Kelly Cleary Quoted on Potential Medicare Lawsuit re: Drug Coverage
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For its article “Will Biogen sue Medicare over its restrictions on the Alzheimer’s drug, Aduhelm? And other big legal questions about the decision,” STAT quoted Akin Gump health care and life sciences partner Kelly Cleary.
The article discusses a lawsuit against Medicare being considered by Biogen and other drugmakers regarding Medicare’s decision to limit coverage for the new drug Aduhelm. One major drugmaker, STAT notes, argues that Medicare does not have the ability to issue coverage with evidence development (CED) determinations.
Cleary, who served as Deputy General Counsel at the Department of Health and Human Services and Chief Legal Officer for Centers for Medicare & Medicaid Services, said, “There are legitimate questions about the appropriateness of this coverage with evidence development paradigm. It’s definitely ripe for review by a court.”
The publication notes Medicare’s argument that it only pays for drugs pursuant to research conducted by the Agency for Healthcare Research and Quality (AHRQ), as well as the fact that AHRQ is not involved in conducting that research. Cleary called that justification for imposing CEDs a “questionable legal theory.”
In the event that a lawsuit should be filed, Cleary predicted that, even were Medicare to lose, the agency would either say it is not covering the drug at all or allow local contractors to decide themselves how to cover the drug.
