Urological Supplies - JA DME

For all DMEPOS items, the initial justification for medical need is established at the time the item(s) is first ordered, therefore, beneficiary medical records demonstrating that the item is reasonable and necessary are created just prior to, or at the time of, the creation of the initial prescription. Once initial medical need is established, ongoing need for urological supplies is assumed to be met. There is no requirement for further documentation of continued medical need if the beneficiary continues to meet the Prosthetic Devices benefit.

Continued Medical Need information can be found in the Urological Supplies (L33803).

Immunosuppressed criteria for the A4353 (intermittent urinary catheter, with insertion supplies) are covered when a beneficiary requires catheterization and the beneficiary is immunosuppressed, for example below (not an all-inclusive list).

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

Note: 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 Urological Supplies (L33803).

Suppliers must obtain documentation supporting the claim that the beneficiary has been using the A4353 prior to becoming Medicare eligible. The beneficiary would not have to go back and retrial the other catheters.

Noridian understands that beneficiaries entering Medicare who are currently on sterile intermittent catheters (A4353) must continue to utilize these catheters. Medicare will not require beneficiaries entering Medicare to go back and trial the A4351 or A4352 and wait for two urinary tract infections (UTIs) within 12 months.

Documentation needed to continue the A4353 would need to be submitted if a claim denial occurs. A redetermination may need to be submitted. Supporting medical records documenting the previous UTIs would be the best documentation to support the use of A4353. If this documentation is not available, provide the most current medical necessity documentation to support the medical need of A4353. As a reminder, Medicare will not request medical records that are more than 7 years. More information on Beneficiaries Entering Medicare can be found on our website.

In 2020, PureWick Urine Collection System™ manufactured by Becton-Dickinson (BD) was assigned a new Healthcare Common Procedure Coding System code (HCPCS), K1006, effective October 1, 2020 through December 31, 2023. For dates of service (DOS) on or after January 1, 2024, the Centers for Medicare & Medicaid Services (CMS) crosswalked coding of the product from K1006 to a new HCPCS code, E2001.

Please view the Joint DME MAC Publication for coding and billing instructions