Top Non-Affirmation Reasons for Lower Limb Prosthetics - JD DME

The Jurisdiction D, DME MAC, Medical Review Department conducts Prior Authorization (PA) reviews for select durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items per the CMS. The quarterly non-affirmation results from July 2024 – September 2024 pertaining to medical necessity and replacement criteria are as follows:

Top Reasons for LLP Non-Affirmation:

• Medical record documentation does not demonstrate the beneficiary’s expected functional potential. Refer to Local Coverage Determination L33787.
  • This accounts for 18% of the non-affirmations.
• Medical record documentation does not demonstrate the beneficiary’s current functional capabilities. Refer to Local Coverage Determination L33787.
  • This accounts for 17% of the non-affirmations.
• Medical record documentation does not indicate replacement of a prosthesis or prosthetic component due to 1. A change in the physiological condition of the beneficiary; 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. Refer to the Social Security Act 1834(h)(1)(G).
  • This accounts for 15% of the non-affirmations.
• Physician’s order does not indicate replacement of a prosthesis or prosthetic component due to 1. A change in the physiological condition of the beneficiary; 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. Refer to the Benefit Policy Manual Pub 100-02 Chapter 15.
  • This accounts for 13% of the non-affirmations.

Educational Resources

Suppliers billing Medicare should be familiar with the documentation requirements and utilization parameters. Visit the Orthotics webpage to access coverage documents (Local Coverage Determination (LCD), Policy Article, National Coverage Determination (NCD)); documentation letters, forms, and checklists; reviews; tips; tools; resources; related articles; and educational events and tutorials, if applicable.

Suppliers can view resources related to applicable HCPCS codes, submitting PA requests, documentation requirements, educational resources and CMS Resources via the Required Prior Authorization Programs webpage.

Noridian provides education via supplier workshops, training opportunities, and presentations.

See the CMS Internet Only Manual (IOM), Publication 100-08, Medicare Program Integrity Manual, Chapter 3 information about probe/error validation reviews.

LCD and Policy Education

FUNCTIONAL LEVELS

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

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

Clinical assessments of beneficiary 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 beneficiary’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.

REPLACEMENT

Medicare payment may be made for the replacement of prosthetic devices which are artificial limbs, or for the replacement of any part of such devices, without regard to continuous use or useful lifetime restrictions if a treating practitioner determines that the replacement device, or replacement part of such a device, is reasonable and necessary. Claims involving the replacement of a prosthesis or major component (foot, ankle, knee, socket) must be supported by a new treating practitioner's order and documentation supporting the reason for the replacement. The reason for replacement must be documented by the treating practitioner, either on the order or in the medical record, and must fall under one of the following:

1. A change in the physiological condition of the patient resulting in the need for a replacement. Examples include but are not limited to, changes in beneficiary weight, changes in the residual limb, beneficiary functional need changes; or,
2. An irreparable change in the condition of the device, or in a part of the device resulting in the need for a replacement; or,
3. The condition of the device, or the part of the device, requires repairs and the cost of such repairs would be more than 60 percent of the cost of a replacement device, or, as the case may be, of the part being replaced.

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 beneficiary. 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 beneficiary weight or prosthetic demands of very active amputees.