On the menu for this week’s potpourri–savings from wellness efforts for a large employer; drug reimbursement for Medicaid programs; using remote monitoring in a health plan context; the FDA’s regulatory approach to mobile health uses; the effect of tort reform on imaging rates and hepatitis C pay-for-performance measures.
The Food and Drug Administration has been reviewing its 510(k) process, which is used for many medical device approvals. Two preliminary reports contain a series of recommendations designed to provide greater predictability in the process, while ensuring identification of significant safety concerns.
Personalized medicine relies on genetic testing for much of its information. Direct-to-consumer genetic testing firms are widespread and a GAO report reveals that much of their work appears shoddy and their marketing deceptive. More regulation appears needed and on the way.