Government: Page 57
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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 -
Trendline
Labor
Hospitals are navigating persistent labor shortages with the need to cut costs — a source of contention that could leave patients caught in the middle.
By Healthcare Dive staff -
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 -
Jon Cherry via Getty Images
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 • Sept. 29, 2021 -
Alex Wong via Getty Images
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 • 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 -
Mark Wilson via Getty Images
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 • 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 -
Kevin C. Cox via Getty Images
CDC recommends Pfizer booster shots for many, overruling advisers on broad use
Though an agency panel voted against advising a third Pfizer vaccine dose for younger people in high-risk jobs like nursing or teaching, it was overriden by CDC Director Rochelle Walensky.
By Shoshana Dubnow , Ned Pagliarulo • Updated Sept. 24, 2021 -
Mario Tama via Getty Images
State Medicaid officials face daunting fall season amid low vaccination rates, record enrollment
Telehealth and behavioral health service needs are also a challenge as the COVID-19 pandemic drags on and the Biden administration encourages more people to get on the rolls.
By Hailey Mensik • Sept. 23, 2021 -
OIG flags potential $5B overpaid to Medicare Advantage plans
The watchdog calls out 20 private insurers, which it does not name, and urges CMS to conduct greater oversight.
By Samantha Liss • Sept. 22, 2021 -
Jon Cherry via Getty Images
Second dose of J&J's coronavirus vaccine increases protection, company says
Long-awaited results from a Phase 3 study run by J&J could support use of a booster dose, although the drugmaker has not officially applied for FDA clearance yet.
By Shoshana Dubnow • Sept. 21, 2021 -
Antonio Masiello via Getty Images
Pfizer says coronavirus vaccine is safe, spurs immune response in children
The results position Pfizer and BioNTech to seek clearance in children as young as 5 years old. But the companies haven't yet shared data on a rare heart inflammation associated with their shot that's a concern for regulators.
By Jonathan Gardner • Sept. 21, 2021 -
Jens Schlueter via Getty Images
FDA advisers support booster dose of Pfizer vaccine in older or high-risk adults
In a back-and-forth meeting Friday, the committee opposed clearing a third shot widely for use in people older than 16, but agreed the benefits outweighed the risks for adults over 65 or those at risk of severe COVID-19.
By Shoshana Dubnow , Ned Pagliarulo • Updated Sept. 17, 2021 -
Permission granted by University of Maryland School of Medicine
New data from Israel, Pfizer show potent effect from third coronavirus shot
The much-anticipated data arrived two days before an important FDA advisory meeting to discuss authorization of a booster dose for Pfizer's coronavirus vaccine.
By Jonathan Gardner • Sept. 16, 2021 -
Carol Highsmith. (2005). "Apex Bldg." [Photo]. Retrieved from Wikimedia Commons.
FTC warns app makers fall under breach notification rule
The agency noted that a breach must be reported regardless of whether it was the result of malicious action. Any unauthorized access, including sharing information without consent, would trigger the rule.
By Shannon Muchmore • Sept. 16, 2021
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