If your transplant program is applying for an exception score for your candidates with Class 5 HCC lesions, you can use the following guidance prepared by the OPTN/UNOS Liver and Intestinal Organ Transplantation Committee.
Policy 9.3.G.iv (Imaging Requirements for Class 5 Lesions), which better defines HCC lesions, was implemented on October 31, 2013. To help transplant programs include appropriate information on an HCC application, UNOS offers the following instructions.
When you are reviewing the imaging study, please review each lesion and determine whether the imaging confirms that the lesion fulfills the Class 5 criteria. The policy (Policy 9.3.G.iv) considers a nodule to be HCC only if it meets the Class 5 radiological criteria. Therefore, only Class 5 HCC lesions should be reported and documented.
Example 1: A patient has 2 lesions, size 2.2 cm and 1.4 cm, both with enhancement and washout during the later contrast phases but without peripheral rim enhancement.
• The 2.2 cm lesion meets the SIZE requirements in 9.3.G.i and is definitive for HCC by meeting the requirements as a Class 5B in Table 9-5. Since this lesion meets the requirements, the candidate is eligible for automatic approval.
• The 1.4 cm lesion meets the SIZE requirements in 9.3.G.i but would not be considered definitive for HCC because it does not meet the requirements for Class 5 in Table 9-5 (i.e., no peripheral rim enhancement). Since this lesion is considered to not be definitive for HCC it should not be reported when requesting automatic exception points.
Example 2: A patient has 2 lesions, size 2.2 cm and 1.4 cm, both without enhancement or washout.
• Neither lesion meets Class 5 requirements. The center may submit an HCC exception application with this information, which will be submitted to the regional review board.
During an audit, UNOS staff will review the medical record documentation for those lesions used to receive either automatic approval or were included on a review board application. In the first example, the program would need to provide documentation of the 2.2 cm Class 5B lesion. In Example Two, documentation of both the 2.2 cm and 1.4 cm lesion would need to be provided. All characteristics used for classifying a lesion must be documented in the medical record.
For ease of reporting, UNOS has also developed a template that can be provided to your radiologists, so that they can provide the interpretation of the OPTN lesion classification. These can be found on Transplant Pro in the Professional Resources section: HCC worksheet and template tables.
For further information, please review the October 2013 webinar: HCC: Appearances are Everything, also found on Transplant Pro under Webinars.