03/11/2008    Keith L. Gurnick, DPM

Are Those Orthotics Really Custom-Made?

There are and have been many barriers to the
general public knowing and understanding the
difference between "true custom prescription
foot orthotics", and the rest of the shoe
inserts available. I often wonder if all of my
podiatry colleagues really know the difference.

A "true custom prescription foot orthotic" is
the type of foot orthotic that is custom made
from start to finish, and is "prescribed" by a
professional with the training and also a
license that allows a prescription to be
written. The patient must be examined and
evaluated in the way that is taught in school
and then taking into account all of the
variables a proper foot orthotic prescription is
written, a correct foot impression is taken and
then a Rx custom foot orthotic laboratory fills
the prescription, and finally the order is
checked and fitted and dispensed to the patient.

Unfortunately, today many prescribed and OTC
shoe inserts are referred to, even on the
packaging as orthotics, yet only some of them
are truly custom prescription foot orthotics.
The public does not know the difference because
we as a profession have never taught them the
difference. And the orthotic lab industry also
has not been proactive in teaching the public
the difference either. When will the
Prescription Foot Orthotic Lab Association, a
group of many credentialed laboratories step up
to the plate and do something about this for the
good of the public and the profession?

Many of our patients do know the difference
between a prescribed custom orthotic and the
imitators, and even many of the young
Podiatrists might not know the difference
because the biomechanics and orthotic education
in the colleges is not emphasized as it once
was. The podiatry schools also need to improve
the education in this arena.

1) When patients come to our offices with the
bag of flat insoles, contoured replacement
insoles, pre-fab orthotics like Superfeet, Foot
Levelers often ordered by chiropractors, and
yes, even orthotics made from foam foot
impressions taken by either by a chiropractor, a
physical therapist, by a nurse in the office of
an orthopedic surgeon and even some podiatrists
they think they have already had "Orthotics" and
they do not understand why they failed to help
or cure their problem. 2) Sometimes these
products have been made in an office, sometimes
ordered over the internet or at a healthy fairs
by persons with no credentials and then sent to
and manufactured by the same foot orthotic
laboratories that make true prescription custom
foot orthotics. 3) Some orthotic laboratories,
in an effort to increase sales and compete,
provide lower cost foot orthotics by making
orthotics off a "library of foot casts" instead
of using each cast to the prescription. I call
this bait and match. Sometimes the doctor is
aware of this and thus is compliant in the
fraud, and sometimes the doctor is not aware of
what is being done. The fact is the public, a
group that can be easily fooled or deceived does
not know the difference and does not get what
they think they are paying for when this
happens. Besides wasting their money, they are
also not getting the proper care which may lead
to wasted time and money, unnecessary surgery
and prolonged pain and disability.

Yet as is often the case in this situation,
mostly when a true custom prescription foot
orthotic is required and made, the patient is
helped, the pain is reduced or gone and the
orthotic has done its job.

As professionals it is our job to know what we
are doing and to do it to the best of our
ability. It is our job to be honest to our
patients and the public. It should be the job of
the schools to educate their students, our
future professionals and the foot orthotic lab
profession should partake a program to educate
the public about foot orthotics.

Keith L. Gurnick, DPM, Los Angeles, CA,
keithgrnk@aol.com

Other messages in this thread:

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03/08/2008    Jeff Root

Are Those Orthotics Really Custom-Made? (David J. Marko)

RE: Are Those Orthotics Really Custom-Made?
(David J. Marko)
From:

In response to the letter by Susan Boren, David
Marko wrote In my opinion, an orthotic
is 'custom' when a negative patient model or 3-D
scan is used to produce an accurately corrected
shape for that specific patient's foot. Then
additional customization is accomplished through
the shaping of the shells and the addition of
covers, accommodations, and posting. This is
exactly what the System Rx method and plaster
cast corrections accomplish. These are the
methods used at DPM Orthotics Inc.

A pre-manufactured orthosis is not a custom
device regardless of Mr. Markos opinion.Let
us examine the facts. When any pre-manufactured
orthotic device is customized, it is a
customized or modified prefab. Using a negative
model, a 3-D scan, or any other method to select
a prefab does not change the nature of how the
device was manufactured, therefore it remains a
pre-fab. A real problem exists if practitioners
mistakenly believe they are receiving custom
manufactured foot orthoses, if in fact they are
receiving prefabs or customized prefabs.

Mr. Marko also wrote: What is a custom
orthotic? This is a gray area.I believe its
the responsibility of any ethical orthotic lab
to make certain that their customers understand
what they are receiving in order to eliminate
this potential gray area. Podiatrists, as the
utmost authorities on foot biomechanics and
orthotic therapy, must share in the
responsibility of becoming educated prescribers
like they are with other prescription products,
such as pharmaceuticals.

A library system involves the use of an
inventory of pre-manufactured molds, digital
shape files, or orthotic devices. Library
systems allow manufactures to eliminate a
significant portion of the manufacturing process
by selecting a predetermined shape for the
orthotic shell. This eliminates the process of
correcting the individual patients physical
cast or foot scan, thereby reducing labor which
in turn, decreases manufacturing costs. In the
case of pre-manufactured molds and digital shape
files, there still remains a percentage of the
manual manufacturing process but this does not
occur on the patients own, unique anatomical
foot model.

Foot scanners and computer manufacturing systems
(CAD/CAM) have the potential to further cloud
the issue. The term mirroring is the act of
scanning and correcting one foot or cast and
then producing an identical but opposite mold or
orthosis for the other foot. This is another
labor saving step for the lab which the customer
may or may not be aware of.

Pre-fabs, modified pre-fabs, and fully custom
manufactured foot orthoses all have a place in
modern day podiatry and foot orthotic therapy.
Increased education and awareness will enable
practitioners and their patients to make better
informed treatment decisions. I commend Susan
Boren for bringing this important issue to light.

Jeff Root, President, Root Lab, jroot@root-
lab.com

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03/07/2008    David J. Marko, President, DPM Orthotics

Are Those Orthotics Really Custom-Made? (Susan Boren)

RE: Are Those Orthotics Really Custom-Made?
(Susan Boren)
From: David J. Marko, President, DPM Orthotics

I am responding to the letter posted on PM News
by one of my local competitors regarding the
production methods at DPM Orthotics.

Like many orthotics labs, DPM Orthotics uses a
multi-disciplined approach to producing custom
foot orthotics. We incorporate the System Rx
methodology which includes its patented
corrections library. We also utilize traditional
plaster corrections. (For those who do not
know, a corrections library is an important
aspect in many modern orthotics labs.)

The System Rx method was invented from a lengthy
study conducted by Mr. Scott Marshall and
involved 133,000 patient models. Mr. Marshalls
study revealed surprising new data about the
mathematical relationship of the uncorrected
replicas (negative cast) and the resulting
corrected replica (positive cast).
The study revealed that mathematically, the foot
is a measurable blend of three dimensional
shapes, beginning with a neutral, negative cast,
and ending with a corrected positive cast. The
measurable difference between the two is the
corrected deformity (intrinsic balancing) and
the medial and lateral expansions.

Simply, if the negative cast and the corrections
are both measurable, then it is possible to pre
determine the corrected shape of the positive
cast and the resulting orthotic. In our
application of the method, critical measurements
are made of the negative model resulting in the
establishment of an x,y,z, axis. Using this
data, the corrected shape is produced from the
System Rx library. If the proper correction is
not found in the library, the order is corrected
using traditional plaster techniques.
Additional customization occurs in shaping,
posting and covering.

What is a custom orthotic? This is a gray area.
Chiropractors prescribe orthotics that are
assembled using only the uncorrected foot
impression as a guide. These are sold and
billed as custom foot orthotics. In podiatry, we
see in-officescanning systems some of which
produce a two-dimensional image of the foot
(width and length). Custom foot orthotics are
produced from this information without a true
medial longitudinal arch measurement. They are
billed as custom.

In my opinion, an orthotic is customwhen a
negative patient model or 3-D scan is used to
produce an accurately corrected shape for that
specific patients foot. Then additional
customization is accomplished through the
shaping of the shells and the addition of
covers, accommodations, and posting. This is
exactly what the System Rx method and plaster
cast corrections accomplish. These are the
methods used at DPM Orthotics Inc.

I invite you to visit the US Patent Office web
site and reference patent #6042759. You will
find a detailed description of the invention and
its multi dimensional applications.

David J. Marko, President, DPM Orthotics Inc.,
OH, davidmarko@sbcglobal.net

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03/04/2008    Robert Scott Steinberg, DPM, Paul Kesselman, DPM

Are Those Orthotics Really Custom-Made? (Dennis Shavelson, DPM)

RE: Are Those Orthotics Really Custom-Made?
(Dennis Shavelson, DPM)
From: Robert Scott Steinberg, DPM, Paul
Kesselman, DPM

When a patient presents to me with continued
problems after receiving expensive "orthotics"
from non-DPMs, I ask them to give me a copy of
the EOB from that treatment. If I find that
the "orthotics" were billed L3000, and they were
not, by any definition of L3000s, then I give
them a letter stating that, adding that in my
expert opinion, the devices made their condition
worse. I tell them to ask for their money back,
and that if the "doctor" refuses, to tell them
they will send my letter to the insurance
company. It has worked every time.

Further, when I bill for orthotic, not only do I
include a letter of medical necessity, I include
a letter describing how I do the biomechanical
exam, the plaster casting with a bisection of
the calcaneous, and I emphasize why an L3000
device is truly a device that corrects and
improves biomechanics. Further, I tell the
medical director that if the insurance company
wants to save a ton of money, that they
carefully review how the impression are made by
DC and other non-DPMs, because in my expert
opinion, I do not feel the devices made by non-
DPMs should not qualify for anything but minimal
payment.

Robert Scott Steinberg, DPM, Schaumburg, IL,
doc@footsportsdoc.com

Dr. Shavelson raised several issues in his
thoughtful letter. His solution to opt out of
your in-network status certainly does provide a
financial solution to the irresponsible orthotic
reimbursement policy of some carriers. In
certain practice environments this is not
realistic nor does it excuse one from fraudulent
billing practices.

A. The devices in question are poorly defined by
any of the existing HCPCS codes.
These individually engineereddevices,
certainly do not meet the definition of L3000-
L3020, as no patient specific 3D positive image
is ever created in the lab nor may they
adequately be described by codes L3030-L3060.

An upgrade to the current HCPCS codes may in
fact be in order. Unfortunately medical coding
has not kept up with technology and DME is far
from the only area where this is true. Several
recommendations come to mind:

1) Bill a miscellaneous code (L2999) and send an
accurate description of the product and how it
is fabricated to the insurance carrier. This
will leave it up to the insurance carrier to
determine their level of reimbursement. No one
would ever be able to accuse you of misleading
billing practices. Unfortunately, this will
result in long delays and reimbursement will be
more carrier variable than with the existing
codes.

2) Ask the manufacturer and/or distributor of
these devices to submit them to SADMERC for a
product review. The application to SADMERC may
request the product be coded with an existing
code or ask for the establishment of a new
HPCPCS code. This is risky for the manufacturer
and distributor. Once a product review letter
has been established, there no longer will be
any question as to how this product should be
coded.

SADMERC will perform a responsible review of
these products at no charge to the manufacturer
and make recommendations regarding reimbursement
policy to private third party payers (Medicare
of course does not cover foot orthotics).
Product reviews generally can be accomplished in
less than 3 months with a minimum of paper work.

3) Podiatrists who wish to use this product may
also contact SADMERC for further coding
assistance on any existing product. This can be
accomplished by following the links on the
www.palmettogba.com website.

B) The requirement for suppliers to maintain
copies of custom orders in the patients chart.
This requirement already exists. Current
supplier standards and newly adopted
accreditation guidelines require that suppliers
maintain records of where they obtained their
durable goods, particularly for custom-
fabricated devices. Invoices for bulk ordered
over-the-counter non- custom devices may be more
difficult to track to a single patient (e.g. cam
walkers, canes, crutches, custom-fitted or over-
the-counter orthotics etc.). This should be far
easier for custom-fabricated orthotics, where
the manufacturers of the device line items their
invoices with the patients name and a
prescription and order form are maintained by
the supplier.

In the near future, all Medicare (and third
party) orders will require you to scan a UPC
code (just as they do in the supermarket) for
bulk items and perhaps the same will be true for
custom devices.

In summary, I would agree with Dr. Shavelson
that the time has come for HCPCS codes to more
accurately describe the manner in which
orthotics can be produced using todays
technology. Perhaps its time to assemble a blue
ribbon panel of the best podiatry has to offer
to assist in this endeavor. Experts in the field
of podiatric biomechanics, orthotic fabrication,
coding and reimbursement should meet and make
their recommendations before they are mandated
to us by the insurance industry.

Paul Kesselman DPM, Woodside, NY,
pkesselman@pol.net

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03/03/2008    Dennis Shavelson, DPM

Are Those Orthotics Really Custom-Made? (Susan L. Boren)

In absorbing the reaction to Dr. Boren's
posting, I feel that the replies live inside the
insurance/government socialized model and are
bandaids at best. In my career, it has become
more and more difficult to remain a part of the
existing model while continuing to offer the
superior care we alone are trained to deliver to
suffering feet and postures.

My opinion sits outside of what the insurance
model wants us to do and requires one of two
courses.

The first is the easier and exists to us all and
that is to become an out-of-network contractor
with the insurances, especially those that cover
orthotics poorly. This would allow DPM's to
cast, prescribe and dispense the best functional
foot orthotics at an appropriate fee AND it
would give the podiatry community the need to
invest in improving their biomechanical skills
in order to dispense devices that command higher
fees because they are truly custom.

The second would be to upgrade the CPT orthotic
coding system acknowledging that a customized
orthotic from an existing shell (the $50
orthotic) does provide a decent level of care
that may be enough for many patients and could
receive reimbursment at a lower level (i.e. for
HMO's and poor payers) and create a code of
L???? for this item with a fee that fits the lab
cost.

In addition, I would require a paid lab invoice
in the $100-150 range to be on file from the
dispensing DPM in order to be paid for L3000 or
other custom codes. This would give patients a
better understanding of the value of a custom
casted and prescribed functional foot orthotic
and insurance companies the ability to cover
devices that they think their clients deserve.
More important, it would give the podiatry
community the opportunity to prove the value of
a custom orthotic that incorporates our
diagnostic and treatment skills.

I have no idea how hard or easy it is to add a
code to the current CPT inventory but maybe this
is a direction to go that serves podiatry and
our patients best.

Dennis Shavelson DPM, Medical Director, The
FootHelpers Lab, drsha@foothelpers.com

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02/28/2008    Susan L. Boren

Are Those Orthotics Really Custom-Made?

RE: Are Those Orthotics Really Custom-Made?
From: Susan L. Boren

About a week ago, one of my long-term customers
from the Chicago area faxed me a marketing flyer
he received from DPM Orthotics, Inc. The flyer
advertised "Individually Engineered Custom Foot
Orthotics" at a flat rate of $65.95 per pair.
The flyer promoted their "System Rx"
Methodology. I researched System Rx to find
that it is an over-the-counter, libraried arch
support (sold by a reputable podiatric supplier)
in a variety of lengths, widths, and arch
heights for $44.95 each (with quantity discounts
available). This supplier promotes this product
as a " semi-rigid, over-the-counter, orthotic
style arch support. They, in no way, attempt to
disguise this OTC as a prescription orthotic.

Companies like DPM Orthotics are buying these
OTC's, doing a little custom
topcover/accommodation work, and selling them as
a prescription device. To my knowledge, the
negative cast, sent by the prescribing
podiatrist, is only used to measure the foot in
an effort to get a close match for the OTC -- no
plaster is ever poured, nor is any type of
positive ever created. The podiatrists that
order these products are led to believe that
they are receiving a prescription orthotic. This
poses the problem of insurance fraud, not to
mention what is in the best interests of the
patient. Is the doctor unknowingly committing
fraud if he/she bills insurance under the L3000,
L3010, L3020, or L3030 codes? The HCPC codes in
my copy of a DME fee schedule requires that
these codes only be used for a removable
insert "molded to patient model" or "formed to
patient foot", be it plaster, impression foam,
fiberglass, and/or digital. Only L3040, L3050,
and L3060 can be used for pre-molded inserts,
which has a lower reimbursement.

The owner of DPM Orthotics, Inc., got his
experience working for MOY Labs, which closed
its doors in the summer of 2006. Thousands of
pairs of negative casts were found inside MOY
with measurements written on them -- matching
their dimensions to libraried OTC's. All of
them were "filled" orders, sent to the
prescribing physician, and dispensed to patients
as prescription orthotics. For those labs that
use AMOS software, creating a library of OTCs is
cheap, fast and easy. There are "labs" popping
up all over the country doing this, and nothing
appears to be being done to either inform or
protect the doctor against this type of
deception. If a podiatrist suspects that their
lab might be passing off a glorified OTC, he/she
can request that the positive, or a printed copy
of the digital scan, be returned with every pair
of orthotics.

It makes it very difficult for honest labs,
truly fabricating a prescription orthotic, to
price-compete in a dishonorable marketplace. In
these times of rising expenses and reduced fees,
a flat rate of $65.95 can be very enticing to
the practitioner (even though they can get the
very same thing from a reputable podiatric
supplier at $44.95!). But let the buyer beware -
- things aren't always what they seem.

Susan L. Boren, President, Earthwalk Orthotics,
Inc., Massillon, OH, eworthotics@neo.rr.com