ModifiedWellcare HawaiiPolicy MC.CP.MP.107

Clinical Policy: Durable Medical Equipment and Orthotics and Prosthetics Guidelines

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This policy establishes medical-necessity requirements for durable medical equipment, orthotics, and prosthetics, including general and equipment-specific criteria, and supplements applicable CMS and Medicare guidance.

Policy Summary

PayerWellcare Hawaii

PolicyDurable Medical Equipment and Orthotics and Prosthetics Guidelines

Policy CodePolicy N/A

Change TypeModified

Effective DateN/A

Next Review DateN/A

Key ActionRequests for spinal orthotics require mandatory secondary review by a medical director and/or therapy advisor.

SourceLink

POLICY UPDATE CHANGES

The policy description was updated to explain that applicable CMS and Medicare manuals do not provide sufficient criteria for consistently determining medical necessity and therefore are supplemented by this policy.

The Breast Prosthetics section and HCPCS codes L8030 and L8035 were removed during the annual review.

The background section was updated during the annual review.

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ModifiedWellcare HawaiiPolicy MC.CP.MP.107

Clinical Policy: Durable Medical Equipment and Orthotics and Prosthetics Guidelines

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Sign up for Wellcare Hawaii Policy MC.CP.MP.107 alerts

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Policy Summary

PayerWellcare Hawaii

PolicyDurable Medical Equipment and Orthotics and Prosthetics Guidelines

Policy CodePolicy N/A

Change TypeModified

Effective DateN/A

Next Review DateN/A

Key ActionRequests for spinal orthotics require mandatory secondary review by a medical director and/or therapy advisor.

SourceLink

POLICY UPDATE CHANGES

The Breast Prosthetics section and HCPCS codes L8030 and L8035 were removed during the annual review.

The background section was updated during the annual review.

Equipment categories governed

AllGeneral criteria required

2Breast prosthetics codes removed

4Compression therapy codes listed

3 yearsExpected minimum DME life

Coverage Criteria

General DME, orthotics, and prosthetics criteria

Covered when all general and applicable equipment-specific criteria are met.

General criteria: The equipment is necessary and reasonable for treatment of an illness or injury or to improve the functioning of a physical deficit; the member/enrollee and/or caregiver receives education regarding use of the device with demonstrated understanding; and the member/enrollee and/or caregiver completes a trial of the requested device with demonstrated ability to use it safely and effectively.

The equipment must be expected to make a meaningful contribution to treatment or improvement of a malformed body member.

Equipment reasonableness and cost

Reasonableness considerations apply in addition to medical usefulness.

Reasonableness and cost

The expense is not disproportionate to the therapeutic benefits; the item is not substantially more costly than a medically appropriate and realistically feasible alternative plan of care; and the item does not serve essentially the same purpose as equipment already available.
The item does not include deluxe features or serve aesthetic or added-convenience purposes that do not meet the reasonableness test.
No medically necessary, lower-cost item exists that would meet the member/enrollee's medical needs.
If such a lower-cost item exists, the higher-cost item will be denied.

Hip orthotics

Hip orthotics are medically necessary when ordered by an orthopedic surgeon for treatment of, or postoperatively for, a qualifying condition.

Hip orthotic criteria

The request is ordered by an orthopedic surgeon.
ONE of the following indications
- The member/enrollee has undergone total hip arthroplasty.
- The member/enrollee has a hip labral tear.

Non-pneumatic compression devices

Non-pneumatic compression devices are not medically necessary.

Insufficient evidence: There is insufficient clinical evidence to support the safety and effectiveness of non-pneumatic compression devices over standard pneumatic compression devices.

Myoelectric rehabilitation

Myoelectric rehabilitation is not medically necessary.

Insufficient evidence: There is insufficient evidence in published peer-reviewed literature to support myoelectric rehabilitation.

The policy statement is the applicable medical-necessity determination.

Wheelchair-mounted JACO robotic arm

The wheelchair-mounted JACO Assistive Robotic Arm is not medically necessary.

Insufficient evidence: There is insufficient clinical evidence to support the safety and improved health outcomes of the JACO Assistive Robotic Arm over other technologies.

Deluxe features and items rented or purchased primarily for aesthetic reasons or added convenience do not meet the equipment reasonableness standard. Coverage is evaluated based on medical necessity, therapeutic benefit, cost compared with feasible alternatives, and whether the equipment duplicates equipment already available.

The section addressing breast prosthetics was removed during the annual review, along with HCPCS codes L8030 and L8035. These codes are no longer listed in this policy.

Non-pneumatic compression devices are not medically necessary because there is insufficient clinical evidence to support their safety and effectiveness compared with standard pneumatic compression devices.

Myoelectric rehabilitation is not medically necessary because the policy identifies insufficient evidence in published peer-reviewed literature to support its use.

The wheelchair-mounted JACO Assistive Robotic Arm is not medically necessary because there is insufficient clinical evidence to support its safety and improved health outcomes compared with other technologies.

Coding and Covered Services

Compression Therapy - Non-pneumatic compression devicesHCPCSNot Covered

E0678	Non-pneumatic compression devices
E0679	Non-pneumatic compression devices
E0680	Non-pneumatic compression devices
E0681	Non-pneumatic compression devices

Prosthetics and Orthotics - Spinal OrthoticsHCPCSCovered

L0700	Spinal Orthotics
L0710	Spinal Orthotics
L0720	Spinal Orthotics
L0999	Spinal Orthotics
L1000	Spinal Orthotics
L1001	Spinal Orthotics
L1005	Spinal Orthotics
L1006	Spinal Orthotics

Prosthetics and Orthotics - Hip orthoticsHCPCSCovered

L1640	Hip orthotics
L1680	Hip orthotics
L1685	Hip orthotics
L1686	Hip orthotics
L1690	Hip orthotics

Prosthetics and Orthotics - Upper prosthetics and additionsHCPCSCovered

L6000	Prosthetics and additions: Upper
L6010	Prosthetics and additions: Upper
L6020	Prosthetics and additions: Upper
L6026	Prosthetics and additions: Upper
L6028	Prosthetics and additions: Upper
L6029	Prosthetics and additions: Upper
L6031	Prosthetics and additions: Upper
L6032	Prosthetics and additions: Upper
L6033	Prosthetics and additions: Upper
L6037	Prosthetics and additions: Upper

1–10 of 75

1/8

Prosthetics and Orthotics - Myoelectric RehabilitationHCPCSNot Covered

E0738	Myoelectric Rehabilitation
E0739	Myoelectric Rehabilitation

Wheelchairs - Robotic Arm, Wheelchair-mounted (JACO)HCPCSNot Covered

E1399

Wheelchair-mounted JACO assistive robotic arm

Provider Review and Action Requirements

Prior Authorization

Mandatory Spinal Orthotics Review

Requests for spinal orthotics require mandatory secondary review before authorization or approval. The review must be conducted by a medical director and/or therapy advisor.

Prior Authorization

Case-by-Case Prosthetics Review

Upper-extremity prosthetics, myoelectric prosthetics, and related additions are reviewed on a case-by-case basis by a medical director and/or therapy advisor.

Note

Device-Use Education Required

Before the device is provided, the member/enrollee and/or caregiver must receive education regarding device use and demonstrate understanding.

Policy Background

Durable medical equipment (DME) is equipment that can withstand repeated use, is primarily and customarily used for a medical purpose, is appropriate for use in the home, and is generally not useful in the absence of illness or injury. DME is generally manufactured for home use, although it is not limited to use in the home, and is expected to have a useful life of at least three years. Orthotic devices support weak or deformed body parts or restrict motion, while prosthetic devices replace a body part or function.

Definitions

Durable medical equipment

Medical purposePrimarily and customarily used to serve a medical purpose.

DurabilityCan withstand repeated use.

Home useAppropriate for use in the home.

Medical necessity characteristicGenerally not useful to a person in the absence of an illness or injury.

Orthotic devices

ConstructionRigid and semi-rigid devices.

Support functionUsed to support a weak or deformed body part.

Medical Necessity Requirements

General medical necessity

DME, orthotics, and prosthetics are medically necessary when all general and applicable equipment-specific criteria are met.

General requirements: The equipment is necessary and reasonable for treatment of an illness or injury or to improve the functioning of a physical deficit; the member/enrollee and/or caregiver receives education regarding use of the device with demonstrated understanding; and the member/enrollee and/or caregiver trials the device with demonstrated ability to use it safely and effectively.

The item should make a meaningful contribution to treatment or improvement of a malformed body member.

Hip orthotics

Hip orthotics are medically necessary when ordered by an orthopedic surgeon for treatment of, or postoperatively for, a qualifying indication.

Hip orthotic criteria

The request is ordered by an orthopedic surgeon.
ONE of the following indications

Rental and Purchase Rules

Equipment	Rental rule	Details
Durable medical equipment	Rental classification	An item is considered durable if it can withstand repeated use—meaning it is the type of item that could normally be rented. Medical supplies of an expendable nature are not considered durable under this definition.

Documentation Requirements

Documentation Required

Document medical necessity and successful use

Document that the equipment is necessary and reasonable for treatment of an illness or injury or to improve functioning of a physical deficit. Also document education with demonstrated understanding and a device trial showing safe and effective use by the member/enrollee and/or caregiver, as applicable.

Documentation Required

Establish medical nature and home effectiveness

When the medical nature of equipment is uncertain, document supporting advice from local medical organizations, facilities, or physical medicine and rehabilitation specialists. For new equipment, obtain supplier or manufacturer information on its design, purpose, effectiveness, home-use method, and test or clinical-study results.

Not Covered Services

The following equipment is not medically necessary under this policy: non-pneumatic compression devices, myoelectric rehabilitation, and the wheelchair-mounted JACO Assistive Robotic Arm. The stated basis is insufficient clinical or published peer-reviewed evidence regarding safety, effectiveness, or improved health outcomes compared with established alternatives or other technologies.

Policy Summary

PayerWellcare Hawaii

PolicyDurable Medical Equipment and Orthotics and Prosthetics Guidelines

Policy CodePolicy N/A

Change TypeModified

Effective DateN/A

Next Review DateN/A

Key ActionRequests for spinal orthotics require mandatory secondary review by a medical director and/or therapy advisor.

SourceLink

On This Page

Note

Device Trial and Safe Use

A trial of the requested device must be provided, with demonstrated ability to use it safely and effectively.

Prior Authorization

Spinal Orthotics Secondary Review

Spinal orthotics requests require a mandatory secondary review by a medical director and/or therapy advisor.

Prior Authorization

Upper Prosthetics Case Review

Upper-extremity and myoelectric prosthetics and additions must be reviewed case by case by a medical director and/or therapy advisor.

Documentation Required

Documentation for New or Unusual Equipment

Documentation may be requested to establish whether new or unusual equipment is medical in nature and to support its design, purpose, effectiveness, and safe use in the home.

Documentation from local medical organizations, facilities, or specialists in physical medicine and rehabilitation may be required.
For equipment new to the market, supplier or manufacturer information may be requested, including available testing or clinical-study results.

Denial Risk

Lower-Cost Suitable Alternative

When a medically necessary, lower-cost item exists that meets the member/enrollee’s medical needs, the higher-cost item will be denied.

Denial Risk

Deluxe or Convenience Features

Deluxe features or items purchased or rented for aesthetic reasons or added convenience do not meet the reasonableness test and are not medically necessary.

Denial Risk

Insufficient Evidence

The policy finds insufficient clinical or peer-reviewed evidence to support coverage for certain equipment and services.

Non-pneumatic compression devices: insufficient evidence of safety and effectiveness over standard pneumatic compression devices.
Myoelectric rehabilitation: insufficient evidence in published peer-reviewed literature.
Wheelchair-mounted JACO Assistive Robotic Arm: insufficient evidence to support safety and improved health outcomes over other technologies.

Motion controlUsed to restrict or eliminate motion in a diseased or injured body part.

Prosthetic devices

FormCustom-made artificial limbs or other assistive devices.

Replacement functionReplace a body part or function.

Qualifying causesMay result from traumatic injuries, vascular disease, diabetes, cancer, or congenital disorders.

DME durability characteristics

Repeated useCan withstand repeated use.

Expected lifeHas an expected life of at least three years.

DME definitionMeets the definition of durable medical equipment.

Primary purposeIs primarily and customarily used to serve a medical purpose.

Manufacturing and use settingIs manufactured primarily for use in the home environment, but is not limited to use in the home.

Member/enrollee's home

Private residencesMay include the member/enrollee's own dwelling, apartment, or a relative's home.

Residential institutionsMay include a home for the aged or some other type of institution.

Hospital exclusionAn institution is not considered the member/enrollee's home when it meets at least the basic requirement in the definition of a hospital.

Skilled nursing facility exclusionAn institution is not considered the member/enrollee's home when it meets at least the basic requirement in the definition of a skilled nursing facility.

Permanent inpatient exceptionAn inpatient skilled nursing facility or inpatient hospice may be defined as the member/enrollee's home when the member/enrollee is permanently admitted and has changed their home address to that facility.

The member/enrollee has undergone total hip arthroplasty.
The member/enrollee has a hip labral tear.