Issue 229: Welcome back to E&O: SaMD, a paying subscribers-only weekly newsletter focused on the world of digital pharma products, prescription digital therapeutics and other FDA-regulated digital health.
E&O: Software as a Medical Device
Busy week trying to piece together what was going on in the proposed Physician Fee Schedule for 2025, so I’ll be back with more news blurbs next week. Onto the billing codes news below… Was this forwarded to you? Increasingly, E&O is a covered benefit from many forward-looking digital health-focused employers. Why not yours? Consider a Business or Enterprise subscription today. Click this link to become a paying subscriber (there are personal plans available too).
CMS proposes new G codes for mental health-related prescription digital therapeutics. Did CMS miss the revision to RTM codes last year?
If you have been toiling away in market access for a prescription digital therapeutics company for the past few years, it’s hard not to be excited by the news that CMS proposed three new HCPCS codes focused on FDA-cleared, prescription digital therapeutics for mental health conditions in its recently published 2025 Physician Fee Schedule draft.
Remember: These G Codes are only proposed. So, they may not be accepted into the final Fee Schedule for 2025. (If you recall back in 2022 (E&O Issue 158), CMS proposed to create four temporary G Codes to replace two of the RTM codes, but ended up scrapping that plan in its final fee schedule for 2023.)
Read on for a quick recap of what the three codes cover, followed by a look at whether these G Codes are any different from the RTM Codes (which were revised during the same time period that these G Codes were being conceptualized), and finally some informed speculation on who is behind the G Codes’ advent.
New acronym alert: DMHTs. CMS introduced a new acronym to describe the group of digital therapeutics that these three new G Codes describe: Digital Mental Health Treatments (DMHTs). (The Society for Digital Mental Health and its leadership have used that phrase for years, but few others have adopted — it until now.)
CMS’s new supply code for prescription digital therapeutics:
“Effective beginning in CY 2025, we propose that physicians and practitioners who are authorized to furnish services for the diagnosis and treatment of mental illness would be able to bill a new HCPCS code: GMBT1 (Supply of digital mental health treatment device and initial education and onboarding, per course of treatment that augments a behavioral therapy plan) for furnishing a DMHT device. GMBT1 would be payable only if the DMHT device has been FDA cleared and the billing practitioner is incurring the cost of furnishing the DMHT device to the beneficiary. Furnishing of the DMHT device must be incident to the billing practitioner’s professional services in association with ongoing treatment under a plan of care by the billing practitioner.”
So, there are a few requirements — a few that caught my eye:
- Payable only if the DMHT device has been FDA cleared as a “computerized behavioral therapy device for psychiatric disorders” — a very specific Class II medical device category. (This is more limited in scope than the RTM codes.)
- Payable only if the billing practitioner is incurring the cost of furnishing the DMHT device to the beneficiary. (This will require PDT companies to sell to providers first.)
- The DMHT device must be provided in association with ongoing treatment under a plan of care. (So, the PDT needs to augment the care plan and not replace it or be a standalone treatment.)
The other two codes are crosswalks from the RTM codes. GMBT2 is for the first 20 minutes of monthly management services related to the patients therapeutic use of the DMHT device. GMBT3 is for each additional 20 minutes. (I won’t copy/paste the full descriptions, because you are probably familiar with the RTM codes.)
Did CMS just propose to recreate codes that were already accepted by the AMA’s CPT Editorial Panel last year?
CMS wrote in the proposed fee schedule for 2025:
“We propose to create three new HCPCS codes for DMHT devices modeled on coding for RTM services… Interested parties requested that we adopt coding specifically for DMHT devices, where the digital software device is the actual therapy/intervention (the algorithm software is the DMHT) as opposed to a therapeutic monitoring device that transmits patient data as described by CPT code 98978 for which we finalized contractor pricing in CY 2023.”
Here, CMS is making the case that these G Codes are necessary because the existing RTM CPT codes focus on a “therapeutic monitoring device” instead of “the actual therapy/intervention.” That may have been true when those interested parties first wrote CMS about the need for these codes, but in October 2023 — a month after CMS collected comments on this topic — the AMA’s CPT Editorial Panel voted to revise the RTM codes to include the word “intervention”.
“Digital Cognitive Behavioral Therapy: Accepted revision of codes 98975, 98976, 98977, 98978 to include digital therapeutic intervention; and revision of the Remote Therapeutic Monitoring Services and the Remote Therapeutic Monitoring Treatment Management Services guidelines.” Effective date: January 2025.
So, I’m having trouble seeing what’s really new here. Are the G Codes better than the revised RTM codes in some way? They both would go into effect in 2025, but the RTM code is ahead of the G Codes since that went to the MACs for contractor pricing back in 2023. If they are accepted, they will be sent out to the MACs for pricing in 2025. If the codes describe the same thing, and one is further along — is there any reason to create these G Codes? Well, part of the answer might depend on what the MACs priced 98978 at before it was revised to focus on “interventions.” And I can’t seem to find any info on that. (Hit reply if you know how that turned out.)
In its recent proposal, CMS implied that the G Codes could end up with a pretty low price point. It mentioned that on the low end, comparable products are priced at between $0 and $140 per year:
“There is still more variation in pricing for comparable products that are available for considerably lower prices in various markets, with prices ranging from free to $140 per year, based on an online search (https://www.carepatron.com/app/cbt-therapy-apps, accessed March 20, 2024).”
Big Health, the American Psychological Association, and The Society for Digital Mental Health submitted similar requests for the creation of these G Codes.
After reading many of the comment letters to CMS, it is clear to me that the three main proponents of these G Codes are Big Health, the American Psychological Association, and The Society for Digital Mental Health. They each wrote letters to CMS that proposed the creation of dedicated G Codes with similar restrictions that CMS ended up proposing in its fee schedule for 2025. Here’s what Big Health wrote to CMS back in September 2023:
“For example, several have and continue to be submitted to the CPT Editorial Panel for reporting dCBT as incident-to services. Assuming some of these code proposals are adopted, this would provide an appropriate mechanism to facilitate coverage for these devices when furnished incident-to a healthcare practitioner’s service. If such coding is not adopted, we encourage CMS to use its authority to adopt such coding under the HCPCS system where CMS would establish a separate set of dedicated G-codes to account for digital therapeutic devices that are ordered by a Medicare enrolled practitioner who incurs a direct practice expense in order to manage the treatment of a beneficiary.”
Last year, as I was tracking revisions to the RTM codes in the fall, I also speculated that Big Health and the APA were behind the requests to revise the RTM codes to include the word “intervention”. (Were they hedging their bets and then accidentally ended up creating duplicate codes?)
In November 2023, CMS published its final Physician Fee Schedule for 2024 and in it the agency gave an update on this topic (E&O Issue 214). At the time it suggested that if the RTM codes were revised at the September 2023 CPT Editorial Panel meeting, it would review them and proceed accordingly:
“In response to the commenters’ statement that there are new coding proposals shown in the public agenda for the September 2023 CPT Editorial Panel meeting to allow for reporting of digital CBT (dCBT) and remote therapeutic treatment and other digital therapeutics as incident-to services, we note that we routinely rely on the CPT coding process as a critical part of how services, including those involving emerging technologies, that might be paid under the PFS are understood and provided by medical professionals. While we do not always rely on CPT exclusively, we look forward to reviewing any forthcoming codes and potential recommendations for the valuation of such codes through our standard annual processes.”
So, CMS seemed very much aware of the revision — but created the G codes anyway? Sure seems like the slow-moving CPT process at AMA and the slower moving Physician Fee Schedule at CMS are like ships passing in the night. Are both sets of codes necessary? Is this proposal from CMS actually helpful? Or just wasted effort?
What do you think?
Trials: Click Therapeutics, Bliss, Bold, GAIA
Here’s a round-up of recent changes to clinical trials focused on digital therapeutics.
New: Click Therapeutics and Boehringer Ingelheim test an abbreviated version of digital therapeutic for schizophrenia
This 58-person trial trial began in May. The title is the only part of the study posting that reveals any of the details. More:
“An Exploratory, Double-arm, 8-week Study to Explore the Feasibility and Acceptability of Abbreviated Treatment With CT-156 for People With Schizophrenia.”
New: French company Bliss Therapeutics tests VR-based digital therapeutic instead of sedation during cancer operation
This study is currently recruiting more than 300 participants. More:
“Bliss DTx is a Digital Therapeutics (DTx) which uses virtual reality augmented with sound and visual stimuli to reduce pain during Port-A-Cath setting.”
Completed: Bold Health’s trial for Zemedy app for IBS
The trial managed to recruit more than 400 participants for its acceptability and efficacy study that compared Zemedy vs education and relaxation training. More
Completed: GAIA’s study on reviga, a digital therapeutic for burn out More:
“In this single-blinded randomized controlled clinical trial 290 patients with stress or burnout will be investigated regarding the effectiveness of a digital therapeutic for improvement of stress level, the unguided online intervention reviga.”
Links to E&O’s reports, databases, newsletters
Click below for dedicated pages for each of those categories:
- Read through the long-form E&O research reports here.
- Search and sort the E&O databases here.
- Skim more than 300 past issues of E&O newsletters here.
