07/10/2023    Ralph Zicherman, DPM

Medicare Simple Partial Nail Avulsion Guidelines Unproven, Unnecessary, Unsafe

For Medicare insurance guidelines to be accurate,
and offer successful treatments for clinical
problems, they must carefully adhere to the format
of evidence based medicine. This accepted process
involves reviewing the best research and evidence,
critically appraising and evaluating such evidence,
with the physicians then using their professional
and clinical experience to extrapolate the
scientific evidence as it applies to the specific
patient. In the end, the physician must apply all
the research, information, and skills in the
context of individual patients’ values and or
preferences, which at times, may and can conflict
with limited single treatment options offered by
narrow insurance guidelines. After treatment, the
outcomes are evaluated and constantly reevaluated
to insure the impact of treatment remains positive
and timely. This process has not been followed in
developing the Medicare nail avulsion guidelines,
raising serious questions regarding the best and
most appropriate care for patients presenting with
nail infections.

In the early '80s, Medicare contractors changed
nail avulsion guidelines, for the treatment of nail
infections, to require incisions to the eponychium.
This was put into effect without Medicare
contractors providing any accepted rationale,
reasoning, science, or research for the guideline
changes. Medicare contractors once again changed
guidelines in the late '80s, to require an even
more aggressive incision to the matrix, once again
without offering any accepted science, research,
rationale, reasoning, or motivation for their
guideline decisions. In these instances, the
guidelines were changed twice, without offering any
explanations for their actions. A careful review of
nail avulsion research and literature in the ‘80s,
shows no studies to support the guidelines changes.

Prior to the guideline changes in the ‘80s, nail
avulsions often consisted of the removal of small
sections of the local infected nail, without any
involvement of matrix or eponychium. This less
aggressive treatment, resulted in the resolution of
most infections, with little complication, pain, or
matrix damage. The failure of Medicare contractors
to provide the basis for the changes to their
guidelines in the early ’80s, and ‘90s has created
serious questions and confusion regarding proper
care for nail infections.

For a procedure, which has been performed millions
of times, we have no clear information about who
determined the Medicare guideline changes, the
basis for these decisions, and what was discussed
during meetings involving the guideline changes. We
still do not have this information, in spite of the
guidelines being in place for the past 40 years.
How can we make important clinical decisions about
patient care, without a clear understanding of the
rationale behind the Medicare guidelines changes.
Were guidelines changed to reflect research showing
improved results and patient satisfaction from more
aggressive incisions to the matrix - eponychium, or
were guidelines simply based on failed research and
unproven opinion of consultants? The silence from
Medicare contractors on these issues, suggests a
failure in the guideline formulation process of the
nail avulsion procedure.

Cochran and met-analysis reviews by Bloomfield in
2003, Eekhof in 20012, and Exley in 2023 evaluated
thousands of nail avulsion studies and patients,
finding the vast majority containing poor levels of
science, poor control of patient variables, and
deficient random controlled sampling and
experimental design. The latest met- analysis by
Exley, stated that, “Despite the high number of
publications, the quality of research was poor and
conclusions that can be inferred from existing
trials is limited……To put this another way, 3,756
people have taken part in research studies that do
little to guide clinical practice……..More, high
quality clinical trials to inform clinical decision
making are urgently needed in nail surgery.” From
these large Cochran and met analysis studies of
nail nail avulsions, we must assume that much past
and current nail avulsion studies and research are
of limited use in formulating clinical
applications. If this is the case, what was the
research and experimental basis for the guideline
changes to require incisions to the matrix and
eponychium in the early ‘80s and ‘90s? Were
inappropriate, poor quality research, with improper
conclusions, the basis for guideline changes, as
suggested by the Cochran and met-analysis reviews,
resulting in Medicare guidelines lacking a
foundation of science based medicine, or were
non=medical issues and poor decision making the
basis of guideline changes? Medicare contractors
must be made to explain their past actions in order
to resolve these issues, and accept the fact that
they may be responsible for patients receiving
improper, overly aggressive treatments, lacking
science based medical care.

In terms of the nail avulsion procedure, there is
no proof that removing 10 mm of nail to be more
effective than removing 9 mm or 8 mm of nail. In
addition, there is no proof that more aggressive
treatments are more successful than lesser
incisions in terms of recurrence or relief of
symptoms. If this is the case, what is the basis
for Medicare guidelines decisions requiring a more
aggressive treatment (matrix - eponychium), which
offers no clear advantage over conservative less
aggressive intervention (proximal to the nail fold
and cuticle). In the absence of good experimental
proof, conservative less aggressive treatments
should always be a more appropriate treatment
option, over unproven aggressive treatments
involving incisions to the matrix or eponychium. In
this instance, we must consider the fact that
effective treatments prior to the guideline changes
in the ‘80s, represent a conservative safer less
aggressive treatment option, opposed to more
aggressive treatments with no science based
evidence. These less aggressive treatments were
used for hundreds of years prior to the guidelines
changes, with satisfactory resolution of nail
infections.

While the Medicare guidelines require incisions to
the matrix - eponychium, there are no studies to
support more aggressive treatment, as offering any
advantage over lesser incisions to the cuticle or
distal nail plate, which avoids damaging matrix
structures. In contrast to requiring incisions to
the matrix, there has been an abundance of research
and studies illustrating the importance of nail
matrix stem cells (nail plate matrix, nail fold
matrix, nail bed matrix) as important biological
barriers to disease. There are also numerous
studies documenting permanent damage to the nail
plate structures, as a result of matrix stem cell
stem cell trauma, which should suggest avoiding
unnecessary incisions to the matrix anatomy during
nail avulsion procedures. Confusingly, even with
studies and research showing nail plate damage
resulting from matrix stem cell trauma, the
guidelines have failed to incorporate these finding
in their nail avulsion guidelines since the ‘80s.
The failure of the guidelines to incorporate
relevant matrix stem cell damage research, suggests
a failure of the current guidelines to represent
accurate factual medical science, neglecting the
best interests of patients.

Additional guideline confusion has resulted due to
a failure of incorporating anatomical clarity, as a
result of poorly defining nail organ descriptions.
This can be seen as a result of a failure of the
Medicare guidelines to make a distinction between
sterile matrix, germinal matrix, nail bed matrix,
nail plate matrix, or nail fold matrix, and simply
referring to the matrix as a single, easily
identifiable anatomical structure. In reality,
these are all separate anatomical structures
occupying different anatomical positions, and
simply referring to a matrix without clear
definitions is not medically appropriate. In
addition, in spite of the presence of a nail bed
matrix, which was first discussed in 1980, and nail
fold matrix discussed in the late 80’s, there has
been no mention of these structures in the Medicare
nail avulsion guidelines over the past 40 years.
While nail anatomy has progressed over the years,
the guidelines have failed to incorporate these
important findings.

In addition to the proposition of the incision
requirements being unnecessarily aggressive in
length (matrix - eponychium), and lacking science
based evidence, the incision requirements (to the
matrix-eponychium) are critically deficient with
regards to an unproven, incapable, avulsion
technique as well. The avulsion technique is an
imprecise, inexact, traumatic, pulling, twisting,
and tearing of tissue. The avulsion technique is
not a consistent or accurate means of verifying
invisible, microscopic, obstructed matrix anatomy
(matrix - eponychium), as suggested in the Medicare
guidelines. With this being the case, the entire
procedure lacks an essential element necessary in
meeting guideline requirements for the
identification of the matrix anatomy structure.
While the guidelines require incision and therefore
identification of the microscopic, obstructed,
invisible matrix, the avulsion process is unable to
provide such visualization. As a result, without
accurate methods for the verification of anatomy,
the entire procedure remains a blind procedure,
using clinical judgement and guesswork, not exact
identification of structures.

Of additional importance, during the process of
avulsing the nail, sections of matrix are also
removed, due to the nail having direct attachments
to the matrix. With this being the case, the nail
avulsion procedure as described by Medicare, should
be seen as as a partial matrixectomy (removal of
sections of matrix), calling into question the
entire accuracy of the insurance coding for this
procedure (11730 or 11750).

The guideline incision length requirement (matrix-
eponychium) remains unproven, lacks accurate
science based evidence, and fails to show any
improvement over less aggressive incisions. In
addition, there is no accurate or consistent
process of identifying the required guideline
anatomy (matrix - eponychium) during nail avulsion
process, since the avulsion technique is inexact
and imprecise. Medicare also fails to properly
define and specify the exact location of the
matrix - eponychium anatomy used in the guidelines
(sterile matrix, germinal matrix, nail bed matrix,
nail fold matrix, matrix horns, apical matrix,
proximal matrix, distal matrix) by simply requiring
incision to the matrix, without any specificity.
Finally, in spite of requiring incisions to the
matrix, the guidelines fail to incorporate accurate
matrix stem cell function, damage, and biology
research and studies, showing this anatomy as being
a sensitive, delicate, structure, susceptible to
damage, which often leads to nail plate dystrophy.

With regards to the nail avulsion guidelines, they
seem to have been based on poorly designed studies,
of low quality research, while at the same time,
appropriate research and studies regarding nail
anatomy and matrix stem cell function and damage
have been ignored. In contrast to guideline
requirements of incisions to the matrix -
eponychium, treatment of nail infections prior to
the 80’s offered the resolution of nail infections,
using less aggressive incisions, which were
proximal to the matrix and eponychium, with anatomy
that was easily identifiable, and lacking matrix
involvement or damage. This would suggest the
current Medicare guidelines being unproven, unsafe
and unnecessary.

As part of good medical evidenced based decision
making, treatments must take into account
individual patient needs and variables, and the
possibility of individualizing treatments. With
regards to the nail avulsion procedure, we must ask
if the individual interest of patients are met,
when every nail infection is being treated using
the same Medicare required incision to the matrix -
eponychium. The answer to this question is an
obvious no. This can best be seen by answers to the
following questions. Should a severe nail
infection, receive the same aggressive treatment as
a minor infection? Should an infection limited to
the distal aspect of the nail plate be treated the
same as one located more proximally? Should an
infection caused by tight footgear, be treated the
same as one caused by poor nail trimming? Should a
patient with vascular disease or diabetes have the
same aggressive treatment as a patient in good
health? These are questions that physicians must
face every day, which are left unanswered by
Medicare nail avulsion guidelines, requiring the
same treatment option for almost every nail
infection. If this is the case, why have the
guidelines taken such an unnecessary treatment
approach.

Logically, good medical protocol for the treatment
of nail infections, involves individualized
treatments, to meet variables involving
comorbidities, the severity of infection, the
condition of the nail, and patient wishes. The
Medicare guidelines leave no room for these
important treatment variables, leaving questions of
safety, necessity, and what is in the best interest
of patients largely unaddressed. While it appears
less aggressive incisions and treatment, used for
100’s of years, which avoided the matrix and
eponychium, and offered greater safety and equally
effective treatment, continues to be ignored by the
Medicare guidelines. This is clearly evident, when
the same nail avulsion guidelines have been used
without any significant changes for the past 40
years, in spite of an abundance of cautionary
research and studies involving matrix stem cell
anatomy, function, damage, and biology. In this
instance, Medicare has failed to evaluate and
reevaluate treatment outcomes, to ensure that the
effect of their treatment guidelines remain
positive and timely.

Ralph Zicherman, DPM, Detroit, MI

Other messages in this thread:

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07/19/2023    Lawrence Rubin, DPM

Medicare Simple Partial Nail Avulsion Guidelines Unproven, Unnecessary, Unsafe (Ralph Zicherman, DPM)

Dr. Zicherman's response to my post regarding
Medicare's past revision of utilization guidelines
for CPT coded nail avulsion procedures questioned
the authority of the Office of the Inspector
General (OIG) to require Medicare to curb "abusive"
billing by podiatrists. The following link to the
OIG website explains this ability:
https://www.ftc.gov/office-inspector-general/what-
you-need-know-about-office-inspector-general

It is also important to know that since 2002,
podiatrists have been at high risk of audits and
punitive actions for what the OIG considers abusive
billing for debridement of onychomycosis. Read more
about this here:
https://oig.hhs.gov/oei/reports/oei-04-99-00460.pdf

The reality of all this is that Medicare claims
from podiatrists that involve toenail avulsion
and/or debridement are under close monitoring by
Medicare. They are among the most common services
that subject a podiatrist to an audit.

I strongly advise all podiatrists who submit
Medicare claims for nail avulsion and debridement
services to follow the advice of the OIG itself:
Implement the Office of the Inspector General (OIG)
Individual and Small Group Practice Compliance
Program that evidences your adherence to published
CMS-Medicare utilization guidelines.

The OIG states that, even if there is a suspicion
of abusive billing following a Medicare audit,
having a practice compliance program, "will be a
mitigating factor" against punitive action. In my
past and present work involving Medicare compliance
issues, I have found this OIG statement to be true.

Here are the details about the OIG Individual and
Small Group Compliance Program Act:
https://oig.hhs.gov/documents/compliance-
guidance/801/physician.pdf

Lawrence Rubin, DPM, Las Vegas, NV

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07/18/2023     Ralph Zicherman, DPM

Medicare Simple Partial Nail Avulsion Guidelines Unproven, Unnecessary, Unsafe (Lawrence Rubin, DPM)

Thank you Dr. Rubin (who served on the Medicare
HFCA CAC). You say that the reason for changes to
the Medicare nail avulsion guidelines were mandated
by The Medicare office Of the Inspector General. I
find this quite surprising and shocking, since the
“Inspectors General are empowered by congress to
identify and inform the legislative branch of
incidence of waste, fraud, abuse, and
mismanagement,” not formulate medical decisions or
guidelines.

In reviewing the 21st Century Cures Act, The Social
Security Act, and the Medicare Integrity Manuel,
there is no mention of The OIG having any role in
developing LCD or treatment guidelines. MACs
(Medicare Advisory Committee) have science
committees, professional consultants, medical
writers, scientist, researchers, advisory
committees, statisticians, physicians, actuaries,
the office Of Inspector General is not part of the
equation in making medical decisions. The OIG does
not have the resources, expertise, manpower. or
congressional authority to formulate or change
guidelines.

If it is accurate, that the nail avulsion
guidelines were changed and based on a mandate by
the OIG, we should all be concerned that an
investigative body of the federal government has
formulated medical policy, without having the power
or structure to do so. The rules and guidelines for
formulating LCD”s are lengthy and complex, to
insure patient safety, patients best interest, and
good medical protocol and decision making for
treatment that is medically necessary. There is no
process, mechanism, governmental authority, or
administrative checks, balances to allow for the
OIG to be involved in LCD guideline or medical
decision making.

Having the OIG make medical decisions, would be
like the FBI, telling us how to do a bunionectomy,
If it is accurate, that the OIG mandated the
changes to the nail avulsion guidelines, what is
the purpose of MAC’s or LCD’s. We should all be
alarmed and concerned. This would imply that for
the past 40 years our treatment of nail avulsions
had no basis in science, or research, rather the
explanation that guidelines were changed in order
to limit reimbursements and procedure numbers. How
many practitioners have understood, that for the
past 40 years, we were following guidelines
formulated by the OIG, not the HCFA (Medicare), and
that our actions were primarily to reduce
reimbursements and procedure numbers, not
necessarily the best interest of patients

The medical-ethical legal implications, of changing
a medical treatment or guidelines, making them more
aggressive and traumatic, in order to reduce
reimbursements and procedure numbers, should alarm
physicians and patients alike. We should have been
informing patients that the need for incising nail
infections to the matrix and eponychium, were to
reduce reimbursements and procedure numbers, not
for reasons of medical necessity. That patients had
unnecessarily aggressive procedures performed,
which resulted in nail plate dystrophy, vascular
damage, matrix damage, amputation, and in some
instances bone damage, as a result of the OIG
trying to reduce reimbursements and procedure
numbers, not medical necessity.

How many practitioners or patients were made aware
of the fact that medical decisions were being made
by an investigative branch of the government,
having no congressional power or administrative
process for making such decisions. MAKING A
PROCEDURE MORE AGGRESSIVE, IN ORDER TO REDUCE
REIMBURSEMENTS, IS INDEFENSIBLE, AND
UNCONSCIONABLE.

If true, this represents a failure of the entire
medical guideline decision making process. There
needs to be an immediate investigation by the APMA,
HFCA, MAC, Congress, and OIG. Patients have been
damaged unnecessarily, physicians have been
following guidelines based on OIG mandates, not LCD
requirements established by congress, and
physicians have been audited and prosecuted,
without properly being informed of the basis of
the nail avulsion guidelines.

Currently, there are already two national law firms
investigating class actions involving patient
damaged as a result of nail avulsion procedures. As
a profession, we need to get in front of this
issue before it turns into a national headline. I
have spent the past 10 years trying to warn the
profession about serious problems with the nail
avulsion guidelines, and hope that the profession
views these concerns as serious as well.

Ralph Zicherman, DPM, Detroit, MI

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07/13/2023    Lawrence Rubin, DPM

Medicare Simple Partial Nail Avulsion Guidelines Unproven, Unnecessary, Unsafe (Jack Ressler, DPM) From:

I want to thank Dr. Ressler for his, “Killing the
Chicken Who Lays the Golden Eggs” story. He
witnessed the flagrant abuse and outright fraud in
the early 1980's that occurred when all too many
podiatrists abused the billing of CPT code 11730 -
nail avulsion.

It is so sad that even now, because of this long
ago situation, it is no longer a question of
whether or not a podiatrist will be subjected to a
random or targeted audit of 11730 coding and
billing. It is more a question of when this audit
will occur. But this is not the end of the Golden
Egg story. Things got worse.

In the early 1980s, the abuse Dr. Ressler describes
tarnished the reputation of podiatry in the minds
of HCFA administrators. Congress was aware of that
reputation, probably from information obtained from
HCFA. So, reportedly to prevent the same podiatry
abuse that was occurring via 11730 false billing,
in the late 1980s, Congress reacted by putting into
law restrictive medical necessity and utilization
control requirements. These requirements had to be
met before a diabetic patient could receive a pair
of soon to be available therapeutic shoes
prescribed and supplied by a podiatrist. The law
went into effect in 1993, and remains in effect
today.

Then as now, in order for a diabetic patient to
receive therapeutic shoes supplied directly from
their prescribing podiatrist, a primary care
physician must confirm the medical necessity
documentation the prescribing podiatrist submits –
even when that licensed and qualified prescribing
and supplying podiatrist adheres to required
documentation that adequately supports the medical
necessity of the shoes.

And if you research this on the Internet, you will
find references to the fact that HCFA wanted this
“second opinion,” because administrators believed
many podiatrists would, “just offer patients a pair
of free shoes every year, and they would bill
Medicare for those shoes without following medical
necessity guidelines.”

There is no question about it. Compliance matters
matter more than we may think.

Lawrence Rubin, DPM, Las Vegas, NV

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07/12/2023    Jack Ressler, DPM

Medicare Simple Partial Nail Avulsion Guidelines Unproven, Unnecessary, Unsafe (Ralph Zicherman, DPM)

I totally agree with everything Dr. Zicherman has
concisely written. To understand Medicare's
reasoning is as simple as Goggling "The goose and
the golden eggs". Sadly it tells a story of a
countryman who possessed a wonderful goose that
laid golden eggs. Every day he would visit the nest
to find one golden egg which he would take into
town to sell. He began to get rich but as greed
took over, he wasn't getting rich fast enough. He
decided to cut open the goose to remove all of the
golden eggs, obviously killing the goose.

While in podiatry school in the early ‘80s, I
shadowed a podiatrist during his visit to a nursing
home. He must have seen around 30 patients that
day. As he would see a patient, he would utter the
phrase "bilateral bilateral" to his assistant as he
debrided the patients nails. A brief clean-up was
then done, sometimes followed by applying topical
antibiotic ointment. This was done on around 70% of
the patients he treated. Curiously, I asked him,
what does bilateral bilateral mean. His reply was
that he did a simple nail excision procedure on
both borders of both great toes. Enough said. The
11730 procedure code has been the golden egg in
many podiatry practices. Unfortunately, it became a
code that has been highly abused and closely
scrutinized by Medicare.

As stated in other posts, I actually went through
what I would call a silent Medicare audit based on
the high frequency I used this code. Medicare
actually showed up at two of my patients homes that
I did a 11730 procedure on. They asked my patients
two questions, did your toe hurt before the
procedure and did the doctor inject local
anesthesia. I would have had a mess on my hands had
I not gone by Medicare's guidelines with this
procedure. I do think Medicare's requirements on
this procedure could be overkill but that is what
we as a profession have created. We haven't yet
removed all the golden eggs, but the goose is
definitely on life support.

Jack Ressler, DPM, Boca Raton, FL