Category: Breakthrough
By MIKE MAGEE Yale historian, Frank M. Snowden wisely notes in his 2020 book, “Epidemics and Society”, that “We must avoid the pitfall of believing the driver of scientific knowledge is ever a single genius working alone.” His insight came to mind this week as I was reviewing the January 11, 2020 Forbes article by […]
After pushing back the start date twice, CMS now wants to scrap the Trump-era rule, which provides an expedited pathway to Medicare coverage for devices that receive the FDA breakthrough designation.
CMS delayed the start date of its rule that would provide expedited Medicare coverage for products the FDA deems “breakthrough devices” from May 15 to Dec. 15. CMS wants more time to examine concerns expressed about the rule, including that devices may gain coverage despite limited evidence of their use among seniors.
The agency has finalized a rule that allows it to provide immediate Medicare coverage for FDA-approved products that are deemed “breakthrough devices.” The new coverage process would enable seniors to get access to these devices more quickly, but some provider and payer groups are concerned that this could cause patient harm.
Shots: OsteoBoost receives the US FDA’s BDD to reduce the risk of osteoporosis. It uses vibration technology that delivers mechanical stimulation to the hips & spine at a precise, individually calibrated frequency, encouraging the body to reduce bone resorption & potentially create new bone An initial study showed that just one 30min treatment with OsteoBoost […]
Shots: This BT designation is based on P-IIb/III HPTN 083 study assessing cabotegravir (q8w) vs. FTC/TDF tablets (qd PO, 200/300 mg) in a study population of 4,566 for HIV prevention. The data were presented at the 23rd International AIDS Conference (AIDS 2020) Results: HPTN 083 study showed that cabotegravir was 66% more effective at preventing […]