Policy Article Revisions Summary for March 7, 2024

Joint DME MAC Publication
Posted March 7, 2024

Outlined below are the principal changes to the DME MAC Policy Articles (PAs) that have been revised and posted. The policies included are Ankle-Foot/Knee-Ankle-Foot Orthoses, Knee Orthoses, and Spinal Orthoses: TLSO and LSO. Please review the entire Local Coverage Determinations (LCDs) and related PAs for complete information.

Ankle-Foot/Knee-Ankle-Foot Orthoses

PA

Revision Effective Date: 01/23/2024
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Removed: "Fabrication of an orthosis using CAD/CAM or similar technology without the creation of a positive model with minimal self-adjustment at delivery is considered as OTS."
CODING GUIDELINES:
Added: "Use of an additive manufacturing technique, CAD/CAM, or a similar manufacturing technique is not the sole requirement for a product to be designated as custom fabricated."
Removed: "An orthosis that is fabricated from a mold, CAD/CAM, or similar technology but without the creation of a positive model is considered a prefabricated orthosis."
Added: "Additive Manufacturing" with a description
Added: "Additive manufacturing is an acceptable custom fabrication technique as long as it adheres to the CMS DMEPOS Quality Standards, Appendix C."
Removed: "Use of CAD/CAM or similar technology to create an orthosis without a positive model of the patient is considered as OTS if the final fitting upon delivery to the patient requires minimal self-adjustment not requiring expertise as described in this section."
Removed: "Use of CAD/CAM or similar technology to create an orthosis without a positive model of the patient is considered as custom fitted if the final fitting at the time of delivery to the patient requires more than minimal self-adjustment requiring expertise as described in this section."

03/07/2024: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Knee Orthoses

PA

Revision Effective Date: 01/23/2024
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Removed: "Fabrication of an orthosis using CAD/CAM or similar technology without the creation of a positive model with minimal self-adjustment at delivery is considered as OTS."
CODING GUIDELINES:
Added: "Use of an additive manufacturing technique, CAD/CAM, or a similar manufacturing technique is not the sole requirement for a product to be designated as custom fabricated."
Removed: "An orthosis that is fabricated from a mold, CAD/CAM, or similar technology but without the creation of a positive model is considered a prefabricated orthosis."
Added: "Additive Manufacturing" with a description
Added: "Additive manufacturing is an acceptable custom fabrication technique as long as it adheres to the CMS DMEPOS Quality Standards, Appendix C."
Removed: "Use of CAD/CAM or similar technology to create an orthosis without a positive model of the patient is considered as OTS if the final fitting upon delivery to the patient requires minimal self-adjustment not requiring expertise as described in this section."
Removed: "Use of CAD/CAM or similar technology to create an orthosis without a positive model of the patient is considered as custom fitted if the final fitting at the time of delivery to the patient requires more than minimal self-adjustment requiring expertise as described in this section."

03/07/2024: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Spinal Orthoses: TLSO and LSO

PA

Revision Effective Date: 01/23/2024
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Removed: "Fabrication of an orthosis using CAD/CAM or similar technology without the creation of a positive model with minimal self-adjustment at delivery is considered as OTS."
CODING GUIDELINES:
Added: "Use of an additive manufacturing technique, CAD/CAM, or a similar manufacturing technique is not the sole requirement for a product to be designated as custom fabricated."
Removed: "An orthosis that is fabricated from a mold, CAD/CAM, or similar technology but without the creation of a positive model is considered a prefabricated orthosis."
Added: "Additive Manufacturing" with a description
Added: "Additive manufacturing is an acceptable custom fabrication technique as long as it adheres to the CMS DMEPOS Quality Standards, Appendix C."
Removed: "Use of CAD/CAM or similar technology to create an orthosis without a positive model of the patient is considered as OTS if the final fitting upon delivery to the patient requires minimal self-adjustment not requiring expertise as described in this section."
Removed: "Use of CAD/CAM or similar technology to create an orthosis without a positive model of the patient is considered as custom fitted if the final fitting at the time of delivery to the patient requires more than minimal self-adjustment requiring expertise as described in this section."

03/07/2024: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Note: The information contained in this article is only a summary of revisions to the LCDs and/or PAs. For complete information on any topic, you must review the LCDs and/or PAs.

With the update(s) listed above, Noridian would like to remind users how to find the policy that was previously effective. When billing, the supplier should follow guidance that was effective on the date of service. The below steps can be followed to find all previous policies:

  1. Open the currently effective policy on the Medical Coverage Database (MCD)
    1. Links to the MCD can be found on the Active LCDs page on the Noridian website
      1. There is a link at the top of the Active LCD page that goes to a full list of the LCDs or PAs, depending on which link is selected OR
      2. There are direct links to all LCDs under the 'LCD ID number and Effective Date' column
  2. Scroll down to the bottom of the policy
  3. Find the section labeled Public Version(s)
  4. Look for the link to the policy that was effective on the dates of service in question.
  5. Click on hyperlink to go to the policy.
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