On July 10, 2024, the Centers for Medicare & Medicaid Services (CMS) issued its proposed rule for the Medicare Physician Fee Schedule (MPFS) for calendar year (CY) 2025 (Proposed Rule). The MPFS sets physician reimbursement for services provided to Medicare beneficiaries and updates policies related to the delivery of health care to beneficiaries. Although the MPFS applies only to Medicare-covered services, State programs and private payers often rely on the MPFS to inform coverage policies and payment schedules.

The Proposed Rule includes a wide range of updates to payment rates and value-based care programs, as well as initiatives aimed at strengthening primary care and expanding access to behavioral health, among other changes. It also includes several updates relating to coverage for telehealth services and digital health technologies. The following summary highlights these updates, which include the following:

• Coverage of Telehealth Services Using Audio-Only Communication Technology

• Direct Supervision via Two-way Audio-Video Communications Technology

• Telehealth Flexibilities for Opioid Use Disorder Treatment Services

• Payment for Digital Mental Health Treatment Devices

• Addition of Services to the Telehealth Services List

• Teaching Physician Virtual Presence for Services Involving Residents

• Flexibility for Distant Site Practitioner Billing Location

• Telehealth Flexibilities for Federally Qualified Health Centers and Rural Health Clinics

 Although the Proposed Rule is still subject to public review and comment before release of the MPFS final rule later this year, it signals CMS’s current outlook on the evolving role of telehealth in providing access to care for Medicare beneficiaries, especially those in rural and underserved areas.

 Coverage of Telehealth Services Using Audio-Only Communication Technology

During the public health emergency (PHE), CMS allowed the use of audio-only communications technology to provide telephone evaluation and management services and behavioral health counseling and educational services to Medicare beneficiaries. In the Proposed Rule, CMS is proposing to revise the regulatory definition of “interactive telecommunications system,” beginning January 1, 2025, to include two-way, real-time audio-only communication technology for any telehealth service furnished to a beneficiary in their home if the distant site practitioner is technically capable of using an interactive telecommunications system, but the patient is not capable of, or does not consent to, the use of video technology. This change would allow flexibility for instances where patients’ homes may have limited or variable broadband access or patients simply do not want to engage with a practitioner in their home using interactive video. CMS emphasized that practitioners must use their clinical judgment as to whether audio-only technology would be appropriate in each particular instance.

 Direct Supervision via Two-Way Audio-Video Communications Technology

CMS is proposing to continue allowing direct supervision of clinical personnel to be provided virtually through real-time audio-visual telecommunications. Under Medicare requirements, certain services must be provided under the “direct supervision” of a physician or other practitioner. Direct supervision is defined to require the physician or other supervising practitioner to be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the service. (42 CFR § 410.32(b)(3)(ii)).

During the PHE, CMS revised the definition of direct supervision to provide that the presence of the physician or other supervising practitioner can be achieved virtually using audio-video real-time communications technology (excluding audio-only). CMS extended this policy through December 31, 2024, and is now proposing to continue the extension through the end of CY 2025. CMS acknowledged that reverting to the pre-PHE definition may present a barrier to accessing certain services, including incident-to services, and providers would need to alter their practices to once again require the physical presence of the supervising practitioner. CMS declined to permanently extend this flexibility for all services and emphasized the need to seek additional information regarding potential patient safety and quality of care concerns.  

CMS is, however, proposing to permanently allow virtual direct supervision for a subset of incident-to services that CMS believes present less of a patient safety concern than other services that may require immediate intervention of the supervising practitioner. These include the following:

• Services furnished incident to a physician or other practitioner’s service when provided by auxiliary personnel employed by the billing practitioner and working under their direct supervision, and for which the underlying HCPCS code has been assigned a PC/TC indicator of “5”; and

• Services described by CPT code 99211 (Office or other outpatient visit for the evaluation and management of an established patient that may not require the presence of a physician or other qualified health care professional).

 Telehealth Flexibilities for Opioid Use Disorder (OUD) Treatment Services

CMS is also proposing telehealth changes relating to OUD treatment services that are intended to reduce treatment barriers and align telehealth flexibilities with SAMHSA and DEA requirements. Beginning January 1, 2025, CMS is proposing to permanently allow opioid treatment programs (OTPs) to furnish periodic assessments to OUD patients via audio-only telecommunications when two-way audio-video communications technology is not available. CMS is also proposing to permit the initial intake for OUD patients who will receive methadone treatment to occur via two-way audio-visual telecommunication if the OTP determines that an adequate patient evaluation can be accomplished via an audio-visual telehealth platform. Use of such technology must be permitted by SAMHSA and DEA requirements at the time the services are furnished and must meet all other applicable requirements. CMS indicated that these flexibilities are intended to promote health equity, especially for beneficiaries from underserved populations.

 Payment for Digital Mental Health Treatment Devices

The Proposed Rule includes extensive updates aimed at supporting access to behavioral health services. One such proposal is Medicare payment for digital mental health treatment (DMHT) devices that are furnished incident to or integral to professional behavioral health services. The Proposed Rule defines DMHT devices as “software devices cleared by the Food and Drug Administration (FDA) that are intended to treat or alleviate a mental health condition, in conjunction with ongoing behavioral health care treatment under a behavioral health treatment plan of care, by generating and delivering a mental health treatment intervention that has a demonstrable positive therapeutic impact on a patient’s health.”  

CMS is proposing three new HCPCS codes for DMHT devices, which address (1) supply of the DMHT device and initial education and onboarding, (2) the first 20 minutes of treatment management services related to the device, reviewing device data and other patient inputs each month, and (3) each additional 20 minutes of data review. All three codes require that the device be used to “augment a behavioral therapy plan.” In addition, the billing practitioner must diagnose the patient and prescribe or order the DMHT device and provide it incident to the practitioner’s professional services in association with ongoing treatment under the plan of care.

CMS underscored that DMHT devices include only a small subset of digital health products and the proposed policy does not extend to digital platforms and apps marketed as behavioral health and wellness interventions that are not cleared by FDA. To receive payment, the billing practitioner must incur the cost of furnishing the device to the beneficiary. In other words, payment would not be available if the billing practitioner incurs no cost in acquiring and furnishing the DMHT device, or a patient obtains the DMHT device independent of the practitioner.

Addition of Services to the Telehealth Services List

CMS is proposing to add certain services to the Medicare Telehealth Services List on a provisional basis, including caregiver training services and home International Normalized Ratio monitoring. CMS assigns a service “provisional” status if “there is not enough evidence to demonstrate that the service is of clinical benefit, but there is enough evidence to suggest that further study may demonstrate such benefit.” CMS is also proposing to permanently add to the Telehealth Services List individual counseling for preexposure prophylaxis (PrEP) to prevent HIV, which would allow providers to offer PrEP services via telehealth to Medicare beneficiaries.

CMS also denied requests to add various services to the Telehealth Services List for CY 2025, including continuous glucose monitoring services, cardiovascular and pulmonary rehabilitation, health and well-being coaching, and therapy, audiology, and speech language pathology services.

Teaching Physician Virtual Presence for Services Involving Residents

CMS is proposing to extend through December 31, 2025 its current policy allowing teaching physicians to be present virtually for billing purposes for key or critical portions of services furnished involving residents. This policy applies only in instances when the service is furnished virtually (e.g., 3-way telehealth visit with the patient, resident and teaching physician all in separate locations).

 Flexibility for Distant Site Practitioner Billing Location

CMS is proposing to allow distant site practitioners to continue to bill from their currently enrolled practice location instead of using their home address when providing telehealth services from their home. This PHE flexibility was set to expire at the end of CY 2024. However, CMS received extensive comments urging CMS to extend it due to potential threats to the safety and privacy of telehealth practitioners who work from home, as well as the administrative burdens associated with having to change billing practices and add home addresses to the Medicare enrollment file. Acknowledging the shift in practice patterns toward increased use of a practitioner’s home as a distant site, CMS has proposed to continue this policy while considering proposals to protect the safety and privacy of practitioners.

Telehealth Flexibilities for Federally Qualified Health Centers and Rural Health Clinics

CMS is proposing to expand and continue certain telehealth-related flexibilities that apply to Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs), acknowledging the critical role these facilities play in delivering care to underserved populations. First, CMS is proposing to allow payment for non-behavioral health visits furnished via telecommunication technology through December 31, 2025. Second, CMS is also proposing to continue to delay until January 1, 2026 the in-person visit requirement for mental health services furnished via telecommunication by RHCs and FQHCs to beneficiaries in their homes.

 Conclusion

The Proposed Rule provides insight into CMS’s current outlook on telehealth and digital health technologies and the advantages and risks these tools can present. Throughout the Proposed Rule, CMS emphasizes the importance of ongoing evaluation and monitoring of telehealth services to ensure quality of care and program integrity. This includes assessing the impact of telehealth expansions on patient outcomes, access to care, and health care costs. Accordingly, although CMS has extended coverage for certain telehealth services beyond the PHE, it continues to stress the importance of taking an incremental approach to expanding telehealth coverage and reimbursement under Medicare.

Health care providers and other stakeholders can review the Proposed Rule and submit comments through September 9, 2024. Comments will be considered by CMS prior to release of the MPFS final rule later this year.

If you have questions about how these proposed changes could impact you or your organization, London Legal Consulting, LLC can assist. Please contact us today.