U.S. Rep. Suzan DelBene (D-Wash) reintroduced a bill today to improve Medicare patient access to breakthrough medical devices. The Ensuring Patient Access to Critical Breakthrough Products Act of 2019 (H.R. 5333) would require Medicare to temporarily cover all devices approved through the FDA’s breakthrough pathway for three years, during which the Centers for Medicare and […]
NanoVibronix wins reimbursement from CMS for PainShield device
NanoVibronix (NSDQ:NAOV) announced today that it won a unique reimbursement code from the Centers for Medicare and Medicaid for its PainShield surface acoustic wave portable ultrasonic therapeutic device. The Elmsford, N.Y.–based company develops medical devices based around its low-intensity SAW technology that allows the creation of low-frequency ultrasound waves that can be used in multiple medical […]
South Dakota provider to pay $20m to settle POD case
The U.S. Justice Dept. said yesterday that Sanford Health, Sanford Medical Center and Sanford Clinic of Sioux Falls, S.D., agreed to pay more than $20 million to resolve allegations that they submitted false claims to federal healthcare programs. The allegations include violations of the Anti-Kickback Statute and medically unnecessary spinal surgeries, according to a statement […]
Jury convicts doc of re-using single-use catheters
Last week a federal jury reportedly found a southern California doctor guilty after the reuse of single-use catheters and unnecessary medical procedures for Medicare beneficiaries were allegedly carried out under his supervision. Dr. Donald Woo Lee of Temecula, Calif. was found guilty of adulterating a medical device along with seven counts of healthcare fraud, according […]
More reimbursement wins for Inspire Medical Systems
Inspire Medical Systems (NYSE:INSP) said yesterday that it received two additional draft Local Coverage Determinations for its minimally invasive therapy for sleep apnea. The latest proposals were issued by National Government Services and CGS Administrators, which represent a combined 12 states. The companies have different public comment periods, with NGS’s running from Sept. 26 to Nov. […]
LivaNova wins Medicare nod for nerve stimulation trial
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 […]
- 1
- 2
- 3
- …
- 29
- Next Page »
MassDevice Network
@MassDevice
LinkedIn
YouTube