Caution: Direct-to-Consumer Digital Care – All That Glitters Is Not Gold

Please support Telehealth.org’s ability to deliver helpful news, opinions, and analyses by turning off your ad blocker.

HERE IS HOW

Opportunistic corporations are exploding into the telemental health niche blasted open by COVID, which prompted inexperienced investors to race pell-mell into direct-to-consumer teletherapy. Especially in self-paid and insurance-paid ambulatory mental health services, where independent practitioners provide the bulk of the treatment, the shift to telehealth has been improvised, disorganized, unsupervised, and unscrutinized in an alarming one-size-fits-all approach to assisting people with mental health challenges. Mainly where mental health startups operate without the oversight provided by insurers and government agencies who demand accountability, a “do whatever sells” approach to treating the country’s most vulnerable, often including the most impoverished, least educated, the isolated, indigent, anxious, depressed, suicidal, homicidal, traumatized, alcoholic, drug-addicted, unemployed, abandoned, cognitively impaired, or those who seek help “off the record.” This latter group may seek teletherapy services in ways that do not leave a written trail of their mental health status and thereby are not privy to insurance companies and potentially other third parties.   

On the clinician front, many psychotherapists took to “seeing” patients online in unwitting violation of prior HIPAA and related privacy or security regulations regarding the choice of video-based platforms, cross-state licensing requirements, the scope of practice limitations, or the need for training in the competencies relevant to the safety and effectiveness of evidence-based telehealth practice. Traditional assessment is often paid short shrift and relegated to the PHQ-9, GAD-7, or similar quick-and-easy tools. Clinicians who never were taught these and similar instruments are now using them as part of the “protocol” offered by their employers, rather than relying on their clinical training to guide their intake and assessment procedures for clients they serve primarily by text messaging or the telephone.

In the crucible forged by COVID, the stakes are exceptionally high. Many groups are clamoring for intervention to address the growing need for mental health and addiction care. The GIMBHI Market Update: Q3 report states, “In May 2021, delegates from the American Academy of Pediatrics, the APA, Mental Health America, NAMI, and other organizations urged the AMA to address mental health through policy and funding changes.”

Unscrupulous investors then are strategically positioned to exploit a potentially critical weakness in the US healthcare system at the very time when interventions are needed in unprecedented numbers. Treatment control has traditionally been exercised through reimbursement in mental health and addiction. To date, that bar was set by Medicare, and in some states, Medicaid has defined who, what and how much services are reimbursed. The COVID-related combination of Medicare’s widescale reimbursement for previously denied telehealth services and billions of dollars of investor-backed forges into largely unresearched business models offering unlimited mental health and addiction services for $40 – $49 per month has left a professional community dazed, dazzled and confused.

One of the many areas of concern involves the lack of legal mandates for clinicians to report their negative experiences working for such companies. Equally concerning is the lack of visible official effort to assess and analyze the risks entailed by an overnight substitution of electronic visits for in-person psychotherapy since the start of COVID. Direct-to-consumer and self-pay teletherapy are now in full stampede, spurred by commercialization and the excessive freedoms that have become the norm. Unaddressed, it will be increasingly challenging to bring this situation under control. It may already be too late.

As leaders in the telemental health and telebehavioral health worlds since 1994, the Telebehavioral Health Institute, Telehealth.org, is sounding the alarm. In this unprecedented, massive telemental health and teletherapy direct-to-consumer, self-pay rollout, all that glitters is not gold. Particularly for the less scrutinized, smaller telehealth startups, a frightening amount of “fool’s gold” is successfully being hyped as the real thing. 

Please note that the terms mental health and addiction treatment are interchangeably referred to as behavioral health in the article below.

Wild West 2021?

Medical and non-medical telemental health and teletherapy have become a commoditized wild west. Heavily funded startups have made it unconscionably easy for people to hold themselves out as “therapists,” “coaches,” “advisors,” or whatever. Through any of many unqualified for-profit brokerage startups, thousands of these people can now be given caseloads as if they have been reliably approved or certified. As never before, these would-be helpers can quickly and easily acquire trusting customers who expect a relatively low-cost, low-obligation, and convenient expert to produce as much benefit as a licensed, well-trained, more expensive professional.

Known as “direct-to-consumer” telemental health, teletherapy, or digital mental health services, these technology companies serve the consumer public directly, often for a modest cash payment. Socially, scientific approaches to telemental health are being discredited in favor of commoditized “treatments” delivered by unqualified or insufficiently trained individuals and poorly-devised, unvalidated “apps.” Many apps purport to diagnose, treat and advise on all sorts of behavioral disorders, problems of living, and personal and family concerns. Of course, many clients may be better off with this, as snake oil and alcohol have comforted millions of sufferers for millennia. However, it seems inevitable that some unknown number of customers will be ill-served, diverted from competent professional care, dismayed from trying again, and even directly harmed.

What about Legitimate Telehealth Digital Care Models?

Fortunately, the traditional telehealth models that concurrently have been proven effective in hospitals and clinics for decades have also been offered direct-to-consumer and are experiencing a similar boom. Many digital startups also serve vulnerable populations in thoughtful and evidence-based ways. 

COVID has spawned hundreds of newly published peer-reviewed books and journal articles to add to the documented scientific evidence supporting competency-based care. Particularly since the start of COVID, healthcare organizations and providers worldwide are actively making long-term technology decisions to create increasingly flexible, patient-centric digital access to healthcare.

Relying on the existing decades of evidence-based research for guidance, these responsible organizations and providers follow the lead of medical telehealth, with its centralized legal and regulatory compliance, which is required at all levels, and where patient and provider complaints follow a predictable chain of command.

2121 Digital Care Investor Gold Rush

The opposite is true of mental and behavioral healthcare offered by all-too-many direct-to-consumer teletherapy services. They are busy filling their provider networks by hiring the thousands of previous behavioral-provider nay-sayers who hung their digital shingle in 48 hours during mid-March 2020 to respond to COVID. Most of these well-intentioned providers offer telehealth services with minimal education and training. A notable proportion of providers reported in a 2018 article lacked sufficient awareness of relevant regulatory and professional standards.1 Subsequent anecdotal evidence by one of the authors of this paper, who routinely interacts with thousands of providers monthly, supports the lack of clarity regarding legal and ethical requirements among practitioners, even today.

Once enrolled as employees of such companies, many licensed providers are left to their own devices to determine what is “clinically appropriate” within the confines of systems that do not conveniently allow for complete intakes, needed assessment tools, and full video interactivity norms. They are given mediocre in-house “training” that conveniently sidesteps the startup’s ethical and legal deficits. All this occurs when most behavioral health licensing boards have been addressing telehealth more substantively. However, providers are still quite confused by existing law – and many are clear – but entirely misinformed. Significantly few Boards are now guiding consumers in selecting digital providers. Well-informed, evidence-based models of providing telehealth of all types still stand little chance of being noticed by consumers. The “2021 digital care investor gold rush” is officially in full swing.

Digital Care Investor Stampede

In the last 18 months alone, investors have poured several billion dollars into the telemental health field, creating enticing digital jobs for counselors, MFTs, social workers, psychologists, and psychiatrists, among others. Administrators and clinicians now face the challenges of investing in, buying services from, or working for new digital health companies with an unabashed profit motive. All too many of these companies are run by executives who rarely give evidence of understanding the full range of vulnerabilities in the mental health and addiction populations they purport to serve. These time-proven resources use the safety-net system available throughout the US in churches, safe houses, helplines, and other last-resort systems to provide care to the battered, the homeless, the abandoned, the distraught, and other people who have few alternative options. How this safety net has been incorporated into safety protocols is suspect. ​​​​Without direct involvement with this safety net, vulnerable patients will be harmed.

Also of note are the many digital care startups doing an excellent job of hiring, respectfully contracting, offering professional training, and managing responsible clinicians. Many good employers exist. They offer generous salaries, full W-2 employment with benefits, paid training, licensing fees, time off, and their choice of part-time vs. full-time. They provide ample access to supervision and case management support, treat their consumers respectfully, and show clinicians how to access support services, including safety net services in time of need, on the fly, if ever an emergency occurs. Many actively search for good clinicians and evidence-based training, reliable technology, accurate billing services, and other technology services.

Wide-Scale Mental Health Experiment

Despite the seriousness of the risk, so many investors, business leaders, licensed professionals, and vulnerable consumers have never been involved in such a wide-scale mental health experiment without mandated safety precautions. Some of the most careful watchdogs are scientific review boards, but they are rarely engaged in research projects funded by most companies. Scientific protocols for protecting human subjects are not typically at the top of the discussion list in the Boardroom.

Of even more concern are those who seek mental health relief. The typical patient cannot reasonably be expected to pay attention to human subjects’ protocols and whether or not the company is affiliated with safety net services. The hundreds of millions of dollars of teletherapy digital ads sprinkled throughout the consumer’s digital experience don’t hint at these mundane issues. Before saying more about this topic, let’s consider a key history lesson that can shed light on what’s happening, who stands to profit, and who stands to lose.

Digital Health IT History Lesson of Note

A hard lesson learned in the electronic health record (EHR) rollout starting in the 1990s may shed light on the current direct-to-consumer teletherapy rollout, including why an alarm may be warranted. The early rollout of EHR software led to an avoidable and unfortunate backlash that soured providers for decades to come. EHR hype became evident when providers were required to use software that failed to operate as promised, removed them from patient care, and proved to be a colossal waste of time and money. Providers rebelled across the land. Physicians spoke with loud, robust voices to demand the removal of the software.

At issue is that many early EHR software packages were released when they were still in their “beta phase” without final testing. As is typical with technology, products are intentionally released in their “beta phase” without complete testing to a) start earning quick dollars to keep the startup’s “lights on” and b) to get real-world feedback from users who choose to be early adopters. This strategy works particularly well when government agencies and others in positions of authority are asleep at the wheel, underestimating the power and reach of greed accelerated by technology as it interfaces with newbie users.

The result of the EHR rollout? Medical professionals were angry about early EHR technology and reticent to try other potentially useful technologies. Meanwhile, many tech startup board members and investors pocketed massive profits. An additional issue to notice is that with the failure of the massive EHR rollout, the rebels were physicians in positions to reject the EHRs, and they were successful for the most part. And despite this progress, the Veterans Administration’s EHR system reportedly shows still-present problems with “patient safety issues, employee morale, and productivity.” mental health and addiction consumers, on the other hand, are not often aware of these problems and hardly a position to fight back.

The Dollars Fueling A Massive Direct-to-Consumer Digital Care Roll-Out

Direct-to-consumer digital mental health (DMH) valuations are staggering. GIMBHI reported that mental and behavioral health investments more than doubled between 2019 and 2020, and in Q1 2021, it accounted for 19% of all digital health services funding.2 These companies are strategically positioned to play a critical role in expanding access to care when COVID has created an unprecedented need. However, most equity-backed startups are led by business people who would be hard-pressed to understand or respond appropriately to the complex ethical challenges of working with a vulnerable mental health population. These populations include people impacted by COVID combined with complications related to trauma, grief, alcoholism, drug addiction, poverty, or systemic racism.

Back to the $$$,$$$,$$$

To give the reader a sense of the size of the DMH rollout, a mental health startup named BetterUp recently closed $300 million in a series of fundraising rounds to accelerate its international growth and drive new product innovation. The company provides app-based employee coaching and mental health assistance. It recently reported that this latest funding round brings its valuation to $4.7 billion. While BetterUp is likely to have received enough scrutiny to be evidence-based and otherwise legitimate, no one can know what is happening behind the scenes with the more minor, less conspicuous DMH services stampeding into the marketplace.

Many DHM services don’t have trained behavioral professionals as founders, boards of directors, or advisory boards. Most do not have a scientific advisory board. If they do, interested parties may wish to question whether members of these boards have the background to offer informed direction for technology-based services. Professionals with name recognition are often hired to fill these spots, basically to serve as “window-dressing” for sales purposes.

Many companies are currently funded with advertising and recruiting budgets that can go up to millions. They use these funds to provide an unprecedented amount of money to website owners, Google Adwords, social media, and other digital marketing strategies to provide a 24/7, on-demand therapist who promises to help. 

Another fact that gives one serious pause is that research into self-pay, direct-to-consumer business models is scarce. Thousands of US employers have already signed contracts with these companies, despite their lack of an evidence base and who make unsubstantiated claims. These employers may have been fooled into buying “fool’s gold,” believing the common sales tactic of extrapolating unsubstantiated results from existing research. Smoke and mirror prevail. 

Anecdotally, one of the authors of this article was in a position to demand the research behind one of the county’s largest such investor-backed companies, only to be sent five pieces, two of which were not yet published. Unpublished research isn’t considered proof of sales claims. The other three articles received measured small, “mixed” populations, which failed to substantiate the company’s claims. If employers were to dig beyond the sales hype of many of these companies, they would see where claims of being the “digital version of in-person care” fall short of reality. If they took time to consider the precautions exercised by the mainstream behavioral health and teletherapy digital care companies reimbursed by insurance, they would soon see that treating mental health and addictions is no trifling matter. Innocent people die every day, including those requesting help.

Where Are the Digital Care Sheriffs?

Who can stop unscrupulous businesses from selling effective business models rather than evidence-based clinical interventions to vulnerable consumers? The primary governmental response to the COVID-induced stampede has been to exercise enforcement discretion of HIPAA regulations regarding the choice of HIPAA platforms and promote third-party reimbursement for remote treatment sessions on a par with in-person visits. Governmental flexibility was undoubtedly beneficial with the initial public health emergency created by COVID-related restrictions. However, the continued lack of government and other oversight by other leading groups requires more specialized accountability and training that may border on negligence regarding issues of treatment failure and subsequent disposition. Active management is urgently needed for telemental health and teletherapy. 

One of the primary forces to exert control in the US is the tort system involved with civil lawsuits. However, it isn’t likely that the average mental health client will be able to prosecute digital care companies in the numbers needed to effect change. Another group to consider is the Federal Trade Commission, but their involvement is typically related to fraud. Unscrupulous companies are generally careful not to engage in fraudulent activities, but what is now being witnessed falls into the chasm between fraud and neglect, intentional or not. For investors to be so bold as to attempt to disrupt the mental health and addiction treatment status quo, which is admittedly broken, without visible awareness or concern over human welfare, gives one pause. No formal oversight group in the United States is legislatively authorized to protect this particularly vulnerable population from the potential greed of some self-pay, direct-to-consumer digital health companies. 

On the other hand, the Federal Drug Administration exerts tight control over digitalized tools, apps, and other devices when they purport to offer medical, including diagnostic services. The Drug Enforcement Administration also regulates the inter-jurisdictional telehealth practice of drug prescribing over state lines. Still, short of those two areas, they have been cleverly sidestepped by many of these self-pay, digital-care, and teletherapy companies.

Turning to professional licensing boards and their influence over the clinicians hired by such companies, traditional US or Canadian licensing (registration) boards are typically complaint-driven. That is, they do not usually have police licensees. To act, they require that consumers report errant professionals. In most cases, the boards lack the resources and authority to knock on providers’ doors at will. From the perspective of the insured patient, one must realize reporting a clinician can be daunting. The individual may feel shame about his mental health care, fear stigmatization for seeking such care, or not understand how therapy is supposed to work via technology.  

National health care accrediting organizations such as the Joint Commission (JCAHO), the Council on Accreditation (COA), the Commission on Accreditation of Rehabilitation Facilities (CARF),  and URAC publish standards regarding telehealth practices. Still, participation is voluntary and typically exercised by groups who wish to distinguish themselves. Digital health groups are not required to participate.

Are Other Consumer Protections In Place? 

Some professional associations do not search for wayward members online, never mind non-members, nor do many have the authority to stop profit-driven groups from harming consumers. Associations can try to expose them in their blog posts and can ban companies from advertising at their conferences and publications, and some have. 

Proactively, all the professional behavioral health associations have passed ethical codes of relevance, however. The American Psychological Association also gave a set of general telepsychology guidelines in 2013. In conjunction with three other social work associations, the National Association of Social Work developed extensive Standards for Technology in 2017, which subsequently was voted into their ethical code. Two of the national professional associations have guided the issue of inter-jurisdictional practice. The Association of State and Provincial Psychology Boards (ASPPB) has expanded the PSYPACT. The Association of Social Work Boards (ASWB) recently published a detailed report for telehealth social workers licensed to work across state lines. 

While these professional association efforts are related to telebehavioral health, they do not directly provide protections for consumers, which is the point of the current article, but organizing and censoring errant providers is a start. Then again, since most professionals no longer join their national associations, there is no data to show how many clinicians actually understand and are currently implementing these standards or guidelines.

And the Providers?

Most clinicians also are naive about the big digital health picture. For example, most don’t realize that when signing their employment contracts with most of these companies, they assume liability for whatever happens to the client or patient simply because they are responsible for choosing the right technology to help the person in front of them. Ignorance is not a defense in the face of the law. Traditional digital healthcare employment contracts typically release the company from 100% of the liability related to patient care and saddle the unwitting clinician with all that liability.

A severe problem for clinicians is that they often don’t know how to choose employers. Untrained in business law, they are asked to sign contracts with clauses that are obfuscated with legalese. Many clinicians don’t bother or can’t afford to have the contract reviewed by a reputable telehealth attorney. Many don’t know where to find a reputable telehealth attorney if they can afford one. They may rely on an attorney who doesn’t have digital health expertise and therefore offers lukewarm guidance when negotiating a reasonable employer-employee arrangement with needed protections for the clinician. Many of these clinicians may not know the disadvantages of being a 1099 subcontractor. They may not have adequate malpractice insurance arrangements to cover their new services.

People are complex. Imagine an alcoholic parent of two teenagers, one who is doing poorly at school and dabbling in high-risk behaviors. Suppose they seek assistance dealing with a recent extra-marital affair and ensuing serious marital discord at home. Their manager at work has already spoken twice to them about their lack of focus and propensity to make expensive mistakes. Assume they try to get help through one of the popular apps. Further, guess they failed to achieve their goals after six months of regular text-messaging “therapy.”

Here are but a few of the questions that prudent clinicians should be asking:

1. Should the consumer be expected to understand the many differences between digital and in-person care? 
2. Who will help them articulate complaints if they attribute the therapeutic failure to themself rather than to the limitations of the software? 
3. Would it be reasonable for a consumer experiencing a failed teletherapy encounter to conclude that they “tried therapy,  it didn’t work” and will “ever waste all that time again?” What if the consumer had enough self-esteem to realize that their failure was partly because of the delivery mechanism? Is it reasonable to assume that a consumer who receives unsatisfactory digital care would know where and how to complain if they wanted to do so?
4. Does the reader know where and how they would complain?
5. What would be the probable outcome of going to the effort of lodging such a complaint?
6. Who is tracking and assisting those not helped and possibly harmed by the current rollout? 
7. Where is the mental health safety net for these many new companies? 
8. Where are those with voices powerful enough to force a roll-back, a massive correction?

Digital Care Response by the Professional Telehealth Community

As stated in the JAMA Network article entitled, The Rise of Venture Capital Investing in Mental Health, Richard Chipkin, Ph.D. commented:

            Dr. Shah is right when he says that using software to address mental health care needs to be carefully considered… IIt’seasy to make a fast buck on software.

Other stakeholders also mention the need for the professional community to take note. Fierce Health Care’s digital mental health market is booming. Here is why, some experts are concerned; author Heather Landi quoted John Torous’statement, “There is still much we do not know about how the tech part works and for whom.” He added, “With direct-to-consumer advertising and marketing, companies sometimes exaggerate what these apps can do. They will take a small pilot study and extrapolate that it can work for huge populations.” 

Dr. Torus is a direct-to-consumer app researcher and associate professor of psychiatry at Harvard Medical School. He refers to the thousands of new businesses that recently joined the digital health frenzy and not the many responsible telehealth organizations proceeding cautiously. According to Landi, some investors are also raising concerns about the potential downsides of equity backed-digital health services companies and patient safety. For instance, she explained that challenges could occur if a therapist suddenly disappears because a startup fails. After all, it runs out of money. Landi also quoted Adam Chekroud, co-founder and chief product officer of Spring Health, who remarked that many companies don’t validate their products. He said:

            There are a few outlier companies that are committed to clinical validation. Still, in general, the incentives are pretty low for companies to commit to real validation and invest in it.

Human Rights Framework for Evaluating Digital Health Services Ethics

In 2019, researchers Lauri Goldkind and Lea Wolf surveyed 579 consumers to examine the ethics demonstrated by a leading direct-to-consumer teletherapy platform.3 Participants were asked to compare the values of the Human Rights Framework 4 5 6 with the language of one teletherapy platformer of service agreement. That Human Rights Framework emphasizes dignity, non-discrimination, transparency, accountability, and participation. Goldkind & Wolf also reported in 2019 that:

• Clients with prior experience with mental health professionals found the service agreements to be the most ethically compromised. 
• Employed and better-educated individuals also found the service agreement to be ethically suspect. 
• Individuals with less education and who were unemployed were at the most risk for signing consent documents that they didn’t understand. 

The researchers then outlined an example of the ethical questions that can emerge from introducing a new model of profit-driven, on-demand mental health care. Goldkind & Wolf also published a related article in 2021, again reporting that providers express ethical concerns with direct-to-consumer telemental health.7 While professional concern over the lack of information about ethics related to telebehavioral health is nothing new, the need for the professional community to act in constructive ways has never been more pressing.

Conclusion

An unprecedented number of uncontrolled psychological studies are underway, independently conceived and funded by profit-driven investors. These experiments often recruit some of society’s most vulnerable members without recognizing their vulnerabilities. Traditional safety-net mechanisms are ill-positioned to manage the potential failure of these massive experiments. 

Professionals and their organizations are encouraged to be vigilant and take action to prevent the unfettered stampede of unscrupulous companies offering jobs to incompetent clinicians. Both groups are falling prey to “fools gold.”

FIRST STEP: Recognize the urgency of the current state of affairs.

SECOND STEP: Do no harm. Get the training needed to understand the problem and manage it head-on. Learn about the particular digital systems involved, the leadership of any companies relied on for care, and whether its modality is evidence-based. Get a solid grounding in telehealth training approved for CME and CE hours to clarify many nuanced competencies to meet clinical, legal, and ethical compliance requirements.

THIRD STEP: Inform colleagues of these issues and demand that legislators take action. Become advocates for one’s profession and the people being “served.”

Unfortunately, clinician-technologists in the telehealth underground have long since rumored that a correction to beta-phase releases of health information technology would require a large-scale catastrophe. In telebehavioral health, that catastrophe could take the form of a mass shooting in a large, reputable school, the assassination of a public figure, or some other media-worthy event that is then attributed to poorly delivered digital health. That gloomy prediction has never been more salient.

Footnotes and References

1. Glueckauf, R. L., Maheu, M. M., Drude, K. P., Wells, B. A., Wang, Y., Gustafson, D. J., & Nelson, E.-L. (2018). Survey of psychologist’s telebehavioral health practices: Technology use, ethical issues, and training needs. Professional Psychology: Research and Practice, 49(3), 205–219. https://doi.org/10.1037/pro0000188
2. Friis-Healy, E. A., Nagy, G. A., & Kollins, S. H. (2021). It Is Time to REACT: Opportunities for Digital Mental Health Apps to Reduce Mental Health Disparities in Racially and Ethnically Minoritized Groups. JMIR Mental Health, 8(1), e25456.
3. Goldkind, L., & Wolf, L. (2020). Selling your soul on the information superhighway: Consenting to services in direct-to-consumer tele-mental health. Families in Society, 101(1), 6-20.
4. Sabin, J. E., Skimming, K. (2015). A framework of ethics for telepsychiatry practice. International Review of Psychiatry, 27, 490–495.
5. Helfer, L. R. (2006). Toward a human rights framework for intellectual property. UC Davis Law Review, 40, 971.
6. Laplante, L. J. (2008). Transitional justice and peace building: Diagnosing and addressing the socioeconomic roots of violence through a human rights framework. The International Journal of Transitional Justice, 2, 331-355.
7. Goldkind, L., & Wolf, L. (2021). That’s the Beauty of it: Practitioners Describe the Affordances of Direct to Consumer Tele-Mental Health. Families in Society, 1044389421997796.

Accepting Telehealth Jobs: 5 Big Legal & Ethical Mistakes to Avoid

Do you have questions about being employed or looking for employment from a digital health company? Online employment can pose dilemmas that leave clinicians at a loss for how to proceed. This program will answer your questions about how or reasonably uphold your legal and ethical mandates.

Read More