FDA lays out data modernization action plan

"Even small advances in our ability to gain useful insights from data can represent significant opportunities," agency officials wrote in a blog post.

By Nick Paul Taylor • March 4, 2021

Merck to help J&J make vaccine doses in White House-brokered deal

Merck will lend J&J the use of two separate facilities in the unusual agreement, which was brokered by the Biden administration and could help double supply of the one-dose shot.

By Jonathan Gardner • Updated March 2, 2021

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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

Becerra nomination heads to full Senate vote

The 51-48 vote Thursday means arguments and a full floor vote on the nominee will now be scheduled. The only Republican to approve of advancing Becerra was Sen. Susan Collins of Maine.

By Shannon Muchmore • Updated March 11, 2021

One Medical CEO says 'we are not perfect,' vows to improve amid Congress probe

"We remain committed to taking a hard look at our efforts and finding ways to continuously improve," Amir Dan Rubin said amid reports the primary care chain gave the coronavirus vaccine to ineligible people.

By Rebecca Pifer Parduhn • Updated March 5, 2021

FDA authorizes J&J's 1-shot coronavirus vaccine

The agency's emergency clearance makes J&J's vaccine the third available in the U.S., adding much-needed reinforcements at a critical time.

By Ned Pagliarulo • Updated March 1, 2021

4 healthcare antitrust issues to watch

The FTC is looking to get more aggressive with anticompetitive tie-ups while states eye ways to beef up oversight. And if handed the reins of HHS, Xavier Becerra would likely put an antitrust lens to potential rules.

By Samantha Liss • March 1, 2021

Former Senate aide Elizabeth Fowler to lead CMS innovation center

As head of the Center for Medicare and Medicaid Innovation, the former chief health counsel to Democrats will oversee a $10 billion fund to test new payment models.

By Rebecca Pifer Parduhn • March 1, 2021

FTC abandons challenge to Jefferson Health-Einstein merger, allowing deal to proceed

The union between the two Philadelphia providers, first announced two years ago, is now expected to close within six months.

By Samantha Liss • Updated March 1, 2021

CMS moves to stop COVID-19 testing denials, cost sharing in private plans

Congress required comprehensive health plans to cover COVID-19 tests without cost sharing, prior authorization or medical management last year, only for guidance to create uncertainty about the rules.

By Nick Paul Taylor • March 1, 2021

Hospitals likely upcoding severity levels for Medicare patients, OIG says

The most expensive hospital stays increased 20% over the six years studied, which were before the COVID-19 pandemic began, according to the report.

By Ron Shinkman • Feb. 26, 2021

FDA panel backs J&J's coronavirus vaccine, clearing way for shot's authorization

In a unanimous vote, the panel of experts gave a green light to the FDA for clearing J&J's shot, judging the benefits of vaccination outweigh its risk.

By Ned Pagliarulo • Feb. 26, 2021

FDA advisers meet to review J&J's one-shot coronavirus vaccine

Friday's advisory committee meeting is one of the last steps in the FDA's review and could clear the way for an emergency authorization within days.

By Ben Fidler , Ned Pagliarulo , Jonathan Gardner • Updated Feb. 26, 2021

Becerra distances himself from 'Medicare for All,' appears on track for confirmation

The nominee to run HHS also voiced support for expanded reimbursement of virtual care beyond the COVID-19 pandemic. "I don't think we're going back to the old days when it comes to telehealth," he said Wednesday.

By Shannon Muchmore • Feb. 25, 2021

Becerra backs price transparency, provider competition at first Senate panel

President Joe Biden's pick for HHS chief turns Wednesday to the finance panel, which will vote on sending the nomination to the full Senate.

By Shannon Muchmore • Feb. 24, 2021

FDA review supports safety, efficacy of J&J coronavirus vaccine

Agency scientists noted the shot's strong protection against severe COVID-19, even for the virus variant first detected in South Africa and known to weaken vaccine potency.

By Ned Pagliarulo , Jonathan Gardner • Feb. 24, 2021

FDA lays out shortened path for testing vaccines against new coronavirus variants

Lengthy trials won't be needed for updating shots against emerging viral strains, the agency told developers in newly published guidance.

By Ned Pagliarulo • Feb. 23, 2021

Becerra embraces healthcare antitrust record at first Senate hearing

Sen. Richard Burr, R-N.C., gave a taste of GOP opposition to the nominee for HHS Secretary on Tuesday by accusing him of disregarding the value of private sector innovation.

By Shannon Muchmore • Feb. 23, 2021

FDA starts review of how skin pigmentation affects pulse oximeter results

The agency is evaluating published literature related to factors that may affect device accuracy and performance following pressure from senators to address concerns that "racism may be embedded in key clinical tools."

By Nick Paul Taylor • Feb. 22, 2021

Why this week's FDA meeting on J&J's coronavirus vaccine will be important

The FDA is widely expected to authorize the drugmaker's one-dose shot. But the advisory committee meeting beforehand will offer a window into debate over several key issues.

By Ben Fidler , Ned Pagliarulo • Feb. 22, 2021

Hospital admissions not linked to COVID-19 fell dramatically in fall, especially in Midwest

The latest analysis from the Kaiser Family Foundation gives a fuller picture of how the pandemic affected inpatient volume throughout 2020, focusing on trends by age, sex and region.

By Samantha Liss • Feb. 18, 2021

Obama admin alum Chiquita Brooks-LaSure picked to head CMS

Brooks-LaSure will have a lot on her plate. Biden during his campaign ran on expanding the role of the Affordable Care Act and perhaps attempting to build in a public option or lowered Medicare age eligibility.

By Shannon Muchmore • Updated Feb. 19, 2021

Don Rucker reflects on highs and lows of tenure as ONC head and the future of health IT

In this exit interview, Rucker, who has been national coordinator since 2017, looked back on his time at the agency and predicted what industry might expect from the Biden administration.

By Rebecca Pifer Parduhn • Feb. 17, 2021

One-third of US adults postponed care during pandemic: reports

Substantial portions of those who delayed or put off services had one or more chronic health conditions, with many reporting health worsened as a result, researchers from the Urban Institute and RWJF found.

By Ron Shinkman • Feb. 16, 2021

CMS inpatient only policy threatens patient access to appropriate surgical setting

Nixing Medicare's IPO list has unintended consequences, especially for high-risk patients, the president of the American Academy of Orthopaedic Surgeons argues.

By Joseph Bosco • Feb. 16, 2021

Biden admin begins plan to rescind Medicaid work mandates in win for providers

The policies threatened to lower hospitals' Medicaid revenues as enrollees lost coverage, raising uncompensated care costs. But lawsuits and the pandemic have kept states from implementing the controversial Trump-era requirements.

By Samantha Liss • Feb. 16, 2021