Most of the general public first heard about research misconduct from hearings on the problem held by then-Rep. Albert Gore Jr. (D-Tenn.), chairman of the Investigations and Oversight Subcommittee of the House Science and Technology Committee, in 1981 Read More
Research misconduct and fraud not only ruin reputations of investigators and institutions but can also damage the public’s trust in clinical research. Consider the case of Piero Anversa, a key figure in stem cell research. Anversa was accused of falsifying or fabricating data in more than 30 research papers. Read More
Having the right resources at the right time is critical to a clinical trial’s success, and no resource is more valuable than a site’s staff. But the uncertainty about future needs caused by the current pandemic makes it difficult to plan for the right staff mix and scheduling. Read More
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
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.
When preparing a billing plan for a clinical trial, follow the Medicare model to make the best case for reimbursement from other payers, a clinical research compliance expert advises. Read More
When it comes to offering to pay clinical trial subjects to participate, the line between compensation and coercion is difficult to draw but all too easy to cross. Read More
