This article is adapted from the latest STAT report: Decoding Medicare: 10 Key Coverage Decisions and How They’re Made.
mEdicares’ decision to suspend coverage for Biogens Aduhelm despite the Alzheimer’s drug approval by the Food and Drug Administrations has revived long-standing questions about how the federal program determines whether it will pay for new drugs and devices.
In its decision, the Centers for Medicare and Medicaid Services cited a lack of sufficient evidence of Aduhelm’s effectiveness and limited payment for the drug to patients enrolled in the research studies. The agency said it would apply the same limits to other new Alzheimer’s drugs that, like Aduhelm, target amyloid plaques in the brain.
The move has received strong praise from some. But critics of the decision, including some physicians, drug makers and members of Congress, have argued it runs counter to Medicares’ mandate established by Congress when it created the program in 1965 to cover products that are reasonable and necessary for health. diagnosis or treatment. of an illness or injury and would unfairly limit access to a promising new class of drugs.
Rep. Brett Guthrie (R-Ky.), the health subcommittee chairman of the House Energy and Commerce committees, went so far as to ask if perhaps Medicares’ core mandate should be revisited.
Do you think CMS would benefit from Congress providing more clarity on the phrase “reasonable and necessary” in the Medicare program? Guthrie asked CMS Chiquita administrator Brooks-LaSure, at a hearing in April.
This isn’t the first time this question has been asked.
Medicare is increasingly requiring evidence for the safety and effectiveness of new drugs and devices, a trend noted in a new STAT report, Decoding Medicare: 10 Key Coverage Decisions and How They Were Made.
But CMS officials have struggled for decades over how to define the reasonable and necessary standard and which products it should apply to.
In 1989, federal officials who oversee Medicare released a draft law intended to provide greater clarity on this matter. The draft standard included a cost-effectiveness section with a specific exemption for breakthrough or life-saving technologies, for which no comparable alternatives existed. But the cost-effectiveness provision prompted substantial protests from industry groups, leading federal officials to drop the proposed rule.
CMS made another attempt to define reasonable and necessary in a rule the agency finalized in 2021 during the final days of the Trump administration. In January 2021, hoping to give the definition more regulatory weight, the agency included the definition already in its Medicare Program Integrity Handbook. Section 13.5.4 of the manual instructed Medicare administrative contractors to consider three criteria:
- If a product is supplied in accordance with accepted standards of medical practice for the diagnosis or treatment of a patient’s condition
- If a product is provided in an environment appropriate to the medical needs and condition of the patient
- And if a product meets, but does not exceed, a patient’s medical need
However, the Biden administration withdrew the rule later that year.
Decisions made this year by CMS on new Alzheimer’s drugs targeting amyloid will likely determine whether members of Congress like Guthrie pursue revisions to the law that sets Medicare’s reasonable and necessary standard.
An opportunity to make up for it
The FDA has approved Aduhelm as part of its fast track to accelerate the approval of drugs for serious diseases. The agency is expected to decide by July 6 whether to grant traditional approval for another amyloid-targeting drug, Eisais Leqembi, based on Phase 3 data (fast track approval was granted in January. Eli Lilly & Co. earlier this month it released some leading findings for Its Alzheimer’s drug, donanemab, is also designed to treat the disease by clearing amyloid plaques. The company said 47 percent of donanemab participants did not showed no decline in functioning, as measured by the Clinical Dementia Rating-Sum of Boxes scale, compared to 29% of placebo-treated participants.
In a virtual appearance at STAT’s Breakthrough Summit in San Francisco in early May, Daniel Skovronsky, Lilly’s chief scientist and physician, tried to draw a distinction between his company’s drug and Aduhelm.
Looking at aducanumab’s data, it’s hard to fault reasonable people for disagreeing that there’s enough evidence to use this drug, Skovronsky said, referring to Aduhelm by its scientific name.
But Lilly expects to be able to strongly advocate for its medicine, he said, and that should obviate the need to require people to participate in research to gain access to amyloid-targeted drugs. Skovronsky said she expects CMS to change its position and provide reimbursement for the drugs, based on stronger evidence from studies.
I understand how CMS got here on the aducanumab data facts, but now they have an opportunity to fix it, he said.
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