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    OpenPayerPolicy UpdatesReimbursement/Payment PolicyWellcare Hawaii DME O&P Policy Update | OpenPayer
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    ModifiedWellcare HawaiiPolicy CP.MP.107

    Durable Medical Equipment and Orthotics and Prosthetics Guidelines

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    Defines medical necessity, equipment-specific coverage criteria, HCPCS mappings, and review requirements for DME, orthotics, and prosthetics for Wellcare Hawaii members.

    Policy Summary
    PayerWellcare Hawaii
    PolicyDurable Medical Equipment and Orthotics and Prosthetics Guidelines
    Policy CodePolicy CP.MP.107
    Change TypeMultiple material updates to equipment criteria, coding, and review requirements
    Effective Date
    Next Review Date
    Key ActionProvide education and demonstrate understanding of device use and document a trial showing safe and effective use when requesting DME.
    SourceLink
    POLICY UPDATE CHANGES

    Nebulizer, ultrasonic changed to not medically necessary with supporting statement.

    Added contraindications for implantable infusion pumps.

    Wheelchair criteria separated into own table and manual wheelchair criteria added/updated (including replacement rules and coding).

    Criteria and codes added for enclosed beds and wheelchair-mounted assistive robotic arm (JACO); JACO categorized as not medically necessary.

    Replaced 'investigational' phrasing with 'not proven safe and effective' for several device categories (pneumatic compression devices, NMES, peroneal nerve stimulators).

    Replaced existing Standing Frames criteria with new initial request and replacement request criteria and required that replacement requests also meet existing criteria for the initial request.

    Revised pneumatic compression device guidance to state they are not proven safe and effective for lymphedema of the abdomen, trunk, chest, genitals, or neck and for arterial insufficiency.

    Added criteria for Wheelchair-mounted Assistive Robotic Arm (JACO).

    Added multiple HCPCS codes for burn garments (A6502–A6513) and other equipment/code updates across sections (e.g., E0680/E0681, E0738/E0739, L1933/L1952, numerous L-codes).

    Removed several sections/codes or moved criteria to other policies (e.g., cardiac event monitor E0616 to CP.MP.243; invasive home ventilator E0465 to CP.MP.184; removed oxygen tent and certain other supply codes).

    Updated manual wheelchair initial and replacement request criteria and removed certain pediatric wheelchair codes from the manual wheelchair section.

    Policy Summary
    PayerWellcare Hawaii
    PolicyDurable Medical Equipment and Orthotics and Prosthetics Guidelines
    Policy CodePolicy CP.MP.107
    Change TypeMultiple material updates to equipment criteria, coding, and review requirements
    Effective Date
    Next Review Date
    Key ActionProvide education and demonstrate understanding of device use and document a trial showing safe and effective use when requesting DME.
    SourceLink
    On This Page
    Coverage Criteria and Device-Specific RulesHCPCS / CPT / Code Mappings and Notable Code ChangesProvider Responsibilities, Reviews, and Authorization NotesKey DefinitionsDevice-Specific Medical Necessity CriteriaRental, Purchase and One-Time Rental RulesReplacement and Repair RulesDocumentation Requirements for AuthorizationsItems Not Covered or Not Proven Safe and Effective
    multipleequipment groups with specific criteria
    mandatory secondary reviewitems requiring secondary review
    30 daysWCD initial approval
    >60%repair threshold
    5 yearswheelchair useful lifetime
    examplesexamples not medically necessary

    Coverage Criteria and Device-Specific Rules

    General medical necessity criteria

    Covered when ALL of the following are met:

    Equipment is necessary and reasonable for treatment of an illness or injury or to improve functioning of a physical deficit
    Education regarding use of the device has been provided to the member/enrollee and/or caregiver with demonstrated understanding
    A trial of the requested device has been performed with demonstrated ability to use it safely and effectively
    Applicable equipment-specific criteria (device-specific sections) are met

    Enclosed beds and positioning equipment

    Enclosed beds and specialty positioning equipment are medically necessary when ALL of the following are documented:

    A standard bed or standard hospital bed is unable to meet the member's positioning needs due to disability
    Less intensive alternatives to improve safety have been tried and ruled out (examples: bed rails, mattress on floor, removal of hazards, bed alarms, environmental modifications, behavior/medication interventions) and documentation explains why needs could not be met
    Relevant diagnosis is documented (examples: cerebral palsy, developmental delay, neurologic/genetic disorder causing uncontrolled movements, uncontrolled seizure disorder, severe behavior disorder)
    Healthcare provider evaluation (typically OT/PT) including specific functional status, home evaluation, and caregiver education on proper use of the enclosure is provided
    Name of and invoice for the bed or enclosure being requested is included
    NOTE: Enclosed beds should not be used as discipline or restraint; use at night and for short naps only; only basic beds considered medically necessary — upgrades for aesthetics or non-DME features are not covered

    Cardiac and compression therapy

    Cardiac and compression therapy device rules:

    Wearable Cardioverter Defibrillator (WCD) initial requests: member is ≥ 18 years and at increased risk of sudden cardiac death and meets one of specified indications (e.g., awaiting transplant; prior ICD removed for infection awaiting re-implantation; newly indicated ICD delayed for infection or other specified reasons; recent CABG/PCI within 90 days; newly diagnosed potentially reversible nonischemic cardiomyopathy under optimal medical therapy trial)
    WCD authorizations: initial approval for 30 days when criteria met; ongoing approvals may be for 30-day increments up to a total of 90 days when adherence is confirmed and plan of care updated
    Non-pneumatic compression devices are considered NOT MEDICALLY NECESSARY due to insufficient clinical evidence supporting safety and effectiveness over standard pneumatic compression devices

    Infusion and other pumps

    Infusion pumps and ambulatory (external) pump devices are medically necessary when device-specific indications and conditions are met:

    Ambulatory infusion pump indications (ANY of)

    • Administration of deferoxamine for acute iron poisoning
    • Regional chemotherapy delivery for unresectable primary hepatocellular carcinoma or colorectal metastases limited to the liver when clinically indicated
    • Use with opioid drugs for intractable cancer pain when criteria per referenced intrathecal/implantable pump policy are met
    Parenteral pumps are medically necessary when needed for uninterrupted parenteral administration of medication via pump
    Gastric suction pumps (home model) are medically necessary when indicated for inability to empty gastric secretions and meet documentation of indication

    Implantable infusion pumps and related pumps

    Implantable infusion pumps and implantable pump systems are medically necessary ONLY when ALL of the following are documented:

    Indication requires implanted pump delivery (drug and purpose consistent with FDA approval and policy guidance; see CP.MP.173 for intrathecal pain pumps where applicable)
    Prior to implantation there has been a favorable response to an appropriate trial (e.g., intrathecal trial dose for anti-spasmodic therapy) and less invasive therapies have failed or been intolerable (documented trial of noninvasive methods of at least 6 weeks where specified)
    Contraindications are absent, including but not limited to: known allergy/hypersensitivity to the drug being used, active infection, body size insufficient to support the device, presence of another implanted programmable device
    Documentation includes trial response evidence, allergy/infection/size screening, and justification that implanted delivery is medically necessary compared with alternatives

    Respiratory equipment

    Respiratory device determinations (medical necessity vs not medically necessary):

    ANY of the following

    • Oximeter is medically necessary when used as a monitoring/alarm device for: home ventilator or tracheostomy patients; determining or weaning home oxygen; or monitoring an unstable respiratory condition
    • Oximetry is NOT medically necessary when used as a diagnostic procedure, for monitoring a stable respiratory condition, for routine asthma management, or other conditions not listed
    • Ultrasonic nebulizers are NOT MEDICALLY NECESSARY as they provide no clinical advantage over small-volume nebulizers
    • Intrapulmonary percussive ventilation (IPV) devices are NOT MEDICALLY NECESSARY as current evidence does not support effectiveness

    Walkers

    Walkers are medically necessary when the following criteria are met:

    Standard walker: Mobility-related activities of daily living (MRADLs) in the home cannot be met due to the member's mobility limitation
    Walker can be safely used by the member/enrollee (or with caregiver assistance) and will sufficiently resolve the functional mobility deficit

    Heavy-duty walker specific

    • Member/enrollee weighs more than 300 pounds
    • Member/enrollee is unable to use a standard walker due to a severe neurologic disorder or other condition preventing safe/efficient use of a standard walker
    Requests must include documentation of functional limitation, safety for use, and expected functional improvement with walker provision

    Wheelchairs (manual and power) — initial and replacement criteria

    Manual and power wheelchair initial and replacement medical necessity criteria:

    Initial manual wheelchair: Mobility limitation interferes with ability to participate in MRADLs AND the limitation cannot be met with a cane or walker
    Manual wheelchair is expected to significantly improve the member's ability to participate in MRADLs
    Home provides adequate access and maneuvering space for the requested wheelchair

    User/caregiver capability

    • Caregiver is able to assist with wheelchair use
    • Member is able to safely and efficiently self-propel the manual wheelchair

    Replacement allowed when

    Equipment-specific criteria updates

    Selected equipment-specific updates and age-specific requirements (high-level):

    Standing frames: new initial and replacement request criteria established; replacement requests must meet initial request criteria

    Standing frames - initial under age 18

    • Developmental delay in ambulation and at least 18 months of age
    • Documented neurological or neuromuscular impairment and at least 1 year of age
    Replacement standing frames must include documentation supporting height/weight requirements, alertness and responsiveness, absence of contraindications to a standing program, and caregiver training/availability to assist safely
    Pneumatic compression devices are not proven safe and effective for lymphedema of the abdomen, trunk, chest, genitals, or neck and are not for arterial insufficiency

    Equipment-specific criteria references

    Use external authoritative sources to inform device-specific medical necessity determinations:

    Medical necessity determinations should reference applicable CMS NCDs, LCDs, and Coverage Articles (examples cited include facial prostheses, infusion pumps, external infusion pumps, suction pumps, nebulizers, oxygen, walkers, and manual wheelchair bases)
    Clinical literature and evidence summaries cited in the policy (Hayes briefs, systematic reviews, UpToDate, peer-reviewed studies) should be consulted when applying device-specific criteria
    Providers must ensure coverage decisions conform to plan terms and applicable state Medicaid or Medicare determinations; document applicability of NCDs/LCDs/LCAs in the member record when requesting DME/O&P coverage

    HCPCS / CPT / Code Mappings and Notable Code Changes

    Burn garmentsHCPCSCovered
    A6501A6501
    A6502A6502
    A6503A6503
    A6504A6504
    A6505A6505
    A6506A6506
    A6507A6507
    A6508A6508
    A6509A6509
    A6510A6510
    1–10 of 11
    1/2
    Cardiac equipment (Wearable Cardioverter Defibrillator)HCPCSCovered
    K0606K0606
    Non-wearable external defibrillatorHCPCSNot Covered
    E0617E0617
    Compression therapy — Non-pneumatic compression devicesHCPCSNot Covered
    E0678E0678
    E0679E0679
    E0680E0680
    E0681E0681
    Ultraviolet panel lightsHCPCSCovered
    E0691E0691
    E0692E0692
    E0693E0693
    Cold pad pumpHCPCSNot Covered
    E0236E0236
    Prosthetics / Orthotics / Pumps — Representative codesmixedCovered
    L0170L0170
    L0190L0190
    L0200L0200
    L0700L0700
    L0710L0710
    L0720L0720
    L0999L0999
    L1000L1000
    L1001L1001
    L1005L1005
    1–10 of 39
    1/4
    Selected HCPCS referencedHCPCS
    E0130E0130
    E0148E0148
    E2298E2298
    E0575E0575
    Notable code additions and replacementsHCPCS
    A6502A6502
    A6503A6503
    A6504A6504
    A6505A6505
    A6506A6506
    E0680E0680
    E0681E0681
    E0738E0738
    E0739E0739
    L1933L1933
    1–10 of 13
    1/2
    Cited CMS NCDs/LCDs and LCAsmixed
    L33738L33738
    280.14280.14
    L33794L33794
    L33612L33612
    L34824L34824
    L33370L33370
    L33797L33797
    L33791L33791
    L33788L33788
    Repair vs replacement threshold — prosthetics
    Repair vs replacement ruleRepair cost greater than 60% of the replacement cost supports replacement of prosthesis or prosthetic components.
    Proper care requirementProsthesis must have been properly cared for per manufacturer recommendations to qualify for replacement.
    Documentation for replacementMedical documentation must support continued medical need, ongoing motivation to use the device, appropriate functional level, and replacement with same or similar device.
    Mandatory secondary review for complex prostheticsAll requests for upper-extremity and myoelectric prosthetics and additions require mandatory secondary review by a medical director and/or therapy advisor; lower-extremity prosthetics and additions also require mandatory secondary review.

    Provider Responsibilities, Reviews, and Authorization Notes

    Documentation Required

    Document education and trial of device use

    Education on device use must be provided to the member and/or caregiver with documented demonstrated understanding, and a trial of the requested device must be documented showing the member's demonstrated ability to use the device safely and effectively.

    • Document education provided and evidence the member/caregiver demonstrated understanding.
    • Document a trial of the requested device with observed safe and effective use.
    Prior Authorization

    Mandatory secondary review for specified complex items

    All requests for specified items require mandatory secondary review by a medical director and/or therapy advisor before authorization.

    • Applies to enclosed beds and other specified positioning equipment (enclosed beds require mandatory secondary review).

    Key Definitions

    DME definition
    DefinitionDurable medical equipment (DME) is equipment that can withstand repeated use, is primarily and customarily used to serve a medical purpose, is appropriate for use in the home, and is generally not useful in the absence of illness or injury.
    Home useDME is manufactured primarily for use in the home environment but is not limited to home use; institutions meeting hospital or SNF definitions may not be considered a member's home for rental/purchase rules.
    ExclusionsExpendable medical supplies (e.g., incontinence pads, catheters, ace bandages) are not considered durable.
    Orthotic definition
    DefinitionOrthotic devices are rigid and semi-rigid devices used to support a weak or deformed body part or to restrict or eliminate motion in a diseased or injured body part.
    Examples

    Device-Specific Medical Necessity Criteria

    Burn garments criteria

    Burn garments are medically necessary when ALL of the following are met:

    Member/enrollee is at risk of post-burn contracture
    Garment use is combined with physical and/or occupational therapy with intent to prevent need for skin grafting or contractures from hypertrophic scarring

    Prosthetics/Orthotics criteria

    Prosthetic and orthotic medical necessity criteria — initial and replacement considerations:

    Initial prosthesis/orthosis: functional needs are not met with activity modification or lower-cost alternatives and the device is anticipated to meet functional needs
    Clinical examination documents relevant factors (e.g., residual limb length and volume stability, skin integrity, strength, range of motion) supporting candidacy

    Rental, Purchase and One-Time Rental Rules

    EquipmentPurchase vs Rental RulePolicy-level Guidance
    Purchase preferred when medically necessary and cost‑effective; deluxe or convenience features not reasonable; if a medically necessary lesser‑cost item exists, a higher‑cost item will be denied.
    Equipment is necessary when it will make a meaningful contribution to treatment or function; consider expense disproportionate to benefit and availability of adequate alternatives when deciding purchase versus rental.
    ItemRental RuleNotes / Conditions
    One month's rental is considered medically necessary when the member's owned wheelchair is being repaired.
    ItemRental Policy DetailsProvider/Documentation Notes
    Document that owned wheelchair is being repaired; repair history, age, and overall condition may be reviewed to assess overutilization or replacement need. Requests for repairs billed with certain repair codes require secondary review.

    Replacement and Repair Rules

    Prosthesis/prosthetic components — replacement based on damage/repair threshold (>60%)
    Replacement triggerProsthesis or prosthetic components may be replaced when irreparably damaged or when repair cost exceeds 60% of replacement cost.
    Care requirementProsthesis must have been properly cared for in accordance with manufacturer recommendations to qualify for replacement under this rule.
    Required documentationMedical documentation must support continued medical need, functional level, motivation to use device, and intent to replace with same or similar prosthesis/components.
    Manual wheelchair replacement timing — after reasonable useful lifetime of five years or more
    Replacement timingManual wheelchair replacement may be considered after a reasonable useful lifetime of five years or more.
    Other replacement reasons

    Documentation Requirements for Authorizations

    Documentation Required

    Therapist/home evaluation, caregiver education, invoice, and alternatives documentation

    Include a therapist evaluation and home evaluation, documentation of caregiver education, and the invoice or exact name of the requested equipment; document alternatives tried and failed.

    • Therapist/occupational or physical therapy evaluation with specific functional information and home evaluation.
    • Document caregiver education on proper use and the invoice/name of the bed or device requested.
    • Document lower-intensity alternatives that were tried and ruled out.
    Documentation Required

    Submit adherence reports and updated plan of care for WCD continuation

    For ongoing WCD authorization, submit device adherence reports and a provider attestation of adherence plus an updated plan of care to support continuation beyond the initial 30 days.

    • Provide objective adherence data from WCD device reports.
    • Include an updated plan of care documenting ongoing need.

    Items Not Covered or Not Proven Safe and Effective

    The following items are identified as not covered / not medically necessary under this policy, with the rationale summarized from the source guidance: Non‑pneumatic compression devices (HCPCS E0678–E0681 and related codes) are not medically necessary because there is insufficient clinical evidence to support their safety and effectiveness compared with standard pneumatic compression devices (source: policy statement on compression therapy and associated code listing).

    Cold pad pumps (HCPCS E0236) for postoperative management are listed as not medically necessary; the policy states research does not indicate improved outcomes in pain or edema management compared with conservative measures, cold therapy alone, or standard compression therapy.

    Ultrasonic nebulizers (HCPCS E0575) are specified as not medically necessary because they provide no clinical advantage over a small‑volume nebulizer and compressor (E0574), per the policy's respiratory equipment section.

    Intrapulmonary percussive ventilation (IPV) devices (e.g., Volara, Percussionaire; HCPCS E1399 when used for IPV) are considered not medically necessary because current evidence does not support their effectiveness.

    The wheelchair‑mounted assistive robotic arm (JACO) is classified as not medically necessary due to insufficient clinical evidence demonstrating improved safety or health outcomes compared with alternative technologies (the policy references JACO and associated evidence summaries).

    Additionally, the policy flags certain deluxe, aesthetic, or convenience upgrades for DME as not reasonable and therefore not covered when they are beyond medically necessary basic equipment (policy general reasonableness rules and enclosed bed upgrade examples).

    REVIEW: All requests for enclosed beds require mandatory secondary review by a medical director
    • Replacement due to loss, theft, or irreparable damage with documentation supporting continued medical necessity and replacement with same or similar equipment
    • Replacement after reasonable useful lifetime of five years or more OR change in member status requiring different equipment with maximized growth features, with documentation that mobility limitation continues to interfere with MRADLs
    Repairs and temporary rental: One month's rental for a standard manual wheelchair is medically necessary if an owned wheelchair is being repaired; repairs billed with codes K0108, K0739, or E1399 require mandatory secondary review
    Power feature: Power seat elevator on a power wheelchair is medically necessary when assessment/prescription/trials/training involve a licensed/certified medical professional, cognitive function is adequate, a clear functional need is indicated, and the feature will improve functional independence
    Not covered: Wheelchair-mounted robotic arm (JACO) is considered NOT MEDICALLY NECESSARY due to insufficient evidence of safety and improved outcomes
    Criteria were added for wheelchair-mounted assistive robotic arm (JACO) and other code/section updates; some device criteria were moved to other policies (see related policies) and certain codes were deleted or remapped
    Code examples referencedRepresentative HCPCS cited for prosthetics: L7170, L7185, L7186, L7405, L7406, L7499, L5827, L5990, L8030-L8035.
    Wheelchair useful lifetime
    Useful lifetime guidelineReplacement of a manual wheelchair may be considered after a reasonable useful lifetime of five years or more.
    Replacement for loss/theft/irreparable damageReplacement is medically necessary when documentation supports loss, theft, or irreparable damage and continued medical necessity; replacement should be with same or similar equipment.
    Home access requirementHome must provide adequate access and maneuvering space for the requested manual wheelchair for initial and replacement requests.
    Ability/willingness to useMember or caregiver must be willing to use the manual wheelchair; either caregiver assistance or member self-propulsion capability must be documented.
    Heavy-duty walker weight threshold
    Heavy-duty walker thresholdHeavy-duty walker is indicated when the member/enrollee weighs more than 300 pounds.
    Alternative justificationHeavy-duty walker may also be indicated when inability to use a standard walker results from a severe neurologic disorder preventing safe use.
    Standard walker criteriaStandard walker is appropriate when MRADL limitations exist, the walker can be safely used, and functional mobility deficit is expected to improve with its use.
    Visual acuity requirement for glucose monitor criteria
    Updated visual acuity requirementFor blood glucose monitor criteria, visual acuity threshold updated to 20/200 or worse in both eyes.
    Context of updateThis change replaces the prior criterion of visual acuity less than 20/200.
    Implication for coverageMembers meeting this visual acuity threshold may qualify under the device-specific glucose monitor criteria when other requirements are met.
  1. Applies to custom or complex items listed elsewhere such as upper extremity/myoelectric devices and other custom O&P additions referenced in the policy.
  2. Prior Authorization

    Time-limited authorizations for WCD (initial 30 days)

    Initial wearable cardioverter defibrillator (WCD) requests are authorized for 30 days when criteria are met; ongoing requests may be approved in 30-day increments up to a 90-day total with documentation of adherence and an updated plan of care.

    • Initial approval: 30 days for members ≥18 meeting WCD indications.
    • Continuation: 30-day increments up to 90 days contingent on adherence documentation and updated plan of care.
    Prior Authorization

    Secondary review required for repairs billed with K0108, K0739, E1399

    Requests for wheelchair or other DME repairs billed with HCPCS codes K0108, K0739, or E1399 must undergo mandatory secondary review by a medical director or therapy advisor.

    • Identify repair claims using K0108, K0739, or E1399 and submit for secondary review prior to authorization.
    • Secondary review requirement is intended to evaluate repair vs. replacement and prevent overutilization.
    Note

    Prior authorization removals — check current PA requirements

    Certain criteria and items were removed because they no longer require prior authorization; providers should note removed items when preparing requests.

    • Examples: halo procedure and equipment criteria were removed from this policy due to no prior authorization requirement.
    • Review current policy code lists and prior authorization requirements before submitting requests.
    Documentation Required

    Review and document applicable Medicare NCDs/LCDs/LCAs

    Providers are expected to review and document the applicability of Medicare NCDs, LCDs, and Coverage Articles (as well as plan-level and state requirements) prior to requesting DME/O&P coverage, since coverage decisions are subject to those determinations.

    • Document in the patient record that applicable NCDs/LCDs/LCAs were reviewed and applied when relevant.
    • Coverage decisions remain subject to plan terms, state/federal requirements, and Medicare determinations for Medicare members.
    Orthotics include braces and related supportive devices used to improve function or limit motion as part of treatment.
    Prosthetic definition
    DefinitionProsthetic devices are custom-made artificial limbs or other assistive devices that replace a body part or function due to trauma, vascular disease, diabetes, cancer, or congenital disorders.
    Replacement criteriaReplacements are permitted for prosthetics when irreparable damage occurs or repair costs exceed replacement threshold; documentation of continued need is required.
    Durable — definition distinguishing expendable supplies
    DefinitionDurable describes items that can withstand repeated use — the type of item that could normally be rented; expendable supplies are not durable.
    ImplicationDurability supports rental vs purchase determinations and coverage category assignment.
    Medical equipment definition
    DefinitionMedical equipment is equipment primarily and customarily used for medical purposes and not generally useful in the absence of illness or injury; some items may require documentation or specialist input to determine medical nature.
    EvaluationIf equipment is new or ambiguous, supplier/manufacturer information and specialist advice may be required to establish medical equipment status.
    Myoelectric Rehabilitation Systems — definition
    DefinitionMyoelectric Rehabilitation Systems (formerly 'MyoPro Orthosis') are electronic orthotic/rehabilitation systems; policy updates replaced prior L-codes with E0738 and E0739 and states these systems are considered not medically necessary when evidence is insufficient.
    Coding noteHCPCS codes E0738 and E0739 are used for Myoelectric Rehabilitation Systems in the policy coding updates.
    Non-pneumatic compression devices — definition (includes E0680/E0681)
    DefinitionNon-pneumatic compression devices are external compression devices distinct from pneumatic systems; policy includes HCPCS codes E0680 and E0681 for these devices.
    Policy stanceNon-pneumatic compression devices are listed in coding updates; related pneumatic compression device guidance addresses safety/effectiveness limitations for specific anatomic regions.
    Clinical policy — definition / role of clinical policy
    PurposeClinical policy provides medical necessity guidance to assist coverage decisions, developed from standards of medical practice, peer-reviewed literature, agency approvals, and expert review.
    ScopeThe policy guides coverage determinations but does not constitute a contract or guarantee of payment; providers must apply professional judgment.
    Update rationalePolicies are reviewed and updated based on evidence and may be revised as needed; state/Medicare requirements may supersede policy where applicable.
    NCD/LCD/LCA — Medicare coverage determination definitions and relevance
    NCD/LCD/LCA relevanceNational Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) should be reviewed for Medicare members to ensure consistency with policy criteria.
    Provider responsibilityProviders are expected to review applicable Medicare coverage documents prior to applying policy criteria; coverage decisions are subject to plan terms and state/federal requirements.
    ExamplesPolicy cites multiple CMS NCDs/LCDs/LCAs (e.g., facial prostheses, infusion pumps, nebulizers, oxygen, walkers, manual wheelchair bases) as reference materials for device-specific determinations.
    A comprehensive rehabilitation plan is in place with required therapy participation and follow-up care

    Replacement for prosthetics

    • Replacement requested due to irreparable damage or loss/theft with documentation supporting continued medical necessity
    • Repair cost exceeds 60% of replacement cost (repair vs replacement threshold) and prosthesis has been properly cared for per manufacturer's recommendations
    Review requirement: Requests for upper extremity and myoelectric prosthetics (and many custom additions) require mandatory secondary review by a medical director and/or therapy advisor

    Enclosed beds and specialty positioning

    Enclosed beds and specialty positioning — operational documentation required:

    Standard bed cannot meet positioning needs due to height/weight/disability and commercial devices are inadequate for positioning requirements
    Therapist evaluation and ongoing treatment plan are documented; other positioning devices in the home reviewed to avoid duplication
    All requests for positioning seats require mandatory secondary review by a medical director and/or therapy advisor; name and invoice for device required

    Pump criteria

    Pump device medical necessity (summary and implant-specific requirements):

    Ambulatory infusion pumps: medically necessary for listed indications (e.g., deferoxamine for iron poisoning, specified regional chemotherapy) when clinical indications and documentation are met
    Parenteral pumps: medically necessary for uninterrupted parenteral medication administration where prescribed
    Implantable infusion pumps: require documented trial responsiveness, failure of less invasive therapies, FDA-approval for the drug/purpose, and absence of contraindications (e.g., allergy, active infection, insufficient body size, other implanted programmable devices)
    Documentation prior to implantation must include trial response evidence and screening for allergy/infection/size issues

    Manual wheelchair medical necessity

    Manual wheelchair initial and replacement medical necessity — required documentation and conditions:

    Initial manual wheelchair: mobility limitation interferes with MRADLs, cannot be met with cane or walker, and manual wheelchair will significantly improve MRADLs
    Home environment provides adequate access and maneuvering space; member or caregiver willing and able to use the wheelchair (or caregiver able to assist)

    Replacement conditions

    • Replacement due to loss, theft, or irreparable damage with documentation supporting continued need and replacement with like equipment
    • Replacement after reasonable useful lifetime of five years or more with documentation of continued medical necessity
    Repairs: Repair requests must document need and repair history; certain repair codes require mandatory secondary review

    Walker criteria

    Walker criteria — standard and heavy-duty:

    Standard walker medically necessary when MRADLs in the home cannot be met due to mobility limitation, walker can be safely used, and functional mobility deficit is expected to improve with walker use
    Heavy-duty walker medically necessary when standard walker criteria are met AND member weighs more than 300 pounds, or the member is unable to use a standard walker due to a severe neurologic disorder
    Requests must document MRADL limitations, safety for use, and expected functional improvement
    Operational note: Codes for heavy-duty walkers (E0148/E0149) apply when weight or severe neurologic condition criteria are met

    Selected medical necessity criteria

    Selected age-specific and other device criteria (high-level):

    Standing frames: for initial requests under age 18 one of the following must be met: developmental delay in ambulation and ≥18 months of age; or documented neurological/neuromuscular impairment and ≥1 year of age; replacement requests must meet initial criteria
    Replacement standing frame requests must include documentation of height/weight requirements, alertness/responsiveness, absence of contraindications to a standing program, and caregiver training/availability
    Pneumatic compression devices are not proven safe/effective for lymphedema of the abdomen, trunk, chest, genitals, or neck and are not appropriate for arterial insufficiency

    Medical necessity reference guidance

    Guidance on applying external references when making medical necessity determinations:

    Apply cited CMS NCDs, LCDs, and local coverage articles (examples cited in policy) to ensure consistency for Medicare members and to inform determinations for other members as appropriate
    Consult the clinical literature and evidence reviews listed in the policy (systematic reviews, Hayes briefs, UpToDate, peer-reviewed studies) where policy statements reference evidence for device effectiveness
    Document in the member record which NCD/LCD/LCA or clinical evidence was used to support the coverage determination when submitting requests for equipment
    Replacement is also permitted for loss, theft, or irreparable damage with documentation of continued medical necessity and replacement with same or similar equipment.
    Rental during repairOne month's rental for a standard manual wheelchair is considered medically necessary if a member's owned wheelchair is being repaired.
    Standing frames — replacement-specific notes (height/weight/clinical criteria)
    Replacement requirementReplacement requests for standing frames must meet the same criteria as initial requests and include supporting documentation (height/weight, alertness/responsiveness, absence of contraindications, caregiver training/availability).
    Initial criteria summaryInitial standing frame criteria include age-based subcriteria for children (<18) and clinical documentation of developmental delay or neurologic impairment as specified.
    Removed prior languagePolicy removed prior requirement that members be 'able to tolerate upright position' for standing frame replacement; replacement must meet current initial criteria.
    Documentation Required

    Document replacement medical necessity and proof of purchase; justify repairs

    For replacement requests, document medical necessity and provide proof of age and date of original purchase or evidence of loss/theft/irreparable damage; for repairs, include justification and repair history.

    • For replacements due to damage/theft: provide documentation supporting continued need and replacement rationale.
    • For replacements based on useful lifetime: document original purchase date or demonstrate reasonable useful lifetime (e.g., manual wheelchair ≥5 years).
    • For repairs: include repair justification and previous repair history.
    Documentation Required

    Document trial response and screen for contraindications before pump implantation

    For implantable infusion pumps, document indication, evidence of trial response (e.g., favorable intrathecal drug trial for spasticity), and screen for contraindications including allergy and active infection prior to implantation.

    • Provide documentation of favorable response to a trial dose prior to implantation.
    • Document absence of contraindications such as known allergy, active infection, insufficient body size, or presence of another implanted programmable device.
    Documentation Required

    Provide clinical and caregiver documentation for standing frame replacements

    When requesting standing frame replacements, document the clinical and caregiver criteria: height and weight requirements, that the member is alert and responsive, absence of contraindications to a standing program, and that a trained caregiver is available and able to assist safely.

    • Include documentation of height and weight meeting device requirements.
    • Document member alertness/responsiveness and absence of contraindications to standing.
    • Document caregiver training, availability, and ability to safely assist.
    Documentation Required

    Record review and applicability of NCD/LCD and plan criteria in member chart

    Document in the member's record how applicable NCDs/LCDs and plan-level criteria were reviewed and applied when requesting DME/O&P coverage to ensure consistency with Medicare and plan requirements.

    • Record which NCD/LCD/LCA or plan-level criteria were considered and how the member meets those criteria.
    • For Medicaid members, follow state Medicaid manual provisions where they supersede this policy.