Issue 225
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
Here are a few quick things happening in FDA-regulated and pharma-focused digital health:
- Akili shared a few details from its first quarter results this week, but the bigger news you likely already know is that the company had a major lay-off a few weeks ago and is now exploring “potential strategic alternatives” — Wall St. speak for “seeking a buyer.” The only interesting financial detail from Akili was its quarter-over-quarter revenue dip: “Total revenues for the first quarter of 2024 were $383 thousand compared to $749 thousand for the fourth quarter of 2023, primarily due to reduced EndeavorOTC advertising spend.” Any guesses: Who will buy Akili?
- Last month the FDA cleared a new prescription digital therapeutic: MamaLift Plus by Curio Digital Therapeutics. The Class II device used Pear Therapeutics’ Somryst as its predicate. “MamaLift Plus is a prescription-only digital therapeutic intended to provide neurobehavioral interventions to patients 22 years of age and older, as an adjunct to clinician-managed outpatient care. MamaLift Plus treats mild to moderate postpartum depression by improving a patient’s symptoms of depression.”
- In other news you might already know: The FDA named Apple’s AFib History Feature as a Medical Device Development Tool (MDDT) — the first digital health MDDT. “The Apple AFib History Feature can be used as a biomarker test to help evaluate estimates of AFib burden as a secondary effectiveness endpoint within clinical studies intended to evaluate the safety and effectiveness of cardiac ablation devices.”
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CMS seems skeptical of MedRhythm’s HCPCS application for InTandem-specific billing code
MedRhythms has asked CMS to create a new HCPCS code that describes its prescription digital therapeutic for stroke — InTandem. The suggested language for the code that MedRhythms sent to CMS was:
“EXXXX, “Gait modulation system, rhythmic auditory stimulation, closed loop, including all components and accessories”
Notably, MedRhythms never uses the term “digital therapeutic” in its application (at least the publicly available parts). The HCPCS committee has had a habit of suggesting all digital therapeutics applicants consider using the catch-all HCPCS code A9291 for prescription digital cognitive and/or behavioral therapy, FDA-cleared, per course of treatment. But, like others before it, MedRhythms is seeking out its own unique code. It’s clear from InTandem’s device description doesn’t match the language of A9291.
In its preliminary recommendation, CMS seems like it leaning towards a rejection for MedRhythms’ application. (Let me know if you agree or disagree after reading the excerpts below.)
CMS hints at a lack of demand from payers as a primary reason for its stance, but it also posed a series of questions to MedRhythms that might give you some insight into the committee’s thinking:
Demand from insurers lacking?
“The applicant included a letter from Point32Health to support the request for a HCPCS Level II code. CMS acknowledges the letter from Point32Health; however, there is no indication of a program need and no evidence of a need from other insurers for a HCPCS Level II code.”
If it’s FDA exempt how can it be FDA authorized?
“We would like to understand how InTandem is a class II device, exempt from the premarket notification procedures by the FDA, but indicated in the application summary as ‘InTandem is the only FDA authorized medical device that delivers Rhythmic Auditory Stimulation in the home setting.'”
CMS also posed five questions that were more focused on the therapy itself:
1. Could a patient use the auditory aspect without the clip attachment?
2. The applicant indicated that there are differences between InTandem music list and a commercial playlist. The studies provided compared InTandem to an active control, described as walking practice supervised by clinical investigators. Essentially, this comparison was between no music and music. Are there any studies demonstrating how these differences contribute to treatment efficacy?
3. It seems that rhythmic auditory stimulation (RAS) methods, using only a metronome without music, may have similar effectiveness in gait training compared to this device. Therefore, the added significance of incorporating music does not appear to demonstrate greater efficacy in improving gait. Explain how InTandem differs from metronome for gait rehabilitation in patients post-stroke.
4. We would like to understand the distinctiveness of the music therapy for patients with a stroke compared to other types of music therapies for different diagnoses.
5. Are there other uses for the product besides this therapy? For instance, could it be used by patients that did not experience a stroke?
Outcome of RPM/RTM code change request revealed a month early, after AMA’s secretive CPT meeting in Chicago last week
Typically, I’m not able to report any outcomes from the American Medical Association’s CPT Editorial Panel Meetings — which is the group responsible for creating and changing CPT billing codes — until they post their summary panel actions, which typically go up a few weeks after their meetings take place. The meetings are open to the public but secretive. Attendees (historically, anyway?) need to sign confidentiality agreements to attend them, which is why I haven’t attended them to report on them in real-time.
Last week, however, an attendee at the meeting posted on social media about the outcome of the code change application for the Remote Therapeutic Monitoring and Remote Physiologic Monitoring codes: In short, the panel voted not to accept the requested changes. A day later — last Friday — Politico reported the news based on an anonymous source who had attended the meeting. STAT, Fierce Healthcare and others followed with similar reports citing unnamed sources this week.
As E&O reported in Issue 224, the requested changes to the RPM and RTM codes were significant. Among other tweaks, the applicants wanted to give providers the option of billing for between 2 and 15 days instead of just 16 or more days. Here is the full description of the requested changes from the AMA’s publicly available agenda — it describes some but not all of the requested changes in detail:
“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 to include 16-30 calendar days;
- revise the Remote Physiologic Monitoring Treatment Management services guidelines;
- add a new code (99XX5) for remote physiologic monitoring treatment management services;
- revise code 99457 to include 11-20 minutes;
- revise code 99458 to each additional 10 minutes;
- 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);
- revise 98980 to include 11-20 minutes of service;
- and revise the time component for code 98981.”
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