Government: Page 74
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Courtesy of Novavax, Australian Broadcasting Corporation
AHA to HHS: Feds need to take charge in COVID-19 vaccine rollout
The plea coming less than two weeks before the Biden administration takes over suggests the urgency. "As this rollout rapidly evolves, it is absolutely critical that effective situational, real-time leadership is provided nationally."
By Ron Shinkman • Jan. 8, 2021 -
Brian Tucker/Healthcare Dive
Tennessee approved for first Medicaid block grant program
The waiver is approved for 10 years. The incoming Biden administration could attempt to roll it back, but the state would be able to challenge such a move.
By Shannon Muchmore • Jan. 8, 2021 -
Alex Wong via Getty Images
HHS finalizes regulatory review rule, though more lenient than proposed
When pitched in November, the idea sparked concern among providers and other groups fearing it would inject more uncertainty into the industry, and heap additional administrative burden onto HHS.
By Rebecca Pifer Parduhn • Jan. 8, 2021 -
Retrieved from Gage Skidmore/Flickr.
With Democratic trifecta, Biden could shore up ACA
"A lot can be done with a simple majority vote in the Senate," Kaiser Family Foundation's Larry Levitt said on Twitter.
By Shannon Muchmore • Jan. 7, 2021 -
Alex Wong via Getty Images
Not enough time, not enough clarity: Payers push back on CMS prior authorization rule
Following publication on the Federal Register, industry groups had only 17 days to review the rule and draft comments — a major source of concern, insurers said.
By Rebecca Pifer Parduhn • Jan. 6, 2021 -
Permission granted by University of Maryland School of Medicine
FDA says changing coronavirus vaccine dosing could put 'public health at risk'
In an unusual statement, FDA chief Stephen Hahn and top official Peter Marks opposed altering vaccination regimens without further evidence, calling proposals to do so "premature."
By Ben Fidler • Jan. 5, 2021 -
CMS should tweak wage index adjustment to help rural hospitals, OIG says
The report, issued following a federal audit, found rural hospitals had the highest concentration of low-wage providers. Of all hospitals in the bottom quartile of area wage indexes, 53% were operating in rural areas.
By Rebecca Pifer Parduhn • Jan. 4, 2021 -
AHA seeks emergency relief to block enforcement of price transparency rule
Imminent enforcement "will force overburdened hospitals to divert resources that hospitals desperately need to respond to the surge of COVID-19 cases and successfully roll out the vaccines," the hospital lobby argued.
By Samantha Liss • Dec. 23, 2020 -
CMS finalizes rule to ease value-based arrangements for prescription drugs
The changes, effective in 2022, overhaul existing regulations that stymied value-based payments in a bid to expand access to new, expensive drugs like gene therapies, the agency said.
By Rebecca Pifer Parduhn • Dec. 22, 2020 -
ACA exchange enrollment for 2021 holds steady
About a quarter signed up for a plan for the first time — amid historic job losses — while the rest were returning customers or people who were automatically re-enrolled.
By Shannon Muchmore • Dec. 21, 2020 -
Moderna's first FDA clearance brings the US a second coronavirus vaccine
The FDA's emergency authorization of the biotech's shot bolsters an immunization campaign in the U.S. that's just beginning.
By Ben Fidler • Dec. 18, 2020 -
CMS greenlights direct contracting model for Medicaid MCOs, dual eligibles
The possibility of shared savings may spur managed care companies to make new investments in coordinated care to ultimately curb costs in Medicare fee-for-service, the agency said.
By Samantha Liss • Dec. 18, 2020 -
FDA panel endorses Moderna's coronavirus vaccine
A group of independent experts supported use of the biotech's shot, which is likely to receive an emergency authorization from the agency within days.
By Ned Pagliarulo • Updated Dec. 17, 2020 -
Hospital costs drove 2019 health spending, CMS analysis finds
Researchers warned next year's report is expected to look quite different, as the pandemic "will certainly have profound consequences on the provision and consumption of health care in 2020 and perhaps beyond."
By Hailey Mensik • Dec. 17, 2020 -
Abbott antigen test gets FDA nod as first at-home, virtually guided COVID-19 diagnostic
BinaxNOW requires a prescription and a telehealth service to take users through collection. However, public health experts question why prescriptions are being required at all for such tests.
By Greg Slabodkin • Dec. 17, 2020 -
Permission granted by University of Maryland School of Medicine
COVID-19 vaccine supply chain has cyberthreats hidden in plain sight
Outdated systems throughout vaccine distribution logistics carry unprecedented cyberthreats.
By Samantha Schwartz • Dec. 17, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
FDA advisers meet to review Moderna's coronavirus vaccine
Support from the advisory committee Thursday would likely result in an emergency authorization for the shot within days. Track the meeting's progress here.
By Ben Fidler , Jonathan Gardner , Ned Pagliarulo • Updated Dec. 17, 2020 -
Permission granted by E.A. Crunden
HHS starts doling out $25B in third phase of CARES provider funding
The amount exceeds the original $20 billion planned for this tranche, as officials realized more would be needed to get providers close to whole from coronavirus-related losses.
By Shannon Muchmore • Dec. 16, 2020 -
Szekely, Pedro. (2017). "Chicago skyline" [Photograph]. Retrieved from Flickr.
Illinois health regulators block Mercy hospital closure
The hospital on Chicago's South Side wanted to end inpatient services, but a board shot down the plans amid the COVID-19 pandemic. Health system executives want to pivot to an outpatient model of care.
By Samantha Liss • Dec. 16, 2020 -
FDA grants emergency approval for first fully at-home COVID-19 test without prescription
The rapid antigen test from Australian company Ellume will be available over the counter for people with or without symptoms and delivers results in about 20 minutes.
By Susan Kelly • Dec. 16, 2020 -
FDA scientists back safety, efficacy of Moderna's coronavirus vaccine
A review by agency staff affirmed the strongly positive results Moderna reported from a large Phase 3 study, clearing the way for a possible emergency authorization in the coming days.
By Ned Pagliarulo • Dec. 15, 2020 -
Hospitals allege HHS let pharmas evade 340B drug discount rules
Led by California Attorney General Xavier Becerra, President-elect Joe Biden's pick to lead HHS, more than two dozen state attorneys general urged the agency to force drugmakers to comply with the program's rules.
By Hailey Mensik • Updated Dec. 15, 2020 -
HHS finalizes dispute resolution for 340B program
Claims involving an overcharge of $25,000 or more can be submitted. Hospital groups did not react warmly to the announcement.
By Ron Shinkman • Dec. 11, 2020 -
Courtesy of BioNTech
In milestone, FDA clears coronavirus vaccine from Pfizer, BioNTech for emergency use
Vaccinations began Monday as the U.S. starts an unprecedented rollout of the first coronavirus shot authorized by the FDA for emergency use.
By Jonathan Gardner • Dec. 11, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
FDA advisers back Pfizer, BioNTech vaccine, clearing way for emergency approval
A panel of independent experts agreed the benefits of vaccination outweigh the risk, convinced by strong data showing the companies' shot to be 95% effective in preventing COVID-19.
By Ned Pagliarulo • Updated Dec. 10, 2020
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