Government: Page 61
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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 Rebecca Pifer Parduhn • Jan. 10, 2022 -
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 Hailey Mensik • 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 Rebecca Pifer Parduhn • Jan. 7, 2022 -
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 Hailey Mensik • Dec. 23, 2021 -
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 -
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 Shannon Muchmore • 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 Shannon Muchmore • 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 Samantha Liss • 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 Hailey Mensik • 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 -
Sarah Silbiger via Getty Images
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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Surprise BillingHospital, 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 Samantha Liss • Dec. 9, 2021 -
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 Rebecca Pifer Parduhn • Updated Dec. 10, 2021 -
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 Rebecca Pifer Parduhn • 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 Samantha Liss • Dec. 7, 2021 -
Stefan Zaklin / Stringer / via Getty Images via Getty Images
Congress passes on delay to Medicare rate cuts for lab tests, for now
The American Clinical Laboratory Association wants lawmakers to stave off Jan. 1 cuts for nearly 600 lab tests. A stopgap bill late last week did not include a reprieve, but Cowen analysts are optimistic a legislative fix will be found.
By Greg Slabodkin • Dec. 6, 2021 -
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Appeals court limits nationwide halt on health worker vaccine mandates
A federal appeals court Wednesday stopped the nationwide pause on CMS' vaccine mandate, limiting the scope of that injunction to the 14 states that sued for relief.
By Hailey Mensik • Updated Dec. 16, 2021 -
WhiteHouse.gov
Insurers now required to pay for at-home COVID-19 tests
Nearly 150 million insured Americans will benefit from the move, helping to lower their costs for the over-the-counter tests that can retail for around $25 for one kit.
By Samantha Liss • Dec. 2, 2021 -
VA to resume Cerner medical record implementation early next year with new leadership
Officials have released an updated deployment schedule for the beleaguered $16 billion EHR modernization project.
By Rebecca Pifer Parduhn • Dec. 2, 2021 -
Courtesy of Merck & Co.
FDA panel, after debate, narrowly backs Merck COVID pill
While agency advisers raised concerns over molnupiravir's modest benefits and potential risks, a majority felt the antiviral drug is a needed option for COVID-19 patients at high risk of severe disease.
By Jonathan Gardner • Updated Nov. 30, 2021
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