The Centers for Medicare & Medicaid Services (CMS) has updated its coverage criteria for closed system intermittent catheters (A4353) for those regions covered by CGS and Noridian. Currently, A4353 is a covered benefit when a beneficiary requires catheterization and meets one of five criteria to qualify for a closed system catheter.

These five criteria are:

1. The beneficiary resides in a nursing facility,

2. The beneficiary is immunosuppressed,

3. The beneficiary has radiologically documented vesico-ureteral reflux while on a program of intermittent catheterization,

4. The beneficiary is a spinal cord injured female with neurogenic bladder who is pregnant (for duration of pregnancy only),

5. The beneficiary has had distinct, recurrent urinary tract infections, while on a program of sterile intermittent catheterization with A4351/A4352 and sterile lubricant A4332, twice within the 12-month prior to the initiation of sterile intermittent catheter kits.


This new policy update provides clarity around those beneficiaries with spinal cord injuries. For criteria #2 Immunosuppression, the local coverage determination (LCD) lists examples of conditions that commonly cause immunosuppression but states that it is not an all-inclusive list. The LCD now provides that immunosuppressed conditions include (but are not limited to) beneficiaries who are:

  • On a regimen of immunosuppressive drugs post-transplant.
  • On cancer chemotherapy.
  • Has AIDS.
  • Has a drug-induced state such as chronic oral corticosteroid use.High-level spinal cord injury patients (T3 and higher) will be considered for coverage when conducting medical reviews


Please note that the above list indicates that it is not an all-inclusive list. For all conditions, the practitioner is required to clearly document the condition causing the immunosuppression within the beneficiary’s medical records to qualify for criteria 2. These practitioner records must meet the medical necessity based on the coverage criteria listed within the Local Coverage Determination (LCD) L33803.


Additional information regarding both coverage determinations can be found: