The CMS issued a final guidance in November that made none of the changes requested by industry to its coverage-with-evidence-development policy (CED), which was initiated in 2004 by Dr. Mark McClellan, then the CMS administrator. The CMS uses CED when it feels more efficacy data are needed before it can make a final coverage determination on products that have already received Food and Drug Administration approval.
Industry argued that CED requirements are redundant and that the more complicated pathway to payment should either be eliminated or curtailed. “Drugs and biologics already go through a rigorous review and approval process at the FDA,” said Tracy Cooley, a spokeswoman for the Biotechnology Industry Organization, a trade group. “We feel that this should be sufficient for determining safety and efficacy.”
But the policy's proponents inside and outside the agency say the FDA approval process often generates little evidence about how effective certain technologies are in the real world. When its only options are either to cover or not cover a drug or device, the CMS might wind up paying for things that offer little or no benefit to many seniors.
The proponents also say the policy offers Medicare a way to give beneficiaries access to innovative products while manufacturers answer the open-ended questions that may not have been addressed in previous research.
“The challenge we often faced was that we would be presented with technologies that seemed quite promising but the existing studies were not definitive in terms of benefits and what the risk would be,” said Dr. Sean Tunis, a former CMS chief medical officer who also directed its Office of Clinical Standards and Quality. “We just thought it would be valuable to have a third option for promising technology, where we could offer coverage, but with additional data collection.”
Tunis cited approvals given procedures such as positron emission tomography, which is used to detect and track cancer, and transcatheter aortic valve replacements and cochlear implants, which were also made possible by CED. Eighteen out of 43 national coverage determinations between fiscal 2009 and 2013 had an evidence development requirement.
In their comments on the proposed guidance, industry stakeholders had requested the CMS continue to pay for all uses of a technology while a clinical trial ordered under CED was underway. The CMS refused.