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Blog: For Medicare Beneficiaries Living with Alzheimer’s, Basic Human Decency is at a Premium

October 12, 2022   |   Sue Peschin   |   Comparative Effectiveness Research, FDA & Regulatory Policy, Medicare, Clinical Trials
Older woman seated beig hugged from behind by younger woman

Sue Peschin, MHS, President and CEO

The Medicare program recently announced that the decrease in the 2023 Medicare Part B monthly premium was due to “lower-than-projected spending on both Aduhelm and other Part B items and services.” Aduhelm is a medical treatment that was approved by the FDA in June 2021 for people with mild cognitive impairment and mild stage disease due to Alzheimer’s.

This year’s program announcement serves as a partial reversal of last year’s $21.60 monthly premium increase, which cited Aduhelm as the reason behind half of the increase. Last year was the first time that the Centers for Medicare & Medicaid Services (CMS)—the federal agency that runs the Medicare program—had publicly blamed the cost of care for a disease-specific treatment as the rationale for raising premiums. The agency offered no explanation for how the large Part B premium growth due to Aduhelm was calculated. Despite this lack of transparency, the U.S. House Energy and Commerce Committee piled on with a press release using the announcement to promote drug pricing legislation.

Through a blog post, and meetings with the agency at which we were accompanied by people living with the disease, our organization appealed to CMS to stop singling out Alzheimer’s as the cause for the premium increase. In our view, putting Alzheimer’s patients in the middle of the drug pricing debate was discriminatory and could worsen existing stigma about the disease. We spoke with CMS and U.S. Department of Health and Human Services (HHS) officials in successive meetings all the way up to the White House to implore them to never do this again.

So, the fact that the Administration allowed CMS to double down on its Medicare premium announcement gimmick this year was not only tactless, but also heartless.

While lowering Medicare premiums may be considered savvy election year politics, it is a hollow victory for the older adults and people with disabilities who are served by the program. Using Aduhelm as a test case, CMS made a sweeping change in Medicare Part B coverage policy that the agency can apply in the future to limit access to new, FDA-approved drug and biologic treatments for Medicare beneficiaries with any disease.

The national coverage policy used requires “Coverage with Evidence Development,” or CED. Under CED, Medicare covers FDA-approved medical treatments on an extremely limited basis, and under the condition that beneficiaries must enroll in a clinical trial or patient registry.

However, the idea that CED is a temporary determination while CMS collects more “evidence” is a ruse. CMS is a payer, not a biomedical science agency. In practice, the “evidence development” under CED serves as an extreme form of utilization management for millions of Medicare beneficiaries. An April 2022 study published in the American Journal of Managed Care (AJMC) on the CED process notes that of 27 CEDs initiated over the past 15-20 years, less than 20 percent have been concluded, and several never resulted in a study at all. The result is that numerous new treatments and technologies continue to be severely limited without ongoing justification.

Arguments against the use of CED for FDA-approved Alzheimer’s therapies carried weight with 40 U.S. lawmakers, led by Reps. Nanette Diaz Barragán (D-CA), Barbara Lee (D-CA), Brett Guthrie (R-KY), and Mariannette Miller-Meeks (R-IA). Their bipartisan letter to HHS and CMS leaders asked for a reconsideration of the coverage decision due to equity and access concerns for Medicare beneficiaries of color and people with disabilities. Unfortunately, despite the lawmakers’ collective plea, the agency pressed forward with the CED.

Particularly worrisome are the signs from CMS toward wider application of CED. The agency recently asked the Agency for Healthcare Quality and Research (AHRQ) for a draft report with recommendations to update CED clinical study requirements. A public comment letter to AHRQ signed by 20 national organizations expressed serious concerns that “the draft report proposes to add even more ill-defined study ‘options’ to the list of CED study programs that CMS may already employ. The AHRQ report will thus not contribute to the improvement of the CED process, but rather further cloud the already muddy CED waters.”

Why not, instead of Medicare chomping at the bit to restrict treatment access for people with Alzheimer’s and other chronic diseases, we work together to create a culture and policies that respect aging as a greater good and values investments that advance independence, dignity, and equity? I bet a lot of people would be willing to pay a higher premium for that.

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