Government: Page 70
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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 -
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 -
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 -
Alex Wong via Getty Images
Trump admin proposes easing HIPAA to foster value-based care, COVID-19 contact tracing
If finalized, the changes would loosen a number of long-held standards for the privacy of medical records and other protected health information.
By Rebecca Pifer • Dec. 11, 2020 -
CMS looks to crack down on prior authorization
The American Hospital Association cheered the news but was disappointed the proposal excluded Medicare Advantage plans.
By Samantha Liss • Dec. 11, 2020 -
FTC loses bid to stop Philadelphia hospital merger
The agency has reached an agreement with Jefferson Health to bar its acquisition of Albert Einstein Healthcare Network until 11:59 p.m. on Monday.
By Samantha Liss • Updated Dec. 15, 2020 -
Courtesy of BioNTech
FDA advisers meet to review Pfizer, BioNTech's coronavirus vaccine
A panel of vaccine and infectious disease experts will publicly vet the drugmakers' study results on Thursday. Follow the discussion along with BioPharma Dive reporters here.
By Ned Pagliarulo , Ben Fidler , Jonathan Gardner • Updated Dec. 10, 2020 -
Yujin Kim/Healthcare Dive
Dive Awards
The Healthcare Dive Awards for 2020
This year was unprecedented as healthcare workers around the globe battled the novel coronavirus. From those on the front lines to virtual care standout Teladoc, here are the people and companies that rose to the challenge.
By Healthcare Dive Team • Dec. 9, 2020 -
Hospitals prepare to reveal prices online come Jan. 1
"Hospitals are generally very compliant. They are rule-following organizations," said Delphine O'Rourke, a partner at the firm Goodwin. But it may be hard for some rural facilities to meet the deadline as they're pressed by the pandemic.
By Samantha Liss • Dec. 8, 2020 -
Courtesy of BioNTech
FDA scientists appear supportive of Pfizer, BioNTech's coronavirus vaccine
Agency staff didn't raise any red flags in their review of the companies' study results, documents released ahead of a key advisory committee meeting Thursday show.
By Ned Pagliarulo • Dec. 8, 2020 -
ACA defender Becerra tapped for Biden's HHS chief
The California attorney general has voiced opposition to provider consolidation in his state, alleging anticompetitive practices by regional powerhouse Sutter Health and denying a hospital system merger.
By Shannon Muchmore • Dec. 7, 2020 -
MedPAC mulls cautious approach to bumping hospital pay amid pandemic
Commissioners of the influential advisory group seemed largely supportive of the draft recommendation that calls for a base payment increase of 2% for acute care hospitals.
By Samantha Liss • Dec. 7, 2020 -
Brian Tucker/Healthcare Dive
CMMI rolls out geographic model it calls among 'largest bets on value-based care to date'
The program will enlist direct contracting entities, which can include ACOs, health systems and provider groups or health plans, to take responsibility for the total cost of care for Medicare fee-for-service beneficiaries in their region.
By Shannon Muchmore • Dec. 4, 2020 -
Brian Tucker/Healthcare Dive
Trump admin rips up inpatient only surgery list, cuts 340B pay
CMS said the move will allow doctors and consumers more choices of where a procedure can be performed, but hospitals have decried the sweeping changes.
By Samantha Liss • Dec. 3, 2020 -
Trump admin rolls out effort to standardize patient address by close of 2021
Promoting interoperability has been a key health IT priority for CMS, though the COVID-19 pandemic has further hamstrung efforts.
By Rebecca Pifer • Dec. 3, 2020 -
Permission granted by BioNTech SE
CDC panel recommends giving first coronavirus vaccines to healthcare workers, nursing home residents
Advisers on the panel cited risk and disease burden as reasons for setting their priority list as initial vaccine supplies will be extremely limited.
By Jonathan Gardner • Dec. 2, 2020 -
Alex Wong via Getty Images
CMS makes some telehealth coverage permanent, finalizes specialty rate cuts
The final physician fee schedule includes a significant increase to payments for evaluation and management visits, but specialty providers blasted the cuts for their services.
By Rebecca Pifer • Dec. 2, 2020 -
CMS expands ability for hospital-level care at home as Thanksgiving surge expected
Six health systems, including Brigham and Women's and Mount Sinai Health System, were immediately granted waivers for the new program to treat more than 60 acute conditions.
By Shannon Muchmore • Nov. 30, 2020 -
Moderna to ask FDA for emergency approval of coronavirus vaccine
New results confirm the shot's strong efficacy against COVID-19 and should raise confidence vaccination can prevent against severe symptoms as well.
By Ben Fidler • Nov. 30, 2020 -
Medical device makers get more flexibility with value-based care in Stark, anti-kickback final rules
The changes include two safe harbor pathways and "allow you to do things that otherwise might violate the kickback statute or the Stark Law. So, that is always welcome in the industry," one lawyer said.
By Ricky Zipp • Nov. 25, 2020 -
COVID-19 is making it harder for some middle income patients to pay premiums, deductibles: report
The economic impact from COVID-19 could make it harder for workers to pay for their share of employee-sponsored healthcare coverage, a survey from The Commonwealth Fund found.
By Ron Shinkman • Nov. 24, 2020 -
Alex Wong via Getty Images
In last minute agenda push, Trump admin rolls back Stark, anti-kickback rules
The final regs issued Friday are slated to take effect Jan. 19, one day before President-elect Joe Biden is inaugurated. A new administration could still change them, though experts called that unlikely.
By Rebecca Pifer • Nov. 23, 2020 -
Craighead, Shealah. (2020). "White House Update on Coronavirus Testing" [Photograph]. Retrieved from Flickr.
Trump admin pushes last-ditch plan to lower drug prices
The American Hospital Association blasted one measure it said will significantly cut reimbursement for coming "in the middle of a pandemic with cases at record levels, and with less than six weeks’ notice."
By Jonathan Gardner , Ned Pagliarulo • Nov. 20, 2020
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