Medtech


July 11, 2025

[MDT, Otsuka] Renal Denervation: Broad Coverage, With Constraints

By John Leppard

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…

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July 8, 2025

[LNTH, TLX.AU] Pylarify Competitor Pass-Through Precursor

By John Leppard

In what we view as a harbinger of a competitive headwind for LNTH’s Pylarify, CMS this morning provided a unique billing code for TLX.AU’s Gozellix (A9616) to differentiate it from its predecessor drug Illuccix (A9596)….

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July 1, 2025

[DXCM, TNDM, BBNX, RMD, CTEC.LN, COLOB.DC] Medicare Competitive Bidding Coming

By John Leppard

Consistent with our long-held expectations – albeit coming sooner than we had anticipated – a draft CMS rule issued last night strongly suggests it intends to subject continuous glucose monitors (CGMs) [DXCM, ABT] and insulin…

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June 30, 2025

[LIVN, INSP, GMED, MMSI, BSX, MDT] CMS Prior Auth Demo Device Headwinds

By John Leppard

We view CMS’s new Medicare prior authorization model – announced late Friday and scheduled for implementation Jan. 1, 2026 – as an incremental headwind for device manufacturers within the selected therapeutic and geographic areas, which…

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June 27, 2025

[EXAS, GH, GILD, MYGN, HOLX] Preventive Services: SCOTUS Takes

By John Leppard

Consistent with our expectations, the Supreme Court today upheld the validity of U.S. Preventive Services Task Force (USPSTF) appointments and – by extension – the mandate that insures cover recommended services without patient cost-sharing, lifting…

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June 27, 2025

PRCT: Medicare Rate Expectations

By John Leppard

With CMS likely to publish its CY26 physician / hospital outpatient rate proposals the week of July 7-11, we continue to expect physician payments for PRCT’s Aquablation to fall ~20% ($765 to ~$600) [see prior…

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June 24, 2025

[EW] Quick Word on TAVR Coverage Update

By John Leppard

Having received a number of questions on an “update” posted to CMS’s National Coverage What’s New Report yesterday – which some have taken to imply a near-term reopening of the agency’s coverage policy for transcatheter…

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June 12, 2025

Lantheus (LNTH): Where Do Hospital Rates Go?

By John Leppard

Despite some speculation, we do not expect CMS to increase hospital payments for LNTH’s Pylarify from CY25’s mean unit cost (MUC) [$3.1K] to an average sales price (ASP) methodology [$5.8K] (+85%) in the draft CY26…

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June 10, 2025

Lab Tools: Senate’s NIH Pushback

By John Leppard

Today’s hearing on the FY26 NIH budget before a Senate Appropriations Subcommittee bolsters our view [see note] that lawmakers are highly unlikely to endorse the White House request for an $18B (40%) cut, with flat…

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June 6, 2025

EW: Medicare Coverage Queue Delays?

By John Leppard

We suspect the timeline for Medicare coverage expansion will be longer than investors anticipate for EW’s asymptomatic transcatheter aortic valve replacement (TAVR) indication. While we see eventual reductions in procedure volume requirements – expanding eligibility…

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