Government: Page 74
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Amazon gets EUA for direct-to-consumer, at-home COVID-19 test
As the COVID-19 pandemic intensified, the tech behemoth initiated an in-house COVID-19 testing service for employees, initially in the U.S. and later in the U.K.
By Nick Paul Taylor • June 9, 2021 -
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OpinionNonprofit health plan CMOs: Data sharing needed to drive vaccine equity
To achieve vaccine equity and approach herd immunity, healthcare organizations need access to timely, comprehensive vaccine data, the CMOs at the Alliance of Community Health Plans and PacificSource Health Plans argue.
By Connie Hwang and Edward McEachern • June 7, 2021 -
Explore the Trendline➔
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TrendlineSurprise 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 -
Permission granted by Biogen
Deep DiveIn historic move, FDA approves closely watched, controversial Alzheimer's drug
With the decision, the agency cleared the way for what many predict will become a lucrative and highly sought-after option — though fierce debate continues over whether Biogen's aducanumab actually benefits patients.
By Jacob Bell • Updated June 7, 2021 -
Courtesy of One Medical
One Medical buying Medicare-focused Iora in $2.1B deal
The acquisition by the Google-backed primary care chain aligns two players in the value-based care movement, which eschews traditional payer-provider arrangements in favor of a concierge membership model.
By Shannon Muchmore • June 7, 2021 -
Medtronic pulls HeartWare HVAD pump from market amid recalls, patient deaths
The medtech said the move was influenced by growing evidence the system had higher mortality risks than comparable devices. FDA advised providers to use Abbott's HeartMate 3 as an alternative.
By Ricky Zipp • June 4, 2021 -
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CMMI's Fowler: More mandatory payment models likely
"I recognize those come with their own set of disadvantages ... But I support this direction," CMMI head Elizabeth Fowler said Thursday.
By Rebecca Pifer Parduhn • June 3, 2021 -
David Paul Morris via Getty Images
Former FDA official Abernethy joins Google health spinoff
The agency's former acting CIO pushed development of real world evidence as well as improved data sharing. At Verily, she'll head up the unit's clinical research business.
By Jonathan Gardner • June 3, 2021 -
Medicaid insurers at heart of Nevada public option plan
The state will bid out the business to private insurance carriers instead of doing the work in-house. Medicaid managed care organizations Centene, UnitedHealthcare and Anthem will be required to submit a bid.
By Samantha Liss • June 2, 2021 -
Retrieved from National Cancer Institute on September 27, 2019
In first, FDA approves KRAS-blocking cancer drug from Amgen
Lumakras is the first drug proven effective in targeting the KRAS gene, which is often mutated in lung, colon and pancreatic cancers. Amgen will charge $17,900 per month for Lumakras at list price, which doesn't account for rebates or discounts that may be offered to insurers.
By Ned Pagliarulo • June 1, 2021 -
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Family healthcare costs decreased last year for first time in Milliman report's 16-year history
However, the trend is not expected to continue into 2021. Costs are predicted to jump nearly 9% to $28,256 next year for a family of four.
By Samantha Liss • May 28, 2021 -
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Ransomware, other cyber threats mount as medtech industry tries to adapt
"Everything is hackable," said Kevin Fu, the FDA's medical device cybersecurity chief, who noted that ransomware in particular can render a device useless.
By Greg Slabodkin • May 27, 2021 -
Lawmakers revive push for public option with call for feedback
The latest move signals Democrats are serious about an effort to pass legislation enacting the policy, seen as a more moderate alternative to "Medicare for All."
By Samantha Liss • May 27, 2021 -
Courtesy of Abbott, PRNewswire
HHS commits $4.8B to COVID-19 testing for the uninsured
The American Clinical Laboratory Association, whose members include LabCorp and Quest Diagnostics, had urged the Biden administration in February to make more money available.
By Susan Kelly • May 26, 2021 -
Senate confirms Chiquita Brooks-LaSure as head of CMS
Industry groups cheered her confirmation, saying Brooks-LaSure's policy know-how and experience managing insurance programs should help increase equitable access to affordable care in the U.S.
By Rebecca Pifer Parduhn • May 25, 2021 -
Anthem wrongly received $3.4M in MA overpayments, OIG says
The insurer is the latest to face allegations of receiving Medicare Advantage overpayments tied to patients who were inaccurately identified as part of a high-risk group.
By Samantha Liss • May 25, 2021 -
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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 -
[Photograph]. Retrieved from Regional Health Command Atlantic.
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 Rebecca Pifer Parduhn • May 20, 2021 -
Courtesy of Exact Sciences
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 , Rebecca Pifer Parduhn • Updated May 21, 2021 -
Alex Wong via Getty Images
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 -
Alex Wong via Getty Images
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 -
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 -
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 Samantha Liss • Updated May 21, 2021 -
Lintao Zhang / Staff via Getty Images
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
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