Article Detail - JA DME

An inFlow device (Intraurethral Valve-Pump and Activator) (HCPCS Code A4335) is a urinary catheter used as an alternative to clean intermittent catheterization (CIC) in patients with impaired detrusor contractility (IDC). The inFlow device consists of a silicone tube containing a miniature valve and pump and a separate remote control "activator" wand. The tube is inserted with a disposable introducer and remains inside the urethra for about a month. To empty the bladder, the patient sits on the toilet, holds the remote-control wand over the lower pelvic area, and presses a button that magnetically activates a small valve pump in the inserted urethral tube. Once the pump is activated, the bladder drains at a normal rate. Once the button is released, a valve closes, and urine flow stops. The inFlow device is sized for the urethra and initially inserted by a treating practitioner. Normally, the user or caregiver can replace the inFlow device, as insertion is like a urinary catheter.

Initial Coverage

The inFlow device is considered reasonable and necessary as an alternative to intermittent catheterization for beneficiaries with permanent urinary retention (PUR) due to IDC.

One (1) inFlow device will be covered no more than once every 29 days. Claims for the inFlow device billed more than once every 29 days will be denied as not reasonable and necessary.

Continued coverage (beyond the first three months of therapy)

For continued coverage of the inFlow device lasting longer than three months, the treating practitioner must conduct a clinical re-evaluation and document that the beneficiary continues to use and is benefiting from the device. This clinical re-evaluation must be done no sooner than the 31st day but no later than the 91st day after initiating therapy.

Documentation of use and clinical benefit is demonstrated by:

1. An in-person encounter by the treating practitioner showing that urinary symptoms are improved; and,
2. The treating practitioner must verify the beneficiary’s adherence to the use of the inFlow device.

If the above criteria are not met, continued coverage of the inFlow device and related accessories will be denied as not reasonable and necessary.

If the practitioner's re-evaluation does not occur until after the 91st day but the evaluation demonstrates that the beneficiary is benefiting from the inFlow device as defined in criteria 1 and 2 above, continued coverage of the inFlow device will commence with the date of that re-evaluation.

If there is a discontinuation of usage of the inFlow device at any time, the supplier is expected to stop billing for the equipment and related accessories and supplies.

Please refer to the Urological Supplies Local Coverage Determination and related Policy Article for additional information on coverage, coding, and documentation.

For questions about correct coding, contact the Pricing, Data Analysis, and Coding (PDAC) contractor contact center.