The role of biomarker testing in clinical medicine has expanded significantly over the past decade. Once limited primarily to specialized research settings and select disease states, biomarker testing is increasingly being incorporated into routine clinical decision-making across a growing number of medical specialties.
This evolution is reflected not only in the expanding body of scientific literature, but also in a growing body of state legislation.
Today, biomarker testing may be used to assist with diagnosis, treatment selection, disease management, risk stratification, therapeutic monitoring, and other aspects of clinical decision-making. As a result, policymakers, healthcare providers, and payors have increasingly focused on ensuring that clinically validated biomarker testing remains accessible to patients when supported by appropriate evidence.
State Laws Requiring Coverage for Biomarker Testing
Multiple states, including Texas and Louisiana, have enacted laws requiring coverage of biomarker testing when supported by medical and scientific evidence and when the testing provides clinical utility for diagnosis, treatment, management, or ongoing monitoring of a patient's condition.
These laws recognize that biomarker testing may play an important role in evidence-based clinical decision making when supported by applicable scientific evidence, clinical guidelines, regulatory approvals, or other recognized sources of medical evidence.
For example, Texas enacted Chapter 1372 of the Texas Insurance Code, requiring coverage for biomarker testing used for diagnosis, treatment, appropriate management, or ongoing monitoring when supported by recognized sources of medical and scientific evidence. The statute further requires that the testing be evidence-based, scientifically valid, and capable of informing both patient outcomes and provider clinical decision-making.
Texas Biomarker Testing Statute:
Texas Insurance Code Chapter 1372 – Coverage for Biomarker Testing
Similarly, Louisiana enacted legislation requiring coverage for biomarker testing when supported by medical and scientific evidence for purposes such as diagnosis, treatment, appropriate management, and ongoing monitoring of disease or medical conditions. The Louisiana statute recognizes a broad range of testing methodologies, including molecular testing, next-generation sequencing, and biomarker testing.
Louisiana Biomarker Testing Statute:
Louisiana Revised Statutes §22:1028.5 – Biomarker Testing Coverage Requirements
Why These Laws Matter
These statutes reflect an important trend in modern medicine: biomarker testing is increasingly recognized as a clinically useful tool when supported by scientific evidence and integrated into evidence-based patient care.
The legislative frameworks adopted in Texas and Louisiana are built around several core concepts:
- Clinical utility
- Scientific validity
- Evidence-based application
- Provider-directed clinical decision-making
- Integration into patient management and treatment planning
These concepts closely mirror the principles that physicians routinely apply when evaluating new diagnostic technologies and incorporating them into patient care. Importantly, these laws recognize that biomarker testing may provide meaningful clinical value when supported by appropriate scientific evidence and utilized within the context of patient-centered medical care.