Hepatitis C: Screening for Hepatocellular Carcinoma (HCC) in Patients with Cirrhosis

Measure Specification

HCC (hepatocellular carcinoma) is the fourth most common cancer in the world and is the fastest rising cause of cancer-related deaths in the United States. HCV is the leading cause of HCC and the risk of developing HCC is highest in patients with established HCV cirrhosis. Several potentially curative treatments are available for patients with early-stage HCC.

These include surgical resection, liver transplantation, and local ablation. Long-term survival of patients who have liver resection or transplantation for HCC can be high (40% to 70% for resection and 52% to 81% for transplant patients after 5 years). A recent systematic review of 18 nonrandomized studies found that more screened patients had early-stage HCC than clinically diagnosed patients.

More screened patients received potentially curative treatment. However, these studies were limited by their observational nature (including lead time bias) and thus the effect on overall mortality was unclear. There are no randomized controlled trials that evaluated the impact of HCC screening versus no screening on survival in patients with cirrhosis.

A randomized trial of HCC screening is not forthcoming because, even in the absence of high quality data, most informed patients and their clinicians consider randomization unethical and prefer surveillance. In a recent modeling based study (that corrected for lead time bias), US based screening for HCC in compensated HCV cirrhosis patients reduced mortality compared to no screening.

Collectively, these data suggest that screening has a potential to produce benefits in the highest-risk patients, such as those with HCV cirrhosis who are good candidates for potentially curative treatment.

Patients at high risk for developing HCC, including patients with Hepatitis C cirrhosis, should be entered into surveillance programs. Surveillance for HCC should be performed using ultrasonography. Patients should be screened at 6-month intervals (AASLD, 2023). HCC surveillance must be continued indefinitely in patients with cirrhosis (A1). Patients with cirrhosis should undergo regular surveillance for HCC, irrespective of SVR (B1) (EASL, 2014) While current US guidelines only specify using ultrasound, evidence suggests that using multiple screening methods, including incorporating the alpha fetoprotein biomarker into surveillance plans, may be more effective in identifying early stages of HCC.

This measure contains one strata defined by a single submission criteria. This measure produces a single performance rate. For the purposes of MIPS implementation, this patient-process measure is submitted a minimum of once per patient for the performance period. The most advantageous quality data code will be used if the measure is submitted more than once.