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

There are no more messages in this thread.