If it seems like it has become harder to get devices such as valves, stents, diagnostic imaging technologies and drugs covered under Medicare’s national coverage determination process—well, it has. So concludes an analysis published in the February issue of Health Affairs.
James D. Chambers, PhD, of the Center of the Evaluation of Value and Risk in Health at Tufts Medical School in Boston, and colleagues accessed a database at the center that warehouses detailed information on individual national coverage determinations. For this analysis, they evaluated national coverage determinations from February 1999 to August 2012.
They controlled for the volume and consistency of evidence used in decision-making by the Centers for Medicare & Medicaid Services (CMS). To compare decision trends over time, the researchers also grouped decisions into four periods: February 1999-January 2002; February 2002-December 2003; January 2004-mid-March 2008; and mid-March 2008-August 2012.
Of the 213 decisions identified by Chambers et al, 126 were positive, 74 not positive and 13 designated as coverage with evidence development policies. The medical technologies in the three most recent time periods were less likely to gain coverage than those in the 1999-2002 group. The 2008-2012 submissions were 20 times less likely than the 1999-2002 group to be positive.
“The current findings suggest that the evidentiary bar for medical intervention coverage under Medicare national coverage determinations became higher between 1999 and 2012,” they wrote. “In other words, coverage may have become more restrictive.”
The researchers speculated that the CMS may have become more adept over time in its ability to assess evidence, better integrating effectiveness and efficiency into its evaluations. They observed that tighter restrictiveness may lead to fewer innovations in patient care, but that the coverage with evidence development pathway may help offset that from happening. Coverage under that designation may limit the indicated patient population while the sponsor continues to build its case.
“For innovative medical interventions that are supported by an immature evidence base, the appropriate application of coverage with evidence development policies speeds there adoption, while the evidence that is gathered later helps identify the patients who are most likely to benefit,” they wrote.