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.

Report: UnitedHealth under investigation by DOJ for Medicare Advantage upcoding
According to the Wall Street Journal, federal authorities are probing claims that the insurer billed health programs for billions of dollars in undelivered patient care.
FDA approves first therapy for very rare lipid storage disorder
Ctexli (chenodiol) can now be prescribed to patients with cerebrotendinous xanthomatosis, a condition caused by a genetic mutation that leads to cholesterol buildup around vital organs.
FDA announces Class I recall of Boston Scientific pacemakers—replacement may be necessary
These safety issues have been linked to more than 800 injuries and two deaths. It is possible, the FDA warned, that some patients may require a device to be removed and replaced.
FDA ends semaglutide shortage, closing the door on compounded Wegovy, Ozempic
The years-long shortage of Wegovy and Ozempic, two popular prescription-only semaglutide injections, is officially over.
American Heart Association highlights importance of NIH as battle over Trump funding cuts continues
“Now more than ever, we must recognize that our country’s leadership in groundbreaking medical research spurs scientific innovation, improves public health and creates new innovations that save and improve lives nationwide,” Joseph C. Wu, MD, PhD, explained in a statement.

Report: UnitedHealth under investigation by DOJ for Medicare Advantage upcoding

According to the Wall Street Journal, federal authorities are probing claims that the insurer billed health programs for billions of dollars in undelivered patient care.

FDA approves first therapy for very rare lipid storage disorder

Ctexli (chenodiol) can now be prescribed to patients with cerebrotendinous xanthomatosis, a condition caused by a genetic mutation that leads to cholesterol buildup around vital organs.

FDA announces Class I recall of Boston Scientific pacemakers—replacement may be necessary

These safety issues have been linked to more than 800 injuries and two deaths. It is possible, the FDA warned, that some patients may require a device to be removed and replaced.

FDA ends semaglutide shortage, closing the door on compounded Wegovy, Ozempic

The years-long shortage of Wegovy and Ozempic, two popular prescription-only semaglutide injections, is officially over.

heart data research doctor cardiologist AI

American Heart Association highlights importance of NIH as battle over Trump funding cuts continues

“Now more than ever, we must recognize that our country’s leadership in groundbreaking medical research spurs scientific innovation, improves public health and creates new innovations that save and improve lives nationwide,” Joseph C. Wu, MD, PhD, explained in a statement.

Federal judge sides with FTC; case against PBMs to move forward

A federal court dismissed a counterclaim from CVS, UnitedHealth and Cigna that sought to halt the case on constitutional grounds.

doctor in handcuffs after being arrested

Doctor responsible for $742K ‘residency prep’ scheme gets 3-year sentence

Sonny Saggar, MD, a physician working for St. Louis General Hospital, billed Medicare and Medicaid for patient visits his unqualified assistants conducted. He pleaded guilty to conspiracy.

Cardiologist questions FDA’s approval process for high-risk medical devices

The technology used to diagnose, treat and manage cardiovascular disease is always evolving, keeping FDA officials quite busy. But have the agency's standards been slipping in recent years? A cardiologist with Cedars-Sinai Medical Center explored that very question.

Around the web

Cardiovascular Business

American Heart Association highlights importance of NIH as battle over Trump funding cuts continues

Cardiovascular Business

Cardiologist questions FDA’s approval process for high-risk medical devices

Cardiovascular Business

FDA announces new recall of Johnson & Johnson heart pumps over safety concerns

No devices need to be returned at this time. However, the FDA warned, using these heart pumps without reviewing the updated instructions could result in "serious injury or death.”