Urological Supplies - Policy Article

**NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES**

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. Information provided in this policy article relates
to determinations other than those based on Social Security Act 1862(a)(1)(A)
provisions (i.e. "reasonable and necessary").

Urological supplies are covered under the Prosthetic Device benefit (Social
Security Act  1861(s)(8)). In order for a beneficiary's equipment to be
eligible for reimbursement the reasonable and necessary (R&N) requirements set
out in the related Local Coverage Determination must be met. In addition,
there are specific statutory payment policy requirements, discussed below,
that also must be met.

**REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed.
Reg Vol 217)**

Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a
Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the
DME MACs provide a list of the specified codes, which is periodically updated.
The required Face-to-Face Encounter and Written Order Prior to Delivery List
is available [here](https://www.cms.gov/Research-Statistics-Data-and-
Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-
Review/FacetoFaceEncounterRequirementforCertainDurableMedicalEquipment).

Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol
217) that do not meet the face-to-face encounter and WOPD requirements
specified in the LCD-related Standard Documentation Requirements Article
(A55426) will be denied as not reasonable and necessary.

If a supplier delivers an item prior to receipt of a WOPD, it will be denied
as not reasonable and necessary. If the WOPD is not obtained prior to
delivery, payment will not be made for that item even if a WOPD is
subsequently obtained by the supplier. If a similar item is subsequently
provided by an unrelated supplier who has obtained a WOPD prior to delivery,
it will be eligible for coverage.

**GENERAL**

Urinary catheters and external urinary collection devices are covered to drain
or collect urine for a beneficiary who has permanent urinary incontinence or
permanent urinary retention. Permanent urinary retention is defined as
retention that is not expected to be medically or surgically corrected in that
beneficiary within 3 months.

If the catheter or the external urinary collection device meets the coverage
criteria then the related supplies that are necessary for their effective use
are also covered. Urological supplies that are used for purposes not related
to the covered use of catheters or external urinary collection devices (i.e.,
drainage and/or collection of urine from the bladder) will be denied as non-
covered.

The beneficiary 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. Catheters and related supplies will be denied as non-
covered in situations in which it is expected that the condition will be
temporary.

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. Since the beneficiary's urinary
system is functioning, the criteria for coverage under the prosthetic benefit
provision are not met.

When inserting an inFlow device or using urological supplies in a treating
practitioner's office as part of a professional service that is billed to
Medicare, the supplies are considered incident to the professional services of
the health care practitioner and are not separately payable. Claims for these
devices must not be submitted. Claims for the professional service, which
includes the device, must be submitted to the A/B MAC.

If additional inFlow devices or urological supplies are sent home with the
beneficiary, claims for these devices may be billed to the DME MAC only if the
beneficiary's condition meets the definition of permanence as defined in the
Prosthetic Device benefit. In this situation, use the place of service
corresponding to the beneficiary's residence; Place of Service Office (POS) 11
must not be used. If the beneficiary's condition is expected to be temporary,
urological supplies may not be billed. In this situation, they are considered
as supplies provided incident to a treating practitioner's service and payment
is included in the allowance for the treating practitioner services, which are
processed by the A/B MAC.

**POLICY SPECIFIC DOCUMENTATION REQUIREMENTS**

In addition to policy specific documentation requirements, there are general
documentation requirements that are applicable to all DMEPOS policies. These
general requirements are located in the DOCUMENTATION REQUIREMENTS section of
the LCD.

Refer to the LCD-related Standard Documentation Requirements article, located
at the bottom of this Policy Article under the Related Local Coverage
Documents section for additional information regarding GENERAL DOCUMENTATION
REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed
below.

When the prescribing practitioner is also the supplier, and is permitted to
furnish specific items of DMEPOS, a separate order is not required; however,
the medical record must still contain all of the required order elements.

**CONTINUED MEDICAL NEED**

For all DMEPOS items, the initial justification for medical need is
established at the time the item(s) is first ordered, therefore, beneficiary
medical records demonstrating that the item is reasonable and necessary are
created just prior to, or at the time of, the creation of the initial
prescription. Once initial medical need is established, unless continued
coverage requirements are specified in the LCD, ongoing need for urological
supplies is assumed to drain or collect urine for a beneficiary who has
permanent urinary incontinence or permanent urinary retention. There is no
requirement for further documentation of continued medical need as long as the
beneficiary continues to meet the Prosthetic Devices benefit.

**MODIFIERS**

AU MODIFIER:

When codes A4217, A4450, and A4452 are used with Urological Supplies, they
must be billed with the AU modifier. For this policy, codes A4217, A4450, and
A4452 are the only three codes for which the AU modifier may be used. Claim
lines for codes A4217, A4450 and A4452 billed for urological supplies without
an AU modifier will be rejected as missing information.

KX, GA, GY and GZ MODIFIERS:

Suppliers must add a KX modifier to a code for the inFlow device, a catheter,
an external urinary collection device, or a supply used with one of these
items only if both 1 and 2 are met.

  1. The statutory benefit criteria described in the NONMEDICAL NECESSITY COVERAGE AND PAYMENT RULES section above are met, and
  2. The applicable reasonable and necessary (R&N) criteria described in the COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY section of the related LCD are met.

If all of the criteria in the NONMEDICAL NECESSITY COVERAGE AND PAYMENT RULES
section above are not met, a GY modifier must be added to the code.

If all of the applicable R&N criteria in the COVERAGE INDICATIONS, LIMITATIONS
AND/OR MEDICAL NECESSITY section in the related LCD have not been met, a GA or
GZ modifier must be added to the code. When there is an expectation of a
medical necessity (R&N) denial, suppliers must enter the GA modifier on the
claim line if they have obtained a properly executed Advance Beneficiary
Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.

Claim lines billed without a KX, GA, GY or GZ modifier will be rejected as
missing information.

MISCELLANEOUS

Adhesive strips or tape used with male external catheters are included in the
allowance for the code and are not separately payable.

Catheter insertion trays (A4310, A4311, A4312, A4313, A4314, A4315, A4316,
A4353, and A4354) that contain component parts of the urinary collection
system, (e.g., drainage bags and tubing) are inclusive sets and payment for
additional component parts will be allowed only per the stated criteria in
each section of the policy.

Irrigation supplies that are used for care of the skin or perineum of
incontinent beneficiaries are non-covered.

Claims for sterile water/saline (A4217) and tape (A4450 or A4452) that are
billed without an AU modifier or another modifier indicating coverage under a
different policy will be rejected as missing information.

Extension tubing (A4331) will be covered for use with a latex urinary leg bag
(A5112). It is included in the allowance for codes A4314, A4315, A4316, A4354,
A4357, A4358, and A5105 and should not be separately billed with these codes.

Other supplies used in the management of incontinence, including but not
limited to the following items, will be denied as non-covered because they are
not prosthetic devices nor are they required for the effective use of a
prosthetic device:

  1. Creams, salves, lotions, barriers (liquid, spray, wipes, powder, paste) or other skin care products (A6250)
  2. Catheter care kits (A9270)
  3. Adhesive remover (A4455, A4456) (Coverage remains for use with ostomy supplies.)
  4. Catheter clamp or plug (A9270)
  5. Non-Disposable underpads (A4553)
  6. Disposable underpads, e.g., Chux (A4554)
  7. Diapers, or incontinent garments, disposable or reusable (A4520)
  8. Drainage bag holder or stand (A9270)
  9. Urinary suspensory without leg bag (A9270)
  10. Measuring container (A9270)
  11. Urinary drainage tray (A9270)
  12. Gauze pads (A6216, A6217, A6218) and other dressings (coverage remains under other benefits, e.g. surgical dressings)
  13. Other incontinence products not directly related to the use of a covered urinary catheter or external urinary collection device (A9270)
  14. Disposable external urethral clamp or compression device, with pad and/or pouch, (A4360)

**CODING GUIDELINES**

The general term "external urinary collection devices" used in this policy
includes male external catheters and female pouches or meatal cups. This term
does not include diapers or other types of absorptive pads.

A meatal cup female external urinary collection device (A4327) 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 (A4328) is a plastic pouch
which is attached to the periurethral area with adhesive and which can be
connected to a urinary drainage container such as a bag or bottle.

A urinary catheter-anchoring device described by code A4333 has an adhesive
surface, which attaches to the beneficiary's skin and a mechanism for
releasing and re-anchoring the catheter multiple times without changing the
anchoring device.

A urinary catheter-anchoring device described by code A4334 is a strap, which
goes around a beneficiary's leg and has a mechanism for releasing and re-
anchoring the catheter multiple times without changing the anchoring device.

An intermittent urinary catheter with insertion supplies (A4353) is a kit,
which includes a catheter and all supplies necessary for a single, sterile
insertion (see below). Code A4353 may be used if any of the following 1, 2 or
3 is supplied:

  1. A single sterile package containing both an intermittent urinary catheter and all necessary insertion/collection supplies; or
  2. A sterile intermittent urinary catheter plus a separately-packaged sterile kit containing all necessary insertion/collection supplies; or
  3. A sterile "no-touch" type of catheter system.

The insertion kit (A4353) described in #1 and #2 above contains an
intermittent urinary catheter (packaged separately from the other components
in #2), lubricant, gloves, antiseptic solution, applicators, a drape, and a
collection tray/bag in a sterile package intended for single use. The
collection tray/bag is a separate item included within the kit; therefore,
materials that serve as non-sterile packaging to contain all of the items in
the kit do not meet this requirement. Except as noted in #2 above, code A4353
must not be billed if individual insertion kit components are provided as
separate items. When providing a sterile kit, all components are included and
packaged as a kit. Separate billing of individual components is considered as
unbundling.

The product described in #3 is a single-catheter system that is functionally
equivalent to a complete sterile insertion kit (A4353) containing a catheter
and the additional components as described in the previous paragraph. In order
to be coded as A4353, a "no-touch" type of catheter system must be a sterile,
all-inclusive, self-contained system capable of accomplishing intermittent
catheterization with sterile technique without the use of additional supplies
such as gloves, lubricant, collection chamber, etc. Additional individual
components must not be separately billed. Separate billing of additional
supply items is considered as unbundling.

Therapeutic agent for urinary irrigation (A4321) is defined as a solution
containing agents in addition to saline or sterile water (for example acetic
acid or hydrogen peroxide) which is used for the treatment or prevention of
urinary catheter obstruction.

Code A5105 should be used when billing for a urinary suspensory with leg bag.

A4326 is a male external catheter with an integrated collection chamber that
does not require the use of an additional leg bag.

Irrigation solutions containing antibiotics and chemotherapeutic agents should
be coded A9270. Irrigating solutions, such as acetic acid or hydrogen
peroxide, which is used for the treatment or prevention of urinary
obstruction, should be coded A4321.

Adhesive strips or tape used with code A4349 (MALE EXTERNAL CATHETER, WITH OR
WITHOUT ADHESIVE, DISPOSABLE, EACH) should not be billed separately.

Adhesive catheter anchoring devices that are used with indwelling urethral
catheters are billed using codes A4333 and A4334, respectively. An anchoring
device used with a percutaneous catheter/tube (e.g., suprapubic tube,
nephrostomy tube) is billed using code A5200.

Replacement leg straps (A5113, A5114) are used with a urinary leg bag (A4358,
A5105, or A5112). These codes are not used for a leg strap for an indwelling
catheter.

When codes A4217, A4450, and A4452 are used with Urological Supplies, they
must be billed with the AU modifier. For this policy, codes A4217, A4450, and
A4452 are the only three codes for which the AU modifier may be used.

An external catheter that contains a barrier for attachment should be coded
using A4335.

Codes for ostomy barriers (A4369 and A4371) should not be used for skin care
products used in the management of urinary incontinence.

A percutaneous catheter/tube anchoring device (A5200) is a dressing with
adhesive that is designed to be applied directly over the cutaneous opening
through which the catheter/tube passes. This dressing has a hole through which
the catheter/tube passes and a mechanism for firmly anchoring the
catheter/tube to the dressing.

For claims with date of service (DOS) July 26, 2020 through September 30,
2020, the inFlow Intraurethral Valve-Pump system (Vesiflo, Inc.) must be
billed using HCPCS code A4335 (INCONTINENCE SUPPLY; MISCELLANEOUS). Code A4335
is billed as 1 unit of service (UOS) at initial issue, and is all inclusive
(catheter, activator, charging base). Code A4335 must also be used on separate
claim lines for replacement of any of the individual components of the inFlow
Intraurethral Valve-Pump system (catheter, activator, charging base).

For claims with DOS October 1, 2020 through March 31, 2021, the inFlow system
must be billed using HCPCS code(s): K1010 (Indwelling intraurethral drainage
device with valve, patient inserted, replacement only, each), K1011
(Activation device for intraurethral drainage device with valve, replacement
only, each) and/or K1012 (Charger and base station for intraurethral
activation device, replacement only).

For claims with DOS April 1, 2021 through March 31, 2023, the inFlow
Intraurethral Valve-Pump system (Vesiflo, Inc.) must be billed using HCPCS
code A4335 (INCONTINENCE SUPPLY; MISCELLANEOUS). Code A4335 is billed as 1
unit of service (UOS) at initial issue (see below), and is all-inclusive
(catheter, activator, charging base). For replacement of individual
components, code A4335 must be used on separate claim lines for any of the
individual components of the inFlow Intraurethral Valve-Pump system (catheter,
activator, charging base).

For claims with DOS on or after April 1, 2023, the inFlow Intraurethral Valve-
Pump system (Vesiflo, Inc.) must be billed using HCPCS code A4341 (INDWELLING
INTRAURETHRAL DRAINAGE DEVICE WITH VALVE, PATIENT INSERTED, REPLACEMENT ONLY,
EACH).

The initial sizing and insertion of the inFlow device is performed by the
treating practitioner in their office. Claims for these services must be
billed to the Part B MAC. Replacement of the indwelling intraurethral drainage
device with valve is done by a trained caregiver or the beneficiary at home
and may be billed on a monthly basis. If a replacement of the indwelling
intraurethral drainage device with valve is performed by the treating
practitioner, claims for this service must be billed to the Part B MAC.

Since the activator and charging base are provided at the time of initial
issue in the treating practitioner's office to the beneficiary, these may only
be billed to the DME MAC as a replacement using HCPCS code A4342 (ACCESSORIES
FOR PATIENT INSERTED INDWELLING INTRAURETHRAL DRAINAGE DEVICE WITH VALVE,
REPLACEMENT ONLY, EACH).

Payment for items listed in Column II are included in the payment for the
Column I code. In the following table, when providing the items listed in
Column II, the Column I code must be used instead of billing separate Column
II codes when the items are provided at the same time.

Column I

|

Column II  
  
---|---  
  
A4310

|

A4332  
  
A4311

|

A4310, A4332, A4338  
  
A4312

|

A4310, A4332, A4344  
  
A4313

|

A4310, A4332, A4346  
  
A4314

|

A4310, A4311, A4331, A4332, A4338, A4354, A4357  
  
A4315

|

A4310, A4312, A4331, A4332, A4344, A4354, A4357  
  
A4316

|

A4310, A4313, A4331, A4332, A4346, A4354, A4357  
  
A4354

|

A4310, A4331, A4332, A4357  
  
A4357

|

A4331  
  
A4358

|

A4331, A5113, A5114  
  
A5105

|

A4331, A4358, A5112, A5113, A5114  
  
A5112

|

A5113, A5114  
  
  
If a code exists that includes multiple products, that code should be used in
lieu of the individual codes.

Suppliers should contact the Pricing, Data Analysis and Coding (PDAC)
Contractor for guidance on the correct coding of these items.