New IDEAS: Imaging Dementia—Evidence for Amyloid Scanning Study
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New IDEAS is an observational, open-label, longitudinal cohort study designed to address the requirements of the CED provisions of the NCD on beta-amyloid PET. Building on the initial Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) study, New IDEAS will evaluate the association between amyloid PET and patient-centered outcomes in an expanded and more ethnoracially and clinically diverse group of Medicare participants presenting with cognitive impairment. A total of 7,000 Medicare beneficiaries meeting the study’s eligibility criteria will be consented and enrolled over 30 months at sites throughout the United States. To ensure diversity, the study will enroll at least 2,000 Blacks/African Americans, at least 2,000 Latinos/Hispanics, and up to 3,000 additional participants from other racial and ethnic backgrounds. Based on disease stage prior to PET, all participants will be classified as having MCI or dementia. Based on their clinical presentation prior to PET, all participants will be classified as having “typical” (i.e., progressive amnestic) or “atypical” clinical presentations of AD.
Tailored recruitment strategies will be implemented to ensure inclusion of underrepresented populations including Black/African American patients, Latino/Hispanic patients, patients with early-onset (age < 65) cognitive impairment, and patients with typical or atypical presentation of MCI or dementia.
Dementia specialists will team with PET facilities that have trained radiologists/nuclear medicine physicians and access to perform amyloid PET. Amyloid PET will be performed and interpreted at each facility with results provided to the ordering physician for support in further decision making. The dementia specialists will record their diagnosis and intended management plan based on the current clinical and diagnostic information, and assuming no access to amyloid PET at the “pre-PET visit.” PET results will be disclosed to participants and changes in management will be recommended at the “PET disclosure visit.” Patients will return 90 ± 30 days following PET for an in-person “post-PET visit.” At this final visit, specialists will record the diagnosis and implemented management plan, incorporating amyloid PET into clinical decision making. Medicare claims data will be collected directly from CMS for 12 months prior to the PET imaging and 12 months after the PET imaging for each participant.
The New IDEAS study differs from the original study by:
The New IDEAS study is a CMS Coverage with Evidence Development (CED) study and is designed to be analogous to routine care. Paying enrollees' out-of-pocket costs for an FDA-approved and clinically available procedure would not be consistent with routine care.
The New IDEAS study will provide additional data to allow CMS to complete the CED cycle. This may result in Medicare coverage for a brain amyloid PET scan for all eligible Medicare beneficiaries. Once the CED cycle is complete, Medicare coverage, as in the New IDEAS Study, would continue to be subject to individuals’ benefits per their insurance plan(s).
For more information about CED see the CMS website.
That is for CMS to decide. The New IDEAS study leadership has taken several well-considered steps in order to ensure meaningful study results in this regard. These include:
Study participants must be Medicare beneficiaries, with Medicare as their primary health insurance, be referred by a qualified dementia specialist, and must fit the following basic inclusion criteria:
See full inclusion and exclusion criteria for participation in New IDEAS.
A total of 7,000 Medicare beneficiaries meeting the study’s eligibility criteria will be consented and enrolled over 30 months at sites throughout the United States. To ensure diversity, the study will enroll at least 2,000 Black/African Americans participants, at least 2,000 Latinx/Hispanic participants, and up to 3,000 additional participants from other racial and ethnic backgrounds.
Yes. As excerpted from the patient consent:
“If you join the study, your amyloid PET scan will be paid for by Medicare as a covered benefit under the Coverage with Evidence Development (CED) program. As with any medical service covered by Medicare, you will still be responsible for any deductible or co-payment required for the service. The amount you would have to pay will depend on whether or not you have supplemental insurance or other coverage for your deductible and co-payments. Your visits to your doctor will also be billed to your applicable insurances with the same responsibility of deductible or co-payment of the service.”
There is no mechanism in place to allow for coverage of the co-pay.