Modern Healthcare, December 20, 2016. Physicians want wider Medicare coverage for leadless pacemakers, arguing the current reimbursement proposal puts the device out of reach for too many patients. Experts agreed with the CMS that more research is needed. Evidence shows that while the leadless pacemaker eliminates some of the key drawbacks of existing pacemakers, they also increase the likelihood of some complications and may introduce new ones, according to Dr. Jay Ronquillo, director of biomedical informatics at the National Center for Health Research, a no-for-profit think tank focused on health research. “At this point, there is no reason for patients to feel cheated if Medicare doesn’t cover the cost of leadless pacemakers, because leadless pacemakers may be no better, and possibly worse, than pacemakers with leads,” Ronquillo said.
Read More »News That Quotes Us & Our Work
We are often quoted in major newspapers and magazines, and on well-respected TV shows, radio programs, and websites where we share our opinion on issues that matter to you and your health. Stay up to date on health news and our take on it by reading the articles in this section.
Potential FDA Head Could Change Drug Approval Process Dramatically
Big Think, December 17, 2016. President elect Donald Trump has had several controversial cabinet picks so far for his administration. But in the medical community many are especially concerned over the possible tapping of Jim O’Neill for head of the FDA. While one of the FDA’s main jobs is approving medications, O’Neill said in a speech in 2014 that medications should be evaluated for safety only, what he called “progressive approval.” President of the National Center for Health Research, Diana Zuckerman, told The Hill that such a move would toss insurance companies into limbo. Being unable to rest on FDA approval when deciding coverage, such a move would, throw the entire U.S. healthcare system into turmoil.”
Read More »Congress Just Quietly Handed Drug Companies a Dangerous Victory
New Republic, December 14, 2016. Christmas came early for the pharmaceutical industry this year. Last week, the Senate followed the House in passing the 21st Century Cures Act. Though this bill has been lauded by liberals for providing much-needed funds for medical research, its real impact will be elsewhere. Whereas drug approval traditionally required the demonstration of real clinical benefit in a randomized clinical trial, under the Act drug firms will increasingly be able to rely on flimsier forms of evidence for approval of their therapies (incremental steps in this direction, it is worth noting, have already occurred). The Act, by reconfiguring the drug regulatory process, lowers the standards for drug approval—a blessing for drug makers, but an ill omen for public health.
Read More »Congress Passes Bill with Billions for Cancer Research
December 7, 2016. The 21st Century Cures Act, the most expensive and far-reaching health reform bill since the ACA, has just been passed by Congress.
Read More »Trump’s Rumored FDA Candidate Strikes Nerve
The Hill, December 8, 2016. Against all expert opinion, Jim O’Neill, “a snake oil salesman” with no medical background, is rumored to head the Food and Drug Administration (FDA) in 2017.
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