Government


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    Biden administration publishes long-awaited TEFCA interoperability framework

    After TEFCA's many fits and starts, ONC head Micky Tripathi called its finalization a "milestone" marking the beginning of a "new era of electronic health information exchange in the U.S."

    By Jan. 18, 2022
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    WhiteHouse.gov

    Biden administration to buy 500M more rapid COVID-19 tests to give to Americans

    The announcement by President Joe Biden now brings the administration's total purchase to 1 billion test kits. Abbott Laboratories, iHealth and Roche have so far been awarded contracts for a combined 380 million tests.

    By Greg Slabodkin • Jan. 14, 2022
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    Vertical integration and consolidation

    Healthcare companies merging with subsectors of the industry is a growing trend, although certainly not a new one.

    By Healthcare Dive staff
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    Medicare faces blowback over plan to limit coverage of Biogen's Alzheimer's drug

    Biogen, along with allies in industry, plans to pressure Medicare to water down its policy, which limits coverage of Aduhelm and drugs like it to clinical trials.

    By Jonathan Gardner , Jacob Bell • Jan. 14, 2022
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    "Supreme Court" by Matt Wade is licensed under CC BY-SA 3.0

    Providers concerned about staffing shortages post-SCOTUS vaccination mandate ruling

    Nursing facilities are particularly worried about the strain a vaccination mandate could have on their shrinking workforce, and are urging CMS to consider a regular testing option for unvaccinated workers.

    By Jan. 14, 2022
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    SCOTUS narrowly upholds health worker vaccine mandate

    The court's liberal justices agree with the government that CMS has the authority to impose the requirement, just one of many healthcare organizations must comply with to be eligible for Medicare and Medicaid funding.

    By Jan. 13, 2022
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    Sarah Silbiger via Getty Images

    FDA seeks feedback on draft device shortage guidance

    A new document poses a series of questions for industry on the overall design and operation of the policy, and is intended to help manufacturers provide timely information about supply disruptions during public health emergencies.

    By Nick Paul Taylor • Jan. 13, 2022
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    Biden health officials defend COVID-19 testing policies amid diagnostics shortage

    Acting FDA Commissioner Janet Woodcock and others were under fire from senators during a Tuesday hearing for not doing enough to increase the availability of tests.

    By Greg Slabodkin • Jan. 12, 2022
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    Medicare proposes to limit coverage of Biogen Alzheimer's drug

    The program will only cover Aduhelm, which the FDA controversially approved last June, for patients enrolled in clinical trials.

    By Jonathan Gardner , Jacob Bell • Updated Jan. 11, 2022
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    Becerra orders CMS to reassess Medicare premiums after Aduhelm cost cut

    It's an unusual step for HHS, given the plan year has already begun, and follows Biogen slashing the price of its controversial Alzheimer's drug in half.

    By Jan. 10, 2022
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    Win McNamee via Getty Images

    Stakeholders urge Supreme Court to act fast on OSHA mandate

    "We are asking for a stay before enforcement takes effect Monday," an attorney for the National Federation of Independent Businesses said.

    By Ryan Golden • Updated Jan. 10, 2022
  • SCOTUS justices leave opening for healthcare worker vaccine mandate

    The key question is whether the agencies enacting federal COVID-19 vaccine mandates — OSHA and CMS — had the authority to do so, or whether that power falls to the states.

    By Jan. 7, 2022
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    Biden admin proposes stricter network adequacy, marketing standards for MA plans

    CMS is looking to hold Medicare Advantage plans to a higher standard as their rolls swell, targeting their networks, marketing practices and spending; while improving dual-eligible and Part D costs and patient input.

    By Jan. 7, 2022
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    "Supreme Court" by Matt Wade is licensed under CC BY-SA 3.0

    Supreme Court sets Jan. 7 hearing on vaccine mandate rules

    The justices will hear arguments on the requirement that healthcare workers must be fully vaccinated amid a flurry of legal challenges.

    By Dec. 23, 2021
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    Sarah Silbiger via Getty Images

    Most COVID-19 medical device EUAs lack documented supporting data, JAMA study shows

    The use of "low-quality data" is reasonable at the start of a crisis but FDA should consider raising the standard of evidence after multiple products come to market, according to the authors of the study.

    By Nick Paul Taylor • Dec. 22, 2021
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    Biden administration to send military medical personnel to overwhelmed hospitals

    As the omicron variant spreads rapidly, the White House is mobilizing federal agencies to assist hospitals and states in the latest wave of infection.

    By Dec. 21, 2021
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    Federal COVID-19 aid fueled huge jump in national health spending last year

    The pandemic accounted for major changes in who paid for healthcare as job losses spurred changes in coverage types, while people deferred care and spent less out of their own pockets.

    By Dec. 16, 2021
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    HHS to funnel $9B in relief funds to providers

    The federal government will reimburse smaller providers more favorably in this funding round, regulators said, acknowledging these facilities tend to operate on shakier financial footing compared to larger peers.

    By Dec. 15, 2021
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    SCOTUS blocks challenge to New York's health worker vaccine mandate

    The lawsuit was filed by a group of doctors and other medical professionals protesting that the state's requirement for staff in hospitals, long-term care and other healthcare facilities does not allow for a religious exemption.

    By Dec. 14, 2021
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    Flurry of doctor group buyouts helps fuel 'extraordinary' surge in health M&A

    Companies across the healthcare spectrum are pursuing deals to strengthen operations after two years of pandemic-driven challenges, a new PwC report found.

    By Susan Kelly • Dec. 14, 2021
  • Hospital price disclosure push coming up short, JAMA study finds

    Researchers said lack of transparency on costs for services by independent providers that bill separately from hospitals is complicating CMS' effort to help patients shop around for the best value.

    By Susan Kelly • Dec. 13, 2021
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    FDA seeks comment on 3D printing of medical devices at hospitals, doctor's offices

    The agency's discussion paper lays out the benefits and challenges of creating 3D-printed devices in healthcare settings as well as a potential approach for regulatory oversight.

    By Greg Slabodkin • Dec. 13, 2021
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    Hospital, doctor lobbies sue HHS over implementation of surprise billing ban

    Congress intended for an arbiter to be able to consider a constellation of factors when payment disputes arise, but the final rule severely limits what an arbiter can consider, the lawsuit claims.

    By Dec. 9, 2021
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    Megan Quinn/Healthcare Dive

    Senate passes legislation to avoid Medicare cuts in year-end sprint

    The bill, which delays 2% cuts to Medicare rates through March and a separate round of 4% cuts to 2023, now heads to President Joe Biden's desk for his signature.

    By Updated Dec. 10, 2021
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    Medicare Advantage quality bonus program hasn't improved quality, study finds

    The new findings published in Health Affairs suggest the quality bonus program doesn't move the needle on quality despite a significant federal investment — hinting the American people may not be getting enough bang for their buck.

    By Dec. 8, 2021
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    States with robust merger reviews are tougher on hospital tie-ups, study suggests

    Just eight states challenged the majority of the deals that regulators scrutinized during a 10-year time period. Still, it did little to slow price increases, according to new research in Health Affairs.

    By Dec. 7, 2021