Get answers to frequently asked questions about the New IDEAS study
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.
Per cms.gov:
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.
Costs related directly to the PET scan and radiopharmaceuticals will be covered by Medicare per Coverage with Evidence Development (CED) — like any other covered service. Patients or their supplemental Medicare insurance providers will be responsible for the applicable deductibles or co-payments.
CMS also provided advice and guidance over the course of planning and writing of the New IDEAS study protocol. CMS will also be represented on the New IDEAS study steering committee.
The Alzheimer’s Association brought together and led the initial IDEAS study workgroup, convening various stakeholders and thought leaders in order to develop a national coverage with evidence development (CED) protocol in response to the CMS National Coverage Decision. The Alzheimer's Association identified and reconvened the IDEAS study leadership team and CMS to develop the New IDEAS study protocol. Alzheimer’s Association Chief Science Officer Maria Carrillo, PhD, is a co-chair of the study and will participate in guiding the data analyses, interpretation of the data analyses, ongoing oversight and decision making, plus communications for recruitment of participants, referring physicians and study sites.
The Alzheimer’s Association and the Society of Nuclear Medicine and Molecular Imaging were also instrumental in convening the workgroup that developed appropriate use criteria for brain amyloid PET scans.
The American College of Radiology (ACR), founded in 1924, is a professional medical society dedicated to serving patients and society by empowering radiology professionals to advance the practice, science, and professions of radiological care. The ACR provides leadership and logistical support for the New IDEAS Study. The ACR Center for Research and Innovation (CRI) is the clinical research centre of the ACR and has worked on the development of New IDEAS and writing of the protocol. The ACR will provide scientific leadership to the study, including study design, analysis and dissemination, and will provide ongoing oversight and decision making.
Dementia practices and PET facility locations will be approved to participate on a rolling basis. The study team plans to have participating practices and facilities across the United States. Imaging facilities will need to be accessible to patients seeing the referring dementia experts and have access to one of the FDA-approved amyloid imaging agents.
The study plans to cap dementia practice participation at 350 locations. Once sites are selected, they will be listed on the New IDEAS study website. A committee led by the American College of Radiology® is responsible for site selection and will make final decisions based on feasibility questionnaire submissions.
The New IDEAS study is currently reaching out to dementia specialists in areas identified by our community engagement and recruitment team. If you have not been contacted yet and would like to be considered for inclusion in the study, please send an email to newideas@acr.org.
Participation in New IDEAS requires the submission of a site feasibility questionnaire and subsequent approval by the study. Information about the New IDEAS study will also be disseminated via professional organizations dedicated to neurology, psychiatry, geriatrics, nuclear medicine and radiology.
Access the feasibility questionnaire for referring dementia sites.
The New IDEAS study is currently reaching out to dementia specialists in areas identified by our community engagement and recruitment team. Those practices are asked to identify which imaging facility they would plan on referring their patients to. The study team will reach out to the imaging facilities that are identified. If you have not been contacted by the study and would like to be considered as a participating facility, please send an email to newideas@acr.org.
Participation in New IDEAS requires the submission of a site feasibility questionnaire and subsequent approval by the study. Information about the New IDEAS study will also be disseminated via professional organizations dedicated to neurology, psychiatry, geriatrics, nuclear medicine and radiology.
Access the feasibility questionnaire for imaging facilities.
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.
The New IDEAS Study will pay the coinsurance/copayment amounts that study participants would otherwise owe for Medicare-reimbursable amyloid PET scans provided during the study. Study participants who receive their amyloid PET scan on or after January 1st, 2022 are eligible to have their amyloid PET scan coinsurance obligations submitted to the study sponsor for reimbursement, regardless of financial need. Reimbursement is not provided for patients who have supplemental insurance, such as Medigap, that covers 100% of any coinsurance obligations unmet by their primary insurer.
Study participants are still financially responsible for any unmet deductibles as well as coinsurance amounts associated with their visits to the dementia specialist office.
Please review the New IDEAS PET Coinsurance Reimbursement Policy for further details.
The New IDEAS study is currently reaching out to dementia specialists in areas identified by our community engagement and recruitment team. If you have not been contacted yet and would like to be considered for inclusion in the study, please send an email to newideas@acr.org.
Participation in New IDEAS requires the submission of a site feasibility questionnaire and subsequent approval by the study. Information about the New IDEAS study will also be disseminated via professional organizations dedicated to neurology, psychiatry, geriatrics, nuclear medicine and radiology.
Access the feasibility questionnaire for referring dementia sites.
Establishing the cause of cognitive impairment is necessary for doctors to make appropriate recommendations, prescribe the correct treatments, and inform patients and families about what to expect in the future. The best way to establish the cause of cognitive impairment is a thorough clinical assessment by a dementia expert, an evaluation that typically includes blood tests and a brain CT or MRI scan.
However, in some cases the diagnosis remains uncertain after such an evaluation, and further knowledge about the presence or absence of brain amyloid could provide valuable additional information. In some cases, a positive amyloid PET scan may confirm the clinical suspicion of Alzheimer’s disease. In such cases, establishing the diagnosis will help doctors initiate medications approved for the treatment of the disease. Furthermore, doctors will be able to make informed recommendations about the safety of continued employment, driving and independent living — now and in the future.
Patients and caregivers can be referred to the Alzheimer’s Association and other community resources to provide support and assist with future planning.
Studies suggest that, even in lieu of a cure or disease-modifying therapy, most patients seeking a clinical assessment for their cognitive symptoms want to know if the doctor suspects Alzheimer’s disease. Providing patients with the best possible diagnosis adheres to core principles of medical ethics, such as patient autonomy, truth telling, and lack of paternalism.
In other cases, a negative amyloid PET scan would render the diagnosis of Alzheimer’s disease unlikely. This might lead to the diagnosis of an alternative cause of dementia, which may have a different trajectory, prognosis and treatment plan. Doctors would elect to avoid prescribing or discontinue drugs that are effective in Alzheimer’s disease but may be ineffective and potentially even harmful to patients with a different dementia. In some cases, a negative amyloid PET scan might help doctors determine that cognitive impairment is due to a medical condition, mood or sleep disorder, or medication side effect — dramatically altering the prognosis and care plan.
Before enrolling in the New IDEAS study, patients and their doctors should discuss the ramifications of amyloid PET testing and carefully consider how a positive or negative amyloid PET result will impact the care plan as well as the patient’s overall well-being. The scan should not be pursued if it is felt that knowledge of amyloid status will cause significant psychological harm or otherwise negatively impact the patient and family.
Disclosure of the PET scan result and subsequent management recommendations need not wait for the post-PET visit. We hope that clinicians will provide feedback to patients and their families shortly after the scan is read. The post-PET visit then records the patient management implemented by the patient/family.
Two visits are recommended:
To put it in concrete terms: we want to record the actual implemented management at the 90 days post-PET timepoint (e.g., whether someone who was at baseline medication-naïve is actually on a medication), rather than whether it was recommended immediately after the scan (intended management).
The New IDEAS study is currently reaching out to dementia specialists in areas identified by our community engagement and recruitment team. Those practices are asked to identify which imaging facility they would plan on referring their patients to. The study team will reach out to the imaging facilities that are identified. If you have not been contacted by the study and would like to be considered as a participating facility, please send an email to newideas@acr.org.
Participation in New IDEAS requires the submission of a site feasibility questionnaire and subsequent approval by the study. Information about the New IDEAS study will also be disseminated via professional organizations dedicated to neurology, psychiatry, geriatrics, nuclear medicine and radiology.
Access the feasibility questionnaire for imaging facilities.
The New IDEAS study will include the three amyloid PET imaging radiopharmaceuticals that have been approved by the U.S. Food and Drug Administration (FDA) for clinical use:
Amyloid PET tracers that have not been approved by the FDA for clinical use will not be included in the New IDEAS study.
Yes. Note that the technical charge for a PET study on a Medicare inpatient is not billed directly, but rather is considered to be covered by the Diagnostic Related Grouping (DRG) payment to the hospital for that patient. Inclusion of a patient in the New IDEAS Study is necessary, however, for professional component reimbursement for the PET study if performed on an inpatient. It is expected that brain amyloid PET imaging in a patient meeting the eligibility criteria for the New IDEAS Study would rarely need to be done while the patient was hospitalized.
The answer depends on the payer, but in general, yes, Medicare supplemental (Medigap) insurance plans (or Medicaid, if applicable) should cover the co-payment, as for any other Medicare-covered service, in patients with traditional Medicare coverage (Part A and Part B). There are some third party payers that deny picking up the co-payments; Tricare, for example, will not cover these costs. We will list more as we become aware of these payers.
However, any coinsurance costs related to the amyloid PET scan that are not covered by the beneficiary's supplemental plan, will be covered by the study sponsor.
Please refer to the New IDEAS Coinsurance Reimbursement Program Policy for additional detail.
Yes, Medicare Advantage (MA) beneficiaries are eligible to be included in the New IDEAS Study. The MA plans will make payments for MA enrollees. New IDEAS Study claims should be billed to the MA plan. This policy is located in Publication 100-16, Chapter 4: Managed Care Manual 10.7.3 – Benefits and Beneficiary Protections – Payment for Clinical Studies Approved Under Coverage with Evidence.
Beneficiaries enrolled in Medicare Advantage (MA) plans are responsible for any unmet deductibles and co-payments associated with their visits to the dementia specialist.
Any coinsurance related to the amyloid PET scan will be covered by the study sponsor. The PET provider MUST NOT bill the MA enrollee for any co-insurance, outside of an unmet deductible.
Please refer to the New IDEAS Coinsurance Reimbursement Program Policy for additional detail.
Publication 100-3 Section 310.1 of the NCD Manual: Routine Costs in a Clinical Trial states that Medicare Advantage (MA) plans may request prior authorization or approval for enrollees participating in clinical trials or for coverage with evidence development in CMS-approved trials. Referring physicians or PET facilities should obtain pre-authorization for patients in MA plans or document (e.g., date, time and person with whom you spoke) the details of the call. In some instances, the MA plans may direct patients to their preferred providers assuming the MA plan preferred providers are qualified and participating in the New IDEAS CED Study.
If you receive a denial on the prior authorization from a MA plan, it is recommended that all levels of appeal be used with Medicare Advantage plans as we are aware from the IDEAS CED Study, of MA plans that denied the first request for prior authorization for a PET scan. A facility should appeal that denial and, if the first appeal is denied, the facility should appeal once again. You will need to state: “ [T]his patient is enrolled in the CMS-approved CED program known as the New IDEAS Study” and be sure to provide additional documentation to support your request.
As a reminder, Medicare Advantage (MA) beneficiaries are eligible to be included in the New IDEAS Study and the MA plans will make payments for MA enrollees. New IDEAS Study claims should be billed to the MA plan. This policy is located in Publication 100-16, Chapter 4: Managed Care Manual 10.7.3. – Benefits and Beneficiary Protections – Payment for Clinical Studies Approved Under Coverage with Evidence.
The last level of appeal should reach an Independent Review Entity (IRE). More information regarding IRE can be found at https://www.cms.gov/medicare/appeals-and-grievances/mmcag/ire.html. Finally, you may submit a completed New IDEAS claim denial form after the first prior authorization or first post imaging denial. We will simultaneously engage our CMS colleagues to identify why you received that denial; however, we request that you continue all appeals while we review with CMS.
No. All participating sites are required to use Advarra as the IRB of record for New IDEAS. The study has provided detailed instructions on how to use Advarra. Local IRB stamp of approval or acknowledgement is allowed, but oversight of study conduct must be given to Advarra.
Note: required institutional language can be included in the template ICF but must receive approval by the study and Advarra before use.
We will do our best to make sure that the patient and management information obtained during the course of this research study is kept private. However, we cannot guarantee total privacy. Study information may be given out if required by law. If information from this study is published or presented at scientific meetings, participant name and other personal information will not be used.
The New IDEAS study database will contain only unique identifiers for patients to protect their identities. The study investigators will need to know patients’ identities in order to coordinate collection of Medicare claims data for the study. Protected health information (PHI) required for the study will be kept in a database dedicated to PHI, which will be housed separately from the primary database used for analysis purposes. Only the dementia specialist, the ACR data management center, the statistical team coordinating collection of claims data from CMS, and members of the IRB will have access to the records.