An Exciting Time for Personalized Medicine

February 12, 2012

I had the honor and pleasure of speaking at a PMC reception held during the annual Molecular Medicine Tri-Con meeting in San Francisco last month.

The event provided us the opportunity to celebrate our collective successes in driving medicine toward personalized care and to reinforce where we need to continue in our efforts.

For those of us who have been involved in personalized medicine for a long time, it has, on occasion, felt like progress has been as slow as molasses. But if we tally the advancement in its entirety, we can begin to see just how much progress has been made and, furthermore, how it is accelerating.

For instance: Sequencing genomes is much more affordable (and faster); the FDA is engaged and working more collaboratively with us; Medicare reimbursement seems to be improving with Palmetto’s new guidelines; drugs approved and dispensed in isolation are becoming more of the exception than the norm; sequencing-based diagnostics are coming to the clinic fast and furious.
How far we've come! This change has been hard-earned, but it is happening and it is making a real difference in patients’ lives. It’s incredibly rewarding to witness.

While we celebrate our accomplishments, we must also take advantage of the momentum we’ve created to further accelerate progress.

1. We must continue voicing encouragement to other Medicare regions and private payors to reimburse. “Palmetto is doing it; you can too!”
2. Encourage investment in innovation; this space provides important products for patients and returns to investors. Many of the start-ups are now in full commercialization – lots of the early risks have been reduced.
3. We need to ensure the creation and publication of good health economic data quantifying the value that personalized medicine products can provide to the healthcare system. We also need to develop and share standard processes that people can work with to provide their health economics dossiers to reimbursers.
4. We must also continue our dialogue with legislators and get behind the efforts of important organizations like the PMC and the Coalition for 21st Century Medicine. In addition:
a. Continue to communicate with the FDA regarding appropriate premarket oversight of IVDMIAs and further engage on the regulation of other LDTs
b. Work with CMS and Congress on the implementation of the “Date of Service” modification legislation to ensure that these changes to the Medicare laboratory billing rules will improve patient access to advanced diagnostics and support innovation

Amid all of this, we are also moving from a “patient” to “consumer” mindset around health. New technologies (e.g. mobile technologies, social media, ubiquitous wireless sensors, etc.) are engaging consumers. More importantly, they are allowing people to take a more active role in their own health.

As consumers are fully activated, we will see an incredible multiplying effect in the demand for and participation in personalized medicine-related products and services. And it is with the consumer engaged that we will really see personalized medicine evolve to be as much about “well-care” as it is currently about “sick-care.”

Changing the practice of medicine is a Herculean effort. The personal and collective efforts of many, many people are creating the multiplier effect needed for long-term, positive change. I hope you feel proud of where we are. I am inspired by it.

I look forward to working with you as we continue our mission to improve patient care and bring affordable personalized medicine to the masses, making it routine, and the new standard of care.

If the first few weeks of the year are any indication, 2012 is going to be another exciting year for all of us.