Why You Won’t Be Able to Get the Drug You Need, Part II

This is Scott Gottlieb again on medical innovation. See previous post:

When CMS has been given discretion to set coverage policies and payment rates, it has often been preoccupied with cost over clinical benefit. Take the agency’s tortured decisions around the use of implantable defibrillators that shock stopped hearts to prevent sudden death. Medicare sharply restricted use of them in the 1990s. But mounting research proved that the devices, which cost $30,000, could be saving many more lives. So in 2003 Medicare adopted a novel theory to expand coverage to some, but not everyone who needed one. The agency said that only patients with certain measures on their electrocardiograms (called wide QRS) seemed to benefit. It was an easily measurable but ultimately imprecise way to allocate the devices. After another major study firmly debunked the QRS theory, Medicare expanded coverage again in 2005, potentially saving 2,500 additional lives, according to its press release issued with that decision. That experience wasn’t unique. From 1997 to 2007 Medicare denied access to a third of the treatments it evaluated through its coverage process, taking an average of eight months to complete reviews. When coverage was granted, in 85 percent of cases the treatments were restricted, usually to patients with more advanced illnesses.

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