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Direct to Consumer Genetic Testing — The Need for Early Filtering of Genetic Information

By GAIA BERNSTEIN, JD
Gaia Bernstein

Genetic testing for adult onset diseases used to be mainly a medical service. In most cases a person who had a certain genetic disease that was prevalent in her family would go to test to see if she carries the genetic mutation. For example, a woman who had several cases of breast cancer in her family would test for the breast cancer genetic mutation BRCA1/BRCA2 to see if she carries the mutation and has a high probability of getting the disease. But, the proliferation of direct to consumer genetic testing changes the nature of the service to a consumer service. Companies like 23andme and Pathway Genomics (who was planning to start selling its kits in Walgreens) offer consumers the option to buy packages of tests (ranging from 25 to over a 100 conditions). Consumers often buy the tests to satisfy their curiosity or they may even receive them as a gift. People purchasing the testing packages usually do not consult a medical professional when deciding to undergo the tests and receive the results alone by accessing a website.

Yesterday I spoke before the FDA, which is considering regulating direct to consumer genetic testing. My presentation was based on a symposium piece I am working on. I argued for the need for a medical professional to guide people throughout the process and advise them not just on the interpretation of the results but also earlier in the process to determine what genetic information they actually want to have.

Continue reading…

Government as an Engine for Innovation

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Lisa SuennenBy LISA SUENNEN

I’ve been thinking a great deal about the newly formed Center for Medicare and Medicaid Innovation. (CMI). This entity was established as a result of the Affordable Care Act (the new healthcare reform legislation) and its purpose is to “research, develop, test and expand innovative payment and service delivery models that will improve the quality and reduce the costs of care for” patients covered by CMS-related programs.  The legislation gives this entity over $10 billion dollars initially and broad authority to figure out new ways of doing things better and differently than before.   What is great about CMI is that they have the authority to run their programs much more like a business would without many historical governmental constraints.  That’s great news for innovation, which is sorely needed in the U.S. healthcare system.

Among the key objectives that the administration has discussed is how to transition the collective mindset from one of healthcare to one of health.  In other words, if a person is healthy, they do not need health CARE. This is a very important distinction; it puts the emphasis on prevention and wellness as opposed to what you do when somebody is already sick.  In order to affect such a transition, there must be an emphasis on innovation to change the way we have traditionally looked at the healthcare world.

This is an interesting challenge and one that requires a great deal of thoughtfulness in how to approach the universe of innovation opportunities. As venture capitalists, I and my colleagues vet, select and monitor deals and specifically focus on how we pick winners and avoid losers.  It’s a little like being asked to handicap who’s going to win the World Series, but then again, that is pretty much our job as VCs: to act like Billy Beane and pick those most likely to succeed in a capital efficient way based on detailed analysis of trends and meaningful data, not solely based on experience.Continue reading…

Can CMS Be a Venture Capitalist?

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By PAUL LEVY
Paul Levy 1

Lisa Suennen, a venture capitalist, writes this post about the provision in the national health care reform act that created the Center for Medicare and Medicaid Innovation (CMI). This agency has $10 billion to “research, develop, test and expand innovative payment and service delivery models that will improve the quality and reduce the costs of care” for patients covered by CMS-related programs. Lisa notes, “What is great about CMI is that they have the authority to run their programs much more like a business would without many historical governmental constraints. ”

I don’t want to be a stick in the mud, particularly as my able friend Don Berwick takes charge of CMS, but I want to point out that previous efforts by the government to be innovative in other fields have failed because:

(1) Venture funding embodies risk-taking. Government usually does not do this because there is a political imperative never to be blamed for misspending taxpayer money. The bureaucracy, therefore, systematically eliminates ideas that are untested.Continue reading…

Can Health 2.0 Improve EHR Adoption?

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By Matthew Holt



HEALTH 2.o GOES TO WASHINGTON: This panel discussed the Electronic Health Record (EHR) and ways to improve its adoption and the relationship between physicians and patients. The moderator was Joshua Seidman, Office of Provider Adoption Support at ONC 9formerly from Ix Center) and true to his past Josh was focusing on the needs of the patient. The patient representative was the now famous Regina Holiday, with Jon White from AHRQ and Ted Eytan, from the Permanente Federation also on the panel. Watch for the cool AHRQ commercial about patients asking questions.

Introduction to Health 2.0 Goes to Washington

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By Bianca Grogan

SUBTEXT: At the start of  the Health 2.0 Goes to Washington Conference, June 07, 2010, Matthew Holt and Indu Subaiya welcomed all of the conference attendees with an introduction to Health 2.0. In the middle of that introduction Wil Yu, Director of Innovation at the Office of the National Coordinator for Health IT (ONC), gave his opening remarks and spoke about health innovators and initiatives.

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