A4297

At a glance

What changed on January 1, 2026

Before 2026 the code set could not see a hydrophilic coating. A hydrophilic intermittent catheter kit and a plain one both billed as A4353, and the same was true of single catheters under A4351 and A4352, despite a real difference in manufacturing cost and clinical positioning.

Effective for dates of service on or after January 1, 2026, CMS created three codes for hydrophilic intermittent urinary catheters. A4295 is the straight tip, A4296 the coude (curved) tip, and A4297 the hydrophilic catheter supplied with insertion supplies.

CMS struck the word hydrophilic out of two existing descriptors on the same day, and says so itself: "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 The Jurisdiction C supplier manual prints the superseded and the revised wording together, the revised one marked Revised 01/01/2026.

A4353 is not on that list, and this is the part most summaries get wrong. Its descriptor did not change. It still reads "Intermittent urinary catheter, with insertion supplies", it carries no exclusionary wording of any kind, and neither the LCD nor the policy article contains a sentence sending hydrophilic kits away from it. A4353 remains active and is named throughout both current documents.

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."

The operational consequence. A hydrophilic kit submitted under A4353 for a 2026 date of service is billed against an instruction that says to use A4297, even though A4353's own descriptor would still admit it.

What counts as hydrophilic

PDAC states the test as a property of the product: "A hydrophilic catheter self-lubricates when activated with water or 0.9% sterile saline without the use of a separate lubricating gel."

Policy Article A52521 words the same idea as a clinical function, and it is worth noticing which codes its sentence names: "An intermittent catheter with hydrophilic coating (A4295, A4296) is a single use catheter with a hydrophilic coating that, with the addition of water or 0.9% sterile saline, allows for smooth insertion and removal of the catheter without the use of a separate lubricating gel." The article carries no separate definition of what makes an A4297 kit hydrophilic.

Either way it is a property test and not a marketing one. A catheter sold as pre-lubricated that still needs a separate gel is not hydrophilic for coding purposes. The LCD reflects the same distinction in what it pays for alongside the catheter: an episode using A4351 or A4352 covers an individual packet of lubricant (A4332), and an episode using A4295 or A4296 does not.

The same discipline applies to tip geometry, and it is worth stating because naming in this category has misled coders before. A coude code, A4296 for hydrophilic products and A4352 otherwise, requires a fixed, permanently curved tip. A DME MAC joint publication put the test plainly: "A coude catheter has a fixed, curved tip that allows it to more easily be moved through a tortuous urethra."

A product name is not a coding determination. The DME MACs have previously held that a catheter whose own name contained the word coude was in fact a straight catheter, and PDAC has since moved that product line to a different code again, which is precisely why the durable rule is to look the specific model up rather than read the label. Article A55426 says why the register settles it: "For Medicare claim purposes, this product classification listing is accepted as evidence of correct coding." Search a model on PDAC's DMECS Product Classification List

What PDAC asks for is a manufacturer requirement rather than a supplier one, and the two are easy to run together. Its coding guidelines set exactly two requirements for a code verification review. The application must identify the method by which the intrinsic hydrophilic properties of the catheter are achieved, so that its surface binds water into a uniform lubricious layer and the lubricity is restored by immersing the device in water. And the applicant must provide a sample of the item, including instructions for its preparation and use.

What A4297 covers

Policy Article A52521 is the definitive answer to what an A4297 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. A4297 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: except in the second configuration above, where the catheter comes alongside a separately packaged sterile kit, A4297 must not be billed if individual insertion kit components are provided as separate items.

A hydrophilic catheter supplied without insertion supplies is not an A4297. By their descriptors, A4295 and A4296 are the single hydrophilic catheters, straight tip and coude tip respectively, and A4297 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 A4297 appears on it.

Standard Written Order

This is where the published guidance was most widely oversimplified. What the DME MACs actually issued, 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. 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."

A point of precision that gets lost in the other direction. The phrase about a brand name or model number appears only in the first answer, where it describes what the replacement order may contain. The publication never addresses an existing order that was itself written to a brand name and model number. That case arguably falls under the second answer's stated reasoning, but arguably is not a holding, and this page does not attribute it to the source.

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." Separately and unchanged, the LCD's general rule still applies: 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

Medicare is the benchmark, not the whole picture, and the states diverge from it in both directions.

New York sets its own fee. Its Medical Supplies Procedure Codes and Coverage Guidelines manual, effective July 1, 2026, lists A4297 at $5.68. Medicare's allowable in New York for the same quarter is $9.97. That is the comparison worth making, the same code in the same state in the same quarter, rather than a state figure held up against the national Medicare ceiling.

The quantity rule needs its own citation and its own date. New York's provider communication of December 30, 2025 gives A4297 a maximum of 90 units per month. The state's July 2026 manual states a different and broader rule: "A total quantity of up to 200 intermittent catheters, in combination, per 30 days is allowed; claims for any combination of total intermittent urinary catheters and intermittent urinary catheters with supplies greater than 200 will be denied." The two are not necessarily in conflict, the first reading as a per-code cap and the second as a combined one, and this page does not reconcile them.

New York words the coverage test differently as well. It covers the kit codes where the member requires intermittent catheterization outside the home setting, such as at work or school, or has documented recurrent urinary tract infections while using the non-kit codes, and it requires prior approval for any other medical reason. Medicare's four criteria appear nowhere in it.

Montana takes the opposite route. Its January 2026 DME fee schedule lists A4297 at $9.99 under its own pricing-method flag reading MEDICARE, which is the Medicare amount for Montana. Between those two states, a supplier working across state lines cannot assume one fee, one quantity rule or one coverage test.

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 A4297 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 A4297 is such a code: every one of its rural fields is zero. Printing a rural column would state a rate that does not exist. Consistently with that, none of these codes appears in any of the three former competitive bidding area files shipped in the same quarterly release.

The file also carries a national ceiling and a national floor for this code, and CMS marks both as amounts that are not used for pricing claims, so neither is shown here. 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 A4297 beside A4353. The two records are identical across all 53 jurisdictions and in the ceiling and the floor as well; they differ only in the code itself, the jurisdiction indicator and the short descriptor. Medicare set the new hydrophilic kit code at the existing kit code's amounts, so the coating carries no incremental Medicare payment. The same pattern holds for A4295 against A4351 and for A4296 against A4352.

That is also the answer to how a code with no utilization history gets priced. Not through competitive bidding, and not by 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.

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
• Whether A4297 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 A4297 in either direction.4
• Which of the new codes becomes the competitive bidding lead item. This is often reported as an open question and it is not one: CBIC published CMS's answer beside it. CMS said it would announce the lead items for the DMEPOS competitive bidding product categories in late spring or early summer of 2026, and that for the Hydrophilic Urinary Catheters product category, which is distinct from Urological Supplies, it would use the latest data available at that time, including partial 2026 claims data for A4295, A4296 and A4297. That page was last updated on April 2, 2026 and the window it describes has closed. What is open is the content of the announcement. This page has not established whether lead items have since been published, and it does not claim they have not been. Check CBIC before relying on the answer above.7