April 29, 2025
[EXAS] Screening Uncertainty Post-SCOTUS?
Late last week the U.S. Supreme Court (SCOTUS) ordered the parties in Kennedy v Braidwood – evaluating mandatory cost-free coverage of preventive services recommended by the U.S. Preventive Services Task Force (USPSTF) – to submit…
April 21, 2025
Diagnostics: Supreme Court Quick Takes
Following oral arguments this morning, we continue to believe that the Supreme Court will preserve HHS authority to enforce mandatory cost-free coverage of U.S. Preventive Services Task Force (USPSTF) recommendations, preserving the positive status quo…
April 21, 2025
Diagnostics & Supreme Court Expectations
With the Supreme Court (SCOTUS) to hear oral arguments this morning 10-11 am ET [live stream] on the legality of mandatory cost-free coverage of U.S. Preventive Services Task Force (USPSTF) recommendations, we reiterate our long-held…
March 21, 2025
EXAS, GH: Colorectal Cancer Coverage in Hand, Edits to Come?
An update to CMS’s colorectal cancer (CRC) screening National Coverage Determination (NCD) formally establishes coverage for EXAS’ Cologuard Plus ($592) and GH’s Shield ($1,495), with claims processing likely available within 30 days. While we have…
March 12, 2025
Guardant Health (GH): Next Steps on Shield
With the Medicare rate for GH’s Shield colorectal cancer (CRC) screening test set to increase 62% on April 1 ($920 to $1,495) following designation yesterday as an Advanced Diagnostic Laboratory Test (ADLT) – in line…
February 6, 2025
[EXAS, GH, GRAL] Multi-Cancer Coverage: Take 2
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…
January 21, 2025
Guardant (GH) Reveal Medicare Coverage FAQ
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…
January 12, 2025
Diagnostics’ New Supreme Court Risk
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,…
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 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…