Opportunities Have Never Been Greater

Past Successes

Our confidence in the Coalition’s ability to succeed in its goals going forward stems from the achievements we have had in the four short years since our formation. These include working with the FDA to refine the In Vitro Diagnostic Multivariate Index Assay (IVDMIA) draft guidance, which has not been finalized. We have met with the Centers for Medicare & Medicaid Services (CMS) to discuss coverage and reimbursement of advanced diagnostics. We have collaborated with other stakeholders, including trade associations, advisory bodies and representatives of academia to find common ground on regulatory and other concerns. And we have engaged with lawmakers to educate them on both the opportunities for the future and the barriers in current law to the development of laboratory diagnostic tests.

Over the past year, we have succeeded in supporting the introduction and enactment of federal legislation, as part of national health reform, that would alleviate the unintended consequences of Medicare laboratory billing rules known as the “date of service” rules. We have engaged with both the House and Senate on broader personalized medicine legislation, which would clarify premarket oversight and regulation of laboratory-developed tests, improve coding and reimbursement for advanced diagnostics, provide tax credits to encourage development of companion diagnostic tests and facilitate personalized medicine research.

2012 Agenda

Our agenda for the coming year is equally ambitious and promises to be equally successful. In 2012, the Coalition will:

• Engage with FDA Regarding IVDMIAs and Laboratory Diagnostic Tests (LDTs) We will continue to communicate with the FDA regarding appropriate premarket oversight of IVDMIAs and will begin to further engage on regulation of other LDTs
• Promote Personalized Medicine Legislation We will work with Congressional sponsors of the personalized medicine legislation to introduce the bills and secure their consideration by key committees
• Work to Improve Coding, Coverage and Reimbursement We will work toward modernizing the framework for coding, coverage and reimbursement of advanced diagnostics, to better reflect the value of these innovative technologies
• Work with CMS to Implement Date of Service Modification Legislation We will continue to work with CMS and the Congress on the implementation of the Date of Service modification legislation to assure these changes to the Medicare laboratory billing rules improve patient access to advanced diagnostics and support innovation