Medical Devices and Remote Therapeutic Monitoring (RTM): What You Need to Know

There’s been a lot of excitement about Remote Therapeutic Monitoring (RTM) codes recently, rightfully so, but there’s also been a bit of confusion.  The 2022 MPFS Final Rule approved five new general medicine codes (see below) for use by physical and occupational therapists and speech language pathologists in the RTM group.

The rule also permits physical and occupational therapy assistants, under the direct supervision of a therapist, to furnish RTM services. The codes allow for monitoring of health conditions, including musculoskeletal system status, respiratory system status, therapy (medication) adherence, and therapy (medication) response, and allows for non-physiologic data to be collected remotely.  Further, these codes are effective 1/1/2022 and will be classified as “sometimes therapy” codes.

BUT.  Yes, there’s a “but.”  The catch is that remote monitoring requires the use of a medical device as defined by the FDA (i.e., not merely a wellness device). So how does the FDA define a medical device?

The FDA is responsible for regulating medical devices in the United States and defines a medical device as “an instrument, apparatus, implement, machine, contrivance…or other similar or related article, including a component part, or accessory which is…intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease [or] injury, in man.”¹  

Medical devices can include “mobile apps [that] meet the definition of a medical device”² and referred to by the FDA as “software as a medical device.” In order for software to be a medical device it must be “intended for use in performing a medical device function (i.e., for diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease).³

As you may agree, the FDA’s definition of a medical device is quite broad and could encompass any number of technologies – including standalone software applications or integrated software applications.

The flexibility in the FDA’s definition potentially opens up a number of opportunities for therapists to use the new general medicine codes.  That said, the fact that there is no fast and fine definition of medical device leaves room for interpretation as to what constitutes a medical device.  

Before billing these codes, it will be up to individual clinicians, organizations, and vendors to assess whether the technologies they use do indeed meet the FDA’s definition of “medical device” and to respond accordingly.

Appendix

The 5 new RTM codes:

98980-98981 – Remote Therapeutic Monitoring Treatment Management Services

Remote therapeutic monitoring treatment management services are provided when a physician or other qualified health care professional uses the results of remote therapeutic monitoring to manage a patient under a specific treatment plan. To report remote therapeutic monitoring, the service must be ordered by a physician or other qualified health care professional. To report 98980, 98981, any device used must be a medical device as defined by the FDA. Do not use 98980, 98981 for time that can be reported using codes for more specific monitoring services.

Codes 98980, 98981 require at least one interactive communication with the patient or caregiver. The interactive communication contributes to the total time, but it does not need to represent the entire cumulative reported time of the treatment management service. For the first completed 20 minutes of physician or other qualified health care professional time in a calendar month report 98980, and report 98981 for each additional completed 20 minutes. Do not report 98980, 98981 for services of less than 20 minutes. Report 98980 once regardless of the number of therapeutic monitoring modalities performed in a given calendar month.

98975-98977 – Remote Therapeutic Monitoring Services

Remote therapeutic monitoring services (e.g., musculoskeletal system status, respiratory system status, therapy adherence, therapy response) represent the review and monitoring of data related to signs, symptoms, and functions of a therapeutic response. These data may represent objective device-generated integrated data or subjective inputs reported by a patient. These data are reflective of therapeutic responses that provide a functionally integrative representation of patient status.

Codes 98975, 98976, 98977 are used to report remote therapeutic monitoring services during a 30-day period. To report 98975, 98976, 98977, the service(s) must be ordered by a physician or other qualified health care professional. Code 98975 may be used to report the set-up and patient education on the use of any device(s) utilized for therapeutic data collection.

Codes 98976, 98977 may be used to report supply of the device for scheduled (e.g., daily) recording(s) and/or programmed alert(s) transmissions. To report 98975, 98976, 98977, the device used must be a medical device as defined by the FDA. Codes 98975, 98976, 98977 are not reported if monitoring is less than 16 days. Code 98975 is reported for each episode of care.

For reporting remote therapeutic monitoring parameters, an episode of care is defined as beginning when the remote therapeutic monitoring service is initiated and ends with attainment of targeted treatment goals.

*Watch for additional information and guidance from the American Medical Association which should be available with the release of the CPT Changes: An Insider’s View 2022.

References:

^{1 & 2} FDA U.S. Drug and Food Administration, “Device Software Functions Including Mobile Medical Applications,” November 5, 2019.

³ FDA U.S. Drug and Food Administration, “Policy for Device Software Functions and Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff,” September 27, 2019.