Voice Prosthesis, Electrolarynx and

Consumables Clinical Criteria

This criteriahas been developed in consultation with expert clinicians and is based on available evidence at the time of development. This document is designed to specify the criteria to access assistance through EnableNSW for this group of assistive technology, and provide a basis for consistent and transparent decision making.

Voice Prosthesis, electrolarynx and respiratory consumables for laryngectomy
Included Equipment - Voice / Allocation
Electrolarynx
OR
Indwelling Voice Prosthesis
OR
Non-indwelling Voice Prosthesis / 1
OR
Up to 2/yr
OR
Up to 6/yr
Voice Prosthesis Consumables: dilator; gel cap insertion system; gel caps; flushing device; cleaning brush / Once only
Eligible Prescriber
Speech Pathologist with >1 year experience + 3 previous prescriptions for equipment in this category
Included Equipment (Non Standard) - Voice / Allocation
Tracheostoma/hands free speech valve starter kit / Once only
Eligible Prescriber
Speech Pathologist with >3 years experience + 5 previous prescriptions for equipment in this category with input from the treating physician
Included Equipment – Respiratory Consumables / Allocation
Heat Moisture Exchangers (HME)
OR
Foam stoma covers / 365/yr
OR
365/yr
HME attachment devices:
Tracheostoma button
OR
Standard adhesive seals (base plates)
OR
Non-standard adhesive seals / 1/yr
OR
365/yr
OR
180/yr
Laryngectomy tubes (fenestrated or non-fenestrated) / 1/yr
Laryngectomy tubes/tracheostoma button securing device:
Neck straps / 12/yr
Eligible Prescriber
The primary prescribing team may include: Speech pathologist in consultation with a specialist physician in Respiratory Medicine, Ear Nose and Throat, Head and Neck, or Intensive Care.
Exclusions
  • Plug inserts for voice prostheses; cloth stoma covers; shower covers; silicone adhesive; adhesive barrier and remover products, lubricant.
  • Persons who have a short term need for equipment and consumables (less than 12 months)
  • Persons who have not completed an appropriate trial
  • Allocation over and above the listed supply
  • Consumables for short term (including post surgery while surgical sites settle), intermittent, episodic or emergency situations
  • Equipment to facilitate discharge
  • Equipment for treatment purposes
  • Batteries

Contracts in place / 318 Respiratory Consumables
Equipment Eligibility Criteria
  • Voice prostheses may be funded when the trache-oesophageal fistula is stable post surgery AND
the voice prosthesis is required for ongoing, long term use by the consumer for primary communication
  • Electrolarynx may be funded when the consumer requires an electrolarynx for primary communication
  • Laryngectomy Respiratory Consumables may be funded when a minimum 2 week trial has been completed AND the consumables are required for long term use (>12 months).
For laryngectomy respiratory consumables the most clinically appropriate, cost effective option should be considered. Therefore please assess the suitability of a tracheostoma button as a method of attaching heat moisture exchange cassettes
Key information to consider or include in the Equipment Request Form (ERF)
Factors
Confirm
  • The person’s diagnosis and/or functional disability including relevant surgical dates.
  • That the device will be required for ongoing, long term (> 12 months) use by the person.
  • For voice prostheses, that the trache-oesophageal fistula is stable.
Consider
  • That for non-indwelling voice prosthesis the person has the ability to clean the prosthesis insitu and can change the prosthesis or has access to a clinical specialist for device change.
  • That for indwelling voice prosthesis the person has the ability to clean the prosthesis insitu and has access to a clinical specialist for device change.
  • Information from the clinical and functional assessment of relevant skills including: ability to achieve functional voice, cognitive factors, dexterity, and vision.
  • Any relevant medical information that impacts on the person’s current and ongoing ability to use the device such as deterioration or improvement in condition, physiological issues, medications, planned surgery.

Social/ Carer Factors
Consider
  • Whether the carer is able to hear and/or understand the person’s speech when the device is being used.

Environmental and Equipment Factors
Consider
  • That a plan is in place for ongoing local clinical support.
  • That a plan for training has been made for the consumer, and if applicable the carer, regarding the use of the equipment, maintenance, cleaning and ongoing review.
  • That an emergency plan has been made for the consumer, in the event of equipment breakdown including early failure of the voice prosthesis. Please note that EnableNSW is not able to provide loan equipment or emergency orders in the event of unexpected equipment failure.

Trial
  • Trial of equipment is required.
  • Equipment on loan or equipment previously used constitutes a trial.
Provide
  • If non-standard equipment is requested describe how the features/specifications of the recommended equipment will meet the consumer’s needs in the most clinically appropriate and cost effective way.
Consider
  • The person’s functional use of the equipment such as: ability to operate the equipment, change or recharge batteries, clean device, and manage emergency situations.

Plan for delivery and evaluation
  • Provide delivery details and instructions including the name and contact details of the person/carer or any clinicians who should be notified of delivery.

APPENDIX 1.Non standard equipment

Equipment / Non standard equipment may be approved under exceptional circumstances when:
Tracheostoma/ hands free speech valve starter kit / The person is motivated to use hands free speech due to self care needs (please specify relevant self care needs). The person should demonstrate compliant use of heat moisture exchange devices and attachments, and have the required dexterity and cognitive ability to manage a hands free speech valve.
Non Standard Adhesive Seals / The person has trialled a standard adhesive seal for 2 months and due to poor seal or dexterity is unable to safely use the standard adhesive seal

APPENDIX 2.Non standard sUPPLY LEVELS

Equipment / Non standard annual allocation may be approved when:
Indwelling Voice Prosthesis / There is evidence of ongoing fungal infection with poor response to treatment, resulting in early failure of the voice prosthesis. Information regarding average device life of the voice prosthesis and what anti-fungal measures have been taken must be provided. Use of non indwelling prostheses, or fungal resistant voice prostheses, should be considered. A maximum supply of 4 indwelling voice prostheses may be supplied annually.

APPENDIX 3.vOICE PROSTHESIS CONSUMABLES

Equipment / Allocation Amount
Trache-oesophageal Dilator / One will be supplied for persons who independently change the voice prosthesis out of the clinical setting.
Gel Cap Insertion kit / One will be supplied for persons who independently change the voice prosthesis out of the clinical setting
Gel Caps / One pack will be supplied for persons who independently change the voice prosthesis out of the clinical setting.
Cleaning brushes and flushing device / One pack of each will be supplied.

Voice Related Devices and Respiratory ConsumablesJan 2016- 1 -