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, and document an affirmative response, 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 expected to end,
and to confirm any changes or modifications to the order. Contact with the
beneficiary or designee regarding refills must take place no sooner than 30
calendar days prior to the expected end of the current supply. For delivery of
refills, the supplier must deliver the DMEPOS product no sooner than 10
calendar days prior to the expected end of the current supply. 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 and
document an affirmative response, prior to dispensing a new supply of items.
Suppliers must not deliver refills without a refill request and an affirmative
response 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.