Category: Breakthrough

CMS wants to repeal breakthrough device coverage rule, dashing med device industry hopes

Breakthrough, CMS, Coverage, Daily, Designation, FDA, Legal, Medical Devices, Medicare, News, Payers, repeal, rule, SYN, Top Story / September 14, 2021 September 14, 2021

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’ rule granting speedy coverage to FDA-designated ‘breakthrough’ devices delayed again

Breakthrough, CMS, Coverage, Daily, delay, FDA, Legal, MCIT, Medical Devices, Medicare, News, Payers, SYN, Top Story / May 17, 2021 May 17, 2021

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.

New CMS rule to enable immediate coverage for FDA-designated ‘breakthrough’ devices

Breakthrough, CMS, Coverage, Daily, devices, FDA, Legal, Medical Devices, Medicare, News, Payers, rule, Seniors, SYN, Top Story / January 13, 2021 January 13, 2021

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.

Bone Health’s OsteoBoost Vibration Belt Receives the US FDA’s Breakthrough Device Designation for Osteoporosis

Belt, Bone Health Technologies, Breakthrough, Designation, Device, MedTech, OsteoBoost, receives, regulatory, USFDA, Vibration / December 16, 2020 December 16, 2020

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 …

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ViiV Healthcare’s Cabotegravir Receives US FDA’s Breakthrough Therapy Designation for HIV Prevention

Breakthrough, cabotegravir, Designation, HIV, receives, regulatory, therapy, Us FDA, ViiV Healthcare / November 18, 2020 November 18, 2020

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 …

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