Issue 237
Digital health research from Brian Dolan
E&O: SaMD
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.
Here’s a quick bullet on a recent FDA market authorization before we dig into big changes in reimbursement and coding for digital therapeutics…
- Apple continues to rack up FDA market authorizations: Late last month it secured its first 510(k) for its Vision Pro augmented reality device. The device’s new Digital Prism Correction Feature (DPCF) received an FDA 510(k) to digitally adjust images for users with certain vision disorders that require prism correction. (Double vision is a common example.) The FDA took 98 days to OK the feature.
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Just posted: How the final CMS Physician Fee Schedule for 2025 tweaked the Digital Mental Health Treatment G Codes
The final fee schedule is out and the answers to the biggest questions about the three new G Codes for Digital Mental Health Treatment devices are outlined below. (Hit reply and let me know what I missed — it just went up minutes ago, so I had to read quickly.)
Did CMS finalize its plans to reimburse for Digital Mental Health Treatment devices via three new G Codes? Yes. CMS is following through with its proposal to create these three codes. It could have decided to drop the codes after reading comments on the proposed Fee Schedule, but, as expected, it is finalizing them with few changes.
Did CMS clarify whether the definition only applied to software “cleared” by the FDA, implying 510(k)s only? Yes. CMS said devices that secured FDA market authorization either through the 510(k) process or the de novo pathway were included in its scope for these codes. The additional color that de novo devices were included was a refinement on the language in the proposed fee schedule. The scope is much tighter than this, of course, so read on…
Did CMS decide to broaden inclusion criteria for what it considers Digital Mental Health Treatment devices? No, not beyond the allowance for de novo devices mentioned above. CMS maintained its position that the scope only included devices cleared under 21 CFR 882.5801, which only includes a handful of SaMD available in the market today, including new FDA-cleared offerings from Big Health and prescription digital therapeutics from PursueCare, the virtual clinic that acquired some of Pear Therapeutics’ assets.
Did CMS decide to establish a national rate for the new supply code for DMHT devices? No, they decided to send the codes to the MACs as originally planned.
“After consideration of public comments, we are finalizing to contractor price HCPCS code G0552, as proposed. We are also finalizing payment for HCPCS codes G0553 and G0554 as proposed. We note that the invoices we received vary considerably.”
Did CMS decide it would reimburse for DMHT devices when a prescriber furnishes a digital device for mental health treatment when that device was cleared by the FDA for another specific use? It decided not to pay in those cases:
“We are finalizing that payment may only be made for DHMT devices for mental health treatment in accordance with the use indicated in their FDA classification under 21 CFR 882.5801.”
Did the proposed language for the three G Codes change in the final Fee Schedule? Yes and no. The language of the first code, the supply code, did not change but CMS tweaked the other two based on comments from industry in an attempt to make it clear how these codes are different from the RTM CPT codes. Here is CMS’ explanation for the changes:
“We are finalizing refinements to HCPCS codes G0553 and G0554 to clarify that these codes are for treatment management with a DMHT device which is intended as a therapeutic intervention as opposed to RTM devices which, beginning January 1, 2024, will describe devices that may have a digital therapeutic intent as well as be intended to monitor response to a therapeutic intervention not necessarily delivered by an RTM device.”
And here is the final language for the two codes CMS tweaked since the proposed fee schedule:
“We are finalizing HCPCS code G0553 with these refinements: G0553 (First 20 minutes of monthly treatment management services directly related to the patient’s therapeutic use of the digital mental health treatment (DMHT) device that augments a behavioral therapy plan, physician/other qualified health care professional time reviewing information related to the use of the DMHT device, including patient observations and patient specific inputs in a calendar month and requiring at least one interactive communication with the patient/caregiver during the calendar month). We are finalizing HCPCS code G0554 with the following refinements: (Each additional 20 minutes of monthly treatment management services directly related to the patient’s therapeutic use of the digital mental health treatment (DMHT) device that augments a behavioral therapy plan, physician/other qualified health care professional time reviewing information related to the use of the DMHT device, including patient observations and patient specific inputs in a calendar month and requiring at least one interactive communication with the patient/caregiver during the calendar month. (List separately in addition to HCPCS code G0553)).”
What did I miss?
AMA CPT panel makes big changes to RPM/RTM codes, ends requirement for 16 days of data
In mid-October the AMA’s CPT Editorial Panel posted the outcomes of its September meeting and the results included big changes to the Remote Physiological Monitoring and Remote Therapeutic Monitoring CPT codes. Among the big changes: as few as two days of data collection can now be billed and as few as 10 minutes of service is required to trigger a billing event for at least one of the codes. Significant changes like this probably mean the codes will be re-priced at a future meeting of the RUC. (I’ll keep an eye out for that.) While all of the changes aren’t clear yet, this is what the original description for the code change application listed as requested tweaks to the codes:
- “Revise the Digitally Stored Data Services/Remote Physiologic Monitoring guidelines;
- add a remote physiologic monitoring device supply code (99XX4) for 2 to 15 calendar days;
- revise code 99454;
- revise the Remote Physiologic Monitoring Treatment Management services guidelines;
- add a new code (99XX5) for remote physiologic monitoring treatment management services to include 10 minutes of service;
- revise codes 99457, 99458;
- revise the Remote Therapeutic Monitoring Services guidelines;
- revise codes 98975, 98976, 98977, 98978;
- add remote treatment monitoring device supply codes (98XX4, 98XX5, 98XX6) to report respiratory, musculoskeletal and cognitive behavioral therapy for 2-15 calendar days;
- revise the Remote Therapeutic Monitoring Treatment Management services guidelines;
- add a new Remote therapeutic monitoring treatment management services code (98XX7) to include 10 minutes of service;
- revise codes 98980, 98981″
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