Payer Perspectives on Coverage of Biomarker Testing in Cardiovascular Disease.

Cardiovascular (CV)2 disease is a leading cause of morbidity and mortality, currently attributing to 1 of every 4 deaths in the US (1). Conventional risk prediction algorithms are based on major CV risk factors identified in the diseased population. Better tools for early identification and treatment of risk factors are needed (2). To this end, research on CV biomarkers has burgeoned; a PubMed search on “cardiovascular biomarkers” reveals more than a fivefold increase in publications on this topic between 1995 and 2015. These efforts have led to the discovery of a range of emerging biomarkers that may better identify at-risk patients earlier and more effectively for disease prevention and morbidity improvement (3). Yet to date, major national health plans only cover biomarkers conventionally used to diagnose and risk stratify CV disease. Here, we review payer perspectives on coverage for biomarkers tests and suggest resources for gaining greater clarity and transparency in payer evidence expectations for diagnostic and prognostic testing in CV disease.Generally speaking, coverage is provided for medical products and services when there is strong scientific evidence that patients derive meaningful clinical benefits from use of those services. The regulatory frameworks for drugs, biologics, and devices generally provide some basis for payers to make an assessment of benefit in the populations they cover, although there may still be evidence deficits to address. In the context of in vitro diagnostics (IVD) and laboratory-developed tests, however, the regulatory requirements are in flux. Previously, the Food and Drug Administration (FDA) exercised “enforcement discretion” for these products. Then, in 2014, noting that IVD have grown increasingly complex, the FDA proposed a draft framework for oversight of testing (4). Accordingly, payers are less able to rely on regulatory assessment of IVD and apply their own standards for coverage.As a result, for example, …