Abstract
Immediately after the approval of direct-acting antiviral medications for the treatment of hepatitis C virus (HCV) in 2013, state Medicaid programs limited access to these expensive treatments based on liver disease stage, absence of active alcohol or substance use, and prescriber limitations. New York State fee-for-service (FFS) Medicaid eliminated these requirements in May 2016, but the effect on providers and patients obtaining prior authorization (PA) from Medicaid managed care organizations (MCOs) was unknown. We used a mixed methods approach to assess whether the removal of HCV treatment restrictions was associated with changes in Medicaid MCOs' PA approval processes and length of time to treatment initiation at two large urban New York City provider organizations participating in Project INSPIRE, an HCV care coordination demonstration project. At baseline, the top criteria for clinic care coordinators ranking MCOs as being "most difficult" were liver staging criteria, delayed treatment, and requiring a urine toxicology test. At follow-up, liver staging criteria were replaced by medication formulary limitations. Univariate analysis of the Project INSPIRE participant data suggests a decrease in the percentage of participants with insurance/PA-related treatment delays pre- versus post-policy change (23% versus 15%, p value = 0.02). Interrupted time series analysis found a 2 percentage point decrease (p value = 0.02) in the proportion of PAs each month with insurance-related treatment delays that was attributable to policy change. These results from two urban clinics indicate New York State FFS Medicaid's policy change for HCV treatment may have been associated with some changes in Medicaid MCO PA decisions, but MCO PA denials and treatment delays were still observed "on the ground" by clinic staff.