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By Joan Logue
10/09/07
Coding for Molecular Diagnostics: Tips, Pitfalls, and What’s
New for 2007
Washington G-2 Reports recently talked with Joan Logue, a principal with Health
Systems Concepts (Longwood, FL), a national consulting firm for clinical laboratory
Medicare coding and compliance, to get her expert advice on coding for molecular
diagnostic testing.
Many of the code changes and additions for the 2007 Clinical
Laboratory Fee Schedule will affect those who perform molecular testing. What
are those key code changes or new codes relevant to molecular diagnostics?
CPT
has added one new code to the molecular diagnostic codes, 83890 through 83914,
located in the chemistry section. The new code, 83913 Molecular diagnostics;
RNA stabilization, allows the laboratory to bill for this procedure when a
special tube or kit is used to stabilize the RNA in the sample prior to testing.
The 2007 Medicare clinical laboratory fee schedule National Limitation Amount
(NLA) for 83913 will be $18.66.
There are also four new codes added to the molecular infectious agent subsection
in the Microbiology section of CPT. These codes are:
87498 Infectious
agent detection by nucleic acid (DNA or RNA); enterovirus, amplified probe
technique
87640 Infectious agent detection by nucleic acid (DNA or
RNA); Staphylococcus aureus, amplified probe technique
87641 Infectious agent detection by nucleic acid (DNA or
RNA); Staphylococcus aureus, methicillin resistant, amplified probe technique
87653 Infectious agent detection by nucleic acid (DNA or
RNA); Streptococcus, group B, amplified probe technique
The four new infectious
agent codes all have an NLA of $49.04.
Also, CPT added an important parenthetical
to this section that clarifies when to use the molecular infectious agent codes
and how to code when a code is not listed for a specific infectious agent.
The parenthetical states:
(For each specific organism nucleic acid detection
from a primary source, see 87470-87660. For detection of specific infectious
agents not otherwise specified, see 87797, 87798, or 87799 one time for each
agent.)
Prior to this clarification, kits that resulted multiple organisms had
to bill using codes 87800 or 87801, the multiple-organisms codes. The problem
with using these codes is that they are priced at the two-organisms detection
level. This meant when the laboratory used a kit that detected and resulted
more than two organisms, it was only being paid for two. Now, with this clarification,
the laboratories will be paid for each organism resulted.
This parenthetical
does not apply to kits that test for multiple organisms but simply give a yes/no
answer and require further testing to identify the specific organism present.
What are some of the most common pitfalls people
encounter or errors they make when coding for molecular tests?
Not considering
the intent of the code. For example, when code 83907 Molecular diagnostics;
lysis of cells prior to nucleic acid extraction (e.g., stool specimens, paraffin
embedded tissue) was added to CPT in 2006, many labs began billing this code
incorrectly. The intent of the code was that it should be used when a separate
procedure is required prior to the isolation or extraction of nucleic acid.
The examples listed in the code description define types of specimens that
require a significant amount of extra preparation prior to the nucleic acid
extraction.
Not carefully considering the description. If the code does not
have the word “each” in
the description, the laboratory may not report units for the code.
Not understanding the purpose of the step. For example, code 83894 Molecular
diagnostics; separation by gel electrophoresis (e.g., agarose, polyacrylamide)
or code 83789 Spectrophotometry, analyte not elsewhere specified should not
be billed if the purpose of the step is to verify sufficient DNA for the test.
This is a nonbillable quality control step.
What advice do you have to those
who might be new to coding for molecular tests?
The most difficult area to code for is human genetic testing. The codes can
be somewhat ambiguous, which can lead to multiple interpretations of the correct
use of the codes. Coding in this area requires knowledge of the CPT coding
rules, understanding of the current CCI edits and an understanding of the steps
in the assay, why they were performed and whether the step is codable.
Will
Medicare reimburse for ASR-based molecular tests? How are these coded for?
CMS
has left the coverage decision for non-FDA approved, in-house laboratory tests
(home brews) to the local Medicare contractor. Presently, the majority of Medicare
payers cover in-house laboratory tests (using analyte-specific reagents (ASR)). Once
the regional contractors are in place, there may be much more uniform coverage
decisions among the payers.
For human genetic testing, the coded steps must
be provided with the test’s
standard operating procedure (SOP) to correctly code the in-house laboratory
test. Without the SOP, the coder has no knowledge of the codable steps in the
procedure.
For infectious agent in-house developed tests, the laboratory would
code using the specific infectious agent code, if available. If a specific
code is not available, the coder would use the appropriate “not otherwise
specified” code.
Finally, you have seen how coding for molecular tests
has evolved over the years. What trends are you seeing in CMS’s handling
of the molecular area in terms of coding? Any predictions as to what changes
we might see in the coming years?
The molecular code sections for human genetic
testing and for the infectious agents were first revised in 1993 and updated
through the following years. Between 1993 and now, CMS’s primary focus
through the CCI edits was on laboratories not billing 83912 Molecular diagnostics;
interpretation and report with the infectious agent codes.
At the local level,
very few contractors have local policy determinations for the molecular codes. However,
at both the national and local level, this may be changing. It is possible
that CMS will use the new Medically Unlikely Edits (MUEs) table, which will
be updated each quarter starting in 2007, as a tool to limit the units for
molecular codes for both clinical laboratory and pathology.
In addition,
in 2006, no Medicare carrier that I know of covered the microarray code 88384
Array-based evaluation of multiple molecular probes; 11 through 50 probes.
The 2007 proposed Physician Fee Schedule has again left the coverage of this
code up to the local contractor.
At the local level, we may also see some limitations
put in place, and, as the regional contractors are put in place, we may see
even further restrictions. Apparently it is being discussed within Trailblazer,
one of Medicare’s
largest carriers, not to cover any of the microarray codes in the pathology
section. I understand that the professional associations are aware of this
and are taking steps to provide Trailblazer with information on the diagnostic
value of arrays.
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