A pressing need in upcoming decades will be ensuring that older adults, 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 ageing population and designing services and solutions centered around what they require is therefore becoming an urgent public health priority.

Listed below are the key regulatory trends impacting the ageing population theme, as identified by GlobalData.

Authorisation for home use

The US 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 (ECGs,) and others—which were previously cleared or approved for marketing to hospitals—can be marketed for home use without additional submissions.

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

RPM reimbursement

Until recently, it was challenging for healthcare providers to charge 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 the US federal healthcare delivery programmes, 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 for the reimbursement of services that include training a patient how to set up and use RPM technologies, reviewing remotely collected RPM data, and consulting patients regarding their RPM data.

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

This is an edited extract from the Aging Population and Medical Devices – Thematic Research report produced by GlobalData Thematic Research.