Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements (for Pennsylvania Only)
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Policy governing coverage, medical necessity, coding, and documentation requirements for durable medical equipment (DME), orthotics, and related supplies for UnitedHealthcare members in Pennsylvania; applies to home/outpatient DME requests and directs providers to state-specific prior authorization and bulletin guidance.
Added instruction to refer to several Pennsylvania Department of Human Services Medical Assistance Bulletins for coverage criteria for hospital grade breast pumps, lower extremity orthoses, orthopedic shoes and boots, and tracheostomy speaking valves/voice prosthetic devices.
Updated References section to reflect the most current information and archived previous policy version CS032PA.AB.
Coverage Criteria
General DME Medical Necessity
Durable Medical Equipment (DME), related supplies, and orthotics are medically necessary when:
Refer to InterQual and applicable Pennsylvania DHS bulletins for device-specific criteria.
Home Mechanical Ventilators — Necessity
Home mechanical ventilators and respiratory assist devices (applies for 2 years of age or older):
Explicit not-medically-necessary statements in policy.
Refer to InterQual Client Defined CP for specific clinical thresholds and age applicability.
Bi-level PAP — Limitations
Bi-level PAP devices:
Policy cites insufficient evidence for these indications.
Cranial Remolding Orthosis
Cranial remolding orthosis (helmets):
Protective helmets (HCPCS A8000–A8004) are safety devices and are not cranial remolding devices.
Cranial Remolding Orthosis
Cranial remolding orthosis coverage
Do not substitute protective helmets (A8000–A8004) which are considered safety devices rather than therapeutic cranial remolding devices.
Insulin Pumps
Insulin pump coverage
Refer to the Continuous Glucose Monitoring and Insulin Delivery policy for detailed clinical and documentation requirements.
Repair, Replacement, and Upgrade
Repair, replacement, and upgrade coverage when member has a DME benefit
Exceptions evaluated case‑by‑case per member benefit.
Vendors/manufacturers are responsible for repairs for rented equipment and for purchased equipment under warranty.
Requests for exceptions based on member plan and medical necessity.
Home Mechanical Ventilators for COPD
Home mechanical ventilators (HMVs) for COPD — coverage stance based on evidence
Systematic reviews and subgroup analyses show greater benefit in patients with higher baseline PaCO2; evidence quality ranges low to moderate.
Covered with evidence-based criteria
Evidence-supported situations where NIPPV/BPAP may be beneficial
Quality of evidence varied; trial criteria differ (see Köhnlein, Wilson et al., and others).
Murphy et al. trial supports this pathway.
Masa et al. multicenter RCT referenced in evidence summary.
AASM recommendations summarized in policy.
Not sufficiently supported / unproven
Situations considered unproven or insufficient evidence
Policy considers evidence insufficient to support BPAP in this physiologic range.
Adherence requirement drawn from policy evidence statements.
NIV and PAP coverage criteria (guideline-aligned)
Guideline-aligned coverage considerations for NIV/NIPPV in COPD and PAP in sleep-disordered breathing
CHEST, Canadian Thoracic Society, Swiss Society, and ATS guidance support consideration of long‑term NIV in these scenarios.
Used to judge effectiveness and continued therapy per CHEST guidance.
Per CHEST and CMS-based guidance.
Based on AASM recommendations.
CSA treatment pathway described in evidence
Central sleep apnea (CSA) management considerations from clinical evidence
Retrospective series (Chowdhuri et al.) reported CPAP effective in ~50% and CPAP+O2 effective in additional ~35% of cases.
This Medical Policy does not apply to durable medical equipment or supplies used in an outpatient or inpatient facility. Coverage and medical necessity determinations described in this policy apply to DME provided for home or outpatient use and do not govern equipment supplied as part of facility-based care.
Any device that is fully implanted into the body is not covered as DME; implantable components are managed under the medical‑surgical benefit and not under the DME benefit. External components related to implanted systems (for example, cochlear implant external processors) may be considered under the DME benefit per applicable federal, state, or contractual rules. Protective helmets billed with HCPCS codes A8000–A8004 are safety devices and are not considered cranial remolding orthoses.
For COPD indications, the policy considers use of bi‑level PAP / BPAP unproven when the awake arterial PaCO2 is < 52 mm Hg on room air. This stance applies even when asleep PaCO2 meets specific elevated thresholds in some studies; requests outside this physiologic threshold may be denied as not supported by the evidence.
Guideline guidance from the ATS is conditional on use of in‑laboratory overnight polysomnography for NIV titration in stable hypercapnic COPD: the ATS suggests not routinely using an in‑lab overnight PSG to titrate NIV in these patients, reflecting low to very low certainty evidence and recommending individualized clinical judgment.
Home mechanical ventilators are not medically necessary when they are used only in bi‑level PAP mode (HCPCS E0470, E0471) or are used solely to deliver continuous or intermittent PAP (HCPCS E0465, E0466). Such device use does not meet the policy's criteria for HMV provision.
The policy regards HMVs as unproven for individuals with chronic stable COPD when the awake arterial PaCO2 is < 52 mm Hg, because the available evidence shows benefit primarily in hypercapnic patients with higher PaCO2 thresholds.
Bi‑level PAP (BPAP), with or without backup rate, is considered unproven for CSA or OSA when documented adherent use is 4 hours/night during at least a consecutive 21–30 day period. Insufficient objective adherence undermines evidence of effectiveness and may lead to denial.
Coding
| S1040 | Cranial remolding orthosis (cranial molding helmet) |
| S1040 | Cranial molding orthosis (cranial remolding helmet) |
Provider Actions & Prior Authorization
Follow InterQual and PA DHS bulletins for prior authorization
Refer to InterQual criteria and the Pennsylvania Department of Human Services (PA DHS) Medical Assistance bulletins when submitting prior authorization (PA) requests for specific items (e.g., hospital‑grade breast pumps, lower extremity orthoses, orthopedic shoes/boots, tracheostomy speaking valves/voice prosthetic devices) and to determine device‑specific clinical thresholds and PA requirements.
- Use InterQual Client Defined CPs for home mechanical ventilation and noninvasive airway assistive devices for clinical coverage thresholds.
- Follow the cited PA DHS Medical Assistance Bulletins for PA processes and item‑specific criteria (see policy references and the Policy History addition).
Obtain PA and physician documentation for replacements and upgrades
Replacement requests for DME beyond the Reasonable Useful Lifetime (RUL) and requests to upgrade equipment require prior authorization and supporting documentation. Upgrades are treated as a new service and need physician documentation demonstrating a change in the member’s clinical condition.
- Default RUL is 5 years unless otherwise stated in policy or contract.
- Upgrades require the same documentation as a new provision (physician documentation of change in condition).
Document PaCO2 and targeted ventilatory goals in PA requests
Include arterial PaCO2 measurement and the intended ventilatory goals in PA documentation for long‑term NIPPV/BPAP in COPD; evidence‑based trials targeted baseline hypercapnia and specified goals (e.g., reduction in PaCO2).
- Document baseline awake PaCO2 and the clinical goal (examples in trials: target ≥20% reduction or reduction to <6.5 kPa).
- Reference InterQual and trial criteria when arguing medical necessity for home ventilators in hypercapnic COPD.
Consult PA DHS Medical Assistance Bulletins for PA details
Consult the Pennsylvania Department of Human Services Medical Assistance Bulletins cited in this policy for item‑specific prior authorization guidance (hospital grade breast pumps, lower extremity orthoses, orthopedic shoes/boots, tracheostomy speaking valves/voice prosthetic devices). Failure to follow those bulletin requirements may necessitate PA or risk denial.
- Bulletins contain the PA submission rules and clinical criteria for each listed item.
- Policy History explicitly added instruction to refer to these PA DHS bulletins for coverage criteria.
Follow InterQual sequencing and physiologic thresholds for respiratory devices
Sequence respiratory devices per InterQual and guideline thresholds: HMVs and bi‑level PAP must meet InterQual criteria and physiologic thresholds (e.g., PaCO2) and should not be supplied solely to deliver PAP modes that are explicitly NMN.
- HMVs (E0465/E0466) are medically necessary only per InterQual for neuromuscular, restrictive thoracic disease, or select chronic respiratory failure scenarios.
- Do not authorize HMVs when used only in bi‑level PAP mode (E0470/E0471) or only to deliver continuous/intermittent PAP (E0465/E0466) — those uses are not medically necessary per policy.
(No additional action specified)
(See related documentation callouts for required records and data.)
Use CPAP/APAP first—reserve NIV if CPAP ineffective
For obesity hypoventilation syndrome, initiate CPAP/APAP as first‑line per guideline evidence; reserve NIV/BPAP when CPAP is ineffective and document rationale for escalation.
- Masa et al. found CPAP may be preferred first‑line with NIV used if CPAP fails—document trial of CPAP and clinical response before NIV.
- AASM recommends initiating PAP with APAP at home or in‑lab and using CPAP/APAP over BPAP for routine OSA regimes.
Document PAP initiation method and escalation per AASM guidance
Initiate PAP per AASM recommendations (APAP at home or in‑lab titration) and prefer CPAP/APAP over BPAP for routine OSA; include documentation of initiation method and troubleshooting/support interventions in the medical record.
- Document whether PAP initiation was APAP at home or in‑lab titration and record educational/behavioral interventions provided.
- If escalating to BPAP, document why CPAP/APAP was inadequate.
- Refer to AASM recommendations for expected initiation/escalation steps.
Keep complete medical records documenting necessity
Maintain complete, legible medical records to support medical necessity: history, physical exam, and pertinent diagnostic test results must be available upon request to substantiate PA and coverage decisions.
- Records should include relevant histories, exams, and diagnostic test results that directly support the requested DME.
- Make records available upon request for medical review.
Submit physician documentation for upgrades and standard docs for replacements
Provide physician documentation demonstrating change in clinical condition for upgrades and include the same documentation required for an initial provision; document routine wear for replacements and pediatric growth allowances when applicable.
- Upgrades: treat request as a new service with full supporting documentation from the physician.
- Replacements: document RUL exceedance (default 5 years) and irreparability; document routine wear if applicable.
- Pediatric DME must show minimum growth allowance (2 in seat width, 3 in seat depth).
Include ventilator/downloaded device data to demonstrate adherence
Provide objective device‑recorded downloads (built‑in ventilator software or smartcard) showing usage hours and ventilation parameters (e.g., leaks, pressures, tidal volume, backup frequency) to document adherence and effectiveness for NIV/BPAP/HMV.
- Include average nightly hours and percent of nights meeting adherence thresholds.
- Device logs may show inspiratory/expiratory PAP, tidal volume, minute ventilation, respiratory rate, and percent triggered breaths.
Document persistent hypercapnia and plan for home NIV after COPD exacerbation
When requesting home NIV after a COPD exacerbation, document persistent hypercapnia (PaCO2) following the acute event, describe the clinical course, and include the plan comparing home NIV plus oxygen versus oxygen alone with prescribed nightly hours.
- Include description of the prior acute exacerbation, timing of measurements, and oxygen prescription (e.g., oxygen duration/flow) used in the supporting trial protocols.
- Document the intended nightly ventilator usage (trials often instructed ≥6 hours/night).
Document PaCO2 timing and follow‑up expectations for NIV in COPD
For NIPPV/NIV in COPD, document the timing of PaCO2 measurements relative to hospitalization or exacerbation (e.g., persistent hypercapnia at least 2 weeks after hospital discharge) and plan for follow‑up evaluation within about 6 months showing improvement, stabilization, or target PaCO2 reduction.
- Provide arterial blood gas PaCO2 values with dates and indicate whether hypercapnia persisted ≥2 weeks post‑exacerbation.
- Document follow‑up plans and intended metrics for success (normalization, stabilization, ≥20% reduction in PaCO2, or symptom improvement within 6 months).
Risk of denial if item excluded or not ordered by authorized clinician
Items excluded from coverage or not ordered by an authorized clinician (physician or NP/CNS/PA acting within scope) risk denial. Ensure orders are from authorized providers and that the item is not listed as excluded.
- Verify ordering clinician is a physician or an authorized NP/CNS/PA acting within scope per state law.
- Confirm the device is not a fully implanted device or otherwise excluded under the policy before submitting PA.
Implanted devices are not covered as DME
Do not bill implanted devices as DME. Any device fully implanted into the body is not covered under the DME benefit; implanted components are considered under the medical‑surgical benefit and would be denied under DME.
- External components (e.g., cochlear external components) may be DME, but implantable components are medical‑surgical—confirm benefit type before submission.
Awake PaCO2 <52 mm Hg may make BPAP/NIV requests unproven
Requests for BPAP/NIV in COPD where the awake arterial PaCO2 is less than 52 mm Hg on room air are considered unproven and may be denied; include awake PaCO2 to demonstrate eligibility per physiologic thresholds.
- Policy states HMVs and BPAP are unproven for stable COPD when awake PaCO2 < 52 mm Hg.
- Even if asleep PaCO2 meets other thresholds, an awake PaCO2 <52 mm Hg undermines evidence for benefit per policy language.
Insufficient documented adherence (<4 hrs/night over 21–30 days) risks denial
Document objective adherence data; BPAP/NIV for CSA/OSA is considered unproven when device use is less than 4 hours per night on at least 21–30 consecutive days—insufficient adherence may risk denial.
- Adherence thresholds referenced include ≥4 hours/night or ≥4 hours/night on 70% of nights over a consecutive 30‑day period for continued coverage.
- Provide device downloads showing nightly hours and percent of nights meeting the threshold.
Follow PA DHS bulletin PA rules or risk denial for bulletin items
Failure to follow the Pennsylvania DHS Medical Assistance Bulletin prior authorization guidelines for the listed items (hospital grade breast pumps, lower extremity orthoses, orthopedic shoes/boots, tracheostomy speaking valves/voice prosthetic devices) may result in denial or the need to obtain PA per state bulletin instructions.
- Policy History added instruction to consult specific PA DHS bulletins for these items; include bulletin‑required documentation when submitting PA.
- Check the referenced bulletin URLs in the policy References section for the exact PA submission requirements.
Medical Necessity
DME Medical Necessity Highlights — device-specific necessity defined by state DHS bulletins and InterQual criteria
Device-specific medical necessity is defined by state DHS bulletins and InterQual criteria; selected highlights:
See applicable InterQual criteria and Pennsylvania DHS Medical Assistance bulletins.
Refer to InterQual Client Defined CPs for device‑specific clinical thresholds.
Refer to the Plagiocephaly and Craniosynostosis Treatment policy for indications.
Repair/Replacement/Upgrade Medical Necessity
General medical necessity for repair/replacement/upgrade
Includes replacement of essential accessories.
Supply items are exempt from RUL; vendors/manufacturers responsible for rented/warranty repairs.
DME medical necessity nodes — examples drawn from trials
Examples of medical necessity concepts drawn from trials
Reflects Köhnlein and other RCT inclusion criteria.
Reflects Murphy et al.
Reflects AASM recommendations.
Long-term NIV medical necessity in COPD — guideline-aligned criteria
Criteria for medical necessity of long-term NIV/NIPPV in COPD per cited guidelines
Supported by Canadian Thoracic Society, CHEST, Swiss Society, and ATS conditional recommendations.
Canadian guideline suggestion; does not endorse volume-assured over pressure-preset NIV.
ATS recommendation to reassess rather than initiate during admission.
Rental and Purchase Rules
| Equipment | Rule (rental | purchase) |
|---|---|
| General Durable Medical Equipment (DME) | |
| Rental | Purchase per Reasonable Useful Lifetime (RUL = 5 years). Replacement after RUL treated as purchase decision per RUL guidance. |
| Situation | Responsibility / Rule |
|---|---|
| Rented equipment (vendor-supplied) | |
| Vendors/manufacturers are responsible for repairs, replacements, and maintenance for rented equipment. |
| Equipment category | Rental | Purchase considerations |
|---|---|
| Noninvasive ventilators / Bi-level PAP / CPAP / ASV (home mechanical ventilators and respiratory assist devices) | |
| Purchase for long-term home use is typical; rental considerations and short-term use handled per payer/local policy and vendor agreements. Documentation of intended nightly use and device-recorded monitoring recommended to support purchase for long-term therapy. |
| Customized DME | Guidance / Rule |
|---|---|
| Customized durable medical equipment (DME) | |
| Refer to CMS guidance on HCPCS coding and definitions for customized DME; payer rental vs purchase determined per CMS definitions and local coverage rules. |
Replacement / Reasonable Useful Lifetime
Documentation Requirements
Maintain and provide complete medical records for reviews
Maintain and make available medical records that fully support the medical necessity for requested services, including history, physical exam, and pertinent diagnostic results; documentation must be legible and provided upon request during reviews.
- Records should include history, exam, and diagnostic test/procedure results
- Documentation must be legible and available on request
Provide physician documentation to justify upgrades; treated as new requests
Upgrades require physician documentation demonstrating a change in the member's medical condition and must be supported by the same documentation required for an initial provision of equipment (treated as a new request).
- Submit full initial-request documentation for upgrade requests
- Explain clinical change necessitating the upgrade in physician notes
Submit device-recorded usage and parameter downloads to support coverage
Provide device-recorded usage and downloaded ventilator parameters (usage hours, pressures, leaks, tidal volume, minute ventilation, backup rates, percent triggered breaths) to document adherence and effectiveness when requesting coverage or continued use.
- Include average nightly hours and percent nights meeting adherence thresholds when available
- Submit built-in software reports or smartcard downloads
Include recent blood gas results and prior acute event description with NIV requests
Include recent arterial blood gas results (PaCO2 and PaO2), a description of the prior acute COPD exacerbation, and the current oxygen prescription when requesting home NIV for persistent hypercapnia after an exacerbation.
- Provide PaCO2 and PaO2 values and dates
- Describe prior acute event and specify oxygen regimen and prescribed nightly NIV hours
Document PaCO2 values and clinical follow-up showing persistence or improvement
Provide arterial blood gas PaCO2 values with dates and clinical follow-up documentation demonstrating timing relative to exacerbation (e.g., persistent hypercapnia ≥2 weeks post-hospitalization) and evidence of improvement, stabilization, or targeted reduction in PaCO2 within follow-up assessments.
- Show PaCO2 measurement dates and values and follow-up evaluations within ~6 months
- Document evidence of PaCO2 improvement, stabilization, or ≥20% reduction from baseline
Include PAP titration records and adherence/support interventions
Provide PAP titration records, prior PAP trials, and documentation of adherence-support interventions (education, mask fitting, humidification, troubleshooting, behavioral or supportive interventions) to demonstrate attempts to optimize therapy before escalating to alternative modalities.
- Include prior titration settings and trial durations
- Document educational/troubleshooting interventions and behavioral/supportive efforts
Not Covered / Exclusions
Not covered: home mechanical ventilators that are used only in bi‑level PAP mode or only to deliver PAP. Bi‑level PAP for CSA/OSA with inadequate documented adherence (<4 hours/night over the specified monitoring window) is considered not covered. Protective helmets billed with HCPCS A8000–A8004 are safety devices and are not covered as cranial remolding orthoses (see covered code S1040 for cranial remolding helmets when medical criteria are met).
Not covered: any device that is fully implanted into the body is not considered DME. Implantable components are a surgical/medical‑surgical benefit and claims submitted under the DME benefit for fully implanted devices will be denied.
Not covered: protective helmets billed with HCPCS codes A8000–A8004 are classified as safety devices rather than cranial remolding orthoses and are not covered as treatment devices; cranial remolding helmets that meet medical criteria are billed with HCPCS S1040 and may be covered.
Not covered: protective helmets (HCPCS A8000–A8004) are not considered cranial remolding orthoses and therefore are excluded from coverage as therapeutic cranial helmets.
Not covered: BPAP/NIV for COPD patients when awake arterial PaCO2 is < 52 mm Hg. Not covered: BPAP (with or without backup rate) for CSA or OSA when objective, documented adherence is 4 hours/night over the monitoring window of 21–30 consecutive days.
Not covered (scope note): several guideline reviews excluded studies of sleep apnea or obesity hypoventilation from COPD‑focused analyses; those exclusions influenced pooled guideline recommendations and the policy's scope of evidence appraisal.
Background
Durable medical equipment and orthotics are items intended for repeated use that support members in the outpatient/home setting. DME is medically necessary when it meets the state and plan definitions of DME, is ordered by an authorized clinician, and is appropriate for home use. Cranial remolding helmets billed as HCPCS S1040 are covered when medical criteria are met; protective helmets (HCPCS A8000–A8004) function as safety devices and are not considered therapeutic cranial remolding orthoses.
Definitions
Rental & Purchase (Summary)
| Equipment | Rental | Purchase (summary) |
|---|---|
| General DME | |
| Rental or purchase per Reasonable Useful Lifetime (RUL = 5 years); replacement after RUL treated as new purchase evaluation. |
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