Two great articles across my desk this week about CED - Coverage with Evidence Development. This is a big, big topic at CMS, because they held a two-day workshop on it in February, and will likely include it as a major component of pending "TCET" regulations ("Transitional Coverage for Emerging Technology.")
- Both of the papers I will discuss, cite an important third paper from August 2022. This is by Zeitler et al, "Coverage with Evidence Development: Where Are We Now?" (Open access here, my blog at the time, here.)
GROGAN
See an excellent new 2000-word article on CED by Joe Grogan at Health Affairs - here. Grogan is well-known in D.C. and held a high leadership position in health policy under the prior administration. Grogan's article carefully discusses the history of CED, its frequently-limited usefullness, and sees it as a "never-ending purgatory" for most products and services that end up there.
(For AI summaries of Grogan, here.)
PESCHIN et al.
I saw some familiar citations in Grogan, including Zeitler, but I was really happy to see a new citation, Peschin, Farber, and Trinh (2023). This is an open-access white paper at Alliance for Aging Research, 41 pages, here.
It's a bit of a multi-purpose vehicle, part white paper, part advocacy, and part legal memo (with 106 citations in italics - endnote xcviii, anyone?)
It's especially strong on the serious problems with health equity in CMS CED studies, such as national trials with zero, or nearly zero, Black beneficiaries, including in recent trials. Definitely include this one in your CED file.
Peschin: Legal Status of CED
The last chapter of Peschin et al. is an excellent discussion of the potentially weak legal basis of CED, which oddly isn't cited in the Executive Summary. But don't miss it. It cites an Azar-era legal memo by Robert Charrow, then general counsel of HHS (Fn 14). I wrote about the Charrow memo in 2022, here, including providing the world with a cloud copy of the Charrow memorandum.
Additional Background
I had a short blog recently on health equity problems with CED - here. For example, in a 10,000 patient study of Alzheimer's disease in the Medicare population, a current CED study was only able to enroll a minute number of Black patients - about 200 nationwide - despite having notice that this would be an issue, and despite having several years to recruit. See also Black equity issues at the Alzheimer Association - here.
Poor trial design
There have been huge gaps and craziness built into CED trial designs proposed by CMS - see for example, the CED plan provided in the proposal for NCD 90.2, which would have required all Medicare patients getting genomic testing to be followed with quarterly scans for relapse, even those with no mutations, routine chemo, and those triaged to hospice care. In a nutshell, the CED plan made no sense.
No Insight Into Economics
The economic value of CED (or negative value) is rarely discussed quantitatively. I tried to do this in a simple Excel model, which I wrote about in February 2022 here. The bottom line - wearing my MBA and ROI hat, using reasonable discount rates, CED would convert many projects from fundable to not-fundable. In contrast, and I made my spreadsheets based on a tip I heard in a Scott Gottlieb speech - the MCIT program created by the Trump administration would have been strongly value-creating using basic assumptions. (See the February 2022 blog). An MCIT-like-law has been introduced in the current congress by Guthrie and others- here.
It's rarely noted that CED programs vary greatly in the resources that CED provides. The range is vast. For example, as discussed by Grogan, an oxygen study under CED went nowhere. But DME generally reimburses at close to marginal cost, so there would be zero funding from the CED process to even begin to support the required clinical studies. Similarly, a study under CED offer to pay for genetic testing for warfarin genes in a large complex RCT. The value paid for CED testing was a couple hundred dollars, or even zero, if the patient was admitted to hospital (the DRG bundling). Some research was done, but my point is, it was wholly depending on NIH or other funding, and the contribution from "CED" money - especially considering the inpatient status during testing - was next to negligible.
Let me say this another way. For some - not all - CED situations, the financial coverage of the service is so tiny relative to the trial costs (say, $50 per patient vs $5000 per patient) that it is a rounding error for the sponsor (whether that sponsor be NIH, company, or association). For the patient, it doesn't matter either, since he/she will get the service in the trial anyway (otherwise there would be no trial). CED in this sense doesn't even have much impact if the alternative is non-coverage, for the reasons just mentioned, the coverage dollar brought in by CED is so tiny relative to the overall trial cost.