Treatment of Sleep Disordered Breathing in Adults and Children
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Clinical guideline for coverage and medical necessity criteria for positive airway pressure (PAP) therapies (CPAP, APAP, bi-level, ASV) for adults and children with sleep-disordered breathing; intended for Fallon Community Health Plan providers and claim reviewers.
Added clarifying language that members who fail the initial 3-month PAP trial, including due to nonadherence, are eligible to requalify for therapy following a face-to-face clinical reevaluation to determine the etiology of treatment failure.
Clarified criteria language by adding 'AND' after Number 3 of Criterion A on page 3 to reduce ambiguity.
Added definition for Severe COPD and clarified classification changes referring to Severe COPD.
Updated references (2021-2026) and removed duplicates to align with the treatment-focused scope of the policy.
Coverage and Medical Necessity Criteria
Initial CPAP/APAP therapy for adult OSA
Covered when ANY of the following diagnostic conditions are met:
Applicable to adults, symptomatic or asymptomatic; requires positive PSG or HSAT
Meets medical necessity for an initial 90-day PAP trial
Initial CPAP/APAP therapy for pediatric OSA
Covered when ALL of the following are met:
Initial 90-day CPAP/APAP trial considered medically necessary for eligible children
Initial bi-level (E0470) for OSA
Covered when ALL of the following are met:
Initial 90-day bi-level (E0470) trial is considered medically necessary when CPAP has failed or is not tolerated
Bi-level (E0470/E0471) for other sleep disordered breathing (restrictive thoracic disease, severe COPD, CSA, hypoventilation)
Covered when ALL specified physiologic and diagnostic criteria for each disorder are met (criteria vary by condition).
AND documentation that COPD does not contribute significantly to pulmonary limitation
E0471 may be used after E0470 if PaCO2 rises ≥7 mm Hg or PSG on E0470 shows SpO2 ≤88% ≥5 cumulative minutes with AHI <5; continuation allowed up to 3 months post-hospital discharge for stabilization
Consider device warnings and contraindications (e.g., ASV limitations in certain heart failure patients) when selecting E0471
E0471 covered only if E0470 ineffective and specified escalation criteria are met; otherwise E0471 is not medically necessary
Continued coverage beyond initial 90 days
Covered when adherence/documentation requirements are met within days 31–91:
If not met, continued coverage is considered not medically necessary
If not met, continued coverage is considered not medically necessary
Replacement and exclusions
Covered replacements and exclusions:
Documentation may come from the physician or rendering provider
PAP replacement and supply coverage
Covered when ALL of the following are met
Documentation may come from the physician or rendering provider; physician attestation acceptable when prior diagnostic test unavailable
PAP cleaning machines/devices and certain cleaning methods (ozone, UV) are considered convenience and not covered
Non-covered conveniences and alternative therapy considerations
Replacement for upgrading technology is not medically necessary
Over-the-counter oral appliances obtained without a prescription are not medically necessary
Experimental / investigational therapies
The following OSA therapies are considered experimental and investigational or unproven
These therapies are considered experimental/investigational or unproven and are not covered
Requalification criteria
Updates and eligibility clarifications
Face-to-face clinical reevaluation required; documentation should capture the etiology of treatment failure and clinician assessment
Treatment of isolated snoring alone, without evidence of obstructive sleep apnea on a diagnostic sleep study (PSG or HSAT), is not considered medically necessary. The policy explicitly states that if diagnostic criteria for OSA are not met, continued coverage of a PAP device and related accessories will be denied. Duplicate devices supplied solely for convenience (for example, a second "travel" PAP) are considered a convenience and are not medically necessary.
Duplicate equipment (such as an additional travel PAP) and replacement of a PAP device for the purpose of upgrading technology are not medically necessary. Over-the-counter, non‑customized oral appliances obtained without a prescription are likewise not considered medically necessary. Replacement requests for devices or supplies must meet the policy's medical‑necessity replacement criteria (see replacement coverage), including documentation that the existing device is nonfunctioning/out of warranty or is >5 years old unless other policy exceptions apply.
Prior guideline updates modified the policy's scope and specific lists: some items and tests formerly listed as experimental/investigational or as exclusions were moved or removed in earlier revisions. The update history documents clarifications to criteria language and addition of replacement-after-5-years language; however, the full policy contains the authoritative current exclusions and the detailed lists referenced in these update notes.
An E0471 (bi‑level with backup rate) device is considered not medically necessary when the specific hypoventilation syndrome criteria referenced in the policy are not met. The policy permits escalation from E0470 to E0471 only when the documented physiologic and diagnostic escalation criteria are satisfied; absent those criteria, E0471 is not covered.
PAP cleaning machines and marketed cleaning devices are treated as items of convenience and are not covered by the DME benefit when used for routine device cleaning; the policy specifically labels PAP cleaning machines and certain OTC cleaning methods as not covered. Similarly, over‑the‑counter oral appliances obtained without a prescription are not medically necessary and are excluded from coverage.
Editorial and prior changes noted in the guideline history include insertion of clarifying language (for example, adding 'AND' to reduce ambiguity), addition of a 5‑year replacement allowance, and relocation or removal of certain items from experimental/ investigational lists. These editorial updates affect phrasing and where items appear in the full policy but do not alter the requirement that device replacement and coverage follow the medical‑necessity rules documented elsewhere in the policy.
Codes, Diagnostic Thresholds, and Key Clinical Values
| 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 |
| E0561 | Humidifier, non-heated, used with positive airway pressure device |
| E0562 | Humidifier, heated, used with positive airway pressure device |
| E0470 | Respiratory assist device, bi-level pressure capability, without backup rate feature |
| E0471 | Respiratory assist device, bi-level pressure capability, with backup rate feature (describes adaptive servo ventilation) |
| E0601 | CPAP (continuous positive airway pressure) device (also used for reporting APAP) |
| 95811 | Full-night attended polysomnography with positive airway pressure titration (referenced in update notes) |
| HSAT | Home Sleep Apnea Test (referenced as acceptable for some diagnostic criteria) |
Prior Authorization, Documentation, and Operational Steps
Prior auth: Documentation of qualifying sleep test and criteria required
Initial authorization for PAP devices (E0601, E0470, E0471) requires documentation of qualifying diagnostic sleep test results that meet the policy thresholds (adult AHI/RDI/REI ≥15, or 5–14 with at least one listed comorbidity/symptom) or the pediatric criteria; CPAP/APAP may include humidifier codes E0561 or E0562. If these diagnostic or eligibility criteria are not met, continued coverage will be denied.
- Acceptable diagnostic tests: facility-based PSG or HSAT meeting the listed AHI/RDI/REI thresholds.
- Adult thresholds: AHI/RDI/REI ≥15 OR AHI/RDI/REI 5–14 with ≥1 qualifying comorbidity/symptom.
- Pediatric: diagnostic sleep test, weight ≥30 kg, and adenotonsillectomy unsuccessful/contraindicated or surgery deferred.
- Humidifier support codes E0561/E0562 noted as applicable with CPAP/APAP.
Replacement authorization: prescription and device condition required
Replacement devices and supplies require a prescription and confirmation that the device is nonfunctioning and out of warranty or is greater than five years old; documentation may be provided by the physician or rendering provider. If a prior diagnostic test is not available for a replacement request, a physician attestation supporting the diagnosis of OSA is acceptable.
- Replacement device considered medically necessary only when nonfunctioning & out of warranty OR >5 years old.
- Prescription from a qualified health professional required for replacement.
- Physician attestation is acceptable when prior diagnostic test is unavailable.
Prior auth criteria clarified; requalification after 3‑month failure requires face‑to‑face reevaluation
The policy language for prior authorization and eligibility was clarified and now explicitly includes a requalification pathway: members who fail the initial 3‑month PAP trial (including for nonadherence) are eligible to requalify but must have a face‑to‑face clinical reevaluation to document the etiology of failure before reauthorization.
- Follow updated criteria when requesting PAP replacement or re-initiation after initial trial failure.
- Face-to-face clinical reevaluation required to determine etiology of treatment failure prior to requalification.
Step therapy: E0470 required before E0471 unless escalation criteria met
For bi-level therapy escalation, an E0470 (bi-level without backup) is required before requesting an E0471 (bi-level with backup) for many indications; E0471 is permitted when E0470 is ineffective or when the policy’s escalation criteria are met (e.g., PaCO2 increase ≥7 mm Hg or PSG evidence while on E0470).
Therapy sequencing: PAP is first‑line; alternatives considered when PAP intolerable
PAP is the preferred (gold‑standard) therapy for OSA; alternative nonsurgical therapies (e.g., oral appliances) may be considered only when PAP cannot be tolerated or an alternate is clinically appropriate and are subject to the member's EPA or DME benefit terms.
- OTC oral appliances obtained without a prescription are not medically necessary.
- Coverage for custom oral appliances depends on benefit terms and may require separate authorization.
Prior auth: follow updated/clarified criteria and documentation requirements
Ensure prior authorization requests follow the updated criteria and clarified language effective with the policy revisions (including the requalification pathway and clarified criterion phrasing); use the most current documentation when requesting PAP replacement or re‑initiation.
- Apply clarified wording (e.g., inserted 'AND' in specified criteria) and updated definitions (e.g., Severe COPD) when submitting requests.
- Requests after initial trial failure must include face‑to‑face reevaluation documentation per the update.
Documentation: submit sleep study, H&P, treatment plan, and physiologic tests as applicable
Providers must submit diagnostic sleep study results, a physician history and physical, treatment plan/plan of treatment, and procedure notes when requesting initial coverage or replacement; for non‑OSA indications include physiologic testing (ABG, sleep oximetry, spirometry, PSG/HST) as applicable.
- Required: PSG or HSAT results demonstrating policy thresholds, physician H&P, treatment plan, and procedure note.
- For restrictive thoracic disease, severe COPD, CSA, or hypoventilation, include arterial blood gas, sleep oximetry, spirometry (FEV1/FVC), and facility PSG as appropriate.
- Documentation for replacement may be a physician attestation if prior diagnostic test unavailable.
Physiologic testing required for non‑OSA indications (ABG, oximetry, spirometry, PSG/HST)
Physiologic testing is required to support non‑OSA bi‑level indications: include arterial blood gas results, sleep oximetry, spirometry (FEV1/FVC), and facility PSG/HST results as appropriate per the specific disorder criteria.
- Restrictive thoracic disorder: awake PaCO2 ≥45 mm Hg OR sleep oximetry ≤88% ≥5 continuous minutes OR disease‑specific respiratory muscle testing.
- Severe COPD and hypoventilation criteria specify awake PaCO2 thresholds and PSG/sleep oximetry findings as detailed in the policy.
Adherence documentation required for continued coverage (≥4 hrs/night on 70% nights during days 31–91)
To maintain coverage beyond the initial 90‑day trial, providers must document objective adherence: device‑downloaded evidence showing ≥4 hours/night on 70% of nights during any consecutive 30‑day period between day 31 and day 91; failure to meet this adherence may result in discontinuation of coverage.
- Adherence window: no sooner than day 31 and no later than day 91 after therapy initiation.
- Objective adherence definition: ≥4 hours/night on 70% of nights during a consecutive 30‑day period.
Billing/documentation: submit H&P, procedure note, treatment plan, and sleep study; excess services subject to review
Provide the policy‑listed required documentation to support medical necessity for reimbursement: physician history & physical, physician procedure note, treatment plan/plan of treatment, and sleep study results (PSG or HSAT as appropriate). Services exceeding policy‑documented scope are subject to medical review.
- Include supporting sleep study and clinical notes with prior auth and claims.
- Medical review may request additional records when services exceed what policy documents as medically necessary.
Documentation: physician attestation acceptable for replacement when prior test unavailable
Providers may submit a physician attestation to support a replacement device when the prior diagnostic test is unavailable; the attestation must support the diagnosis of OSA and accompanies the prescription for replacement.
- Physician attestation accepted in lieu of prior diagnostic testing for replacement requests.
- Replacement still requires prescription and confirmation device is nonfunctioning/out of warranty or >5 years old.
Denial risk: insufficient objective adherence during days 31–91 may result in discontinuation
If objective adherence criteria during days 31–91 are not met (i.e., member uses PAP <4 hours/night on <70% of nights during any consecutive 30‑day period), continued coverage may be discontinued per the policy.
- Nonadherence identified in the 31–91 day window can lead to discontinuation of equipment and supply coverage.
- For non‑OSA bi‑level indications, a signed dated clinician statement after 61 days documenting average use of 4 hours per 24‑hour period and benefit is required.
Denial risk: E0471 not covered unless hypoventilation/COPD escalation criteria are satisfied
An E0471 device (bi‑level with backup) is considered not medically necessary unless the policy’s specific hypoventilation or COPD escalation criteria are met (e.g., required PaCO2 thresholds, PSG/sleep oximetry evidence, or documented ineffective E0470 use).
Denial risk: duplicate equipment, convenience items, and upgrades not covered
Services or items that are duplicate, for convenience (e.g., travel PAP), or intended solely to upgrade technology are not considered medically necessary and will not be covered.
- Duplicate equipment (travel PAP) and replacement for upgrading technology are not medically necessary.
- PAP cleaning machines and certain cleaning methods may be considered conveniences and not covered.
Requalification: face‑to‑face clinical reevaluation required after initial 3‑month PAP failure
Face‑to‑face clinical reevaluation is required for members who failed the initial 3‑month PAP trial to requalify; documentation of the reevaluation should capture the etiology of treatment failure and clinician assessment.
- Requalification eligibility follows failure (including nonadherence) of the initial 3‑month trial.
- Document the in‑person clinical assessment and rationale for re‑initiating PAP therapy.
Medical review risk: services must be supported by documentation in the medical record
Providers must ensure documentation supporting all claims: if documentation in the record does not support services billed as medically necessary per the policy, those services are subject to medical review and potential denial.
- Maintain sleep study reports, device adherence downloads, clinician notes, and prescriptions in the medical record.
- Be prepared to submit records for medical review when requested.
Clinical Background and Policy Context
Obstructive sleep apnea (OSA) is commonly treated with positive airway pressure (PAP) devices. CPAP/APAP (E0601) provides continuous or auto‑adjusting positive airway pressure to maintain upper airway patency; humidifiers (E0561/E0562) may be used. Bi‑level devices (E0470/E0471) deliver separate inspiratory and expiratory pressures and are indicated when CPAP is ineffective or not tolerated or when specific physiologic criteria (for hypoventilation, severe COPD, or central sleep apnea) are met. Clinical follow‑up during an initial 90‑day trial and objective adherence assessment are required to determine continued medical necessity.
Definitions and Device Classifications
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