[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 desired. The measure would merely allow – rather than require – Medicare coverage of such tests starting in 2029, initially apply to just ~13% of beneficiaries (those aged 50-65) while increasing the top end by one year annually, and cap payments at ~$500 per test until 2031, at which point rates will be based on the weighted median of commercial plan reimbursement.
Coverage Timeline & Performance Standards
As outlined in the bill [p. 507], coverage of MCED screening tests cannot be made available until Jan. 1, 2029, and only those meeting as yet undetermined performance criteria will be eligible:
“The term ‘multi-cancer early detection screening test’ means a test furnished to an individual for the concurrent detection of multiple cancer types across multiple organ sites on or after January 1, 2029, that – (A) is cleared under 510(k), classified under section 513(f)(2), or approved under section 515 of the Federal Food, Drug, and Cosmetic Act….[and] (C) the Secretary determines is – (i) reasonable and necessary for the prevention or early detection of an illness or disability”
The legislation makes clear that the determination of whether a given test is “reasonable and necessary” will take place via the National Coverage Determination (NCD) process, much as had been the case under the NCD for colorectal cancer (CRC) screening using blood-based biomarker tests. Investors will recall that, in addition to mere FDA approval, CMS established preemptive test performance criteria (sensitivity ≥ 74%, specificity ≥ 90%) that all approved offerings must meet to be eligible for coverage.
It is unlikely that CMS would select identical thresholds to CRC for a multi-cancer product, but with GRAL’s Galleri showing an overall sensitivity of just 51.5%, as well as stakeholder input from a 4Q24 FDA panel suggesting that a broader mortality / clinical utility benefit should be identified, it remains to be seen where exactly the line for coverage will be drawn.
Capping Reimbursement
As outlined on p. 509 of the text (our emphasis):
“The payment amount for a multi-cancer early detection screening test (as defined in section 1861(nnn)) is – (A) with respect to such a test furnished before January 1, 2031, equal to the payment amount in effect on the date of the enactment of this subsection for a multi-target stool screening DNA test.”
The phrase “multi-target stool screening DNA test” refers to EXAS’s Cologuard (CPT 81528), per the NCD on the subject, 4Q24 reimbursement for which is set at $508.87. While CMS recently set a payment rate of $592 for EXAS’s next generation Cologuard Plus (0464U), it does not take effect until Jan. 1, 2025. Therefore, the rate that would be “in effect on the date of enactment” would be $509.
In other words, the legislation stipulates that any MCED screening test that meets CMS’s eventual coverage criteria will be paid no more than $509 up through YE 2030, at which point rates would be adjusted to reflect the weighted median of commercial plan reimbursement.
Age Limitations Leave Most Beneficiaries Ineligible
As outlined on pgs. 509-510, covered tests may only be used in those aged 50 to 65 starting in 2029 – or just ~13% of total Medicare beneficiaries – with the top end of that range expanding by just one year annually (our emphasis):
“(A) No payment may be made under this part for a multi-cancer early detection screening test furnished during a year to an individual if – (i) such individual – (I) is under 50 years of age or; (II) as of January 1 of such year, has attained the age specified in subparagraph (B) for such year.”
“(B) Age Specified – For purposes of subparagraph (A)(i)(II), the age specified in this subparagraph is – (i) for 2029, 65 years of age; and (ii) for a succeeding year, the age specified in this subparagraph for the preceding year, increased by 1 year.”
While Medicare enrollment data [here, here] only gives generalized age bands (e.g., 65-74), as opposed to year-by-year, a normal distribution suggests that, beginning in 2029, just ~13% of total beneficiaries would be eligible for coverage, with that figure remaining below 50% until the late 2030s.
Even this may be an overestimate given that, as the population ages and life expectancy increases, we suspect the total number of beneficiaries in the age bands shown above would be more heavily weighted towards the higher end of each range rather than allocated along a normal distribution.