The Medical Imaging & Technology Alliance (MITA) – the leading trade association representing manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices – has submitted comments to the Centers for Medicare & Medicaid Services (CMS) regarding reconsideration of the National Coverage Determination (NCD) for Beta Amyloid Positron Emission Tomography (PET) in dementia and neurodegenerative disease.

“Withdrawing the coverage limit of one lifetime beta amyloid PET scan is an important step towards optimal care for patients with Alzheimer’s. However, revising the scan limit without addressing the limitation on beta amyloid imaging to very limited coverage with evidence development (CED) clinical trial studies will do little to address patient access challenges and is a missed opportunity,” said Patrick Hope, Executive Director, MITA.

MITA’s comments note that CMS’ reconsideration “must go beyond the one test per lifetime limitation in order for patients to appropriately access this critical service.” Moreover, independent of the availability of amyloid targeting therapies, MITA’s comment letter points out that the data accumulated over the past ten years have consistently demonstrated that the knowledge of amyloid status adds value to the management of patients, minimizes misdiagnosis, increases physician confidence in diagnosis, and reduces the risk of adverse events due to potentially inappropriate treatment.

MITA urged CMS to allow Medicare beneficiaries to benefit from this important diagnostic tool by fully reconsidering all provisions of the beta amyloid PET NCD and to support national coverage of beta amyloid PET.

MITA’s full comment letter can be viewed here.

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