Inflation and gas prices might be driving domestic political news, but for vulnerable communities hit hardest by diseases such as Alzheimer’s, health care is always top of mind. That concern rapidly can turn to frustration and anger when dealing with Medicare coverage — especially when promising new treatments are stifled by mismanagement in government bureaucracies.
If the Biden administration’s goal is to upset seniors — a key constituency in a pivotal election year — it is certainly succeeding. Despite inflating seniors’ Medicare Part B premiums to account for new drug costs that have not materialized, the Centers for Medicaid and Medicare Services (CMS) recently announced it won’t lower premiums again until next year, and perhaps not even then. The comedy of errors that led to this announcement is, in fact, a tragedy for seniors hoping to access Alzheimer’s treatments.
When the Food and Drug Administration (FDA) granted accelerated approval last summer for aducanumab (brand name Aduhelm), the first new Alzheimer’s medicine in two decades, it was a watershed moment for millions of patients. This medicine is part of a new class of treatments targeting amyloid beta plaques, one of the root causes of Alzheimer’s disease, rather than merely treating symptoms. It represented hope for patients and loved ones grappling with a devastating disease — and an opportunity to address socioeconomic inequities associated with it. With seniors poised to benefit, and several similar medicines under FDA review, CMS kicked off a process to update Medicare coverage.
But hope quickly shifted to anxiety as exaggerated calculations of the drug’s cost to Medicare contributed to intense pressure on government budgets, and in November 2021, CMS announced a historic spike in Medicare Part B premiums. The agency blamed half of the cost on the impending coverage of new Alzheimer’s medicines, even though it hadn’t completed its coverage analysis for Aduhelm. In other words, it front-loaded this unrealized cost onto seniors, even as inflation reached heights not seen in nearly 40 years.
Then, in April, CMS added insult to injury by restricting Medicare eligibility for these medicines to patients enrolled in certain clinical trials. As a result, only a few thousand patients, rather than a much broader pool of Medicare beneficiaries, stand to benefit from the treatment — massively reducing the potential cost for Medicare. Throughout this process, the Biden administration claimed to be considering how to lower Part B premiums, but ultimately locked them in at all-time highs.
There are several lessons to be drawn from this debacle, and some steps CMS can take to ensure this doesn’t happen again. The first is that CMS should focus on its core responsibility of managing the impact of coverage on programs and leave scientific issues to the FDA. CMS decided to limit coverage, despite the FDA approving Aduhelm using accelerated approval — a process that has been used since 1992 to expedite the availability of drugs combatting life threatening illnesses.
CMS is setting a dangerous precedent by straying out of its lane. It is not the role or responsibility of CMS to question the integrity of the FDA’s scientific process, just as it would be inappropriate for the FDA to analyze Medicare coverage impact, which is CMS’s job.
Furthermore, the decision to restrict coverage casts a shadow of uncertainty over several promising new Alzheimer’s treatments under FDA review. Decisions on lecanemab (Eisai) and gantenerumab (Roche) are expected later this year. Donanemab (Lilly) is in phase 3 trials, with data expected in mid-2023. Going forward, CMS should outline a policy for reviewing data for these medicines as soon as it’s available and — for those with positive outcomes — update coverage to ensure Medicare beneficiaries have timely access to them.
The process is crucial because CMS tends to move very slowly. The agency missed its deadlines for the coverage analysis process in 2021, creating delays that Alzheimer’s patients and their families cannot afford. For now, seniors are left holding the bag. Though CMS claimed it will consider the reduced cost of Alzheimer’s treatments in calculating 2023 payments, it was careful not to promise lower premiums.
Blunders and mismanagement on vital issues such as this surely will contribute to the Democrats’ expected rout in the November midterms. But, for the sake of patients and families, especially those who suffer because of diseases such as Alzheimer’s, let’s hope the aftermath will convince the Biden administration to get it right the next time around.
Mario H. Lopez is president of the Hispanic Leadership Fund, a public policy advocacy organization that promotes liberty, opportunity and prosperity for all Americans. Follow him on Twitter @MarioHLopez.