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…
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 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 8, 2025
Exact Sciences (EXAS): Cologuard Plus Coverage Questions
A Jan. 1 update to CMS’s colorectal cancer (CRC) screening guide appears to support our view that Medicare coverage of EXAS’ Cologuard Plus (0464U: $592) and its 16% rate premium over the legacy version (81528:…
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 18, 2024
[PBMs, Cancer Screening, Medicare Advantage] A Few Surprises in the Healthcare Spending Package but Otherwise Mirroring Prior Compromise
Following Tuesday night’s release of a short-term continuing resolution (CR) funding the government through March 14, we outline some key differences from previously-reported iterations of the healthcare extenders package, involving PBMs [CI, CVS, UNH, ELV],…
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…
November 26, 2024
Exact Sciences: Cologuard Plus Gets 16% Bump, Coverage Questions Remain
In a positive surprise relative to our initial expectations, CMS’s CY25 payment rate of $592 for EXAS’s Cologuard Plus represents a 16% premium to the legacy test’s $509. While this falls slightly shy of the…
November 15, 2024
RFK to HHS: Biopharma / Lifesciences Smoke or Fire?
Key Takeaways: We are initially skeptical that Trump’s selection of Robert F. Kennedy Jr. (RFK) to lead HHS can survive Senate confirmation but, if we are wrong, would note that any HHS secretary is constrained…
November 13, 2024
EXAS, GH: Next Steps on Next Gen Test Rates
Key Takeaways: Following the split market reaction to EXAS [-29%] and GH [+25%] 3Q24 earnings reports last week, and investors looking to the opportunities associated with next generation colorectal cancer (CRC) screening tests Cologuard Plus…