Effective March 19, 2008, CMS issued a National Coverage Determination (NCD) for FDG PET for Infection and Inflammation — establishing non-coverage for this modality when used to explore indications of infection or inflammation (learn more at bit.ly/FDG-PET). Effective Jan. 1, 2021, CMS retired this NCD — citing the criterion established in 2013 to regularly identify and remove NCDs that no longer contain clinically pertinent and current information. With the removal of the NCD, CMS will modify the NCD manual to ensure that contractors have the authority to make a coverage determination when claims are submitted for FDG PET for inflammation or infection. The NCD for FDG PET for Infection and Inflammation had barred coverage for this item/service; therefore, retirement of this NCD under Title XVIII (national non-coverage NCD) allows Medicare Administrative Contractors (MACs) to cover the item or service if the MAC determined that such action was appropriate.

Whether or not FDG PET for infection or inflammation will be covered by the local MAC within any given jurisdiction is unclear at this point in time. Seven MACs cover one or more jurisdictions. Some of these MACs have issued guidance on filing claims for PET-CT for the evaluation of cardiac sarcoidosis. This is communicated in a bulletin from the MAC that is issued on a monthly or quarterly basis or inquiries can be made directly.

At present, none of the MACs have issued official guidance on filing claims for PET-CT for the detection of infection. Members of the ACR, the Society for Nuclear Medicine and Molecular Imaging, the American Society of Nuclear Cardiology, and the American College of Nuclear Medicine are currently holding joint teleconferences with each of the MACs to discuss each MAC’s perspective on the next appropriate steps. Potential next steps include payment of claims outright by a MAC and development of a local coverage determination (LCD), among others. MACs have statutory authority to develop LCDs for their individual jurisdictions. An LCD, as defined in §1869(f)(2)(B) of the Social Security Act, is a determination by a MAC about whether or not a particular item or service is covered in the MAC’s jurisdiction in accordance with section §1862(a)(1)(A) of the Act.

Members of the ACR, the Society for Nuclear Medicine and Molecular Imaging, the American Society of Nuclear Cardiology, and the American College of Nuclear Medicine are currently holding joint teleconferences with each of the MACs to discuss each MAC’s perspective on the next appropriate steps.

The 2016 21st Century Cures Act updated the LCD process in terms of who may request a new LCD or an informal meeting with the MAC to discuss potential LCD requests. This action may be initiated by beneficiaries residing or receiving care and healthcare professionals/interested parties doing business within a MAC jurisdiction (learn more at bit.ly/LCD-process). MACs must follow the revised LCD process to make any changes in coverage. When developing an LCD, the MAC(s) may supplement evidence from required peer-reviewed literature with clinical guidelines, consensus documents, consultation by experts, or advisory opinions by medical associations or other healthcare professionals. Although an LCD is local to every jurisdiction, MACs covering more than a single jurisdiction have typically tried to maintain homogeneity of LCD policies across jurisdictions covered by that MAC. Furthermore, there is a recognized need for greater consistency between existing LCDs across MACs and the joint development of new LCD topics across MACs.

The ACR’s Contractor Advisory Committee Network, the Commission on Nuclear Medicine and Molecular Imaging, and the Economics Committee on Nuclear Medicine are all monitoring progress of discussions with the individual MACs — with the intent of joining other stakeholders in a unified approach to establishing reimbursement for FDG PET for Infection and Inflammation. In the meantime, if a provider performs/interprets an FDG PET for Infection and Inflammation for a Medicare beneficiary and files a claim that is denied by the provider’s MAC, the provider may file an appeal of that denial. If such an appeal is made, please reach out to Alicia Blakey, ACR senior economic policy analyst, at ablakey@acr.org for educational resources that may be used to assist the MAC in assessing the evidence for FDG PET for infectious and inflammatory disease indications.