INDUSTRYNEWS
CMS Launches Redetermination Project Regarding A5513 Process
1. Custom Fabricated: A custom
fabricated item is one that is individually
made for a specific Patient. No other
patient would be able to use this item…
a. Molded-to-Patient-Model: A
particular type of custom fabricated
device in which either:
i. An impression (usually by means
of a plaster or fiberglass cast) of the
specific body part is made directly
on the patient, and this impression is
then used to make a positive model
of the body part from which the final
product is crafted; or
ii. A digital image of the patient’s
body part is made using Computer-
Aided Design-Computer-Aided
Manufacturing (CAD-CAM) software.
This technology includes specialized
probes/digitizers and scanners that
create a computerized positive model,
and then direct milling equipment to
carve a positive model. The device
is then individually fabricated and
molded over the positive model of the
patient. [Emphasis added]
These standards are not met by:
2. Electronic (virtual) beneficiary models
created within CAD-CAM systems which
in turn are used to directly fabricate the
insert; or,
3. Generic models which are used to
create a nonspecific insert for later
modification to individual beneficiary
specifications.
Reduced to what is germane to the discussion,
this language indicates that a CAD-CAM
system that is utilized to actually create the
shell of the orthoses directly produces a device
that does not qualify to be billed under A5513.
The CAD-CAM equipment would have to be
used to create a positive mold of the foot, and
then the device would have to be fabricated over
that positive.
Based on this Joint Publication, CMS then
launched what they are referring to as the
A5513 Product Coding Redetermination Project.
This project allows suppliers (pedorthists) to
continue to bill orthoses made from products
that have been submitted to the CMS Pricing,
Data Analysis and Coding (PDAC) contractor
by their manufacturer, which appear on the
"PFA will be utilizing the
platform of the seats we hold
on the CMS Regional Councils
to try to force the LCD to be
reexamined..."
list [2] (click here) to bill for reimbursement under
A5513 until May 31, 2018. In the meantime,
all manufacturers holding a current PDAC
approval letter must resubmit their product for
review. Part of the review process will involve
examining the manufacturing process utilized
to create the custom insert to verify that the
device is, in fact, direct molded or molded to a
physical model.
PFA disagrees with the notion that an insert
made from what CMS is referring to as
a “virtual” model of the patient’s foot is
inherently less accurate and less appropriate
than one produced over a positive model. If we
look at the traditional method of manufacture,
the foot is cast in some fashion, essentially
“transferring” the contours of the plantar
surface to the negative. The negative is then
used to transfer the contours to a positive
cast. That positive is then used to transfer the
Current Pedorthics September/October 2017
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