Frequently Asked Questions

Get answers to frequently asked questions about the New IDEAS study

Protocol Information

The New IDEAS Study: Imaging Dementia—Evidence for Amyloid Scanning is a Coverage with Evidence Development (CED) study approved by CMS. The New IDEAS study builds upon the original IDEAS study completed in early 2018 which was an unprecedented collaborative study to demonstrate the value of amyloid PET scans in Alzheimer’s Disease diagnosis. New IDEAS will address additional gaps in knowledge that are highly relevant to improve precision in future coverage decisions and implementation of amyloid PET in clinical practice.

The New IDEAS study differs from the original study by:

  • Sample size — New IDEAS has 7,000 (compared with approximately 18,000 in IDEAS, the largest Alzheimer’s disease study).
  • Increased focus on recruitment of underrepresented minority populations.
  • Includes early-onset and typical clinical presentations of Alzheimer’s disease.
  • ApoE genotyping via saliva collection.
  • Optional blood collection to establish a biorepository.
Enrollment is expected to begin in Q4 of 2020 and runs through Q1 2023, provided there are no delays as a result of the global COVID-19 pandemic.

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.

 

Per cms.gov:

  • CED is a paradigm whereby Medicare covers items and services on the condition that they are furnished in the context of approved clinical studies or with the collection of additional clinical data.
  • A CED cycle is considered “completed” when CMS removes a requirement for study participation as a condition of coverage for one or more indications of an item or service.

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.

Compared to the original IDEAS study, the New IDEAS study has a goal of ensuring that patients living in underserved communities are included in Alzheimer’s disease research. Strategic awareness-raising and tailored recruitment strategies led by team investigators who are experts in community-engagement approaches and research methods will support participation of racial and ethnic minority communities in New IDEAS. Key factors in the recruitment will include the research team partnering with community members and healthcare providers in select metropolitan areas to encourage Black/African American and Latinx participation.

The New IDEAS study team will enroll 7,000 Medicare beneficiaries across the United States to kick off the study. Enrollment will include 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 to specifically address the dearth of racially and ethnically diverse research participants in Alzheimer’s disease clinical research.

Among the participants enrolled in New IDEAS, individuals with early-onset dementia (<65 years of age) will be included for analysis, as well as individuals of both typical or atypical clinical presentations of mild cognitive impairment and dementia. New IDEAS will also collect biological samples such as saliva and blood to be stored in a New IDEAS biorepository. New IDEAS researchers and others will use these samples to test and validate emerging genetic and plasma biomarkers for Alzheimer’s disease and all other dementia from an early and accurate diagnosis.

Finally, beyond amyloid PET, there are many additional biomarkers in development for Alzheimer’s disease and other causes of dementia. Results from the New IDEAS study will help create precedent and lay the groundwork for the type of information that regulators will need when considering coverage for future biomarkers.

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:

  • Both studies have been modeled after the largest successful Coverage with Evidence Development (CED) study. The National Oncologic PET Registry (NOPR) collected data to assess the effect of PET on management of over 300,000 Medicare beneficiaries with cancer and afforded broad access to Medicare reimbursement for these patients.
  • Both studies are sufficiently powered to demonstrate changes in health outcomes and patient care management as a result of knowing the results of a brain amyloid PET scan.
The New IDEAS study’s Biostatistics and Data Management Center will monitor participant accrual and data submission. The organizational structure is modeled after other successful studies of this type and attempts to provide the optimal balance between tight control and broad engagement. The combination of a steering committee (with associated subcommittees) and operations center creates an effective structure that will promote rapid completion of the study while ensuring maximum data integrity. Quality assurance procedures for amyloid PET interpretation will include vendor-specific training programs. Vendors will have expert consultants available to local readers for cases that might require additional assistance in interpretation.
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Collaborators & Roles

New IDEAS is sponsored and managed by the American College of Radiology® (ACR®), directed by the Alzheimer’s Association, and advised by the Centers for Medicare and Medicaid Services (CMS).

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 center 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.
Through the Medical Imaging and Technology Alliance, radiopharmaceutical manufacturers have provided advice over the course of the planning, design and conduct of New IDEAS. Manufacturers are represented on the New IDEAS study steering committee and provide financial support to enable the American College of Radiology to begin the study.
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Study Startup

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.

The feasibility questionnaire is available to complete and submit at any time. In general, the study will respond to the applicant within a month of submission. The applicant is not permitted to continue with the next step of site startup before receiving approval from the study team.
You will need to register each component separately. You will also need to complete the feasibility questionnaire for each component. Individual employees can be registered with multiple user roles for both the referring physician site and the PET facility, using the same ACR account.

No. Referring physician practices are required to apply for IRB approval via the central IRB (Advarra). PET facilities are NOT considered “engaged in research” and do not need to apply for IRB approval.

Please refer to the Institutional Review Board page of this website for instructions on how to obtain IRB approval. 

Site agreements from either the PET facility or the referring physician practice should be scanned and emailed to newideas-contracts@acr.org. The agreements will be reviewed and countersigned. The fully executed agreement will be returned to the email address that submitted it. An MS Word version may be requested from the same email address.

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Patient Participation

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:

  • Meet 2018 NIA-AA criteria for MCI or dementia.
  • Meet criteria for “clinically typical” or “clinically atypical” presentation of Alzheimer’s disease.

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.

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Referring Physicians

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.

We define a dementia specialist as a self-identified physician, trained and board certified in neurology, psychiatry or geriatric medicine, who devotes a substantial proportion (≥25%) of patient contact time to the evaluation and care of adults with acquired cognitive impairment or dementia. The study team will verify qualifications during the site feasibility and site registration processes.

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.

Clinical amyloid PET imaging via the New IDEAS study is not appropriate for cognitively normal individuals (and is not a covered service for Medicare beneficiaries).

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:

  1. Clinical visit to provide feedback on scan results (not mandated in study protocol but recommended based on best practices of providing timely feedback, preferred in person). This can be considered time point #4, but it is not a study-related visit and no data collection is required.
  2. 90 day post-PET visit (mandated in study protocol). The post-PET form is completed at 90 days, not immediately post-PET, in order to record actual implemented management, as opposed to the intended management recommended immediately post-PET but not yet implemented.

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).

Yes, the protocol allows for telemedicine platforms to be used for the pre-PET and post-PET visits. You will be asked to document the communication methodology via the case report forms of the visits.
No. The same physician must submit both the pre- and post-PET clinical assessment forms. If this is not possible, the post-PET form for that case cannot be submitted. If the scan has not been completed, the patient can be re-registered and conduct another pre-PET visit. If the scan has already been completed, that patient's case must be terminated within the study database.

Amyloid PET scans in the New IDEAS study will be interpreted by trained readers at the local PET facilities. To be eligible to interpret PET scans in the New IDEAS study, physicians must be board certified in radiology or nuclear medicine and must demonstrate that they have completed the tracer-specific training program provided for each radiopharmaceutical they plan to use. Local PET facilities must also apply via feasibility questionnaire and obtain approval by the study to register.

Access the feasibility questionnaire for PET imaging facilities.

The dementia specialist practice will receive a total of $500 for a complete case. The site will receive $250 for submitting the pre-PET case report form and an additional $250 for the post-PET case report form. These case report forms will be submitted online; you may view them on the New IDEAS study website. Payments will be made monthly via Bank of America to a specific entity via a bank routing number/account. Banking information is collected via the study’s encrypted and secure database.
Veterans Affairs and military hospitals may not participate. The only other restriction is that the radiopharmaceutical must be available in that state.

There is no cost to the participate for referring physician sites or imaging facilities.

We are working closely with CMS and other stakeholders to ensure that reimbursement for New IDEAS PET procedures is smooth for imaging facilities and patients to navigate.

The site does not have a responsibility to collect or ship the biospecimens. However, sites have a responsibility to consent the participant properly, answer any questions the participant may have about sample collection, and record the consent decision within the study database.

All registered participants will receive a saliva collection kit in the mail with instructions on how to collect the saliva and ship the sample back via mail. Participants who also consent to the optional blood collection will be sent a collection kit in the mail with instructions to visit their local Quest Diagnostics laboratory to have their blood drawn. Quest will handle collection and shipment of the sample.
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PET Imaging Facilities

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.

PET facilities must have experience in administering and interpreting brain PET, with preference given to sites that have experience with amyloid PET. Participating PET facilities may be freestanding and accredited by either the ACR, the Intersocietal Accreditation Commission (IAC) or RadSite OR hospital-based and accredited by the Joint Commission, with or without additional accreditation by ACR, IAC or RadSite. PET facilities must document experience performing brain PET, PET/CT or PET/MRI with one of the FDA-approved amyloid imaging agents, or with F-18 fluorodeoxyglucose, or with both. Participating radiologists and nuclear medicine physicians reading images must have completed vendor-provided reader training.
No. Only facilities with full-ring BGO, GSO, LSO or LYSO PET scanners are eligible to participate. Partial-ring systems and dedicated NaI systems are not eligible for use in the New IDEAS study.

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:

  • F-18 florbetapir (Amyvid™)
  • F-18 flutemetamol (Vizamyl™)
  • F-18 florbetaben (Neuraceq™)

Amyloid PET tracers that have not been approved by the FDA for clinical use will not be included in the New IDEAS study.

This study is tracer-agnostic. Amyvid™, Vizamyl™ and Neuraceq™ are all FDA-approved. The tracer used for the scan is dependent upon supplier availability and the facility’s choice; in addition, the interpreting physician must be able to document vendor-specific training. The New IDEAS study team only determines if a PET facility meets study criteria.
A potentially very helpful PET scan will be covered for their patients with cognitive decline in whom the diagnosis is not clear. Participating PET facilities will be reimbursed for the PET scans under CMS Coverage with Evidence Development, which requires research study participation as a condition of Medicare payment.

TRIAD is an image and data exchange platform developed by the American College of Radiology. TRIAD is a standards-based open-architecture platform that supports HIPAA security rules relevant to clinical trials. It automatically de-identifies the DICOM headers and cleans the PHI from the DICOM images before submission.

Access to TRIAD is role-based and controlled by username and password. Once the integration between TRIAD and the New IDEAS database has been built, the designated staff at your facility will be contacted to register for a login; this will occur shortly before activation.

No. The New IDEAS study requires a different agreement to be executed. The template agreement will be provided to the facility at the time of study invitation.
No. Your facility must confirm its accreditation as part of the application process to participate in New IDEAS. An invitation to participate will not be extended until accreditation has been obtained.

Radiopharmaceutical manufacturer assistance is available for technologists and physicians.

Amyvid (florbetapir) 

Neuraceq (florbetaben)

Vizamyl (flutemetamol)

Avid Radiopharmaceuticals
Amyvid_NEWIDEASSupport@Lilly.com
877-9-AMYVID

Life Molecular Imaging
Neuraceq.support@piramal.com
1-855-815-5499

GE Healthcare
IDEAS@ge.com
1-800-654-0118, option 1

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Reimbursement FAQ

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). We encourage patients to check prior to their study as there are some third party payers that have denied picking up the co-payments and deductibles; Tricare, for example, will not cover these costs. We will list more as we become aware of these payers. Additionally, the New IDEAS team developed a letter that providers may use to try to secure reimbursement from a third party payer.

No, for patients in Medicare Advantage (MA) plans, as MA beneficiaries are liable for co-payment/co insurance, where Medicare supplemental insurance does not typically apply.


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 cost-share applicable to their MA plan, meaning that the deductible is NOT waived. The PET provider should bill the MA enrollee for any cost-sharing; this includes both co-payments and deductibles.

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.


The New IDEAS database will generate an e-mail notification to the PET Facility Administrator when all case data required for PET claim submission have been entered (PET report eCRF, PET assessment, and PET scan (image)). At this time, a claim with Medicare can be filed. The PET Center does not need to wait for the 90-day follow up by the dementia specialist.

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Institutional Review Board

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.

No. The PET scans are being done as a covered medical service to aid in the diagnostic evaluation of patients with mild cognitive impairment or dementia under a CMS Coverage with Evidence Development (CED) program. The scan could be obtained without participation in the New IDEAS study, but Medicare only covers the service for enrolled subjects.

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.

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