Appeal type: DME/ Orthotics
Decision: Partially Favorable

We decided that the Plan has to pre-approve vertical shock reducing pylon feature (L5988) flex-walk system or equal (L5981) axial rotation unit, with or without adjustability (L5984) prosthetic shrinker, below knee (L8440) and prosthetic sock, single ply, fitting, below knee (L8470). We decided that the Plan does not have to pre-approve below knee, flexible protective outer surface covering system (L5962). 

You asked the Plan to pre-approve vertical shock reducing pylon feature (L5988) below knee, flexible protective outer surface covering system (L5962) flex-walk system or equal (L5981) axial rotation unit, with or without adjustability (L5984) prosthetic shrinker, below knee (L8440) and prosthetic sock, single ply, fitting, below knee (L8470). You say that the enrollee's physician and your prosthetist believe these items are medically necessary and essential to provide. You ask for reconsideration of this prior authorization request for codes L5988, L5981 and L5984.  The Plan says that the request for K3 foot exceeds enrollee's need and cannot be covered. The notes do not show why approved L5704 is not sufficient to meet enrollee's needs.

We decided that the Plan has to pre-approve vertical shock reducing pylon feature (L5988) flex-walk system or equal (L5981) axial rotation unit, with or without adjustability (L5984) prosthetic shrinker, below knee (L8440) and prosthetic sock, single ply, fitting, below knee (L8470). 

We also decided that the Plan does not have to pre-approve below knee, flexible protective outer surface covering system (L5962).

The Plan must follow Medicare rules. Medicare rules say that items and services that are not medically necessary are not covered.

We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to determine if the Plan was correct in denying the request to pre-approve the advanced foot and components. Our reviewer says that the enrollee partially meets the Medicare criteria. Our physician reviewer found the medical record satisfies Medicare policy in demonstrating this enrollee has a K3 functional level. The Plan attempts to create a more restrictive policy for defining K3 function than Medicare policy would allow.

Regarding functional levels, LCD L33787 reads, in part: 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.

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."

In contrast to these broad, inclusive K3-criteria that generally describe the average Medicare Beneficiary who lives independently at home and in the community, the Plan's denial letter sets more stringent requirements than Medicare. In its own definition of the K3 level, the Plan seeks to create strict use-case criteria with a level of specificity that does not appear in the LCD - "You must need to do more than simple walking. You must need to cross different barriers (such as walking long distances or walking on steep or slippery surfaces)."

The certified prosthetist/orthotist (CPO) and surgeon notes satisfy Medicare requirements for documenting the enrollee's K3 functional potential as well as their general need for the prosthesis, the foot, and soft goods.

LCD L33787 states simply "flex foot system (L5981) is covered for beneficiaries whose functional level is 3 or above."  No further specific documentation is actually required in the LCD, the Policy Article, or any of the relevant Medicare manuals because Medicare's policy recognizes that flex-walk feet are part of the basic standard of care for all community K3 amputee ambulators given that the evidence of their benefits and superiority to less sophisticated alternatives are so well proven and long standing. It is highly likely that original Medicare would have covered the requested prosthetic foot and soft goods for this enrollee.

However, regarding L5962, given the specific documentation requirements for this component, it is incumbent on the CPO to provide a medical record that meets these requirements.  However, in this case, no such justification or context is found in the record to suggest that this enrollee's prosthesis will be exposed to unusually harsh environments necessitating additional protection beyond what is provided with a typical cover (e.g., L5704, which has already been approved by the Plan).  Therefore, the requested foot (L5981, L5984, L5988) as well as the soft goods (L8440, L8470) are hereby approved, but the Plan's denial of L5962 is upheld. 

We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that Medicare rules for coverage of the advanced foot and components have been met. Therefore, we decided that the Plan has to pre-approve vertical shock reducing pylon feature (L5988) flex-walk system or equal (L5981) axial rotation unit, with or without adjustability (L5984) prosthetic shrinker, below knee (L8440) and prosthetic sock, single ply, fitting, below knee (L8470). We have also decided that Medicare rules for coverage of below knee, flexible protective outer surface covering system (L5962) have not been met. Therefore, we decided that the Plan does not have to pre-approve below knee, flexible protective outer surface covering system (L5962).

If the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The Plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will send you a letter.