Becker's Spine Review

28 Executive Briefing The coflex® Interlaminar Stabilization® device is an FDA-approved treatment for lumbar spinal stenosis backed by Level 1 evidence out to 5 years. The coflex® device meets an unmet clinical need for a broad universe of lumbar spinal stenosis patients. These are patients with leg and back pain caused by moderate to severe stenosis who likely need more than a direct decompression to relieve their symptoms, but who don't have the gross instability that might necessitate the excessiveness of fusion. Patients that receive the coflex® device typically experience immediate relief of their stenosis symptoms while maintaining mobility and flexibility in the treated area. The coflex® Interlaminar Stabilization® device is manufactured by Paradigm Spine, LLC (New York, NY), an innovative global leader in non-fusion spinal implant technology. "In the last five years, to be defined as 'value' or 'proven innova- tion,' not only clinical validity, but economic validity related to those services has been brought to the forefront," Mr. Zeringue explains. Patients, employers, providers and insurers are now looking beyond the clinical superiority and expect the same economic proof as well. "Increasingly, medical innovations are solving for those two variables with sharp specificity and efficiency, and accordingly, there are increasing innovative technologies, with data support- ing favorable healthcare outcomes for patients and employees, and healthcare economics to reduce the financial burden on employers and health providers," explains Mr. El-Naggar. Paradigm Spine's coflex® meets the highest standard of "med- ical innovation" qualifications. The coflex® technology has doc- umented peer-reviewed data demonstrating safety, superior clinical efficacy and durability of outcomes over long-term with the addition of positive economic outcomes. Paradigm Spine has proven the use of coflex® potentially decreasing "the over- all financial burden of lumbar spinal stenosis on our healthcare system," Mr. El-Naggar adds. Self-funded employers seek innovation that helps manage their financial risk while simultaneously satisfying their employees. "The ability to empower or enable an employee to access and receive both clinical and economic proven innovation is key," says Mr. Zeringue. "Adopting innovation to meet both financial and quality outcomes need, allows the employer and employee to receive this degree of satisfaction." Leveraging self-funded plans for medical innovations Patients are increasingly speaking up with opinions and need about their healthcare, in seeking the best medical procedures. Both quality and cost factor into these decisions. Seventy per- cent of patients reported increased engagement with their healthcare during the last two years, according to a 2017 Patient Engagement Perspectives Study. "Today patients/employees are more empowered and informed regarding their own healthcare than they have ever been," adds Mr. El-Naggar. "Patients (employees of self-funded employers) are empowered to influence or change the course of their med- ical care and treatments they receive." The Patient Protection and Affordable Care Act promotes in- creased patient engagement, as it burdened patients with in- creased out-of-pocket expenses. "Medical consumerism, or patients engaging in healthcare deci- sions aligns both the parties paying for healthcare, the employer and patient. Proven medical innovations, is what both employ- ers and patients desire and supports increasing medical con- sumerism," Mr. Zeringue notes. If an employer's medical policy does not support proven innova- tion, there are actions for the patient to take. Employees should document a physician prescribed the innovation, and the inno- vation has been proven for the patient's condition. Examples of "proof" may include FDA approval of an innovation, long-term outcomes published in peer-reviewed journals and society guidelines. Employees should also provide, from their perspec- tive, why they desire approval for the service/innovation. Often patients identify benefits of less invasive service, estimate quick- er recovery and more often, ability to receive care in an ambula- tory surgery center, avoiding the inpatient admission. "Employees have a substantial opportunity that cannot be un- derstated to seek out the medical procedures/innovations they and their medical care providers believe are best for them, re- gardless of the explicitly stated coverage policy of their insur- ance plan," says Mr. El-Naggar. While providers work the authorization appeal process on the payer front, employees should seek approval with their HR de- partments. As HR directors and benefits managers focus on the satisfaction of their employees, healthcare options to include medical innovations are important. Employees active in obtain- ing approval for their care will allow employers to consider and provide access to optimal treatments. "Already this year, we've seen a number of large employers with self-funded healthcare, including Wal-Mart, Albertson's, Boeing and many hospital systems, approve employee requests for co- flex®. These examples of coflex® approval by the employers were made following provider receipt of a prior-authorization denial," adds Mr. El-Naggar. Employers, HR departments and employees all play a role in advancing access to proven medical innovations. "Similar to patients, employers look to clinically and economically proven medical innovation to lower costs and provide high-quality pa- tient outcomes along with increased employee/patient satisfac- tion. The combination of both employer and employee align- ment is what allows for expaned medical innovation access," says Mr. Zeringue. Conclusion As demand for healthcare value continues, providers must de- liver increased quality care and lower costs. Self-funded em- ployers look to and rely upon clinical and economically prov- en services and medical innovations to offer employees where quality is improved and cost may be lowered. Equipped with a better understanding of their care plans, ben- efits and ability to obtain approvals for care, employees will no longer fail to have a role and influence during decisions related to their healthcare. Providers, employers and payers must all align to ensure patient engagement and patient satisfaction is at the top of mind. Via self-funded health plans, employers have the power to seek out and fight for medical innovations that offer patients the best outcomes. Medical innovation — supported by clinical and eco- nomic validity — will help all stakeholders satisfy the patient. n

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