Wet-dry dressings are considered part of routine nursing care and are not medically necessary for active wound care or debridement. The goal of the AHRQ report was to define the state of the evidence for skin substitutes as chronic wound care products. In rare cases, the goal of ambulatory wound care may simply be to prevent progression of a wound that is not expected to improve due to severe underlying debilitation or other factors such as inoperability.
In rare cases, the goal of wound care provided in an outpatient setting may be only to prevent progression of the wound, which, due to severe underlying weakness or other factors such as inoperability, is not expected to improve.
WOUND CARE HS-216
Negative Pressure Wound Therapy
On a weekly basis at home, in the outpatient clinic or outpatient hospital setting, the wound(s) being treated with the NPWT pump should be assessed. NOTE: If criteria are NOT met, continued coverage of the NPWT pump and supplies will be denied as NOT medically necessary. In the judgment of the attending physician, sufficient wound healing has occurred to the extent that NPWT can be discontinued; OR,.
Wound healing is defined as improvement occurring either at the surface (length times width) or deep within the wound; OR, Four months have passed (including the time NPWT was applied in a hospital setting prior to discharge) using the NPWT pump in the treatment of the most recent wound; OR, Once the equipment or supplies are no longer used for the member, whether or not on a physician's order.
NPWT pumps must accommodate more than one dressing set for multiple wounds on a single limb. Therefore, it is NOT medically necessary for more than one pump per member to be billed for the same period and will be denied. Coverage is provided up to a maximum of 15 dressing sets per wound per month unless there is documentation that the wound size requires more than one dressing set per dressing change.
Noncontact Normothermic Wound Therapy (E/I)
Coverage is provided up to a maximum of 10 container sets per month, unless there is documentation of a large amount of drainage (greater than 90 ml of exudate per day). For high-volume exudative wounds, a stationary pump with the largest capacity reservoir should be used.
Ultrasound Therapy for Wound Healing (Mist Therapy™) 32
There is no documentation of further need for debridement or ongoing wound infection or complicated wounds or dressings. Debridement of the wound(s) in the absence of necrotic, devitalized, fibrotic, or other tissue or foreign matter that would interfere with wound healing. The timing, frequency, and number of CTP reapplications should be appropriate for the material used and the clinical condition of the member.
In this case, an unsuccessful course of treatment is defined as an incomplete treatment after the maximum number of applications and/or the maximum duration of treatment time indicated by the FDA label of the individual product and/or this LCD. CTPs are contraindicated in members with inadequate control of underlying conditions or exacerbating factors or other contraindications (eg, uncontrolled diabetes, active infection, active Charcot arthropathy of the ulcerated extremity, and/or vasculitis). Skin substitutes are contraindicated in members with known hypersensitivity to any component of a specific skin substitute (eg, bovine allergy).
In diabetic foot ulcers, if satisfactory healing progress is not noted after 9 weeks of treatment and 3 applications of the CTP, reapplication of the CTP is not recommended and other treatment modalities should be considered. For venous stasis ulcers, if a 50 percent or greater improvement is noted and documented after 12 weeks of compression treatment and the appropriate number of applications of the CTP, one or more subsequent reapplications of the CTP will be eligible for Medicare coverage. Otherwise, re-application of the CTP is not recommended and will not be reimbursed and other treatment modalities should be considered.
Covered Products
Only when adequate treatment of the underlying disease processes contributing to the ulcer, for example diabetes, is provided and documented in conjunction with the treatment; AND. The patient must be competent and/or have the support system necessary to participate in the aftercare associated with treating the wound with Apligraf®. The member must be competent and/or have the support system necessary to participate in the aftercare associated with treating the wound with Dermagraft®.
Re-treatment of the same wound with Dermagraft® within one year of the last successful or unsuccessful treatment is considered not medically necessary. The survival of the dermal substitute decreases significantly when the 24 steps noted in the FDA labeling are not followed, therefore the 24 steps must be followed and documented. Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected leg.
Application of skin substitute grafts is contraindicated in patients with known hypersensitivity to any component of the specific skin substitute graft (eg allergy to beef). The member must be competent and/or have the support system necessary to participate in follow-up care associated with treatment of the wound with GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair. Documentation should also include measurement of the ulcer immediately prior to placement of OASIS® Wound Matrix and OASIS® Ultra Trilayer Matrix and prior to each additional weekly placement;.
Not covered for re-treatment of the same ulcer with PriMatrix® after unsuccessful course of treatment. No coverage re-treatment of the same ulcer with Theraskin® after an unsuccessful course of treatment.
General Notes
Adequate arterial blood supply as demonstrated by ankle-brachial index (ABI) of 0.65 or greater in limbs undergoing the procedure in full-thickness wounds of at least 3 weeks' duration and extending through the dermis. Adequate arterial blood supply as demonstrated by ankle-brachial index (ABI) of 0.65 or greater in limbs undergoing the procedure. For use as a temporary wound dressing for surgically excised full-thickness and deep partial-thickness thermal burn wounds in individuals requiring such dressing prior to autograft placement; OR.
For the treatment of intermediate dermal to undetermined depth burn wounds that typically require debridement and can be expected to heal without auto-grafting.
Covered CPT Codes
100 cm2; each additional 100 sq cm of wound surface area, or part thereof, or each additional 1% of body surface area in infants and children, or part thereof (list separately in addition to primary procedure code) 15275 Application of skin substitute graft to face, scalp, eyelids, mouth, neck , ears, webs, genitals, hands, feet,. 15277 Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet and/or multiple digits, total wound surface area greater than or equal to 100 cm2; first 100 cm2 wound surface area, or 1% of body surface area in infants and children. 15278 Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet and/or multiple digits, total wound surface area greater than or equal to 100 cm2; each additional 100 sq cm of wound surface area, or part thereof, or each additional 1% of body surface area in infants and children, or part thereof (list separately in addition to primary procedure code).
97032 Application of a modality to one or more areas; electrical stimulation (manual), every 15 minutes 97605 Negative pressure wound therapy (eg, vacuum-assisted drainage collection), including topical. 29581 Application of multi-layer compression system; leg (below knee), including ankle and foot 97014 Application of a modality to 1 or more areas; electrical stimulation (unsupervised). 97605 Negative pressure wound therapy (eg, vacuum-assisted drainage collection), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session; total wound(s) area less than or equal to 50 square centimeters).
97606 Negative pressure wound therapy (eg, vacuum-assisted drainage collection), including topical application(s), wound assessment, and ongoing care instruction(s), per session; the total area of the wound is greater than 50 square centimeters. Vascular studies include the patient care necessary to perform the studies, supervise the studies, and interpret the study results with copies for paper patient records by analyzing all data, including bidirectional vascular flow or imaging when available. The use of a simple hand-held or other Doppler device that does not produce paper copies or produces a record that does not allow analysis of bidirectional vascular flow is considered part of the physical examination of the vascular system and is not separately reported.
Covered HCPCS Level II ®*Codes
Covered HCPCS Codes (Products) 33
Covered ICD-10-CM Codes
L89.43 Pressure ulcer at the contiguous site of back, buttocks and hip, stage III L89.44 Pressure ulcer at the contiguous site of back, buttocks and hip, stage IV L89.513 Pressure ulcer of right ankle, stage III. T81.31XD - T81.31XS Disruption of external operative (surgical) wound, not elsewhere classified T81.33XD - T81.33XS Disruption of traumatic injury wound repair. Documentation in the member's medical record for investigation, care, compliance and wound measurements by treating doctor, OG,.
The member has used a support surface for pressure sores on the back of the body or pelvis (not required if the wound is not on the body or pelvis), AND,.
Non-Covered Indications
National coverage assessment for electrical stimulation (ES) and electromagnetic therapy for the treatment of wounds (270.1). Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study. Non-contact low-frequency ultrasound using the MIST therapy system (Celleration Inc.) for the treatment of arterial and diabetic foot ulcers of the lower extremities.
The percent change in wound area of diabetic foot ulcers over a four-week period is a robust predictor of complete healing in a twelve-week prospective study. Economic evaluation of the treatment of chronic wounds: hydroactive wound dressings in combination with enzymatic ointment versus gauze dressings in patients with pressure ulcers and venous leg ulcers in Germany. The efficacy and safety of Dermagraft in improving healing of chronic diabetic foot ulcers: results from a prospective randomized trial.
Graftskin, a human skin equivalent, is effective in the management of non-infected diabetic neuropathic foot ulcers: a prospective randomized multicentre clinical trial. Clinical effectiveness of an acellular dermal regenerative tissue matrix compared with standard wound management in healing diabetic foot ulcers: a prospective, randomized, multicenter study. Determination of local coverage: application of bioengineered skin substitutes in chronic non-healing wounds of the lower extremities (L35041).
