Medicare has approved a LivaNova (NSDQ:LIVN) study of vagus nerve stimulation (VNS) to treat depression, the company said today. The Centers for Medicare and Medicaid Services accepted the London-based company’s protocol for a clinical trial to study the safety and effectiveness of adding VNS to traditional depression treatment in patients with treatment-resistant depression. Approval of […]
Inspire Medical adds more LCDs
Inspire Medical Systems (NYSE:INSP) yesterday said, for the second time this week, that two local coverage determination drafts were published for coverage of its sleep apnea therapy. Inspire Medical had two LCDs published August 26 by Medicare contractors Noridian Medicare and Palmetto GBA. Yesterday the Minneapolis-based company said Novitas Solutions and First Coast Service Options also […]
Inspire Medical Systems touts reimbursement wins
Inspire Medical Systems (NYSE:INSP) said two local coverage determination drafts were published to propose coverage of its sleep apnea therapy system. Minneapolis-based Inspire’s sleep apnea device uses hypoglossal nerve stimulation to treat obstructive sleep apnea. The two LCDs will be issued by Noridian Medicare and Palmetto GBA. The two companies collectively represent 19 states. According […]
Former FDA commissioners want more funding for real-world evidence
Three former FDA commissioners are calling on Congress to fully fund the agency’s $60 million fiscal year 2020 budget for using more real-world evidence to evaluate drugs, biologics and devices. Most of that money — $23 million — is earmarked for medical devices. The document is titled “Expanding the Use of RealWorld Evidence in Regulatory […]
Abbott’s MitraClip may win expanded Medicare coverage
Abbott’s (NYSE:ABT) MitraClip heart valve device may secure Medicare coverage for an additional procedure. The Center for Medicare and Medicaid Services (CMS) announced yesterday that it will study whether to extend coverage of the MitraClip transcatheter mitral valve repair (TMVR) device in cases of secondary mitral regurgitation, which results from left ventricular dysfunction. Medicare already pays […]
Abiomed wins extended Medicare coverage for Impella
Abiomed (NSDQ:ABMD) has won a one-year reprieve from a proposed 27% Medicare reimbursement cut to hospitals for the use of its Impella ventricular support device. In April, the Centers for Medicare & Medicaid Services (CMS) floated the rate cut proposal for inpatient surgeries involving external assist devices inserted into the heart, such as Impella. The […]
Medicare might cover more cutting-edge medtech and pay more for it, too
The Centers for Medicare and Medicaid Services (CMS) said today it wants to give Medicare patients better access to cutting-edge medical devices, and that it’s willing to pay more for them beginning in fiscal year 2020. In its proposed rule, CMS said it might pay more for “certain transformative new devices” for inpatients through a […]
Ocular Therapeutix’s ophthalmic device gains Medicare coverage early
Ocular Therapeutix (NSDQ:OCUL) said today that the Centers for Medicare and Medicaid Services has assigned a specific and permanent reimbursement J-code for its Dextenza ophthalmic insert, which is approved for the treatment of ocular inflammation and pain following ophthalmic surgery. The code assigned to Dextenza through the Healthcare Common Procedure Coding System will become effective on […]
Nanowear to launch trial of heart failure-monitoring underwear
Nanowear said today that it has launched a heart failure management and alert diagnostic validation study of its medical-grade, cloth-based nanosensor technology. The SimpleSense undergarment has a closed-loop machine learning platform designed to capture and algorithmically score phonocardiography, impedance cardiography measuring stroke volume and cardiac output, and multi-channel ECG assessing heart rate and heart rate […]
Cardiologist questions use of Boston Scientific Watchman device
A Philadelphia cardiologist has written a newspaper column questioning the efficacy and cost of Boston Scientific’s Watchman device for stroke prevention. The Watchman left atrial appendage closure device is designed to prevent blood clots that form in the heart’s left atrial appendage from reaching the brain. Boston Scientific (NYSE:BSX) markets it as an alternative to blood-thinning […]
CMS expands TAVR coverage
The Centers for Medicare and Medicaid Services have updated the criteria for hospitals and physicians to begin or continue providing transcatheter aortic valve replacement surgery. The decision gives hospitals and providers more flexibility to meet the CMS requirements for performing TAVR, the agency said Friday. The original National Coverage Determination (NCD) for TAVR procedures was cleared in […]
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