Hepatitis denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement and prospective authorization and coverage for residential treatment center (RTC) services (ASAM 3.5). Per the American Society of Addiction Medicine (ASAM) criteria, this patient meets Level 3.5 criteria for RTC services provided. ASAM criteria focus on six dimensions to determine the appropriate level of care, which includes: (1) intoxication and withdrawal potential; (2) biomedical conditions; (3) emotional, behavioral, and cognitive conditions; (4) readiness to change; (5) relapse, continued use, or continued problem potential; and (6) recovery environment. For dimension 1, the patient had no signs or symptoms of withdrawal after detoxification was completed.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Mavyret for treatment of the enrollee’s chronic hepatitis C virus (HCV), genotype 1a. Findings: The physician reviewer found that according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. The guidelines recommend that all patients should be treated, regardless of fibrosis stage. As ultrasound elastography showed a lack of cirrhosis, thus this patient should be treated as a non-cirrhotic patient. The guidelines recommend that non-cirrhotic treatment naive genotype 1a patients should be treated with Mavyret.

Where the denial was upheld

A 48-year-old male enrollee has requested for an additional 12 weeks of Pegasys and ribavirin for treatment of his hepatitis C virus. Findings: The physician reviewer found that the current approved treatment for hepatitis C is pegylated interferon (Pegasys) plus ribavirin for a total of 48 weeks in genotype-1 patients. Some studies have suggested that a longer treatment period may be warranted in those patients who have a late documented viral clearance while on therapy. Currently, a 12-week time point is used to determine the presence of an early viral response (EVR); however, many studies indicate that a 4-week point may also be useful in predicting a response to 48 weeks of therapy.

The patient is a 57-year-old man with hepatitis C genotype 1 and cirrhosis. He has failed treatment with interferon and ribavirin due to side effects including bone marrow and psychiatric effects. He has a long list of complicating diagnoses including hypertension and cholelithiasis. The patient’s provider has recommended the patient begin treatment with ribavirin monotherapy. The Health Plan has denied authorization and coverage for the requested therapy on the basis it is not medically necessary for treatment of the patient’s medical condition.The issue of treatment failure and the benefit of ongoing therapy with interferon or ribavirin as a method to suppress inflammation has been addressed in the published guidelines of the American Association for the Study of Liver Disease.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving hepatitis, then check the rights and deadlines that apply to your plan.