In recent years, the Centers for Medicare & Medicaid Services (“CMS”) has expanded payment for remote monitoring services that improve care coordination for Medicare beneficiaries. On November 2, 2023, CMS released the calendar year 2024 Medicare Physician Fee Schedule final rule (“MPFS Final Rule”), which clarifies certain guidance for remote monitoring services, and discussed a recent request for information regarding digital therapies.

As part of these efforts, CMS has established separate reimbursement for a variety of care management services to recognize and pay for services not appropriately captured by existing codes for in-person patient encounters. Care management services are patient management and support services that are provided by or under the direction of a physician or qualified healthcare professional. Remote monitoring is a type of care management service that uses digital technologies to collect medical and other health data from patients remotely and transmits the information electronically to the patient’s healthcare provider for assessment. Remote monitoring is typically used between in-person visits with a healthcare practitioner, and the data collected is used to formulate, update and manage the patient’s treatment plan.

There are currently two distinct types of remote monitoring services that are reimbursable under the MPFS Final Rule. Remote physiological monitoring (“RPM”) uses medical devices to obtain basic data, such as blood pressure and weight, and transmits it to healthcare providers for review and assessment. Remote therapeutic monitoring (“RTM”) uses non-physiological data to monitor a patient’s health or response to treatment, such as medication compliance, musculoskeletal activity or respiratory activity. Both services use a series of codes that account for initial setup and patient education on the remote monitoring device, transmission of data, and interpretation and analysis of the data by the patient’s healthcare provider.

During the public health emergency (“PHE”) for the COVID-19 pandemic, CMS issued certain waivers and flexibilities that broadened patient access to remote monitoring services.

As discussed in the preamble commentary related to PHE flexibilities for remote monitoring services, CMS did not extend the waivers and flexibilities for remote monitoring services furnished after the conclusion of the PHE on May 11, 2023. In response to questions from interested parties about billing scenarios and appropriate use of codes, CMS reiterated and clarified the following previously established policies related to remote monitoring services:

· RPM services may only be furnished to established patients. However, if patients received initial monitoring services during the PHE, they can be considered established patients for purposes of the patient requirements effective after the end of the PHE. · Monthly remote monitoring services may be reported only once during a 30-day period. · Only one practitioner may bill under RPM or RTM codes during a 30-day period when at least 16 days of data are collected on at least one medical device (as such term is defined by the Federal Food, Drug, and Cosmetic Act). · Practitioners can bill RPM or RTM codes concurrently with other care management services codes as long as time or effort is not counted twice. However, RPM and RTM codes may not be billed together, even if multiple devices are used. CMS also responded to comments on proposed clarifications and feedback related to RPM and RTM services, confirming the following:

· CMS has not specified in prior rulemaking whether RTM services require an established patient relationship (as required with RPM services) but states in the MPFS Final Rule that there does not need to be an established patient relationship for RTM services. However, CMS expects RTM services will be furnished to a patient after an initial interaction between the patient and the provider billing for such services and that RTM services will be furnished consistent with a treatment plan established during that initial interaction. CMS intends to clarify this point in future rulemaking. · Billing practitioners who receive a global service payment for surgery are prohibited from billing for RPM or RTM services furnished during the global period. However, practitioners (such as physical and occupational therapists) are permitted to furnish RPM or RTM services during the global period if the provider did not furnish the global procedure and thus did not receive the global service payment. · Addressing an erroneous statement published in the proposed rule, CMS clarified that the 16-day data collection requirement does not apply to Current Procedural Terminology (CPT®) codes for certain remote monitoring treatment management services, including 99457, 99458, 98980 and 98981, which account for time spent in a calendar month. PUBLIC COMMENTS IN RESPONSE TO CMS’ REQUEST FOR INFORMATION ON DIGITAL THERAPIES

In the MPFS proposed rule, CMS requested information on digital therapies, including digital cognitive behavioral therapy (“CBT”). As previously noted, although CMS has established Medicare payment rates for remote monitoring services, CMS has not established reimbursement for other types of digital therapies. In recent years, the FDA has reviewed and cleared several mobile medical applications that are intended to address specific health conditions and generally require a prescription or referral from a clinician. CMS sought information from stakeholders to better understand how digital technology is used in clinical practice and how that affects coding and payment.

Commenters noted the existing CMS authority to pay for durable medical equipment (“DME”) and services that are furnished “incident to” healthcare professionals’ services. Stakeholders encouraged CMS to use authority under these benefit categories to establish payment for digital therapeutics cleared by the FDA with other prescription medical devices that fall under existing benefit categories. Commenters also encouraged CMS to establish a separate set of G-codes to account for scenarios when digital therapeutic devices are acquired by a Medicare-enrolled practitioner and furnished to a patient.

CMS noted that existing RTM codes include monitoring patient adherence and therapy response for use with CBT and, in 2022, established a contractor-priced CPT code for the supply of a device for CBT monitoring. CMS recognized the new coding proposals on the public agenda for the September 2023 CPT Editorial Panel to allow for reporting of digital CBT, remote therapeutic treatment and other digital therapies as incident to services. Moreover, CMS expressed continued interest in feedback related to this topic, including commentary about any potential codes for review through the existing American Medical Association processes and considerations for future rulemaking that would improve the accuracy of coding and payment under the MPFS. The response did not rule out consideration for G-codes as part of proposals to improve the accuracy of payment. In addition, despite recognition of the value of RPM and RTM services, CMS has reiterated that the COVID-19 PHE flexibilities have not been extended. CMS remains interested in the use of remote monitoring for CBT, and stakeholders should continue to monitor for new developments and provide feedback.

In the MPFS Final Rule, CMS has established reimbursement methods for a variety of patient management and support services which, heretofore, were not appropriately captured by existing codes for in-person patient encounters. These care management services are categorized as RPM and RTM services. Such services are provided by or under the direction of a physician or qualified healthcare professional. This expansion of the use of technology support in the treatment of patients was certainly accelerated by the COVID-19 PHE. At this point, however, CMS was not willing to extend COVID-19 PHE flexibilities. Through the MPFS Final Rule, CMS has demonstrated its continued interest in the expanded use of RPM and RTM services to broaden access to care for Medicare beneficiaries.