APMA News - March/April 2023 - 26

coding update
" Investigational and
Experimental " Services
By Barbara Aung, DPM, and Lawrence Santi, DPM
To determine whether a device, medical
treatment, or supply is proven safe and effective,
the following examples of reliable evidence may
be used:
* Published formal technology assessments and/
or high-quality meta-analysis
* Well-designed randomized studies published in
credible, peer-reviewed literature
* High-quality case-control or cohort studies
* Historical control studies, or case reports and/or
case series
* Reports of expert opinion from national professional
medical societies or national medical
policy organizations
With respect to clinical studies, only those
Many third-party payers define " investigational "
or " experimental " as the use of a service, procedure,
or supply that is not recognized by the plan
as standard medical care for the condition, disease,
illness, or injury being treated. A service may be
considered investigational/experimental if:
* The services, procedures or supplies do not have
FDA approval.
* There is insufficient or inconclusive medical and
scientific evidence to permit the plan to evaluate
the therapeutic value of the service, procedure,
or supply.
* There is inconclusive medical and scientific
evidence in peer-reviewed medical literature that
the service, procedure, or supply has a beneficial
effect on health outcomes.
* The service, procedure, or supply under
consideration is not as beneficial as any
established alternatives.
The AMA CPT® Editorial Panel develops CPT1
Category III codes to allow for data collection concerning
the use of " emerging technology, services,
and procedures. " The creation of a CPT Category
III code " neither implies nor endorses clinical efficacy,
safety or the applicability to clinical practice. "
Due to the purpose these Category III codes serve,
third-party payers may consider the item, service,
or procedure represented by these codes to be not
medically necessary.
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apmanews
MARCH/APRIL 2023
containing scientifically valid data and that are
published in peer-reviewed literature are typically
considered as reliable evidence. Specifically, reports,
articles, or statements by providers or groups
of providers containing only abstracts, anecdotal
evidence, or personal professional opinions are
not included normally in the definition of reliable
evidence. Also not typically included is the fact
that a provider or several providers have elected to
adopt a device, medical treatment, or procedure as
their personal treatment or procedure of choice or
standard of practice.
Some examples of lower extremity-relevant
products and procedures that may be deemed
" investigational and experimental " by a third-party
payer and, therefore not medically necessary in its
eyes, include:
* The use of certain implants for treatment of hallux
rigidus. For example, Anthem, in conjunction
with AIM Specialty Health, considers the only
total joint implant acceptable for the treatment
of hallux rigidus to be the Swanson-double
stemmed silastic implant.2
The rationale behind
their decision is that this product has numerous
case reports and studies, and it has " endured the
test of time. "
* Some third-party payers consider the Cartiva3
first
metatarsophalangeal joint implant as experimental
and medically unnecessary due to the lack of
high-quality case-control or cohort studies.
APMA News - March/April 2023

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