CMS Proposed Changes for 2021: Are You Ready?

This is a big one! With more pharmacists and other healthcare professionals pursuing RPM services during COVID-19, there has been a lot of buzz on the rules and requirements of RPM. CMS acknowledged the ambiguity surrounding RPM services and clarified many areas of question as part of the proposed changes for 2021. Keep in mind that not all of these clarifications are being positively accepted by many currently offering RPM services. For those who are not familiar with Remote Physiologic Monitoring (RPM), commonly referred to as remote patient monitoring, it involves the collection and analysis of digitally collected physiologic data that is used to develop and guide treatment plans. CMS clarified that RPM services are appropriate for both chronic and acute illnesses or conditions. 

In the proposed changes, CMS noted that 99453 for the initial set-up and patient education on use of equipment is intended to be billed once per episode of care. They defined an episode of care as “beginning when the remote physiologic monitoring service is initiated and ends with attainment of targeted treatment goals.” This code covers the time dedicated to educating a patient on the use of one or more medical devices. From this definition, it may be assumed that the code may be billed more than once if a patient must be initiated on a new device when a new treatment need is identified. Further clarification may be needed from the final rule as many had interpreted that this code was billable only once. CMS also clarified that since the CPT code descriptors do not specify that clinical staff must be the ones furnishing CPT codes 99453 and 99454, they can be completed by auxiliary personnel who are not considered to be clinical staff. As another update, policies now allow patient consent for RPM to be obtained at the time services are furnished and they even stated that consent can be obtained by individuals performing RPM services under contract with the billing physician or other practitioner. During the PHE of COVID-19, RPM services can be offered to both new and established patients of a practice but at the end of the PHE, patients must be established to be eligible for the service. 

One of the areas of question for RPM was relevant to the device code, CPT code 99454. The CPT prefatory language states that monitoring must occur for at least 16 days of a 30-day period for CPT codes 99454 and 99453 to be billed. Many questioned whether this was a requirement or guidance of best practices but CMS aligns with the CPT language and is requiring that there must be 16 days of readings within a 30-day period. To confirm, this is 16 days and not 16 transmissions, meaning that multiple readings within one day will not change the requirement. This being said, for the duration of the public health emergency for COVID-19, a minimum of 2 days of data collection are required over a 30-day period, rather than the 16 days. 

Many have questioned whether RPM devices must be FDA cleared as medical devices prior to use for RPM services. Per the CPT language, it is specified that devices used for RPM services must meet the FDA definition of a medical device. They also stated that they found no language requiring that these medical devices be cleared by the FDA. Devices used for RPM must have the capabilities to upload physiologic data and this requirement is not met by patient self-recorded or self-reported data. The device must digitally collect and transmit the patient’s physiologic data and must also be reasonable and necessary for the diagnosis of the patient. This information should be used to guide the development and management of the treatment plan.