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The complex and ever-changing healthcare landscape can lead to questions around reimbursement and coverage of intermittent catheters (IC). This page is a resource to better understand reimbursement and coverage for IC, including recent coding changes that may affect how these products are billed and reimbursed. Staying informed can be crucial for ensuring proper coverage and avoiding potential issues with claims.
For any questions, please reach out to our Reimbursement and Market Access team at USreimbursement@coloplast.com
NEW:
Upcoming CMS HCPCS Code Changes for Intermittent Catheters
Stay informed about the latest CMS updates: Three new HCPCS codes will soon be introduced to distinguish hydrophilic coating technology within the intermittent catheter category.
Key details begin on page 5 of the official CMS document.
Register Now: July 15th Webinar with AcuServe
Webinar Topic: Preparing for Upcoming Intermittent Catheter HCPCS Code Changes
Join Noel Neil, VP of Auditing and Corporate Compliance at AcuServe, and Anna Markiewicz, Sr. Manager of Payor Relations at Coloplast, as they break down the new coding structure and what it means for your business.
Date: July 15, 2025 at 12pm EST
Speakers: Noel Neil & Anna Markiewicz
Hosted by: Coloplast & AcuServe
Medicare program outline1
Medicare is a federal insurance program that covers individuals who are 65 years of age or older, people under age 65 with certain disabilities and people of all ages with end-stage renal disease (permanent kidney failure requiring dialysis or a kidney transplant).
Medicare is an 80/20 plan, meaning Medicare covers 80% and the remaining 20% is the beneficiaries responsibility.
For any item to be covered by Medicare, it must:
- Be eligible for a defined Medicare benefit category,
- Be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and
- Meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act §1862(a)(1)(A) provisions (i.e. “reasonable and necessary”).
Part A - Hospital Insurance
- Hospital Stays
- SNF
- Hospice
- Some Home Health
Part B - Medical Insurance
- Outpatient care
- Physical & Occupational Therapy
- DME (medical supplies included)
- Some Home Health
Part C - Medicare Advantage
- Commercial Insurances offer Medicare Benefits
Part D - Prescription Drug Coverage
- Beneficiary pays a monthly premium
New HCPCS Codes for Intermittent Catheters
Background:
On August 16, 2024, the Centers for Medicare & Medicaid Services (CMS) announced changes to the HCPCS code set for intermittent catheters. This includes the modification of two existing codes and the creation of three new codes to specifically identify products with hydrophilic coating technology. These changes acknowledge the clinical value of hydrophilic coatings and are intended to improve patient access and encourage continued innovation in urological care.
To support the successful adoption of new and revised HCPCS codes related to intermittent catheters, we encourage taking the following steps:
- Familiarize yourselves with the new HCPCS codes and updated code descriptions related to hydrophilic catheter technology: A4295, A4296, and A4297.
- Coordinate with your billing and coding teams to ensure accurate documentation and coding practices that reflect these updates.
- Advocate for appropriate reimbursement by working with your payer contacts to ensure coverage supports patient access to hydrophilic-coated catheter products.
The Pricing, Data Analysis and Coding (PDAC) contractor created a Hydrophilic Intermittent Urinary Catheter Crosswalk PDAC - Hydrophilic Intermittent Urinary Catheter Crosswalk
Additional information and resources on the New HCPCS Codes for Intermittent Catheters can be found on the American Association for Homecare website
The following chart compares the current and new HCPCS codes:
Coloplast is having a webinar on July 15th for further details and education on the new codes.
Register Now: July 15th Webinar with AcuServe
Webinar Topic: Preparing for Upcoming Intermittent Catheter HCPCS Code Changes
Join Noel Neil, VP of Auditing and Corporate Compliance at AcuServe, and Anna Markiewicz, Sr. Manager of Payor Relations at Coloplast, as they break down the new coding structure and what it means for your business.
Date: July 15, 2025 at 12pm EST
Speakers: Noel Neil & Anna Markiewicz
Hosted by: Coloplast & AcuServe
Medicare coverage for intermittent catheters 2,3
- Intermittent catheters (IC) are covered for Medicare beneficiaries who have a permanent impairment of urination. This is generally defined as a condition of long and indefinite duration.
- Medicare covers three types of intermittent catheters.
What products are considered A4353?
A4353 is a kit, which includes a catheter and all supplies necessary for a single, sterile insertion (see below). Code A4353 may be used if any of the following 1, 2 or 3 is supplied:
- A single sterile package containing both an intermittent urinary catheter and all necessary insertion/collection supplies;
- A sterile intermittent urinary catheter plus a separately-packaged sterile kit containing all necessary insertion/collection supplies;
- A sterile "no-touch" type of catheter system
The product described in #3 is a single-catheter system that is functionally equivalent to a complete sterile insertion kit (A4353) containing a catheter and the additional components as described in the previous paragraph. In order to be coded as A4353, a "no-touch" type of catheter system must be a sterile, all-inclusive, self-contained system capable of accomplishing intermittent catheterization with sterile technique without the use of additional supplies such as gloves, lubricant, collection chamber, etc.
- Exact quantity of IC per month is determined by the clinician based on what is reasonable & necessary for each patient individual need
- Click here for the most up-to-date Urological Medicare Policy and Urological Medicare Article
Medicare documentation for intermittent catheters 2,3,4
General Medicare documentation list
Prescription:
- Patients’ information (name, date of birth)
- Type of IC prescribed (general description, a HCPCS code, a HCPCS code narrative, or a brand name/model number)
- Quantity of IC (specific number)
- Prescribing clinicians’ signature
- Clinician name or National Provider Identifier (NPI)
- Order date
Medical Record: *
- Documentation of permanent urinary incontinence or permanent urinary retention.
- Medical justification for a type of intermittent catheter that is being prescribed
- Must match the prescription (frequency of IC, quantity of IC, type of IC, length of need)
Click here for the intermittent catheters documentation checklist (DME MAC Jurisdictions B & C)
Medicare documentation required by intermittent catheter type*
A4351 - Straight Tip, with or without coating
- Everything in the general Medicare documentation list
A4352 - Coude Tip, with or without coating
- Everything in the general Medicare documentation list
- Documentation indicating that patient has tried and is unable to pass a straight tip catheter
- Documented medical need for a coude catheter
Use of a coude tip catheter in female patients is rarely reasonable and necessary
A4353 - Closed System or sterile kit
- Everything in the general Medicare documentation list
- Patient meets one of 5 criteria:
- Patient resides in a nursing facility
- Patient is immunosuppressed
- Patient has documented vesico-ureteral reflux
- Patient is a spinal cord injured female with neurogenic bladder who is pregnant
- Patient has had 2 documented urinary tract infections(UTI) while on a straight or coude tip IC within 12 months
Required documentation for UTIs:
- Urine culture showing greater than 10,000 bacteria for each UTI
- One additional symptom:
- Fever
- Systemic leukocytosis
- Change in urinary urgency, frequency, or incontinence
- Appearance of new or increase in autonomic dysreflexia (sweating, bradycardia, blood pressure elevation)
- Physical signs of prostatitis, epididymitis, orchitis
- Increased muscle spasms
- Pyuria (greater than 5 white blood cells [WBCs] per high-powered field)
Closed system (A4353): criteria information
1. Noridian article on coverage criteria for intermittent urinary catheters A4353 - Immunosuppressed Beneficiaries Meeting Criteria 2.
On November 1st, 2023, Noridian published an article further clarifying coverage criteria for intermittent catheters A4353 and beneficiaries meeting the immunosuppressed criteria in the Urological Supplies LCD (L33803).
Click here for the full article
2. CGS Urological Supplies Webinar
On the CGS webinar landing page, click on the Urological Supplies October 4, 2023 Webinar (minute marker 18:37). Alongside the recording, a link to the transcript is also available as a PDF.
Click here to view the webinar
3. Webinar
A joint webinar with AcuServe on qualification requirements for closed-system catheters. This webinar brings awareness to all five qualification requirements for closed-system intermittent catheters (A4353). Furthermore, it emphasizes the importance of medical documentation and discusses established appeal and audit strategies.
Click here to view the webinar
4. Medicare Administrative Contractor council clarification for immunosuppression criteria for A4353 (closed system)
Upon release of new ICD-10 immunodeficiency diagnosis codes in October 2020, a literature search was conducted to examine the link between immunodeficiency and high-level spinal cord injuries. The compiled evidence was sent to the DME MAC Council for consideration in April of 2021 with the question outlined below. In October 2021, the DME MAC council provided the clarification that identified additional diagnosis codes for individuals with spinal cord injuries who may qualify for A4353 under the immunosuppressed criteria within the Medicare Urological Policy.
Discussion with Medicare Jurisdiction B&C DME MAC:
Coloplast asked: "Does the A4353 immunosuppressed policy criteria apply to patients who are immunosuppressed due to external factors, specifically high-level spinal cord injuries?"
MAC Response: "The DME MACs have received and reviewed the reference list and literature demonstrates that high-level spinal cord injury patients experience increased infections, such as pneumonia, at a higher rate relative to mid (T4-T8), and lower level thoracic injury (T9-T12). The list of examples in the Urological Supplies LCD (L33803) describe scenarios that could result in immunosuppression and is not all-inclusive but rather represents common conditions likely to result in immunosuppression. The example of high-level spinal cord injury patients (higher than T3) will be considered for coverage when conducting medical reviews of Intermittent catheterization using a sterile intermittent catheter kit (A4353)."
New immunodeficiency ICD-10 codes added October 1, 2020*
- 3 new ICD-10 diagnosis codes were created to increase the level of specificity for reporting of patients with immunodeficiency related conditions. The use of these new diagnosis codes alone does not satisfy the Medicare medical necessity requirement for A4353.
- The medical record must reflect all relevant information to support the claim for A4353. The diagnosis must be well documented in the medical record with other supporting documentation that clearly meets the coverage criteria (1-5) under the Urological Medicare Policy.
- Click here for a printable resource of the DME MAC clarification for immunosuppression and A4353
Medicare resources
- Medicare Urological Supplies Policy LCD - Urological Supplies (L33803) (cms.gov)
- Medicare Urological Supplies Article Article - Urological Supplies - Policy Article (A52521) (cms.gov)
- 2023 Medicare DME fee schedule DMEPOS Fee Schedule | CMS
- Documentation checklist for intermittent catheters Urological Supplies: Intermittent Catheters Documentation Checklist (DME MAC Jurisdictions B & C) (cgsmedicare.com)
- Noridian clarification for A4353 under the immunosuppression criteria
