The Centers for Medicare & Medicaid Services (CMS) released new details Thursday about how it plans to collect patient data as a condition of coverage for a new class of Alzheimer’s drugs, once the medications get full approval from the FDA.

CMS detailed a plan earlier this month to cover the costly drugs for patients enrolled in Medicare Part B who meet the criteria for coverage. That criteria includes patients’ physicians and clinical teams participating in registries to collect evidence about how the drugs work in the real world.

The coverage plan will be likely put to the test with a potential approval for Biogen and Eisai’s Leqembi slated for this summer.

A year ago, CMS issued a narrow and controversial Medicare coverage proposal for Biogen’s Alzheimer’s disease drug Aduhelm. The agency said drugs approved under the FDA’s accelerated pathway will only be covered when administered in eligible clinical trials.

The new CMS registry approach is intended to make the drugs more widely available once they gain full FDA approvals.

The nationwide registry for clinicians, which will be available on CMS’ website, will be free to use, according to the fact sheet.

Clinicians will submit information to this registry when furnishing this drug to people with Medicare. The “Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease Registry” will be available nationwide on CMS’s website if the FDA gives any of these drugs traditional approval, the agency said.

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