Director, Health Policy & Regulatory Affairs
Society of Nuclear Medicine and Molecular Imaging
THE FOLLOWING COMMENTS WILL ALSO BE SUBMITTED AS AN ATTACHMENT TO CAGInquiries@CMS.HHS.GOV
Re: National Coverage Analysis Reconsideration Request for Positron Emission Tomography (CAG-00065R2)
Dear Dr. Jacques:
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) and American College of Radiology are pleased to reaffirm our support for reconsideration of Section 220.6 of the Medicare National Coverage Determinations Manual, which addresses coverage limitations for PET scans. Additionally, the American College of Cardiology (ACC) and American Society for Nuclear Cardiology (ASNC) with the SNMMI and ACR support this reconsideration with the understanding, as stated by CMS, that this request would not preclude CMS from accepting internal or external requests to open an NCA on any specific uses of PET. In this joint medical specialty letter, we respectfully request that CMS remove the current non-coverage language as it pertains to new PET radiopharmaceuticals that receive approval from the Food and Drug Administration (FDA).
Support Coverage at the Discretion of the Local MAC for New FDA-approved PET radiopharmaceuticals
We are strongly in support of Medical Imaging Technology Alliance’s (MITA) recent letter that requested a limited revision of the PET NCD which maintains the integrity of the NCD for tracers reviewed within, but forecloses the inappropriate extension of non-coverage to new FDA-approved tracers that have not received even minimal actual review by the agency. Suggested revisions would state that coverage of new FDA-approved PET radiopharmaceuticals is at the discretion of the local Medicare Administrative Contractors unless specifically addressed under a National Coverage Determination.
The proposed revisions would allow the PET NCD to mirror the statements in other National Coverage Determination Manuals, specifically Magnetic Resonance Imaging (220.2) and Computed Tomography (220.1). Magnetic Resonance Imaging was revised in July of 2010 to state, “Effective June 3, 2010, all other uses of MRI or MRA for which CMS has not specifically indicated coverage or non-coverage continue to be eligible for coverage through individual local contractor discretion.” Similarly, the Computed Tomographic Angiography (CTA) section of Computed Tomography (220.1) states that “decisions should be made by local contractors through a local coverage determination process or case-by-case adjudication.”
Discussion Regarding Evidence
Our medical specialties remain committed to working with CMS and other stakeholders in creating a clear and open dialogue to provide peer-reviewed information for new PET radiopharmaceuticals. As part of these efforts, the societies plan to work with other organizations to develop educational resources to help ensure appropriate utilization of PET/CT by referring physicians, as well as nuclear medicine physicians and radiologists. As evidence, the 7-20-2012 MedSolutions comment letter, correctly points out, the efforts of the SNMMI and the Alzheimer’s Association support to continued research by convening a task force to develop recommendations for the use of amyloid imaging. Our societies will continue to support studies of potential benefits to patients that will serve as the basis for appropriateness criteria guidelines to assist referring physicians and other providers.
We also note the Phase 3 clinical trial of flurpiridaz F18 by Lantheus Medical Imaging. http://clinicaltrials.gov/ct2/show/NCT01347710. In addition to having physiologic advantage over Rb82 and Ammonia N13 (higher extraction fraction at stress flow rates, compatible with exercise stress, and lower proton range resulting in improved spatial resolution), it has the potential to have a significant impact on clinical cardiac PET, since it is unit dosed. As opposed to Rb82 (on-site generator) or Ammonia N13 (cyclotron produced with a relatively short T½ of ~10 minutes necessitating close proximity to a cyclotron), Flurpiridaz is F18 based with a 110 minute half life. This agent, like F18FDG, can be compounded at a local radiopharmacy and then delivered in a unit-dose fashion (much like the SPECT agents that we commonly use). Furthermore, Flurpiridaz has characteristics which make it well suited to measure absolute myocardial blood flow. For these reasons, we believe it makes sense to allow MACs to cover use of other agents, such as this, that may receive FDA approval in the next several years.
Finally, as noted in the MITA response letter dated, August 2, 2012, we endorse this letter and concepts, that newly approved PET radiopharmaceuticals are subjected to rigorous well-controlled clinical trials that are demonstrative of the safety and efficacy of the FDA approval process and provide a level of evidence which is sufficient for the next step in the process; the option of coverage at the local contractor discretion.
In summary, recent advances in imaging and CMS’s past experience with PET coverage no longer support a rationale for a pre-emptive national non-coverage policy for new PET radiopharmaceutical agents that undergo rigorous FDA review and approval.
We appreciate your consideration of our recommendations. Should you have any questions, please contact Sue Bunning, Director of Health Policy and Regulatory Affairs at email@example.com or (703) 326-1182.
Frederic H. Fahey, DSc
Harvey L. Neiman, MD, FACR
William A. Zoghbi, MD, FACC
John J. Mahmarian, MD, FASNC