The Biden Administration is stumbling from one unforced error to the next. In its latest blow to a key voting constituency, the Centers for Medicaid and Medicare Services (CMS) has decided to stick seniors with the cost of the agency’s miscalculation for Medicare Part B premiums. This bureaucratic comedy of errors is playing out like a tragedy for seniors—especially those hoping to access new Alzheimer’s treatments.
How did we get here? Back in November 2021, CMS announced a historic spike in Medicare Part B premiums and deductibles due in large part to the arrival of new Alzheimer’s medicines, one of which the FDA had approved earlier that year. Though CMS was still assessing how to cover this treatment, the agency assumed a very high coverage (and therefore cost) impact and preemptively made seniors foot the bill, despite their fixed incomes already stretched thin by record inflation.
But then in April, CMS decided to restrict access to these medicines only to patients enrolled in certain clinical trials, massively reducing both the benefit to seniors and the cost for Medicare. Despite the fact that at most a few thousand seniors will now likely need Medicare to cover the cost of treatment, CMS said it won’t premiums until next yet—and maybe not even then.
Writing in The Hill, Mario Lopez, President of the Hispanic Leadership Fund, makes several recommendations to avoid repeating these mistakes:
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.
Another data point regulators should consider for future coverage decisions comes from a new study of Medicare out-of-pocket cost exposure. Paying for care beyond what Medicare covers is an ongoing concern for the nearly 50 million Part B beneficiaries aged 65 and up, as expenditures for these drugs and services are growing faster than those covered by other Medicare programs. That concern was reiterated in the public discussion around new Alzheimer’s treatments and the potential out-of-pocket costs seniors could have to foot.
The study looked at the totality of coverage that Medicare beneficiaries secured in 2021 and estimated that 97% of seniors 65 and up had some form of coverage through their plans, secondary insurance, or supplemental coverages that capped or eliminated out-of-pocket expenditures for Part B drugs and services. The remaining 3% were responsible for a 20% coinsurance pay.
It’s important that seniors in this latter category are not left to face a decision between accessing life-saving medicines and going broke. But the study concludes that Medicare’s design ensures that the overwhelmingly majority of beneficiaries should be able to access medicines through Part B without incurring unlimited out-of-pocket costs. This should help regulators and policymakers more accurately assess the financial impact for seniors as new Alzheimer’s treatments become available.