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. 

Bipartisan group of 233 House members call for Medicare reform

In a letter, the undersigned asked Congress to halt cuts to Medicare reimbursement and enact a permanent system to adjust rates to inflation. 

Wartime powers enacted to address nationwide IV fluid shortage

The Biden Administration has invoked parts of the Defense Production Act to address shortages that stem from Hurricane Helene damaging a Baxter production facility in North Carolina. 

HeartFlow Plaque Analysis Example

New Category I CPT code issued for AI-enabled coronary plaque analysis software

The news comes just days after CMS confirmed these technologies would start receiving expanded Medicare coverage in November. HeartFlow and other AI vendors have already shared their excitement over the decision. 

doctors nurses ai in healthcare fda oversight

How the FDA sees its role vis-à-vis AI in healthcare

The U.S. Food and Drug Administration has its hands full making sure medical AI products are safe, efficacious and trustworthy before they hit the market. The rise of ever-more-innovative iterations of the technology—not least generative AI—is only adding to the burden. 

Texas hospitals to begin asking patients about citizen status

The Texas Hospital Association said answering the question, which stems from an executive order from Gov. Greg Abbot, will not impact patient care.

cyberattack cybersecurity IT

Homeland Security warns healthcare organizations of hackers using 'password spraying' tactic

The agency said cybercrime cells in Iran are using brute force to breach and maintain covert access to IT systems. 

Chicago - Circa May 2018: Blue Cross Blue Shield headquarters signage and logo.

Blue Cross settles largest healthcare antitrust case in history for $2.8B

The settlement also includes an agreement for operational changes at all of the insurer's 33 independent partners.

The iCardio.ai EchoMeasure AI software to automate measurements for cardiac echo imaging. It was FDA cleared in October 2024.

FDA approves AI startup’s new software for echo assessments

iCardio.ai, co-founded by a cardiologist, is part of the Cedars-Sinai Accelerator program. The startup has already announced new partnerships with Viz.ai, Abbott and others in the cardiac health space. 

Around the web

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.

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. 

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.