Surgical dressings include both primary dressings (i.e., therapeutic or protective coverings applied directly to wounds or lesions either on the skin or caused by an opening to the skin) and secondary dressings (i.e., materials that serve a therapeutic or protective function and that are needed to secure a primary dressing). Indications and Limitations of Coverage For any item to be covered, it must:
For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage. If the coverage criteria described below are not met, the claim will be denied as not medically necessary. For an item to be covered, a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item without first receiving the completed order, the item will be denied as not medically necessary. Surgical dressings are covered for as long as they are medically 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. (Refer to Coding Guidelines) Surgical dressings used in conjunction with investigational wound healing therapy (e.g., platelet derived wound healing formula) may be covered if all applicable coverage criteria are met based on the number and type of surgical dressings that are appropriate to treat the wound if the investigational therapy were not being used. When a wound cover with an adhesive border is being used, no other dressing is needed on top of it and additional tape is usually not required. Reasons for use of additional tape must be well documented. An adhesive border is usually more binding than that obtained with separate taping and is therefore indicated for use with wounds requiring less frequent dressing changes. Use of more than one type of wound filler or more than one type of wound cover in a single wound is rarely medically necessary and the reasons must be well documented. An exception is an alginate or other fiber gelling dressing wound cover or a saline, water, or hydrogel impregnated gauze dressing which might need an additional wound cover. It may not be appropriate to use some combinations of a hydrating dressing on the same wound at the same time as an absorptive dressing (e.g., hydrogel and alginate). Because composite dressings, foam and hydrocolloid wound covers, and transparent film, when used as secondary dressings, are meant to be changed at frequencies less than daily, appropriate clinical judgment should be used to avoid their use with primary dressings which require more frequent dressing changes. When claims are submitted for these dressings for changes greater than once every other day, the quantity in excess of that amount will be denied as not medically necessary. While a highly exudative wound might require such a combination initially, with continued proper management the wound usually progresses to a point where the appropriate selection of these products results in the less frequent dressing changes which they are designed to allow. An example of an inappropriate combination is the use of a specialty absorptive dressing on top of non-impregnated gauze being used as a primary dressing. 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 5 cm x 5 cm (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 current 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 also expected to have a mechanism for determining the quantity of dressings that the patient is actually using and to adjust their provision of dressings accordingly. No more than a one 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. An even smaller quantity may be appropriate in the situations described above. Surgical dressings must be tailored to the specific needs of an individual patient. 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 physician, and that are medically necessary are covered. The following are some specific coverage guidelines for individual products when the products themselves are necessary in the individual patient. The medical necessity for more frequent change of dressing must be documented in the patient's medical record and submitted with the claim. (see Documentation Requirements section). Alginate or other fiber gelling dressing (A6196-A6199) Composite dressing (A6203-A6205) Contact layer (A6206-A6208) Foam dressing (A6209-A6215) Gauze, non-impregnated (A6216-A6221, A6402-A6404, A6407) Gauze, impregnated, with other than water, normal saline, hydrogel, or zinc paste (A6222-A6224, A6266) Gauze, impregnated, water or normal saline (A6228-A6230) Hydrocolloid dressing (A6234-A6241) Hydrogel dressing (A6231-A6233, A6242-A6248) 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 medically necessary. Documentation must substantiate the medical necessity for code A6248 billed in excess of 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 medically necessary. Specialty absorptive dressing (A6251-A6256) Transparent film (A6257-A6259) Wound filler, not elsewhere classified (A6261-A6262) Wound pouch (A6154) Tape (A4450, A4452) Light compression bandage (A6448-A6450), Moderate/High compression bandage (A6451, A6452), Self-adherent bandage (A6453-A6455), Conforming bandage (A6442-A6447), Padding bandage (A6441) Conforming bandage dressing change is determined by the frequency of change of the selected underlying dressing. Gradient Compression Wrap (A6545)
Reasons for Noncoverage Surgical dressings are covered when either of the following criteria are met:
The surgical procedure or debridement must be performed by a physician or other healthcare professional to the extent permissible under State law. Debridement of a wound may be any type of debridement (examples given are not all-inclusive): surgical (e.g., sharp instrument or laser), mechanical (e.g., irrigation or wet-to-dry dressings), chemical (e.g., topical application of enzymes), or autolytic (e.g., application of occlusive dressings to an open wound). Dressings used for mechanical debridement, to cover chemical debriding agents, or to cover wounds to allow for autolytic debridement are covered although the agents themselves are non-covered. Examples of situations in which dressings are non-covered under the Surgical Dressings benefit are:
Surgical dressing codes billed without modifiers A1-A9 (see Coding Guidelines) are non-covered under the Surgical Dressings benefit. Certain dressings may be covered under other benefits. Small adhesive bandages (e.g., Band-Aid or similar product) are not primarily used for the treatment of wounds addressed in the Surgical Dressings policy. Therefore, these dressings are non-covered under the surgical dressing benefit. The provider can bill the member for the non-covered service. A silicone gel sheet (A6025) used for the treatment of keloids or other scars does not meet the definition of the surgical dressing benefit and will be denied as non-covered. A first-aid type adhesive bandage (A6413) does not meet the definition of the surgical dressing benefit and will be denied as non-covered. A provider can bill the member for the non-covered service. If a physician applies surgical dressings as part of a professional service that is billed, the surgical dressings are considered incident to the professional services of the health care practitioner and are not separately payable. Claims for these dressings must not be submitted. If dressing changes are sent home with the patient, claims for these dressings may be submitted. In this situation, use the place of service corresponding to the patient's residence; Place of Service Office must not be used. The following are examples of wound care items which are non-covered under the surgical dressing benefit: skin sealants or barriers (A6250), wound cleansers (A6260) or irrigating solutions, solutions used to moisten gauze (e.g., saline), silicone gel sheets, topical antiseptics, topical antibiotics, enzymatic debriding agents, gauze or other dressings used to cleanse or debride a wound but not left on the wound. Also, any item listed in the latest edition of the Orange Book (e.g., an antibiotic-impregnated dressing which requires a prescription) is considered a drug and is non-covered under the Surgical Dressings benefit. Claims for tape (A4450 and A4452) which are billed without an AW modifier (see Coding Guidelines section) or another modifier indicating coverage under a different policy will be denied as non-covered. When dressings are covered under other benefits, there is no separate payment using surgical dressing codes. Payment for any type of dressing in these situations is included in the allowance for other codes. Examples, not all-inclusive, are:
Note that the allowance for items referred to using the term “kit” (e.g., in procedure codes A4625, A4629, B4224, B4034, B4035, B4036) includes not only the individual major supply items, but also any gauze, tape, other dressing supplies, etc. necessary for their use. Light compression bandage (A6448-A6450), Moderate/High compression bandage (A6451, A6452), Self-adherent bandage (A6453-A6455), Conforming bandage (A6442-A6447), Padding bandage (A6441) Moderate or high compression bandages, conforming bandages, self-adherent bandages, and padding bandages are covered when they are part of a multi-layer compression bandage system used in the treatment of a venous stasis ulcer. All of these bandages are non-covered when used for strains, sprains, edema, or situations other than as a dressing for a wound. Gradient compression stockings/wraps (A6531, A6532, A6545) Codes A6531, A6532, and A6545 are non-covered for the following conditions: venous insufficiency without stasis ulcers, prevention of stasis ulcers, prevention of the reoccurrence of stasis ulcers that have healed, treatment of lymphedema in the absence of ulcers. In these situations, since there is no ulcer, the stockings/wraps do not meet the definition of a surgical dressing. Gradient compression stockings/aids described by codes A6530, A6533-A6544, A6549, S8420-S8431 and surgical stockings described by codes A4490-A4510 are non-covered for all indications because they do not meet the definition of a surgical dressing. The provider can bill the member for the non-covered service. A nonelastic binder for an extremity (A4465) is non-covered for all indications because it does not meet the definition of a surgical dressing. The provider can bill the member for the non-covered service. Compression burn garments (A6501-A6513) Documentation Requirements 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 billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected procedure code. Items submitted with an EY modifier will be denied as not medically necessary. The order must specify (a) the type of dressing (e.g., hydrocolloid wound cover, hydrogel wound filler, etc.), (b) the size of the dressing (if appropriate), (c) the number/amount to be used at one time (if more than one), (d) the frequency of dressing change, and (e) the expected duration of need. A new order is needed if a new dressing is added or if the quantity of an existing dressing to be used is increased. A new order is not routinely needed if the quantity of dressings used is decreased. However a new order is required at least every 3 months for each dressing being used even if the quantity used has remained the same or decreased. Information defining the number of surgical/debrided wounds being treated with a dressing, the reason for dressing use (e.g., surgical wound, debrided wound, etc.), and whether the dressing is being used as a primary or secondary dressing or for some noncovered use (e.g., wound cleansing) must be obtained from the physician, nursing home, or home care nurse. The source of that information and date obtained must be documented in the supplier's records. Current clinical information which supports the reasonableness and necessity of the type and quantity of surgical dressings provided must be present in the patient's medical records. Evaluation of a patient's wound(s) must be performed at least on a monthly basis unless there is documentation in the medical record which justifies why an evaluation could not be done within this timeframe and what other monitoring methods were used to evaluate the patient's need for dressings. Evaluation is expected on a more frequent basis (e.g., weekly) in patients in a nursing facility or in patients with heavily draining or infected wounds. The evaluation may be performed by a nurse, physician or other health care professional. This evaluation must include the type of each wound (e.g., surgical wound, pressure ulcer, burn, etc), its location, its size (length x width in cm.) and depth, the amount of drainage, and any other relevant information. This information must be available upon request. When surgical dressings are billed, the appropriate modifier (A1 – A9, AW, EY, or GY) must be added to the code when applicable. If A9 is used, information must be submitted with the claim indicating the number of wounds. If GY is used, a brief description of the reason for non-coverage (e.g., "A6216GY - used for wound cleansing") must be entered in the narrative field of the electronic claim. When codes A4649, A6261 or A6262 are billed, the claim must include a narrative description of the item (including size of the product provided), the manufacturer, the brand name or number, and information justifying the medical necessity for the item. This information must be entered in the narrative field of the electronic claim.
Composite dressings (A6203-A6205) are products combining physically distinct components into a single dressing that provides multiple functions. These functions must include, but are not limited to: (a) a physical (not chemical) bacterial barrier that is present over the entire dressing pad and extends out into the adhesive border, (b) an absorptive layer other than an alginate or other fiber gelling dressing, foam, hydrocolloid, or hydrogel, and (c) either a semi-adherent or nonadherent property over the wound site. Contact layers (A6206-A6208) are thin non-adherent sheets placed directly on an open wound bed to protect the wound tissue from direct contact with other agents or dressings applied to the wound. They are not absorptive. They are porous to allow wound fluid to pass through for absorption by a separate overlying dressing. They remain on the wound for an extended time while the absorptive dressings are changed. A foam dressing (A6209-A6215) is a sterile, nonlinting, absorptive dressing which is made of open cell, medical grade expanded polymer. It has a nonadherent property over the wound site. Impregnated gauze dressings (A6222-A6233, A6266, A6456) are woven or non-woven materials into which substances such as iodinated agents, petrolatum, zinc paste, crystalline sodium chloride, chlorhexadine gluconate (CHG), bismuth tribromophenate (BTP), water, aqueous saline, hydrogel, or other agents have been incorporated into the dressing material by the manufacturer. These codes are not used for gauze dressings containing silver. Specialty absorptive dressings (A6251-A6256) are unitized multi-layer dressings which provide (a) either a semi-adherent quality or nonadherent layer, and (b) highly absorptive layers of fibers such as absorbent cellulose, cotton, or rayon. These may or may not have an adhesive border. A wound pouch (A6154) is a waterproof collection device with a drainable port that adheres to the skin around a wound. Code A6025 should only be used for gel sheets used for the treatment of keloids or other scars. Hydrogel sheets used in the treatment of wounds are billed with codes A6242-A6247. When dressings are covered under other benefits, they may not be billed separately using surgical dressing codes. See Reasons for Noncoverage section of this policy for additional information. Wound fillers are dressing materials which are placed into open wounds to eliminate dead space, absorb exudate, or maintain a moist wound surface. Wound fillers come in hydrated forms (e.g., pastes, gels), dry forms (e.g., powder, granules, beads), or other forms such as rope, spiral, pillows, etc. For certain materials, unique codes have been established - i.e., collagen wound filler (A6010, A6011, A6024), alginate or other fiber gelling wound filler (A6199), foam wound filler (A6215), hydrocolloid wound filler (A6240, A6241), hydrogel wound filler (A6248), and non-impregnated packing strips (A6407). Wound fillers not falling into any of these categories are coded as A6261 or A6262. The units of service for wound fillers are 1 gram, 1 fluid ounce, 6 inch length, or one yard depending on the product. If the individual product is packaged as a fraction of a unit (e.g., 1/2 fluid ounce), determine the units billed by multiplying the number dispensed times the individual product size and rounding to the nearest whole number. For example, if eleven (11) 1/2 oz. tubes of a wound filler are dispensed, bill 6 units (11 x 1/2 = 5.5; round to 6). For some wound fillers, the units on the package do not correspond to the units of the code. For example, some pastes or gels are labeled as grams (instead of fluid ounces), some wound fillers are labeled as cc. or ml. (instead of fluid ounces or grams), some are described by linear dimensions (instead of grams). In these situations, the supplier must contact the manufacturer to determine the appropriate conversion factor or unit of service which corresponds to the code. Wound covers are flat dressing pads. A wound cover with adhesive border is one which has an integrated cover and distinct adhesive border designed to adhere tightly to the skin. In order to be billed using a “with adhesive border” code, the adhesive border must be present along all sides of the dressing and must be proportionate to the size of the dressing pad and at least ½ inch wide. Some wound covers are available both without and with an adhesive border. For wound covers with an adhesive border, the code to be used is determined by the pad size, not by the outside adhesive border dimensions. For example, a hydrocolloid dressing with outside dimensions of 6 in. x 6 in. which has a 4 in. x 4 in. pad surrounded by a 1 in. border on each side is coded as A6237, " ... pad size 16 sq. inch or less..." A first-aid type adhesive bandage (e.g., Band-Aid or similar product) is a wound cover with a pad size of less than 4 square inches. It must be billed with code A6413. Products containing multiple materials are categorized according to the clinically predominant component (e.g., alginate, collagen, foam, gauze, hydrocolloid, hydrogel). Other multi-component wound dressings not containing these specified components may be classified as composite or specialty absorptive dressings if the definition of these categories has been met. Multi-component products may not be unbundled and billed as the separate components of the dressing. Dressings containing silver are coded based on the other components of the dressing. For example, foam dressings that contain silver are billed using the foam dressing codes. Gauze dressings that contain silver are billed with the non-impregnated gauze dressings codes. For products with features that go beyond the usual scope of surgical dressings (e.g., a large wound cover with a slit in the middle and a plastic pouch which covers the dressing and is intended to protect an indwelling venous catheter), the coding determination will be based on the dominant component that falls under the Surgical Dressings benefit category and that is appropriate for the management of the wound itself. Gauze or gauze-like products are typically manufactured as a single piece of material folded into a several ply gauze pad. Coding must be based on the functional size of the pad as it is commonly used in clinical practice. For all dressings, if a single dressing is divided into multiple portion/pieces, the code and quantity billed must represent the originally manufactured size and quantity. Impregnated dressings that are listed in the FDA Orange Book must be billed using code A9270 and must not be billed using codes A6222-A6224, A6231-A6233, or A6266. Elastic bandages are those that contain fibers of rubber (latex, neoprene), spandex, or elastane. Roll bandages that do not contain these fibers are considered non-elastic bandages even though many of them (e.g., gauze bandages) are stretchable. Codes A6442-A6447 describe roll gauze-type bandages made either of cotton or of synthetic materials such as nylon, viscose, polyester, rayon, or polyamide. These bandages are stretchable, but do not contain elastic fibers. These codes include short-stretch bandages. Codes A6448-A6450 describe ACE type elastic bandages. Codes A6451 and A6452 describe elastic bandages that produce moderate or high compression that is sustained typically for one week. They are commonly included in multi-layer compression bandage systems. Suppliers billing these new codes must be able to provide, upon request, documentation from the manufacturer verifying that the performance characteristics specified in the code narratives have been met. When multi-layer compression bandage systems are used for the treatment of a venous stasis ulcer, each component is billed using a specific code for the component - e.g., moderate or high compression bandages (A6451, A6452), conforming bandages (A6443, A6444), self-adherent bandages (A6454), padding bandages (A6441), zinc paste impregnated bandage (A6456). For the compression stocking codes A6531 and A6532, one unit of service is generally for one stocking. However, if a manufacturer has a product consisting of two components which are designed to be worn simultaneously on the same leg, the two components must be billed as one claim line with one unit of service – e.g., a product which consists of an unzippered liner and a zippered stocking. The only products that may be billed with code A6545 (non-elastic compression wrap) are those which have received a written Coding Verification Review from the Pricing, Data Analysis, and Coding (PDAC) contractor and that are posted in the Product Classification List on the PDAC web site. Modifiers A1-A9 have been established to indicate that a particular item is being used as a primary or secondary dressing on a surgical or debrided wound and also to indicate the number of wounds on which that dressing is being used. The modifier number must correspond to the number of wounds on which the dressing is being used, not the total number of wounds treated. For example, if the patient has four (4) wounds but a particular dressing is only used on two (2) of them, the A2 modifier must be used with that procedure code. Modifiers A1-A9 are not used with codes A6531 and A6532. If the dressing is not being used as a primary or secondary dressing on a surgical or debrided wound, do not use modifiers A1-A9. When dressings are provided in noncovered situations (e.g., use of gauze in the cleansing of a wound or intact skin), a GY modifier must be added to the code and a brief description of the reason for noncoverage included - e.g., "A6216GY - used for wound cleansing." Items submitted with a GY modifier will be denied as non-covered. The provider can bill the member for the non-covered service. When tape codes A4450 and A4452 are used with surgical dressings, they must be billed with the AW modifier (in addition to the appropriate A1-A9 modifier). When gradient compression stocking codes A6531 and A6532 or the gradient compression wrap code A6545 are used for an open venous stasis ulcer, they must be billed with the AW modifier (but not an A1-A9 modifier). For this policy, codes A4450, A4452, A6531, and A6532, and A6545 are the only codes for which the AW modifier may be used. The right (RT) and/or left (LT) modifiers must be used with codes A6531, A6532, and A6545 for gradient compression stockings and wraps. When the same code for bilateral items (left and right) is billed on the same date of service, bill both items on the same claim line using RTLT modifiers and 2 units of service. Claims billed without modifiers RT and/or LT will be rejected as incorrect coding. When dressing codes are billed for items covered under another benefit (e.g., gauze for a continent ostomy which is covered under the prosthetic device benefit) claims must be billed according to the documentation requirements specified in the applicable policy (see Ostomy Supplies policy for details). Suppliers should contact the Pricing, Data Analysis, and Coding (PDAC) contractor for guidance on the correct coding of these items. https://www.dmepdac.com/
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. CMS Publication 100-3, Medicare National Coverage Determinations Manual, Chapter 1, Section 270.5
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records. Medical policies are designed to supplement the terms of a member's contract. The member's contract defines the benefits available; therefore, medical policies should not be construed as overriding specific contract language. In the event of conflict, the contract shall govern. Medical policies do not constitute medical advice, nor the practice of medicine. Rather, such policies are intended only to establish general guidelines for coverage and reimbursement under Medicare Advantage plans. Application of a medical policy to determine coverage in an individual instance is not intended and shall not be construed to supercede the professional judgment of a treating provider. In all situations, the treating provider must use his/her professional judgment to provide care he/she believes to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions. Medicare Advantage retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Medicare Advantage. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use. |