MDT (US)

The joint CMS / FDA press release this morning outlining the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway for breakthrough medical devices strikes us more as a rebranding of the existing transitional…

In advance of the CMS draft coverage decision for transcatheter aortic valve replacement (TAVR) due June 15 (final Sept. 15), we expect policy changes that – while positive – may be more incremental in their…

Coming roughly in line with our timing expectations outlined in early June (admittedly, a quarter or so early), we would expect CMS’s reopening of its transcatheter aortic valve replacement (TAVR) coverage policy to provide greater…

With CMS finalizing [Fact Sheet, Final Rule] its intention to include continuous glucose monitors (CGM) [DXCM, ABT], insulin pumps [TNDM, BBNX], and urological / ostomy supplies [COLOB.DC, CTEC.LN] in the next round of the Competitive…

We view CMS’s final coverage policy for renal denervation (RDN) [Medtronic (MDT), Otsuka (4578.JT)] as largely consistent with the initial proposal, but with some modest new guardrails that may incrementally slow utilization and delay /…

Despite the nearly ubiquitous opposition of stakeholders, we think CMS will likely finalize its intention to include continuous glucose monitors (CGMs) [DXCM, ABT] in the next round of the Competitive Bidding Program (CBP), along with…

CMS’s CY26 hospital outpatient proposal last night hews closely to our expectations going in: INSP: With the company targeting use of LIVN’s cranial nerve code for its Inspire V device, payment group reassignment likely would…

We view CMS’s coverage proposal for renal denervation (RDN) [Medtronic (MDT), Otsuka (4578.JT)] as an incremental positive relative to our expectations, but likely to be largely in line in terms of its effects. With patients…

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…

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…