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 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.
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.

New hypertrophic cardiomyopathy guidelines highlight importance of exercise, new drug class

HCM is widely underdiagnosed, but the American College of Cardiology and American Heart Association hope their new guidelines can help cardiologists learn more about the potentially fatal condition and improve patient care.

May 10, 2024

Six hospital groups urge UnitedHealth to take responsibility for Change Healthcare hack notifications

In a public letter, the groups are urging UnitedHealth Group to announce a timeline for notifying patients about what personal data was stolen in the breach of Change Healthcare's systems.

May 10, 2024

Radiologists should oppose the FTC’s noncompete ban, healthcare legal expert contends

Attorney Tom Greeson criticized the American College of Emergency Physicians for supporting the ban, believing it “weakens their membership,” and urged ACR and the RBMA to do the opposite.

May 10, 2024

Ohio doctor gets 7 years in prison for violating Controlled Substances Act

The Department of Justice said Thomas Romando, MD, illegally prescribed over 137,000 pills to nine patients over a five-year period.

May 10, 2024

UPMC settles $38M whistleblower lawsuit for Medicare fraud

Surgeons at the health system were accused of performing unnecessary procedures and receiving bonuses as kickbacks. UPMC does not admit wrongdoing.

May 10, 2024

FDA announces new recall of delivery catheters after patient’s death

The recall includes specific lots of five different medical devices used to treat stroke and other neurovascular diseases.

May 10, 2024

White House highlights actions taken by RadNet, Siemens Healthineers as signs of Biden Cancer Moonshot progress

“These accomplishments deliver significant progress toward addressing President Biden’s goal to end cancer as we know it."

May 10, 2024

Lawmakers introduce bipartisan bill granting due process rights to contracted radiologists

UPDATED: Currently, such rights—to a fair process before termination, restriction or reduction of professional activities—are not offered to all physicians.

May 10, 2024

Policy & Regulations

FDA issues Class I recall on counterfeit infusion pump batteries

‘Fundamental for all patients’: Exploring the benefits of palliative care for stroke survivors

CMS proposes Medicare coverage for transcatheter tricuspid valve replacement

FDA issues alert on PCNL sheath safety after patient death

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