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. 

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GoodRx slapped with $1.5M fine by FTC over patient privacy

According to the FTC, the company failed to notify consumers it had disclosed personal health information to Facebook, Google and other companies.

Healthcare industry reacts to PHE ending in May

MGMA and AHA discuss how the end of the PHE will impact healthcare stakeholders.

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New rule aims to claw back overcharges from MA plans

The move could reclaim overpayments of an estimated $479 million from 2018 and $4.7 billion over 10 years.

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HHS proposes new rule to expand birth control access under the ACA

The Department of Health and Human Services (HHS) proposed a new rule that would expand access to contraception under the ACA “so that all women who need or want birth control are able to obtain it."

Novavax NVX-CoV2373 COVID-19 vaccine myocarditis

COVID-19 public health emergency to end in May

"If the PHE were suddenly terminated, it would sow confusion and chaos into this critical wind-down," the White House said.

Doctor gets prison time for operating pill mill

A Pennsylvania physician sold medically unnecessary prescriptions for oxycodone and other controlled substances to about 120 individuals from 2016 to 2020.

Mahurkar Acute Dual Lumen High-Flow Hemodialysis Catheter

FDA announces recall of hemodialysis catheters due to risk of leaks, adverse outcomes

“The use of the defective catheter may cause serious adverse health outcomes, including bleeding or the need for surgical removal and replacement of the affected catheter,” according to an FDA advisory.

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Record-breaking number of Americans enrolled in health insurance for 2023

A record-breaking 16.3 million people signed up for health insurance coverage on the Affordable Care Act marketplace during the latest open enrollment period.

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Around the web

Cardiovascular Business
FDA says years-long tirzepatide shortage is resolved, will give limited leeway to compounders

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.

AI in Healthcare
From Capitol Hill to a hospital near you? 5 federal recommendations for healthcare AI policy

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. 

Cardiovascular Business
Merck spends up to $2B to license new weight loss drug with potential heart benefits

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.