A4353

At a glance

What changed on January 1, 2026, and what did not

A4353's descriptor did not change. This is the single most widely mis-stated fact about the code, and it is checkable in one step: the descriptor in the current LCD, revision effective April 1, 2026, is the same string as the descriptor in the LCD revision effective January 1, 2024. It still reads "Intermittent urinary catheter, with insertion supplies", it carries no exclusionary wording of any kind, and CMS's own alpha-numeric HCPCS file for July 2026 marks the record as no maintenance and gives it no termination date.

Two descriptors near it did change, and those are the ones CMS names. In its own words: "Starting January 1, 2026, we revised the descriptors for HCPCS codes A4351 and A4352. There are no changes to the existing fee schedule amounts for these codes." The words "or hydrophilic" came out of both. A4353 is not on that list, and the Jurisdiction C supplier manual reflects the same thing in the way it prints the appendix, stamping A4351 and A4352 with revised wording and printing A4353 plain.

What actually moved hydrophilic kits to A4297 is a billing instruction, published jointly by the four DME MACs: "Suppliers must discontinue use of A4351, A4352, and A4353 and utilize the new HCPCS codes A4295, A4296, and A4297 on claims for hydrophilic catheters with dates of service on or after January 1, 2026." That is an instruction about which code to use for a particular product, not a change to what A4353 means and not a retirement of A4353.

So A4353 remains active for kits that are not billed under the new hydrophilic codes, and it is named throughout both current governing documents. It holds its own row in the LCD's utilization table, it appears in the catheter insertion tray heading, it is one of the three per-episode options, and the policy article's kit definition is written for A4353 and A4297 together.

One rule about A4353 genuinely did change on January 1, 2026, and it is the quantity ceiling. Before that revision the utilization table did not contain A4295, A4296, A4297 or a combined row. The revision added the three new codes 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 the two kit codes will be denied. A4353's own 200 stayed where it was; what is new is that a second code now counts against it.

What A4353 covers

Policy Article A52521 is the definitive answer to what an A4353 is: "An intermittent urinary catheter with insertion supplies (A4297, A4353) is a kit, which includes a catheter and all supplies necessary for a single, sterile insertion." The code may be used where any one of three things is supplied.

First, a single sterile package containing both an intermittent urinary catheter and all necessary insertion and collection supplies.

Second, a sterile intermittent urinary catheter plus a separately packaged sterile kit containing all necessary insertion and collection supplies.

Third, a sterile no-touch type of catheter system.

For the first two, the article says what has to be in the kit: an intermittent urinary catheter, lubricant if applicable, gloves, antiseptic solution, applicators, a drape, and a collection tray or bag, in a sterile package intended for single use. The collection tray or bag is a separate item included within the kit, so non-sterile outer packaging that merely holds the components together does not meet the requirement.

For the third, read the requirement the right way round. A no-touch system must be sterile, all-inclusive and self-contained, capable of accomplishing intermittent catheterization with sterile technique without additional supplies such as gloves, lubricant or a collection chamber. The point is that it must not need a collection chamber supplied separately, not that it must come with one.

Billing the parts separately is unbundling, and the LCD is blunt about it. A4353 should not be used for billing if the components are packaged separately rather than together as a kit; separately provided components do not provide the equivalent degree of sterility achieved with a kit; and if separate components are provided instead of a kit they will be denied as not reasonable and necessary. The policy article states it as a prohibition and carries the one exception worth holding on to, which is the second configuration above, where the catheter comes alongside a separately packaged sterile kit.

A catheter supplied without insertion supplies is not an A4353. A4351 and A4352 are the single catheters, straight tip and coude tip respectively, and A4353 is the one that comes with the insertion supplies.

Coverage and medical necessity

Two gates, not one. A urological supply is covered under the Prosthetic Device benefit at Social Security Act section 1861(s)(8), which requires that the beneficiary have permanent urinary incontinence or permanent urinary retention and a permanent impairment of urination. The policy article adds the negative: using a urological supply to treat a chronic urinary tract infection or another bladder condition, where there is no permanent incontinence or retention, is non-covered, because the urinary system is functioning and the prosthetic benefit is not met.

Then the reasonable and necessary gate. Intermittent catheterization is covered when basic coverage criteria are met and the beneficiary or caregiver can perform the procedure. For each covered episode Medicare will cover one catheter (A4351, A4352) with an individual packet of lubricant (A4332), or one catheter (A4295, A4296), or one sterile intermittent catheter kit (A4297, A4353) if additional criteria are met. The kit is the third option, and the additional criteria are what this section is about.

A kit is covered when the beneficiary requires catheterization and meets one of the following criteria (1-4). One, the beneficiary resides in a nursing facility. Two, the beneficiary is immunosuppressed. Three, the beneficiary has radiologically documented vesico-ureteral reflux while on a program of intermittent catheterization. Four, the beneficiary has had distinct, recurrent urinary tract infections while on a program of sterile intermittent catheterization with either A4295 or A4296 with no sterile lubricant (A4332), or A4351 or A4352 with sterile lubricant (A4332), twice within the 12 months before starting kits.

Spinal cord injury sits inside criterion two, not beside it. The LCD lists it as one of the examples of immunosuppression, along with a post-transplant immunosuppressive regimen, cancer chemotherapy, AIDS and a drug-induced state such as chronic oral corticosteroid use, and it says the examples are not all-inclusive. What makes it operationally powerful is a sentence in the policy article rather than in the LCD: "For intermittent catheterization using a sterile intermittent catheter kit (A4297, A4353), documentation in the medical records of a diagnosis of spinal cord injury (SCI) is sufficient to establish the beneficiary is immunocompromised."

So a documented spinal cord injury diagnosis at any level satisfies criterion two, with no further evidence of immunocompromise and no recurrent infections, reflux or nursing-facility residence needed. It does not make spinal cord injury a criterion of its own, and the difference is not academic: two commenters asked the DME MACs to list it as a standalone clinical indication and they declined, recording the request as outside the scope of the reconsideration. The benefit-category requirements in the paragraph above still have to be met either way.

The recurrent-infection route carries a definition that is easy to miss. The LCD counts an infection only where there is a urine culture with greater than 10,000 colony forming units of a urinary pathogen together with at least one of a listed set of findings: fever, systemic leukocytosis, a change in urinary urgency, frequency or incontinence, new or increased autonomic dysreflexia, physical signs of prostatitis, epididymitis or orchitis, increased muscle spasms, or pyuria of greater than 5 white blood cells per high-powered field.

Coverage of a kit is per episode. One intermittent catheter with insertion supplies (A4297, A4353) is covered per episode of reasonable and necessary sterile intermittent catheterization.

One thing this page does not tell you. A52521 states that Final Rule 1713 requires a face-to-face encounter and a written order prior to delivery for specified HCPCS codes, and links to the list CMS and the DME MACs maintain. That list is a separate document and it has not been read here, so nothing is asserted either way about whether A4353 appears on it.

Standard Written Order

An order that named A4353 is the case the DME MACs answered first, and it is the branch that gets lost when the guidance is summarised. What they published, jointly and in July 2025, was an answer to two questions, and which answer applies depends on how the existing order was written.

A new order is required only where the existing order lists a HCPCS code, which is exactly the position of a supplier holding orders written to A4353 for a product now billed as A4297. The first answer, verbatim: "Yes. A new SWO is required, based on the New Order Requirements in the Standard Documentation Requirements for All Claims Submitted to DME MACs Policy Article (A55426). The new order can list the new HCPCS code A4295, A4296, or A4297, as appropriate, or the description can be a general description (e.g., hydrophilic catheter) or a brand name/model number."

No new order is required where the existing one describes the product. The second answer, verbatim: "No. Since the beneficiary's current SWO verbiage is descriptive of the new hydrophilic catheter HCPCS code(s), no new order is required. Suppliers must start utilizing the new HCPCS codes A4295, A4296, and A4297 when billing claims for dates of service on or after January 1, 2026."

The common claim that the code split obliged the whole industry to rewrite its catheter orders is not what the DME MACs published. Orders written descriptively were unaffected. Orders written to a code number were not. CGS restated the same answer in plain language in its own provider education material three months later: "The answer is no. Since the current SWO verbiage is descriptive of the new hydrophilic catheter HCPCS code(s), no new order is required."

None of this touches an order for a kit that continues to be billed as A4353. The publication is about moving to the new hydrophilic codes; it says nothing about re-ordering a product whose code has not changed. Separately and unchanged, the LCD's general rule still applies to every claim under this policy: an order must be communicated to the supplier before a claim is submitted, and billing without one is denied as not reasonable and necessary.

Beyond Medicare

One state schedule was read for this code, and it is the case where a state adopts Medicare rather than setting its own number. Montana Healthcare Programs' DME services fee schedule for January 2026 lists A4353 at $9.99 under its own pricing-method flag reading MEDICARE, which is the Medicare amount for Montana in the same period.

That is worth stating rather than assuming, because states do both. Montana reprints the Medicare amount and says so, in a column of its own giving the method. A state that sets its own fee instead produces a different number for the same code, and a supplier working across state lines cannot assume one fee, one quantity rule or one coverage test. This page does not generalise from one schedule, and no claim is made here about what any other state pays for A4353.

Quantity limits

Medicare baseline

From the July 2026 DMEPOS fee schedule, file DME26-C, effective July 1, 2026. These are the amounts CMS labels as used for pricing claims.

The file is keyed by state and not by DME MAC jurisdiction, and A4353 takes only five distinct values across the 53 jurisdictions it lists, which are the 50 states, the District of Columbia, Puerto Rico and the U.S. Virgin Islands. Alaska, Hawaii and Puerto Rico sit above the national ceiling, and that is not an error: CMS defines the ceiling and the floor as the maximum and minimum amounts for areas within the contiguous United States, so the non-contiguous jurisdictions are outside what those two fields bound.

No rural column is shown, and that is not an omission either. CMS states that codes not adjusted using competitive bidding information will only have fee schedule amounts in the non-rural columns, and A4353 is such a code: every one of its rural fields is zero. Printing a rural column would state a rate that does not exist.

The file also carries a national ceiling of $9.99 and a national floor of $8.49 for this code, and CMS marks both as amounts that are not used for pricing claims. For this payment class, which is ostomy, tracheostomy and urological supplies, they are calculated from the median and 85 percent of the median, respectively, of the local fee schedule amounts.

The finding worth leading with is what happens when you put A4353 beside A4297. The two records are identical across all 53 jurisdictions and in the ceiling and the floor as well, and they differ in only three fields: the code itself, the short descriptor, and the jurisdiction indicator. Medicare set the new hydrophilic kit code at this code's existing amounts, so from A4353's side the arithmetic is that the 2026 split changed nothing about what it pays. The same pattern holds for A4351 against A4295 and for A4352 against A4296.

That identity is also the answer to how a code with no utilization history gets priced, and it is worth knowing that the answer was not gap-filling. CMS added fee schedule amounts for A4295, A4296 and A4297 in the CY 2026 update after obtaining public consultation on the benefit category and payment determinations under 42 CFR 414.114 and 414.240, and the amounts it added were the ones A4353 already carried.

Related codes

Timeline

Open questions

• Whether the 200-unit ceiling can be exceeded with documentation. L33803 carries two sentences and does not reconcile them. Near the top of the section: "The medical necessity for use of a greater quantity of supplies than the amounts specified in the policy must be well documented in the beneficiary's medical record and must be available upon request." And for these two codes specifically: "Billing more than 200 units per month total for A4297 and A4353 will be denied as not reasonable and necessary." Both are quoted here rather than resolved, because nothing published resolves them.1
• What a hydrophilic kit billed under A4353 for a 2026 date of service actually does. The instruction is unambiguous and it lives outside both governing documents: the four DME MACs published jointly that "Suppliers must discontinue use of A4351, A4352, and A4353 and utilize the new HCPCS codes A4295, A4296, and A4297 on claims for hydrophilic catheters with dates of service on or after January 1, 2026." Neither L33803 v61 nor A52521 v55 restates it, neither attaches a denial to it, and A4353's own descriptor was not revised and carries no exclusion. So the rule a supplier must follow is clear while its published consequence is not, and this page does not invent one.714
• Whether A4353 is on the Required Face-to-Face Encounter and Written Order Prior to Delivery list. Policy Article A52521 states that Final Rule 1713 requires a face-to-face encounter and a written order prior to delivery for specified HCPCS codes, and links to the list that CMS and the DME MACs maintain and periodically update. That list is a separate document, it was not read for this page, and so no face-to-face or written-order-prior-to-delivery requirement is asserted for A4353 in either direction.4