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 […]
How much do the world’s biggest medtech companies pay physicians?
The top 50 medical device companies in the world paid physicians and teaching hospitals $690.3 million last year in general payments, according to an analysis of Medical Design and Outsourcing‘s Big 100 and CMS Open Payments data. Medtech companies averaged $17.3 million in general payments to doctors last year, spending an average of 0.2% of […]
Judge orders FDA, CMS to produce missing documents in Theranos case
A federal judge has ordered the FDA and the Centers for Medicare & Medicaid Services (CMS) to produce documents pertinent to the government’s criminal case against discredited Theranos founder Elizabeth Holmes. The FDA and CMS have until Dec. 31 to provide the documents, including correspondence with Wall Street Journal reporter John Carreyrou, who broke the […]
Study: Nearly $1 trillion wasted in U.S. healthcare annually
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 […]
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