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Since the start of the pandemic, more companies have adopted digital tools to give people access to mental healthcare. Investors poured a record amount into these tools, roughly $2 billion in equity funding, according to data from CBInsights. Startups got a boost when the Food and Drug Administration waived regulatory requirements that “computerized behavioral therapy devices” submit a 510(k) premarket notification.
Despite these changes, digital mental health tools still face significant challenges to adoption in the U.S. The lack of reimbursement or evidence standards are two big barriers to uptake.
In a paper published in Psychiatric Services, a group of stakeholders shared three recommendations for improving adoption in the U.S.
The group was led by Patricia Areán, a professor of psychiatry and behavioral sciences at the University of Washington, and David Mohr, director of Northwestern University’s Center for Behavioral Intervention Technologies. It included scientists from Optum, Kaiser Permanente, Microsoft, Talkspace and SilverCloud Health.
Offering digital mental health as a treatmentFirst, the group recommended offering guided digital mental health as a treatment option for patients experiencing anxiety, depression and PTSD. Citing a review of 66 clinical trials, they said that programs where patients received support from a clinician or coach were generally more effective than fully-automated tools, where patients were more likely to drop out of the study.
The authors of the report found that guided digital treatments for alcohol and substance use disorder showed “significant but more modest benefits.” There wasn’t as much efficacy data available on the effectiveness of digital health tools for serious mental illness, such as schizophrenia or bipolar disorder.
Making digital health reimbursableThey also recommended developing reimbursement mechanisms that fit into the current healthcare landscape. Kaiser Permanente recently began working to integrate digital health tools into physicians’ workflow to make it easier to “refer” patients, but for most fee-for-service providers, there’s little structure as to how to pay for digital health treatment.
Currently, most digital health tools don’t have billing codes, “making broad adoption of digital mental health treatment services financially unworkable in U.S. health care organizations,” the authors of the report noted.
Over the summer, the American Medical Association rolled out a set of new CPT codes for online evaluation and care management, as more care shifted to a virtual setting. These codes currently only apply to physicians, physician assistants and nurses, though they could be expanded to cover a broader range of practitioners, according to the report.
Building a standards frameworkFinally, the group recommended building an evidence standards framework to help health plans and providers pick products that are effective, safe and equitable.
Most available mental health apps are not currently regulated by the FDA. For example, tools to chat with a therapist like Talkspace or to connect patients to online resources, like MyStrength, don’t fall under the agency’s purview. Even when digital health companies do seek FDA clearance, it doesn’t always address the information that payers and providers are looking for, such as the cost-effectiveness of services.
The authors of the paper suggested at least one well-powered, well-designed randomized clinical trial as the best practice standard for effectiveness. In some cases, tools could be compared to other, previously validated methods, though caution is needed.
For example, while there is strong evidence for the use of Internet-based cognitive-behavioral therapy (CBT), “… very few of the products that claim to be based on cognitive-behavioral therapy actually contain the CBT core elements,” they noted.
Privacy practices have also been a recurring concern with digital health tools. One study of 36 apps for depression and smoking cessation found that 29 transmitted data to services provided by Google or Facebook, but only 12 disclosed this in a privacy policy.
An evidence standard should ensure that all collected data is kept confidential, and privacy policies should clearly explain to patients how their data is stored and used.
To be effective, digital tools should be easy to use for as many people as possible. Screen readers should be able to parse content for users who are visually impaired, and effective tools should also consider whether users speak another language or have limited data usage on their smartphone plan, the authors noted.
Photo credit: diego_cervo, Getty Images

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