Recommendations

New York State developed a series of recommendations for the eradication of HCV by the year 2030. Below are the five categories and the actions associated with them.

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+Hepatitis C Prevention

1

Expand the number of SEPs in NYS and the existing SEPs’ geographic reach.

NYS currently has 23 waivered SEPs that provide harm reduction services and safer substance use supplies to people who use drugs (PWUD). To meet the needs of the local population, expansion funding is needed to facilitate the establishment of additional satellite sites, mobile services, peer-delivered syringe exchange, and telemedicine or transformation into comprehensive drug user health hubs. Funding may also be used to provide essential HCV prevention supplies for all methods of use (i.e., sniffing, swallowing, smoking, and injecting) and services to screen, treat, and prevent HCV, such as onsite HCV RNA testing, buprenorphine induction, harm reduction counseling, and focused outreach to populations disproportionately impacted by HCV including formerly incarcerated individuals, people of color, and men who have sex with men.
NYS currently has 23 waivered SEPs that...

2

Fund expanded outreach to support people who use drugs through all methods of use.

Establish a new Youth Prevention Centers network (including mobile) as part of existing SEPs to conduct outreach in nontraditional settings and address all relevant transmission vector supplies – including safer sniffing and/or smoking equipment. Centers would support a variety of programs including specific interventions to delay initiation of injection for opioid users through peer support interventions, such as “Break the Cycle,” to reduce the likelihood of experienced injectors assisting non-injectors with their first injections, testing and direct services via telehealth, social and family reintegration.
Centers would support a variety of programs...

3

Expand HCV Prevention Strategies in state and local correctional facilities.

Injection drug use, primarily of opioids, is a major risk factor for acquisition or re-infection with HCV. To prevent HCV infection and re-infection, state and local correctional facilities across NYS should increase access to sterile syringes and injection equipment. Additionally, Medication Assisted Treatment (MAT) programs should be implemented and expanded in NYS Department of Corrections and Community Supervision (DOCCS) and local jails. All individuals entering NYS DOCCS or local jails who already receive MAT must have treatment continued.

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.

Injection drug use, primarily of opioids...

4

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.

This new MAT Program will increase access to confidential MAT and HCV services for uninsured and under-insured New Yorkers and for commercially insured New Yorkers who want to avoid disclosure of these confidential services through billing statements. NYS residents who are not enrolled in Medicaid and have a personal income under the Federal Poverty Level should be eligible. NYS residents should also be eligible if they are already covered by commercial health insurance and meet the above criteria. Income is based on the covered individual’s income rather than the family income, like the NYS Family Planning Benefits Program which covers confidential family planning services.
This new MAT Program will increase...

5

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.

Systems should be established to facilitate primary care providers who care for adolescents and young adults to incorporate Screening, Brief Intervention and Referral to Treatment (SBIRT) and buprenorphine prescribing for MAT into routine practice. NYS Office of Alcoholism and Substance Abuse Services (OASAS) and NYSDOH should support adolescent focused SBIRT and buprenorphine certification training and identify local (or via telehealth) substance abuse treatment providers to support those medical providers.

Medicaid Managed Care plans should be encouraged to participate in development of innovative payment models to support this work. Adolescent medicine fellowship training in NYS should include didactic and experiential training on adolescent opioid addiction, MAT, and HCV management – including buprenorphine waiver training.

Systems should be established to facilitate...

6

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).

Evaluation for this program will include the clinic’s ability to engage a population with a high level of HCV and reduce risky behaviors associated with transmission of HIV, HCV, and bacterial infections. Evidence from Canada and other countries has shown that the injection drug using population benefits from a medically supervised program where patients self-administer prescription pharmaceutical opioids (e.g., hydromorphone), resulting in decreased unsupervised injection and other drug use behaviors that can lead to HCV infection.

In addition, this program has been shown to decrease overdoses, decrease mortality, and facilitate ongoing treatment engagement. Recently, the Study to Assess Long-term Opioid Medication Effectiveness in Vancouver, British Columbia, Canada, demonstrated the noninferiority of hydromorphone as compared to diacetylmorphine (i.e., heroin) in terms of efficacy, and the superiority of hydromorphone over diacetylmorphine in terms of decreased adverse events. In 2017, the British Columbia Ministry of Health published the evidence-based Guidance of Injectable Opioid Agonist Treatment for Opioid Use Disorder.

Evaluation for this program will include...

7

Recognizing that the opioid epidemic is a public health emergency, allow for safer injection facilities across NYS.

Safer Injection Facilities (SIFs) have three decades of research behind them proving that they prevent overdose deaths, provide linkage to care including substance use treatment, reinforce safer injection practices that prevent disease transmission and injection related infections, save public medical expenditures and engage those drug users at highest risk. At the most pragmatic level, trained staff of a SIF can provide on-site teaching to injectors about best practices to prevent disease transmission and other infections.

Testing as well as linkage to care and treatment should be offered at SIFs as they are at SEPs. A research study has already been proposed that should be looked toward as a model of how to evaluate sites, including emphasis on their ability to engage the drug using population and reduce risky behaviors associated with transmission of HIV, HCV, and bacterial infections.

Safer Injection Facilities (SIFs) have three decades...

8

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.

As part of a comprehensive approach to prevent HCV, provide increased funding for public campaigns that focus on decreasing stigma, increasing health literacy, and educating the public on the importance of HCV screening, diagnosis, linkage to care, and the possibility of a cure.

Some components of beneficial campaigns include annual training of health care providers and social service providers by integrating viral hepatitis information into existing curricula, and expanding current public awareness campaigns using advertisements, distributing literature, media, and social media will aid in decreasing HCV stigma.

Ensure messages reach schools and faith-based communities to meet all at-risk individuals.

Well-designed health literacy materials both in print and using social media geared to populations at-risk, including PWID, formerly incarcerated persons, MSM, transgender people and affected communities, will serve to reduce the stigma associated with HCV and increase access to treatment. Materials should clearly explain the risk behaviors associated with HCV transmission including injection and non-injection drug use and sexual transmission, especially among men who identify as gay, bisexual or other men who have sex with men. For an effective awareness campaign, materials should be culturally responsive and in multiple languages to prevent stigmatize persons living with or at risk for HCV.

As part of a comprehensive approach...

9

Engage adolescents, young adults and their support systems (i.e., families, teachers, faith leaders) in anti-stigma drug education efforts.

A partnership with the SEPs and other harm reduction organizations should create an anti-stigma drug education campaign; develop a curriculum and programs, including train-the-trainer, for adolescents and their parents where students can safely learn and discuss risks of prescription narcotic pain medication use and recreational opioid use and risks of transition to heroin use, drug injection, and disease transmission.
A partnership with the SEPs...

+Hepatitis C Testing and Linkage to Care

1

Mandate HCV antibody to RNA reflex testing.

Diagnostics for chronic HCV remain limited to two-step testing, and a significant proportion of persons with positive HCV antibody never receive confirmatory testing with HCV RNA. Mandatory HCV antibody to RNA reflex testing has been shown to improve the proportion of people who receive confirmatory testing, thus effectively eliminating this gap in the care cascade.

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.
Diagnostics for chronic HCV remain limited to two-step testing...

2

Allow sharing of HCV test results to HCV care coordinators and patient navigators.

The absence of point-of-care (POC) testing for confirmed active HCV infection at this time entails a delay in diagnosis and presents a delay in linkage to care. To optimize the impact of HCV screening, positive results of HCV RNA should be routed not only to the ordering provider, but to HCV care coordinators/patient navigators to ensure rapid linkage to care with HCV-treating providers and minimize loss to follow up.This may be done by generating automatic EHR reports of positive HCV RNA and routing them to hepatitis patient navigators, or they may be incorporated into existing HIV reporting chains if no hepatitis navigation program exists.
The absence of point-of-care (POC) testing for confirmed active HCV...

3

Implement universal HCV screening of all pregnant women.

HCV infection is a leading cause of liver-related morbidity and mortality. Injection drug use is the most common risk for HCV infection. HCV can be transmitted vertically from mother to child. Vertical transmission occurs in 5.8% of infants born to women who are infected only with HCV and in up to twice as many infants born to women who are also infected with HIV or who have high HCV viral loads. NYS outside of NYC has reported an increase of HCV among women of childbearing age (15-44 years). The most common risk reported among these cases is IDU. Universal, one-time testing for all pregnant woman during their first trimester should be implemented, with repeat screening in the third trimester for women engaging in at-risk behaviors.
HCV infection is a leading cause of liver-related morbidity...

4

Facilitate screening and diagnosis through automatic prompts in EHR systems.

EHR prompts such as best practice alerts or clinical decision support (CDS) tools have been shown to significantly improve HCV screening of baby boomers without prior HCV testing in primary care settings and among hospitalized patients.Screening should be implemented using an EHR prompt in clinical settings.

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.

EHR prompts such as best practice alerts...

5

Expand POC testing to non-medical settings.

Expansion of targeted testing to venues outside of the established health care system is required to diagnose the significant proportion of relatively healthy individuals with HCV who are not engaged in medical care. Support and training should be granted to expand rapid, POC HCV antibody testing and confirmatory testing in outreach settings without medical staff or infrastructure, particularly those settings where patients are deemed high risk for loss to follow-up. Sites must be identified and supported that are likely to serve at-risk populations such as persons who inject or use drugs, MSM, transgender men and women, immigrants from highly endemic areas, persons in neighborhoods with high seroprevalence rates as mapped by surveillance data, homeless persons, and those with a history of incarceration, substance use or mental health issues. Coordination with HIV testing sites should be encouraged and paired dual-routine HIV/HCV testing should become standard of practice at many of these sites. Effort should be devoted to incorporating HCV RNA testing into locations where screening is done to allow immediate access to diagnostic testing.
Expansion of targeted testing to venues outside...

6

Expand and extend the New York State HCV Testing Law.

Given the national rise in HCV incidence in adults >18 years largely attributable to the ongoing opioid epidemic, there has been growing interest in expanding age-based testing. Universal screening has been shown to be cost-effective in modeling and is now recommended by the American Liver Foundation. Therefore, modification of the NYS HCV Testing Law is recommended to include a mandate for universal one-time HCV opt-out testing (i.e. notifying the patient that the test is normally performed but that the patient may elect to decline or defer testing) of all adults 18 and older in primary care settings (internal medicine, family medicine, and OB/GYN) and in all hospitalized patients.This mandate should be supported for antenatal screening of all pregnant women.

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.

Given the national rise in HCV incidence in adults...

7

Remove financial barriers to testing and linkage to care.

Key strategies for removing financial barriers to testing and linkage to care include the provision of adequate funding for Community Based Organizations (CBOs) who are closely connected and have trusting relationships with high-risk populations to provide testing and linkage to care services; eliminating insurance company and pharmaceutical barriers; and investigating and implementing innovative financing strategies for eligible partners. There is a need to ensure that appropriate reimbursement mechanisms (both private and public) are instituted so that health care delivery sites can afford to integrate these services.

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.

Key strategies for removing financial barriers to testing and linkage to care...

8

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.).

HCV infections in NYS have increased significantly among young people in the past decade, largely attributable to injection drug use. Ongoing HCV transmission is high within this population, presenting a major challenge to elimination. Yet young PWID are a complex population to engage in HCV care. Perceived lack of deservingness of HCV treatment and stigma, perceived lack of referral to treatment, dissatisfaction with provider interactions, and perceived lack of need for treatment have been identified as barriers to HCV testing and care engagement in young PWID.

  • 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.
HCV infections in NYS have increased significantly among young people...

9

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.

Multiple factors contribute to the inconsistent nature of HCV surveillance in NYS, including, but not limited to: a lack of clinical and laboratory awareness of and compliance with testing and reporting recommendations and requirements; the asymptomatic nature of chronic infection; and, insufficient resources for statewide hepatitis surveillance, particularly investigation and confirmation (epidemiological, clinical, laboratory) of infection, and collection, analysis, interpretation and dissemination of data . Currently, case definition and diagnosis are mostly based on electronic laboratory reporting.

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.

Multiple factors contribute to the inconsistent nature of HCV...

10

Expand patient navigation and outreach programs.

Patient navigation has been demonstrated to successfully identify at-risk individuals with HCV infection and link large proportions to care. Patient navigator-focused inventions, such as the NYC DOHMH’s “Check Hep C” program, are estimated to cost $978 per patient, which is low compared with the cost of treatment complications of HCV.At this time, the HCV epidemic is shifting from stable baby boomers engaged in the health care system to young, non-urban PWID with limited health care engagement and to individuals with significant psychiatric illness, homelessness, undocumented status or other structural barriers to obtaining health care. Scale-up of patient navigation with a scope that incorporates outreach to these groups is necessary to identify and link them to care, and once linked, to support patients and providers from diagnosis to cure.

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.

Patient navigation has been demonstrated to successfully identify at-risk individuals...

11

Advocate for better, more flexible HCV tests.

Currently, HCV RNA testing is the only method approved for confirming active HCV infection. Reflexing directly to HCV RNA testing following a reactive antibody screening test is the best way to ensure the required testing is completed. However, very few HCV RNA tests have been Food and Drug Administration (FDA)-approved for HCV diagnosis, and those that are available involve expensive test kits and dedicated instrument systems that may not be amenable for use by low-volume testing laboratories. POC options for HCV RNA testing do not yet exist in the U.S.HCV core antigen testing could offer a more cost-effective, simpler alternative to HCV RNA testing for confirming active infection; however, there are no FDA-approved HCV core antigen tests currently available. Furthermore, all current FDA-approved HCV diagnostic tests require venipuncture blood collection. This may impede diagnosis because trained phlebotomists are not available at many community-based HCV rapid testing sites. Even when phlebotomy is available, it can be technically challenging to perform on PWID, and many will forego HCV diagnostic testing if venipuncture is required.Dried blood spots (DBS) collected by fingerstick offer a feasible alternative to venipuncture; however, no FDA-approved HCV tests allow for DBS testing.

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.

Currently, HCV RNA testing is the only method approved...

12

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.

Provider education surrounding HCV screening has been instrumental in improving HCV testing rates in some settings and in areas lacking electronic health record prompts. Effective provider education should increase awareness and knowledge of HCV risk factors warranting screening, NYS HCV testing law requirements, test result interpretation, effective counseling methods, linkage to care options for chronic HCV-infected patients, and outcomes of HCV treatment linked to directly acting antivirals.
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.

Provider education surrounding HCV screening has been instrumental...

+Hepatitis C Care and Treatment Access

1

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.
As per the guidelines of the NYSDOH AIDS Institute Clinical Guidelines Program...

2

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.
Adherence is paramount for successful cure...

3

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.

To enhance the capacity of NYS’s health care workforce to deliver...

4

Commercial payers should limit out of pocket expenses that pose a barrier to access to HCV treatment.

In some instances, commercial payers require members to pay a percentage of total HCV treatment cost or to pay high premiums for treatment and support services. Often these are cost prohibitive and prevent people from accessing and/or completing treatment. NYS should monitor financial barriers to treatment that may exist in the commercial insurance market and advocate for commercial payers to limit the out of pocket costs incurred by HCV treatment, including the establishment of co-pay programs and the use of co-pay cards.
In some instances, commercial payers require members to pay a percentage...

5

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.
HCV infection disproportionately impacts people...

6

Increase uptake of telehealth services by health systems to reach underserved HCV populations with limited specialists.

Telehealth is the delivery of health care by telecommunications technology. Studies have found that patients in rural areas were more likely to receive HCV treatment if their physicians participated in telemedicine. Furthermore, the care provided by telehealth providers is as effective as specialist care. Recognizing that telehealth is a viable option for expanding treatment access to HCV care in underserved and rural settings, more third-party payers are starting to reimburse for telehealth services. However, reimbursement rates remain low, telehealth services are incompletely reimbursed by payers, and many providers remain unaware or unsure of how to effectively integrate telehealth into their practices.

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.

Telehealth is the delivery of health care...

+Surveillance, Data and Metrics

1

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.
Data sharing is necessary to ensure the ability...

2

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:

  1. Detect new or newly reported cases,
  2. Record demographic information, risk factors, and potential exposures, and
  3. 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.

Viral hepatitis surveillance involves longitudinal...

3

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 consider available treatments...

4

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.

The HCV elimination plan needs to have a…

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Estimate the size of the population of PWID population and incidence of HCV infection among PWID in NYS.

PWID are the largest population at high risk for acquiring HCV. The most commonly cited estimated size of the NYS PWID population is approximately 140,000. However, it is based only on the state’s six largest metropolitan statistical areas, is over 10 years old, and doesn’t reflect the current opioid epidemic.

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.

PWID are the largest population at high risk…

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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.
Establish a dashboard to serve as a single...