US telehealth controlled substances prescribing waiver may expire at year’s end; DEA may further restrict

Current waivers end 31 December without DEA, Congressional action. The Drug Enforcement Administration (DEA) apparently through inaction, will allow the current virtual prescribing flexibilities impacting Schedule II and higher drugs to expire at the end of year. These waivers which removed the in-person examination requirement under the Ryan-Haight Act were instituted during the Covid pandemic and extended twice [TTA 11 Oct 23, 11 May 23] with a final expiration of 31 December 2024.

Reportedly, the DEA is not only wishing to reinstate the status quo ante, but also reportedly wants to institute additional restrictions. However, any draft rule that would reimpose or changes restrictions has not been put out for the public comment period, review, and final rule implementation which typically takes anywhere from 60 to 120 days, well past year’s end. Last year, when a draft rule was released for comment, nearly 40,000 comments were received.

At the time of the 2023 extension that kicked this particular can down the road into the end of a presidential election year, DEA had stated that they would use 2024 to finalize telemedicine prescribing rules, but no action has been taken. Since then, the Department of Justice has filed multiple charges of Medicare and Medicaid fraud and illegal distribution of controlled substances against seven Done Global employees [TTA 3 July and prior], with investigations pending on practices by provider Cerebral and pharmacy Truepill

Under the aegis of the American Telemedicine Association (ATA), a coalition of 330+ organizations have again written as of Tuesday 10 September to the current administration and both houses of Congress to 1) extend the waivers for two years, as part of the end of the Federal fiscal year (starting 1 Oct) package, and 2) use the time for DEA to “to fulfill its congressional mandate to establish a special registration pathway that balances access to medically necessary care with appropriate enforcement.” The rationale centers on the lack of time, but strongly around the availability of psychiatrists throughout most of the US–there are none in half of US counties especially in rural areas. (The average MD psychiatrist is well over 50, nearing retirement, and not well reimbursed for his or her time–which is why med school grads in heavy debt don’t gravitate to the specialty.) What is not stated is that many if not most telepsychiatry providers do not have models that will support in-person evaluations as required without waivers.

There are no public actions or responses either by Congress or by the DEA as of today (13 September).

ATA press release, Biden Administration letter, House letter, Senate Leadership letter, Healthcare Dive

ATA Action, ATA’s trade organization and advocacy arm, has also formed a political action committee (PAC), ATA Action PAC. Its stated purpose is to support incumbent Federal candidates including Congressmembers who support their goals in virtual care policy. Candidates on the Federal or state levels will not receive support.  Release

Short takes: follow up on Cano Health’s survival moves, eMed transitioning Babylon Health UK but Babyl Rwanda shuts, DEA extends telehealth prescribing for controlled substances thru 2024

Cano Health takes the reverse stock split option to stay solvent. In Cano’s latest telenovela episode, a familiar stratagem for companies to drive up a dangerously low share price is to reverse stock split, usually in a large ratio. Cano is facing delisting on the NYSE as its shares traded, as of 11 September, below the $1 minimum for 30 days. [TTA 29 Sept]  Shareholders are being asked to approve a 1 for 60 ratio with the board having the right to adjust it down to 1-for-5 and up to 1-for-100, for both Class A and B common stock. At the current share price of $0.21, a new share’s value would be $12.60. No meeting date has been set, though the press release bluntly states that 30% shareholder ITC Rumba, LLC and the 20% held by current and former members of management and the board intend to vote in favor of it, achieving the necessary simple majority. 1:60 does sound last-ditch, reminiscent of Babylon Health’s late 2022 moves in a 1 for 25 exchange, before attempting to go private–and we know how that turned out. Release

eMed transitioning Babylon Health services in the UK. A check on Babylon Health’s UK website provides FAQs for current users. It leads with promises to expand digital-first primary care services on this registration page for visits, and to develop a chronic care management service starting with medical weight management using Wegovy. The FAQs also state there will be no disruptions to GP at Hand. There is a rebranding (left/above) that sunsets the Babylon name but retains the stylized heart. 

Babyl Rwanda‘s separate website and the eMed pages for Babyl Rwanda are still up, but a local report from 24 September states that the company has ceased operations in Rwanda. As of August, the government was scrambling to find buyers and to maintain operations to 2.4 million Rwandans. “According to Julien Mahoro Niyingabira, the Rwanda Health Communication Centre (RHCC) Division Manager, the Ministry of Health is in discussions with Babyl Rwanda to ensure continuity of services despite the closure of Babylon Health.” How that will be possible without a buyer to pay employees and maintain the operation is debatable. The New Times (Rwanda)

As for the US, the Babylon Health US site also remains up and intact with a small disclaimer at the top that US services are no longer available and to contact your health plan. It is the same as on our last visit on 14 September. It is odd to see, after another month, that no one has disabled the US services or corporate pages such as Investors. This is possibly because the architecture for the US pages are off the UK site (the tab at top has the eMed logo) and nobody is in the US operation to take down the pages. The US operation, in Chapter 7 bankruptcy liquidation, is now in the tender hands of the US bankruptcy courts, where filings, documentation, and processes move slowly indeed with no further public news.

And when you can’t decide, extend. The Drug Enforcement Administration (DEA) and Health and Human Services (HHS) once again are extending Covid-time flexibilities for prescribing controlled substances through 2024.  After 38,000 comments on the proposed changes to rules after the last extension in May, DEA and HHS punted again on reimposing Ryan-Haight Act restrictions that would require in-person evaluations/visits prior to prescribing. This allows clinicians to prescribe Schedule II–V controlled medications via audio-video telemedicine encounters, including Schedule III–V narcotic controlled medications approved by the Food and Drug Administration (FDA) for maintenance and withdrawal management treatment of opioid use disorder. Final rules will be timed for Fall 2024. Another year’s breathing room for  6 Oct DEA announcement, Federal Register 10 October “Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications”, Healthcare Dive

Mid-week roundup: CVS-Oak Street closes, DEA extends controlled substance telehealth waiver, Bright Health selling CA MA plans, Talkspace, Teladoc turnarounds? (updated)

CVS closed its $10.6 billion deal for Oak Street Health, well before the anticipated end of 2023. It picks up 169 primary care offices in 21 states–and an unprofitable operation that clocked a loss last year of $510 million without much of a change till 2025. The quick closing was likely spurred by both the Department of Justice (DOJ) and the Federal Trade Commission (FTC) letting their antitrust challenge period expire at the end of March with nary a whimper. DOJ and FTC, the latter which has been remarkably ‘pixelated’ of late on privacy issues with GoodRx and Teladoc’s BetterHelp, evidently passed on ‘egg on the face’ and let the ovoid land squarely on Elizabeth Warren’s Senate desk. She had asked FTC to ‘carefully scrutinize’ the deal. Shareholders received a tidy $39 per share. OSH will remain a multi-payer practice and now-former CEO Mike Pykosz will lead the company under CVS’ new healthcare delivery arm. This follows on CVS’ closing of Signify Health [TTA 30 March].  CVS release, FierceHealthcare Our prior gimlety coverage of CVS/OSH: 16 Feb, 2 March, Unlike OSH, CVS had a strong Q1 with $2.1 billion in profit, slightly down from 2022’s $2.4 billion, and an 11% boost in revenue. FierceHealthcare

DEA in-person prescribing requirements on Schedule II and higher controlled substances postponed indefinitely. The proposed rule would have added back in-person requirements for telehealth prescribing of controlled substances after the official end of the Public Health Emergency and its in-person waivers on 11 May. On 25 April, the DEA filed a draft temporary rule with the Office of Management and Budget for the extension. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 requires that Schedule II medications and narcotics (including Adderall and Ritalin) require an in-person prescription, while Schedule III or higher medications, including buprenorphine, Ambien, Valium, Xanax and ketamine can be prescribed for 30 days via telehealth but would require an in-person visit before a refill. The DEA was deluged with 38,000 comments and advocacy pressure from ATA. The change has also thrown a wrench in the works of online mental health companies which prescribe many of these drugs. FierceHealthcare  Updated–The ATA has weighed in favorably about the DEA postponement. Kyle Zebley, executive director of ATA Action, stated in their release that “Our hope is that the DEA will use the time of an extension to be responsive to the concerns of telehealth advocates, patients, and the American people to create rules that ensure access to clinical care that is not inappropriately restricted.”

Bright Health put its California Medicare Advantage plans up for sale. The company, staring down at bankruptcy [TTA 7 Apr, 20 Apr] does not yet have a buyer for the MA plans. When they are sold, it will be Bright’s exit as a health insurer, as it has exited MA plans in Florida and exchange plans everywhere else–in a flurry of state investigations ranging from Tennessee to Texas. Bright plans to focus on its provider arm, NeueHealth. Healthcare Dive

Talkspace narrowed its loss, increased revenue. The telemental health provider narrowed its Q1 net loss to $8.8 million compared to 2022’s $18.3 million in Q4 2022 and $20.4 million in Q1. Revenue increased to $33.3 million versus last year’s Q1 of $30.2 million. Their source of business has shifted to B2B with a 71% increase, a sharp departure from their formerly dominant consumer segment which has declined 40%.  Their 2023 forecast revenue is $130-135 million. It is still facing a Nasdaq delisting as trading below $1.00 per share and a class action lawsuit on subscription renewals. Mobihealthnews

Teladoc also waxed positive, ‘beating the Street’ with Q1 revenue growth of 11% to $629 million. This was powered as expected by BetterHelp, Teladoc’s direct-to-consumer mental health business. Their revenue grew to $279 million, a 21% increase. Teladoc’s enterprise business also had a 5% boost to almost $350 million. Their weight loss business is expected to be another net positive income generator, but not affecting results until 2024 as it won’t be introduced until Q3 [TTA 21 April]. The road to profitability will be a long one, as losses this quarter were $69.2 million, but compared to last year’s $6.7 billion writedown of Livongo, it’s positively smooth. Healthcare Dive

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

West Virginia considers expanding prescription medication via telemedicine

The West Virginia legislature has been considering a new bill to expand the range of medications that may be prescribed in a telemedicine encounter. The bill was passed by the House of Representatives last week and sent to the Senate for consideration.

The House Bill 2509 proposes to amend the West Virginia Medical Practice Act to enable physicians to prescribe certain controlled substances when using telemedicine technologies. According to Mobihealthnews this would specifically include medication for mental and behavioral health, although bill itself does not refer to these conditions. A note at the end of the bill states “The purpose of this bill is to permit a physician to prescribe certain controlled substances when using telemedicine technologies.”

It seems that the legislation in the US dealing with telemedicine is fragmented and becoming more so. There was the issue of whether health insurance companies would cover telemedicine consultations, then the issue of medicare and medicaid covering the telemedicine consultations, then the state medical boards refusing cross border telemedicine and now issues on individual medications that can or can’t be prescribed. This will make it increasingly difficult for those practitioners who decide to enter the telemedicine arena.It is not a sustainable approach to pass a new law on every issue relating to telemedicine. Telemedicine is merely medicine practiced via a different route and regulation and standardisation of processes associated with telemedicine should be divested to a suitably established agency overseen by the legislature, similar to how the medical boards operate. In fact, this could easily be an additional responsibility given to the medical boards.