Billing and Coding: Genomic Sequence Analysis Panels in the Treatment of Solid
Organ Neoplasms

This article contains coding and other guidelines that complement the Local
Coverage Determination (LCD) for Genomic Sequence Analysis Panels in the
Treatment of Solid Organ Neoplasms.

**Coding Information:**  
  
Procedure codes may be subject to National Correct Coding Initiative (NCCI)
edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to
billing Medicare.  
  
For services requiring a referring/ordering physician, the name and NPI of the
referring/ordering physician must be reported on the claim.  
  
A claim submitted without a valid ICD-10-CM diagnosis code will be returned to
the provider as an incomplete claim under Section 1833(e) of the Social
Security Act.  
  
The diagnosis code(s) must best describe the patient's condition for which the
service was performed.

**Specific Coding Information:**

Regarding Non-Small Cell Lung Cancer (NSCLC) and Metastatic Colorectal Cancer
(mCRC), the following guidelines apply:

Targeted genomic sequence analysis panel, solid organ neoplasm, DNA analysis,
5-50 genes (CPT 81445 or 81449) is a useful representation of the aggregate of
these gene tests, and may be used (along with other listed panel codes) as
long as the panel contains, at a minimum, 5 or more gene tests for molecular
biomarkers determined to meet Medicare coverage criteria as listed above.
Evaluation of other genes or genomic sequences not addressed by NCCN or other
professional guidelines are not precluded, but their inclusion in panels
recognized by this code should not be interpreted as endorsement of such
testing by genomic sequencing procedures and laboratories and users of such
testing are advised to adhere to traditional regulatory and institutional
oversight mechanisms to assure their clinical validity and utility.

**Documentation Requirements:**

Documentation must be adequate to verify that coverage guidelines listed above
have been met. Thus, the medical record must contain documentation that the
testing is expected to influence treatment of the condition toward which the
testing is directed. The laboratory or billing provider must have on file the
physician requisition which sets forth the diagnosis or condition (ICD-10-CM
code) that warrants the test(s).

Examples of documentation requirements of the ordering physician/non-physician
practitioner (NPP) include, but are not limited to, history and physical or
exam findings that support the decision making, problems/diagnoses, relevant
data (e.g., lab testing, imaging results).

Documentation requirements of the performing laboratory (when requested)
include, but are not limited to, lab accreditation, test requisition, test
record/procedures, reports (preliminary and final), and quality control
record.

Documentation requirements for LDT(s)/protocols (when requested) include
diagnostic test/assay, lab/manufacturer, names of comparable assays/services
(if relevant), description of assay, analytical validity evidence, clinical
validity evidence, and clinical utility.

Providers are required to code to specificity however, if CPT 81479 (unlisted
molecular pathology procedure) is used the documentation must clearly identify
the unique molecular pathology procedure performed. When multiple procedure
codes are submitted on a claim (unique and/or unlisted) the documentation
supporting each code should be easily identifiable. If on review the
contractor cannot link a billed code to the documentation, these services will
be denied based on Title XVIII of the Social Security Act, 1833(e).

For these tests, the ordering provider must provide to the laboratory copies
of the signed informed consent documentation.

**Utilization Guidelines:**

Screening services such as pre-symptomatic genetic tests and services used to
detect an undiagnosed disease or disease predisposition are not a Medicare
benefit and are not covered. Similarly, Medicare may not reimburse the costs
of tests/examinations that assess the risk of a condition unless the risk
assessment clearly and directly affects the management of the patient.

A specific genetic test may only be performed once in a lifetime per
beneficiary for inherited conditions; however, when medically reasonable and
necessary, genetic testing may be done on acquired conditions such as
malignancies (including separate malignancies developing at different times)
as they are treated and are being followed, in order to assess response or
other relevant clinical criteria. Likewise, there are situations where medical
record and literature documentation are able to demonstrate that serial
testing can be reasonably predicted to provide additional clinically useful
information. When the record documents that this information, such as
confirmed significant response to current therapy, is likely to assist in
modifying treatment, serial testing can be considered reasonable and necessary
and eligible for coverage.