• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts & Webinars
    • Podcasts
    • Webinars
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates
Home » Dexcom surges on Medicare nod for continuous glucose monitors

Dexcom surges on Medicare nod for continuous glucose monitors

January 13, 2017 By Sarah Faulkner

CMS grants coverage for CGMsDexCom (NSDQ:DXCM) said yesterday that the Centers for Medicare & Medicaid classified therapeutic continuous glucose monitors as durable medical equipment under Medicare Part B. The company’s Dexcom G5 Mobile is the only CGM system that falls under this classification, according to San Diego, Calif.-based DexCom, since patients can make treatment decisions using the device.

DXCM shares were down -2.1% at closing yesterday, but came back 12.3% this morning in pre-market trading.

“This landmark CMS Ruling will make available the most important technology in diabetes management to the Medicare population,” Dexcom’s president & CEO Kevin Sayer said in prepared remarks. “We are pleased with this important step forward and we look forward to working with Medicare on implementing coverage in the coming months to ensure beneficiaries have access to this life-saving device.”

The coverage decision is ahead of schedule, as analysts anticipated the move to be made later this year or early 2018. Nearly 25% of patients with type I diabetes fall under Medicare, so analysts expect that DexCom could exceed its recently-issued 2017 sales guidance of $710 – $740 million.

Previously, patients were paying about $3000 annually, out-of-pocket, for CGMs.

Leerink analyst Danielle Antalffy wrote in a note to investors today that CMS will reimburse the durable piece of equipment, the receiver, at $236-$277, plus $248.38 each month for the disposable transmitters and sensors. Annually, CMS will reimburse each patient over $3200.

The ‘therapeutic’ requirement for CGMs means that DexCom has a potentially meaningful competitive advantage, Antalffy wrote. Abbott Laboratories (NYSE:ABT) is seeking a dosing claim for it’s FreeStyle Libre sensor, but Antalffy said that they believe that the sensor accuracy will need to improve before it can be classified as ‘therapeutic’.

Other companies that market CGMs saw their shares fall yesterday. Senseonics (NYSE:SENS) shares were down -6.7%, while Tandem Diabetes Care (NSDQ:TNDM) shares fell -4.4% to $2.20 per share.

“AdvaMed applauds CMS’s decision to recognize certain continuous glucose monitoring devices approved for use in making diabetes treatment decisions as durable medical equipment,” AdvaMed president & CEO Scott Whitaker said in prepared remarks. “This significant step will allow Medicare to cover these particular life-changing devices for people with diabetes. With this decision, CMS has opened the door for millions of beneficiaries to better manage their condition and experience improved quality of life. CGM devices are already covered by nearly all private health plans, and CMS’s ruling follows years of advocacy efforts by AdvaMed and allied organizations to improve patient access to these advanced technologies. CGMs improve diabetes management and patients’ lives by helping to manage insulin therapy. CMS’s decision to cover certain therapeutic CGMs will ensure that America’s seniors will have access to a CGM technology that can simplify and improve diabetes management and overall health. However, it is important to ensure that this decision also leads to coverage for other CGM-augmented systems that use sensor readings to automatically and continuously adjust insulin delivery for patients with diabetes.”

Filed Under: Diabetes, Regulatory/Compliance, Wall Street Beat Tagged With: Abbott, Centers for Medicare and Medicaid Services (CMS), Dexcom, Senseonics, tandemdiabetes

In case you missed it

  • Calyxo raises $32.7M for kidney stone treatment
  • Getinge anesthesia systems recall is Class I
  • RefleXion closes $125M debt facility
  • Senseonics announces equity grants to employees
  • New data backs Aerin’s RhinAer for treating chronic rhinitis
  • Enovis completes Insight Medical acquisition
  • Orchestra BioMed to go public, partner with Medtronic on cardiac neuromodulation therapy
  • Memic Innovative Surgery is now Momentis Surgical
  • Lyra Therapeutics appoints new chief medical officer
  • Masimo’s SafetyNet monitoring reduced length of COVID-19 hospital stays, study says
  • CeQur is launching a discreet, convenient ‘wearable insulin pen’
  • Teva appoints former Vertex exec as new head of R&D, CMO
  • Enovis partners with Kelvi on hot and cold therapies
  • West Pharmaceutical Services debuts new needle syringe system
  • Titan Medical names Cary G. Vance as new president, CEO
  • Acutus completes first closing in left-heart access portfolio sale to Medtronic
  • FDA clears Intuitive, Siemens Healthineers imaging integration for robotic bronchoscopy

RSS From Medical Design & Outsourcing

  • FDA can’t explain drop in device recalls, but experts point to COVID disruptions
    The FDA acknowledged interruptions with notifications from recalling firms during the pandemic, while regulatory experts point to fewer inspections and fewer procedures. FDA medical device product recalls dropped last year to their lowest level since 2013, according to a Medical Design & Outsourcing analysis of recall data from the regulatory agency. Medtech regulatory experts said the COVID-19… […]
  • DeviceTalks Boston 2022: Here’s what you missed on the show floor
    At DeviceTalks Boston 2022, there was a wealth of expertise to be had from exhibitors including Viant, ICS, PSN Labs, Propel and more. From stories of overcoming challenges during the COVID-19 pandemic to medical device materials pitfalls to avoid, MassDevice and MDO executive editor Chris Newmarker hit the DeviceTalks Boston show floor to discover insights. […]
  • Supply Chain EVP Greg Smith sees fewer suppliers in Medtronic’s future
    All eyes are on Medtronic’s global operations and supply chain leader as he works to modernize its operations and scrutinize suppliers. EVP of Global Operations and Supply Chain Greg Smith anticipates fewer suppliers in Medtronic’s future, he said in an interview this week. Smith spoke with DeviceTalks Editorial Director Tom Salemi in his first published… […]
  • CeQur is launching a discreet, convenient ‘wearable insulin pen’
    CeQur designed its Simplicity device to make insulin delivery as seamless as possible for people with diabetes. When it comes to managing diabetes, CeQur wants to make insulin therapy as convenient as possible. For those who prefer to manage their own insulin delivery, the Simplicity device might just do exactly that. Simplicity, a wearable, disposable… […]
  • Meddux opens new facility in Colorado
    Engineering, design, development and manufacturing company Meddux announced that it opened a new facility in Boulder, Colorado. The new, 22,000-square-foot facility doubles the overall square footage from its previous location in Colorado. According to a news release, it helps the company to quadruple its product development area and double its manufacturing footprint. Meddux’s new facility… […]
  • Reducing the Overall Cost of Validation
    By PTI Engineered Plastics Reliable medical devices and equipment are essential for researchers and doctors to accurately diagnose and treat a wide range of diseases. That is why there is such stringent oversight from the FDA to ensure these products meet the necessary requirements and specifications. To ensure compliance with regulators, manufacturers follow installation qualification… […]
  • BBS Automation has a deal to buy medtech supplier Kahle Automation
    BBS Automation said it plans to purchase high-speed automation supplier Kahle Automation to expand its medtech and life sciences business. Kahle will operate as Kahle – a BBS Company, according to a news release from Munich, Germany-based BBS and Lombardy, Italy-based Kahle. The deal is subject to regulatory approval. Terms were not disclosed. Kahle’s co-owners —… […]
  • How safe is health information after the overturning of Roe?
    The U.S. Department of Health and Human Services today issued guidance meant to better protect women’s health information as state abortion bans kick in after the U.S. Supreme Court’s overturning of Roe v. Wade. Despite the HHS actions, women may still wonder whether their health information is entirely safe going forward — a potential challenge… […]
  • Dexcom focuses on early diabetes diagnosis as COVID links emerge
    New evidence is showing that COVID-19 may increase a person’s risk of diabetes, but it could be years until we know for sure. In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said. Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s… […]
  • Blackrock Neurotech and Pitt work on first at-home BCI system for remote trials
    Blackrock Neurotech and the University of Pittsburgh’s Rehab Neural Engineering Labs (Pitt RNEL) are working together on the first portable brain-computer interface (BCI) to allow patients to participate in research trials from home. A Blackrock representative said it’s the final step as the company prepares to launch its first commercial product early next year. Salt… […]
  • How medical device companies are responding to abortion bans
    Days after the U.S. Supreme Court’s decision to overturn Roe v. Wade’s protection of abortion rights, medical device companies are among those reassuring workers about healthcare access. Corporate communications to employees and the public at large come as trigger laws in nearly half of the states outlaw abortion immediately. Some medtech companies are not using… […]

Primary Sidebar

DeviceTalks Weekly

July 1, 2022
Boston Scientific CEO Mike Mahoney on building a corporate culture that drives high growth results
See More >

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World

Device Talks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our Device Talks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us
Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS