Single Source Procurement: Hepatitis C Program

Pursuant to New York State Finance Law § 163.10(b), The New York State Department of Health is presenting the following summary of relevant circumstances, and material and substantial reasons why a competitive procurement was not feasible.

The purpose of the NYS DOH Hepatitis C Program is to identify hepatitis C virus (HCV) infected individuals early during infection and to ensure timely access to medical care, treatment and other supportive services, thus reducing the overall morbidity, mortality and economic impact associated with this disease. Foundation for AIDS Research (FAR) will purchase and distribute OraQuick HCV Rapid Test kits and controls. The OraQuick HCV Rapid Antibody Test, manufactured by OraSure Technologies, Inc, is the only FDA approved rapid testing technology currently available for HCV screening. This is a point of care screening test used to detect HCV antibodies, similar to the laboratory based enzyme immunoassay (EIA). Results from this test will be available within 20 minutes, eliminating the need for the client to return for the results.

HCV infection is a major health problem. Currently, it is estimated that 3.2 million people are chronically infected with HCV, with up to 75% unaware of their status. HCV is the leading cause of liver disease, liver cancer, and transplants in the U.S. HCV-related deaths doubled from 1999-2007 to over 16,000/year. Without increased resources for counseling, testing, and medical referral services, CDC predicts HCV-related mortality might double or triple over the next 10-20 years, with estimated health care burden direct and indirect costs in the billions of dollars The FDA-approved HCV rapid antibody test allows people to be tested with a finger stick and receive results in 20 minutes. This test will allow more people to know their status earlier in the course of the illness. Early clinical evaluation and ongoing monitoring improves health outcomes, as treatment response decreases as liver disease progresses. Hepatitis C is curable. New treatments have improved the overall HCV cure rate, have more tolerable side effects, and shorten the duration of treatment for most to 12-24 weeks. Many more therapies are in phase I and II clinical trials. The use of this testing technology will allow more people to know their HCV status, receive counseling messages and education on how to keep their liver healthy and prevent transmission to others, and get linked to HCV care and treatment in a timely manner. These interventions will aid in reducing the overall morbidity and mortality associated with chronic liver disease.

Foundation for AIDS Research has been successful in negotiating with vendors for favorable pricing because they purchase these supplies in large quantities. FAR's process for identifying the lowest cost supplier for each item, faultless rapid delivery, and electronic reporting/follow-up system make the agency uniquely qualified for this project. The pilot contract with FAR for these services (T028776) has proven to be highly successful. The AIDS Institute of the New York State Department of Health has determined that no other organization has the necessary experience, capacity, or expertise to provide this service to the public at this level of magnitude, urgency, and cost effectiveness. Therefore, we are requesting a five year contract beginning on 4/1/2014 to continue these critical services to vulnerable populations.

Procurement / Program Name	Hepatitis C Program
Contractor Name(s)	Foundation for AIDS Research
Contract Period	4/1/2014 – 3/31/2019
Contract Number(s)	C029348