Government: Page 18
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FDA
Deep Dive5 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 Rebecca Pifer • Oct. 24, 2024 -
Spencer Platt via Getty Images
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 Rebecca Pifer • Oct. 23, 2024 -
Samantha Liss/Healthcare Dive
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 Rebecca Pifer • 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 Rebecca Pifer • 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. WadeSupreme 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 Sydney Halleman • Oct. 9, 2024 -
Daniel Karmann/Picture-Alliance/DPA/AP
Deep DiveThe 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 , Jasmine Ye Han • Oct. 9, 2024 -
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CMS to increase oversight on exchange brokers
The agency has reported a growing number of complaints about ACA health plan applications submitted by brokers.
By Emily Olsen • Oct. 7, 2024 -
Courtesy of UnitedHealth Group
UnitedHealth sues CMS over Medicare Advantage star ratings
A handful of plans owned by the nation's largest MA payer are the latest to ask the court to help raise their valuable quality scores.
By Rebecca Pifer • Oct. 4, 2024 -
Joe Raedle via Getty Images
Texas sues major PBMs, pharma companies over high insulin prices
The litigation comes as pharmacy benefit managers Express Scripts, CVS Caremark and Optum Rx face growing criticism over their role in high drug costs — including a recent lawsuit from the Federal Trade Commission.
By Emily Olsen • Oct. 4, 2024 -
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CMS should take stronger stance on hospital pricing compliance: GAO
The CMS fails to check hospitals’ pricing data for accuracy and completeness, raising questions about whether the data can be used as intended to help payers and patients shop for services, according to the government agency.
By Susanna Vogel • Oct. 4, 2024 -
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Lawmakers urge Biden administration to extend telehealth prescribing flexibilities for opioid use disorder
A bipartisan group of two dozen representatives pushed officials to preserve the pandemic-era prescribing changes for buprenorphine, arguing telehealth increases access and prevents overdoses.
By Emily Olsen • Oct. 3, 2024 -
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Medicare tweaks rules for second round of drug price talks
The agency will offer earlier meetings with drugmakers as well as solicit more patient feedback on the process.
By Ned Pagliarulo • Oct. 3, 2024 -
Spencer Platt via Getty Images
Humana’s Medicare Advantage dilemma worsens amid precipitous drop in 2025 star ratings
Only 25% of Humana members will be in plans with four stars or above next year, down from 94% this year, the insurer disclosed last week. The downgrade could wipe out Humana’s profits in 2026.
By Rebecca Pifer • Oct. 3, 2024 -
Illustration: Xavier Lalanne-Tauzia for Industry Dive
CHS offloads two North Carolina hospitals to Iredell Health
The sale offers a lifeline for struggling Davis Regional Psychiatric Hospital, which stakeholders worried could close after CHS’ deal to sell the facility to Novant Health fell through in June.
By Susanna Vogel • Oct. 3, 2024 -
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J&J drops 340B rebate plan following government pressure
Threatened with steep sanctions and losing access to Medicare and Medicaid, Johnson & Johnson is rolling back a plan to give hospitals after-the-fact rebates for drugs in the 340B drug discount program.
By Rebecca Pifer • Oct. 1, 2024 -
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Tracking Steward's declineSteward CEO sues senators day before he steps down
The news comes days after the Senate voted to hold Ralph de la Torre in criminal contempt for failing to comply with a congressional subpoena.
By Susanna Vogel • Sept. 30, 2024 -
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MA premiums to decrease on average in 2025
The CMS said premiums, benefits and plan choices will hold steady in 2025, even as insurers have warned they could cut MA offerings in a bid to preserve profits.
By Emily Olsen • Sept. 30, 2024 -
Karen Ducey/Getty Images via Getty Images
OpinionThe unexpected consequences of hospital quality scores
One clinical affairs expert argues that it’s time to reexamine the federal Hospital-Acquired Condition Reduction Program.
By Alice Brewer • Sept. 27, 2024 -
Drew Angerer/Getty Images via Getty Images
Senators introduce bill to set healthcare cybersecurity standards
The legislation, sponsored by Sens. Ron Wyden and Mark Warner, would direct the HHS to develop minimum cybersecurity standards for providers, health plans, claims clearinghouses and business associates.
By Emily Olsen • Sept. 26, 2024
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