Molecular diagnostic testing: Alphabet soup with a side of codes

Abstract

Effective and affordable health care depends on the availability of accurate, reliable and clinically valid monitoring tests. Faulty tests can lead to misdiagnosis or failure to diagnose, resulting in patients receiving unnecessary treatment, delays in treatment or no treatment when treatment is needed. Safe and effective genomic testing is increasingly more important with advances in precision/personalized medicine. The rapid evolution of technology and molecular testing has brought new hope to patients and new pressures to payors. While genomic panel testing is time and cost efficient, minimally disruptive for patients and physicians, and spares valuable specimens, payors struggle with evidence-based approaches to coverage determinations in an environment where clinical treatment options cannot keep pace with technology. The result: a highly complex coding structure, disparate coverage policies, and extremely variable reimbursement for genomic testing. Providing the right treatment to the right patient at the right time depends on meaningful tests proven to impact clinical decisions, integrated with the most current data relevant to the practice of medicine, and recognized as medically necessary to tailor treatment for the unique biology of a disease. An understanding of the test reimbursement landscape is critical to implementation of a successful personalized medicine business model.