article thumbnail

CMS Updates Medicare Coverage for AI-Coronary Plaque Analysis

DAIC

Centers for Medicare and Medicaid Services (CMS) – including CGS, National Government Services (NGS), Palmetto GBA and Wisconsin Physicians Service Insurance Corporation (WPS) – provided updated LCDs for current procedural terminology (CPT) codes 0623T - 0626T. tim.hodson Wed, 10/16/2024 - 12:36 Oct. The four contractors for the U.S.

CMS 52
article thumbnail

BioCardia Announces CMS Approval of Coverage for CardiAMP Cell Therapy Confirmatory Phase III Heart Failure Study

DAIC

CMS has reviewed the CardiAMP Heart Failure II Trial and approved the investigational product, related and routine items and services for purposes of Medicare coverage. CMS has reviewed the CardiAMP Heart Failure II Trial and approved the investigational product, related and routine items and services for purposes of Medicare coverage.

CMS 111
article thumbnail

Procyrion Announces First Patient Enrollments in the DRAIN-HF Pivotal IDE Trial for Aortix Percutaneous Mechanical Circulatory Support Technology

DAIC

The DRAIN-HF study will evaluate the Aortix percutaneous mechanical circulatory support (pMCS) technology in patients with acute decompensated heart failure (ADHF) who are unresponsive to standard medical therapy. The company recently announced it has received CMS approval for Medicare coverage during the DRAIN-HF pivotal trial.

article thumbnail

ONC Releases HTI-2 Proposed Rule to Improve Health IT Interoperability, Update Standards For EHRs, More

American College of Cardiology

The Office of the National Coordinator for Health Information Technology (ONC) released on July 10 the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule, building on the HTI-1 final rule released in 2023 and additional information blocking rules released (..)

CMS 45
article thumbnail

Edwards Lifesciences Expands Structural Heart Portfolio With Acquisitions of JenaValve and Endotronix

DAIC

Edwards has entered into an agreement to acquire JenaValve Technology , a pioneer in the transcatheter treatment of aortic regurgitation (AR), a deadly disease that impacts a significant and growing population and is largely untreated today. A CMS national coverage determination is expected in early 2025.

article thumbnail

HeartFlow AI Plaque Analysis Achieves Major Milestone Towards Medicare Coverage

DAIC

milla1cf Tue, 06/04/2024 - 20:54 June 4, 2024 — HeartFlow, a leader in cardiovascular healthcare technology, is pleased to announce a key Medicare policy development, which should allow for future expanded patient access to their Plaque Analysis product.

Medicare 104
article thumbnail

New Legislation Speeds Progress on Patient Access to New Technologies

Society of Thoracic Surgeons - Technology

After a medical device or intervention has been proven to be safe and effective and reasonable and necessary for coverage, CED requires innovators to monitor how their technology performs in the real world. This process leads to earlier and safer patient access to new technologies and a more direct pathway to coverage for innovators.