Codes covered only if selection criteria met; prior auth as required

Certain CPT, HCPCS and ICD-10 codes listed in this policy are covered only when the policy’s selection criteria are met; obtain prior authorization as required by the payer for procedures and prosthesis insertion/replacement using these codes.

• Covered CPT codes include 31611 and 31360-31365 when selection criteria are met.
• Covered HCPCS include L8500, L8501, L8505, L8507, L8509, L8511–L8515 when selection criteria are met.
• Covered ICD-10 codes include C32.0–C32.9, D02.0, D14.1, Z85.21, Z90.02 when selection criteria are met.

PA must document pulmonary function and manual dexterity

Prior authorization documentation should confirm the member meets the policy’s selection criteria by demonstrating adequate pulmonary function to force air through the prosthesis and sufficient manual dexterity to care for the device daily.

• Document pulmonary function sufficient to force air from the trachea through the prosthesis into the esophagus.
• Document manual dexterity to clean and care for the prosthesis 2–3 times daily.

Check policy history and CPB for prior authorization requirements

Refer to the policy history and the Clinical Policy Bulletin (CPB) notes for any payer-specific prior authorization requirements or administrative details related to authorization.

• See Policy History (last review 07/27/2023; next review 06/13/2024) for administrative updates.
• See Clinical Policy Bulletin Notes for additional administrative information.

Recognize indwelling and non-indwelling devices as medically necessary when recommended

The policy recognizes both indwelling and non-indwelling TE voice prostheses as medically necessary when recommended by a laryngologist or speech-language pathologist; device choice may be based on prior device performance and device life evidence.

• Indwelling devices (e.g., Blom-Singer, Provox 2) are covered when recommended.
• Non-indwelling devices (e.g., Provox NiD) are covered when recommended and may be chosen based on durability or patient preference.

No explicit step therapy; use evidence to guide device sequencing

The policy does not impose explicit step therapy or mandatory device sequencing; clinical evidence comparing prosthesis types may inform device selection for failure modes like peri‑prosthetic or endoprosthesis leakage.

• No required trial of one prosthesis type before another is stated in the policy.
• Evidence (e.g., Provox Vega vs XtraSeal, Provox Vega vs ActiValve) may guide selection for recurrent leakage or frequent replacements.

Document removal/replacement technique (e.g., retrograde with Blom‑Singer TEP set)

Providers should follow the documented guidance for removal and replacement techniques (e.g., retrograde removal with the Blom‑Singer TEP set) and include the method used in procedure notes.

• If retrograde technique is used, document use of the Blom‑Singer TEP set and the steps taken to preserve the TEP tract.

Recommendation by laryngologist or SLP and replacement rationale required

A recommendation for initial insertion or replacement must come from a laryngologist or a speech‑language pathologist and the record must document the clinical rationale for replacement (e.g., leakage, device failure) consistent with the selection criteria.

• Treatment plan should state that recommendation was made by a laryngologist or speech‑language pathologist.
• Document the reason for replacement and note device lifespan expectation (typically 3–6 months when clinically indicated).

Document procedure method and confirm eligibility at time of service

Procedure documentation must state the removal/replacement method used and confirm the patient met the selection criteria (adequate pulmonary function and manual dexterity) at the time of service.

• Include the specific technique (e.g., retrograde removal) and devices/tools used.
• Confirm in the record that the member has adequate pulmonary function and manual dexterity per Appendix selection criteria.

Reference policy history for administrative requirements

Refer to the policy history for review dates and administrative changes; providers should consult the policy history for any updates that may affect coverage or preauthorization procedures.

• Last review: 07/27/2023; Effective date: 08/17/2001; Next review: 06/13/2024.

Document manual dexterity and pulmonary function — affects coverage

Patient suitability factors such as manual dexterity and pulmonary function directly affect candidacy and therefore coverage; document these clinical assessments in the medical record.

• Manual dexterity: ability to clean the prosthesis 2–3 times daily affects candidacy.
• Pulmonary function: ability to force air through the prosthesis into the esophagus must be demonstrated.

Not meeting selection criteria risks denial

Failure to meet the policy’s selection criteria (inadequate pulmonary function or insufficient manual dexterity) may result in denial of coverage; ensure documentation supports suitability.

• If records do not demonstrate the two Appendix selection criteria, prior authorization or claim payment may be denied.

CPB notes: guidance only; not an offer of coverage

Clinical Policy Bulletins are intended to assist in administering plan benefits and do not constitute offers of coverage; absence of coverage in a CPB does not change contract language—check member’s plan for definitive coverage terms.

• CPBs provide a general description of benefits and are not a contract or guarantee of coverage.