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Med Device Online - March 10, 2021
The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote inspections, and what accommodations should be made for clinical trials disrupted by COVID-19. On top of that, FDA found itself facing an enormous and unprecedented amount of political pressure, with its actions, or lack thereof, potentially altering the presidential election. Yet through it all, the agency continued to largely fulfill its core responsibilities of ensuring compliance and helping to bring new products to market, including, for example, approving by its own reckoning 132 novel medical devices, a significant increase over 2019. Now that we are in 2021, what big developments can we expect from FDA in general and regarding medical devices in particular? This article explores some of the FDA initiatives and activities worth fol
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Essentially, one commentator calculates that, with these changes, a family of four making $85,000 with $25,000 in health insurance coverage costs, will go from no federal support to a maximum payment for insurance of $7,000, or subsidies for such coverage will go from zero to $18,000. The American Rescue Plan provides various additional levels of support for all income levels, as shown in the table above.
2. Expands ACA cost-sharing support for the unemployed. The Senate legislation adds cost-sharing support for unemployed Americans enrolled in a qualified health plan. Currently, for those enrolled in such a plan who make between 100 and 400 percent of the FPL, the ACA mandates insurers reduce cost-sharing in phased amounts to make out-of-pocket expenses more affordable for lower-income Americans. The Senate legislation amends this provision for 2021 to deem that any person who received (or is approved to receive) unemployment compensation for any week during 2021 meets the req
It’s a temporary plan until its call center gets up and running.
Anyone interested in scheduling an appointment to receive their first or second dose is invited to use the new portal.
After you sign up, a COVID-19 vaccine provider will contact those who are eligible to schedule an appointment.
Those not eligible yet will have their information saved and contacted when they do become eligible.
“Once our mass vaccination events were over, we really needed another solution to get people in for appointments so this was the best thing we could come up with until our call center was ready,” says Leah Swanson, Public Health Emergency Preparedness Coordinator.