November is not always a spicy month where federal agencies are concerned, but FDA and CMS have come through to give us something to talk about. Below are a couple of items to mull over as you enjoy a leisurely, stress-free drive or comfy, un-cramped flight to celebrate Thanksgiving with loved ones. CMS makes a virtue of necessity The final guidance for the Medicare coverage with evidence development (CED) program is a relatively brief document considering the impact it will have, but also considering the length...
The Centers for Medicare & Medicaid Services has published a draft guidance for the new framework for coverage with evidence development, or CED, a very interesting framework indeed. Following is a list of some fascinating tidbits from the draft guidance. Interesting item #1: The passage stating that CMS is examining the question of “whether local contractors should have the discretion to apply CED in local coverage” is pretty close to an earthquake. I’m assuming that most CED trials will have to span more than one Medicare carrier’s jurisdiction, which suggests a patchwork of CED coverage or a need to get...
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...
The story has been out for a while about transcatheter aortic valve replacement (TAVR), so maybe it's time to project into the future. Before we head there, however, we should revisit the past. The pivotal event in this story is the drug-eluting stent, a device that gave birth to what FDA's Bram Zuckerman, MD, described as the DES trauma. The DES story is twofold; rapid physician adoption and late-stent thrombosis (LST). FDA saw the rate of adoption as an unruly and harmful stampede because of LST, but...
Hopefully not lost in all the comings and goings of more than 8,500 people at the J.P. Morgan Healthcare Conference in San Francisco last week were some important take-home messages about the future of med-tech, a future that promises many challenges for the industry, but also many rewards for those willing to follow promising trends. 1. Healthcare Information Technology is going to be big this year and probably into the foreseeable future. This is the final year in which hospitals and physicians can demonstrate meaningful use and get maximum healthcare dollars under the stimulus, so there should probably be some clarification...
Screening for various diseases is controversial these days thanks to the U.S. Public Services Task Force and similar agencies in other nations, which have suggested a more cautious approach to screening. These suggestions have been blasted by doctors and patient groups for obvious reasons. Former Medical Device Daily executive editor Jim Stommen took up prostate cancer screening in a posting at this blog a few weeks back, and while I agree with Jim on a lot of things, I felt one perspective was missing; that of the federal budget. The problem is that no national economy can support indiscriminate...
By JIM STOMMEN Medical Device Daily Contributing Writer Talk about eating from the public trough: The folks who run Medicare are putting their money where our collective mouths are. The nation’s largest health insurance plan reported awhile back that it will pay for screenings and preventive services aimed at helping recipients battle obesity and its attendant medical ailments. For those who screen positive for obesity, the newly covered benefits include initial weekly counseling for the first month, followed by five months of every-other-week appointments. Presuming weight loss continues, another six months of once-monthly sessions may follow. My initial response...
Donald Berwick's tenure at the Center for Medicare & Medicaid Services was brief, but should come as no shock to anyone who knows how the former physician came to the job. What's stunning is how many believe the Obama administration and House and Senate Democrats bear no responsibility for the brevity of his stint at CMS. Let's take things in chronological order. First, President Obama and Democrats in Congress drafted what is probably the largest piece of legislation ever to pass without any input from the legislative minority. They then rammed the vote through Congress with only feeble support...
By Adi Renbaum, senior VP for health policy and reimbursement, Neocure Group Cook Medical's Zilver PTX is likely to become the first peripheral drug-eluting stent (DES) to be approved in the U.S., after an FDA advisory panel voted unanimously in favor of the device on Oct. 13. Approval would give the sponsor, Cook Medical (Bloomington, Indiana) access to a peripheral arterial disease (PAD) market valued at $1 billion, depending on whose figures one relies. I attended the Oct. 13 advisory committee hearing for the device and observed the panel members comment that this was among the best submissions they had...
Well, FDA and the Centers for Medicare & Medicaid Services are at it again with parallel review, but this time they've tacitly acknowledged what everyone knew all along; that it would never be willingly adopted by more than a very few device makers. In the Federal Register notice of Oct. 11, the two agencies state that the two-year pilot for parallel review won't accommodate more than five applications per year. When FDA and CMS initially tried to drum up interest in the idea, a number of observers told me industry would never flock to the idea in any numbers...
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