Ousted Cerebral CEO may sue company, accuses management of scapegoating on Schedule 2 prescribing

Troubled telemental health provider Cerebral may face a lawsuit from former CEO Kyle Robertson. Ousted in May when the company’s prescriptions for ADHD patients started to be excluded from pharmacies such as Truepill, CVS, and Walmart for Schedule 2 (potential for abuse and misuse) medications such as Adderall, Ritalin, and Vyvanse [TTA 6 May], Robertson has written a letter to Cerebral demanding access to documents. The types of documents requested, according to (paywalled) Insider, include “possible breaches of fiduciary duty, mismanagement and other violations of law.” Usually, these are a setup to determine whether others on the company board and leadership were the real culprits in business mismanagement, and a prelude to a legal filing.

CBS News obtained a copy of the Robertson letter, in which “Robertson says he was pressured by the company’s investors to “sell more stimulants” and believes his ouster was an effort to “scapegoat” him as these investigations arose.  He was urged by one board member  that “the easier you make it for people to get stimulants, the better for the business and its customers.” and also claimed that an investor told Robertson’s partner the company’s “ADHD business is crushing and it’s a cash cow … Kyle’s got to push this thing further.” Other documents obtained by CBS allegedly detail clinical safety issues, staff “practicing with expired (or) suspended license(s),” and duplicate accounts which could set the stage for overprescribing. Other documents allege lack of training, pushing prescriptions to 95% of patients, and disregarding state regulations putting licenses at risk. [TTA 29 June] The current management, led by David Mou, has denied this all.

Multiple investigations are proceeding. From May on, Cerebral came under investigation by the Federal Trade Commission (FTC) on deceptive advertising and marketing practices, the Drug Enforcement Agency (DEA) as part of increased scrutiny of telehealth providers and pharmacies possibly overprescribing telehealth-generated prescriptions, and most significantly, the Department of Justice (DOJ) subpoenas on allegations of overprescribing. A prior wrongful dismissal lawsuit by Matthew Truebe, Cerebral’s former VP of product and engineering, alleged that the company put growth before patient safety, including prescribing ADHD drugs to 100% of diagnosed patients as a retention strategy. The concatenation of evidence from multiple sources makes a lawsuit by Robertson, who also cites other factors, probable–unless this is being used as a tablespoon to sweeten his severance.

Prior to that, Cerebral was one of the leaders in the still-hot digital mental health category. In December 2021, their $300 million Series C raise led by Softbank boosted their valuation past $4.8 billion, employed 4,500, and had 210,000 patients. In October, they released 400 staff but other reports indicate far more. Also FierceHealthcare

Perspectives: Creating consistent standards isn’t a once and done job

TTA has an open invitation to industry leaders to contribute to our Perspectives non-promotional opinion area. Today’s contribution is from Rhod Joyce, Deputy Director of Innovation Development at NHS Transformation Directorate and previously Head of Partnerships for NHSX. As Deputy Director of Innovation Development within the NHS Transformation Directorate, Rhod works to support the ecosystem in the development, assurance, and deployment of digital tools and services at scale. Key programs include the Digital Health Partnership Award and the Digital Health Technology Assessment Criteria. He drives support for patients to access digital health apps to support the management of long-term conditions and leads the Transformation Directorate’s Partnerships team.

This is the second Perspectives contributed by Wysa, an AI-enabled therapy coach for mental and emotional wellness. It recently was granted an FDA Breakthrough Device Designation prior to premarket review. 

Interested contributors should contact Editor Donna. (Pictures and graphs are welcome)

Technology is evolving and becoming more and more commonplace in healthcare. As a result of the pandemic, more people are open to the idea of digital treatment tools, and the NHS has pledged to provide ways to ensure that digital inclusion is accelerated. On-demand healthcare, virtual reality, online treatment sessions, big data, and predictive healthcare are all improving access and outcomes. Online and digital health resources can help with prevention, self-care, shared care and shared decision-making, long-term condition management, and appropriate use of urgent and emergency care.

The challenge for commissioners comes when trying to select which tool is best. There are over 350,000 digital health apps in the market, with an average of 250 new health apps being released every day. The question then becomes, how can commissioners and clinical leads uphold safety standards, whilst putting the best tools in the hands of clinicians and patients?

Historically the NHS has worked to a number of different standards, with various contributions to the Apps Library and a digital assessment questionnaire that had evolved. From a patient-facing perspective that was very complex, but it also raised issues for commissioners who had no common standard to work towards.

In most industries such as banking or travel, there is a baseline standard that everyone adheres to and knows is a minimum – an ISO or equivalent. But healthcare has been lacking. That is why we brought together all the standards so that digital health technologies that are being considered by NHS or social care organizations should be assessed against the Digital Technology Assessment Criteria (DTAC), regardless of procurement route, by the NHS or social care organization that is buying the product.

It defines standards for clinical safety, data protection, cybersecurity, and technical assurance and interrupts and also with a view of accessibility and usability and they are set out now as the absolute baseline that digital health technologies need to meet to operate safely within health and social care. While DTAC is intended to be a ‘one size fits all’ baseline criteria in terms of safety and security, it is intended to be part of procurement, it is not intended to be the complete question set for procurements and should be supplemented with additional specifications including any policy and regulatory requirements.

Because clinical safety isn’t a once and done thing. Having a set of standards does not mean that once that box is ticked an application is fine and available to use for everyone. It’s necessary to continuously uphold clinical standards and safety logs that prove efficacy and excellence. Every interaction, assessment, and engagement will result in new information that needs to be tested against the appropriate criteria. A clinical safety risk profile is dependent on a daily update.

When we look at developing standards we need to look at a systems focus, national programs, and patient-facing criteria. These areas are three very different things but in the past have been looked at together, which has muddied the waters. DTAC applies to all types of digital health technologies, from electronic patient records to public-facing health apps.

By ensuring that the patient needs and healthcare system requirements are front and center of every development, every innovation, every interaction, we can be sure that we are delivering the right tools for truly personalized care. That commitment can’t be a one off. If we’re going to do the right thing, let’s do it repeatedly. Only with a common set of standards that are continually being addressed and revisited, can we safely operate and allow for the innovation and progression that the NHS needs to meet an increasingly complex and varied range of needs in a modern healthcare setting.

Perspectives: why digital apps need an in-house clinical safety lead

TTA has an open invitation to industry leaders to contribute to our Perspectives non-promotional opinion area. Today’s contribution is from Emma Taylor of Wysa, an AI-enabled therapy coach for mental and emotional wellness. It recently was granted an FDA Breakthrough Device Designation prior to premarket review. Ms. Taylor is Wysa’s UK child and adolescent mental health services (CAMHS) Clinical Lead and Clinical Safety Officer. She is a clinical nurse consultant specializing in children and young adult mental health, including digital mental health.

Interested contributors should contact Editor Donna. (Pictures and graphs are welcome)

One of the reasons that the NHS is so widely loved by patients and revered around the world is its commitment to doing the best thing by patients. Where many patients are is online. With over 350,000 digital health apps on the market, and an average of 250 new health apps released every day, how can we uphold safety standards while putting the best tools into the hands of clinicians, patients, employers, and employees?

Unfortunately, most tech and digital organizations don’t have in-house clinical safety officers to be accountable for clinical safety and ensure that effective clinical risk management is carried out at all stages of development and deployment.

A clinical safety officer’s role is to ensure that conclusions which are drawn are complete, objective, and based on robust evidence. Often that means pushing back and drawing an inference that perhaps a particular intervention or tool is not right for a section of the population.

Having an in-house clinical safety officer at a technology company enables them to be faster moving without compromising on integrity and safety. Having this capability in house allows a tech company to accelerate innovation in a way that is safe and aligned to both system-wide and patient needs, bearing in mind what the NHS needs to deliver the best health outcomes for the population.

As well as in-depth understanding of the rigorous evidence bases for the interventions we are delivering, we have to look at the wider context in which a tool is operating. So within mental health, it’s about seeing social media trends, and the impact that viral videos for example might be having. It’s about seeing the effects of the economy and the cost of living. Or world events and worry. It’s about looking at the language people are using and ensuring any AI language processing picks up on potential nuance and is aware of flags for concern. Most importantly, it is about working with service users to understand the contexts within which they use the technology and how they need it to work for them.

It is also essential to listen to users, and reflect and identify the experiences of people and what they want, need, and what works for them. Young people want more digital tools for mental health. That is what they are telling us. But not every technology company is doing the right thing. If they do not have clinical safety at their core, negative outcomes can occur. A clinical safety officer is constantly asking questions. What happens if this is taken out of context? What happens if something interacts? What if someone hacks? And ultimately what is the clinical risk?

Working as a clinical safety officer is an incredibly collaborative role, where it is necessary to collaborate with service users and staff across organizations such as ORCHA as well as the NHS. This means that we are able to embrace the legislative changes and be part of the conversations around what needs to be in the next round of legislation, to keep safety standards as high as possible.

Risks are always shifting and changing, and an in-house clinical safety officer means that clinical safety documents are kept up to date and implemented so that patients get the best outcomes. It’s important not to get caught up in the capabilities of technology in and of itself, and to ensure that the digital tool is safe and aligned to the real world and the system in which it operates. In the end, having a clinical safety lead is about patient safety and creating an environment that digital health care is an integral and robust part of, innovating for the best patient outcomes.

The clunk continues: Q2 2022 digital health funding fades to $4.1B in Q2, down 50% from 2021

Digital health funding continues to take a plunge. Knocked about by the hangover from the pandemic, a grinding war between Russia and Ukraine, gasoline prices jacked up worldwide, and knock-on inflation and looming stagflation, funding continues to slide. The decline in Q2 digital health deals and funding to $4.1 billion more truly reflects the downturn than Q1’s relatively buoyant $6.1 billion, which benefited from the carryover of deals negotiated during 2021’s boom and closing then [TTA 6 April]. Year over year, it was half of 2021’s high of $8.3 billion.

  • 2022’s first half (H1) total of $10.3 billion was down 31% from 2021’s $15 billion. Despite this, it is 63% above the pandemic-stricken 2020’s H1 $6.3 billion. 
  • Average deal size has dropped to $31.2 million from 2021’s full-year $39.5 million and even 2020’s $30.6 million, accounting for inflation in the past two years. Looking at funding size by series year over year, Series A funding is flat but funding for Series B, C, and D+ have dropped substantially.
  • No startups went public but four digital health companies announced plans to go public or were reported to be planning public exits. One SPAC was announced in June to close in Q3, that of VSee and iDoc Telehealth with Digital Health Acquisition Corporation. SPACs, as this Editor has noted, have gone from Funding Hero to Zero under 2022’s economics, causing many SPACs to crack (Owlet, Talkspace) and increased scrutiny by the Feds [TTA 9 June]. SOC Telehealth, an early SPAC, went private after a 90% share price drop [TTA 8 Feb].
  • Average monthly M&A has dropped substantially. 2021’s monthly average of 23 has dropped to 20 in Q1 and 13 in Q2, for a H1 average of 16.
  • Most popular funding areas are mental health (a far ahead #1 at $1.3 billion), oncology, and cardiovascular. Diabetes dropped from #2 to #4, skewed last year by Teladoc’s acquisition of Livongo. Oncology rose to #2 from #6 in 2021. For mental health, given increased Federal scrutiny and legal problems of companies like Cerebral plus the expansion of Teladoc and Amwell into the area, this Editor does not expect telemental health companies to continue to attract this level of funding but may be attractive for M&A.
  • Disease monitoring (a/k/a RPM) as a value proposition moved from #8 to #3 in investment at $1.4 billion. R&D and on-demand healthcare remained in their #1 and #2 positions.

As TTA has noted previously, this was all to be expected. Will 2022 funding perk up like 2020’s did through Q3 and Q4, or fall off like in 2019 as money sits on the sidelines? Rock Health does try to put a rosier shine on the retrenchment in its roundup, as has venture capital–reality can be good for you. Another depressive factor is regulatory uncertainty in multiple areas and Federal involvement, which some companies can work to their advantage. The Rock Health summary discusses this at length. Also Mobihealthnews

Wednesday news roundup: PicnicHealth $60M Series C, can a downturn be good for digital health, Cerebral ran wild, a tart take on HIMSS and where it’s going

PicnicHealth had a bit of one, even in this down market. This company which uses machine learning to build data sets for life sciences by working directly with patients and giving them single-source access to their data raised a $60 million Series C via new investor B Capital Group, with existing investors Felicis Ventures and Amplify Partners. The new funding will be used to build 30 new patient-centered real-world data cohorts. Adam Seabrook, Partner at B Capital Group, will be joining the PicnicHealth board of directors. Their total raise to date is $97 million since 2014 (Crunchbase). The platform was launched in 2020. FierceBiotech, release

Funding news may be a little light nowadays, and if you’re public, you’re looking at double digit share price losses, but couldn’t you guess–the downturn may be good for digital health founders! That’s the view of Big VC General Catalyst’s Hemant Taneja, said at Collision 2022, a Toronto tech conference. Now before you’ve thought the man has totally gone out of his gourd with $5+ gallon gasoline (US), 10% inflation, and rolling blackouts looming on both coasts and the UK, it is true that businesses founded in downturns tend to be tough–my father’s business was founded at the start of the Great Depression. As Mr. Taneja put it, tighter times make for more mission-driven “better founders, better investors and better executives”. Secular trends are in their favor in tech and digital transformation, but there will be another correction coming as the market is over-capitalized. Is it the dot-com boom/bust all over again? Only time will tell, but the crackups are already piling up. FierceHealthcare

Speaking of crackups, Cerebral. A report in the annoyingly paywalled Business Insider tells a tale of Telemental Health Running Wild. Former employees and ~2,000 leaked documents claim that Cerebral had no more than a nodding acquaintance with clinical standards until the Feds stepped in. For starters, they took on patients they should not have, didn’t train their nurse-practitioners and other employees, pushed prescriptions to 95% of patients, disregarded state regulations putting licenses at risk, and generally had more twists than a barrel of pretzels. And this was a company prescribing Schedule 2 drugs that had at peak 210,000 active patients and 4,500 employees.  HISTalk summarizes the article, with our thanks. But it’s par for the course, according to a new JMIR (Journal of Medical Internet Research) study also mentioned that found that “many digital health companies have a low level of clinical robustness and do not make many claims as measured by regulatory filings, clinical trials, and public data shared online.” 

And returning to HISTalk (29 June news), there’s a group of comments from a “HIMSS insider” about how that organization is being managed that long-time observers of this organization will find interesting. Employees thought that HIMSS22 was “awkward”. New and cool conferences HLTH (which initially faltered) and ViVE (which HIMSS didn’t even bother to scout) have taken much of the ‘must attend’ and buzz away from HIMSS. Now this wasn’t supposed to happen with the buy of hipper Health 2.0, to which your Editor was connected–but H2O was HIMSS-ized and effectively killed off even before the pandemic. Regional conferences have disappeared, along with a fair number of employees. HIMSS Analytics is sold. Now this could be all one person’s opinion–but what do you think?

CVS, Walmart refuse Cerebral, Done Health controlled substance prescriptions via telehealth; Cerebral CEO replaced

More hot water dumped by CVS Health and Walmart on Cerebral, Done Health. The two retail giants announced last week that they would refuse to fill prescriptions of all controlled substances by telemental health providers Cerebral and Done Health. Cerebral was already under investigation by DOJ on over-prescribing of controlled substances by its provider network as a business practice, including advertising [TTA 10 May]. It turns out that seed-stage Done Health, a telemental provider specializing in ADHD diagnosis and support, is also facing the same scrutiny and treatment. 

Cerebral had already restricted prescribing controlled substance prescriptions for new ADHD patients as of 9 May. They initially continued to prescribe controlled substances for new patients diagnosed with other mental health conditions, according to a memo from their chief medical officer to their clinician network, but stopped that on 20 May with an exception for opioid use disorder. Truepill, Cerebral’s recommended mail order pharmacy, had stopped filling all Cerebral Schedule 2 prescriptions prior to that date. The CVS and Walmart refusals close off two more pharmacies for patients. FierceHealthcare

Earlier in the month, Cerebral CEO and co-founder Kyle Robertson was forced out by the Cerebral board. His replacement by medical officer and president Dave Mou, MD is effective immediately. According to reports, Robertson is fighting their action, calling it illegal and accusing the board of making him the scapegoat for the company’s problems. FierceHealthcare

Companies like Cerebral and Done grew quickly in 2020-21 due to the pandemic-driven loosening of psychiatric patient evaluations, eliminating the usual initial in-person initial visit and permitting online treatment. Restrictions were also loosened for diagnoses permitting the prescription of Schedule 2 drugs (those judged to have potential for abuse) with solely a video visit and follow up. With fast growth came more need to maintain that growth, according to current and former employees.  

Upon taking the CEO position, in an email to the prescriber team, Dr. Mou announced that patients on controlled substances would be transitioned as follows: a visit prior to 1 August to establish a treatment plan to transition to a non-controlled medication, titrating off of their controlled substance, or transferring their care to a local provider by 15 October. With the pandemic policies around telehealth ending soon, this is called playing defense, though it well may stop growth. Wall Street Journal, The Verge

DOJ investigates telemental Cerebral on over-prescribing of controlled medications

DOJ dropped an anvil on Cerebral’s head Friday night. Last week’s reports on the Drug Enforcement Agency (DEA) investigation of telemental health provider Cerebral were confirmed on Friday with the official notification that the US Attorney’s Office for the Eastern District of New York had subpoenaed the company as part of their investigation into possible violations of the Controlled Substances Act. According to the Wall Street Journal, the subpoena was issued to Cerebral Medical Group, the corporation it uses to contract with clinicians and provide healthcare services. The company is fully cooperating with the investigation by the Department of Justice, which includes turning over records pertaining to their prescribing of controlled substances such as Adderall and Xanax. This has been reported by FierceHealthcare which is citing (paywalled) Insider.

Last week, Cerebral announced that it would stop prescribing controlled substance prescriptions for new ADHD patients as of 9 May. However, they would continue prescribing controlled substances for other mental health conditions, according to a memo from their chief medical officer to their clinician network.

Cerebral’s Saturday statement in response to the subpoena maintains (from FierceHealthcare):

“To be clear, at this time, no regulatory or law enforcement authority has accused Cerebral of violating any law”

and

“Cerebral has dedicated significant time, energy, and resources to ensuring that its policies and procedures regarding the prescription of controlled substances and other medications both are medically appropriate and comply with all applicable state and federal law,” the statement also said. “As a responsible company, Cerebral is continuously improving its systems and practices. The foundation of this company is built on evidence-based, ethical, and compliant practices so that our patients can receive the highest quality of care and achieve the best clinical outcomes.”

The company has done well with the increased demand for mental health services provided via telehealth including remote evaluating and prescribing. In December, their $300 million Series C raise boosted their valuation past $4.8 billion.

Darkening this rosy picture is, as TTA noted last week, that a former VP of product and engineering, Matthew Truebe, has sued Cerebral for wrongful dismissal. According to him, the company put growth before patient safety, including overprescribing medications for ADHD. Other reports indicate that the DEA interviewed other former Cerebral nurse practitioners who felt pressured to prescribe ADHD medication after a short video call. The Verge

Cerebral has also gained notoriety for dodgy advertising claims pertaining to ADHD and other conditions. In January, advertising on TikTok and Instagram was pulled for claims that obesity is “five times more prevalent” among adults with ADHD, and stated that getting treatment for the mental health disorder could help patients “stop overeating.” These followed inquiries by Forbes and NBC News. Also pulled was their Facebook advertising around prescribing Type 2 diabetes medications, GLP-1 agonists, as a “wonder drug” for weight loss. 

Will this put a damper on the burgeoning area of telemental health and remote prescribing? Stay tuned. Also Becker’s. 

Weekend news and deals roundup: Allscripts closes sale of hospital EHRs, closing out CEO; DEA scrutiny of Cerebral’s ADHD telehealth prescribing; more telehealth fraud; Noom lays off; fundings; and why healthcare AI is only ML

That was fast. Allscripts closed its $700 million March sale of its hospital and large physician practice EHRs to Constellation Software Inc. through N. Harris Group. The Allscripts EHRs in the transaction are Sunrise, Paragon, Allscripts TouchWorks, Allscripts Opal, and dbMotion. They reported their Q1 results today. According to HISTalk earlier this week, CEO Paul Black will be stepping down, with President Rick Poulton stepping in immediately. Update–this was confirmed on their investor call Thursday and the transition is effective immediately. No reasons given, but there were no effusive farewells.  Healthcare Dive

A damper on telemental health? Online mental health provider Cerebral, which provides talk therapy, audio/video telehealth, and prescriptions for anxiety, depression, insomnia, ADHD, and other conditions, is finding itself under scrutiny. This week, its main mail fulfillment pharmacy partner, Truepill, stopped filling prescriptions for Adderall, Ritalin, Vyvanse, and other controlled Schedule 2 pharmaceuticals. Cerebral is redirecting current patients with these prescriptions to local pharmacies and as of 9 May, will not prescribe them to new ADHD patients.

Based on reports, the Drug Enforcement Agency (DEA) is looking at Cerebral in particular as part of a wider scrutiny of telehealth providers and pharmacies filling telehealth-generated prescriptions due to allegations of overprescribing. It also didn’t help that a former VP of product and engineering plus whistleblower claims in a wrongful dismissal lawsuit that Cerebral execs wanted to prescribe ADHD drugs to 100% of diagnosed patients as a retention strategy. Bloomberg Law. Unfortunately, Insider is paywalled but you may be able to see a report in the Wall Street Journal. Becker’s Hospital Review, FierceHealthcare

Also troubling telehealth is recurrent fraud, waste, and abuse cases involving Medicare and Medicaid. Back in 2020 the National Healthcare Fraud Takedown took down over 80 defendants in telemedicine fraud [TTA 2 Oct 20, 30 Jan 21]. The Eastern District of NY based in Brooklyn has indicted another physician, an orthopedic surgeon, in a $10 million fraud involving durable medical equipment (DME). In exchange for kickbacks from several telemedicine companies, he allegedly prescribed without examination and with only a cursory telephone conversation DME such as orthotic braces. DOJ release

Some fundings and a sale of note–and a big layoff at a well-known digital health leader:

  • Blue Spark Technologies, an RPM company with a patented Class II real-time, disposable, continuous monitoring body temperature patch good for 72 hours, TempTraq, raised a $40 million intellectual property-based debt solution (??) to fund growth led by GT Investment Partners (“Ghost Tree Partners”) with support from Aon plc (NYSE: AONRelease
  • Specialty EHR Netsmart acquired TheraOffice, a practice management platform for physical therapy and rehabilitation practices which will be added to its existing CareFabric platform. Neither terms nor management transitions were disclosed in the release.
  • ‘White label’ telehealth/virtual health provider Bluestream Health is implementing its systems in Mankato Clinic, with 13 facilities across southern Minnesota. It’s a rarity–physician-owned and led–and in business since 1916. This also fits into a new telehealth trend–providers working with ‘white label’ telehealth companies and not with the Big 5. Release
  • Ubiquitously advertised (in US) weight-loss app Noom is laying off a substantial number of employees–180 coaches plus 315 more employees. Reportedly they are pivoting away from on-demand text chat to scheduled sessions that don’t require so many people. While profitable in 2020 ($400 million) and with Series F funding of over $500 million in 2021, it’s come under criticism that while its pitch heavily features easy behavioral change achieved through cognitive behavioral therapy (CBT), their real core of weight loss is severe calorie restriction. Engadget
  • Element5, an administrative software provider for post-acute facilities, raised a $30 million Series B from Insight Partners. They claim that their software is AI and RPA (robotic process automation) based. ReleaseMobihealthnews

And speaking of the AI pitch in healthcare, a VC named Aike Ho explains why she doesn’t invest in healthcare AI companies because there’s no such thing in healthcare–it’s just machine learning. On that, Ms. Ho and your Editor agree. She also makes the point that the market they address is ancillary and not core services, plus they have difficulty clinching the sale because they don’t relate well to achieving or can’t prove at this stage improved clinical outcomes. Ms. Ho’s looooong series of Tweets is succinctly summarized over at HISTalk (scroll down halfway).

Wisconsin’s $5M for child psychiatry, community telehealth; FQHC patients prefer audio-only telehealth–Rand

The state of Wisconsin is granting $5 million to telehealth vendors, equally split between child telemental health and community telehealth delivery. Governor Tony Evers announced the grant series which was funded by the American Rescue Plan, the third COVID stimulus round of 2021 as part of the State and Local Fiscal Recovery Fund to bolster rural telehealth plus mental health. With COVID fading, the funds are being redeployed by states for related health initiatives.

Applications are due 6 May for:

  • Up to five one-year grants of approximately $500,000 will be provided to Wisconsin hospitals and health systems to expand and improve child psychiatry telehealth services
  • Between 25 and 50 providers to partner with community organizations to establish neighborhood telehealth access points at food pantries, homeless shelters, libraries, long-term care facilities, community centers, and schools. These are targeted to reach people with limited access to technology and reliable internet service. These are also one-year grants of up to $100,000 each.

While big telehealth funding for mental health grabs the headlines, at the local level, it is these state initiatives that often keep both providers and smaller telehealth companies going. State of Wisconsin release, mHealth Intelligence

RAND Corporation’s study of telehealth in Federally Qualified Health Centers (FQHCs) found that audio-only telehealth was used more frequently during the pandemic, and continued to be used by patients for behavioral health even when primary care shifted back to in-person visits. The study group was the California Health Care Foundation (CHCF)’s 45-center Connected Care Accelerator (CCA) program started in July 2020. These centers serve rural, low-income, and underserved populations, common in places like Wisconsin (this Editor worked with a successful FQHC ACO there) and in California.

Audio and video telehealth was problematic for both the patient population and the clinics. Those with limited English proficiency participated in a significantly lower percentage of video visits. Behavioral health centers also had difficulties. Centers that coordinated efforts to replace audio-only with video visits had specific promising practices.

According to the RAND study, “key facilitators of telehealth implementation were leadership support, patient willingness to use the technology, platforms that were easy to use and access, a sense of urgency within clinics, changes in reimbursement policy, and training opportunities for staff.” Another recommendation was to retain centers to serve as distant telehealth sites (and to be reimbursed). Also mHealth Intelligence

Over 400 telehealth groups urge Congress to retain CARES Acts gains on remote care

430 telehealth and remote care companies, along with major health providers and associations, have organized to petition Congress to make permanent the changes instituted by the Coronavirus Aid, Relief, and Economic Security (CARES) Act for the duration of the COVID-19 public health emergency (PHE). These changes will expire this year unless the pandemic emergency extends into 2022.

Like the Senate Telemental Health Care Access Act of 2021 that would extend telemental health Medicare coverage to patients without a prior in-person visit [TTA 16 June], the extension of CARES Act coverage would require Congressional action to amend the Social Security Act: for telemental health, Title XVIII; for telehealth, Section 1834(m). While the Telemental bill is actually in the Senate, the permanent expansion of telehealth and remote care would require its own and far more complicated bill and corresponding regulations.

Based on the letter (PDF link), these changes would include:

  1. Remove Obsolete Restrictions on the Location of the Patient and Provider. This is the rural geographic restriction.
  2. Maintain and Enhance HHS Authority to Determine Appropriate Providers, Services, and
    Modalities for Telehealth. This would expand the list of practitioners, services, and also expand telehealth in some cases to audio-only consults.
  3. Ensure Federally Qualified Health Centers, Critical Access Hospitals, and Rural Health Clinics
    Can Furnish Telehealth Services After the PHE. These are the ‘safety net’ providers for underserved and rural areas.
  4. Remove Restrictions on Medicare Beneficiary Access to Mental and Behavioral Health Services
    Offered Through Telehealth. This covers much the same ground as the Telemental bill.

What is unclear, of course, it being Washington, is how quickly Congress will bestir itself to enact these changes to existing law before the end of 2021 and the expiration of the CARES Act window with, presumably, the end of the PHE. American Telemedicine Association (ATA) releaseHealthcareITNews, FierceHealthcare

Telemental Health Care Access Act introduced in US Senate to repeal in-person requirements for mental telehealth care

Eliminating the Medicare requirement for an in-person visit prior to telehealth used for mental health services. Yesterday, the Telemental Health Care Access Act of 2021 (PDF link) was introduced in the US Senate. It is a bipartisan bill sponsored by four senators, Bill Cassidy, MD (R-LA), Tina Smith (D-MN), Ben Cardin (D-MD), and John Thune (R-SD). It specifically amends Title XVIII of the Social Security Act to ensure coverage of mental health services furnished through telehealth without a prior in-person visit.

The 2021 Consolidated Appropriations Act on one hand removed the geographic restrictions for Medicare, but on the other imposed a restriction that requires physicians to see their mental health patients in-person at least six months prior to a Medicare-reimbursed telehealth visit. It’s significant as Medicare and the Physician Fee Schedule (PFS) [TTA 3 Dec 20] set the standards for commercial payers on coverage and reimbursement. The bill, so new it does not have a number yet, is designed to eliminate that requirement.

In the US, there is an acute shortage (at least 6,000) of mental health providers, particularly psychiatrists. Back in 2013, 70 percent of psychiatrists were over the age of 50 and due to retire. As to the top of the funnel, few medical graduates choose psychiatry due to compensation issues (paying for expensive medical education). Those who do are trained in residencies and tend to stay near large cities, further exacerbating the existing geographic imbalance. It’s a situation that hits this Editor close to home as her own brother is one of those semi-retired psychiatrists. He apparently has not been replaced in the clinic practice in which he worked for over 20 years and his private practice is self-limited. Most of the psychiatrists in his suburban area are retiring as well. Psychiatric mental health advanced practice registered nurses (PMH-APRN) fill only part of this gap. (For a further discussion of APRNs and their role in mental health practice, see this issue of Psychiatric Times)

Telemental health can fill some of the gap in rural areas, for continued support in mental health counseling and medical management, and for those who would benefit from cognitive therapies, a burgeoning area for telehealth companies.

The bill is supported by the American Telemedicine Association (ATA), the American Psychiatric Association, the American Psychological Association, and at least 30 companies (including the leading telehealth providers such as Teladoc and Doctor on Demand) and non-profit organizations such as the American Foundation for Suicide Prevention. ATA release and overview of present in-person requirementsSenator Bill Cassidy release.

VA’s Secretary Shulkin wants more private care options for veterans as part of reforms

Released days before our Thanksgiving turkey (or steak, or lasagne), the Department of Veterans Affairs Secretary David Shulkin, in an interview with The Wall Street Journal (paywalled), stated his aims to increase veteran access to private care without having to rely on the VA to approve or coordinate it. This is in the direction of the recently signed bill with $2.1 bn in funding for the Veterans Choice program that targets veterans living in areas without ready access to VA facilities, or who are told they cannot get an appointment within VA within 30 days.

“The direction I’m taking this is to give veterans more choice in their care and be the decision maker for their care, which I fundamentally believe is a concept that has to be implemented,” Shulkin said. He admitted that opening the VA to private care programs will be gradual. Mentioned in the article were commodity, non-urgent services like podiatry and audiology.

For instance, the Veterans Choice program started in 2014 after wait times exploded in multiple regions, delaying care past 30 days for over half a million veterans for years well into 2015. Veterans died after waiting for care or follow up for months, notably at the Phoenix VA, creating a massive and rightfully political problem. 

Dr. Shulkin’s drive for reform and speed of care is also increasing the pace telehealth expansion with programs such as Anywhere to Anywhere which would allow cross-state consults and care that published their Federal proposed rule last month, and the rollout of VA Video Connect [TTA 9 Aug]. Earlier this year, four companies were awarded a total of over $1 bn to provide Home Telehealth over five years, reviving a fading program and updating it to not only smaller in-home tablets, but also to mobile and laptop devices. As noted in our OnePerspective article on telemental health deployment, the VA has the largest program in the US, dating back to the early 2000s.

While some veterans organizations, such as the Veterans of Foreign Wars, have been critical of moves towards integrating private care, this Editor cannot see where the problem truly is. Healthcare Dive, The Hill 

Can expanding telehealth help VA solve veteran access crisis?

The Department of Veterans Affairs (VA) has been both one of the largest US users of telehealth in various forms–and widely criticized for practices including veteran patient wait lists for care, a lack of accountability, a scheduling system full of problems, an ancient EHR (VistA), and an inability to meet interoperability and modernization goals set over years. Telehealth is, in fact, one of VA’s bright spots with store-and-forward imaging, clinical video telemedicine and home telehealth.

At the American Telemedicine Association ATA 2016 meeting Monday, Under Secretary for Health and VA Chief Executive Dr. David Shulkin noted that the crisis has pushed VA into other options for achieving the goals set for the end of year: every VA medical center provides same day primary care services and same day mental health services. One area of focus is telemental health. Dr Shulkin announced in his plenary speech the opening of five new Mental Health Telehealth Clinical Resource Centers this summer, located in Charleston, Salt Lake City, Pittsburgh, and a consortium of facilities in Boise, Seattle, and Portland, Oregon. West Haven, Connecticut is already open as a specialty hub focused on the most severe and complex mental health issues, such as chronic depression and bipolar disorder. Other VA telemedicine initiatives include kiosks and text messaging to help with medication adherence and chronic condition management. (We’ve reported on their partnering with nhssimple to develop ANNIE, a sister of NHS’ Flo in text messaging to encourage patients in their health monitoring, TTA 2 Dec 15.)

VA delivered 2.1 million episodes of telehealth care last year (FY 2015), in 45 specialty areas of care, including 400,000 telemental health visits. They also reduced bed days by 56 percent, reduced readmissions by 32 percent, and decreased total psychiatric admissions by 35 percent, maintaining high user satisfaction scores at 89 percent.

Dr Shulkin also noted that four generations of veterans are served by VA–WWII, Korea, Vietnam and Desert Shield through current Iraq/Afghanistan–and all four have different delivery requirements. He closed with what is, for VA which has been very proud of their ‘home grown’ solutions from the time of Dr Adam Darkins in the early 2000s on, something unusual: “We’re looking to learn, we’re looking to work with all of you who are innovating to help take better care of veterans.” (Next on tap: the award of the next five-year round of home telehealth providers, which is presently down to two Grizzled Pioneers, Medtronic (Cardiocom) and Viterion.) MobihealthnewsVA press release

Veterans Affairs boosts telehealth, HIT in proposed 2016/2017 budgets

The US Department of Veterans Affairs (VA), in its proposed 2016 budget released earlier this week, is increasing support for telehealth/mHealth along with programs that use these services–rural health and mental health. Telehealth’s VA budget from FY 2014 increased from $986 million to just below $1.1 billion in the current year. In FY 2016 (beginning 1 Oct), the VA is allocating $1.22 billion of a $56 billion budget, and in 2017 advance appropriations, $1.37 billion–a year-to-year increase of 11 percent and 12 percent respectively .

VA has the largest telehealth program in the US, divided into three main functional areas: (more…)

VA reduced bed days by 59%, hospital admissions by 35% in 2013

Not all is gloom ‘n’ doom at the US Department of Veterans Affairs (VA), rightly excoriated for cooking the books on wait times for admissions, allowing an estimated 40 veterans to die waiting for care at the epicenter of the coverup, a Phoenix VA hospital, its secretary resigning. A consistent bright spot has been its use of telehealth and telemedicine, along with the Department of Defense (DOD), making them the largest US telehealth contractors. Neurosurgeon Adam Darkins, MD, who is their chief consultant for telehealth services, kept a speaking date at Tuesday’s Government Health IT Conference in Washington, DC to present encouraging results.

  • The VA’s FY2013 telehealth program totaled 608,900 patients and 1.8 million telehealth episodes of care. 45 percent of the patient population live in rural areas, receiving care from 151 VA Medical Centers (VAMC) and over 705 Community Based Outpatient Clinics (CBOCs)
  • 2009 to 2012 data show showed a 4 percent cost reduction after a year in a telehealth program, versus a one-year spike of 48 percent in costs for those veterans outside telehealth
  • Cost savings are estimated at just under $2,000 per year per patient
  • Over 41,000 patients were enabled to live independently in their homes using telehealth
  • VA also leads in telemental health, with its National Center providing 2,893 video consults to 1,033 patients at 53 sites in 24 states
  • The program is expanding at a rate of 22 percent per year

VA’s telehealth covers six areas: clinical video telehealth, home telehealth, (more…)

Telemedicine in the TIME Swampland

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/08/blue-blazes.jpg” thumb_width=”175″ /]TIME’s ‘Swampland’ section may be referring to the original siting of Washington, DC on reclaimed swamp land off the Potomac River, but this swampy article ultimately struggles to solid land. You will have to meander through the UVA Center for Telehealth, the Center for Connected Health Policy, WellPoint, the Institute for e-Health Policy and of course Partners Healthcare’s cardiac program [TTA 27 Aug] before addressing the real problem: the desirability of broader telemedicine reimbursement and a consistent policy in US Federal programs such as Medicare and Federally-subsidized Medicaid administered through the states. Currently Medicare reimbursement is restricted to specific rural areas, Native American territories/Indian Health Service, and of course the often-mentioned mess of cross-state physician licensing. However, the Accountable Care Act is not going to be the savior as its implementation is hardly going smoothly. Earlier CMS policies on 30-day same cause readmissions have had far more impact. There is the to-be-expected muddling of telemedicine (virtual consults) and telehealth (monitoring)–and robotics gets a ‘say wot?’ mention. The kicker is the headline and accompanying picture:

“Saving U.S. Health Care With Skype”

Skype, while used in ‘telemental health’ [TTA 11 May], is not HIPAA-compliant for patient privacy.  Were TIME’s famed fact-checkers asleep? 

Hat tip (and thanks) to reader Bob Pyke.