CurrentAetnaPolicy 0479

Respiratory Devices: Incentive Spirometers, Vaporizers and Intermittent Positive Pressure Breathing Machines

This policy governs medical necessity, exclusions, and coding for incentive spirometers, vaporizers, and intermittent positive pressure breathing (IPPB) machines for Aetna members.

Policy Summary

PayerAetna

PolicyRespiratory Devices: Incentive Spirometers, Vaporizers and Intermittent Positive Pressure Breathing Machines

Policy CodePolicy 0479

Change TypeNo material changes

Effective DateJun 15, 2001

Next Review DateMay 9, 2024

Key ActionSubmit relevant HCPCS/DME codes (e.g., E0487, A9284, E0500) when selection and medical necessity criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3Device categories

E0500,E0487,A9284HCPCS examples

32%PPCs risk reduction

1.8dShorter LOS

31IS meta-analysis RCTs

05/09/2024

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Coverage Determinations and Evidence

Evidence summaries (no coverage criteria specified)

Incentive spirometry (IS) has been evaluated in multiple randomized controlled trials (RCTs) and systematic reviews for prevention of post-operative pulmonary complications (PPCs). A Cochrane-type review found no statistically significant differences between IS and physiotherapy for risk of developing pulmonary complications after upper abdominal surgery and concluded there is low-quality evidence regarding lack of effectiveness and a need for well-designed trials (chunk 18).

A rigorous meta-analysis of 31 RCTs (3,776 adults) comparing IS to other chest rehabilitation strategies after cardiac, thoracic, or upper abdominal surgery found IS alone did not significantly reduce 30-day PPCs (RR=1.00, 95% CI: 0.88–1.13), 30-day mortality (RR=0.73, 95% CI: 0.42–1.25), or length of hospital stay (mean difference = -0.17 days, 95% CI: -0.65 to 0.30), suggesting little to no benefit of IS alone in these settings (chunk 26).

For pulmonary resection specifically, a systematic review/meta-analysis including 5 RCTs and 3 retrospective cohort studies (total 10,322 patients) reported that IS was associated with shorter hospital length of stay (MD = -1.80 days, 95% CI: -2.95 to -0.65), reduced risk of PPCs (OR = 0.68, 95% CI: 0.51–0.90), and reduced postoperative pneumonia (OR = 0.82, 95% CI: 0.68–0.995); benefits were more pronounced in patients with pre-operative predicted FEV1 < 80% (chunk 27).

In bariatric surgery, a randomized non-inferiority trial (n=224) comparing routine post-operative IS to clinical observation found no significant differences in post-operative hypoxemia, Sao2 levels, or 30-day pulmonary complications (chunk 29).

In patients with traumatic rib fractures, a small RCT (n=50) reported reduced pulmonary complications and improved pulmonary function tests (FVC and FEV1) with IS versus control; however, authors noted limitations including small sample size, short-term follow-up, limited generalizability, and difficulty blinding (chunks 35, 36).

The SpiroTimer, an IS adherence reminder device, in a randomized trial among CABG patients increased IS use and showed improvements in some clinical outcomes (reduced final-visit atelectasis severity, shorter fever duration, reduced non-invasive ventilation use, reduced ICU and overall LOS for certain subgroups, and lower 6-month mortality in non-elective patients); investigators noted these benefits occurred when adherence was higher (chunks 39, 40, 44).

Authors and reviewers have highlighted methodological limitations across many studies (heterogeneous interventions, variable adherence, combined co-interventions, and generally low or moderate quality evidence), limiting certainty of effects and generalizability (chunks 18, 26, 36).

Evidence summary and implications

Overall synthesis: The totality of evidence is mixed and context-dependent. High-quality meta-analysis and systematic reviews generally show little to no benefit of IS alone for reducing PPCs, mortality, or hospital length of stay after cardiac, thoracic, or upper abdominal surgery (chunk 26). Conversely, some meta-analyses focused on pulmonary resection and certain small RCTs (e.g., rib fracture patients) report reductions in PPCs, pneumonia, or LOS; however, these findings are limited by heterogeneity, study quality, and population differences (chunks 27, 35, 36).

Role of adherence and adjuncts: Trials of adherence-enhancing devices (SpiroTimer) demonstrate that increased IS use is achievable and may be associated with improved intermediate and some clinical outcomes in selected surgical subgroups, suggesting that effectiveness of IS may depend on actual patient adherence and concurrent rehabilitation strategies (chunks 39, 40, 44).

Clinical implications: Routine use of IS as a stand-alone intervention for all post-operative patients is not supported by higher-quality aggregate evidence; benefits may be present in specific populations (e.g., pulmonary resection, patients with reduced pre-operative pulmonary function, traumatic rib fractures) or when adherence is ensured. Decision-making should consider individual patient risk factors, surgical type, baseline lung function, and feasibility of ensuring adherence (chunks 26, 27, 35, 39).

Billing Codes and Clinical Coding Guidance

Covered CPT Codes (if selection criteria met)CPTCovered

94640	Pressurized or nonpressurized inhalation treatment for acute airway obstruction and/or for diagnostic purposes such as sputum induction with aerosol generator, nebulizer, metered dose inhaler or IPPB device.
43631-43635	Gastrectomy and Vagotomy (related preoperative use of incentive spirometer prior to bariatric surgery).
43644-43645	Laparoscopy, surgical, gastric restrictive procedure (preoperative incentive spirometer use).
43770-43775	Laparoscopy, surgical, gastric restrictive procedure (preoperative incentive spirometer use).
43842-43848	Gastric restrictive procedure (preoperative incentive spirometer use).
61000-64999	Surgery/nervous system (related procedures).
94010-94621, 94642-94799	Pulmonary medicine procedures related to respiratory device use.

Covered HCPCS Codes (if selection criteria met)HCPCSCovered

E0487	Spirometer, electronic, includes all accessories.
E0500	IPPB machine, all types, with built-in nebulization; manual or automatic valves; internal or external power source.

HCPCS Codes Related / NeutralHCPCS

A9284	Spirometer, nonelectric, includes all accessories.
E0550-E0585	Humidifiers/compressors/nebulizers for use with oxygen IPPB equipment.
S8096	Portable peak flow meter.

HCPCS Codes Not Covered / Investigational for CPB IndicationsHCPCSNot Covered

E0605	Vaporizer, room type (not covered for listed indications).
SpiroTimer	Incentive spirometer user reminder — No specific code; considered not covered for listed indications.

Covered ICD-10 Codes (range)ICD-10Covered

J00-J99

Diseases of the respiratory system (covered when selection criteria are met).

ICD-10 Codes Not Covered for Listed IndicationsICD-10Not Covered

D57.01, D57.211, D57.431, D57.451, D57.811	Sickle cell disease with acute chest syndrome (not covered for listed indications).
J05.0	Acute obstructive laryngitis [croup] (not covered for listed indications).
Q90.0-Q90.9	Down syndrome (not covered for listed indications such as improvement of oromotor and pulmonary functions).
S12.000A-S12.691S	Fracture of vertebral column with spinal cord injury (not covered for listed indications).
S12.9XXA-S12.9XXS	Fracture codes of cervical region (not covered for listed indications).
S14.0XXA-S14.159S	Injury to the neck/spinal cord (not covered for listed indications).
S14.0XXS-S14.159S	Spinal cord injury, sequelae (not covered for listed indications).
S22.000A-S22.089S	Fracture of thoracic vertebrae with spinal cord injury (not covered for listed indications).
S24.0XXA-S24.159S	Injury to thoracic spinal cord region (not covered for listed indications).
S24.0XXS-S24.159S	Spinal cord injury, sequelae (not covered for listed indications).

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Inspiratory capacity / vital capacity thresholds — contraindication thresholds (VC <10 mL/kg, IC <33% predicted)

Inspiratory capacity / vital capacity thresholds — contraindication thresholdsVital capacity <10 mL/kg; Inspiratory capacity <33% predicted

Prior Authorization, Documentation, and Workflow

Prior Authorization

DME HCPCS codes covered when selection criteria met

Durable medical equipment billing codes E0487 (electronic spirometer), A9284 (nonelectric spirometer) and E0500 (IPPB machine) are referenced as covered when the policy’s medical necessity/selection criteria are met; submit these HCPCS codes only for indications that meet the CPB’s coverage criteria.

E0487 — Spirometer, electronic, includes all accessories
A9284 — Spirometer, nonelectric, includes all accessories
E0500 — IPPB machine, all types, with built‑in nebulization

Note

No prior authorization requirement stated in these excerpts

The provided sections do not state any explicit prior authorization requirement or process for incentive spirometers, IPPB machines, or related devices.

Clinical Background and Definitions

Atelectasis is a common postoperative problem and occurs in patients with neuromuscular or chest wall disease. Incentive spirometers are intended to encourage sustained deep inspirations to expand the lungs above spontaneous tidal volumes; this physiologic rationale underlies their use and the policy’s coverage of IS for specified postoperative neuromuscular or chest wall indications.

Incentive spirometer — definition

DeviceHandheld incentive spirometer encourages patients to take sustained deep breaths to expand the lungs above spontaneous volumes

Primary intended usePromote deep lung expansion to prevent or treat atelectasis in post-operative patients and those with neuromuscular or chest wall disease

Clinical noteDemonstrated benefit in some controlled studies; adherence is important for effectiveness

Intermittent positive pressure breathing (IPPB) — device description

Device/method

Policy Dates and Version History

2001-06-15effective

Policy became effective.

2023-07-12last_review

Policy was last reviewed.

2024-05-09next_reviewLatest

Next scheduled review date.

Policy Summary

PayerAetna

PolicyRespiratory Devices: Incentive Spirometers, Vaporizers and Intermittent Positive Pressure Breathing Machines

Policy CodePolicy 0479

Change TypeNo material changes

Effective DateJun 15, 2001

Next Review DateMay 9, 2024

Key ActionSubmit relevant HCPCS/DME codes (e.g., E0487, A9284, E0500) when selection and medical necessity criteria are met.

SourceLink

On This Page

Policy implications: Given inconsistent and population-specific evidence, coverage decisions may reasonably restrict IS as DME to indications and patient groups with demonstrated or plausible benefit (for example, post-operative use for patients with neuromuscular or chest wall disease and selective use in other high-risk surgical or trauma populations), and consider devices that enhance adherence as adjuncts warranting further study (chunks 3, 26, 27, 39, 41).

Evidence gaps and research needs: Additional well-designed, adequately powered RCTs that (1) stratify by surgical type and baseline pulmonary function, (2) measure and promote adherence, and (3) assess patient-centered clinical outcomes and cost-effectiveness are needed to clarify which subgroups benefit from IS and whether reminder devices or combined rehabilitation strategies improve outcomes in a cost-effective manner (chunks 18, 26, 41).

Note

Prior authorization not specified in provided sections

No prior authorization requirements are specified in the document chunks supplied; the policy text in these sections does not describe a PA workflow or required authorizations.

Prior Authorization

PA governed by plan provisions, not specified here

The bulletin notes administration of benefits is plan‑specific; prior authorization rules, if any, are governed by individual plan provisions rather than by this Clinical Policy Bulletin.

Step Therapy

Sequence therapy: try incentive spirometry before IPPB

Clinical guidance in the background recommends trying incentive spirometry first and reserving IPPB for patients only when there is objective proof that IPPB achieves larger inspired volumes than the patient can achieve independently.

Try incentive spirometry before IPPB when clinically appropriate.
Use IPPB only if it demonstrably increases inspired volume over patient effort.

Step Therapy

No required step‑therapy sequences specified

There are no required step‑therapy sequences or mandated prior trials described in the provided text; the CPB does not specify prior conservative treatments that must be attempted before DME coverage.

Step Therapy

No step‑therapy requirements in these chunks

The excerpts do not describe any formal step‑therapy requirements, prior trials, or device sequencing rules for IS or IPPB.

Billing Rule

Use and submit relevant CPT/HCPCS/ICD‑10 codes tied to covered indications

When billing for covered indications, include the relevant CPT/HCPCS and ICD‑10 codes referenced by the policy (examples: HCPCS E0500 for IPPB machine; E0487 and A9284 for spirometers; ICD‑10 range J00‑J99 when selection criteria are met).

Use HCPCS E0487/E0500/A9284 only when the member meets the policy’s selection/medical necessity criteria.
Report ICD‑10 codes (e.g., J00‑J99) that correspond to the covered respiratory diagnosis when submitting claims.

Documentation Required

Document trial outcomes (FVC/FEV1, LOS, mortality, oxygenation)

Clinical studies and trials cited in the policy report outcomes such as forced vital capacity (FVC) or FEV1 changes, hospital length of stay, mortality, and arterial oxygenation; document these measures in the medical record when relevant to assessment of device benefit.

Document baseline and follow‑up FVC/FEV1 values and any change over time.
Record hospital length of stay and mortality outcomes when assessing post‑operative respiratory interventions.
Include arterial oxygenation measurements if available.

Documentation Required

Policy history noted; no procedural documentation mandates here

Policy history and review dates are listed in the bulletin (effective 06/15/2001; last review 07/12/2023; next review 05/09/2024), but these chunks do not impose additional procedural documentation requirements.

Documentation Required

Provider responsibility: bulletin is a partial description of benefits

Treating providers are solely responsible for medical advice and treatment; the Clinical Policy Bulletin provides a partial description of plan benefits and does not constitute a contract or replace plan documents.

Denial Risk

Coverage exclusions: vaporizers and investigational uses not covered

Vaporizers (e.g., HCPCS E0605) are expressly not covered because they are not considered primarily medical; devices or uses designated investigational (for example the SpiroTimer or uses not listed as medically necessary) are not covered.

Vaporizers are not covered (policy limitation).
SpiroTimer and other indicated investigational uses are considered experimental/investigational and not covered.

Note

No explicit administrative authorization or billing denial triggers listed here

The provided excerpts do not list specific administrative authorization triggers or explicit billing denial criteria for claims beyond the policy’s coverage statements.

Note

No explicit PA, documentation, or denial triggers in this excerpt

These chunks do not state specific prior authorization conditions, documentation thresholds, or explicit denial triggers for IS or IPPB beyond the coverage and investigational statements.

Denial Risk

Administrative denial risk: plan/program benefit limitations may apply

Coverage determinations in this Clinical Policy Bulletin do not constitute offers of coverage and may be subject to plan or program benefit limitations; administrative denials can result when plan benefits do not align with the CPB statements.

Clinical Policy Bulletins are a partial description of plan or program benefits and not a contract.
Aetna may update the bulletin and coverage remains subject to plan terms.

Intermittent positive pressure breathing (IPPB) is a machine-delivered positive-pressure inhalation technique

Intended purposesUsed to prevent or treat atelectasis and sometimes to deliver aerosolized/bronchodilator medications

Clinical considerationsUse has declined because benefit is difficult to demonstrate; IPPB should be used when it can increase inspired volumes beyond patient effort

IPPB — method of delivery

DefinitionIPPB is a method of delivering nebulized medication or positive-pressure inspiratory breaths via a machine

Comparative evidenceStudies show no advantage of IPPB over simple nebulization for delivery of nebulized epinephrine in croup

ContraindicationContraindicated in persons with untreated tension pneumothorax

Post-operative pulmonary complications (PPCs) — definition and components

DefinitionPost-operative pulmonary complications (PPCs) are a composite of events such as pneumonia, atelectasis, and related respiratory morbidity occurring after surgery

Outcomes measuredCommonly measured outcomes include PPC incidence, post-operative pneumonia, atelectasis severity, and hospital length of stay

Clinical relevancePPCs are associated with prolonged hospital stay, increased costs, morbidity, and mortality following thoracic and other surgeries

SpiroTimer device — definition

DeviceSpiroTimer is an add-on use-tracking incentive spirometer reminder that records time-stamped inspiratory breaths and provides an hourly reminder bell

Intended benefitDesigned to improve adherence to incentive spirometry by prompting and recording inspiratory events

Evidence summaryRandomized trial after CABG showed increased daily inspiratory breaths and improved atelectasis severity and some clinical outcomes when the reminder was active

Acute chest syndrome (ACS) — definition (sickle cell disease context)

ConditionAcute chest syndrome (ACS) is a severe pulmonary complication of sickle cell disease associated with high mortality

Management contextMultiple interventions including incentive spirometry and positive expiratory pressure devices have been studied, but evidence is limited

Evidence gapAvailable RCTs are few; more high-quality trials with larger populations are needed to define effectiveness of treatments for ACS

Clinical Policy Bulletins are developed to assist in administering plan benefits and provide only a partial, general description of plan or program coverage. They are not contracts, do not guarantee coverage or outcomes, and may be updated; treating providers remain responsible for medical care decisions.