Getting big-ticket medical devices, drugs and procedures covered by Medicare is getting harder, according to a new analysis of national coverage decisions between 1999 and 2012. The CMS was about 20 times more likely to say no in the more recent years.
“That's a real change,” said senior study author Peter Neumann, director of the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, Boston. “The CMS is scrutinizing more carefully. Now you've really got to show the evidence.”
Indeed the need for evidence was a resounding message to medical-device manufacturers at an industry conference last October. Hospitals, health insurers, quality improvement leaders and others are telling the industry they want innovation but also need a proven benefit to justify the cost. The Advanced Medical Technology Association, a trade group known as AdvaMed, issued a white paper during the conference warning that value-based contracts that put too much emphasis on cost could threaten patients' access to innovations. AdvaMed also funded the new Tufts research on Medicare coverage determinations.
The CMS decides whether new interventions are “reasonably necessary” and should be paid for under the federal healthcare program. The Tufts researchers, whose findings are , analyzed 213 decisions made between February 1999 and August 2012. They included medical devices, surgeries, diagnostic imaging technologies and Part B drugs. A total of 74 were denied coverage during that time period, and the majority of those denials happened in more recent years.
Half of the 54 decisions CMS made between March 2008 and August 2012 were negative. For example, the agency declined to cover a transcatheter aortic valve replacement procedure, a surgical procedure for diabetes, and transcutaneous electrical nerve stimulation for chronic lower back pain. About a decade earlier, between February 1999 and January 2002, of the 53 scrutinized, 42 were covered and only 11 were not. (See the full list of covered vs. non-covered items.)
The Tufts researchers controlled for factors like the number of randomized clinical trials and how many patients were in them, as well as the presence of statements of support from professional societies, clinical guidelines and public comments. The number of patients in the trials and the existence of favorable recommendations and clinical guidelines were positively associated with gaining coverage. However, Medicare was less likely to pay if there were alternative interventions and no estimate of cost-effectiveness.
A higher threshold for coverage raises questions about patients' access to new therapies and the challenges faced by manufacturers as they attempt to bring them to the market, said study co-author, Matt Chenoweth, a Tuft's research associate.
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