Healthcare Policy News

Second Moderna Booster Gets FDA Approval, Biden Administration Eyes ACA Fix

FDA approval for a second Moderna Booster was based on Israeli Omicron studies, and the Biden Administration is looking to update the ACA and expand subsidized coverage for millions of Americans

FDA approval, Coronavirus, ACA, cybersecurity

Source: Getty Images

By Hayden Schmidt

- Moderna received FDA approval for its application to market a second round of boosters to adults 50 years and older. The fourth shot in the sequence has been shown to restore some of the immunity lost over time.

And in a meeting with former President Obama on Tuesday, the Biden Administration announced the expansion of subsidized coverage under the ACA by fixing the so-called “Family Glitch.”

Meanwhile, about 6 million people have had their healthcare data compromised by cyberattacks since the beginning of this year. In March alone, there were 30 breaches reported to HHS and 1.5 million victims affected.

Attorney General Resolves Allegations Against Practice Fusion

The Vermont Attorney General has resolved allegations against EHR vendor Practice Fusion after the company denied that it had violated the terms of its deferred prosecution agreement (DPA). Part of the allegations against Practice Fusion claimed that the company had failed to procure an oversight organization after its previous one had resigned. Resulting from the resolution, Practice Fusion had its DPA extended by 11 weeks, and the company will pay a $200,000 fine. Practice Fusion had previously been fined $145 million for an opioid prescribing kickback scheme that the company was involved in. READ MORE.

30 Healthcare Data Breaches Reported to HHS in March

Nearly 1.5 million victims were affected by the 30 healthcare data breaches reported to the Department of Health and Human Services in March of 2022. This number is down from the preceding months, including 50 breaches in January and 47 in February. Overall, nearly 6 million people have been affected by 127 breaches so far in 2022. The largest breach of the year affected Broward Health and impacted the data of 1,351,431 patients. READ MORE.

Biden Administration Propose ACA “Family Glitch” Fix

The Biden Administration is expected to change the Obama-era Affordable Care Act, increasing coverage and decreasing premiums. The proposed change would provide subsidies for workers if their family plan costs more than 10 percent of their income. By closing the “Family Glitch,” millions of previously excluded Americans will be eligible for subsidized coverage. Additionally, the Biden Administration will ask federal agencies to look for options to expand affordability measures in the ACA plan. READ MORE.

FDA Approval for Second Moderna Booster Dose

The Food and Drug Administration (FDA) amended Moderna’s COVID-19 emergency use authorization to allow for a fourth dose in adults aged 50 and older. The application was approved based on Israeli data that indicated the vaccines granted some protection during the Omicron surge. Other studies have shown that a fourth mRNA dose can effectively restore the waning immunity that occurs over time. READ MORE.

Medical Device Security Bill Introduced in The Senate

A group of US Senators and Representatives have introduced the Protecting and Transforming Cyber Healthcare (PATCH) Act, which aims to increase security for a range of medical products and software. The PATCH Act would require that new devices demonstrate specific safety and effectiveness levels throughout the device lifecycle. This includes cybersecurity requirements for medical devices and continual improvements to security capabilities throughout the product’s life. READ MORE.

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