Issue 216
Welcome back to E&O: PDTs, a paying subscribers-only weekly newsletter focused on the world of digital pharma products and FDA-regulated digital health.
E&O: Rx Digital Therapeutics
Here are a few quick bullets on things happening in FDA-regulated and pharma-focused digital health:
- Better Therapeutics announced “company-wide salary reductions” this week that will take effect at the beginning of the year. Better said the move would “strengthen its financial position and maintain investments to support the commercial launch of AspyreRx.” Better’s CFO Mark Heinen also resigned in recent weeks.
- Mahana Therapeutics has launched its digital therapeutic for tinnitus, called Mahana Tinnitus. (E&O first reported on this DTx way back in January 2023.) Unlike its flagship digital therapeutic, Mahana IBS, the new program is not FDA-cleared, but it is only available via Mahana’s healthcare provider partners. “Mahana Tinnitus is a Cognitive Behavioral Therapy (CBT) program that teaches ways of building new habits that may lessen the impact of tinnitus symptoms on your daily life. The program provides education about the mind-body connection and strategies for changing thoughts, feelings, and behaviors that may help people live well with tinnitus. The FDA has not evaluated Mahana Tinnitus or any claims contained within. Mahana Tinnitus is not intended to diagnose, treat, cure, or prevent any disease.”
- Point32Health, the health insurance company formed via the merger of Harvard Pilgrim and Tufts Health Plan, wrote a letter to HHS and other agencies that suggested the federal government help providers assess clinical effectiveness of digital therapeutics. “We recommend the federal government consider a policy of facilitating transparency in the digital health space to further the adoption of this important area of emerging medicine. First, we recommend the establishment of a transparent database of clinically effective digital therapeutics that have demonstrated improvements via Randomized Controlled Trials. This would be an easily searchable repository by disease and other critical factors. Second, CMMI should develop a model where digital therapeutics that meet certain threshold effectiveness criteria could receive coverage through Medicare, including primary care provider payments to incorporate DTx into their practice. And finally, the federal government should publish an annual report on realworld evidence on digital health. We can provide additional details in this area upon request.”
- Otsuka also wrote a letter to the agencies in response to the same proposed rule. In it they wrote: “For example, prescription digital therapeutics (PDTs) are clinically validated, FDA-approved or cleared digital treatments prescribed by a health care professional to treat a health condition. These therapeutic innovations present a unique opportunity for plans and issuers to enable beneficiaries to overcome barriers to mental health care, such as having a limited number of providers in a community, and have the potential to improve how health care providers interact with and monitor their patients remotely. Often, however, plans and issuers have limited incentives to provide any additional services beyond what they perceive as their minimal obligations, notwithstanding any long-term potential for cost savings. As technology and treatment modalities continue to evolve, the Departments may want to consider whether the current classifications appropriately capture the key benefit categories. In the meantime, however, they should enforce standards that require plans and issuers to facilitate access to established, evidence-based treatments recommended by mental health providers.”
- In Germany’s nationwide digital health formulary (DiGA), a digital health program from HiDoc named Cara Care for Irritable Bowel Syndrome (IBS) secured a permanent listing on the formulary after nearly two years with a temporary listing.
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New CPT code change requests: Online digital E/M services for new patients, restore RTM language, delete various remote monitoring codes, and more
The American Medical Association’s next CPT Editorial Panel meeting is set for February 2024, and the preliminary agenda is out today. Below are the code change applications related to digital health — but remember, some of these will be withdrawn before the meeting and others will merge. Still others will be rejected during the meeting’s proceedings. That said, here’s what’s cooking:
“Digital Cognitive Behavior Therapy – Request to restore the language of CPT codes 98975, 98976, 98977, 98978 and the guidelines of the Remote Therapeutic Monitoring Services and Remote Therapeutic Monitoring Treatment Management Services to the current language included in the 2024 code set.”
Someone asked the AMA to “restore” the prior language for Remote Therapeutic Monitoring Services under the header of “Digital Cognitive Behavioral Therapy,” which seems like an attempt to undo the language change to the RTM codes that I wrote about back in October.
“Remote Monitoring – Establish codes 9XX0X, 9XX1X for device supply with daily recordings; delete the Digitally Stored Data Services/Remote Physiologic Monitoring subsection guidelines and delete codes 99453, 99454, 99457, 99458; relocate codes 99091, 99473, 99474 to the Medicine section in the Non-Face-to-Face Nonphysician Services subsection; revise the Medicine Non-Face-to-Face Nonphysician Services and Remote Therapeutic Monitoring Services subsection headings and guidelines; revise code 98975 and delete codes 98976-98978; revise the Remote Therapeutic Monitoring Treatment Management Services guidelines; and revise codes 98980,98981.”
This looks like a major rewrite and reshuffling of the RPM and RTM code sets. It also establishes two device supply codes.
“Online Digital Evaluation and Management – New and Established Patients: Establish codes 98XX1, 98XX2, 98XX3, 994X0, 994X1, 994X2 to report online digital evaluation and management services for new patients.”
Similar codes to the above exist today but for established patients only. This tweak could be particularly meaningful to text-based virtual care companies because it adds new patients. CMS has historically interpreted these codes to refer to messages only and not in-person or video communications. Something to watch.
Two related Category III code applications worth tracking:
“Cat III-AI-based QT Interval Monitoring – Establish code XX19T to report QT interval monitoring during drug administration and assessment for QT prolongation.”
and
“Cat III-Algorithm-based Electrocardiogram – Establish codes XX20T, XX21T, XX22T to report algorithm-based electrocardiogram.”
Trials: Click Therapeutics, Woebot, and GAIA
This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others mentioned in previous issues. Just a few this week:
New and now recruiting: Click Therapeutics study on treating anxiety and pain in cancer and MS
Two new studies from Click this week. The first one is an “exploratory” study that aims to recruit 180 participants. According to the trial’s posting, Click is going this one alone. More:
“CT-100 is a platform that provides interactive, software-based therapeutic components that may be used as part of a treatment in future software-based prescription digital therapeutics… Targeted cognitive training is used to reduce symptoms relevant to multiple sclerosis (MS) and cancer. Biases to direct attention towards or away from certain stimuli can exacerbate a variety of symptoms in many different indications. For example, in chronic pain conditions, patients are more attentive to pain-related stimuli, which can lead to hypersensitization (Crombez 2013). Similarly, hypersensitivity to threat-related stimuli can exacerbate anxiety (Bar-Haim 2010). In this treatment, users are trained to re-orient attention away from negative stimuli, such as pain- or threat-related stimuli.”
New and now recruiting: Click Therapeutics, Boehringer Ingelheim study on treating schizophrenia with shorter course of digital therapeutic
More:
“An exploratory, double-arm, 4-week study to explore the feasibility and acceptability of abbreviated treatment with CT-156 for people with Schizophrenia.”
Done recruiting: Gaia study on digital therapeutic to treat stress and burn out
Gaia managed to recruit 295 people for this study — five more participants than originally anticipated. More:
“In this single-blinded randomized controlled clinical trial 290 patients with stress or burnout will be investigated regarding the effectiveness of a digital therapeutic for improvement of stress level, the unguided online intervention reviga.”
Completed: Woebot’s study on user satisfaction with its BUILD app
More:
“This exploratory randomized, double-blind, controlled trial explores user satisfaction with the BUILD mobile application. The BUILD app uses a relational agent (Woebot) to engage users in therapeutic conversations. Eligible participants will be randomized to one of two treatment conditions: (1) an experimental condition in which Woebot uses large language models to understand user sentiment, and based on this understanding of natural language generate responses through a controlled process or (2) a digital control condition in which Woebot selects from a list of responses based on natural language processing. … Results from this study will provide preliminary data on user satisfaction and feasibility and inform product development iteration for inclusion in a statistically powered clinical randomized controlled trial.”
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