Kelly Cleary Quoted by Bloomberg Law on Medicare Coverage for Alzheimer’s Drug

For its article “Brewing Alzheimer’s Drug Plan Fights Rest in Patients’ Hands,” Bloomberg Law quoted Akin Gump health care and life partner Kelly Cleary.

The article notes that the Centers for Medicare & Medicaid Services (CMS) restricted coverage for Biogen Inc’s Alzheimer’s drug Aduhelm, and that the drug maker is considering challenging the legality of CMS’s decision, including indirectly supporting an administrative appeal or lawsuit filed by individual beneficiaries who have been denied access to the drug.

The article also notes that CMS said it would provide coverage with evidence development (CED) for Aduhelm and other similar drugs, which would restrict coverage to patients in randomized controlled trials or prospective comparative studies.

Cleary, who served as Deputy General Counsel at HHS and Chief Legal Officer for CMS, said that she questions whether CMS should have the authority to condition Medicare coverage on participation in a clinical trial.

On the topic of a court challenge, she said that it could help resolve the matter, but Biogen and other drugmakers could risk losing all coverage for Aduhelm and comparable drugs. Cleary explained that were a court to rule that CMS does not have the authority to implement CEDs, the agency could “make a determination that it is not reasonable or necessary ever, and therefore completely restrict coverage.”