86 FR 65039 (small section from 65038)
November 19, 2021 Final PFS rule for CY2022
65039-40
For the PFS, we
typically assign contractor pricing for
Category III codes since they are
temporary codes assigned to emerging
technology and services. We followed
this established process for Category III
codes by assigning and listing them as
contractor pricing in Appendix B in the
CY 2018 PFS final rule
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Comment: Several commenters
expressed concern that CMS repeatedly
stated that software and analysis fees are
not direct expenses. Commenters
disagreed and stated that software that
is directly attributed to a specific
physician service is a direct expense,
and furthermore that there are multiple
examples of the implementation of such
costs. Several comments provided a list
of current CPT codes that they stated
included software as a direct PE input,
such as CPT code 95905 (Motor and/or
sensory nerve conduction, using
preconfigured electrode array(s),
amplitude and latency/velocity study,
,,,, Several commenters raised the
issue of software as a medical device
(SaMD) and stated that it should be
considered a direct PE expense similar
to other medical equipment.
Commenters stated that even though
SaMD does not require physical space
in an office or administrative staff hours
to maintain it, SaMD does require
ongoing upgrades, improvements, and
security mitigation, as well as the same
regulatory oversight by the Food and
Drug Administration (FDA) as hardware
medical devices. Commenters stated
that the legal, regulatory, and financial
burdens incumbent of a SaMD
manufacturer are no different than those
of hardware medical device
manufacturers.
Response: We appreciate the detailed
feedback from the commenters
regarding the issues surrounding
software and analysis fees. We agree
with the commenters that there have
been occasions in the past where we
have finalized the inclusion of software
as a direct PE expense if it met our
criteria as typical and medically
necessary for the service in question and
could be individually allocable to a
particular patient for a particular
service. For example, we included the
sheer wave elastography software
(ED060) as a direct PE input for CPT
codes 76981–76983 in CY 2019. In this
case, the sheer wave elastography
software was an additional resource cost
added to the general ultrasound room
(EL015) equipment without which the
service cannot be performed. We have
been more hesitant to classify software,
licensing, and analysis fees that are not
associated with physical equipment
used in the performance of a service as
they pose more significant challenges
for our traditional PE methodology.
Therefore, we wish to clarify that
although we have typically considered
software costs to be indirect PE under
our methodology, as these costs were
not individually allocable to a particular
patient for a particular service, there
have been exceptions to this general
principle where software costs have
been included directly in the service
under review.
As we stated in the proposed rule, we
believe that costs associated with
software, licensing, and analysis fees are
not well accounted for in the PE
methodology. Unlike a piece of
equipment, such as the retinal camera,
an analysis fee for software does not
require physical space in an office or
administrative staff hours to maintain it.
These types of costs were much less
prevalent when the Physician Practice
Information Survey (PPIS) was last
administered in 2007 and 2008 and of
course did not exist at all in the case of
AI-based services. We remain concerned
that if we were to consider software
analysis fees and software as a medical
device expenses to be direct costs in all
cases, we may inadvertently allocate too
many indirect costs for supplies that
may not require additional indirect
expenses. The data underlying the PPIS
assumes that direct expenses will
require costs associated with physical
space and physical maintenance that
may not appropriate for these new types
of software. However, we do recognize
that practitioners are incurring resource
costs for purchase of the software and
its ongoing use, which is why we
proposed the crosswalk to CPT code
92325 to capture these resource costs for
CPT code 92229. We believe that the use
of this crosswalk and other similar
crosswalks are the best way to value
services that make use of software,
licensing, and analysis fees at the
moment while we explore ongoing
potential updates to the PE
methodology.