Respiratory Assist Device (RAD) coverage — E0470 / E0471
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Defines coverage, medical necessity criteria, and documentation requirements for RADs (E0470, E0471) for Northwood members, including indications such as restrictive thoracic disorders, severe COPD, central or complex sleep apnea, hypoventilation syndromes, and chronic respiratory failure due to COPD. Affects treating practitioners, suppliers, and prior authorization processes.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
inv-01: Restrictive Thoracic Disorders — Covered when ALL of the following are met
Covered when ALL of the following are met
If all criteria met, either E0470 or E0471 (practitioner judgment) is covered for the first three months of therapy.
inv-02: Severe COPD (E0470) — Covered when ALL of the following are met
Covered when ALL of the following are met
If all criteria met, E0470 is covered for the first three months of therapy. If not met, E0470 and related accessories will be denied as not reasonable and necessary.
inv-03: Escalation to E0471 for Severe COPD — An E0471 is covered for severe COPD members who qualified for E0470 when ONE of the following situations is met
An E0471 is covered for severe COPD members who qualified for E0470 when ONE of the following situations is met
E0471 may be started any time after a period of initial E0470 use if both A and B are met.
If neither situation is met, billing for E0471 will be denied as not reasonable and necessary.
inv-04: Central Sleep Apnea / Complex Sleep Apnea — Covered when ALL of the following are met prior to initiating therapy
Covered when ALL of the following are met prior to initiating therapy
If criteria met, either E0470 or E0471 (practitioner judgment) will be covered for the first three months of therapy.
inv-05: Situation 2: Severe COPD — upgrade to E0471 — Covered when ALL of the following are met for members with severe COPD who qualified for E0470 and being considered for E0471:
Covered when ALL of the following are met for members with severe COPD who qualified for E0470 and being considered for E0471:
Assessment must be performed no sooner than 61 days after initial E0470 issue; meeting both criteria supports coverage of E0471.
inv-06: Central Sleep Apnea or Complex Sleep Apnea — Covered when ALL of the following are met for CSA or complex sleep apnea prior to initiating therapy:
Covered when ALL of the following are met for CSA or complex sleep apnea prior to initiating therapy:
If met, either E0470 or E0471 (practitioner judgment) covered for the first three months.
inv-07: Hypoventilation Syndrome — E0470 — E0470 covered when ALL of A and B and EITHER C or D are met:
E0470 covered when ALL of A and B and EITHER C or D are met:
Refer to Chronic Respiratory Failure consequent to COPD for FEV1/FVC < 70%.
If neither C nor D is met, E0470 will be denied as not reasonable and necessary.
inv-08: Hypoventilation Syndrome — E0471 — E0471 covered when ALL of A and B and EITHER C or D are met:
E0471 covered when ALL of A and B and EITHER C or D are met:
Refer to severe COPD section for FEV1/FVC < 70%.
If criteria not met, E0471 will be denied as not reasonable and necessary.
inv-09: RAD with Backup Rate Feature — Chronic Respiratory Failure (COPD) — RAD with backup rate feature covered for home use for an initial 6 months when ALL are met:
RAD with backup rate feature covered for home use for an initial 6 months when ALL are met:
By the end of the initial 6-month period, therapy must meet high-intensity NIV settings (IPAP ≥ 15 cm H2O and backup rate ≥ 14 breaths/min).
inv-10: RAD without Backup Rate Feature — COPD — RAD without backup rate covered for initial 6 months when ALL are met:
RAD without backup rate covered for initial 6 months when ALL are met:
Intended for members who cannot tolerate high-intensity NIV or when backup rate is medically inappropriate; covered for initial 6 months.
inv-11: RAD Upon Hospital Discharge — Covered when ALL are met for post-discharge RAD:
Covered when ALL are met for post-discharge RAD:
If met, RAD with or without backup rate feature covered in the home immediately upon discharge for an initial 6-month period.
inv-12: Continuing Usage and Outcome Criteria — Continued coverage after initial period requires specified usage and clinical outcomes:
Continued coverage after initial period requires specified usage and clinical outcomes:
Required for continued coverage beyond the initial period. A signed and dated practitioner statement completed no sooner than 61 days after initiation must attest to compliant use and benefit for continuation beyond three months.
Failure to demonstrate compliant use is grounds for denial of continued coverage.
inv-13: Continued Coverage Requirement — Covered when policy criteria are met; otherwise coverage denied
Covered when policy criteria are met; otherwise coverage denied
inv-14: Coverage criteria revisions / cross-reference — Document notes revisions to initial coverage criteria and cross-references
Document notes revisions to initial coverage criteria and cross-references
This block documents revision statements and pointers to related sections; see full policy for complete revised language.
If the coverage criteria for restrictive thoracic disorders are not fully met, then E0470 or E0471 and related accessories will be denied as not reasonable and necessary. This includes failure to document the required neuromuscular disorder or thoracic cage abnormality, the specified physiologic thresholds, or that COPD does not significantly contribute to the pulmonary limitation. See the continued coverage section for requirements beyond the initial three months.
If the coverage criteria for severe COPD (E0470) are not fully met — including the arterial PaCO2 threshold, nocturnal desaturation requirements, or documentation that CPAP/sleep apnea have been considered — then E0470 and related accessories will be denied as not reasonable and necessary.
No aspect of a home sleep test may be performed by a DME supplier. This prohibition explicitly includes delivery and/or pickup of the home sleep testing device by the supplier.
Claims for A9279 (remote monitoring feature/device) are denied as non-covered; DME suppliers must not bill A9279 for remote monitoring services. Separately, the Exsufflation Belt (K1021) is considered experimental and investigational and is not covered for pulmonary restrictive or obstructive breathing.
Claims for A9279 are denied as non-covered and suppliers must not bill A9279 for remote monitoring services. This denial is stated explicitly in the policy and reiterated in the change history.
Billing for E0470 or E0471 will be considered not reasonable and necessary and denied when the specific coverage criteria for the indicated condition are not satisfied. Denials include failures to meet the stated physiologic thresholds, sleep testing or timing requirements, or the escalation criteria for E0471.
If the clinical criteria and required timing for E0470, E0471 and related accessories are not met (including escalation timing, documented PaCO2 thresholds, nocturnal desaturation criteria, or required evaluations), the claim will be denied as not reasonable and necessary. Continued coverage beyond initial periods is contingent on meeting the policy's specified reassessment and usage requirements.
Billing quantities of supplies greater than the policy-described usual maximum amounts will be denied as not reasonable and necessary. Suppliers should follow the policy table for per-code usual maximum amounts when dispensing accessories and replacement items.
The Exsufflation Belt (K1021) is classified as experimental and investigational and is not covered for pulmonary restrictive or obstructive breathing. Claims for K1021 should be denied as not covered.
HCPCS / Coding Tables
| 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 | N/A (listed among accessory codes) |
| 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 | N/A (listed among accessory codes) |
| A7033 | N/A (listed among accessory codes) |
| A7034 | N/A (listed among accessory codes) |
| A7035 | HEADGEAR USED WITH POSITIVE AIRWAY PRESSURE DEVICE |
| K1021 | EXSUFFLATION BELT, INCLUDES ALL SUPPLIES AND ACCESSORIES |
| A9279 | MONITORING FEATURE/DEVICE, STAND-ALONE OR INTEGRATED, ANY TYPE, INCLUDES ALL ACCESSORIES, COMPONENTS AND ELECTRONICS, NOT OTHERWISE CLASSIFIED |
| E0467 | HCPCS code added to ventilator code listings |
| A9279 | Remote monitoring services — claims denied as non-covered |
| K1021 | Experimental and investigational |
| A7027 | Accessory code (listed in historical changes) |
| A7028 | Accessory code (listed in historical changes) |
| A7029 | Accessory code (listed in historical changes) |
| A7037 | Quantity changed to 1 per 3 months (historical) |
| E0470 | Device code referenced in initial coverage criteria revisions |
| E0471 | Device code referenced in initial coverage criteria revisions and prior least-cost alternative language |
Provider Responsibilities, Prior Authorization, and Denial Risks
Prior authorization — follow Medicare/NCD guidance
Refer to Medicare policy L33800 and NCD CAG-00465N for Medicare member coverage criteria; for non‑Medicare members, coverage is contingent on meeting the documented policy criteria prior to device coverage.
Initial 6‑month coverage period for RAD in COPD
Initial home RAD coverage for COPD (with or without backup rate) is provided for an initial 6‑month period when the COPD-specific documentation and PaCO2 thresholds in the policy are met.
New E0467 ventilator coding guidance
HCPCS code E0467 was added to ventilator code listings and guidance for coding multifunction ventilators appears in the policy; ensure E0467 is used only when the device includes all listed multifunction features.
- If the multifunction ventilator does not include all listed functions it must not be coded as E0467 (see policy).
Step‑up from E0470 to E0471 requires documented escalation criteria
For COPD members initially covered with E0470, escalation to E0471 is permitted only after documented worsening PaCO2 (≥7 mm Hg from baseline) with PSG confirmation OR per Situation 2 criteria evaluated no sooner than 61 days after initial E0470 issue showing persistent PaCO2 ≥52 mm Hg and nocturnal SpO2 ≤88% (≥5 cumulative minutes, min 2‑hour recording).
Post‑discharge RAD — documentation and timing
Post‑discharge RAD coverage is allowed immediately upon hospital discharge for an initial 6‑month period when the member required a RAD or ventilator within 24 hours prior to discharge and the treating practitioner documents the member is at risk of rapid symptom exacerbation or PaCO2 rise.
Document diagnostic data and symptoms in medical record
The treating practitioner must document symptoms characteristic of sleep‑associated hypoventilation and include specific diagnostic data (e.g., awake ABG PaCO2, sleep oximetry or PSG results, FVC or MIP for neuromuscular disease) in the medical record to support coverage.
- Examples of required data: ABG PaCO2, sleep oximetry/PSG nocturnal SpO2 results, spirometry (FEV1/FVC), MIP or FVC for neuromuscular disease.
Sleep study recording time — event count requirement
If AHI or CAHI is calculated from less than 2 hours of continuous recorded sleep, the total number of recorded events used must be at least the number that would be required in a 2‑hour period (≥10 events) when computing indices.
Practitioner attestation required for continued coverage
For continued coverage beyond the initial period, obtain a signed and dated practitioner statement completed no sooner than 61 days after therapy initiation confirming the member is using the device an average of 4 hours per 24‑hour period and is benefiting from therapy.
- Supplier must obtain this attestation for continued coverage beyond three months.
ACA 6407 — face‑to‑face exam and documentation
Per ACA 6407, the treating physician (practitioner) must conduct a face‑to‑face examination within six months prior to the written order and ensure the documentation describing the medical condition is received prior to delivery for applicable DME items.
Denial risk — E0471 billed without required escalation evidence
An E0471 billed without meeting the escalation criteria (Situation 1 or Situation 2) will be denied as not reasonable and necessary.
Denial risk — excess supply quantities
Billing quantities of supplies greater than the policy's usual maximum amounts will be denied as not reasonable and necessary; follow the accessory quantity limits in the policy table.
A9279 denied (policy restatement)
Claims for A9279 are denied as non‑covered (policy reiteration).
Background and Scope
Respiratory assist devices (E0470, E0471) provide noninvasive bi-level ventilatory support for members with sleep-associated hypoventilation, neuromuscular respiratory weakness, severe COPD, central or complex sleep apnea, and related hypoventilation syndromes. Diagnostic evaluation to support coverage typically includes arterial blood gas measurement (PaCO2), sleep oximetry or attended polysomnography, and respiratory muscle testing (MIP or FVC) when neuromuscular disease is suspected. Coverage is conditional — devices are covered only when the policy's specific clinical criteria and documentation requirements are met, and continued coverage requires documented device usage and clinical improvement per the policy.
Definitions and Terms
Policy Revision History
Initial policy release (first publication of the Respiratory Assist Device policy).
Added quantities to full face mask codes (accessory quantity updates).
Removed E0472 and moved obstructive sleep apnea section to PAP policy; added definitions for K0554 and K0555 and other editorial changes.
Added accessory codes A7027–A7029 and changed quantity of A7037 to 1 per 3 months; policy updated/annual review entries recorded.
Annual review completed with no material changes documented.
Added Important Note to all Medical Policies.
Annual review; references to policy added.
Added reference to NH Medicaid.
Annual review completed with no changes.
Annual review completed with no changes.
Annual review completed.
Annual review performed; added E0467 coding guidelines to ventilator code listings.
Annual review completed; no clinical changes noted (recorded as annual review with added E0467 guidance carried forward).
Annual review; revised terminology from 'physician' to 'practitioner'.
Annual review; added HCPCS code E0467 to ventilator listings, prohibited DME suppliers from performing any aspect of a home sleep test, and recorded that claims for A9279 are denied as non-covered.
Annual review; K1021 classified as experimental and investigational and added to policy references.
Annual review completed (no further changes beyond prior updates).
Annual review completed with no changes recorded.
Annual review completed with no changes recorded.
Annual review recorded adding new NCD coverage criteria for Chronic Respiratory Failure consequent to COPD.
Annual review scheduled/recorded; revised 'Initial Coverage Criteria for E0470 and E0471' and other coverage criteria cross-references for 2025 updates.
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