Senators Press HHS Chief on Alzheimer's Drugs, Opioids at Budget Hearing

WASHINGTON -- Alzheimer's disease treatments, the opioid epidemic, and funding for rural healthcare were all in the spotlight during a Senate hearing on the Biden administration's proposed budget for the Department of Health and Human Services (HHS) in fiscal year 2024.

"It is with great disappointment that [I understand] CMS [the Centers for Medicare & Medicaid Services] is blocking and acting as a roadblock for patient access to drugs that could be very helpful to these patients," Sen. Susan Collins (R-Maine) told HHS Secretary Xavier Becerra, the lone witness at Wednesday's hearing held by the Senate Appropriations Subcommittee on Labor, HHS, Education, and Related Agencies. "I just do not understand CMS's misguided and outright unprecedented decision to not cover a whole class of Alzheimer's drugs. It is not CMS's job to second-guess the drug approvals of the FDA. That's not what CMS is supposed to do."

Collins was referring to the agency's decision in January not to cover the Alzheimer's disease treatment lecanemab (Leqembi) for Medicare beneficiaries unless the beneficiary is enrolled in a clinical trial of the drug. The FDA approved lecanemab under an accelerated approval pathway, as it had done with aducanumab (Aduhelm) in 2021. Medicare also has the same coverage requirement for aducanumab.

"It's not enough to say you can get it if you're in a clinical trial," Collins continued. "That's so little help to states like ours where there may not be a clinical trial going on, or it may be far away from most people in the state. I'm just asking you to tell CMS to let this drug be used, and let people get access to it when the patient and the clinician agree it's the appropriate treatment."

But Becerra pushed back. "There's no doubt we want to get to the type of lifesaving treatment Americans can benefit from," he said. "The difficulty here is that we have to remember that the process that the FDA uses is different from the process that legally CMS must use to make their determinations. And while it may not make a lot of sense to folks, there is a legal distinction. And CMS has to remain consistent in the way it treats any drugs."

Subcommittee chair Sen. Tammy Baldwin (D-Wisc.) asked Becerra to discuss the administration's plans for tackling the mental health and substance use disorder crises, which have worsened during the pandemic. "In my state of Wisconsin, there were over 1,427 opioid-related deaths in 2021, a 16% increase over 2020 and a 70% increase over the number of deaths in 2018," she said. "I know my colleagues are seeing similar grim statistics in their states. Of particular interest, I will want to know what the administration is doing to curb the tragic increase in overdoses and poisonings due to fentanyl. This drug is wreaking havoc across the country, and we must partner to take an 'all of government' approach to prevent it from coming into our communities."

"This budget invests some $11 billion, including some $10 billion in discretionary funding for programs that try to target opioids and overdose-related activities," Becerra said. "It is a significant increase over previous years, and it complements the work that we've done to establish a new strategy when it comes to drug overdose and treatment, where we don't only try to prevent people from taking up a drug, but also ... we worry about harm reduction, to make sure that we're preventing people from harming themselves before they finally can get the treatment they need." HHS also is investing in post-treatment services so people become productive members of society after they finish treatment, he added.

Sen. Cindy Hyde-Smith (R-Miss.) asked what HHS was doing to help keep smaller, rural hospitals open. Although hospitals are paid a set amount for each patient's illness using the diagnosis-related group (DRG) system, "patients are staying longer and they're exceeding those DRG payments, and hospitals are losing money hand over fist," she said. "They're held longer in their smaller hospitals while waiting for bed placements in a larger hospital ... But how do we overcome a financial challenge that was made worse by COVID and inflation? Have you or the agency considered establishing a temporary per diem payment to the hospitals to help address this?"

Becerra agreed this was a problem. "Everyone is trying to figure out: How do we get resources and commitments into these communities?" he said. "One of the things we're trying is [with] graduate medical education slots ... Maybe we could try to get some of these into communities that haven't always had these teaching slots available, because the evidence shows that if you locate a student in the residency program, by the time they finish that residency program in that community, they often stay there and develop their practice there."

Hyde-Smith seemed dissatisfied with that answer. "So are you saying that a temporary per diem is not being considered?"

"I have to get back to you -- I'm not sure if that is one of the considerations," said Becerra. "I would suspect that one of the issues with a temporary per diem would be the cost. Where would the money come from to do that?"

Sen. Jeanne Shaheen (D-N.H.) wanted to know how well the $35-per-month cap on insulin copayments for Medicare beneficiaries -- passed as part of the Inflation Reduction Act -- was working. "Do we have any data that shows what the impact of that has been?"

"We're beginning to collect the data," Becerra said. "And the anecdotal stories I'm hearing from actual insulin users is perhaps the best evidence." He cited a North Carolina woman he had spoken to who was shocked when she was only charged $35 for her monthly supply of insulin after previously paying $117. "She went back to the insurer and said, 'I think I owe some money.' She had to be told, 'No, that's the cost now.'"

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