Appeal type: DME/ Orthotics
Decision: Unfavorable

We decided that the Plan does not have to pre-approve advanced foot, for the enrollee.
You asked the Plan to pre-approve the advanced foot. You say that the durable medical equipment is medically necessary. The Plan denied your request. The Plan says the durable medical equipment is not medically necessary.
The Plan must follow Medicare rules. We looked at the file and Medicare rules. Based on this information, we decided that Medicare rules for coverage of the advanced foot have not been met. Unfortunately, we cannot approve what you have asked for. The notes do not show why the requested advanced foot is needed. That is why the requested prosthetic foot is still denied. A request for a foot that meets your needs and Medicare guidelines can be reviewed if submitted. More information will be given to your prosthetic provider. Member has a right transtibial amputation from January 2018. ASSOCIATED COMORBIDITIES: Back Pain, Diabetes Mellitus, Obesity, Osteoarthritis, Peripheral Artery Disease (PAD), Peripheral Vascular Disease (PVD), Peripheral Neuropathy, Renal Failure, Venous Insufficiency. Prosthesis was approved on prior review except for K3 foot L5980, All Lower Extremity Prostheses Flex-Foot System, and L5986, All Low Extrem Prosth Multi-Axial Rotation Unit. Member's physician contains handwritten addendum stating that physician agrees with K3 designation. However, no clinical information in the physician's office visit note is provided to support this contention. No therapy notes were submitted with this request to support the member as being at the K3 level. Notes from the prothetist (vendor) state that member is at K3 level. Prosthetist's note states that
the member has "the ability or potential for ambulation with variable cadence/activity beyond simple locomotion." Other than the statement that the physician agrees with K3 designation, the physician office visit note offers no clinical evidence to corroborate the vendor's notes. Member is noted to require a cane to ambulate, has multiple comorbidities as listed above and has suffered falls. Per Medicare guidelines, "Records from suppliers or healthcare professionals with a financial interest in the claim outcome are not considered sufficient by themselves for determining that an item is reasonable and necessary." The prosthetist is the vendor and therefore has financial interest in the outcome of the claim. The prosthetist (vendor) has supplied an Amputee Mobility Predictor Assessment Tool that states that the member is at the K3 level. Medicare guidelines further state that "Supplier-produced records, even if signed by the prescribing physician/practitioner, and attestation letters (e.g. letters of medical necessity) are deemed not to be part of a medical record for Medicare payment purposes." While a detailed prescription/written order signed by the member's physician ordering a K3 foot, "A prescription is not considered to be part of the medical record" per Medicare criteria. Medicare criteria require that the statement that the member needs a K3 foot "must be corroborated by information contained in the medical record." Three is no clinical documentation in a physician's or therapist's note to corroborate that member's current functional status is consistent with K3, as required by Medicare guidelines. Request for K3 prosthetic foot for the member does not meet the Medicare criteria of reasonable and necessary. Therefore, we decided that the Plan does not have to pre-approve advanced foot, for the enrollee.