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Prepared Comment on Medicare’s Coverage with Evidence Development (CED)

Published February 13, 2023

The following statement was made by Alliance President & CEO Sue Peschin during the public comment portion of the Centers for Medicare & Medicaid Services (CMS) virtual meeting of its Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) on February 13, 2023.

Good morning. I’m Sue Peschin, and I serve as president and CEO of the Alliance for Aging Research. The Alliance receives funding from BMS, Eisai, Biogen, and Lilly for non-branded health education and advocacy on CED-related issues.

I have comments on the proposed clinical study criteria, but I want to start by providing some context.

Many of you know the experience of going to the doctor for yourself, or with a loved one, and being told the office must call the insurance carrier to obtain coverage approval for a particular treatment. Or the doctor may break the news that you have to first try and fail on a standard treatment before insurance will cover a newer, better one. This is called utilization management, and it’s regularly used by insurance companies to save money.  

Coverage with evidence development—or CED—has become utilization management for the Medicare Part B program.

Under a CED, Medicare denies coverage for an FDA-approved item or service except through a very limited clinical study—either a CED clinical trial or data registry. Both CED clinical trials and data registries are subject to the criteria you’re voting on.

Today, the Alliance is releasing a report called Façade of Evidence: How Medicare’s Coverage with Evidence Development Rations Care and Exacerbates Inequity. Our reportincludes examples where only a fraction of estimated eligible beneficiaries are treated in very small CED studies—sometimes as little as in the dozens, as in the case of cochlear implants—and that has been over 17 years.

Once CMS places a treatment in CED, it’s extraordinarily difficult for it to end. An August 2022 systematic review of CED in The American Journal of Managed Care identified that CMS issued a total of 27 NCDs requiring CED between 2005-2022. Only four CEDs have been retired by the Agency and several of the current 22 CEDs have been ongoing for more than 15 years.  

Our report finds that Medicare beneficiaries in rural communities and communities of color are more likely to be denied access under CEDs because the conditions of coverage primarily direct care to urban medical centers in wealthier areas. Worse, CMS has exploited inequitable participation in existing CED clinical studies as justification to keep CED going—this happened with the amyloid PET and TAVR CEDs.

The vague CED study criteria being voted on will afford CMS unchecked power to not only lock up many more Part B treatments and services in future CEDs, but to throw away the keys. Here are just a few examples:

In CMS’s use of the terms “sponsor/investigator,” the Agency doesn’t distinguish between the parties that will carry out the CED study and the parties that are responsible for the overall conduct, funding, and oversight of the study.

The “Context,” recommendation sets up a “pass/fail” construct by requiring that “sponsors/investigators establish an evidentiary threshold for the primary outcome(s) so as to demonstrate clinically meaningful differences with sufficient precision.” It’s totally inappropriate for CMS to require this in post-market evidence development to demonstrate use is “reasonable and necessary” for Medicare beneficiaries.

While these recommendations removed the explicit inclusion of the Randomized Controlled Trial (RCT) they fail to clearly state that the use of an RCT—especially an RCT that is placebo controlled—should be rare and relied on only in unusual circumstances. We are concerned that these criteria are veiled attempts to require RCT participation for novel drugs authorized by the FDA under Accelerated Approval. CMS may not agree with Congress on the FDA’s Accelerated Approval pathway, but that doesn’t give them the right to take it out on Medicare beneficiaries with Alzheimer’s or other life-threatening conditions.

In addition to reviewing the CED process, my request is for the CMS Office of Inspector General to examine whether MEDCAC Chair and Vice Chair Drs. Ross and Dhurva should be permitted to vote on these recommendations, and whether another Chair and Vice Chair should be appointed for this meeting. On October 27—right after public comment on AHRQ’s report, with the process still open—Drs. Ross and Dhurva aired their views publicly in an opinion piece in the New England Journal of Medicine before CMS asked them to do so, which goes against the MEDCAC charter. The Federal Advisory Committee Act instructs against biasing activity, and Drs. Ross and Dhurva’s op-ed seems counter to that.

CMS is a payer; it is not a biomedical agency or anyone’s family doctor. There are strong signs that CMS intends to apply CED to upcoming FDA-approved gene and immunotherapy drugs and encourage Congress to codify its CED authority. These are worrisome issues that should concern all of us.

Thank you for the opportunity to present.