01-130 Urinary Catheters Findings of Medical Review
Noridian Healthcare Solutions, LLC, (Noridian), as the Supplemental Medical Review Contractor (SMRC) for the Centers for Medicare and Medicaid (CMS), has conducted post-payment review of Medicare DME intermittent urinary catheter claims billed with dates of service from January 1, 2022, through November 30, 2024. Below are the review results:
| Project ID | Project Title | Error Rate for Reviewed Claims | No Response to ADR Denials |
|---|---|---|---|
| 01-130 | Urinary Catheters | 28% | 22% |
Background
A urinary catheter allows urine to pass through tubing by inserting a catheter tip into the urethra and past the sphincter into the bladder to allow urine to drain. Urinary catheters that remain in the bladder are referred to as indwelling catheters and require a drainage bag to be worn by the beneficiary. Intermittent urinary catheters are removed when the bladder has emptied and does not require a drainage bag to be worn. With each intermittent catheterization, a new sterile catheter is used with sterile preparation every time the bladder needs to be drained.
Intermittent urinary catheterization is used by beneficiaries with difficulties in releasing urine naturally and who need catheter-based management of the urinary bladder due to conditions that prevent complete bladder emptying. Intermittent catheterization aids in emptying the bladder of urine and be performed by either the beneficiary or caregiver in the home environment.
Conditions requiring this procedure include but are not limited to neurogenic bladder disorders like spinal cord injury, spina bifida, or multiple sclerosis. There are also non-neurogenic bladder disorders like obstruction due to prostate enlargement, urethral strictures, or post-operative urinary retention. Medicare provides reimbursement for urinary catheters under the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) benefit.
On February 9, 2024, the Washington Post published an article titled, “U.S. investigates alleged Medicare fraud scheme estimated at $2 billion 
,” which alerted readers of an investigation surrounding the utilization of intermittent catheters that resulted from beneficiary complaints suggesting potential fraud. As a result of the investigation, seven suppliers were identified in a scheme to bill claims for Medicare beneficiaries who either did not need the catheters or did not receive them.
In May 2024, Noridian Healthcare Solutions, LLC (Noridian) as the Supplemental Medical Review Contractor (SMRC), completed research on Healthcare Common Procedure Coding System (HCPCS) codes A4351(Intermittent urinary catheter, straight tip), A4352 (Intermittent urinary catheter, coude tip), and A4353 (Intermittent urinary catheter, with insertion supplies) and noted an increase in claim volume.
Reason for Review
The SMRC was tasked to perform data analysis and conduct medical record review on claims billed with intermittent urinary catheter HCPCS codes A4351, A4352, and A4353 billed with dates of service January 1, 2022, through November 30, 2024.
The SMRC conducted medical record reviews in accordance with applicable waivers, flexibilities, statutory, regulatory, and sub-regulatory guidance.
Common Reasons for Denial
- Non-Response to the Additional Documentation Request (ADR)
- Refer to Social Security Act (SSA) Title XVIII, Section 1815(a), 1833(e), & 1862(a)(1)(A). No documentation was received in response to the additional documentation request (ADR) letter.
- Missing Refill Request
- Refer to 42 Code of Federal Regulations (CFR) 410.38, Medicare Program Integrity Manual (MPIM), Publication 100-08, Chapter 5, Section 5.2.6. & Standard Documentation Requirements A55426. There is no documentation of beneficiary contact and beneficiary affirmation that the refill is needed. The documentation submitted did not include a refill request and/or was missing confirmation the beneficiary needed supplies.
- Documentation Did Not Support Medical Necessity
- Refer to Social Security Act (SSA) 1862, Internet-Only Manual, Publication 100-08, Medicare Program Integrity Manual (MPIM), Chapter 3, Section 3.6.2.2. The documentation submitted does not support medical necessity as listed in coverage requirements in the National Coverage Determination or Local Coverage Determination. The documentation submitted did not support permanent urinary impairment of urination and/or recurrent urinary tract infections to support medical necessity.
References
Social Security Act (SSA) Title XI
- §1135 Authority to waive requirements during national emergencies
Social Security Act (SSA), Title XVIII
- §1815(a) Payment to Providers of Services
- §1833(e) Payment of Benefits
- §1834(a) Payment for Durable Medical Equipment
- §1861(n) Durable Medical Equipment Definition
- §1862(a)(1)(A) Exclusion from Coverage and Medicare as a Secondary Payer
- §1877(g) Limitation on Certain Physician Referrals
- §1879(a)(1) Limitation on Liability of Beneficiary where Medicare Claims are Disallowed
- §1893(b) Medicare Integrity Program
42 Code of Federal Regulations (CFR)
- §411.15(k)(1) Particular Services Excluded from Coverage
- §424.5(a)(6) Basic Conditions
- §424.57(c)(12.) Special Payment Rules for Items Furnished by DMEPOS Suppliers and Issuance of DMEPOS Supplier Billing Privileges
Internet Only Manual (IOM), Medicare Benefit Policy Manual (MBPM), Publication (Pub.) 100-02
- Ch. 15, §110.1. A Definition of Durable Medical Equipment
- Ch. 15, §120 Prosthetic Devices
- Ch. 16 General Exclusion from Coverage
IOM, Medicare Claims Processing Manual (MCPM), Pub. 100-04
- Ch. 1 General Billing Requirements
- Ch. 20 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS)
- Ch. 23 §20.9 National Correct Coding Initiative (NCCI)
- Ch. 30, §50 Advance Beneficiary Notice of Non-coverage (ABN)
IOM, Medicare Program Integrity Manual (MPIM), Pub. 100-08
- Ch. 3 Verifying Potential Errors and Taking Corrective Actions
- Ch. 4, §4.7.3.1 Supplier Proof of Delivery Documentation Requirements
- Ch. 5 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items and Services Having Special DME Review Considerations
- Ch. 13, §13.5.4 Reasonable and Necessary Provisions in LCDs
Local Coverage Determination (LCD)
- L33803 Urological Supplies. Effective October 1, 2015
Local Coverage Article (LCA)
- A52521 Urological Supplies – Policy Article. Effective October 1, 2015
- A55426 Standard Documentation Requirements for All Claims Submitted to DME MACs. Effective January 1, 2017
Other
- Centers for Medicare and Medicaid Services CMS. Durable Medical Equipment, Prosthetics, Orthotics and Supplies: CMS Flexibilities to Fight COVID-19. May 10, 2023. Retrieved from Durable Medical Equipment, Prosthetics, Orthotics and Supplies: CMS Flexibilities to Fight COVID-19
- Comprehensive Error Rate Testing CERT. 2022 Medicare Fee-for-Service Supplemental Improper Payment Data. December 8, 2022. Retrieved from 2022 Medicare Fee-for-Service Supplemental Improper Payment Data | CMS
- CERT. 2023 Medicare Fee-for-Service Supplemental Improper Payment Data. December 7, 2023. Retrieved from 2023 Medicare Fee-for-Service Supplemental Improper Payment Data | CMS
Last Updated Dec 4, 2025