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.
Over 100 AI-enabled radiology algorithms added to FDA's list of approvals
The updated list contains 146 newly approved AI devices and, as usual, algorithms tailored to radiology lead the way.
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.

Merck Januvia Janumet Steglujan Nitroso-STG-19 (NTTP) type 2 diabetes

Merck sues US government over Medicare's drug price negotiation liberties, calls program a 'sham'

Merck believes the Inflation Reduction Act-launched effort “coerces” manufacturers to enter into agreements to sell their top products at a fraction of their actual value.

Incorrect place-of-service codes resulted in Medicare overpayments totaling in the millions

The audit revealed that Medicare overpaid by approximately $22.5 million due to incorrect place-of-service coding completed by practitioners.

Federal bill would require more transparency from private equity-backed physician practices

H.R. 3561 also would apply to groups owned by physicians, hospitals, insurers, or venture capital firms, who could face fines of $2M for failing to comply.

‘It was killing some of these radiology departments’: State grapples with long licensing delays

Some rad techs have waited upward of four months to receive their credentials, with it taking days prior to COVID.

FDA clears GE HealthCare MRI tool that can cut scan times by up to 83%

Sonic DL is powered by deep learning technology and targeted for use in cardiac MRI, the company said Monday.

Will PET imaging be covered alongside new Alzheimer's drugs? CMS dodges topic in new coverage decision

The recent CMS coverage determination did not make any mention of beta-amyloid PET imaging that is necessary for both diagnosing Alzheimer’s and monitoring the effectiveness of related treatments.

FDA announces recall of certain Impella heart pumps after 3 patient injuries, nearly 200 complaints

The FDA has labeled this as a Class I recall, which means using these devices can lead to significant injuries, including death.

AMA, radiology groups ‘strongly oppose’ federal bill that would expand nurses’ authority

The Improving Care and Access to Nurses Act aims to let APRNs practice “to the full scope of their education and clinical training.”

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

Over 100 AI-enabled radiology algorithms added to FDA's list of approvals

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