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.
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.
Coverage Criteria and Device-Specific Rules
General medical necessity criteria
Covered when ALL of the following are met:
Enclosed beds and positioning equipment
Enclosed beds and specialty positioning equipment are medically necessary when ALL of the following are documented:
Cardiac and compression therapy
Cardiac and compression therapy device rules:
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
Implantable infusion pumps and related pumps
Implantable infusion pumps and implantable pump systems are medically necessary ONLY when ALL of the following are documented:
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:
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
Wheelchairs (manual and power) — initial and replacement criteria
Manual and power wheelchair initial and replacement medical necessity criteria:
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
- 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
Equipment-specific criteria updates
Selected equipment-specific updates and age-specific requirements (high-level):
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
Equipment-specific criteria references
Use external authoritative sources to inform device-specific medical necessity determinations:
HCPCS / CPT / Code Mappings and Notable Code Changes
| K0606 | K0606 |
| E0617 | E0617 |
| E0236 | E0236 |
| L33738 | L33738 |
| 280.14 | 280.14 |
| L33794 | L33794 |
| L33612 | L33612 |
| L34824 | L34824 |
| L33370 | L33370 |
| L33797 | L33797 |
| L33791 | L33791 |
| L33788 | L33788 |
Provider Responsibilities, Reviews, and Authorization Notes
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.
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).
- Applies to custom or complex items listed elsewhere such as upper extremity/myoelectric devices and other custom O&P additions referenced in the policy.
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 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.
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.
Key Definitions
Device-Specific Medical Necessity Criteria
Burn garments criteria
Burn garments are medically necessary when ALL of the following are met:
Prosthetics/Orthotics criteria
Prosthetic and orthotic medical necessity criteria — initial and replacement considerations:
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
Enclosed beds and specialty positioning
Enclosed beds and specialty positioning — operational documentation required:
Pump criteria
Pump device medical necessity (summary and implant-specific requirements):
Manual wheelchair medical necessity
Manual wheelchair initial and replacement medical necessity — required documentation and conditions:
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
Walker criteria
Walker criteria — standard and heavy-duty:
Selected medical necessity criteria
Selected age-specific and other device criteria (high-level):
Medical necessity reference guidance
Guidance on applying external references when making medical necessity determinations:
Rental, Purchase and One-Time Rental Rules
| Equipment | Purchase vs Rental Rule | Policy-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. |
| Item | Rental Rule | Notes / Conditions |
|---|---|---|
| One month's rental is considered medically necessary when the member's owned wheelchair is being repaired. |
| Item | Rental Policy Details | Provider/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
Documentation Requirements for Authorizations
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.
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.
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.
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.
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.
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.
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).
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