Positive Airway Pressure therapy for sleep disordered breathing
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Defines medical necessity, initial trial, and continued coverage criteria for CPAP/APAP and bi-level PAP devices and related supplies for adults and children with obstructive sleep apnea and other sleep-disordered breathing conditions.
Added clarifying language that members who fail the initial 3-month PAP trial, including due to non-adherence, are eligible to requalify for therapy following a face-to-face clinical re-evaluation to determine the etiology of treatment failure.
Clarified Positive Airway Pressure (PAP) therapy criteria and added program exceptions and Medicare Advantage/DSNP/Managed Medicaid coverage clarifications.
Modifications to repeat attended titration and pediatric split-night criteria for clarity, including adding HSAT as acceptable test for hypoglossal nerve stimulation diagnostic testing and adjusting oxygen saturation placement between criteria.
Updated references and definitions including addition of Severe COPD definition and removal of references over 10 years not applicable to treatment policy.
Coverage Criteria for PAP and Related Therapies
Initial CPAP/APAP therapy (Adults)
Covered when ALL of the following are met for initial 90-day period:
APAP may be initiated at home for members without significant comorbidities; initial coverage period is 90 days.
Initial CPAP/APAP therapy (Children)
Covered when ALL of the following are met for initial 90-day period:
Treatment of snoring alone without obstructive sleep apnea is not medically necessary; initial coverage period is 90 days.
Bi-level therapy for OSA (E0470)
Covered when ALL of the following are met:
Initial period of medical necessity is 90 days for E0470 when used for OSA.
Bi-level therapy (E0470/E0471) for COPD, restrictive, hypoventilation, CSA
Covered when ALL of the specified physiologic and prior-trial criteria are met:
An E0471 may be considered any time after an initial period of E0470 use when additional criteria are met.
Members started on bi-level at hospital discharge may continue up to 3 months to allow stabilization and re-evaluation.
E0471 is considered medically necessary when an E0470 is being used and found to be ineffective and the listed spirometry and escalation criteria are met.
Central sleep apnea (CSA) and treatment-emergent CSA
Covered when ALL of the following are met:
Adaptive Servo-Ventilation (E0471) should not be used in individuals with symptomatic chronic CHF with reduced ejection fraction (LVEF ≤45%) due to increased cardiovascular mortality risk; may be used at clinician discretion if LVEF >45% or for mild CHF-related CSA.
Continued coverage criteria
Continued coverage requires documented adherence:
For bi-level devices used to treat diagnoses other than OSA, a signed and dated practitioner statement completed no sooner than day 61 declaring average use of 4 hours per 24-hour period and clinical benefit is acceptable instead of device download data.
Replacement, exclusions, and supply coverage
Replacement covered when provider documents:
If prior diagnostic test is unavailable, physician attestation supporting the diagnosis of OSA will be accepted to support replacement.
FDA has not evaluated ozone or UV light products for CPAP cleaning; such products (including Philips UV Light Sanitizer Box) are not approved cleaning methods for Philips Respironics devices or masks.
Supply Coverage, Convenience Exclusions, OTC and Experimental Therapies
Covered when ALL of the following are met or as specified:
Coverage applies only when member meets PAP therapy criteria.
Upgrading technology without medical justification is not medically necessary; ozone/UV cleaning products are not approved methods.
Prescription oral appliances may be considered under EPA or DME benefit terms as applicable.
See policy experimental/investigational list for full details.
Revised diagnostic and titration coverage criteria
Policy includes criteria for diagnostic testing, attended titration (including repeat titration), PAP therapy initiation and continuation, and device-specific pathways:
Added clarifying language allowing requalification after evaluation.
Pediatric split-night study criteria were clarified to include re-titration when specified combinations occur; HSAT added as acceptable diagnostic test for hypoglossal nerve stimulation candidacy.
These revisions aim to reduce inappropriate approvals and better match clinical practice.
Treatment of snoring alone, without obstructive sleep apnea, is not considered medically necessary. Duplicate PAP equipment provided solely for convenience (for example, a second “travel” PAP device) and replacement of a PAP device solely to upgrade technology are considered convenience items and are not medically necessary. If the policy criteria for medical necessity are not met for initial therapy, continued coverage of a PAP device and related accessories will be denied.
Duplicate equipment (such as a second travel PAP) and PAP cleaning machines/devices are considered items of convenience and are not covered. The FDA has not evaluated ozone gas or UV light products claiming to clean, sanitize, or disinfect CPAP machines and accessories; ozone and UV cleaning products (including the Philips UV Light Sanitizer Box) are not approved cleaning methods for Philips Respironics devices or masks. Over-the-counter non‑prescription oral appliances obtained without a prescription are not considered medically necessary.
Editorial housekeeping was performed to remove references older than ten years and those not applicable to a treatment policy while updating definitions and references to current guidance (2021–2026). These adjustments streamline the policy and align definitions and testing/titration language with recent guideline and operational changes.
An E0471 device (bi-level with backup rate, including adaptive servo‑ventilation variants) is not medically necessary when hypoventilation syndrome criteria are not met. Additionally, ASV (E0471) should not be used in individuals with symptomatic chronic heart failure with reduced ejection fraction (LVEF ≤45%) because of increased cardiovascular risk; ASV may be considered only when LVEF is greater than 45% or at clinician discretion for mild CHF‑related central sleep apnea.
The following items and therapies are considered not medically necessary or experimental: PAP cleaning machines/devices and over‑the‑counter, non‑customized mandibular appliances obtained without a prescription are not medically necessary. Specified OSA therapies (for example: sleep strip, oral neuromuscular electrical stimulation devices such as eXcite OSA, oral pressure therapy like Winx, Provent, atrial overdrive pacing, CAPSO, positional electrical devices such as Night Shift/Night Balance, electrosleep, Injection Snoreplasty, LAUP, over‑the‑counter non‑customized mandibular appliances, Pillar palatal implants, RF volumetric tissue reduction, tongue‑base suspension, transpalatal advancement pharyngoplasty, and diaphragmatic‑phrenic nerve stimulation for CSA) are considered experimental, investigational, or unproven and therefore not covered.
Editorial updates removed outdated “not medically necessary” statements where appropriate and performed general housekeeping to reflect current evidence and operational practice; specific prior wording that was administrative rather than clinical was streamlined or deleted to reduce confusion.
Coding, HCPCS, and Supply Frequencies
| E0601 | Continuous Positive Airway Pressure (CPAP) and Auto titrating Positive Airway Pressure (APAP) |
| E0561 | CPAP or APAP with humidifier (heated) |
| E0562 | CPAP or APAP without heated humidifier / with humidifier (documented as options) |
| E0470 | Bi-level Positive Airway Pressure WITHOUT back-up rate |
| E0471 | Bi-level Positive Airway Pressure WITH back-up rate (including ASV variants) |
| A4604 | Tubing with integrated heating element for use with positive airway pressure device. |
| A7027 | Combination oral/nasal mask, used with continuous positive airway pressure device, each. |
| A7028 | Oral cushion for combination oral/nasal mask, replacement only, each. |
| A7029 | Nasal pillows for combination oral/nasal mask, replacement only, pair. |
| A7030 | Full face mask used with positive airway pressure device, each. |
| A7031 | Face mask interface, replacement for full face mask, each. |
| A7032 | Cushion for use on nasal mask interface, replacement only, each. |
| A7033 | Pillow for use on nasal cannula type interface, replacement only, pair. |
| A7034 | Nasal interface (mask or cannula type) used with positive airway pressure device, with or without head strap. |
| A7035 | Headgear used with positive airway pressure device. |
| 95811 | Full-night attended PAP titration |
Provider Requirements, Prior Authorization, and Documentation
Prior authorization: 90-day initial trial; continued coverage requires adherence or attestation
Initial coverage for CPAP/APAP (and E0470 bi-level devices for OSA) is permitted for a 90-day trial when the member meets the policy diagnostic and clinical criteria. Continued coverage beyond 90 days requires documentation of adherence during days 31–91 (objective device data or acceptable practitioner attestation for select bi-level uses). Replacement requires prescription and confirmation the device is nonfunctioning/out of warranty or >5 years old.
- Initial period: 90 days when diagnostic/clinical criteria met (adults and children per policy).
- Continued coverage requires adherence documentation between day 31 and day 91 (see adherence threshold).
- Replacement requires prescription and confirmation device is nonfunctioning/out of warranty or >5 years old.
Medicare/DSNP: Apply NCD/LCDs (CPAP 240.4; L33718; L33800)
For Medicare Advantage and DSNP members, the applicable National and Local Coverage Determinations are used to determine medical necessity: CPAP NCD 240.4, PAP Devices LCD L33718, and Respiratory Assist Devices LCD L33800. For DSNP members, if Medicare criteria do not fully approve a request, the policy guidelines on page 1 are used.
- Use NCD 240.4 for CPAP determinations.
- Use LCD L33718 for PAP devices for OSA.
- Use LCD L33800 for respiratory assist devices.
- DSNP requests default to Medicare criteria first; if not approved, revert to policy page 1 guidelines.
Attended titration & diagnostic testing: revised repeat titration and pediatric split-night; HSAT added
Attended PAP titration and repeat titration criteria were revised for clarity; pediatric split-night study criteria were updated to include re-titration in specified combinations and HSAT was added as an acceptable diagnostic test for hypoglossal nerve stimulation candidacy.
- Repeat attended titration criteria adjusted (oxygen saturation placement moved to match full-night titration and a 3rd criterion added for treatment-emergent CSA/failed split-night titration).
- Pediatric split-night (95811) criteria clarified to add 'and re-titration' for specified combinations and a new Criterion D.
- HSAT added as acceptable diagnostic test for hypoglossal nerve stimulation.
Bi-level pathway: E0470 after failed CPAP; E0471 only after E0470 ineffective with escalation criteria
Bi-level without backup (E0470) is indicated when CPAP has been tried and proven ineffective or is not tolerated as documented by a qualified health professional. E0471 (with backup rate) may be considered after an initial period of E0470 use when E0470 is ineffective or when specific escalation criteria (e.g., worsening PaCO2 or nocturnal desaturation while on E0470) are met.
Alternate therapies: consider only when PAP not tolerated; OTC oral appliances not covered
PAP therapy is identified as the 'gold standard' treatment for OSA; alternative non‑surgical therapies (including prescription oral appliances) may be considered only when PAP cannot be tolerated or an alternate is clinically appropriate. OTC oral appliances obtained without a prescription are not medically necessary.
- Consider alternatives only when PAP is not tolerated or contraindicated.
- Coverage for oral appliances may be subject to EPA or DME benefit terms; OTC appliances without prescription are not covered.
Requalification: face-to-face evaluation required after failed initial PAP trial
Members who fail the initial 90-day PAP trial (including due to non‑adherence) must have a face-to-face clinical re-evaluation by the treating physician before they are eligible to requalify for subsequent PAP therapy.
- Face-to-face evaluation required to determine etiology of treatment failure prior to requalification.
- Requalification is contingent on the re-evaluation findings.
Objective adherence: device download showing ≥4 hrs/night on 70% of nights (days 31–91)
For continued coverage, provide objective device download data demonstrating use ≥4 hours per night on 70% of nights during a consecutive 30‑day period anytime between day 31 and day 91 after initiation of therapy.
- Download must cover a consecutive 30‑day period within days 31–91.
- Threshold: ≥4 hours/night on 70% of nights.
Required supporting documentation: H&P, procedure note, treatment plan, and PSG/HSAT results
Submit supporting clinical documentation with requests: physician history & physical, physician procedure note, treatment plan/plan of treatment, and sleep study results (PSG or HSAT as appropriate) to support medical necessity.
- Required items: physician history & physical, physician procedure note, treatment plan, and PSG or HSAT results.
- Services beyond policy limits are subject to medical review and must be supported by documentation.
Re-evaluation required: in-person clinical assessment before requalification
A face-to-face clinical re-evaluation by the treating physician is required for members to requalify for PAP therapy after failing the initial 3‑month trial.
- Re-evaluation must be in-person and performed by the treating physician.
- Required before approving repeat coverage following initial failure (including non-adherence).
Denial risk: continued coverage denied if initial medical necessity criteria not met
Continued coverage will be denied if the initial medical necessity criteria are not met (for example, absence of qualifying diagnostic test results or failure to meet OSA diagnostic thresholds).
- If initial criteria for medical necessity are not met, continued coverage of PAP device and accessories will be denied.
- Treatment of snoring alone without OSA is not medically necessary.
Non-adherence consequence: failure to meet objective use criteria may end coverage
If objective adherence criteria during days 31–91 are not met, continued coverage of the PAP device and related supplies is considered not medically necessary and may be discontinued.
- Failure to meet the ≥4 hours/night on 70% of nights threshold on a consecutive 30‑day period within days 31–91 will render continued coverage not medically necessary.
- Coverage may be discontinued per health plan policy in cases of lack of adherence.
Documentation for medical necessity: services beyond policy require medical review
Services or supplies provided in excess of what is documented in this policy are subject to medical review; submit documentation that supports medical necessity as described in the policy.
- Medical review requires physician H&P, procedure note, treatment plan, and sleep study results (PSG or HSAT).
- Be prepared to provide documentation for replacements, upgrades, or additional services.
Denial risk: revised criteria tighten approvals and increase scrutiny
Policy revisions clarified and narrowed several criteria (for example, repeat titration language) to reduce inappropriate approvals; providers should expect increased scrutiny and denials when criteria are not met.
- Deleted broader wording that previously allowed wider approvals for repeat titration; oxygen saturation criteria were reorganized to match full‑night titration.
- Expect closer review of repeat titration and requalification requests under the revised criteria.
Definitions and Device Descriptions
Obstructive sleep apnea (OSA) is commonly treated with positive airway pressure (PAP). CPAP delivers a fixed positive airway pressure, APAP (auto‑titrating PAP) automatically adjusts pressure based on physiologic signals, and bi‑level devices deliver separate inspiratory and expiratory pressures; variants with a backup rate (e.g., E0471/ASV) provide device‑delivered breaths when spontaneous breathing is insufficient. Initial PAP therapy is typically authorized for an initial period of 90 days with close follow‑up to assess efficacy and adherence.
Policy Update History
New coverage guideline issued including adherence criteria and ASV definitions; guideline reformatted and references updated.
Updated definitions, ASV indications, measurement standards and added standard PAP supply replacement schedule and REI; clarified oxygen saturation requirements for PAP titration.
Scheduled review updated testing guidance including witnessed apnea as standalone risk, adjusted LVEF threshold for CHF, and aligned PAP compliance with CMS; HSAT allowance timeframe increased for certain indications.
Clarified requirements for replacement PAP devices when broken and in-use, and refined lab-based sleep study evidence needs for COPD, asthma, refractory arrhythmia and other conditions.
Added explicit replacement allowance for PAP devices after 5 years and updated references and definitions.
Revised repeat attended titration criteria (moved O2 saturation criterion for clarity, removed ambiguous APAP language, added criterion for treatment-emergent sleep apnea and failed split-night titration), updated pediatric split-night re-titration rules, and allowed HSAT for hypoglossal nerve stimulation diagnostic testing.
Updated Medicare Advantage/DSNP language and clarified Severe COPD classification and other page-level clarifications; references updated.
Aligned Medicare NCD/LCD language and added Program Exceptions; added clarifying PAP language that members who fail the initial 3-month PAP trial (including for non-adherence) may requalify after a face-to-face clinical re-evaluation and removed references older than 10 years where appropriate.
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