Medtech


March 5, 2025

Life Science Tools: Court Intervention & NIH’s New Management

By John Leppard

Events today support our view that NIH grant funding benefitting life science tools (LST) manufacturers will likely stabilize, and that the Trump administration’s Feb. 7 announcement of a 15% cap on indirect costs for all…

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March 3, 2025

[DXCM, OMI, AHCO] Glucose Monitors in the Crosshairs?

By John Leppard

We anticipate risks for manufacturers [DXCM, ABT] and suppliers [OMI, AHCO] of continuous glucose monitors (CGM) beginning this spring / summer, given that: The HHS Office of Inspector General (OIG) will likely publish the results…

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February 19, 2025

Renal Denervation: Medicare Coverage at 10%-20% of TAM?

By John Leppard

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…

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February 8, 2025

Life Science Tools: NIH Indirect Cost Cut Risks

By John Leppard

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…

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February 6, 2025

[EXAS, GH, GRAL] Multi-Cancer Coverage: Take 2

By John Leppard

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…

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January 29, 2025

RFK Risks Post-Confirmation Hearing

By John Leppard

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…

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January 21, 2025

Guardant (GH) Reveal Medicare Coverage FAQ

By John Leppard

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…

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January 13, 2025

Medtronic: Medicare RDN Coverage in 4Q24

By John Leppard

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…

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January 13, 2025

Inspire V Payment & Coverage Quick Take

By John Leppard

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…

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January 12, 2025

Diagnostics’ New Supreme Court Risk

By John Leppard

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,…

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