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Repair and Replacement of Durable Medical Equipment (DME) and Prosthetic Devices
MA05.062j

Policy

DURABLE MEDICAL EQUIPMENT
 
Repair or replacement of durable medical equipment (DME), or of a medically necessary accessory that is needed for the essential functioning of the DME in relation to the individual's condition, is covered and eligible for reimbursement consideration by the Company as follows:

REPAIR
The repair of a DME item or accessory is covered and eligible for reimbursement consideration when all of the following are met:
  • The DME item itself is covered by Medicare.
  • The DME or accessory is provided by a DME supplier.
  • The cost to repair, rather than replace, the item is justified based on the useful lifetime of the item.
  • The continued use of the DME remains medically necessary.
Labor associated with the repair of DME is eligible for separate reimbursement consideration and is reported using the applicable Health Common Procedure Coding System (HCPCS) Level II code.

REPLACEMENT
The replacement of a previously approved DME item or accessory is covered and eligible for reimbursement consideration when all of the following criteria are met:
  • The DME item itself is covered by Medicare.
  • The replacement DME item or accessory is provided by a DME supplier.
  • The continued use of the DME remains medically necessary for the individual.
  • The DME replacement is not an additional item (e.g., for use when traveling or for an additional residence).
  • The replacement is equivalent to a previously approved DME item.
  • The replacement accessory is for a DME item previously owned/purchased by or for the individual and either one of the following applies:
    • There is a change in the individual's condition that requires a replacement (e.g., weight loss or gain, growth)
    • The DME does not function properly because it has reached or exceeded its life expectancy as determined by the manufacturer.
      • The Company may determine the reasonable useful lifetime of a specific item based on the manufacturer's recommendation or the Food and Drug Administration (FDA)-approved labeling. In the absence of the manufacturer's recommendations or FDA labeling, the Company may determine the reasonable useful lifetime of a specific item, but in no case can it be less than 5 years. Replacement due to wear is not covered during the reasonable useful lifetime of the equipment; however, the Company will cover repair up to the cost of replacement for medically necessary equipment owned by the individual.

Requests for technological advancements or newly released upgrades to equipment, when the original equipment still functions properly and/or there are no significant changes in the individual's condition, are considered not medically necessary and, therefore, not covered.

REPAIR AND REPLACEMENT


If a rental item breaks, it is the individual's responsibility to work with the Company to replace or repair the item.

If a purchased item breaks and is under warranty, it is the individual's responsibility to work with the manufacturer to replace or repair the item.

If a purchased item breaks and is not under warranty, the Company will provide benefits for the repair or replacement of the item as long as the above criteria are met.

Replacement of equipment which the individual owns or is purchasing or is a capped rental item is covered in cases of loss, or irreparable damage or wear, and when required because of a change in the individual's condition.


PROSTHETIC DEVICES


The repair or replacement of a prosthetic device, supplies, or one or more of its components (parts) is covered and eligible for reimbursement consideration by the Company when the external prosthetic device itself is covered under the individual's medical benefits and all of the following requirements for a repair or replacement are met.

REPAIR
The repair of a prosthetic device or one or more of its components (parts) is covered and eligible for reimbursement consideration by the Company when all of the following requirements are met:
  • The prosthetic device does not function properly.
  • The device is not under a manufacturer's warranty.
  • The device is covered by Medicare.
  • The repair of the device is covered under the individual's medical benefits.
  • The cost to repair the device or its components (parts) is less than the cost to replace it and is justified based on the useful life of the prosthetic device as determined by the manufacturer.
  • The continued use of the device remains medically necessary and appropriate for the individual's condition.
The labor associated with the repair of a prosthetic device is covered and eligible for separate reimbursement consideration and is reported using the applicable Healthcare Common Procedure Coding System (HCPCS) Level II code (refer to the attached Coding Table below).

REPLACEMENT
The replacement of a previously approved external prosthetic device or one or more of its components (parts) or supplies is covered and eligible for reimbursement consideration by the Company when all of the following requirements are met:
  • The replacement device is covered by Medicare.
  • The replacement device is provided by an eligible ancillary provider.
  • The continued use of the device remains medically necessary for the individual and appropriate for the individual's condition.
  • The replacement is not an additional device (e.g., for use when traveling or for an additional residence).
  • The replacement is equivalent to a previously approved external prosthetic device/component.
  • The device itself is not under a manufacturer's warranty. However, the replacement of a supply to a covered external prosthetic device is covered.
  • The replacement device is for an individual who has either one of the following:
    • A change in condition that impacts the fit or function of the device and, therefore, requires its replacement (eg, growth)
    • A device that does not function properly and has reached or exceeded its useful lifetime duration as determined by the manufacturer
​​​​The Company may determine the reasonable useful lifetime of a specific prosthetic device based on the manufacturer's recommendation or the Food and Drug Administration (FDA)--approved labeling.

In the absence of manufacturer's recommendations or FDA labeling, the Company may determine the reasonable useful lifetime of a specific external prosthetic device, but is generally not less than five years. Replacement due to misuse, abuse, or failure to adequately maintain or care for the item is excluded from coverage.

Requests for a different type of a prosthetic device or one or more of its components (parts) due to a change in medical and/or functional status, such that the prosthesis can no longer meet the individual’s needs for control, durability (maintenance), function (speed, work capability), and usability are considered new requests, not requests for replacement. These requests are evaluated against the medical necessity criteria for the new type of prosthesis requested.

Replacement of a device is covered in cases of loss, or irreparable damage or wear, and when required because of a change in the individual's condition.

NONCOVERED REPAIR OR REPLACEMENT

The repair or replacement of a prosthetic device or one or more of its components (parts) is considered noncovered and, therefore, not eligible for reimbursement consideration by the Company, in each of the following circumstances:
  • The device itself is not covered.
  • The request is for a visual prosthetic device (i.e., medically necessary glasses or contact lenses covered under the individual's medical benefit), which is not a benefit for most products of the Company. However, this repair or replacement statement of noncoverage does not apply to an ocular prosthesis, which is an artificial eye that replaces a missing eye due to congenital anomaly, disease, surgical removal (enucleation), or trauma.
  • The request is for a technologically advanced or newly released upgrade to an original device that still functions properly and/or there is no significant change in the individual's condition.
  • The device or one or more of its components (parts) is under a manufacturer's warranty. In this case, it is the individual's responsibility to arrange the repair or replacement of an external prosthetic device with the manufacturer while it is under warranty.
  • The request is solely being made to allow or enhance an individual's leisure, recreational activity, appearance, or athletic performance.

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports. This policy is consistent with Medicare's documentation requirements, including the following required documentation:

STANDARD WRITTEN ORDER REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete standard written order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective standard written order at the time of an audit or after an audit for submission as an original standard written order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY REQUIREMENTS
Medical record documentation must include a contemporaneously prepared delivery confirmation or member's receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES (WHEN APPLICABLE)
The durable medical equipment (DME) supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately seven days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual's medical record. Delivery of the supplies should not be done earlier than approximately five days before the individual would exhaust their on-hand supply.

For specified DME items, documentation of a face-to-face encounter between the treating professional provider and the individual meeting the above requirements, including an assessment of the individual's clinical condition supporting the need for the prescribed DME item(s), must be provided to and kept on file by the DME supplier.

If required documentation is not available on file to support a claim at the time of an audit or record request, the durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.​

Guidelines

This policy is consistent with Medicare’s coverage determination for repair or replacement of DME, prosthetic devices and supplies. The Company’s payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, repair or replacement of DME, prosthetic devices and supplies is covered under the medical benefits of the Company’s Medicare Advantage products when the coverage criteria listed in this medical policy are met.

Description

Durable medical equipment (DME) is equipment that can withstand repeated use, is primarily and customarily used to serve a medical purpose, is generally not useful to a person in the absence of illness or injury, and is appropriate for use in the home. Examples of DME include, but are not limited to, wheelchairs, commodes, crutches, and hospital beds.

Medicare defines durable medical equipment (DME) as equipment that:
  • Can withstand repeated use
  • Is primarily and customarily used to serve a medical purpose
  • Generally is not useful to a person in the absence of an illness or injury
  • Is appropriate for use in the home
All requirements of this definition must be met before an item is considered to be DME. However, although an item may be classified as DME, it may not be covered in every instance. Coverage in a particular case is subject to the requirement that the item be necessary and reasonable for the treatment of the individual's illness or injury or to improve the functioning of his or her malformed body member.

Examples of equipment that meets the definition of DME include, but are not limited to:
  • Canes
  • Crutches
  • Walkers
  • Commode chairs
  • Home oxygen equipment
  • Hospital beds
  • Traction equipment
  • Wheelchairs

Repair is the restoration of a DME item or one of its components to correct problems due to wear or damage.

Replacement is the removal and substitution of a DME item or one of its components or supplies that are necessary for proper functioning.

 

A prosthesis is a device that replaces all or part of an absent body organ, including contiguous tissue, or the function of a permanently inoperative or malfunctioning body organ. An external prosthetic device is a prosthesis that is worn on or external to the body such as, but not limited to, an artificial limb.

A supply or component (part) of a prosthetic device is one that is necessary for the essential functioning of the prosthetic device in relation to the individual's condition.

The repair of a prosthetic device or component is the restoration of the device or one or more of its components (parts) to correct problems due to wear or damage.

The replacement of a prosthetic device is the removal and substitution of the device or one or more of its components (parts) or supplies that are necessary for its proper functioning.


References

Centers for Medicare & Medicaid Services (CMS). Carriers Manual. Part 3 - Claims Process. Chapter II - Coverage and Limitations. §2100.4: Repairs, Maintenance, Replacement, and Delivery. [CMS Web site]. 09/08/05. Available at:https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R1725B3.pdf. Accessed November 17, 2020.

Centers for Medicare and Medicaid Services (CMS). Medicare Benefit Policy Manual. Chapter 15 - Covered Medical and Other Health Services. §110.2: Repairs, Maintenance, Replacement, and Delivery. [CMS Web site.] 12/23/05. Available at:
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c15.pdf. Accessed November 17, 2020.

Centers for Medicare and Medicaid Services (CMS). Transmittal #30. Change Request (CR) #3693: Policy for Repair and Replacement of Durable Medical Equipment (DME). [CMS Web site]. 02/18/05. Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R30BP.pdf. Accessed November 17, 2020.

Centers for Medicare and Medicaid Services (CMS). Transmittal #3713. Change Request (CR) #9966: Extension of Payment Change for Group 3 Complex Rehabilitative Power Wheelchairs Accessories and Seat and Back Cushions under Section 16005 of the 21st Century Cures Act. [CMS Web site]. 02/03/17. Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R3713CP.pdf. Accessed November 17, 2020.

Medicare Advantage Evidence of Coverage.

 

Centers for Medicare & Medicaid Services (CMS). Medicare Claims Processing Manual. Chapter 20 – Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS). 10.1.3 - Prosthetics and Orthotics (Leg, Arm, Back, and Neck Braces, Trusses, and Artificial Legs, Arms, and Eyes.) [CMS Web site]. 05/26/06. Available at: http://www.cms.hhs.gov/manuals/downloads/clm104c20.pdf. Accessed November 17, 2020.

Evidence of Coverage.


Noridian Health Care Solutions, LLC. Local Coverage Determination (LCD): Facial Prostheses (L33738). Revised Effective 01/01/2020. Original Effective Date: 10/01/2015. Available at: https://med.noridianmedicare.com/documents/2230703/7218263/Facial Prostheses LCD and PA. Assessed November 17, 2020. ​


Coding

CPT Procedure Code Number(s)
N/A

ICD - 10 Procedure Code Number(s)
N/A

ICD - 10 Diagnosis Code Number(s)
N/A

HCPCS Level II Code Number(s)
See Attachment A.

Revenue Code Number(s)
N/A

Modifiers​​​

WHEN THERE IS NO SPECIFIC HCPCS CODE FOR THE REPAIR OR REPLACEMENT OF A DME OR PROSTHETIC DEVICE, THE FOLLOWING MODIFIER IS APPENDED TO THE HCPCS CODE FOR THE DEVICE ITSELF:


RA Replacement of a DME, Orthotic or Prosthetic item

RB Replacement of a part of a DME, Orthotic or Prosthetic item furnished as part of a repair​


Coding and Billing Requirements


Policy History

Revisions From MA05.062j:
01/02/2024This policy has been indentified and updated for the HCPCS code update effective 01/02/2024​.

​HCPCS code A4457 has been added to this policy


HCPCS code K1013 has been removed from this policy.


Revisions From MA05.062i​:
​01/01/2024

Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.
04/01/2023This policy has been identified and updated for the HCPCS code update effective 04/01/2023.

The following procedure codes has been added to Attachment A of this policy:
A4341 and A4342

Revisions From MA05.062h​:
10/01/2021This policy has been updated for the HCPCS code update, effective 10/01/2021.

The following HCPCS narrative has been revised in Attachment A of this policy:

K1013: Enema tube, any type, replacement only, each

The following procedure code has been added to Attachment A of this policy:
A4453: Rectal catheter for use with the manual pump-operated enema system, replacement only

Revisions From MA05.062g​:
04/01/2021This policy has been updated for the HCPCS code update, effective 04/01/2021.

The following procedure code has been added to the policy:

K1013: Enema tube, any type, replacement only, each


The following Procedure codes have been deleted from attachment A of this policy:

K1010: Indwelling intraurethral drainage device with valve, patient inserted, replacement only, each
K1011: Activation device for intraurethral drainage device with valve, replacement only, each
K1012: Charger and base station for intraurethral activation device, replacement only​​

Revisions From ​MA05.062f:
02/08/2021

This version of the policy will become effective 02/08/2021.

 

This policy has been updated to communicate the Company's continuing position on repair and replacement of DME. In this version applicable codes and information from the archived Repair and Replacement of Prosthetic Devices were included.​

 

The following HCPCS codes have been added: A7020, E2225, E2226, K0015, K0070,L5704, L5705, L5706, L5707,L7902, L8696

 

The following HCPCS codes have been deleted: A4638, A4639, A4890, A7031, A7032, A7033, A7045, A7046, A7502, E0249

 

The following HCPCS codes have been transferred into this policy from retired MA05.063d: A4363, A5113, A5114, L5700, L5701, L5702, L5703, L5971, L6883, L6884, L6885, L6915, L7367, L7368, L7510, L7520, L8048, L8049, L8505, L8511, L8512, L8513, L8514, L8615, L8616, L8617, L8618, L8619, L8621, L8622, L8623,L8624, L8625, L8627, L8628, L8629, L8681, L8684, L8689, L8691, L8693, L8694, L8695


Revisions From MA05.062e​:
10/01/2020This policy has been updated for the HCPCS code update, effective 10/01/2020.

The following HCPCS codes has been added to the policy:

K1010: Indwelling intraurethral drainage device with valve, patient inserted, replacement only, each

K1011: Activation device for intraurethral drainage device with valve, replacement only, each

K1012: Charger and base station for intraurethral activation device, replacement only​


Revisions From MA05.062d:
10/01/2018This policy has been updated for the HCPCS code update, effective 10/01/2018.

The following HCPCS code has been termed from the policy:

K0037: High mount flip-up footrest, replacement only, each


Revisions From MA05.062c:
11/01/2017This version of the policy will become effective 11/01/2017.

The intent of this policy remains unchanged, but the policy has been updated to further clarify current benefits. The following HCPCS code has been added to this policy: E2378.

Revisions From MA05.062b:
01/01/2017This policy has been identified for the HCPCS code update, effective 01/01/2017.

The following HCPCS narratives have been revised and therefore, are now added into this policy; in Attachment A:

CODE: E0995
FROM:Wheelchair accessory, calf rest/pad, each
TO: Wheelchair accessory, calf rest/pad, replacement only, each

CODE: E2206
FROM: Manual wheelchair accessory, wheel lock assembly, complete, each
TO: Manual wheelchair accessory, wheel lock assembly, complete, replacement only, each

CODE: E2220
FROM: Manual wheelchair accessory, solid (rubber/plastic) propulsion tire, any size, each
TO: Manual wheelchair accessory, solid (rubber/plastic) propulsion tire, any size, replacement only, each

CODE: E2221
FROM: Manual wheelchair accessory, solid (rubber/plastic) caster tire (removable), any size, each
TO: Manual wheelchair accessory, solid (rubber/plastic) caster tire (removable), any size, replacement only, each

CODE: E2222
FROM: Manual wheelchair accessory, solid (rubber/plastic) caster tire with integrated wheel, any size, each
TO: Manual wheelchair accessory, solid (rubber/plastic) caster tire with integrated wheel, any size, replacement only, each

CODE: E2224
FROM: Manual wheelchair accessory, propulsion wheel excludes tire, any size, each
TO: Manual wheelchair accessory, propulsion wheel excludes tire, any size, replacement only, each

CODE: K0019
FROM: Arm pad, each
TO: Arm pad, replacement only, each

CODE: K0037
FROM: High mount flip-up footrest, each
TO: High mount flip-up footrest, replacement only, each

CODE: K0042
FROM: Standard size footplate, each
TO: Standard size footplate, replacement only, each

CODE: K0043
FROM: Footrest, lower extension tube, each
TO: Footrest, lower extension tube, replacement only, each

CODE: K0044
FROM: Footrest, upper hanger bracket, each
TO: Footrest, upper hanger bracket, replacement only, each

CODE: K0045
FROM: Footrest, complete assembly
TO: Footrest, complete assembly, replacement only, each

CODE: K0046
FROM: Elevating legrest, lower extension tube, each
TO: Elevating legrest, lower extension tube, replacement only, each

CODE: K0047
FROM: Elevating legrest, upper hanger bracket, each
TO: Elevating legrest, upper hanger bracket, replacement only, each

CODE: K0050
FROM: Ratchet assembly
TO: Ratchet assembly, replacement only

CODE: K0051
FROM: Cam release assembly, footrest or legrest, each
TO: Cam release assembly, footrest or legrest, replacement only, each

CODE: K0052
FROM: Swingaway, detachable footrests, each
TO: Swingaway, detachable footrests, replacement only, each

CODE: K0069
FROM: Rear wheel assembly, complete, with solid tire, spokes or molded, each
TO: Rear wheel assembly, complete, with solid tire, spokes or molded, replacement only, each

CODE: K0071
FROM: Front caster assembly, complete, with pneumatic tire, each
TO: Front caster assembly, complete, with pneumatic tire, replacement only, each

CODE: K0072
FROM: Front caster assembly, complete, with semipneumatic tire, each
TO: Front caster assembly, complete, with semi-pneumatic tire, replacement only, each

CODE: K0077
FROM: Front caster assembly, complete, with solid tire, each
TO: Front caster assembly, complete, with solid tire, replacement only, each

CODE: K0098
FROM: Drive belt for power wheelchair
TO: Drive belt for power wheelchair, replacement only

Revisions From MA05.062a:
11/30/2016This policy was updated with the following revisions;

The following HCPCS codes have been removed from Attachment A2 of this policy:

K0017 - Detachable, adjustable height armrest, base, replacement only, each
K0018 - Detachable, adjustable height armrest, upper portion, replacement only, each

Revisions From MA05.062:
10/14/2015 The policy has been reviewed and reissued to communicate the Company’s continuing position on repair or replacement of DME and supplies.
01/01/2015This is a new policy.

Note: On 12/18/2014 this Notification was revised to include 1/1/2015 HCPCS coding updates. Attachment A of this policy was updated as follows:
  • Codes A4602 has been added.
  • Code A4601 has a revised narrative.

1/2/2024
1/12/2024
MA05.062
Claim Payment Policy Bulletin
Medicare Advantage
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No