July 23, 2025
Guardant Health (GH) Reveal Rate Expectations
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)…
July 16, 2025
MMSI: Wrapsody Pass-Through Reprieve Unlikely
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…
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 15, 2025
Skin Substitutes: When it Rains it Pours [MDXG, ORGO, CTEC.LN, COLOB.DC]
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…
July 14, 2025
PRCT: Pro Fee -28%, Competitor -25%
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…
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…
July 8, 2025
[LNTH, TLX.AU] Pylarify Competitor Pass-Through Precursor
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)….
July 1, 2025
[DXCM, TNDM, BBNX, RMD, CTEC.LN, COLOB.DC] Medicare Competitive Bidding Coming
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…
June 30, 2025
[LIVN, INSP, GMED, MMSI, BSX, MDT] CMS Prior Auth Demo Device Headwinds
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…
June 27, 2025
[EXAS, GH, GILD, MYGN, HOLX] Preventive Services: SCOTUS Takes
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…