Congress today took the final step in approving a bill that will put in place new federal standards for pharmaceutical compounders, something drug safety advocates have been calling for since a devastating fungal meningitis outbreak last year claimed at least 64 lives and sickened hundreds of others, at least two in Texas. We wrote about these efforts this summer, when the bills were tied down amid opposition from industry. The bill, which passed the Senate Monday on a voice vote and will be on its way to the President's desk, is summarized here. It's a compromise bill that makes it voluntary for pharmacies that compound drugs on a large scale to register as so-called outsourcing facilities.
The U.S. Attorney in San Antonio has settled a $3,675,000 whistleblower lawsuit against the Baptist Health System for filing false claims for Medicare reimbursement. According to the U.S. Attorney's Office, the federal investigation under the False Claims Act was triggered by allegations in a whistleblower lawsuit brought by a former employee of the Baptist Health System. Assistant U.S. Attorney Harold Brown said Norma Rivera reported she tried twice to bring the problem to the attention of her employers. Brown said Baptist claimed Rivera did not bring the problem to authorities in 2004 as she stated and that when she pointed it out in 2006, they immediately implemented corrective action.
Some Minnesota physicians returning from the American Heart Association meeting in Dallas say they will stick with old guidelines for determining when to use cholesterol-lowering drugs, or statins, until the validity of a new risk calculator is verified. The calculator, released Nov. 12 by the Heart Association and the American College of Cardiology, is designed to estimate a patient's risk of having a heart attack or stroke over the next 10 years. But after testing the calculator, several prominent cardiologists and researchers found that it vastly overestimates the number of patients who need statin therapy.
So much attention is paid to the problems in the trenches that it is easy to forget just how far we've come in the past few years. It was only 2008 when the oft-cited DesRoches NEJM survey showed that 4 percent of physicians had a clinically active electronic medical records system (my term for what they called fully functional EMRs). The following year, even an old-timer like me was surprised when a companion survey showed only 1.5 percent of hospitals had such a system.
As I wrote this earlier month, doctors often know when a patient has been the victim of a medical error – sometimes before the patient does. But too often they don't say anything about the mistakes, according to a recent report in The New England Journal of Medicine. Feedback to the post was so thoughtful that ProPublica decided to host a Google + hangout about the topic. We invited four experts to join us – two doctors and two patient advocates. Here are five takeaways from the conversation.
Senior Obama administration officials, including several in the White House, were warned by an outside management consultant early this year that the effort to build the HealthCare.gov site was falling behind and at risk of failure unless immediate steps were taken to correct the problems, according to documents released by House investigators. The report, by McKinsey & Company, which was prepared in late March at the request of the Department of Health and Human Services, said that management indecision and a ?lack of transparency and alignment on critical issues? were threatening progress, despite the tight deadline.