Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Lower Limb Prostheses
Policy #:MA05.024c

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.

MEDICALLY NECESSARY

A lower limb prosthesis is considered medically necessary and, therefore, covered when ALL of the following criteria are met:
  • The individual has undergone an amputation of the lower extremity.
  • The individual is motivated to ambulate.
  • The individual has a potential functional ability of Level 1 or greater (see the table below for the classifications of functional ability).
  • The prosthesis is prescribed by an eligible professional provider and fitted/made by an orthotist or prosthetist.

For individuals with a unilateral lower extremity amputation, only one lower limb prosthesis is considered medically necessary and, therefore, covered.

FUNCTIONAL LEVELS
Determination of medical necessity for certain components/additions to the prosthesis is based on the individual's potential functional ability. Potential functional ability is based on the reasonable expectations of the prosthetist and the treating professional provider, considering factors that include, but are not limited to:
  • The individual's past history (including prior prosthetic use if applicable)
  • The individual's current condition (including the status of the residual limb and the nature of any other medical problems)
  • The individual's desire to ambulate

Clinical assessment of an individual's potential functional ability must be based on Medicare's Functional Classification Levels (MFCL).

Level 0 Does not have the ability or potential to ambulate or transfer safely with or without assistance, and a prosthesis does not enhance their quality of life or mobility.
Level 1 Has the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at fixed cadence. Typical of the limited and unlimited household ambulator.
Level 2 Has the ability or potential for prosthetic ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator.
Level 3 Has the ability or potential for prosthetic ambulation with variable cadence. Typical of the community ambulator who has the ability to traverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion.
Level 4 Has the ability or potential for prosthetic ambulation that exceeds basic ambulation skills, exhibiting high impact, stress, or energy levels. Typical of the prosthetic demands of the child, active adult, or athlete.

TYPES OF PROSTHESES

The individual must meet all of the medical necessity criteria listed above in order for the types of prostheses listed below to be covered.

PROSTHETIC FOOT COMPONENT
A basic lower extremity prosthesis includes a solid ankle cushion heel (SACH) foot. Other types of prosthetic feet are considered for coverage, based on the functional ability and level of the individual.

An external keel SACH foot (L5970) or single-axis ankle/foot (L5974) is considered medically necessary and, therefore, covered for individuals whose potential functional ability is at Level 1 or above.

A flexible-keel foot (L5972) or multiaxial ankle/foot (L5978) is considered medically necessary and, therefore, covered for individuals whose potential functional ability is at Level 2 or above.

A microprocessor-controlled ankle foot system (L5973), an energy-storing foot (L5976), a dynamic-response foot with a multi-axial ankle (L5979), a flex-foot system (L5980), a flex-walk system or equal (L5981), and a shank-foot system with vertical-loading pylon (L5987) are considered medically necessary and, therefore, covered for individuals whose potential functional ability is at Level 3 or above.

PROSTHETIC ANKLE COMPONENT
An axial rotation unit (L5982, L5984, L5985, L5986) is considered medically necessary and, therefore, covered for individuals whose potential functional ability is at Level 2 or above.

PROSTHETIC KNEE COMPONENT
A basic lower extremity prosthesis includes a single-axis, constant-friction knee. Other prosthetic knees are considered for coverage, based on the functional ability and level of the individual.

A high-activity knee control frame (L5930) is considered medically necessary and, therefore, covered for individuals whose potential functional ability is at Level 4.

A fluid, pneumatic, or electronic/microprocessor knee (L5610, L5613, L5614, L5722, L5724, L5726, L5728, L5780, L5814, L5822, L5824, L5826, L5828, L5830, L5840, L5848, L5856, L5857, L5858) is considered medically necessary and, therefore, covered for individuals whose potential functional ability is at Level 3 or above.

Other knee systems (L5611, L5616, L5710, L5711, L5712, L5714, L5716, L5718, L5810, L5811, L5812, L5816, L5818) are considered medically necessary and, therefore, covered for individuals whose potential functional ability is at Level 1 or above.

Addition to a lower extremity prosthesis, endoskeletal knee-shin system, powered and programmable flexion/extension assist control, includes any type of motor(s) (L5859) is considered medically necessary and, therefore, covered when ALL of the following criteria are met:
  • The individual has a microprocessor-controlled knee (swing and stance phase type [L5856], including electronic).
  • The individual is at a functional Level 3 only.
  • The individual has a documented morbidity of the spine and/or sound limb affecting hip extension and/or quadriceps function that impairs functioning at Level 3 with the use of a microprocessor-controlled knee alone.
  • The individual is able use a product that requires daily charging.
  • The individual is able to understand and respond to error alerts and alarms indicating problems with the function of the unit.

If the above coverage criteria for the knee component are not met, then L5859, will be considered not medically necessary and, therefore, not covered.

PROSTHETIC HIP COMPONENT
A pneumatic or hydraulic polycentric hip joint (L5961) is considered medically necessary and, therefore, covered for individuals whose functional level is 3 or above.

PROSTHETIC SOCKET
  • Two test (diagnostic) sockets (L5618, L5620, L5622, L5624, L5626, L5628) per individual prosthesis are considered medically necessary and, therefore, covered. Requests for additional sockets require additional documentation.
    • Test sockets are considered not medically necessary and, therefore, not covered for IPOPs (L5400, L5410, L5420, L5430, L5450, L5460).
  • No more than two of the same socket inserts (L5654, L5655, L5656, L5658, L5661, L5665, L5673, L5679, L5681, L5683) are allowed per individual prosthesis at the same time. Additional inserts are considered not medically necessary and, therefore, not covered.

Socket inserts used in conjunction with a suspension locking mechanism (L5673, L5679, L5681, or L5683) are considered medically necessary and, therefore, covered. These include socket inserts with or without a distal umbrella adapter for attaching the pin/lanyard of the locking mechanism.
  • The suspension locking mechanism that is integrated into the prosthesis socket, the pin(s), and lanyard, or other component, that is attached to the socket insert are addressed by code L5671. However, L5671 does not include the socket insert itself.

Socket replacements (custom or prefabricated [L5673, L5679]) are considered medically necessary and, therefore, covered if there is adequate documentation of functional and/or physiological need. Documentation may include, but is not limited to: changes in the residual limb and functional need changes, or irreparable wear-and-tear damage due to an individual's excessive weight or to prosthetic demands of very active amputees.

ACCESSORIES (E.G., STUMP STOCKINGS, HARNESSES)
Accessories are considered medically necessary and, therefore, covered when they are essential to, or aid in, the effective use of a medically necessary lower limb prosthesis that meets the criteria listed in this policy (L5654, L5655, L5656, L5658, L5661, L5665, L5666, L5668, L5670, L5672, L5676, L5677, L5678, L5680, L5682, L5684, L5685, L5686, L5688, L5690, L5692, L5694, L5695, L5696, L5697, L5698, L5699, L5704, L5705, L5706, L5707, L7367, L7368, L8400).

TRANSTIBIAL (BELOW-KNEE) PROSTHESES
When an initial below-knee prosthesis (L5500) or a preparatory below-knee prosthesis (L5510, L5520, L5530, L5540) is provided, prosthetic substitutions and/or additions of procedures and components are considered medically necessary and, therefore, covered in accordance with the functional level assessment of the individual. However, the accessories represented by HCPCS codes L5629, L5638, L5639, L5646, L5647, L5704, L5785, L5962, and L5980 are not intended for use with an initial or preparatory below-knee prosthesis. If these codes are reported in conjunction with an initial or preparatory below-knee prosthesis, they are considered not medically necessary and, therefore, not covered.

When a below-knee preparatory prefabricated prosthesis (L5535) is provided, prosthetic substitutions and/or additions of procedures and components are considered medically necessary and, therefore, covered in accordance with the functional level assessment of the individual. However, the accessories represented by HCPCS codes L5620, L5629, L5645, L5646, L5670, L5676, L5704, and L5962 are not intended for use with a below-knee preparatory prefabricated prosthesis. If these codes are reported in conjunction with a below-knee preparatory prefabricated prosthesis, they are considered not medically necessary and, therefore, not covered.

TRANSFEMORAL (ABOVE-KNEE) PROSTHESES
When an initial above-knee prosthesis (L5505) or a preparatory above-knee prosthesis (L5560, L5570, L5580, L5590, L5595, L5600) is provided, prosthetic substitutions and/or additions of procedures and components are considered medically necessary and, therefore, covered in accordance with the functional level assessment of the individual. However, the accessories represented by HCPCS codes L5610, L5631, L5640, L5642, L5644, L5648, L5705, L5706, L5710, L5711, L5712, L5714, L5716, L5718, L5722, L5724, L5726, L5728, L5780, L5790, L5795, L5964, and L5980 are not intended for use with an initial or preparatory above-knee prosthesis. If these codes are reported in conjunction with an initial or preparatory above-knee prosthesis, they are considered not medically necessary and, therefore, not covered.

When an above-knee preparatory prefabricated prosthesis (L5585) is provided, prosthetic substitutions and/or additions of procedures and components are considered medically necessary and, therefore, covered in accordance with the functional level assessment of the individual. However, the accessories represented by HCPCS codes L5624, L5631, L5648, L5651, L5652, L5705, L5706, L5964, and L5966 are not intended for use with an above-knee preparatory prefabricated prosthesis. If these codes are reported in conjunction with an above-knee preparatory prefabricated prosthesis, they are considered not medically necessary and, therefore, not covered.

REPAIR AND REPLACEMENT
For information on the repair and/or replacement of prostheses, refer to the Company's policy on the repair and replacement of external prosthetic devices.

The repair or replacement of a lower limb prosthesis, 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 requirements for a repair or replacement are met.

NOT MEDICALLY NECESSARY

A lower limb prosthesis is considered not medically necessary and, therefore, not covered for an amputee whose potential functional ability is at Level 0.

If a prosthesis is considered not medically necessary, all related components and accessories for that prosthesis are also considered not medically necessary and, therefore, not covered.

Components and/or accessories for a prosthesis that do not serve a functional purpose are considered not medically necessary and, therefore, not covered.

A user-adjustable heel-height feature (L5990) is considered not medically necessary and, therefore, not covered.

EXPERIMENTAL/INVESTIGATIONAL

The microprocessor foot or ankle system addition with power assist, which includes any type motor (L5969), is considered experimental/investigational and, therefore, not covered.

NOT COVERED

A prosthetic donning sleeve (L7600) is not covered by the Company because it is an item not covered by Medicare. Therefore, it is not eligible for reimbursement consideration.

NOT ELIGIBLE FOR SEPARATE REIMBURSEMENT

The following items are included in the reimbursement for a prosthesis and are, therefore, not separately reimbursed:
  • Evaluation of the residual limb and gait
  • Fitting of the prosthesis
  • Cost of base component parts and labor contained in HCPCS base codes
  • Repairs due to normal wear or tear within 90 days of delivery
  • Adjustments of the prosthesis or the prosthetic component made when fitting the prosthesis or component and for 90 days from the date of delivery when the adjustments are not necessitated by changes in the residual limb or the individual's functional abilities.

Foot covers are included in the HCPCS base codes that represent the prosthetic foot component and are, therefore, not separately reimbursable.

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 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.

An order for each item billed must be signed and dated by the professional provider who is treating the member and kept on file by the supplier. Medical record documentation must include a shipment confirmation or member's receipt of supplies and equipment. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Reimbursement for devices will be made only if there is sufficient documentation in the individual's medical record showing current functional capabilities and functional need for the technological or design features. Documentation should also include expected functional potential and an explanation if there is a difference between the individual's current status and expected potential. This information must be retained in the professional provider's or prosthetist's files, and be available upon request.

The prosthetist must retain documentation in the medical record of the prosthesis or prosthetic component replaced, the reason for replacement, and a description of the labor involved. It is recognized that there are situations in which the reason for replacement includes, but is not limited to: changes in the residual limb, functional need changes, or irreparable damage or wear/tear due to excessive weight or prosthetic demands of highly mobile amputees.
Policy Guidelines

A repair is a restoration of the prosthesis to correct problems due to wear or damage.

An adjustment is any modification to the prosthesis due to a change in the individual's condition or to improve the function of the prosthesis.

This policy is consistent with Medicare's coverage criteria. The Company's payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, lower limb prostheses 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.

However, services that are identified in this policy as not medically necessary or not covered are not eligible for coverage or reimbursement by the Company.

Description

A lower limb prosthesis is an artificial lower extremity for an individual who has sustained an amputation due to complications of disease or trauma. The design of the prosthesis is dependent on the functional level of the recipient and is geared toward replacing the function of a lower extremity, providing comfort, and minimizing limitations.
References

Noridian Article A52496. Lower limb Prostheses. [Noridian Web site]. Original: 10/01/2015. (Revised: 01/01/2018). Available at:
https://med.noridianmedicare.com/documents/2230703/7218263/Lower+Limb+Prostheses+LCD+and+PA/d3244c51-74d3-4214-a789-7481bc2e03d5.
Accessed February 25, 2019.

Noridian. Local Coverage Determination (LCD). L33787: Lower limb prostheses. [Noridian website]. Original: 10/01/2015. (Revised: 11/01/2018). Available at: https://med.noridianmedicare.com/documents/2230703/7218263/Lower+Limb+Prostheses+LCD+and+PA/d3244c51-74d3-4214-a789-7481bc2e03d5. Accessed February 25, 2019.

Noridian. Noncovered Items. Last Updated October 25, 2018. Available at: https://med.noridianmedicare.com/web/jadme/topics/noncovered-items. Accessed February 25, 2019.



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:

K0 Lower extremity prosthesis functional level 0-does not have the ability or potential to ambulate or transfer safely with or without assistance and a prosthesis does not enhance their quality of life or mobility

K1 Lower extremity prosthesis functional level 1 - has the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at fixed cadence, typical of the limited and unlimited household ambulator.

K2 Lower extremity prosthesis functional level 2 - has the ability or potential for ambulation with the ability to traverse low level environmental barriers such as curbs, stairs or uneven surfaces. typical of the limited community ambulator.

K3 Lower extremity prosthesis functional level 3-has the ability or potential for ambulation with variable cadence, typical of the community ambulator who has the ability to traverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion

K4 Lower extremity prosthesis functional level 4 - has the ability or potential for prosthetic ambulation that exceeds the basic ambulation skills, exhibiting high impact, stress, or energy levels, typical of the prosthetic demands of the child, active adult, or athlete.



Coding and Billing Requirements


Cross References

Attachment A: Lower Limb Prostheses
Description: HCPCS Level II Codes Number(s) and Narrative(s)







Policy History

MA05.024c
04/22/2019This version of the policy will become effective 04/22/2019. The intent of this policy remains unchanged; however, the following weight range criteria for an addition to a lower extremity prosthesis, endoskeletal knee-shin system, powered and programmable flexion/extension assist control, includes any type of motor(s) (L5859) has been deleted consistent with Noridian's local coverage determination:
  • The individual's weight is between 110 lbs and 275 lbs.

The following criteria has been added to this policy for the Repair and Replacement a lower limb prostheses:
  • The repair or replacement of a lower limb prostheses, 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 requirements for a repair or replacement are met.

The following HCPCS code has been added to Attachment A of this policy:
L5999 Lower extremity prosthesis, not otherwise specified

MA05.024b
12/19/2018This policy has been reviewed and reissued to communicate the Company’s continuing position on Lower Limb Prostheses.
01/01/2018This policy has been identified for the HCPCS code update, effective 01/01/2018.

The following HCPCS codes have been added to this policy:
  • L7700 Gasket or seal, for use with prosthetic socket insert, any type, each

MA05.024a
06/21/2017This policy was reviewed and reissued in accordance with the Company's Policy Confirmation Review track. The references were updated accordingly. The policy was updated to be consistent with current template wording and format. Source for the policy: BCBSA policy 1.04.05: Microprocessor-Controlled Prostheses for the Lower Limb last reviewed April 2016.
08/17/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on lower limb prostheses.
11/20/2015This version of the policy will become effective 11/20/2015.

This policy was updated to add a policy coverage position for the microprocessor foot or ankle system addition with power assist (L5696) as experimental/investigational.

MA05.024
01/01/2015This is a new policy.

Note: on 12/18/2014 this Policy Notification was updated in accordance with the HCPCS coding update effective 1/1/2015.

The following revisions were made to this policy, in Attachment A.

The following HCPCS narrative has been revised in this policy:

Code: L7367

From: Lithium ion battery, replacement
To: Lithium ion battery, rechargeable, replacement




Version Effective Date: 04/22/2019
Version Issued Date: 04/22/2019
Version Reissued Date: N/A