Moderna, escalating dispute with NIH, claims government had no role in key vaccine patent

The biotech claimed its NIH partners were involved only after a key discovery was made "by Moderna scientists using Moderna technology." The dispute over who invented a critical part of the vaccine could end up in court.

By Jonathan Gardner , Ben Fidler • Nov. 12, 2021

Biden nominates Robert Califf to return to as head of FDA

If confirmed by Congress, the cardiologist would return to lead an agency taxed by a heavy workload reviewing COVID-19 drugs and vaccines.

By Ned Pagliarulo , Jonathan Gardner • Updated Nov. 12, 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

Pfizer again asks FDA to authorize COVID-19 boosters for all adults

Agency advisers had opposed a broad booster dose clearance in September, leading the FDA to limit use to older adults and those at high risk of COVID-19.

By Jonathan Gardner • Nov. 10, 2021

Health centers raise alarm about rolling back Medicaid coverage post-public health emergency

The clinics are worried about people with Medicaid coverage being deemed ineligible and losing insurance once states revert back to pre-pandemic Medicaid policies and eligibility, a new survey found.

By Rebecca Pifer Parduhn • Nov. 10, 2021

Pfizer pill for COVID-19 shows dramatic benefit in major study finding

The drugmaker, which last week won FDA clearance of its vaccine in younger children, plans to quickly ask the agency for emergency authorization of the drug in high-risk patients.

By Jonathan Gardner • Nov. 5, 2021

Democrats' drug pricing plan, while scaled back, could still squeeze pharma top-sellers

Legislation backed by President Joe Biden and top Democratic lawmakers would allow for price negotiation on up to 20 older drugs, potentially impacting blockbusters from Pfizer, Bristol Myers Squibb and others.

By Jonathan Gardner • Nov. 5, 2021

Adults support major changes to US healthcare system amid rising costs, survey finds

Those surveyed showed the widest support for policy changes that could lower drug costs, followed by measures limiting what both hospitals and doctors can charge for services, according to the Robert Wood Johnson Foundation.

By Hailey Mensik • Nov. 4, 2021

Controversial UnitedHealth-Change tie-up gets new deadline for DOJ review

Consummation of UnitedHealth's $13 billion Change acquisition is now teed up for February at the earliest, though the deal could close even sooner if the DOJ unexpectedly drops its investigation — or later, if the agency challenges.

By Rebecca Pifer Parduhn • Nov. 4, 2021

FDA issues long-awaited draft software guidance in overhaul of 16-year-old policy

Bradley Merrill Thompson, an attorney at Epstein Becker Green, said the new guidance is sorely needed by the medical device industry. "In the realm of software, [16 years is] an eternity," Thompson said. 

By Nick Paul Taylor • Nov. 4, 2021

CDC panel unanimously backs use of Pfizer's COVID-19 vaccine in young children

CDC director Rochelle Walensky signed off on the committee's recommendations Tuesday night, allowing kids to start receiving the vaccine.

By Shoshana Dubnow • Updated Nov. 3, 2021

CMS finalizes plans to hike price transparency penalties, extend telehealth flexibilities

The agency is also moving forward with a plan to stop the elimination of the Medicare inpatient-only list, which is a win for hospitals.

By Shannon Muchmore • Nov. 3, 2021

Why are women more likely to use telehealth?

As Washington mulls over telehealth regulations post-COVID-19, it's important not to roll back access in a way that could disproportionately affect women, experts say.

By Rebecca Pifer Parduhn • Nov. 2, 2021

Texas Medical Association sues to block parts of surprise billing ban

The lawsuit primarily takes issue with the independent dispute resolution process the regulations governing the law put in place. The No Surprises Act is slated to take effect on Jan. 1.

By Ron Shinkman • Nov. 1, 2021

Federal data shows ACA, Medicaid coverage kept uninsured rate steady as open enrollment kicks off

And the numbers suggest ACA and Medicaid enrollment may be continuing the momentum notched last year as consumers turned to the programs in droves after losing job-based coverage.

By Rebecca Pifer Parduhn • Nov. 1, 2021

Moderna faces new delay in plans to bring coronavirus vaccine to US teenagers, young kids

The FDA wants to better understand the risk of vaccine-associated myocarditis in 12- to 17-year-olds based on real-world use overseas.

By Ben Fidler • Nov. 1, 2021

FDA clears Pfizer's coronavirus vaccine for young kids, moving US to next stage of rollout

The authorization makes the shot available to nearly 28 million kids between the ages of 5 and 11, though a CDC panel next week could hold significant sway over who among them should be vaccinated.

By Shoshana Dubnow • Oct. 29, 2021

Drug price restraints dropped as Biden prioritizes other measures

Despite majority control of Congress, it appears unlikely the Biden administration will be able to pass meaningful pricing reform, though a slimmed-down bill may still be in the works.

By Jonathan Gardner • Oct. 29, 2021

FDA advisers support using Pfizer's coronavirus vaccine in young children

The expert panel pressed Pfizer and the FDA on the shot's safety, but ultimately were convinced by the potential for significant benefit in 5- to 11-year-olds.

By Ned Pagliarulo • Oct. 27, 2021

Regulatory burdens strapped medical practices over the past year, MGMA finds

Prior authorization requirements were the most frequently cited hurdle, while requirements for Medicare's Quality Payment Program and COVID-19 workplace mandates tied for second, a survey by the medical practices group found.

By Hailey Mensik • Oct. 27, 2021

Merck agrees to license COVID-19 pill widely through pact with patent group

The deal with the Medicines Patent Pool is meant to increase access in lower-income countries to molnupiravir, an experimental drug that could become the first oral treatment for COVID-19.

By Kristin Jensen • Oct. 27, 2021

A look at Teladoc's primary care strategy from its head of US group health

In an interview, Kelly Bliss teased upcoming clients for a new virtual-first primary care product and parsed out Teladoc's growth strategies for 2022 and beyond.

By Rebecca Pifer Parduhn • Oct. 27, 2021

CARES funding to hospitals hit hard by COVID-19 was unevenly distributed, study finds

Larger academic medical centers received a significantly larger proportion of federal coronavirus relief funds than smaller and more rural hospitals, a study of more than 950 facilities concluded.

By Ron Shinkman • Oct. 22, 2021

CDC panel backs COVID-19 boosters for Moderna, J&J vaccine recipients

Advisers' recommendations followed the FDA's clearance of additional doses for certain people vaccinated with Moderna's and J&J's shots, while also endorsing a mix-and-match approach.

By Jonathan Gardner , Shoshana Dubnow • Updated Oct. 22, 2021

What to watch at FDA meeting on COVID-19 vaccines for kids

The outcome of a high-stakes advisory panel Tuesday could open the door for millions of kids to receive Pfizer's coronavirus vaccine. Here's what we know.

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

CMMI wants every Medicare beneficiary in an accountable care plan by 2030

Officials acknowledged provider concerns that current models are too burdensome and benchmarks too complex, which the innovation center aims to fix.

By Hailey Mensik • Oct. 21, 2021