Historically, the Centers for Medicare & Medicaid Services (CMS) covered PET services only through a National Coverage Determination (NCD) for PET imaging. The majority of the early coverage was limited primarily to those scans performed with the radiopharmaceutical Fluorodeoxyglucose F 18 (FDG), commonly called FDG. However, coverage for PET services has expanded over the last several years.
Today, coverage can be permitted at the discretion of the local Medicare Administrative Contractors (MACs) for new oncologic PET radiopharmaceuticals. However, all other types of PET radiopharmaceuticals may only be covered through the NCD process. CMS may cover these PET radiopharmaceuticals nationally by revising the NCD for PET. Alternatively, they may determine that a process known as Coverage with Evidence Development (CED) should be undertaken for a particular product or class of products. The CED process collects additional information about the patient and their treatment plan in order to assess whether the PET services effectively result in a change in patient management, and ultimately outcome. It is typically required when CMS believes that the clinical evidence is insufficient but promising.
In 2013, CMS issued important changes to their PET coverage policies:
- Effective for dates of service on or after March 7, 2013, CMS determined that, unless there is a specific NCD to the contrary, local MACs may determine coverage (or non-coverage) within their respective jurisdictions for PET using new, proprietary radiopharmaceuticals for their FDA-approved labeled indications for oncologic imaging only. This includes those radiopharmaceuticals that may be approved by FDA in the future.
NCD for Positron Emission Scans, Publication 100-3 section 220.6
- On June 11, 2013, CMS posted a final NCD memorandum that announced two important coverage policy revisions for FDG PET for solid tumors. In this coverage decision, CMS also included integrated FDG PET/CT and integrated FDG PET/MRI in the term FDG PET.
- 1. CMS ended CED that had previously been required for several cancer indications when using FDG PET to inform initial and/or subsequent Anti-tumor Treatment Strategies (ATS).
- 2. CMS will cover three FDG PET scans when used to guide subsequent management of ATS after completion of initial anti-cancer therapy for any cancer indication. Additional coverage of FDG PET scans beyond the three scans will be determined by local MACs.
Decision Memo for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R4), June 11, 2013
- On September 27, 2013, CMS issued a policy indicating that the evidence was insufficient to conclude that the use of positron emission tomography (PET) beta amyloid is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member for Medicare beneficiaries with dementia or neurodegenerative disease.
However, they believed that there is sufficient evidence that the use of PET Aß imaging is promising in two scenarios: (1) to exclude Alzheimer’s Disease (AD) in narrowly defined and clinically difficult differential diagnoses, such as AD versus frontotemporal dementia (FTD); and (2) to enrich clinical trials seeking better treatments or prevention strategies for AD, by allowing for selection of patients on the basis of biological as well as clinical and epidemiological factors. In these cases, CMS will cover one PET Aß scan per patient through CED, in clinical studies that meet certain criteria.
NCD for Beta Amyloid Positron Tomography in Dementia & Neurodegenerative Disease, Publication 100-3, 220.6.20
In response to CMS’ decision regarding amyloid PET imaging, multiple stakeholders, led by the Alzheimer’s Association began the lengthy process of designing a clinical trial that would meet the CMS criteria. That trial, known as the Imaging Dementia – Evidence for Amyloid Scanning, or IDEAS Study. Enrollment for the IDEAS study will end on December 7, 2017. For more information on the Study, please visit https://www.ideas-study.org/.
Commercial insurers’ coverage policies may vary from those of CMS and pre-authorization for the PET scans is typically required.