CurrentUnitedHealthcarePolicy CS032KY.08

Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements (for Kentucky Only)

Applies Kentucky-specific DME, orthotics, supplies, repairs/replacements; aligns medical necessity with federal/state/contractual requirements and InterQual criteria and references KAR Title 907, Chapter 001, Regulation 479.

Policy Summary

PayerUnitedHealthcare

PolicyDurable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements (for Kentucky Only)

Policy CodePolicy CS032KY.08

Change TypeMaterial guideline and criteria revisions

Effective DateMay 1, 2026

Next Review Date

Key ActionProvide complete medical record documentation (history, exam, diagnostic tests) to support medical necessity and make available upon request.

SourceLink

POLICY UPDATE CHANGES

Policy does not apply to Durable Medical Equipment or supplies used in an outpatient or inpatient facility

Revised list of clinical guidelines to be applied when determining medical necessity: added InterQual® Medicare: Post Acute & Durable Medical Equipment and InterQual® Client Defined CP; removed InterQual® Ventilators NCD reference

Home mechanical ventilators are not medically necessary for individuals with stable COPD with arterial PaCO2 < 52 mm Hg while awake on room air

Clarified bilevel PAP (BiPAP) language: considered unproven and not medically necessary for COPD patients with arterial PaCO2 < 52 mm Hg while awake on room air

Instruction to refer to Kentucky Administrative Regulations (KAR) Title 907 Chapter 001 Regulation 479 for medical necessity clinical coverage criteria

Added medical records documentation requirements language

Kentucky-onlyGeographic scope

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InterQual referenced

External criteria dependency

2Thresholds specified

Multiple device categories referencedPolicy scope breadth

Coverage Summary

This policy applies only to the state of Kentucky and addresses coverage for durable medical equipment (DME), orthotics, medical supplies, and repairs/replacements. The policy’s overall coverage stance is mixed: some items (for example, cranial remolding orthoses billed as HCPCS S1040 and certain respiratory devices in specified clinical scenarios) are covered when medical criteria are met, while other items (for example, protective helmets HCPCS A8000–A8004 as safety devices) are not covered as cranial remolding devices. The policy aligns medical necessity determinations with federal, state, and contractual requirements, refers claim reviewers to KAR Title 907, Chapter 001, Regulation 479 for coverage, limitations, and reimbursement, and notes that the policy does not apply to DME or supplies used in an outpatient or inpatient facility.

Key thresholds & scope

Geographic scopeKentucky-only

Major guideline sourcesInterQual + KAR refs (InterQual CP; InterQual Medicare added; KAR Title 907 Ch. 001 Reg. 479)

PaCO2 threshold (home ventilator / BiPAP exclusion)arterial PaCO2 < 52 mm Hg while awake on room air => not medically necessary

Adherence threshold (BiPAP/BPAP)< 4 hours during sleep time on at least 21–30 consecutive days => considered unproven / not medically necessary

Material clinical changesAdded: policy excludes DME/supplies used in outpatient/inpatient facility; Added/clarified PaCO2 < 52 mm Hg exclusion and revised InterQual references (InterQual Medicare added; Ventilators NCD removed)

Medical Necessity Determinations and Criteria

General Medical Necessity Determination

When determining medical necessity, apply the following in order:

Apply guidelines in order: Federal, state, and contractual requirements
Apply guidelines in order: InterQual® CP: Durable Medical Equipment
Apply guidelines in order: UnitedHealthcare Community Plan Medical Policy
Apply guidelines in order: InterQual® Medicare: Post Acute & Durable Medical Equipment

Coding

Cranial remolding deviceHCPCSCovered

S1040

Cranial remolding orthosis (cranial molding helmet)

Protective helmets (not cranial remolding)HCPCSNot Covered

A8000	Protective helmet, not cranial remolding (example code range A8000-A8004 indicated)
A8001
A8002
A8003
A8004

Bilevel PAP devicesHCPCS

E0470	Bilevel PAP device, backup rate not specified
E0471	Bilevel PAP device, backup rate unspecified (alternate code for bilevel)

Referenced regulations/guidelines (not procedure codes)mixed

KAR Title 907 Chapter 001 Regulation 479

Medical supplies, equipment, and appliances covered benefits and reimbursement (Kentucky)

UnitedHealthcare has adopted the PDAC (Centers for Medicare & Medicaid Services’ Palmetto contractor) as the source for correct DMEPOS coding and coding clarification; adjudicators should use PDAC coding guidance when reviewing DME claims in accordance with the policy’s billing rules.

Provider Actions and Requirements

Documentation Required

Medical records to support medical necessity

Patient medical record must document relevant medical history, physical exam, and diagnostic test results to fully support medical necessity and be available upon request.

Relevant medical history
Physical examination
Results of pertinent diagnostic tests or procedures

Documentation Required

Equipment upgrade / replacement documentation

A change in the member's medical condition requiring equipment upgrade or replacement requires the same documentation as a new request; equipment upgrades are treated as equivalent to a new service.

Clinical Evidence and Definitions

Clinical evidence and guideline-based criteria drive medical necessity determinations for DME in this policy. UnitedHealthcare uses InterQual® criteria as the primary source for DME and home mechanical ventilation decisions and instructs reviewers to refer to InterQual® (and InterQual® Client Defined custom criteria if needed) along with applicable Kentucky Administrative Regulations (KAR Title 907, Chapter 001, Regulation 479) when applying clinical coverage rules; medical record documentation must fully support medical necessity and be available upon request.

Study/Source	Key Finding
Wu et al. (2022) systematic review
LTHNIPPV reduced all-cause mortality (RR 0.76; 95% CI 0.61-0.95) in stable hypercapnic COPD; greater benefit if baseline PaCO2 ≥ 55 mm Hg
Wilson et al. (2020) systematic review
BPAP associated with reduced mortality (OR 0.66), fewer admissions, lower intubation need in hypercapnic COPD; overall evidence low to moderate
Bhatt et al. (2013) RCT
NIPPV showed modest dyspnea and QoL improvements in severe COPD with PaCO2 < 52 mm Hg but study underpowered
Köhnlein et al. (2014) multicenter RCT
Long-term NIPPV improved survival in advanced stable hypercapnic COPD (reduced 1-year mortality from 33% to 12% in trial)

Term	Definition
Durable Medical Equipment (DME)
Medical Equipment that withstands repeated use; is primarily and customarily used to serve a medical purpose; is generally not useful in the absence of an illness or injury; and is appropriate for use in the home. (907 KAR 1:479)
Medical Supplies
Items that are consumable, nonreusable, disposable, and primarily and customarily used to serve a medical purpose. (907 KAR 1:479)
PaCO2
Arterial partial pressure of carbon dioxide, measured in mm Hg
Bilevel PAP (BiPAP)
Positive airway pressure device providing different pressures for inspiration and expiration, may or may not include a backup rate

Medicare Determinations

Name	Type	Number	Effective Date
Home Mechanical Ventilators and Respiratory Assist Devices (Applies for 2 Years of Age or Older)
NCD

Revision History

2026-05-01addedLatest

Added language to Summary of Changes: Policy does not apply to Durable Medical Equipment or supplies used in an outpatient or inpatient facility.

2026-05-01revisedLatest

Revised list of clinical guidelines used to determine medical necessity: added InterQual® Medicare: Post Acute & Durable Medical Equipment and InterQual® Client Defined CP: Durable Medical Equipment Home Mechanical Ventilation Devices (Custom) - UHG; removed InterQual® Ventilators NCD reference.

Policy Summary

PayerUnitedHealthcare

PolicyDurable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements (for Kentucky Only)

Policy CodePolicy CS032KY.08

Change TypeMaterial guideline and criteria revisions

Effective DateMay 1, 2026

Next Review Date

Key ActionProvide complete medical record documentation (history, exam, diagnostic tests) to support medical necessity and make available upon request.

SourceLink

On This Page

Apply guidelines in order: CMS DME MAC guidance

Application

Policy applicability

Geographic scope: This medical policy only applies to the state of Kentucky
Facility exclusion: This policy does not apply to Durable Medical Equipment or supplies used in an outpatient or inpatient facility

Cranial Remolding Orthosis

Coverage statement

Covered code: Cranial molding helmets (cranial remolding orthosis) billed with HCPCS S1040 are covered when they meet medical criteria
Refer to the Plagiocephaly and Craniosynostosis Treatment (for Kentucky Only) medical policy
Reference policy: For all indications, refer to the Medical Policy: Plagiocephaly and Craniosynostosis Treatment (for Kentucky Only)
Not cranial remolding: Protective helmets (HCPCS A8000-A8004) are not cranial remolding devices and are considered safety devices, not covered as remolding devices

Home Mechanical Ventilators and Respiratory Assist Devices (age ≥ 2 years)

Coverage/medical necessity guidance and exclusions

Home Mechanical Ventilators (age ≥ 2)

InterQual primary: Refer to InterQual® CP: Durable Medical Equipment Home Mechanical Ventilation Devices for medical necessity criteria
If InterQual cannot determine medical necessity, refer to InterQual® Client Defined CP: Durable Medical Equipment Home Mechanical Ventilation Devices (Custom) - UHG
Exclusion for stable COPD: 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 airarterial PaCO2 < 52 mm Hg (awake, room air)
Added in policy history

Bilevel PAP / BiPAP / BPAP (including humidifiers)

Coverage/limitations

InterQual reference: Bilevel PAP devices (HCPCS E0470 and E0471) are considered medically necessary in certain clinical scenarios; refer to InterQual® CP: Durable Medical Equipment, Noninvasive Airway Assistive Devices for criteria
Adherence limitation: Bilevel PAP (with or without backup rate) is considered unproven and not medically necessary for CSA and OSA when adherent use is less than 4 hours during sleep time on at least 21 to 30 consecutive 24-hour periodsadherent use < 4 hours during sleep time on at least 21–30 consecutive days
Due to insufficient evidence of safety and efficacy
COPD limitation: Bilevel PAP is unproven and not medically necessary for individuals with COPD with arterial PaCO2 < 52 mm Hg while awake on room air (even when asleep PaCO2 criteria are met)arterial PaCO2 < 52 mm Hg (awake, room air)
Due to insufficient evidence

BPAP with Backup Rate

Coverage/limitations

Adherence-based limitation: BPAP with or without backup rate is considered unproven for individuals with CSA or OSA when adherent use of BPAP is less than 4 hours during sleep time for at least 21 to 30 consecutive 24-hour periodsadherent use < 4 hours during sleep time on at least 21–30 consecutive days
Due to insufficient evidence of safety and efficacy

Repair and Replacement / Equipment Upgrades

Operational rules

Regulatory reference: For DME repair and replacement, refer to Kentucky Administrative Regulations (KAR) Title 907, Chapter 001, Regulation 479
Documentation equivalence: A change in the member's medical condition and equipment needs requires the same documentation as a new request
Upgrades treated as new: Equipment upgrades are equivalent to a new service

Implanted Devices

Coverage exclusion

Fully implanted exclusion: Any device fully implanted into the body is not covered as DME; if covered, it is part of the surgical benefit
Cochlear implant clarification: External components of cochlear implants (speech processor, microphone, transmitter coil) are DME; implantable components are a medical-surgical benefit

Contact Lenses & Scleral Bandages (Shells)

Coverage pathway

Not DME; vision program: Contact lenses or scleral shells used to treat injury or disease are not considered DME and may be covered under KAR Title 907, Chapter 001, Regulation 632 (Vision program)
Examples: corneal abrasion, keratoconus, severe dry eye

Enteral Pumps

Coverage assignment

Coverage assignment: Enteral pumps are covered as DME; refer to Medical Policy: Enteral Nutrition (Oral and Tube Feeding) (for Kentucky Only) for formula information

Insulin Pumps

Coverage statement

Coverage of pumps: Both disposable and durable insulin pumps are covered
Refer to Continuous Glucose Monitoring and Insulin Delivery policy for state specifics
State mandates: State-specific mandated coverage of diabetes supplies should be referenced to federal, state, or contractual requirements

Lymphedema Stockings for the Arm

Coverage classification

DME classification: Post-mastectomy lymphedema stockings for the arm are considered DME
Refer to state or contractual requirements for mandated coverage

Applicability and General Instruction

Policy applies when federal, state, and contractual requirements permit; exclusions and applicability noted:

Policy scope note: This policy applies when federal, state, and contractual requirements permit; benefit coverage determined by those requirements which govern in event of conflict
InterQual primacy: UnitedHealthcare uses InterQual® as primary criteria; may use other UnitedHealthcare policies if InterQual® not applicable
Documentation requirement: Medical record documentation must fully support medical necessity and may be required for review (history, physical exam, pertinent diagnostic tests)
Documentation should be legible and available upon request

Home Mechanical Ventilators and Respiratory Assist Devices — COPD / Hypercapnia

Coverage exclusions and clinical thresholds for home mechanical ventilators and bilevel PAP devices:

COPD / Hypercapnia exclusions and thresholds

HMV exclusion for stable COPD: 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 airarterial PaCO2 < 52 mm Hg (awake, room air)
Added in policy history
BiPAP COPD limitation: Bilevel PAP is considered unproven and not medically necessary for individuals with COPD with arterial PaCO2 < 52 mm Hg while awake on room air (even when asleep PaCO2 criteria met)arterial PaCO2 < 52 mm Hg (awake, room air)
Revised language clarifying evidence insufficiency
Adherence threshold retained: Bilevel PAP, with or without backup rate, is considered unproven and not medically necessary for CSA and OSA when adherent use is less than 4 hours during sleep time on at least 21 to 30 consecutive 24-hour periodsadherent use < 4 hours during sleep time on at least 21–30 consecutive days
Retained adherence threshold

Use of Clinical Guidelines and References

Guidelines to be applied when determining medical necessity:

InterQual Medicare added: InterQual® Medicare: Post Acute & Durable Medical Equipment added as a referenced guideline
InterQual ventilators NCD removed: InterQual® Medicare: Post Acute & Durable Medical Equipment, Ventilators NCD reference removed
InterQual client defined added: InterQual® Client Defined, CP: Durable Medical Equipment Home Mechanical Ventilation Devices: Invasive, Noninvasive, and Multifunction (Custom) - UHG added
KAR reference: Refer to Kentucky Administrative Regulations (KAR), Title 907, Chapter 001, Regulation 479 for DME covered benefits and reimbursement

Prior Authorization

Refer to InterQual criteria for ventilators and bilevel PAP

Medical necessity for home mechanical ventilators and certain bilevel PAP indications must be determined using InterQual® CP criteria; if InterQual cannot determine medical necessity, refer to the InterQual® Client Defined (Custom) criteria as a fallback.

Billing Rule

Coding source for DME

UnitedHealthcare has adopted PDAC as the source for correct DMEPOS coding and coding clarification per CMS guidance.

Documentation Required

Support medical necessity with clinical records

Providers must maintain and provide medical record documentation (relevant history, physical exam, diagnostic tests) to support requested DME/NIV services as part of reviews; documentation should be legible, maintained in the patient's record, and made available upon request.

Relevant medical history
Physical examination
Pertinent diagnostic test results

Prior Authorization

Use InterQual® criteria for medical necessity determinations

When applying for coverage, adjudicators and providers should reference InterQual® criteria as the primary clinical standard and also consult applicable Kentucky Administrative Regulations (KAR) provisions and UnitedHealthcare policy when InterQual® is not applicable.

2026-05-01addedLatest

Added explicit clinical threshold in policy history: Home mechanical ventilators are not medically necessary for individuals with stable COPD with arterial PaCO2 < 52 mm Hg while awake on room air.

2026-05-01revisedLatest

Replaced prior wording about 'insufficient high-quality evidence' with streamlined language about insufficient evidence: bilevel PAP (BiPAP) is considered unproven and not medically necessary for COPD patients with arterial PaCO2 < 52 mm Hg while awake on room air.

detailaddedLatest

Added instruction that medical records documentation may be required and must fully support medical necessity (includes history, physical exam, and pertinent diagnostic tests); documentation must be legible and available upon request.

detailaddedLatest

Added operational note to refer to Kentucky Administrative Regulations (KAR) Title 907, Chapter 001, Regulation 479 for DME coverage, limitations, and reimbursement; reference added to Policy History and Benefit Considerations.