SUPERCEDED LCD: Centers for Medicare & Medicaid Services

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Contractor Information

Contractor Name ^{back to top}

CIGNA Government Services
Contractor Number ^{back to top}
18003
Contractor Type ^{back to top}
DME MAC

LCD Information

LCD ID Number ^{back to top}

L5008

LCD Title ^{back to top}
Negative Pressure Wound Therapy Pumps

Contractor's Determination Number ^{back to top}
NPWT

AMA CPT / ADA CDT Copyright Statement ^{back to top}
CPT codes, descriptions and other data only are copyright 2009 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

CMS National Coverage Policy ^{back to top}


Primary Geographic Jurisdiction ^{back to top}
Alabama Arkansas Colorado Florida Georgia Louisiana Mississippi North Carolina New Mexico Oklahoma Puerto Rico South Carolina Tennessee Texas Virginia Virgin Islands West Virginia

Oversight Region ^{back to top}
Region IV

DME Region LCD Covers ^{back to top}
Jurisdiction C

Original Determination Effective Date ^{back to top}
For services performed on or after 10/01/2000

Original Determination Ending Date ^{back to top}


Revision Effective Date ^{back to top}
For services performed on or after 07/01/2007

Revision Ending Date ^{back to top}
09/30/2009

Indications and Limitations of Coverage and/or Medical Necessity ^{back to top}
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. For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage and/or medical necessity. EQUIPMENT: INITIAL COVERAGE: A Negative Pressure Wound Therapy (NPWT) pump and supplies are covered when either criterion A or B is met: A) 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, should have been tried or considered and ruled out prior to application of NPWT. 1) 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: a) Documentation in the patient’s medical record of evaluation, care, and wound measurements by a licensed medical professional, and b) Application of dressings to maintain a moist wound environment, and c) Debridement of necrotic tissue if present, and d) Evaluation of and provision for adequate nutritional status. 2) For Stage III or IV pressure ulcers: a) The patient has been appropriately turned and positioned, and b) The patient has used a group 2 or 3 support surface if the pressure ulcer is on the posterior trunk or pelvis (see LCD on support surfaces), c) The patient’s moisture and incontinence have been appropriately managed. 3) For neuropathic (for example, diabetic) ulcers: a) The patient has been on a comprehensive diabetic management program, and b) Reduction in pressure on a foot ulcer has been accomplished with appropriate modalities. 4) For venous insufficiency ulcers: a) Compression bandages and/or garments have been consistently applied, and b) Leg elevation and ambulation have been encouraged. B) Ulcers and Wounds Encountered in an Inpatient Setting: 1) 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. 2) 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 (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 continuation is ordered 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 medically necessary. NPWT pumps (E2402) must be capable of accommodating more than one wound dressing set for multiple wounds on a patient. Therefore, more than one E2402 billed per patient for the same time period will be denied as not medically necessary. A licensed health care professional, for the purposes of this policy, may be a physician, physician’s assistant (PA), registered nurse (RN), licensed practical nurse (LPN), or 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: An NPWT pump and supplies will be denied at any time as not medically 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; • untreated osteomyelitis within the vicinity of the wound; • cancer present in the wound; • the presence of a fistula to an organ or body cavity within the vicinity of the wound. NPWT pumps and their supplies that have not been specifically designated as being qualified to use HCPCS code E2402 via written instructions from the SADMERC will be denied as not medically necessary. CONTINUED COVERAGE: C) 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: 1) On a regular basis, a) directly assess the wound(s) being treated with the NPWT pump, and b) supervise or directly perform the NPWT dressing changes, and 2) On at least a monthly basis, document changes in the ulcer’s dimensions and characteristics. If criteria C-1 and C-2 are not fulfilled, continued coverage of the NPWT pump and supplies will be denied as not medically necessary. WHEN COVERAGE ENDS: D) For wounds and ulcers described under A or B above, an NPWT pump and supplies will be denied as not medically necessary with any of the following, whichever occurs earliest: 1) Criteria C1-C2 cease to occur, 2) In the judgment of the treating physician, adequate wound healing has occurred to the degree that NPWT may be discontinued, 3) 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) 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. 5) Once equipment or supplies are no longer being used for the patient, whether or not by the physician’s order. SUPPLIES: Coverage is provided up to a maximum of 15 dressing kits (A6550) per wound per month unless there is documentation that the wound size requires more than one dressing kit for each dressing change. 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..

Coding Information

Bill Type Codes: ^{back to top}

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: ^{back to top}

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 ^{back to top}

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

HCPCS MODIFIER:

EY - No physician or other licensed health care provider order for this item or service
KX - Specific required documentation on file.

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

ICD-9 Codes that Support Medical Necessity ^{back to top}

Not specified.

XX000 Not Applicable

Diagnoses that Support Medical Necessity ^{back to top}

Not specified.

ICD-9 Codes that DO NOT Support Medical Necessity ^{back to top}

Not specified

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation ^{back to top}

Diagnoses that DO NOT Support Medical Necessity ^{back to top}

Not specified.

General Information

Documentation Requirements ^{back to top}

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 patient’s medical records will reflect the need for the care provided. 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. This documentation must be available upon request.

An 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. 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.

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. 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. 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 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.

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.

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

1) The pump has been used to treat a single wound and the claim is for the 5th or subsequent month’s rental, or
2) The pump has been used to treat more than one wound and the claim is for the 5th 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 4 total months of rental.

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

When NPWT therapy exceeds 4 months on the most recent wound and reimbursement ends, individual consideration for additional months may be sought using the appeals process. Documentation should be submitted with the appeal explaining the special circumstances necessitating the extended therapy time.

When billing for quantities of supplies greater than those described in the policy as the usual maximum amounts, there must be clear documentation in the medical record corroborating the medical necessity for the additional quantities.

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

Appendices ^{back to top}

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

Stage I - Observable pressure related alteration of intact skin whose indicators as compared to the adjacent or opposite area on the body may include changes in one or more of the following: skin temperature (warmth or coolness), tissue consistency (firm or boggy feel) and/or sensation (pain, itching). The ulcer appears as a defined area of persistent redness in lightly pigmented skin, whereas in darker skin tones, the ulcer may appear with persistent red, blue, or purple hues.

Stage II - Partial thickness skin loss involving epidermis, dermis, or both. The ulcer is superficial and presents clinically as an abrasion, blister, or shallow crater.

Stage III - Full thickness skin loss involving damage to, or necrosis of, subcutaneous tissue that may extend down to, but not through, underlying fascia. The ulcer presents clinically as a deep crater with or without undermining of adjacent tissue.

Stage IV - Full thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures (e.g., tendon, joint capsule). Undermining and sinus tracts also may be associated with Stage IV pressure ulcers.

Utilization Guidelines ^{back to top}

Refer to Indications and Limitations of Coverage and/or Medical Necessity.

Sources of Information and Basis for Decision ^{back to top}

Advisory Committee Meeting Notes ^{back to top}

Start Date of Comment Period ^{back to top}

End Date of Comment Period ^{back to top}

Start Date of Notice Period ^{back to top}

10/01/2000

Revision History Number ^{back to top}

009

Revision History Explanation ^{back to top}

Revision Effective Date: 03/01/2008
In accordance with Section 911 of the Medicare Modernization Act, this policy was transitioned to DME MAC CIGNA Government Services (18003) LCD L11517 from DME PSC TrustSolutions (77012) LCD L11517.

Revision Effective Date: 07/01/2007
INDICATIONS AND LIMITATIONS OF COVERAGE:
Moved: Documentation requirements for extra supplies to the Documentation Requirements section of the LCD
Removed: DMERC references
DOCUMENTATION REQUIREMENTS:
Revised: Documentation requirements for extra supplies.
Removed: DMERC references

Revision Effective Date: 06/01/2007
In accordance with Section 911 of the Medicare Modernization Act of 2003, Virginia and West Virginia were transitioned from DME PSC TriCenturion (77011) to DME PSC TrustSolutions (77012).

Revision Effective Date: 07/01/2006
INDICATIONS AND LIMITATIONS OF COVERAGE:
Removed: Individual consideration language from “When Coverage Ends” section.
DOCUMENTATION SECTION:
Corrected: Reference to “Indications” section.
Added: Statement concerning claims that exceed 4 months of therapy.

Revision Effective Date: 03/01/2006:
In accordance with Section 911 of the Medicare Modernization Act of 2003,
this policy was transitioned to DME PSC TrustSolutions (77012) from DMERC Palmetto GBA (00885).

Revision Effective Date: 01/01/2006
INDICATIONS AND LIMITATIONS OF COVERAGE AND/OR MEDICAL NECESSITY
Removed: HCPCS codes A6550 and A6551 as requiring SADMERC verification.
Deleted: A6551 and inserted canister code A7000 as having a maximum of 10 canisters allowable per month
HCPCS CODES AND MODIFIERS:
Added: A7000
Revised: A6550
Deleted: A6551

Revision Effective Date: 10/01/2005
LMRP converted to LCD and Policy Article
Revised: Criteria D3 & D4
DOCUMENTATION REQUIREMENTS:
Revised: Instructions for use of KX modifier.
Removed: Requirement for additional documentation being submitted in the 5th month.

Revision Effective Date: 04/01/2004
HCPCS CODES & MODIFIERS:
Added: E2402, A6550, A6551
Deleted: K0538, K0539, K0540
INDICATIONS AND LIMITATIONS OF COVERAGE:
Added: References to new codes and removed deleted codes.
CODING GUIDELINS:
Added: References to new codes and removed deleted codes.

Revision Effective Date: 04/01/2003
HCPCS CODES AND MODIFIER:
Added: EY modifier
INDICATIONS AND LIMITATIONS OF COVERAGE:
Added: Standard language concerning coverage of items without an order.
DOCUMENTATION REQUIREMENTS:
Added: Standard verbiage concerning use of EY modifier for items without an order.
Added: Language regarding extra quantities being ordered and the need for documentation with each claim for excess quantities as well as in the patient’s medical record to corroborate medical necessity.

The revision date listed below is the date the revision was published and not necessarily the effective date for the revision.

07/01/2002 - Staging of pressure ulcers revised under Definition section. Section E, which is no longer applicable at this time, has been deleted from the Coverage and Payment Rules section. Replaced ZX modifier with KX modifier.

Reason for Change ^{back to top}

Last Reviewed On Date ^{back to top}

Medicare Coverage Database

LCD for Negative Pressure Wound Therapy Pumps (L5008)