Population aging and medical devices: regulatory trends

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A pressing need over the coming decades will be to ensure that the elderly, who increasingly constitute a significant percentage of the population, can function independently and maintain an acceptable quality of life. Addressing the unmet care and support needs of the aging population and designing services and solutions centered around their needs is therefore becoming an urgent public health priority.

Below are the key regulatory trends impacting the topic of population aging, as identified by GlobalData.

Home Use Authorization

The United States Food and Drug Administration (FDA) has changed some of its enforcement policies so that home care devices such as physiological monitors, oximeters, spirometers, apnea monitors, electrocardiograms ( ECG) and others, which were previously licensed or approved for marketing to hospitals – may be marketed for home use without additional submissions.

The relaxed regulations also allow for hardware and software modifications to be made to existing licensed devices to increase the ability of those devices to be used for remote patient monitoring (RPM) without seeking additional approval. The FDA has said these relaxed regulations will only remain in effect during the Covid-19 pandemic, but the US administration and regulators are calling for some of these changes to be made permanent.

RPM refund

Until recently, it was difficult for healthcare providers to bill and receive reimbursement for RPM technologies and telehealth. Existing Current Procedural Terminology (CPT) codes, which are reimbursement codes used by the Centers for Medicare and Medicaid Services (CMS) for US federal healthcare delivery programs, were limited to RPM technologies and telehealth before 2018. Since then, an older CPT code (99091) and four newer CPT codes (99453, 99454, 99457, and 99458) now allow reimbursement for services that include training a patient on the setup and use of RPM technologies, reviewing remotely collected RPM data, and consulting with patients regarding their RPM data.

These changes strongly suggest that regulators anticipated that RPM technologies and telehealth would become an increasingly part of healthcare delivery prior to the Covid-19 pandemic. As hospitals and healthcare providers seek ways to manage a rapidly aging population with complex chronic healthcare needs, the evolution of RPM reimbursement presents a unique opportunity for the elderly care market.

This is an edited excerpt from Population aging and medical devices – Thematic research report produced by GlobalData Thematic Research.

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