The Centers for Medicare & Medicaid Services (CMS) finalized policies that increase access to artificial hearts and ventricular assist devices (VADs). In August, CMS proposed the coverage policy updates meant to increase access to VADs and artificial hearts, which represented potentially good news for major VAD makers Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) and for people with heart failure who […]
Centers for Medicare and Medicaid Services (CMS)
UK regulators recommend iRhythm cardiac arrythmia device
iRhythm Technologies (NSDQ:IRTC) announced that it received a recommendation for adoption from National Institute for Health and Care Excellence (NICE). San Francisco-based iRhythm said in a news release that it is the first technology to pass through a new digital health tech pilot, resulting in the successful recommendation for adoption from NICE. The company’s Zio XT […]
Home dialysis gets a boost from Medicare
Medicare will now provide additional coverage for certain home dialysis equipment for patients with chronic kidney failure. The final rule published today encourages the development of new and innovative home dialysis machines. It follows a September announcement of a new model to shift Medicare payments from traditional fee-for-service payments to payments in which providers are incentivized for encouraging the […]
CVRx secures reimbursement win from CMS
CVRx announced that it received the CMS inpatient new technology add-on payment (NTAP) for its Barostim Neo implantable device. Effective Oct. 1, 2020, and ranging over a three-year duration, Medicare is slated to provide an add-on payment for Barostim Neo worth up to 65% of the device cost (up to a maximum amount allowed of […]
ReWalk gains Medicare coverage
ReWalk Robotics (NSDQ:RWLK) announced today that it received authorization from CMS as a medicare provider. Marlborough, Mass.-based ReWalk is now able to bill Medicare directly for the procurement of its ReWalk personal exoskeleton for Medicare beneficiaries, thanks to the authorization from the Centers for Medicare & Medicaid Services (CMS), according to a news release. In July, […]
Medical Alley Association asks CMS to make it easier for breakthrough devices to win coverage
Medtech receiving a breakthrough device designation from FDA should be able to satisfy all of CMS’s non-cost criteria for transitional pass-through payments, according to the Medical Alley Association. The Minnesota-based trade group’s CEO Shaye Mandle made the proposal in comments submitted Sept. 24 in response to a proposed rule from CMS to revise the Medicare […]
AdvaMed pushes for Medicare coverage of digital health tech
Medtech trade group AdvaMed today called on the federal government to expand Medicare coverage to digital health technologies. The Medicare statute does not directly address coverage of digital health technologies, nor does it specifically limit or prohibit their coverage. But it doesn’t make Medicare coverage easy, either. Get the full story on our sister site, […]
Medicare to cover more home dialysis
The Centers for Medicare & Medicaid Services (CMS) announced that it finalized an expansion of its care offerings for patients with chronic kidney disease. CMS completed its end-stage renal disease (ESRD) treatment choices (ETC) model for improving or maintaining the qualityof care and reducing Medicare expenditures for patients with chronic kidney disease, impacting approximately 30% […]
Myomo lands Medicare coverage
Myomo (NYSE:MYO) announced that it received authorization to be a Medicare provider through the Centers for Medicare & Medicaid Services. CMS, under the U.S. Dept. of Health and Human Services, now includes Cambridge, Mass.-based Myomo in its Medicare Supplier Directory at Medicare.gov, which enables Myomo to bill Medicare directly when it delivers its MyoPro orthosis in […]
Ambu, Boston Sci execs see domination for single-use scopes
Hospital closures connected to COVID-19 have cut into the sales of many medical device companies, but executives at rival makers of single-use scopes say pandemic has only heightened existing concerns about contamination, exposure and cost. In interviews in this week’s DeviceTalks Weekly Podcast, executives from Ambu A/S and Boston Scientific (NYSE:BSX) said improved technology make […]
The top 5 MassDevice stories of the week — September 4, 2020
Medtronic (NYSE:MDT) and a major development involving medtech reimbursement dominated medical device industry news over the past week. As the week closes out, there’s also a trending story on MassDevice that includes good news: Abbott (NYSE:ABT) is reportedly hiring 2,000 new employees in Illinois to increase manufacturing for its rapid COVID-19 test. Want to hear more about […]
