significance patients referring physicians institutional review board pet facilities medicare reimbursement collaborators

 

Significance

Is the IDEAS Study on its own enough to change CMS policy re: Medicare coverage of brain amyloid PET imaging?

That is for CMS to decide. The IDEAS Study leadership has taken several well-considered steps in order to ensure meaningful study results in this regard. These include:

Why is the IDEAS Study important? What is at stake?

One aim of the IDEAS Study is to assess whether, in diagnostically uncertain cases, amyloid PET helps clinicians diagnose the cause of cognitive impairment and provide the most appropriate treatments and recommendations. Also, we hope to show that, by enabling an early and accurate diagnosis, this novel technology can improve health outcomes, such as reducing unnecessary hospitalizations and emergency room visits, and increasing appropriate prescription of medications.

We are confident that, at the end of this study, we will have amassed sufficient data to assess whether amyloid imaging has a positive impact on patient outcomes and should thus be reimbursed by Medicare and other third-party payers.

The IDEAS Study will provide access to amyloid imaging for more than 18,000 patients for whom there is ambiguity about the cause of their cognitive decline/dementia and who can benefit from an early and accurate diagnosis.

In addition, approval of the IDEAS Study brings additional, unanticipated resources to the Alzheimer’s research field — potentially $100 million over four years.

Finally, beyond amyloid PET, there are many additional “biomarkers” in development for Alzheimer’s disease and other causes of dementia. Results from the 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.

Often clinical trials are conducted at little or no cost to the participating patient. Is the IDEAS-Study different?

The IDEAS Study is not a traditional clinical trial. The efficacy of a new drug or a novel diagnostic technique is not part of the research. Brain amyloid PET scans required for this study are FDA approved and currently commercially available for clinical care.

However, at this time, Medicare does not cover brain amyloid PET scans for patients receiving normal clinical care outside of a special CMS-designated coverage policy, Coverage with Evidence Development (CED). CED links coverage to a study (in this case, the IDEAS Study) designed to collect data to improve the understanding of and develop evidence for a technology’s impact on the health of Medicare beneficiaries.

More about Coverage with Evidence Development (CED)

As mentioned, the IDEAS Study is a CMS Coverage with Evidence Development (CED) study and is designed to be analogous to routine care. Paying enrollee’s out-of-pocket costs for an FDA-approved and clinically available procedure would not be consistent with routine care.

Per CMS.gov:

The IDEAS Study will provide additional data allowing CMS to complete the CED cycle which 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 IDEAS Study, would continue to be subject to individuals’ benefits per their insurance plan(s).

For more information about CED see: https://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=27

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Patients

Is there value for people with no dementia symptoms?

Clinical amyloid PET via the IDEAS Study is not appropriate for cognitively normal individuals (and is not a covered service for Medicare beneficiaries). For more information on the IDEAS Study go to: Clinical Trials NCT02420756.

When will accrual to the IDEAS Study start?

The IDEAS Study activated on February 8, 2016. All participating dementia specialist practices who have completed the activation process and have approved dementia specialists are now enrolling eligible patients.

Who is eligible to participate in the IDEAS Study?

To guide clinicians on how best to use amyloid PET in the evaluation of people with cognitive decline, an expert group convened by the Alzheimer’s Association and the Society of Nuclear Medicine and Molecular Imaging developed appropriate use criteria (AUC) for amyloid PET scans.

According to the AUC, brain amyloid PET imaging should only be considered in people with clear, measurable cognitive deficits when substantial diagnostic uncertainty remains even after a comprehensive evaluation by a dementia specialist, and in whom knowledge of amyloid status is expected to change management. Amyloid PET may have greatest value in patients with either: (1) progressive, unexplained mild cognitive impairment; or (2) dementia of uncertain cause due to atypical or mixed symptoms or unusually early age-of-onset.

For the IDEAS Study, 18,488 Medicare beneficiaries, age 65 or older, who meet the criteria above will be enrolled over 24 months at approximately 200 sites throughout the United States.

The patient will visit a dementia expert who will determine if the patient meets the AUC and if he or she consents to participate in the study. If so, the dementia expert will refer the patient to a PET facility for an amyloid PET scan and will complete a pre-PET Case Report Form (CRF) within 30 days of the PET scan. Within seven days following the PET scan, a PET Report and PET CRF will be submitted by the PET facility. After the PET scan, the patient will meet with the dementia expert to discuss the results. In addition, the dementia expert will complete a post-PET assessment and submit a post-PET CRF. The IDEAS Study will also obtain Medicare administrative claims for each participant for the year following the amyloid PET scan.

What type of diagnostic evaluation is required prior to enrollment in the IDEAS Study?

A patient will be eligible for the IDEAS Study if there is diagnostic uncertainty after a comprehensive clinical evaluation by a dementia expert, including laboratory tests (complete blood count, comprehensive metabolic panel, thyroid function tests, and vitamin B12 level) and structural brain imaging (CT or MRI). Information about other diagnostic tests completed prior to referral (e.g., lumbar puncture, FDG-PET) will be collected but these tests are not required.

As a patient, how do I enroll in the IDEAS Study?

Patients may be enrolled through a dementia specialist who is participating in the study. Once accrual begins, a list of participating dementia specialists will be posted on the IDEAS Study website.

How will individuals be referred to participate in the IDEAS Study?

Participating dementia experts will refer patients to the IDEAS Study if they meet the study’s eligibility criteria and consent to participate in the study.

Will patients need to pay the Medicare co-pay?

Yes. Excerpted from the patient consent: “Your amyloid PET scan will be paid for by Medicare as a covered benefit as part of the Coverage with Evidence Development 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.” There is no mechanism in place to allow for coverage of the co-pay.

 

 

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Referring Physicians

What oversight and accountability measures are in place to ensure the integrity of the study design, implementation, and data?
The ACRIN® Biostatistics and Data Management Center (BDMC) will monitor participant accrual and data submission. Total target accrual for this study is 18,488 participants.

The IDEAS Study organizational structure has been 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.

Since there currently is no effective treatment or prevention, what is the value of amyloid PET imaging in clinical practice?

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 by a thorough clinical assessment by a dementia expert, an evaluation that typically includes blood tests and a brain CT or MRI. 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. The Alzheimer’s Association’s 2015 Alzheimer’s Disease Facts and Figures report found that only 45% of people with Alzheimer’s disease or their caregivers say they were told the diagnosis by their doctor.

However, 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 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 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 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 wellbeing. 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.

Is there value for people with no dementia symptoms?

Clinical amyloid PET via the IDEAS Study is not appropriate for cognitively normal individuals (and is not a covered service for Medicare beneficiaries). For more information on the IDEAS Study visit: Clinical Trials NCT02420756.

Does a dementia specialist need to wait until the 90 day visit to advise a patient of the results of the PET scan?

Disclosure of the PET scan result and subsequent management recommendations NEED NOT wait for the post-PET visit. It is hoped that clinicians would provide feedback to the patients and families shortly after the scan is read.

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?

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)

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.
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).

Is it possible to do the 90 day follow up by telephone, rather than in person with the subject?

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 dementia specialist who entered the pre-PET clinical assessment form has left the practice and there is one outstanding post-PET form. Can another participating physician complete the post-PET clinical assessment form?
No, the same physician must submit both the pre and post-PET clinical assessment forms. The post-PET form for that case cannot be submitted.

The protocol states in section 4.1.3. inclusion criteria that the diagnosis of MCI or dementia must be verified by a dementia specialist within 24 months. What if the patient was diagnosed by another physician (non-dementia specialist) sometime in the last 4 years? Is it just the dementia specialist diagnosis that we are concerned about in this criterion?

It is just the diagnosis by the dementia specialist in 24 months that is being referenced in section 4.1.3. It is allowable to include patients who received a diagnosis of MCI or dementia by another provider who is not a dementia expert prior to the 24 month window.

When will accrual to the IDEAS Study start?

The IDEAS Study activated on February 8, 2016. All participating dementia specialist practices who have completed the activation process and have approved dementia specialists are now enrolling eligible patients.

How can physicians get involved?

The IDEAS Study is currently collecting contact information from dementia experts wishing to be considered for inclusion in the study and from PET imaging centers to which those experts expect to refer their patients for amyloid imaging. The IDEAS email address is: IDEAS-Study@acr.org. Information about the IDEAS Study will also be disseminated via professional organizations dedicated to neurology, psychiatry, geriatrics, nuclear medicine, and radiology.

What is the definition of a dementia specialist and what is the qualification verification process?

Referring dementia specialist: 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.

Who will interpret PET scans in IDEAS?

Amyloid PET scans in the IDEAS Study will be interpreted locally — by trained readers at the local PET facilities. To be eligible to interpret PET scans in the 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.

What is the protocol number, sponsor, and do I need a CDA (confidential disclosure agreement?)
The sponsor is the American College of Radiology Imaging Network and the number of this protocol is ACRIN 7155. No CDA is needed.

Do both PET facilities and referring physician practices need to apply for IRB approval?

No. Referring physician practices are required to apply for IRB approval via their local IRB or the central IRB (Schulman Associates). PET facilities are NOT considered “engaged in research” and do not need to apply for IRB approval. Physicians at both the referring physician practice and the PET facility are considered subjects of research and complete a one-time consent which is then uploaded to the IDEAS database. The consent template varies depending on whether Schulman Associates (CIRB) or the local IRB will be used.

What is the case reimbursement amount? How is it paid?

The dementia specialist practice receives $225 for submitting the pre-PET case report form and $525 for the post-PET case report form. These case report forms will be submitted via the web, but one may view them at the IDEAS Study website. Payments will be made via Bank of America to a specific entity via a bank routing number/account.

How do I upload a site agreement or business associate agreement?

Site agreements from either the PET facility or the referring physician practice should be scanned and e-mailed to IDEAS-Contracts@acr.org. They will be reviewed, countersigned, and the fully executed agreement will be returned to the same person (e-mail address) who submitted it. If a WORD version is required, it may requested at the same e-mail address.

When will sites be informed that they may participate?

As of  May 11, 2017, The IDEAS-Study is not accepting new Referring Physician Site Registrations.

We are interested in participating both as a Referring Physician Site and a PET Facility. In order to register as both types, would I register under each separately, or is there an option to combine registration as we are one site?

You would need to register each component separately.

I am at a VA; may I participate?

Neither VA nor military hospitals may participate. The only other restriction is that the radiopharmaceutical must be available in that state.

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Institutional Review Board

The purpose of this research study is to examine how brain imaging helps guide doctors in patient treatment and whether these changes in treatment lead to better medical outcomes. The research component is to study if the PET brain imaging will help improve treatment; the PET scan itself is not part of the research, but a procedure recommended by the doctor as part of clinical care. That is, the PET facility is not considered engaged in research. Medicare has agreed to cover the cost of the amyloid PET scans of participants in the IDEAS Study as part of their Coverage with Evidence Development program so that the researchers can evaluate whether the scans lead to improved patient outcomes. The clinical trials.gov number is NCT0240756.

Are the PET scans done for research purpose?
No, PET scans are not being done for research purposes. They are being done as a covered medical service to aid in the diagnostic evaluation of patients with mild cognitive impairment or atypical dementia as per the appropriate use criteria defined by Johnson et al in 2013 (link to article:alz.org/auc) under a CMS Coverage with Evidence Development (CED) program. The scan could be obtained without participation in the IDEAS trial, but Medicare only covers the service for enrolled subjects.

What are the inclusion criteria for the dementia specialist population?
A dementia specialist is defined in the amyloid PET Appropriate Use Criteria (AUC) as a 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 (Johnson et al. 2013).

Why are the dementia specialists considered a participant population (i.e. subjects of research)?
The dementia specialists are considered a participant population because an objective of this study is to assess how the amyloid PET results impact their planned and actual management of their patients. Thus, dementia specialists serve as both subjects of research AND engaged investigators.

How will dementia specialists be recruited?
Dementia specialists will be recruited through word of mouth and by outreach from professional and advocacy organizations such as the Alzheimer’s Association, the International Association of Gerontology and Geriatrics, the American Academy of Neurology, Society for Nuclear Medicine and Molecular Imaging, the American Society of Neuroradiology.

Is there any compensation for dementia specialist participants?
The dementia specialist will be compensated for their role as engaged investigators (responsible for obtaining patient consent or supervising those delegated to obtain consent) and for completion of the case report forms for the study. Those amounts can be used at the discretion of the dementia specialist to support the study (study coordinator and staff). The dementia specialists are compensated for their role as investigators, not as subjects of research.

Describe the pre and post clinical assessments that the dementia specialist completes for the enrolled patient population.
Paper versions of the electronic case report forms are available at www.ideas-study.org,

Are there any questionnaires or survey being used to obtain data?
No, there are no surveys or questionnaires for patients. Dementia specialists are completing case report forms that rely in part on medical information obtained from patients during their routine clinical encounters.

What is the consent process for the dementia specialist?
Adequate information concerning the study will be given to the dementia specialist participant (research subject) in the consent form, providing adequate opportunity for the dementia specialist, as research subject, to consider his/her options. The study team will also respond to any questions raised by the dementia specialist as part of the consent process in order and continue to provide information situation requires.

At what point will identifiers collected for recruitment purposes be destroyed?
All information about individuals who are screen failures or those who declined to be in the study without consent/authorization will be destroyed immediately after it has been used for recruitment purposes.

Why can’t you obtain a participant’s authorization to review his or her protected health information?
The investigators are unable to obtain someone’s authorization without first knowing the clinical status about whom to approach.

Why would it not be possible to recruit potential participants without access to protected health information?
The investigator would not know who to approach without first identifying potential participants by accessing their information in the medical record.

How will confidentiality be maintained?
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’s name and other personal information will not be used.

The 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 separately housed from the primary database used for analysis purposes. Only the dementia specialist, the ACRIN data management center, the statistical team coordinating collection of claims data from CMS, and members of the IRB will have access to the records. De-identified information may be provided as required by law

What information will be collected from study patients?
Upon obtaining informed consent, the following will be collected:

• Documentation of information likely included in th dementia specialist evaluation for eligibility for the study – specifics about the patient’s current health including known other diseases/conditions that may impact cognition, medications, standard laboratory tests and non-PET structural brain imaging (CT or MRI).
• Patient’s name, address, social security number (SSN), Medicare identification number, and date of birth so the researchers can request information from Medicare about his or her medical care after the scan

Who is funding the IDEAS study?
The IDEAS Study is a national CMS-approved Coverage with Evidence Development study being funded and managed by the Alzheimer’s Association and the American College of Radiology (ACR). The sources of funding for these organizations include their own funds, support from the three industry vendors of FDA-approved amyloid imaging agents (Eli Lilly and Company, Inc., GE Healthcare, and Piramal, Inc.), and from the fees that will be paid by participating PET facilities. Medicare will be paying for the PET scans as a covered service.

How long is the authorization to participate in the IDEAS study valid?
The authorization to participate in the IDEAS study is valid for an indefinite period of time. However, a study participant can change his or her mind at any time and withdraw his or her permission to allow his or her personal information to be used in the research. If this happens, the participant must withdraw his or her permission in writing. Beginning on the date a participant withdraws his or her permission, no new personal information will be used for research. However, researchers and the sponsor may continue to use and disclose the personal information that was provided before the participant withdrew his or her permission

In section 5.4.3 of the protocol, it states, “Emergency room visits, and all cause hospitalizations during this 90-day interval also will be collected.” Please clarify where this data will be collected?
The 90-day post-PET visit will collect no details about ER visits or hospitalizations, but only whether it occurred. The occurrence of these events will help validate the data will be collected from CMS claims as part of Aim 2.

The IDEAS-Study website contains a portal into a database where electronic case report form data are collected. Please describe the security.

IDEAS-Study Application Security
The IDEAs portal and central server physically reside in the ACR co-location cage inside the Equinix DC3 in Ashburn, Virginia.

Authentication/Authorization
The IDEAS Study users must enter a valid username and password to gain access to the system. The user accounts are created and managed by the Facility/Practice Administrator within the IDEAS application. Facilities may only manage their own user accounts.
Once authenticated, a user can access only the data (registry and PHI) that belongs to his/her facility. The IDEAS application does not share data across facilities. In the event of a system breach, ACR will follow the Incident Response SOP. This includes corrective actions, escalations, and triggering any breach notification protocols as required by laws and regulations.

Firewall
The IDEAS application uses a clustered pair of Fortinet Unified Threat Management (UTM) firewalls in an active/active mode. This firewall is a Layer 7 UTM firewall that includes the UTM features which includes intrusion protection. The firewall limits access to the site via HTTPS traffic to the web server only.

The SQL server is not directly accessible from the internet and resides in a separate network segment and is separated via the UTM firewall. All traffic to/from the Web Server and the SQL server buss pass through a firewall for inspection and is limited to only the port/protocols required (e.g. https, sql, rdp) Remote access to the Web and SQL servers are restricted to the internal ACR network only, and enforce user and password identification for access.

Machine Security
The Web and SQL machines are built on the Microsoft Windows 2012R2. Administrative level accounts utilize password complexity, enforce a password of 10 or more characters in length, and are changed on a regular basis. Administrative level account passwords are known only to the DBA and System Administration personnel.

SSL Security
The web server uses a Symantec Class 3 EV SSL CA – G3 SSL with a 2048 bit Asymmetric key. SSL Encryption of data is provided by TLS 1.1/1.2 SHA256 2048 bit key (Verisign). PHI is encrypted using AES 256 algorithm.

Backups
Performed nightly, Monday thru Friday.

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PET Facilities

Which radiopharmaceuticals will be included in the IDEAS Study?

The 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™), and F-18 florbetaben (Neuraceq™). Amyloid PET tracers that have not been approved by the FDA for clinical use will not be included in the IDEAS Study.

Who decides which of the 3 tracers should be used for imaging?
This study is tracer-agnostic and Amyvid™, Vizamyl™, and Neuraceq™ are all FDA-approved. The tracer used for the scan is dependent upon supplier availability; in addition, the interpreting physician must be able to document vendor-specific training. The IDEAS Study team only determines if a PET facility meets study criteria

How will PET facilities be recruited for the IDEAS Study?

The primary recruitment will focus on the dementia experts who will be paired with one or more local PET facilities.

When will clinical dementia and PET imaging site recruitment begin and how does contracting work? What role, if any, will contract manufacturing organizations and suppliers play in signing up and contracting imaging sites to participate in the IDEAS Study?

Recruitment will begin in the second half of 2015. All sites may only be enrolled through approval from the American College of Radiology (ACR®).

As an imaging site, what are the requirements to participate in the IDEAS Study?

Imaging site: PET facility with experience in administering and interpreting brain PET — with preference to sites that have experience with amyloid PET. Participating PET facilities may be (1) free standing and accredited by either the ACR, the Intersocietal Accreditation Commission (IAC), or RadSite or (2) hospital based and accredited by the Joint Commission, with or without additional accreditation by ACR, IAC, or RadSite. The PET facility must document that it has 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.

Who will have access to PET images and data?

All requests for data or image access will be handled by the Research and Publications Committee, a sub-committee of the Steering Committee.

What is the incentive for dementia experts and PET facilities to participate?

An expensive and potentially very helpful PET scan will be covered for their patients with cognitive decline in whom the diagnosis is not clear. In addition, a modest stipend will be provided to participating dementia experts for completion of required case report forms on each patient enrolled in the IDEAS Study.

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.

What is the purpose of the escrow account? Is this like a tax on each scan performed by a site? Why are PET sites paying this?

The IDEAS Study allows subjects to obtain a PET scan as part of recommended care within the limits of the Coverage with Evidence Development (CED), a program of the Centers for Medicare & Medicaid Services (CMS). CMS is paying only for the technical and professional fees for the PET scans (with the patient and/or Medicare supplemental insurance responsible for deductible or co-pay charges). The actual costs of doing the research to generate the evidence that it is hoped will lead to coverage by CMS is being covered by a number of sources, including the manufacturers of amyloid imaging agents, the Alzheimer’s Association and the American College of Radiology. As was the case with the National Oncologic PET Registry (NOPR), each PET facility that chooses to participate is asked to contribute toward the expense of the overall study by paying a nominal $50 fee per scan.

How do I upload a site agreement or business associate agreement?

Site agreements from either the PET facility or the referring physician practice should be scanned and e-mailed to IDEAS-Contracts@acr.org. They will be reviewed, countersigned, and the fully executed agreement will be returned to the same person (e-mail address) who submitted it. If a WORD version is required, it may requested at the same e-mail address.

What is TRIAD?

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 the application is role-based and controlled by username and password. Once the integration between TRIAD and the IDEAS database has been built, you will be contacted to register for a login; this will occur shortly before activation.

Our site participated in the National Oncology PET Registry (NOPR); does the same business associate agreement we signed with ACR cover IDEAS?

No. The IDEAS Study requires a different version.

Will the IDEAS-Study allow use of all types of PET scanners?

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 IDEAS Study.

Can a PET Facility register for the IDEAS Study while the imaging center is in progress of obtaining accreditation?

Yes, the website is updated to allow the Facility Administrator registering to select in process. The Facility Administrator should contact the IDEAS team (IDEAS-Study@acr.org ) if additional assistance is required.

Where will the PET facilities be located? Will the number of PET facilities be limited? Who will decide which PET facilities participate?

The PET facility locations are yet to be determined but will need to be accessible to patients seeing the referring dementia experts and have access to one of the FDA-approved amyloid imaging agents. There are currently no plans to limit the number of sites. Once sites are selected, they will be listed on the IDEAS Study website. The ACR is responsible for the study’s operation and will make the final decisions on site eligibility.

Is there technical or interpretative assistance available?

Yes, radiopharmaceutical manufacturer assistance is available for technologists and physicians:

Amyvid (florbetapir) – Avid Radiopharmaceuticals
E-mail: Imagingteam@avidrp.com; Phone: 215-220-4865

Neuraceq (florbetaben) – Piramal Imaging
E-mail: Neuraceq.support@piramal.com; Phone: 1-855-815-5499

Vizamyl (flutemetamol) – GE Healthcare
E-mail: IDEAS@ge.com; Phone: 1-800-654-0118, Option 1

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Medicare Reimbursement

Medicare Reimbursement

A PET imaging facility may not perform an IDEAS Study PET scan until the referring physician has submitted a pre-PET clinical assessment form to the IDEAS Study database. Once the PET scan has been completed and the appropriate data uploaded to the IDEAS Study database, a system-generated notification is sent from the email address IDEAS-Study@acr.org to the PET imaging facility indicating that the case data are complete. These notifications should be maintained as documentation in the event that CMS opts to audit the PET imaging facility.

After receiving the notification, the PET facility (and the interpreting physician, if technical and professional component billing are performed separately) may submit the claim for the service to the local Medicare Administrative Contractor (MAC) or MA plan as appropriate.

2016 PET technical component reimbursement for amyloid PET imaging performed on patients enrolled in the IDEAS Study will be based on the following:


Hospital-based PET Facilities

  1. The National 2016 HOPPS payment for CPT code 78811 or 78814 (limited body PET or PET/CT, respectively) ($1,285.17 ‒ $228.37) = $1,056.80 (rates are adjusted by local wage indexes, so the exact payment will vary slightly based on region); and
  1. A pass-through payment for the cost of the amyloid imaging agent, calculated quarterly (generally about $3,000), depending on the specific agent administered. These rates change quarterly and are based on actual average sales price reported by the manufacturer to Medicare, plus 6%. Visit the CMS website for quarterly pass-through amounts located in the addendum B files posted for January, April, July and October of each year.

 

As noted in item 1 above, the offset for the cost of the diagnostic radiopharmaceutical attributed to APC 5594 ($228.37 for CY 2016) is deducted from the procedure, not from the pass-through amount for the drug. For hospital-based PET facilities, there is no co-payment or co-insurance assigned to pass-through drugs; there is a co-payment or co-insurance for the procedure.

Physician Offices and Independent Diagnostic Testing Facilities (IDTFs)

For physician offices and IDTFs, payment is determined by the Medicare Physician Fee Schedule (MPFS). The technical component payment for the procedure is carrier priced but is often capped at the HOPPS technical component rate ($1,285.17). Payment for the diagnostic radiopharmaceutical is based on the invoice cost (approximately $3,000, depending on the product used).

In the MPFS setting, all rates are subject to co-payment, co-insurance and any deductibles that the patient’s Medicare plan requires. The co-payment policies for the radiopharmaceutical differ in the MPFS setting versus the HOPPS transitional pass-through.

Professional Component Payment

The national payment rates for the professional reading of the IDEAS study are 78811-26 $78.77 and 78814-26 $110.28.

For specific details regarding how to bill studies performed as part of the IDEAS Study, providers should refer to current official Medicare claims and coverage instructions.

For information on the Medicare NCD for Beta Amyloid PET in dementia and neurodegenerative disease, see:

For information on the mandatory reporting of an eight-digit clinical trial number on claims currently in use for all CED programs, including the IDEAS Study, see:

The clinical trial number for the IDEAS Study is 02420756.

We caution PET facilities, especially those with automated billing systems, to set up in advance internal mechanisms to hold these claims until all of the required case data for the IDEAS Study has been entered and this has been acknowledged by the IDEAS Study database with a system-generated e-mail to the PET Facility Administrator.

 

Additional Resources

Click here to view sample Medicare Reimbursement forms.

Click here to access the Medicare Reimbursement Overview Presentation: “IDEAS-Study: The Nuts & Bolts of Medicare Reimbursement”

 

 

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Does the IDEAS Study apply to Medicare inpatients?
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 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 IDEAS Study would rarely need to be done while the patient was hospitalized.

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Will a Medicare patient’s Medigap insurance cover the cost of the co-payment for an IDEAS Study PET scan?
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 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.

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Will managed Medicare plans (Medicare Advantage) reimburse for scans done as part of the IDEAS Study?
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 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

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Are Medicare Advantage beneficiaries who participate in the IDEAS Study liable for cost-share such as co-payment and deductibles? 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.

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Is pre-authorization still needed for patients in managed Medicare plans also called Medicare Advantage (MA) plans? What if they deny our request for pre authorization?
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 IDEAS CED Study.

It is recommended that all levels of appeal be used with Medicare Advantage plans as we are aware of MA plans that have 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 IDEAS Study” and be sure to provide additional documentation (see links below) to support your request.

As a reminder, Medicare Advantage (MA) beneficiaries are eligible to be included in the IDEAS Study and the MA plans will make payments for MA enrollees. 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 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.

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When are imaging centers able to file a claim with Medicare for the PET procedure and tracer?
The 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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Collaborators

How is the IDEAS Study funded?

Costs related directly to the PET scan will be covered by Medicare — like any other covered service. Patients (or their supplemental Medicare insurance providers) will be responsible for applicable deductibles or co-payments. Plans for funding additional research and operational costs are currently being finalized. A variety of sources [beyond Centers for Medicare & Medicare Services (CMS)] will be tapped for the balance of funds needed to conduct the IDEAS Study. These will include:


What has the Alzheimer’s Association role been so far, and what will it be going forward?

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 protocol in response to the CMS National Coverage Decision. The Association identified and convened the IDEAS Study leadership team and worked with that team and CMS to develop the study protocol. Maria Carrillo, PhD, Alzheimer’s Association Chief Science Officer, 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 (SNMMI) were also instrumental in convening the workgroup that developed appropriate use criteria (AUC) for brain amyloid PET scans.

What has the American College of Radiology’s role been so far, and what will it be going forward?

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 IDEAS Study.

The ACR Imaging Network (ACRIN®) is the clinical research center of the ACR and has worked on the development of IDEAS and the writing of the protocol through the efforts of Barry Siegel, MD, Bruce Hillner, MD and Constantine Gatsonis, PhD. ACRIN will provide scientific leadership to the study to include study design, analysis, and dissemination and will provide ongoing oversight and decision-making.

What has the role of the Centers for Medicare & Medicare Services been so far, and what will it be going forward?

The CMS provided advice and guidance over the course of the planning and writing of the IDEAS Study protocol. In the study, CMS will provide coverage for the PET scans and radiopharmaceuticals per CED. CMS will also be represented on the IDEAS Study Steering Committee.

What has the role of the manufacturers of FDA-approved amyloid radiopharmaceuticals been so far, and what will it be going forward?

Through the Medical Imaging & Technology Alliance (MITA), the manufacturers have provided advice over the course of the planning, design and conduct study protocol.  Manufacturers are also be represented on the IDEAS Study Steering Committee.

Who will be leading the IDEAS Study?

The IDEAS Study Chair is Gil D. Rabinovici, MD, Associate Professor of Neurology at the University of California, San Francisco, a behavioral neurologist with research expertise in amyloid PET.

The leadership team (IDEAS Study co-chairs) includes:

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