When it comes to managing investigational drug products, the stakes are high. If even one small batch of control drugs get mixed in with the test drug supply or if one shipment of medication is stored outside of the proper temperature range or one person administers drugs incorrectly, it can put patients at risk, throw research data into question and even lead to the study’s termination.
Even though Medicare covers some of the costs of qualifying clinical trials, failure to comply with billing regulations can cost health systems millions of dollars in federal fines and penalties. Research Practitioner looks at the complexity of this clinical trial billing and offers some guidelines and advice from experts in the field.
Medicare began covering routine care that was part of clinical trials of new drugs and treatments in hopes that the Medicare coverage would speed drug development through the pipeline. In 2007, the Centers for Medicare & Medicaid Services (CMS) published an update to the 2000 routine care initiative that outlines which costs and what trials qualify for Medicare coverage. This National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1) is commonly referred to as NCD 310.1.1