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. 

Drug companies unhappy with Supreme Court decision on patent law challenges

The U.S. Supreme Court has upheld changes to patent law made by Congress in 2011 that can make it easier for generic drug manufacturers to invalidate patents.

142 in Congress want end to FDA ban on gay men donating blood

24 senators and 118 representatives—six of them Republicans—signed letters addressed to the Food and Drug Administration asking for decades-old restrictions on gay men donating blood to be lifted.

Zika vaccine goes to trial, but governmental and medical challenges abound

The effort to contain the Zika virus in North America could see a much-needed boost in the near future. Human-based vaccine trials could start within weeks, the drug’s developer announced. 

White House to Congress: Include funding provisions in opioid bills

The White House wants to make sure Congress’ bills to curb opioid use in the U.S. include plans for funding. President Obama has said he wants to see up to $1.1 billion offered for opioid addiction treatment and management of the crisis.

CMS proposes changes to Medicaid eligibility error rate programs

In order to implement parts of the Affordable Care Act (ACA), CMS has proposed a new rule to adjust programs for payment errors and eligibility quality control under Medicaid and CHIP.

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State news: Calif. opposes Anthem-Cigna merger, Ore. doctors’ union announces labor deal

Here’s a roundup of the latest healthcare news from California, Oregon, Illinois, Ohio and New York

Supreme Court sends mixed message on False Claims Act liability

A unanimous U.S. Supreme Court decision seemed to open the door to more False Claims Act lawsuits against healthcare organizations while simultaneously applying some limitations which would favor providers.

Should doctors on probation have to disclose their status to patients?

Patients aren’t likely to be told anything to about their physicians’ criminal history, even in cases where they’ve settled criminal charges related to their work, like sexual abuse of patients and performing operations while drunk.

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.