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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Ultromics EchoGo AI platform. When the Centers for Medicare & Medicaid Services (CMS) finalized the 2024 Hospital Outpatient Prospective Payment System final rule, it included an updated reimbursement for the EchoGo Heart Failure platform from Ultromics. EchoGo Heart Failure is now associated with an ambulatory payment classification (APC) code of APC 5743 and a payment rate of $284.88.

CMS increases reimbursement for AI-powered heart failure platform

Ultromics thinks the significant payment increase will help ramp up utilization among U.S. healthcare providers.

November 8, 2023
The U.S. Food and Drug Administration (FDA) has approved Recor Medical’s Paradise Ultrasound Renal Denervation (RDN) system for uncontrolled hypertension. The Recor system gained FDA clearance in November 2023.

FDA approves first renal denervation system for uncontrolled hypertension

The system, designed for patients with uncontrolled hypertension who are unresponsive to medication, uses ultrasound ablation to target nerves in the renal arteries, increasing blood flow. This approval comes just months after an FDA advisory panel voted in favor of the system. 

November 8, 2023
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American Heart Association ‘enthusiastically’ joins other cardiology groups in push for new, independent medical board

AHA members have voted to throw their full support behind the efforts to establish a new American Board of Cardiovascular Medicine. 

November 7, 2023
Product Recall

FDA announces Class I recall of nearly 2,000 catheter kits

Medical facilities and distributors have been advised to immediately discontinue the use of these devices due to a significant labeling issue. 

November 7, 2023
While a vast majority of heart transplants in the United States are successful, unplanned hospitalizations after the procedures are still incredibly common. Top 10 reasons for readmission after heart transplant.

Surgeons warn it is too early to recommend a TAVR-first strategy for low-risk patients

The Society of Thoracic Surgeons and European Association for Cardio-Thoracic Surgery say more information is still required before any conclusions can be made about the long-term benefits of TAVR in low-risk patients.

November 6, 2023
Barostim Neo 2 CVRx heart failure nerve stimulator on display at HRS 2023. Photo by Dave Fornell

CMS increases reimbursement for CVRx’s implantable Barostim device for heart failure

Implanting the Barostim device is now associated with an average payment amount of $45,000, up significantly from the previous average of $29,000.

November 3, 2023
Medicare money payment reimbursement dollar decline. More than 100 U.S. medical societies are throwing their support behind a new proposal that could reform out-of-date Medicare policies and help limit future payment cuts. 

Cardiologists, heart surgeons and imaging experts push for changes that could prevent ‘permanent and unjustifiable Medicare cuts’

More than 100 U.S. medical societies are throwing their support behind a new proposal that could reform out-of-date Medicare policies and help limit future payment cuts. 

November 3, 2023
The Evoque transcatheter tricuspid valve replacement (TTVR) system for tricuspid regurgitation from Edwards Lifesciences. The Evoque is the first transcatheter tricuspid valve approved by the FDA. It is the first TTVR cleared in the U.S.

More good news for Edwards: ‘Landmark study’ confirms new TTVR system reduces tricuspid regurgitation, improves symptoms

New data presented at TCT 2023 suggest the Evoque tricuspid valve replacement system could make a significant impact on the lives of patients with severe TR. 

October 27, 2023
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Around the web

Health Imaging
New imaging protocols proposed to curb rise of cardiovascular infections

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

Radiology Business
What does radiology have to do with climate change?

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."

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