If you read Ken Walz’s recent post based upon his interview with AdvaMed Conference Producer Ray Briscuso, you already know that AdvaMed 2011 – bringing together more than 1,500 key MedTech executives from companies in every sector of the industry – promised to be an important conference, exhibition and partnering event for medical device, diagnostic and health information companies. Ken attended the conference – as did I – with the intent of absorbing all we could, sharing highlights, and reporting back via this blog.
From Ken’s perspective, one of the major themes permeating the remarks of many AdvaMed 2011 presenters was UNCERTAINTY. “While speakers referred to various causes for the uncertainty facing the MedTech industry, most of them tied it back to federal laws impacting health care and the potential for federal budget cutting to constrain the U.S. Food & Drug Administration’s ability to rapidly approve new devices and diagnostic tools,” he said.
For more on what some presenters and attendees had to say during and about the conference, read on:
Excerpts from Remarks Given by U.S. Department of Health & Human Services Secretary Kathleen Sebelius:
“For decades, the medical device industry has been a shining example of American innovation and creativity. Your products – from coronary stents to dialysis technology to cutting edge imaging – have played a key role in adding 30 years to the life of the average American over the last century. Our Department is committed to creating an environment where you can continue to innovate, improve lives, and create jobs.”
“As we look to the future, the medical device industry and the federal government share a vision of innovation unleashed. And the single most important thing the Food and Drug Administration can do to help make that vision a reality is to ensure the timely approval of safe and effective medical devices.”
Highlights from “CEOs Unplugged” Panel on Policy & Advocacy:
Jim Mazzo, President, Abbott Medical Optics; SVP, Abbott
On state of MedTech industry: “We are fortunate to be a part of this industry in this country… Recognize that there are many positives in spite of the issues we are facing and don’t get caught up in the uncertainties. We’re being recognized as an industry that is going to provide jobs and is going to provide life-saving technologies.”
Steve Ubl, President & CEO, AdvaMed:
On the FDA 510(k) Process: “The program is fundamentally sound. AdvaMed is proud of our policy work in this arena and we feel we are making solid progress in our discussions with the FDA.”
On the Medical Device Tax, healthcare reform, and other policy issues that may impact U.S. innovation: “The device industry is an engine of medical and economic progress… We can lead the way in innovation as long as we continue to have incentives for research and development.”
Mike Mussallem, Chairman & CEO, Edwards Lifesciences Corporation:
On state of MedTech industry: “The aging population, technological innovations, and growth in the emerging world are the wind beneath this industry’s wings.”
Attendee comments:
“This conference isn’t about a ‘Wow, gee’ factor for any particular technology’s potential. It’s more about the direction in which the industry as a whole is headed and where or how technologies will fit within.”
– Paul Cronin, Business Development Manager, Medical Technologies Division, IDA Ireland (Twitter: @idaireland)
“Our participation at this year’s conference is the beginning of a broader partnership between the AdvaMed and AUTM and gave us an opportunity to talk about our global tech portal, which will be available early next year. It will allow universities to post information on their technologies available for licensing and for companies to search the database for free. We believe it will provide good match ups between university technologies and the companies interested in them.”
– Vicki L. Loise, Executive Director, Association of University Technology Managers (AUTM) (Twitter: @autm_network)
“The partnering forum at AdvaMed2011 was awesome – it was what brought us to the conference. For our business, partnering discussions allow for finding common goals and for great use of limited resources. These discussions are much more effective for us than simply having an exhibit booth. In particular, we appreciated the opportunity to connect with large diagnostic companies like Qiagen, J&J and Roche.”
– Montserrat Capdevila, Director of Sales/Marketing, International Relations, Johns Hopkins University Tech Transfer (Twitter: @JHUTechTransfer)
Obviously, these are but a sampling of the takeaways, highlights and industry insights from the AdvaMed 2011 conference. Were you in attendance? What were your key learnings? Add your comments below.
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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.
Tags: bcbs, genetics, genomic research, genomics, health providers, health tech, insurance
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Entrance-to-market is always a challenging process in the bio-med industry, but where one would normally consider product quality and peer assessment as lead indicators of success, it can be something quite different and unexpected that affects rapid market adoption—such as simple profit-based economics. This is a lesson learned by the San-Francisco-based company XDx, Inc. (Expression Diagnostics) in conjunction with the launch of its diagnostics test Allomap®.
XDx’s Vice President of Corporate Development and Legal Affairs Matthew J. Meyer recently presented at the 3rd Annual Personalized Medicine Partnerships Conference in Bethesda, Maryland. Here, I recap some of the highlights of Meyer’s case study presentation and then offer some insights from Ken Walz, one of the founder’s of Popper and Company.
According to Meyer, the heart transplantation market in the U.S. encompasses nearly 140 centers performing more than 2,000 transplants per year. With the average cost of the procedure at around $750K and topping out at nearly $1M when post-transplant therapy and care is included, the industry fully supports a growing $2B impact on the U.S. healthcare system. Transplant patients and hospital institutions not only face substantial costs in upfront care, but the patient must also pay for and endure between 20 and 35 painful biopsies in an attempt to reduce rejection and minimize immunosuppression.
Founded in 2000 with the goal of significantly improving patient management in transplant care and autoimmune diseases like lupus through the development and commercialization of non-invasive diagnostic tests, XDx gained FDA clearance in 2008 for its groundbreaking Allomap® molecular diagnostic test. AlloMap uses simple blood draws to achieve the equivalent of biopsy results by analyzing genetic activity (gene-expression testing) to predict the absence of heart transplant rejection. Allomap’s Molecular Expression Test has become a “standard of care” and after several successful validation studies, including the landmark IMAGE trial published in the New England Journal of Medicine in April 2010, it has been clinically demonstrated to be “non-inferior” to biopsy and written into the International Society of Heart and Lung Transplantation (ISHLT) guidelines—the first and only blood test ever included in such guidelines.
So what’s delaying Allomap® from achieving market success? One significant factor that appears to be at play is that the Allomap® test reduces the need for biopsy, a procedure which generates revenue for some physicians performing the test and the institutions in which the tests are performed. XDx has learned a lesson that other companies entering the personalized medicine market will surely need to heed—a product needs more than comparative clinical effectiveness and clinical validation to achieve rapid market penetration. Financial considerations matter and when costly invasive procedures are replaced, companies will need to engage all stakeholders and focus on a financial middle ground where physicians gain something of value.
Following are Walz’s insights on the implications of this case study and its potential impact on advances in quality care.
Jamie: Ken, what are your reactions to this case study? How do you feel about physicians being slow to adopt a new diagnostics tool because use of this test removes part of their revenue stream? Can this happen with other diagnostics tools?
Ken: I’m not surprised. Because of the financial structure of our health care system, reimbursement (i.e., revenue) comes into play often when a physician is deciding whether to order a test or to do a procedure. We have seen many examples of this across diagnostics.
Jamie: Is there anything you’d suggest XDx could have done to soften the marketplace in advance of approval of Allomap® and its introduction into the market?
Ken: Engage patients. Based on Matthew’s presentation (and from my recollection of hearing XDx’s CEO speak last year), the Allomap® test is a much better option for the patient than biopsy. Within the parameters of what FDA allows, XDx should continue to look for ways to raise awareness among patients who would in turn demand the test as an alternative to biopsy.
Jamie: What broader implications based on this example would you like to highlight?
Ken: This case study is somewhat typical of what should be expected from a health care system with multiple actors and misaligned incentives. That’s not likely to change so companies should look for ways to engage the ultimate user (i.e., patient) to try to force alignment of those incentives and to ensure the patient can receive a medical solution that is in his or her best interest.
Let us know your thoughts on this issue of profit-based incentives impeding the adoption of new health care technologies that are better for the patient and save the healthcare system precious dollars. Should these issues be more strongly addressed through and by advocacy groups? How do you feel about how these issues can impact patient access to quality care? We look forward to hearing from you.
Tags: allomap, entrance to market, guest posts, health economics, health tech, jamie lacey moreira, matthew meyer, xdx
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