Local Coverage Determination (LCD)

Urological Supplies

L33803

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Contractor Information

LCD Information

Document Information

LCD ID
L33803
LCD Title
Urological Supplies
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL33803
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 04/01/2021
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
06/11/2020
Notice Period End Date
07/25/2020
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

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Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

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CMS National Coverage Policy

None

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.

The purpose of a Local Coverage Determination (LCD) is to provide information regarding “reasonable and necessary” criteria based on Social Security Act § 1862(a)(1)(A) provisions.

In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:

  • The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.
  • The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.
  • Refer to the Supplier Manual for additional information on documentation requirements.
  • Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the “reasonable and necessary” criteria, based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

The statutory coverage criteria for coverage of urological supplies are specified in the related Policy Article.

The medical necessity for use of a greater quantity of supplies than the amounts specified in the policy must be well documented in the beneficiary'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 covered for routine catheter maintenance. Non-routine catheter changes are covered when documentation substantiates medical necessity, such as for the following indications:

  1. Catheter is accidentally removed (e.g., pulled out by beneficiary)
  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 covered when the criteria for an indwelling catheter (above) are met and there is documentation in the beneficiary'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 beneficiary. For example, use of a Coude (curved) tip indwelling catheter (A4340) in a female beneficiary 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 reasonable and 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 the section "Continuous Irrigation of Indwelling Catheters" for indications for continuous catheter irrigations.) In other situations, A4346, A4313 and A4316 will be denied as not reasonable and necessary.

CATHETER INSERTION TRAY (A4310, A4311, A4312, A4313, A4314, A4315, A4316, A4353, and A4354)

One insertion tray will be covered per episode of indwelling catheter insertion. More than one tray per episode will be denied as not reasonable and necessary.

One intermittent catheter with insertion supplies (A4353) will be covered per episode of reasonable and necessary sterile intermittent catheterization (see below).

URINARY DRAINAGE COLLECTION SYSTEM (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

Number per month

A4314

1

A4315

1

A4316

1

A4354

1

A4357

2

A4358

2

A5112

1

 

Code

Number per 3 month

A5102

1


Leg bags are indicated for beneficiaries who are ambulatory or are chair or wheelchair bound. The use of leg bags for bedridden beneficiaries would be denied as not reasonable and 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 reasonable and 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 reasonable and necessary.

INTERMITTENT IRRIGATION OF INDWELLING CATHETERS

Supplies for the intermittent irrigation of an indwelling catheter are covered 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 reasonable and 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 beneficiary'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 reasonable and 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 reasonable and necessary.

CONTINUOUS IRRIGATION OF INDWELLING CATHETERS

Supplies for continuous irrigation of a catheter are covered 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 reasonable and 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 reasonable and necessary.

Irrigation solutions containing antibiotics and chemotherapeutic agents (A9270) will be denied as non-covered. 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 beneficiary's medical records should indicate this medical necessity and these medical records must be available upon request.

INTERMITTENT CATHETERIZATION

Intermittent catheterization is covered when basic coverage criteria are met and the beneficiary or caregiver can perform the procedure.

For each episode of covered catheterization, Medicare will cover:

  1. One catheter (A4351, A4352) and an individual packet of lubricant (A4332); or
  2. One sterile intermittent catheter kit (A4353) if additional coverage criteria (see below) are met.

Intermittent catheterization using a sterile intermittent catheter kit (A4353) is covered when the beneficiary requires catheterization and the beneficiary meets one of the following criteria (1-5):

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

Number per Month

A4332

200

A4351

200

A4352

200

A4353

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 reasonable and 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 beneficiaries), there must be documentation in the beneficiary'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 reasonable and necessary.

EXTERNAL CATHETERS/URINARY COLLECTION DEVICES

Male external catheters (condom-type) or female external urinary collection devices are covered for beneficiaries 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 as not reasonable and necessary when ordered for beneficiaries 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 covered 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 reasonable and 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 reasonable and necessary.

INITIAL COVERAGE FOR THE INFLOW DEVICE

The inFlow device is considered to be reasonable and necessary as an alternative to intermittent catheterization for beneficiaries with Permanent Urinary Retention (PUR) due to Impaired Detrusor Contractility (IDC).

One (1) inFlow device may be covered no more than once every 29 days. Claims for the inFlow device billed more than once every 29 days will be denied as not reasonable and necessary.

CONTINUED COVERAGE FOR THE 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 beneficiary 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 beneficiary’s adherence to use of the inFlow device.

If the above criteria are not met, continued coverage of the inFlow device and related accessories will be denied as not reasonable and necessary.

If the practitioner re-evaluation does not occur until after the 91st day but the evaluation demonstrates that the beneficiary 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 covered 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 covered every 3 months or sooner if the rubber/foam casing deteriorates.

Tape (A4450, A4452) which is used to secure an indwelling catheter to the beneficiary's body is covered. 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 reasonable and necessary.

Adhesive catheter anchoring devices (A4333) and catheter leg straps (A4334) for indwelling urethral catheters are covered. More than 3 per week of A4333 or 1 per month of A4334 will be denied as not reasonable and necessary. A catheter/tube anchoring device (A5200) is covered 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 reasonable and necessary.

Urethral inserts (A4336) are covered for adult females with stress incontinence (refer to the ICD-10 Codes section in the LCD-related Policy Article for applicable diagnoses) when basic coverage criteria are met and the beneficiary 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


GENERAL


A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.

REFILL REQUIREMENTS

For DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products that are supplied as refills to the original order, suppliers must contact the beneficiary prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the beneficiary. This shall be done to ensure that the refilled item remains reasonable and necessary, existing supplies are approaching exhaustion, and to confirm any changes or modifications to the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product. This is regardless of which delivery method is utilized.

For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request from a beneficiary. Items delivered without a valid, documented refill request will be denied as not reasonable and necessary.

Suppliers must not dispense a quantity of supplies exceeding a beneficiary's expected utilization. Suppliers must stay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with the treating practitioner that any changed or atypical utilization is warranted.

Regardless of utilization, a supplier must not dispense more than a three (3) - month quantity at a time.

Summary of Evidence

Background

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 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 of Evidence

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 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 – Moderate

Strength – Moderate

Weight – 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.

Coding Information

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

The appearance of a code in this section does not necessarily indicate coverage.

HCPCS MODIFIERS:

AU – Item furnished in conjunction with a urological, ostomy, or tracheostomy supply

EY - No physician or other licensed health care provider order for this item or service

GA – Waiver of liability statement issued as required by payer policy, individual case

GY - Item or service statutorily excluded or does not meet the definition of any Medicare benefit

GZ – Item or service expected to be denied as not reasonable and necessary

KX - Requirements specified in the medical policy have been met

HCPCS CODES

Group 1 Codes
CodeDescription
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
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
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
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
A9270 NON-COVERED ITEM OR SERVICE

General Information

Associated Information

DOCUMENTATION REQUIREMENTS

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioner’s office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

GENERAL DOCUMENTATION REQUIREMENTS

In order to justify payment for DMEPOS items, suppliers must meet the following requirements:

  • SWO
  • Medical Record Information (including continued need/use if applicable)
  • Correct Coding
  • Proof of Delivery

Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.

Refer to the Supplier Manual for additional information on documentation requirements.

Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

Items covered in this LCD have additional policy-specific requirements that must be met prior to Medicare reimbursement.

Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.

MISCELLANEOUS

APPENDICES

UTILIZATION GUIDELINES

Refer to Coverage Indications, Limitations, and/or Medical Necessity

Sources of Information
Reserved for future use
Bibliography
  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, DEN130044_Vesiflo_inFlow_de_novo_summary. Oct 2014. http://www.accessdata.fda.gov/cdrh_docs/reviews/DEN130044.pdf. Accessed January 3, 2020.
  4. U.S. Food and Drug Administration. Medical Devices; Gastroenterology-Urology Devices; Classification of the Urethral Insert With Pump for Bladder Drainage. 21 CFR 876. https://www.federalregister.gov/d/2015-07815. Accessed January 3, 2020.
  5. 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: 628–633.
  6. 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
  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, 2019. https://www.uptodate.com/contents/chronic-urinary-retention-in-women. Accessed January 3, 2020.
  14. Chancellor M: Chapter 10, Advanced Technology. The Underactive Bladder. Springer 2016; 155-161. http://www.springer.com/us/book/9783319236865

Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
04/01/2021 R8

Revision Effective Date: 04/01/2021
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: Trademark symbol from first use of inFlow
HCPCS CODES:
Removed: K1010, K1011 and K1012 (effective for DOS on or after 04/01/2021)

04/29/2021: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.

  • Revisions Due To CPT/HCPCS Code Changes
10/01/2020 R7

Revision Effective Date: 10/01/2020
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: HCPCS A4335 from inFlow device reference due to new HCPCS codes as of 10/01/2020
HCPCS CODES:
Added: K1010, K1011 and K1012 (effective DOS on or after 10/01/2020)

10/15/2020: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to add CMS HCPCS coding determinations.

  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
07/26/2020 R6

Revision Effective Date: 07/26/2020
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Format of HCPCS code references, from code ‘spans’ to individually-listed
Added: Billing and coverage information for the inFlow device (HCPCS Code A4335)
Removed: Denial statement for inFlow device (A4335)
GENERAL:
Added: References to Standard Written Order (SWO)
REFILL REQUIREMENTS:
Revised: “ordering physicians” to “treating practitioners”
SUMMARY OF EVIDENCE:
Added: Information related to inFlow device
ANALYSIS OF EVIDENCE:
Added: Information related to inFlow device
CODING INFORMATION:
Removed: Field titled “Bill Type” Removed: Field titled “Revenue Codes” Removed: Field titled “ICD-10 Codes that Support Medical Necessity”
Removed: Field titled “ICD-10 Codes that DO NOT Support Medical Necessity”
Removed: Field titled “Additional ICD-10 Information”
DOCUMENTATION REQUIREMENTS:
Revised: “physician’s” to “practitioner’s”
GENERAL DOCUMENTATION REQUIREMENTS:
Revised: “Prescriptions (orders)” to “SWO”
BIBLIOGRAPHY:
Added: Section related to inFlow device
RELATED LOCAL COVERAGE DOCUMENTS:
Added: Response to Comments (A58231)

  • Provider Education/Guidance
  • Reconsideration Request
  • Other
01/01/2019 R5

Revision History Effective Date: 01/01/2019
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Removed: Statement to refer to diagnosis code section below
Added:
Refer to Covered ICD-10 Codes in the LCD-related Policy Article
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Moved: All diagnosis codes to the LCD-related Policy Article diagnosis code section per CMS instruction
ICD-10 CODES THAT DO NOT SUPPORT MEDICAL NECESSITY:
Moved: Statement about noncovered diagnosis codes moved to LCD-related Policy Article noncovered diagnosis code section per CMS instruction

  • Other (ICD-10 code relocation per CMS instruction)
01/01/2017 R4 Revision History Effective Date: 01/01/2017
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: Standard Documentation Language
Added: New reference language and directions to Standard Documentation Requirements
Added: General Requirements
Revised: Refill Requirements
HCPCS Code:
Added: A4553
DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: General Documentation Requirements
Added: New reference language and directions to Standard Documentation Requirements
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: Direction to Standard Documentation Requirements
Removed: Information under Miscellaneous and Appendices
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements article
  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
07/01/2016 R3 Effective July 1, 2016 oversight for DME MAC LCDs is the responsibility of CGS Administrators, LLC 18003 and 17013 and Noridian Healthcare Solutions, LLC 19003 and 16013. No other changes have been made to the LCDs.
  • Change in Assigned States or Affiliated Contract Numbers
01/01/2016 R2 Revision Effective Date: 01/01/2016
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Added: Non-reimbursement language for the inFlowTM Intraurethral Valve-Pump system (A4335)
DOCUMENTATION REQUIREMENTS:
Revised: Standard Documentation Language to remove start date verbiage from Prescription Requirements (Effective 11/05/2015)
  • Provider Education/Guidance
10/01/2015 R1 Revision Effective Date: 08/01/2015
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Standard Documentation Language to add covered prior to a beneficiary’s Medicare eligibility
DOCUMENTATION REQUIREMENTS:
Revised: Standard Documentation Language to add who can enter date of delivery date on the POD
(Note: Standard Documentation Language updates noted above are effective for DOS on or after 10/31/2014)
Added: Language for HCPCS codes A4217, A4450, A4452 when submitted without correct modifier
  • Provider Education/Guidance

Associated Documents

Attachments
N/A
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
04/22/2021 04/01/2021 - N/A Currently in Effect You are here
10/09/2020 10/01/2020 - 03/31/2021 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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