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Reimbursement > Continence Care

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.

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

Medicare coverage for intermittent catheters2, 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 (at least 3 months)
  • Medicare covers three types of intermittent catheters.

A4351

 

A4352

 

A4353

 

 


Intermittent urinary catheter; straight tip, with or without coating (Teflon™, silicone, silicone elastomer, or hydrophilic, etc.), each

 


Intermittent urinary catheter; coude (curved) tip, with or without coating (Telfon™, silicone, slicone elastomeric, or hydrophilic, etc.), each

 

 


Intermittent urinary catheter, with insertions supplies

Quantity per month: 200   Quantity per month: 200  

Quantity per month: 200

       

 

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:

  1. A single sterile package containing both an intermittent urinary catheter and all necessary insertion/collection supplies;
  2. A sterile intermittent urinary catheter plus a separately-packaged sterile kit containing all necessary insertion/collection supplies;
  3. 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.

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Medicare documentation required by IC type2, 3, 4*

General Medicare documentation list

Prescription:

  • Patients’ information (name, date of birth)
  • Type of IC prescribed (HCPCS code, description of IC type: straight, coude, closed)
  • Catheterization frequency per day and 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 (not expected to be medically or surgically corrected within 3 months)
  • Primary diagnosis to support medical necessity for an intermittent catheter
  • Must match the prescription (frequency of IC, quantity of IC, type of IC, length of need)

* Might be requested by the DME supplier to have on file (12 months prior to IC) to show continued need/use if applicable

Medicare documentation required by intermittent catheter type*

A4351

Straight Tip, with or without coating Required documentation
  • Everything in the general Medicare documentation list
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A4352

Coude Tip, with or without coating Required documentation
  • 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
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A4353

Closed System or sterile kit Required documentation
  • Everything in the general Medicare documentation list
  • Patient meets one of 5 criteria:
    1. Patient resides in a nursing facility
    2. Patient is immunosuppressed
    3. Patient has documented vesico-ureteral reflux
    4. Patient is a spinal cord injured female with neurogenic bladder who is pregnant
    5. Patient has had 2 documented urinary tract infections(UTI) while on a straight or coude tip IC within 12 months

Required documentation for UTIs:

  1. Urine culture showing greater than 10,000 bacteria for each UTI
  2. 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)
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Medicare Administrative Contractor council clarification for immunosuppression criteria for a closed catheter system (A4353)

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*

   D84.81

Immunodeficiency due to conditions classified elsewhere (e.g. diabetes)

   D84.821

Immunodeficiency due to current or past medication (e.g. immunosuppressant)

   D84.822

Immunodeficiency due to external causes (e.g., SCI)

  • 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

*Reimbursement Disclaimer: Coloplast Corp. provides this information for convenience and your general reference only. It does not constitute legal advice or a recommendation regarding clinical practice. Reimbursement, coverage and payment policies can vary from one insurer and region to another and is subject to change without notice. The provider has the responsibility to determine medical necessity and to submit appropriate codes and charges for care provided. Coloplast does not guarantee coverage or payment of products and Coloplast makes no guarantee that the use of this information will prevent differences of opinion or disputes with Medicare, insurers, or other payers as to the correct form of billing or the amount that will be paid. This information is provided for your general information only and is not intended to replace any advice you receive from your own internal or external insurance coverage consultants, reimbursement specialists or legal counsel.

  1. https://www.cms.gov/Medicare/Medicare-General-Information/MedicareGenInfo
  2. LCD - Urological Supplies (L33803). www.cms.gov. Accessed March 8, 2022. https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33803&ContrID=140
  3. Article - Urological Supplies - Policy Article (A52521). www.cms.gov. Accessed March 8, 2022. https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52521&ver=33
  4. https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=55426&ver=91

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