Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Repair or Replacement of an External Prosthetic Device
Policy #:MA05.063c

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

The repair or replacement of an external 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 an external 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 external 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 an external 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 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 external 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 an external 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 an external prosthetic device or one or more of its components (parts) is considered noncovered and, therefore, is 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:

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete 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 order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
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
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.

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.
Policy Guidelines

This policy is consistent with Medicare’s coverage determination for repair or replacement of an external prosthetic device 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 an external prosthetic device and supplies are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

Description

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 an external prosthetic device is one that is necessary for the essential functioning of the external prosthetic device in relation to the individual's condition.

The repair of an external 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 an external 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). 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 September 22, 2017.

Evidence of Coverage.

Noridian Health Care Solutions, LLC. Local Coverage Article. Facial Prostheses - Policy Article (A52463). Revised Effective 01/01/2017. Original effective: 10/01/2015. https://med.noridianmedicare.com/documents/2230703/7218263/Facial+Prostheses. Accessed October 19, 2017.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)

See Attachment A


Revenue Code Number(s)

N/A


Misc Code

MODIFIERS:

WHEN THERE IS NO SPECIFIC HCPCS CODE FOR THE REPAIR OR REPLACEMENT OF AN EXTERNAL 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


Cross References

Attachment A: Repair or Replacement of an External Prosthetic Device
Description: A list of Health Care Common Procedure Coding System (HCPCS) codes with repair or replacement in the narrative.







Policy History

MA05.063c
01/01/2018This policy has been identified for the HCPCS code update, effective 01/01/2018.

The following HCPCS codes have been added to attachment A of this policy:

L8625 External recharging system for battery for use with cochlear implant or auditory osseointegrated device, replacement only, each

L8694 Auditory osseointegrated device, transducer/actuator, replacement only, each

The following HCPCS code narratives have been revised in attachment A of this policy:

From: L8618 Transmitter cable for use with cochlear implant device, replacement
To: L8618 Transmitter cable for use with cochlear implant device or auditory osseointegrated device, replacement

From: L8624 Lithium ion battery for use with cochlear implant device speech processor, ear level, replacement, each
To: L8624 Lithium ion battery for use with cochlear implant or auditory osseointegrated device speech processor, ear level, replacement, each

From: L8691 Auditory osseointegrated device, external sound processor, replacement
To: L8691 Auditory osseointegrated device, external sound processor, excludes transducer/actuator, replacement only, each

MA05.063b
12/15/2017This version of the policy will become effective 12/15/2017. This policy has been updated to communicate the Company’s continuing position on repair or replacement of an external prosthetic device and supplies. The intent of this policy remains unchanged, but the policy has been updated to further clarify current benefits.

The following criteria has been added to this policy:
    REPAIR
    • The prosthetic device does not function properly.

The following HCPCS code has been added to this policy:
    L8048 Unspecified maxillofacial prosthesis, by report, provided by a nonphysician

MA05.063a
09/28/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on repair or replacement of an external prosthetic device and supplies.
01/01/2016This version of the policy will become effective 01/01/2016.

The following HCPCS code, L8621, has been revised in Attachment A, of this policy.

MA05.063
08/19/2015The policy has been reviewed and reissued to communicate the Company’s continuing position on repair or replacement of an external prosthetic device and supplies.
01/01/2015This is a new policy.
Note: On 12/16/2014 this Notification was revised to include 1/1/2015 HCPCS coding update. Attachment A of this policy was updated as follows:
  • Code L7367 has a revised narrative.





Version Effective Date: 01/01/2018
Version Issued Date: 12/29/2017
Version Reissued Date: N/A