Understand what the FDA defines as a medical device. Healthcare providers use remote patient monitoring (RPM) to efficiently monitor their patients’ conditions without frequent in-person visits. As innovative and helpful as RPM can be for providers and their patients, several obstacles can hinder your RPM program’s growth. Learn about RPM deployment challenges and how you can ensure the program runs smoothly. Refresh Your RPM Knowledge RPM is a method of using devices to evaluate and manage your patients’ acute and chronic conditions without the need for frequent in-person visits. The RPM devices provide clinicians with regular information about the patient’s condition and can provide feedback to support the patient. “The provider is given meaningful data to understand what’s happening with the patient. We all know the simple example of white coat syndrome, where the patient will come in, their blood pressure might be monitoring normal at home, but you’re seeing that they have elevations when they’re in the office. RPM is a way to have a continuous feedback loop of things that are going on with the patient, that the providers can take action on to help influence the overall health of the patient,” explained Raemarie Jimenez, CPC, CDEO, CIC, CPB, CPMA, CPPM, CPC-I, CANPC, CRHC, chief product officer at AAPC during the “Complexities of Remote Monitoring” session at AAPC’s DOCUCON conference. Currently, healthcare features several examples of RPM, which include: RPM technology offers several benefits for providers and patients. These benefits include: While some patients will require regular in-office testing, diagnostics, or monitoring, other patients — such as those with acute illnesses, pregnancy complications, or chronic conditions — can benefit from RPM. Identify RPM Challenges for Providers RPM is a great method for observing your patient outside of your facility and getting an accurate picture of how their condition affects their day-to-day life. However, RPM is more than handing over a device and telling the patient to turn it on when they get home. Healthcare providers face multiple challenges in finding the right devices, patients following through on the monitoring plan, and staying in compliance. Understand what the vendor provides: Healthcare providers and coders can have trouble acclimating themselves to each vendor’s different type of documentation. “One of the biggest issues that I’ve heard from our members who have implemented some type of remote monitoring program is that every vendor has a different format of reporting,” Jimenez explained. “We’re creatures of habit. We get used to certain templates in our EHRs, a certain way that a provider might document information,” she observed. At the same time, each RPM device is different, and each device records different data. Providers have to sift through the abundant data to find the information they actually need to evaluate the patient and assess the care plan. Patient adherence: Carefully crafting a care plan for your patients is all well and good, but unless they follow through with it, the plan is as good as the paper it’s written on. “Providers can give the best advice, come up with the best possible solution to keep that patient healthy, but if the patient doesn’t want to do it, they’re not going to do it,” Jimenez said. For example, a patient diagnosed with sleep apnea may require a continuous positive airway pressure (CPAP) machine when they sleep. With RPM, the provider can issue the patient a CPAP machine that regularly delivers the patient’s sleep information back to the provider. However, if the patient finds the machine cumbersome and uncomfortable during use and refuses to follow the treatment plan, then their payer could end up refusing to reimburse the provider for the CPAP machine. This would result in the patient losing the RPM device and the provider having to find another treatment avenue. Compliance: As mentioned earlier, implementing RPM with your patients is more than giving them a device and turning it on — you must ensure that device is compliant with industry regulations. For example, wearable RPM devices continuously transmit information back to your healthcare facility. Ensuring the security of the device’s connection to your facility is critical to protecting the patient’s data from cyberthreat actors and data breaches. “Getting your IT department involved to understand what type of integration might be required in order for that device to transmit information back to the electronic health record, so the physician does have access to it in order to evaluate the data is another thing that you want to take into account,” Jimenez said. Overcome RPM Hurdles Even though healthcare providers face challenges in implementing, maintaining, and receiving reimbursement for RPM services, there are ways to ensure your RPM program runs smoothly. One of the main components of a successful RPM program is ensuring you’re using approved devices for use and reimbursement. According to the CPT® guidelines for Remote Physiologic Monitoring Treatment Management Services, “To report remote physiological monitoring, the device used must be a medical device as defined by the FDA, and the service must be ordered by a physician or other qualified health care professional.”
Section 201(h) of the U.S. Food and Drug Administration (FDA) Federal Food, Drug, and Cosmetic Act (FD&C Act) states that “any instrument, machine, contrivance, implant, in vitro reagent that’s intended to treat, cure, prevent, mitigate, diagnose disease in man” is considered a medical device. Most RPM devices in healthcare fall under Class II devices, which require a 510(k) submission to receive FDA clearance for use. Simultaneously, providers should use documentation best practices to ensure all of the necessary information is included in the patient’s record as needed for reimbursement. This documentation can include: The documentation should also include information about the device setup, educating the patient on using the device, how the data is transmitted, how the information is used for treatment, and time spent performing different RPM tasks. This specific information will assist your medical coders and billers identify the correct RPM codes to help ensure accurate reimbursement for your services.