Key facts for NCD 230.10
- Benefit category
- Prosthetic Devices
- Effective date
- 10/07/1996
- Transmittal
- Transmittal 89
- Versions published
- 1
- Manual chapter
- 230
- NCD Manual (Pub. 100-03)
TL;DR
NCD 230.10 sets Medicare's national policy for incontinence control devices under the benefit category "Prosthetic Devices", effective 10/07/1996. Mechanical/hydraulic incontinence control devices are accepted as safe and effective in the management of urinary incontinence in patients with permanent anatomic and neurologic dysfunctions of the bladder. This class of devices achieves control of urination… It has been revised once since publication and binds every Medicare Administrative Contractor nationally.
Indications and limitations of coverage
A. Mechanical/Hydraulic Incontinence Control Devices
Mechanical/hydraulic incontinence control devices are accepted as safe and effective in the management of urinary incontinence in patients with permanent anatomic and neurologic dysfunctions of the bladder. This class of devices achieves control of urination by compression of the urethra. The materials used and the success rate may vary somewhat from device to device. Such a device is covered when its use is reasonable and necessary for the individual patient.
B. Collagen Implant
A collagen implant, which is injected into the submucosal tissues of the urethra and/or the bladder neck and into tissues adjacent to the urethra, is a prosthetic device used in the treatment of stress urinary incontinence resulting from intrinsic sphincter deficiency (ISD). ISD is a cause of stress urinary incontinence in which the urethral sphincter is unable to contract and generate sufficient resistance in the bladder, especially during stress maneuvers.
Prior to collagen implant therapy, a skin test for collagen sensitivity must be administered and evaluated over a 4 week period.
In male patients, the evaluation must include a complete history and physical examination and a simple cystometrogram to determine that the bladder fills and stores properly. The patient then is asked to stand upright with a full bladder and to cough or otherwise exert abdominal pressure on his bladder. If the patient leaks, the diagnosis of ISD is established.
In female patients, the evaluation must include a complete history and physical examination (including a pelvic exam) and a simple cystometrogram to rule out abnormalities of bladder compliance and abnormalities of urethral support. Following that determination, an abdominal leak point pressure (ALLP) test is performed. Leak point pressure, stated in cm H2O, is defined as the intra-abdominal pressure at which leakage occurs from the bladder (around a catheter) when the bladder has been filled with a minimum of 150 cc fluid. If the patient has an ALLP of less than 100 cm H2O, the diagnosis of ISD is established.
To use a collagen implant, physicians must have urology training in the use of a cystoscope and must complete a collagen implant training program.
Coverage of a collagen implant, and the procedure to inject it, is limited to the following types of patients with stress urinary incontinence due to ISD:
• Male or female patients with congenital sphincter weakness secondary to conditions such as myelomeningocele or epispadias;
• Male or female patients with acquired sphincter weakness secondary to spinal cord lesions;
• Male patients following trauma, including prostatectomy and/or radiation; and
• Female patients without urethral hypermobility and with abdominal leak point pressures of 100 cm H2O or less.
Patients whose incontinence does not improve with 5 injection procedures (5 separate treatment sessions) are considered treatment failures, and no further treatment of urinary incontinence by collagen implant is covered. Patients who have a reoccurrence of incontinence following successful treatment with collagen implants in the past (e.g., 6-12 months previously) may benefit from additional treatment sessions. Coverage of additional sessions may be allowed but must be supported by medical justification.
Text reproduced from the CMS Medicare Coverage Database record for NCD 230.10 version 1. View the original on cms.gov.
Revision history
09/1996 - Revised coverage guidelines. Effective date 10/07/1996. (TN 89)
06/1994 - Specified patient selection criteria that must be met before implant product or procedure can be covered. Effective date 07/11/1994. (TN 70)
How this NCD shows up on remittances
A service denied under a National Coverage Determination returns CARC 50 (not deemed medically necessary) with remark N386 (decision based on an NCD); a denial citing a local policy instead carries N115. Because NCDs bind nationally, the appeal path is documentation that the patient meets the indications above, not a contractor-policy argument.
How QuickIntell applies NCD 230.10
QuickAuth checks the ordered service and diagnosis against NCD and LCD criteria before the encounter, QuickCode validates the diagnosis pairing on the claim, and QuickRCM routes CARC 50 denials with the policy text and the covered-code list attached so the appeal starts with evidence.
Frequently asked questions — NCD 230.10
What does NCD 230.10 cover?
A. Mechanical/Hydraulic Incontinence Control Devices The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database.
When did NCD 230.10 take effect?
The current version (1) is effective 10/07/1996, published in transmittal 89. This is the only published version.
Does a Local Coverage Determination override NCD 230.10?
No. A National Coverage Determination binds all Medicare Administrative Contractors; an LCD can only address services or circumstances the NCD leaves open. Claims denied under this NCD typically return CARC 50 with remark N386 (NCD) rather than N115 (LCD).
Sources
Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.
- Medicare Coverage Database NCDs via the CMS Coverage APIVersion API snapshot 2026-09-27 · effective 2026-09-20 · file national-coverage-ncd.jsonSHA-256 a90fadfd264b9ef4…
Disclaimer
This page reproduces the CMS National Coverage Determination text and, for laboratory NCDs, the CMS ICD-10 edit lists, as an operational reference. Coverage decisions depend on the full policy, the claim and the contractor; nothing here is legal, clinical or billing advice. CPT codes are shown as numbers only; CPT descriptors are copyright AMA.