Government: Page 2


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    The draft guidance, which replaces a 2018 document, sets recommendations for how medical device companies should approach cybersecurity in premarket submissions.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

    '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
  • 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
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    Sarah Silbiger via Getty Images
    Deep Dive

    '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
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    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
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    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
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    Permission granted by JM Electrical

    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    Although the system has withdrawn a proposal for three suburban surgery centers, it did secure recommendations for conditional approval for two other large-scale projects.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 April 5, 2022
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    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
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    CMS

    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 April 5, 2022
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    Sarah Silbiger via Getty Images

    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 March 31, 2022
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    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 March 31, 2022
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    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
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    Diego Camargo/Healthcare Dive

    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
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    Fotolia

    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 March 29, 2022
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    Mario Tama via Getty Images

    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 March 25, 2022
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    Deep Dive // HIMSS22

    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 March 25, 2022
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    Drew Angerer / Staff via Getty Images

    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 March 24, 2022
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    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 March 24, 2022
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    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 March 23, 2022
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    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 March 17, 2022
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    Mario Tama via Getty Images

    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
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    Deep Dive // HIMSS22

    '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 March 15, 2022
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    Fotolia

    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
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    Carol Highsmith. (2005). "Apex Bldg." [Photo]. Retrieved from Wikimedia Commons.

    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 March 14, 2022
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    Drew Angerer / Staff via Getty Images
    Deep Dive

    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 March 9, 2022