The Forgotten "Coverage with Evidence Development": HCFA and Heart Transplants

"Coverage with Evidence Development" (CED) has received increasing attention since 2006, when CMS authorized the National Oncologic PET Registry to track and monitor expanded use of PET scans in less-common cancers.   By 2012, total scans in the program had exceeded 200,000 (here), which, at $1000 per scan, represents over $200M of nuclear imaging tests conducted under a "real-world evidence" paradigm.  By comparison, the Obama Precision Medicine Initiative, announced with much fanfare in January 2015, has been proposed with a budget of...circa $200M.

A search of the phrase "Coverage with Evidence Development" at PubMed yields over five dozen hits (e.g. here).  The Medicare agency maintains a webpage for "Coverage with Evidence Development" programs (here), and recently updated its policy guidance for CED (here).   Two Medicare contractors, Novitas and Palmetto GBA, have published guidance for local CED programs (e.g. MolDX Manual, accessed 2/3/2015, page 6, here).   The Center for Medical Technology Policy, headed by Sean Tunis, has a webpage devoted to CED white papers and articles (here).  Tunis  has authored numerous articles on CED (e.g. here).   Finally, on the Hill, in early 2015, draft legislation proposed additional authorities for Medicare's implementation of CED (see here, title II, Section H.)

Arguably, the first clear example of the CED concept actually occurred 35 years ago.

Update: See also, Evans RW et al, Insurance coverage of heart transplantation in the United States, J Heart Lung Transplant 36:1294 (2017), PMID 29173390.  I did not have this at the time of writing.  Evans covers many of the same historical documents in a peer-reviewed format.