatment of urinary incontinence, including all such injections on any one day, if:

(a) the urinary incontinence is due to neurogenic detrusor overactivity as demonstrated by urodynamic study of a patient with:

(i) multiple sclerosis; or

(ii) spinal cord injury; or

(iii) spina bifida and who is at least 18 years of age; and

(b) the patient has urinary incontinence that is inadequately controlled by anti-cholinergic therapy, as manifested by having experienced at least 14 episodes of urinary incontinence per week before commencement of treatment with botulinum toxin type A; and

(c) the patient is willing and able to self-catheterise; and

(d) the requirements relating to botulinum toxin type A under the Pharmaceutical Benefits Scheme are complied with; and

(e) treatment is not provided on the same occasion as a service described in item 104, 105, 110, 116, 119, 11900 or 11919

For each patient - applicable not more than once except if the patient achieves at least a 50% reduction in urinary incontinence episodes from baseline at any time during the period of 6 to 12 weeks after first treatment

(Anaes.)

Fee: $253.05 Benefit: 75% = $189.80

(See para TN.11.1 of explanatory notes to this Category)

Botulinum Toxin Type A Purified Neurotoxin Complex (Botox), injection of, for the treatment of chronic migraine, including all injections in 1 day, if:

(a)    the patient is at least 18 years of age; and

(b) the patient has experienced an inadequate response, intolerance or contraindication to at least 3 prophylactic migraine medications before commencement of treatment with botulinum toxin, as manifested by 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, before commencement of treatment with botulinum toxin; and

(c)    the requirements relating to botulinum toxin type A under the Pharmaceutical Benefits Scheme are complied with

For each patient-applicable not more than twice except if the patient achieves and maintains at least a 50% reduction in the number of headache days per month from baseline after 2 treatment cycles (each of 12 weeks duration)

Fee: $137.45 Benefit: 75% = $103.10 85% = $116.85

(See para TN.11.1 of explanatory notes to this Category)

Botulinum Toxin Type A Purified Neurotoxin Complex (Botox), intravesical injection of, with cystoscopy, for the treatment of urinary incontinence, including all such injections on any one day, if:

(a)    the urinary incontinence is due to idiopathic overactive bladder in a patient: and

(b)    the patient is at least 18 years of age; and

(c)    the patient has urinary incontinence that is inadequately controlled by at least 2 alternative anti-

    cholinergic agents, as manifested by having experienced at least 14 episodes of urinary incontinence per week

    before commencement of treatment with botulinum toxin; and

(d)    the patient is willing and able to self-catheterise; and

(e)    treatment is not provided on the same occasion as a service mentioned in item 104, 105, 110, 116, 119, 11900 or     11919

For each patient-applicable not more than once except if the patient achieves at least a 50% reduction in urinary incontinence episodes from baseline at any time during the period of 6 to 12 weeks after first treatment

(H)  

(Anaes.)

Fee: $253.05 Benefit: 75% = $189.80

(See para TN.11.1 of explanatory notes to this Category)