About 25% of U.S. healthcare spending — between $760 billion and $935 billion annually — is wasted, according to a new report published today. Researchers from Humana (NYSE:HUM) and the University of Pittsburgh School of Medicine searched medical literature from January 2012 to May 2019, looking for waste and savings opportunities in six domains of […]
HHS proposes regulatory changes to promote value-based payment arrangements
UPDATED Oct. 9, 2019, with comments from press briefing in Minneapolis. The U.S. Department of Health and Human Services today proposed what it’s describing as a modernization of the physician self-referral law in order to promote value-based healthcare. The proposed regulatory changes, which are heading into a 75-day public comment period, say the physician self-referral […]
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 […]
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 […]
Mylan agrees to settle SEC EpiPen probe for $30 million
Mylan (NSDQ:MYL) is nearing a $30 million settlement with the Securities and Exchange Commission (SEC) over an investigation involving the company’s EpiPen auto-injector and the Medicaid drug rebate program. The SEC probe was announced in 2016, shortly after Mylan agreed to pay $465 million to the U.S. Department of Justice to settle claims that it underpaid […]
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 […]
Baxter throws $500m behind CMS push for dialysis innovation
Baxter (NYSE:BAX) officials apparently think their company can benefit from a Trump administration and CMS proposal to provide extra reimbursement for new and innovative dialysis equipment and supplies. Just days ago, CEO Joe Almeida told analysts in an earnings call that the company planned to invest $500 million to significantly increase production capacity and meet new […]
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 […]
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 […]
- 1
- 2
- 3
- …
- 36
- Next Page »
MassDevice Network
@MassDevice
LinkedIn
YouTube