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March 7, 2024

Policy Article Revisions Summary for March 7, 2024

Joint DME MAC Publication

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

Ankle-Foot/Knee-Ankle-Foot Orthoses PAExternal Website

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

Knee Orthoses PAExternal Website

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

Spinal Orthoses: TLSO and LSO PAExternal Website

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.

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