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The federal government is clarifying how it regulates remote patient monitoring, with changes that could significantly affect – and potentially restrict – how care providers use telehealth and mHealth to care for patients at home.
The changes come from the Centers for Medicare & Medicaid Services, and were part of CMS’ proposed 2021 Physician Fee Schedule, released on August 3. The impact of these changes was somewhat lost in the hubbub surrounding the proposed expansion of telehealth coverage and President Trump’s Executive Order calling for more telehealth in rural areas.
These proposed changes could alter a connected health platform that’s becoming popular with care providers looking to push care out of the hospital, clinic or doctor’s office and into the home, where they can continually monitor a patient’s care and make care management changes based on real-time information collected from the patient.
According to Thomas (TJ) Ferrante, senior counsel at the Foley & Lardner law firm and a member of its Telemedicine & Digital Health Industry Team, the changes clarify how CMS will regulate and reimburse for RPM, which is defined as Evaluation and Management (E/M) services that focus on the collection and analysis of patient physiologic data, most often collected in the home setting, for the purpose of creating a care management plan related to a chronic or acute health condition. CMS created new codes for RPM services in 2019 and 2020 and has tweaked its guidelines for services delivered under general supervision for purposes of incident to billing.
For the upcoming year, Ferrante says CMS has made three significant changes, each of which “would impose more restrictions (or) burdens on RPM in a significant way.” The relevant Medicare codes are CPT codes 99091, 99453, 99454, 99457 and 99458.
Differentiating Between New and Established Patients
According to Ferrante and an August 5 Health Care Law Today blog penned by Ferrante and colleagues Nathaniel Lacktman and Emily Wein, CMS had expanded RPM coverage to both new and established patients during the COVID-19 public health emergency. The emergency rule was designed to give providers more leeway to treat patients – especially those infected by the virus – through virtual care channels, to contain the virus and avoid infecting the care team.
That will change, however, when the emergency ends, and CMS reverts to RPM coverage only for established patients. According to Ferrante, CMS hasn’t clarified whether providers can use telehealth – specifically, a real-time audio-visual telemedicine platform – to onboard new patients into an RPM program.
“The RPM industry should keep watch on this concept to see if CMS clarifies in the final rule that a provider-patient relationship can be established and a patient can be enrolled into an RPM program virtually using telehealth,” he says. “Allowing patients to enroll into RPM programs pursuant to a telehealth visit would open the doors to innovative business models unhampered by an in-person, physical exam pre-requisite to RPM services.”
Identifying the Technology
CMS has clarified that the “interactive communication” requirement in CPT code 99457 includes not only gathering, analyzing and using the data, but also spending at least 20 minutes on a video platform or the phone with the patient. Many providers have assumed that the 20 minutes covers both data gathering and conversation.
“This is the first time CMS provided published guidance on the interactive communication requirement in the context of RPM and is not how most of the industry has, to date, viewed the requirement, is not consistent with clinical need, nor is it consistent with the way the code is valued,” Ferrante says. “We anticipate (and encourage) significant industry stakeholder push back on this in the public comments requesting that 99457 and 99458 can be billed for the time spent during the calendar month both reviewing the data and communicating with the patient about the data, short of an actual patient visit.”
“It may be helpful for the AMA and its Digital Medicine Payment Advisory Group (the group of experts who helped create the RPM codes in the first place) to offer clarification on whether it actually intended the RPM codes to require a practitioner to spend at least 20 minutes per month of time communicating via audio or video with the patient,” Ferrante and his colleagues noted in their blog. “A more reasonable reading of the code descriptor and intent is that the interactive communication with the patient is part of the 20 minute minimum, but the practitioner can also include time spent reviewing and analyzing the patient’s RPM data and determining how to change the care management accordingly.”
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Using Multiple Devices
CMS has clarified that providers can only bill once under CPT codes 99453 and 99454 per patient during a 30-day period no matter how many devices a patient uses. This would hinder providers looking to gather data from different devices, such as a weight scale, blood pressure cuff and blood- glucose monitor.
“For example, a diabetes patient who uses a wireless scale to help with weight monitoring who may also have chronic heart failure and needs a blood pressure monitoring device would only be able to bill the codes once despite having multiple and separate conditions requiring additional devices and setup,” Ferrante points out. “RPM companies likely will advocate in the public comments that CMS clarify that the codes be limited to being billed once per physiological condition but that additional codes can be billed for monitoring of additional physiological conditions, as clinically appropriate.”
Among other clarifications coming from CMS, the agency pointed out in its proposed rule that RPM services can be used for patients not only with chronic conditions, but also with acute conditions. And they don’t include diagnostic tests.
In addition, CMS has noted that auxiliary personnel, in addition to clinical staff, can furnish RPM services described by CPT codes 99453 and 99454 as long as they’re under the general supervision of a billing physician or practitioner.
“Auxiliary personnel include other individuals who are not clinical staff but are employees, or leased or contracted employees,” Ferrante and his colleagues noted in their blog. “As noted in the 2021 Proposed Rule, CMS supported its proposal under the idea that “the CPT code descriptors do not specify that clinical staff must perform RPM services.”
Finally, in its proposed 2021 Physician Fee Schedule, CMS for the first time clarified how and RPM program should be run.
“CMS stated that after analyzing and interpreting a patient’s remotely collected physiologic data, the next step in RPM is the development of a treatment plan informed by the analysis and interpretation of the patient’s data,” Ferrante, Lacktman and Wein wrote in the blog. “At this point, the physician develops a treatment plan with the patient and then manages the plan until the targeted goals of the treatment plan are attained, which signals the end of the episode of care.”
“CPT code 99457 and its add-on code, CPT code 99458, describe the treatment and management services associated with RPM,” they wrote. “This suggests that Codes 99457 and 99458 cannot be billed until after the initial 30 day period of monitoring, as opposed to being billed simultaneously during the same time period. However, CMS does not provide this level of detail, nor does it address whether any of the RPM codes are co-dependent on each other such, for example, whether 99457 or 9458 can be billed even if the requisite elements of 99453 or 99454 are not met, (e.g., if only 15 days of monitoring occurred).”
CMS is soliciting public comment on the proposed changes through the end of September. Ferrante says the changes “should be considered a call-to-action by industry stakeholders to submit comments and influence future policy.”
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