When multiple keywords are selected, results include recommendations that meet the criteria of at least one of the keywords selected (i.e. filters combine keywords using an OR expression).
+Hepatitis C Prevention
Expand the number of SEPs in NYS and the existing SEPs’ geographic reach.
Fund expanded outreach to support people who use drugs through all methods of use.
Expand HCV Prevention Strategies in state and local correctional facilities.
Treatment should also be available to those with Opioid Use Disorder (OUD) who are not on treatment at the time of incarceration. MAT has been shown to reduce injection and is associated with reduction in transmission of HCV and HIV. These medications, along with access to sterile injection equipment, are vital to maintaining HCV cures achieved in NYS DOCCS and/or local jails. Furthermore, inmates with opioid use disorder are significantly more likely to engage in MAT upon release from incarceration if they have initiated or continued methadone or buprenorphine.
Create a NYS Medicaid waiver program to cover expenses of confidential OUD services, including MAT and HCV testing and treatment, for New Yorkers, including adolescents and young adults.
Improve access to substance use treatment for young people by increasing primary care and specialty system capacity to screen and treat adolescents and young adults.
Develop and implement a 2-year pilot study to assess feasibility and effectiveness of a medically supervised program where patients self-administer prescription pharmaceutical opioids (e.g., hydromorphone/dilaudid).
Recognizing that the opioid epidemic is a public health emergency, allow for safer injection facilities across NYS.
Enhance efforts that raise awareness, provide information and education about preventing HCV for the public, patients, health care providers, social service providers, and elected officials.
Engage adolescents, young adults and their support systems (i.e., families, teachers, faith leaders) in anti-stigma drug education efforts.
+Hepatitis C Testing and Linkage to Care
Mandate HCV antibody to RNA reflex testing.
Reflex testing was recommended in a “Dear Colleague” letter from the NYSDOH in November 2015. In September 2017, Article 13 of the NYC Health Code was amended to require all labs to perform HCV RNA reflex testing on all positive HCV antibody specimens. However, rates of reflex testing in facilities across NYS remain far from 100%.
- Provision of technical support is recommended for laboratories to facilitate HCV antibody to RNA reflex testing in all settings where blood draws can be conducted.
- NYSDOH, like the NYCDOHMH, should provide benchmarking to compare hospital/health care network achievements in the proportion of HCV antibody tests sent for RNA testing.
- NYS Clinical Laboratory Evaluation Program (CLEP) should work with laboratories with repeated poor performance on HCV reflex testing, defined as those with reflex testing <90% of all samples run for anti-HCV, to determine barriers to reflex testing and facilitate solutions.
- Electronic Health Records (EHRs) should eliminate stand-alone anti-HCV as an orderable test and the only orderable antibody test should be “HCV antibody with reflex to HCV RNA.”
- Finally, NYSDOH should also require all labs to perform HCV reflex testing like NYCDOHMH.
Allow sharing of HCV test results to HCV care coordinators and patient navigators.
Implement universal HCV screening of all pregnant women.
Facilitate screening and diagnosis through automatic prompts in EHR systems.
For optimal uptake, these CDS tools should be implemented with input of local stakeholders, including physician leadership, IT, and hospital administration. To prevent “alert fatigue,” prompts should be one-time only, opt-out with hard stop at lab order entry (blood draw), and paired with an automatic lab order of anti-HCV with reflex RNA when systems allow.
For eligible hospitalized patients, automatic anti-HCV antibody with reflex RNA should be built into admission order sets. EHR prompts should be based on internal logic that determines testing eligibility in terms of whether an individual has had a prior test, not prompting if testing has already been done within the health care network served by that EHR.
Expand POC testing to non-medical settings.
Expand and extend the New York State HCV Testing Law.
Within emergency departments (EDs), the ability to offer HCV screening is compromised by the need for rapid management of other conditions. However, prevalence of anti-HCV upon screening of baby boomers in one NYC ED was 7.8%, significantly higher than the national estimate, and universal testing in the same ED demonstrated higher than national prevalence. The scope of the law should be expanded to include opt-out testing for all patients 18 and older presenting to EDs. This mandate should also be expanded to apply to student health clinics, sexual health clinics, opioid clinics, mental health clinics and psychiatric admissions.
The 2020 sunset provision in the current NYS HCV testing law would considerably hamper elimination efforts and momentum. The current statutory requirement should be made permanent.
Remove financial barriers to testing and linkage to care.
NYSDOH AIDS Institute should expand all current HIV/STI screening and SEP contracts to include HCV testing and linkage to care. New RFAs should be created to target high-risk populations and to address barriers to care. These contracts should fund insurance navigators and patient navigators who will assist in linking patients to care. Finally, additional innovative financing strategies should be investigated and encouraged to support HCV programs, such as 340B and Medicaid Section 1115 Demonstration Projects.
Design screening and linkage to care, and treatment delivery models and processes that better engage complex patient populations (e.g., active drug users, homeless, mentally ill, etc.).
- Better, creative strategies and processes for screening and linkage need to be developed for PWID, as well as for the frequently overlapping groups with significant barriers to health care engagement (homeless, mentally ill, criminal justice-involved persons) if strides toward elimination are to be sustainable.
- There should be increased funding and technical assistance for establishing and promoting POC, repeated HCV testing at least annually at venues that interface with PWID, for example, youth drop-in centers, syringe exchange programs, peer-delivered syringe exchange programs, lesbian, gay bisexual, transgender, queer (LGBTQ) community centers, alternative to incarceration facilities, substance abuse treatment centers and homeless shelters.
- NYSDOH and NYCDOHMH should fund and support peer and patient navigators to conduct outreach testing in decentralized and mobile models where patients can be accessed in venues not traditionally served by medical workers.
- Individuals with professional licenses should be given the ability to screen for HCV (i.e., pharmacists) and receive reimbursement.
- HCV POC testing should be incorporated into NYC and NYS HIV partner services infrastructure and investigating regulations around partner testing as applied to HCV.
- HCV testing staff should be trained to encourage people identified with HCV to bring in their injecting network for testing, and NYS should explore incentivization for network identification.
- To better reach young PWID, increased promotion of HCV screening and education is recommended at community colleges, technical colleges, other higher educational institutions across NYS, and within voluntary occupational wellness programs.
- Increases in funding are necessary for the implementation of increased screening, and additional funding is required for oversight to ensure appropriate quality control mechanisms are created throughout NYC and the state.
Create tools to improve surveillance and outbreak detection so that testing can be offered to those at risk and follow up provided to those diagnosed with HCV.
Thus, an effective surveillance system for HCV infection necessitates an investment in technology to facilitate reporting of high-quality laboratory data. In NYS, this means ensuring compliance with HCV reporting guidelines, including the reporting of both positive and negative HCV RNA test results, accurate and complete data entry in the Electronic Clinical Laboratory Reporting System, and investment in more efficient systems for tracking the spread of HCV and effectively targeting prevention efforts.
The spread of HCV can be curtailed by identifying people at risk, testing and treating infected individuals, and implementing community-based prevention measures. Rapid detection of HCV transmission networks is a critical step in this process; however, current surveillance systems and contact tracing methods are labor-intensive and yield incomplete data. Expanded support is recommended for using next generation sequencing technology and automated data analysis systems to allow for rapid identification of HCV outbreaks and transmission networks. Sharing transmission network data with state and local health departments can help target interventions to prevent further spread of the virus. This is best accomplished by investing in surveillance and prioritizing funding to counties and municipalities with above-average incidence and prevalence.
Contact tracing for patients diagnosed with acute HCV is recommended. Additional strategies for improving outbreak detection include expanding outreach and education regarding HCV testing algorithms to both clinical providers and laboratories.
Expand patient navigation and outreach programs.
Funding and support are required for health care and CBOs serving at-risk groups to implement HCV navigation programs across NYS based on experienced models such as “Check Hep C.” This would incorporate new hiring or workforce development of existing community health workers, establishment of standardized training programs and promotion of navigator services within HCV referral infrastructures across NYS.
Navigators are critically needed for sites where HCV can be identified for young PWID and marginalized groups, but where no HCV-treating providers are immediately present. These include, among others, venues such as EDs, drug rehabilitation centers, OB/GYN clinics, sexual health clinics, mental health clinics and hospitals, SEPs, mobile health vans, opioid clinics, student health, community-based or immigrant service organizations, pharmacy-based “minute clinics” and urgent care clinics. Information on navigation services should be added to the NYSDOH HCV Provider website and the online NYC DOHMH HCV Health Map.
In addition, a referral helpline should be established for testing staff or patients to facilitate access to navigation services and HCV providers. Once linkage is established, hepatitis navigators should be fully integrated into the health care team, with access to the electronic health record, specialty pharmacies, and representatives for patient assistance programs.
Advocate for better, more flexible HCV tests.
There is an urgent need for HCV tests and strategies that are faster, simpler, less expensive, and more flexible with respect to test setting, testing capacity and specimen types. New, innovative technologies and strategies may be available to address these needs, but the time and expense it takes to obtain FDA approval and bring a new test to the U.S. market are barriers to improving testing options. In addition, current technologies and strategies should be used to their fullest extent to ensure that HCV testing is reaching the populations at most need.
The NYSDOH should communicate the gaps and needs related to HCV test availability to relevant stakeholders including health care providers, clinical laboratories, community-based programs, advocacy groups and health departments and organize stakeholders to advocate for more HCV test options. The NYSDOH should lead a coordinated effort among the stakeholders to convey the existing gaps in test accessibility to manufacturers and regulatory agencies (i.e., FDA), reinforce the impact of these gaps using robust data, and prioritize the actions needed to close these gaps.
Establish a training and technical assistance center to expand training and other educational opportunities for medical providers, testing and linkage to care staff, and the public.
Several educational interventions for providers have been shown to be effective in improving HCV screening rates, including resident-led initiatives in primary care clinics. Also, directed feedback educating providers on their personal screening rates compared with colleagues improved provider adoption of HCV screening guidelines. On-line educational courses demonstrated a reduction in provider knowledge gaps and increased provider capacity to educate and encourage client engagement in HCV care.
To promote these interventions from a state level, statewide engagement from NYS DOH with graduate medical education program leadership is required to integrate trainee-led HCV screening education initiatives into a quality improvement intervention. Technical assistance should be provided to hospital and outpatient quality departments to help facilities provide comparative data on provider screening and linkage to care rates. The NYS DOH should expand current on-line and in-person provider trainings, with continuing education credits, on HCV for providers in community-based primary care, urgent care, opiate replacement, student health and mental health.
NYSDOH and NYCDOHMH advisories, including a resource list of available trainings, should be disseminated periodically to all state providers of HCV testing guidelines. Finally, to foster focused provider education in high HCV prevalence areas, increased staffing is recommended to support utilization of NYSDOH and NYCDOHMH HCV surveillance data.
Utilization of and increased NYS funding to established partners are recommended to provide trainings for HCV testing staff at CBOs, SEPs, harm reduction settings, homeless shelters and organizations targeting youth. Training should focus on sample collection for HCV diagnostic testing at CBOs. In addition, NYSDOH and NYCDOHMH should lead quarterly trainings for non-clinical sites in HCV rapid testing, sample collection, and counseling. They should also establish a quality control program to track and monitor sites that will conduct specimen collection for HCV diagnostic testing following antibody screening. Support networks should be created for CBO-based HCV testing and linkage staff through monthly calls or regional meetings to share testing and linkage strategies and best practices.
+Hepatitis C Care and Treatment Access
NYS should provide clear expectations and policy guidance for payers to ensure access to all clinically appropriate HCV treatment per NYSDOH AIDS Institute Clinical Guidelines Program and American Association for the Study of Liver Disease (AASLD)/Infectious Disease Society of America (IDSA) clinical guidelines and ensure the availability of necessary supportive services for all persons infected with HCV.
As per the guidelines of the NYSDOH AIDS Institute Clinical Guidelines Program and AASLD/IDSA, “Treatment is recommended for all patients with chronic HCV infection, except those with short life expectancy that cannot be remediated by HCV therapy, liver transplantation, or another directed therapy. Patients with a short life expectancy owing to liver disease should be managed in consultation with an expert.” Payers should approve appropriate drug regimens based on the evidence-based guidelines. Payers should not impose restrictions that are based on severity of liver damage (fibrosis), measures of sobriety, previous treatment experience, treatment readiness, or prescriber restrictions. Payers should also not be allowed to deny patients for retreatment, regardless of whether for virologic relapse or reinfection. NYS should monitor insurance providers’ compliance with these recommendations. Payers should be required to submit hepatitis C coverage information including prior authorization requirements to the State for publication on a publicly accessible NYSDOH website. Furthermore, NYS should provide financial support for full coverage of HCV treatment costs to NYS Medicaid plans and consider additional financial support through other means such as high-cost drug pools, risk corridors, and stop-loss provisions.
Increase resources to address patient barriers to treatment, such as substance use disorders, mental health disorders, cognitive impairment, and other social determinants of health.
Adherence is paramount for successful cure. Often, comorbid psychosocial issues are the biggest barrier for patients. Improved access to harm reduction services, mental health treatment, opiate agonist treatment and other evidence-based interventions improve patient outcomes. Patient navigators, case managers, directly observed therapy, and peer educators are instrumental for successful treatment.
Increase clinical education resources and support for providers regarding HCV diagnosis, management and treatment, particularly for providers in settings with high prevalence or limited HCV provider access. Encourage involvement of non-physician health care providers throughout the entire HCV treatment cascade.
To enhance the capacity of NYS’s health care workforce to deliver appropriate and evidence-based clinical services to patients with HCV and, therefore, to improve all patients’ ultimate health outcomes, more education resources and support for providers across the full spectrum of care for HCV are needed. This includes provider education in HCV screening, diagnosis, and management as well as how substance use, HIV co-infection, and mental health disorder intersects with HCV management. This is especially needed in urban and rural communities, which may have high prevalence or limited HCV provider access. Tele-mentoring, HCV telephone support (warmlines), trainings (live and distance learning), preceptorships, mentorships, and clinical toolkits are all potential strategies for increasing knowledge and skills of physicians and non-physician health care providers, such as nurse practitioners, physician assistants, pharmacists, and registered nurses.
Furthermore, increasing awareness of scope of practice for non-physician health care providers can encourage involvement of non-physician providers’ role throughout the HCV treatment cascade. For example, pharmacists can currently prescribe HCV medications and order labs under a collaborative drug therapy management plan. However, many physicians and pharmacists are not aware of such provisions or are utilizing the collaborative drug therapy management plan. Increasing awareness and encouragement for developing these types of collaborative arrangements should improve access and quality of care and treatment for HCV infection.
Commercial payers should limit out of pocket expenses that pose a barrier to access to HCV treatment.
Increase resources and attention for high risk and/or vulnerable populations: persons living with HIV, transgender persons, persons with substance use disorders, and other key populations that emerge with increased surveillance.
HCV infection disproportionately impacts people with substance use disorders, immigrants, transgender persons, and incarcerated persons. These same patient populations also face systems of stigma and health disparity. Improving health outcomes of these communities requires ongoing efforts to decrease health disparities. This entails increasing provider access, improved medication access, case management and/or care coordination, and strengthening ancillary services including mental health and substance use treatment, as well as harm reduction services and opiate agonist treatment. Providing treatment in diverse, patient-centered contexts, such as in methadone treatment facilities, harm reduction facilities, syringe exchange programs, long term residential drug treatment programs, and jail/prison health centers, will improve treatment access.
Increase uptake of telehealth services by health systems to reach underserved HCV populations with limited specialists.
Therefore, increasing awareness of telehealth availability and support for innovative reimbursable telehealth models to reach underserved HCV patient populations is needed. This can include a centralized technical assistance program and/or a tool kit for interested health systems to develop their own telehealth model, train providers on the use of telehealth, advocate for increased HCV telehealth reimbursement, and fund research for cost-effectiveness studies.
+Surveillance, Data and Metrics
Develop data use agreements, data sharing policies, and a regulatory agenda to facilitate necessary data sharing between public health entities, health care providers, other service providers [e.g., correctional facilities, Syringe Exchange Program (SEPs)], and regional health information organizations.
Data sharing is necessary to ensure the ability to track outcomes in a timely manner across service providers [e.g., newly diagnosed persons referred elsewhere for HCV care and treatment] and maximize collaboration across entities, and sectors conducting and overseeing implementation activities, taking into account state and local regulations.
Recognize and support viral hepatitis surveillance as a core public health function of state and local health departments. Systematically evaluate existing health care provider and laboratory-based surveillance systems and develop a robust infrastructure to strengthen surveillance so that key epidemiologic and programmatic questions about the HCV epidemic can be adequately addressed.
Viral hepatitis surveillance involves longitudinal population-based processes, including provider and laboratory-based reporting and timely local health department case investigation, to:
- Detect new or newly reported cases,
- Record demographic information, risk factors, and potential exposures, and
- Add new information (e.g., laboratory test results) to previously reported cases.
The monitoring of HCV trends in NYS, including measurement of disparities, disease outcomes, and the effectiveness of prevention measures and treatment, is dependent upon the timeliness, accuracy, and completeness of surveillance data along with expert interpretation of changes in surveillance practices and case definitions over time.
Thus, identifying and prioritizing ways to support and strengthen state and local HCV surveillance systems is of critical importance to the accurate monitoring of progress towards eliminating HCV and the success of the HCV elimination initiative.
Estimate baseline status for key outcomes to inform the development of realistic but ambitious targets for these outcomes as part of the NYS HCV elimination plan.
- Systematically consider available treatments, epidemiological data, surveillance data, resources, programmatic capacity, HCV-related policies, similar initiatives in other jurisdictions, and mathematical modeling scenarios to estimate baseline status for key outcomes related to HCV elimination in NYS.
- Set realistic but ambitious targets for these outcomes as part of NYS’ HCV elimination plan.
- Consider the creation of a working group within the initiative that includes people with HCV, for setting and periodically revisiting NYS’s targets for HCV elimination.
- Primary and secondary aggregate HCV elimination outcome metrics should be compiled semi-annually at the statewide, regional or county levels in relation to targets and disseminated to all stakeholders.
Systematically track and disseminate information on implementation strategies, efforts and policies that go into the NYS HCV Elimination Plan and that are expected to result in achieving the plan’s goals. There must be statewide and county-level data on activities directly supported or marshaled by the plan that are aiming to support the plan’s elimination goals.
The HCV elimination plan needs to have a systematic mechanism for tracking new programmatic implementation and policy development in support of the plan’s elimination goals. First, partner entities should be identified and their treatment capacity towards implementing the plan initiatives should be described, and aggregated metrics compiled, at the county level.
Second, a tracking system should be created to document in aggregate at the county level who is implementing HCV elimination activities and what is being implemented as well as where and when such activities are being implemented. An organization designated by the NYSDOH should be responsible for the management of this implementation tracking system. Aggregate HCV elimination implementation metrics should be compiled semi-annually at the county level in relation to targets and disseminated to all stakeholders.
Estimate the size of the population of PWID population and incidence of HCV infection among PWID in NYS.
This population is highly dynamic, with some members ceasing to inject drugs and new persons beginning to inject. Many of the persons ceasing to inject will require treatment for HCV infection, and all persons beginning to inject will need HCV prevention services. Thus, monitoring and assessing the effectiveness of Eliminating HCV in New York will require statewide knowledge of the size of and turnover in the PWID population and the extent of recent transmission of HCV infection in this population.
There are several research studies currently being conducted in NYS that have information that could be used to update old estimates of the size of and turnover in the PWID population in the state and estimate the incidence of new HCV infection in this group. A working group should be formed to integrate currently available information and perform new studies as needed to obtain these estimates. These estimates should also address demographic and geographic subgroups.
Systematically track and disseminate timely statewide, regional or county-level information on key HCV elimination outcomes to the initiative’s stakeholders, including people infected and affected by HCV, to convey progress towards achieving the goals and targets of the initiative.
Establish a dashboard to serve as a single comprehensive and definitive source of local data to track and report on the HCV elimination plan progress, as well as to help target resources and make appropriate course corrections at the county level when indicated by the data. This dashboard should include information on key outcomes and targets, as well as the status of the implementation efforts. Where time and resources allow, dissemination should take place in forums, including but not limited to peer-reviewed journals, conferences, online resources and community meetings.