Congress, alongside provider and consumer groups, continues spat over surprise billing ban rules

While payers and providers must start complying with the No Surprises Act by Jan. 1, the fight over rules implementing the ban is heating up as provider groups object to what they think is a favoring of insurers.

By Hailey Mensik • Nov. 17, 2021

CMS guides hospitals on co-location of staff, services

The agency's final guidance on the practice of sharing resources in an effort to improve provider efficiency drew praise from the American Hospital Association.

By Susan Kelly • Nov. 17, 2021

As Congress weighs drug price restraints, ICER calls out 'unsupported' increases

In a new report, ICER highlighted AbbVie's price hikes on Humira, which the group said resulted in more than $1 billion in U.S. spending last year without any new evidence of health benefits.

By Jonathan Gardner • Nov. 16, 2021

Congress: Target the middlemen who drive up drug costs

"The PBM market lacks the three elements essential for competition — choice, transparency and a lack of conflict of interest," antitrust attorney and former FTC policy director David Balto argues.

By David Balto • Nov. 15, 2021

Biogen's pricey Alzheimer's drug contributes to major Medicare premium hikes

The 15% jump in Part B premiums for 2022 is a case study in how just one expensive medication can affect the spending of millions in the U.S.

By Rebecca Pifer Parduhn • Nov. 15, 2021

Zelis helps address new NSA and TiC regulations

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

Nov. 15, 2021

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

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