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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White House unveils lower prices for popular heart, diabetes drugs after Medicare negotiations

Apixaban, empagliflozin, rivaroxaban and sacubitril/valsartan are just some of the medications included in this initial round of Medicare price negotiations. Their new prices were reduced by 56%, 66%, 62% and 53%, respectively. 

Impella Heart Pump Abiomed RECOVER IV RCT cardiogenic shock

Crisis averted: Recalled heart pumps found after being sent to customers by mistake

The FDA warned that the devices failed a safety inspection, but were still distributed for patient use. They have now all been located. 

cardiologists evaluating the human heart to provide a treatment strategy

Managing stable angina: How cardiologists can find the right mix of revascularization, therapy and interventions

The management of stable angina has been evolving at a rapid rate. Using a one-size-fits-all strategy is becoming a thing of the past, replaced by a patient-centered approach that requires open communication and a healthy understanding of recent clinical research.

Tandem Diabetes Care is recalling a recent update of the mobile app for its t:slim X2 insulin pump due to repeated software issues that may cause the pump to shut down unexpectedly. The FDA has said this is a Class I recall.

Patient risks persist for insulin pump caught in Class I recall

A software update for the pump's mobile app was expected to fix ongoing battery issues, but the problem remains. 

Siemens Healthineers has gained U.S. Food and Drug Administration (FDA) clearance for Acuson Origin, its new cardiovascular ultrasound system featuring advanced artificial intelligence (AI) capabilities. The Acuson Origin represents a significant update from the prior Siemens Healthineers cardiovascular ultrasound system, the Acuson SC2000.

Siemens Healthineers gains FDA clearance for new AI-powered cardiovascular ultrasound system

The Acuson Origin system includes advanced AI algorithms designed to assist users with the treatment of diagnostic, structural heart, vascular, electrophysiological and pediatric patients. It also comes packaged with a new 4D ICE catheter capable of multiplanar reconstruction imaging with or without the use of an electrocardiogram.

Recor Medical's Paradise Ultrasound Renal Denervation System

CMS increases inpatient payment for Recor Medical, Medtronic renal denervation systems

Physicians using the Paradise Ultrasound Renal Denervation system from Recor Medical or Symplicity Spyral Renal Denervation system from Medtronic will soon be eligible for a much more significant reimbursement when treating Medicare patients in an inpatient setting. 

CMS may double Medicare payments for cardiac CT

The agency is gathering feedback on a proposal to double the amount hospitals are paid for coronary computed tomography angiography, with the comment period ending Sept. 9.

physician tracking patient data and reporting on outcomes

Cardiology groups introduce new performance, quality measures for heart failure

The American College of Cardiology, American Heart Association and Heart Failure Society of America worked together on the updated document, adding three new performance measures and six new quality measures. They did not remove a single recommendation from the previous document published in 2020.

Around the web

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

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