This article was originally published in Start Up
Companies with new, often implantable devices that enable the remote monitoring of patients aim to enable a new, more efficient kind of disease management. However, one of the biggest hurdles to adoption of disease management to date has been lack of reimbursement. The patients that can most benefit from disease management--sufferers of congestive heart failure, for example--tend to be elderly people that are covered by Medicare, which has no mechanisms to reimburse for disease management. So, beyond the usual hurdles that device companies face, of working the kinks out of technology and proving its clinical value to physicians, patient monitoring companies also need to find the right delivery model that helps them get paid for their technology.
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CardioNet created the first product in a new category: mobile cardiac outpatient telemetry. By enabling the continuous monitoring of ambulatory patients for up to 30 days, CardioNet proved - and validated in clinical trials - that it could substantially improve the diagnosis of arrhythmias more effectively than what was then the standard of care. In 2009, the company was approaching profitability when the local Medicare carrier upon which its business depends unexpectedly slashed reimbursement for the company's core product. The management of CardioNet is frustrated. CardioNet has tried to do things the right way. The company validated its technology in a 300-patient controlled clinical trial proving superior efficacy against a gold standard in a disease where early and accurate diagnosis can clearly improve outcomes. Clinicians recognize the value of CardioNet's product, as evidenced by the 50% growth in patient volumes the company enjoyed last year, and the 30 to 40% growth it's expecting for this year. Yet the company fights for the recognition of payors, and for its life. Now, in the face of these reimbursement pressures, CardioNet's number one priority is to gain Medicare reimbursement at the national level, at a rate, it hopes, that recognizes both the costs and value of long-term 24/7 ambulatory monitoring, thereby both validating the company's strategy and supporting the development of wireless medicine as a whole.
Transoma, which was developing an implantable ECG monitor for continuous, wireless arrhythmia monitoring closed its doors in December. Before that, Medtronic failed to gain FDA approval for an implantable hemodynamic monitor for heart failure. That's two strikes; what will it take for companies with implants for wireless monitoring to stay in the game? Jay Yadav, MD, of CardioMEMS gives his opinion.
This is the device industry's wireless wake-up call. With all the speed and acceleration of an advancing information technology industry, forces outside of the medical device industry are driving shifts in medical product markets and business models. Those forces include the consumerization. globalization, systematization, and economies of scale created by IT. Wireless medicine enables connectivity between caregivers and patients, continuous monitoring of patients with chronic diseases, and a new paradigm for personalized medicine, one based on the patterns that can be gleaned from enormous volumes of individualized patient data, rather than on blood-based biomarkers.