The federal government has clarified the way it regulates remote patient monitoring and the changes could significantly impact and potentially restrict the usage of telehealth and mHealth by care providers while they take care of patients at home.

These changes come from the Centers for Medicare & Medicaid Services, and were part of CMS’ proposed, ‘2021 Physician Fee Schedule’, which was released on August 3.

These proposed changes could alter the connected health platform whose popularity has increased among care providers who are wanting to push care out of the hospital, clinic or doctor’s office into the home, where they can monitor a patient’s care on a continuous basis and make care management changes on the basis of real-time information collected from the patient.

Thomas (TJ) Ferrante, senior counsel at the Foley & Lardner law firm and a member of its Telemedicine & Digital Health Industry Team, believes that the changes clear the queries on how CMS will regulate and reimburse for RPM defined as Evaluation and Management (E/M) services focusing on the collection and analysis of patient physiologic data.

This data is most often collected in a home setting to create a care management plan related to a chronic or acute health condition.

CMS has created new codes for RPM services in 2019 and 2020. It has tweaked its guidelines for services delivered under general supervision for incident-to billing.

CMS has made three vital changes, each of which would be imposing more restrictions or burdens on RPM in an important manner. The Medicare codes are CPT codes 99091, 99453, 99454, 99457 and 99458.

Ferrante along with colleagues Nathaniel Lacktman and Emily Wein, mentioned on Health Care Law Today blog that CMS had expanded RPM coverage for new and established patients during the COVID-19 public emergency.

This rule during the public emergency was meant to give providers more leeway to treat patients, especially those infected by the virus with virtual care channels in order to contain the virus and avoid infecting the care team.

But this is set to change when the emergency will end and CMS reverts to RPM coverage only for established patients. According to Ferrante, CMS hasn’t made a clarification on whether providers can use telehealth specifically for a real-time audio-visual telemedicine platform- to onboard new patients into RPM program.

CMS has mentioned that the “interactive communication” requirement in CPT code 99457 will encompass not only gathering, analyzing and using the data, but also spending at least 20 minutes on a video platform or the phone along with the patient.

A lot of providers have assumed that the 20 minutes cover both data gathering and conversation.

CMS has also clarified that providers can just bill once under CPT codes 99453 and 99454 per patient in a 30-day period irrespective of how many devices a patient uses.

This will restrict providers from looking to gather data from multiple devices, such as a blood-glucose monitor, weight scale, and blood pressure.

CMS, in its proposed rule mentions that RPM services can be used for patients facing chronic conditions, but also with acute conditions. This doesn’t include diagnostic tests.

CMS noted that auxiliary personnel, in addition to clinical staff, can extend RPM services as mentioned by CPT codes 99453 and 99454 as long as they are under the general supervision of a billing physician or practitioner.

CMS is inviting public comments on these proposed changes through the end of September.