Summary Of Evidence

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Analysis of Evidence

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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.

The purpose of a Local Coverage Determination (LCD) is to provide information regarding “reasonable and necessary” criteria based on Social Security Act § 1862(a)(1)(A) provisions.

In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:

• The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.
• The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.
• Refer to the Supplier Manual for additional information on documentation requirements.
• Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

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

EQUIPMENT:

INITIAL COVERAGE:

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, K0744, K0745, and 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 3 or 4 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
         
         
   2. For Stage 3 or 4 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
         
         
   3. 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
         
         
   4. For venous insufficiency ulcers:
       
      1. Compression bandages and/or garments have been consistently applied, and
      2. Leg elevation and ambulation have been encouraged
         
         
2. 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 practitioner, the best available treatment option.
      
      
   2. 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 treating 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:

A 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 a 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
         
         
   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 reasonable and necessary.

WHEN COVERAGE ENDS:

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

1. Criteria C1-C2 cease to occur,
   
   
2. In the judgment of the treating practitioner, 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 a NPWT pump in the treatment of the most recent wound
   
   
5. Once equipment or supplies are no longer being used for the beneficiary, whether or not by the treating practitioner’s order

SUPPLIES:

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

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.

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.

GENERAL

A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.

REFILL REQUIREMENTS

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

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.

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 treating practitioners 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.