Bigfoot Biomedical CEO hits back against CMS over data-sharing decision

Bigfoot Biomedical CEO Jeffrey Brewer has spoken out about a recent data-sharing decision made by CMS, saying that he plans to lobby Medicare to reverse its latest move. Earlier this year, CMS said it would begin covering the use of particular continuous glucose monitors for people with diabetes. But since that decision, the agency has […]

Medtronic is closer to VenaSeal coverage: Here’s how

Medtronic is touting its new CPT codes for the VenaSeal varicose vein closure device – codes that company officials think bring the device closer to positive coverage from public and private insurers in the U.S. CMS announced the new codes on Nov. 1 as part of final rules for the 2018 Medicare Physician Fee Schedule (CMS-1676-F)

Should the medical device industry pay user fees to CMS?

Achieving reimbursement from payers has become a major challenge for medical device companies. Could the solution lie in having them pay user fees to CMS – the way they do to FDA? That was the question floated by Nadim Yared, president of CVRx and the current chairman of AdvaMed, during this week’s Medtech Conference powered by

Wading into parallel reviews as a reimbursement strategy

The process of gaining reimbursement is one of the most expensive and perilous activities a medical technology company will undergo. Some are exploring how (and whether) a strategy that encourages working with both FDA and CMS at the same time can help cut down the resource costs associated with reimbursement. Seth Goldenberg, director of product

Why regional reimbursement strategies could be right for medtech

The medtech space is facing increasing challenges, particularly in the reimbursement space. Although the process is difficult, device makers may find that regional reimbursement strategies better suit their immediate needs to get products to market, according to experts at NAMSA. Let’s start with the challenges. We know that clinical trials for devices are far more

Medtech stories we missed this week: March 24, 2017

From companies receiving CE marking to other companies adjusting their distribution deals, here are medtech stories we missed this week but thought were still worth mentioning. 1. Viveve Medical closes public offering Viveve Medical announced that it closed its underwritten public offering of 8,625,00 shares of its common stock, according to a March 22 news release.

Pixium logs German reimbursement win for Iris II ‘bionic eye’

Pixium Vision (EPA:PIX) said today that its Iris II ‘bionic eye’ won NUB 1 reimbursement status from the German Institute for the Hospital Remuneration System. The company’s epi-retinal implant has 150 electrodes and a bio-inspired camera intended for patients who have lost sight due to retinitis pigmentosa. A computer processes images captured by the camera and

Medtech needs clinical registries for pre- and postmarket data: Here’s why

Vicki Anastasi, global head of medical device and diagnostic research, ICON plc Clinical registries are becoming valuable resources for medical device manufacturers. These clinical registries can be used in a few ways: building pre-approval documentation, and in post-approval monitoring. Using registries effectively will save both time and money for medtech companies. But companies need to

GI Dynamics notches German reimbursement win

GI Dynamics (ASX:GID) said today that its EndoBarrier device won NUB 1 reimbursement status from the German Institute for the Hospital Remuneration System. This status is the highest of 4 levels, which will bring in full reimbursement for the Lexington, Mass.-based company at the 143 participating hospitals. Payers at these hospitals will be required to cover

How the 2016 elections will impact healthcare, according to EBG

As part of its Thought Leaders in Health Law series, Epstein Becker Green have released an essential video for those in the healthcare industry. Health care and life sciences attorneys Stuart M. Gerson, Ted Kennedy Jr., and Philo D. Hall join Bob Atlas, president of EBG Advisors to examine the impact that the 2016 U.S.

CytoSorbents gains on German reimbursement win

CytoSorbents Corp. (NSDQ:CTSO) shares jumped 9% to $5.35 apiece today after the company reported that it landed a permanent reimbursement procedure code for its CytoSorb therapy in Germany. The Monmouth Junction, N.J.-based company developed its blood purification therapy to treat inflammation in critically-ill patients and for use during cardiac surgery. CytoSorb is an extracorporeal cytokine

Design from data: Cognoa CEO Vaughan on learning, failing, marketing and getting paid

“If I asked you what the Uber app is, what would you say?” That’s the question Brent Vaughan, the CEO of Cognoa recently asked me. I said something obvious, like, “It’s a cheap, convenient ride.” He invited me to think of it in a different way. “It is really a peace of mind app, don’t you

UDI and reimbursement: What we know so far about Medicare’s plan to implement UDI

Support is growing for unique device identification (UDI) tools to be used in insurance claims for implanted devices. Proponents say implementing UDIs into insurance forms is a necessary step for the Centers for Medicare & Medicaid Services (CMS) and private insurance bodies to track and measure device failures, reduce costs, and improve outcomes. Who is responsible? The

Reimbursement thinking for medtech designers and engineers

Reimbursement: It’s a dreaded topic for designers and engineers, says Mike Drues, president of Vascular Sciences. “It can be boring because people approach it like it is a box to check.” But he says, it’s not just about the money and checking boxes. “Engineers have to care about reimbursement because it is fundamental to ensuring

Is reimbursement a medical device company’s worst nightmare?

by Lisa Weeks, Marketing Communications Specialist, MasterControl In 2014, reimbursement trumped regulatory as the industry’s biggest concern.1 As we move further into 2015, it remains at the forefront of stakeholders’ minds. In its 2015 Medical Device Industry Survey, Emergo asked 636 presidents, CEOs and managing directors of medical device companies what issues were keeping them