US · guidance
CMS Pub. 100-03, ch. 1, § 50.4
Tracheostomy Speaking Valve
CIM 65-16
A trachea tube has been determined to satisfy the definition of a prosthetic device, and
the tracheostomy speaking valve is an add on to the trachea tube which may be
considered a medically necessary accessory that enhances the function of the tube. In
other words, it makes the system a better prosthesis. As such, a tracheostomy speaking
valve is covered as an element of the trachea tube which makes the tube more effective.
History
(Rev. 1, 10-03-03)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-08-25
- Edition
- iom-2026-08-25
- Content hash
560365c5fdd8f9124230b3153fd166aa8e28b5b758355f78380d6f68187bcd94
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Unofficial copy of government-published law, reproduced from official sources with full provenance. Not an official publication; verify against official sources before relying on it in a filing. Records in the 'guidance' corpus, and only that corpus, are sub-regulatory (interpretive guidelines, survey procedures) and are not binding law. Validity bounds follow each jurisdiction's declared temporalBasis.