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.

Mangione now faces federal charges, death penalty in murder of UHC CEO
After Luigi Mangione, the man accused of killing UnitedHealthcare CEO Brian Thompson, was extradited to New York, federal prosecutors unsealed a new set of murder charges.
FDA issues Class I recall on counterfeit infusion pump batteries
ICU Medical alerted customers to knockoff batteries being circulated by suppliers. Due to a risk of the batteries not holding a charge, the recall has been given the FDA’s most serious designation.
‘Fundamental for all patients’: Exploring the benefits of palliative care for stroke survivors
Approximately 800,000 strokes occur each year in the United States alone. A majority of people survive, due in part to key advances in patient care over the years, but they often go forward without receiving the long-term help they need to recover and thrive.
CMS proposes Medicare coverage for transcatheter tricuspid valve replacement
Edwards Lifesciences sent a formal request to CMS in February after its Evoque TTVR device gained FDA approval. The agency is now accepting public comments for 30 days.
FDA issues alert on PCNL sheath safety after patient death
Trokamed sent a letter to customers warning them to never use its Mini PCNL Sheaths for suction and irrigation, due to a risk of kidney rupture.

Radiology provider Akumin’s creditor takes complete control of the company

“Alternative investment firm” Stonepeak spent an additional $130 million on Akumin before taking over the organization this month.

February 5, 2024

Medical malpractice gavel diagnostic error mistake stethoscope

Patient sues SimonMed Imaging claiming tech injected her with Valium instead of contrast media prior to MRI

Plaintiff attorneys also allege the sedative was administered in an excessive dose, forcing the woman to go back on anti-seizure meds and delay her fertility treatment.

February 5, 2024

CDC: Updated COVID jab significantly reduces odds of infection

The latest COVID-19 vaccine began entering recipients’ bodies last September. Now comes early CDC data supporting the formulation’s general effectiveness.

February 4, 2024

William T. Thorwarth ACR American College of Radiology

Is Medicare’s appropriate-use criteria program doomed? ACR chief discusses what went wrong and how it can get back on track

Radiology Business recently sat down with William T. Thorwarth Jr., MD, to discuss the future of value-based care in the specialty and how Congress can help remedy the program of what ails it.

February 2, 2024

Cardinal Health recalls some Monoject syringes

The company’s “Cardinal Health”-branded Monoject syringes, released in June 2023, were manufactured by a different contractor and differed slightly in dimensions from the “Covidien”-branded syringes, which could put patients at risk.

February 2, 2024

FDA approves first transcatheter tricuspid valve replacement device, the EVOQUE system from Edwards Lifesciences

Edwards makes history, receives FDA approval for transcatheter tricuspid valve replacement device

The approval, based on positive results from the TRISCEND II trial, represents a significant milestone for the treatment of severe tricuspid regurgitation.

February 2, 2024