Medtech


July 23, 2025

Guardant Health (GH) Reveal Rate Expectations

By John Leppard

We view CMS’s clinical laboratory advisory panel today as an incremental positive for Guardant Health (GH), despite what appears to be a lack of endorsement for the company’s request that payments for Reveal (0569U: $1,644)…

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July 16, 2025

MMSI: Wrapsody Pass-Through Reprieve Unlikely

By John Leppard

With shares of MMSI off today – we suspect in part on investor disappointment over the lack of any discussion of the company’s Transitional Pass-Through (TPT) payment application for its Wrapsody product in CMS’s CY26…

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July 16, 2025

Misses For LNTH, LIVN, PRCT, Wins for BSX / MDT

By John Leppard

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…

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July 15, 2025

Skin Substitutes: When it Rains it Pours [MDXG, ORGO, CTEC.LN, COLOB.DC]

By John Leppard

We view MDXG and ORGO as most negatively exposed to CMS’s proposed skin substitute policy issued last night, which would pay physicians a flat $125 / cm2 rather than product-specific rates based on Average Sales…

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July 14, 2025

PRCT: Pro Fee -28%, Competitor -25%

By John Leppard

CMS’s draft CY26 Physician Fee Schedule (PFS) released this evening would reduce payments for PRCT’s Aquablation by -28% in 2026, going from a volume-weighted average of $765 across the seven Medicare Administrative Contractors (MACs) to…

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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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