New York State (NYS)
Removal of Prior Authorization for Hep C Medications
Frequently Asked Questions
1. Are insurance companies aware of this change?
Yes, insurance companies (Medicaid Managed Care plans, MMC) are aware of this change. On July 23, 2020, the New York State Medicaid Drug Utilization Review (NYS DUR) Board recommended changes to the Medicaid pharmacy prior authorization programs. This included changes for the hepatitis C agents – In addition to the standard clinical criteria for non-preferred products, all products require prior authorization if there is no evidence of a Federal Drug Administration (FDA)-approved or compendia-supported diagnosis in history or if the patient is being retreated. The DUR Board does include Medicaid Managed Care (MMC) plan representation. The MMC plans were also notified via an email communication from the NYS Department of Health (DOH) prior to the Medicaid Update.
2. Does this change effect those in a commercial/private insurance plan?
This change does not affect commercial/private insurance.
3. Does this change effect those in Medicare?
No, this change does not impact any Medicare pharmacy rules or requirements.
4. When did the removal of prior authorization (PA) go into effect for NYS Medicaid Fee for Service (FFS) and MMC plans?
The removal of PA criteria went into effect for NYS Medicaid FFS and Medicaid Managed Care in the fourth quarter of 2020.
5. In what situations is PA still required?
PA is still required in the following situations:
- Retreatment
- When prescribing a non-preferred drug
- When there is no evidence of a Federal Drug Administration (FDA)-approved or compendia-supported diagnosis in history
6. What are the current clinical criteria for prior authorization for Hep C Direct Acting Antivirals in FFS?
The current clinical criteria for prior authorization for Hep C Direct Acting Antivirals in FFS are:
- Confirm diagnosis of FDA-approved or compendia-supported indication.
- For patients being retreated require confirmation of patient readiness and adherence
Evaluation by using scales or assessment tools readily to determine a patient’s readiness to initiate Hep C treatment, specifically drug and alcohol abuse potential. Assessment tools are available to healthcare practitioners at: https://www.drugabuse.gov/nidamed-medical-health-professionals/screening-tools-resources/chart-screening-tools OR https://prepc.org/
The Medicaid FFS Hep C Worksheet is an optional tool providers can use when submitting PA.
7. What are the current clinical criteria for prior authorization for Hep C Direct Acting Antivirals in MMCs?
Each MMC plan has their own set of clinical criteria, which closely mirrors Medicaid FFS. The criteria can be found on their respective web sites. For links to the MMC plan web sites, go to NYS Medicaid Managed Care Pharmacy Benefit Information Center and click on the MMC plan icon.
8. When and why is genotype required in the PA process?
In line with the AASLD treatment guidelines genotype is only needed to determine if resistance testing is required when Elbasvir/grazoprevir (Zepatier), Ledipasvir/sofosbuvir (Harvoni) or Sofosbuvir/velpatasvir (Epclusa) is prescribed.
9. When is resistance testing required?
In line with the AASLD treatment guidelines resistance testing is required only when Elbasvir/grazoprevir (Zepatier) or Ledipasvir/sofosbuvir (Harvoni) are prescribed for patients with genotype 1a or Sofosbuvir/velpatasvir (Epclusa) is prescribed for genotype 3.
10.What are the current preferred Hep C Direct Acting Antiviralson the FFS formulary?
The current preferred DAAs on the FFS formulary are:
- Mavyret™
- ribavirin
- sofosbuvir/velpatasvir (gen Epclusa®)
- Vosevi®
11. Where can I find more information on the NYS Medicaid FFS Preferred Drugs?
For more information on the NYS Medicaid FFS Preferred Drug List, go to: https://newyork.fhsc.com/downloads/providers/NYRx_PDP_PDL.pdf
12. Where can I find the preferred Hep C Direct acting Antivirals for the MMC plans?
Each MMC plan has their own formulary. The formularies can be found on their respective web sites. For links to the MMC plan web sites, go to NYS Medicaid Managed Care Pharmacy Benefit Information Center and click on the MMC plan icon.
13. If I have questions about prior authorization for Hep C medications, who can I contact?
For questions about PA send an email to Medicaid Pharmacy Department via email at: ppno@health.ny.gov
14. What documentation can a provider share with MMC plans, if told PA is still required?
15. What should a provider do if they receive a denial for a medication when all criteria for approval have been met?
Providers can reach out to the Medicaid Pharmacy Department via email at: ppno@health.ny.gov. Please include the MMC plan name, patient name, ID, DOB and details of the denial.
16. Where can someone find more information on the NYS Medicaid Pharmacy Programs?
For more information on the NYS Medicaid Pharmacy Programs: http://www.health.ny.gov/health_care/medicaid/program/pharmacy.htm
17. How can someone find a Hep C provider in NYS?
To find a Hep C provider in NYS go to: https://providerdirectory.aidsinstituteny.org/
18. Where can someone find out information on the pharmacy benefit transition?
Effective April 1, 2023, per a Medicaid Redesign Team budget initiative, Medicaid will move the pharmacy benefit for 5.3 million Medicaid managed care members back to Medicaid fee-for-service (FFS). More information on this initiative can be found at: https://www.health.ny.gov/health_care/medicaid/redesign/mrt2/pharmacy_carve_out/
Last Updated on August 1, 2022 by HepFree NYC
