Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

President Biden declares COVID-19 pandemic is ‘over’

President Joe Biden said the COVID-19 “pandemic is over” during an interview with 60 Minutes.

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District Court ruling in Texas calls ACA preventive care requirement ‘unconstitutional’

The federally-appointed judge expressed concerns that volunteer experts on the U.S. Preventive Services Task Force have the power to make binding recommendations.

Monkeypox update: FDA focuses on testing as cases continue to rise

The new guidance offers a validation template that can assist test developers in submitting an Emergency Use Authorization (EUA) request. 

FDA authorizes COVID-19 variant booster shots

The Federal Food and Drug Administration (FDA) has amended its emergency use authorizations (EUAs) to include updated booster shots targeting the BA.4 and BA.5 COVID-19 subvariants.

insurance payer payment insurer

HHS investing nearly $100M in health navigators for open enrollment

The funding, which is through the Centers for Medicare and Medicaid Services (CMS), includes $98.9 million that will help ensure consumers can navigate health insurance enrollment through the Marketplace, Medicaid and the Children’s Health Insurance Program (CHIP).

 

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White House says all federally-funded research must be available to the public

The Biden administration has mandated that all federally-funded research become available to the public––for free.

UnitedHealth CFO sued in retirement plan case

The suit alleges the company’s 401(k) retirement plan invested in low-performing target-date funds in favor of its business relationship with Wells Fargo.

Dyad Medical Echo:Prio FDA

Regulatory Roundup: FDA approves new-look self-expanding stent, clears 2 advanced AI models

The FDA has had a busy month, overseeing the recall of nearly 88,000 implantable cardiac devices, juggling the continued rise of monkeypox cases in the United States and maintaining an active Breakthrough Devices program. This rundown covers some of the agency's biggest moves during that time. 

Around the web

The tirzepatide shortage that first began in 2022 has been resolved. Drug companies distributing compounded versions of the popular drug now have two to three more months to distribute their remaining supply.

The 24 members of the House Task Force on AI—12 reps from each party—have posted a 253-page report detailing their bipartisan vision for encouraging innovation while minimizing risks. 

Merck sent Hansoh Pharma, a Chinese biopharmaceutical company, an upfront payment of $112 million to license a new investigational GLP-1 receptor agonist. There could be many more payments to come if certain milestones are met.