Recent Study Updates

Note: Data reflects patient registrations. Total scans may not exceed cohort maximums defined by the study protocol. 

New IDEAS Newsletter

Read the most recent New IDEAS Study Newsletter here to learn more about ongoing initiatives. Read the most recent newsletter or past newsletters.

New IDEAS Study Leadership Announces Last Day to Register Participant in New IDEAS Portal 

After careful consideration of numerous factors and evaluation of the risk-benefit tradeoff for patients, Study leadership has decided to end Study accrual on Friday, March 1, 2024 at 11:59pm EST. At that time, patient registration into the Study Portal will be closed. This deadline is applicable to all race/ethnicity cohorts of the Study. This decision was difficult; however, Study leadership is confident that this is the best course of action based on the following factors:

• CMS retiring of National Coverage Determination (NCD) on amyloid PET, ending Coverage with Evidence Development (CED) as a criterion for coverage of these scans.
• Recent increases in prior authorization denials of Study participants’ amyloid PET scans, namely for patients with Medicare Advantage (MA) plans.
• Disconnect between the protocol and the real-world may jeopardize the relationship between the patient, practice, and imaging facilities, and poses billing risks outside of the control of Study Team oversight.

For more information, please read the full official Study Closure Memorandum and Study Closure Guide and Frequently Asked Questions for more information and next steps for your dementia practice or PET imaging facility. 

Please direct any questions or concerns to newideas@acr.org. 

Important Update: Impact of CMS's Removal of CED Criterion for Amyloid PET Scans on New IDEAS Study

The New IDEAS Study protocol was initially approved as a Coverage with Evidence Development (CED) Study under the supervision of the Centers for Medicare & Medicaid Services (CMS). On October 13, 2023, CMS issued a public announcement that retired the National Coverage Determination (NCD) on amyloid PET and ended CED as a criterion for coverage of amyloid PET scans. As a result of the retirement of the NCD, the CED is no longer applicable to the New IDEAS Study. Please review the following important information:

• PET imaging facilities should continue business as usual and continue to scan patients enrolled in the Study, including newly enrolled patients. Study scans should be billed to Medicare as they have been prior to the CMS announcement. Reminder, Study guidance is provided on the Sample Claim Forms. Any additional billing guidance will be disseminated by the Study Team when available.
• The New IDEAS Coinsurance Reimbursement Program remains active and in effect.
• Please notify the New IDEAS Operations Team if your practice or facility experiences any problems with coverage of amyloid PET scans for patients enrolled in New IDEAS. 

Please direct any questions or concerns to newideas@acr.org. 

Referring Dementia Practice Updates

Regulatory Updates - October 2023

Actions for Participating Sites:

The Study Sponsor has obtained IRB approval for a patient-facing notice explaining changes to CED in lay terminology. This notice has been approved for all IRB-approved sites, with site-level approval letters accessible in the Advarra IRB CIRBI Portal. Upon receiving site-level approval for the patient-facing letter, sites must:

1. Log in to the CIRBI Portal, download the patient-facing letter from the "IRB Issued Documents" section.
2. Disseminate the letter to already consented patients awaiting PET scans and those interested in participating.
3. File a copy of the document in the protocol file.

New Updates to Pre-PET and Post-PET Form - September 2023

Effective September 2023, Lecanemab was added as an anti-amyloid pharma therapy option on the Pre-PET and Post-PET forms. Please review and download the latest version of the Case Report Form Packet for Dementia Practices. These changes are currently live in the New IDEAS Portal. 

All Other Race/Ethnicity Cohort Enrollment Update - August 2023

Effective September 1, 2023, the New IDEAS Study Team will re-open the “All Other Races/Ethnicities” cohort to only those sites who have registered at least ten (10) participants since March 1, 2022 (Note: Registrations must represent 10 unique individuals, not re-registrations).

Sites that meet the registration waiver criterion:

• Will automatically be allowed to register patients in the All Other Races/Ethnicities cohort in the New IDEAS Portal beginning September 1, 2023.
• Should continue to focus on enrollment of other minoritized populations (e.g., Asians, Pacific Islanders, Indigenous populations) into the newly opened cohort (See the Case Report Form Packet pg. 3 for race/ethnicity identifiers)
• Will be limited to 10 new patient registrations per month in the All Other Races/Ethnicities cohort to ensure equal representation and access to care across participating sites in the study. 

Sites that do not meet the registration waiver criterion have two options:

1. Continue active study participation with authorization to enroll Black/African American and/or Hispanic/Latinx participants until the cohorts are closed. (Note: Sites that meet the above registration waiver criterion after September 1, 2023 will be issued a registration waiver until the All Other Races/Ethnicities cohort is closed.)
2. Request site termination. If the site feels that it can no longer contribute to meet study’s enrollment goals for the Black/African American and Hispanic/Latinx cohorts, please email newideas@acr.org and submit a termination report to the IRB.

PET Imaging Facility Updates

Updated PET Imaging Facility Billing Guidance - November 2023

Please review the following transmittals and MLN articles regarding NCD 220.6.20 - Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease. Transmittal R12364CP and R12364NCD and MM13429 (Released November 16, 2023). Please contact newideas@acr.org with any questions. 

Medicare Reimbursement and Medicare Advantage Prior Authorization Denials

If your facility is currently experiencing issues with prior authorization requests or Medicare reimbursement for amyloid PET scans conducted through New IDEAS, please contact the New IDEAS Operations Team at newideas@acr.org.

Detailed instructions on proper Medicare billing processes can be found on the study website. Reminder, the study has a template letter available for use when communicating with Medicare Advantage Plans. This resource has been proven successful in obtaining prior authorization for coverage

Community Engagement Updates

Highlights

New IDEAS Study Champions attended the Delta Sigma Theta Sorority Heath & Wellness Expo near Dallas in March to share information about the study and the importance of memory care. 

Become a Study Champion

Study Champions are trained volunteers who partner with community organizations within their region to spread information about the New IDEAS Study. Champions must live in near one of the following metropolitan areas - Chicago, Dallas, Houston, Los Angeles, Miami, Philadelphia/New Jersey, San Diego, Washington DC/DMV.

If you become a Study Champion, you will receive training on New IDEAS and learn how to build strong community relationships and cultural humility.

Email NewIdeasStudy.CES@med.unc.edu to learn more about becoming a New IDEAS Study Champion.

Page last updated: March 4, 2024