MDT (US)

CMS’s finalized national coverage determination (NCD) last night should support an incremental ~120 bps in growth for EW’s TAVR franchise in 2027, with the agency largely codifying the criteria initially outlined in its June proposal….

With CMS set to release its finalized update to the TAVR NCD by Sept. 13 [likely posted after the close here], we largely expect it to maintain the core elements of the original proposal. More…

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…

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…