CMS Director To Diagnostics Industry: Prove Your Cancer Tests Work
This article was originally published in The Gray Sheet
“Why are insurers so reluctant to get enthusiastic and really embrace molecular diagnostics?” asked the director of CMS’ coverage and analysis group at a recent cancer diagnostics symposium. “Because half the time we have no idea what on earth we’re paying for.”
You may also be interested in...
FDA-approved labels for more than 100 drugs feature pharmacogenomic biomarker data, but only one-sixth of those biomarkers are supported by data showing a clear association with health benefits, a JAMA study found. Researchers recommend stricter standards and a standardized pharmacogenomics section of labeling.
The overall message of three trials published recently in The New England Journal of Medicine: “This pharmacogenetic testing has either no usefulness in the initial dosing of vitamin K antagonists or, at best, marginal usefulness, given the cost and effort required to perform this testing,” according to an editorial also in NEJM.
The Infectious Diseases Society of America released a policy paper that “raises the red flag about the paucity of new and rapid tests despite years of promises from the molecular era.” It recommends simplifying regulations and improving the reimbursement process, as well as physician education.