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February 2017 - Issue 9
Welcome to the Battelle Health & Analytics, a quarterly publication from Battelle. We put this together as a service to our public health clients, to keep you informed of the latest public health news from our researchers and the industry.
The Battelle Health & Analytics team works with agencies and healthcare institutions to advance public health research, practice and policy with the latest science and technology. Battelle Health and Analytics will keep you up-to-date on cutting edge research and public health innovations.
Interest in and demand for Value-Based Purchasing (VBP) models is growing. But what happens when VBP runs up against innovative treatment options—such as the use of precision medicine diagnostics to improve knowledge of treatment options? These payment models may create barriers to the success of new medical advances if they are not properly accounted for in the model.
Researchers at Battelle recently examined this issue, using precision medicine as a case study standing in for innovation more broadly. Kara Morgan, a Research Leader on the Battelle Health Analytics team, presented the findings in a “Rapid Fire” session at the Academy Health National Health Policy Conference this January in Washington, D.C.
Under a VBP model, reimbursement decisions for drugs, medical devices and therapies are based on their demonstrated impact on quality measures. In other words, hospital and healthcare providers are paid, to some degree, based on quality measure results rather than just the cost of treatment, as in more traditional fee-for-service models. The Centers for Medicare & Medicaid Services (CMS) are moving towards implementing VBP, and some private insurers are also moving in this direction.
The overall goal of VBP is to move the practice of medicine towards evidence-based treatment options and provide a real incentive for healthcare practitioners to better evaluate the use of ineffective treatments that add cost without adding value. Proponents believe that VBP models have the potential to lower overall healthcare spending while increasing the quality of care for patients. While it is hard to argue with these goals, concerns have been expressed that VBP could negatively impact medical innovation.
The formative study that Battelle conducted looked at the decision-making processes around using precision medicine diagnostic tools for cancer treatment. It also identified possible barriers to more fully realizing the potential of these tools for improved patient outcomes.
Precision medicine could give cancer patients faster diagnoses and access to treatments with better outcomes and fewer side effects. Advances in the understanding of genetic factors in treatment efficacy have enabled the development of diagnostic tools that allow doctors to identify potential treatment options that were not previously recognized. This information can be used to prescribe targeted, patient-specific treatment regimens.
However, while the diagnostics to conduct genetic screening for several types of cancer are well developed, they are not yet widely used. The cost of the diagnostic tools is still high and, since treatment options do not yet exist for every cancer mutation, the output from the test is not always going to be valuable. As a result, payers generally have been reluctant to reimburse for these tools, preferring instead to reimburse for tools and treatments under current “Standards of Care” that have longer histories of evidence behind them. Currently, precision diagnostics for cancer are often seen as a “tool of last resort” for patients who have not responded to other forms of treatment.
Our research looked at the decision models for patients, providers and payers in making selection or reimbursement decisions for precision medicine tools. We found that existing Standards of Care are strong drivers for decision making for providers and payers—and rightly so for areas of care not undergoing radical change. All three types of decision makers were concerned about the existing evidence behind the tools. However, the groups had different and sometimes conflicting priorities when looking at the decision to use precision medicine tools.
In order for genetic testing for cancer treatment to become more widely used, costs will need to come down and the perceived value will need to go up. In part, perceived value will depend on the approval of more targeted treatment options matched to specific test results. It will also require analysis demonstrating that patients receiving the tests have better outcomes than those who do not.
Currently, the reliance on existing Standards of Care for reimbursement decisions can act as a barrier to the acceptance of new and innovative healthcare options. A more dynamic approach for updating the Standards of Care is needed in order for the transition to these new tools and the benefits to patients to be realized. In time, many of these novel treatments and diagnostics could significantly improve patient outcomes and reduce overall healthcare costs by reducing spending on treatments that will not work for the patient. However, demonstrating these results goes beyond the evidence of clinical efficacy and into a new, emerging area of evidence of “value-to-patient” that includes comparison to alternative treatment options.
Value-based payment programs are not intentionally designed to stifle innovation, but their construct does assume a somewhat static Standard of Care. This approach can be adapted to better support development of innovative approaches such as precision medicine, but change would be needed. Our recommendations are that this adaption should consider these questions:
As the speed of discovery and change accelerates in medicine, purchasing models will need to be reviewed to ensure that patients have access to the best treatments and diagnostic options. This will require building a more dynamic system for updating Standards of Care to capture fast-moving science. However, care also must be taken to ensure that Standards of Care are informed by the best possible evidence. Additional work is needed to define the evidence required to update Standards of Care and refine value-based measures so that they fully capture the value of new treatment options. Our research suggests that developing the analysis and decision support tools necessary to support new medical advances while meeting the needs of patients, providers and value-based payers is possible, but will be challenging.
Each year, the annual R&D 100 Awards recognize the most significant technologies created during the previous year. Some of the world’s most innovative organizations vie for recognition. Winning one of the coveted awards is a widely recognized stamp of validation—they’re known as the “Oscars of Innovation” for a good reason. This year, scientists and engineers from Battelle brought fascinating technology to the event and were rewarded with a top prize. NeuroLife, a Battelle-invented system that currently allows a paralyzed man to have conscious control of his fingers, hand and wrist—via his thoughts—took home three prizes.
In addition to being named one of the top 100 technologies for the year, NeuroLife also received special recognition for Social Responsibility and brought home the Editor’s Choice Award. The Battelle team was recognized at R&D Magazine’s annual ceremony on Nov. 4 at National Harbor in Maryland. Battelle, along with the national labs it has a role in managing for the U.S. Department of Energy, won a total of 17 awards, bringing its historical tally to 355 during the last 54 years.
“The work we’ve accomplished to date, and the major milestone we’ve achieved, is a significant step toward producing technologies that will allow people with disabilities to regain some of their lost quality of life,” said Herb Bresler, a Senior Research Leader who leads Battelle’s NeuroLife program. “We are continuing to develop the system as well as its component technologies, which we believe will have applications beyond helping people with spinal cord injury. We could not have achieved this goal without the entire team, including our clinical collaborators at The Ohio State University Wexner Medical Center and our current study participant, whose dedication to this program has been extraordinary.”
NeuroLife is a pioneering neural bypass technology that has enabled a quadriplegic study participant to regain functional movement of his hand. Using an off-the-shelf brain implant that was implanted by study partner Dr. Ali Rezai and his team at the Ohio State University Wexner Medical Center, the NeuroLife system collects and interprets neural activity from the participant, translates that data and transfers it to a sleeve on the forearm. The sleeve stimulates muscles so the hand can perform the task the participant is imagining—he thinks “make a fist” and then his hand makes a fist in near-real time (less than one-tenth of a second from thought to corresponding action).
The study began in 2014 and many advances have been made in the intervening months. Study sessions are performed twice a week at the Wexner Medical Center with the participant along with OSU doctors and Battelle scientists and engineers. A major paper in Nature magazine was published in 2016.
Two other technologies created with the support of researchers in Battelle’s Health & Consumer Solutions business were also recognized as part of the R&D 100 Awards. Battelle partnered with the Ohio Soybean Council on Soy-PK Reactive Oligomer Cross-Linker Resin, which received Green Technology special recognition. Soy-PK Resin is a safe alternative to epoxy resins containing bisphenol-A (BPA), which is common in coatings for metal beer, beverage, and food can coatings. Additionally, DESiN LLC received an R&D 100 Award for Obi, a system for people with conditions that keep them from being able to feed themselves, which Battelle helped to develop.
Battelle DroneDefender™, which achieved finalist status for the Top 100 technology awards, burst onto the scene on Oct. 15, drawing immediate attention and demand. It is an inexpensive, easy-to-use, lightweight, point-and-shoot system that can stop suspicious or hostile drones in flight. With a demonstrated range of 400 meters, DroneDefender provides instant threat mitigation, disrupting the drone using a proprietary radio control frequency disruption. DroneDefender is only available for sale to federally authorized users because of FCC restrictions. More than 100 have been sold to the Department of Defense and the Department of Homeland Security.
“We’re proud to see Battelle’s talented teams of men and women being recognized for these achievements by the R&D community,” said Battelle’s Steve Kelly, Senior Vice President of Contract Research. “They innovate every day to solve important challenges for our client business and mission needs.”
Wanda Gamble, Vice President of Battelle’s Health & Analytics business unit, oversees a portfolio of work that includes federal healthcare clients such as the departments of Health and Human Services and Veterans Affairs, HHS components and the Military Health System.
Wanda recently spoke to ExecutiveBiz for this in-depth conversation on Battelle’s health analytics collaborations with federal agencies. She also offers an outlook on the future of precision medicine and her views on the unique role nonprofit organizations like Battelle can offer in the healthcare market.
Read the full story at ExecutiveBiz.
Please join us in welcoming our latest additions to the Battelle Health and Analytics team. Their research and clinical expertise will help us to continue to expand our public health research programs and services.
Kent Nardin joined the Health and Analytics Unit as a Research Associate. Kent comes to us from Equifax, where he worked in their Unemployment Division. A recent graduate from Franklin University with an undergraduate degree in Computer Science, Kent also holds a B.S in Mathematics from The Ohio State University.
Dr. Scott Novak joined the Public Health Improvement & Response (PHI&R) team to establish a research program focused on opioids and marijuana use and abuse. Scott holds a Ph.D. in Quantitative Sociology from the University of Kentucky at Lexington, an M.A. in Medical Sociology from the University of Kentucky at Lexington, an M.S. in Statistics (Honors) from Harvard University, a B.S. in Statistics from the University of Wisconsin at Madison and a B.A. in Sociology from the University of Wisconsin at Madison. Scott comes to Battelle from RTI, where he directed the program of research on prescription drug abuse within RTI's Behavioral Health Epidemiology Program.