Assessing the Evidence for Genomics

June 2nd, 2011
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Genomic research is accelerating at a rapid pace and improvements in technology are fueling these advances (as has previously been addressed within the Popper and Co. blog). We’re now entering a phase of evaluating how to incorporate translated genomic information into clinical testing. With this comes a critical need to verify how and when to use a test, how these tests can modify clinical care, and how this process translates into improved outcomes for patients.
In April, Margaret Piper, Ph.D., M.P.H., presented at the Personalized Medicine Partnerships Conference outside of Washington, DC.  Dr. Piper is director, genomic resources, at the Technology Evaluation Center of the Blue Cross and Blue Shield (BCBS) Association. Her presentation, “Assessing the Evidence for Genomics: Focus on the Patient,” centered on the impact of genomics on administrative processes and the adoption of new technologies into clinical care. As Dr. Piper noted, “We’re generating a lot of information that relates genomics to disease, but we’re only just starting to gather information on how to translate this into treatments and medical decision making.”

Standing on the cusp of this rising tide of genomics data raises challenges for health providers (including medical school students) as well as for insurance administrators and health technology companies. The BCBS Technology Evaluation Center seeks to provide healthcare decision makers with patient-centered assessments of new technology based on evidence (or essentially, on published data).  The center conducts systematic reviews, issues special reports, assesses clinical evidence, and uses a panel of independent medical experts to provide assessments to aid in creation of guidelines and practice patterns. Most importantly though, the center strives to evaluate outcomes that patients can appreciate.
After hearing Dr. Piper, I directed some questions to Caroline Popper of Popper and Co. to glean her insights. The first question involves the Center’s criteria for issuing basic guidance only on “published” outcomes.
JLM:   Given that the Center is only providing guidance based on published evidence, what might this mean for timing in terms of adoption of new technologies into the marketplace?

CP:  Making data-driven decisions and evaluating costs vs. benefits makes sense. However, there are other market forces at play that will drive adoption before rigorous assessment is complete—such as basic consumerism and the Internet. Over time though, a balance between sound data-driven decision making and what I call “irrational exuberance” will be found. Clearly, organizations like the Technology Center have a big role to play. Most importantly, they should make sure there’s no perception that simple cost-control is the only driver for adoption of technology into clinical practice.

The second issue that struck me was around coding for reimbursement since Dr. Piper explained how healthcare plans are still in the dark about how to code molecular testing, for example. She noted that BCBS is working along with various insurance plans to address this issue, and that coding changes that may be implemented in 2012 may help. Still, the issue of immediate processing bears some further thought.
JLM: What can be done today to help insurance plans have a clear path for covering molecular testing? Can you shed some light on pending coding changes?

CP: Dr. Piper may have been referring to the implementation of codes by Centers for Medicare and Medicaid Services that have more to do with the value of the information generated then the work units that generate the information. This process will reimburse tests that are very useful and improve quality while saving cost, even though the tests may be simple to perform. It will eliminate or reduce the common default practice of code stacking—a process that piles up as providers use as many existing codes for every component of a test as possible in order to achieve a higher reimbursement.

And lastly, I wanted Caroline’s insight on a part of the presentation centering on how device or diagnostics companies bring their technologies to Dr. Piper’s Tech Center for assessment. According to Dr. Piper, if a device or diagnostics company has a new technology, it would bring it to the attention of one of the 39 independent BCBS entities and then the entity would feed it up to the Tech Center. The Tech Center can’t talk directly to a company about all that is needed for a positive assessment, but the Center staff might schedule an hour to talk through some suggestions.
JLM: What advice would you give to a diagnostics company getting ready to schedule an hour with the Tech Center?

CP: Have a clear idea of what the test will claim, whether it goes to the FDA or if it’s a LDT (lab-developed test). Make sure you know how the test fits into the standard care paradigm, i.e., how the physician will use the information from the test in managing the care of the patient.

JLM: What questions should company representatives be prepared to ask and what should they have on hand for the meeting?

CP: They should ask what the Tech Center considers good measurable endpoints and whether it is feasible to collect these points during the validation process. They should come with the pilot results about the analytical performance of the test, a good understanding of the competing alternatives, and a reasonably comprehensive view of all the elements of an episode of care in which the test plays a role.

Do you have other questions for Caroline on this topic? Do you have experiences with how new diagnostic technologies factor into medical decision-making? Let us know your thoughts.

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About the Author:

Popper and Company takes a comprehensive approach to helping our clients leverage information to improve the efficiency of healthcare delivery. We’re a team of diverse professionals – physician entrepreneurs across multiple disciplines, engineers, scientists, and clinicians – each with a unique perspective and problem-solving capabilities.