Medtech

We view CMS’s final coverage decision on transcatheter tricuspid valve replacement (TTVR) as an incremental positive for Edwards Lifesciences’ (EW) Evoque, in that it eliminates proposed limitations to only those with severe tricuspid regurgitation (TR)…

With the Medicare rate for GH’s Shield colorectal cancer (CRC) screening test set to increase 62% on April 1 ($920 to $1,495) following designation yesterday as an Advanced Diagnostic Laboratory Test (ADLT) – in line…

Events today support our view that NIH grant funding benefitting life science tools (LST) manufacturers will likely stabilize, and that the Trump administration’s Feb. 7 announcement of a 15% cap on indirect costs for all…

We anticipate risks for manufacturers [DXCM, ABT] and suppliers [OMI, AHCO] of continuous glucose monitors (CGM) beginning this spring / summer, given that: The HHS Office of Inspector General (OIG) will likely publish the results…

We suspect CMS’s draft National Coverage Determination (NCD) for renal denervation (RDN) [Medtronic, Otsuka] – scheduled for release July 13 – will limit eligibility to 10-20% (~3.1M-7.5M) of the estimated ~32M Medicare beneficiaries with hypertension…

NIH’s surprise announcement Friday of a 15% cap on indirect costs for both new and existing grants will likely trigger fresh uncertainty for life science tools (LST) manufacturers. While indirect costs are technically distinct from…

Bicameral reintroduction this week of legislation to allow – not require – Medicare coverage of multi-cancer early detection (MCED) tests starting in 2028 bolsters our view of its likely inclusion in a mid-March spending bill…

The four hours RFK spent with the Senate Finance Committee today bolsters our view that he is likely to be confirmed as HHS Secretary. Despite investor concerns with his antipathy for corporate medicine, we think…

Following GH’s announcement this AM of Medicare coverage of its tissue-naïve Reveal test for minimal residual disease (MRD) surveillance testing, we wanted to highlight some additional salient points omitted from the company’s press release. The…

In keeping with expectations laid out in our note late last week, CMS’s opening of a National Coverage Analysis (NCA) for renal denervation (RDN) [Medtronic (MDT), Otsuka (4578.JT) / ReCor] this afternoon has a target…