Current Reimbursement and Regulatory Roadblocks Inhibit the Rapid Development and Deployment of Potentially Life-saving Molecular Diagnostics
San Diego, Calif., -- August 21, 2013 -- XIFIN, Inc., the financial cloud computing company whose platform is revolutionizing the business of healthcare diagnostics from patient to payment, today announced the release of a new white paper outlining a practical approach for payors to establish evidence standards and coverage criteria that encourage innovation while optimizing the healthcare dollar.
While effective coverage determination methodologies have been developed for many areas in Healthcare, they are insufficient for the needs of the dynamic molecular diagnostic environment. Molecular diagnostics present new challenges for coverage that are so different from other medical services and devices that neither the “gold standard” randomized control trial, nor Coverage with Evidence Determination (CED), works well as a coverage determination methodology. The possibility of restricted access to potentially life-saving medical research is very real, as are restricted coverage-caused delays in the development and clinical use of laboratory tests needed to drive new patient therapies.
The white paper, “A Pay-for-Value, Data-Driven Approach for the Coverage of Innovative Genetic Tests,” co-authored by Richard Ding, CEO bioTheranostics, Inc., Dr. Paul Billings, CMO Life Technologies Inc., and XIFIN CEO Lâle White, VP of Commercialization Strategies Rina Wolf, and Director of Business Development David Lorber, PhD, explores how changing from the current highly regulated and over-taxed fee-for-service model to a market-driven, risk-sharing, pay-for-value model involving payors, providers, physicians and patients, will reduce overall costs, decrease time to market, increase quality of care and improve the ROI for investing in and developing innovative diagnostics.
Co-author Ding stated, “The explosion of genetic testing is completely transforming how many life-threatening health conditions are being treated today, dramatically increasing longevity and quality of life for many patients. It is imperative that the cost and value of these tests be factored into payor reimbursement to encourage appropriate use of diagnostics and to support the growth of personalized medicine.”
The proposed value-based model outlined in the white paper advances a coverage determination process that encourages innovation in the agile molecular diagnostics environment. The technology-enabled coverage determination process presents a unique opportunity for a self-regulating system that inherently optimizes patient outcomes, payor cost containment and developer recovery on investment.
Diagnostics influence an estimated 80% of medical decisions, so although they represent a tiny fraction of total healthcare spend, they have the greatest potential to reign in burgeoning healthcare costs ($2.9 trillion and growing) through the increasing use of molecular diagnostic tests that support precision medicine. Changes in reimbursement and coverage are urgently needed to meet the growing demand for both optimized healthcare outcomes and the alignment of incentives for all parties in the U.S. healthcare system.
“Today’s antiquated regulatory and coverage protocols are inadequate for the rapid pace required as molecular diagnostics evolve,” stated co-author White. “More importantly, the current regulatory system must recognize the economic value of these tests in order to support the rapid development and deployment of potentially life-saving diagnostics.”
Genetic tests are evolving so rapidly that they face the very real possibility of obsolescence before receiving coverage determinations under the current assessment guidelines. For investors, this means that in many cases the risk-adjusted ROI for molecular diagnostics may approach zero, a situation that is likely to have a chilling effect on funding for personalized medicine as well as patient outcomes.
The white paper is available for free download at www.xifin.com/pfv.