This Local Coverage Determination (LCD) offers coverage indications and
guidelines for wound care involving debridement, electrical stimulation and
electromagnetic therapy, negative pressure wound therapy, low frequency non-
contact non-thermal ultrasound (MIST Therapy), and topical oxygen therapy
(TOT).

For the purposes of this LCD, wound care is defined as care of wounds that are
refractory to healing or have complicated healing cycles either because of the
nature of the wound itself or because of complicating metabolic and/or
physiological factors.

Active wound care procedures are performed to remove necrotic tissue and/or
devitalized tissue to promote healing. Providers are responsible to determine
medical necessity and use the appropriate current CPT/HCPCS code for service
provided. Please consult the current AMA CPT book for the complete code
description of the procedures being performed to submit claims.

This LCD supplements but does not replace, modify, or supersede existing
Medicare applicable National Coverage Determinations (NCDs) or payment policy
rules and regulations for additional wound care. Federal statute and
subsequent Medicare regulations regarding provision and payment for medical
services are lengthy. They are not repeated in this LCD. Neither Medicare
payment policy rules nor this LCD replace, modify, or supersede applicable
state statutes regarding medical practice or other health practice professions
acts, definitions and/or scopes of practice. All providers who report services
for Medicare payment must fully understand and follow all existing laws,
regulations, and rules for Medicare payment for additional wound care sessions
and must properly submit only valid claims for them. Please review and
understand them and apply the medical necessity provisions in the policy
within the context of the manual rules. Relevant CMS manual instructions and
policies are provided in CMS National Coverage Policy section.

This policy **does not** address metabolically active human skin
equivalent/substitute dressings, burns, skin cancer or hyperbaric oxygen
therapy.

**Debridement**

Debridement is defined as the removal of foreign material and/or devitalized
or contaminated tissue from or adjacent to a traumatic or infected wound until
surrounding healthy tissue is exposed. This LCD applies to debridement of
localized areas such as wounds and ulcers. The mere removal of secretions,
cleansing of a wound, does not represent a debridement service.

At least ONE of the following conditions must be present and documented:

  * Pressure Injury, Stage II, III or IV,
  * Venous insufficiency ulcers,
  * Arterial insufficiency ulcers including diabetic lower extremity ulcers,
  * Dehiscenced wounds,
  * Wounds with exposed hardware or bone,
  * Neuropathic ulcers,
  * Neuroischaemic ulcers,
  * Diabetic Foot Ulcer(s)
  * Complications of surgically created or traumatic wound where accelerated granulation therapy is necessary which cannot be achieved by other available topical wound treatment.

Should deep tissue pressure injury or Stage II injury progress to Unstageable,
Stage III or Stage IV requiring debridement then documentation supporting this
must be included in the medical record

**Goals of Debridement:**  
Remove devitalized tissue  
Decrease risk of infection  
Promote wound healing  
Prevent further complications

**Debridement may be categorized as selective or non-selective:**

Selective debridement refers to the removal of specific, targeted areas of
devitalized or necrotic tissue from a wound along the margin of viable tissue.
Occasional bleeding and pain may occur. The routine application of a topical
or local anesthetic does not elevate active wound care management to surgical
debridement. Selective debridement includes selective removal of necrotic
tissue by sharp dissection including scissors, scalpel, and forceps; and
selective removal of necrotic tissue by high-pressure water jet. Selective
debridement should only be done under the specific order of a physician.

Wound Care Non-Selective Debridement includes:

  * Surgical debridement is excision or wide resection of all necrotic or devitalized tissue, possibly including excision of the viable wound margin. This is usually carried out in the operating room by a surgeon. Anesthesia is usually required. It is frequently used for deep tissue infection, drainage of abscess or involved tendon sheath, or debridement of bone.
  * Sharp debridement is the removal of necrotic or foreign material just above the level of viable tissue and is performed in an office setting or at the patient's bedside with or without the use of local anesthesia. Sharp debridement is less aggressive than surgical debridement but has the advantage of rapidly improving the healing conditions in the ulcer. These typically are the services of recurrent, superficial, or repeated wound care.
  * Enzymatic Debridement is debridement with topical enzymes used when the necrotic substances to be removed from a wound are protein, fiber, and collagen. The manufacturers' product insert contains indications, contraindications, precautions, dosage, and administration guidelines.
  * Wet to moist dressing: This type of dressing is used to keep the wound moist. This type of dressing is used to remove drainage and necrotic tissue from wounds.

Debridement of the wound(s), if indicated, must be performed judiciously and
at appropriate intervals. Medicare expects that with appropriate care and no
extenuating medical or surgical complications or setbacks, wound volume or
surface dimensions should decrease over time or wounds optimally will
demonstrate granulation tissue. Wounds that fail to demonstrate measurable
reduction in size at 2 to 4 weeks despite appropriate therapy are unlikely to
heal. There is also literature to support that a reduction of less than 40%
for venous and less than 50% diabetic ulcers at 4 weeks is an overall
predictor of outcome for healing.

Medicare expects the wound care treatment plan to be modified in the event
that appropriate healing is not achieved. Debridement should be performed by a
health care professional acting within the scope of his/her legal authority.

Evidence of improvement includes measurable changes (decreases) of some of the
following:

Drainage (color, amount, consistency)  
Inflammation  
Swelling  
Pain  
Wound dimensions (diameter, depth, tunneling)  
Necrotic tissue/slough

**Use of Evaluation and Management (E/M) Codes in Conjunction with
Debridement(s)**

Patients who have chronic wounds may frequently have underlying medical
problems that require concomitant management in order to bring about wound
closure. In addition, patients may require education, other services, and
coordination of care both in the preoperative and postoperative phases of the
debridement procedure. An E/M service provided and documented on the same day
as a debridement service may be covered by Medicare only when the
documentation clearly establishes the service as a "separately identifiable
service" that was reasonable and necessary, as well as distinct, from the
debridement service(s) provided.

**Biophysical Agents**

Biophysical agents or modalities such as electrical stimulation; induced
electrical stimulation;  
negative pressure wound therapy; hyperbaric oxygen; and non-contact, non-
thermal ultrasound all add some form of energy to the wound bed to help drive
the healing process forward, especially in the compromised tissues of patients
who tend to get pressure ulcers.

**Electrical Stimulation and Electromagnetic Therapy**

Please refer to: CMS Publication 100-03, _Medicare National Coverage
Determination (NCD) Manual_ , Chapter 1-Part 4,  270.1 Electrical Stimulation
(ES) and Electromagnetic Therapy for the Treatment of Wounds.

**Negative Pressure Wound Therapy**

Negative Pressure Wound Therapy (NPWT), utilizing either durable or disposable
medical equipment, involves the application of controlled or intermittent
negative pressure to a properly dressed wound cavity. Suction (negative
pressure) is applied under airtight wound dressings to promote the healing of
open wounds **resistant to prior treatments**. Coverage of traditional NPWT
(tNPWT) device/unit/type, or supplies is under DME and providers should
consult their DME LCD for specific coverage, parameters, and guidelines.

**Low Frequency, Non-contact, Non-thermal Ultrasound (MIST Therapy)**

Low frequency, non-contact, non-thermal ultrasound is a system that uses
continuous low frequency ultrasonic energy to atomize a liquid and deliver
continuous low frequency ultrasound to the wound bed. This modality is often
referred to as "MIST Therapy".

There should be documented improvements in the wound(s) evident after six MIST
treatments.  
Improvements include documented reduction in pain, necrotic tissue, or wound
size or improved granulation tissue. Continuing MIST treatments for wounds
demonstrating no improvement after six treatments is considered not reasonable
and necessary. No more than 18 services of low frequency, non-contact, non-
thermal ultrasound (MIST Therapy) within a six-week period will be considered
reasonable and necessary. Also, Low Frequency, Non-Contact, Non-Thermal
Ultrasound treatments would be separately billable if other active wound
management and/or wound debridement is not performed.

**Topical Oxygen Therapy**

Refer to Change Request (CR) 10220, _Hyperbaric Oxygen (HBO) Therapy (Section
C, Topical Application of Oxygen_.

Despite many recent advances in wound care, the challenge of managing chronic
wounds remains  
complicated by the lack of agreement on clearly defined comprehensive wound
care principles and consistently accepted analytical scientific methods to
evaluate outcomes.

**Negative Pressure Wound Therapy (NPWT)**  
There is moderate evidence in the peer-reviewed published literature to
indicate that NPWT using a powered device approved by the U.S. Food and Drug
Administration (FDA) is effective for a specific subgroup of patients who have
failed a comprehensive, conventional wound therapy program that includes all
reasonable, well-established alternative medical treatments. There is also
moderate evidence to support the use of this therapy as an alternative to
surgery. There is insufficient evidence to support the routine use of NPWT.

Although NPWT appears effective and its superiority to conventional techniques
has been demonstrated, there are still some critical concerns concerning its
efficacy. Because its mechanisms of action remain partly unclear and because
there are still some gaps between evidence-based data and the excellent
clinical results, further prospective, randomized, ideally blinded studies are
needed.1

**Low Frequency, Non-contact, Non-thermal Ultrasound (MIST Therapy)**  
A 2011 meta-analysis, three randomized-control trials. 444 patients with
various chronic wounds.  
It found 85% wound-area reduction in a mean of 7 weeks, wound-volume reduction
of 80% at a mean of 12 weeks, and 42% complete wound closure at 12 weeks. By
comparison, a meta-analysis of standard-of-care treatment found only 24%
complete wound closure at 12 weeks.  
Thus, Noncontact, Low Frequency Ultrasound (NLFU) achieves almost twice the
healing of the standard treatment.2

**Topical Oxygen Therapy (TOT)**  
Because of the difficulties in obtaining reliable wound measurements, wound
closure is an important and measurable goal, and we agree with the FDA that
complete wound closure is the most objective and clinically meaningful
endpoint. Studies were weighted stronger when randomized and with controls,
and when study end-points or patient selection did not change during the
study. The review of the literature that was conducted for TOT is summarized
below.

Azimian's paper was a sample of 100 hospitalized adult patients were recruited
to this single blinded multi-center study and were randomly assigned to an
intervention or control group. Patients in the intervention group received
transdermal wound oxygen therapy (TWOT). TWOT consisted of the direct
application of humidified high-pressure oxygen via disposable catheter, at a
rate of 10 liters per minute, to the wound site for 20 minutes, three times a
day for 12 days. The authors concluded that transdermal wound oxygen therapy
could effectively promote the healing of pressure wounds on the sacral and
ischial areas of the body. However, due to the relatively small study sample,
they recommended larger studies be pursued.

Blackman's paper describes a controlled, single site study of a prospective
comparison of the healing rates of chronic diabetic foot ulcers (DFUs) treated
with either topical wound oxygen therapy (TWO2) or advanced moist wound
therapy (AMWT). Only 28 patients were included in the trial. The authors
concluded that the wounds of study patients treated with TWO2 were
significantly more likely to heal and in a shorter period than those treated
with AMWT, and that well designed randomized controlled trials to confirm the
efficacy of TWO2 were needed.

The goal of this prospective, randomized study, reported by Driver was to
evaluate the efficacy of the use of transdermal continuous oxygen therapy
(TCOT) in patients with nonhealing diabetic foot wounds by following wound
healing and biological markers of tissue response. Eligible patients were
randomized either to the intervention group (n = 9) or control group (n=8) by
a block randomization scheme. TCOT provided a continuous delivery of 99.8%
pure oxygen by cannula at a rate of 3 mL/hour directly to the wound site. The
manufacturer of the TCOT device supported this study. The authors concluded
that the clinical efficacy of TCOT was established, as there was a significant
difference in percent volume reduction in wound size for the TCOT group
compared to the control group. No wounds completely healed during the study.

Niederauer 2015 reports a planned interim analysis of a randomized, balanced,
double blind, sham controlled, parallel group clinical trial performed to
evaluate use of a device providing the continuous diffusion of oxygen (CDO) to
diabetic foot ulcers (DFU) compared to treatment of the ulcers with standard
moist wound therapy (MWT).

The full sample size of the study is anticipated to be 84 subjects. With this
report of the results of the first 50% of subjects who completed a twelve-week
course of treatment (n=42). The primary outcome of the investigation is
complete wound closure defined as complete reepithelization with no drainage.
Those in the sham group received no oxygen to the wound but did receive
standard of care MWT. Patients were followed for twelve weeks or until wound
closure, whichever came first. Dressing change frequency depended on rate of
exudate and varied from 2-12 times per week.

Upon analysis of the data, the investigators excluded any subject that had
fast wound healing between the screening and visit number one.  
As the study progressed, the authors found it necessary to have regular
conference calls with investigators to provide emphasis on the proper
principles of moist wound therapy, and the number of dressing changes.  
Any subject who withdrew from the study, for any reason, was excluded from the
statistical analysis. This study reported on the first 42 subjects (active
group: n = 21; sham group, n= 21) to complete the study per protocol. The
authors reported that they found no significant and beneficial treatment
effect in the active arm of the study.

However, in a series of subsequent analyses, the authors found that among
subjects with wound size of at least 1.5 cm2 and who experienced wound closure
and excluding subjects who experienced fast closure between Screen and Visit 1
(Active n=9; Sham n=3), the average number of days to closure was
significantly lower among the active group than the sham group. However,
stratification was then used and at the median randomization date, wound
closure was found to be significantly increased in those individuals in the
active group seen after the median randomization date. The authors concluded
that this interim analysis suggested improved healing with CDO versus MWT for
slower to close, larger chronic wounds.

Niederauer (2017) followed up on the interim report (2015) that was published
in _Wound Medicin_ e; with the protocol being amended to change the minimum
baseline wound size and run-in rate of wound closure inclusion/exclusion
criteria. Subjects that failed these criteria were removed from the study.
Sixty-six of 146 subjects were now dropped or excluded from the study after
randomization. The authors stated that the results of this study suggest that
CDO over a wound leads to significantly higher rates of closure and faster
time to closure compared to similarly treated patients receiving standard
therapy provided along with a sham device.

In a paper by Tawfick, a parallel group observational comparative study was
used to examine the safety and efficacy of topical wound oxygen (TWO2) versus
conventional compression dressings in the management of refractory nonhealing
venous ulcers. Here patient preference determined group allocation. The ulcer
healing time among wounds treated with TWO2 was shorter regardless of the
duration or size of the ulcer. During the twelve-month follow up, none of the
37 healed TWO2 ulcers showed signs of reoccurrence, while five of the thirteen
healed ulcers by compression did. The authors concluded that TWO2 produced
superior outcomes to compression therapy in the treatment of refractory venous
ulcers by achieving shorter healing times and reducing recurrence rates. They
also noted that a randomized controlled trial was underway to study the
benefits of TWO2.

Yu's paper reports a pilot randomized controlled trial to compare a continuous
topical oxygen delivery system to standard best practice in patients with
nonhealing DFUs. Patients were randomized into either a group which received
topical oxygen as well as standard of care (SOC) (n=10) or into a nonplacebo
control group which received standard of care alone (n = 10). The study was
performed for eight weeks. One subject in the continuous topical oxygen group
dropped out; and the results of one subject in the control group were
discarded as an outlier, due to the large size of the wound. (n=18 total). The
authors concluded that though this study was underpowered, it demonstrated
that topical oxygen applied continuously to a chronic wound can have a great
effect on healing.

_Level of Evidence_  
Quality -Moderate  
Strength - Limited  
Weight - Limited