New York State Hepatitis C Testing Program - Linkage to Diagnostic Testing and Care
NYS Hepatitis C Testing Program Implementation Guide Home Page
Linkage to HCV Diagnostic Testing (Ribonucleic Acid (RNA)) and Care
The NYS HCV Testing Program follows the standard of care for HCV testing as outlined by the Centers for Disease Control (CDC) and Prevention’s HCV Testing Algorithm. Linkage to care is an important component of this two-step HCV testing process. An HCV rapid antibody test will only determine if an individual has been exposed to HCV. Access to a second diagnostic test (HCV RNA) will confirm if the individual is currently infected. The NYS HCV Testing Program is committed to ensuring access to HCV RNA testing through formal linkage agreements and/or the ability to offer testing through the NYS Department of Health (DOH) Wadsworth Center, Bloodborne Viruses Laboratory (BVL) (only for enrolled programs approved to offer/conduct HCV RNA testing).
All enrolled programs must have at least one written linkage agreement with a health care provider who will, at minimum, offer HCV RNA testing. Programs deemed eligible to offer HCV RNA testing on-site require a linkage with a health care provider willing to accept referrals for HCV medical care and treatment evaluation. It is also acceptable to refer clients to their primary care providers for those requesting this option.
All referral appointments must be tracked to determine whether the client accessed referral services. Linkage agreements should include specific language on the referral tracking process. A HIPAA-compliant signed release of information form must be obtained from the client to authorize access to referral information in the medical record. Enrolled programs are expected to track whether a client attended the scheduled referral appointment, but they are not expected to elicit or report the outcome of the appointment (i.e., HCV RNA test result, start of HCV treatment, reason for discontinuing treatment, etc.).
New York State Hepatitis C Virus Testing Program: Ensuring Access to HCV RNA Testing
As indicated above, enrolled programs have two options for linking HCV rapid antibody reactive clients to HCV RNA testing- by referral or by submitting dried blood spot specimens to the Wadsworth Center BVL. A provider’s capacity to offer HCV RNA testing through the Wadsworth BVL will be assessed as part of the enrollment process.
Refer for HCV RNA Testing
Enrolled programs providing HCV RNA testing through referral must have at least one written linkage agreement with a provider who can, at minimum, perform HCV RNA testing for those with HCV rapid antibody reactive test results. Programs may also refer reactive clients to a primary care provider, if one is identified by the client. All referrals for HCV RNA testing must be tracked to determine if the client attended the referral appointment. Enrolled programs are not required to elicit or report the outcome of the appointment (i.e., HCV RNA test result).
- The NYS HCV Testing Program will not cover the costs associated with HCV RNA testing performed by a referral provider.
- NYS HCV Testing Program staff are available to assist with identifying potential linkage options. A linkage agreement does not need to be with a specialist, but it must be with a provider interested in and capable of providing HCV medical evaluation and treatment (see NYSDOH definition of experienced provider).
- The AIDS Institute (AI), Bureau of Hepatitis Health Care funds 15 HCV Care and Treatment Programs that provide on-site hepatitis C medical care, care coordination, treatment and supportive services to either mono-infected and/or HIV/HCV coinfected persons. During enrollment, the NYS HCV Testing Program staff will provide contacts for funded HCV Care and Treatment Programs that may serve as linkage options.
Sample Linkage Agreement
Offer HCV RNA Testing
The NYS HCV Testing Program partners with the Wadsworth Center BVL to offer immediate access to HCV RNA testing for qualified enrolled programs. Approved programs may offer free HCV RNA testing to clients with a HCV rapid antibody reactive test, provided that the test was supplied by the NYS HCV Testing Program. This component is limited to program that are enrolled in and conducting HCV rapid antibody testing through the NYS HCV Testing Program. The service is currently not available for providers seeking a pay source for diagnostic testing for clients tested outside of the NYS HCV Testing Program.
*Since the cost of testing is covered by NYSDOH, test sites cannot charge the clients and/or their health insurance for this service*
Interested enrolled programs must have staff proficient with dried blood spot specimen collection, processing and storage. Participation in this component of the program must be pre-approved, and programs seeking approval must submit a written protocol (either integrated into the current policies and procedures or added as an addendum) that outlines the following:
- Process for training staff and ensuring ongoing proficiency in specimen collection and handling. For more information on specimen collection and handling, see Quality Assurance.
- Roles and expectations of the provider ordering the test, as described in Program Requirements, including but not limited to responsibility for reporting HCV RNA test results per NYS Public Health Law – Communicable Disease Reporting.
- A written linkage agreement with a health care provider who can provide follow-up HCV medical care and treatment evaluation for clients with a detectable HCV RNA test result. Clients with a detectable HCV RNA test result must be referred to a provider for follow-up HCV medical care and treatment evaluation. All referrals for medical care must be tracked to determine if the client attended the referral appointment. Enrolled programs are not expected to elicit or report the outcomes of these appointments, (i.e., start of HCV treatment, reason for discontinuing treatment, etc.).
Once approved, NYS HCV Testing Program staff, in conjunction with Wadsworth BVL, will provide training on specimen collection protocols (excluding phlebotomy). All necessary procedures for specimen collection, labeling and shipment will be reviewed with approved programs prior to the start of testing. The cost of shipping specimens to the BVL will not be covered by the NYS HCV Testing Program. Dried Blood Spot specimens are sent to the BVL via the United States Postal Service (USPS). Enrolled programs are required to cover the shipping cost of DBS specimens.
Sample Linkage Agreement
- Sample Linkage Agreement for Offering HCV RNA Testing (PDF)
- Sample Linkage Agreement to either Refer/Offer HCV RNA Testing (PDF)
AIDS Institute (AI) Funded HCV Care and Treatment Programs
The NYS DOH Bureau of Hepatitis Health Care funds fifteen programs statewide to link people with HCV to care and treatment. All programs provide on-site HCV medical care, care coordination, treatment and supportive services in primary care settings (i.e., community health centers, drug treatment programs and hospital based clinics). Several of the programs also provide these services to HIV/HCV coinfected persons. A key position in each program is the Linkage to Care Specialist who will:
- Actively connect patients to HCV care and treatment;
- Assess barriers to care and provide linkages to supportive services (e.g., transportation, housing, insurance); and
- Assist with care coordination to successfully navigate patient through the care continuum.
Potential linkage options with the funded HCV Care and Treatment Programs will be explored during the enrollment process, and contact information will be provided, if applicable. For areas without access to a funded Care and Treatment Program, programs can find HCV treatment providers in the link to the statewide provider directory below.
