IDEAS-Study Participant Informed Consent – 03.03.2017

There have been some issues involving informed consents documents for participants on the IDEAS study. Please see reminders below and let us know if you have any questions. The Code of Federal Regulations (CFR) mandates certain requirements for the informed consent process.*

REMINDERS:

Below is a screenshot of the IRB page on the IDEAS Study website at: http://www.ideas-study.org/referring-physicians/institutional-review-board/. The highlighted item is a set of screenshots for accessing approval documents provided by Schulman IRB.

How to access the Schulman portal to obtain your approval documents

Example of IRB approved consent document below

All sites submitting study documents to Schulman do so via a secure portal, by accessing www.sairb.com and choosing login to Schulman eTools.  Access to all approved site study documents is available through login to the Schulman Webportal 3D from www.sairb.com and choosing the Study Documents feature and clicking the envelope associated with the document type Amended Approval Letter with Revised ICD.  Please ensure you are using the correct version to consent potential participants.

Please see STAMP sample below.  The stamp date is your site’s approval date.  The VERSION date will be at the bottom of the page.

Should you have questions, please contact IDEAS-Regulatory@acr.org or Maria Stivers (Schulman IRB) at mstivers@sairb.com.

* Always remember that Informed consent is a continuous process that is must comply with 45 Code of Federal Regulations (CFR) 46.116. General requirements for informed consents and 45 CRF 46.117 Documentation of informed consents.


Enrollment Cap Policy for IDEAS Study Dementia Specialists -11.17.2016

Enrollment Cap Policy

The IDEAS Study has instituted an enrollment cap for each referring physician (dementia expert) participating in the study.

The policy’s intent is to increase study generalizability by promoting diversity in dementia expert representation and patient recruitment across socio-demographic and geographic populations.

For each individual referring physician, the maximum number of patients throughout the entire study that may be enrolled is 250. The distribution of cases enrolled also will vary based on the study’s aim outlined below.

Study Aims

Aim 1: To assess the impact of amyloid PET on the management of patients meeting appropriate use criteria. The prospectively-recruited sample size of amyloid PET-known participants for Aim 1 is 11,050 participants (assuming a distribution of 40% dementia and 60% MCI).

Aim 2: To assess the impact of amyloid PET on hospital admissions and emergency room visits in the study cohort (amyloid PET-known) compared to matched patients not in the cohort (amyloid PET-naïve) over 12 months. The prospectively-recruited sample size of amyloid PET-known participants for Aim 2 is 18,488 participants.

The enrollment cap is distributed as follows:

160 for an individual referring physician in Aim 1 (which has an estimated national accrual total of 11,050 and includes participants for whom both a pre- and post- PET clinical assessment case report forms are completed).

90 for an individual referring physician in Aim 2 (which has a national accrual goal of an additional 7,438 patients for whom only pre-PET clinical case report forms will be collected).

The Operations Office will alert individual physicians when 140 participants have been enrolled to enable planning.


Ideas Study Bright Ideas Newsletter -July 13,2016

IDEAS Study Outreach Toolkit Now Available
New toolkit can aid your outreach to other doctors and spur patient accrual with IRB-approved materials. Read more.Medicare Claims Assistance for IDEAS Imaging Facilities
An IDEAS claims consultant can help with reimbursement issues. If denied payment, email using Claims Denial Checklist instructions. Please see the Sample Medicare Claims Form and other online resources for help on completing claims forms. Read more.

Attend IDEAS Study Event at Alzheimer’s Association International Conference
Talk to the IDEAS Study principal investigator and IDEAS staff July 26 from 12–2 p.m. ET at the Delta Hotel Toronto (75 Lower Simcoe St., Parkdale Room) during the AAIC meeting. RSVP here.

461 Active Sites
246 Dementia Specialists
215 PET Facilities

2569 Patients Enrolled
Goal:18,488

Tips

Referring Physician Practice Tip — Avoid Protocol Violations!
The Pre-PET clinical assessment form and case registration must both be submitted before the PET scan may commence. The case will cancel 30 days after the pre-PET submission if the PET Completion case report form is not submitted. If the PET scan has NOT been conducted (why no PET completion form submitted), that subject may be re-registered by the dementia specialist and a new case registration and pre-PET case report form submitted.

PET Imaging Facility Tip – Case Cancellation
A PET facility must complete the PET scan within 30 days of the pre-PET submission date or the case will cancel. Reminder: PET imaging facilities must electronically submit (using name/password) the following data to ensure an IDEAS confirmation allowing the facility to submit a bill to Medicare.

PET scans should also be submitted in a timely manner to the ACR archive via TRIAD. PET Facility staff will not find the case listed in the TRIAD portal if a specific participant refused collection in the informed consent.
What Year was the PET scan invented?
Answer in the next issue

Frequently Asked Questions

Question: Will managed Medicare plans (Medicare Advantage) reimburse for scans done as part of the IDEAS Study?
Answer: Yes, Medicare Advantage (MA) beneficiaries are eligible to be included in the IDEAS Study. The MA plans will make payments for MA enrollees. IDEAS Study claims should be billed to the MA plan. This policy is located here.
Question: Are Medicare Advantage beneficiaries who participate in the IDEAS Study liable for cost-share such as co-payment and deductibles?
Answer: Beneficiaries enrolled in Medicare Advantage (MA) plans are responsible for cost-share under 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. Read more on Medicare reimbursement.

News

Does knowing the truth help in Alzheimer’s? Read more »

Alzheimer’s study underway on a potential diagnostic tool. Read more »

Brain scans show how Alzheimer’s emerges. Read more »


 

IDEAS Study Medicare Claim Denials – Please Let Us Know!- 5.30.2016

TO: IDEAS Study PET imaging facility administrators (please forward as needed to coders and billers)

The IDEAS Study is aware that a number of Medicare Administrative Contractors (MACs) and Medicare Advantage plans are denying claims for amyloid PET scans performed under the IDEAS Study Coverage with Evidence Development (CED) program. We are working closely with the Centers for Medicare & Medicaid Services (CMS) to resolve these problems as quickly as possible.

If your facility receives denials of IDEAS Study claims, please inform us via IDEAS-Study@acr.org . In order for us to assist you with any denial, we need to review a de-identified copy of the submitted claim form (electronic or paper copy with all PHI redacted) and a de-identified copy of the Explanation of Benefits (EOB) showing the reason for the denial. These documents should be sent to IDEAS-Study@acr.org. The IDEAS-Study claims consultant will review and be in touch with the person indicated on the e-mail submission.

Additionally, to assist with billing, we also created sample Medicare claims and a site billing checklist available on the IDEAS website at: http://www.ideas-study.org/forms/.

SPECIAL NOTICE FOR IDTF SITES ONLY (does NOT apply to Hospitals or Physician offices)

If your PET facility is an Independent Diagnostic Testing Facility (IDTF), please verify that your facility has notified your Medicare Administrative Contractor via the CMS-855B Form listing all the CPT and HCPCS level II codes used for the IDEAS Study. A list of all the potential IDEAS Study CPT/HCPCS codes as of 5-16-2016 are CPT 78811, 78814, A9586 and A9599. Check back in June as we anticipate two new HCPCS codes to be added and these would need to be submitted on an updated CMS-855B prior to performing and billing those new codes.

For your information, it is a requirement that all CPT/HCPCS codes/procedures that an IDTF intends to perform when enrolling with the CMS-855B are listed. If an IDTF that is already enrolled wants to perform additional CPT and HCPCS code tests that were not originally specified on its CMS-855B and that are for procedure types and supervision levels similar to its previously allowed codes, the contractor shall have the IDTF amend its CMS-855B to add the additional codes and equipment listing (if necessary). A new site visit is not required. However, if the enrolled IDTF will be performing CPT or HCPCS codes for different types of procedures, or with different supervisions levels, a new site visit is required. Claims submitted with procedure codes not reported on the CMS-855B form and reviewed by the contractor will be denied.

The IDEAS Study Operations Team


Post-PET Visit and Clinical Assessment Form Completion – 5.16.2016

To: Referring Physicians:

Please review the frequently asked questions (FAQ) and responses below:

Question:
It was my understanding the dementia specialist didn’t have to wait 90 days to see the patient for follow up. Is there any way that the specialist would eventually be able to input the POST-PET data before this 90 day period since patient would be seen earlier than this time frame?

Answer:
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)
2. 90 day post-PET (mandated in study protocol, to record actual implemented patient management, in person)
The post-PET form is completed at 90 days and 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. The 90 day post PET visit is expected to be done in person unless extraneous circumstances arise.
To put it in concrete terms: we are interested whether someone who was at baseline medication naïve is actually on a medication at 90 days post-PET (actual implemented management), rather than whether it was recommended immediately after the scan (intended management).

Question:
Is it possible to do the 90 day follow up by telephone, rather than in person with the subject?
Answer:
Telephone follow up is allowed only in very rare, unusual situations in which the patient may be physically unable to return to the practice. The percentage of cases in which a referring physician indicates telephone follow up at 90 days is being monitored and could trigger site disqualification.

The IDEAS-Study Operations Team


IDEAS Study – PET Facilities – Medicare Reimbursement Information – 4.26.2016

TO: IDEAS Study PET imaging facility administrators (please forward as needed)

• Sample Medicare Claims and a Site Checklist have now been posted to the IDEAS website at: the forms page.

• Novitas Solutions, Inc. important guidelines affecting the IDEAS Study

Effective on April 20, 2016 Novitas has updated the claims processing system related to Positron Emission Tomography (PET) Beta Amyloid Imaging (PET Aβ Imaging) for CPT codes 78811 or78814. This means that IDEAS sites may resubmit previously denied claims and submit any held claims for processing. If you continue to receive denials of claims submitted after April 20, 2016 date, please inform IDEAS.

If your PET facility is an Independent Diagnostic Testing Facility (IDTF) that submits claims to Novitas, CMS is aware of the need to update their policies to include the HCPCS Beta Amyloid codes. A revision to the policy will be forthcoming to include the CPT Codes A9599 and A9586. After the policy has been updated, IDTFs will need to follow the coverage guidelines in the Local Coverage Determination (LCD): Independent Diagnostic Testing Facility (IDTF) (L35448) as follows:

IDTFs are required to report the exact CPT/HCPCS codes/procedures they intend to perform when enrolling with the CMS-855B form. If an IDTF which is already enrolled wants to perform additional CPT or HCPCS code tests that were not originally specified on its CMS-855B and that are for procedure types and supervision levels similar to its previously allowed codes, the contractor shall have the IDTF amend its CMS-855B to add the additional codes and equipment listing. A new site visit is not required. However, if the enrolled IDTF will be performing CPT or HCPCS codes for different types of procedures, or with different supervision levels, a new site visit is required. Claims submitted with procedure codes not reported on the CMS-855B form and reviewed by the contractor will be denied.

To be clear, after the policy is updated to reflect the codes, please resubmit an 855B application to request the CPT and HCPCS code(s) be added for your site. Until this is completed providers are not approved to bill Medicare for IDEAS patients.

We have also requested that Novitas add two new codes HCPCS codes that will be effective for claims with dates of service on or after July 1, 2016; those codes are noted below for your information. Additional educational materials will be provided by IDEAS. Please note that the two HCPCS codes listed below are not effective until third quarter claim submissions (for dates of service (DOS) on or after July 2016).

Q9983 “Florbetaben f18, diagnostic, per study dose, up to 8.1millicuries ”, effective 7/1/16

and

Q9982 “Flutemetamol F18, diagnostic, per study dose, up to 5 millicuries”, effective 7/1/16

Novitas Solutions – www.novitas-solutions.com
PART A – Jurisdiction L: Delaware, New Jersey, Pennsylvania, Maryland and the District of Columbia;
Jurisdiction H: Arkansas, Colorado, Louisiana, Mississippi, New Mexico, Oklahoma and Texas.
PART B – Jurisdiction L: Delaware, New Jersey, Pennsylvania, Maryland and the District of Columbia;
Jurisdiction H: Arkansas, Colorado, Louisiana, Mississippi, New Mexico, Oklahoma and Texas.
For Part B services, the A/B MAC Jurisdiction L includes the Counties of Arlington and Fairfax in Virginia and the City of Alexandria in Virginia. Services for the remainder of the state of Virginia are covered under A/B MAC Jurisdiction 11.

The IDEAS Study Operations Team


IMPORTANT PAYMENT INFORMATION for dementia specialist practices -4.17.2016

We are delighted to announce that the IDEAS Study database now includes the features for referring physician (dementia specialists) practices to enter the person who will be responsible for providing tax and banking account information. This person will have a “role” in our secure database as “financial user.”

The IDEAS Study Practice Administrator (to whom this e-mail is sent) is the only person who may add the financial user to the database. I have attached screenshots to assist you. Once added to the database, the financial user will receive a system-generated e-mail providing information about creating an ACR ID (username) and a password. The financial user will then submit an electronic W9 tax form and bank information via our secure database.

The first payment will be made by April 29 for the enrolled cases for which a pre-PET case report was submitted between February 8 and March 31 if the W9 and banking account information has been completed by the site finance user by April 27.

Please do not hesitate to write IDEAS-Study@acr.org or call (215-574-3156) if you have questions.

Sincerely,

Cynthia Olson for the IDEAS Study Operations Team

Adding a Financial User to the IDEAS Study Apri 2016- word document attachment


Update from the IDEAS Study Operations Office -2.18.2016

It is rewarding to see the number of sites interested in the IDEAS Study! Full information is available at www.ideas-study.org. Referring physician practices and PET imaging facilities will need to register separately; below, you may review the process from registration to activation. The person registering the site or facility becomes the point person (Administrator) for all communications from our staff at the IDEAS operations office.

Referring Physician Practice (Dementia Specialist)

DE_Registration Process

 

PET Imaging Facility

PET Facility_Registration Process

Several Tips:
• All IDEAS Study PET Facility/Practice Administrators have access to view the progress of participating physicians at the respective site from INCOMPLETE to UNDER REVIEW to APPROVED. The ACR will approve a site if there is only ONE APPROVED physician so as not to hold up any one site from activation; it is the site’s responsibility to ensure that all physicians have completed the requirements: 1) establish an ACR ID, log in and answer physician-specific questions and 2) upload the IRB-stamped consent form. In addition, all dementia specialists are required to view the Best Practices webinar on the Alzheimer’s Association site; we receive a weekly update of those physicians who have viewed the webinar.

• The database role of IDEAS Practice or Facility Administrator has access to add/delete all IDEAS database users at a site which triggers a system-generated e-mail to each participant. The administrator can re-send that invitation if the e-mail has been lost by clicking on EDIT USER and RE-SEND INVITE. (This is only for sites/users added after January 14.) The invitation e-mail includes 2 links: one will allow you to establish the ACR ID. After establishing the ACR ID, one must return to the invitation e-mail and CLICK on the 2nd link to connect oneself to the IDEAS database and then LOG IN. If you were added to a site before January 14, look in your SPAM or JUNK e-mail for an e-mail from ACR Support advising you of your ACR ID and providing a temporary password.

• All business associate agreements and contracts require legal counsel review and execution. The executed contract will be returned to the person submitting it at IDEAS-Contracts@acr.org. Please anticipate at least 10 business days for completion of this task at a minimum.

• Registration is NOT complete until one has touched SUBMIT. A Registrant may always return to a fully submitted registration and make changes to it or upload a required document, but until it is submitted, no action is taken on it.

Looking forward to a great study!

The IDEAS-Study Operations Team


IDEAS-Study Update -Guidelines for Amyloid PET/TRIAD Update – 2.03.2016

TO: Registered IDEAS-Study PET Imaging Facility Administrators (please forward to IDEAS researchers/staff at your facility):

Please note that the guidelines for amyloid PET, referenced in section 5.3.1 of the protocol, have now been finalized and are attached.

As a follow up to our earlier e-mail this week regarding TRIAD (below), please be advised that although the TRIAD software may be downloaded and installed on user computers, the log-in screen will not appear to the user until the IDEAS study is activated on February 8 at noon ET.
_________________________________________________________________________________________
The American College of Radiology (ACR) developed TRIAD (Transfer of Images and Data) a cloud- based, secure image and data exchange platform to support image and data sharing for clinical trials. The TRIAD software will be used for PET scan image transmission in the IDEAS study and is easily installed at an image facility.

TRIAD meets FDA regulatory requirements for use in clinical trials; it is Title 21 CFR Part 11 compliant.
For more information about the TRIAD information transmission software, click here: http://triadhelp.acr.org/

Action Steps:
1. Ensure that you have activated your ACR ID to enable your TRIAD user role. You may double-check all users at your site’s location on the IDEAS database.
2. Install TRIAD

How do I install TRIAD?

• Go to https://triadinstall.acr.org/triadclient/

TRIAD will be the sole means of image transfer to the ACR image archive. All imaging site personnel who are registered for the IDEAS-Study have a TRIAD user role and access to upload images. IDEAS Study PET facility administrators have access to the IDEAS database to add users to the roster, automatically enabling TRIAD access.

Thank you.

ATTACHMENT: SNMMI-EANM- Guidelines for Amyloid PET Imaging of the Brain


IDEAS-Study To Activate on February 8 – 2.1.2016

On behalf of Principal Investigator Gil Rabinovici and the study leadership, I am delighted to announce that the Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) Study will open to subject accrual on February 8 by noon ET. Any referring physician practice that has been approved and activated may proceed to recruit and enroll subjects.

All enrollment and data collection will be completed on line through the secure IDEAS electronic data capture system, accessible from the IDEAS website, www.Ideas-Study.org. Additional instructions are included in the attached screenshots. Registered IDEAS-Study Administrators at referring physician practices and PET facilities are encouraged to review their site’s readiness status by logging in at ideas-study.org.

A list of fully approved and activated referring physician practices and imaging centers will be posted at the IDEAS-Study.org website upon activation. As always with large research studies, we may not have anticipated every issue and will communicate any such circumstance that arises that might necessitate suspending accrual.

If you have any questions, please contact the IDEAS-Study team at IDEAS-Study@acr.org or 215-574-3156.

We look forward to a successful study!

Sincerely,
Cynthia Olson for the IDEAS Study Operations Team

ATTACHMENT: Enrolling Subjects Using the IDEAS-Study Database


TRIAD Installation for IDEAS-Study at PET Facilities – 1.29.2016

TO: Registered IDEAS-Study PET Facility Administrators:

The American College of Radiology (ACR) developed TRIAD (Transfer of Images and Data) a cloud- based, secure image and data exchange platform to support image and data sharing for clinical trials. The TRIAD software will be used for PET scan image transmission in the IDEAS study and is easily installed at an image facility.

TRIAD meets FDA regulatory requirements for use in clinical trials; it is Title 21 CFR Part 11 compliant.
For more information about the TRIAD information transmission software, click here: http://triadhelp.acr.org/

Action Steps:
1. Ensure that you have activated your ACR ID to enable your TRIAD user role. You may double-check all users at your site’s location on the IDEAS database.
2. Install TRIAD

How do I install TRIAD?

• Go to https://triadinstall.acr.org/triadclient/

TRIAD will be the sole means of image transfer to the ACR image archive. All imaging site personnel who are registered for the IDEAS-Study have a TRIAD user role and access to upload images. IDEAS Study PET facility administrators have access to the IDEAS database to add users to the roster, automatically enabling TRIAD access.

Thank you.
The IDEAS-Study Operations Team

ATTACHMENT: TRIAD Image Submission Instructions