Coverage is subject to the terms, conditions, and limitations of the member's contract. State mandates do not automatically apply to all plans; therefore, individual benefits must be verified.
MEDICALLY NECESSARY
A lower limb prosthesis is considered medically necessary and, therefore, covered when all of the following medical necessity criteria are met:
- The individual has undergone amputation of a lower extremity or has congenital absence or malformation 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 unilateral lower extremity amputation or unilateral congenital absence or malformation of the lower extremity, only one lower limb prosthesis is considered medically necessary and, therefore, covered. 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.
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 the following Medicare Functional Classification Level (MFCL) classification levels:| 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.
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- In the initial postoperative period, cast changes are necessary as the residual limb muscles atrophy, usually at 7- to 10-day intervals.
In the intermediate period between the amputation procedure and definitive prosthetic fitting, the following preparatory prostheses are considered medically necessary and, therefore, covered: L5510, L5520, L5530, L5535, L5540, L5560, L5570, L5580, L5585, L5590, L5595, L5600.
- The type of preparatory prosthesis used is based on the physician's clinical judgment, considering the status of the residual limb and the individual's history, current condition, and desire to ambulate.
- This period of prosthetic utilization is defined by continued rapid changes in limb volume due to the initiation of ambulation and consistent prosthetic use.
- Transition from a preparatory prosthesis should only occur with relative stabilization of the residual limb size and consistency of prosthetic fit for several months.
DEFINITIVE PROSTHESIS
A definitive prosthesis is considered medically necessary and, therefore, covered when either of the following criteria are met:
- For an individual whose residual limb is no longer changing shape or volume
- This period of prosthetic utilization is defined by relatively full residual limb maturation and stability (this occurs after an individual has utilized a preparatory prosthesis consistently for approximately 6 months and limb volume has stabilized, resulting in a relatively constant socket fit).
- Component selection for the definitive prosthesis is based on the potential functional ability of the individual.
- For an individual who is at a functional mobility level of K3 or above and is receiving an approved microprocessor knee (see Cross-Reference Policy section)
COMPONENTS OF A DEFINITIVE PROSTHESIS
PROSTHETIC FOOT COMPONENT
A basic lower extremity prosthesis includes a solid ankle cushion heel (SACH) foot. Other prosthetic feet are considered medically necessary and, therefore, covered based on the potential functional ability 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.
- An energy-storing foot (L5976), a dynamic response (L5979), a flex-foot system (L5980), a flex-walk system or equal (L5981), or a shank foot system with vertical-loading pylon (L5987) is 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, 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 medically necessary and, therefore, covered based on the potential functional ability 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 or pneumatic knee (L5610, L5613, L5614, L5722, L5724, L5726, L5728, L5780, L5814, L5822, L5824, L5826, L5828, L5830, L5840, L5841, L5848) 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, L5814, L5816, L5818) are considered medically necessary and, therefore, covered for individuals whose potential functional ability is at Level 1 or above.
PROSTHETIC HIP COMPONENT
A pneumatic or hydraulic polycentric hip joint (L5961) is covered for patients 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, 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, functional need changes, or irreparable wear-and-tear damage due to excessive patient weight or prosthetic demands of very active amputees.
SHOES
- Shoes (L3250) are considered medically necessary and, therefore, covered if they are an integral part of a covered lower limb prosthesis and are medically necessary for the proper functioning of the prosthesis.
- A shoe (L3250) that is billed as a replacement for a previously covered shoe and is an integral part of an existing lower limb prosthesis for an individual with a partial foot amputation is considered medically necessary and, therefore, covered. In such cases, the item must meet the requirements included in the Company's policy on repair and replacement of external prosthetic devices.
- A shoe is considered not medically necessary and, therefore, not covered for any other condition or if billed in any manner (e.g., separately, simultaneously with the prosthesis) other than as a replacement shoe for an existing lower limb prosthesis.
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 covered lower limb prosthesis that meets the medical necessity 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 Healthcare Common Procedure Coding System (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 will be denied as not medically necessary.
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 will be denied as not medically necessary.
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 will be denied as not medically necessary.
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 will be denied as not medically necessary.
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 lower limb prosthesis itself is covered under the individual's medical benefits and all of the requirements for a repair or replacement are met.
The repair or replacement of a lower limb prosthesis or one or more of its components (parts) is considered noncovered and not eligible for reimbursement when 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.
Additionally, repair and replacement is not covered if either the device itself 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 the device is under warranty.
Requests for a different type of lower limb prosthesis or one or more of it components (parts) due to a change in medical and/or functional status, such that the lower limb 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 lower limb prosthesis requested.
The Company may determine the reasonable useful lifetime of a specific external prosthetic device based on the manufacturer's recommendation or the US 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 it is generally not less than 5 years. Replacement due to misuse, abuse, or failure to adequately maintain or care for the item is excluded from coverage.
NOT MEDICALLY NECESSARY
A lower limb prosthesis is considered not medically necessary and, therefore, not covered for an individual 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.
BILLING REQUIREMENTS
The right (RT) and left (LT) modifiers must be used when reporting prostheses codes. When the same codes for prostheses, sockets, or components for bilateral users are billed on the same date of service, the items must be entered on the same line of the claim form, using the appropriate RT/LT modifiers, and billed for two units of service.
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.
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
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 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 7 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 5 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 DME supplier may be required to reimburse the Company for overpayments.
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 technologic 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 where 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 individuals.
