A lower limb prosthesis is an artificial replacement for any or all parts of the lower extremity (leg).  A prosthesis is used to provide an individual who has an amputated limb with the opportunity to perform functional tasks, particularly ambulation (walking), which may not be possible without the limb.

For any item to be covered, it must:

1. be eligible for a defined Medicare benefit category;
2. be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the    functioning of a malformed body member; and,
3. meet all other applicable statutory and regulatory requirements.

For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage.

A lower limb prosthesis is covered when the patient:

1. Will reach or maintain a defined functional state within a reasonable period of time; and
2. Is motivated to ambulate.

For an item to be covered, a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary.

Functional Levels:
A determination of the medical necessity for certain components/additions to the prosthesis is based on the patient’s potential functional abilities.  Potential functional ability is based on the reasonable expectations of the prosthetist and treating physician, considering factors including, but not limited to:

1. The patient’s past history (including prior prosthetic use, if applicable); and
2. The patient’s current condition including the status of the residual limb and the nature of other medical problems; and
3. The patient’s desire to ambulate.

Clinical assessments of patient rehabilitation potential must be based on the following 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 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 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.

The records must document the patient’s current functional capabilities and his/her expected functional potential, including an explanation for the difference, if that is the case.  It is recognized, within the functional classification hierarchy, that bilateral amputees often cannot be strictly bound by functional level classifications.

General:
If a prosthesis is denied as not medically necessary, related additions will also be denied as not medically necessary. 

When an initial below knee prosthesis (L5500) or a preparatory below knee prosthesis (L5510-L5530, L5540) is provided, prosthetic substitutions and/or additions of procedures and components are covered in accordance with the functional level assessment except for codes L5629, L5638, L5639, L5646, L5647, L5704, L5785, L5962 and L5980 which will be denied as not medically necessary. 

When a below knee preparatory prefabricated prosthesis (L5535) is provided, prosthetic substitutions and/or additions of procedures are covered in accordance with the functional level assessment except for codes L5620, L5629, L5645, L5646, L5670, L5676, L5704 and L5962 which will be denied as not medically necessary. 

When an above knee initial prosthesis (L5505) or an above knee preparatory (L5560-L5580, L5590-L5600) prosthesis is provided, prosthetic substitution and/or additions of procedures and components are covered in accordance with the functional level assessment except for codes L5610, L5631, L5640, L5642, L5644, L5648, L5705, L5706, L5964, L5980 and L5710-L5780, L5790-L5795 which will be denied as not medically necessary. 

When an above knee preparatory prefabricated prosthesis (L5585) is provided, prosthetic substitution and/or additions of procedures and components are covered in accordance with the functional level assessment except for codes L5624, L5631, L5648, L5651, L5652, L5705, L5706, L5964 and L5966 which will be denied as not medically necessary. 

In the following sections, the determination of coverage for selected prostheses and components with respect to potential functional levels represents the usual case.  Exceptions will be considered in an individual case if additional documentation is included which justifies the medical necessity.  Prostheses will be denied as not medically necessary if the patient’s potential functional level is 0. 

FEET

A determination of the type of foot for the prosthesis will be made by the treating physician and/or the prosthetist based upon the functional needs of the patient.  Basic lower extremity prostheses include a SACH foot.  Other prosthetic feet are considered for coverage based upon functional classification.

• An external keel SACH foot (L5970) or single axis ankle/foot (L5974) is covered for patients whose functional level is 1 or above.
• A flexible-keel foot (L5972) or multi-axial ankle/foot (L5978) is covered for patients whose functional level is 2 or above.
• A microprocessor controlled ankle foot system (L5973), energy storing foot (L5976), dynamic response foot with multi-axial ankle (L5979), flex foot system (L5980), flex-walk system or equal (L5981), or shank foot system with vertical loading pylon (L5987) is covered for patients whose functional level is 3 or above.

Coverage is extended only if there is sufficient clinical documentation of functional need for the technologic or design feature of a given type of foot.  This information must be retained in the physician’s or prosthetist’s files.

A user-adjustable heel height feature (L5990) will be denied as not medically necessary. 

KNEES

A determination of the type of knee for the prosthesis will be made by the treating physician and/or the prosthetist based upon the functional needs of the patient.  Basic lower extremity prostheses include a single axis, constant friction knee.  Other prosthetic knees are considered for coverage based upon functional classification.

• A high activity knee control frame (L5930) is covered for patients whose functional level is 4.
• A fluid, pneumatic, or electronic knee (L5610, L5613, L5614, L5722-L5780, L5814, L5822-L5840, L5848, L5856, L5857, L5858) is covered for patients whose functional level is 3 or above.
• Other knee systems (L5611, L5616, L5710-L5718, L5810-L5812, L5816, L5818) are covered for patients whose functional level is 1 or above.

Coverage is extended only if there is sufficient clinical documentation of functional need for the technologic or design feature of a given type of knee.  This information must be retained in the physician’s or prosthetist’s files.

ANKLES

An axial rotation unit (L5982-L5986) is covered for patients whose functional level is 2 or above.

HIPS

A pneumatic or hydraulic polycentric hip joint (L5961) is covered for patients whose functional level is 3 or above.

SOCKETS

More than two test (diagnostic) sockets (L5618-L5628) for an individual prosthesis are not medically necessary unless there is documentation in the medical record which justifies the need.  Exception:  A test socket is not medically necessary for an immediate prosthesis (L5400-L5460).

No more than two of the same socket inserts (L5654-L5665, L5673, L5679, L5681, L5683) are allowed per individual prosthesis at the same time.

Socket replacements are considered medically necessary if there is adequate documentation of functional and/or physiological need.  It is recognized that there are situations where the explanation includes but is not limited to: changes in the residual limb; functional need changes; or irreparable damage or wear/tear due to excessive patient weight or prosthetic demands of very active amputees.

Reasons for Noncoverage

Lower limb prostheses are covered under the Prosthetic Benefit. In order for a member to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the medical policy must be met. In addition to meeting the benefit policy, there are specific statutory payment policy requirements, discussed below, that also must be met.

Services that do not meet the medical necessity criteria on this policy will be considered not medically necessary. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

The following items are included in the reimbursement for a prosthesis and, therefore, are not separately billable under the prosthetic benefit:

• Evaluation of the residual limb and gait
• Fitting of the prosthesis
• Cost of base component parts and labor contained in procedure 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 patient’s functional abilities.

Payment for a prosthesis is including in the payment to a hospital if:

1. The prosthesis is provided to a patient during an inpatient hospital stay prior to the day of discharge; and
   
2. The patient uses the prosthesis for medically necessary inpatient treatment or rehabilitation.

A claim must not be submitted in this situation.

Payment for a prosthesis described by codes L5000-L5020, L5400-L5460, L5987 and L8400-L8480 is included in the payment to a Skilled Nursing Facility (SNF) if:

1. The prosthesis is provided to a patient during the Medicare Part A covered SNF stay prior to the day of discharge; and
   
2. The patient uses the prosthesis for medically necessary inpatient treatment or rehabilitation.

A claim must not be submitted in this situation. Claims for other lower limb prostheses provided to patients in a Part A covered SNF stay and claims for any lower limb prosthesis provided in a SNF when the stay is not covered by Part A are submitted to the DME MAC.

Payment for a prosthesis delivered to a patient in a hospital or SNF is eligible for coverage if:

1. The prosthesis is medically necessary for a patient after discharge from a hospital or Part A covered SNF stay; and
2. The prosthesis is provided to the patient within two days prior to discharge to home; and
3. The prosthesis is not needed for inpatient treatment or rehabilitation, but is left in the room for the patient to take home.

ADJUSTMENTS, REPAIRS AND COMPONENT REPLACEMENT

Routine periodic servicing, such as testing, cleaning, and checking of the prosthesis is non-covered.  Adjustments to a prosthesis required by wear or by a change in the patient’s condition are covered under the initial physician’s order for the prosthesis for the life of the prosthesis.

Repairs to a prosthesis are covered when necessary to make the prosthesis functional.  If the expense for repairs exceeds the estimated expense of purchasing another entire prosthesis, no payments can be made for the amount of the excess.  Maintenance which may be necessitated by manufacturer’s recommendations or the construction of the prosthesis and must be performed by the prosthetist is covered as a repair.

Replacement of a prosthesis or prosthetic component is covered if the treating physician orders a replacement device or part because of any of the following:

1. A change in the physiological condition of the patient; or
2. Irreparable wear of the device or a part of the device; or
3. The condition of the device, or part of the device, requires repairs and the cost of such repairs would be more than 60% of the cost of a replacement device, or of the part being replaced.

Replacement of a prosthesis or prosthetic components required because of loss or irreparable damage may be reimbursed without a physician’s order when it is determined that the prosthesis as originally ordered still fills the patient’s medical needs.

MISCELLANEOUS

A prosthetic donning sleeve (L7600) will be denied as non-covered. The provider can bill the member for the denied service.

Documentation Requirements

It is expected that the patient's medical records will reflect the need for the care provided.  The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports.  This documentation must be available upon request.

Prescription (Order) Requirements

General:
All items billed require a prescription. An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request. Items dispensed and/or billed that do not meet these prescription requirements and those below must be submitted with an EY modifier added to each affected HCPCS code.

Dispensing Orders

Equipment and supplies may be delivered upon receipt of a dispensing order except for those items that require a written order prior to delivery. A dispensing order may be verbal or written. The supplier must keep a record of the dispensing order on file. It must contain:

• Description of the item
• Member's name
• Prescribing Physician's name
• Date of the order and the start date, if the start date is different from the date of the order
• Physician signature (if a written order) or supplier signature (if verbal order)

For the "Date of the order" described above, use the date the supplier is contacted by the physician (for verbal orders) or the date entered by the physician (for written dispensing orders).

Signature and date stamps are not allowed. Signatures must comply with the CMS signature requirements outlined in PIM 3.3.2.4.

The dispensing order must be available upon request.

For items that are provided based on a dispensing order, the supplier must obtain a detailed written order before submitting a claim.

Detailed Written Orders

A detailed written order (DWO) is required before billing. Someone other than the ordering physician may produce the DWO. However, the ordering physician must review the content and sign and date the document. It must contain:

• Member's name
• Physician's name
• Date of the order and the start date, if start date is different from the date of the order
• Detailed description of the item(s) (see below for specific requirements for selected items)
• Physician signature and signature date

For items provided on a periodic basis, including drugs, the written order must include:

• Item(s) to be dispensed
• Dosage or concentration, if applicable
• Route of Administration
• Frequency of use
• Duration of infusion, if applicable
• Quantity to be dispensed
• Number of refills

For the "Date of the order" described above, use the date the supplier is contacted by the physician (for verbal orders) or the date entered by the physician (for written dispensing orders).

Frequency of use information on orders must contain detailed instructions for use and specific amounts to be dispensed. Reimbursement shall be based on the specific utilization amount only. Orders that only state "PRN" or "as needed" utilization estimates for replacement frequency, use, or consumption are not acceptable.

The detailed description in the written order may be either a narrative description or a brand name/model number.

Signature and date stamps are not allowed. Signatures must comply with the CMS signature requirements outlined in PIM 3.3.2.4.

The DWO must be available upon request.

A prescription is not considered part of the medical record. Medical information intended to demonstrate compliance with coverage criteria may be included on the prescription but must be corroborated by information contained in the medical record.

Medical Record Information

General:
The Indications and Limitations of Coverage and/or Medical Necessity section of this medical policy contains numerous reasonable and necessary (R&N) requirements. The Reasons for Noncoverage section contains numerous non-reasonable and necessary, benefit category and statutory requirements that must be met in order for payment to be justified. Suppliers are reminded that:

• Supplier-produced records, even if signed by the ordering physician, and attestation letters (e.g., letters of medical necessity) are deemed not to be part of a medical record.
• Templates and forms are subject to corroboration with information in the medical record.

Information contained directly in the contemporaneous medical record is the source required to justify payment except as noted elsewhere for prescriptions and CMNs. The medical record is not limited to physician's office records but may include records from hospitals, nursing facilities, home health agencies, other healthcare professionals, etc. (not all-inclusive). Records from suppliers or healthcare professionals with a financial interest in the claim outcome are not considered sufficient by themselves for the purpose of determining that an item is reasonable and necessary.

Proof of Delivery

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. For medical review purposes, POD serves to assist in determining correct coding and billing information for claims submitted. Regardless of the method of delivery, the contractor must be able to determine from delivery documentation that the supplier properly coded the item(s), that the item(s) delivered are the same item(s) submitted for reimbursement and that the item(s) are intended for, and received by, a specific member.

Suppliers, their employees, or anyone else having a financial interest in the delivery of the item are prohibited from signing and accepting an item on behalf of a member (i.e., acting as a designee on behalf of the member). The signature and date the member or designee accepted delivery must be legible.

For the purpose of the delivery methods noted below, designee is defined as "Any person who can sign and accept the delivery of durable medical equipment on behalf of the member."

Proof of delivery documentation must be available on request. All services that do not have appropriate proof of delivery from the supplier will be denied and overpayments will requested. Suppliers who consistently fail to provide documentation to support their services may be referred to the OIG for imposition of Civil Monetary Penalties or other administrative sanctions.

Suppliers are required to maintain POD documentation in their files. There are three methods of delivery:

1. Delivery directly to the member or authorized representative
2. Delivery via shipping or delivery service
3. Delivery of items to a nursing facility on behalf of the member

Method 1 - Direct Delivery to the Member by the Supplier

Suppliers may deliver directly to the member or the designee. In this case, POD to a member must be a signed and dated delivery slip. The POD record must include:

• Member's name
• Delivery address
• Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description)
• Quantity delivered
• Date delivered
• Member (or designee) signature and date of signature

The date of signature on the delivery slip must be the date that the DMEPOS item was received by the member or designee. In instances where the supplies are delivered directly by the supplier, the date the member received the DMEPOS supply must be the date of service on the claim.

Method 2 - Delivery via Shipping or Delivery Service Directly to a Member

If the supplier utilizes a shipping service or mail order, the POD documentation must be a complete record tracking the item(s) from the DMEPOS supplier to the member. An example of acceptable proof of delivery would include both the supplier's own detailed shipping invoice and the delivery service's tracking information. The supplier's record must be linked to the delivery service record by some clear method like the delivery service's package identification number or supplier's invoice number for the package sent to the member. The POD record must include:

• Member's name
• Delivery address
• Delivery service package identification number, supplier invoice number or alternative method that links the supplier's delivery documents with the delivery service records
• Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description)
• Quantity delivered
• Date delivered
• Evidence of delivery

If a supplier utilizes a shipping service or mail order, suppliers must use the shipping date as the date of service on the claim.

Suppliers may also utilize a return postage-paid delivery invoice from the member or designee as a POD. This type of POD record must contain the information specified above.

Method 3 - Delivery to a Nursing Facility on Behalf of a Member

When a supplier delivers items directly to a nursing facility, the documentation described for Method 1 (see above) is required.

When a delivery service or mail order is used to deliver the item to a nursing facility, the documentation described for Method 2 (see above) is required.

Regardless the method of delivery, for those members that are residents of a nursing facility, information from the nursing facility showing that the item(s) delivered for the member's use were actually provided to and used by the member must be available upon request.

An order for the prosthesis including each separately billed component must be signed and dated by the treating physician, kept on file by the supplier, and be available upon request.  Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected procedure code.

Repair/Replacement

Adjustments and repairs of prostheses and prosthetic components are covered under the original order.  Claims involving the replacement of a prosthesis or major component (foot, ankle, knee, socket) must be supported by a new physician’s order.

The prosthetist must retain documentation of the prosthesis or prosthetic component replaced, the reason for replacement, and a description of the labor involved irrespective of the time since the prosthesis was provided to the member.  This information must be available upon request.  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 patient weight or prosthetic demands of very active amputees.

When submitting a prosthetic claim, the billed code for knee, foot, ankle and hip (procedure codes L5610-L5616, L5710-L5780, L5810-L5840, L5848, L5856, L5857, L5858, L5930, L5961, L5970-L5987) components must be submitted with modifiers K0-K4, indicating the expected patient functional level.   This expectation of functional ability information must be clearly documented and retained in the prosthetist’s records.  The simple entry of a K modifier in those records is not sufficient.  There must be information about the patient’s history and current condition which supports the designation of the functional level by the prosthetist.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

The L7510 code is used to bill for any “minor” materials (those without specific procedure codes) used to achieve the adjustment and/or repair.

Code L7520 is used to bill for labor associated with adjustments and repairs that either do not involve replacement parts or that involve replacement parts billed with code L7510.  Code L7520 must not be billed for labor time involved in the replacement of parts that are billed with a specific procedure code.  Labor is included in the allowance for those codes. 

One unit of service of code L7520 represents 15 minutes of labor time.  Documentation must exist in the supplier's records indicating the specific adjustment and/or repair performed and the time involved.  The time reported for L7520 must only be for actual repair time.  Time performing the following services (not all-inclusive) must not be billed using code L7520:

• Evaluation to determine the need for a repair or adjustment or follow-up assessment
• Evaluation of problems regarding the fit or function of the prosthesis
• General patient education or gait instruction
• Programming of electronic componentry

Code L5671 includes both the part of the suspension locking mechanism that is integrated into the prosthesis socket and the pin(s), lanyard, or other component which is attached to the socket insert.  L5671 does not include the socket insert itself.  The socket inserts used in conjunction with a suspension locking mechanism are billed with codes L5673, L5679, L5681 or L5683, as appropriate.  These codes include socket inserts with or without a distal umbrella adapter for attaching the pin or lanyard of the locking mechanism.

Codes L5681 and L5683 are for use only with the initial issue of a custom fabricated socket insert.  Additional inserts (either custom fabricated or prefabricated) provided at the time of initial issue or replacement socket inserts are coded L5673 and L5679, whichever is applicable. 

Codes L5647 and L5652 describe a modification to a prosthetic socket that incorporates a suction valve in the design.  The items described by these codes are not components of a suspension locking mechanism  (L5671).

With the exception of items described by specific procedure codes, there should be no separate billing and there is no separate payment for a component or feature of a microprocessor controlled knee, including, but not limited to, real time gait analysis, continuous gait assessment, or electronically controlled static stance regulator.

Codes L5940-L5960 for ultra-light materials may only be used when materials such as carbon fiber, fiberglass, Kevlar®, or other advanced composite lamination materials are used in the fabrication of a socket for an endoskeletal prosthesis.  They are not used for ultralight materials used in other components of a prosthesis - e.g., knee/shin system, pylon, ankle, foot, etc.  For codes L5940-L5960, the unit of service is per limb.

Foot covers are included in the codes for a prosthetic foot component and are not separately payable.

The right (RT) and left (LT) modifiers must be used with prosthesis codes.  When the same code for prostheses, sockets, or components for bilateral amputees are billed on the same date of service, the items (RT and LT) will be entered on the same line of the claim using the LTRT modifiers and billed with two units of service.  Claim lines billed without the RT and/or LT modifiers will be rejected as incorrect coding.

Suppliers should contact the DME Pricing, Data Analysis, and Coding Contractor (PDAC) for guidance on the correct coding of these items.

Provider News

06/2011, Medicare Advantage covers pneumatic or hydraulic polycentric hip joint for functional level of three or above.

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the patient's medical records will reflect the need for the care provided. The patient's medical records include the physician's office records, hospital records, nursing
home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.