Still Skeptical about Personalized Medicine?

Over a century ago Sir William Osler, M.D., stated: “Variability is the law of life and as no two faces are the same, so no two bodies are alike and no two individuals react alike and behave alike under the abnormal conditions which we know as disease.” Despite our deep and long-standing understanding of the heterogeneity of disease and the variations in response to treatment, we are slow to adopt the notion that despite its complexity, the heterogeneity of human illness is decipherable. Skepticisms that we can actually deliver on the promise of personalized medicine is understandable, since converting such variables as severity of illness, uncertain vulnerability to side effects, co-morbid conditions and our cultural environment, to name a few, to precise algorithms for care seem daunting.

So, why has it taken so long for medical science to unravel this heterogeneity and why should we be optimistic that personalized medicine will happen? In part, our current views stems from where we have previously focused our attention. “Bergkrankheit “(mountain sickness) was known in the 14th century as an affliction of metal ore miners in Europe. By the 20th century we knew this as lung cancer and attributed it to a variety of environmental exposures. In this century, we have further refined our description of this disease to specific aberrations in molecular pathways, which if not entirely causative, account for much of the disease biology.

By contrast, medicinal chemistry as a science started much later than clinical medicine and is now closing the gap between knowing precisely what causes an illness to precisely what to do about it to improve the outcome for individual patients. No doubt we have a long way to go, but the current pace of personalized medicines suggests that it is becoming everyday reality for many lung cancer patients.

Join Dr. Stephen Eck on November 28, 2012, when he moderates a panel discussion at the 8th Annual Personalized Medicine Conference hosted by Partners HealthCare Center for Personalized Genetic Medicine, Harvard Medical School, and Harvard Business School. 

Do Not Stymie Innovation by Denying Reimbursement

Last week the public comment period closed for the Centers for Medicare and Medicaid Services (CMS) proposed payment determination for Multianalyte Assays with Algorithmic Analyses (MAAAs) in the CY 2013 New and Reconsidered Clinical Laboratory Fee Schedule (CLFS) Test Codes and Preliminary Payment Determinations (“the Preliminary Determination”).

MAAAs are procedures that utilize multiple results derived from assays of various types. The American Medical Association gives the following definition: “Algorithmic analysis, using the results of these assays as well as other patient information (if used), is then performed and reported typically as a numeric score(s) or as a probability. MAAAs are typically unique to a single clinical laboratory or manufacturer. The results of individual component procedure(s) that are inputs to the MAAAs may be provided on the associated laboratory report; however these assays are not reported separately using additional codes.”

MAAAs are not new.  CMS and private payers routinely pay for them and many of them, having been added to clinical care guidelines, are now considered standard of care.

The proposal, as it stands, will likely prevent providers from receiving reimbursement for MAAAs. Without a clear reimbursement pathway, we risk stifling innovation by sending a powerful message to developers and providers that they cannot recoup investments made in the development, clinical validation, and commercialization of innovative diagnostic products.

Innovators focused on developing new therapies and accompanying diagnostics have difficult decisions to make regarding what products to invest in and bring to market. They must have confidence that future innovative diagnostics will be recognized and valued or improvements in patient care could be at risk.

At the urging of our members, the Personalized Medicine Coalition (PMC) sent a letter to CMS on this issue, noting that the Preliminary Determination:

• Reverses current practice as many of the MAAAs are well-established tests that have been covered and reimbursed by Medicare for several years and are medically necessary given their status as the standard of care in treatment guidelines;
• Jeopardizes personalized medicine and medical innovation by not separately recognizing and valuing the MAAA CPT codes; and
• Represents a lack of transparency in the CMS decision-making process.

PMC recommended that the Preliminary Determination be altered to take into consideration these perspectives, shared by all PMC member organizations, to ensure that the decision does not inadvertently impact current patient care and the future of biomedical innovation.

Healthcare delivery and our research enterprise continue to change as innovators apply new scientific discoveries to the development of new therapies to treat and manage illnesses.  Our reimbursement policies must also adjust in step in order to support our evolving healthcare system.

Today, physicians across the country use sophisticated diagnostics to guide treatment decisions, a trend that we expect will continue. The rise in personalized medicine will lead to efficiencies in the healthcare system that increase the quality of patient care while saving patients exposure to unnecessary treatments that may not help them. Let us not halt innovation in healthcare by hasty policy decisions, such as the Preliminary Determination, that are not fully vetted for unintended consequences.