Prior authorization required

Prior authorization is required for hypoglossal nerve stimulation procedures and related device work (insertion/implantation, replacement, revision, and removal) for Fallon Health products listed; for MassHealth ACO and Community Care members (age ≥18) Fallon will apply InterQual® CP criteria for HNS implantation and HNS revision/removal/replacement effective for dates of service on or after November 1, 2025.

• Applies to insertion/implantation, replacement, revision, and removal of hypoglossal nerve neurostimulator and related components.
• InterQual® CP:Procedures, Hypoglossal Nerve Stimulator (HNS) Implantation and InterQual® CP:Procedures, HNS Revision or Removal and/or Replacement will be used for MassHealth ACO and Community Care members age ≥18 starting 2025-11-01.

Confirm PSG, prior PAP failure/intolerance, and DISE

Prior authorization requests must document objective sleep testing, prior PAP therapy attempts with documented failure or intolerance, and DISE findings excluding complete concentric palatal collapse when applicable.

• Polysomnography (PSG) performed within 6 months or baseline PSG performed at enrollment to confirm AHI.
• Evidence of DISE (VOTE) assessment with documentation that circumferential/complete concentric palatal collapse was excluded.
• Documentation that the patient has failed or cannot tolerate PAP therapy despite attempts to improve compliance and has considered other alternative/adjunct therapies.

Prior authorization and coverage governance

Coverage determinations for Medicare Advantage follow CMS NCDs/LCDs and applicable Medicare statutes/regulations; Fallon follows MassHealth Medical Necessity Guidelines for MassHealth members and will use InterQual for specified lines of business per the policy.

• When Medicare coverage is governed by an LCD (e.g., L38387), the Medicare contractor determination governs for Medicare Advantage members.
• Fallon generally follows MassHealth guidelines for MassHealth members; benefit plan documents may impose additional limits.
• InterQual adoption for MassHealth ACO and Community Care members age ≥18 is effective 2025-11-01.

Therapy failure requirement (PAP failure/intolerance)

Prior authorization requires demonstration that the member failed or is intolerant of PAP therapy despite attempts to improve adherence; this failure/intolerance is a required step before considering HNS.

• Provider must document attempts to improve PAP compliance and that PAP was ineffective or not tolerated.
• Standard of care alternatives and adjunct therapies should have been considered prior to HNS.

PAP as first-line therapy; consider surgery only after evaluation

Positive airway pressure (PAP) is considered the most efficacious first-line therapy; surgical options including hypoglossal nerve stimulation are reserved for patients who have failed or cannot tolerate PAP and after shared decision-making about surgical risk/benefit.

• AASM guidance expects objective testing and that surgery proceed only after clinical evaluation and mutual agreement on acceptable risk.
• Surgery is not first-line given proven safety and efficacy of PAP therapy.

Step therapy expectation vs PAP

Step therapy expectation: HNS is not first-line — candidates must have documented PAP failure/intolerance; prior authorization and medical necessity review will expect evidence of PAP attempts before approving HNS.

• Documented inability to adhere to or benefit from PAP is expected before HNS is authorized.
• InterQual criteria (for applicable lines of business) and AASM guidance support PAP as first-line therapy.

Prior authorization — required documentation

Prior authorization requests must include clinical documentation: recent polysomnography to confirm AHI (preferably within 6 months), DISE documentation including VOTE assessment, evidence of prior PAP intolerance/failure, and patient demographics/clinical data matching device-specific inclusion criteria.

• If no PSG within 6 months, baseline PSG may be performed to confirm eligibility.
• DISE videos/results should document absence of complete concentric collapse at the soft palate when required by device selection.
• Include documentation of attempts to improve PAP adherence and reasons for intolerance or inadequate benefit.

Include recent PSG and DISE documentation

Documentation should include a recent full-night polysomnogram (PSG) to confirm AHI and DISE results documenting absence of complete concentric palatal collapse (VOTE assessment) when applicable; PSG the night of activation was performed in trials and may be relevant to follow-up care.

• PSG within 6 months is preferred; if absent, a baseline PSG was used in trials to confirm eligibility.
• DISE VOTE classification and reviewer documentation excluding circumferential palatal collapse should be provided.

Billing and medical necessity authority (CMS NCDs/LCDs, MassHealth)

Include diagnosis codes required by Medicare LCDs when submitting claims for Medicare members; Fallon follows CMS NCDs/LCDs for Medicare Advantage members and MassHealth guidance for MassHealth members when making medical necessity and billing determinations.

• Medicare claims for Inspire HNS must include primary diagnosis G47.33 and a secondary BMI-related code per the LCD (Z68.1–Z68.34).
• Fallon adheres to applicable Medicare contractor LCDs/NCDs and MassHealth guidance for coverage and payment.

Experimental/Investigational exclusions — denial risk

Requests for HNS that are considered experimental/investigational (for example, procedures not meeting the policy coverage criteria, or bilateral Genio 2.1 implants) will be denied as not medically necessary.

• Unilateral Inspire HNS requests that do not meet the policy's coverage criteria are considered experimental/investigational and subject to denial.
• Bilateral hypoglossal nerve stimulation using the Genio 2.1 System is explicitly considered experimental/investigational and not medically necessary.

Patients outside studied inclusion criteria — denial risk

Patients who fall outside studied inclusion criteria may be denied coverage; examples include age below or above device-specific ranges, AHI or BMI outside device inclusion thresholds, and complete concentric palatal collapse on DISE.

• Genio 2.1: safety/effectiveness not established for patients under 22 or over 75 years, AHI <15 or >65 events/hr, BMI >32 kg/m2, or complete concentric collapse at the soft palate.
• Unilateral HNS candidates should meet the device-specific age, AHI, and BMI ranges and DISE selection criteria to avoid denial risk.

Medicare diagnosis coding requirement

For Medicare members, claims must include primary diagnosis code G47.33 (obstructive sleep apnea) and a secondary diagnosis code indicating BMI <35 (Z68.1–Z68.34) as required by the applicable LCD.

• Failure to include G47.33 and the BMI-related secondary diagnosis per LCD guidance may result in claim denial for Medicare Advantage members.

MassHealth ACO site-of-service payment restriction for CPT 64582/64583/64584

For MassHealth ACO members, CPT 64582, 64583, and 64584 are not payable when performed in an Ambulatory Surgical Center; these codes are payable only when performed in an acute outpatient hospital setting per policy notes.

• Implantation CPT 64582 and revision/removal CPTs 64583/64584 have site-of-service payment restrictions for MassHealth ACO members.
• Verify site of service when billing MassHealth ACO claims for HNS implantation, revision, or removal.