Government: Page 57
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Q&A
FDA digital health chief talks new role with agency, AI tech
Bakul Patel, chief digital health officer for the Center for Devices and Radiological Health, will help FDA meet its strategic priorities and set regulatory policies for new technologies such as AI and machine learning.
By Elise Reuter • Feb. 17, 2022 -
AstraZeneca notches win in ongoing 340B legal fight
The decision vacates a violation letter HHS sent to the drugmaker that argued it was illegally restricting discounts on drugs providers delivered through contract pharmacies.
By Shannon Muchmore • Feb. 17, 2022 -
Molina plans steep reduction in marketplace enrollment
The payer is expected to lose two-thirds of its marketplace enrollment by the end of the year, according to executives.
By Samantha Liss • Feb. 16, 2022 -
Nonprofit hospitals may provide less community benefit than for-profits in some states, study suggests
The results raise questions about the magnitude of tax subsidies nonprofits receive, and whether policymakers should better tie subsidies to facility performance in providing community benefit.
By Hailey Mensik • Feb. 16, 2022 -
DOJ has until Feb. 27 to sue to block UnitedHealth's $8B Change acquisition
The companies said they would give the DOJ 10 days notice before completing the merger, during which the DOJ could launch a lawsuit to block it. On Feb. 17, UnitedHealth and Change gave the regulators that notice.
By Rebecca Pifer Parduhn • Updated Feb. 22, 2022 -
Win McNamee via Getty Images
Califf confirmed as FDA chief in close vote, ending protracted vacancy
Several Democratic lawmakers opposed Califf over his industry ties and the FDA's past policies on opioid painkillers, drawing out the confirmation process and making the final vote close.
By Jonathan Gardner • Feb. 15, 2022 -
Win McNamee via Getty Images
CMS delays hospital star ratings release
The updated five-star ratings are now expected in July instead of April after the agency identified an error in one of the measures.
By Samantha Liss • Feb. 15, 2022 -
Alex Wong via Getty Images
Biden admin awards $55M in virtual care grants to community health centers
HHS Secretary Xavier Becerra said Monday that the Biden administration would continue to "step up" to assist community health centers, including working with Congress to try to double their funding.
By Rebecca Pifer Parduhn • Feb. 15, 2022 -
Courtesy of Pfizer
FDA delays review of Pfizer's COVID-19 vaccine for young children in surprise shift
The agency pushed back plans to expedite review of the shot in children under 5, seeking more data on a third dose. An advisory meeting scheduled for next week has been postponed as a result.
By Ben Fidler • Feb. 14, 2022 -
Hospital leaders, Congress mull fixes to current staffing woes
The omicron variant is posing new challenges as staff call in sick or quit their jobs entirely for higher-paying traveling nurse positions. That's leaving hospitals in a bind as they treat higher acuity COVID-19 patients.
By Hailey Mensik • Feb. 11, 2022 -
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Only 14% of hospitals comply with federal price transparency rules, advocacy group finds
The report said only two of 361 hospitals at three of the largest hospitals systems — HCA Healthcare, CommonSpirit Health and Ascension — were estimated to be in compliance with the federal standard.
By William Borden • Feb. 11, 2022 -
Stefan Zaklin via Getty Images
Apache tells Senate committee the Log4j vulnerability could take years to resolve
While a software bill of materials could improve supply chain security, users are still downloading vulnerable versions of software.
By David Jones • Feb. 10, 2022 -
Megan Quinn/Healthcare Dive
Congress poised to address mental health crisis — including fining payers for benefit inequities
"If we're going to respond to the behavioral health issues the pandemic has made worse ... that will take legislative action," Senate health committee Chairwoman Patty Murray, D-Wash., said.
By Rebecca Pifer Parduhn • Feb. 4, 2022 -
Megan Quinn/Healthcare Dive
Senators pinpoint MA oversight, cutting drug costs to address looming Medicare insolvency
"We should be addressing this in a more serious fashion than we are," Sen. Bill Cassidy, R-La., said.
By Rebecca Pifer Parduhn • Feb. 3, 2022 -
Staffing firms defend traveling nurse rates as industry groups, Congress push for investigation
Legislators in some states are even looking to cap the rate hospitals can pay agencies for temporary nurses as worker shortages persist across the U.S.
By Hailey Mensik • Feb. 3, 2022 -
stock.adobe.com/Somkid
FDA must improve medical device interoperability through data standards: JAMA article
The authors list a range of potential positive outcomes of improved device interoperability, using the experience of the consumer technology and telecommunications industries to make their case.
By Nick Paul Taylor • Feb. 3, 2022 -
Along with rate increase for MA plans, CMS pitches closer look at social determinants of health
Cowen analysts said the rate increase "should support another year of benefit enhancements & strong enrollment growth," and noted that in recent years the final rate has been higher than what was first proposed.
By Shannon Muchmore • Feb. 3, 2022 -
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The pipeline of new antibiotics is drying up. A bill in Congress aims to change that.
Despite the growing threat of drug-resistant bacteria, few new antibiotics are reaching the market because of hurdles that biotech executives and experts say stand in the way.
By Jonathan Gardner • Feb. 2, 2022 -
Courtesy of Pfizer
Pfizer, BioNTech begin process of asking FDA for COVID-19 vaccine clearance in young kids
The companies said the FDA, in an unusual step, requested they submit the clinical trial data they currently have while testing of a third dose in children under 5.
By Kristin Jensen • Feb. 2, 2022 -
Mario Tama via Getty Images
Deep Dive // Surprise BillingAs hospitals sue over surprise billing ban, healthcare experts ask why
While provider associations take the battle to court, private equity backed physician groups are absent from the litigation.
By Samantha Liss • Feb. 1, 2022 -
Courtesy of Bose
FDA's OTC hearing aid proposal exposes industry, stakeholder rifts
Different manufacturers have lined up on opposite sides of a debate about key aspects of the agency's proposed rule that would create a new category of over-the-counter hearing aids.
By Nick Paul Taylor • Feb. 1, 2022 -
Payers, researchers warn CMS proposal could cut funds to insurers enrolling high-risk consumers
Insurers are flagging concerns about changes to a CMS model aimed at encouraging more healthy consumers to sign up for coverage, while new research finds the proposal could backfire.
By Susan Kelly • Jan. 31, 2022 -
Adeline Kon/Healthcare Dive/Healthcare Dive
Staffing agencies 'exploiting' nurse shortage, hospital lobby says in letter urging White House to investigate
With nurses in high demand, hospitals and nursing homes are forced to accept "exorbitant" rates set by staffing agencies, their lobbies argue.
By Samantha Liss • Jan. 28, 2022 -
ACA open enrollment period drove record number of sign-ups
Expanded tax credits through the American Rescue Plan made coverage more affordable and greater outreach efforts helped accelerate enrollment, health officials said.
By Hailey Mensik • Jan. 27, 2022 -
Sarah Silbiger via Getty Images
FDA finalizes guidance on including patient perspectives in medtech clinical trials
The documents elaborate on how to engage patients to improve trial design and use patient-reported outcomes.
By Nick Paul Taylor • Jan. 27, 2022
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