STATEMENT OF
THOMAS V. HOLOHAN, M.D.
CHIEF PATIENT CARE SERVICES OFFICER
DEPARTMENT OF VETERANS AFFAIRS
BEFORE THE
SUBCOMMITTEE ON NATIONAL SECURITY, VETERANS AFFAIRS, AND INTERNATIONAL RELATIONS
COMMITTEE ON GOVERNMENT REFORM
U.S. HOUSE OF REPRESENTATIVES

July 12, 2000

Mr. Chairman and members of the Subcommittee, I am pleased to appear before you today to discuss our ongoing efforts to address issues of Hepatitis C (HCV) in the veteran population receiving care through the Department of Veterans Affairs (VA). I am accompanied by Jimmy Norris, Chief Financial Officer for the Veterans Health Administration.

Since our last report to you in June, 1999, VA has achieved a number of goals in its attempt to establish an appropriate system-wide approach to the HCV problem. These efforts include better identification and treatment of HCV patients, expanded educational and counseling efforts, commencement of a multi-center research trial, collaborative outreach programs, and changes in funding allocation methodology in order to more accurately reflect the resources required by HCV treatment.

The HCV Registry

The Emerging Pathogens Index (EPI) registry is a computer program which automatically extracts information regarding each positive test for Hepatitis C virus antibody in the VA, and forwards that information to a central data base. Data in the Registry indicate that from FY 1998 through the second quarter of this fiscal year, approximately 325,000 veterans have been tested; of that number, 65,000 unique veteran patients have been found to have HCV.

Risk Factor Evaluation

To encourage screening and to more accurately determine the number of veterans who are being evaluated for risk factors, formal clinical reminders are being added to the information base available to VA clinicians. Patients who have had a blood test for antibodies to HCV, or who have a diagnostic code (ICD-9 code) associated with HCV are considered to have been appropriately tested or diagnosed. Absent those criteria, a reminder notice for risk factor evaluation and possible testing appears on the computer screen. The enhancement is now in place, and preliminary evaluation is underway. In addition, a performance measure targeting the percentage of patients that should be screened over the next year is currently under development.

Treatment

The guidelines for treatment of HCV are under continual review, and are modified as new information is available. The most recent update was completed in January 2000 (Appendix 1).

Information from the Pharmacy Benefits Management database indicates that since July 1999, an average of 344 new patients are started on combination therapy with interferon-alpha and ribavirin (Rebetron) each month. This represents approximately 14 percent of newly diagnosed cases. The specific number of patients treated for HCV with interferon-alpha alone is not currently known but is under study. VA clinicians with specific expertise in HCV had estimated that about 20% of all HCV positive veteran patients might be appropriate candidates for treatment. We believe that the pharmacy database numbers, when complete, are likely to validate those initial estimates.

Centers of Excellence

During the past year, the Centers of Excellence in Hepatitis C, located in San Francisco and Miami, have been involved in numerous important projects; these include:

• Completion and distribution of veteran-specific educational materials for the 22 Networks, Veterans Service Organizations, and VA’s Vet Centers.
• Completion of counseling guidelines and a "Train the Trainer" educational seminar in March 2000. A second seminar is scheduled for September 2000.
• Continuation of a VHA Cooperative Studies Protocol to assess the prevalence of HCV in the veteran population.
• Implementation of an industry funded multi-center trial to determine a number of outcomes which include treatment response to combination therapy, assessment of those factors which affect disease progression, and detection of any differences in response rates attributable to race/ethnicity.
• Clinical research on new drugs for the treatment of HCV.
• Development of a model for use by Networks and facilities to help achieve consistency in the provision of care across the entire system.

• Preparation of a "telephone triage" booklet for use at all levels of the organization to answer patient questions and direct them to appropriate care.

Outreach Efforts

VA has continued to collaborate with the American Liver Foundation, Hepatitis Foundation International and the Veterans Service Organizations. Patient testing programs were held during the months of March, April and early July. Presentations were made at the annual meeting of Hepatitis Foundation International, at several VSO national meetings and to VA’s Council on Minority Veterans. VA also participated in the Public Service Awareness Week with a staffed booth on the mall featuring our efforts in HCV. The first meeting of the American Liver Foundation’s Veterans Council was held in June 2000, to discuss barriers to outreach and develop an action plan to overcome these barriers for veterans who are users of the traditional VA system of care and those who are not. Veteran-specific brochures have been prepared by a number of Networks, and similar efforts are being prepared on a national scale.

Funding and Resources

The Acting Under Secretary for Health has initiated the release of additional funding in FY 2000 for HCV and changes in the resource allocation formula that will begin in FY 2001. This fiscal year, an additional $20 million from the national reserve fund will be distributed across the VISNs in proportion to their existing expenditures for HCV. While the distribution is based upon past resource use, it closely follows the HCV patient numbers by VISN, thus reflecting both actual and potential workload and resource utilization. (Appendix 2) Beginning in FY 2001, VERA funding will include recognition of the costs and distribution of HCV, thereby assuring appropriate funding both for patient care and geographic distribution of patients. At present, available information indicates that about 78% of HCV patients whose annual drug costs are at least $5,000 are already reimbursed under VERA at the Complex care price.

VA Web Site

VHA has established a web site, accessible via the internet, to provide information on HCV. This includes patient and physician educational materials, evaluation and screening guidelines, treatment guidelines, treatment side effects, slide presentations from the Clinical and HCV Counseling Symposia, and links of interest. This can be accessed through the address: www.va.gov/hepatitisc.

Summary

Mr. Chairman, VA continues to lead the nation in identification, counseling and treatment of patients with HCV. The release of $20 million from the National Reserve account and adjustments to VERA for 2001 will support our VA health care facilities in addressing outreach, screening, diagnosis, and treatment for patients with HCV. While the prevalence and costs of HCV vary across the country, we will work to assure that a consistent level of screening, testing and access to treatment are available wherever the veteran receives care. We look forward to working with Congress to assure that the VA’s care for HCV represents the best practice in the nation.

This concludes my statement. We will be pleased to respond to the Committee’s questions.