External Urinary Collection Devices - PureWick System

1 PG0492 06/30/2021 External Urinary Collection Devices - PureWick System Policy Number: PG0492 Last Review: 06/30/2021 GUIDELINES This policy does not certify benefits or authorization of benefits, which is designated by each individual policyholder contract. Paramount applies coding edits to all medical claims through coding logic software to evaluate the accuracy and adherence to accepted national standards. This guideline is solely for explaining correct procedure reporting and does not imply coverage and reimbursement. SCOPE X Professional/DME Provider _ Facility DESCRIPTION An External urine Collection device is category defined as a catheter or product that attaches to the External genitalia or pubic area.

2 These Collection systems drain urine via tubing attached to a bag or via tubing, which suctions urine to a container. EUCDs are primarily used in men or women with Urinary incontinence . Urinary incontinence defined as the involuntary leakage of urine, which may be caused by aging, disease, post-surgical complications, trauma or other conditions. The PureWick Female External Catheter allows for simple, non-invasive urine output management in female patients. Using low-pressure wall suction, the PureWick Female External Catheter wicks urine away from the patient and into a designated Collection canister. The PureWick System is a urine Collection System that includes the PureWick female External catheter, a flexible, disposable "wick", which is attached to a continuous low-pressure pump, the PureWick urine Collection System .

3 The System is designed to gently pull the urine from the External catheter into the sealed Collection canister. The female External catheter works outside the body to absorb and wick urine. The wick is replaced every 8-12 hours or if it is soiled with feces or blood. POLICY HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan The PureWick urine Collection System is unproven and not medically necessary for the management of Urinary incontinence . Therefore, procedure K1006 is not covered. Advantage effective 01/01/2021 The Ohio Department of Medicaid indicates coverage for procedure K1006. Therefore, procedure K1006 is covered per the coverage criteria indicated below without a prior authorization.

4 COVERAGE CRITERIA HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan, Advantage Paramount considers External Urinary Collection Devices , male External catheters (condom-type) (A4349) and female pouches or meatal cups (A4327, A4328), medically necessary prosthetics for members who have permanent Urinary incontinence . The External Urinary Collection device is utilized as an alternative to an indwelling catheter. The term " External Urinary Collection Devices " used in this policy includes male External catheters and female pouches or meatal cups ADVANTAGE | ELITE | HMO INDIVIDUAL MARKETPLACE | PROMEDICA MEDICARE PLAN | PPO PG0492 06/30/2021 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.

5 If documentation does not justify the medical need claims will be denied as not reasonable and necessary. A meatal cup female External Urinary Collection device is a plastic cup, which is held in place around the female urethra by suction or pressure and is connected to a Urinary drainage container such as a bag or bottle. A pouch type female External Collection device is a plastic pouch which is attached to the peri-urethral area with adhesive and which can be connected to a Urinary drainage container such as a bag or bottle. Male External catheters (condom-type) or female External Urinary Collection Devices are not considered medically necessary when ordered for members who also use an indwelling catheter.

6 Exclusion External Urinary Collection Devices does not include diapers or other types of absorptive pads. HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan The PureWick urine Collection System is unproven and not medically necessary for the management of Urinary incontinence . There are no peer-reviewed published literature specific to the PureWick System , or External Urinary Collection System using a continuous low-pressure pump. Thus, there is no evidence to show the PureWick System to be as an equally effective alternative in managing Urinary incontinence . Advantage While there is insufficient evidence in the published medical literature to demonstrate the safety, efficacy and long-term outcomes of the PureWick urine Collection System , the Ohio Department of Medicaid indicated coverage for procedure K1006.

7 The member must have a permanent impairment of urination. This does not require a determination that there is no possibility that the beneficiary's condition may improve sometime in the future. If the medical record, including the judgment of the treating practitioner, indicates the condition is of long and indefinite duration (ordinarily at least 3 months), the test of permanence is considered met. The use of a urological supply for the treatment of chronic Urinary tract infection or other bladder condition in the absence of permanent Urinary incontinence or retention is non-covered. Medicaid beneficiaries under the age of 21 years are entitled to all medically necessary DME. DME is medical necessary when it is required to correct or ameliorate disabilities or physical or mental illnesses or condition.

8 Any numerical limit on the amount of a particular item of DME can be exceeded for Medicaid beneficiaries under the age of 21 years if medically necessary. Likewise, time period for replacement of DME will not apply to Medicaid beneficiaries under the age of 21 years if the replacement is medically necessary. When prior authorization is required, the information submitted with the request must be sufficient to document the reasons why the requested DME item or quantity is medical necessary CODING/BILLING INFORMATION The appearance of a code in this section does not necessarily indicate coverage. Codes that are covered may have selection criteria that must be met. Payment for supplies may be included in payment for other services rendered.

9 HCPCS CODE A4326 Male External catheter with integral Collection chamber, any type, each [alternative to indwelling only - for members with permanent incontinence ] A4327 Female External Urinary Collection device; metal cup, each [alternative to indwelling only - for members with permanent incontinence ] A4328 Female External Urinary Collection device; pouch, each [alternative to indwelling only - for members with permanent incontinence ] PG0492 06/30/2021 A4349 Male External catheter, with or without adhesive, disposable, each (condom-type) [alternative to indwelling only - for members with permanent incontinence ] K1006 Suction pump, home model, portable or stationary, electric, any type, for use with External urine management System REVISION HISTORY EXPLANATION ORIGINAL effective DATE: 02/01/2021 Date Explanation & Changes 02/01/2021 Policy created 06/30/2021 The ODM updated fee schedules July 1, 2021 indicate that as of 01/01/2021 procedure K1006 is now covered.

10 Policy updated with coverage criteria for procedure K1006, for the Advantage product line, no prior authorization required. REFERENCES/RESOURCES Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and services Ohio Department of Medicaid American Medical Association, Current Procedural Terminology (CPT ) and associated publications and services Centers for Medicare and Medicaid Services, Healthcare Common Procedure Coding System , HCPCS Release and Code Sets Industry Standard Review Hayes, Inc. Industry Standard Review