05/08/2019    Paul Kesselman, DPM

DoctorInsole Custom-Grade Orthotic Insoles Receive Medicare Approval

Medicare does not approve devices and any use of
that term to describe a device regarding the
coding validation it receives from the PDAC DME
Medicare agency is more than misleading. There is
sufficient language provided on the PDAC website
to inform the consumer, supplier and applicant
that the PDAC and Medicare does not approve
devices. The PDAC agency has the task of
inspecting a device (and any accompanying
literature) and validates the device being
inspected, meets the criteria for a specific
HCPCS code. Therefore, the correct terminology is
a device received product coding validation from
the PDAC.


As for coverage, let there be no mistake, those
issues are not within the realm of jurisdiction
of the PDAC, but of the DME MAC. The DME MAC
Orthopedic Footwear policy is quite clear on foot
orthotic coverage for L3000-L3060. Specifically
those codes are not reimbursed by Medicare unless
the device is placed into a shoe which has a
"permanently" affixed brace attached to the shoe
(think of Forrest Gump and Polio patient
devices). Use of the KX modifier is only
appropriate in this rare circumstance (I've only
used the KX modifier with foot orthotics a hand
full of times in 35 years). Otherwise these types
of devices and other codes listed in the
Orthopedic Footwear LCD are not covered by
Medicare. The vast majority of foot orthotics
should either not be billed to Medicare, or if
the patient insists, should be coded with a GY
and RT/LT modifiers. This will issue a PR
(patient responsibility) remark, denotes to the
patient they are responsible for payment. It may
also result in the secondary payer either issuing
a denial or payment (depending on the secondary
carriers coverage policy).

This issue requires serious consideration by
every reader, as the BMAD data continues to
reflect increasing (potentially fraudulent)
payments by Medicare to podiatrists for foot
orthotic devices (L3000-L3060) to the tune of
approximately $5M annually. While some may be
appropriate, the vast majority are not and could
be construed of as fraudulent billing.

These types of devices are also not usually
covered by third party insurance. In some cases,
they may be covered by state Medicaid agencies,
where the payment may be less than or equal to
your costs. PDAC has no jurisdiction over any
insurance carrier other than Fee for Service
Medicare with regards to product validation or
coverage (this includes Medicare Advantage
Plans).

I applaud this company for going through the
painstaking PDAC approval process (which I have
done so for many companies), nevertheless the
reader must be aware that PDAC code validation
does not in any way translate to Medicare
approval or reimbursement. It is the DME MACs
who have the final say on coverage parameters.
The PDAC is a private agency with a CMS contract
whose duty is to validate product coding and not
to make statements of approval by Medicare, or
any other CMS agency.

Paul Kesselman, DPM, Woodside NY

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