Kelly Cleary Quoted by The Pink Sheet on Medicare Coverage of Alzheimer’s Drugs

For its article “Medicare's CED For Alzheimer's Drugs May Exceed Statutory Authority, Former HHS Attorneys Say,” The Pink Sheet quoted from comments made by Akin Gump health care and life sciences partner Kelly Cleary at a recent webinar sponsored by Alliance for Aging Research.

The article discusses the view, held by Cleary and others, that the Centers for Medicare and Medicaid Services (CMS) diverged from precedent and its statutory authority in proposing that Medicare would only cover Alzheimer’s drugs, including Aduhelm, for those patients enrolled in approved randomized clinical trials.

Cleary said, “I think there are problems with their authority here, primarily with the entire CED [Coverage with Evidence Development] paradigm itself.” She noted that the relevant Social Security Act provision states that “even if CMS doesn’t think something is reasonable and necessary to treat an illness,” Medicare can still pay for it for research purposes as conducted or supported by the Agency for Healthcare Research and Quality [AHRQ].

However, she said, that, as she read the proposed coverage decision, she did not see that AHRQ was funding or conducting a study. She asked, “So, what is AHRQ doing to support a study? Because they need to support it for this legal theory to work out.”

She said that CED, contrary to some agency statements, does not involve expanding access to “things that would otherwise be foreclosed. That’s not the case here and that’s not the case with some of the other CED coverage decisions that have come down in recent years.”

Cleary noted that CMS has justified many past CED decisions by stating that product research involved an insufficient number of Medicare beneficiaries, which, she says, is not the case with Aduhelm: “I think I read that 80% of the clinical trial participants were age 65 or older. It's really just a head-on disagreement with the entire evidentiary base itself.”

She said that this situation is one in which “if you start to pull the thread a little bit the sweater unravels and [CMS] is applying CED in an entirely new way.” Cleary said that this is a trend that is not going away, and that the “threat of that coverage decision is going to be a dark cloud over innovation.” She believes that Congress or a court needs to step in and answer these questions about authority in a way that “forces the department’s hand…for more rational ways of coverage.”