National Coverage Analysis (NCA) Tracking Sheet

Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease

CAG-00431R

Issue

Positron Emission Tomography (PET) is a minimally invasive diagnostic imaging procedure used to evaluate normal tissue as well as diseased tissues in conditions such as cancer, ischemic heart disease and some neurologic disorders. An injected radioactive tracer gives off subatomic particles, known as positrons, as they decay. PET uses a positron camera (tomograph) to measure the decay of these radioisotopes. The rate of tracer decay provides biochemical information on the tissue being studied. Certain tracers allow for imaging of beta-amyloid plaques in the brain of patients with cognitive impairment who are being evaluated for possible Alzheimer's disease or other causes of cognitive decline.

Currently NCD 220.6.20 covers one PET amyloid-beta (Aß) scan per patient in CMS approved studies under coverage with evidence development (CED).

CMS internally generated the opening of this NCD analysis based on stakeholder feedback, including public comments received during the finalization of the NCD for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=305) because clinical study protocols may involve more than one PET Aß scan per patient.

The purpose of this NCD reconsideration is to determine if the current policy of one scan per patient per lifetime should be revised.

Benefit Category

Diagnostic Tests (other)

Requestor Information

Requestor NameRequestor Letter
Internal N/A

Important Dates

Formal Request Accepted and Review Initiated
06/16/2022
Expected NCA Completion Date
03/16/2023
Public Comment Period
06/16/2022 - 07/15/2022
Proposed Decision Memo Due Date
12/16/2022
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
David Dolan
David.Dolan@cms.hhs.gov
410-786-3365
Lead Medical Officers
Joseph Hutter, M.D.

Actions Taken

June 16, 2022

CMS initiates this NCD analysis for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the topic under review.

Instructions on submitting comments can be found at: http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html.

To submit a comment, please use the blue "Comment" bubble at the top of the page. Enter comments directly into the “Submit A Public Comment” webpage.

December 15, 2022

CMS will not be issuing a proposed NCD on Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease today. A proposed decision is forthcoming after CMS has reviewed newly published evidence that is relevant to the proposed NCD.