J&J, without details, makes case for a coronavirus booster shot

A second shot given six months after the first appears to provide a bigger immune response, the company said, a finding J&J aims to take to regulators in the U.S. and elsewhere.

By Ben Fidler • Aug. 25, 2021

Medicaid, ACA policies for COVID-19 kept rate of uninsured steady, researchers find

The uninsured rate remained at 11% from March 2019 to April 2021, thanks to a freeze in Medicaid disenrollment and increased ACA subsidies, according to a report from the Urban Institute.

By Hailey Mensik • Aug. 24, 2021

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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

FDA grants full approval to Pfizer, BioNTech's coronavirus vaccine

The long-awaited decision could strengthen the case for vaccine mandates as public health officials seek to boost rates of immunization amid a wave of COVID-19 cases.

By Jonathan Gardner • Updated Aug. 23, 2021

Biden said to rule out Woodcock as permanent FDA chief

A news report indicated the agency's longtime drug reviewer is no longer in consideration for the role, leaving the FDA's top job in flux as key decisions near on coronavirus booster shots and vaccinations for children.

By Jonathan Gardner • Aug. 20, 2021

AHA moves to shift cost blame to health plans in letter to antitrust regulators

The letter included an updated AHA-funded study on the benefits of hospital mergers, which was previously criticized by outside experts for cherry-picked data, among other methodological weaknesses.

By Rebecca Pifer • Aug. 19, 2021

The federal price transparency rules have critical gaps that must be addressed to achieve their objectives

Castlight Health CEO Maeve O'Meara argues that if regulations aren't implemented in a meaningful way for consumers, the efforts will likely fail to inform healthcare decision making and achieve the desired cost savings.

By Maeve O'Meara • Aug. 18, 2021

Payments to MA plans raised overall Medicare spend by $7B in 2019, analysis finds

The Kaiser Family Foundation chalked the higher spending up to how MA is paid, including how benchmarks for plan payments are set and the risk adjustment process.

By Rebecca Pifer • Aug. 18, 2021

US to offer coronavirus boosters to all Americans in aggressive plan to counter delta's spread

The Biden administration's call comes ahead of FDA authorization for additional doses in people who aren't immunocompromised, although agency head Janet Woodcock joined other officials in supporting the plan.

By Ned Pagliarulo • Updated Aug. 18, 2021

Medtechs need to up their cybersecurity threat modeling game, FDA says

The agency "will be looking for much more detailed and comprehensive" cyber threat models as part of premarket review, said Suzanne Schwartz, director of CDRH's Office of Strategic Partnerships and Technology Innovation.  

By Greg Slabodkin • Aug. 18, 2021

CMS extends deadlines for Medicaid redeterminations after COVID-19 public health emergency ends

Due to significantly increased workloads, state health officials will now have 12 months instead of six after the PHE ends to complete pending verifications, redeterminations and renewals.

By Hailey Mensik • Aug. 17, 2021

FDA authorizes third coronavirus vaccine dose for immunocompromised people

A CDC advisory panel is expected to vote on Friday to recommend the additional dose, after which certain people with weakened immune systems can receive a third shot of Pfizer's or Moderna's vaccine.

By Shoshana Dubnow • Aug. 13, 2021

UnitedHealth settles for $15.6M after Labor Department finds mental health cuts, denials

"You should expect to see more investigation," of those not abiding by the federal mental health parity law, a top DOL official said. "I predict this will be a very active issue for us for years to come."

By Shannon Muchmore • Aug. 12, 2021

Biden embraces Medicare drug price negotiation as Democrats seek to widen health coverage

But the proposal, which features several familiar and long-debated policy ideas, could face an uphill battle in Congress as the drug industry lines up against it.

By Jonathan Gardner • Updated Aug. 12, 2021

HCA accused of hospital monopoly in North Carolina

After acquiring Mission Health System in 2019, the hospital operator has continued tactics of all-or-nothing arrangements with payers and gag clauses, driving up prices and insurance premiums, the class action complaint alleges.

By Shannon Muchmore • Aug. 11, 2021

HHS 'making progress' on disincentives for providers found info blocking, ONC head says: HIMSS21

The fact that HHS has yet to codify appropriate disincentives for providers found guilty of information blocking is probably the "biggest gap to be filled on the enforcement side," Micky Tripathi said.

By Rebecca Pifer • Aug. 10, 2021

Digital therapeutics — a double-edged sword?

Aloha McBride, EY's global health leader, argues that algorithms need to be regularly audited and screened for bias and discrepancies, while clinicians play a vital role in explaining the key features of apps and patient privacy risks.

By Aloha McBride • Aug. 10, 2021

Delaware caps hospital price growth to fund more primary care

Gov. John Carney signed the multi-pronged healthcare bill on Friday. "As I think about the things, particularly in healthcare that we focus on, there's not much that's more important than this," he said.

By Samantha Liss • Updated Oct. 5, 2021

FDA puts Class I label on Boston Scientific recall estimated to affect one-third of pacemaker line

The medtech giant took the action after discovering devices, once hailed as a growth driver, can incorrectly enter safety mode, putting patients at risk of serious injury.

By Nick Paul Taylor • Aug. 9, 2021

Telehealth has promising future if obstacles can be overcome, poll finds

A new survey by the Bipartisan Policy Center concludes that telehealth could continue to be used on a large scale after the COVID-19 pandemic winds down, and could help prevent unnecessary emergency room visits.

By Ron Shinkman • Aug. 6, 2021

OIG audit targets Aetna’s Medicare Advantage plans as government cracks down on fraud

CVS contends the reviews are a regular part of doing business in federal programs, and it "expects CMS and the OIG to continue these types of audits."

By Rebecca Pifer • Aug. 5, 2021

DOJ reportedly considering suit to block UnitedHealth-Change tie-up

The deal was first announced in January and immediately drew opposition, including from competing payers, the American Hospital Association and the American Antitrust Institute, over anticompetitive concerns.

By Rebecca Pifer • Aug. 5, 2021

Telehealth waivers wind down, restricting some providers from delivering care across state lines

A number of states allowed medical professionals licensed elsewhere to hold virtual visits with their residents during the pandemic. While some are making those rollbacks permanent, others are going back to pre-pandemic rules.

By Hailey Mensik • Aug. 4, 2021

After controversial approval, doctors are still debating how to use Biogen's Alzheimer's drug

Nearly two months since Aduhelm became available, many physicians have yet to use the first treatment approved in the U.S. to slow Alzheimer's disease.

By Jacob Bell • Updated Aug. 3, 2021

FTC warns it may challenge deals later as it's hit by 'tidal wave' of merger filings

"Companies that choose to proceed with transactions that have not been fully investigated are doing so at their own risk," the regulator said Tuesday.

By Samantha Liss • Aug. 4, 2021

Medicare-reliant hospitals perform worse financially, more likely to face closure or acquisition: Health Affairs

But researchers cautioned policymakers not to view the results as a reason to avoid reducing Medicare reimbursement.

By Samantha Liss • Aug. 3, 2021