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Reasons for Non-Affirmed Prior Authorization for Lower Limb Prostheses

Order Issues

The order was missing or incomplete.

The order submitted with the prior authorization request must include the following:

  • Beneficiary's name or Medicare Beneficiary Identifier (MBI)
  • Order Date
  • General description of the item
    • The description can be either a general description (e.g., wheelchair or hospital bed), a HCPCS code, a HCPCS code narrative, or a brand name/model number.
    • For equipment – In addition to the description of the base item, the SWO may include all concurrently ordered options, accessories or additional features that are separately billed or require an upgraded code (List each separately)
  • Treating Practitioner Name or NPI
  • Treating practitioner's signature

Medical Record Issues

The treating practitioner's order, supplier prepared statement, or the practitioner's attestation, by itself, does not provide sufficient documentation of medical necessity or no medical record documentation was received.

For any DMEPOS item to be covered by Medicare, the patient's medical record must contain sufficient documentation of the patient's medical condition to substantiate the necessity for the type and quantity of items ordered and for the frequency of use or replacement (if applicable).

The information should include the patient's diagnosis and other pertinent information including, but not limited to, duration of the patient's condition, clinical course (worsening or improvement), prognosis, nature and extent of functional limitations, other therapeutic interventions and results, past experience with related items, etc.

A supplier prepared statement, nor a physician attestation, by itself provides sufficient documentation of medical necessity, even though it is signed by the treating physician or supplier. There must be information in the patient's medical record that supports the medical necessity for the item.

Refer to the Medicare Program Integrity Manual Chapter 5PDF.

The medical record contained an amendment, correction, or delayed entry that does not comply with accepted record keeping principles.

Refer to Section 10 of Supplier Manual Chapter 3 – Supplier DocumentationPDF for additional information.

The medical record documentation is not authenticated (handwritten or electronic) by the author.

Medicare requires that healthcare providers ordering or documenting the medical necessity for items or services received by Medicare beneficiaries must be identifiable. This is generally accomplished through a handwritten or electronic signature (signature stamps are not acceptable); however, when the author of a record is unclear, document(s) must be authenticated before payment can be made. The following information outlines the guidance from the Centers for Medicare & Medicaid Services (CMS) regarding acceptable methods for authentication provided/ordered be authenticated by the author.

Additional information is available in section 5 of Supplier Manual Chapter 3 – Supplier DocumentationPDF.

The medical record documentation does not demonstrate the beneficiary's current functional capabilities.

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:

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

Clinical assessments of beneficiary rehabilitation potential must be based on the classification levels in the Local Coverage Determination (LCD).

The records must document the beneficiary's current functional capabilities and their 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.

Refer to the Local Coverage Determination L33787External Website.

Updated: 11.14.23


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