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Personalized Medicine Coalition Sheds New Light on Progress and Challenges Facing the Development of Personalized Medicine

White Paper Outlines Reimbursement Challenges Hindering Growth

WASHINGTON (July 9, 2014)


According to a new report from the Personalized Medicine Coalition (PMC) released today, members of the personalized medicine community are calling for critical changes in payment and coverage policies to encourage innovation and improve the quality of health care for millions of patients.

PMC’s new white paper, “The Future of Coverage and Payment for Personalized Medicine Diagnostics,” documents both the progress of personalized medicine and the ways in which some recent coverage and payment policies have discouraged its advancement.

“Over the past decade we’ve seen considerable growth in the scope and impact of personalized medicine, but we have far to go,” said Amy Miller, Ph.D., executive vice president of PMC. “Comprehensive coverage and payment policies are necessary to encourage future investment in personalized medicine. As the paper shows, we have the opportunity to impact change, thus ensuring higher quality care and potentially lowering systemic costs if the right treatments are targeted to the right patients.”

The report discusses three major public policy concerns:

  • Imminent Federal Pricing of Highly Innovative Molecular Tests: Between 2012 and 2014, there were multiple changes in the system for coding and pricing genomic tests, which shook the system of molecular diagnostic reimbursement, extending as far as a near suspension of federal payments for genomic tests in the first quarter of 2013. Even larger policy decisions will face the Centers for Medicare & Medicaid Services (CMS) in 2014 and 2015. PMC says that it is crucial that reimbursement levels — set unilaterally by policymakers — not only ensure access to high-quality tests, but also encourage the development of additional innovative tests based on substantial risk-based research and development.
  • Inconsistent Standards and Paradigms for Evaluating Diagnostic, Prognostic, and Predictive, Personalized Molecular Diagnostic Tests: Health technology assessments represent a rapidly growing area of international government policy, which has accelerated in the past several years as governments seek to contain costs. Although most agree that personalized molecular diagnostics improve patient management and the delivery of care, the report contends that assessments to determine coverage and payment are not clear, predictable or appropriate, thus discouraging investment.
  • Lack of Incentives for Genomic Medicine: There are areas where genomic medicine could have a major impact on public health, but traditional funding, pricing or reimbursement systems fail to provide enough incentive for its development. These areas include funding the education of physicians, allied professionals and patients as well as creating incentives to develop new tools that could revolutionize many therapeutic areas.

“Issues for personalized medicine are foreseeable and real,” said Bruce Quinn, M.D., Ph.D., principal report author and senior health policy advisor, Foley Hoag LLP. “We need to monitor, evaluate and contribute to the debate in these three areas to ensure personalized medicine is integrated into the development of Medicare policy in the years ahead. We need a reimbursement system that encourages the improvement of patient care through medical innovation. Patients expect no less.”

The report also contrasts the public positions of the two most important federal agencies for the entry of personalized medicine into the health care system — FDA and CMS. In October 2013, the FDA released a cross-agency, 60-page document entitled, “Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development,” which discusses FDA’s initiatives to advance personalized medicine. Conversely, CMS’ main public documents in 2013 focused on the cost-cutting proposals discussed in this white paper, without regard to either innovation or improving patient access to care.

A full list of PMC’s publications, including the newly released “The Case for Personalized Medicine,” are available here.


Chris Wells
Phone: 202-580-9780

About the Personalized Medicine Coalition:
The Personalized Medicine Coalition (PMC), representing innovators, scientists, patients, providers and payers, promotes the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system. For more information about PMC, visit

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