March 2016, Vol. 5, No. 2

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Regulation and Reimbursement Policies Will Determine the PMI’s Legacy

Edward Abrahams, PhD

The Last Word

abrahams-StrokeOn February 25, the Obama administration laid out the next steps for the Precision Medicine Initiative (PMI) before an eager crowd of stakeholders at the White House. The initiative is promising.

Zeroing in on President Obama’s vision of building a research cohort that includes 1 million Americans, the National Institutes of Health expects to enroll 79,000 people by the end of 2016. The effort includes plans to encourage data sharing, establish a coordinating center that will serve as headquarters for the project, and start developing standardized applications that will make it easier for people to contribute data, which, in turn, will inform research in the future. The PMI’s efforts are supported by a robust network of private stakeholders led by Vanderbilt University and Verily, formerly known as Google Life Sciences.

These elements combine to form a program that is likely to accelerate the pace of progress in personalized medicine research. The PMI’s legacy, however, will not be determined solely based on its ability to accomplish that.

According to the Personalized Medicine Coalition Executive Vice President Amy M. Miller, PhD, who attended the White House’s “Precision Medicine Initiative Summit,” the downstream impact of the PMI will ultimately depend on the extent to which US policies encourage the timely integration of personalized medicine into healthcare systems. Of particular importance are policies related to the regulatory environment for diagnostics and reimbursement for personalized medicine products and services.

Relevant policies are being decided now. Following the release of its highly controversial draft guidance framework for regulating laboratory developed tests in July 2014, the FDA received feedback from a wide range of stakeholders and plans to finalize the framework in 2016. In addition, the Centers for Medicare & Medicaid Services has proposed and received feedback on a framework to implement the Protecting Access to Medicare Act of 2014 that would require clinical laboratories to begin reporting data that will be used to determine new payment rates for clinical laboratory tests on January 1, 2017.

Regulatory and reimbursement policies like these will have profound implications for personalized medicine. If improperly designed, they will make it harder to get products and services approved and reimbursed, stifling investment in innovation and inhibiting patient access to new therapies. If that happens, the significance of the PMI’s efforts to accelerate progress, no matter how well intentioned, will be diminished.

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