Getting Medicare coverage for big-ticket medical devices, procedures and drugs is getting a lot more difficult, according to a study published in the journal Health Affairs.
In fact, the study found that coverage determinations between March 2008 and August 2012 were 20 times less likely to be positive than coverage determinations from February 2009 through January 2002.
In the study, researchers from Tufts Medical Center in Boston analyzed 213 coverage determinations made between February 1999 and August 2012. These involved medical devices, diagnostic imaging technologies, surgeries and Part B. drugs. Of the 213 coverage decisions, 126 were positive, 74 were non-coverage decisions, and 13 were coverage with evidence development policies. Most of the denials, however, have occurred recently.
For example, half of the 54 decisions CMS made between March 2008 and August 2012 were negative, while in the period between February 1999 and January 2002, 42 out of 53 coverage decisions were covered.
“When we controlled for both the volume and the consistency of the supporting clinical evidence and for other factors important in CMS’s decision making in national coverage determinations,” the authors wrote, “the coverage odds for medical interventions that were evaluated more recently were estimated to be roughly twenty times less likely to be positive, compared to the odds for the interventions that were evaluated earliest in our data set.”
Why is it becoming more difficult to get positive national coverage determinations?
The authors suggested that one reason could be that CMS’s evidence standards have changed over time as it becomes more sophisticated at analyzing evidence and assessing study quality. It’s also possible that CMS is using coverage policy as a means to “promote the efficient use of interventions,” the authors wrote, particularly as they become more expensive.
A higher evidentiary bar for coverage determinations has a number of implications, the authors concluded. “Coverage policy is an important payer tool for promoting the appropriate use of medical interventions,” the authors wrote,” but CMS’s rising evidence standards also raise questions about patients’ access to new technologies and about hurdles for the pharmaceutical and device industries as they attempt to bring innovations to the market.”