Molecular Diagnostics
Molecular diagnostics is a technique used to analyze biological markers in an individual’s genetic code and how their cells express their genes as proteins, by applying molecular biology to medical testing. The technique is used to diagnose and monitor disease, detect risk, and decide which therapies will work best for individual patients.
These tests are useful in a range of medical specialties, including infectious disease — the largest driver of molecular diagnostics –- oncology, human leukocyte antigen typing (which investigates and predicts immune function), coagulation, and pharmacogenomics — the genetic prediction of which drugs will work best. They overlap with clinical chemistry (medical tests on bodily fluids).
By analyzing the specifics of the patient and their disease, molecular diagnostics offers the prospect of personalized medicine. Technological advances in diagnostics, particularly in the area of personalized medicine, are changing the structure of the diagnostics industry, according to a report by ARCA Biopharma Inc., a Colorado-based biopharmaceutical company. New technology is expanding applications and driving continued growth in the specialized testing market, the report says.
This has led to a shortage of medical technologists (MTs) and clinical laboratory scientists (CLSes). Hospital laboratories and pathology groups have been urged to take the increased competition for scarce medical laboratory workers as a signal that competition for MTs and CLSes from private sector companies will only increase in coming years. Pathologists and clinical laboratory managers will have to rethink the strategies their medical labs use to recruit, hire, and retain medical technologists and clinical laboratory scientists.
At the same time, pathologists and researchers foresee a huge development opportunity for biomarker-based molecular diagnostics in support of translational medicine. Rapid developments in that field – the practice of improving the health of individuals and the community through applying new knowledge into diagnostic tools including medical laboratory tests, medicines, procedures, policies, and education – include a role for pathologists who are discovering and validating molecular biomarkers associated with diseases.
How Private Payers Audit Labs for Possible Claims Fraud
EDITOR’S NOT…
UHC Will Delay Enforcement of Z-codes for Genetic Test Claims
IN THE LATEST BACKPEDAL ON ITS NEW POLICY, UNITEDHEALTHCARE (UHC) appears to have dropped its requirement for genetic testing laboratories to use Z-codes for claims under commercial health plans—for now. Earlie…
OIG: Billing Code 81408 Is at ‘Risk of Improper Payment’
CEO SUMMARY: Clinical lab executives familiar with molecular test coding and billing will not be surprised to learn that billing code 81408—commonly used on genetic test claims—is at risk of fra…
With Z-codes, Will Other Payers Follow UnitedHealthcare’s Lead?
EDITOR’S NOT…
Technical Assessment Challenges for Z-Code Applications
CEO SUMMARY: Effective on Aug. 1, UnitedHealthcare will require Z-code submissions for many genetic tests. During a recent webinar, experts tackled a topic that may prove troublesome for labs seeking Z-codes: technical assessments. Key advice is to provide specific data about clin…
UnitedHealthcare’s Z-code Policy Starts on Aug. 1
CEO SUMMARY: UnitedHealthcare’s (UHC) response to the ever-growing number of unique genetic tests and the continuing growth in the volume of those claims is a new policy. Effective Aug. 1, UHC will require a Z-code with genetic test claims. This req…
UHC’s Z-Code Requirement to Commence on Aug. 1
CEO SUMMARY: In what may be an alarming development for certain clinical laboratories, as of Aug. 1, UnitedHealthcare will require Z-codes for molecular test claims filed under its co…
Pharmacogenetic Tests Deliver for Avera Health Lab
CEO SUMMARY: When Avera Institute for Human Genetics wanted to expand its genomics program, it used its past learning with pharmacogenetics to guide the effort. Two key insights? Ask physicians abo…
Eight Macro Trends for Clinical Labs in 2023
CEO SUMMARY: Laboratory administrators and pathologists will want to carefully study eight important trends that will guide their business strategies in 2023. Many of these macro trends center on financial and operational difficulties and ways to steer around these obstacles. Anothe…
How Genomic Testing Labs Can Improve Their Relationships with Payers
CEO SUMMARY: For payers and health plans, it may be a matter of trust that initially curtails speedy reimbursement of new and novel genomic test claims. A panel …
CURRENT ISSUE
Volume XXXI, No. 16 – November 25, 2024
Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.
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