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.

Ohio health system sued by DOJ over alleged antitrust violations related to payer contracts
The U.S. Department of Justice and the state attorney general's office allege OhioHealth used its position of market dominance to pressure commercial plans into always keeping its hospitals and clinics in-network, even when competitors offer services for a better rate.
It’s about to get harder for many Medicare patients to see a cardiologist
UnitedHealthcare now requires patients enrolled in certain Medicare Advantage plans to receive a PCP referral before seeing a cardiologist. On May 1, the insurer will start denying all claims that do not include the necessary referral. UnitedHealthcare argues that "stronger PCP engagement" is good for patient care, but many stakeholders disagree.
FDA approves new Biotronik pacing lead for LBBAP
The next-generation device includes a stylet-driven lead and a fixed helix. It was designed and developed specifically with LBBAP in mind.
With SCOTUS striking down ‘Liberation Day’ tariffs, Trump implements 15% tax on all imports
The U.S. Supreme Court ruled President Donald Trump’s sweeping global tariffs unconstitutional. The administration responded by imposing a 10% rate across the board, later hiked to 15%. That will remain in effect for 150 days and require an act of Congress to extend.
New group names 4 things US healthcare can—and should—handle on behalf of Alzheimer’s patients, caregivers
Alzheimer’s disease already has the nation in a crisis of care capacity. The pressure to do more in response is mounting. Meanwhile the true total cost is hard to estimate since so many dementia caregivers are unpaid family members and other volunteers.

Updated: Dexcom recalls more than 700K CGM receivers over safety issues—dozens of adverse events reported

There is an increased risk that these devices will not provide audible alerts for low or high blood glucose levels. The FDA has ruled that this is a Class I recall, highlighting the safety risks associated with missed alerts.

Fed up with patients recording their imaging exams, radiographers call for more stringent cellphone policies

This problem doesn't just affect imaging staff but all healthcare workers, one organization cautions.

FDA announces recall of interventional product that could cause ‘serious injury or death’

Vendor Centerline Biomedical recently initiated the action, removing certain IOPS (Intra-Operative Positioning System) Guidewires, used in vascular procedures, from the market.

Ivenix infusion kits recalled by FDA due to serious manufacturing defect

Lines included in the kits were misassembled and could result in a botched blood transfusion. Due to the risk of serious injury or death, the recall has been designated as Class I.

FDA recalls pediatric breathing kits after eight serious injuries

Endotracheal tubes inside Medline neonatal intubation kits have been deemed too narrow, putting newborn patients at risk for hypoxia. This recall has been given the most serious FDA designation due to the risk of death.

Bayer seeks FDA approval for gadoquatrane, its latest low-dose GBCA

The investigational agent uses 60% less gadolinium without sacrificing image quality, according to recent clinical trial findings.

Senate unveils budget proposal that ditches House’s radiologist Medicare pay hike

Radiology advocates on Monday said they were "deeply disappointed" with the decision while emphasizing it is still early in the process.

radiologist radiology pay compensation money dollar

Radiology Partners scores No Surprises Act wins at 600% of ‘qualifying payment amount’

UPDATED: “These high numbers highlight the disconnect between the two sides as they debate what constitutes a reasonable payment for OON services,” experts write in Health Affairs.

Policy & Regulations

Ohio health system sued by DOJ over alleged antitrust violations related to payer contracts

It’s about to get harder for many Medicare patients to see a cardiologist

FDA approves new Biotronik pacing lead for LBBAP

With SCOTUS striking down ‘Liberation Day’ tariffs, Trump implements 15% tax on all imports

New group names 4 things US healthcare can—and should—handle on behalf of Alzheimer’s patients, caregivers