The Centers for Medicare and Medicaid Services (CMS) in August announced a proposed rule to cancel the Episode Payment Models (EPMs) used in cardiac bundled payments for patients with acute chest pain. The proposed rule also may eliminate the cardiac rehabilitation (CR) incentive payment model. Acute cardiac care bundled payments for patients with myocardial infarction who undergo percutaneous coronary intervention (PCI) with or without stenting, or coronary bypass graft surgery (CABG), was supposed to go into effect July 1, 2017. CMS pushed this back to Jan.

Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT) in patients implanted with the Resolute Onyx Drug-Eluting Stent (DES) during percutaneous coronary intervention (PCI). Designed to evaluate clinical DAPT outcomes between two DES for the first time ever, the RESOLUTE ONYX ONE-MONTH DAPT Study intends to help inform DAPT guidelines for newer-generation DES that currently favor bare-metal stents (BMS) for patients with stable ischemic heart disease who might require a shorter dual antiplatelet regimen.

August 18, 2017 — The American Society of Nuclear Cardiology (ASNC) has released a joint expert consensus document with the Society of Nuclear Medicine and Molecular Imaging (SNMMI) on the role of 18F-FDG positron emission tomography/computed tomography (PET/CT) in cardiac sarcoid detection and therapy monitoring.

Healthcare cybersecurity concerns have increased dramatically as EMRs and medical devices become more digitally connected.

August 17, 2017 — Cybersecurity has become a growing concern in healthcare as patient data, medical systems and implantable devices become more digitally connected. The lax cyber security measures in healthcare IT have also spurred a large number of hacking attacks and ransomware attacks on U.S. hospitals over the past few years. After a financial market report last August unveiled cybersecurity vulnerabilities on electrophysiology devices and monitoring systems that use wireless communications, there have been questions about how security of medical devices should be regulated. The U.S.

Houston Methodist Hospital and Siemens Healthineers have entered into a multi-year agreement to bring cutting-edge technology to Houston Methodist that is not currently available in the Texas Medical Center. This agreement will provide innovative, world-class medical technology to Houston Methodist Hospital and all of its community hospital facilities.

ScImage Inc. was recently awarded a new DIN-PACS IV (Digital Imaging Network/Picture Archiving and Communications System) contract by the U.S. government. The contract is potentially valued up to $400 million, and the terms include one five-year base period and one five-year option period.

The FDA is concerned about cybersecurity of ICDs and cyber security of other medical devices.

There is growing concern among patients and regulators that medical devices, especially implantable electrophysiology (EP) devices with wireless capabilities, are vulnerable to cyber attack. While there are no known instances of a hacker accessing and manipulating a patient’s implanted device, this fear was raised publicly in August 2016 when the financial investment firm Muddy Waters reported specific vulnerabilities with St.

August 16, 2017 — BioCardia Inc. recently announced completion of treatment for the 10-patient roll-in cohort for the pivotal Phase III CardiAMP Heart Failure Trial. A pre-specified review of the 30-day outcomes in this cohort by the Data Safety Monitoring Board is anticipated in the third quarter of 2017.

August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivalirudin doses on net adverse clinical events (NACEs) and mortality. Patients recovering from PCI with bivalirudin are at a lower risk of bleeding, but also suffer an increased risk of acute stent thrombosis (ST). Bivalirudin is a direct thrombin inhibitor that can prevent blood clots during and after an angioplasty procedure.

CMS considers eliminating cardiac bundled payments.

August 16, 2017 — The Centers for Medicare and Medicaid Services (CMS) announced a proposed rule to reduce the number of mandatory geographic areas participating in the Center for Medicare and Medicaid Innovation’s (Innovation Center) Comprehensive Care for Joint Replacement (CJR) model from 67 to 34. In addition, CMS proposes to allow CJR participants in the 33 remaining areas to participate on a voluntary basis. In this rule, CMS also proposes to make participation in the CJR model voluntary for all low-volume and rural hospitals in all of the CJR geographic areas.
Subscribe to
© Copyright Wainscot Media. All Rights Reserved.
Subscribe Now