6 months ago 50 HIV, hepatitis C, and coinfection community/patient advocates met in NYC to prepare a policy statement. This is the statement we agreed upon.

PREAMBLE:

Hepatitis C is a serious and prevalent co-morbidity of HIV disease. An estimated 25 to 30% of all HIV-positive persons in the United States are coinfected with the hepatitis C virus (HCV), and up to 90% of those who acquired from injection drug use are HIV/HCV coinfected. Hepatitis C is an opportunistic infection of HIV disease, and progresses more rapidly in HIV-positive people. Although highly-active antiretroviral therapy (HAART) is safe and effective for coinfected people, they are at greater risk for developing antiretroviral-induced hepatotoxicity, which can be treatment-limiting in some cases. Hepatitis C is treatable, but many are not diagnosed or treated; some have developed liver disease that is too advanced to treat, or lack access to HCV treatment. End-stage liver disease secondary to hepatitis C coinfection has emerged as a leading cause of death among HIV-positive persons in the United States and parts of Europe.

INTRODUCTION:

The following policy principles were developed in an effort to provide direction for improving health care access and practices for HIV/HCV coinfected individuals. These principles are the product of a December 2004 meeting of HIV and HCV policy, treatment and consumer representatives, HIV/HCV health care providers and HIV/HCV pharmaceutical industry representatives in New York City.

In an effort to establish principles that deal with the many issues facing effective treatment of HIV/HCV coinfected individuals, these principles have been grouped into the following categories:

1)    Surveillance and Data

2)    Counseling, Testing, and Evaluation

3)    Education

4)    Systems of Support

5)    Research

1)    Surveillance and Data Policy

a)    Epidemiology/Surveillance

i)      CDC must collect and disseminate reliable population-level HIV/HCV coinfection data.

ii)    HHS must name an HCV policy coordinator to be based in Washington, DC at the Office of Health and Science, Department of Health and Human Services, to serve as a contact point for federal HCV monoinfection and HIV/HCV coinfection policy issues.

b)    Treatment and Costs

i)      In order to provide reliable need-based projections, the following data are required. They would be most efficiently gathered by a consortium led by the federal government (HHS) with members from the VA, CDC, AHQR, NIH, the pharmaceutical industry, academic health centers, key providers and community advocates:

(1)  Verifiable estimates of the number of HIV/HCV patients who may benefit from HCV treatment.

(2)  Projected cumulative and per-patient costs for such treatment.

(3)  Reviews of current insurance status of coinfected individuals (Medicaid, Medicare, private, uninsured, underinsured).

(4)  Pharmacoeconomic data on direct cost/benefit of current treatment algorithms by payer.

(5)  Pharmacoeconomic data on global indirect cost/benefit (productivity, etc.).

2)    Testing, Counseling and Evaluation Policy

a)    Continuum of Service

Testing, counseling, education, evaluation, and treatment should be implemented and evaluated as a continuum of services available to all coinfected patients. Once pretest counseling has been initiated, the entire process should be made available to all patients based upon their own fully informed assessment of their needs developed in partnership with appropriate health care providers.

i)      All coinfected patients should be medically evaluated for HCV coinfection and offered treatment, if indicated.

ii)    Confidential testing should be voluntary and supported by counseling and a thorough informed consent process. Results should be de-identified for data collection purposes.

b)    Reimbursement

Low reimbursement levels present major challenges to accessing high quality HCV diagnostics and care. Reimbursement rates for HCV diagnostic tests must be based on actual costs.

c)    Post-test Services

All coinfected patients should be offered, at minimum, post-test counseling, comprehensive disease evaluation and a full range of secondary prevention services including (but not limited to) alcohol reduction, substance abuse treatment, dietary counseling, education concerning and assistance in accessing clinical research protocols, and risk reduction including, but not limited to availability of syringe exchange programs, availability of buprenorphine and methadone maintenance. These comprehensive services should be coordinated into a standard of care for all coinfected patients.

d)    Coordination of Services

The services outlined in point c must be coordinated by a wide variety of sites that may serve coinfected individuals in other capacities. These sites include substance abuse and mental health facilities, primary care providers, prisons, homeless services, and others in a manner that ensures ease of access by HIV/HCV coinfected patients.

e)    Harm Reduction

Harm reduction programs should be supported and adequately reimbursed for their services. These programs have provided demonstrably valuable primary and secondary prevention services to HCV at-risk and infected individuals. Programs should include the widest array of services possible from clean injection equipment to buprenorphine and methadone maintenance.

3)    Treatment Policy

a)    Standard of Care (SoC)

The standard of care for the treatment of HIV/HCV coinfection should be included in all relevant Guidelines (USPHS, IDSA, AGA, AASLD, etc.).

i)      Current guidelines are limited to diagnostics and therapy for HIV and HCV. All comprehensive treatment guidelines for HIV/HCV coinfection must provide for both coordinated gastrointestinal/infectious disease diagnostics and management, and for other required care and support including (but not limited to) the following:

(1)  mental health management

(2)  substance use management

(3)  side effect management

(4)  case management

(5)  peer and other social support systems

(6)  comprehensive access to required pharmaceuticals for the treatment/management of all medical and side-effects attendant to treatment

(7)  access to buprenorphine and methadone maintenance

ii)    Guidelines similar to the USPHS Guidelines for the Use of Antiretroviral Agents in HIV Infected Adults and Adolescents should be created to promulgate adequate HCV and HIV/HCV coinfection treatment.

b)    Federal Agencies

i)      We recommend that the public health service hold a coinfection summit to develop a public plan for addressing coinfection issues (such as those presented in this document) for VA, CDC, CMS, SAMSHA, HRSA, Bureau of Prisons, HUD and other agencies that should be involved in the implementation of HCV public health policy.

4)    Access to Care/Financing Policy

a)    Publicly Funded Systems

Current data strongly suggests that the vast majority of HIV/HCV coinfected persons are dependant on publicly financed systems of care or are uninsured/underinsured and have minimal or no access to adequate health care providers. These systems are inadequate for delivering the standard of care outlined in Treatment, above. The issues that need to be addressed in each system include the following:

i)      Medicaid

(1)  Current barriers:

(a)  To be eligible for Medicaid, most patients must be SSI-defined disabled from HIV and/or HCV.

(b)  Reimbursement levels for many Medicaid services are inadequate to provide the standard of care for coinfected patients. In addition, strict reimbursement limits prevent many Medicaid patients from receiving adequate mental health care and medications for treatment related side effects (e.g., anemia, reduction in white blood cell counts) and the required range of diagnostic testing including viral load testing.

(2)  Potential solutions:

(a)  The Early Treatment for HIV Act, if enacted by the Congress and adopted by the states could help to solve the eligibility problem by providing access to Medicaid for all HIV+ patients who met financial qualifications.

(b)  A more comprehensive and uniform solution would be provided by the implementation of the IOMs proposed federal entitlement for HIV care, outlined in the next section.

(c)  Leadership by HHS at the federal level could significantly improve access to and the quality of HIV/HCV coinfection services. Both HRSA (CARE Act, community health centers) and CMS (Medicaid and Medicare) should promote comprehensive standards of care (as noted above) as guidance for all federally funded programs.

(d)  A mechanism by which private and public payers for coinfection care come together to agree on payment levels that do not effectively discourage access to care.

ii)    Uninsured/Underinsured

(1)  The 2004 Institute of Medicine report on Delivery of HIV care recommends that the federal government establish an entitlement to HIV/AIDS care for all uninsured and underinsured HIV+ people earning less than 250% of the federal poverty level. The IOM stated that only under such an entitlement would all patients who needed it be guaranteed access to the standard of care that could save lives, reduce per patient costs, and deliver better quality care through Centers of Excellence. That entitlement would assure that all low-income coinfected patients would have access to both HIV and HCV diagnostics and care and to a comprehensive drug formulary, substance abuse and mental health care and case management.

(2)  Until and unless a comprehensive solution such as the IOM recommendation is adopted, other programs such as the CARE Act must be funded adequately to deliver appropriate care (HIV and coinfection) throughout the nation.

iii)   Ryan White CARE Act

(1)  The Ryan White CARE Act must be adequately funded to provide treatment and services to all eligible HIV/HCV coinfected patients who need them wherever in the United States or funded U.S. territories they live.

(2)  The re-authorized Care Act must include language integrating services and care for HCV coinfection into the existing infrastructure that provides services and care for HIV.

iv)   Community Health Centers

(1)  Additional federal funding should be made available to replicate programs with proven success in treating HCV infected patients that are being administered by community health centers.

v)     Medicare

(1)  CMS must assure that dually eligible Medicare/Medicaid beneficiaries will not experience any gaps in services under the implementation of the Medicare Modernization Act (MMA).

(2)  CMS must work to change Medicare payment policies to assure beneficiaries have access to mental health and substance abuse services under the same terms and conditions as apply to reimbursed medical services.

(3)  HIV/HCV coinfected Medicare enrollees should be designated as a special population in order to assure that adequate services are available to this population.

vi)   SAMHSA

(1)  HHS must coordinate a meeting between SAMHSA and HIV and HCV providers and advocates to create new guidelines mandating better coordination between SAMSHA and other public health programs.

vii)  Federal and State Prisons

(1)  Prisons are a central locus for HIV/HCV coinfection and, as such, must be mandated to provide quality coinfection care under Guidelines promulgated by the public health service and professional provider organizations.

b)    Provider Reimbursement/All Health Care Payment Systems

i)      Inadequate reimbursement rates for HCV, HIV, mental health and substance abuse providers is leading to increasing difficulties in accessing quality coinfection care. A comprehensive solution for this problem for patients suffering from serious and/or potentially life-threatening conditions must be proposed and implemented for both private and public sector insurance.

5)    Research

a)    Diagnostics

i)      Intensive research is required to validate non-invasive methods for determining the extent of hepatic liver damage.

ii)    Research is required to develop accurate, inexpensive and simple surrogate markers for use in both clinical trial and clinical practice settings.

b)    Treatment: Research priorities

i)      Rapid development of compounds that will improve the efficacy of currently available combinations, especially for genotype 1 patients. Compounds should be tested for efficacy in coinfected patients as soon as it is safe to do so.

ii)    Real world assessments of utilization of antiretrovirals in coinfected patients including measures of tolerability, protocols for initiation of treatment (HCV vs. HIV), and best measures of side effects that may be related to co-administration of HIV and HCV treatment.

iii)   There is an acute need for an effective, inexpensive HCV vaccine. The NIH vaccine center should coordinate an expedited search.

iv)   Cost/benefit related research needs are outlined in Surveillance and Data Policy, above.