Government

Biden administration publishes long-awaited TEFCA interoperability framework

After TEFCA's many fits and starts, ONC head Micky Tripathi called its finalization a "milestone" marking the beginning of a "new era of electronic health information exchange in the U.S."

By Rebecca Pifer • Jan. 18, 2022

Biden administration to buy 500M more rapid COVID-19 tests to give to Americans

The announcement by President Joe Biden now brings the administration's total purchase to 1 billion test kits. Abbott Laboratories, iHealth and Roche have so far been awarded contracts for a combined 380 million tests.

By Greg Slabodkin • Jan. 14, 2022

Explore the Trendline➔

Vertical integration and consolidation

Healthcare companies merging with subsectors of the industry is a growing trend, although certainly not a new one.

By Healthcare Dive staff

Medicare faces blowback over plan to limit coverage of Biogen's Alzheimer's drug

Biogen, along with allies in industry, plans to pressure Medicare to water down its policy, which limits coverage of Aduhelm and drugs like it to clinical trials.

By Jonathan Gardner , Jacob Bell • Jan. 14, 2022

Providers concerned about staffing shortages post-SCOTUS vaccination mandate ruling

Nursing facilities are particularly worried about the strain a vaccination mandate could have on their shrinking workforce, and are urging CMS to consider a regular testing option for unvaccinated workers.

By Rebecca Pifer • Jan. 14, 2022

SCOTUS narrowly upholds health worker vaccine mandate

The court's liberal justices agree with the government that CMS has the authority to impose the requirement, just one of many healthcare organizations must comply with to be eligible for Medicare and Medicaid funding.

By Hailey Mensik • Jan. 13, 2022

FDA seeks feedback on draft device shortage guidance

A new document poses a series of questions for industry on the overall design and operation of the policy, and is intended to help manufacturers provide timely information about supply disruptions during public health emergencies.

By Nick Paul Taylor • Jan. 13, 2022

Biden health officials defend COVID-19 testing policies amid diagnostics shortage

Acting FDA Commissioner Janet Woodcock and others were under fire from senators during a Tuesday hearing for not doing enough to increase the availability of tests.

By Greg Slabodkin • Jan. 12, 2022

Medicare proposes to limit coverage of Biogen Alzheimer's drug

The program will only cover Aduhelm, which the FDA controversially approved last June, for patients enrolled in clinical trials.

By Jonathan Gardner , Jacob Bell • Updated Jan. 11, 2022

Becerra orders CMS to reassess Medicare premiums after Aduhelm cost cut

It's an unusual step for HHS, given the plan year has already begun, and follows Biogen slashing the price of its controversial Alzheimer's drug in half.

By Rebecca Pifer • Jan. 10, 2022

Stakeholders urge Supreme Court to act fast on OSHA mandate

"We are asking for a stay before enforcement takes effect Monday," an attorney for the National Federation of Independent Businesses said.

By Ryan Golden • Updated Jan. 10, 2022

SCOTUS justices leave opening for healthcare worker vaccine mandate

The key question is whether the agencies enacting federal COVID-19 vaccine mandates — OSHA and CMS — had the authority to do so, or whether that power falls to the states.

By Hailey Mensik • Jan. 7, 2022

Biden admin proposes stricter network adequacy, marketing standards for MA plans

CMS is looking to hold Medicare Advantage plans to a higher standard as their rolls swell, targeting their networks, marketing practices and spending; while improving dual-eligible and Part D costs and patient input.

By Rebecca Pifer • Jan. 7, 2022

Supreme Court sets Jan. 7 hearing on vaccine mandate rules

The justices will hear arguments on the requirement that healthcare workers must be fully vaccinated amid a flurry of legal challenges.

By Hailey Mensik • Dec. 23, 2021

Most COVID-19 medical device EUAs lack documented supporting data, JAMA study shows

The use of "low-quality data" is reasonable at the start of a crisis but FDA should consider raising the standard of evidence after multiple products come to market, according to the authors of the study.

By Nick Paul Taylor • Dec. 22, 2021

Biden administration to send military medical personnel to overwhelmed hospitals

As the omicron variant spreads rapidly, the White House is mobilizing federal agencies to assist hospitals and states in the latest wave of infection.

By Shannon Muchmore • Dec. 21, 2021

Federal COVID-19 aid fueled huge jump in national health spending last year

The pandemic accounted for major changes in who paid for healthcare as job losses spurred changes in coverage types, while people deferred care and spent less out of their own pockets.

By Shannon Muchmore • Dec. 16, 2021

HHS to funnel $9B in relief funds to providers

The federal government will reimburse smaller providers more favorably in this funding round, regulators said, acknowledging these facilities tend to operate on shakier financial footing compared to larger peers.

By Samantha Liss • Dec. 15, 2021

SCOTUS blocks challenge to New York's health worker vaccine mandate

The lawsuit was filed by a group of doctors and other medical professionals protesting that the state's requirement for staff in hospitals, long-term care and other healthcare facilities does not allow for a religious exemption.

By Hailey Mensik • Dec. 14, 2021

Flurry of doctor group buyouts helps fuel 'extraordinary' surge in health M&A

Companies across the healthcare spectrum are pursuing deals to strengthen operations after two years of pandemic-driven challenges, a new PwC report found.

By Susan Kelly • Dec. 14, 2021

Hospital price disclosure push coming up short, JAMA study finds

Researchers said lack of transparency on costs for services by independent providers that bill separately from hospitals is complicating CMS' effort to help patients shop around for the best value.

By Susan Kelly • Dec. 13, 2021

FDA seeks comment on 3D printing of medical devices at hospitals, doctor's offices

The agency's discussion paper lays out the benefits and challenges of creating 3D-printed devices in healthcare settings as well as a potential approach for regulatory oversight.

By Greg Slabodkin • Dec. 13, 2021

Hospital, doctor lobbies sue HHS over implementation of surprise billing ban

Congress intended for an arbiter to be able to consider a constellation of factors when payment disputes arise, but the final rule severely limits what an arbiter can consider, the lawsuit claims.

By Samantha Liss • Dec. 9, 2021

Senate passes legislation to avoid Medicare cuts in year-end sprint

The bill, which delays 2% cuts to Medicare rates through March and a separate round of 4% cuts to 2023, now heads to President Joe Biden's desk for his signature.

By Rebecca Pifer • Updated Dec. 10, 2021

Medicare Advantage quality bonus program hasn't improved quality, study finds

The new findings published in Health Affairs suggest the quality bonus program doesn't move the needle on quality despite a significant federal investment — hinting the American people may not be getting enough bang for their buck.

By Rebecca Pifer • Dec. 8, 2021

States with robust merger reviews are tougher on hospital tie-ups, study suggests

Just eight states challenged the majority of the deals that regulators scrutinized during a 10-year time period. Still, it did little to slow price increases, according to new research in Health Affairs.

By Samantha Liss • Dec. 7, 2021