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.

artificial intelligence healthcare providers legal

3 AI to-do’s for legally aware healthcare providers

Healthcare providers might be the most underrated of all AI stakeholders. Never mind that close to half of 200 CEOs surveyed believe healthcare is the field in which AI is likely to make the most transformative contribution.

Video of American Society of Echocardiography (ASE) leadership explaining how the society recognized early the need for standardization and training for on and stepped forward to offer training for various point of care ultrasound (POCUS) users and to bring them into its membership. Image shows a critical care COVID patient being scanned with a Philips Lumify point-of-care ultrasound system with doctors on screen helping guide the user. #POCUS #ASE #ASE2023

ASE training clinicians as point-of-care ultrasound grows

The American Society of Echocardiography recognized the lack of training and standardization for point-of-care ultrasound users and decided to do something about it.

Radiology societies express ‘significant concern’ around proposed BlueCross BlueShield policy

BCBS last month suggested curtailing coverage for peripheral nerve stimulation devices, used to relieve pain, which drew ire from thousands of physicians.

Private equity’s ‘voracious’ acquisition of radiology practices is increasing imaging prices, study asserts

Such ownership changes were associated with an 8.2% price increase in radiology and statistically significant upticks across 8 of the 10 specialties examined.

Medtronic has received FDA approval for its IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

FDA says treating PAD with paclitaxel-coated devices does not increase mortality risk

After warning healthcare providers about a heightened risk of mortality back in 2019, the FDA has now updated its stance on the use of these devices.

FDA asked to investigate ‘eye-popping’ amount of caffeine in Logan Paul’s Prime energy drinks

Should an energy drink with more caffeine than five cans of soda be marketed to kids? Sen. Chunk Schumer shared his concerns in a new letter to FDA Commissioner Robert Califf, MD, a veteran cardiologist.

Big Pharma’s industry payments to diagnostic radiologists have risen sharply since 2019

Merk & Co. paid the largest amount to the specialty between 2017-2021, followed by Hologic and Pfizer, researchers wrote recently.

Radiologists capture growing market share for key interventional procedure while cardiologists lose ground

Among Medicare beneficiaries, there was a marked drop in the delivery of percutaneous renal artery angioplasty, used to treat a narrowed artery, between 2010 and 2018.

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