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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Texas AG sues hospital for $10K after off-duty police barred from carrying guns

Texas Attorney General Ken Paxton claims Memorial Hermann Health System violated a state law that authorizes any establishment serving the public to allow police officers to carry firearms, even if they’re dressed in civilian clothing. 

SCAI celebrated William W. O'Neill, MD, and Cindy L. Grines, MD, two veteran interventional cardiologists who played key roles guiding the development of primary percutaneous coronary intervention (PCI) as a treatment for ST-elevated myocardial infarction (STEMI) patients.

Cardiologists reflect on developing primary PCI in face of criticism and pushback

SCAI celebrated cardiologists William W. O'Neill, MD, and Cindy L. Grines, MD, for the important roles they played in the development of primary PCI. “It was challenging,” Grines explained. “We had the pharmaceutical industry that was anti-primary angioplasty and we had a lot of our own colleagues that were anti-primary angioplasty."

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PBMs sue FTC for alleged Fifth Amendment violation

Caremark, Express Scripts and Optum Rx claim the FTC’s internal administrative court is unconstitutional. The agency sued the PBMs in September, claiming they engage in collusive business practices. 

FDA issues Class I alert on Philips ventilators after 4 injuries

All serial numbers and lots of several Philips ventilators are at risk for damaged airflow sensors if used with in-line nebulizers.

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Trump selects Emmy-winning TV personality Dr. Oz to head CMS

President-elect Donald Trump announced the nomination of former "Dr. Oz Show" star Mehmet Oz just days after appointing Robert F. Kennedy Jr. as secretary of health. 

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FDA issues Class I recall of infusion pump batteries due to risk of burns

Rechargeable batteries used on CADD-Solis Li-ion infusion systems may short out if damaged, possibly causing the case to melt. No injuries have been reported.

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When life sciences met artificial intelligence

The pace of AI adoption is quickening in the sector, which includes biopharmaceuticals, digital health, clinical diagnostics and medical devices.

DEA, HHS extend telehealth controlled substance prescription rule

The COVID-era flexibility has been extended until 2026 as the DEA and HHS work on a permanent fix that will appease regulators and providers alike. 

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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.