Billing and Coding: Molecular Pathology Procedures

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L34519 Molecular Pathology Procedures. Please
refer to the LCD for reasonable and necessary requirements.  
  
 **Coding Guidance  
  
** **Notice** : It is not appropriate to bill Medicare for services that are
not covered (as described by the entire LCD) as if they are covered. When
billing for non-covered services, use the appropriate modifier.  
  
The American Medical Association (AMA) Current Procedural Terminology (CPT)
manual states molecular pathology procedures are medical laboratory procedures
involving the analyses of nucleic acid to detect variants in genes that may be
indicative of germline (e.g., constitutional disorders) or somatic (e.g.,
neoplasia) conditions, or to test for histocompatibility antigens (e.g., HLA).
Given the elimination of the stacking procedure codes and the array based
evaluation codes molecular pathology codes now include all analytical services
performed in the test (e.g., cell lysis, nucleic acid stabilization,
extraction, digestion, amplification, and detection). (Note: molecular
pathology procedure techniques, such as microbial identification using
molecular pathology techniques and in situ hybridization analyses, may be
described in other sections of the Pathology and Laboratory section of CPT.  
  
Code selection is typically based on the specific gene(s) that is being
analyzed. Codes that describe tests to assess for the presence of gene
variants use common gene variant names. Typically, all of the listed variants
would be tested. However, these lists are not exclusive. If other variants are
also tested in the analysis, they would be included in the procedure and not
reported separately. Full gene sequencing should not be reported using codes
that assess for the presence of gene variants unless the CPT code specifically
states full gene sequence in the code descriptor. In other words, you may only
assign the CPT code that is described as "full gene sequence" if the test
assay performed was a full gene sequence.  
  
Tier 2 molecular pathology procedures represent medically useful procedures
that are generally performed in lower volumes than Tier 1 molecular pathology
procedures (e.g., the incidence of the disease being tested is rare). They are
arranged by level of technical resources and interpretive work by the
physician or other qualified healthcare professional. If the analyte tested is
not listed under one of the Tier 2 codes or is not represented by a Tier 1
code in CPT, use of the unlisted CPT code 81479 is required.  
  
HCPCS code G0452 with modifier 26 should be used by pathologists when an
interpretation of a molecular pathology test is performed. Non physician
practitioners (e.g., PhD, scientists etc.) are not eligible to report this
code, only physicians may use/bill this code. This code should not be billed
without modifier 26 since it is an interpretation code only.  
  
**Documentation Requirements**

  1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
  2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
  3. The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
  4. Documentation must be adequate to verify that coverage guidelines 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 that warrants the test(s). 
  5. 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.
  6. For molecular pathology tests, the ordering provider must provide to the laboratory copies of the signed informed consent documentation. 
  7. An Advance Beneficiary Notice of Noncoverage (ABN) is required before furnishing a beneficiary a test which the physician or laboratory believes to be noncovered as not reasonable or necessary. The physician or laboratory must obtain a signed ABN from the beneficiary (or representative) that the physician or laboratory has informed him/her on the non-coverage of the test and that there will be a charge for the test.