Personalized Medicine Education and Advocacy

Thought leadership in personalized medicine

Accessing Innovation: Why CMS Must be Actively Engaged in the ‘Moonshot’ and Precision Medicine Initiatives

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by Amy M. Miller, Ph.D., PMC Executive Vice President


Amy M. Miller, Ph.D.

Over the last two months, the administration has solidified its commitment to personalized medicine by naming esteemed leaders to head Vice President Biden’s Cancer “Moonshot” Task Force and the President’s Precision Medicine Initiative.

These efforts to improve global health are exciting, and the world looks forward to the discoveries that come from them. However, we have a set of personalized medicines, related diagnostic tests and other innovations that can, right now, improve care for many, and in some cases, provide that moonshot for one.

Yet even in the face of such incredible advances in science and medicine, we also have one sector whose decisions put a damper on that enthusiasm.

As many of you know, the Centers for Medicare and Medicaid Services (CMS) have a history of making policy decisions that have the unintended consequence of deterring use of and investment in personalized medicine products and services, most notably personalized medicine tests. Cutting-edge treatments and services for breast cancer, for example, represent some of the most incredible innovations of the last decade. Yet, payment rates for innovative diagnostic tests used to treat the disease have been cut significantly in the past, and may stand to be cut again. Until these kinds of decisions are revisited, even the most extraordinary progress in research will have only a modest impact on patient care.

In fact, unless CMS is actively engaged in the PMI and “Moonshot” initiatives, we might have a situation where new tools for improving health, such as therapeutics targeted to a particular marker, are not covered and paid for at sustainable rates. For example, CMS’ Center for Medicare and Medicaid Innovation (CMMI) is thinking up some programs to improve health care at a lower cost.  One would hope that under such a mandate personalized medicines would be advantaged, not disadvantaged, since we know with greater certainty that these therapies will work for their target populations.

Yet, CMMI is proposing a plan to cut payments for drugs provided in a physician’s office or a hospital, and many targeted treatments for a subset of breast cancer patients whose tumors are HER2-positive might be disadvantaged by the plan. We encourage CMS to value personalized medicines and their related diagnostics and to recognize this improvement in patient care with appropriate coverage and payment policies.

Furthermore, we encourage the administration to see its commitment to personalized medicine holistically. PMC has long argued that personalized medicine does not fit into the existing system of how health care is regulated, delivered and paid for. Each aspect of the health care system, from discovery to regulation, delivery and payment policy, must be aligned with the field’s principles. Most notably, CMS must be engaged in the dialogue.

Only then can the hope for change be realized fully.


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