Aerosolized Anti-infective Treatment for Sinusitis — Clinical/Medical Policy (ENT)
Defines SelectHealth's coverage position for aerosolized (nebulized) anti-infective treatments for sinusitis across commercial, Medicare Advantage, and Medicaid lines; affects prescribing providers and billing staff processing related claims.
Policy Summary
PayerSelectHealth
PolicyAerosolized Anti-infective Treatment for Sinusitis
Policy CodePolicy N/A
Change TypeCoverage clarifications and criteria revisions
Effective DateMay 25, 2023
Next Review DateN/A
Key ActionVerify member benefits and obtain required prior authorization when requesting coverage; aerosolized anti-infective therapy for sinusitis is not covered.
Reformatted overall criteria to show differences in coverage criteria according to plan type/area and removed coverage of Auditory Brainstem Implants for Commercial Plan Policy.
Modified language in 'Limited benefit from amplification' requirements for adults to align with updated clinical standards adopted by CMS.
Added the requirement: Select Health covers communication devices when used only for activities of daily living (ADL); and when desired results cannot be achieved through using natural communication methods.
Changed the minimum age eligible for this treatment in criterion #1 from 18 to 7 years, then later from 7 years to 8 years to align with FDA approval.
For Commercial Plan Policy, added coverage criteria for Colorado Based Plans effective 1/1/24.
Lowered age requirement for commercial plan policy from 22 years to 18 years and added coverage criteria for adolescents with Down Syndrome (ages 13 to 18); modified AHI eligibility to 15–100 events/hour and clarified polysomnography timing to within 24 months.
Not covered
Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.
coverage stance
2 uncontrolled + 1 RCTstudies summarized
3-monthrequired hearing aid trial
>=5 yrsminimum pediatric CI age
HCPCS/CPT/J listedcoding section present
Coverage Criteria and Medical Necessity
inv-01: Not covered — experimental/investigational
Policy coverage determination
Primary coverage rule: Aerosolized anti-infective therapy for the treatment of sinusitis is considered experimental/investigational and is not covered due to inadequate published clinical evidence of effectiveness.
Applies to SelectHealth Commercial and CHIP plans; clinical evidence summarized in the policy shows weak and inconsistent results.
inv-02: Coverage by product — coverage stance varies by product
Coverage stance varies by product:
Commercial and CHIP: Select Health does NOT cover altered auditory feedback (AAF) devices for the treatment of stuttering; these devices are considered experimental/investigational.
Applies to SelectHealth Commercial and CHIP plans.
Medicare: Coverage is determined by the Centers for Medicare & Medicaid Services (CMS); if CMS has not adopted a coverage determination and InterQual criteria are not available, the Select Health Commercial policy applies.
Providers should check the CMS coverage database for current Medicare positions.
State Medicaid (Utah): Coverage is determined by the Utah State Medicaid program; if Utah Medicaid has no published position and InterQual criteria are not available, the Select Health Commercial criteria apply.
Providers should consult Utah Medicaid resources for state-specific policy.
inv-03: Conductive or Mixed Hearing Loss — Medical Necessity
Covered when ALL of the following are met for conductive or mixed hearing loss:
Clinical eligibility: Unilateral or bilateral implantable osseointegrated bone conduction device is being considered as an alternative to an air-conduction hearing aid in patients 5 years of age or older who meet at least one medical criterion (e.g., congenital or surgically induced malformations refractory to medical therapy; chronic external otitis/dermatitis or otitis media that has failed appropriate medical therapy; tumors of the external canal or tympanic cavity; inability to use traditional amplification after middle ear surgery).age >= 5 years
Medical criteria listed in policy (examples in source).
Audiologic criteria: Pure tone average bone-conduction threshold measured at 0.5, 1, 2, and 3 kHz meets device-specific FDA-established levels for the intended device; for bilateral implantation, interaural symmetry requirements apply.device-specific bone-conduction PTA limits; interaural difference <10 dB average or <15 dB at individual frequencies
Specific device thresholds and interaural symmetry parameters are listed in the policy text.
inv-04: Single-Sided Sensorineural Deafness — Medical Necessity
Covered when ALL of the following are met for single-sided sensorineural deafness (SSD):
SSD criteria: Patient has congenital or acquired severe-to-profound sensorineural hearing loss in the affected ear; cochlear implant is not appropriate or indicated; the osseointegrated bone conduction device will be implanted in the affected ear.severe-to-profound SSD
Bone-anchored hearing aids using a headband are covered when implantation is not possible (e.g., due to age or skull bone thickness) and other criteria are met; other uses are investigational.
inv-05: General cochlear implant coverage criteria
Covered when ALL of the following are met for Utah-based plans (and as specified for other state plan variations):
Age eligibility: Patient meets age requirements for the indicated subgroup (e.g., children: >=9 months for bilateral CI consideration; adult SSD/AHL criteria reference age >=18).Children: >= 9 months; Adults: see subgroup criteria
Age thresholds vary by indication and plan; see subgroup-specific criteria.
Hearing loss severity: Member has severe-to-profound sensorineural hearing loss meeting PTA definitions used in policy: severe = three-frequency PTA >=70 dB; profound = three-frequency PTA >=90 dB at 1000, 2000, and 4000 Hz.PTA >=70 dB (severe) or >=90 dB (profound)
PTA calculated at 1000, 2000, and 4000 Hz per policy; 500 Hz excluded.
Limited benefit from hearing aids: Documented limited benefit from appropriately fitted hearing aids after a medically appropriate 3-month trial, defined for adults as <=60% correct on recorded open-set sentence tests in best-aided condition; for children, age-appropriate metrics apply and pediatric 'insufficient access' may be defined as aided monosyllabic word scores <=5%.
inv-06: Adult SSD/AHL criteria
Covered for single-sided deafness (SSD) or asymmetric hearing loss (AHL) in adults when:
Age: Member is 18 years of age or older.>= 18 years
Applies to adult unilateral cochlear implantation for SSD/AHL.
Limited benefit: Documented limited benefit from unilateral amplification: <=60% correct on recorded open-set sentence tests in the best-aided condition after at least a 3-month trial of hearing aid/CROS/other device without subjective benefit.<= 60% correct; 3-month trial
Exceptions to the trial may be made for documented clinical reasons.
inv-07: Pediatric SSD/AHL criteria (ages 5–18)
Covered for pediatric SSD/AHL when ALL are met:
Age: Member is between 5 and 18 years of age.5 <= age <= 18
Applies to pediatric unilateral cochlear implantation for SSD/AHL.
Hearing loss severity: Severe-to-profound sensorineural hearing loss in at least one ear as defined by PTA thresholds in policy (PTA >=70 dB or >=90 dB at 1000, 2000, 4000 Hz as specified).PTA >=70 dB or >=90 dB per definition
PTA calculated at 1000, 2000, 4000 Hz; 500 Hz excluded.
Hearing aid trial: Medically appropriate 3-month hearing aid trial demonstrating insufficient access to sound, defined as aided speech perception test scores of 5% or less on developmentally appropriate monosyllabic word lists in the ear to be implanted alone, unless an exception is documented.
inv-08: Covered indications — grouped coverage criteria per subgroup
Covered when ALL of the following are met (per the specific subgroup below):
Adult unilateral CI for SSD/AHL: Adult (>=18) with single-sided deafness or asymmetric hearing loss; limited benefit from unilateral amplification defined as <=60% correct in best-aided open-set sentence testing; at least a 3-month hearing aid/CROS/other device trial without subjective benefit is required unless an exception applies.>=18 years; <=60% correct; 3-month trial
Exceptions include urgent clinical circumstances (e.g., meningitis, sudden hearing loss) with documented clinical rationale.
Pediatric unilateral CI for SSD (age 5-18): Member aged 5-18 with severe-to-profound sensorineural hearing loss in at least one ear meeting PTA thresholds AND a medically appropriate 3-month hearing aid trial showing 'insufficient access to sound' (aided monosyllabic word scores <=5%) unless exception is documented.5-18 years; PTA thresholds per policy; aided score <=5%; 3-month trial
PTA thresholds and testing methods are specified in policy text.
inv-09: Covered criteria (Commercial plan and CHIP)
Covered when ALL of the following are met
ADL and assessment requirements: Device is used only for activities of daily living (ADL) and desired results cannot be achieved through natural communication methods; device recommended by a speech-language pathologist after a thorough assessment including diagnosis, functional impairments, prognosis, expected goals, and demonstration of ability to use the device in a home setting for 3 months.3-month home trial
SLP should hold appropriate certification where required.
Physical and cognitive ability: Patient is physically and cognitively able to use the device independently without assistance.
If complex/high-tech device requested, provide rationale why less sophisticated device will not meet needs.
Restorative devices post-surgery: Speech generating devices applied to neck/throat necessary to restore spoken language after surgical loss of intelligible speech are considered restorative and covered as prosthesis under standard DME limitations.
inv-10: Commercial plan coverage criteria
Covered when ALL of the following are met
Age: Patient is 8 years of age or older.>= 8 years
This reflects the revised minimum age in the commercial plan criteria.
Tympanometry: Tympanogram demonstrates Type B or Type C.Type B or C
Required as part of assessment prior to Eustachian tube balloon dilation.
ETDQ-7 average score (total divided by 7) is greater than 2.1 after medical management.ETDQ-7 > 2.1
Score should be obtained after at least 8 weeks of medical management unless contraindicated.
inv-11: Age eligibility (commercial plan)
Policy includes age-based eligibility criteria for commercial plans (details in criterion #1 altered in revisions).
Age eligibility edits: Minimum eligible age for the referenced commercial plan criterion was sequentially revised (previously changed from 18 to 7 years, then to 8 years) to align with FDA approvals; current minimum age stated in policy is >= 8 years for the affected procedure.age >= 8 years
Full, detailed criteria for the procedure are located elsewhere in the policy.
inv-12: Initial therapy — Inspire (adults)
Covered when ALL of the following are met:
Inspire adult coverage criteria: 1) Age > 18 years; 2) Moderate-to-severe OSA with AHI 15–100 events/hour confirmed by polysomnography or home sleep testing within 24 months of consult; 3) Central and mixed apneas comprise <=25% of total AHI; 4) Recommendations from both an ENT and a sleep specialist; 5) Documentation of CPAP failure (AHI > 15 despite CPAP) or CPAP intolerance (use <4 hours/night on >=5 nights/week) or non-compliance for >=6 months; 6) No anatomical findings that would compromise performance (e.g., complete concentric collapse); 7) BMI < 40 kg/m2; 8) Dental appliance deemed ineffective or inappropriate; 9) Implantation performed by an ENT.AHI 15-100 events/hour; BMI <40; age >18
Criteria reflect current commercial plan indications and revision history adjustments.
inv-13: Adolescent (Down syndrome) — Inspire
Covered when ALL of the following are met:
Inspire adolescent (Down syndrome) criteria: 1) Age 13–18 years; 2) Severe OSA with AHI >=10 and <=50; 3) No anatomical findings that would compromise device performance (including no complete concentric collapse at the soft palate as determined by drug-induced sleep endoscopy); 4) Consideration of all other standard alternative/additional treatments; 5) Central and mixed apneas comprise <25% of AHI; 6) Documentation of CPAP failure or CPAP intolerance or non-compliance for >=6 months; 7) Recommendation by both an ENT and a sleep specialist; 8) Implantation performed by an ENT.AHI >=10 to <=50; age 13-18
This subgroup was added in revision history to reflect adolescents with Down syndrome.
inv-14: Hearing aids (Colorado plans)
Covered when ALL of the following are met:
Hearing aids (CO plans) criteria: 1) Covered for members ages 18 and under; 2) Hearing loss verified by a physician licensed pursuant to Colorado statute and medically appropriate per accepted professional standards; 3) Coverage includes initial and replacement hearing aids not more frequently than every 5 years and a new aid when alterations cannot adequately meet needs; 4) Coverage includes related services and supplies such as assessment, fitting, adjustments, and auditory training per accepted professional standards.age <= 18 years; replacement <= every 5 years
These Colorado-specific requirements were added effective 1/1/24.
inv-15: Inspire Upper Airway Stimulation — Covered with criteria
Covered when ALL of the following are met
Inspire UAS coverage prerequisites: Patient meets FDA/policy indications: age eligibility per subgroup (commercial adults >=18; adolescents with Down syndrome 13–18 when specified), moderate-to-severe OSA with AHI 15–100 events/hour confirmed within 24 months, BMI <40 kg/m2, documentation of PAP (CPAP/BPAP) failure or intolerance (AHI >15 despite CPAP use) or non-compliance for >=6 months, central/mixed apneas <=25% of AHI, and recommendations from ENT and sleep specialists.AHI 15-100 events/hr; BMI <40; timing of study within 24 months
Evidence base summarized in policy indicates low-to-moderate quality studies (e.g., STAR trial) supporting effectiveness in selected patients.
inv-16: Coverage criteria for Meniett device
Covered when ALL of the following are met
Meniett coverage criteria: 1) Device recommended by a board-certified otolaryngologist; 2) Despite maximal medical therapy the member continues to experience debilitating vertigo; 3) Member successfully completes a 2-month trial of therapy before Select Health will approve purchase of the device.2-month trial
Only the Meniett device is covered; other low-pressure pulsatile devices are considered experimental/investigational.
inv-17: Palatal implants (Pillar) — Not Covered
Palatal implants (Pillar) coverage stance
Palatal implants - Coverage stance: Select Health does NOT cover palatal (Pillar) implants for snoring or obstructive sleep apnea; these implants are considered experimental/investigational and not covered under Commercial Plan and CHIP.
Associated not-covered billing codes are listed in the policy.
inv-18: Phrenic nerve stimulation (Remede) — Covered with criteria
Phrenic nerve stimulation (PNS) covered when ALL criteria met
PNS coverage criteria: 1) Moderate-to-severe central sleep apnea diagnosed by an overnight in-lab study; AND 2) Failed adaptive support ventilation (ASV) such as BiPAP/CPAP or ASV/CPAP is not medically appropriate.AHI thresholds per policy (moderate-to-severe)
Applicable to adults; devices such as the Remede System are referenced.
inv-19: Phrenic Nerve Stimulation (PNS) — Medical Necessity
Select Health considers phrenic nerve stimulation medically necessary when ALL of the following are met:
PNS medical necessity: 1) Moderate-to-severe central sleep apnea established by an overnight in-lab study; 2) Failed adaptive support ventilation (ASV) (e.g., BiPAP or CPAP) or ASV is not medically appropriate for the patient.AHI thresholds consistent with moderate-to-severe CSA
Prior authorization required; applies to adult members.
inv-20: Propel and Sinuva Implants — Medical Necessity
Select Health may cover either the Propel implant during surgical treatment or the Sinuva implant postoperatively when ALL of the following are met:
Propel/Sinuva coverage criteria: 1) Age >= 18 years; 2) Chronic rhinosinusitis with severe bilateral polyposis (multiple polyps in each nasal vault); 3) Previous history of sinus surgery; 4) No sensitivity to mometasone furoate; 5) Failed >=3 months of maximal medical therapy (topical and oral steroids); 6) Propel used intraoperatively in ethmoid, maxillary, or frontal sinuses or Sinuva used outpatient for ethmoid or frontal sinuses.one implant per rolling 12 months
Coverage limited to one Propel (intraoperative) or one Sinuva (postoperative) per rolling 12 months.
inv-21: Eligibility for Propel (intraoperative) or Sinuva (postoperative)
Covered when ALL of the following are met:
Propel/Sinuva eligibility: 1) Age >= 18 years; 2) Chronic rhinosinusitis with severe polyposis (bilateral with multiple polyps in each nasal vault); 3) Previous history of sinus surgery; 4) No sensitivity to mometasone furoate; 5) Failed 3 months of maximal medical therapy (topical and oral steroids); 6) Propel used intraoperatively in ethmoid, maxillary, or frontal sinuses or Sinuva used outpatient for ethmoid or frontal sinuses.
One implant per rolling 12 months; aspirin-sensitive patients should preferentially consider desensitization for asthma when appropriate.
SelectHealth considers aerosolized (nebulized) anti-infective therapy for the treatment of sinusitis to be experimental/investigational and not covered. This determination is based on limited and inconsistent clinical evidence from small uncontrolled studies and a single randomized trial that showed no clear additional benefit of adding antibiotics to nebulized saline, and on the absence of guideline endorsement for this treatment approach.
SelectHealth does not cover altered auditory feedback (AAF) devices (e.g., SpeechEasy) for the treatment of stuttering under Commercial and CHIP plans; these devices are classified as experimental/investigational and claims for such devices will be denied.
Temporal bone osseointegrated (bone-anchored) devices are considered investigational for indications not specifically listed in the policy, including use for bilateral sensorineural hearing loss; such uses are not covered.
Certain Idaho plan products (Small Employer and Individual plans) exclude coverage for cochlear implants, hearing aids, and osseointegrated bone conduction devices for adults; exceptions are limited (for example, dependent children with congenital or acquired hearing loss at risk for developmental deficits). Coverage is always subject to the member's specific benefit contract.
Auditory brainstem implants were removed from coverage for the SelectHealth Commercial Plan policy during the documented reformattings and are excluded for that plan type.
Devices and accessories primarily intended for educational use are not covered. SelectHealth lists specific speech-generating device (SGD) HCPCS codes (e.g., E2500–E2508, E2511, E2512) as investigational/unproven and excludes them from coverage when used primarily for educational purposes.
SelectHealth does not cover repeated balloon dilation of the Eustachian tube; repeated procedures are considered experimental/investigational and will not be authorized.
Inclusion or exclusion of a procedure, diagnosis, or device code in this policy does not by itself guarantee member coverage or reimbursement. Coverage decisions depend on the member's individual benefit plan in effect at the time of service and verification of eligibility and benefits is required prior to authorization.
The Inspire Upper Airway Stimulation system is covered only when specified candidacy criteria are met; it is not intended for patients with a documented complete concentric collapse at the soft palate and requires documentation such as age, AHI within the policy-specified range, prior PAP failure/intolerance, specialty recommendations, BMI limits, and absence of disqualifying anatomic findings.
SelectHealth does not cover the Latera Absorbable Nasal Implant for Commercial Plan and CHIP; the device is considered experimental/investigational due to insufficient published evidence on safety and health outcomes.
Low-pressure pulsatile therapy is covered only for the specified Meniett system; SelectHealth does not cover other low-pressure pulsatile devices for Meniere's disease, which are considered experimental/investigational.
Otoplasty (CPT 69300) is listed as not covered for the indications described in the microtia repair section of the policy excerpt.
Palatal implants (Pillar procedure) for snoring or obstructive sleep apnea are classified as investigational/unproven and are not covered; related unlisted CPT/HCPCS codes (e.g., 42299, C9727) are noted as non-covered.
SelectHealth may authorize either a Propel (intraoperative) or a Sinuva (postoperative) implant only when all clinical criteria are met, and coverage is limited to one implant per rolling 12 months. Evidence limitations noted in the policy (small heterogeneous trials, short follow-up, lack of head-to-head comparisons) are cited when considering these devices.
The policy documents methodological limitations in the evidence for sinus implants versus standard postoperative care — trials are small and heterogeneous, often lack active comparators and adequate follow-up, and some were manufacturer-sponsored; these limitations mean implants cannot be considered a demonstrated substitute for optimal standard post-operative management.
Available literature on aerosolized antibiotics for sinusitis is mixed and limited to small uncontrolled and randomized trials; overall the evidence does not support a routine clinical benefit from adding nebulized antibiotics to saline and professional society guidelines do not endorse routine use.
Published studies of altered auditory feedback and related device trials report variable, individualized responses and no consistent long-term benefit across participants; larger randomized studies are lacking and results are mixed.
Use of osseointegrated devices to rehabilitate bilateral sensorineural hearing loss is considered investigational/experimental in indications not specified by the policy (and therefore not covered).
Services or procedures that fall outside the member's defined benefit or that do not meet the policy's candidacy criteria (for example, age limits, audiologic thresholds, or required trials) may be denied; providers must verify member benefits and obtain any required preauthorization before proceeding.
Procedures for which the patient does not meet documented candidacy criteria — such as required pure-tone average thresholds, speech perception test results, or completion of medically appropriate hearing aid trials — are not covered as medically necessary.
Billing and Coding
Covered HCPCS CodesHCPCSCovered
A7013
Filter; disposable; used with aerosol compressor or ultrasonic generator
A7014
Filter; nondisposable, used with aerosol compressor or ultrasonic generator
A7015
Aerosol mask, used with DME nebulizer
E0572
Aerosol compressor; adjustable pressure, light duty for intermittent use
E0574
Ultrasonic electronic aerosol generator with small volume nebulizer
E0575
Nebulizer; ultrasonic, large volume
E0580
Nebulizer; durable, glass or autoclavable plastic, bottle type, for use with regulator or flowmeter
E0585
Nebulizer; with compressor and heater
J7685
Tobramycin, inhalation solution, compounded product, administered through DME, unit dose form, per 300 milligrams
Nebulizer/DME Misc HCPCSHCPCS
E1399
Durable medical equipment, miscellaneous
Cochlear Implant CPT CodesCPTCovered
69930
Cochlear device implantation, with or without mastoidectomy
92601
Diagnostic analysis of cochlear implant; patient younger than 7 years of age; with programming
92602
Diagnostic analysis of cochlear implant; patient younger than 7 years of age; subsequent reprogramming
92603
Diagnostic analysis of cochlear implant; age 7 or older; with programming
92604
Diagnostic analysis of cochlear implant; age 7 years or older; subsequent reprogramming
Cochlear Implant HCPCS/L-CodesHCPCSCovered
L8614
Cochlear device, includes all internal and external components
L8615
Headset/headpiece for use with cochlear implant device, replacement
L8616
Microphone for use with cochlear implant device, replacement
L8617
Transmitting coil for use with cochlear implant device, replacement
L8618
Transmitter cable for use with cochlear implant device or auditory osseointegrated device, replacement
L8619
Cochlear implant external speech processor and controller; integrated system, replacement
L8621
Zinc air battery for use with cochlear implant device and auditory osseointegrated sound processors, replacement; each
L8622
Alkaline battery for use with cochlear implant device, any size
L8623
Lithium ion battery for use with cochlear implant device speech processor, other than ear level, replacement; each
L8624
Lithium ion battery for use with cochlear implant or auditory osseointegrated device speech processor; ear level, replacement; each
1–10 of 14
1/2
Communication Devices CoveredmixedCovered
92521
Evaluation of speech fluency (eg, stuttering, cluttering)
Open implantation of hypoglossal nerve neurostimulator array, pulse generator; and distal respiratory sensor electrode or electrode array
64583
Revision or replacement of hypoglossal nerve neurostimulator array and distal respiratory sensor electrode or electrode array, including connection to existing pulse generator
64584
Removal of hypoglossal nerve neurostimulator array, pulse generator; and distal respiratory sensor electrode or electrode array
64999
Unlisted procedure, nervous system (When specified as implantation of a hypoglossal nerve stimulator)
L8679
Implantable neurostimulator; pulse generator; any type
L8680
Implantable neurostimulator electrode, each
L8686
Implantable neurostimulator pulse generator; single array, nonrechargeable, includes extension
Latera / Nasal Valve Repair Not Covered CodesCPTNot Covered
30468
Repair of nasal valve collapse with low energy, temperature-controlled (eg, radiofrequency) subcutaneous/submucosal remodeling
30469
Repair of nasal valve collapse with low energy, temperature-controlled (eg, radiofrequency) subcutaneous/submucosal remodeling
C9749
Repair of nasal vestibular lateral wall stenosis with implant(s)
Insertion or replacement of neurostimulator system for treatment of central sleep apnea; complete system
0425T
Insertion or replacement; sensing lead only
0426T
Insertion or replacement; stimulation lead only
0427T
Insertion or replacement; pulse generator only
0428T
Removal of neurostimulator system; pulse generator only
33276
Insertion of phrenic nerve stimulator system (pulse generator and stimulating lead[s])
33277
Insertion of phrenic nerve stimulator transvenous sensing lead
33278
Removal of phrenic nerve stimulator; system, including pulse generator and lead(s)
Prior Authorization, Documentation, and Billing Actions
Note
Coverage determination varies by program
Coverage determinations vary by line of business. For Medicare Advantage, applicable CMS/NCD/LCD determinations take precedence; if no CMS determination exists and InterQual criteria are unavailable, SelectHealth Commercial criteria apply. For State Medicaid (Community Care), state Medicaid policy governs; if no state position exists and InterQual criteria are unavailable, SelectHealth Commercial criteria apply. Verify program-specific coverage before submitting an authorization request.
Medicaid: follow the State of Utah (or relevant state) Medicaid coverage position first.
Prior Authorization
Prior authorization required when requesting implantation
Prior authorization is required for requests involving implantation procedures (for example, cochlear implants, osseointegrated bone conduction devices, Inspire UAS, phrenic nerve stimulation, and other implantable devices). Obtain preauthorization and confirm the member’s specific plan benefit (including any plan limits or grandfathered plan exclusions) before scheduling the procedure.
Key Definitions and Terms
Aerosolized anti-infective therapy definition
DefinitionDelivery of compounded antibiotic, antifungal, or other anti-infective medications as an aerosolized solution via a nebulizer into the nasal/sinus cavities (examples: PARI Sinus, Sinus Dynamics).
Typical administrationPatient pours individual dose into nebulizer cup and inhales nasally for ~10 minutes, typically twice daily for 2–3 weeks.
Device requirementLarge-volume or specially designed nebulizer systems are used to generate particles sized to deposit within paranasal sinuses.
Altered auditory feedback (AAF) definition
DefinitionDevices that provide auditory feedback via an earpiece using delayed auditory feedback (DAF) or frequency-altered feedback (FAF) to alter perceived timing or pitch of the user's voice.
Examples
Background and Evidence Summary
Aerosolized anti-infective therapy delivers compounded antibiotic or antifungal medications as an aerosolized solution via a nebulizer into the nasal/sinus cavities (examples of devices cited in the literature include large-volume nebulizers such as PARI Sinus and Sinus Dynamics). Treatments are typically self-administered intranasally for approximately 10 minutes twice daily for 2–3 weeks. The clinical evidence for efficacy and safety is weak, consisting mainly of small uncontrolled studies and one randomized trial, and professional treatment guidelines do not recommend routine use.
Policy Summary
PayerSelectHealth
PolicyAerosolized Anti-infective Treatment for Sinusitis
Policy CodePolicy N/A
Change TypeCoverage clarifications and criteria revisions
Effective DateMay 25, 2023
Next Review DateN/A
Key ActionVerify member benefits and obtain required prior authorization when requesting coverage; aerosolized anti-infective therapy for sinusitis is not covered.
Exceptions to the hearing aid trial may apply for clinical urgencies (e.g., meningitis, sudden hearing loss).
3-month trial; aided score <=5%
Exceptions allowed for urgent clinical circumstances.
Pediatric unilateral CI for AHL (age 5-18): Member aged 5-18 with asymmetric hearing loss with severe-to-profound sensorineural loss in at least one ear (PTA >=70 or >=90 dB at 1000,2000,4000 Hz), a 3-month hearing aid trial with insufficient access (<=5%), and a difference of at least 15 dB PTA between ears.5-18 years; PTA >=70/>=90 dB; aided score <=5%; interaural PTA difference >=15 dB; 3-month trial
Audiologic definitions and allowed exceptions are detailed in the policy.
Standard DME frequency/limitations apply.
Medical management duration: Failure of medical management after at least 8 weeks of decongestants (unless contraindicated).>= 8 weeks
Imaging demonstrates absence of internal carotid artery dehiscence into the Eustachian lumen bilaterally.
Bilateral imaging confirmation required.
Examples: cochlear implant CPT 69930 and associated HCPCS L86xx device codes; Inspire implantation and device programming codes; PNS insertion/replacement CPT/HCPCS/T-codes.
Failure to obtain prior authorization may result in denial or reduced payment.
Note
Benefit verification & criteria confirmation
Verify member benefits and eligibility at the time of service. Coverage of devices and procedures depends on the member’s contract and plan-specific rules; inclusion of codes in policy does not guarantee member coverage.
Contact Customer Service using the number on the member ID card for benefit confirmation.
Providers may contact SelectHealth Provider Relations for questions about policy application.
Documentation Required
Prior authorization and documentation required
Prior authorization must include all required clinical documentation to support medical necessity. Incomplete or missing documentation is a common reason for denial.
Include diagnostic testing, specialist recommendations, prior therapy documentation, and device-specific audiology or sleep reports as applicable.
Confirm and obtain preauthorization prior to device purchase or implantation.
Billing Rule
Inspire UAS procedure and device codes (authorization relevant)
Inspire UAS: include procedure and device codes and supporting documentation with any authorization request. Authorization review will consider both the implantation procedure codes and device-related supply/programming codes.
Required coding examples (use when applicable): procedure CPT/HCPCS/T codes for implantation and device-specific codes per policy.
Provide ENT and sleep specialist recommendations, recent sleep study (within 24 months), and CPAP failure/intolerance documentation.
Prior Authorization
Prior authorization for Meniett device
Meniett device (low-pressure pulsatile therapy) requires prior authorization. A board-certified otolaryngologist must recommend the device and the member must complete a successful 2-month trial prior to approval for purchase.
Coverage limited to Meniett device only; other low-pressure pulsatile devices are investigational and not covered.
Document recommendation by board-certified otolaryngologist, evidence of failure of maximal medical therapy, and completion/success of the 2-month trial.
Always verify benefits and obtain preauthorization where required. Policies are updated regularly; confirming plan-level coverage and prior authorization requirements prevents claim denials.
Inclusion of procedure or device codes in policy is informational only and does not guarantee member coverage.
Contact Customer Service or Provider Relations to confirm preauthorization requirements and obtain prior authorization numbers.
Denial Risk
Investigational / excluded uses — denial risk
Investigational, experimental, or excluded devices and indications will be denied. Examples include aerosolized anti-infective therapy for sinusitis, altered auditory feedback (AAF) devices for stuttering, intra-oral bone conduction hearing aids, Latera absorbable nasal implant, palatal (Pillar) implants for snoring/OSA, and other therapies explicitly labeled investigational in policy.
Aerosolized anti-infective therapy for sinusitis — denied as investigational.
AAF devices (SpeechEasy) for stuttering — not covered (investigational).
Intra-oral bone conduction devices and Latera implant — investigational and not covered.
Palatal implants (Pillar) — not covered; CPT/unspecified unlisted palate procedure codes may be denied.
Denial Risk
Repeated procedure denial risk
Repeated or multiple procedures designated investigational will be denied. For example, repeated Eustachian tube balloon dilations are considered investigational and not covered.
Eustachian tube: repeat balloon dilations are considered experimental — denials likely for repeat procedures.
Repeated use/purchase of investigational devices will be denied.
Denial Risk
Denial triggers for hearing aids (Colorado)
For Colorado plans, physician verification is required for hearing aid coverage per state statute. Absence of the required physician verification or other state-specific documentation may lead to denial.
Colorado: hearing loss must be verified by a physician licensed under the applicable state statute; include required physician verification in the authorization/claim documentation.
Check state plan rules (e.g., age limits, frequency of replacement) and include statutory attestations when required.
Denial Risk
Non-covered devices — denial trigger
Requests to purchase non-covered devices (devices explicitly labeled non-covered or investigational in policy other than specified covered devices such as Meniett) will be denied. Do not submit authorization or claim for non-covered devices without discussing benefit exceptions.
Example: purchase requests for pulsatile devices other than Meniett will be denied.
Providers should verify device coverage before procurement; obtaining prior authorization does not guarantee coverage of non-covered devices.
Denial Risk
Palatal implants — not covered
Palatal implants (e.g., Pillar) for snoring or obstructive sleep apnea are not covered. These are considered investigational/experimental and will be denied.
Billing: unlisted palate/uvula CPT 42299 or related codes for palatal implants may be denied as investigational.
Do not submit for coverage unless there is an explicit plan exception or contract language authorizing the service.
Note
Benefits verification
Benefits must be verified prior to providing services. Verify member eligibility, benefit limits (including cochlear implant benefit limitations), and any plan exclusions or grandfathered plan rules at the time of the request.
Benefit verification required at time of service; use member ID card Customer Service number.
Cochlear implants may be a limited benefit under some grandfathered plans — confirm applicability to the member.
Documentation Required
Required audiologic documentation
Required audiologic documentation must be submitted with authorization requests for hearing-related implants and devices. Provide device-specific FDA threshold compliance, pure-tone averages, speech perception scores, and best-aided test results where applicable.
Include PTA (0.5, 1, 2, 3/4 kHz) bone-conduction thresholds per device FDA-specified levels.
Provide best-aided speech perception scores (e.g., sentence or monosyllabic word tests) and symmetry data for bilateral implant considerations.
Documentation Required
Required clinical documentation
Provide required clinical documentation supporting medical necessity: specialty recommendations, diagnostic testing, duration and results of prior therapies, symptom questionnaires (e.g., ETDQ-7), tympanograms, and imaging when indicated.
Examples: ENT or otologist recommendation, tympanogram Type B/C for Eustachian tube procedures, ETDQ-7 score, imaging demonstrating lack of carotid dehiscence for ET balloon dilation.
For cochlear implants: audiology reports, documented limited benefit from appropriately fitted hearing aids, and speech perception testing.
Documentation Required
Required SLP assessment and home trial
For augmentative and alternative communication devices, include a thorough SLP assessment and documentation of a home trial (at least 3 months) demonstrating the patient’s ability to use the device and that less complex devices are insufficient.
SLP assessment must document diagnosis, functional impairments, prognosis, goals, and rationale why a higher-tech device is necessary.
Document a 3-month home trial (use logs or objective data) showing device use and functional benefit.
Documentation Required
Required documentation for medical necessity
For procedures requiring medical management trials, document age, duration of conservative therapy, test scores, and other required elements per policy. Lack of required documentation will result in denial.
Eustachian tube balloon dilation: age ≥8 years, tympanogram Type B or C, ETDQ-7 score, at least 8 weeks of decongestants (unless contraindicated), transnasal endoscopy, and imaging to rule out ICA dehiscence.
Cochlear implant: age requirements, documented 3-month hearing aid trial (unless exception), and objective speech perception/PTA results.
Note
Confirm benefits and preauthorization
Confirm benefits and obtain preauthorization prior to device purchase or scheduling procedures. Contact Customer Service or Provider Relations to determine whether prior authorization is required and which documentation must be submitted.
Providers should not assume coverage based on policy language alone; benefit verification is required.
Preauthorization contact information: use the number on the member ID card or SelectHealth Provider Relations.
Documentation Required
Required documentation for coverage — specialty procedures
For coverage determinations that require specialty support (e.g., PNS, Inspire, cochlear implantation), include all required diagnostic studies, specialty recommendations, and prior therapy failure documentation with the authorization request.
PNS: overnight in-lab diagnosis documenting central sleep apnea and documentation of failed ASV/CPAP or inappropriateness.
Inspire: ENT and sleep specialist recommendations, polysomnography/home sleep test within 24 months, and CPAP failure/intolerance evidence.
Note
Contact and benefit verification
Contact Customer Service or Provider Relations to verify benefits and preauthorization requirements for the member before delivering services. Providers may be directed to submit full clinical records to support medical necessity.
Provider Relations phone: (801) 442-3692 (as listed in policy source).
Member Customer Service: number on member ID card.
Prior Authorization
PNS documentation requirements
Phrenic nerve stimulation (PNS) prior authorization requires documentation of an in-lab overnight diagnosis of central sleep apnea and prior failure or inappropriateness of ASV/CPAP. Include applicable insertion, removal, and programming CPT/T codes in the authorization request.
Documentation: overnight in-lab study confirming moderate-to-severe central sleep apnea.
Codes to include when requesting authorization: 0424T–0436T (T-codes), and relevant 3327x series CPT codes for insertion/removal/programming.
Denial Risk
Evidence does not support routine coverage
The evidence does not support routine coverage for therapies labeled investigational in policy (for example, aerosolized anti-infective therapy for sinusitis). Such requests should be denied unless new evidence or program-specific exceptions apply.
Aerosolized anti-infective therapy: inadequate clinical evidence — considered experimental/investigational and not covered for sinusitis.
Requests for investigational therapies should include supporting peer-reviewed evidence for reconsideration.
Note
Alternative to conventional hearing aids — osseointegrated devices
Osseointegrated/implantable bone conduction devices are an alternative to conventional air-conduction hearing aids when specified medical and audiologic criteria are met. For candidates, document inability to use traditional amplification and meet device-specific audiologic thresholds.
Provide documentation of congenital or surgically-induced external ear canal malformations, chronic external otitis/dermatitis refractory to therapy, tumors, or inability to use hearing aids.
Include device-specific FDA threshold compliance and audiology reports.
Step Therapy
Hearing aid trial requirement
A documented hearing aid trial is required prior to cochlear implantation in most circumstances. Typically a medically appropriate 3-month trial with appropriately fitted binaural hearing aids is required unless a clinical exception is documented.
For children and adults, document a 3-month hearing aid trial and objective measures of limited benefit (e.g., ≤60% sentence scores for adults; age-appropriate measures for children).
Exceptions allowed for urgent clinical circumstances (e.g., meningitis, sudden profound loss) if documented.
Step Therapy
Amplification trial step (cochlear candidacy)
Amplification trial expectations: demonstrate limited benefit from appropriately fitted hearing aids before advanced interventions. For adults, limited benefit is defined as ≤60% correct on open-set sentence tests in best-aided condition.
Children: use age-appropriate tests (e.g., ESP, MLNT/LNT) with defined thresholds for limited benefit.
Document the fitting, verification, and trial period in the audiology report.
Step Therapy
Step to consider less-sophisticated devices first
Consider and document less-sophisticated or conservative devices/therapies before approving complex or implantable devices. Authorization reviewers expect rationale why a simpler device would not meet the patient’s needs.
For communication devices: SLP must justify why a higher-tech device is necessary and why less complex devices are insufficient.
For OSA and similar conditions: document trials of first-line, less invasive therapies prior to implantable solutions.
Step Therapy
Conservative therapy required before procedure
Conservative therapy must be documented as failed before proceeding with certain procedures. For example, Eustachian tube balloon dilation requires at least 8 weeks of medical management (e.g., decongestants) unless contraindicated; Propel/Sinuva require failure of 3 months of maximal medical therapy prior to use.
Eustachian tube: document 8-week duration of decongestants and other medical management.
Propel/Sinuva: failed 3 months of topical and oral steroids and prior sinus surgery as applicable.
Note
No universal step therapy — follow policy-specific requirements
No universal step therapy is specified across all policies in this section; however, many device-specific policies require documented trials of first-line therapies (e.g., CPAP for OSA, hearing aids for cochlear candidacy) and documentation of failure or intolerance before advanced therapies are authorized.
Policy-specific step requirements (e.g., Inspire, PNS, cochlear implants) are listed in each device policy and must be followed.
When in doubt, confirm required conservative therapy steps during benefit verification and prior authorization.
Step Therapy
Step therapy requirements for Inspire (PAP prerequisite)
Inspire UAS requires documented trials of PAP therapies and/or oral appliances and evidence of CPAP failure or intolerance. Provide objective CPAP usage data or clinician documentation of intolerance when submitting an authorization.
CPAP failure defined as AHI >15 despite CPAP usage; CPAP intolerance defined as <4 hours/night on average for ≥5 nights/week or other documented noncompliance for at least 6 months.
Also document dental appliance trial results when relevant and include ENT + sleep specialist recommendations.
Prior Authorization
Required trial before purchase
Certain devices require a successful trial period before purchase will be authorized. For example, Meniett requires a successful 2-month trial prior to approving device purchase.
Document trial start/end dates, objective symptom improvement, and clinician assessment of trial success.
Include trial documentation with the authorization request for device purchase.
Step Therapy
Step therapy for PNS
Phrenic nerve stimulation (PNS) coverage requires prior failure of ASV/CPAP or documentation that ASV is inappropriate. Confirm and document prior adaptive support ventilation failure when requesting authorization.
PNS step therapy: failed ASV or ASV not medically appropriate is required prior to coverage.
Include prior therapy records and rationale for inappropriateness when applicable.
Step Therapy
Conservative therapy requirement (general)
Many policies include a conservative therapy requirement prior to approval of implants or device-based therapies. Document adequate trials of medical therapy, devices, or less invasive procedures before requesting authorization for implantable solutions.
Examples: Propel/Sinuva — failed 3 months maximal medical therapy; Eustachian tube dilation — failed 8 weeks of medical management.
Document trial details, medications used, dosages, durations, and clinician assessments.
SpeechEasy and similar altered auditory feedback systems (use DAF and/or FAF techniques).
Evidence notePublished literature consists of small uncontrolled reports and a 6-month clinical trial with mixed individual responses and limited long-term data.
Persistent developmental stuttering definition
DefinitionDevelopmental stuttering that has not undergone spontaneous or therapy-related remission prior to puberty (persistent developmental stuttering).
Typical onsetMost commonly begins between ages 2–5 years; onset prior to age 12 for developmental stuttering.
PrognosisAn estimated 50%–80% of preschool children with developmental stuttering recover with or without therapy before puberty; persistence denotes the 'persistent' qualifier.
Hearing loss severity ranges (dB HL)
Normal10–15 dB HL
Mild26–40 dB HL
Moderate41–55 dB HL
Moderately severe56–70 dB HL
Severe71–90 dB HL
Profound>=91 dB HL
Audiologic eligibility thresholds (device-specific FDA limits)
MetricPure-tone average bone-conduction threshold measured at 0.5, 1, 2, and 3 kHz must meet device-specific FDA-established limits.
Device examplesExamples listed in policy include Cochlear Americas BAHA/Osia and MED-EL Bonebridge/Samba with specified decibel levels for FDA eligibility.
Bilateral implantation symmetryFor bilateral implants, interaural average left-right bone conduction difference <10 dB across 0.5,1,2,3 kHz (or <15 dB at individual frequencies).
Severe and profound hearing loss (PTA thresholds)
Severe hearing lossThree-frequency PTA >= 70 dB at 1000, 2000, and 4000 Hz.
Profound hearing lossThree-frequency PTA >= 90 dB at 1000, 2000, and 4000 Hz.
PTA frequencies usedPTA calculated at 1000, 2000, and 4000 Hz (500 Hz is excluded for candidacy calculations).
Limited benefit from amplification — adult and pediatric thresholds
Adult thresholdLimited benefit from amplification defined as <= 60% correct on recorded open‑set sentence tests in the best‑aided condition.
Pediatric metricChildren assessed by age‑appropriate measures; examples include < =20% correct on MLNT/LNT for some ages or lack of progress in auditory skills for younger children.
Hearing aid trialA medically appropriate 3‑month hearing aid trial with documented insufficient benefit is generally required unless clinically contraindicated.
Insufficient access to sound — pediatric metric
Pediatric insufficient accessAided speech perception test scores of 5% or less on developmentally appropriate monosyllabic word lists in the ear to be implanted indicate 'insufficient access to sound'.
Age groupApplied to children (criteria reference pediatric SSD/AHL ages 5–18).
Related requirementUsually follows a medically appropriate 3‑month hearing aid trial unless exception documented.
Pure-tone average (PTA) calculation used
Definition usedPure-tone average (PTA) is calculated at 1000, 2000, and 4000 Hz (500 Hz excluded) to identify mid-to-high frequency severe-to-profound hearing loss for candidacy.
PurposeExclusion of 500 Hz allows residual low-frequency hearing to be present while still identifying candidates with significant mid/high‑frequency loss.
Clinical notePTA values used in coverage criteria correspond to the three-frequency PTA thresholds (>=70 dB, >=90 dB) described elsewhere in policy.
Limited benefit from amplification (adults) — <=60% sentence score
Adult limited benefit thresholdBest‑aided open‑set sentence score ≤ 60% correct defines limited benefit from amplification for adults.
Trial requirementApplied after a medically appropriate hearing aid trial (typically 3 months) unless an exception is documented.
Use caseThreshold used to determine candidacy for unilateral or bilateral cochlear implantation and for SSD/AHL adult criteria.
Digitized speech definition
Digitized speechDevices using prerecorded messages recorded by someone other than the user for playback (whole‑message output).
Typical useProvides fixed prerecorded phrases/words selectable by the user; limited to messages recorded in advance.
Policy implicationCertain digitized SGD types may be listed in investigational/not‑covered sections depending on indication and device class.
Synthesized speech definition
Synthesized speechTechnology that translates user input into device‑generated speech, enabling creation of novel messages rather than playback of prerecorded phrases.
CapabilitiesAllows message formulation via spelling, symbols, or other inputs and can support a wider range of communication than digitized speech.
ExamplesSpeech generating software on laptops, PDAs, or dedicated SGDs that render text or symbol input into synthetic voice output.
Upgrades and accessories definition
UpgradesSubsequent versions of SGD software or memory modules that include enhanced features or improvements (software/memory upgrades).
AccessoriesMounting systems, access devices (optical head pointers, joysticks, scanning devices), switches and other hardware to enable use by the patient.
Assessment requirementNeed for upgrades/accessories should be supported by SLP assessment documenting functional benefit and access needs.
Balloon dilation of the Eustachian tube definition
DefinitionA transnasal endoscopic procedure using a balloon catheter to dilate the cartilaginous portion of the Eustachian tube to improve patency (also named BDET/BET).
ApproachMinimally invasive transnasal endoscopic tuboplasty analogous to balloon sinuplasty; device consists of a balloon catheter with positioning markers and safety features.
PrerequisitesPolicy requires documentation of failed medical management (minimum durations and ETDQ‑7 scoring) before considering ETBD; repeated dilation is not covered.
Tympanogram types
Type ANormal middle ear compliance (normal tympanogram).
Type BLittle or no eardrum movement suggesting middle ear fluid or effusion (abnormal).
Type CNegative middle ear pressure suggesting eustachian tube dysfunction or retraction (abnormal).
ETDQ-7 — definition and threshold
DefinitionSeven-item Eustachian Tube Dysfunction Questionnaire (ETDQ‑7) used to quantify symptoms of ETD.
Scoring thresholdAverage ETDQ‑7 score > 2.1 (total score divided by 7) after medical management supports consideration for ETBD.
Role in coverageETDQ‑7 is used after at least 8 weeks of medical therapy (decongestants unless contraindicated) to document persistent symptomatic ETD.
Eustachian Tube Balloon Catheter (definition)
Device definitionA balloon catheter (Eustachian Tube Balloon Catheter) used transnasally under endoscopic guidance to dilate the cartilaginous portion of the Eustachian tube.
PurposeUsed to improve Eustachian tube patency in patients with eustachian tube dysfunction refractory to medical therapy.
Relation to ETBDThis term is synonymous with balloon dilation of the Eustachian tube as described in policy.
Inspire UAS definition
DeviceInspire Upper Airway Stimulation (UAS) system: an implanted neurostimulator with sensing and stimulation leads that senses breathing and delivers mild hypoglossal nerve stimulation to maintain airway patency during sleep.
ComponentsSmall implanted generator, breathing sensor lead, and stimulation lead controlled by an external patient remote.
Indication noteFDA‑approved for adult patients failing or intolerant of PAP therapies and without complete concentric collapse at the soft palate (policy summarizes coverage criteria separately).
CPAP failure/intolerance policy definitions
CPAP failureCPAP failure defined as AHI greater than 15 despite CPAP usage.
CPAP intoleranceCPAP intolerance defined as usage <4 hours/night on ≥5 nights/week, or documented non‑compliance for ≥6 months.
Policy roleDocumentation of CPAP failure or intolerance is required for Inspire candidacy per policy criteria.
Inspire UAS — device definition and indication
DeviceInspire UAS: an implanted hypoglossal nerve stimulation system indicated for adult patients with moderate‑to‑severe OSA who fail or cannot tolerate PAP therapy and who meet anatomical and AHI/BMI criteria.
MechanismSenses breathing patterns and delivers mild hypoglossal nerve stimulation timed to inspiration to maintain multilevel airway patency.
DefinitionLatera Absorbable Nasal Implant: a bioabsorbable implant composed of PLLA/PDLA copolymer placed in the lateral nasal wall to support nasal cartilage and treat dynamic nasal valve collapse.
Absorption timeDesigned to be absorbed by the body in approximately 18 months after implantation.
UseIntended to support lateral nasal cartilage and reduce symptoms of airway obstruction; policy lists it as experimental/investigational for Commercial/CHIP plans.
Meniett/pulse generator system definition
DefinitionMeniett/pulse generator system: a device delivering computer‑controlled low‑pressure pulses transmitted to the middle ear (typically via a tympanostomy tube) acting on the round window membrane for symptom control in Meniere's disease.
Device examplesMeniett (covered) versus other devices such as the P100 which are considered experimental/uncovered.
Coverage prerequisitePolicy requires otolaryngologist recommendation, failure of maximal medical therapy, and a successful 2‑month trial prior to purchase approval.
Pillar Procedure (palatal implants) definition
DefinitionPillar Procedure (palatal implants): minimally invasive implants placed in the soft palate to stiffen tissue, induce fibrosis, and reduce palatal flutter/snoring.
MechanismImplants provide structural support to the muscular layer of the soft palate, promoting fibrosis and decreased tissue vibration.
Coverage stanceSelectHealth classifies palatal (Pillar) implants for snoring/OSA as investigational/unproven and does not cover them for these indications.
Phrenic nerve stimulation (PNS) definition
DefinitionPhrenic nerve stimulation (PNS): an implanted system delivering unilateral transvenous stimulation to the phrenic nerve to rhythmically contract the diaphragm, generating negative intrathoracic pressure and reducing central sleep apneas.
System exampleRemede System: a fully implanted neurostimulator with pulse generator and transvenous stimulation and sensing leads programmed with an external system.
Procedure noteImplantation is comparable to cardiac pacemaker procedures with transvenous lead placement and a subcutaneous pulse generator pocket; device programming is performed externally after healing.
Remede System / PNS definition
Remede SystemAn implanted neurostimulator delivering unilateral transvenous phrenic nerve stimulation with sensing lead and pulse generator to rhythmically contract the diaphragm and decrease central apneas (FDA‑cleared for moderate‑to‑severe CSA in adults).
ComponentsBattery‑powered pulse generator implanted in pectoral pocket, stimulation lead positioned adjacent to a phrenic nerve via venous access, and a sensing lead (eg, azygos vein).
Therapy initiationTherapy typically initiated ~1 month after implantation to allow lead healing; programming and titration are performed with an external programmer.
Propel and Sinuva implants definition
Propel and SinuvaBioresorbable, mometasone furoate–coated sinus stents used to deliver local corticosteroid: Propel is placed intraoperatively at ESS and elutes over ~30 days; Sinuva is placed postoperatively in the ethmoid sinus and elutes over ~90 days.
IndicationsUsed for chronic rhinosinusitis with severe bilateral polyposis in patients who have failed maximal medical therapy and typically in the context of prior sinus surgery.
Coverage limitPolicy limits coverage to one Propel (intraoperative) or one Sinuva (postoperative) implant per rolling 12 months when criteria are met.
Propel definition
PropelA bioabsorbable, steroid‑eluting implant deployed intraoperatively at the time of endoscopic sinus surgery to deliver mometasone furoate to sinus mucosa over ~30 days.
Clinical evidenceRandomized and case‑series studies (e.g., ADVANCE trials) report reductions in post‑operative interventions, adhesions, and polyposis in short‑term follow‑up.
PlacementIntended for use in ethmoid, maxillary, or frontal sinuses during ESS per manufacturer instructions and policy criteria.
Sinuva definition
SinuvaA bioabsorbable steroid‑releasing sinus implant placed into the ethmoid sinus postoperatively to elute mometasone furoate over approximately 90 days; may be removed at physician discretion.
Use caseUsed post‑ESS for treatment of nasal polyps in patients with recurrent polyposis who have failed maximal medical therapy.
Evidence noteClinical evaluations and manufacturer evidence support short‑term improvements in sinonasal outcomes; policy restricts use per specific coverage criteria and frequency limits.
Maximal medical therapy definition
DefinitionMaximal medical therapy: a course including topical and oral steroids (and other appropriate medical measures) for at least 3 months prior to considering implant placement (Propel/Sinuva).
PurposeRequired to demonstrate failure of conservative management before implant use for chronic rhinosinusitis with polyposis.
Policy implicationFailure of >=3 months of maximal medical therapy is a prerequisite for coverage of Propel or Sinuva implants per policy criteria.