Government: Page 67


  • The FDA logo on a glass pane at the agency's campus in Silver Spring, Maryland.
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    Jacob Bell/Healthcare Dive
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    FDA review supports safety, efficacy of J&J coronavirus vaccine

    Agency scientists noted the shot's strong protection against severe COVID-19, even for the virus variant first detected in South Africa and known to weaken vaccine potency.

    By Ned Pagliarulo , Jonathan Gardner • Feb. 24, 2021
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    Jacob Bell
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    FDA lays out shortened path for testing vaccines against new coronavirus variants

    Lengthy trials won't be needed for updating shots against emerging viral strains, the agency told developers in newly published guidance.

    By Ned Pagliarulo • Feb. 23, 2021
  • Trendline

    Labor

    Hospitals are navigating persistent labor shortages with the need to cut costs — a source of contention that could leave patients caught in the middle.

    By Healthcare Dive staff
  • California Attorney General Xavier Becerra, President Joe Biden's nominee for HHS secretary, at his confirmation hearing before the Senate health committee.
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    Retrieved from C-SPAN on February 23, 2021
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    Becerra embraces healthcare antitrust record at first Senate hearing

    Sen. Richard Burr, R-N.C., gave a taste of GOP opposition to the nominee for HHS Secretary on Tuesday by accusing him of disregarding the value of private sector innovation.

    By Feb. 23, 2021
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    Jacob Bell
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    FDA starts review of how skin pigmentation affects pulse oximeter results

    The agency is evaluating published literature related to factors that may affect device accuracy and performance following pressure from senators to address concerns that "racism may be embedded in key clinical tools."

    By Nick Paul Taylor • Feb. 22, 2021
  • Transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
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    Why this week's FDA meeting on J&J's coronavirus vaccine will be important

    The FDA is widely expected to authorize the drugmaker's one-dose shot. But the advisory committee meeting beforehand will offer a window into debate over several key issues.

    By Ben Fidler , Ned Pagliarulo • Feb. 22, 2021
  • Hospital admissions not linked to COVID-19 fell dramatically in fall, especially in Midwest

    The latest analysis from the Kaiser Family Foundation gives a fuller picture of how the pandemic affected inpatient volume throughout 2020, focusing on trends by age, sex and region.

    By Feb. 18, 2021
  • Chiquita Brooks LaSure, reportedly picked to be CMS administrator for President Joe Biden
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    Retrieved from Manatt on February 18, 2021
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    Obama admin alum Chiquita Brooks-LaSure picked to head CMS

    Brooks-LaSure will have a lot on her plate. Biden during his campaign ran on expanding the role of the Affordable Care Act and perhaps attempting to build in a public option or lowered Medicare age eligibility.

    By Updated Feb. 19, 2021
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    Peter Ashkenaz, ONC
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    Q&A

    Don Rucker reflects on highs and lows of tenure as ONC head and the future of health IT

    In this exit interview, Rucker, who has been national coordinator since 2017, looked back on his time at the agency and predicted what industry might expect from the Biden administration.

    By Feb. 17, 2021
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    Fotolia
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    One-third of US adults postponed care during pandemic: reports

    Substantial portions of those who delayed or put off services had one or more chronic health conditions, with many reporting health worsened as a result, researchers from the Urban Institute and RWJF found.

    By Ron Shinkman • Feb. 16, 2021
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    Adobe Stock
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    Opinion

    CMS inpatient only policy threatens patient access to appropriate surgical setting

    Nixing Medicare's IPO list has unintended consequences, especially for high-risk patients, the president of the American Academy of Orthopaedic Surgeons argues.

    By Joseph Bosco • Feb. 16, 2021
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    Dollar Photo Club
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    Biden admin begins plan to rescind Medicaid work mandates in win for providers

    The policies threatened to lower hospitals' Medicaid revenues as enrollees lost coverage, raising uncompensated care costs. But lawsuits and the pandemic have kept states from implementing the controversial Trump-era requirements.

    By Feb. 16, 2021
  • A volunteer in a clinical trial is dosed with BNT162, an experimental coronavirus vaccine developed by Pfizer and BioNTech
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    Permission granted by BioNTech SE
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    Health system execs: national approach needed to stem vaccine disarray

    "We don't know until we open the package how many doses we're getting that week," EVP of Ascension Joe Cacchione said Thursday during a webinar organized by the American Hospital Association. 

    By Feb. 11, 2021
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    Getty
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    COVID-19 leads to explosion in cyberattacks, data breaches

    A survey from CI Security found successful hacks involving healthcare organizations or their business associates soared in the second half of last year, leading to a jump in the number of breached patient records.

    By Ron Shinkman • Feb. 10, 2021
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    Jacob Bell
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    Visby gets FDA nod for single-use, rapid point-of-care COVID-19 PCR test

    The palm-sized diagnostic gives results in 30 minutes without the need for additional instruments or readers. While Abbott's ID Now provides results in 13 minutes or less, it is the size of a toaster and requires a cartridge.

    By Greg Slabodkin • Feb. 10, 2021
  • As COVID-19 becomes a business, vaccine makers confront thorny pricing questions

    Yearly vaccinations could be required after the pandemic ebbs. Will drugmakers change how they approach pricing their shots?

    By Jonathan Gardner • Feb. 10, 2021
  • Oklahoma selects 4 private payers to manage Medicaid for $2B, faces legal suit

    The state maintains the switch will improve costs while maintaining access, but the move to cede Medicaid control to for-profit entities is highly controversial.

    By Feb. 9, 2021
  • An AstraZeneca scientists involved in vaccine research
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    Courtesy of AstraZeneca
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    New data on AstraZeneca vaccine add to worries over coronavirus variant from South Africa

    South Africa will use other shots in its immunization campaign after AstraZeneca's offered "minimal protection" against a coronavirus variant that has spread throughout the country.

    By Ben Fidler • Feb. 8, 2021
  • Pandemic habits could cause US health spending to decelerate over 2 decades, Deloitte predicts

    The consultancy's predictive modeling based its estimate on the rise of digital health products and more consumer engagement. Such a slowing contrasts more dire spending forecasts made prior to the COVID-19 crisis.

    By Feb. 8, 2021
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    Adeline Kon/Healthcare Dive
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    Fitch: Biden's healthcare plans could boost nonprofit hospitals

    The ratings agency cited administration plans to bolster the Affordable Care Act, which could reverse the increased number of uninsured people, as among the factors driving brighter prospects.

    By Ron Shinkman • Feb. 4, 2021
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    Getty Images
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    J&J asks FDA for emergency clearance of coronavirus vaccine

    The regulator scheduled an advisory committee meeting for Feb. 26, making an authorization by the end of the month possible. 

    By Ned Pagliarulo • Updated Feb. 5, 2021
  • The FDA logo on a glass pane at the agency's campus in Silver Spring, Maryland.
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    Jacob Bell/Healthcare Dive
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    FDA appoints first medical device cybersecurity chief

    University of Michigan professor Kevin Fu will serve a one-year term as acting cyber director at the Center for Devices and Radiological Health. Experts fear the chaos of the pandemic creates the perfect storm for hackers to exploit.

    By Greg Slabodkin • Feb. 4, 2021
  • Low Medicare EKG rate a potential setback for device makers

    Wall Street analysts questioned whether the lower-than-expected rates are final and what the prospects are for renegotiation. Shares of market leader iRhythm fell over 32% on Friday.

    By Ricky Zipp • Updated Feb. 1, 2021
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    Getty Images
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    Medicare buy-in for older adults could cut health costs, increase coverage value: Urban Institute

    A Medicare buy-in is not a specific prong of President Joe Biden's health policy agenda, but there are currently two proposals in Congress designed to build upon the ACA.

    By Feb. 3, 2021
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    Courtesy of Ellume Health
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    Biden administration awards $231M to increase US production of at-home, OTC COVID-19 test

    Australian company Ellume will use the funding to establish a U.S. manufacturing facility that is projected to increase production capacity by 640,000 tests per day by December.

    By Susan Kelly • Feb. 2, 2021
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    Brian Tucker Industry Dive Image | courtesy of California Office of Attorney General
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    How might Xavier Becerra operate as HHS Secretary?

    The nominee has made headlines since leaving the House of Representatives, in part by leading blue state efforts to defend the ACA. Less high-profile, perhaps, were his efforts to block major hospital mergers in California.

    By Ron Shinkman • Feb. 1, 2021