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Voice Prosthesis for Voice Rehabilitation Following Total Laryngectomy

Number: 0560



Policy
  1. Aetna considers indwelling tracheo-esophageal (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 the Appendix).

  2. Aetna considers replacement of indwelling TE 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 Blom-Singer Indwelling Low-Pressure Voice Prosthesis (Helix Medical Inc., Carpinteria, CA), Provox 2 (Atos Medical, Milwaukee, WI), and VoiceMaster (E. Bension Hood Laboratories, Inc., Pembroke, MA).

  3. Aetna considers hand-held artificial larynx devices such as the Nu Vois (Lauder Enterprises Inc., San Antonio, TX), the OptiVox (Bivona Medical Technologies, Gary, IN), the Servox (Seimens Hearing Instruments, Piscataway, NJ), the SolaTone and the TruTone (Griffin Laboratories, Temecula, CA), and the UltraVoice (UltraVoice, New Town Square, PA) medically necessary.
  4. Aetna considers non-indwelling voice prostheses (e.g., the Provox NiD, Atos Medical, Milwaukee, WI) 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).
Background

Tracheo-esophageal (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.

Tracheo-esophageal 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 1-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.

Non-Indwelling Voice Prothesis (e.g., the Provox NiD):

Hancock et al (2005) examined the feasibility of and patient satisfaction with the Provox NiD non-indwelling voice prosthesis.  Pre- and post-study questionnaires were used to evaluate the patients' former voice prosthesis and the Provox NiD voice prosthesis.  In addition, measurements of pull-out force, maximum phonation time and loudness were made for both voice prostheses.  In-vitro measurements of airflow characteristics were also made.  Following a 6-week trial, all patients provided feedback on the new voice prosthesis and the results were used to further improve the Provox NiD.  This final version of the new voice prosthesis was subsequently tried and evaluated by 10 patients 6 months later.  Overall results showed that patient satisfaction with the Provox NiD non-indwelling voice prosthesis was favorable.  The pull-out force for the new prosthesis was significantly higher than that for the formerly used prosthesis and its aerodynamic characteristics were better.   The authors concluded that the new Provox NiD non-indwelling voice prosthesis investigated in this study provided a good option for laryngectomized patients using non-indwelling voice prostheses and can potentially improve safety and increase patients' satisfaction with their voice and speech.

In a longitudinal retrospective cohort study, Lewin and colleagues (2014) evaluated the indications, complications, and device life of the Provox NiD in a large cohort at a tertiary US cancer center.  These investigators reviewed the records of patients who used the NiD prosthesis (2005 to 2011) for general indicators, device life, and complications.  A total of 186 patients who used the NiD were included (median follow-up of 21.4 months).  The NiD was placed at initial fit in 41 (22 %) patients, whereas 145 (78 %) tried a NiD after using another type of prosthesis.  Most patients used the NiD similarly to an indwelling device.  Median NiD device life was significantly longer than that of other non-indwelling prostheses (45 versus 29 days, p = 0.0061), and did not significantly differ from that of standard indwelling devices (45 versus 50 days, p = 0.4263); 38 % (71 of 189) of NiD users had a history of early leakage (less than 8 weeks) using a different prosthesis before trying the NiD.  Among patients with a pre-existing history of early leakage, almost 90 % of NiD prostheses outperformed the device life of other products.  The authors concluded that the NiD prosthesis offered satisfactory device life on a par with indwelling prostheses in this cohort of NiD users.  Coupled with favorable published airflow characteristics and satisfactory trachea-esophageal voice, these data suggested that the NiD offered a durable, low-cost prosthetic alternative in contemporary practice.  A unique indication for NiD may be improved device life in some patients with a history of early leakage.

 

Appendix

The following selection criteria apply to an indwelling or non-indwelling TE voice prosthesis for voice rehabilitation following total laryngectomy:

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

  2. Member should have the manual dexterity to care for the voice prosthesis daily.
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes covered if selection criteria are met:
31611 Construction of tracheoesophageal fistula and subsequent insertion of an alaryngeal speech prosthesis (e.g., voice button, Blom-Singer prosthesis)
Other CPT codes related to the CPB:
31360 - 31365 Laryngectomy, total
HCPCS codes covered if selection criteria are met:
L8500 Artificial larynx, any type
L8501 Tracheostomy speaking valve
L8505 Artificial larynx replacement battery/accessory, any type
L8507 Tracheo-esophageal voice prosthesis, patient inserted, any type, each [e.g., the Provox NiD]
L8509 Tracheo-esophageal voice prosthesis, inserted by a licensed health care provider, any type
L8511 Insert for indwelling tracheoesophageal prosthesis, with or without valve, replacement only, each
L8512 Gelatin capsules or equivalent, for use with tracheoesophageal voice prosthesis, replacement only, per 10
L8513 Cleaning device used with tracheoesophageal voice prosthesis, pipet, brush, or equal, replacement only, each
L8514 Tracheoesophageal puncture dilator, replacement only, each
L8515 Gelatin capsule, application device for use with tracheoesophageal voice prosthesis, each
ICD-9 codes covered if selection criteria are met:
161.0 - 161.9 Malignant neoplasm of larynx
212.1 Benign neoplasm of larynx
231.0 Carcinoma in situ of larynx
V10.21 History of malignant neoplasm of larynx
CPT Codes / HCPCS Codes / ICD-10 Codes
Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+":
ICD-10 codes will become effective as of October 1, 2015:
CPT codes covered if selection criteria are met:
31611 Construction of tracheoesophageal fistula and subsequent insertion of an alaryngeal speech prosthesis (e.g., voice button, Blom-Singer prosthesis)
Other CPT codes related to the CPB:
31360 - 31365 Laryngectomy, total
HCPCS codes covered if selection criteria are met:
L8500 Artificial larynx, any type
L8501 Tracheostomy speaking valve
L8505 Artificial larynx replacement battery/accessory, any type
L8507 Tracheo-esophageal voice prosthesis, patient inserted, any type, each [e.g., the Provox NiD]
L8509 Tracheo-esophageal voice prosthesis, inserted by a licensed health care provider, any type
L8511 Insert for indwelling tracheoesophageal prosthesis, with or without valve, replacement only, each
L8512 Gelatin capsules or equivalent, for use with tracheoesophageal voice prosthesis, replacement only, per 10
L8513 Cleaning device used with tracheoesophageal voice prosthesis, pipet, brush, or equal, replacement only, each
L8514 Tracheoesophageal puncture dilator, replacement only, each
L8515 Gelatin capsule, application device for use with tracheoesophageal voice prosthesis, each
ICD-10 codes covered if selection criteria are met:
C32.0 - C32.9 Malignant neoplasm of larynx
D02.0 Carcinoma in situ of larynx
D14.1 Benign neoplasm of larynx
Z85.21 Personal history of malignant neoplasm of larynx


The above policy is based on the following references:
    1. Blom ED. Current status of voice restoration following total laryngectomy. Oncology. 2000;14(6):915-922. 
    2. Ackerstaff AH, Hilgers FJ, Meeuwis CA, et al. Multi-institutional assessment of the Provox 2 voice prosthesis. Arch Otolaryngol Head Neck Surg. 1999;125(2):167-173. 
    3. Graville D, Gross N, Andersen P, et al. The long-term indwelling tracheoesophageal prosthesis for alaryngeal voice rehabilitation. Arch Otolaryngol Head Neck Surg. 1999;125(3):288 -292. 
    4. Leder SB, Erskine MC. Voice restoration after laryngectomy: Experience with the Blom-Singer extended-wear indwelling tracheoesophageal voice prosthesis. Head Neck. 1997;19(6):487-493. 
    5. Aust MR, McCaffrey TV. Early speech results with the Provox prosthesis after laryngectomy. Arch Otolaryngol Head Neck Surg. 1997;123(9):966-968. 
    6. Hilgers FJ, Ackerstaff AH, Balm AJ, et al. Development and clinical evaluation of a second-generation voice prosthesis (Provox 2), designed for anterograde and retrograde insertion. Acta Otolaryngol. 1997;117(6):889-896. 
    7. van den Hoogen FJ, Meeuwis C, Oudes MJ, et al. The Blom-Singer tracheostoma valve as a valuable addition in the rehabilitation of the laryngectomized patient. Eur Arch Otorhinolaryngol. 1996;253(3):126-129. 
    8. van den Hoogen FJ, Oudes MJ, Hombergen G, et al. The Groningen, Nijdam and Provox voice prosthesis: A prospective clinical comparison based on 845 replacements. Acta Otolaryngol. 1996;116(1):119-124. 
    9. Castellanos PF, et al. Tumors of the larynx and laryngopharynx. In: Otorhinolaryngology. Head and Neck Surgery. 15th ed. Ch. 32. JJ Ballenger, JB Snow, eds. Baltimore, MD: Williams & Wilkins; 1996:585-652. 
    10. Chung RP, Dagli AS, Geskus J, et al. The ultra-low resistance Groningen voice prosthesis: Clinical experiences. Rev Laryngol Otol Rhinol (Bord). 2001;122(2):129-133.
    11. Trussart C, Lawson G, Remacle M. Voice prostheses: Long-term follow-up retrospective study (three- to sixteen-year follow-up of 22 patients). Rev Laryngol Otol Rhinol (Bord). 2003;124(5):299-304.
    12. Makitie AA, Niemensivu R, Juvas A, et al. Postlaryngectomy voice restoration using a voice prosthesis: A single institution's ten-year experience. Ann Otol Rhinol Laryngol. 2003;112(12):1007-1010.
    13. Pou AM. Tracheoesophageal voice restoration with total laryngectomy. Otolaryngol Clin North Am. 2004;37(3):531-545.
    14. Bunting GW. Voice following laryngeal cancer surgery: Troubleshooting common problems after tracheoesophageal voice restoration. Otolaryngol Clin North Am. 2004;37(3):597-612.
    15. Gerwin JM, Culton GL. Quality of life in prosthetic voice users. Otolaryngol Head Neck Surg. 2005;133(5):685-688.
    16. Leder S B, Acton L M, Kmiecik J, et al. Voice restoration with the advantage tracheoesophageal voice prosthesis. Otolaryngol Head Neck Surg. 2005;133(5):681-684.
    17. Schwandt LQ, Tjong-Ayong HJ, van Weissenbruch R, et al. Differences in aerodynamic characteristics of new and dysfunctional Provox 2 voice prostheses in vivo. Eur Arch Otorhinolaryngol. 2006;263(6):518-523.
    18. Kazi R, Kiverniti E, Prasad V, et al. Multidimensional assessment of female tracheoesophageal prosthetic speech. Clin Otolaryngol. 2006;31(6):511-517.
    19. Traissac L, Chene G, Devars F, et al. Voice rehabilitation after total laryngectomy using the Newvox voice prosthesis. Rev Laryngol Otol Rhinol (Bord). 2007;128(3):163-172.
    20. Soolsma J, van den Brekel MW, Ackerstaff AH, et al. Long-term results of Provox ActiValve, solving the problem of frequent candida- and "underpressure"-related voice prosthesis replacements. Laryngoscope. 2008 Feb;118(2):252-257.
    21. Boscolo-Rizzo P, Zanetti F, Carpené S, Da Mosto MC. Long-term results with tracheoesophageal voice prosthesis: Primary versus secondary TEP. Eur Arch Otorhinolaryngol. 2008;265(1):73-77.
    22. Jacobs K, Delaere PR, Vander Poorten VL. Submucosal purse-string suture as a treatment of leakage around the indwelling voice prosthesis. Head Neck. 2008;30(4):485-491.
    23. Kosztyła-Hojna B, Rogowski M, Łuczaj J, Kasperuk J. The voice and speech quality in laryngectomy patients rehabilitated with second generation voice prosthesis. Pol Merkur Lekarski. 2008;25(147):230-235.
    24. Mastronikolis NS, Stathas T, Papadas TA, et al. Voice restoration after total laryngectomy using provox 2 (generation II) prosthesis. Eur Rev Med Pharmacol Sci. 2008;12(5):327-330.
    25. Deschler DG, Bunting GW, Lin DT, et al. Evaluation of voice prosthesis placement at the time of primary tracheoesophageal puncture with total laryngectomy. Laryngoscope. 2009;119(7):1353-1357.
    26. Hilgers FJ, Ackerstaff AH, Jacobi I, et al. Prospective clinical phase II study of two new indwelling voice prostheses (Provox Vega 22.5 and 20 Fr) and a novel anterograde insertion device (Provox Smart Inserter). Laryngoscope. 2010;120(6):1135-1143.
    27. Kapila M, Deore N, Palav RS, et al. A brief review of voice restoration following total laryngectomy. Indian J Cancer. 2011;48(1):99-104.
    28. Reumueller A, Leonhard M, Mancusi G, et al. Pharyngolaryngectomy with free jejunal autograft reconstruction and tracheoesophageal voice restoration: Indications for replacements, microbial colonization, and indwelling times of the Provox 2 voice prostheses. Head Neck. 2011;33(8):1144-1153.
    29. Zimmer-Nowicka J, Morawiec-Sztandera A. Causes and indwelling times of multiple voice prosthesis replacements in patients after total laryngectomy -- analysis of 184 replacements in 42 patients. Otolaryngol Pol. 2012;66(5):322-327.
    30. Hilgers FJ, Dirven R, Wouters Y, et al. A multicenter, prospective, clinical trial evaluating a novel adhesive baseplate (Provox StabiliBase) for peristomal attachment of postlaryngectomy pulmonary and voice rehabilitation devices. Laryngoscope. 2012;122(11):2447-2453.
    31. Choussy O, Hibon R, Bon Mardion N, Dehesdin D. Management of voice prosthesis leakage with Blom-Singer large esophage and tracheal flange voice prostheses. Eur Ann Otorhinolaryngol Head Neck Dis. 2013;130(2):49-53.
    32. Lewin JS, Portwood MA, Wang Y, Hutcheson KA. Clinical application of the Provox NiD voice prosthesis: A longitudinal study. Laryngoscope. 2014;124(7):1585-1591.
    33. Zocratto OB, Vieira MB, Maia AF, et al. The Amatsu's tracheoesophageal shunt: Analysis of 84 cases. J Voice. 2014;28(4):512-514.
    34. Hancock K, Houghton B, Van As-Brooks CJ, Coman W. First clinical experience with a new non-indwelling voice prosthesis (Provox NID) for voice rehabilitation after total laryngectomy. Acta Otolaryngol. 2005;125(9):981-990.
    35. Kılıç C, Tunçel U, Comert E. Provox 2 use for voice restoration after total laryngectomy. Kulak Burun Bogaz Ihtis Derg. 2014;24(6):339-343.
    36. Polat B, Orhan KS, Kesimli MC, et al. The effects of indwelling voice prosthesis on the quality of life, depressive symptoms, and self-esteem in patients with total laryngectomy. Eur Arch Otorhinolaryngol. 2014 Oct 19  [Epub ahead of print].
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