Medtech

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…

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:…