Issue 353

Welcome back to E&O: a paying subscribers-only weekly newsletter focused on three areas of health tech: FDA-regulated software devices, digital health as an employee benefit, and national virtual clinics.

 Exits & Outcomes Newsletter

This week’s newsletter focuses on the finalized Physician Fee Schedule for 2026, which includes new coverage for ADHD digital interventions. But first, a few quick notes:

• The FDA granted a De Novo clearance to Pulsenmore for an app and ultrasound device that allows patients to remotely capture ultrasound images to determine fetal heart rate. This is a prescription-only device, but it recalls a prediction that Dr. Eric Topol made 15 years ago while demoing GE’s Vscan device — that home-based ultrasound capture would be made available. Here is Pulsenmore’s indicated use statement: “The Pulsenmore ES ultrasound system is intended to enable the acquisition of ultrasound images that allow interpreting healthcare providers to determine fetal heart rate. The Pulsenmore ES Ultrasound System is intended for limited diagnostic ultrasound imaging in BMode and M-Mode in Fetal/Obstetric applications, when traditional scanning at a health clinic is impractical or when the use of telehealth (clinician-guided mode) or software-guided self-scanning (App-guided mode) is in the best interests of the patient. The device is intended to be used by pregnant women with a singleton pregnancy at the gestational age of 14-38 weeks, when clinically indicated to determine the heart rate on the order of a physician in non-clinical environments. When directed by their physician, the patient can either follow the steps specified by the ES software application (app-guided mode) or under the direction of a healthcare professional (clinician-guided mode). A physician interprets the images acquired with the device in a remote access setup. Access to the device operation must be granted by healthcare professionals.” The in-app guidance feature reminds me of CellScope’s digital ear scope, which had a similar functionality. That device is now on the market as Children’s Tylenol SmartCheck Digital Ear Scope.
• The FDA also granted a De Novo clearance to PainChek Adult, a software application that assists providers in conducting a pain assessment in non-verbal adults. The intended use statement: “PainChek Adult is an observational pain assessment software application used to assist healthcare professionals in the assessment of pain in non-verbal patients who have been diagnosed with moderate to severe dementia and who are living in nursing homes. Specifically, PainChek Adult is intended to be used by trained medical doctors, nurses, licensed practical and vocational nurses, certified nursing assistants, clinical psychologists, physical therapists and occupational therapists to assess pain in the indicated population.”
• Omada Health reported its third quarter results this week. A few highlights: Total members not stand at 831,000, up from 752,000 at the end up Q2. Q3 revenue is $68 million, up from $61 million in Q2. Gross margin stays steady at 66 percent. The company has also revised up its 2025 expectations: It now expects total annual revenue in the range of $251.5 million to $254.5 million, up from a prior range of $235 million to $241 million. Also, Omada announced that it (finally) plans to start prescribing GLP-1s when appropriate.
• Hinge Health also shared its Q3 results. Its quarterly revenue was $154.2 million vs $139.1 million in Q2. Total number of clients is now 2,560 vs 2,359 clients at the end of Q2. Its last twelve months of calculated billings is $624.2 million — up from $568.4 million at the end of last quarter. It also revised up its expected revenue for the year to between $572 million and $574 million — that’s up from the $548 million to $552 million range it gave at the end of Q2.
• Finally… a funding scoop: Auxira Health, a virtual cardiology clinic that spun out of MedStar and counts the American Heart Association as an investor, quietly raised $7.8 million in funding last month. For more, Fierce had a good write-up on Auxira back in July.

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CMS offers no surprises and a few explanations in its final Physician Fee Schedule for 2026

CMS posted its final Physician Fee Schedule for 2026, and as is often the case the final document didn’t include any surprises for digital health companies related to the proposals E&O has been tracking. The more formal proposals in CMS’s earlier draft are going forward and CMS is not taking action at this time on the ideas it floated as possible future proposals. The agency seems unlikely to move ahead with its idea to cover non-FDA-cleared digital tools — that might be the one newsy bit in the final PFS. Here’s a quick round-up on all things digital mental health and G Code-related in the final PFS for 2026:

CMS explains why it won’t set a national price for G0552 (supply of a digital mental health treatment device): “At this time, we do not believe we can appropriately price all the DMHT devices for which we would make payment under our current policies and proposals, and therefore, we did not propose any changes to the existing contractor-priced status for HCPCS code G0552. As we have noted, the technologies and DMHT therapies are evolving rapidly. We have recognized that our payment policy, too, will evolve. Given the dynamic nature of the development of these devices and the variation in methods of action for potential technology platforms, we do not have sufficient information needed to establish national pricing for devices described by HCPCS code G0552 at this time.”

CMS gives proponents of national pricing a sliver of hope: “We have continued to seek information and may consider national pricing through future rulemaking.”

CMS promises to better educate MACs about how to reimburse for G0552: “In response to the comments, we will work with the CMS MACs to improve the understanding of the billing rules for HCPCS code G0552.”

As proposed, CMS expanded the G0552 code to include digital devices cleared by the FDA for ADHD treatment: “We believe it is appropriate to group these devices under a single HCPCS code, G0552. We are finalizing payment for DMHT devices cleared under section 510(k) of the FD&C Act or granted De Novo authorization by FDA and in each instance classified at 21 CFR section 882.5803, Digital therapy device for Attention Deficit Hyperactivity Disorder (ADHD), as proposed.”

CMS declined to expand G0552 to include coverage for digital therapeutics focused on gastrointestinal conditions, fibromyalgia, or sleep disturbances — for now. In its proposal it asked for comments on such an expansion but didn’t propose to cover them like it did for ADHD devices, so no action here is somewhat expected: “At this time, we are not further expanding payment under our DMHT payment policy. We will continue to solicit input from interested parties for coding and payment policies to expand payment for FDA cleared and authorized digital mental health treatment devices. We may consider expanding our payment policy to include them under future rulemaking.”

CMS declined to create new codes for “digital tools used by practitioners” that could encourage healthy lifestyles for their patients as part of a mental health treatment plan. The CMS used some clunky phrasing for this one but it was basically a move to cover non-FDA-cleared digital devices. CMS described reactions to this idea as mostly negative and so: “At this time, after consideration of all these comments we are not finalizing any new coding and payment for such digital tools.”

CMS opted not to take action on new coding for devices like Cognoa’s autism quasi-diagnostic device: “We received public comments on the comment solicitation regarding whether creating an add-on G code and contractor pricing is needed for the administration of an FDA authorized eyetracking technology and other technology to aid in the diagnosis of ASD in pediatric patients; or whether it would be more appropriate to go through the CPT Editorial Panel process to obtain a Category III CPT code for this treatment… After consideration of public comments, we express appreciation for the feedback from commenters and will take the comments into consideration for possible future rulemaking.”

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