Noridian Healthcare Solutions, LLC (Noridian), as the Supplemental Medical Review Contractor (SMRC) for the Centers for Medicare and Medicaid (CMS), is conducting post-payment review of Medicare DME intermittent urinary catheter claims billed with dates of service from January 1, 2022, through December 31, 2023. This notification includes the reasons for the review, documentation that will be requested in the Additional Documentation Request (ADR) letter, and resources providers/suppliers may wish to consult when submitting claims.

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.

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 is 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 December 31, 2023.

The SMRC will conduct medical record reviews in accordance with applicable waivers/flexibilities/statutory, regulatory, and sub-regulatory guidance.

Claim Sample Detail

Access related project details below.

• Documentation Requirements
• References

Documentation Requirements

Below is a list of specific documentation requirements that will be included in each ADR to obtain the necessary documentation to perform the review.

Providers/suppliers are requested to submit each of the Documentation Requirements outlined below, if and as applicable to the claim on review.

1. Standard Written Order (SWO)
2. Documentation to support national and local coverage requirements
3. Medical record documentation, including treatment plan, by the prescribing/ordering provider to support the item(s) provided and quantity of item(s) provided is/are reasonable and necessary
4. Medical record documentation to support permanent impairment of urination
5. Medical record documentation to support the intermittent catheterization can be performed by the beneficiary and/or caregiver
6. Diagnostic tests, lab results, pathology reports, and other pertinent test results and interpretations
7. For intermittent catheterization using a sterile intermittent catheter kit (HCPCS code A4353), medical record documentation to support the beneficiary meets one of the following five criteria:
   • Resides in a nursing home; or
   • Is immunosuppressed; or
   • Has radiologically documented vesico-ureteral reflux while on a program of intermittent catheterization; or
   • Is a spinal cord injured female with neurogenic bladder who is pregnant; or
   • Has had distinct, recurrent urinary tract infections, while on a program of intermittent catheterization, twice within the 12-months prior to the initiation of sterile intermittent catheter kits.
8. Documentation to support continued medical need
9. Documentation of the request for refill
10. Proof of Delivery
11. Signature log or signature attestation for any missing or illegible signatures within the medical record (all personnel providing services)
12. Advance Beneficiary Notice of Non-Coverage (ABN)/Notice of Medicare Non-Coverage (NOMNC)
13. Any other supporting/pertinent documentation
14. If medical record documentation is submitted via esMD: Beneficiary identification, date of service, and provider of the service should be clearly identified on each page of the submitted documentation
15. PLEASE NOTE: The supplier or provider is responsible for obtaining all documentation from the ordering/referring provider to ensure medical necessity criteria have been met.

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
• The Washington Post. U.S. investigates alleged Medicare fraud scheme estimated at $2 billion. February 9, 2024. Retrieved from U.S. investigates alleged Medicare fraud scheme estimated at $2 billion – The Washington Post

Last Updated Oct 24, 2024