Negative Pressure Wound Therapy Pumps - 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").

Negative pressure wound therapy equipment is covered under the Durable Medical
Equipment benefit (Social Security Act 1861(s)(6)). 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 (LCD) must be met. In addition, there are specific statutory
payment policy requirements, discussed below, that also must be met.

Disposable wound suction pumps and related supplies (A9272) will be denied as
statutorily noncovered because they do not meet the DME benefit.

**  
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, it will be eligible
for coverage.

**  
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.

Information describing the history, previous treatment regimens (if
applicable), and current wound management for which a NPWT pump is being
billed must be present in the beneficiary's medical record and be available
for review upon request. This documentation must include such elements as
length of sessions of use, dressing types and frequency of change, and changes
in wound conditions, including precise measurements, quantity of exudates,
presence of granulation and necrotic tissue and concurrent measures being
addressed relevant to wound therapy (debridement, nutritional concerns,
support surfaces in use, positioning, incontinence control, etc.).

Information describing the wound evaluation and treatment, recorded in the
beneficiary's medical record, must indicate regular evaluation and treatment
of the beneficiary's wounds, as detailed in the Coverage Indications,
Limitations and/or Medical Necessity section of the related LCD.

Documentation of quantitative measurements of wound characteristics including
wound length and width (surface area), and depth, and amount of wound exudate
(drainage), indicating progress of healing must be entered at least monthly.
The supplier of the NPWT equipment and supplies must obtain from the treating
clinician, an assessment of wound healing progress, based upon the wound
measurement as documented in the beneficiary's medical record, in order to
determine whether the equipment and supplies continue to qualify for Medicare
coverage. (The supplier need not view the medical records in order to bill for
continued use of NPWT. Whether the supplier ascertains that wound healing is
occurring from month to month via verbal or written communication is left to
the discretion of the supplier. However, the beneficiary's medical records may
be requested in order to corroborate that wound healing is/was occurring as
represented on the supplier's claims for reimbursement.)

When billing for NPWT, a diagnosis code (specific to the 5th digit or
narrative diagnosis), describing the wound being treated by NPWT, must be
included on each claim for the equipment and related supplies.

The medical record must include a statement from the treating practitioner
describing the initial condition of the wound (including measurements) and the
efforts to address all aspects of wound care (listed in A1 through A4 in the
related LCD). For each subsequent month, the medical record must include
updated wound measurements and what changes are being applied to effect wound
healing.

Month-to-month comparisons of wound size must compare like measurements i.e.
depth compared to depth or surface area compared to surface area.

If the initiation of NPWT occurs during an inpatient stay, in order to
accurately account for the duration of treatment, the initial inpatient date
of service must be documented. This date must be available upon request.

When NPWT therapy exceeds 4 months on the most recent wound and reimbursement
ends, individual consideration for one additional month at a time may be
sought using the appeals process. Information from the treating practitioner's
medical record, contemporaneous with each requested one-month treatment time
period extension, must be submitted with each appeal explaining the special
circumstances necessitating the extended month of therapy. Note, the LCD
provides coverage for the use of NPWT limited to initiating healing of the
problem wounds described in the "Coverage Indications, Limitations and/or
Medical Necessity" section of the related LCD rather than continuation of
therapy to complete healing since there is no published medical literature
demonstrating evidence of a clinical benefit for the use of NPWT to complete
wound healing. Therefore, general, vague or nonspecific statements in the
medical record such as "doing well, want to continue until healed" provide
insufficient information to justify the need for extension of treatment. The
medical record must provide specific and detailed information to explain the
continuing problems with the wound, what additional measures are being
undertaken to address those problems and promote healing and why a switch to
alternative treatments alone is not possible.

When billing for quantities of canisters greater than those described in the
related LCD as the usual maximum amounts, there must be clear and explicit
information in the medical record that justifies the additional quantities.

**  
WRITTEN ORDER PRIOR TO DELIVERY (WOPD)**

Effective for claims with dates of service on or after 05/25/2017, a WOPD is
no longer required.

**  
MODIFIERS**

KX, GA, and GZ Modifiers:

Suppliers must add a KX modifier to a code only if all of the criteria in the
"Coverage Indications, Limitations and/or Medical Necessity" section of the
related LCD have been met.

The KX modifier must not be used with a NPWT pump and supplies for wounds if:

  1. The pump has been used to treat a single wound and the claim is for the fifth or subsequent month's rental, or
  2. The pump has been used to treat more than one wound and the claim is for the fifth or subsequent month's rental after therapy has begun on the most recently treated wound. In this situation, the KX modifier may be billed for more than four total months of rental.

In all of the situations above describing use of the KX modifier, if all of
the coverage criteria have not been met, the GA or GZ modifier must be added
to a claim line for the NPWT pump and supplies. When there is an expectation
of a reasonable and necessary 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 or GZ modifier will be rejected as missing
information.

**  
CODING GUIDELINES**

NPWT is provided with an integrated system of components. This system contains
a pump (E2402), dressing sets (A6550) and a separate collection canister
(A7000). Wound suction systems that do not contain all of the required
components are not classified as NPWT. See below for component specifications.

  
EQUIPMENT:

Code E2402 describes a stationary or portable Negative Pressure Wound Therapy
(NPWT) electrical pump which provides controlled sub-atmospheric pressure that
is designed for use with NPWT dressings (A6550) and canisters (A7000) to
promote wound healing. The NPWT pump must be capable of being selectively
switched between continuous and intermittent modes of operation and is
controllable to adjust the degree of sub-atmospheric pressure conveyed to the
wound in a range of 40-80 mm Hg sub-atmospheric pressure. The system must
contain sensors and alarms to monitor pressure variations and exudate volume
in the collection canister.

Disposable wound suction system pumps and related supplies must be coded A9272
(WOUND SUCTION, DISPOSABLE, INCLUDES DRESSING, ALL ACCESSORIES AND COMPONENTS,
ANY TYPE, EACH).

  
SUPPLIES:

Code A6550 describes an allowance for a dressing set which is used in
conjunction with a stationary or portable NPWT pump (E2402). A single code
A6550 is used for each single, complete dressing change, and contains all
necessary components, including but not limited to any separate, non-adherent
porous dressing(s), drainage tubing, and an occlusive dressing(s) which
creates a seal around the wound site for maintaining sub-atmospheric pressure
at the wound.

HCPCS code A7000 describes a canister set which is used in conjunction with a
stationary or portable NPWT pump and contains all necessary components,
including but not limited to a container, to collect wound exudate. Canisters
may be various sizes to accommodate stationary or portable NPWT pumps.

Code A9272 (WOUND SUCTION, DISPOSABLE, INCLUDES DRESSING, ALL ACCESSORIES AND
COMPONENTS, ANY TYPE, EACH) describes a disposable wound suction device.
Suction is developed through the use of any type of mechanism. This device
includes all components, accessories and dressings. Code A9272 is all-
inclusive. Supplies used with disposable wound suction systems are not
separately billable. Examples (not all-inclusive) include: SNaP (Spiracure),
PICO (Smith and Nephew), VAC Via (KCI). Disposable wound suction items other
than those coded as A9272 must be coded A9270 (noncovered item or service).
For example, an elastomeric suction device would be correctly coded A9270.

The only products which may be billed using codes E2402 are those for which a
written Coding Verification Review has been made by the Pricing, Data Analysis
and Coding (PDAC) Contractor and subsequently published on the appropriate
Product Classification List.

Suppliers should contact the PDAC for guidance on the correct coding of these
items.