Coverage Criteria and Medical Necessity with Medicare

by  Christine Woolstenhulme, QMC QCC CMCS CPC CMRS
Apr 4th, 2016 - Reviewed/Updated Aug 3rd

Negative Pressure Wound Therapy (NPWT) is defined as the application of sub-atmospheric 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.

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.

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

1. Ulcers and Wounds in the Home Setting:

The beneficiary 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.

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:

1. Documentation in the beneficiary’s medical record of evaluation, care, and wound measurements by a licensed medical professional, and
2. Application of dressings to maintain a moist wound environment, and
3. Debridement of necrotic tissue if present, and
4. Evaluation of and provision for adequate nutritional status

• For Stage III or IV pressure ulcers:

1. The beneficiary has been appropriately turned and positioned, and
2. The beneficiary has used a group 2 or 3 support surface for pressure ulcers on the posterior trunk or pelvis (see LCD on support surfaces), and
3. The beneficiary’s moisture and incontinence have been appropriately managed

• For neuropathic (for example, diabetic) ulcers:

1. The beneficiary has been on a comprehensive diabetic management program, and
2. Reduction in pressure on a foot ulcer has been accomplished with appropriate modalities

• For venous insufficiency ulcers:

1. Compression bandages and/or garments have been consistently applied, and
2. Leg elevation and ambulation have been encouraged

1. 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.

1. The beneficiary 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 beneficiary 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 beneficiary. Therefore, more than one E2402 billed per beneficiary 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 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 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.

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:

3. 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,
   
   
   1. Directly assess the wound(s) being treated with the NPWT pump, and
   2. Supervise or directly perform the NPWT dressing changes, and
   
   
   • 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 reasonable and necessary.

WHEN COVERAGE ENDS:

4. 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

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