Stryker (NYSE:SYK) and Boston Scientific (NYSE:BSX) announced that they are withdrawing some of their financial guidance for the first quarter and full-year 2020 amid the COVID-19 pandemic. Originally, Kalamazoo, Mich.-based Stryker reported an expected organic sales growth for 2020 to be in the range of 6.5% to 7.5% and its full-year earnings per share to range between […]
7 ways the coronavirus is affecting medtech
Medtech companies face some tough times as the deadly coronavirus pandemic gains steam. But could this be the medical device industry’s Dunkirk, too? Just days ago, MassMEDIC president Brian Johnson made a call-out on LinkedIn for people to send ideas about how Massachusetts medical device companies could help fight COVID-19. He drew an analogy to […]
CMS recommends postponing most elective procedures
The Centers for Medicare and Medicaid Services (CMS) released guidance late yesterday asking healthcare providers to postpone adult elective surgeries and procedures, including dental procedures, until further notice. The move is an attempt to preserve the supply of ventilators and personal protective equipment such as masks and gowns while protecting patients and staff from exposure […]
CMS considers extending Medicare coverage for heart devices
The Centers for Medicare and Medicaid Services (CMS) may extend coverage for artificial hearts and ventricular assist devices (VADs). Currently, Medicare covers artificial hearts for beneficiaries enrolled in a CMS-approved clinical study, a status that hasn’t been updated since 2008. Artificial heart-maker SynCardia wrote a letter last year to CMS asking it to extend coverage […]
House bill asks CMS to cover breakthrough devices for Medicare patients
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 […]
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