Wearable sensors are transforming healthcare practice in ways that could not be imagined even a few decades ago. They make it possible to monitor patients more closely and around the clock. Alerts can be generated if readings stray outside a target range. Data can be shared securely and wirelessly with caregivers and healthcare professionals. And the aggregated data sets provide fertile fields for researchers looking for new insights into diseases and chronic conditions. Our regulatory agencies often run more slowly than these technological advances. This is not necessarily a bad thing, in my personal opinion, as there can be good reason to proceed cautiously.
Eventually, the regulations do catch up with the advances. One case in particular had patients and healthcare professionals scratching their head. In January 2017, the Centers for Medicare and Medicare Services (CMS) approved Medicare coverage for continuous glucose monitors (CGMs). At that time, however, the agency did not approve the use of smartphone apps with these devices. As a result, this convenient method of sharing data with caregivers and doctors was not covered. This led to stakeholders voicing their concerns with CMS. This summer, CMS issued a announcement that included this statement:
After a thorough review of the law and our regulations, CMS is announcing that Medicare’s published coverage policy for CGMs will be modified to support the use of CGMs in conjunction with a smartphone, including the important data sharing function they provide for patients and their families.
The announcement also states that a revised policy article will be published “in the near future” at which point the coverage change will become effective.
We need effective and careful regulation of medical devices and procedures that could harm or kill patients, yet we also need a system that is responsive to the rapidly changing technology landscape in order to gain the full benefit of these advances. The trick is to balance the risk and reward. This is one more reason that manufacturers must make sure that there is adequate and reliable research results that make it clear what those risks and rewards are.