CAPACITY OF THE HEALTHCARE SYSTEM TO INCREASE PROVISION OF HIV TESTING

Transcription

1 Institute of Medicine (2010) CAPACITY OF THE HEALTHCARE SYSTEM TO INCREASE PROVISION OF HIV TESTING Workshop on the Capacity of the Healthcare System to Identify and Provide Care for Individuals with HIV/AIDS Andrew N Young MD PhD Emory University School of Medicine Department of Pathology & Laboratory Medicine Grady Health System Director of Clinical Laboratories andrew.n.young@emory.edu ANYOUNG@gmh.edu 1

2 Revised Recommendations for HIV Testing Adults and adolescents in all healthcare settings Routine opt-out HIV screening for all patients age Annual screening for those at high risk for HIV infection No requirement for separate written consent No requirement for pretest prevention counseling Consideration given to rapid testing and result communication Pregnant women in all health-care settings HIV screening in routine panel of prenatal screening tests Repeat third trimester screening in areas with high prevalence Are there barriers to increase HIV testing capacity? 2

3 Potential Barriers to Increased HIV Testing Ethical questions: Do state laws still require consent and pretest counseling? What are the benefits and risks to increased testing? Administrative questions: Will additional tests be reimbursed adequately? Will testing remain compliant with regulatory requirements? Practical questions: Will testing processes have adequate capacity and quality? Where will tests be performed (in laboratories or point of care)? How will tests be performed (non-waived or waived methods)? 3

4 Ethical Questions State requirements for consent and counseling National HIV/AIDS Clinician Consultation Center 11 states not compatible with CDC guidelines (March 2009) Benefits versus risks/costs of routine HIV screening: Benefits Detect more cases at earlier stage Link patients to care, counseling Reduce high-risk behavior Reduce transmission Risks/Costs Increased false positives HIV stigma Overwhelming of healthcare system Non-reimbursed costs Broad (but not universal) consensus that benefits > risks/costs 4

5 Administrative Questions: Reimbursement USPSTF recommendations for HIV screening (2007) Focused Update of a 2005 Systematic Evidence Review Population Recommendation High-risk adolescents and adults, pregnant women A Low-risk adults and adolescents C Patient Protection and Affordable Care Act (PPACA): Insurers to pay for preventive services with USPSTF A/B rating Health Research and Educational Trust: Resource for public and private coverage for HIV screening 5

6 Administrative Questions: Regulations Clinical Laboratory Improvement Amendments (CLIA) Compliance with CLIA standards is required for: Legal conduct of clinical laboratory testing for patient care Screening, diagnosis, monitoring, assessment of impairment Reimbursement for services by Medicare and Medicaid CLIA standards are defined by complexity of testing Non-waived: more stringent requirements Personnel qualifications, quality management, inspections Waived: less stringent requirements 6

7 Administrative Questions: Regulations The Joint Commission requirements for waived testing: Competency assessment, protocol adherence, quality control Waived Testing: 3 of top 10 Ambulatory Care citations, First Half 2010 The Joint Commission Perspectives, September

8 Practical Questions: Testing Methods FDA-approved assays include automated and rapid tests Detect HIV antibody with >99% sensitivity and specificity Do not detect viral protein or RNA in acute HIV infection Approaches to Routine HIV Screening Location of Testing Large commercial and hospital laboratories Small hospital, clinic or physician office laboratories Point of care (emergency departments, clinics, etc) Common Testing Platform Automated assays Non-automated assays; rapid tests Rapid tests CLIA Category Non-waived Non-waived or waived Waived 8

9 Options for HIV Screening min Advantages to Automated Testing High test throughput Orders/Results interface Lower cost per test Advantages to Point of Care Testing High patient acceptance No specimen transportation Direct communication of results 9

10 FDA-Approved Rapid HIV Tests Test System OraQuick ADVANCE Rapid HIV-1/2 Antibody Uni-Gold Recombigen HIV Reveal G-3 Rapid HIV-1 Antibody MultiSpot HIV-1/HIV-2 Rapid Clearview HIV 1/2 STAT-PAK Clearview COMPLETE HIV 1/2 Sample Type Oral fluid Whole Blood Plasma Whole blood Serum/Plasma Serum Plasma Serum Plasma Whole Blood Serum/Plasma Whole Blood Serum/Plasma CLIA (Category) Waived Waived Non-Waived Waived Non-Waived Non-Waived Non-Waived Non-Waived Non-Waived Waived Non-Waived Waived Non-Waived Sensitivity (95%CI) 99.3% ( ) 99.6% ( ) 99.6% ( ) 100% ( ) 100% ( ) 99.8% ( ) 99.8% ( ) 100% ( ) 100% ( ) 99.7% ( ) 99.7% ( ) 99.7% ( ) 99.7% Specificity (95%CI) 99.8% ( ) 100% ( ) 99.9% ( ) 99.7% ( ) 99.8% ( ) 99.1% ( ) 98.6% ( ) 99.9% ( ) 99.9% ( ) 99.9% ( ) 99.9% ( ) 99.9% ( ) 99.9% ( ) ( ) * List prices range from $ $25.00 Per Device (External Controls may not be included) Adapted from: HIV-2 Detection Yes No No Yes Yes Yes 10

11 Studies of Increased HIV Testing Cost-benefit analyses of routine HIV screening: Emergency Department-based studies of rapid testing: Are more patients tested and linked to care vs standard testing? Is rapid testing sustainable? 76% opt-out rate 11

12 THRIVE Project (Grady Health System) CDC Demonstration Project: Program objectives: Integrate rapid HIV testing in Emergency Department Diagnose unrecognized HIV infection Link patients to follow-up care Program statistics (through August 2010): More than 10,000 patients tested (50.2% male) 85% test acceptance rate 172 (1.7%) new preliminary diagnoses (75.2% male) 88.4% returned for Western Blot results 75% attended initial follow-up appointment 12

13 THRIVE Project: Data 13

14 Summary: Barriers to Increased HIV Testing Ethical barriers for routine HIV screening: Several states require separate consent and pretest counseling Risk and cost/benefit for routine HIV screening is still debated Administrative barriers for routine HIV screening: Current USPSTF C grade makes reimbursement uncertain Large-scale implementation of rapid testing is a compliance risk Practical barriers for routine HIV screening: Large-scale rapid HIV testing may not be sustainable Can laboratory-based testing provide timely results? Ultimate approach should study laboratory testing in total context 14

15 Laboratory Testing Capacity: Context Testing is a component of the continuum of patient care Testing occurs through a standard path of workflow Point of care and laboratory-based testing each offer unique strengths and limitations throughout these process pathways 15

16 Future Trends Combination assays for HIV antibody and antigen Useful to capture acute HIV infection (before antibody emerges) One automated assay is approved by FDA; others are pending One rapid assay is approved in Europe; not yet FDA-approved CDC guidelines for rapid confirmation tests Rapid tests to replace HIV Western blot (under current review) Impact of HIV screening on capacity for monitoring tests CD4 count, viral RNA load, genotyping/phenotyping Generally done in large laboratories with automated methods Laboratory capacity should not be strained 16