Medicare coverage for FDA-designated breakthrough medical devices will have to wait several more months, despite broad support. The Centers for Medicare and Medicaid Services (CMS) issued a final rule on Medicare Coverage of Innovative Technology (MCIT) in January, granting coverage for breakthrough devices the same day as their FDA approvals, for up to four years. Immediately […]
Medicare
CMS extends joint replacement pricing by 3 years
The Centers for Medicare and Medicaid Services (CMS) has extended bundled pricing for hip and knee replacements for three years. The final rule, published in the Federal Register, extends the “Comprehensive Care for Joint Replacement” cost-bundling program through Dec. 21, 2024. The cost-cutting program began in January 2016, when CMS required all hospitals in 67 geographic […]
Boston Scientific, Stryker may get extension on Medicare payments
CMS has issued a proposal for the 2022 fiscal year that would potentially help big medtech companies like Boston Scientific and Stryker. Released yesterday, the proposal for the Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) offers updated Medicare payment policies and rates for operating and capital-related costs of acute […]
Xavier Becerra confirmed as HHS secretary
The U.S. Senate narrowly voted to confirm Xavier Becerra as the U.S. Dept. of Health & Human Services (HHS) secretary today. Becerra received the nomination for the position from President Joe Biden in December 2020. Today, the Senate voted 50-49 in favor of Becerra, who will have to resign his seat as California’s attorney general. […]
CMS consolidates coverage for Intersect ENT’s corticosteroid-eluting implant
Intersect ENT (NSDQ:XENT) announced today that it received consolidated Medicare coverage for its Sinuva sinus implant. Menlo Park, Calif.-based Intersect ENT said in a news release that CMS published an average selling price (ASP) for the Sinuva implant, providing predictability, transparency and confidence of reimbursement for providers and payers in the future. Get the full story […]
Abbott’s MitraClip receives boost as CMS expands coverage for TMVR
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 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 […]
