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    J&J sues federal government for halting 340B rebate plan

    The New Jersey-based drugmaker is trying to get the courts’ backing to pay hospitals rebates for two drugs in the 340B drug discount program, instead of offering upfront discounts.

    By Nov. 13, 2024
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    DOJ sues to block UnitedHealth’s $3.3B buy of home health firm Amedisys

    The DOJ’s complaint is intentionally broad to maximize its chances of success, according to one expert. Still, the incoming Trump administration could throw cold water on the challenge.

    By Nov. 12, 2024
  • Trendline

    Surprise Billing

    Federal legislation banning surprise bills has hit a barrage of roadblocks, complicating efforts to protect consumers from unexpected out-of-network charges.

    By Healthcare Dive staff
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    Many hospitals still aren’t complying with price transparency rule: OIG

    In a sample of 100 hospitals, 34 didn’t meet requirements for publishing machine-readable files of their charges while 14 didn’t follow rules to post shoppable services.

    By Emily Olsen • Nov. 12, 2024
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    MedPAC backs tying physician pay to inflation, but ducks specifics

    During a meeting Thursday, commissioners debated different solutions to lackluster physician pay with one theme in common: linking doctors’ annual payment update to the Medicare Economic Index.

    By Nov. 8, 2024
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    HHS settles 2 ransomware investigations as attacks rise

    The settlements mark the sixth and seventh healthcare ransomware enforcement actions from regulators.

    By Emily Olsen • Nov. 7, 2024
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    How the healthcare industry is reacting to a second Trump term

    Donald Trump’s first term as president was characterized by significant turbulence for government healthcare programs. Here’s how some of the most influential industry groups responded to the Republican’s reelection.

    By Nov. 7, 2024
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    MACPAC calls for greater transparency amid steep rise in Medicaid directed payments

    Dramatic growth in an opaque Medicaid funding mechanism is exacerbating concerns about the program’s fiscal integrity — while spurring financial gains for the hospital industry.

    By Nov. 5, 2024
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    Photo illustration: Industry Dive; Joe Readle/Getty Images; Brandon Bell/Getty Images

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    As presidential election looms, disparate approaches to cyber policy come into focus

    Government officials and security leaders are hoping the nation’s need for cyber resilience will transcend partisan politics regardless of the election results. 

    By David Jones • Nov. 5, 2024
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    Michelle Tarver faces challenges as new CDRH leader. But patient groups, industry are optimistic.

    Tarver is taking over as director of the Center for Devices and Radiological Health as the regulator grapples with questions around artificial intelligence in medical devices and racial bias in pulse oximeters.

    By Elise Reuter • Nov. 4, 2024
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    Elevance Health sues HHS over Medicare Advantage star ratings

    The payer joins several other insurers suing federal regulators over the 2025 quality ratings, which Elevance argues will cost it at least $375 million in bonus payments and rebates.

    By Emily Olsen • Nov. 4, 2024
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    Physicians, hospitals decry 2025 Medicare payment rates

    Physicians will see their Medicare reimbursement fall 2.9% next year if Congress doesn’t stop the cuts. Meanwhile, reimbursement for hospital outpatient departments is rising 2.9%.

    By Nov. 4, 2024
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    Medicare saves record $2.1B from largest accountable care program

    Citrus ACO in Central West Florida had the highest savings rate, while Health Connect Partners — an ACO operated by hospital giant Providence — had the highest total savings in the Medicare Shared Savings Program last year.

    By Oct. 31, 2024
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    Pennsylvania attorney general sues Prospect Medical alleging ‘corporate greed’

    The lawsuit argues Prospect broke the terms of its agreement to purchase Pennsylvania system Crozer Health and seeks to stop the hospital operator from closing more facilities.

    By Susanna Vogel • Oct. 31, 2024
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    FDA
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    Deep Dive

    5 steps to navigate the FDA’s new lab developed test rule

    Laboratories face a series of upcoming deadlines to comply with stricter FDA oversight of in-house tests. Here are five strategies labs can take to be ready.

    By Susan Kelly • Oct. 28, 2024
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    State Medicaid directors concerned about program’s stability: KFF

    The presidential election, loss of higher federal funding, inflationary pressures and other challenges are leaving state regulators uncertain about Medicaid’s “new normal.”

    By Oct. 24, 2024
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    Insurer lobby blames government policies for 2025 Medicare Advantage market makeup

    The Better Medicare Alliance is warning of disruptions to care for America’s seniors, though MA premiums and major benefits are essentially unchanged next year.

    By Oct. 23, 2024
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    Centene sues HHS over Medicare Advantage star ratings fall

    Centene is emulating other insurers unhappy with how regulators handled quality ratings for 2025. The flurry of complaints is “symptomatic of what appear to be systemic issues” with CMS calculations, Centene said.

    By Oct. 23, 2024
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    Humana sues HHS over calamitous Medicare Advantage star ratings decrease

    It’s the latest in a string of lawsuits from health insurers scrambling to protect their prized quality scores and the money those ratings represent.

    By Oct. 21, 2024
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    Senate report slams Medicare Advantage insurers for using predictive technology to deny claims

    UnitedHealth, CVS and Humana used technology to increase MA prior authorization denials for post-acute services, boosting profits, according to a report from a Senate subcommittee.

    By Susanna Vogel • Oct. 21, 2024
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    FDA outlines new Drug Supply Chain Security Act exemptions

    Several groups have been granted additional time to comply with the more than 10-year-old legislation, which requires complete end-to-end supply chain visibility for pharmaceutical products.

    By Kelly Stroh • Oct. 14, 2024
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    FTC increases premerger reporting requirements over provider objections

    Companies will be required to disclose more information about minority investors and past M&A activity. Provider groups said the new requirements would be burdensome for hospitals.

    By Susanna Vogel • Oct. 14, 2024
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    Opinion

    When managing a healthcare practice, what’s the value of prevention?

    Here are the legal issues providers need to know as litigation increases around healthcare fraud and abuse, according to two experts.

    By Nadia de la Houssaye and Donald W. Washington • Oct. 10, 2024
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    UnitedHealth, CVS push to remove FTC Chair Lina Khan from PBM case

    Attorneys argue Khan and two other commissioners are biased against pharmacy benefit managers and should recuse themselves from an ongoing lawsuit against the middlemen.

    By Emily Olsen • Oct. 10, 2024
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    Overturning of Roe v. Wade

    Supreme Court declines to weigh in on Texas emergency abortion case

    It’s a loss for the Biden administration, which has tried to require states to provide abortions for emergency care since Roe v. Wade was overturned.

    By Oct. 9, 2024
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    Deep Dive

    The number of AI medical devices has spiked in the past decade

    The FDA has authorized nearly 1,000 medical devices with artificial intelligence features as companies including GE Healthcare and Siemens Healthineers build out their AI efforts.

    By Elise Reuter , Oct. 9, 2024