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.

Most hospitals are not complying with price transparency laws

Hospitals have been required to post their prices of their 300 most common procedures since Jan. 1, 2021. However, a majority of providers are still not fully complying.

When Apple previewed its watchOS 9 update in early June, one of the key features the company highlighted was a new tracking option for atrial fibrillation (AFib) patients. The AFib History feature, approved for patients 22 years and older who have been diagnosed with AFib, was designed to help users gain a better understanding of their symptoms and easily share data with healthcare providers.

Regulatory Roundup: FDA clears several new solutions, including Apple’s latest AFib offering

The FDA had a busy June, clearing multiple solutions designed to treat patients with cardiovascular conditions.

Radiology contributes less than thought to the national healthcare spend

An analysis of CMS data has shown radiology had little to do with increases in Medicare costs over a 10-year period ending in 2019.

Cardiologists push back on FDA’s thyroid monitoring/contrast media proposal

According to a new SCAI statement, the FDA's recommendation would result in "far-reaching consequences" across multiple specialties.

Breaking: Supreme Court overturns Roe v. Wade

The U.S. Supreme Court has decided to overturn Roe v. Wade, which guaranteed the Constitutional right to abortion access for nearly 50 years.

Contrast shortage update: House Members urge President Biden to intervene

Members who signed the letter were particularly critical of the fact that the shortage is a result of COVID lockdowns in China, stating that this crisis brings to light “the urgent need to establish an outbound investment review process to ensure that critical capabilities are not being offshored ..."

FDA rules Juul vape products can’t be marketed, sold

The move means Juul Labs cannot sell and distribute its products. Plus, Juul must remove products that are currently on the U.S. market or risk enforcement action.

FDA announces another recall for troubled heart device after a patient death

This latest recall involves the device's batteries, which are separating due to a "welding defect."

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