Days before the 2024 presidential election, the Centers for Medicare & Medicaid Services (CMS) released an unpublished version of the final calendar year 2025 physician fee schedule (PFS) final rule.
CMS finalized nearly all of the digital health policies as proposed that it set out in July's draft rule, but they are meager offerings. In the final rule, the agency seemed to decry its limited authority on all areas of digital health payment policy, including digital therapeutics and telehealth.
Congress has not yet extended Medicare telehealth flexibilities, which expire Dec. 31, 2024. Though it's relatively certain the flexibilities will be extended for another two years, the looming telehealth cliff severely limited what policies CMS could extend through 2025.
CMS highlighted its limited authority to address Medicare telehealth coverage. While it made audio-only telehealth permanent, it declined to set other policies in stone, such as which address a telehealth provider should report to CMS and virtual supervision for residents.
CMS added new codes for digital therapeutics for mental healthcare. From the proposed rule, it changed the definition for two of the three digital mental health technology (DMHT) codes to separate them from the existing remote therapeutic monitoring codes off which they are based.
CMS also explained its thinking for an alternative payment methodology for telehealth visits in rural health clinics and federally qualified health centers. It declined to act on the approach this year.
Digital mental health technologies
CMS moved forward with the proposed payment for digital mental health treatment devices, or digital therapeutics, cleared by the FDA for mental or behavioral health treatment.
“A physician or other practitioner who is authorized to diagnose, evaluate, and treat a mental health disorder may prescribe or order a DMHT device as permitted under the device’s FDA clearance,” the final rule says.
FDA regulation currently considers insomnia, substance use disorder, depression and anxiety in this category, but CMS said its payment for DMHTs are not limited to these diagnoses.
CMS modeled the DMHT payments on remote therapeutic monitoring codes. It will offer reimbursement for codes G0552-4, which represent a device supply code and two treatment management codes.
The device supply payment, G0552, will be adjudicated by individual Medicare Administrative Contractors. The four invoices CMS received from interested parties varied widely. CMS said in the final rule that it does not yet have enough evidence to assign a price to the devices.
G0552 requires the payment to be a supply cost the practitioner has incurred. Payment would not be available if the patient supplied their own device.
CMS did establish payment for G0553-4, which represents treatment management services in increments of 20 minutes. Both codes were assigned an RVU of 0.67. For CY2025, practitioners will be paid roughly $21.67, depending on geography, for each instance of billing.
Commenters said the new DMHT codes conflict with the existing RTM codes and could confuse providers. CMS provided a distinction between the technologies: RTM devices may be a treatment and/or monitor patient response to therapy, whereas DHMTs only provide treatment. CMS calls the DMHT codes “more specific” than the RTM codes.
CMS revised the definition of the two codes to amplify that under the treatment management codes, providers review related “information” and not related “data,” which puts the code too close to RTM.
CMS clarified that it will not institute a payment reduction if the patient does not complete their course of treatment, as mental health patients are prone to stop and start treatment.
“We are at a starting point of Medicare payment for DMHT devices as supplies furnished incident to professional behavioral health services used in conjunction with ongoing behavioral health care treatment under a behavioral health treatment plan of care and anticipate that this will be an iterative process,” the rule says.
Though CMS seems to have made strides forward on reimbursing digital therapeutics through its new DMHT coding structure, it clearly stated the need for Congress to create a new benefit category for all other DTx.
Telehealth
CMS called out the need for Congress to act to extend the majority of key Medicare telehealth waivers that have expanded the services since 2020.
"The final rule reflects CMS’ goal to preserve some important, but limited, flexibilities in our authority, and expand the scope of and access to telehealth services where appropriate," a fact sheet said.
CMS pigeonholed some telehealth proposals that will need to be addressed in future rulemaking. CMS finalized a one-year extension that shields providers' home addresses from publicly accessible Medicare websites. It will also allow the virtual supervision of residents in 2025, but another extension would need to be granted for 2026. CMS will also have to address outstanding instances of virtual direct supervision.
It made permanent coverage of audio-only telehealth visits. It also will permanently allow direct supervision via telehealth in certain cases, like with established patients, and allow access to pre-exposure prophylaxis (PrEP) for HIV prevention via telehealth.
CMS said Congress needs to address the geographic and originating site restrictions, which under pre-pandemic law requires Medicare beneficiaries to be located in a rural area to receive telehealth services and requires them to conduct the visit from an approved site, like a rural health clinic. The patient would not be allowed to do the visit from home.
The geographic restriction would largely prevent older Americans who live in suburban and urban parts of the country from accessing telehealth through Medicare. There are some exceptions to the restrictions.
CMS needs additional authority from Congress to continue to allow some provider types, like physical therapists, occupational therapists and speech language pathologists, to provide telehealth services to Medicare beneficiaries.
Many commenters on the draft fee schedule rule asked for specific codes on the provisional services list to be moved to the permanent Medicare telehealth services list. CMS said it would not review individual codes on the provisional list until it can conduct a full review.
“We are not making determinations on whether to recategorize provisional codes as permanent until such time as CMS can complete a comprehensive analysis of all such provisional codes which we expect to address in future rulemaking,” CMS wrote.
For CY2025, the only codes that joined the permanent telehealth services list were for PrEP and audio-only services.
Rural health clinics and federally qualified health centers
Since the beginning of the pandemic, Congress and CMS have tried to expand the ability for rural health clinics and federally qualified health centers to conduct telehealth visits and be paid for them.
The CY2022 PFS granted payment parity to RHCs and FQHCs when they furnish telemental health services. Usually, an in-person visit would be required within six months of the telemental health visit, but Congress waived the requirement through the end of 2024.
Non-mental health services are paid at a special rate established by the CARES Act, which pays less for telehealth than in-person services. The billable code, G2025, was worth $96.87 in 2024, according to the National Association of Rural Health Clinics.
In CY2025, CMS decided to keep its telehealth payment methodology for non-behavioral health visits furnished in RHCs and FQHCs. The code, G2025, is a weighted average of all PFS telehealth claims.
CMS said it considered a payment alternative for RHCs and FQHCs that would have given all telehealth visits the same status as telemental health visits. This way, telehealth could be paid for like in-person visits, through the RHC all-inclusive rate or FQHC prospective payment system.
However, CMS determined that changing the payment methodology could result in significantly higher payment than telehealth providers receive in other settings. The PFS says CMS will continue with its previous payment methodology for another year, though it signaled it may be open to reform.
“We continue to monitor and analyze information made available to us in order to develop, propose, and finalize more permanent policy in future rulemaking, particularly given the potential for congressional action.”
CMS will continue to allow direct supervision requirements to be fulfilled through telehealth, excluding audio-only, through Dec. 31, 2025.
Opioid treatment programs
CMS will allow opioid treatment programs to use telehealth for periodic assessments of patients on methadone, buprenorphine and naltrexone permanently.
CMS cited evidence that audio-only telehealth services are used most by the oldest Medicare beneficiaries—making up nearly half of all visits—and by lower resourced groups.
“Evidence further reveals that Medicare beneficiaries who are older than 65 years old, racial/ethnic minorities, dual-enrollees in Medicare and Medicaid, or living in rural areas, or who experience low broadband access, low-income, and/or for whom English in not their primary language, are more likely to be offered and use audio-only telemedicine services than audio-video services,” the final rule says.
It also notes that tribal populations have the highest instance of opioid use disorder of any population, and a third of the population relies on audio-only services.
CMS will allow patients to be inducted onto buprenorphine through audio-visual and audio-only telehealth. It is not extending the audio-only induction to methadone, which SAMHSA has said carries more risk.
Patients can be inducted into opioid treatment programs for methadone treatment through an audio-only visit if they are seen in person by another DEA-registered provider.