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LCD revision 12 creates the 200-unit combined ceiling and the spinal cord injury example

LCD revision · high importance

Announced
2025-11-13
Effective
2026-01-01

This single revision is the origin of both headline rules on the A4297 page. It added A4295, A4296 and A4297 to the Usual Maximum Quantity of Supplies table at 200 per month each, added a row reading "Any combination of A4297 and A4353" at 200, and added the sentence below the table stating that billing more than 200 units per month total for A4297 and A4353 will be denied as not reasonable and necessary. Before it, none of that language existed.

The same revision added "has a diagnosis of spinal cord injury at any level" to the examples under the immunosuppression criterion, removed a criterion covering pregnant spinal-cord-injured women with neurogenic bladder, and rewrote the recurrent urinary tract infection criterion to name the specific catheter and lubricant combinations a beneficiary must have been using.

The response to comments published alongside it records that two commenters asked for spinal cord injury to be listed as a standalone clinical indication and that the DME MACs declined, holding the request outside the scope of the reconsideration.

Codes this entry bears on

Sources

  1. [1] Local Coverage Determination L33803, Urological Supplies · CGS Administrators, LLC and Noridian Healthcare Solutions, LLC (the four DME MAC jurisdictions), via the CMS Medicare Coverage Database · checked 2026-08-07

    Version 61, revision effective 2026-04-01. Retrieved through the Coverage API (/v1/data/lcd/?lcdid=33803&ver=61 plus its revision-history, hcpc-code and related-documents endpoints) and re-read verbatim from this page on 2026-08-07, which answered a plain automated fetch with HTTP 200 and 224,983 bytes. Coverage API weekly snapshot, data captured through 2026-08-02 and refreshed 2026-08-06; the API is not a live read. The quantity ceiling this page leans on is in this document and not in the policy article, verbatim: "The maximum quantity of sterile catheterization kits (A4297, A4353) is 200 units per month. Billing more than 200 units per month total for A4297 and A4353 will be denied as not reasonable and necessary." Note the section named DOCUMENTATION REQUIREMENTS comes back in the API field `associated_info`, not in `doc_reqs`, which is empty; a reader who checks only the obvious field concludes wrongly that the LCD has no documentation section.

  2. [2] Response to Comments A60353, Urological Supplies (DL33803) · CGS Administrators, LLC and Noridian Healthcare Solutions, LLC (the four DME MAC jurisdictions), via the CMS Medicare Coverage Database · checked 2026-08-07

    Version 4, published 2025-11-13. HTTP 200, 187,411 bytes on 2026-08-07. The Q&A itself is served by the Coverage API at /v1/data/article/response-comment?articleid=60353; the article's own `description` field holds only the preamble, so a reader who fetches the article body alone finds none of the substance. Cited for response 7, in which two commenters asked that spinal cord injury be made a standalone clinical indication and the DME MACs declined, recording that the request was outside the scope of the reconsideration.

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