MAC Update on Retirement of NCD for FDG PET Infection & Inflammation

March 11, 2021

As you may know, the Centers for Medicare and Medicaid Services (CMS) retired the National Coverage Determination (NCD) for the non-coverage of FDG PET for infection and inflammation, effective January 1, 2021. Removal of the 2008 NCD opens up a path to reimbursement, which ultimately will improve care for patients. In the absence of a Medicare Administrative Contractor (MAC) Local Coverage Determination (LCD), NCD, or CMS Manual Instruction, reasonable and necessary guidelines still apply.

Section 1862(a) (1) (A) of the Social Security Act directs the following:

No payment may be made under Part A or Part B for any expenses incurred for items or services not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

The MAC will determine if an item or service is “reasonable and necessary” under §1862(a) (1) (A) of the Act if the service is:

Safe and effective; not experimental or investigational; and appropriate, including the duration and frequency in terms of whether the service or item is:

Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the beneficiary’s condition or to improve the function of a malformed body member; furnished in a setting appropriate to the beneficiary’s medical needs and condition; ordered and furnished by qualified personnel; and one that meets, but does not exceed, the beneficiary’s medical need.

For any service reported to Medicare, it is expected that the medical documentation clearly demonstrate that the service meets all of the above criteria. All documentation must be maintained in the patient’s medical record and be available to the contractor upon request.

SNMMI has met with Palmetto GBA, WPS Government Healthcare Administrators (WPS GHA), and CGS Administrators and has communicated with Novitas Solutions and Noridian Healthcare Solutions. At present, no MACs are in the process of developing an LCD, although CGS did express an interest. SNMMI will keep working with all the MACs as well as our own members on claims processing issues.

Although all MACs are required to process claims according to reasonable and necessary guidelines in the absence of an LCD, WPS GBA told us they are not looking to develop an LCD at this time; rather, they prefer to monitor claims (as they expect the volume to be low). They assured us that there should not be any reimbursement issues with FDG PET for inflammation and infection. However, if you are experiencing issues and are in WPS GBA's jurisdiction, please contact