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.

Lehigh Valley Health admits to controlled substances violations in $2.75M settlement
The Pennsylvania-based health system reported drug diversion incidents to authorities involving a pharmacy technician who used employee passwords to steal pills from one of its hospitals.
Sanitation issue forces FDA recall of ventilator suction systems
Ballard Closed Suction Systems will need to be returned to the manufacturer for a refund due to the high risk of a potentially fatal infection stemming from their use.
Medicare now covers TriClip procedures for patients with symptomatic tricuspid regurgitation
CMS has finalized a new national coverage determination for T-TEER, sometimes known as transcatheter tricuspid valve repair. Abbott's TriClip is the only device approved by the FDA for T-TEER, but other treatment options are under development.
Healthcare AI today: HL7 Int’l opens AI office, Justice Dept. uses AI, epidemiologist harbors AI skepticism, more
HL7 International is open for AI business. The interoperability organization announced the launch of its new AI office July 8.
Shared decision-making visits significantly boost CT lung cancer screening adherence
SDM "is more than just a billing requirement—it’s a valuable opportunity to engage patients," says radiologist Farouk Dako, MD, MPH.

FDA greenlights software that supports blood-flow analysis via MRI without contrast

iTFlow enables the visualization of fluid dynamics in the heart and blood vessels in both 2D and 3D, developer Cardio Flow Design said Monday.

American College of Radiology tells CMS new quality measure would pose too much burden

The agency is proposing a new electronic clinical quality measure for inpatients tied to "excessive radiation dose or inadequate image quality."

‘Past the breaking point’: AMA calls for urgent action to fix ‘dilapidated’ payment system

The American Medical Association said it is developing a targeted, grassroots campaign to begin fighting for Medicare reform.

The Surmodics Pounce Thrombectomy System

FDA clears new ‘grab-and-go’ interventional device for below-the-knee blood clot removal

The new device was designed to remove thrombi and emboli from peripheral arteries ranging from 2 to 4 mm.

Deal struck to preserve coverage for USPSTF-endorsed imaging services

“ACR strongly supports the federal efforts to preserve access to such care,” college Executive VP Cynthia R. Moran told Radiology Business.

Millions of Americans have 'unnecessarily' lost Medicaid coverage since April

Many did not lose coverage because they were deemed ineligible during the redetermination process, but due to procedural reasons, such as not completing required paperwork.

AI artificial intelligence stethoscope doctor

American Medical Association to advise on the use of AI in medicine

The goal is to inform users on how to best utilize AI tools while also practicing caution, as many are still in their early stages of deployment and can pose risks.

FDA warns healthcare providers about recalled CPB, ECMO devices

Multiple medical devices used during cardiopulmonary bypass and extracorporeal membrane oxygenation procedures have been voluntarily recalled due to issues with their packaging.

Policy & Regulations

Lehigh Valley Health admits to controlled substances violations in $2.75M settlement

Sanitation issue forces FDA recall of ventilator suction systems

Medicare now covers TriClip procedures for patients with symptomatic tricuspid regurgitation

Healthcare AI today: HL7 Int’l opens AI office, Justice Dept. uses AI, epidemiologist harbors AI skepticism, more

Shared decision-making visits significantly boost CT lung cancer screening adherence