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. 

FDA recalls the INRatio and INRatio2 PT/INR monitoring systems

The FDA has announced that Alere has recalled their INRatio and INRatio2 PT/INR monitoring systems.

Princeton health economist says ACA death spiral has arrived

With rising premiums and the departure of major insurers, there’s been plenty of pessimism towards the Affordable Care Act’s health insurance exchanges, but Princeton University health economist Uwe Reinhardt, PhD, has an even harsher assessment on their future.

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6 ACA exchange reforms suggested by AHA

In a letter to HHS Secretary Sylvia Burwell, the American Hospital Association (AHA) suggested several possible changes to the Affordable Care Act’s health insurance exchanges, arguing “swift action” is needed to stabilize the markets.

FDA recommends Zika testing for all blood donations

The FDA is advising all U.S. states and territories to screen donated blood and blood components for the Zika virus, a major expansion of screening efforts to prevent spread of the mosquito-borne virus through blood supplies.

One-third of U.S. may be limited to one choice of insurer on exchanges in 2017

Nearly 36 percent of the exchange market rating regions in the U.S. may have only one insurance company participating in the Affordable Care Act’s exchanges, according to an analysis from Avalere.

Device and drug makers keep paying doctors disciplined for misconduct

Thousands of physicians who have been disciplined for serious misconduct, like having sex with patients, are still getting paid by pharmaceutical and medical device companies to act as advisers or promotional speakers, according to an analysis from ProPublica.

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Tenn. regulator says state exchange ‘very near collapse’

The head of Tennessee’s insurance department said the state’s health insurance exchange is “very near collapse” after approving large rate increases for the three insurers offering coverage in 2017, according to The Tennessean.

N.J. hospital accused of false advertising, questionable business practices

Meadowlands Hospital Medical Center (MHMC) in Seacaucus, New Jersey, has been the subject of an investigative series from NJ Spotlight, accusing the facility of lying about the quality of its services and having a long record of safety violations.

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.