Acceptance Hurdles
The iRhythm Zio Patch was cleared by the FDA in 2009 and has been commercially available for over 3 years. However, its broad acceptance and adoption has, in the author's opinion, been somewhat limited by insurance reimbursement. For US Medicare patients, during 2012–2013, the devices have a CMS 'T' code for evaluation before a national decision is made on reimbursement. Some major US health insurance carriers have chosen to not reimburse for the Zio Patch system. There are various explanations regarding the poor reimbursement and acceptance in this field. They primarily center on attempts to limit costs, the potential for overuse and the current regulatory environment resulting in a reluctance to adopt any new technology advances. It has been suggested that some health carriers are hiding behind the guise of 'investigational' to avoid reimbursement [HIGGINS SL, PERS. COMM.]. Healthcare providers share the blame as there has been little clamor regarding the poor reimbursement for heart rhythm monitors. In the interim, physicians who desire compensation face a challenge due to the complex healthcare system.
Heart rhythm event monitoring is a classic example of the impact of regulations on medical technology in the new healthcare era. Makower et al. surveyed 200 medical technology companies to obtain data on regulation in medical innovation. They found greater satisfaction with regulations in the EU compared with the USA. Paul Yock, Director of the Stanford University Biodesign Program, concluded: "In the USA we now we have a much more conservative approval process, combined with an economic crunch. Unfortunately for innovators, those two factors can come together to take the gas out of innovation".
For cardiac rhythm monitoring with the Zio Patch, a major obstacle to clinical acceptance is inadequate reimbursement by government and private payors. In light of the changes in healthcare reimbursement currently ongoing in the USA, in the author's opinion, it is unlikely this process will change for the better. As previously noted, this area of medicine is uniquely impacted by two factors: clinical need coupled with an interest in limiting medical costs. The intersection of these two principles has resulted in the encouragement of a 'loss leader' approach to heart rhythm monitoring where physicians may absorb the inadequate reimbursement in hopes of recouping their loss with reimbursement for other activities. However, cardiac specialists who previously accepted poor reimbursement for heart rhythm monitoring may no longer do so if invasive procedure reimbursement is further diminished. Dramatic reductions in invasive cardiac electrophysiologic procedure and device implantation reimbursement are currently being implemented in the USA. It is too early to evaluate their implications for event monitor use.