How is it August already? Reg season is flying by! We know that the fiscal year 2025 Inpatient Prospective Payment System (IPPS) final regulation will be released imminently. However, in the meantime, let’s take another bite out of the Calendar Year (CY) 2025 Physician Fee Schedule (PFS) proposed reg, this time focusing on proposals related to telehealth and digital health services. To help me dig into these proposals, I’m bringing in my colleagues Rachel Stauffer and Amy Kelbick.
Back in May, before the CY 2025 PFS proposed reg was issued, Regs & Eggs previewed potential telehealth policies that the reg might include. We stated that the Centers for Medicare & Medicaid Services (CMS) would likely issue telehealth proposals amid an unclear telehealth landscape, since certain Medicare waivers that stakeholders have relied on since the start of the COVID-19 public health emergency (PHE) will expire at the end of the CY without congressional action. Although Congress could possibly extend the waivers before the proposed reg was issued, CMS could not assume any Congressional action until it occurred. In other words, we stated that “if Congress doesn’t act by June or July, CMS must assume in the CY 2025 PFS proposed reg that most telehealth flexibilities won’t exist in 2025.”
Well, Congress has not acted, and CMS did assume in the PFS reg that the waivers will expire. CMS noted that this assumption limited the agency’s ability to advance coverage and reimbursement for telehealth services. Citing several reasons, CMS did not move forward with valuing new current procedural terminology (CPT) codes for telemedicine evaluation and management services and did not move any codes on the Medicare Telehealth Services List from provisional to permanent (although it did add a few new codes to the permanent list that were not previously on the provisional list). In all, CMS seems to have taken a “wait and see” approach and may decide to take more significant action on telehealth once the congressional picture is clearer.
While some could argue that CMS did not take many decisive steps related to advancing telehealth services in the reg, the agency did in fact include several noteworthy proposals:
- Definition of “Interactive Telecommunications System: CMS revised the definition of interactive telecommunications system. The new definition permits the use of audio-only equipment for all telehealth services (not just mental health services) furnished to established patients in their homes if the distant site physician or practitioner is technically capable of using an interactive telecommunications system as defined previously, but the patient is not capable of, or does not consent to, the use of video technology. Although the ability to receive telehealth services from a patient’s home depends on the extension of the “originating site” waiver (which is among those currently set to end this year), CMS is setting the stage for an expansion of the use of audio-only services if the waiver is extended.
- Provider Home Address: CMS proposed to continue to permit a distant site practitioner to use their currently enrolled practice location instead of their home address when providing telehealth services from their home through CY 2025. The agency notes the importance of ensuring provider safety and privacy as well as the shift in practice patterns towards distinct care, making it appropriate to continue this flexibility for another year.
- Supervision Requirements: CMS proposed to continue to allow direct supervision to include virtual presence through audio/video real-time communications technology, as it did during the COVID-19 PHE and for CY 2024. Instead of requiring the supervising physician’s (or other practitioner’s) physical presence, the temporary policy permits a supervising physician (or other practitioner) to be considered “immediately available” through virtual presence using two-way, real-time audio/visual technology for diagnostic tests, incident to services, pulmonary rehabilitation services, and cardiac and intensive cardiac rehabilitation services, as well as certain hospital outpatient services.
CMS also proposed to permanently allow the virtual presence flexibility for certain services valued under the PFS that typically are performed in their entirety by auxiliary personnel. Finally, CMS proposed to extend through December 31, 2025, the CY 2024 policy that allows the teaching physician to have a virtual presence in all teaching settings—but only in clinical instances when the service was furnished virtually (for example, a three-way telehealth visit, with all parties in separate locations). This allows teaching physicians to have a virtual presence during the key portion of the Medicare telehealth service for which payment is sought, through audio/video real-time communications technology, in all residency training locations.
In addition to telehealth policies, CMS proposed to cover digital therapeutics that treat mental and behavioral health conditions under Medicare Part B as “incident to” services. Digital therapeutics are evidence-based software products intended to help manage or treat a particular condition. The therapy can act directly as a medical intervention or guide the delivery of a medical intervention. Most digital therapeutics are not currently covered by Medicare, as there has been a lack of clarity on how to acquire a code using the CPT process. CMS also has not previously made it clear that certain digital therapeutics could be furnished under Medicare Part B as an incident to benefit.
In the CY 2024 proposed reg, CMS sought feedback to better understand how digital therapeutics were utilized and who was utilizing them, as well as scientific and clinical evidence around effectiveness. In the CY 2025 proposed reg, CMS took the feedback into consideration and proposed Medicare payment to billing practitioners for digital therapeutics that:
- Treat mental health conditions;
- Are cleared by the US Food and Drug Administration;
- Are furnished incident to or are integral to professional behavioral health services; and
- Are used in conjunction with ongoing behavioral health care treatment under a behavioral health treatment plan of care.
CMS proposed to establish three new “G” codes that clinicians can bill for the supply of a digital therapeutic and initial education and onboarding, the first 20 minutes of monthly treatment management services directly related to the patient’s therapeutic use of the digital mental health treatment device, and each additional 20 minutes of monthly treatment management services. The creation of the G code for the supply of the digital therapeutic signifies that CMS believes these devices need a separate code apart from what’s currently available for remote therapeutic monitoring devices.
While the upcoming waiver expirations and the uncertainty of future congressional action seemingly acted as a speed bump to CMS’s ability to expand coverage of telehealth services, it was not a stop light that prevented the agency from going forward with any telehealth or digital health policies. Recognizing that healthcare services are no longer solely delivered in the four walls of an office or a healthcare facility, stakeholders and advocates in the telehealth space argue that it will be important for CMS to continue to move the needle in areas where it legally can. While these stakeholders likely will be watching closely to see if Congress extends the waivers before the end of the year, they will also be commenting on the policies in the proposed reg and waiting to see what the agency decides to finalize in the CY 2025 PFS final reg due out in early November.
Until next week, this is Jeffrey (and Rachel and Amy) saying, enjoy reading regs with your eggs.
[View source.]
