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

The Jurisdiction A, 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 January 2025 - March 2025 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 current functional capabilities. Refer to Local Coverage Determination L33787.
  • This accounts for 22% of the non-affirmations.
• Medical record documentation does not demonstrate the beneficiary’s expected functional potential. Refer to Local Coverage Determination L33787.
  • This accounts for 19% of the non-affirmations.
• Medical record documentation does not demonstrate the beneficiary will reach or maintain a defined functional state within a reasonable period of time. Refer to Local Coverage Determination L33787.
  • This accounts for 15% of the non-affirmations.
• Documentation was not submitted from the prosthetist to support functional level.
  • This accounts for 9% 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 physician, 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 (see the FUNCTIONAL LEVEL CHARACTERISTICS section in the LCD related Policy Article for additional details):

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.

When submitting a prosthetic claim, the billed code for knee, foot, ankle and hip (HCPCS codes L5610, L5611, L5613, L5614, L5616, L5710, L5711, L5712, L5714, L5716, L5718, L5722, L5724, L5726, L5728, L5780, L5810, L5811, L5812, L5814, L5816, L5818, L5822, L5824, L5826, L5828, L5830, L5840, L5848, L5856, L5857, L5858, L5859, L5930, L5961, L5970, L5971, L5972, L5973, L5974, L5975, L5976, L5978, L5979, L5980, L5981, L5982, L5984, L5985, L5986, L5987) components must be submitted with modifiers K0 - K4, indicating the expected beneficiary 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 beneficiary’s history and current condition which supports the designation of the functional level by the prosthetist.

COVERAGE CRITERIA

A lower limb prosthesis is covered when the beneficiary:

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