04/04/2024    Ralph Zicherman, DPM, Herman Zicherman, DPM,

Nail Avulsion Procedure and Guidelines CPT 11730 Local Coverage Reconsideration / Challenge

National Government Services,
NGS.lcd.reconsideration@anthem.com

Nail infections and treatments have been recorded
and written about for the past 4,000 years. Nail
infections affect about 25 to 35 million patients
per year in the United States, and are responsible
for considerable complications, ranging from pain,
swelling and inflammation, to limitations in
ambulation, gangrene, amputation, and death.

The treatment for nail infections, has been termed
a partial nail avulsion, which up until the early
‘80s simply required the excision and removal of
the infected nail segment, for Medicare
reimbursement. This was a simple effective
treatment, with little complication or difficulty,
for the temporary correction and treatment of a
nail infection. Depending on the extent of
infection, the health of the patient, and the
condition of the nail, a physician could elect to
remove as much or as little nail as his clinical
judgment felt was necessary, for the infection to
resolve.

At some point in the early ‘80s, Medicare
contractors began requiring the removal of 1/2 the
nail boarder for reimbursement, and later incisions
to the eponychium, and then an incision to the nail
matrix (root of the nail situated on the bone of
the proximal phalanx) for reimbursement.
Unfortunately, under these circumstances the
Medicare guidelines have been changed three times,
requiring the removal of more nail segments at each
change of the guidelines, without disclosing the
rationale, reasoning, science, or motivation for
the guideline changes.

The failure of the Medicare contractors in
disclosing the basis of the guideline changes, has
left serious questions about the procedure
requirements (incision to the matrix/eponychium),
and has resulted in considerable confusion and
questions, concerning inaccuracies, and
ambiguities of the guidelines. The confusion
surrounding the guidelines, has resulted in an
unnecessarily aggressive procedure, causing
unnecessary patient damage and trauma (nail matrix,
bone, vasculature damage), lacking science and
research, leaving serious issues and questions
involving the validity and accuracy of the
Medicare nail avulsion guidelines.

While the Medicare guidelines require an incision
the nail matrix (root), there is no science or
research that such an incision is necessary for the
temporary treatment of a nail infection. There is
no science or research that an incision to the
matrix is superior to an incision to the
eponychium, or that an incision to the eponychium
is superior to the removal of 1//2 the nail border,
or that the removal of 1/2 the nail border is more
successful than simply removing the section of
infected nail. With this being the case, why have
Medicare contractors continued to require the
removal of increasing segments of nail tissue, when
lesser incisions have been proven to offer a
satisfactory treatment approach, and have been used
for 100’s of years, avoiding unnecessary trauma and
damage to the patient (nail, vascular , bone).

It is important to note, that prior to the Medicare
guideline changes in the early 80’s, which required
an incision to the matrix for a temporary nail
avulsion procedure, the only mention of a matrix
incision was for the treatment of a permanent nail
correction, not a temporary nail correction.
Medicare contractors have never explained or
provide research or science for over 40 years, for
why a temporary nail avulsion treatment
necessitated an incision to the nail matrix ( root
of nail situated in close proximity to the bone).
In essence, the Medicare guidelines requirements
for a temporary treatment of a nail infection, now
requires an incision near bone, which makes little
sense and should be concerning to anyone who would
ever have such a procedure performed, especially
since less aggressive treatments are available and
have been used successfully prior to the guideline
changes for many years.

In this instance, we have a less aggressive, safer,
less damaging procedure, which only required the
removal of the infected section nail, being
replaced by a more aggressive, damaging procedure,
requiring an incision to the nail matrix, without
any disclosure of medical necessity or science
based evidence. This set of circumstances calls
into question the validity, accuracy, and necessity
of the Medicare nail avulsion guidelines for this
procedure. Logically, we should see research and
science supporting any medical or procedure changes
to guidelines, at the time guideline changes are
made. In this instance, the Medicare guidelines for
the nail avulsion procedure have been changed three
times, without offering any science or research,
to support the changes being made. A close review
of the literature at the time of the guideline
changes, finds no research or science to support
the need for a matrix incision for a temporary nail
infection, leaving questions about the necessity
and rationale for the changes.

With regards to the guideline changes in the early
80’s, Medicare has not clearly revealed the basis,
rationale, reasoning, or motivation for the
guideline changes for the nail avulsion procedure,
what was discussed during the changes, or who was
ultimately responsible for the guideline changes.
This information is vital in determining the basis
and objectives of treatments and guideline
requirements, but has been not been disclosed for
40 years. How have 15 independent Medicare
contractors (MAC’s) throughout the United States,
each require a similar change in the nail avulsion
guidelines (incision to the matrix), without the
support of any science or research. It would appear
that contractors simply parroted a single
contractors guidelines, without any serious
questions or checks and balances, regarding medical
necessity, patient safety, patient damage, lack of
research, or independent investigations.

Aside from a lack of science and research to
support the guideline required incision to the nail
matrix, the Medicare guideline required incision to
the matrix / eponychium, possess considerable
obstacles in being able to accurately perform or
verify the the procedure guideline requirements.
The matrix anatomy is variable, undefined, and
ambiguous, within the context of the Medicare
guidelines, without a means of consistent and
accurate identification, making the verification of
having followed the guidelines almost impossible
for physicians.

While the guidelines require an incision to the
matrix / eponychium, the guidelines never specify
or define if they are referring to the nail plate
matrix, nail bed matrix, nail fold matrix, germinal
matrix, sterile matrix, matrix horns, apical
matrix, or the lunula. Each of these structures
occupy different anatomical positions, making the
Medicare guideline requirements for an incision to
the matrix ambiguous and confusing, resulting in
different incisions, dependent on the matrix
anatomy being used. Equally confusing is the
eponychium anatomy, which is also undefined by the
guidelines, and often confused with the nail fold,
cuticle, and cornified section of the nail fold. In
some instances, the eponychium is confusingly
referred to as the true cuticle, which adds
additional confusion to this anatomical structure.
The questions about the exact position of the
matrix / eponychium anatomy has resulted in a lack
of consensus among medical professionals regarding
these anatomical structures, and a great deal of
variations and interpretations when the nail
avulsion procedure is being performed.

Also confusing, with respect to the matrix /
eponychium anatomy, is the fact that these
structure are invisible, obstructed by the proximal
nail fold, and microscopic, making an incision into
this anatomy a blind procedure. Complicating
matters even more, the avulsion technique, which
Medicare guidelines use as a means of extracting
the nail and identifying the matrix / eponychium
anatomy, is an inexact, imprecise process, of
tearing and pulling tissue, which is unable to make
any accurate or consistent identification of the
matrix /eponychium anatomy. Under these
contradictory circumstances, medical guidelines
require a matrix incision, however, the method
Medicare provides for verification and
identification of the required anatomy (Avulsion),
is not capable of providing this function. This
puts the physician in a position of never being
able to conclusively verify and prove what was done
during a procedure, creating enormous audit and
prosecution disadvantage for any physician
performing the nail avulsion procedure.

Under these complicated circumstances, the
physician is left to using his clinical judgement
and guesswork in determining what has been done, or
if the Medicare guidelines have been met, with the
knowledge that no science based evidence exists for
the Medicare requirements of a matrix incision, and
less aggressive treatments are available, which
avoids unnecessary patient trauma and damage. In
this uncertain scenario, it is not uncommon to see
many different interpretations of the guidelines by
physicians performing this procedure, with some
variations due to anatomical confusion, and others
due to concern of unnecessary patient damage and a
lack of science and research, failing to support
the Medicare guideline requirements. In any case,
guidelines composed of performing a blind
procedure, on invisible, ambiguous, obstructed
anatomy, which lacks appropriate research or a
consistent accurate means of identifying anatomy,
serves as a poor basis of guidelines of any medical
procedure.

Additional issues surrounding the Medicare required
incision to the matrix / eponychium, involves
complications resulting in both improper coding of
the procedure, and matrix stem cell damage, not
properly evaluated, integrated, or acknowledged by
the Medicare guidelines. The nail avulsion
procedure 11730 is described by medicare as the
surgical removal of nail tissue. However, during
the nail avulsion process, sections of matrix /
eponychium are removed as well, making the
procedure an actual partial matrixectomy 11750.
This is due to the fact that the nail is attached
to the matrix, and sections of matrix are removed,
during the inexact, and imprecise, tearing and
pulling of the nail anatomy, with use of the
avulsion technique. With the removal of the matrix
stem cells during the avulsion process, there is
improper insurance coding of the nail avulsion
procedure, in addition to complications involving
nail plate damage, damage to the vasculature, and
insult to the underlying bone tissue. These
complications result in nail plate dystrophy
(loose, discolored, thickened nails), vascular
damage, and bone infection and lysis
(demineralization).
The issues of improper coding and post operative
complications have not been presented,
acknowledged, or integrated into the guidelines for
the past 40 years, in spite of science and research
confirming their presence. Concern for avoiding
unnecessary patient trauma and damage, and the
issues surrounding improper insurance coding has
significant implications for audits,
reimbursements, and prosecutions involving this
procedure, which have avoided and ignored such
issues.

In evaluating the Medicare guidelines, there are
serious issues regarding the anatomy, coding,
science based evidence, and unnecessary patient
damage. A close look at the etiology used by the
guidelines, shows a deficiency and confusion as
well. Etiology is defined as the cause of a
medical problem. In the guidelines, Medicare
describes the etiology of nail infections as a nail
growing into the skin. Unfortunately, nails do not
suddenly change direction and grow into the skin.
For more than 50 years, the primary reason
(etiology) for nail infections has been direct
trauma, improper trimming, improper shoe gear, and
comorbidities (diabetes and vascular disease), not
the nail suddenly changing direction and growing
into the skin, as implied by the guidelines.

In these instances, appropriate treatment can
consist of the removal of sufficient nail width to
allow for soft tissue healing, not an unnecessary
incision to the nail matrix, as described in the
guidelines. In more than 95 % of nail infections
there is no evidence of any nail growing into the
skin. In 5 % of cases there is evidence of a nail
spicule breaking the skin, and causing a bacterial
infection in the distal aspect of the digit, which
can also be appropriately treated by removing
sufficient nail width, also avoiding the matrix
incision required by the Medicare guidelines.

While the mistaken notion and etiology promoted by
the Medicare guidelines, which suggests that nails
can suddenly change direction and curve to grow
into the skin, may support a longitudinal incision
to the matrix, the majority of localized infections
caused by trauma to the nail fold do not require an
incision to the matrix for treatment. What must be
remembered, when formulating treatment for nail
infections, is that nail growing into the skin is
not the etiology for any significant amounts of
nail infections. If this is the case, the etiology
of nail infections used by the Medicare guidelines
is not only incorrect, it is not representative or
relevant for the vast majority of nail infections,
leaving questions about the validity and accuracy
of the guidelines.
The importance of the errors involved in the
etiology used by the Medicare guidelines, is that
this results in unnecessary longitudinal incisions
to the matrix, when more emphasis and appropriate
treatment should be placed on the removal of nail
width avoiding the matrix, to allow for the healing
of a localized infection, being caused by trauma
and irritation between the nail and nail fold, not
growth of nail into the skin. If guidelines fail in
accurately describing an etiology (cause) of a
medical problem, how accurate can the treatment be,
that is being described by the guidelines. If the
etiology is incorrect, can the guidelines and
treatment based on the mistaken etiology have any
accuracy or validity?

With ongoing questions about the Medicare nail
avulsion anatomy, procedure coding, unnecessary
patient damage, unnecessary aggressive approach,
science based evidence, etiology, and the need for
a matrix incision, the entire medical necessity and
validity of the Medicare nail avulsion procedure
guidelines becomes questionable. The federal
guidelines for the criteria of medical necessity of
a guideline or procedure is established by the
Social Security act, The 21st Century Cures Act,
and the Medicare Integrity Manuel. The main
criteria for medical necessity involves safety,
avoiding any over treatment, use of the best
alternative treatments, following medical protocol,
using established science based evidence with
supportive rational, reasoning, and motivation in
establishing guidelines and treatments.

The Medicare nail avulsion guidelines fail in
meeting essential criteria established by federal
regulations for medical necessity. The unnecessary
aggressive matrix incisions required by the
guidelines is responsible for unnecessary patient
damage and trauma, leaving questions regarding
safety. The matrix incision is at best an over
treatment, since lesser incisions, removing smaller
segments of nail result in appropriate treatment.
In addition, since a lesser incision offers
successful treatment, a better less aggressive
alternative is available, other than the Medicare
required incision to the matrix.
The lack of science based evidence for the matrix
incision, coupled with a failure to disclose the
reasoning, motivation, or rational for the matrix
incision requirement, with evidence of an over
treatment and a better alternative treatment,
result in a failure of the Medicare nail avulsion
guidelines and treatment to meet the federal
guideline criteria of a medically necessary
procedure, established by the 21st Century Cures
Act, Medicare Integrity Manuel, and the Social
Security act, calls into question the validity of
the guidelines and their audits.

Another concerning aspects of the Medicare nail
avulsion guidelines, which require an incision to
the matrix, is the fact that no research or science
supports the need for such an incision, for the
treatment of a nail infection with a temporary nail
avulsion procedure. While a matrix incision is
necessary for a permanent nail correction, there is
no need for an incision to the matrix in the
treatment of a temporary correction. Regardless of
these facts and issues, Medicare guidelines have
required the removal of increasing amounts of nail
tissue since the early 80’s.

Guidelines have been changed three times by
Medicare contractors, without disclosing the
science, rational, reasoning, or motivation for the
changes. Guidelines have been changed three times
by Medicare contractors, without explaining how
removing more nail at each guideline change is
beneficial for the patient, or results in more
appropriate treatment. While there is no evidence
that removing increasing amounts of nail tissue is
necessary (incision to the matrix) for treatment,
provides a safer procedure, offers better results,
results in less complications, allows better
healing, or less recurrence, the guidelines have
continued to require the removal of increasing
amounts of nail tissue over the years, with added
risks to patients.
Nail infections have been treated successfully for
hundreds of years, with the simple removal of the
irritated nail segment, without the need of a
matrix incision, which questions the need or
rational for such an incision, or the continued
removal of more nail tissue. Since science and
research forms the basis for patient treatment, we
must ask where the science and research evidence
exists for the Medicare guideline requirements of
increased aggressiveness over the years (incision
to the matrix), and why there has been no
disclosure for 40 years of supportive studies or
science.

A careful review of studies cited by Medicare
contractors, used to support their nail avulsion
guideline requirements, shows these cited studies
fail to support the guideline requirements in place
for the past 40 years. Studies by Exley and Eekoff
provide Cochran and met analysis of hundreds of
nail avulsion studies involving thousands of
patients, concluding nail avulsion studies over the
years represent poor research and study design,
with limited abilities to make any supportive
conclusions. Such research forms a poor basis for
guidelines or medical procedure decisions. With
this being the case, we must ask if the basis of
the Medicare guideline decision for an incision to
the matrix is the result of no science, or poor
science. In either case, this suggests a poor
decision making process.

While the Medicare guidelines require an incision
to the matrix, Medicare cited studies recommend
avoiding the matrix, and avoiding matrix damage,
since this causes and exposes the patient to damage
and dystrophy in nail structure (thickened, loose,
discolored nail dystrophy). While the Medicare
guidelines require an incision to the matrix, the
cited studies recommend an individualized
treatment, dependent on patient comorbidities,
extent of infection, and the condition of the nail.
In contrast the guidelines offer a single approach
requiring an incision to the matrix. In many
instances the studies clearly state that there
remains no one best treatment for nail infections.
Importantly, none of the cited studies offer any
consistent or accurate means of identifying the
required anatomy, or establishing the need for a
matrix incision, in the treatment of a temporary
nail avulsion, contrary to the Medicare guideline
requirements.
Not one of the cited studies evaluated
complications of matrix stem cell damage, in spite
of requiring incisions into this anatomy or the
results and comparisons of lesser incisions, which
avoided the matrix. Confusingly, in one cited study
the anatomy was incorrect, with the eponychium
being referred to as the cuticle, and in another
instance, while the Medicare guidelines seem to
require injectable anesthesia for this procedure,
the cited studies feel topical anesthesia is
appropriate. Critically, the cited study for the
revenue trail involving the treatment of a
recurrent infection, which established an 8 month
time table for additional allowable treatments
after a nail infection recurrence, is in error.

While this study established a nail growth rate of
1 mm / day, there was no evaluation by the study
for when treatment of a recurring infection is
necessary. Regardless of the failure of this
particular study to support the revenue trail for
recurrent nail infections, Medicare contractors
cited this study for such support. This faulty
evaluation of research, seems to be representative
of the same faulty process involved in establishing
the unnecessary requirements for a matrix
incision, having occurred without any supportive
science or research.

In essence, the cited studies for the nail avulsion
procedure fails to support the guideline
requirements for a matrix incision, and posses more
questions than answers as to why this requirement
has remained in place for more than 40 years.
Without a proper evaluation and interpretation of
research, there can be no basis for guideline
requirements (matrix incision). With regards to the
nail avulsion guidelines, no proper evaluation of
science or research has taken place. In these
instances there is a possibility of an abuse of
discretion, a legal process in which there is a
failure to properly and accurately evaluate science
and research, with the end result of the guidelines
incentivizing “useless or sham surgery,” having no
value or medical necessity. This has occurred in
the past with useless knee surgery, performed for
years, in spite of research and science showing
such surgery useless, and may be same case with
useless nail surgery incisions to the matrix.

A clear understanding of the deficiencies and
problems involved with the current Medicare nail
avulsion guidelines, can be seen on reviewing the
nail avulsion fraud trial of Podiatrist Samir Zaky
(2013). Dr Zaky was prosecuted for nail avulsion
fraud. During the trial a Dr Feldman and Trepal
were called as prosecution expert witnesses. Dr
Feldman was a consultant with Medicare and was
active when the nail avulsion guidelines were
changed from the removal of 1/2 the nail border to
an incision up to the eponychium. Dr Feldman
testified that the reason for changing the
guidelines (making them more aggressive) was to
insure the guidelines were crystal clear, without
any confusion. There was no mention of any
supporting science or research or newly discovered
medical necessity. However, the need expressed for
clarity, cited as a reason for the guideline
changes by the expert is not accurate, with
guideline changes requiring incision to an
unclearly defined ambiguous eponychium anatomy. In
looking at the research at the time, there has
never been any mention of confusion regarding the
nail avulsion procedure, with an incision removing
1/2 the nail border being descriptive and accurate,
without any confusion or problems of
interpretation.

In opposition, the new requirement for an incision
to the eponychium, whose anatomy is invisible,
obstructed, and microscopic, and often confused
with the nail fold and the cuticle, is clearly
confusing with a lack of consensus among
physicians. This being an odd choice of anatomy, if
one wishes to offer crystal clarity and reliability
to a procedure guideline. In this instance it is
additionally concerning, when the expert was asked
to define the eponychium, whose anatomy he
supported in making a change in the guidelines, he
remarked that the eponychium was the cuticle, which
was incorrect. In this case, the expert consultant
for Medicare at the time, supported a change of
anatomy in the guidelines, and yet was unable to
define the anatomy he was using, and could offer no
science or research for the guideline changes.

The testimony by the other witness, Dr. Trepal was
equally disappointing, when he also incorrectly
identified the cuticle as the eponychium. The Zaky
trial gives evidence that the guidelines were
changed, without any science based evidence, or a
clear understanding of the anatomy involved. With
this being the case, there fails to be any medical
necessity for the guideline requirement of a matrix
incision, and such treatment is without any
appropriate science or research to support such
actions. In spite of these shortcomings, Medicare
guidelines having established a standard of care
for this procedure, which has lacked the best
interest of patients for the past 40 years, in
combination with confusing, inaccurate, ambiguous
procedure guidelines, which continue to be the
basis of the most audited and prosecuted procedure
in Podiatry.

Finally, while audits hopefully result in accurate
statistics, the statistics for nail avulsion
procedures lack consistency, and fails to show any
significant increase in nail avulsions over the
years, in spite of conditions favoring such
increases being present. It is estimated that up to
30 million patients a year experience nail
infections, and that the rate of nail infections is
continually rising, however, Medicare statistics
have not shown significant increases over the years
for this procedure. This contradiction is
problematic, in light of facts being present,
which should be responsible for yearly increases in
these procedures. Factors such as increasing
population levels, increasing aged populations, and
increased awareness of the problem, should all have
contributed to a yearly increase in this pathology.

Additionally, medical doctors report that 20 % of
all patient visits for extremity problems involve
nail issues. Even the American Diabetic
Association, has stated that 99 % of individuals
will have a nail Issue in their lifetime. One study
in Korea, cites a 25 % increase in nail infections
over a ten year time period. These factors all give
evidence for the position that we should be seeing
significant yearly increases nail infection
treatments, however, Medicare statistics have not
show a significant increase over the years, for the
nail avulsion procedure. With this being the case,
only two explanations are possible, in one,
doctors are doing the procedure and billing for it,
or they are doing nail avulsions and billing for
another procedure. Billing for other procedures, in
order to avoid the scrutiny of Medicare nail
avulsion audits and prosecutions, have been ongoing
for the past several years, coinciding with the
increased Medicare scrutiny of this procedure. In
these instances, a patient presenting for a nail
avulsion procedure, may be being billed for an
abscess, hematoma, ulceration, biopsy, or office
visit, in order to avoid audit scrutiny or the fear
from prosecutions. With this being the case, the
entire statistical presentation for the nail
avulsion procedure becomes difficult to discern,
making for inaccurate interpretations, conclusions,
and comparisons. These actions (avoiding billing
for nail avulsions in order to avoid scrutiny of
audits), can seen immediately after high profile
audits and prosecutions are publicized, which are
then followed by reductions in billings for this
procedure, resulting in erroneous underreported and
failed statistics.

In what appears to be overwhelming
evidence, we must ask if the Medicare nail avulsion
guidelines are valid or accurate, if they contain
serious inaccuracies and questions involved with
anatomy, safety, patient damage, procedure coding,
etiology, science based evidence, medical
necessity, necessity of a matrix incision, and an
inherent inability to accurately and consistently
identify the microscopic, invisible, obstructed
involved anatomy or being able to verify what has
been done during the procedure.

It is hoped that the information contained in this
report begins a close evaluation and examination of
the process involved with the nail avulsion
Medicare guideline requirements, and begins a
process of addressing serious issues neglected by
Medicare contractors, the Podiatry profession, and
the medical community, in hopes of providing a
safer more effective treatment, for the very common
medical issue of nail infections, which affect
millions of patients each year.

Ralph Zicherman, DPM, Herman Zicherman, DPM,
West Bloomfield MI

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