Abbott (NYSE:ABT) announced today that CMS revised its coverage for TMVR, opening up new possibilities for its MitraClip device. The CMS National Coverage Determination (NCD) expands coverage for transcatheter mitral valve repair (TMVR) to include patients with secondary (or functional) mitral regurgitation (MR) resulting from heart failure. According to an Abbott news release, the CMS decision […]
Medicare
Medicare to cover breakthrough devices
FDA-designated breakthrough devices will have Medicare coverage the same day they are approved, under a final rule issued this week by the Centers for Medicare and Medicaid Services (CMS). The Medicare Coverage of Innovative Technology (MCIT) rule will provide national Medicare coverage as early as the same day as FDA market authorization for breakthrough devices […]
CMS finalizes coverage updates that increase access to VADs
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 […]
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 […]
Joe Biden’s plan for COVID-19 and how the industry is reacting
Following the weekend’s news that Joe Biden is now president-elect of the U.S., plenty of focus is shifting to his plan for COVID-19. While positive news regarding Pfizer and BioNTech’s vaccine candidate came through this morning, the pandemic is still roaring on, with the U.S. hitting a record 128,000 new cases on Saturday as the […]
FDA flags false-positives with COVID-19 antigen tests
The FDA announced today that it is alerting laboratory staff and healthcare providers of false-positive results for rapid COVID-19 antigen tests. Generally, antigen tests are indicated for the qualitative detection of SARS-CoV-2 antigens in authorized specimen types collected from individuals suspected of COVID-19 by their healthcare provider within a certain number of days of symptom […]
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, […]
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% […]
