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. 

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FDA flags defective packaging of Exactech shoulder joint devices

Equinoxe Shoulder System joint replacement devices have shipped in bags missing a crucial oxygen barrier, potentially putting patients at risk.

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Government watchdog takes up FDA recall inquiry following report

The reporting detailed Philips' delay in issuing a recall of its breathing machines, drawing the ire of two U.S. Senators who have been pushing for an investigation into how the FDA handles oversight.

Richard Heller, MD, RSNA Board member, associate chief medical officer for health policy and communications, and national director of pediatric radiology at Radiology Partners, explains some insurance companies are trying to take advantage of the No Surprises Billing Act by telling radiology practices they need to accept lower rates to remain part of the providers in-network.

Radiologists urged to report insurance companies forcing lower reimbursements due to No Surprises Act

Some payers are taking advantage of the NSA by forcing practices to accept lower rates to remain in-network, says Rad Partners' Richard Heller, MD. 

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CES speakers talk about AI in health, need for trust

Keynote speakers noted the need to move at the “speed of trust” in order to reach potential for healthcare.

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FDA clears mass importing of Canadian drugs

Florida’s program is the first to get official approval in an effort to reduce drug costs.

Video interview with Radiology Business Management Association (RBMA) President Kit Crancer, and executive director of the Rayus Quality Institute, where he said the lack of federal policy on insurance coverage for diagnostic breast exams as opposed to screening exams

State legislation addresses gaps in breast imaging coverage, ensures affordable diagnostic exams

RBMA President Kit Crancer said a lack of federal policy has driven 20 states to adopt laws requiring that insurance cover the costs. 

doctor with overweight patient who may be treated with TAVR or surgery

Are GLP-1 agonists safe? FDA finds no evidence popular weight loss medications cause suicidal thoughts or actions

The popular drugs, originally developed to treat diabetes, are being used more and more in the United States to help obese and overweight patients lose weight.  

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Binding cybersecurity standards are close at hand for healthcare

Hospitals that want to remain eligible for federal dollars—including CMS reimbursement—will soon need to show their cybersecurity is up to snuff.

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Around the web

Cardiovascular Business
FDA says years-long tirzepatide shortage is resolved, will give limited leeway to compounders

The tirzepatide shortage that first began in 2022 has been resolved. Drug companies distributing compounded versions of the popular drug now have two to three more months to distribute their remaining supply.

AI in Healthcare
From Capitol Hill to a hospital near you? 5 federal recommendations for healthcare AI policy

The 24 members of the House Task Force on AI—12 reps from each party—have posted a 253-page report detailing their bipartisan vision for encouraging innovation while minimizing risks. 

Cardiovascular Business
Merck spends up to $2B to license new weight loss drug with potential heart benefits

Merck sent Hansoh Pharma, a Chinese biopharmaceutical company, an upfront payment of $112 million to license a new investigational GLP-1 receptor agonist. There could be many more payments to come if certain milestones are met.