Genomics-based Technologies: Access and Reimbursement Issues
Institution: Harvard Pilgrim Health
FOA Number: PA-14-077
Genomics-based technologies are increasingly used in clinical care and are highly relevant to public health because of their potential use in assessing risk, diagnosing, and developing treatment plans. Access to genomic tests often depends on cost and coverage of services by the health plan. No studies, to our knowledge, identify whether access and reimbursement issues relating to guideline-recommended pharmacogenomic tests exist, and what the potential implications of barriers to access and/or differential access for patients, providers, and society are. This current investigation will be th first study, to our knowledge, that focuses on guideline-recommended pharmacogenomic tests that have sufficient evidence for implementation into clinical practice. Our objective is to examine access and reimbursement issues and implications from the perspectives of relevant stakeholders. For Aim 1, we will review and compare coverage policies of major insurers to determine differences in access to guideline-recommended pharmacogenomic tests and to assess if coverage policies comply with evidence- based clinical guidelines. Aim 2 involves a qualitative study to explore perspectives of patients and providers based on their experienced or perceived barriers to access. Payers/insurers will also be interviewed to identify factors influencing coverage decisions on pharmacogenomic tests and the decision-making process. Aim 3 will integrate results from our empirical research and theoretical frameworks to critically analyze ethical and policy implications of barriers to access and/or differential access to guideline-recommended pharmacogenomic tests. The study is being proposed at the right time as genomic health care expands rapidly and will be conducted by our experienced team with complementary expertise in health policy, genomics, and qualitative research. The proposed work is significant in that it will generate understanding of barriers to access in current practic and the decision making process. Our work will have broad impact on clinical practice and health policy. Findings can inform policymakers as they continue to refine the decision-making process and coverage policy design to allow affordable and equitable access to pharmacogenomic tests and other genomics-based technologies.
NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Jul 23, 2015
Apr 30, 2017
Algorithms; anticancer research; base; Biology; cancer therapy; Centers for Disease Control and Prevention (U.S.); Cetuximab; Clinical; clinical care; clinical decision-making; clinical practice; Clinical Practice Guideline; colorectal cancer; Complex; cost; Cost Sharing; Cost-Sharing Insurance; Data; Decision Making; design; Development; Diagnosis; Disease; disease diagnosis; disorder prevention; economic implication; Eligibility Determination; Empirical Research; ERBB2 gene; Ethical Analysis; Ethics; evidence base; evidence based guidelines; exome sequencing; Expenditure; experience; Family health status; Future; Genes; Genetic screening method; genome sequencing; Genomics; Goals; Guidelines; Health; Health Care Ethics; health disparity; Health Planning; Health Policy; Health Services; Healthcare; Healthcare Systems; improved; Individual; innovation; insight; Insurance and Payment Issues; Insurance Carriers; insurance coverage; Interview; Investigation; Knowledge; KRAS2 gene; Label; lapatinib; Lead; Level of Evidence; malignant breast neoplasm; Medical; Medicine; Modern Medicine; Outcome; Patients; Persons; pharmacogenomics; Policies; policy implication; Policy Maker; Policy Research; population health; Process; Provider; Public Health; Qualitative Methods; Qualitative Research; Recommendation; Research; Risk; Science; Services; social; Societies; System; Technology; Testing; Time; treatment planning; United States Food and Drug Administration; whole genome; Work