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 announces recall of insulin delivery pods
Small tears were found on the inside of some of Insulet Corporation's Omnipod 5 pods. The issue was linked to a total of 18 serious adverse events.
New dyslipidemia guideline puts add-on testing, early screening in the spotlight
The updated recommendations represent a collaboration between the American College of Cardiology, American Heart Association and several other U.S. healthcare organizations.
Veterans facing significant challenges accessing radiology services, VA watchdog says
In one instance, a veteran's wife reported difficulty scheduling a critical imaging appointment for her husband amid concern his cancer was spreading.
Data breach on care management company impacts 5K patients at NYC Health
Many of the details are unknown, as an investigation is ongoing. The National Association on Drug Abuse Programs said it became aware of an invasion of its network in January 2026. The nonprofit supports 35,000 people—mainly Medicaid enrollees—in the state of New York.
FDA merges all adverse event reporting systems into new AEMS platform
Adverse event reports for food, drugs, vaccines, dietary supplements and medical devices will soon be available in one place. The U.S. Food and Drug Administration said the change will simplify reporting for consumers and allow it to react in real-time to FOIA requests.

statue justice legal verdict malpractice case lawsuit scale

Cardiology practices pay $17.7M to settle fraud allegations brought on by whistleblowers

A total of 16 cardiology practices from 12 states settled with the DOJ to resolve allegations they overbilled Medicare for imaging agents used to diagnose cardiovascular disease.

Medicare Money dollar payment reimbursement

Congress ditches doc fix in stopgap end-of-year funding bill

“It is extremely disappointing that the incoming administration would upend a bipartisan agreement that prevented devastating cuts," the RBMA said Friday.

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.

older patient with a doctor at their house

‘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.

Edwards Evoque transcatheter tricuspid valve replacement TTVR

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.

Sahajanand Medical Technologies (SMT) Hydra TAVR

Hydra TAVR valve gains key approval as global reach continues to grow

The self-expanding device is now available in more than 20 countries and received CE mark approval back in 2020. However, it has not yet been approved by the U.S. Food and Drug Administration for use in the United States.

Policy & Regulations

FDA announces recall of insulin delivery pods

New dyslipidemia guideline puts add-on testing, early screening in the spotlight

Veterans facing significant challenges accessing radiology services, VA watchdog says

Data breach on care management company impacts 5K patients at NYC Health

FDA merges all adverse event reporting systems into new AEMS platform