Medtech

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…

INSP’s disclosure today that physicians will likely be billing its Inspire V device procedures under CPT 64568 ($596) during a “transition period” – rather than existing Inspire IV code CPT 64582 ($816), as we had…

The Supreme Court’s (SCOTUS) decision on Friday to hear oral arguments in Becerra v. Braidwood, presumably in late March / early April, will likely serve as an overhang for screening test manufacturers [EXAS, GH, MYGN,…

This morning’s opening of a Medicare National Coverage Determination (NCD) for privately-held Impulse Dynamics’ Optimizer System bolsters our view that coverage for renal denervation (RDN) systems [Medtronic (MDT), Otsuka / ReCor (4578.JT)] is unlikely to…

A Jan. 1 update to CMS’s colorectal cancer (CRC) screening guide appears to support our view that Medicare coverage of EXAS’ Cologuard Plus (0464U: $592) and its 16% rate premium over the legacy version (81528:…

With medical device, equipment, diagnostics, and life science tools (LST) companies set to descend on San Francisco next week for a key investor conference, below we provide a set of significant policy-related questions for clients…

We view CMS’s draft coverage policy for transcatheter tricuspid valve replacement (TTVR) as incrementally more positive for EW’s Evoque relative to our initial expectations. The lack of facility / operator volume thresholds will likely allow…

While positive on its face, the inclusion of multi-cancer early detection (MCED) screening test [GRAL, EXAS, GH] coverage provisions in tonight’s continuing resolution (CR) to fund the government through March 14 leaves much to be…

With CMS due to publish its draft National Coverage Determinations (NCD) for EW’s Evoque transcatheter tricuspid valve replacement (TTVR) by Dec. 20, followed by ABT’s TriClip edge-to-edge repair (T-TEER) by Apr. 3, we view EW…