Billing and Coding: Molecular Pathology Procedures

This article contains coding and other guidelines that complement the Local
Coverage Determination (LCD) for Molecular Pathology Procedures.

**Specific Coding of Molecular Testing Panels**

The submission of claims using individual gene CPT codes, when either 5-50 or
>50 gene panels are ordered, is considered incorrect coding. Correct coding
requires that when a panel code is ordered, it should be billed, rather than
the individual gene codes. CPT code 81445, 81449, 81450, or 81451 should be
billed when 5 to 50 genes are ordered. CPT code 81455, or 81456, should be
billed when 51 or greater genes are ordered for molecular biomarkers. Please
refer to Local Coverage Determination L37810 Genomic Sequence Analysis Panels
in the Treatment of Solid Organ Neoplasms and the associated Article A56867.
When a panel with greater than one or less than five genes is ordered, use the
corresponding existing panel CPT code or CPT code 81479 if none exists.

**Coding Information**

Coding guidance in this article is categorized into four, distinct CPT/HCPCS
sections:

* CPT/HCPCS section-Group1- _Tier 1 Covered Codes_ for which limited coverage may be provided for the genetic tests and for which specific ICD-10-CM diagnosis to CPT procedure groupings may be listed

* CPT/ HCPCS section-Group 2- _Tier 1 Codes that require Individual Review_ for which coverage may be provided for the genetic tests submitted, if documentation supports medical necessity, and for which specific ICD-10-CM diagnosis to CPT procedure groupings may be listed.

* CPT/HCPCS section-Group 3- _Tier 1 Non-covered Codes_ for which genetic testing is unlikely to impact therapeutic decision-making in the clinical management of the patient and will be denied automatically as not medically necessary.

* CPT/HCPCS section-Group 4- _Tier 2/NOC Covered Code/Gene Combinations_ for which limited coverage may be provided for specific genes listed in the Group 4 paragraph; _Tier 2/NOC Individual Review Code/Gene Combinations_ ; _Tier 2/NOC Non-covered Code/Gene Combinations_.

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.

**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/nonphysician
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.

When the documentation does not meet the criteria for the service rendered or
the documentation does not establish the medical necessity for the services,
such services will be denied as not reasonable and necessary.

**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.