1. Aetna considers indwelling tracheoesophageal (TE) voice prosthesis medically necessary when it is recommended by a laryngologist or a speech-language pathologist for voice rehabilitation following total laryngectomy (see selection criteria in appendix).

2. Aetna considers replacement of indwelling tracheoesophageal voice prosthesis medically necessary.  Medically necessary replacement every 3 to 6 months is consistent with the documented life span of most of these prostheses.  Replacement is usually carried out as an outpatient procedure.

   Notes:  Indwelling TE voice prostheses available in the Unites States include Provox 2 (Atos Medical, Milwaukee, WI), VoiceMaster (E. Bension Hood Laboratories, Inc., Pembroke, MA), and Blom-Singer Indwelling Low-Pressure Voice Prosthesis (Helix Medical Inc., Carpinteria, CA).

3. Aetna considers handheld artificial larynx devices such as the Servox (Seimens Hearing Instruments, Piscataway, NJ), the UltraVoice (UltraVoice, New Town Square, PA), the OptiVox (Bivona Medical Technologies, Gary, IN), the TruTone and the SolaTone (Griffin Laboratories, Temecula, CA), and the Nu Vois (Lauder Enterprises Inc., San Antonio, TX) medically necessary.

Tracheoesophageal (TE) voice prostheses allow laryngectomized patients to produce TE speech by shunting air from the lungs into the esophagus and vibrating the esophageal tissue.  Blom and Singer were the first to use TE voice prosthesis for voice rehabilitation following total laryngectomy.  Panje designed a similar prosthesis with an extra flange that helped to secure the prosthesis in the fistula.  This fixation method is now known as indwelling or semi-permanent fixation.

Tracheoesophageal voice prostheses have been shown to provide good voice and speech results following total laryngectomy as a consequence of disease (e.g., laryngeal tumors).  The procedures for restoring phonation after total laryngectomy, usually performed under general or local anesthesia, entail puncturing the back wall of the trachea to form a passage with the front wall of the esophagus.  After creation of a hole (tracheostoma), the Blom-Singer or another type of TE prosthesis is inserted and secured using the flanges of the prosthesis.  To speak, the patient inhales deeply and as the patient exhales, air is shunted into the esophagus, producing TE speech.  There is a one-way valve on the distal tip of the prosthesis, which is inserted into the esophagus.  This allows air to pass from the trachea through the prosthesis and into the esophagus.  The valve prevents aspiration from the esophagus into the trachea.  In older models of TE voice prosthesis, the patient had to cover the tracheostoma with his/her thumb to speak.  Studies have reported that the short-term success rate for TE speech rehabilitation to be 80 to 90%; however, the long-term success rate is reported to be approximately 70%.  

It is important that patients have the manual dexterity to clean the prosthesis 2 to 3 times every day.  They should have adequate pulmonary function to force air from the trachea through the prosthesis into the esophagus.  Thus, patients who have poor manual dexterity (e.g., individuals with severe rheumatoid arthritis, amputations, or deformities of the upper extremities) or those with severe pulmonary disease and/or repeated pneumonitis are poor candidates for TE voice prosthesis under accepted guidelines.  Furthermore, patients should also be motivated in using the prosthesis.

Leakage of fluid (saliva, reflux) through or around a voice prosthesis as well as increased airflow resistance are the main indications to remove the prosthesis for inspection and, if necessary, for replacement.  The general life span of TE voice prosthesis is 3 to 6 months.  Variations in diet as well as compliance with daily maintenance affect the durability of the prosthesis.  Replacement of TE voice prosthesis should only be carried out by a physician or a speech-language pathologist; and is usually performed in an outpatient setting.

Appendix

The following selection criteria apply to an indwelling tracheoesophageal voice prosthesis for voice rehabilitation following total laryngectomy:

1. Member should have the manual dexterity to care for the voice prosthesis daily; and

2. Member should have adequate pulmonary function to force air from the trachea through the prosthesis into the esophagus.