Government: Page 64
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Biden circling former FDA chief Califf to again lead agency: report
The Washington Post reported the administration was "closing in" on the choice, citing unnamed sources. Still, the White House declined to comment and Califf could face opposition from Senate Democrats.
By Ricky Zipp • Oct. 15, 2021 -
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FDA staff take neutral stance on Moderna, J&J boosters ahead of two-day meeting
Advisers are discussing an authorization of Moderna's booster on Thursday, with a vote on recommendations to the FDA expected this afternoon.
By Shoshana Dubnow • Oct. 14, 2021 -
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FDA breakthrough nods go to liquid biopsies for Alzheimer's, cancer drug response
The agency gave the designation to Quanterix's blood test, which has the potential to aid evaluation of people who present with cognitive impairment, and Nonagen Bioscience's non-invasive bladder cancer test.
By Nick Paul Taylor • Oct. 13, 2021 -
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AstraZeneca builds case for long-acting COVID-19 drug, but is it too late?
The British drugmaker could soon become the first with both a marketed vaccine and treatment for COVID-19, a notable achievement. Yet competition has blunted the potential impact of each of them.
By Ben Fidler • Oct. 12, 2021 -
Medicare Advantage, Part D plans with 4 or more stars soaring, CMS says
About 90% of people currently enrolled in MA plans offering prescription drug coverage are enrolled in a plan that will earn four stars in 2022.
By Hailey Mensik • Oct. 11, 2021 -
Courtesy of Merck & Co.
Merck, Ridgeback seek US clearance of first oral COVID-19 drug
The two partners have officially filed for emergency authorization of their antiviral pill, a milestone in the fight against COVID-19. It's not yet clear whether vaccine recipients will be eligible for treatment, however.
By Ben Fidler • Oct. 11, 2021 -
Permission for use granted by IQVIA
Sponsored by IQVIAThe 21st Century Cures Act update: where we've been and where we're going
Learn what's changed and how you can leverage technology and data to shape the healthcare of tomorrow.
Oct. 11, 2021 -
Sean Gallup via Getty Images
Deep DiveWill a software bill of materials help or hurt medical device cybersecurity?
For years, FDA has talked about the need for an electronically readable inventory of third-party components in devices, as a way to address the problem of widespread cyber vulnerabilities.
By Greg Slabodkin • Oct. 8, 2021 -
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Pfizer officially seeks FDA clearance for coronavirus vaccine in children
The companies' application starts a pressure-packed FDA review that could open up COVID-19 shots for tens of million Americans between the ages of 5 and 11.
By Shoshana Dubnow • Oct. 7, 2021 -
Alex Wong via Getty Images
Feds OK health plan discounts for coronavirus vaccination
Such rewards must meet certain requirements, however, including a rule that they not exceed 30% of the cost of employee-only coverage.
By Kate Tornone • Oct. 7, 2021 -
Hospital M&A in 2021 characterized by fewer but much larger deals
Hospitals are increasingly looking outside traditional care delivery methods threatened by COVID-19 to diversify business models by pursuing stakes in home health, virtual care and post-acute services.
By Shannon Muchmore • Oct. 7, 2021 -
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J&J asks FDA to clear booster dose of its coronavirus vaccine
The agency is holding an advisory committee meeting on Oct. 15 to discuss a second dose of J&J's shot, as well as boosting with different vaccines.
By Ned Pagliarulo • Oct. 6, 2021 -
Chip Somodevilla via Getty Images
Collins to step down as NIH head in transition for research agency
After 12 years in the top job, the veteran director says a new scientist should assume leadership of the world's largest biomedical research institution.
By Jonathan Gardner • Oct. 5, 2021 -
Mario Tama via Getty Images
Air ambulance charges zoom upward for commercial insurers, but not Medicare
Allowed in-network charges for fixed-wing air ambulances rose 76.4% between 2017 and 2020, and now top $15,000, a new study by Fair Health found.
By Ron Shinkman • Oct. 4, 2021 -
MA premiums will dip as payers expand footprints
Cigna, UnitedHealth and Centene are all entering new areas for 2022, but analysts say benefit options show that bids from insurers are relatively conservative.
By Shannon Muchmore • Updated Oct. 5, 2021 -
Samantha Liss/Healthcare Dive
Centene reaches $72M settlement with Illinois, Arkansas for alleged Medicaid overcharges
The two states allege Centene failed to disclose relevant discounts and inflated dispensing fees. The latest settlements come months after similar agreements were reached in Ohio and Mississippi.
By Samantha Liss • Oct. 1, 2021 -
Jose Luis Pelaez Inc/Blend Images
Surprise BillingDoctors slam surprise billing rule that details dispute resolution process
The interim final rule established that existing rates in a provider's geographic area will be a strong anchor for final payment decisions by arbitrators.
By Shannon Muchmore • Oct. 1, 2021 -
Courtesy of Merck & Co.
Merck says antiviral pill effective against COVID-19, lifting hopes for first oral drug
The drugmaker, along with partner Ridgeback Biotherapeutics, plan to ask the FDA for emergency authorization "as soon as possible."
By Ben Fidler • Oct. 1, 2021 -
AMA calls out shrinking payer competition amid rising antitrust interest in Washington
The study by the physician group is the latest salvo in a messaging war between provider and payer lobbies as they work to shift the blame for rapidly rising medical costs.
By Rebecca Pifer Parduhn • Sept. 29, 2021 -
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CMS defends proposal to nix MCIT pathway, but medtechs hold out hope
If the bid to repeal the breakthrough payment rule is finalized, the agency's CMO committed to an alternative pathway that evaluates devices for Medicare patients potentially via clinical trials, outcome registries and real-world data.
By Greg Slabodkin • Sept. 29, 2021 -
Sarah Silbiger via Getty Images
Top FDA official takes over vaccine office as agency weighs COVID-19 shots for children
Difficult vaccine decisions lie ahead. The agency could soon determine how to handle boosters for recipients of Moderna and Johnson & Johnson's shots.
By Ben Fidler • Sept. 29, 2021 -
Free insurance under COBRA for Americans without job-based coverage ends Thursday
Experts say there was huge demand for the six-month subsidy, with one estimate finding more than 16 million people lost their employer-sponsored health insurance during the pandemic.
By Rebecca Pifer Parduhn • Sept. 29, 2021 -
Lance Cheung. (2018). "20180927-RD-LSC-0093" [Photograph]. Retrieved from Flickr.
OpinionBroadband investments can improve health, as long as insurers don't roll back telehealth coverage
Jason Resendez of Consumers for Quality Care argues it's time for insurers, policymakers and health systems to embrace telehealth as an integral part of the future of healthcare.
By Jason Resendez • Sept. 27, 2021 -
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6 drug companies could face steep fines for violating 340B law
The ongoing refusal of Eli Lilly, AstraZeneca, Novartis, Novo Nordisk, Sanofi and United Therapeutics to offer discounts to safety-net providers through community pharmacy partnerships has been referred to OIG for enforcement.
By Rebecca Pifer Parduhn • Sept. 24, 2021 -
Sarah Silbiger via Getty Images
FDA green lights booster dose of Pfizer vaccine for older, more vulnerable Americans
The authorization is more narrow than envisioned by the Biden administration last month, but still makes potentially millions of Americans eligible for a third Pfizer shot.
By Shoshana Dubnow • Sept. 23, 2021
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