Top Non-Affirmation Reasons for Lower Limb Prosthetics

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 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 has large or multiple stage III or IV pressure ulcer(s) on the trunk or pelvis. Refer to National Coverage Determination 280.1, Local Coverage Determination 33642 and Policy Article 52490.
    • This accounts for 24% of the non-affirmations.
  • Claims history indicates same or similar durable medical equipment within the last five years. Refer to Medicare Claims Processing Manual 100-04, Chapter 20, Section 50.1.
    • This accounts for 15% of the non-affirmations.
  • Documentation does not include verification that the equipment was lost, stolen, or irreparably damaged in a specific incident. Refer to Medicare Claims Processing Manual 100-04, Chapter 20, Section 50 & Standard Documentation Requirements A55426.
    • This accounts for 15% of the non-affirmations.
  • Medical record documentation does not indicate the beneficiary has multiple stage II pressure ulcers located on the trunk or pelvis. Refer to National Coverage Determination 280.1, Local Coverage Determination 33642 and Policy Article 52490.
    • This accounts for 14% 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

COVERAGE CRITERIA

A group 2 support surface is covered if the beneficiary meets at least one of the following three Criteria (1, 2 or 3):

  1. The beneficiary has multiple stage II pressure ulcers located on the trunk or pelvis (refer to the "ICD-10 Codes that are Covered" section in the LCD-related Policy Article for applicable diagnoses) which have failed to improve over the past month, during which time the beneficiary has been on a comprehensive ulcer treatment program including each of the following:
    1. Use of an appropriate group 1 support surface, and
    2. Regular assessment by a nurse, physician, or other licensed healthcare practitioner, and
    3. Appropriate turning and positioning, and
    4. Appropriate wound care, and
    5. Appropriate management of moisture/incontinence, and
    6. Nutritional assessment and intervention consistent with the overall plan of care
  2. The beneficiary has large or multiple stage III or IV pressure ulcer(s) on the trunk or pelvis (refer to the "ICD-10 Codes that are Covered" section in the LCD-related Policy Article for applicable diagnoses),
  3. The beneficiary had a myocutaneous flap or skin graft for a pressure ulcer on the trunk or pelvis within the past 60 days (refer to the "ICD-10 Codes that are Covered" section in the LCD-related Policy Article for applicable diagnoses), and has been on a group 2 or 3 support surface immediately prior to discharge from a hospital or nursing facility within the past 30 days

If the beneficiary is on a group 2 surface, there should be a care plan established by the physician or home care nurse which includes the above elements. The support surface provided for the beneficiary should be one in which the beneficiary does not "bottom out" (see Appendices section).

When a group 2 surface is covered following a myocutaneous flap or skin graft, coverage generally is limited to 60 days from the date of surgery.

When the stated coverage criteria for a group 2 mattress or bed are not met, a claim will be denied as not reasonable and necessary.

Continued use of a group 2 support surface is covered until the ulcer is healed, or if healing does not continue, there is documentation in the medical record to show that: (1) other aspects of the care plan are being modified to promote healing, or (2) the use of the group 2 support surface is reasonable and necessary for wound management.

SAME OR SIMILAR

Same or similar denials occur when the patient's CMN history indicates a piece of equipment is the same or similar to the equipment being billed.

To determine whether same or similar items have previously been provided, suppliers must obtain all possible information from a patient, which may include the following:

  • Patient's correct Health Insurance Claim number;
  • Whether the patient has employer insurance or is enrolled in a Health Maintenance Organization (HMO);
  • If the patient currently has or had an identical or similar item in the past;
  • When the patient received the items and whether or not the items have been returned;
  • Where the item will be used; and
  • CMN or DIF information, if required.

By using the Suggested Intake Form, it assures this information is obtained. This form is available on our website under the Forms section and it contains beneficiary information, ordering physician information and questions for the beneficiary and the supplier. Suppliers can customize their own intake form to meet their needs as well.

The Noridian Medicare Portal or Interactive Voice Response System can be used to verify that a beneficiary has not had a same or similar item within the previous five years. Follow the steps listed under the manual on the Noridian Medicare Portal to check for same or similar items.

REPLACEMENT

The definition of replacement is found in the CMS Benefit Policy Manual (Internet-only manual 100-02), Chapter 15, Section 110.2.C. That section generally defines replacement as the provision of an entire identical or nearly identical item when it is lost, stolen or irreparably damaged.

Beneficiary owned items or a capped rental item may be replaced in cases of loss or irreparable damage. Irreparable damage may be due to a specific accident or to a natural disaster (e.g., fire, flood). Contractors may request documentation confirming details of the incident (e.g., police report, insurance claim report).

Replacement of items due to irreparable wear takes into consideration the Reasonable Useful Lifetime (RUL) of the item. The RUL of DME is determined through program instructions. In the absence of program instructions, carriers may determine the RUL, but in no cases can it be less than 5 years. If the item has been in continuous use by the beneficiary on either rental or purchase basis for its RUL, the beneficiary may elect to obtain a replacement.

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