Public comments for: Amendment to Clinical Laboratories (Article 13 of the NYC Health Code) Regarding the Performance of Confirmatory Hepatitis C RNA Testing

Comments

Comment:
Harm Reduction Coalition writes to express our support for the proposed amendment to Health Code ยง13.03(b)(3) to require laboratories to routinely perform a confirmatory RNA hepatitis C virus (HCV) test when there is a reactive HCV antibody test result. The cascade of care for hepatitis C shows a significant loss to follow up between preforming the HCV antibody test and the HCV diagnostic test. If both samples were taken at the same time, it would be possible to confirm active chronic HCV infection for individuals who have a reactive HCV antibody test. A statistically significant number of people who have become infected with HCV clear the virus on their own without becoming chronically infected. The HCV antibody test cannot differentiate between people who have cleared the virus on their own and people who are living with chronic HCV infection. This means that HCV diagnostic testing is important step before HCV treatment is initiated. HCV treatment should be initiated as early as possible so that people living with the virus can limit the damage to their livers and so that there is a shorter time frame when the virus can be transmitted.
Agency: DOHMH
Comment:
Amida Care writes to express its support for amending the Health Code to require laboratories to routinely peform a confirmatory RNA hepatitis C virus (HCV) when there is a positive HCV antibody test result. The amendment would be consistent with recommendations from the US Preventative Service Task Force. The recommendation states that in order to identify patients with active HCV infection assessment of viremia is needed. Reflexive HCV RNA testing with all positive antibody results will allow earlier detection of chronic HCV infection, expedite linkage to care for treatment, and avoid an extra follow up visit for isolated RNA testing to confirm infection. Indeed certain reference laboratories already have reflexive HCV RNA testing in place, thus recognizing the importance of earlier diagnosis.
Agency: DOHMH
Comment:
Re: the proposed law for mandatory Hepatitis C viral load confirmation: While laudable for public health reasons, compliance with this law by clinical reference laboratories will be challenging for the following reasons: 1. Hepatitis C antibody screening is done on serum. Hepatitis C RNA viral load confirmation on most testing platforms requires a different matrix, or type of specimen, which is plasma. The vast majority of samples received by our laboratory for hepatitis C serologic [screening] testing do not include a plasma sample , making it difficult to comply. Our laboratory does offer a test for both screening and confirmation, but it is rarely ordered. 2. In the event that a NYC clinician orders only the screening test on an outpatient, no 3rd party payor will reimburse the laboratory for mandated testing that is not ordered by a licensed physician. 3. Plasma samples for Hepatitis C RNA testing are only stable at room temperature for 6-8 hours; therefore, an aliquot (pour-off) of plasma must be frozen at the site of draw and must be received frozen by the lab, which presents logistical transport issues.
Agency: DOHMH
Comment:
The deputy commissioner in his testimony to the Board of Health on June 13th repeated twice that 25% of infected individuals will spontaneously clear the virus on their own, which provides a rationale for testing prior to referral to treatment. However, reported rates of clearance are highly dependent on the population selected and studies have varied widely (reviewed J. M. Micallef; J. M. Kaldor; G. J. Dore J Viral Hepat. 2006;13(1):34-41.). In the NYC population rates are much, much lower than 25% - certainly less than 10% of HCV antibody positive individuals here are found to be viral load undetectable on diagnosis (about 5% in my experience). This presents a much weaker case for insisting on HCV viral load prior to referral.
Agency: DOHMH
Comment:
Many HCV antibody tests are repeated multiple times and blanket enforcement of this rule will result in many wasted tests for HCV RNA being triggered. The treating physician needs the results from an RNA test performed at the time treatment is initiated, and results from tests automatically triggered prior to seeing the treating physician are wasted. The goal is to make sure the patient is referred to a treating/evaluating physician, which is what should be measured. Making the RNA a required reflex and then measuring that performance, is setting up to show success on a false proxy measure. This does not appreciable advance the goal of making sure patients are referred to and follow-up with treatment.
Agency: DOHMH