Revision in Hepatitis C Prescriber Requirements
Date Issued: 10/3/2018
In March 2018, Governor Cuomo announced the first state-level strategy to end hepatitis C virus (HCV) in New York State (the full announcement can be read here: governor.ny.gov/news/governor-cuomo-announces-statewide-expansion-enhanced-rental-assistance-program-increase-access). This strategy includes efforts to increase access to medications and treatment. Consistent with this effort, effective August 1, 2018, the HCV-direct-acting antiviral (DAA) prescriber experience and training clinical criteria (below) implemented by the Medicaid program based on past Drug Utilization Review (DUR) Board action will no longer be required:
- Require confirmation of prescriber experience and training.
- Prescribed by hepatologist, gastroenterologist, infectious disease specialist, transplant physician, or health care practitioner experienced and trained in the treatment of HCV or a health care practitioner under the direct supervision of a listed specialist. AND
- Clinical experience is defined as the management and treatment of at least 10 patients with HCV infection in the last 12 months and at least 10 HCV-related Clinical Medical Education (CME) credits in the last 12 months. OR
- Management and treatment of HCV infection in partnership (defined as consultation, preceptorship, or via telemedicine) with an experienced HCV provider who meets the above criteria.
In addition, the New York State Department of Health (NYSDOH) will no longer utilize the Medicaid Hepatitis C Practitioner Information Request Form process and will remove the HCV Approved Practitioners List from the website. As noted in the NYSDOH AIDS Institute HCV Guideline-Treatment of Chronic HCV Infection with Direct Acting Antiviral (hivguidelines.org/hcv-infection/treatment-with-daa/), when prescribing HCV antiviral therapy, clinical experience and appropriate continuing education are both important to ensure that HCV medications are prescribed safely and correctly and that all patients receive the highest quality of care.
It is recommended that care providers new to HCV treatment should consult with a liver disease specialist when treating patients with chronic HCV infection and any of the following conditions:
- Compensated and decompensated cirrhosis
- Concurrent hepatobiliary conditions
- Extrahepatic manifestations of HCV, including renal, dermatologic, and rheumatologic manifestations
- Significant renal impairment (creatinine clearance <30 mL/min) and/or undergoing hemodialysis
- Active hepatitis B (HBV) infection, defined as HBV surface antigen–positive and detectable HBV DNA
- Retreatment after any DAA treatment failure
Additionally, providers should refer patients with chronic HCV infection and decompensated liver disease and patients who are pre- or post-transplant to a liver disease specialist. Depending on their level of experience and expertise, care providers may also want to refer patients who have coexisting conditions (including HIV) that require treatment with complex drug regimens to a care provider with experience in the management of complex patients with HCV infection.