Wound care (L37166): Medicare Part A/B local coverage determination (LCD)
comment summary

**Comments received:  **

**Comment #1:** A common issue was on the proposed noncoverage of disposable
negative pressure wound therapy (dNPWT) devices (CPT codes 97607 and 97608)
and how one reference was omitted from the local coverage determination's
(LCD) "Sources of Information" section: Armstrong et al. 2012 study. There
were multiple comments expressing disagreement with the noncoverage of the
disposable NPWT devices. Even though the available literature is not of good
quality since it has sponsor bias, for appropriately-selected patients, these
devices are highly effective and achieve better patient compliance since they
allow more mobility to the patient and are more convenient than NPWT that
utilizes durable medical equipment (DME).

Also, there were several comments stating that disposable NPWT (97607/8) has
been a covered benefit for Medicare beneficiaries under First Coast Service
Options (First Coast) jurisdiction since 2014 when NPWT was removed from the
Noncovered Services LCD (L33777).

**Contractor response:** First Coast agrees that the available literature is
not of high quality due to some of the reasons identified in comment #1. The
Armstrong 2012 reference was inadvertently left off of the draft, but it was
evaluated by First Coast Medical Policy staff in 2013 and was considered low
in quality of evidence for several factors (e.g., small sample size, lack of
comparator, numerous patients lost to follow-up, author bias-- two of the
authors received funding by the sponsors of the study: Spiracur (manufacturer
at the time) for the SNAP device and KCI for the VAC device.) The Armstrong
2012 study will be added to the LCD when it is finalized. The Contractor also
recognizes studies show disposable NPWT may be just as effective as the
traditional NPWT, and it has been determined that there will be access to
coverage for NPWT utilizing durable medical equipment or non-durable medical
equipment in appropriately selected patients.

In response to the removal of disposable NPWT codes from the Noncovered
Services LCD, CPT codes 97607-97608 were removed from the LCD in 2013 to
gather more data on these services. A service or procedure that is removed
from noncoverage or not addressed in the Noncovered Services LCD **does**
**not** provide positive coverage and is given individual consideration on a
case-by-case basis. Thus, dNPWT was not given positive coverage by the First
Coast jurisdiction when it was removed from the Noncovered Services LCD.

**Comment #2:** A few commenters requested clarification of the use of wet-to-
dry and dry-to-dry dressings as they state are no longer the standard of care.

**Contractor response:** Clarification is provided on judicious use and
efficacy of wet-to-dry and dry-to-dry dressings.

**Comment #3:** When Unna Boot is applied and a wound debridement is
performed, the LCD does not allow for both, but CCI allows for both if an
appropriate modifier/different site is applicable. If for a separate condition
and same anatomical site, this should be allowed.

**Contractor response:** The National Correct Coding Initiative (NCCI) Policy
Manual for Medicare Services Chapter 4, section G states that debridement
codes (11042-7, 97597) should not be reported with a strapping code (29580,
29581) for the same anatomic area. After consideration, this language would be
more appropriate for a coding article rather than the LCD since it relates
more to billing and coding information and does not address reasonable and
necessary considerations for coverage. A coding article will be developed for
provider guidance and posted when the policy becomes effective.

**Comment #4:** A number of commenters suggested clarification regarding
paring or cutting of corns / non-plantar calluses. Commenters stated that
regardless of pathology, when an ulcer is present, appropriate wound care is
indicated and should be covered.

**Contractor response:** This language in the Limitations section was taken
directly from our existing wound debridement services LCD (L33566). There have
not been any reconsideration requests to remove or revise this limitation.
However, we appreciate the comment and agree that once there is skin breakdown
underneath a corn or non-plantar callus, it becomes an ulcer and may require
debridement. Therefore, the limitations addressing ulcers which may arise
after paring or cutting of corns or non-plantar calluses as not reasonable and
necessary wound debridement services have been removed from the finalized LCD.

**Comment #5:** Numerous comments were submitted requesting removal of
debridement frequency limitation. Commenters stated that patients may require
more than eight services in a year depending on many different factors.
Commenters stated current literature does not support a specific number of
debridements for proper wound care but rather debridements should be specific
to the wound to encourage healing.

**Contractor response:** Data analysis illustrates that a minority of patients
receiving wound care actually receive more than eight debridements involving
debridement of subcutaneous tissue, muscle/ fascia or bone in a rolling 360
day period. While it is recognized that some patients have an unusual and
prolonged course of wound healing and / or palliation, debridements of an
unusually excessive number should be accompanied by meticulous documentation
illustrating that the service performed is both medically reasonable and
necessary. It is expected that these services would be performed as indicated
by current medical literature and/or standards of practice. Utilization of
more than eight debridements in a rolling 360 day period may be subject to pre
or post payment medical review (records requested).

**Comment #6:** Several comments were received requesting removal of the
documentation requirement regarding photographs. Commenters requested
clarification on whether photographs are required. Commenters stated requiring
photographs could become an unnecessary burden to providers.

**Contractor response:** Photographic documentation for wounds has been
amended to suggestions for best practices in wound care. First Coast
recognizes that photographic submission is not possible in many cases but may
be particularly beneficial as an adjunct to document wound healing,
particularly in wounds which are more extensive in nature or require prolonged
or repetitive services.

**Comment #7:** While there is an agreement that the initial debrided bone
sample should have a pathology report, subsequent bone removal would not
necessitate additional pathology, which is increasing costs without a medical
benefit. Only the initial pathology is required.

**Contractor response:** Pathology requirements mandating reporting of
debridement codes of fascia and bone have been amended to guidelines for
documentation. Submission of pathology codes may be particularly beneficial in
initial debridements of muscle/ fascia or bone and in wounds requiring
prolonged or excessive care.

**Comment #8:** Comments were submitted requesting removal of the frequency
limitation for Negative Pressure Wound Therapy (NPWT). Comments reflected
concern that the frequency limitations were arbitrary, and the draft policy
bibliography did not support the clinical or scientific basis for the
limitation.

**Contractor response:** Wounds heal at varying degrees and are affected by
various factors. While the frequency of application of NPWT is generally
recommended at two to three times per week, data analysis of application of
NPWT illustrates that a minority of beneficiaries of wound care will actually
receive more than six applications in a four month period in order to achieve
the desired objective in the care of the wound. Wounds which require prolonged
and excessive application of NPWT devices should be accompanied by meticulous
documentation illustrating that the service is both medical necessary and
reasonable. It is expected that these services would be performed as indicated
by current medical literature and/or standards of practice. Utilization of
more than six NPWT applications in a four month period may be subject to pre
or post payment medical review (records requested).

**Comment #9:** A number of commenters requested clarification regarding wound
care dressing changes and skills of physicians, podiatrist, physical
therapists, occupational therapists, or wound care nurses. Commenters stated
the policy implied that providers listed in the following statement would not
be reimbursed for services should they remove and perform a subsequent
reapplication of a dressing: "Dressing changes (removal and subsequent
reapplication) alone do not require the skills of physicians, podiatrists,
physical therapists, occupational therapists or wound care nurses and in fact
are usually performed by non-physician providers."

**Contractor response:** Dressing changes (removal and subsequent
reapplication) alone generally do not require the skills of physicians. They
may be performed by physical therapists, occupational therapists, licensed
professional nurses, or wound care nurses. The LCD has been amended to provide
clarification.

**Comment #10:** All references in the LCD should refer to Podiatrists as
physicians and not distinguish between the two.

**Contractor response:** Podiatrists are defined as physicians alongside
doctors of medicine and osteopathy. The final LCD was amended to remove the
reference about podiatrists.

**Comment #11:** A number of commenters requested clarification of what would
be considered experimental or investigational since the policy states, "Wound
debridement utilizing experimental or investigational methods is considered
not reasonable and necessary. Therefore, it would not be reasonable and
necessary to report these services with any CPT code."

**Contractor response:** As stated under the History/Background section of the
LCD, any method which is unproven by valid scientific literature would be
considered not reasonable and necessary.

**Comment #12:** Multiple comments were received requesting rewording of
language pertaining to palliative wound care. Commenters offered concern that
the language in the draft policy suggests abandonment of patients who require
palliative care.

**Contractor response:** The language in the policy has been changed to
clarify that the optimal objective for wound therapy is progressive healing of
the wound. Multiple factors, etiologies, and co-morbid conditions affect
healing, and wound care for palliation may serve a role in avoiding prolonged
hospitalizations.

**Comment #13:** Several commenters requested clarification of language in the
History section regarding wound care performed by the patient or the patient's
caregiver. Commenters said the draft policy is correct "in most cases" but
asked for clarification regarding patients for whom it is not the case that,
"a wound will reach a state at which its care should be performed primarily by
the patient and/or the patient's caregiver with periodic physician assessment
and supervision."

**Contractor response:** The LCD will be clarified as follows: While complete
healing of the wound may be the primary objective, a secondary desired
objective is that, with appropriate management, a wound may reach a state at
which its care may be performed primarily by the patient and/or the patient's
caregiver with periodic physician assessment and supervision.

**Comment #14:** The Documentation Requirements section states that a
patient's expected restoration potential must be significant in relation to
the extent and duration of treatment required in achieving this potential. If
wound closure is not a reasonable goal, then the expectation is to optimize
recovery and establish an appropriate non-skilled maintenance program. This
requirement appears to violate the American Disability Act for patients with
spinal cord injuries, motor neuron disease, demyelinating disease, visual
impairment from diabetic retinopathy, severe arthritis, strokes, mild
dementia, etc. All of these patients would be incapable of caring for their
wounds and recognizing serious events. In other words, a "non-skilled
maintenance program" is not possible in the absence of a Federal mandate,
which compels family members to provide this care. This assumes the patient
has an immediate family to compel.

**Contractor response:** Medicare coverage is defined by reasonable and
necessary criteria per Social Security Act section 1862 (a) 1(A).This
statement is an expectation; it does not preclude a skilled maintenance
program or palliative wound care when reasonable and necessary.

**Comment #15:** Several commenters requested the following specific
requirements pertaining to wound healing be removed from the policy because
even though the concept of a wound healing trajectory has been popularized, it
cannot be generalized to all clinical scenarios: "Wound volume or surface
dimension should decrease by at least ten percent per month or Wounds will
demonstrate granulation tissue advancement of no less than one mm/week."

**Contractor response:** Wounds heal at varying rates and are affected by
various factors. An allusion referring to the rate of healing of the wound
will be removed from the LCD.

**Comment #16:** Several commenters requested clarification regarding the
following statement regarding the use of anesthesia for CPT codes
97597-97598: "This procedure typically requires no anesthesia and there is
generally no bleeding associated with it." Commenters stated there is no need
to include statements about bleeding in this policy.

**Contractor response:** Medically reasonable and necessary use of the various
anesthesia modalities, if needed, is at the discretion of the provider. Also,
the reference about bleeding tissue has been clarified.

**Comment #17:** A number of commenters requested removal of dermatologic
conditions under Wound Care Surgical Debridements (eczema, bullous skin
diseases, etc.) as these are not related to wounds.

**Contractor response:** After consideration, some of the conditions which
were referred to as dermatologic have been amended or removed.

**Comment #18:** A number of comments were received requesting the addition of
biofilm or bioburden to Covered Indications for debridement. The following
statement is in the Limitations section of the draft policy: "Removal of non-
tissue integrated fibrin exudates, crusts, biofilms or other materials from a
wound without removal of tissue does not meet the definition of any
debridement code and may not be reported as such." Commenters state that a
wound could look "clean" but have subclinical bioburden present that would
need to be addressed through debridement.

**Contractor response:** The contractor agrees that this statement is
incorrect. There are active wound care management CPT codes that reference
removal of biofilm and may be reported for such debridement. Please reference
CPT and coding guidelines.

**Comment #19:** A number of commenters requested removal of utilization
guidelines for low-frequency, non-contact, non-thermal ultrasound (MIST
Therapy) while several commenters supported the guidelines.

**Contractor response:** The utilization guidelines have not been changed for
MIST Therapy. Guidelines for the use of low-frequency, non-contact, non-
thermal ultrasound (MIST Therapy) are supported by the manufacturer.

**Comment #20:** Comments were submitted requesting removal of the debridement
frequency limitation for debridement codes involving muscle / fascia or bone.
Commenters expressed concern that five muscle debridement services per
calendar year would not allow for appropriate wound care especially for
bedridden decubitus patients that may have different wounds at different times
in a given calendar year.

**Contractor response:** Debridement codes involving fascia or bone would be
expected to lessen over a period of time as the wound heals. Data analysis
illustrates that a minority of beneficiaries receiving wound care actually
receive more than five debridements involving muscle/fascia or bone in a
rolling 360 day period. Debridements of an unusually prolonged or excessive
number should be accompanied by meticulous documentation illustrating that the
service is both medical necessary and reasonable. It is expected that these
services would be performed as indicated by current medical literature and/or
standards of practice. Utilization of more than five debridement codes
involving fascia or bone in a rolling 360 day period may be subject to pre or
post payment medical review (records requested).

**Comment #21:** Several commenters expressed concerns with wording throughout
the LCD and requested clarification or removal of specific statements.

**Contractor response:** Comments related to wording or style, not relevant to
coverage, were too numerous to be addressed on the comment response document.
All comments were reviewed and noted.