By Kelly Roman, Vice President of Fisher Wallace Labs On February 10, 2012, the FDA convened an advisory panel hearing on whether to reclassify cranial electrotherapy stimulation (CES) devices. Despite being a low-risk device, CES has lingered in Class 3 (high risk) for more than 30 years as a result of being a grandfathered 510(k) medical device. The regulatory fate of CES, which is currently cleared to treat depression, anxiety and insomnia, will emerge at a time when antidepressants have been proven ineffective in treating soldiers with post-traumatic stress; CES has had great success treating this population. CES manufacturers such...

At the risk of becoming mired in the past, we are inclined to glance backward now and then to see where we’ve been and ask what the past says about where we’re going. So let’s examine July 30, 1965, the date President Lyndon Johnson signed Medicare into law. As may or may not be widely known, the initial forecast of the cost of Medicare was way off. In 1967, so the story goes, the House Ways and Means Committee guessed that Medicare would aggregately cost roughly $12 billion a year by 1990, a figure that ran fairly close to $110...

The July 20 hearing at the Court of Appeals for the Federal Circuit addressing the Myriad case did not last a terribly long time, but there were a few object lessons to take away. We last visited this situation shortly after the Supreme Court decision in Prometheus v Mayo, when I opined that there might not be much reason to hit the panic button, and I have to say I didn’t hear much on July 20 to change my mind. But who can say for certain? After all, who’d have guessed at the 9-0 outcome at the Supreme Court (a.k.a.,...

An acquaintance of mine who, like me, has inflammatory bowel disease, received a call recently from her local hospital informing her they had lost her MRI images. They found them, but she is concerned they will have to retake them anyway because at this point her images are no longer current enough for the doctor to make an informed treatment decision. This is a prime example of why all hospitals should use electronic health records (EHRs). At a time when health IT (HIT) companies are cropping up faster than Starbucks coffee shops, and the federal government is handing out incentive...

Well, God forbid people in my line of work should run out of things to be outraged about, but the saga of the FDA whistleblowers has boiled over again. As readers of MDD Perspectives know, one of the members of FDA’s staff involved in all this blowing of whistles had a bad reputation before he arrived at FDA. Robert Smith, MD, made a name for himself suing hospitals for alleged overbilling of Medicare, and more recently crying to Congress and the White House that he wasn’t getting his way with his demand for PMAs for software and hardware used in...

Crohn’s and Ulcerative Colitis, known collectively as inflammatory bowel disease (IBD), do not discriminate between age, race, gender, economic status, or geographic borders. It is truly an equal-opportunity disease! I was 18, a freshman in college, when I was diagnosed with ulcerative colitis (UC) and was told I was “too young” to be that sick. IBD was an old-person's disease, my gastroenterologist said. He was wrong, of course. Because my symptoms were not taken seriously from the beginning, I continued to get worse over the course of the next three years of college. Looking back, I don’t know how I managed...

I am living with a pain in the rear. Casey Abrams, a musician and American Idol alumnus, would say I am living with a “chip on my shoulder,” but I prefer to be as literal as possible. So yes, I live with a pain in the rear – along with about 1.4 million other Americans who have been diagnosed with ulcerative colitis (UC) and Crohn’s disease – collectively known as inflammatory bowel disease (IBD). In advance of releasing his debut album today (June 26), Abrams created an original song, “Chip on Your Shoulder” and music video inspired by his personal...

The biggest judicial showdown in quite a while is finally over, and here are a couple of things to consider while we’re playing numerology games in an effort to interpret the scribblings of nine citizens in black robes we all now refer to as SCOTUS. I for one can understand why the Supreme Court was unimpressed with the attempt to argue the validity of the Affordable Care Act on the basis of the Commerce Clause. In this decision the Court basically said the government cannot force citizens to participate in commerce, a position that comports with precedent. By the way,...

The highest court in the land is poised to make a ruling that will undoubtedly change the face of healthcare forever. As the Supreme Court is set to bury or uphold President Obama's presidential campaign healthcare plan, there should be one question that people should be asking no matter what the outcome is. What's next? If the Supreme Court doesn't strike down the individual mandate portion of the plan, the component that would push families to either pay for coverage (generally with help from the tax subsidies) or pay a fine, then the question remains how are we going to...

The story of the transcatheter aortic valve implant is well underway thanks to the fact that the Sapien valve, made by Edwards Lifesciences, is on the market, but there is more to this story. Following are three aspects of the TAVR story that bear watching. One: Coverage does not equal adequate reimbursement David Cohen, MD, of St. Luke's Mid-America Heart Institute took up this issue at CRT 2012. Cohen offered a number of details, but his talk boiled down to the fact that the bottom line for TAVR is written in red ink for many hospitals. Cohen said the Medicare...