Voice Related Devices and Respiratory Consumables Clinical Criteria This criteria has 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 1 Indwelling Voice Prosthesis or Up to 2/yr Non-indwelling Voice Prosthesis Up to 6/yr Voice Prosthesis Consumables: dilator; gel cap insertion system; gel caps; Once only flushing device; cleaning brush 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) 365/yr OR OR Foam stoma covers 365/yr HME attachment devices: Tracheostoma button 1/yr OR OR Standard adhesive seals (base plates) 365/yr OR OR Non-standard adhesive seals 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. Consumers who have a short term need for equipment and consumables (less than 12 months) Consumers 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 Voice Related Devices and Respiratory Consumables V2 August 2014 -1- Voice Related Devices and Respiratory Consumables Clinical Criteria This criteria has 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. Contracts in place 318 Respiratory Consumables Ineligible Groups Consumers who are eligible for services and equipment to be provided under any of the following will not be eligible to receive equipment through EnableNSW (see EnableNSW Policy). ADHC owned and operated supported accommodation facilities Respite or temporary care facilities Transitional Aged Care Package Commonwealth Home Care Packages (levels 1-4) Motor Accidents Authority Lifetime Care and Support Authority Dust Disease Board Department of Veteran’s Affairs Gold Card holder Department of Veteran’s Affairs White Card holder if the requested assistive technology is for an injury/condition developed during/or as a result of time in service Third party/Worker’s Compensation/other compensation related to the injury/disease 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. Voice Related Devices and Respiratory Consumables V2 August 2014 -2- Voice Related Devices and Respiratory Consumables Clinical Criteria This criteria has 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. Key information to consider or include in the Equipment Request Form (ERF) Consumer Factors Confirm The consumer’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 consumer. For voice prostheses, that the trache-oesophageal fistula is stable. Consider That for non-indwelling voice prosthesis the consumer 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 consumer 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 consumer’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 consumer’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 consumer’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 consumer/carer or any clinicians who should be notified of delivery. Voice Related Devices and Respiratory Consumables V2 August 2014 -3- Voice Related Devices and Respiratory Consumables Clinical Criteria This criteria has 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. APPENDIX 1. NON STANDARD EQUIPMENT Equipment Non standard equipment may be approved under exceptional circumstances when: Tracheostoma/ The consumer is motivated to use hands free speech due to self care needs hands free speech (please specify relevant self care needs). The consumer should demonstrate valve starter kit 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 The consumer has trialled a standard adhesive seal for 2 months and due to poor Adhesive Seals 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 Trache-oesophageal Dilator Gel Cap Insertion kit Gel Caps Cleaning brushes and flushing device Allocation Amount One will be supplied for consumers who independently change the voice prosthesis out of the clinical setting. One will be supplied for consumers who independently change the voice prosthesis out of the clinical setting One pack will be supplied for consumers who independently change the voice prosthesis out of the clinical setting. One pack of each will be supplied. Voice Related Devices and Respiratory Consumables V2 August 2014 -4-