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

FDA authorizes additional Moderna, J&J shots, broadening booster rollout

The agency also cleared booster shots of all three currently available vaccines to be used interchangeably, a so-called mix-and-match approach that recent study results showed could boost immune responses.

By Shoshana Dubnow • Oct. 21, 2021

Biden administration rolls out plan for vaccinating children as FDA weighs clearance

The plan is dependent on FDA authorization and CDC recommendation of Pfizer's vaccine for children aged 5 to 11 by early next month.

By Shoshana Dubnow • Oct. 20, 2021

Over-the-counter hearing aids proposed by FDA

The policy change would allow consumer electronics manufacturers to get into the lucrative hearing aid market that has been dominated by a few companies, a Cowen analyst said.

By Greg Slabodkin • Oct. 19, 2021

Anatomy of a medical device recall: How defective products can slip through an outdated system

A fragmented system has medtechs notifying hospitals via mail or FedEx, leading to missed notices, putting patients at risk, critics say.

By Ricky Zipp • Oct. 19, 2021

Zelis helps address new NSA and TiC regulations

Learn more about innovative solutions that can help you comply with new regulations.

Oct. 18, 2021

FDA panel endorses second shot for adults who received J&J vaccine

Agency advisers unanimously supported offering a second dose of J&J's coronavirus vaccine to adults who previously received it, though guidance could change as regulators evaluate mixing boosters.

By Ben Fidler • Oct. 15, 2021

Medtechs need strategy to prevent bias in AI-machine learning-based devices: FDA

The agency is mulling the types of information medtechs might include in labeling for such devices to support transparency. A Philips rep cautioned about the pitfalls of "information overload." 

By Greg Slabodkin • Oct. 15, 2021