Government: Page 63


  • Glass vials of Moderna COVID-19 vaccine.
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    Gabriel Kuchta via Getty Images
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    Moderna, with new results, set to seek vaccine clearance for young teens

    The biotech's shot was strongly protective against COVID-19 in a study of 12- to 17-year-olds, a finding that could soon make it the second vaccine available for adolescents in the U.S.

    By Ben Fidler • May 25, 2021
  • Deep Dive

    Medtronic HeartWare system hit with slew of Class I recalls, device reports since 2012 PMA

    The pump has a higher rate of malfunction reports than rivals, according to an ECRI analysis of the FDA's MAUDE database. But it's hard to draw conclusions from a disparate system of safety reporting.

    By Ricky Zipp • May 24, 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
  • A physician holds a telehealth session with a patient via computer.
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    [Photograph]. Retrieved from Regional Health Command Atlantic.
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    More than 1 in 4 Medicare beneficiaries used telehealth between summer and fall last year

    A Kaiser Family Foundation report also found a majority of beneficiaries using virtual care accessed it over the phone, hinting at continued demand for audio-only telehealth beyond the COVID-19 public health emergency.

    By May 20, 2021
  • Exact Sciences precision oncology lab
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    Courtesy of Exact Sciences
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    US panel trims colorectal cancer screening age, broadening payer mandate

    The action means private insurers have to cover the screening of adults aged 45 to 49 years under the Affordable Care Act.

    By Nick Paul Taylor • May 19, 2021
  • Eli Lilly fires back against HHS order to repay providers for violating 340B

    As California's Attorney General, HHS chief Xavier Becerra led a group of states pushing the agency to force drugmakers to comply with the controversial drug discount program late last year.

    By Hailey Mensik , Updated May 21, 2021
  • A picture of the exterior of the US Department of Health and Human Services. In front of the building is a black sign designating the building's name.
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    Alex Wong via Getty Images
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    HHS asks Supreme Court to keep site-neutral payments in place

    Hospitals and HHS have been wrangling about the issue since the federal agency moved to cut payments to hospital-owned outpatient sites in 2019.

    By Ron Shinkman • May 17, 2021
  • A picture of the exterior of the US Department of Health and Human Services. In front of the building is a black sign designating the building's name.
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    Alex Wong via Getty Images
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    CMS again delays breakthrough device payment rule in nod to skeptics

    Medtech manufacturers pushed for the MCIT rule, but high-profile detractors like payer lobby America's Health Insurance Plans and doctor groups drove CMS to delay implementation, citing potential risks to Medicare beneficiaries.

    By Nick Paul Taylor • May 17, 2021
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    Despite CMS rule, few hospitals post prices in a coherent fashion, study says

    Among 25 common items and procedures posted by the 100 largest hospitals, far fewer than 20% of facilities had decipherable pricing for any single item, according to the research in JAMA Network Open.

    By Ron Shinkman • May 14, 2021
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    Fotolia
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    Missouri Medicaid expansion hits snag, headed to court

    Medicaid expansion in Missouri will now be decided by the courts as its legislature refused to allocate funds after voters approved expansion last year.

    By Updated May 21, 2021
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    Lintao Zhang / Staff via Getty Images
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    EU plans to impose additional regulations on medtech AI products, other 'high risk' systems

    The proposed legal framework, which addresses potential artificial intelligence risks, seeks to regulate the technology and issue fines for noncompliance that could total billions of dollars, positioning Europe for a "leading" AI role globally.

    By Nick Paul Taylor • May 13, 2021
  • Nurses wearing masks walk through a hospital hall, in front of a "We Will Survive" sign.
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    Justin Sullivan via Getty Images
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    Report calls for broader scope of practice for nurses, better support for equity, mental health

    Demand for nurses will only grow post-pandemic, as will the rigors of the job, according to the paper published Tuesday from the National Academy of Medicine and Robert Wood Johnson Foundation.

    By Hailey Mensik • May 12, 2021
  • A podium showing the logo for the Centers for Disease Control and Prevention is seen.
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    Kevin C. Cox via Getty Images
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    CDC panel endorses Pfizer vaccine for 12- to 15-year-olds

    The vote, which the CDC officially adopted hours after, gives a clear green light for states to begin vaccinating younger adolescents with the shot.

    By Ned Pagliarulo • Updated May 13, 2021
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    Sean Gallup via Getty Images
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    FDA authorizes Pfizer's coronavirus vaccine for younger teens

    The emergency clearance greatly expands the pool of people who can be vaccinated in the U.S. just as some states begin to report waning demand.

    By Ned Pagliarulo • May 11, 2021
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    Adeline Kon/Healthcare Dive
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    Billions of dollars remain in the provider relief fund. Hospital execs are left in the lurch waiting for relief.

    "My greatest frustration is just the unknown," one Illinois hospital official said. "There seems to be a vacuum of information out there about how much is there, when would you expect it, how do you apply for it."

    By May 11, 2021
  • Boston Scientific Acurate neo2 valve
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    Courtesy of Boston Scientific
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    TAVR readmission rates vary widely between hospitals for unknown reasons

    Length of stay and discharge disposition only explained 15% of the inter-hospital variation. Researchers called for efforts to identify practices associated with low rates or readmission.

    By Nick Paul Taylor • May 11, 2021
  • A picture of the exterior of the US Department of Health and Human Services. In front of the building is a black sign designating the building's name.
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    Alex Wong via Getty Images
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    Providers supportive of push to overhaul HIPAA, but air serious concerns about data privacy, timing

    "We urge OCR to reconsider implementing a massive change to patient privacy laws in the midst of this transition," AMA commented on the Trump-era rule.

    By May 10, 2021
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    Sarah Silbiger via Getty Images
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    Pharma erupts as Biden administration backs waiver of vaccine patent rights

    The shift in U.S. policy might not undermine future research as the drug industry claims. Easing patent protections, though, isn't likely to translate to an immediate boost in vaccine supply.

    By Jonathan Gardner , Ned Pagliarulo • May 7, 2021
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    Drew Angerer via Getty Images
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    ACA special enrollment period sign-ups surged in April

    The Biden administration began the SEP primarily to help people who have lost coverage due to the COVID-19 pandemic and related economic fallout.

    By May 7, 2021
  • A transmission electron microscope image of SARS-CoV-2, isolated from a patient in the U.S.
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49535193876/in/album-72157713108522106/.
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    Adagio, flush with cash, launches large study of next-gen COVID-19 antibody

    The privately held biotech believes its drug might treat or prevent infections from existing variants and future coronavirus strains, which could make it a threat to marketed therapies from Regeneron and Eli Lilly.

    By Kristin Jensen • May 5, 2021
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    Fotolia
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    State lawmakers mull out-of-state nurse licenses after pandemic rollbacks

    Many tried to join the Nurse Licensure Compact before the pandemic, "but COVID was a kind of glaring example of how the compact could help," Rebecca Fotsch at the National Council of State Boards of Nursing said.

    By Hailey Mensik • May 4, 2021
  • ONC head Micky Tripathi headshot
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    Adeline Kon/Healthcare Dive
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    Q&A

    Full speed ahead on interoperability: Q&A with ONC head Micky Tripathi

    In a wide-ranging interview, Tripathi addressed what the government can do to build on the regulations, noting further delays are unlikely and predicting industry will soon see further action on codifying disincentives for bad actors.

    By May 3, 2021
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    Kentucky must rebid Medicaid contracts again, judge rules

    This ruling puts six insurers at risk of losing their lucrative contracts with the state. It's unclear when the state will rebid the work.

    By April 30, 2021
  • CMS finalizes joint replacement pricing extension

    Some analysts say the agency's initiative may evolve to put pricing pressure on orthopaedic devices. However, they contend companies can mitigate that threat by selling more products to customers.

    By Nick Paul Taylor • April 30, 2021
  • Ajay Purohit, a Biogen employee, points to brain scans of people with Alzheimer's
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    Permission granted by Biogen
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    FDA greenlights device to retrain muscles in stroke patients

    The noninvasive brain-computer interface technology uses data from the uninjured side of a patient's brain to recover motor function in the affected arm and hand.

    By Susan Kelly • April 29, 2021
  • In big win for hospitals, CMS pitches nixing mandate to submit some payer-negotiated rates

    The proposed rule would also add 1,000 graduate medical education slots over the next five years, with a priority given to facilities in rural areas and with underserved patient populations.

    By , April 28, 2021