Minutes - Amyloid Imaging Stakeholder Update
FRIDAY, March 22, 2013
1. CMS Review of Comment Submissions: SNMMI, Alz Assoc, MEDCAC Presenters, Others
The SNMMI and Alzheimer’s Association Amyloid Imaging Taskforce published in January 2013 the Appropriate Use Criteria (AUC) on Amyloid PET Imaging after 8 months of discussions and writing. The findings and joint publications by the journals Alzheimer’s & Dementia and the Journal of Nuclear Medicine can be found at the following sites (http://www.alz.org/research/funding/amyloid_imaging_task_force.asp or http://interactive.snm.org/index.cfm?PageID=12318). The importance of this evidence-based document and the three appropriate indications were stressed at the MEDCAC meeting and at a subsequent meeting between CMS and the Alzheimer’s Association. This information provided the basis for requesting that CMS provide full coverage for amyloid PET imaging.
Preamble: (i) a cognitive complaint with objectively confirmed impairment; (ii) AD as a possible diagnosis, but when the diagnosis is uncertain after a comprehensive evaluation by a dementia expert; and (iii) when knowledge of the presence or absence of Ab pathology is expected to increase diagnostic certainty and alter management.
1. Patients with persistent or progressive unexplained MCI
2. Patients satisfying core clinical criteria for possible AD because of unclear clinical presentation, either an atypical clinical course or an etiologically mixed presentation
3. Patients with progressive dementia and atypically early age of onset (usually defined as 65 years or less in age)
SNMMI will be meeting with CMS on April 17th and will be stressing coverage for the 3 indications discussed above. Coverage Evidence Development (CED) will not be discussed unless asked.
Statements by the presenters at the MEDCAC meeting:
Michael Devous, Norman Foster, and Steven Salloway are in final preparation of a letter to go to CMS and will also ask others to sign this letter, including other dementia experts. The letter will focus on the 3 appropriate indications, along with discussing the definition of a dementia expert. This will be sent out for review and co-signers today.
A concern for CMS was the definition and identification of the mild cognitive impairment (MCI) population.
Mary Richards, Sr. Director of Federal Affairs for the Alz. Association discussed the history and current positioning with CMS. Two weeks after the MEDCAC meeting ago the Alz. Assoc. met with CMS to begin discussions on the diagnosis of Alzheimer’s disease, complications with comorbidities, the value of a diagnosis, and identifying MCI individuals. The Alz. Assoc. and SNMMI put out a press release immediately following the MEDCAC meeting indicating disappointment in MEDCAC recommendations. CMS was asked by the Association to set aside the MEDCAC recommendations and to proceed using a scientific basis for evaluating reimbursement for this technology.
The meeting with Drs. Patrick Conway, Louis Jacques, and Shari Ling at CMS focused on the point that information at the MEDCAC meeting was not accurate, but wanted to work with them in a positive manner going forward. CMS indicated feedback and information was important at this point and a draft guidance document would be released in July. It will be important to show consensus around the AUC and how it would be implemented. The National Alzheimer’s Plan does speak to diagnosis of Alzheimer’s and could be another venue to bring this topic to public policy discussions.
Maria Carrillo, VP of Med Sci at the Alzheimer’s Association mentioned that three specific points were raised by CMS:
1) How did the Amyloid Imaging Taskforce determine that the dementia expert was the best person to order the scan?
2) How to define the MCI population? There was a concern about individuals with subjective memory complaints broadening the population for coverage.
3) How to address the limited accessibility of this technology and specialists? There was a concern for individuals in rural areas. This technology may not be appropriate for primary care physicians, but needs a dementia expert to order the test and interpret the scans.
Norman Foster agreed with Maria on the specific points stressed to CMS in the Association’s meeting, the MCI population as those that have persistent, objective deficits where the cause remains undetermined after a neurological evaluation. It was stressed that the 3 appropriate indications in the AUC should define a subset of individuals needing scans.
Peter Herscovitch indicated: 1) referral to a larger center is not unique to amyloid PET imaging (e.g. endarterectomy), 2) an amyloid scan is only part of the full evaluation, and 3) a dementia expert would be the best person to consult with the patient before the scan and when discussing the results.
ApoE genotyping is not recommended in clinical care. There have been a number of guidelines in the last 10 years which indicated that genotyping is not clinically relevant. ApoE genotyping is not reimbursed.
CMS is evaluating amyloid PET imaging as to whether it is reasonable and necessary. It is important not to discuss the research and clinical utility together, for it is a source of confusion for CMS.
Maria also stressed that the Association has not mentioned CED in any conversations and is supporting full coverage of the AUC recommendations. SNMMI is in agreement with this stance and is making similar statements on coverage without opening the door to CED at this time.
2. Editorials under preparation: Neurology/Alzheimer’s & Dementia
Michael Devous indicated that he, as well as others, are preparing two editorials that will provide more information to CMS on MCI and “value of knowing.” He would like to share a draft with the AIT to allow the language around defining the MCI population to be similar to that being discussed by the AIT. This would allow harmonization of the points being made to CMS.
Scientific consensus is important to convey to CMS.
It was indicated that some stakeholders have raised issues about components of the Preamble (in the AUC document) stated in conjunction with the 3 appropriate indications.
3. AIT next steps regarding revisions and future directions
AIT will be considering the definition of dementia expert and reconvening to discuss the appropriate language to define the MCI population described in the AUC. Additionally, they will consider the educational plan for training individuals conducting the scans and those interpreting the scans and giving appropriate counseling. The AIT taskforce will stay in its current configuration.
4. Policy Stakeholder Comments: MITA, LEAD, Others
Brian Abraham (Medical Imaging &Technology Alliance, MITA) (representing PET drug and equipment manufacturers) is in complete support of coverage for amyloid PET imaging as spelled out in the AIT appropriate use criteria document. At MEDCAC, MITA indicated that diagnostic tools need to be viewed differently than medical treatments and cited the AUC as the standard to which coverage should be applied. MITA has sent a letter to CMS to clarify points missed in the MEDCAC meeting and is crafting another letter to CMS supporting coverage of amyloid PET imaging as specified in the AUC.
Ian Kremer (Leaders Engaged on Alzheimer’s Disease, LEAD Coalition) will be weighing in with CMS and is supportive of coverage for amyloid PET imaging and agrees with the consensus expressed on this call.
Al Naqvi (World Molecular Imaging Society, WMIS) indicated that WMIS is fully supportive of coverage of amyloid PET imaging. (http://www.wmis.org/2013/02/wmis-supports-experts-commits-to-resolve-beta-amyloid-issues-with-cms).
Mykol Larvie (the American Society of Neuroradiology) stated that they are fully supportive of amyloid PET imaging coverage as specified by the AUC and wishes to contribute to this effort.
Nick Manetto (FaegreBD Consulting/US Against Alzheimer’s Disease) will continue to meet with CMS, develop editorials, and would like to continue working with this group to support coverage of amyloid PET imaging.
Anita McGlothlin (American College of Radiology) indicated ACR is supportive of amyloid PET imaging and was discussing Coverage with Evidence Development.
5. Industry stakeholder update: Avid/Lilly, GEHC, Navidea, Piramal
Mark Mintun (Avid/Lilly) requested National Coverage Analysis (2012) last summer for the class of amyloid PET reagents based on the FDA label population, which focused on the yet to be released appropriate use criteria. They were disappointed with the MEDCAC results and have subsequently been in contact with CMS indicating they are in full support of the 3 indications in the AIT’s appropriate use criteria document and are requesting full coverage. There is a planned meeting with Patrick Conway in early April.
Lilly is continuing its education of thought leaders and policymakers, such as legislators, to understand the need for early diagnosis and the need for a positive decision by CMS for coverage of amyloid PET imaging.
Jane Nature (GEHC) is fully supportive of the AUC and the MITA initiative. GE will continue to interact directly with CMS and through MITA.
Dave Pendleton (Navidea) does support the AUC indications and will lend their support to see coverage of amyloid PET imaging.
Steve Sandor (Piramal) indicated that Piramal is supportive and their position is reflected in the MITA initiative.
Stakeholders who have been involved in the process to date have been giving useful scientific feedback and information to CMS, however there is not an open or formal comment period. Having individuals comment to CMS could complicate the issue if not properly focused or well informed, stressing the importance of having the community address recommendations with one voice and point to the AUC. The CMS Draft memo is due at the beginning of July, so time is short for comments. It was suggested that David Knopman (Mayo) and/or John Morris (Wash. U) could reach out to the Amer. Acad. of Neurology to direct individuals to the AUC documents to encourage them to use similar language and recommendations so as not to confuse CMS. It is especially important to distinguish between research and clinical use of amyloid PET imaging in discussions with CMS.
Sue Bunning (SNMMI) reiterated that this is it not a formal comment period and comments should focus on the science and not the political aspects of CMS coverage.
6. National Alzheimer’s Plan Activity
The National Alzheimer’s plan, as part of the National Alzheimer’s Project Act (NAPA), does reference the importance of early detection and diagnosis of Alzheimer’s disease. The NAPA called for the creation of a National Alzheimer’s Advisory Council. The council is keeping HHS apprised on the amyloid PET imaging coverage issue. Shari Ling from CMS sits on the advisory council and updates Patrick Conway on how this issue is proceeding. The recommendation to the council is for coverage and that coverage with evidence development is not needed. This is supported by the science, the consensus in the scientific community supporting the published AUC for amyloid PET imaging, and the review conducted by the FDA. The next advisory council meeting, April 29th, will discuss amyloid PET imaging and is open to the public. There will also be a webcast. Information can be found on www.alz.org/NAPA.
Alzheimer’s Association position with regard to discussing this issue with legislators is to try not to revisit issues from past legislation on PET imaging, for it would be counterproductive.
SNMMI also taking a similar position as the Alz. Assoc. and not pushing this coverage as a legislative piece. It will be part of their talking points, but not a specific ask in their regular meetings on Capitol Hill.
7. Action Items/Next Steps
It is important to continue to offer information and help to CMS, as well as to reinforce full coverage (not CED) for the 3 specific indications documented in the AUC.
Another stakeholders’ teleconference will be scheduled in April.