370 Form

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Medical Policy
Urological Supplies Policy Number: 370 BCBSA Reference Number: N/A Related Policies
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Table of Contents Indwelling Catheters ...................................................................................................................................... 1 Catheter Insertion Trays ................................................................................................................................ 2 Urinary Drainage Collection Systems ........................................................................................................... 2 Intermittent Irrigation of Indwelling Catheters ............................................................................................... 3 Continuous Irrigation of Indwelling Catheters ............................................................................................... 3 Intermittent Catheterization ........................................................................................................................... 4 External Catheters/Urinary Collection Devices ............................................................................................. 5 Initial Coverage for Inflow Device ................................................................................................................. 5 Continued Coverage for Inflow Device Beyond the First Three Months of Therapy .................................... 5 Miscellaneous Supplies ................................................................................................................................. 6 Prior Authorization Information...................................................................................................................... 6 CPT Codes / HCPCS Codes / ICD Codes .................................................................................................... 7 Policy History .............................................................................................................................................. 10 Endnotes ..................................................................................................................................................... 11

Policy1 Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
The medical necessity for use of a greater quantity of supplies than the amounts specified in the policy must be well documented in the member’s medical record and must be available upon request.

Indwelling Catheters A4311, A4312, A4313, A4314, A4315, A4316, A4338, A4340, A4344, and A4346 No more than one catheter per month is considered MEDICALLY NECESSARY for routine catheter maintenance.

Non-routine catheter changes are considered MEDICALLY NECESSARY when documentation substantiates medical necessity, such as for the following indications:

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1. Catheter is accidentally removed (e.g., pulled out by member)
2. Malfunction of catheter (e.g., balloon does not stay inflated, hole in catheter)
3. Catheter is obstructed by encrustation, mucous plug, or blood clot

4. History of recurrent obstruction or urinary tract infection for which it has been established that an acute event is prevented by a scheduled change frequency of more than once per month

   A specialty indwelling catheter (A4340) or an all silicone catheter (A4344, A4312, or A4315) is considered MEDICALLY NECESSARY when the criteria for an indwelling catheter (above) are met and there is documentation in the member’s medical record to justify the medical need for that catheter (such as recurrent encrustation, inability to pass a straight catheter, or sensitivity to latex (not all-inclusive)).

   In addition, the particular catheter must be necessary for the member. For example, use of a Coude (curved) tip indwelling catheter (A4340) in a female member is rarely reasonable and necessary. If documentation is requested and does not substantiate medical necessity, payment for A4340, A4344, A4312, or A4315 will be denied as NOT MEDICALLY NECESSARY.

   A three-way indwelling catheter either alone (A4346) or with other components (A4313 or A4316) will be covered only if continuous catheter irrigation is reasonable and necessary. (Refer to Continuous Irrigation of Indwelling Catheters for indications for continuous catheter irrigations.) In other situations, A4346, A4313 and A4316 will be denied as NOT MEDICALLY NECESSARY.

   Catheter Insertion Trays A4310, A4311, A4312, A4313, A4314, A4315, A4316, A4353, and A4354

   One insertion tray is considered MEDICALLY NECESSARY per episode of indwelling catheter insertion.

   More than one tray per episode will be denied as NOT MEDICALLY NECESSARY.

   One intermittent catheter with insertion supplies (A4353) is considered MEDICALLY NECESSARY per episode of reasonable and necessary sterile intermittent catheterization (see below).

   Urinary Drainage Collection Systems A4314, A4315, A4316, A4354, A4357, A4358, A5102, and A5112

   Payment will be made for routine changes of the urinary drainage collection system as noted below.

   Additional charges will be allowed for reasonable and necessary non-routine changes when the documentation substantiates the medical necessity, (e.g., obstruction, sludging, clotting of blood, or chronic, recurrent urinary tract infection).

   Usual Maximum Quantity of Supplies Code Code Description Number per month A4314 Insertion tray with drainage bag with indwelling catheter, Foley type, two-way latex with coating (Teflon, silicone, silicone elastomer or hydrophilic, etc.) 1 A4315 Insertion tray with drainage bag with indwelling catheter, Foley type, two-way, all silicone 1 A4316 Insertion tray with drainage bag with indwelling catheter, Foley type, three- way, for continuous irrigation 1 A4354 Insertion tray with drainage bag but without catheter 1 A4357 Bedside drainage bag, day or night, with or without antireflux device, with or without tube, each 2 A4358 Urinary drainage bag, leg or abdomen, vinyl, with or without tube, with straps, each 2 A5112 Urinary drainage bag, leg or abdomen, latex, with or without tube, with straps, each 1

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Code Code Description Number per 3 months A5102 Bedside drainage bottle with or without tubing, rigid or expandable, each 1

Leg bags are indicated for members who are ambulatory or are chair or wheelchair bound.

The use of leg bags for bedridden members would be denied as NOT MEDICALLY NECESSARY.

If there is a catheter change (A4314, A4315, A4316, A4354) and an additional drainage bag (A4357) change within a month, the combined utilization for A4314, A4315, A4316, A4354, and A4357 should be considered when determining if additional documentation should be submitted with the claim. For example, if 1 unit of A4314 and 1 unit of A4357 are provided, this should be considered as two drainage bags, which is the usual maximum quantity of drainage bags needed for routine changes.

Payment will be made for either a vinyl leg bag (A4358) or a latex leg bag (A5112). The use of both is NOT MEDICALLY NECESSARY.

The medical necessity for drainage bags containing absorbent material such as gel matrix or other material, which are intended to be disposed of on a daily basis has not been established. Claims for this type of bag will be denied as NOT MEDICALLY NECESSARY.

Intermittent Irrigation of Indwelling Catheters Supplies for the intermittent irrigation of an indwelling catheter are considered MEDICALLY NECESSARY when they are used on an as needed (non-routine) basis in the presence of acute obstruction of the catheter.

Routine intermittent irrigations of a catheter will be denied as NOT MEDICALLY NECESSARY. Routine irrigations are defined as those performed at predetermined intervals. In individual cases, a copy of the order for irrigation and documentation in the member’s medical record of the presence of acute catheter obstruction may be requested when irrigation supplies are billed.

Covered supplies for reasonable and necessary non-routine irrigation of a catheter include either an irrigation tray (A4320) or an irrigation syringe (A4322), and sterile water/saline (A4217). When syringes, trays, sterile saline, or water are used for routine irrigation, they will be denied as NOT MEDICALLY NECESSARY.

Irrigation solutions containing antibiotics and chemotherapeutic agents (A9270) will be denied as non- covered. Irrigating solutions such as acetic acid or hydrogen peroxide, which are used for the treatment or prevention of urinary obstruction (A4321), will be denied as NOT MEDICALLY NECESSARY.

Continuous Irrigation of Indwelling Catheters Supplies for continuous irrigation of a catheter are considered MEDICALLY NECESSARY if there is a history of obstruction of the catheter and the patency of the catheter cannot be maintained by intermittent irrigation in conjunction with reasonable and necessary catheter changes.

Continuous irrigation as a primary preventative measure (i.e., no history of obstruction) will be denied as NOT MEDICALLY NECESSARY. Documentation must substantiate the medical necessity of catheter irrigation and in particular continuous irrigation as opposed to intermittent irrigation. The records must also indicate the rate of solution administration and the duration of need. This documentation must be available upon request.

Covered supplies for reasonable and necessary continuous bladder irrigation include a 3-way Foley catheter (A4313, A4316, and A4346), irrigation tubing set (A4355), and sterile water/saline (A4217). More than one irrigation tubing set per day for continuous catheter irrigation will be denied as NOT MEDICALLY NECESSARY.

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Irrigation solutions containing antibiotics and chemotherapeutic agents (A9270) will be denied as NOT MEDICALLY NECESSARY. Payment for irrigating solutions such as acetic acid or hydrogen peroxide will be based on the allowance for sterile water/saline (A4217).

Continuous irrigation is a temporary measure. Continuous irrigation for more than 2 weeks is rarely reasonable and necessary. The member’s medical records should indicate this medical necessity and these medical records must be available upon request.

Intermittent Catheterization Intermittent catheterization is considered MEDICALLY NECESSARY when basic coverage criteria are met and the member or caregiver can perform the procedure.

For each episode of MEDICALLY NECESSARY catheterization, we provide coverage for:
A. One catheter (A4351, A4352) and an individual packet of lubricant (A4332); or B. One sterile intermittent catheter kit (A4353) if additional coverage criteria (see below) are met.

Intermittent catheterization using a sterile intermittent catheter kit (A4353) is considered MEDICALLY NECESSARY when the member requires catheterization and the member meets ONE of the following criteria (1-5):

1. The member resides in a nursing facility,
2. The member is immunosuppressed, for example (not all-inclusive): o on a regimen of immunosuppressive drugs post-transplant, o on cancer chemotherapy, o has AIDS, o has a drug-induced state such as chronic oral corticosteroid use.
3. The member has radiologically documented vesico-ureteral reflux while on a program of intermittent catheterization,
4. The member is a spinal cord injured female with neurogenic bladder who is pregnant (for duration of pregnancy only),

5. The member has had distinct, recurrent urinary tract infections, while on a program of sterile intermittent catheterization with A4351/A4352 and sterile lubricant A4332, twice within the 12-month prior to the initiation of sterile intermittent catheter kits.

   A member would be considered to have a urinary tract infection if they have a urine culture with greater than 10,000 colony forming units of a urinary pathogen AND concurrent presence of ONE OR MORE of the following signs, symptoms or laboratory findings: • Fever (oral temperature greater than 38º C [100.4º F]) • Systemic leukocytosis • Change in urinary urgency, frequency, or incontinence • Appearance of new or increase in autonomic dysreflexia (sweating, bradycardia, blood pressure elevation) • Physical signs of prostatitis, epididymitis, orchitis • Increased muscle spasms • Pyuria (greater than 5 white blood cells [WBCs] per high-powered field).

   Usual Maximum Quantity of Supplies Code Code Description Number per month A4332 Lubricant, individual sterile packet, each 200 A4351 Intermittent urinary catheter; straight tip, with or without coating (Teflon, silicone, silicone elastomer, or hydrophilic, etc.), each 200 A4352 Intermittent urinary catheter; Coude (curved) tip, with or without coating (Teflon, silicone, silicone elastomeric, or hydrophilic, etc.), each 200 A4353 Intermittent urinary catheter, with insertion supplies 200

5 A4295 Intermittent urinary catheter; straight tip, hydrophilic coating, each 200 A4296 Intermittent urinary catheter; coude (curved) tip, hydrophilic coating, each 200 A4297 Intermittent urinary catheter; hydrophilic coating, with insertion supplies 200

Refer to Coding Guidelines section of the related Policy Article for contents of the kit (A4353). A4353 should not be used for billing if the components are packaged separately rather than together as a kit. Separately provided components do not provide the equivalent degree of sterility achieved with an A4353. If separate components are provided instead of a kit (A4353) they will be denied as NOT MEDICALLY NECESSARY.

Use of a Coude (curved) tip catheter (A4352) in female beneficiaries is rarely reasonable and necessary. When a Coude tip catheter is used (either male or female members), there must be documentation in the member’s medical record of the medical necessity for that catheter. An example would be the inability to catheterize with a straight tip catheter. This documentation must be available upon request. If documentation is requested and does not substantiate medical necessity, claims will be denied as NOT MEDICALLY NECESSARY.

External Catheters/Urinary Collection Devices Male external catheters (condom-type) or female external urinary collection devices are considered MEDICALLY NECESSARY for members who have permanent urinary incontinence when used as an alternative to an indwelling catheter.

The utilization of male external catheters (A4349) generally should not exceed 35 per month. Greater utilization of these devices must be accompanied by documentation of medical necessity.

Male external catheters (condom-type) or female external urinary collection devices will be denied NOT MEDICALLY NECESSARY when ordered for members who also use an indwelling catheter.

Specialty type male external catheters (A4326) such as those that inflate or that include a faceplate or extended wear catheter systems are considered MEDICALLY NECESSARY only when documentation substantiates the medical necessity for such a catheter. If documentation does not justify the medical need claims will be denied as NOT MEDICALLY NECESSARY.

For female external urinary collection devices, more than one meatal cup (A4327) per week or more than one pouch (A4328) per day will be denied as NOT MEDICALLY NECESSARY.

Initial Coverage for Inflow Device The inFlow device is considered MEDICALLY NECESSARY as an alternative to intermittent catheterization for members with Permanent Urinary Retention (PUR) due to Impaired Detrusor Contractility (IDC).

One (1) inFlow device may be considered MEDICALLY NECESSARY no more than once every 29 days. Claims for the inFlow device billed more than once every 29 days will be denied as NOT MEDICALLY NECESSARY.

Continued Coverage for Inflow Device Beyond the First Three Months of Therapy Continued coverage of the inFlow device beyond the first three months of therapy requires that, no sooner than the 31st day but no later than the 91st day after initiating therapy, the treating practitioner must conduct a clinical re-evaluation and document that the member continues to use and is benefiting from the inFlow device.

Documentation of use and clinical benefit is demonstrated by:

1. An in-person encounter by the treating practitioner with documentation that urinary symptoms are improved; AND
2. The treating practitioner verifies the member’s adherence to use of the inFlow device.

6 If the above criteria are not met, continued coverage of the inFlow device and related accessories will be denied as NOT MEDICALLY NECESSARY.

If the practitioner re-evaluation does not occur until after the 91st day but the evaluation demonstrates that the member 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 discontinuation of usage of the inFlow device at any time, the supplier is expected to ascertain this and stop billing for the equipment and related accessories and supplies.

Miscellaneous Supplies Appliance cleaner (A5131) is considered MEDICALLY NECESSARY when used to clean the inside of certain urinary collecting appliances (A5102, A5105, A5112). More than one unit of service (16 oz.) per month is rarely reasonable and necessary.

One external urethral clamp or compression device (A4356) is considered MEDICALLY NECESSARY every 3 months or sooner if the rubber/foam casing deteriorates.

Tape (A4450, A4452) which is used to secure an indwelling catheter to the member’s body is considered MEDICALLY NECESSARY. More than 10 units (1 unit = 18 sq. in.; 10 units = 180 sq. in. = 5 yds. of 1 inch tape) per month will be denied as NOT MEDICALLY NECESSARY.

Adhesive catheter anchoring devices (A4333) and catheter leg straps (A4334) for indwelling urethral catheters are considered MEDICALLY NECESSARY. More than 3 per week of A4333 or 1 per month of A4334 will be denied as NOT MEDICALLY NECESSARY.

A catheter/tube anchoring device (A5200) is considered MEDICALLY NECESSARY and separately payable when it is used to anchor a covered suprapubic tube or nephrostomy tube. If code A5200 is used to anchor an indwelling urethral catheter, the claim will be denied as NOT MEDICALLY NECESSARY.

Urethral inserts (A4336) are considered MEDICALLY NECESSARY for adult females with stress incontinence (refer to the ICD-10 Codes section in the Policy Article for applicable diagnoses) when basic coverage criteria are met and the member or caregiver can perform the procedure. They are not indicated for women: • With bladder or other urinary tract infections (UTI) • With a history of urethral stricture, bladder augmentation, pelvic radiation or other conditions where urethral catheterization is not clinically advisable • Who are immunocompromised, at significant risk from UTI, interstitial cystitis, or pyelonephritis, or who have severely compromised urinary mucosa • Unable to tolerate antibiotic therapy • On anticoagulants • With overflow incontinence or neurogenic bladder.

Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) Prior authorization is not required. Commercial PPO and Indemnity Prior authorization is not required.

7 CPT Codes / HCPCS Codes / ICD Codes
Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following codes are included below for informational purposes only; this is not an all-inclusive list.

The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity:

HCPCS Codes HCPCS codes:

Code Description A4217 Sterile water/saline, 500 ml A4310 Insertion tray without drainage bag and without catheter (accessories only) A4311 Insertion tray without drainage bag with indwelling catheter, foley type, two-way latex with coating (teflon, silicone, silicone elastomer or hydrophilic, etc.) A4312 Insertion tray without drainage bag with indwelling catheter, foley type, two-way, all silicone A4313 Insertion tray without drainage bag with indwelling catheter, foley type, three-way, for continuous irrigation A4314 Insertion tray with drainage bag with indwelling catheter, foley type, two-way latex with coating (teflon, silicone, silicone elastomer or hydrophilic, etc.) A4315 Insertion tray with drainage bag with indwelling catheter, foley type, two-way, all silicone A4316 Insertion tray with drainage bag with indwelling catheter, foley type, three-way, for continuous irrigation A4318 Female external urinary collection cup, with or without ring attachment, per day A4320 Irrigation tray with bulb or piston syringe, any purpose A4321 Therapeutic agent for urinary catheter irrigation A4322 Irrigation syringe, bulb or piston, each A4326 Male external catheter with integral collection chamber, any type, each A4327 Female external urinary collection device; meatal cup, each A4328 Female external urinary collection device; pouch, each A4331 Extension drainage tubing, any type, any length, with connector/adaptor, for use with urinary leg bag or urostomy pouch, each A4332 Lubricant, individual sterile packet, each A4333 Urinary catheter anchoring device, adhesive skin attachment, each A4334 Urinary catheter anchoring device, leg strap, each A4335 Incontinence supply; miscellaneous A4336 Incontinence supply, urethral insert, any type, each A4338 Indwelling catheter; foley type, two-way latex with coating (teflon, silicone, silicone elastomer, or hydrophilic, etc.), each A4340 Indwelling catheter; specialty type, (e.g., coude, mushroom, wing, etc.), each A4341 Indwelling intraurethral drainage device with valve, patient inserted, replacement only, each A4342 Accessories for patient inserted indwelling intraurethral drainage device with valve, replacement only, each A4344 Indwelling catheter, foley type, two-way, all silicone, each A4346 Indwelling catheter; foley type, three way for continuous irrigation, each A4349 Male external catheter, with or without adhesive, disposable, each

8 A4351 Intermittent urinary catheter; straight tip, with or without coating (teflon, silicone, silicone elastomer, or hydrophilic, etc.), each A4352 Intermittent urinary catheter; coude (curved) tip, with or without coating (teflon, silicone, silicone elastomeric, or hydrophilic, etc.), each A4353 Intermittent urinary catheter, with insertion supplies A4354 Insertion tray with drainage bag but without catheter A4355 Irrigation tubing set for continuous bladder irrigation through a three-way indwelling foley catheter, each A4356 External urethral clamp or compression device (not to be used for catheter clamp), each A4357 Bedside drainage bag, day or night, with or without anti-reflux device, with or without tube, each A4358 Urinary drainage bag, leg or abdomen, vinyl, with or without tube, with straps, each A4360 Disposable external urethral clamp or compression device, with pad and/or pouch, each A4402 Lubricant, per ounce A4450 Tape, non-waterproof, per 18 square inches A4452 Tape, waterproof, per 18 square inches A4455 Adhesive remover or solvent (for tape, cement or other adhesive), per ounce A4456 Adhesive remover, wipes, any type, each A4520 Incontinence garment, any type, (e.g., brief, diaper), each A4553 Non-disposable underpads, all sizes A4554 Disposable underpads, all sizes A5102 Bedside drainage bottle with or without tubing, rigid or expandable, each A5105 Urinary suspensory with leg bag, with or without tube, each A5112 Urinary drainage bag, leg or abdomen, latex, with or without tube, with straps, each A5113 Leg strap; latex, replacement only, per set A5114 Leg strap; foam or fabric, replacement only, per set A5131 Appliance cleaner, incontinence and ostomy appliances, per 16 oz. A5200 Percutaneous catheter/tube anchoring device, adhesive skin attachment A6590 External urinary catheters; disposable, with wicking material, for use with suction pump, per month A6591 External urinary catheter; non-disposable, for use with suction pump, per month A9270 Non-covered item or service

Description Impaired detrusor contractility (IDC) is defined by the International Continence Society (ICS) as “a contraction of reduced strength and/or duration, resulting in prolonged bladder emptying and/or failure to achieve complete bladder emptying within a normal time span.” IDC may also be referred to as atonic bladder or detrusor underactivity. IDC most commonly develops due to neurologic disease or injury, such as multiple sclerosis, stroke, spinal cord injury, diabetic neuropathy, and Parkinson’s disease. Clean intermittent catheterization (CIC) is most commonly used to drain the bladder in patients with IDC. The average frequency of self-catheterizations is four to six times daily. In patients who cannot self- catheterize or do not have a caregiver to assist with catheterization, an indwelling (“Foley”) catheter or suprapubic tube may be used.1,2

The inFlow device (Intraurethral Valve-Pump and Activator), is a urinary catheter intended to be used as an alternative to CIC in patients with 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, which 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 and initially inserted by a treating practitioner; and it must be replaced every 29

9 days. Generally, the user or caregiver can replace the inFlow device, since insertion is similar to a urinary catheter.

In 2014, the Food and Drug Administration (FDA) issued approval for the inFlow device via the De Novo pathway. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN130044.pdf

Summary Seven clinical studies that included a total of 501 participants have been published on the inFlow device.5- 11 The pivotal multicenter trial5 upon which FDA approval was based included 273 participants from 18 sites (15 U.S., 3 international) and was a single-arm crossover design that evaluated the inFlow device compared with CIC in women with IDC who had been successfully using CIC. The primary endpoint was post-void residual urine (PVR) after the inFlow device use compared with PVR after CIC use. Quality of life (QOL) was evaluated as a secondary endpoint. Safety measures included UTI rates and other adverse events. Of the 273 participants, 77 women completed the study; the primary reason for withdrawal was discomfort. For the primary endpoint, 115 women had baseline and treatment PVR data available and were evaluable. The study exceeded its primary endpoint goal of 95% comparable PVRs; 98% of participants had comparable PVR values for inFlow device and CIC. Of the 85 patients with available baseline and treatment QOL data, QOL scores increased by a mean of 25 points when using the inFlow device (p<0.0001). The study authors considered these results statistically and clinically significant. For participants completing the study, UTI rate per month decreased with continued inFlow device use, and the authors found the inFlow device to be equivalent or superior to CIC for UTI rate. No serious adverse events were associated with the inFlow device. Reported adverse events included mild bladder inflammation, mild device awareness/discomfort, mild pain, and mild incontinence. The safety profile for participants that withdrew from the study was not significantly different from those who completed the study. The study authors noted that patients who were more likely to tolerate the inFlow device had lower voiding-related QOL, more ambulatory and manual dexterity limitations, and were more dependent on adult diapers. Of those who completed the study, 34.2% had spinal disease/injury, 25% had multiple sclerosis, 18.4% had spina bifida, and 17% had some paralysis.

The remaining six non-comparative studies6-11 were published between 1997 and 2004 and reported on small groups of patients outside the United States. Improvements in QOL, low UTI rates, and no serious adverse events were reported in most studies.

A recent review article1 noted that the inFlow device is a treatment alternative for women with detrusor underactivity.

Professional Society Recommendations and Guidelines In a 2016 consensus statement on treatments for chronic urinary retention (CUR), the American Urological Association (AUA) discussed IDC as one cause of CUR but did not mention the inFlow device.12 In 2016 and 2017, the AUA endorsed the inFlow device as a potential management strategy for IDC.

In September 2017, the National Multiple Sclerosis Society, International Organization of Multiple Sclerosis Nurses, and Consortium for Multiple Sclerosis Centers collectively submitted a formal letter to CMS requesting coverage for the inFlow device.

External Assessments In a review of chronic urinary retention in women, UpToDate notes that, “An intraurethral valve-pump may be an alternate option to intermittent self-catheterization for women with DU and resultant CUR. The device does not remedy the DU itself. Women who may benefit include those with physical limitations that preclude self-catheterization or those who no longer wish to perform catheterization.”13

The pivotal clinical trial data for FDA approval indicates that use of the inFlow device results in lower monthly UTI rates and significant QOL improvements for women with IDC who have been using CIC. Other than a high rate of discontinuation of the use of the inFlow device due to patient discomfort, no

10 serious adverse events were reported. More recent publications indicate that the inFlow device may be a treatment alternative for a subset of patients with detrusor underactivity.

Analysis of Evidence: Rationale for Determination Level of Evidence Quality Strength Weight Moderate Moderate Moderate

Conclusion The inFlow device (HCPCS Code A4335) is an alternative to intermittent catheterization for a subset of beneficiaries with PUR due to IDC.

Other Technical Corrections HCPCS Code Span Changes: In the Coverage Indications, Limitations, and/or Medical Necessity section, the DME MACs revised the Urological Supplies LCD to remove HCPCS code spans and list the applicable HCPCS codes individually. This change allows for flexibility and accuracy in coding and coverage when CMS creates new HCPCS codes or revises existing HCPCS codes. No changes in existing reasonable and necessary requirements are impacted by this change.

Policy History Date Action 4/2026 Clarified coding information. 1/2026 Clarified coding information. 4/2023 Clarified coding information.
10/2021 New medical policy describing medically necessary and not medically necessary urological supplies. Effective 10/1/2021. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines References

1. Hartigan SM, Reynolds WS, Dmochowski RR. Detrusor underactivity in women: A current understanding. Neurourol Urodyn. 2019 Nov;38(8):2070-2076.
2. Osman NI, Chapple CR, Abrams P, Dmochowski R, Haab F, Nitti V, Koelbl H, van Kerrebroeck P, Wein AJ. Detrusor underactivity and the underactive bladder: a new clinical entity? A review of current terminology, definitions, epidemiology, aetiology, and diagnosis. Eur Urol. 2014 Feb;65(2):389-98.
3. FDA Center for Devices and Radiological Health, DEN130044VesifloinFlowdenovosummary. Oct 2014. http://www.accessdata.fda.gov/cdrhdocs/reviews/DEN130044.pdf. Accessed January 3,
5. U.S. Food and Drug Administration. Medical Devices; Gastroenterology-Urology Devices; Classification of the Urethral Insert With Pump for Bladder Drainage. 21 CFR
6. https://www.federalregister.gov/d/2015-07815. Accessed January 3, 2020.
7. Chen TYH, Ponsot Y, Carmel M, Bouffard N, Kennelly MJ, Tu LM. Multi-Centre Study of Intraurethral Valve-Pump Catheter in Women with a Hypotonic or Acontractile Bladder. Eur Urol 2005; 48: 628–
9. Mazouni C; Karsenty G; Bladou F; Serment G. Urethral device in women with chronic urinary retention: an alternative to self-catheterization? Eur J Obstet Gynecol Reprod Biol 2004; 115(1): 80- 84

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7. Lynch WJ, Testa GA, Bell D: A Study to Determine Subjective and Objective Benefits of a Remote- Controlled Intra-Urethral Device for the Management of Female Acontractile Bladder. Brit J Urol 2003; 92: 960-963.
8. Madjar S, Halachmi S, Wald M, Issaq E, Moskovitz B, Beyar M, Nativ O: Long-term follow-up of the inFlow™ intraurethral insert for the treatment of women with voiding dysfunction. Eur Urol 2000; 38:161-166.
9. Madjar S, Sabo E, Halachmi S, Wald M, Issaq E, Moskovitz B, Beyar M, Nativ O: A remote controlled intraurethral insert for artificial voiding - A new concept for treating women with voiding dysfunction. J Urol 1999; 161:895-898.
10. Schurch S, Suter S, Dubs M: Intraurethral sphincter prosthesis to treat hyporeflexic bladders in women – Does it work? Brit J Urol 1999; 84:789-794.
11. Nativ O, Moskovitz B, Issaq E, Condrea A, Kastin A, Halachmi S, Burbara J, Madjar S, Beyar M: A new intraurethral sphincter prosthesis with a self-contained urinary pump. ASAIO J 1997; 43:197-203.
12. American Urological Association. Non-Neurogenic Chronic Urinary Retention: Consensus Definition, Management Strategies, and Future Opportunities. 2016. https://www.auanet.org/guidelines/chronic- urinary-retention. Accessed January 3, 2020.
13. Rickey LM, Brubaker L, Eckler K. Chronic urinary retention in women. UpToDate. May 23,
14. https://www.uptodate.com/contents/chronic-urinary-retention-in-women. Accessed January 3,
16. Chancellor M: Chapter 10, Advanced Technology. The Underactive Bladder. Springer 2016; 155-

17. http://www.springer.com/us/book/9783319236865

    Endnotes

    1 Based on Local Coverage Determination (LCD): Urological Supplies L33803 Local Coverage Article: Urological Supplies - Policy Article A52521