Longyear Health

 

Remote-Patient Monitoring Policy Overview

In the 2018/2019 Medicare Physician Fee Schedule (PFS), the Centers for Medicare and Medicaid Services (CMS) finalized a rule to allow for reimbursement for remote-physiological monitoring, also known as remote patient monitoring (RPM). RPM involves the transmission of patient-level data from the patient, in a variety of settings but primarily the home, to a healthcare provider or care team. For the 2021 PFS, the new rule finalizes many of the proposals from the prior year’s comment period. Importantly, taking a historical view of RPM reimbursement, this particular rule change has led to a wide range of innovations in care delivery through the funding mechanism of RPM. The most impactful changes were changes to the general supervision requirement and the incident to billing provisions. 

It is important to note that the RPM codes released by Medicare are broad enough to allow for a wide range of new, technologically-enhanced clinical models to be implemented. Not all RPM clinical programs are the same, so this guide provides an overview of the basic CMS requirements: 

RPM Overview

RPM involves the transmission and clinical analysis of patient physiologic data in order to promote proactive, real-time patient care plan management. RPM supports the widely accepted goal of moving from a reactive care delivery system to a proactive one. From a Medicare billing perspective, the five primary Medicare RPM codes are CPT codes 99453, 99454, 99457, and 99458, and 99091. 

99453 describes 15 minutes for patient education and set-up on a connected device. 99454 is billed when patients transmit data for a minimum of 16 days each 30 days. 99457 and 99458 are utilized for 20-minute intervals of care plan management based on the RPM data collected. 99091 provides a separate code for billing time spent only by a qualified healthcare professional (QHP). These services, as of 2021 can be billed via clinical staff under the general supervision of a qualified healthcare professional, typically a physician or a mid-level healthcare provider. 

Appropriate Patient Qualifiers and Diagnoses

Originally, in 2019, CMS framed the RPM services as those to be rendered to patients with chronic conditions. However, CMS clarified, in 2021, that practitioners may furnish RPM services to remotely collect and utilize physiological data from patients with acute conditions, as well. Thus, RPM services can enable a wide range of clinical models at various points across the care continuum. Models such as using RPM to provide better longitudinal care for patients with hypertension or diabetes, the use of RPM to prevent readmissions in congestive heart failure patients post-discharge, and the use of RPM for post-operative care have been studied and implemented based on these clarifications. RPM, in some instances, can be viewed as the use of technology to bridge the gaps of care along the patient care continuum. 

Which practitioners are able to order RPM services? 

RPM codes are considered evaluation and management (E/M) services and so they must be ordered, or prescribed, to patients by practitioners who are eligible to bill Medicare E/M services. Typically, these are clinicians such as physicians and nurse practitioners. CMS has been petitioned to allow additional providers to bill for RPM services, however, the same rules continue to apply as of the 2022 PFS. However, in the 2022 PFS, CMS has adopted reimbursement for a new set of CPT codes called remote-therapeutic monitoring (RTM) that are specifically designed to broaden the types of clinicians that can render technologically-enhanced virtual care services in a manner similar to RPM. Specifically, RTM allows for clinicians to track metrics such as medication adherence, treatment plan adherence, respiratory status, pain, and other clinically-relevant metrics. A key distinction between RPM, in addition to the broadened set of clinicians eligible to bill, is that patient self-reported metrics are acceptable. 

Operationalizing the Codes into a Clinical Model 

It is important to think about how evidence-based clinical models and interventions can fit into the RPM codes rather than simply following the minimum requirements to bill. Data collected for the sake of collecting data rather than to sustainably improve care is a clinically-useless and wasteful practice. RPM codes, like any other Medicare service, require the services to be medically necessary and appropriate for the patients to which they are rendered. The five RPM codes allow for a good range of flexibility for healthcare organizations to launch a program, but careful attention should be paid to the clinical interventions to be delivered as part of an RPM program. For example, what is done with the data once collected? Who will deliver the results? 

CPT code 99091 can only be rendered by a physician or other QHP, whereas CPT codes 99457 and 99458 can be furnished by a QHP, or by clinical staff under the general supervision of the physician. This is important to note as, operationally, it is more likely that clinical staff will be available to furnish RPM services due to common physician time constraints.  

A clinical staff member is defined in the AMA CPT Codebook as “a person who works under the supervision of a physician or other qualified healthcare professional and who is allowed by law, regulation, and facility policy to perform or assist in the performance of a specified professional service but does not individually report that professional service.” 

In the 2021 PFS, CMS clarified that auxiliary personnel, in addition to clinical staff, could perform the activities described by CPT codes 99453 and 99454 under the general supervision of the billing QHP. Auxiliary personnel include other individuals who are not clinical staff but are employees, or contracted employees

Consent to RPM can be obtained at the time RPM services are furnished. The consent can be obtained by individuals under contract with the billing physician or qualified healthcare professional. It is important for patients to be aware they are participating. From a programmatic perspective, RPM services are a new concept for patients, thus a clear communications plan should be established to promote trust and transparency.

Devices and Device Management 

According to CMS, the device provided for RPM must meet the FDA’s definition of a medical device as described in section 201(h) of the Federal, Food, Drug, and Cosmetic Act. CMS has stated that there is no language in the CPT Codebook indicating the RPM device must be FDA-cleared/registered, but under the FDA’s purview clearance may be appropriate, or, even, required depending on the device. CMS has also not suggested that the RPM device must be officially “prescribable” by a physician–though some devices may require a prescription to be offered to a patient. There are many types and forms of devices on the market with varying degrees of accuracy and precision. It is important to utilize devices with appropriate clinical validation to ensure the sanctity of the RPM data-set and the trust of patients. 

It is important to note that RPM devices must automatically transmit data from patients. Said differently, patient self-report is not acceptable. Typically, devices transmit data via a Bluetooth connection to a smartphone or via cellular networks (e.g.,4G LTE). RPM technologies that collect patient data via text message are not acceptable, thus, so-called “device-less” RPM companies are not compliant with the current CMS rules. 

It is always important to note that any service provided to a Medicare beneficiary must be reasonable and necessary for the treatment or diagnosis of the patient’s condition. This holds true with RPM services. 

Data Transmission Requirements 

One of the more rigid and challenging components of a RPM program is the “16-day” requirement to bill CPT code 99454. According to CMS, the monitoring must occur on 16 days of a 30-day period in order for CPT codes 99453 and 99454 to be billed.  CMS stated these two codes are not to be reported for a patient more than once during a 30-day period. 

CPT 99453 can be billed only once per RPM monitoring episode where an episode of care is defined as, according to CMS, “beginning when the remote physiologic monitoring service is initiated and ends with attainment of targeted treatment goals.”

For the 2021 PFS, CMS added some further clarity around the data transmission component. CMS noted that while multiple devices may be supplied to a patient RPM codes may only be billed for one device and by a single healthcare provider for a single patient. Thus, according to this rule, if a patient has a cardiologist and a primary care physician, only one of those practitioners may bill for RPM. This is a potential issue administratively and begs the question: how do fragmented providers know of other programs and who has priority? These rules are still somewhat unclear, so future PFS rulemaking should clarify. 

What should happen during clinical time under a RPM care model? 

As a part of the 2021 PFS RPM updates, CMS clarified an important question posed by RPM programs related to the ratio of time that must be spent speaking with the patient versus reviewing RPM data. Until recent years, healthcare services, and reimbursement, was centered around in-person encounters. With RPM, the idea that patients may not be physically in the same place as the care team presents a unique set of questions for CMS around billing requirements. Thus, CMS clarified, in 2021, that the 20-minutes of clinical work time associated with CPT codes 99457 and 99458 includes a clinician’s time engaged in “interactive communication” with the patient/caregiver as well as time spent on other care management activities. 

Importantly, CMS has made it very clear that “interactive communication” for purposes of CPT codes 99457 and 99458 requires, at a minimum, a real-time synchronous, two-way audio interaction. This can also include a video component, but regardless of medium, the clinical time must have some degree of interactive communication. 

As a part of the 2021 PFS rulemaking process, CMS has provided a Fact Sheet on December 1, 2020, that again supports that the entire 20-minute time period need not be interactive, but may also include time performing other care management activities. 

It is important to note that interactions with patients resulting from data transmitted during a RPM program can lead down many different clinical pathways and interventions. In some circumstances, it may be appropriate for medication changes, in others it may be an opportunity to coach patients on diet and exercise. It is important that the RPM services feed into clear care management or care plan alterations based on the data. 

While RPM is often viewed as monitoring a single metric for a single condition, we know that patients in the Medicare population are often far more complex, clinically. Thus, while a patient may be in a hypertension management RPM program, their congestive heart failure may progress during an RPM monitoring event and thus clinical teams must have the latitude to manage care associated with that particular condition. Often, this is why RPM advocates and CMS have suggested that RPM services are complimentary with complex care management services (CCM). Looking at the codes alone, RPM seems fairly straightforward, but in practice, the clinical complexities associated with patient care benefit from the broad designations of the code set. 

What are 99453 and 99454? 

When first launched, CMS described the RPM clinical and billing operations as beginning with the two practice expense-only codes (99453 and 99454). The rate attributed to these codes is estimated to cover clinical staff time, supplies, and the medical device used for the transmission of the RPM data, itself. The CPT code 99453, and it’s the corresponding rate, is designed to cover clinical staff time for educating a patient and/or caregiver about using the RPM device system. The CPT code 99454, and it’s rate, is built to include the medical device supplied to the patient and the monthly transmission of data. CMS has outlined these two codes as expense codes that cover devices designated as equipment. These codes can be billed for time spent by clinical 

How do 99091 and 99457 and 99548 work together? 

For the 2021 PFS, CMS made clear its position that codes 99091 and 99457 could be billed concurrently during the same time period, provided the same time spent is not considered the same between the two codes. Thus 20 minutes must be spent on 99457 in addition to 20 minutes spent on 99091. 

Conclusion

RPM reimbursement from Medicare is an important step forward to modernizing the ways in which healthcare service organizations manage patients. The use of digital technologies in healthcare is expected to increase significantly, indeed, it already has from 2010 to 2021. For decades, researchers and healthcare leaders in policy, medicine, and public health have been advocating for improved models of chronic disease care as 75% of healthcare expenditures are attributable to preventable and/or manageable chronic conditions like congestive heart failure, diabetes, hypertension, hyperlipidemia, and COPD. RPM was adopted by CMS as a strategy to encourage clinical models that improve longitudinal, proactive care for patients with these conditions. Since broadening RPM to include acute conditions, CMS has opened the door to more advanced models of data-driven care for patients across the care continuum and spanning a wide range of conditions and indications.