Issue 246
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 focused on FDA-regulated digital health… before we get into new FDA clearance updates, details on the big Apple Health Study, another reincarnation of the bill calling for PDT reimbursement, and more…
- In a follow-up piece of news to our write-up about Luminopia’s FDA clearance for its amblyopia-focused prescription digital therapeutic — Anthem recently posted a medical policy that states that Luminopia is medically necessary in some cases. This is a rare case where a commercial insurance plan has agreed to pay for a prescription digital therapeutic. (Highmark is one of the only other insurance companies that has posted a similar medical policy.) But how much will they pay? While a positive coverage determination like this is a big deal, now Luminopia needs to negotiate with Anthem to get a fair price — an even rarer accomplishment for digital therapeutics companies.
- The CMS HCPCS Committee finally posted details on applications for new HCPCS codes set to be discussed at the next public meeting in June. Only one looked to be somewhat relevant to digital health: “Hearing Healthcare Centers of NC LLC submitted a request to establish four new HCPCS modifiers to be used with HCPCS Level II code V5261 to further define digital hearing aid technology levels. Manufacturers of hearing aids use different technologies in making hearing aids. These modifiers can differentiate the levels of technology inside the hearing aid. Some of the digital hearing aids have sensor technology, Bluetooth connectivity, sudden sound stabilizers, environmental programs, directional microphones, tinnitus support, neural noise suppression, rechargeable battery or disposable battery and more. The cost per hearing aid can range from $200 to $4,000 depending on the technology used in the hearing aid (such as, customization, speech understanding, sound quality, and connectivity). Reimbursement for hearing aids is too low and insurers do not pay for claims or appeals filed for higher reimbursement based on technology.” In its preliminary remarks, CMS said it hasn’t heard of a need for this stratification and reminded the applicant that Medicare doesn’t pay for hearing aids by statute. So, this is mostly for Medicaid then? Seems like an uphill battle for this applicant.
- In other CMS news, the agency published a request for information focused on the “Health Technology Ecosystem”. The RFI describes itself as focused on “the market of digital health products for Medicare beneficiaries as well as the state of data interoperability and broader health technology infrastructure.” Read it here.
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The Access to Prescription Digital Therapeutics bill has been reintroduced in Congress with a new name
It’s been a nearly annual tradition since 2019. Once again, the Access to Prescription Digital Therapeutics bill has been reintroduced to both houses of Congress, but this time it has a catchier name: “H.R.3288 – To amend titles XVIII and XIX of the Social Security Act to provide for coverage of prescription digital therapeutics under the Medicare and Medicaid programs, and for other purposes.” The text of the bill is not publicly available yet, but the American Telemedicine Association, its key proponent, told me the text is identical to its most recent reincarnation. So, like the version of the bill introduced during the 2023-2024 Congress, the new bill seeks to do a number of things, including:
- Establish a new benefit category in the Medicare program for prescription digital therapeutics.
- Establish a payment methodology for PDTs within one year of the bill passing Congress.
- The payment methodology will be based on “the actual list charge of such prescription digital therapeutic” and/or “the weighted median (calculated by arraying the distribution of all payment rates reported for the most recent period … for each prescription digital therapeutic weighted by volume for each payor and each manufacturer)”.
- Within two years HHS has to establish product-specific HCPCS codes for prescription digital therapeutics.
- On an annual basis, PDT manufactures will need to send to Congress a report that includes “the payment rate that was paid by each private payor for each prescription digital therapeutic during the period” and “the volume of such prescription digital therapeutic distributed to each such payor” and “the number of individual users of such prescription digital therapeutic”.
FDA clearance tracker: More details on recent clearances for Freespira and Cognoa
Freespira: Freespira finally revealed what its recently secured 510(k) clearance for its Freespira Breathing System, which treats symptoms associated with panic disorder, panic and anxiety attacks, and PTSD — was all about. The company’s intervention, which was previously only indicated for use by adults is now cleared for adolescents aged 13 to 17. In its announcement, the company also revealed its all-time patients treated number:
“Freespira’s adolescent indication leverages multiple studies over a decade and more than 6,000 patients treated, demonstrating sustained symptom relief and significant economic benefits.”
It also said that it is adopting the new mental health G Codes that CMS set-up in last year’s Physician Fee Schedule.
Cognoa: So, it turns out the most recent FDA clearance for CanvasDx, a digital diagnostic aid for autism spectrum disorder, is a Predetermined Change Control Plan (PCCP) “that allows for planned updates and modifications based on real-world data within the cleared indications for use.” Here are the ways Cognoa can use this PCCP to update its software without additional 510(k)s:
“Quantitative measures of machine learning-enabled device software functions (ML-DSF) performance specifications. This includes re-training the ML model based on new data within the intended use population from the same type and range of input signal. The re-training may result in internal decision trees with different weights or overall structure. Device inputs to the ML-DSF. This may involve expanding the algorithm to include new inputs of the same signal type.”
Trial updates: Apple Health Study, Toivoa mental health PDTs for people with disabilities, Click trials’ tweaks
New details on Apple’s big study: The Apple Health Study
Apple announced its new big Apple Health Study back in February with a lot of fanfare. Here are a few more details that I picked up after reading through the company’s recent post about the trial on clinicaltrials [dot] gov. The Apple Health Study aims to enroll “at least” 500,000 participants. Apple said back in February that its new study builds on the work of three of its previous studies focused on women’s health, hearing health, heart health and movement. Those studies had combined in enrollments of more than 350,000, so clearly this new effort is much more ambitious on the recruitment front. So far, the study lists two locations that correspond with the study’s two lead investigators (more on them below) Boston, MA and Washington DC. When Apple announced the study it revealed that Calum MacRae, MD, PhD, of Brigham and Women’s Hospital in Boston would be the principal investigator of the study. While she wasn’t mentioned at launch, an additional principal investigator is listed on the study’s government posting: medtech consulting firm MCRA’s Tiffany Avery MD, a former NantHealth executive. Avery has a background in medical oncology, epidemiology, and cancer and health disparities. MacRae has a background in cardiology and genetics. So, it’s likely cancer and cardiology are focus areas of the big study. In an update to the Research app’s description on the AppStore, Apple now describes some likely focus areas of the trial:
“Researchers are especially interested in the interconnectivity of various areas of health, such as the relationship between the menstrual cycle and heart health, or how hearing health can influence mental health. The study brings together diverse perspectives to advance science and develop features that work for us all.”
Study description from clinicaltrials [dot] gov:
“This Study aims to build a diverse and inclusive group of participants to help researchers advance our understanding of how signals and information collected from apps and devices relate to health and may be used to predict, detect, monitor, and manage changes in health. Participants will be asked to complete tasks and surveys, using their iPhone and Apple Research app which include: Selecting the types of data they would like to share with the study such as health and sensor data Complete tasks and surveys including areas such as personal demographic information, personal medical history, family history, and social determinants of health.”
Toivoa, a prescription digital therapeutics company, just completed a human factors-focused exploratory study for its PDT for people with disabilities who are “struggling with” anxiety and/or depression
This is a new company for me and I missed this study when it first posted last year, but it is now complete:
“The Study will evaluate Rauha as an experimental digital therapeutic for persons with Disabilities suffering from anxiety and/or depression. The study will evaluate completion rates of the program and survey the user’s experience upon completion. Changes in anxiety and depression scores will be monitored during the study.”
Toivoa apparently intends to submit Rauha to the FDA for market authorization based on a box checked in its clinicaltrials [dot] gov post. Toivoa has a pipeline of PDTs focused on people with disabilities who are “struggling with mental health”. The programs are a bit of a mixed bag (some are customers and some are indications, I think?) but they include hearing and mobility (adult), hearing and mobility (adolescent), employer, oncology, long COVID, and seniors. The company’s study notes that participants will have access to mental health coaches and a community, so the company is not pursuing a classic PDT go-to-market — it has a heavy focus on services too. More on Toivoa, which was founded by Laura Randa, a former commercial exec at pharma companies like Novartis and GSK, here.
Click and Boehringer Ingelheim are set to complete their open label extension study for a PDT focused on schizophrenia next month:
“The purpose of the proposed OLE study is to evaluate the maintained efficacy and safety of a second consecutive course of Click Therapeutics Study App as an adjunct treatment to standard of care (SOC) in participants who were on the Study App and have recently completed the Click Therapeutics Randomized Clinical Trial.”
The trial was originally schedule to finish up in April but just got pushed back to June.
Click also tweaked its other study focused on its PDT for schizophrenia by changing the study’s focus from “treatment” to “device feasibility”. The study recently finished up. Click also changed the total number of enrolled from 50 to 72.
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