Health system execs: national approach needed to stem vaccine disarray

"We don't know until we open the package how many doses we're getting that week," EVP of Ascension Joe Cacchione said Thursday during a webinar organized by the American Hospital Association. 

By Samantha Liss • Feb. 11, 2021

COVID-19 leads to explosion in cyberattacks, data breaches

A survey from CI Security found successful hacks involving healthcare organizations or their business associates soared in the second half of last year, leading to a jump in the number of breached patient records.

By Ron Shinkman • Feb. 10, 2021

Explore the Trendline➔

Surprise Billing

Federal legislation banning surprise bills has hit a barrage of roadblocks, complicating efforts to protect consumers from unexpected out-of-network charges.

By Healthcare Dive staff

Visby gets FDA nod for single-use, rapid point-of-care COVID-19 PCR test

The palm-sized diagnostic gives results in 30 minutes without the need for additional instruments or readers. While Abbott's ID Now provides results in 13 minutes or less, it is the size of a toaster and requires a cartridge.

By Greg Slabodkin • Feb. 10, 2021

As COVID-19 becomes a business, vaccine makers confront thorny pricing questions

Yearly vaccinations could be required after the pandemic ebbs. Will drugmakers change how they approach pricing their shots?

By Jonathan Gardner • Feb. 10, 2021

Oklahoma selects 4 private payers to manage Medicaid for $2B, faces legal suit

The state maintains the switch will improve costs while maintaining access, but the move to cede Medicaid control to for-profit entities is highly controversial.

By Rebecca Pifer Parduhn • Feb. 9, 2021

New data on AstraZeneca vaccine add to worries over coronavirus variant from South Africa

South Africa will use other shots in its immunization campaign after AstraZeneca's offered "minimal protection" against a coronavirus variant that has spread throughout the country.

By Ben Fidler • Feb. 8, 2021

Pandemic habits could cause US health spending to decelerate over 2 decades, Deloitte predicts

The consultancy's predictive modeling based its estimate on the rise of digital health products and more consumer engagement. Such a slowing contrasts more dire spending forecasts made prior to the COVID-19 crisis.

By Rebecca Pifer Parduhn • Feb. 8, 2021

Fitch: Biden's healthcare plans could boost nonprofit hospitals

The ratings agency cited administration plans to bolster the Affordable Care Act, which could reverse the increased number of uninsured people, as among the factors driving brighter prospects.

By Ron Shinkman • Feb. 4, 2021

J&J asks FDA for emergency clearance of coronavirus vaccine

The regulator scheduled an advisory committee meeting for Feb. 26, making an authorization by the end of the month possible. 

By Ned Pagliarulo • Updated Feb. 5, 2021

FDA appoints first medical device cybersecurity chief

University of Michigan professor Kevin Fu will serve a one-year term as acting cyber director at the Center for Devices and Radiological Health. Experts fear the chaos of the pandemic creates the perfect storm for hackers to exploit.

By Greg Slabodkin • Feb. 4, 2021

Low Medicare EKG rate a potential setback for device makers

Wall Street analysts questioned whether the lower-than-expected rates are final and what the prospects are for renegotiation. Shares of market leader iRhythm fell over 32% on Friday.

By Ricky Zipp • Updated Feb. 1, 2021

Medicare buy-in for older adults could cut health costs, increase coverage value: Urban Institute

A Medicare buy-in is not a specific prong of President Joe Biden's health policy agenda, but there are currently two proposals in Congress designed to build upon the ACA.

By Rebecca Pifer Parduhn • Feb. 3, 2021

Biden administration awards $231M to increase US production of at-home, OTC COVID-19 test

Australian company Ellume will use the funding to establish a U.S. manufacturing facility that is projected to increase production capacity by 640,000 tests per day by December.

By Susan Kelly • Feb. 2, 2021

How might Xavier Becerra operate as HHS Secretary?

The nominee has made headlines since leaving the House of Representatives, in part by leading blue state efforts to defend the ACA. Less high-profile, perhaps, were his efforts to block major hospital mergers in California.

By Ron Shinkman • Feb. 1, 2021

Vaccine makers prepare response as coronavirus mutations raise alarms

So far, both Pfizer's and Moderna's vaccines appear to work against more transmissible variants, but preparation is underway for the day they don't.

By Jonathan Gardner • Feb. 1, 2021

Novavax vaccine prevents COVID-19 in studies, but less effective against new variants

The drugmaker is already discussing an authorization with health authorities in the U.K., and plans to begin talks with the FDA and other regulators, too.

By Jonathan Gardner • Jan. 29, 2021

J&J says single dose of coronavirus vaccine 66% effective in large trial

The vaccine's efficacy was higher in the U.S., but lower in Latin America and South Africa, where new, more infectious virus variants are circulating.

By Ned Pagliarulo • Jan. 29, 2021

Payers welcome reopening of ACA marketplaces

Healthcare.gov will be open for a special enrollment period from Feb. 15 through May 15, though advocates say robust outreach and marketing efforts need to be coupled with the move.

By Samantha Liss • Jan. 28, 2021

Biden campaign cyber chief named federal CISO

Cybersecurity veterans praised the appointment, highlighting Chris DeRusha's extensive government and private sector experience.

By David Jones • Jan. 28, 2021

FDA approves first-of-its-kind lupus drug

Lupkynis, the first oral drug approved for lupus nephritis, comes with a high list price. Its developer, Aurinia Pharmaceuticals, expects average net revenue of roughly $65,000 per patient per year.

By Jacob Bell • Jan. 27, 2021

Biden invokes DPA to combat supply shortages, but experts say it's no 'magic wand'

The administration's strategy document notes that supply chains are facing shortages of several types of personal protective equipment and supplies related to COVID-19 vaccines and testing.

By Matt Leonard • Jan. 27, 2021

Moderna to study vaccine booster aimed at coronavirus variant

Laboratory tests indicated the biotech's shot would still protect against virus variants detected in the U.K. and South Africa, although the latter appeared to result in a weaker immune response.

By Ned Pagliarulo • Jan. 26, 2021

Biden to create new enrollment period for ACA exchanges

While most state-based exchanges created special enrollment periods earlier in the COVID-19 pandemic, CMS under former President Donald Trump resisted calls to do so as his administration fought the landmark law in the courts.

By Shannon Muchmore • Jan. 26, 2021

Biden gives OSHA 2 weeks to issue new coronavirus guidance

The president also asked the agency to reconsider its decision to skip emergency temporary standards.

By Kate Tornone • Jan. 25, 2021

ACLA seeks lab reimbursement changes as need for COVID-19 testing surges

Julie Khani, president of the American Clinical Laboratory Association, which includes Quest and LabCorp, called for eliminating testing coverage gaps and clarifications around what tests are paid for by insurers.

By Greg Slabodkin • Jan. 25, 2021