December 16, 2025
EW, ABT, MDT: TAVR Coverage Coming
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…
November 29, 2025
DXCM, TNDM, BBNX, RMD, COLOB.DC, CTEC.LN: Competitive Bidding Comes for CGM, Pumps, & More
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…
October 29, 2025
[MDT, Otsuka] Renal Denervation: Broad Coverage, With New Guardrails
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 /…
October 9, 2025
CGMs & Insulin Pumps: Competitive Bidding Lookahead
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…
July 16, 2025
Misses For LNTH, LIVN, PRCT, Wins for BSX / MDT
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…
July 11, 2025
[MDT, Otsuka] Renal Denervation: Broad Coverage, With Constraints
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…
February 19, 2025
Renal Denervation: Medicare Coverage at 10%-20% of TAM?
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…
January 13, 2025
Medtronic: Medicare RDN Coverage in 4Q24
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…
January 10, 2025
Medtronic (MDT): Renal Denervation Coverage Read-Through?
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…
January 6, 2025
Conference Policy Prep Pack: Devices, Diagnostics, & Tools
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…