CurrentUnitedHealthcarePolicy MP.009.35

Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements – Commercial and Individual Exchange Medical Policyopen_in_new

Defines UnitedHealthcare Commercial and Individual Exchange coverage, medical necessity criteria, exclusions, repair/replacement/upgrade rules, and clinical guidance for DME, orthotics, medical supplies, and home mechanical ventilation (age ≥2). Applies to outpatient/home DME (not facility).

Policy Summary

PayerUnitedHealthcare

PolicyDurable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements – Commercial and Individual Exchange Medical Policyopen_in_new

Policy CodePolicy MP.009.35

Change TypeRevisions and additions to HMV and PAP coverageInterQual reference updates

Effective DateFebruary 1, 2026

Next Review Date

Key ActionProvider must have a physician order and medical records documenting that criteria are met; documentation may be requested to assess coverage and does not guarantee coverage.

SourceLink

POLICY UPDATE CHANGES

Added language that this policy does not apply to DME or supplies used in an outpatient or inpatient facility.

Added language that home mechanical ventilators are not medically necessary for individuals with stable COPD with an arterial PaCO2 of less than 52 mm Hg while awake on room air.

Replaced prior wording to clarify that home mechanical ventilators are not medically necessary when used only to deliver continuous or intermittent positive airway pressure (HCPCS codes E0465 and E0466).

Reworded bilevel PAP policy language to state bilevel PAP is unproven and not medically necessary for CSA/OSA when adherent use is <4 hours during sleep on at least 21-30 consecutive days.

Revised medical necessity clinical coverage criteria for HMVs to reference InterQual® Client Defined criteria and removed a previous InterQual® Medicare NCD reference.

Added InterQual® Medicare: Post Acute & Durable Medical Equipment to list of guidelines UnitedHealthcare uses in absence of related policy.

Updated supporting clinical evidence references and archived previous policy version MP.009.34.

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5Reasonable Useful Lifetime (years)

≥2HMV applicability age (years)

4 hrsBilevel PAP adherence threshold for CSA/OSA

52 mm HgPaCO2 wakefulness threshold for COPD exclusion

≥4Adherent hours/day threshold

Coverage Summary

Scope: This policy (Effective February 1, 2026) defines UnitedHealthcare Commercial and Individual Exchange coverage for Durable Medical Equipment (DME), orthotics, medical supplies, and repairs/replacements for outpatient/home use (applies to ages ≥ 2 years for home mechanical ventilators). It is current and applies to physician-ordered outpatient equipment primarily used in the home setting and is subject to the member specific benefit plan document.

Coverage stance (high level): coverage is mixed. DME, orthotics, and related supplies are covered when they meet the plan's medical necessity definition and are ordered by a physician; repair, replacement, and upgrade are allowed when criteria are met and when equipment is beyond its Reasonable Useful Lifetime (RUL) of 5 years or is irreparable. Certain device categories have special rules or exclusions: Home Mechanical Ventilators (HMV) and respiratory assist devices follow InterQual clinical criteria and include specific exclusions; bilevel PAP/BPAP is considered unproven/not medically necessary in specified low-adherence or PaCO2 scenarios; orthotics that stabilize an injured body part are covered as DME; medical supplies necessary for effective use of DME are covered with listed limits (e.g., ostomy and urinary catheter supplies).

Exclusions and notable limits: this policy does not apply to DME or supplies used in an outpatient or inpatient facility; many comfort/convenience items, non-medical devices, routine maintenance, and specified listed items are excluded. Special device callouts: HMVs are not medically necessary when used only in bilevel PAP mode or only to deliver continuous/intermittent PAP (HCPCS cited); bilevel PAP is unproven for CSA/OSA when adherence is < 4 hours during sleep on at least 21–30 consecutive days, and for COPD when awake arterial PaCO2 < 52 mm Hg.

Pivotal thresholds & quick facts

Reasonable Useful Lifetime (RUL)5 years

HMV applicability age>= 2 years

Bilevel PAP adherence threshold (CSA/OSA)4 hours per sleep period

PaCO2 awake threshold (COPD exclusion)52 mm Hg (arterial) while awake on room air

Adherent use definition>= 4 hours/night on >=70% of nights (e.g., >=4 hours/day on >=70% of days each month)

Consecutive days adherence evaluation period21-30 consecutive days

Medical Necessity Criteria

General Medical Necessity for DME

DME, related supplies, and orthotics are medically necessary when ALL of the following are met:

ALL of the following

Ordered by a physician
The item(s) meets the plan's medically necessary definition (refer to the member specific benefit plan document)
Criteria are met (see above)
The item is not otherwise excluded from coverage

Home Mechanical Ventilators and Respiratory Assist Devices (Age ≥2)

Coding

Home Mechanical Ventilator / PAP HCPCS cited in textHCPCS

E0465	Home mechanical ventilator (cited as device used to deliver continuous or intermittent PAP; also noted as HMV considered medically necessary in certain scenarios)
E0466	Home mechanical ventilator (see E0465)
E0470	Bilevel positive airway pressure device (bilevel PAP) — cited as used-only = not medically necessary; considered medically necessary in certain scenarios per InterQual
E0471	Bilevel positive airway pressure device (see E0470)

Cranial remolding orthosis / helmet codesHCPCSNot Covered

S1040	Cranial remolding helmet (excluded except when meeting medical criteria per Plagiocephaly and Craniosynostosis Treatment policy)
A8000-A8004	Protective helmet — considered safety device, not a cranial remolding device

Example orthopedic/orthotic and DME coding (referenced)mixedCovered

unspecified

Examples cited (AFO, KO, LSO, TLSO) — policy notes HCPCS-defined orthotics are covered as DME; specific HCPCS codes not listed in Part 1

Home mechanical ventilators HCPCS referencedHCPCSNot Covered

E0465	Ventilator, portable, for tracheostomy patients or noninvasive use (example listed in policy)
E0466	Ventilator, transport/portable, other description (example listed in policy)

Provider Actions & Requirements

Documentation Required

Physician order and medical records

Provide a physician order and maintain medical records showing criteria are met. Medical records may be requested for review and do not guarantee coverage.

Physician order is required
Medical records may be requested to assess coverage
Documentation does not guarantee coverage

Documentation Required

Documentation for urinary catheters

Include documentation of the number and type of urinary catheters needed to support coverage of catheter supplies.

Document number of catheters required
Document catheter type (external, indwelling, intermittent)

Background & Evidence

Background: Durable Medical Equipment (DME) is defined as physician-ordered medical equipment for outpatient use primarily in the home, used for medical purposes, not consumable except as needed, not useful in the absence of disease or disability, and serving a medical purpose.

Definitions and scope notes: the policy provides specific definitions including Customized (uniquely constructed or substantially modified items), types of urinary catheters (external, indwelling, intermittent), and Irreparable (deterioration from day-to-day use where a specific event cannot be identified). It establishes the Reasonable Useful Lifetime (RUL) standard of 5 years for DME replacements (computed from delivery date) and explains repair, replacement, and upgrade rules.

Scope exclusions and application: the policy explicitly states it does not apply to DME or supplies used in an outpatient or inpatient facility. Benefit coverage is determined by the member specific benefit plan document; medical records may be requested to assess whether clinical criteria are met but do not guarantee coverage.

Related guidance and tools: for HMV and respiratory assist device clinical coverage criteria, the policy references InterQual® CP: Durable Medical Equipment Home Mechanical Ventilation Devices and InterQual® CP: Durable Medical Equipment, Noninvasive Airway Assistive Devices. In the absence of a related policy, UnitedHealthcare uses InterQual Durable Medical Equipment, InterQual Medicare: Post Acute & Durable Medical Equipment, and CMS DME MAC guidance as medical necessity references.

Study/Source	Key finding
Wu et al. (2022) meta-analysis	LTHNIPPV reduced all-cause mortality in stable hypercapnic COPD (RR 0.76); greater benefit for baseline PaCO2 ≥55 mm Hg; PaCO2 reduction associated with lower mortality
Wilson et al. (2020)	Systematic review/meta-analysis found NIPPV/BPAP associated with reduced mortality and hospital admissions in hypercapnic COPD (quality low–moderate)
Bhatt et al. (2013) RCT	Small RCT in stable COPD with PaCO2 <52 mm Hg showed modest symptomatic and QoL improvements with NIPPV; underpowered for mortality
Cochrane Pinto et al. (2022)	CPAP may reduce AHI in CSA with heart failure but effect on mortality uncertain; evidence low/uncertain
Köhnlein et al. (2014) multicenter RCT	Long-term NIPPV improved survival in advanced stable hypercapnic COPD (1-year mortality 33% control vs 12% intervention) with limitations noted
Blau et al. (2012) ABPR-PAP vs CPAP RCT	AHI decreased in both groups with no significant difference; high adherence (94%) in small sample
Pépin et al. (2018) large adherence cohort	At 90 days adherence: CPAP 73.8%, ASV 73.2%; switch group improved from 62.7% to 76.6% after switching; mean usage ~5.27–5.73 hrs/day
Askland et al. (Cochrane 2020)	Behavioral/supportive interventions may increase PAP device usage; evidence supports some adherence benefit
Liao et al. (2017) meta-analysis	Long-term NIPPV decreased PaCO2 in stable hypercapnic COPD but mortality and other outcomes were not significantly different across trials
Zhou et al. (2017) RCT with built-in software	Home NIV with built-in software improved adherence (mean use 5.6 hrs/day) and reduced PaCO2 at 3 months; lacked long-term outcomes

Definitions

Durable Medical Equipment (DME)

Medicare Determinations

Name	Number	Type	Effective Date
Referenced CMS coverage updates for NIV		NCD

Revision History

02/01/2026addedLatest

Added language that this policy does not apply to Durable Medical Equipment or supplies used in an outpatient or inpatient facility. (material change)

02/01/2026added

Added language that home mechanical ventilators are not medically necessary for individuals with stable COPD with an arterial PaCO2 of less than 52 mm Hg while awake on room air. (material change)

02/01/2026

Policy Summary

PayerUnitedHealthcare

PolicyDurable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements – Commercial and Individual Exchange Medical Policyopen_in_new

Policy CodePolicy MP.009.35

Change TypeRevisions and additions to HMV and PAP coverageInterQual reference updates

Effective DateFebruary 1, 2026

Next Review Date

Key ActionProvider must have a physician order and medical records documenting that criteria are met; documentation may be requested to assess coverage and does not guarantee coverage.

SourceLink

On This Page

Coverage determinations for HMVs and bilevel PAP devices use InterQual clinical criteria; specific exclusions and necessary conditions are listed:

ALL of the following

Not medically necessary when ANY of the following apply
- HCPCS codes E0470 and E0471 used only in a bilevel positive airway pressure (PAP) mode
  HCPCS codes E0470 and E0471
- Used for conditions that qualify for use of a respiratory assistance device that are not life‑threatening conditions for which interruption of respiratory support would quickly lead to serious harm or death
- HCPCS codes E0465 and E0466 used only to deliver continuous or intermittent PAP
  HCPCS codes E0465 and E0466
Home mechanical ventilators (HCPCS codes E0465 and E0466) are considered medically necessary to treat neuromuscular diseases, thoracic restrictive diseases, and chronic respiratory failure consequent to COPD in certain clinical scenarios; for specific medical necessity criteria, refer to InterQual CP: Durable Medical Equipment Home Mechanical Ventilation Devices
Refer to InterQual CP: Durable Medical Equipment Home Mechanical Ventilation Devices
Bilevel PAP special rules
- Bilevel PAP (E0470, E0471) considered medically necessary in certain clinical scenarios per InterQual CP: Durable Medical Equipment, Noninvasive Airway Assistive Devices
- Bilevel PAP is unproven and not medically necessary for central sleep apnea and obstructive sleep apnea when adherent use is < 4 hours during sleep time on at least 21 to 30 consecutive 24‑hour periods< 4 hours during sleep time on at least 21 to 30 consecutive 24‑hour periods
  Due to insufficient evidence of safety and efficacy
- Bilevel PAP is unproven and not medically necessary for individuals with COPD when arterial PaCO2 is < 52 mm Hg while awake on room air (even with specified asleep PaCO2 elevations)PaCO2 < 52 mm Hg while awake on room air
  Even when asleep PaCO2 >=55 mm Hg for >=10 minutes or asleep PaCO2 increase >10 mm Hg from baseline awake and >50 mm Hg for >=10 minutes

Repair, Replacement, Upgrade Criteria

Repair, replacement, and upgrade of DME are covered when the member has a DME benefit and ANY of the following apply:

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Medical Supplies Coverage

Medical supplies used with covered DME are covered when necessary for effective use; ostomy and urinary catheter specifics follow:

ALL of the following

Medical supplies used with covered DME are covered when necessary for the effective use of the item/device (e.g., oxygen tubing/mask, batteries for power wheelchairs and prosthetics, tubing for a delivery pump)
Ostomy supplies are limited to irrigation sleeves, bags, irrigation catheters, pouches, face plates, belts, and skin barriers
Urinary catheters: Benefits for External, Indwelling, and Intermittent Urinary Catheters for incontinence or retention; related supplies for indwelling catheters limited to urinary drainage bag and insertion tray (kit), anchoring device, irrigation tubing set
Documentation should include the number and type of catheters needed

Orthotics and Braces

Orthotic braces are considered DME when they stabilize an injured body part or treat spinal curvature; examples provided:

ANY of the following

Ankle foot orthotic (AFO)
Knee orthotics (KO)
Lumbar-sacral orthotic (LSO)
Thoracic-lumbar-sacral orthotic (TLSO)
Necessary adjustments to shoes to accommodate braces

Coverage Limitations and Exclusions

The following are excluded or limited (examples listed):

ANY of the following

Additional accessories primarily for comfort or convenience are not covered (e.g., air conditioners, air purifiers/filters, humidifiers, TVs, telephones)
Batteries for non-medical equipment (e.g., flashlights, smoke detectors, phones, watches, weight scales) are not covered
Non-medical mobility devices (e.g., commercial strollers) are excluded (exclusion does not apply to pediatric wheelchairs)
Remodeling or home/vehicle modifications to accommodate DME (e.g., ramps, stair lifts) are excluded
Cranial molding helmets and cranial banding are excluded except when meeting medical criteria per Plagiocephaly and Craniosynostosis Treatment policy
Dental braces are excluded
Devices/computers to assist communication and speech are excluded (see exception for dedicated speech generating devices and tracheo-esophageal voice devices)
Diagnostic/monitoring equipment purchased for home use (e.g., blood pressure monitor, oximeters) are excluded unless described as covered service
Elastic splints, sleeves, or bandages are excluded unless part of a covered service
Oral appliances for snoring are excluded
Orthotic braces that straighten or change the shape of a body part are excluded
Prescribed/non-prescribed publicly available devices, software, and monitors usable for non-medical purposes are excluded
Replacement due to malicious damage, neglect, abuse, loss, or theft is excluded
Routine periodic maintenance is excluded
Specific items excluded even if prescribed: blood pressure cuff/monitor, enuresis alarm, non-wearable external defibrillator, trusses or girdle, ultrasonic nebulizers
Upgrade or replacement when existing equipment is still functional is excluded

Bilevel PAP / BPAP coverage determination (evidence-based statements)

Coverage statements and conclusions reflected in policy revisions and evidence summaries:

ALL of the following

Bilevel PAP (with or without backup rate) is considered unproven and not medically necessary due to insufficient evidence of safety and efficacy for individuals with central sleep apnea (CSA) and obstructive sleep apnea (OSA) when adherent use of bilevel PAP is for less than 4 hours during sleep time on at least 21 to 30 consecutive 24‑hour periods.< 4 hours during sleep time on at least 21 to 30 consecutive 24‑hour periods
Bilevel PAP is unproven and not medically necessary due to insufficient evidence of safety and efficacy for individuals with chronic obstructive pulmonary disease (COPD) with an arterial PaCO2 of less than 52 mm Hg while awake on room air.PaCO2 < 52 mm Hg while awake on room air

Home Mechanical Ventilators (HMV) - exclusions and medical necessity clarifications

Policy revisions specify when HMVs are not medically necessary:

ANY of the following

Home mechanical ventilators are not medically necessary for individuals with stable COPD with an arterial PaCO2 of less than 52 mm Hg while awake on room air.PaCO2 < 52 mm Hg while awake on room air
Ventilators used only to deliver continuous or intermittent positive airway pressure (HCPCS codes E0465 and E0466) are not medically necessary.
HCPCS codes E0465 and E0466
Revised list of uses for HMVs that are not medically necessary is provided elsewhere in policy; full list referenced in policy excerpt.
Full list appears elsewhere in policy

Adherence and effectiveness thresholds referenced in evidence/guidelines

Usage/adherence thresholds and PaCO2/NIPPV targets cited by trials and guidelines:

ALL of the following

Adherence thresholds: Adherent use often defined as ≥ 4 hours per night on at least 70% of nights during a defined period (e.g., 30 days) or ≥4 hours/day on ≥70% of days each month; policy references evaluation over 21–30 consecutive days for certain determinations.>=4 hours/night on >=70% of nights or >=4 hours/day on >=70% days
Consecutive days evaluation period referenced: 21–30
NIPPV PaCO2 targets: NIPPV targeted to reduce baseline PaCO2 by ≥ 20% or achieve PaCO2 values lower than 6.5 kPa (≈ 48.8 mm Hg) in trials of hypercapnic COPD.≥20% reduction or PaCO2 < 6.5 kPa
CHEST/CMS usage criterion: CHEST/CMS criteria referenced: continued use of BPAP or HMV requires usage of at least 4 hours/day on at least 70% of days each month.at least 4 hours/day on at least 70% of days each month

Prior Authorization

InterQual criteria use

Coverage determinations for home mechanical ventilators and bilevel PAP reference InterQual clinical criteria. Providers should consult and reference the InterQual CP for the specific medical necessity criteria applicable to these devices.

InterQual CP: Durable Medical Equipment Home Mechanical Ventilation Devices
InterQual CP: Durable Medical Equipment, Noninvasive Airway Assistive Devices

Billing Rule

PDAC coding source

UnitedHealthcare uses PDAC as a source for correct DME coding and coding clarification; follow National Correct Coding Initiative (NCCI) requirements.

Use PDAC for DMEPOS coding and clarification
Follow the National Correct Coding Initiative requirements

Documentation Required

Upgrade/replacement documentation

Requests for equipment upgrades are treated as new service requests and require the same documentation as an initial request, including physician justification of change in the member’s medical condition.

Physician documents change in medical condition necessitating upgrade
Upgrade request requires same documentation as a new request

Prior Authorization

Medical record documentation may be required

Medical records documentation may be requested to determine whether clinical criteria are met; benefit determination is governed by the member specific benefit plan and documentation does not guarantee coverage.

Records may be requested for review of clinical criteria
Coverage determined by member specific benefit plan

Documentation Required

Assess PaCO2 and adherence

Document the arterial PaCO2 (while awake on room air) and objective device usage/adherence (hours per night and percent of nights) to support medical necessity for long-term noninvasive ventilation or continued device coverage.

Record arterial PaCO2 measured while awake on room air
Document device usage: hours per night and percentage of nights (adherence)

Medical equipment ordered by a physician for outpatient use primarily in the home; used for medical purposes; non‑consumable except as needed; not useful without disease/disability; serves a medical purpose.

CustomizedItems uniquely constructed or substantially modified for a specific member per physician description and orders.

IrreparableDeterioration from day‑to‑day use where no specific event caused damage; considers Reasonable Useful Lifetime.

Reasonable Useful Lifetime (RUL)Standard useful lifetime for DME is 5 years (computed from delivery date).

Adherent useUse of device >=4 hours/night on at least 70% of nights during a defined period (commonly 30 days).

PaCO2Partial pressure of carbon dioxide in arterial blood; used with thresholds (e.g., 52 mm Hg awake) to guide NIV/HMV decisions.

02/01/2026revised

Reworded bilevel PAP policy language to state bilevel PAP is unproven and not medically necessary for CSA/OSA when adherent use is <4 hours during sleep on at least 21-30 consecutive days. (material change)

02/01/2026revised

Revised medical necessity clinical coverage criteria for HMVs to reference InterQual® Client Defined criteria and removed a previous InterQual® Medicare: Ventilators NCD Medical Necessity Plans reference. (non-material change)

02/01/2026added

Added InterQual® Medicare: Post Acute & Durable Medical Equipment to the list of guidelines UnitedHealthcare uses in absence of related policy. (non-material change)

02/01/2026added

Updated supporting clinical evidence references and archived previous policy version MP.009.34. (non-material change)