Debi Reissman, PharmD


Using Biomarkers to Guide Therapy, Coverage Decisions

March 14, 2009

In August 2008, as part of its Critical Path Initiative, the FDA released a table listing genomic biomarkers that have established roles in determining drug response.1 This initiative, started in 2004, is aimed at identifying “patients likely to benefit from a treatment and patients more likely to respond adversely to a product,” according to the FDA’s Office of Management, Budget Formulation and Presentation.

Defining Preventive Care Under CDHPs

February 01, 2008

Consumer-directed health plans (CDHPs) are attracting new interest as a result of a ruling by the Internal Revenue Service (IRS) over what constitutes preventive services. CDHP benefit designs take various forms, but in general, these are low-premium, high-deductible plans that provide full or close to full coverage for enrollees once the deductible is met and are typically tied to a health savings account (HSA).