LCD/NCD Portal

L5008

 

NEGATIVE PRESSURE WOUND THERAPY PUMPS

 

Region IV

DME

Jurisdiction C

 

10/01/2011

 

• For any item to be covered by Medicare, it must

o be eligible for a defined Medicare benefit category

o be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member

o meet all other applicable Medicare statutory and regulatory requirements.

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

 

 

• EQUIPMENT:

 

• INITIAL COVERAGE:

o Negative Pressure Wound Therapy (NPWT) is defined as the application of subatmospheric pressure to a wound to remove exudate and debris from wounds.

 NPWT is delivered through an integrated system of a suction pump, separate exudate collection chamber and dressing sets to a qualified wound.

 In these systems, exudate is completely removed from the wound site to the collection chamber. Refer to the CODING GUIDELINES section of the Policy Article for information about equipment and supply specifications.

o Other suction pump systems (K0743 – K0746) may also be used to remove exudate from a wound. Refer to the Suction Pumps Local Coverage Determination for information about coverage of these items.

o A Negative Pressure Wound Therapy pump (E2402) and supplies (A6550, A7000) are covered when either criterion A or B is met:

 Ulcers and Wounds in the Home Setting:

• The patient has a chronic Stage III or IV pressure ulcer (see Appendices Section), neuropathic (for example, diabetic) ulcer, venous or arterial insufficiency ulcer, or a chronic (being present for at least 30 days) ulcer of mixed etiology. A complete wound therapy program described by criterion 1 and criteria 2, 3, or 4, as applicable depending on the type of wound, must have been tried or considered and ruled out prior to application of NPWT.

• For all ulcers or wounds, the following components of a wound therapy program must include a minimum of all of the following general measures, which should either be addressed, applied, or considered and ruled out prior to application of NPWT:

o Documentation in the patient’s medical record of evaluation, care, and wound measurements by a licensed medical professional

o Application of dressings to maintain a moist wound environment

o Debridement of necrotic tissue if present

o Evaluation of and provision for adequate nutritional status.

• For Stage III or IV pressure ulcers:

o The patient has been appropriately turned and positioned

o The patient has used a group 2 or 3 support surface for pressure ulcers on the posterior trunk or pelvis (see LCD on support surfaces)

o The patient’s moisture and incontinence have been appropriately managed.

• For neuropathic (for example, diabetic) ulcers:

o The patient has been on a comprehensive diabetic management program

o Reduction in pressure on a foot ulcer has been accomplished with appropriate modalities.

• For venous insufficiency ulcers:

o Compression bandages and/or garments have been consistently applied, and

o Leg elevation and ambulation have been encouraged.

 Ulcers and Wounds Encountered in an Inpatient Setting:

• An ulcer or wound (described under A above) is encountered in the inpatient setting and, after wound treatments described under A-1 through A-4 have been tried or considered and ruled out, NPWT is initiated because it is considered in the judgment of the treating physician, the best available treatment option.

• The patient has complications of a surgically created wound (for example, dehiscence) or a traumatic wound (for example, pre-operative flap or graft) where there is documentation of the medical necessity for accelerated formation of granulation tissue which cannot be achieved by other available topical wound treatments

o (for example, other conditions of the patient that will not allow for healing times achievable with other topical wound treatments).

• In either situation B-1 or B-2, NPWT will be covered when treatment is ordered to continue beyond discharge to the home setting.

• If criterion A or B above is not met, the NPWT pump and supplies will be denied as not reasonable and necessary.

• NPWT pumps (E2402) must be capable of accommodating more than one wound dressing set for multiple wounds on a patient.

o Therefore, more than one E2402 billed per patient for the same time period will be denied as not reasonable and necessary.

• A licensed health care professional, for the purposes of this policy, may be a:

o Physician.

o Physician’s assistant (PA).

o Registered nurse (RN).

o Licensed practical nurse (LPN).

o Physical therapist (PT).

 The practitioner should be licensed to assess wounds and/or administer wound care within the state where the beneficiary is receiving NPWT.

 

• OTHER EXCLUSIONS FROM COVERAGE:

o An NPWT pump and supplies will be denied at any time as not reasonable and necessary if one or more of the following are present:

 The presence in the wound of necrotic tissue with eschar, if debridement is not attempted

 Osteomyelitis within the vicinity of the wound that is not concurrently being treated with intent to cure

 Cancer present in the wound

 The presence of an open fistula to an organ or body cavity within the vicinity of the wound.

o NPWT systems, pumps and their associated supplies, that have not been specifically designated as being qualified to use HCPCS codes E2402 via written instructions from the Pricing, Data Analysis and Coding (PDAC) Contractor will be denied as not reasonable and necessary.

 

• CONTINUED COVERAGE:

o For wounds and ulcers described under A or B above, once placed on an NPWT pump and supplies, in order for coverage to continue, a licensed medical professional must do the following:

 On a regular basis

 Directly assess the wound(s) being treated with the NPWT pump

 Supervise or directly perform the NPWT dressing changes

 On at least a monthly basis, document changes in the ulcer’s dimensions and characteristics.

o If criteria C-1 and C-2 are not fulfilled, continued coverage of the NPWT pump and supplies will be denied as not reasonable and necessary.

 

• WHEN COVERAGE ENDS:

o For wounds and ulcers described under A or B above, an NPWT pump and supplies will be denied as not reasonable and necessary with any of the following, whichever occurs earliest:

 Criteria C1-C2 cease to occur

 In the judgment of the treating physician, adequate wound healing has occurred to the degree that NPWT may be discontinued

 Any measurable degree of wound healing has failed to occur over the prior month. Wound healing is defined as improvement occurring in either surface area (length times width) or depth of the wound.

 4 months (including the time NPWT was applied in an inpatient setting prior to discharge to the home) have elapsed using an NPWT pump in the treatment of the most recent wound.

 Once equipment or supplies are no longer being used for the patient, whether or not by the physician’s order.

 

• SUPPLIES:

o Coverage is provided up to a maximum of 15 dressing kits (A6550) per wound per month.

o Coverage is provided up to a maximum of 10 canister sets (A7000) per month unless there is documentation evidencing a large volume of drainage (greater than 90 ml of exudate per day).

 For high volume, exudative wounds, a stationary pump with the largest capacity canister must be used.

o For DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use.

 For DMEPOS products (A6550 and A7000) 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/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.

• (CMS Program Integrity Manual, Internet-Only Manual, CMS Pub. 100-8, Chapter 5, Section 5.2.6).

 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.

o 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 ordering physicians that any changed or atypical utilization is warranted.

 Regardless of utilization, a supplier must not dispense more than a one (1)-month quantity at a time.

 

 

Bill Type Codes:

• Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.

• Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type.

• Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

 

Revenue Codes:

• Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service.

• In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination.

• Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

 

 

CPT/HCPCS Codes

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

 

 

HCPCS MODIFIERS:

 

• 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

 

• 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:

 

EQUIPMENT

E2402 NEGATIVE PRESSURE WOUND THERAPY ELECTRICAL PUMP, STATIONARY OR PORTABLE

 

SUPPLIES

A6550 WOUND CARE SET, FOR NEGATIVE PRESSURE WOUND THERAPY ELECTRICAL PUMP, INCLUDES ALL SUPPLIES AND ACCESSORIES

A7000 CANISTER, DISPOSABLE, USED WITH SUCTION PUMP, EACH

 

 

Documentations 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."

o It is expected that the patient's medical records will reflect the need for the care provided.

o The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports.

o This documentation must be available upon request.

• An detailed written order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request.

o Items delivered before a signed written order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.

o Orders for NPWT are only valid for up to an initial four months of therapy because of the coverage limitation in the Indications and Limitations of Coverage section.

• Documentation of the history, previous treatment regimens (if applicable), and current wound management for which an NPWT pump is being billed must be present in the patient’s medical record and be available for review upon request.

o 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.).

• Documentation of wound evaluation and treatment, recorded in the patient’s medical record, must indicate regular evaluation and treatment of the patient’s wounds, as detailed in the Indications and Limitations of Coverage Section.

o 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.

o 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 patient’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 patient’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, an ICD-9-CM 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 physician describing the initial condition of the wound (including measurements) and the efforts to address all aspects of wound care (listed in A1 through A4).

o For each subsequent month, the medical record must include updated wound measurements and what changes are being applied to effect wound healing.

o 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.

o 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.

o Information from the treating physician’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.

o Note, this policy provides coverage for the use of NPWT limited to initiating healing of the problem wounds described in the “Indications and Limitations of Coverage and/or Medical Necessity” section of this 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.

o 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.

o 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 policy as the usual maximum amounts, there must be clear and explicit information in the medical record that justifies the additional quantities.

 

• REFILLS

o A routine refill prescription is not needed. A new prescription is needed when:

 There is a change of supplier

 There is a change in treating physician

 There is a change in the item(s), frequency of use, or amount prescribed

 There is a change in the length of need or a previously established length of need expires

 State law requires a renewal

o For items that the patient obtains in person at a retail store, the signed delivery slip or copy of itemized sales receipt is sufficient documentation of a request for refill.

o For items that are delivered to the beneficiary, documentation of a request for refill must be either a written document received from the beneficiary or a contemporaneous written record of a phone conversation/contact between the supplier and beneficiary.

 The refill request must occur and be documented before shipment.

 A retrospective attestation statement by the supplier or beneficiary is not sufficient.

 The refill record must include:

 Beneficiary’s name or authorized representative if different than the beneficiary

 A description of each item that is being requested

 Date of refill request

 Quantity of each item that the beneficiary still has remaining

o This information must be kept on file and be available upon request.

 

• KX, GA and GZ MODIFIERS:

o Suppliers must add a KX modifier to a code only if all of the criteria in the “Indications and Limitations of Coverage and/or Medical Necessity” section of this policy have been met.

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

 The pump has been used to treat a single wound and the claim is for the fifth or subsequent month’s rental,

 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.

o 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.

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

o Refer to the Supplier Manual for more information on documentation requirements.

 

• Appendices

o The staging of pressure ulcers used in this policy is as follows:

 Suspected Deep Tissue Injury:

 Purple or maroon localized area of discolored intact skin or blood-filled blister due to damage of underlying soft tissue from pressure and/or shear.

 The area may be preceded by tissue that is painful, firm, mushy, boggy, warmer or cooler as compared to adjacent tissue.

 Stage I

 Intact skin with non-blanchable redness of a localized area usually over a bony prominence.

 Darkly pigmented skin may not have visible blanching; its color may differ from the surrounding area.

 Stage II

 Partial thickness loss of dermis presenting as a shallow open ulcer with a red pink wound bed, without slough.

 May also present as an intact or open/ruptured serum-filled blister.

 Stage III

 Full thickness tissue loss.

 Subcutaneous fat may be visible but bone, tendon or muscle is not exposed.

 Slough may be present but does not obscure the depth of tissue loss.

 May include undermining and tunneling.

 Stage IV

 Full thickness tissue loss with exposed bone, tendon or muscle.

 Slough or eschar may be present on some parts of the wound bed.

 Often include undermining and tunneling.

 Unstageable:

 Full thickness tissue loss in which the base of the ulcer is covered by

 slough (yellow, tan, gray, green or brown)

 Eschar (tan, brown or black) in the wound bed.

 

Sources of Information and Basis for Decision

 

National Pressure Ulcer Advisory Panel (NPUAP) Revised Staging Definitions for Pressure Ulcers on August 28, 2008

 

A35363 - Negative Pressure Wound Therapy Pumps - Policy Article - Effective October 2011

 

Local Coverage Determination (LCD) for Negative Pressure Wound Therapy Pumps (L5008)