Artificial Liver Assist Devices for the Treatment of Liver Failure

This policy covers use of artificial liver assist devices—including cell‑free ALS (e.g., MARS®), albumin‑dialysis systems, and cell‑based bioartificial liver (BLS) devices (e.g., ELAD®)—to provide temporary extracorporeal support for toxin removal and metabolic/liver function replacement in patients with acute/fulminant liver failure, acute‑on‑chronic liver failure, selected intoxications (e.g., acetaminophen, amatoxin), or as a bridge to transplantation or native liver regeneration. Major limitations: many ELSS/BAL systems are investigational or available only via clinical trials/compassionate use and lack FDA marketing approval for bioartificial liver indications (MARS® is FDA‑cleared only for overdose/poisoning); they are not indicated for chronic/long‑term liver replacement, are generally limited to short‑term use (≈30 days), and carry risks such as hypotension, bleeding, infection and other serious adverse events.

"Temporary extracorporeal support for patients with liver failure to replace or augment liver function"