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 […]
Medicare
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% […]
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 […]
Abbott wins Medicare reimbursement for FreeStyle Libre 2
Abbott (NYSE:ABT) announced today that its next-generation FreeStyle Libre 2 iCGM is now available to Medicare patients. The integrated continuous glucose monitoring (iCGM) system met the codes for therapeutic CGM systems used for coverage by the U.S. Centers for Medicare & Medicaid Services (CMS), making it accessible to all Medicare patients with diabetes who meet the […]
CMS agrees to cover ‘breakthrough’ medical devices
Medicare patients will have coverage for medical devices the FDA designates as breakthrough technology under a proposed rule released this morning. Once the Medicare Coverage of Innovative Technology (MCIT) final rule goes into effect, national Medicare coverage will begin on the date a breakthrough device’s FDA market authorization would begin and continue for 4 years. […]
CMS pushes for return to essential kidney treatments, transplants
The Centers for Medicare & Medicaid Services (CMS) has announced updated guidance urging for the resumption of kidney procedures. CMS said its guidance is designed to ensure medical providers can able return to offering essential surgical, life-sustaining procedures while reinforcing infection control precautions at dialysis facilities in COVID-19 hotspots. The guidance includes a checklist of […]
