Comments on SACGHS Draft Report "Coverage and Reimbursement of Genetic Tests and Services"

Policy Position

Date: May 11, 2005

The Personalized Medicine Coalition (PMC) is pleased to submit comments on the draft report of the Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) entitled "Coverage and Reimbursement of Genetic Tests and Services." The PMC encompasses a broad spectrum of academic, industrial, patient and healthcare provider constituencies. Its expanding membership includes universities and academic medical centers, non-profit research entities, trade associations, patient advocacy groups, government officials (ex-officio), healthcare organizations, healthcare providers, payers, information technology companies and research-based commercial corporations that offer an array of products and services, including research tools, diagnostic technologies and products, screening services and therapeutic interventions. The PMC is a non-governmental, non-profit group, dedicated to advancing the understanding and adoption of personalized medicine concepts and products for the ultimate benefit of patients who need them.

We define personalized medicine as the use of new methods of molecular analysis to better manage a patient's disease or predisposition towards a disease. It aims to achieve optimal medical outcomes by helping physicians and patients choose the disease management approaches likely to work best in the context of a patient's genetic and environmental profile. The PMC seeks to promote discussion and understanding that will lead to the development of sound public policy on matters that will affect the realization of the promise of personalized medicine.

Founded to advance genomic medicine, the PMC has a keen interest in the current state of coverage and reimbursement of genetic/genomic tests and services as well as any and all efforts to improve patient access through a revamped test evaluation and reimbursement process. We encourage the Committee to focus on potential private sector solutions when it assesses historically inadequate methodology for establishing appropriate reimbursement for genetic/genomic services. In particular, it should seek to encourage the development of sophisticated new tests and services by recommending the establishment of adequate reimbursement policies.

The PMC requests the opportunity to participate in the Committee's development of appropriate coverage and reimbursement recommendations for genetic/genomic services. We look forward to working with the Committee as it considers the broad range of patient and societal issues raised by the development and use of genetic/genomic services leading to a personalized medicine paradigm.