Government: Page 2

FDA clarifies cybersecurity recommendations for device makers in new guidance

The draft guidance, which replaces a 2018 document, sets recommendations for how medical device companies should approach cybersecurity in premarket submissions.

By Elise Reuter • April 8, 2022

'Appropriate' transition period for COVID-19 test EUAs when public health emergency ends

The FDA is planning to give holders of EUAs for COVID-19 diagnostics and other devices 180 days notice of its intent to end their authorizations, in anticipation of U.S. public health emergency declarations stopping.

By Greg Slabodkin • April 8, 2022

Explore the Trendline➔

Labor

Amid a surge in COVID-19 cases, hospitals need nurses so desparetly they're offering massive sign-on bonuses and staffing firms say open positions for both temporary and permanent nursing roles are at all-time highs

By Healthcare Dive staff

'Where's the patient?': Experts question FDA's final recall guidance

While the guidance encouraged the use of electronic communications in recalls, a change experts have advocated for, some questioned why the agency did not address more problems with the system.

By Ricky Zipp • April 7, 2022

FDA advisers grapple with how to update COVID-19 vaccines

About half of eligible Americans haven't received a booster and may be less protected should cases surge. Health officials hope to soon ready an updated shot, but experts on the committee struggled to identify the best approach.

By Ned Pagliarulo • Updated April 7, 2022

Biden proposes rule to fix ACA's 'family glitch'

The new regulation could help an estimated 200,000 uninsured people in the U.S. gain coverage, while 1 million could benefit from less expensive plans.

By Susan Kelly • April 6, 2022

Facing opposition, Mass General Brigham pulls back surgery center plans

Although the system has withdrawn a proposal for three suburban surgery centers, it did secure recommendations for conditional approval for two other large-scale projects.

By Samantha Liss • April 5, 2022

Nurses union fights in court for permanent COVID-19 protection rule

National Nurses United argued before a federal appeals court on Monday that an existing temporary emergency standard isn't enough to protect healthcare workers from the ongoing threat of COVID-19.

By Susan Kelly • April 5, 2022

Medicare Advantage plans will see 8.5% revenue bump in 2023

CMS is not changing the risk adjustment calculation, which is meant to compensate plans for treating sicker patients. That's despite calls for an overhaul in the wake of allegations of abuse of the system.

By Shannon Muchmore • April 5, 2022

5 FDA decisions to watch in the second quarter

Between April and June, the agency will advance key regulatory reviews in ALS and gene therapy as well as host an advisory meeting on cancer drugs.

By Ben Fidler , Ned Pagliarulo , Jacob Bell • April 4, 2022

Hospital lobby says merger guidelines don't need 'major revisions'

Antitrust regulators are angling to modernize the guidelines, which have not been updated in more than a decade, as the Biden administration increasingly cracks down on consolidation.

By Samantha Liss • March 31, 2022

Surprise medical bills rank as public's second-highest financial worry, survey finds

While 58% of the public said they're worried about being able to afford surprise bills, the majority of people with private insurance stated they knew nothing about the consumer protection law that went into effect in January.

By Rebecca Pifer • March 31, 2022

Eyeing Europe's COVID-19 resurgence, AHA asks HHS to renew public health emergency

In a letter to HHS Secretary Xavier Becerra, hospitals emphasized the need to be prepared for more potential disruptions to the healthcare delivery system.

By Susan Kelly • March 29, 2022

Two years into the COVID-19 pandemic

Hospitals overhauled their operations in COVID-19's early days. Now, two years into the pandemic, they are looking ahead at the future of their business, including revenue diversification and workforce stability.

March 29, 2022

US health spending growth decelerated in pandemic's second year

According to new numbers from the CMS, national health spending grew 4.2% last year to almost $4.3 trillion, a significant slowdown from the 9.7% growth rate in 2020.

By Rebecca Pifer • March 29, 2022

AHA wants healthcare workers protected like airline staff amid rising workplace violence

No federal laws protect healthcare workers from violence on the job like they do flight crews. AHA wants the DOJ to support legislation that would make violence against healthcare workers a federal offense.

By Hailey Mensik • March 25, 2022

ONC head Micky Tripathi on info-blocking complaints, provider penalties and future of TEFCA

Tripathi shared his thoughts on data-sharing complaints, when the industry can expect penalties for providers found information blocking and how the government plans to build on TEFCA moving forward.

By Rebecca Pifer • March 25, 2022

Wisconsin passes law making threats against healthcare workers a felony

The state already has a law making it a felony to commit battery against nurses, emergency care providers or those working in an emergency department, but this expands that protection to threats.

By Hailey Mensik • March 24, 2022

Record 14.5M Americans signed up for ACA coverage this year

But the generous subsidies that contributed to the increase in enrollment are temporary and set to expire at the end of the year absent congressional action.

By Rebecca Pifer • March 24, 2022

White House stops paying providers for COVID-19 testing, treatment of uninsured patients

The Biden administration said it will also stop reimbursing providers for vaccinating uninsured patients by April due to shrinking pandemic relief funds.

By Hailey Mensik • March 23, 2022

Irked by no payment bump, physician lobby pushes Congress for fix

"At a minimum, Congress must establish a stable, annual Medicare physician payment update that keeps pace with inflation and practice costs," AMA wrote in its letter.

By Samantha Liss • March 17, 2022

Pfizer, BioNTech seek FDA clearance of 4th shot amid worries over next COVID wave

The companies are forging ahead with plans to provide a second booster to people over 65, citing evidence, largely from observational studies in Israel, that diminishing protection may be restored with an additional shot.

By Ben Fidler • March 16, 2022

'The promise it really brings': talking TEFCA with Sequoia Project CEO Mariann Yeager

ONC's main partner in creating a nationwide framework for data exchange shared details on timeline, buy-in and the vision for TEFCA on the sidelines of HIMSS22.

By Rebecca Pifer • March 15, 2022

Site that lets consumers compare hospital prices goes live

Turquoise Health's online search platform lists prices for medical procedures and rates the transparency efforts of nearly 6,000 hospitals.

By Susan Kelly • March 15, 2022

Grassley pushes for PBM probe

The senator wants FTC commissioners to come up with a more targeted focus for the study and suggested narrowing a review to the impact on consumers and their out-of-pocket costs.

By Samantha Liss • March 14, 2022

Threats, obscenities, homicide: Healthcare workers stressed by pandemic face elevated violence

Millions of healthcare workers across the country are becoming inured to workplace violence, which can range from verbal abuse and threats to physical attacks and even homicide.

By Hailey Mensik • March 9, 2022