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 8, 2025
Exact Sciences (EXAS): Cologuard Plus Coverage Questions
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:…
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…
December 20, 2024
EW: Tricuspid Coverage Positive, With Some Caveats
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…
December 17, 2024
[GRAL, EXAS, GH] Multi-Cancer Test Coverage: Details Fall Flat
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…
December 11, 2024
[EW, ABT] Tricuspid Coverage Expectations
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…
December 10, 2024
DXCM vs ABT in Updated ADA Guidelines
We view ABT as likely better positioned than DXCM following updated guidelines from the American Diabetes Association (ADA) that clinicians “consider” the use of continuous glucose monitors (CGM) in “adults with type 2 diabetes treated…
December 3, 2024
Life Science Tools: NIH Cuts in Context
With the life science tools (LST) space still trailing broader market moves following the Nov. 5 election, in part due to investor concerns over NIH funding, we continue to believe that significant budget cuts are…
November 26, 2024
Exact Sciences: Cologuard Plus Gets 16% Bump, Coverage Questions Remain
In a positive surprise relative to our initial expectations, CMS’s CY25 payment rate of $592 for EXAS’s Cologuard Plus represents a 16% premium to the legacy test’s $509. While this falls slightly shy of the…
November 25, 2024
RFK’s Medical Coding Reforms: Don’t Hold Your Breath
Key Takeaways: With investors questioning RFK’s reported plans to restructure the medical coding system used by Medicare, Medicaid, and commercial health insurers , we remain highly skeptical of meaningful changes within the next 5-10 years,…