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.

Medicare provides reimbursement for surgical dressing under the Surgical Dressings Benefit. This benefit only provides coverage for primary and secondary surgical dressing used on the skin on specified wound types. Refer to the related Policy Article NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES for information about these statutory requirements.

In addition to the statutory requirements, 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.

DRESSINGS

The following are specific guidelines for individual product types.

Alginate Or Other Fiber Gelling Dressing (A6196-A6199)

Alginate or other fiber gelling dressing covers are covered for moderately to highly exudative full thickness wounds (e.g., stage 3 or 4 ulcers); and alginate or other fiber gelling dressing fillers for moderately to highly exudative full thickness wound cavities (e.g., stage 3 or 4 ulcers). They are not reasonable and necessary on dry wounds or wounds covered with eschar. Dressing change is up to once per day. One wound cover sheet of the approximate size of the wound or up to 2 units of wound filler (1 unit = 6 inches of alginate or other fiber gelling dressing rope) is used at each dressing change.

Collagen Dressing Or Wound Filler (A6010, A6011, A6021-A6024)

A collagen-based dressing or wound filler is covered for full thickness wounds (e.g., stage 3 or 4 ulcers), wounds with light to moderate exudate, or wounds that have stalled or have not progressed toward a healing goal. They can stay in place up to 7 days. Collagen based dressings are not covered for wounds with heavy exudate, third-degree burns, or when an active vasculitis is present.

Composite Dressing (A6203-A6205)

Composite dressings are covered for moderately to highly exudative wounds. Composite dressing change is up to 3 times per week, one wound cover per dressing change.

Contact Layer (A6206-A6208)

Contact layer dressings are used to line the entire wound to prevent adhesion of the overlying dressing to the wound. They are not reasonable and necessary when used with any dressing that has a non-adherent or semi-adherent layer as part of the dressing. They are not intended to be changed with each dressing change. Dressing change is up to once per week.

Foam Dressing Or Wound Filler (A6209-A6215)

Foam dressings are covered when used on full thickness wounds (e.g., stage 3 or 4 ulcers) with moderate to heavy exudate. Dressing change for a foam wound cover used as a primary dressing is up to 3 times per week. When a foam wound cover is used as a secondary dressing for wounds with very heavy exudate, dressing change is up to 3 times per week. Dressing change frequency for foam wound fillers is up to once per day.

Gauze, Non-Impregnated (A6216-A6221, A6402-A6404, A6407)

Non-impregnated gauze dressing change is up to 3 times per day for a dressing without a border and once per day for a dressing with a border. It is usually not reasonable and necessary to stack more than 2 gauze pads on top of each other in any one area.

Gauze, Impregnated, With Other Than Water, Normal Saline, Hydrogel, Or Zinc Paste (A6222-A6224, A6266)

Coverage is based upon the characteristics of the underlying material(s). Dressing change for gauze dressings impregnated with other than water, normal saline, hydrogel or zinc paste is up to once per day.

Gauze, Impregnated, Water Or Normal Saline (A6228-A6230)

There is no medical necessity for these dressings compared to non-impregnated gauze which is moistened with bulk saline or sterile water. When these dressings are billed, they will be denied as not reasonable and necessary.

Hydrocolloid Dressing (A6234-A6241)

Hydrocolloid dressings are covered for use on wounds with light to moderate exudate. Dressing change for hydrocolloid wound covers or hydrocolloid wound fillers is up to 3 times per week.

Hydrogel Dressing (A6231-A6233, A6242-A6248)

Hydrogel dressings are covered when used on full thickness wounds (e.g., stage 3 or 4 ulcers) with minimal or no exudate. Hydrogel dressings are not reasonable and necessary for stage 2 ulcers. Dressing change for hydrogel wound covers without adhesive border or hydrogel wound fillers is up to once per day. Dressing change for hydrogel wound covers with adhesive border is up to 3 times per week.

The quantity of hydrogel filler used for each wound must not exceed the amount needed to line the surface of the wound. Additional amounts used to fill a cavity are not reasonable and necessary. Maximum utilization of code A6248 is 3 units (fluid ounces) per wound in 30 days.

Use of more than one type of hydrogel dressing (filler, cover, or impregnated gauze) on the same wound at the same time is not reasonable and necessary.

Specialty Absorptive Dressing (A6251-A6256)

Specialty absorptive dressings are covered when used for moderately or highly exudative full thickness wounds (e.g., stage 3 or 4 ulcers). Specialty absorptive dressing change is up to once per day for a dressing without an adhesive border and up to every other day for a dressing with a border.

Transparent Film (A6257-A6259)

Transparent film dressings are covered when used on open partial thickness wounds with minimal exudate or closed wounds. Dressing change is up to 3 times per week.

Wound Filler, Not Elsewhere Classified (A6261-A6262)

Coverage is based upon the characteristics of the underlying material(s). Dressing change is up to once per day.

Wound Pouch (A6154)

Dressing change is up to 3 times per week.

Zinc Paste Impregnated Bandage (A6456)

A zinc paste impregnated bandage is covered for the treatment of venous leg ulcers that meet the statutory requirements for a qualifying wound (surgically created or modified, or debrided). Dressing change frequency for A6456 is weekly.

Claims for A6456 used for treatment of venous insufficiency without a qualifying wound or when used for other non-qualifying conditions will be denied as statutorily non-covered, no benefit. Refer to the related Policy Article NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES for information about the statutory benefit requirements.

Tape (A4450, A4452)

Tape is covered when needed to hold on a wound cover, elastic roll gauze or non-elastic roll gauze. Additional tape is not required when a wound cover with an adhesive border is used. Tape change is determined by the frequency of change of the wound cover. Quantities of tape submitted must reasonably reflect the size of the wound cover being secured. Utilization per dressing change for wound covers measuring:

• 16 square inches or less is up to 2 units
• 16 to 48 square inches, up to 3 units
• Greater than 48 square inches, up to 4 units

Light Compression Bandage (A6448-A6450), Moderate/High Compression Bandage (A6451, A6452), Self-Adherent Bandage (A6453-A6455), Conforming Bandage (A6442-A6447), Padding Bandage (A6441)

Compression bandages and multi-layer systems are only covered when they are used as a primary or secondary dressing over wound(s) that meet the statutory requirements for a qualifying wound (surgically created or modified, or debrided).

Claims for compression bandages and multi-layer systems used without a qualifying wound or when used for other non-qualifying conditions will be denied as statutorily non-covered, no benefit. Refer to the related Policy Article NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES for information about the statutory benefit requirements.

Most compression bandages are reusable. Frequency of replacement would be no more than one per week unless they are part of a multi-layer compression bandage system.

Conforming bandage dressing change is determined by the frequency of change of the selected underlying dressing.

Gradient Compression Wrap (A6545)

A gradient compression wrap is only covered when it is used as a primary or secondary dressing over wounds that meet the statutory requirements for a qualifying wound (surgically created or modified, or debrided).

Claims for gradient compression wraps used without a qualifying wound or when used for other non-qualifying conditions will be denied as statutorily non-covered, no benefit. Refer to the related Policy Article NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES for information about the statutory benefit requirements.

Utilization of a gradient compression wrap (A6545) is limited to one per 6 months per leg. Quantities exceeding this amount will be denied as not reasonable and necessary. Refer to the related Surgical Dressings Policy Article NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section for information concerning non-coverage once the ulcer has healed.

Dressing With Materials Not Recognized As Effective

Medicare recognizes the surgical dressing materials described by the product types listed above to be effective. They are considered reasonable and necessary when used as described by this policy. Medicare limits reimbursement to items that have sufficient clinical evidence to demonstrate that use of the item is safe and effective (see Medicare Program Integrity Manual, Chapter 13). Materials that lack sufficient clinical evidence are not recognized as effective and are not considered reasonable and necessary. The safety and effectiveness of the following materials have not been established:

• Balsam of Peru in castor oil
• Iodine – other than iodoform gauze packing
• Carbon Fiber
• Charcoal
• Copper
• Honey
• Silver

The above list is not exhaustive. Any material other than the materials explicitly listed among the reimbursable dressing types discussed above (i.e., alginate, collagen, foam, gauze, hydrocolloid, hydrogel, etc.) is not considered reasonable and necessary until sufficient credible clinical evidence is available to justify inclusion of the material into this policy as a reimbursable surgical dressing component.

Dressings containing multiple components are classified based upon the clinically predominant component. Multi-component dressings predominantly comprised of materials not recognized as effective are not considered reasonable and necessary even if there is some minor proportion of effective materials included in the composition of the complete product. Claims for surgical dressings composed predominantly of materials not listed as reimbursable in the policy will be denied as not reasonable and necessary.

Refer to the related Surgical Dressings Policy Article CODING GUIDELINES for information regarding the coding of dressings made of multiple materials.

MISCELLANEOUS

Surgical dressings are covered for as long as they are reasonable and necessary. Dressings over a percutaneous catheter or tube (e.g., intravascular, epidural, nephrostomy, etc.) are covered as long as the catheter or tube remains in place and after removal until the wound heals. Dressings used over a percutaneous catheter or tube may be included in supply allowances associated with other policies. In this situation, there is no separate coverage under this LCD. (Refer to the related Surgical Dressings Policy Article CODING GUIDELINES).

When a wound cover with an adhesive border is being used, no other dressing is needed on top of it and additional tape is not required. Reasons for use of additional tape must be well documented.

Use of more than one type of wound filler or more than one type of wound cover in a single wound is not reasonable and necessary. The exception is a primary dressing composed of: (1) an alginate or other fiber gelling dressing; or, (2) a saline, water, or hydrogel impregnated gauze dressing. Either of these might need an additional wound cover.

It is not appropriate to use combinations of a hydrating dressing on the same wound at the same time as an absorptive dressing (e.g., hydrogel and alginate).

The frequency of recommended dressing changes depends on the type and use of the surgical dressing. When combinations of primary dressings, secondary dressings, and wound filler are used, the change frequencies of the individual products should be similar. For purposes of this policy, the product in contact with the wound determines the change frequency. It is not reasonable and necessary to use a combination of products with differing change intervals. For example, it is not reasonable and necessary to use a secondary dressing with a weekly change frequency over a primary dressing with a daily change interval. Such claims will be denied as not reasonable and necessary.

It is not reasonable and necessary to use a secondary dressing with primary dressings that contain an impervious backing layer with or without and adhesive border.

Dressing size must be based on and appropriate to the size of the wound. For wound covers, the pad size is usually about 2 inches greater than the dimensions of the wound. For example, a 2 in. x 2 in. wound requires a 4 in. x 4 in. pad size.

The quantity and type of dressings dispensed at any one time must take into account the status of the wound(s), the likelihood of change, and the recent use of dressings.

Dressing needs may change frequently (e.g., weekly) in the early phases of wound treatment and/or with heavily draining wounds. Suppliers are required to monitor the quantity of dressings that the beneficiary is actually using and to adjust their provision of dressings accordingly. Refer to the REFILL REQUIREMENTS section for additional information.

Surgical dressings must be tailored to the specific needs of an individual beneficiary. When surgical dressings are provided in kits, only those components of the kit that meet the definition of a surgical dressing, that are ordered by the treating practitioner, and that are reasonable and necessary are covered.

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 practitioner that any changed or atypical utilization is warranted. Regardless of utilization, no more than a month’s supply of dressings may be provided at one time, unless there is documentation to support the necessity of greater quantities in the home setting in an individual case.