by Amy M. Miller, Ph.D.

The thought first crossed my mind in January, but it was validated on November 17. Unmistakably, 2015 is the year of personalized medicine.

November 17 started with two hearings on both sides of the Capitol. On the Senate side, Robert Califf, M.D., answered questions during his nomination hearing for the FDA commissioner position. The number of Senators referencing personalized medicine was remarkable, and a few members demonstrated deep knowledge of the field by mentioning laboratory-developed test (LDT) regulation specifically. But the activities on the other side were even more extraordinary.

While the Senate was questioning Califf, the House of Representatives Energy and Commerce Health Subcommittee held an entire hearing on LDT regulation. At focus was purportedly draft regulation circulated by the health subcommittee. The content of the hearing, however, reflected a much deeper analysis.

During the hearing, Patrick Conway, M.D., and Jeffrey Shuren, M.D., J.D., outlined the very different roles that the Centers for Medicare and Medicaid Services (CMS) and FDA play in the diagnostics space. Conway described how the Clinical Laboratory Improvement Amendments (CLIA) program focuses on laboratory operations, while test regulation is under the purview of FDA. When asked, repeatedly, if CLIA could be strengthened to accommodate the new science of personalized medicine, Conway consistently answered, without equivocation, “no.” For his part, Shuren stated FDA’s intention to finalize LDT guidance in early 2016.

Throughout both proceedings the newfound support personalized medicine now enjoys in Congress and in the executive branch was on display. We were watching progress. And the day wasn’t over.

Later on that day many stakeholders breathed a sigh of relief as CMS revoked its proposal to reduce the reimbursement rate for CareDx’s impactful personalized medicine test, AlloMap®, by 77 percent, restoring the recommended payment rate for the test to its original $2,821. Many similar determinations also conformed to community requests, and were well received as big wins for the personalized medicine community.

So, when I ended November 17 by attending the Coalition’s networking reception in Boston, I had occasion to celebrate. But even as 2015 winds down on these positive notes, the personalized medicine field still faces policy challenges.

Unfortunately, unpredictable and arbitrary policy decisions, like the proposal to reduce the reimbursement rates for AlloMap® and other personalized medicine tests, are common at CMS. These decisions are unnecessarily disruptive to the field, and it is my hope that in the coming year CMS will adhere to recommendations that seek to protect the interests of personalized medicine, like those PMC provided in its letter on the proposed rule for implementing the Protecting Access to Medicare Act (PAMA) passed in 2014.

Adhering to these kinds of recommendations is of paramount importance, because in the year of personalized medicine, extraordinary days like November 17 are becoming all too common.

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Amy M. Miller, Ph.D.
Executive Vice President
Personalized Medicine Coalition