Issue 168
Welcome back to E&O Fridays, a paying subscribers-only weekly newsletter focused on the world of digital pharma products and FDA-regulated digital health.
E&O Fridays.
Here’s what’s going on this week in FDA-regulated and pharma-focused digital health…
- Di-Gone: German government removes another prescription digital therapeutic: ReHappy has been kicked out of the country’s national digital health formulary program. This is the third DiGa to be removed so far. 33 remain. ReHappy is an app and wrist-worn activity tracker that aims to help people recover after a stroke. ReHappy was removed from the formulary after a one-year trial period, during which the company could not demonstrate that its program was effective.
- Swing Therapeutics has decided to commercially launch Stanza, a prescription digital therapy for fibromyalgia patients, in the US under the FDA’s public health emergency waiver for psychiatric devices. (It’s a bit surprising that Swing is making this move now when the PHE may be officially approaching its end, but maybe they can squeak it in if they are close to an FDA submission anyway?) Swing CEO Mike Rosenbluth wrote on LinkedIn: “We are concurrently running a multi-site randomized controlled clinical study which we intend to use to support a broader FDA clearance of the treatment.” More
- News you know: The FDA published an apparently controversial final guidance on the regulation of clinical decision support (CDS) software. Chances are you’ve already read all about it. Check out the document linked here along with options to submit comments to the agency.
- The FDA also published a post-mortem on its Pre-Cert Pilot, which it officially declared concluded. The report also finds that the FDA needs an act of Congress before it can implement a program like Pre-Cert at scale: “Appropriate new legislative authority would be necessary to support the development and implementation of a new regulatory paradigm.”
- One more thing… Wavely Diagnostics has registered its ear infection screening app with the FDA as a Class II 510(k) exempt medical device. “Wavely’s phone-based diagnostics app coupled with a paper funnel turns a smartphone into an acoustic tool [that] only needs to be placed at the opening of the ear canal; it is non-invasive and user-friendly, so parents can get quick, reliable answers the first time they use it.”
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CMS to Akili: No new HCPCS code for EndeavorRx. CMS to Pear: Digital therapeutics are not DME.
This past week the Centers for Medicare & Medicaid Services released its final decisions from the June 2022 HCPCS public meetings where both Akili and Pear Therapeutics made requests related to HCPCS billing codes.
This is a follow-up to what I wrote back in May for Issue 149 before the HCPCS meeting took place, but the thing to understand about these HCPCS efforts is that:
- There’s currently no Medicare benefit category for prescription digital therapeutics.
- As a result, CMS has suggested that all prescription digital therapeutics companies use the same generic HCPCS code, which it created after Pear asked for three HCPCS codes for each of its commercially launched therapeutics.
- One-size-fits-all doesn’t work, however, because PDT companies argue that payors should pay more for some digital therapeutics than others — just as they do for pharmaceuticals.
What happens next: Given the results of the June meeting outlined below, prescription digital therapeutics companies now need to convince Congress to create a new Medicare benefit category for their products, which they believe will, in turn, allow them to more successfully lobby CMS for individual HCPCS codes in the future.
OK, enough background, onto the news:
CMS tweaks HCPCS code A9291 so Akili can use it too: First, Akili tried to make the case that the HCPCS billing code A9291 (which is for prescription digital behavior therapy, FDA-cleared) didn’t work for EndeavorRx, because EndeavorRx was a non-behavioral therapy. Akili asked for its own HCPCS code specific to EndeavorRx. Here’s how CMS summed up what Akili and its proponents (which included a rep from Pear Therapeutics) said at the meeting back in June:
“They asserted that existing HCPCS code A9291, as it reads right now, limits the flexibility for payers to cover PDTs for non-behavioral therapies such as pediatric ADHD, and therefore there is an unmet need for specific, discrete HCPCS Level II code. EndeavorRx is not associated with behavior, and does not train behaviors and/or provide behavior-type therapy, but related to cognitive therapy. Another speaker explained the advancements and pervasiveness of prescription software.
Commenters stated that one generic HCPCS Level II code does not allow payers to efficiently cover several PDTs with different mechanisms of action, price points, benefit categories and utilization management requirements. Thus, manual adjudication of claims would be required, which inherently creates a greater potential for error, and places an administrative burden on the payer.”
Ultimately, this argument only convinced CMS to tweak the language of the existing HCPCS code mentioned above so that Akili could use it too. (Wonder if CMS will continue to add language to this after future meetings for other PDTs that don’t fit the description?) CMS provided some of its reasoning:
“Revise existing HCPCS Level II code A9291, ‘Prescription digital behavioral therapy, fda cleared, per course of treatment’ to now read ‘Prescription digital cognitive and/or behavioral therapy, fda cleared, per course of treatment.’ CMS believes that HCPCS Level II code A9291, as revised, describes EndeavorRx.
EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined type ADHD, who have a demonstrated attention issue. We understand that the indications for use also state that EndeavorRx may not display benefits in typical behavioral symptoms, such as hyperactivity. However, it uses the same principles of human learning and development as well as cognitive processing to overcome problem behavior and emotional thinking.
CMS understands the field of prescription digital therapeutics is expanding. However, we do not recognize a need for separate, more specific HCPCS codes to distinguish between items and price points at this time. CMS is not aware of a claims processing need or written policies on the part of other insurers for separately reporting prescription digital therapies; as other payer policies evolve, we expect that will inform future coding actions.”
CMS does not buy Pear’s argument that PDTs are durable medical equipment: Moving on to Pear’s request to categorize its three prescription digital therapeutics as durable medical equipment. In the end, CMS decided that software is not DME, but while making their argument it does seem like CMS is contradicting the FDA’s definition of software as a medical device. Certainly seems like Pear helped reveal some daylight between how CMS views software vs the FDA. Here’s how CMS summed up Pear’s argument:
“The primary speaker stated that as a threshold matter, CMS is incorrect that Pear’s [digital behavioral therapy] devices are not ‘devices’: Pear’s DBTs are legally classified and authorized/cleared as medical devices under the Food, Drug, and Cosmetic Act by the FDA. Both Congress and CMS have historically deferred to the FDA on fundamental questions regarding the classification of medical technology for marketing in the U.S. Further, as medical devices, the speaker felt Pear’s DBT devices met all five prongs of the regulatory definition for DME.”
CMS didn’t add any new insights in their final decision, but the main paragraph stated:
“We continue to believe these products fall outside the definition of DME. The durable medical equipment benefit is for equipment such as a wheelchair, hospital bed, ventilator, or oxygen concentrator rented to a patient for use in their home. Software that is run on computers would not work unless the patient also has a smartphone, computer or another type of durable device that would enable use of the software. Smartphones and computers are generally useful to individuals in the absence of illness or injury and are therefore not DME. Without the computer, the software would not work. Digital therapies or computer software are housed on non-medical devices like smartphones or computers and the equipment and software as a whole are not DME. Whether or not the item could fall under some other Medicare benefit category can be considered, but would not be addressed under the [durable medical equipment, prosthetics, orthotics and supplies benefit category determination] process.”
Sure seems like CMS is suggesting that Pear and Akili convince Congress to create a new benefit category with this line:
“Whether or not the item could fall under some other Medicare benefit category can be considered…”
If it created a new Medicare benefit category, how much would CMS spend on prescription digital therapeutics over the next decade? $600M?
As Exits & Outcomes has noted for the past few years, there has been an effort led by the Digital Therapeutics Alliance to convince Congress to pass legislation that would add a new Medicare benefit category for prescription digital therapeutics.
The most recent iteration of the bill is named The Access to Prescription Digital Therapeutics Act of 2022.
About a week ago some members of the Digital Therapeutics Alliance met with staff and members on Capitol Hill to continue to make the case for the bill. One of the documents that this group has used to make its case is a May 2021 analysis written by The Morgan Company that attempts to put a price tag on Medicare and Medicaid reimbursement for prescription digital therapeutics for the next 10 years (really 2021-2030).
Basically, how much of an impact on the federal budget might the Access to PDTs bill have?
The Morgan Company, which discloses that a group of prescription digital therapeutics companies commissioned it to write the analysis, concludes that it will cost the government about $600 million in increased direct federal spending over the next 10 years. That includes about $470 million in direct federal spending on prescription digital therapeutics for Medicare patients and about $130 million in direct federal spending for Medicaid patients.
The analysis includes a list of prescription digital therapeutics that were FDA-cleared, under review, or pre-approval at the time (May 2021). There are fewer than 40 digital therapeutics on the list.
Surprisingly, the list only includes three PDTs from Pear — schizophrenia, IBS, pain — besides the three it already has on the market. Besides Akili’s EndeavorRx, the list includes one other Akili PDT — major depressive disorder — that is pre-approval. Might those on the Hill assume these are the only PDTs in these companies’ pipelines for the next 10 years?
Suffice it to say, the document is an interesting study on how prescription digital therapeutics companies portray their ambitions to Congress vs Wall Street.
Clinical trial updates: GAIA, Woebot, iRhythm, AppliedVR, DoD, Winterlight, and Michael J Fox
This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others E&O mentioned in previous issues.
iRhythm aims to address UK’s NICE’s 2020 concerns about Zio in new study
This is an interesting study that explicitly aims to drive adoption of the Zio for ambulatory electrocardiogram monitoring in England:
“In 2020 an independent evaluation of the Zio service as part of the Digital Health Technologies programme at NICE was conducted. From the available clinical and economic evidence, the evaluation concluded that further evidence is needed to estimate the resource use associated with Zio compared with standard care, particularly the number of outpatient visits and repeat testing needed. Additionally, it recommended further evidence is needed for the longer-term clinical consequences such as anticoagulant uptake and other changes to treatment related to the results from monitoring. (MTG52) Therefore, this study aims to address these uncertainties and identify whether the Zio service could be used in the health and social care system in England.”
GAIA sets up RCT for insomnia digital therapeutic, somnovia, in Germany
New details on a randomized control trial that will compare somnovia to care as usual:
“The trial aims to evaluate the effectiveness of a novel digital health application (somnovia), which was designed to increase sleep quality in persons with insomnia disorder. Therefore, 290 people with insomnia disorder will be recruited and randomized to two groups: (1) a control group, in which they may engage with any treatment for insomnia disorder and are offered access to somnovia after a delay of 6 months (i.e., Care-as-Usual [CAU]), or (2) to a treatment group that immediately receives 6-month access to somnovia and may also use CAU. The primary outcome measure is the score of the Insomnia Severity Index (ISI), collected at three months post-baseline.”
Woebot tweaks its Phase II study’s endpoints, enrollment goal, and masking
Woebot tweaked most of its outcome measures for its Phase II study on its digital therapeutic for substance use disorder. The study is now set to start this week. The company also upped its anticipated participant goal from 268 to 400. It changed its masking from triple-masked to single (just participants). More:
“This study aims to validate W-SUDs as a digitally-delivered substance use disorder program through a fully-powered randomized control trial that will test the comparative efficacy of the mobile-app based substance use disorder program (W-SUDs) to reduce substance use relative to a psychoeducation control condition, which has no cognitive behavioral therapy and the content is not delivered through a conversational user interface.”
Mass General Hospital to pilot AppliedVR’s RelieveVRx
This small pilot study aims to recruit about 10 people to test out AppliedVR’s FDA-cleared prescription digital therapeutic, RelieveVRx:
“The goal of this study is to pilot test a skills-based virtual reality (VR) for acute orthopedic injury. It will measure the feasibility, signals of improvement, exploratory pain mechanisms, and user experience of an established skills-based program (RelieveVRx) for acute orthopedic injury.”
Department of Defense researchers developing a digital therapeutic to treat depressive symptoms in veterans with history of mild traumatic brain injury
The most interesting tweak to this study is that the researchers changed their answer to whether or not this was an FDA-regulated medical device from “no” to “yes”. More:
“The Center for Neuroscience and Regenerative Medicine (CNRM) Clinical Trials Unit has developed the first cognitive-behavioral therapy (CBT) digital therapeutic (DTx) mobile application to counteract depressive symptoms in military service members and veterans with a history of mild traumatic brain injury (mTBI). This trial will assess the efficacy of the novel CBT-DTx for depression following mTBI compared to an educational comparison DTx.”
Winterlight Labs finished recruiting for study of voice biomarkers of psychiatric disease
This study aimed to recruit 200 participants, but there’s no word yet if they hit that goal yet:
“The general objectives of this study are to build a proof-of-concept, speech-based, digital biomarker for identifying the presence and tracking the severity of psychiatric disease.”
“The purpose of this study is to gather longitudinal data to examine how speech features and symptoms change over different intervals of time and the reliability of repeated, high-frequency test administration. Participants will complete a variety of speech and language tasks using the Winterlight Assessment (iOS app) every day for 30 days. The following is the list of assessments that participants will complete; 1) Daily assessment of mood, 2) Winterlight assessment which contains a series of verbal response tasks where participants are recorded through a tablet app, and 3) Clinical assessments.”
Now recruiting: Northwestern University, Michael J Fox Foundation, and Koneksa’s study on voice biomarkers for Parkinson’s
Speaking of voice biomarkers… This study is now recruiting about 120 participants:
“Although multiple approaches to this problem have been proposed in addition to commercially available speech analytics platforms, there is currently no established measure which incorporates the disparate aspects of affected speech to fully characterize Parkinson’s symptom progression, particularly in the prodromal phase. The measurement concept being evaluated in the present study utilizes a custom smartphone-based speech assessment tool to extract multiple hypothesis-driven acoustic features from patient speech in a real-life environment. The resultant features will be used to train a pair of supervised machine learning models to predict clinical PD symptom severity scores, and to distinguish prodromal PD patients from both healthy matched controls and PD patients in more advanced phases of disease progression.”
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